Despite their similar functions, each current and emerging therapy for treating hemophilia has a unique safety profile, and each needs to be weighed apart from agents both within and outside its pharmacologic class, a hemophilia specialist said.

“My view is that each new molecule coming to the hemophilia space, including variant factor molecules, needs to be scrutinized separately, without class assumptions or extrapolations, and it’s clear that thrombosis risk has become a priority safety consideration,” said Dan Hart, MBChB, MRCP, FRCPath, PhD, from Barts and the London School of Medicine and Dentistry.

He reviewed the comparative safety of standard and novel therapies for hemophilia at the annual congress of the European Association for Haemophilia and Allied Disorders.
 

Factor inhibitors

Inhibitors occur in both hemophilia A and hemophilia B, and are primarily seen in patients with childhood exposure to factor concentrates. Inhibitors, which include anti–factor VIII and factor IX alloantibodies, are more common among patients with severe hemophilia and those with more disruptive factor VIII and factor IX mutations.

“There can be transient vs. persistent inhibitors, and arguably the more you look, the more you find, but clinically we never miss high-titer inhibitors that have a big impact on individuals and the subsequent decisions about management,” he said.
 

Hamster vs. human

It’s currently unclear whether there is an immunologic advantage for previously untreated patients to be started on factor VIII concentrates derived from recombinant human cells lines, or from products derived from Chinese hamster ovary (CHO) or baby hamster kidney (BHK) cell lines, Dr. Hart said.

“We need to ensure that we’re not selective about comparator choice for new products in the absence of head-to-head studies,” he said.
 

Route of administration matters

Inhibitors appear to be a more common occurrence among patients who received factor concentrates subcutaneously, compared with intravenously, Dr. Hart noted, pointing to a 2011 study indicating a background annual risk of 5 cases of inhibitor development per 1,000 treatment years in previously treated patients who received intravenous therapy (Blood. 2011 Jun 9;117[23]:6367-70).

In contrast, in a phase 1 trial of subcutaneous turoctocog alfa pegol, 5 out of 26 patients had detectable N8-GP–binding antibodies after 42-91 exposure days. Of these patients, one developed an inhibitor to factor VIII, and anti–N8-GP antibody appearance was associated with a decline in factor VIII plasma activity in four of the five patients. In addition, five patients reported a total of nine bleeding episodes requiring treatment during prophylaxis. As a result of this trial, further clinical development of the subcutaneous version was suspended. (J Thromb Haemost. 2020 Feb;18[2]:341-51).

Other subcutaneously administered factors are currently in development, Dr. Hart noted.
 

Nonfactor inhibitors?

“The nonfactor agents do have the risk of generating antibodies: Monoclonal antibodies outside the hemophilia setting provoke antidrug antibodies,” he said.

Although there is no consensus regarding which assay can best monitor antidrug antibodies (ADA), enzyme-linked immunosorbent assay (ELISA) can detect neutralizing antibodies and other antibodies.

In the hemophilia setting, surrogate markers for loss of drug efficacy include longer activated partial thromboplastin time (ATTP) or a drop in serum drug levels. Worsening bleeding phenotype can also be a marker for loss of efficacy, albeit an imperfect one.

Emicizumab (Hemlibara), the first nonfactor monoclonal agent to make it to market, has the largest dataset available, and evidence suggests a rate of neutralizing antibodies with this agent of less than 1% in the HAVEN clinical trial series, but 5.2% in the single-arm STASEY trial.

“We shouldn’t assume that other biophenotypics will have a similar ADA rate, and this needs to be evaluated for each molecule, as it will need to be for other monoclonals” such as anti–tissue factor pathway (TFPI) antibodies, Dr. Hart emphasized.
 

Pegylation

Pegylated compounds include polyethylene glycol, an inert polymer, covalently bound to the therapeutic protein to extend its half-life, and theoretically, reduce immunogenicity.

Many patients may already have exposure to pegylated products in the form of peginterferon to treat hepatitis C, consumer products such as toothpaste, cough medicine, and cosmetics, and, more recently, in vaccines against COVID-19.

Safety considerations with pegylated agents in hemophilia include concerns about accumulation of polyethylene glycol (PEG), although “some of the preclinical models looking at excretion of PEG are difficult to interpret in my view, and people debate about whether studies are long enough, but it’s undoubtedly the case that toxicology dosing is order of magnitude higher than the routine dosing in hemophilia,” he said.

After more than 5 years of experience with pegylated products there is no clinical evidence of concern, although “it’s not clear, actually, what we’re looking for, whether it’s a clinical parameter, or imaging or histological parameter.”

Patients may also not have lifelong exposure to pegylated products, as it is unlikely that they will stay on the same product for decades, Dr. Hart said.
 

Thrombosis

As of June 30, 2020, more than 7,200 persons with hemophilia have received emicizumab, and there have been 23 reported thrombotic events, 19 of which occurred in the postmarketing period. Of the reported cases, six patients had a myocardial infarction, and all of these patients had at least one cardiovascular risk factor.

The antithrombin agent fitusiran was associated with one fatal thrombotic event in a phase 2, open-label extension trial, leading to a pause and resumption with mitigation protocols, but that trial has since been paused again because of additional, nonfatal thrombotic events.

Nonfatal thrombotic events have also occurred in clinical trials for the investigational anti-TFPI monoclonal antibodies BAY 1093884 and concizumab, but none have thus far been reported in phase 3 trial of marstacimab.

“We need renewed efforts for prospective reporting and independent review of all adverse events of all agents, old and new: This will need some guidance nationally and internationally, and I think the relevant trial [serious adverse events] need to be reported in peer review literature, and clinicaltrials.gov updated in a timely manner, regardless of whether that strategy was successful or unsuccessful,” Dr. Hart said.
 

Risk with longer-acting agents?

In the question and answer following his presentation, Christoph Königs, MD, PhD, from University Hospital Frankfurt, asked whether there was potential for increased thrombosis risk with second-generation extended half-life (EHL) molecules in clinical trials.

“As we edge towards normalization of hemostasis, clearly the other non–hemophilia dependent issues of thrombosis risk come into play,” Dr. Hart acknowledged. “I think it will be an inevitability that there will be events, and we need to understand what the denominators are – hence my pitch for there being a renewed effort to try and collate sufficient data that we can really define events happening with people treated with standard half-life [products] through into the novel agents,” he said.

Dr. Hart disclosed grant/research support and speaker bureau activities for Bayer, Octapharma, Takeda, and others. Dr. Königs has reported no relevant disclosures.

Despite their similar functions, each current and emerging therapy for treating hemophilia has a unique safety profile, and each needs to be weighed apart from agents both within and outside its pharmacologic class, a hemophilia specialist said.

“My view is that each new molecule coming to the hemophilia space, including variant factor molecules, needs to be scrutinized separately, without class assumptions or extrapolations, and it’s clear that thrombosis risk has become a priority safety consideration,” said Dan Hart, MBChB, MRCP, FRCPath, PhD, from Barts and the London School of Medicine and Dentistry.

He reviewed the comparative safety of standard and novel therapies for hemophilia at the annual congress of the European Association for Haemophilia and Allied Disorders.
 

Factor inhibitors

Inhibitors occur in both hemophilia A and hemophilia B, and are primarily seen in patients with childhood exposure to factor concentrates. Inhibitors, which include anti–factor VIII and factor IX alloantibodies, are more common among patients with severe hemophilia and those with more disruptive factor VIII and factor IX mutations.

“There can be transient vs. persistent inhibitors, and arguably the more you look, the more you find, but clinically we never miss high-titer inhibitors that have a big impact on individuals and the subsequent decisions about management,” he said.
 

Hamster vs. human

It’s currently unclear whether there is an immunologic advantage for previously untreated patients to be started on factor VIII concentrates derived from recombinant human cells lines, or from products derived from Chinese hamster ovary (CHO) or baby hamster kidney (BHK) cell lines, Dr. Hart said.

“We need to ensure that we’re not selective about comparator choice for new products in the absence of head-to-head studies,” he said.
 

Route of administration matters

Inhibitors appear to be a more common occurrence among patients who received factor concentrates subcutaneously, compared with intravenously, Dr. Hart noted, pointing to a 2011 study indicating a background annual risk of 5 cases of inhibitor development per 1,000 treatment years in previously treated patients who received intravenous therapy (Blood. 2011 Jun 9;117[23]:6367-70).

In contrast, in a phase 1 trial of subcutaneous turoctocog alfa pegol, 5 out of 26 patients had detectable N8-GP–binding antibodies after 42-91 exposure days. Of these patients, one developed an inhibitor to factor VIII, and anti–N8-GP antibody appearance was associated with a decline in factor VIII plasma activity in four of the five patients. In addition, five patients reported a total of nine bleeding episodes requiring treatment during prophylaxis. As a result of this trial, further clinical development of the subcutaneous version was suspended. (J Thromb Haemost. 2020 Feb;18[2]:341-51).

Other subcutaneously administered factors are currently in development, Dr. Hart noted.
 

Nonfactor inhibitors?

“The nonfactor agents do have the risk of generating antibodies: Monoclonal antibodies outside the hemophilia setting provoke antidrug antibodies,” he said.

Although there is no consensus regarding which assay can best monitor antidrug antibodies (ADA), enzyme-linked immunosorbent assay (ELISA) can detect neutralizing antibodies and other antibodies.

In the hemophilia setting, surrogate markers for loss of drug efficacy include longer activated partial thromboplastin time (ATTP) or a drop in serum drug levels. Worsening bleeding phenotype can also be a marker for loss of efficacy, albeit an imperfect one.

Emicizumab (Hemlibara), the first nonfactor monoclonal agent to make it to market, has the largest dataset available, and evidence suggests a rate of neutralizing antibodies with this agent of less than 1% in the HAVEN clinical trial series, but 5.2% in the single-arm STASEY trial.

“We shouldn’t assume that other biophenotypics will have a similar ADA rate, and this needs to be evaluated for each molecule, as it will need to be for other monoclonals” such as anti–tissue factor pathway (TFPI) antibodies, Dr. Hart emphasized.
 

Pegylation

Pegylated compounds include polyethylene glycol, an inert polymer, covalently bound to the therapeutic protein to extend its half-life, and theoretically, reduce immunogenicity.

Many patients may already have exposure to pegylated products in the form of peginterferon to treat hepatitis C, consumer products such as toothpaste, cough medicine, and cosmetics, and, more recently, in vaccines against COVID-19.

Safety considerations with pegylated agents in hemophilia include concerns about accumulation of polyethylene glycol (PEG), although “some of the preclinical models looking at excretion of PEG are difficult to interpret in my view, and people debate about whether studies are long enough, but it’s undoubtedly the case that toxicology dosing is order of magnitude higher than the routine dosing in hemophilia,” he said.

After more than 5 years of experience with pegylated products there is no clinical evidence of concern, although “it’s not clear, actually, what we’re looking for, whether it’s a clinical parameter, or imaging or histological parameter.”

Patients may also not have lifelong exposure to pegylated products, as it is unlikely that they will stay on the same product for decades, Dr. Hart said.
 

Thrombosis

As of June 30, 2020, more than 7,200 persons with hemophilia have received emicizumab, and there have been 23 reported thrombotic events, 19 of which occurred in the postmarketing period. Of the reported cases, six patients had a myocardial infarction, and all of these patients had at least one cardiovascular risk factor.

The antithrombin agent fitusiran was associated with one fatal thrombotic event in a phase 2, open-label extension trial, leading to a pause and resumption with mitigation protocols, but that trial has since been paused again because of additional, nonfatal thrombotic events.

Nonfatal thrombotic events have also occurred in clinical trials for the investigational anti-TFPI monoclonal antibodies BAY 1093884 and concizumab, but none have thus far been reported in phase 3 trial of marstacimab.

“We need renewed efforts for prospective reporting and independent review of all adverse events of all agents, old and new: This will need some guidance nationally and internationally, and I think the relevant trial [serious adverse events] need to be reported in peer review literature, and clinicaltrials.gov updated in a timely manner, regardless of whether that strategy was successful or unsuccessful,” Dr. Hart said.
 

Risk with longer-acting agents?

In the question and answer following his presentation, Christoph Königs, MD, PhD, from University Hospital Frankfurt, asked whether there was potential for increased thrombosis risk with second-generation extended half-life (EHL) molecules in clinical trials.

“As we edge towards normalization of hemostasis, clearly the other non–hemophilia dependent issues of thrombosis risk come into play,” Dr. Hart acknowledged. “I think it will be an inevitability that there will be events, and we need to understand what the denominators are – hence my pitch for there being a renewed effort to try and collate sufficient data that we can really define events happening with people treated with standard half-life [products] through into the novel agents,” he said.

Dr. Hart disclosed grant/research support and speaker bureau activities for Bayer, Octapharma, Takeda, and others. Dr. Königs has reported no relevant disclosures.

Despite their similar functions, each current and emerging therapy for treating hemophilia has a unique safety profile, and each needs to be weighed apart from agents both within and outside its pharmacologic class, a hemophilia specialist said.

“My view is that each new molecule coming to the hemophilia space, including variant factor molecules, needs to be scrutinized separately, without class assumptions or extrapolations, and it’s clear that thrombosis risk has become a priority safety consideration,” said Dan Hart, MBChB, MRCP, FRCPath, PhD, from Barts and the London School of Medicine and Dentistry.

He reviewed the comparative safety of standard and novel therapies for hemophilia at the annual congress of the European Association for Haemophilia and Allied Disorders.
 

Factor inhibitors

Inhibitors occur in both hemophilia A and hemophilia B, and are primarily seen in patients with childhood exposure to factor concentrates. Inhibitors, which include anti–factor VIII and factor IX alloantibodies, are more common among patients with severe hemophilia and those with more disruptive factor VIII and factor IX mutations.

“There can be transient vs. persistent inhibitors, and arguably the more you look, the more you find, but clinically we never miss high-titer inhibitors that have a big impact on individuals and the subsequent decisions about management,” he said.
 

Hamster vs. human

It’s currently unclear whether there is an immunologic advantage for previously untreated patients to be started on factor VIII concentrates derived from recombinant human cells lines, or from products derived from Chinese hamster ovary (CHO) or baby hamster kidney (BHK) cell lines, Dr. Hart said.

“We need to ensure that we’re not selective about comparator choice for new products in the absence of head-to-head studies,” he said.
 

Route of administration matters

Inhibitors appear to be a more common occurrence among patients who received factor concentrates subcutaneously, compared with intravenously, Dr. Hart noted, pointing to a 2011 study indicating a background annual risk of 5 cases of inhibitor development per 1,000 treatment years in previously treated patients who received intravenous therapy (Blood. 2011 Jun 9;117[23]:6367-70).

In contrast, in a phase 1 trial of subcutaneous turoctocog alfa pegol, 5 out of 26 patients had detectable N8-GP–binding antibodies after 42-91 exposure days. Of these patients, one developed an inhibitor to factor VIII, and anti–N8-GP antibody appearance was associated with a decline in factor VIII plasma activity in four of the five patients. In addition, five patients reported a total of nine bleeding episodes requiring treatment during prophylaxis. As a result of this trial, further clinical development of the subcutaneous version was suspended. (J Thromb Haemost. 2020 Feb;18[2]:341-51).

Other subcutaneously administered factors are currently in development, Dr. Hart noted.
 

Nonfactor inhibitors?

“The nonfactor agents do have the risk of generating antibodies: Monoclonal antibodies outside the hemophilia setting provoke antidrug antibodies,” he said.

Although there is no consensus regarding which assay can best monitor antidrug antibodies (ADA), enzyme-linked immunosorbent assay (ELISA) can detect neutralizing antibodies and other antibodies.

In the hemophilia setting, surrogate markers for loss of drug efficacy include longer activated partial thromboplastin time (ATTP) or a drop in serum drug levels. Worsening bleeding phenotype can also be a marker for loss of efficacy, albeit an imperfect one.

Emicizumab (Hemlibara), the first nonfactor monoclonal agent to make it to market, has the largest dataset available, and evidence suggests a rate of neutralizing antibodies with this agent of less than 1% in the HAVEN clinical trial series, but 5.2% in the single-arm STASEY trial.

“We shouldn’t assume that other biophenotypics will have a similar ADA rate, and this needs to be evaluated for each molecule, as it will need to be for other monoclonals” such as anti–tissue factor pathway (TFPI) antibodies, Dr. Hart emphasized.
 

Pegylation

Pegylated compounds include polyethylene glycol, an inert polymer, covalently bound to the therapeutic protein to extend its half-life, and theoretically, reduce immunogenicity.

Many patients may already have exposure to pegylated products in the form of peginterferon to treat hepatitis C, consumer products such as toothpaste, cough medicine, and cosmetics, and, more recently, in vaccines against COVID-19.

Safety considerations with pegylated agents in hemophilia include concerns about accumulation of polyethylene glycol (PEG), although “some of the preclinical models looking at excretion of PEG are difficult to interpret in my view, and people debate about whether studies are long enough, but it’s undoubtedly the case that toxicology dosing is order of magnitude higher than the routine dosing in hemophilia,” he said.

After more than 5 years of experience with pegylated products there is no clinical evidence of concern, although “it’s not clear, actually, what we’re looking for, whether it’s a clinical parameter, or imaging or histological parameter.”

Patients may also not have lifelong exposure to pegylated products, as it is unlikely that they will stay on the same product for decades, Dr. Hart said.
 

Thrombosis

As of June 30, 2020, more than 7,200 persons with hemophilia have received emicizumab, and there have been 23 reported thrombotic events, 19 of which occurred in the postmarketing period. Of the reported cases, six patients had a myocardial infarction, and all of these patients had at least one cardiovascular risk factor.

The antithrombin agent fitusiran was associated with one fatal thrombotic event in a phase 2, open-label extension trial, leading to a pause and resumption with mitigation protocols, but that trial has since been paused again because of additional, nonfatal thrombotic events.

Nonfatal thrombotic events have also occurred in clinical trials for the investigational anti-TFPI monoclonal antibodies BAY 1093884 and concizumab, but none have thus far been reported in phase 3 trial of marstacimab.

“We need renewed efforts for prospective reporting and independent review of all adverse events of all agents, old and new: This will need some guidance nationally and internationally, and I think the relevant trial [serious adverse events] need to be reported in peer review literature, and clinicaltrials.gov updated in a timely manner, regardless of whether that strategy was successful or unsuccessful,” Dr. Hart said.
 

Risk with longer-acting agents?

In the question and answer following his presentation, Christoph Königs, MD, PhD, from University Hospital Frankfurt, asked whether there was potential for increased thrombosis risk with second-generation extended half-life (EHL) molecules in clinical trials.

“As we edge towards normalization of hemostasis, clearly the other non–hemophilia dependent issues of thrombosis risk come into play,” Dr. Hart acknowledged. “I think it will be an inevitability that there will be events, and we need to understand what the denominators are – hence my pitch for there being a renewed effort to try and collate sufficient data that we can really define events happening with people treated with standard half-life [products] through into the novel agents,” he said.

Dr. Hart disclosed grant/research support and speaker bureau activities for Bayer, Octapharma, Takeda, and others. Dr. Königs has reported no relevant disclosures.

People with rheumatic diseases should get vaccinated against SARS-CoV-2 as soon as possible, the American College of Rheumatology (ACR) recommends.

Choreograph/iStock/Getty Images

“It may be that people with rheumatic diseases are at increased risk of developing COVID or serious COVID-related complications,” Jonathan Hausmann, MD, assistant professor of medicine at Harvard Medical School, Boston, said in an ACR podcast. “So the need to prevent COVID-19 is incredibly important in this group of patients.”

The guidelines recommend a delay in vaccination only in rare circumstances, such as for patients with very severe illness or who have recently been administered rituximab, Jeffrey R. Curtis, MD, MPH, lead author of the guidelines, said in the podcast.

“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” ACR President David Karp, MD, PhD, said in a press release.

So the ACR convened a panel of nine rheumatologists, two infectious disease specialists, and two public health experts. Over the course of 8 weeks, the task force reviewed the literature and agreed on recommendations. The organization posted a summary of the guidelines on its website after its board of directors approved it Feb. 8. The paper is pending journal peer review.
 

Some risks are real

The task force confined its research to the COVID-19 vaccines being offered by Pfizer and Moderna because they are currently the only ones approved by the Food and Drug Administration. It found no reason to distinguish between the two vaccines in its recommendations.

Because little research has directly addressed the question concerning COVID-19 vaccination for patients with rheumatic diseases, the task force extrapolated from data on other vaccinations in people with rheumatic disease and on the COVID-19 vaccinations in other populations.

It analyzed reports that other types of vaccination, such as for influenza, triggered flares of rheumatic conditions. “It is really individual case reports or small cohorts where there may be a somewhat higher incidence of flare, but it’s usually not very large in its magnitude nor duration,” said Dr. Curtis of the University of Alabama at Birmingham.

The task force also considered the possibility that vaccinations could lead to a new autoimmune disorder, such as Guillain-Barré syndrome or Bell palsy. The risk is real, the task force decided, but not significant enough to influence their recommendations.

Likewise, in immunocompromised people, vaccinations with live virus, such as those for shingles, might trigger the infection the vaccination is meant to prevent. But this can’t happen with the Pfizer and Moderna COVID-19 vaccines because they contain messenger RNA instead of live viruses, Dr. Curtis said.

Courtesy University of Alabama at Birmingham

How well does it work?

One unanswered question is whether the COVID-19 vaccines work as well for patients with rheumatic diseases. The task force was reassured by data showing efficacy across a range of subgroups, including some with immunosenescence, Dr. Curtis said. “But until we have data in rheumatology patients, we’re just not going to know,” he said.

The guidelines specify that some drug regimens be modified when patients are vaccinated.

For patients taking rituximab, vaccination should be delayed, but only for those who are able to maintain safe social distancing to reduce the risk for COVID-19 exposure, Dr. Curtis said. “If somebody has just gotten rituximab recently, it might be more ideal to complete the vaccine series about 2-4 weeks before the next rituximab dose,” he said. “So if you are giving that therapy, say, at 6-month intervals, if you could vaccinate them at around month 5 from the most recent rituximab cycle, that might be more ideal.”

The guidance calls for withholding JAK inhibitors for a week after each vaccine dose is administered.

It calls for holding SQ abatacept 1 week prior and 1 week after the first COVID-19 vaccine dose, with no interruption after the second dose.

For abatacept IV, clinicians should “time vaccine administration so that the first vaccination will occur 4 weeks after abatacept infusion (i.e., the entire dosing interval), and postpone the subsequent abatacept infusion by 1 week (i.e., a 5-week gap in total).” It recommends no medication adjustment for the second vaccine dose.

For cyclophosphamide, the guidance recommends timing administration to occur about a week after each vaccine dose, when feasible.

None of this advice should supersede clinical judgment, Dr. Curtis said.

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

People with rheumatic diseases should get vaccinated against SARS-CoV-2 as soon as possible, the American College of Rheumatology (ACR) recommends.

Choreograph/iStock/Getty Images

“It may be that people with rheumatic diseases are at increased risk of developing COVID or serious COVID-related complications,” Jonathan Hausmann, MD, assistant professor of medicine at Harvard Medical School, Boston, said in an ACR podcast. “So the need to prevent COVID-19 is incredibly important in this group of patients.”

The guidelines recommend a delay in vaccination only in rare circumstances, such as for patients with very severe illness or who have recently been administered rituximab, Jeffrey R. Curtis, MD, MPH, lead author of the guidelines, said in the podcast.

“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” ACR President David Karp, MD, PhD, said in a press release.

So the ACR convened a panel of nine rheumatologists, two infectious disease specialists, and two public health experts. Over the course of 8 weeks, the task force reviewed the literature and agreed on recommendations. The organization posted a summary of the guidelines on its website after its board of directors approved it Feb. 8. The paper is pending journal peer review.
 

Some risks are real

The task force confined its research to the COVID-19 vaccines being offered by Pfizer and Moderna because they are currently the only ones approved by the Food and Drug Administration. It found no reason to distinguish between the two vaccines in its recommendations.

Because little research has directly addressed the question concerning COVID-19 vaccination for patients with rheumatic diseases, the task force extrapolated from data on other vaccinations in people with rheumatic disease and on the COVID-19 vaccinations in other populations.

It analyzed reports that other types of vaccination, such as for influenza, triggered flares of rheumatic conditions. “It is really individual case reports or small cohorts where there may be a somewhat higher incidence of flare, but it’s usually not very large in its magnitude nor duration,” said Dr. Curtis of the University of Alabama at Birmingham.

The task force also considered the possibility that vaccinations could lead to a new autoimmune disorder, such as Guillain-Barré syndrome or Bell palsy. The risk is real, the task force decided, but not significant enough to influence their recommendations.

Likewise, in immunocompromised people, vaccinations with live virus, such as those for shingles, might trigger the infection the vaccination is meant to prevent. But this can’t happen with the Pfizer and Moderna COVID-19 vaccines because they contain messenger RNA instead of live viruses, Dr. Curtis said.

Courtesy University of Alabama at Birmingham

How well does it work?

One unanswered question is whether the COVID-19 vaccines work as well for patients with rheumatic diseases. The task force was reassured by data showing efficacy across a range of subgroups, including some with immunosenescence, Dr. Curtis said. “But until we have data in rheumatology patients, we’re just not going to know,” he said.

The guidelines specify that some drug regimens be modified when patients are vaccinated.

For patients taking rituximab, vaccination should be delayed, but only for those who are able to maintain safe social distancing to reduce the risk for COVID-19 exposure, Dr. Curtis said. “If somebody has just gotten rituximab recently, it might be more ideal to complete the vaccine series about 2-4 weeks before the next rituximab dose,” he said. “So if you are giving that therapy, say, at 6-month intervals, if you could vaccinate them at around month 5 from the most recent rituximab cycle, that might be more ideal.”

The guidance calls for withholding JAK inhibitors for a week after each vaccine dose is administered.

It calls for holding SQ abatacept 1 week prior and 1 week after the first COVID-19 vaccine dose, with no interruption after the second dose.

For abatacept IV, clinicians should “time vaccine administration so that the first vaccination will occur 4 weeks after abatacept infusion (i.e., the entire dosing interval), and postpone the subsequent abatacept infusion by 1 week (i.e., a 5-week gap in total).” It recommends no medication adjustment for the second vaccine dose.

For cyclophosphamide, the guidance recommends timing administration to occur about a week after each vaccine dose, when feasible.

None of this advice should supersede clinical judgment, Dr. Curtis said.

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

People with rheumatic diseases should get vaccinated against SARS-CoV-2 as soon as possible, the American College of Rheumatology (ACR) recommends.

Choreograph/iStock/Getty Images

“It may be that people with rheumatic diseases are at increased risk of developing COVID or serious COVID-related complications,” Jonathan Hausmann, MD, assistant professor of medicine at Harvard Medical School, Boston, said in an ACR podcast. “So the need to prevent COVID-19 is incredibly important in this group of patients.”

The guidelines recommend a delay in vaccination only in rare circumstances, such as for patients with very severe illness or who have recently been administered rituximab, Jeffrey R. Curtis, MD, MPH, lead author of the guidelines, said in the podcast.

“Our members have been inundated with questions and concerns from their patients on whether they should receive the vaccine,” ACR President David Karp, MD, PhD, said in a press release.

So the ACR convened a panel of nine rheumatologists, two infectious disease specialists, and two public health experts. Over the course of 8 weeks, the task force reviewed the literature and agreed on recommendations. The organization posted a summary of the guidelines on its website after its board of directors approved it Feb. 8. The paper is pending journal peer review.
 

Some risks are real

The task force confined its research to the COVID-19 vaccines being offered by Pfizer and Moderna because they are currently the only ones approved by the Food and Drug Administration. It found no reason to distinguish between the two vaccines in its recommendations.

Because little research has directly addressed the question concerning COVID-19 vaccination for patients with rheumatic diseases, the task force extrapolated from data on other vaccinations in people with rheumatic disease and on the COVID-19 vaccinations in other populations.

It analyzed reports that other types of vaccination, such as for influenza, triggered flares of rheumatic conditions. “It is really individual case reports or small cohorts where there may be a somewhat higher incidence of flare, but it’s usually not very large in its magnitude nor duration,” said Dr. Curtis of the University of Alabama at Birmingham.

The task force also considered the possibility that vaccinations could lead to a new autoimmune disorder, such as Guillain-Barré syndrome or Bell palsy. The risk is real, the task force decided, but not significant enough to influence their recommendations.

Likewise, in immunocompromised people, vaccinations with live virus, such as those for shingles, might trigger the infection the vaccination is meant to prevent. But this can’t happen with the Pfizer and Moderna COVID-19 vaccines because they contain messenger RNA instead of live viruses, Dr. Curtis said.

Courtesy University of Alabama at Birmingham

How well does it work?

One unanswered question is whether the COVID-19 vaccines work as well for patients with rheumatic diseases. The task force was reassured by data showing efficacy across a range of subgroups, including some with immunosenescence, Dr. Curtis said. “But until we have data in rheumatology patients, we’re just not going to know,” he said.

The guidelines specify that some drug regimens be modified when patients are vaccinated.

For patients taking rituximab, vaccination should be delayed, but only for those who are able to maintain safe social distancing to reduce the risk for COVID-19 exposure, Dr. Curtis said. “If somebody has just gotten rituximab recently, it might be more ideal to complete the vaccine series about 2-4 weeks before the next rituximab dose,” he said. “So if you are giving that therapy, say, at 6-month intervals, if you could vaccinate them at around month 5 from the most recent rituximab cycle, that might be more ideal.”

The guidance calls for withholding JAK inhibitors for a week after each vaccine dose is administered.

It calls for holding SQ abatacept 1 week prior and 1 week after the first COVID-19 vaccine dose, with no interruption after the second dose.

For abatacept IV, clinicians should “time vaccine administration so that the first vaccination will occur 4 weeks after abatacept infusion (i.e., the entire dosing interval), and postpone the subsequent abatacept infusion by 1 week (i.e., a 5-week gap in total).” It recommends no medication adjustment for the second vaccine dose.

For cyclophosphamide, the guidance recommends timing administration to occur about a week after each vaccine dose, when feasible.

None of this advice should supersede clinical judgment, Dr. Curtis said.

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

The COVID-19 pandemic, multiple national displays of racial and social injustice, and recent political strife have left many feeling uncertain, anxious, sad, angry, grief-stricken, and struggling to cope. Coping may be especially difficult for our clients already grappling with mental health concerns, and many are looking to mental health professionals to restore a sense of well-being.

Marija Jovovic/Getty Images

As professionals, we may be unsure about the best approach; after all, we haven’t experienced anything like this before! We’re facing many unknowns and unanswered questions, but one thing we do know is that we’re dealing with constant change. And, in fact, the only certainty is continued change and uncertainty. The truth of uncertainty can be challenging to contend with, especially when so much, including our country’s future, is in question. In times like this, there is likely no perfect treatment, but mindfulness can serve as a powerful intervention for coping with uncertainty and change, and for managing a range of difficult reactions.

The ‘what’ of mindfulness: Awareness, being in the now, and nonattachment

It’s crucial that we understand what mindfulness really is. It’s become something of a buzzword in American society, complete with misconceptions. Mindfulness has roots in many faith traditions, but as it’s practiced in the Western world, it usually has roots in Hinduism and Buddhism.

Mindfulness roughly means “awareness”; this is an approximate translation of the Pali (an ancient Indian language) word “Sati.” Mindfulness is moment-to-moment awareness and acceptance of our present experiences, thoughts, and feelings, without judgment or attachment. Attachment relates to the continually changing nature of all thoughts, feelings, and situations. Because everything is continuously changing, we needn’t become attached; attachment can keep us from being in the now. Acceptance means facing the now, which is essential when we feel tempted to avoid or deny painful feelings or situations. Acceptance doesn’t mean that we’ve resigned to being in pain forever; it merely means that we’re willing to see things as they actually are right now. This honest assessment of the present can prepare us for next steps.

Being in touch with the now helps us reconnect with ourselves, promote clarity about our situation and choices, and increases our awareness of our thoughts and feelings, moment to moment. It can also help us realize when we’ve fallen into unhelpful or catastrophic thinking, the risk of which is high during intense stress and uncertainty like what we’re facing now. Mindfulness helps us catch ourselves so we have the opportunity to make different choices, and feel better.
 

The how of mindfulness: Symptom management and changes in the brain

Research on mindfulness suggests that it can improve coping with anxiety,¹ regulate mood,² improve depression,³ reduce rumination,⁴ and mitigate trauma symptom severity.

Because mindfulness can effectively address psychiatric concerns, mindfulness-based clinical interventions such as mindfulness-based stress reduction and mindfulness-based cognitive therapy have been developed. These may reduce anxiety,⁵ depression, and posttraumatic stress disorder.⁶ Mindfulness can have a powerful impact on the brain; it’s been shown to improve the functioning of the regions associated with emotional regulation⁷ and change the regions related to awareness and fear.⁸ So, whether mindfulness is practiced in our clients’ everyday lives or used as the basis of therapeutic programs, it can promote well-being.
 

The how of mindfulness: In everyday life and treatment

How can we help our clients enjoy mindfulness’ benefits? I suggest that we start with ourselves. We’ll be more effective at guiding our clients in using mindfulness if we have our own experience.

And, mindfulness may help us to be more attentive to and effective in treatment. There is research demonstrating that treatment providers can benefit from mindfulness practices,⁹ and that clinicians who practice mindfulness report higher levels of empathy toward their clients.¹⁰ Because mindfulness is about attention and nonjudgmental and nonattached observation, it can be incorporated into many aspects of everyday life. Many options are available; we might encourage our clients to begin their day with a mindful pause, simply breathing and observing thoughts, feelings, sensations, or anything else that comes up. If they find themselves fixated on negative thinking or feelings, nonjudgmentally recognizing these experiences as temporary can help to prevent immersion and overwhelm. We can also encourage mindful pauses throughout the day, perhaps during tasks such as housekeeping, working, talking with others, exercising, and even eating.

It can be beneficial to practice mindfulness before, during, and after situations that our clients know may bring on increased stress, anxiety, negative mood, and other undesirable experiences, such as watching the news or using some forms of social media. For clients who want more structure or guidance, several mobile apps are available, such as InsightTimer, Ten Percent Happier, or for Black clients, Liberate, which may be especially helpful for the impacts of racial injustice. Apps may also help clients who want to establish a formal mindfulness meditation practice, which may decrease anxiety and depression in some clinical populations.¹¹ And, of course, with training, we can incorporate mindfulness into treatment. We may encourage clients to start our treatment or therapy sessions with a mindful pause to help them attain calm and focus, and depending on their concerns and needs, during times at which they feel particularly strong emotions. Clients may consider taking a Mindfulness-Based Stress Reduction course if something more intensive is needed, or clinicians may consider becoming trained in mindfulness-based cognitive therapy. Because recognition is increasing that mindfulness can address many clinical concerns, and because we’re contending with unprecedented challenges, mindfulness training for clinicians has become widely available.


 

Calm, clarity, and choices

None of us as individuals can eliminate the strife our country is living through, and none of us as clinicians can completely prevent or alleviate our clients’ pain. But by employing mindfulness, we can help clients cope with change and uncertainty, gain greater awareness of themselves and their experiences, feel calmer, attain more clarity to make better choices, and ultimately, feel better.

References

1. Bernstein A et al. J Cogn Psychother. 2011;25(2):99-113.

2. Remmers C et al. Mindfulness. 2016;7(4):829-37.

3. Rodrigues MF et al. Trends Psychiatry Psychother. Jul-Sep 2017;39(3):207-15.

4. Chambers R et al. Cogn Ther Res. 2008;32(3):303-22.

5. Montero-Marin et al. Psychol Med. 2019 Oct;49(13)2118-33.

6. Khusid MA, Vythilingam M. Mil Med. 2016 Sep;181(9):961-8.

7. Kral TRA et al. Neuroimage. 2018 Nov 1;181:301-13.

8. Desbordes G et al. Front Hum Neurosci. 2012 Nov 1. doi: 10.33891/fnhum.2012.00292.

9. Escuriex BF, Labbé EE. Mindfulness. 2011;2(4):242-53.

10. Aiken GA. Dissertation Abstracts Int Sec B: Sci Eng. 2006;67(4-B),2212.

11. Goyal M et al. JAMA Intern Med. 2014 Mar;174:357-68.

Dr. Collins is a Brooklyn-based licensed counseling psychologist, educator, and speaker. She is experienced in addressing a wide range of mental health concerns within youth, adult, and family populations. Her work has a strong social justice emphasis, and she is particularly skilled at working with clients of color. She has been a mindfulness practitioner for 10 years and is passionate about sharing the practice with others. Dr. Collins has no conflicts of interest.

The COVID-19 pandemic, multiple national displays of racial and social injustice, and recent political strife have left many feeling uncertain, anxious, sad, angry, grief-stricken, and struggling to cope. Coping may be especially difficult for our clients already grappling with mental health concerns, and many are looking to mental health professionals to restore a sense of well-being.

Marija Jovovic/Getty Images

As professionals, we may be unsure about the best approach; after all, we haven’t experienced anything like this before! We’re facing many unknowns and unanswered questions, but one thing we do know is that we’re dealing with constant change. And, in fact, the only certainty is continued change and uncertainty. The truth of uncertainty can be challenging to contend with, especially when so much, including our country’s future, is in question. In times like this, there is likely no perfect treatment, but mindfulness can serve as a powerful intervention for coping with uncertainty and change, and for managing a range of difficult reactions.

The ‘what’ of mindfulness: Awareness, being in the now, and nonattachment

It’s crucial that we understand what mindfulness really is. It’s become something of a buzzword in American society, complete with misconceptions. Mindfulness has roots in many faith traditions, but as it’s practiced in the Western world, it usually has roots in Hinduism and Buddhism.

Mindfulness roughly means “awareness”; this is an approximate translation of the Pali (an ancient Indian language) word “Sati.” Mindfulness is moment-to-moment awareness and acceptance of our present experiences, thoughts, and feelings, without judgment or attachment. Attachment relates to the continually changing nature of all thoughts, feelings, and situations. Because everything is continuously changing, we needn’t become attached; attachment can keep us from being in the now. Acceptance means facing the now, which is essential when we feel tempted to avoid or deny painful feelings or situations. Acceptance doesn’t mean that we’ve resigned to being in pain forever; it merely means that we’re willing to see things as they actually are right now. This honest assessment of the present can prepare us for next steps.

Being in touch with the now helps us reconnect with ourselves, promote clarity about our situation and choices, and increases our awareness of our thoughts and feelings, moment to moment. It can also help us realize when we’ve fallen into unhelpful or catastrophic thinking, the risk of which is high during intense stress and uncertainty like what we’re facing now. Mindfulness helps us catch ourselves so we have the opportunity to make different choices, and feel better.
 

The how of mindfulness: Symptom management and changes in the brain

Research on mindfulness suggests that it can improve coping with anxiety,¹ regulate mood,² improve depression,³ reduce rumination,⁴ and mitigate trauma symptom severity.

Because mindfulness can effectively address psychiatric concerns, mindfulness-based clinical interventions such as mindfulness-based stress reduction and mindfulness-based cognitive therapy have been developed. These may reduce anxiety,⁵ depression, and posttraumatic stress disorder.⁶ Mindfulness can have a powerful impact on the brain; it’s been shown to improve the functioning of the regions associated with emotional regulation⁷ and change the regions related to awareness and fear.⁸ So, whether mindfulness is practiced in our clients’ everyday lives or used as the basis of therapeutic programs, it can promote well-being.
 

The how of mindfulness: In everyday life and treatment

How can we help our clients enjoy mindfulness’ benefits? I suggest that we start with ourselves. We’ll be more effective at guiding our clients in using mindfulness if we have our own experience.

And, mindfulness may help us to be more attentive to and effective in treatment. There is research demonstrating that treatment providers can benefit from mindfulness practices,⁹ and that clinicians who practice mindfulness report higher levels of empathy toward their clients.¹⁰ Because mindfulness is about attention and nonjudgmental and nonattached observation, it can be incorporated into many aspects of everyday life. Many options are available; we might encourage our clients to begin their day with a mindful pause, simply breathing and observing thoughts, feelings, sensations, or anything else that comes up. If they find themselves fixated on negative thinking or feelings, nonjudgmentally recognizing these experiences as temporary can help to prevent immersion and overwhelm. We can also encourage mindful pauses throughout the day, perhaps during tasks such as housekeeping, working, talking with others, exercising, and even eating.

It can be beneficial to practice mindfulness before, during, and after situations that our clients know may bring on increased stress, anxiety, negative mood, and other undesirable experiences, such as watching the news or using some forms of social media. For clients who want more structure or guidance, several mobile apps are available, such as InsightTimer, Ten Percent Happier, or for Black clients, Liberate, which may be especially helpful for the impacts of racial injustice. Apps may also help clients who want to establish a formal mindfulness meditation practice, which may decrease anxiety and depression in some clinical populations.¹¹ And, of course, with training, we can incorporate mindfulness into treatment. We may encourage clients to start our treatment or therapy sessions with a mindful pause to help them attain calm and focus, and depending on their concerns and needs, during times at which they feel particularly strong emotions. Clients may consider taking a Mindfulness-Based Stress Reduction course if something more intensive is needed, or clinicians may consider becoming trained in mindfulness-based cognitive therapy. Because recognition is increasing that mindfulness can address many clinical concerns, and because we’re contending with unprecedented challenges, mindfulness training for clinicians has become widely available.


 

Calm, clarity, and choices

None of us as individuals can eliminate the strife our country is living through, and none of us as clinicians can completely prevent or alleviate our clients’ pain. But by employing mindfulness, we can help clients cope with change and uncertainty, gain greater awareness of themselves and their experiences, feel calmer, attain more clarity to make better choices, and ultimately, feel better.

References

1. Bernstein A et al. J Cogn Psychother. 2011;25(2):99-113.

2. Remmers C et al. Mindfulness. 2016;7(4):829-37.

3. Rodrigues MF et al. Trends Psychiatry Psychother. Jul-Sep 2017;39(3):207-15.

4. Chambers R et al. Cogn Ther Res. 2008;32(3):303-22.

5. Montero-Marin et al. Psychol Med. 2019 Oct;49(13)2118-33.

6. Khusid MA, Vythilingam M. Mil Med. 2016 Sep;181(9):961-8.

7. Kral TRA et al. Neuroimage. 2018 Nov 1;181:301-13.

8. Desbordes G et al. Front Hum Neurosci. 2012 Nov 1. doi: 10.33891/fnhum.2012.00292.

9. Escuriex BF, Labbé EE. Mindfulness. 2011;2(4):242-53.

10. Aiken GA. Dissertation Abstracts Int Sec B: Sci Eng. 2006;67(4-B),2212.

11. Goyal M et al. JAMA Intern Med. 2014 Mar;174:357-68.

Dr. Collins is a Brooklyn-based licensed counseling psychologist, educator, and speaker. She is experienced in addressing a wide range of mental health concerns within youth, adult, and family populations. Her work has a strong social justice emphasis, and she is particularly skilled at working with clients of color. She has been a mindfulness practitioner for 10 years and is passionate about sharing the practice with others. Dr. Collins has no conflicts of interest.

The COVID-19 pandemic, multiple national displays of racial and social injustice, and recent political strife have left many feeling uncertain, anxious, sad, angry, grief-stricken, and struggling to cope. Coping may be especially difficult for our clients already grappling with mental health concerns, and many are looking to mental health professionals to restore a sense of well-being.

Marija Jovovic/Getty Images

As professionals, we may be unsure about the best approach; after all, we haven’t experienced anything like this before! We’re facing many unknowns and unanswered questions, but one thing we do know is that we’re dealing with constant change. And, in fact, the only certainty is continued change and uncertainty. The truth of uncertainty can be challenging to contend with, especially when so much, including our country’s future, is in question. In times like this, there is likely no perfect treatment, but mindfulness can serve as a powerful intervention for coping with uncertainty and change, and for managing a range of difficult reactions.

The ‘what’ of mindfulness: Awareness, being in the now, and nonattachment

It’s crucial that we understand what mindfulness really is. It’s become something of a buzzword in American society, complete with misconceptions. Mindfulness has roots in many faith traditions, but as it’s practiced in the Western world, it usually has roots in Hinduism and Buddhism.

Mindfulness roughly means “awareness”; this is an approximate translation of the Pali (an ancient Indian language) word “Sati.” Mindfulness is moment-to-moment awareness and acceptance of our present experiences, thoughts, and feelings, without judgment or attachment. Attachment relates to the continually changing nature of all thoughts, feelings, and situations. Because everything is continuously changing, we needn’t become attached; attachment can keep us from being in the now. Acceptance means facing the now, which is essential when we feel tempted to avoid or deny painful feelings or situations. Acceptance doesn’t mean that we’ve resigned to being in pain forever; it merely means that we’re willing to see things as they actually are right now. This honest assessment of the present can prepare us for next steps.

Being in touch with the now helps us reconnect with ourselves, promote clarity about our situation and choices, and increases our awareness of our thoughts and feelings, moment to moment. It can also help us realize when we’ve fallen into unhelpful or catastrophic thinking, the risk of which is high during intense stress and uncertainty like what we’re facing now. Mindfulness helps us catch ourselves so we have the opportunity to make different choices, and feel better.
 

The how of mindfulness: Symptom management and changes in the brain

Research on mindfulness suggests that it can improve coping with anxiety,¹ regulate mood,² improve depression,³ reduce rumination,⁴ and mitigate trauma symptom severity.

Because mindfulness can effectively address psychiatric concerns, mindfulness-based clinical interventions such as mindfulness-based stress reduction and mindfulness-based cognitive therapy have been developed. These may reduce anxiety,⁵ depression, and posttraumatic stress disorder.⁶ Mindfulness can have a powerful impact on the brain; it’s been shown to improve the functioning of the regions associated with emotional regulation⁷ and change the regions related to awareness and fear.⁸ So, whether mindfulness is practiced in our clients’ everyday lives or used as the basis of therapeutic programs, it can promote well-being.
 

The how of mindfulness: In everyday life and treatment

How can we help our clients enjoy mindfulness’ benefits? I suggest that we start with ourselves. We’ll be more effective at guiding our clients in using mindfulness if we have our own experience.

And, mindfulness may help us to be more attentive to and effective in treatment. There is research demonstrating that treatment providers can benefit from mindfulness practices,⁹ and that clinicians who practice mindfulness report higher levels of empathy toward their clients.¹⁰ Because mindfulness is about attention and nonjudgmental and nonattached observation, it can be incorporated into many aspects of everyday life. Many options are available; we might encourage our clients to begin their day with a mindful pause, simply breathing and observing thoughts, feelings, sensations, or anything else that comes up. If they find themselves fixated on negative thinking or feelings, nonjudgmentally recognizing these experiences as temporary can help to prevent immersion and overwhelm. We can also encourage mindful pauses throughout the day, perhaps during tasks such as housekeeping, working, talking with others, exercising, and even eating.

It can be beneficial to practice mindfulness before, during, and after situations that our clients know may bring on increased stress, anxiety, negative mood, and other undesirable experiences, such as watching the news or using some forms of social media. For clients who want more structure or guidance, several mobile apps are available, such as InsightTimer, Ten Percent Happier, or for Black clients, Liberate, which may be especially helpful for the impacts of racial injustice. Apps may also help clients who want to establish a formal mindfulness meditation practice, which may decrease anxiety and depression in some clinical populations.¹¹ And, of course, with training, we can incorporate mindfulness into treatment. We may encourage clients to start our treatment or therapy sessions with a mindful pause to help them attain calm and focus, and depending on their concerns and needs, during times at which they feel particularly strong emotions. Clients may consider taking a Mindfulness-Based Stress Reduction course if something more intensive is needed, or clinicians may consider becoming trained in mindfulness-based cognitive therapy. Because recognition is increasing that mindfulness can address many clinical concerns, and because we’re contending with unprecedented challenges, mindfulness training for clinicians has become widely available.


 

Calm, clarity, and choices

None of us as individuals can eliminate the strife our country is living through, and none of us as clinicians can completely prevent or alleviate our clients’ pain. But by employing mindfulness, we can help clients cope with change and uncertainty, gain greater awareness of themselves and their experiences, feel calmer, attain more clarity to make better choices, and ultimately, feel better.

References

1. Bernstein A et al. J Cogn Psychother. 2011;25(2):99-113.

2. Remmers C et al. Mindfulness. 2016;7(4):829-37.

3. Rodrigues MF et al. Trends Psychiatry Psychother. Jul-Sep 2017;39(3):207-15.

4. Chambers R et al. Cogn Ther Res. 2008;32(3):303-22.

5. Montero-Marin et al. Psychol Med. 2019 Oct;49(13)2118-33.

6. Khusid MA, Vythilingam M. Mil Med. 2016 Sep;181(9):961-8.

7. Kral TRA et al. Neuroimage. 2018 Nov 1;181:301-13.

8. Desbordes G et al. Front Hum Neurosci. 2012 Nov 1. doi: 10.33891/fnhum.2012.00292.

9. Escuriex BF, Labbé EE. Mindfulness. 2011;2(4):242-53.

10. Aiken GA. Dissertation Abstracts Int Sec B: Sci Eng. 2006;67(4-B),2212.

11. Goyal M et al. JAMA Intern Med. 2014 Mar;174:357-68.

Dr. Collins is a Brooklyn-based licensed counseling psychologist, educator, and speaker. She is experienced in addressing a wide range of mental health concerns within youth, adult, and family populations. Her work has a strong social justice emphasis, and she is particularly skilled at working with clients of color. She has been a mindfulness practitioner for 10 years and is passionate about sharing the practice with others. Dr. Collins has no conflicts of interest.

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.¹ In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.²

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.³ Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.^4,5
 

^{What should we do with the results?}

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.¹ In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.²

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.³ Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.^4,5
 

^{What should we do with the results?}

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

If you have had the chance to watch any TV over the last 6 months, you have probably seen the commercials for home devices that allow patients to quickly check for atrial fibrillation in the comfort of their own home.

In an ad for one of these products, KardiaMobile, a cardiologist says this device “detects atrial fibrillation, one of the major causes of stroke.” You might also have heard that the Apple Watch has an opt-in feature that constantly screens for atrial fibrillation without any effort being made by the patient, or can check on-demand for AFib if a wearer experiences palpitations or an abnormal heart beat. Both of these devices generate a standard limb–lead ECG (essentially lead I) by connecting the device to both arms and producing a 30-second rhythm strip.

KardiaMobile recently introduced a newer device. When you place this device on a bare knee and touch one electrode with fingers from the right hand and another electrode with fingers from the left hand, the device produces a six-lead ECG. These small devices send an image of the ECG to a patient’s smartphone over Bluetooth, and the results can be easily read, printed out, or sent to the doctor for further analysis. Additionally, both of KardiaMobile’s devices utilize artificial intelligence to analyze a rhythm strip in real time and let the patient know if the ECG is normal, shows AFib, or is unable to be analyzed.

The electrocardiographic technology was formerly only available in a medical setting. It required an expensive machine and could only be interpreted by someone with expertise developed through years of training. Now it is readily available to patients in their homes. But how accurate is the technology and how are we going to use it?
 

How effective is KardiaMobile at detecting AFib?

Studies have looked at both KardiaMobile and the Apple Watch. One study of KardiaMobile in patients with Afib who were admitted for antiarrhythmic drug initiation showed that about a quarter of readings could not be classified because of artifact and other reasons. After exclusion of unclassified recordings, the KardiaMobile interpretation had 97% sensitivity and 94% specificity for AFib detection when compared with physician-interpreted ECGs.¹ In a large review of the device’s accuracy, there was about 85% sensitivity and specificity of the automated readings.²

How does the Apple Watch find AFib?

Like the KardiaMobile device, the Apple Watch can be used whenever patients notice symptoms or whenever they and their physicians decide the device would be useful. In addition, though, the Apple Watch has a function where the wearer can opt in to have the watch screen for AFib in the background whenever the watch is worn.

The watch monitors heart rate using photoplethysmography, where light-sensitive photodiodes detect blood pulses to assess heart rate variability. When an irregular heart rate is detected, the AW alerts the user of possible AFib. Once alerted, the wearer can then utilize a second function to obtain a single-lead ECG. Heart rate, rhythm, and a 30-second ECG tracing are saved in the Bluetooth-linked iPhone’s health app and can be exported for review by a physician.

In a study of over 400,000 participants, among participants notified of an irregular pulse through screening there was a positive predictive value of 84%.³ Single-lead EKGs initiated by watch wearers had a specificity for AFib of 99.6% among tracings with good wave forms, indicating very few false positives. Only 1 individual of the 263 individuals who had normal sinus rhythm on 12-lead ECG was classified as having AFib, though in 7% sinus rhythm could not be confirmed because of poor tracings.^4,5
 

^{What should we do with the results?}

It’s impressive that these devices deliver accurate information with very good specificity. Our hope is that detecting AFib with one of these devices will lead to an intervention being made that will decrease a patient’s risk of stroke. But it is not clear if routine screening in asymptomatic adults will accomplish this.

While more data is needed, we must acknowledge that our patients will soon be bringing us results from home. Regardless of what we think of this technology, we need to decide what to do when patients call us with results from these devices.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. William A et al. Heart Rhythm. 2018 Oct;15(10):1561-5.

2. KardiaMobile for the ambulatory detection of atrial fibrillation. NICE Medtech innovation briefing. 29 October 2020 Oct 29. www.nice.org.uk/guidance/mib232.

3. Perez MV et al. N Engl J Med. 2019; 381:1909-17.

4. Using Apple Watch for Arrhythmia Detection, December 2018. Apple. https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf. Accessed 2019 Apr 5.

5. De Novo Classification Request for ECG App. https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf. Accessed 2019 Apr 29.

More than 50% of health care workers infected with SARS-CoV-2 report that their sense of smell has not returned to normal an average of 5 months post infection, new research shows.

Nenad Cavoski/iStock/Getty Images Plus

The findings illustrate that olfactory problems are common not only during the acute COVID-19 phase but also “in the long run” and that these problems should be “taken into consideration” when following up these patients, study investigator Johannes Frasnelli, MD, professor, department of anatomy, Université du Québec à Trois-Rivières, said in an interview.

Loss of the sense of smell can affect quality of life because it affects eating and drinking, and may even be dangerous, said Dr. Frasnelli. “If your sense of smell is impaired, you may unknowingly eat spoiled food, or you may not smell smoke or gas in your home,” he said. In addition, Dr. Frasnelli noted that an impaired sense of smell is associated with higher rates of depression. The findings will be presented at the annual meeting of the American Academy of Neurology in April.

‘Striking’ finding

Research shows that about 60% of patients with COVID-19 lose their sense of smell to some degree during the acute phase of the disease. “But we wanted to go further and look at the longer-term effects of loss of smell and taste,” said Dr. Frasnelli.

The analysis included 813 health care workers in the province of Quebec. For all the patients, SARS-CoV-2 infection was confirmed through testing with a nasopharyngeal viral swab.

Participants completed a 64-item online questionnaire that asked about three senses: olfactory; gustatory, which includes tastes such as sweet, sour, bitter, salty, savory and umami; and trigeminal, which includes sensations such as spiciness of hot peppers and “coolness” of mint.

They were asked to rate these on a scale of 0 (no perception) to 10 (very strong perception) before the infection, during the infection, and currently. They were also asked about other symptoms, including fatigue.

Most respondents had been infected in the first wave of the virus in March and April of 2020 and responded to the questionnaire an average of 5 months later.

The vast majority of respondents (84.1%) were women, which Dr. Frasnelli said was not surprising because women predominate in the health care field.

The analysis showed that average smell ratings were 8.98 before infection, 2.85 during the acute phase, and 7.41 when respondents answered the questionnaire. The sense of taste was less affected and recovered faster than did the sense of smell. Results for taste were 9.20 before infection, 3.59 during the acute phase, and 8.05 after COVID-19.

Among 580 respondents who indicated a compromised sense of smell during the acute phase, the average smell rating when answering the questionnaire was 6.89, compared to 9.03 before the infection. More than half (51.2%) reported not regaining full olfactory function.

The fact that the sense of smell had not returned to normal for half the participants so long after being infected is “novel and quite striking,” said Dr. Frasnelli.

However, he noted, this doesn’t necessarily mean all those with a compromised sense of smell “have huge problems.” In some cases, he said, the problem “is more subtle.”
 

Not a CNS problem?

Respondents also completed a chemosensory dysfunction home test (CD-HT). They were asked to prepare common household food items, such as peanut butter, sugar, salt, and vinegar, in a particular way – for example, to add sugar or salt to water – and provide feedback on how they smell and taste.

For this CD-HT analysis, 18.4% of respondents reported having persistent loss of smell. This, Dr. Frasnelli said, adds to evidence from self-reported responses and suggests that in some cases, the problem is more than senses not returning to normal.

“From the questionnaires, roughly 50% said their sense of smell is still not back to normal, and when we look at the CD home test, we see that almost 20% of subjects indeed have pretty strong impairment of their sense of smell,” he said.

The results showed no sex differences, although Dr. Frasnelli noted that most of the sample were women. “It’s tricky to look at the data with regard to sex because it’s a bit skewed,” he said.

Male respondents were older than female participants, but there was no difference in impairment between age groups. Dr. Frasnelli said this was “quite interesting,” inasmuch as older people usually lose some sense of smell.

The researchers have not yet examined whether the results differ by type of health care worker.

They also have not examined in detail whether infection severity affects the risk for extended olfactory impairment. Although some research suggests that the problem with smell is more common in less severe cases, Dr. Frasnelli noted this could be because loss of smell is not a huge problem for patients battling grave health problems.

As for other symptoms, many respondents reported lingering fatigue; some reported debilitating fatigue, said Dr. Frasnelli. However, he cautioned that this is difficult to interpret, because the participants were health care workers, many of whom returned to work during the pandemic and perhaps had not fully rested.

He also noted that he and his colleagues have not “made the link” between impaired smell and the degree of fatigue.

The COVID-19 virus appears to attack supporting sustentacular cells in the olfactory epithelium, not nerve cells.

“Right now, it seems that the smell problem is not a central nervous system problem but a peripheral problem,” said Dr. Frasnelli. “But we don’t know for sure; it may be that the virus somehow gets into the brain and some symptoms are caused by the effects of the infection on the brain.”

The researchers will extend their research with another questionnaire to assess senses 10-12 months after COVID-19.

Limitations of the study include the subjective nature of the smell and taste ratings and the single time point at which data were collected.
 

Confirmatory findings

Commenting on the research in an interview, Thomas Hummel, MD, professor, smell and taste clinic, department of otorhinolaryngology, Technische Universität Dresden (Germany), said the new results regarding loss of smell after COVID-19 are “very congruent” with what he and his colleagues have observed.

Research shows that up to one in five of those infected with SARS-CoV-2 experience olfactory loss. “While the numbers may vary a bit from study to study or lab to lab, I think 5% to 20% of post–COVID-19 patients exhibit long-term olfactory loss,” Dr. Hummel said.

His group has observed that “many more are not back to normal,” which conforms with what Dr. Frasnelli’s study reveals, said Dr. Hummel.

Also commenting on the research, Kenneth L. Tyler, MD, professor of neurology, University of Colorado at Denver, Aurora, and a fellow of the American Academy of Neurology, said the study was relatively large and the results “interesting.”

Although it “provides more evidence there’s a subset of patients with symptoms even well past the acute phase” of COVID-19, the results are “mostly confirmatory” and include “nothing super surprising,” Dr. Tyler said in an interview.

However, the investigators did attempt to make the study “a little more quantitative” and “to confirm the self-reporting with their validated CD home test,” he said.

Dr. Tyler wondered how representative the sample was and whether the study drew more participants with impaired senses. “If I had a loss of smell or taste, maybe I would be more likely to respond to such a survey,” he said.

He also noted the difficulty of separating loss of smell from loss of taste.

“If you lose your sense of smell, things don’t taste right, so it can be confounding as to how to separate out those two,” he noted.
The study was supported by the Foundation of the Université du Québec à Trois-Rivières and the Province of Quebec. Dr. Frasnelli has received royalties from Styriabooks in Austria for a book on olfaction published in 2019 and has received honoraria for speaking engagements. Dr. Hummel and Dr. Tyler have disclosed no relevant financial relationships.

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

More than 50% of health care workers infected with SARS-CoV-2 report that their sense of smell has not returned to normal an average of 5 months post infection, new research shows.

Nenad Cavoski/iStock/Getty Images Plus

The findings illustrate that olfactory problems are common not only during the acute COVID-19 phase but also “in the long run” and that these problems should be “taken into consideration” when following up these patients, study investigator Johannes Frasnelli, MD, professor, department of anatomy, Université du Québec à Trois-Rivières, said in an interview.

Loss of the sense of smell can affect quality of life because it affects eating and drinking, and may even be dangerous, said Dr. Frasnelli. “If your sense of smell is impaired, you may unknowingly eat spoiled food, or you may not smell smoke or gas in your home,” he said. In addition, Dr. Frasnelli noted that an impaired sense of smell is associated with higher rates of depression. The findings will be presented at the annual meeting of the American Academy of Neurology in April.

‘Striking’ finding

Research shows that about 60% of patients with COVID-19 lose their sense of smell to some degree during the acute phase of the disease. “But we wanted to go further and look at the longer-term effects of loss of smell and taste,” said Dr. Frasnelli.

The analysis included 813 health care workers in the province of Quebec. For all the patients, SARS-CoV-2 infection was confirmed through testing with a nasopharyngeal viral swab.

Participants completed a 64-item online questionnaire that asked about three senses: olfactory; gustatory, which includes tastes such as sweet, sour, bitter, salty, savory and umami; and trigeminal, which includes sensations such as spiciness of hot peppers and “coolness” of mint.

They were asked to rate these on a scale of 0 (no perception) to 10 (very strong perception) before the infection, during the infection, and currently. They were also asked about other symptoms, including fatigue.

Most respondents had been infected in the first wave of the virus in March and April of 2020 and responded to the questionnaire an average of 5 months later.

The vast majority of respondents (84.1%) were women, which Dr. Frasnelli said was not surprising because women predominate in the health care field.

The analysis showed that average smell ratings were 8.98 before infection, 2.85 during the acute phase, and 7.41 when respondents answered the questionnaire. The sense of taste was less affected and recovered faster than did the sense of smell. Results for taste were 9.20 before infection, 3.59 during the acute phase, and 8.05 after COVID-19.

Among 580 respondents who indicated a compromised sense of smell during the acute phase, the average smell rating when answering the questionnaire was 6.89, compared to 9.03 before the infection. More than half (51.2%) reported not regaining full olfactory function.

The fact that the sense of smell had not returned to normal for half the participants so long after being infected is “novel and quite striking,” said Dr. Frasnelli.

However, he noted, this doesn’t necessarily mean all those with a compromised sense of smell “have huge problems.” In some cases, he said, the problem “is more subtle.”
 

Not a CNS problem?

Respondents also completed a chemosensory dysfunction home test (CD-HT). They were asked to prepare common household food items, such as peanut butter, sugar, salt, and vinegar, in a particular way – for example, to add sugar or salt to water – and provide feedback on how they smell and taste.

For this CD-HT analysis, 18.4% of respondents reported having persistent loss of smell. This, Dr. Frasnelli said, adds to evidence from self-reported responses and suggests that in some cases, the problem is more than senses not returning to normal.

“From the questionnaires, roughly 50% said their sense of smell is still not back to normal, and when we look at the CD home test, we see that almost 20% of subjects indeed have pretty strong impairment of their sense of smell,” he said.

The results showed no sex differences, although Dr. Frasnelli noted that most of the sample were women. “It’s tricky to look at the data with regard to sex because it’s a bit skewed,” he said.

Male respondents were older than female participants, but there was no difference in impairment between age groups. Dr. Frasnelli said this was “quite interesting,” inasmuch as older people usually lose some sense of smell.

The researchers have not yet examined whether the results differ by type of health care worker.

They also have not examined in detail whether infection severity affects the risk for extended olfactory impairment. Although some research suggests that the problem with smell is more common in less severe cases, Dr. Frasnelli noted this could be because loss of smell is not a huge problem for patients battling grave health problems.

As for other symptoms, many respondents reported lingering fatigue; some reported debilitating fatigue, said Dr. Frasnelli. However, he cautioned that this is difficult to interpret, because the participants were health care workers, many of whom returned to work during the pandemic and perhaps had not fully rested.

He also noted that he and his colleagues have not “made the link” between impaired smell and the degree of fatigue.

The COVID-19 virus appears to attack supporting sustentacular cells in the olfactory epithelium, not nerve cells.

“Right now, it seems that the smell problem is not a central nervous system problem but a peripheral problem,” said Dr. Frasnelli. “But we don’t know for sure; it may be that the virus somehow gets into the brain and some symptoms are caused by the effects of the infection on the brain.”

The researchers will extend their research with another questionnaire to assess senses 10-12 months after COVID-19.

Limitations of the study include the subjective nature of the smell and taste ratings and the single time point at which data were collected.
 

Confirmatory findings

Commenting on the research in an interview, Thomas Hummel, MD, professor, smell and taste clinic, department of otorhinolaryngology, Technische Universität Dresden (Germany), said the new results regarding loss of smell after COVID-19 are “very congruent” with what he and his colleagues have observed.

Research shows that up to one in five of those infected with SARS-CoV-2 experience olfactory loss. “While the numbers may vary a bit from study to study or lab to lab, I think 5% to 20% of post–COVID-19 patients exhibit long-term olfactory loss,” Dr. Hummel said.

His group has observed that “many more are not back to normal,” which conforms with what Dr. Frasnelli’s study reveals, said Dr. Hummel.

Also commenting on the research, Kenneth L. Tyler, MD, professor of neurology, University of Colorado at Denver, Aurora, and a fellow of the American Academy of Neurology, said the study was relatively large and the results “interesting.”

Although it “provides more evidence there’s a subset of patients with symptoms even well past the acute phase” of COVID-19, the results are “mostly confirmatory” and include “nothing super surprising,” Dr. Tyler said in an interview.

However, the investigators did attempt to make the study “a little more quantitative” and “to confirm the self-reporting with their validated CD home test,” he said.

Dr. Tyler wondered how representative the sample was and whether the study drew more participants with impaired senses. “If I had a loss of smell or taste, maybe I would be more likely to respond to such a survey,” he said.

He also noted the difficulty of separating loss of smell from loss of taste.

“If you lose your sense of smell, things don’t taste right, so it can be confounding as to how to separate out those two,” he noted.
The study was supported by the Foundation of the Université du Québec à Trois-Rivières and the Province of Quebec. Dr. Frasnelli has received royalties from Styriabooks in Austria for a book on olfaction published in 2019 and has received honoraria for speaking engagements. Dr. Hummel and Dr. Tyler have disclosed no relevant financial relationships.

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

More than 50% of health care workers infected with SARS-CoV-2 report that their sense of smell has not returned to normal an average of 5 months post infection, new research shows.

Nenad Cavoski/iStock/Getty Images Plus

The findings illustrate that olfactory problems are common not only during the acute COVID-19 phase but also “in the long run” and that these problems should be “taken into consideration” when following up these patients, study investigator Johannes Frasnelli, MD, professor, department of anatomy, Université du Québec à Trois-Rivières, said in an interview.

Loss of the sense of smell can affect quality of life because it affects eating and drinking, and may even be dangerous, said Dr. Frasnelli. “If your sense of smell is impaired, you may unknowingly eat spoiled food, or you may not smell smoke or gas in your home,” he said. In addition, Dr. Frasnelli noted that an impaired sense of smell is associated with higher rates of depression. The findings will be presented at the annual meeting of the American Academy of Neurology in April.

‘Striking’ finding

Research shows that about 60% of patients with COVID-19 lose their sense of smell to some degree during the acute phase of the disease. “But we wanted to go further and look at the longer-term effects of loss of smell and taste,” said Dr. Frasnelli.

The analysis included 813 health care workers in the province of Quebec. For all the patients, SARS-CoV-2 infection was confirmed through testing with a nasopharyngeal viral swab.

Participants completed a 64-item online questionnaire that asked about three senses: olfactory; gustatory, which includes tastes such as sweet, sour, bitter, salty, savory and umami; and trigeminal, which includes sensations such as spiciness of hot peppers and “coolness” of mint.

They were asked to rate these on a scale of 0 (no perception) to 10 (very strong perception) before the infection, during the infection, and currently. They were also asked about other symptoms, including fatigue.

Most respondents had been infected in the first wave of the virus in March and April of 2020 and responded to the questionnaire an average of 5 months later.

The vast majority of respondents (84.1%) were women, which Dr. Frasnelli said was not surprising because women predominate in the health care field.

The analysis showed that average smell ratings were 8.98 before infection, 2.85 during the acute phase, and 7.41 when respondents answered the questionnaire. The sense of taste was less affected and recovered faster than did the sense of smell. Results for taste were 9.20 before infection, 3.59 during the acute phase, and 8.05 after COVID-19.

Among 580 respondents who indicated a compromised sense of smell during the acute phase, the average smell rating when answering the questionnaire was 6.89, compared to 9.03 before the infection. More than half (51.2%) reported not regaining full olfactory function.

The fact that the sense of smell had not returned to normal for half the participants so long after being infected is “novel and quite striking,” said Dr. Frasnelli.

However, he noted, this doesn’t necessarily mean all those with a compromised sense of smell “have huge problems.” In some cases, he said, the problem “is more subtle.”
 

Not a CNS problem?

Respondents also completed a chemosensory dysfunction home test (CD-HT). They were asked to prepare common household food items, such as peanut butter, sugar, salt, and vinegar, in a particular way – for example, to add sugar or salt to water – and provide feedback on how they smell and taste.

For this CD-HT analysis, 18.4% of respondents reported having persistent loss of smell. This, Dr. Frasnelli said, adds to evidence from self-reported responses and suggests that in some cases, the problem is more than senses not returning to normal.

“From the questionnaires, roughly 50% said their sense of smell is still not back to normal, and when we look at the CD home test, we see that almost 20% of subjects indeed have pretty strong impairment of their sense of smell,” he said.

The results showed no sex differences, although Dr. Frasnelli noted that most of the sample were women. “It’s tricky to look at the data with regard to sex because it’s a bit skewed,” he said.

Male respondents were older than female participants, but there was no difference in impairment between age groups. Dr. Frasnelli said this was “quite interesting,” inasmuch as older people usually lose some sense of smell.

The researchers have not yet examined whether the results differ by type of health care worker.

They also have not examined in detail whether infection severity affects the risk for extended olfactory impairment. Although some research suggests that the problem with smell is more common in less severe cases, Dr. Frasnelli noted this could be because loss of smell is not a huge problem for patients battling grave health problems.

As for other symptoms, many respondents reported lingering fatigue; some reported debilitating fatigue, said Dr. Frasnelli. However, he cautioned that this is difficult to interpret, because the participants were health care workers, many of whom returned to work during the pandemic and perhaps had not fully rested.

He also noted that he and his colleagues have not “made the link” between impaired smell and the degree of fatigue.

The COVID-19 virus appears to attack supporting sustentacular cells in the olfactory epithelium, not nerve cells.

“Right now, it seems that the smell problem is not a central nervous system problem but a peripheral problem,” said Dr. Frasnelli. “But we don’t know for sure; it may be that the virus somehow gets into the brain and some symptoms are caused by the effects of the infection on the brain.”

The researchers will extend their research with another questionnaire to assess senses 10-12 months after COVID-19.

Limitations of the study include the subjective nature of the smell and taste ratings and the single time point at which data were collected.
 

Confirmatory findings

Commenting on the research in an interview, Thomas Hummel, MD, professor, smell and taste clinic, department of otorhinolaryngology, Technische Universität Dresden (Germany), said the new results regarding loss of smell after COVID-19 are “very congruent” with what he and his colleagues have observed.

Research shows that up to one in five of those infected with SARS-CoV-2 experience olfactory loss. “While the numbers may vary a bit from study to study or lab to lab, I think 5% to 20% of post–COVID-19 patients exhibit long-term olfactory loss,” Dr. Hummel said.

His group has observed that “many more are not back to normal,” which conforms with what Dr. Frasnelli’s study reveals, said Dr. Hummel.

Also commenting on the research, Kenneth L. Tyler, MD, professor of neurology, University of Colorado at Denver, Aurora, and a fellow of the American Academy of Neurology, said the study was relatively large and the results “interesting.”

Although it “provides more evidence there’s a subset of patients with symptoms even well past the acute phase” of COVID-19, the results are “mostly confirmatory” and include “nothing super surprising,” Dr. Tyler said in an interview.

However, the investigators did attempt to make the study “a little more quantitative” and “to confirm the self-reporting with their validated CD home test,” he said.

Dr. Tyler wondered how representative the sample was and whether the study drew more participants with impaired senses. “If I had a loss of smell or taste, maybe I would be more likely to respond to such a survey,” he said.

He also noted the difficulty of separating loss of smell from loss of taste.

“If you lose your sense of smell, things don’t taste right, so it can be confounding as to how to separate out those two,” he noted.
The study was supported by the Foundation of the Université du Québec à Trois-Rivières and the Province of Quebec. Dr. Frasnelli has received royalties from Styriabooks in Austria for a book on olfaction published in 2019 and has received honoraria for speaking engagements. Dr. Hummel and Dr. Tyler have disclosed no relevant financial relationships.

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

In recent decades, natural products have had increased consumer attention in industrialized nations. One of the challenges is that “natural” can be more of a perception than a standard. “Herbal products” is a more frequently used and perhaps a more apt term. Herbal products come in many forms, including herbs used in food preparation, teas, infusions, caplets, dried extracts, essential oils, and tinctures.

Multiple prescription medications have pharmacologically active compounds that originated from herbal products, both historically and currently. Examples include the cardiac stimulant digoxin (foxglove plant), the antimalarial quinine (Cinchona bark), and antihypertensives (Rauwolfia serpentina). Indeed, the first pharmacologically active compound, morphine, was extracted from the seed pods of opium poppies approximately 200 years ago. This demonstrated that medications could be purified from plants and that a precise dose could be determined for administration. However, herbal products are grown and harvested in varying seasonal conditions and soil types, which, over time and geography, may contribute to variability in the levels of active compound in the final products.

The importance of active compound purification and consistent precise dosage in herbal products brings up the topic of regulation. Herbal products are considered dietary supplements and as such are Food and Drug Administration regulated as a food under the 1994 Dietary Supplement Health Education Act. Regulation as a food product does not involve the same level of scrutiny as a medication. There is no requirement that manufacturers check for purity and consistency of their product’s active compound(s). Manufacturers must ensure that the claims they make about herbal products are not false or misleading. They must also support their claims with evidence. However, there is no requirement for the manufacturers to submit this evidence to the FDA. This can translate into a discrepancy between the claim on the product label and scientific evidence that the product does what it claims to do. In other words, the product may not be effective.

With uncertain efficacy, the safety of herbal products comes into focus. Very few herbal products (or their specific active compounds) have been scientifically studied for safety in pregnancy and lactation. Further, herbal products may contain contaminants. Metals such as lead and mercury occur naturally. Yet, because of human activities, both may have collected in areas where herbal products are grown. From a safety perspective, both can be concerning in pregnancy or lactation. Lead and mercury are two examples of metal contaminants. Other contaminants may include pesticides, chemicals, and bacteria or other microorganisms. Some liquid herbal products such as tinctures contain alcohol, which should be avoided in pregnancy. An additional consideration would be the potential for herbal products, including any of their known or unknown product contents, to interact with prescribed medications or anesthesia.
 

Select examples of herbal products

Astragalus is the root of an herb and it is used for reasons of boosting immunity, energy, and other functions. These and its purported promotion of breast milk flow (galactagogue) are unsupported. Safety concerns include irregular heartbeat and dizziness, rendering it unsafe for use in pregnancy and of unknown efficacy and safety in lactation.

Kombucha is an herbal product made from leaves (tea), sugar, a culture, and other varying products. Like many herbal products, it is both manufactured and home brewed. It is used for probiotic and antioxidant reasons. As a fermented product, kombucha may contain 0.2%-0.5% alcohol. There is no known safe level of alcohol and no known safe type of alcohol for use in pregnancy. Alcohol exposure in pregnancy can result in fetal alcohol spectrum disorders, involving a range of birth defects and life-long intellectual, learning and behavioral disorders. Alcohol found in breast milk approximates the level of alcohol found in the maternal bloodstream. Alcohol-containing products should be avoided in pregnancy and lactation.

Nux vomica is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. It comes from the raw seeds (toxic) of an evergreen tree. It has serious safety concerns and yet it is still in use. It contains strychnine, which can harm both the pregnant individual and the developing fetus. It is not recommended in lactation.

Red raspberry leaf is a leaf, brewed and ingested as a tea. It is used for reasons of preventing miscarriage, relieving nausea and stomach discomfort, toning the uterus, reducing labor pain, increasing breast milk production, and other functions. In low doses, it appears to be safe. In high doses, it can induce smooth muscle relaxation. Efficacy has not been demonstrated with labor and delivery or in increasing breast milk production.

Tabacum is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. Its full name is Nicotiana tabacum (tobacco) and it contains 2%-8% nicotine, which should be avoided in pregnancy. Nicotine is a health danger for the pregnant individual and can damage a developing fetus’ brain and lungs.

Unless otherwise scientifically demonstrated, herbal products should be considered medications with pharmacologic activity, potential adverse effects, and potential toxicity in pregnancy and lactation. It’s easy for a patient to forget about reporting any nonprescription medications during a patient-provider visit. As a provider, purposefully asking about all over-the-counter and herbal products during each visit can prompt the patient to provide this important information. Further, it may facilitate discussion about the continuation/discontinuation of products of unknown safety and unknown benefit, culminating in the serious reflection: “Is it really worth the risk?”

For further information about the safety of herbal products, consult local Poison Control Centers, MothertoBaby, MothertoBaby affiliates, and the National Institutes of Health Drugs and Lactation Database, LactMed.

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology, and represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy has worked with multiple pharmaceutical manufacturers regarding studies of medication safety in pregnancy, most recently Biohaven Pharmaceuticals, New Haven, CT.

.

In recent decades, natural products have had increased consumer attention in industrialized nations. One of the challenges is that “natural” can be more of a perception than a standard. “Herbal products” is a more frequently used and perhaps a more apt term. Herbal products come in many forms, including herbs used in food preparation, teas, infusions, caplets, dried extracts, essential oils, and tinctures.

Multiple prescription medications have pharmacologically active compounds that originated from herbal products, both historically and currently. Examples include the cardiac stimulant digoxin (foxglove plant), the antimalarial quinine (Cinchona bark), and antihypertensives (Rauwolfia serpentina). Indeed, the first pharmacologically active compound, morphine, was extracted from the seed pods of opium poppies approximately 200 years ago. This demonstrated that medications could be purified from plants and that a precise dose could be determined for administration. However, herbal products are grown and harvested in varying seasonal conditions and soil types, which, over time and geography, may contribute to variability in the levels of active compound in the final products.

The importance of active compound purification and consistent precise dosage in herbal products brings up the topic of regulation. Herbal products are considered dietary supplements and as such are Food and Drug Administration regulated as a food under the 1994 Dietary Supplement Health Education Act. Regulation as a food product does not involve the same level of scrutiny as a medication. There is no requirement that manufacturers check for purity and consistency of their product’s active compound(s). Manufacturers must ensure that the claims they make about herbal products are not false or misleading. They must also support their claims with evidence. However, there is no requirement for the manufacturers to submit this evidence to the FDA. This can translate into a discrepancy between the claim on the product label and scientific evidence that the product does what it claims to do. In other words, the product may not be effective.

With uncertain efficacy, the safety of herbal products comes into focus. Very few herbal products (or their specific active compounds) have been scientifically studied for safety in pregnancy and lactation. Further, herbal products may contain contaminants. Metals such as lead and mercury occur naturally. Yet, because of human activities, both may have collected in areas where herbal products are grown. From a safety perspective, both can be concerning in pregnancy or lactation. Lead and mercury are two examples of metal contaminants. Other contaminants may include pesticides, chemicals, and bacteria or other microorganisms. Some liquid herbal products such as tinctures contain alcohol, which should be avoided in pregnancy. An additional consideration would be the potential for herbal products, including any of their known or unknown product contents, to interact with prescribed medications or anesthesia.
 

Select examples of herbal products

Astragalus is the root of an herb and it is used for reasons of boosting immunity, energy, and other functions. These and its purported promotion of breast milk flow (galactagogue) are unsupported. Safety concerns include irregular heartbeat and dizziness, rendering it unsafe for use in pregnancy and of unknown efficacy and safety in lactation.

Kombucha is an herbal product made from leaves (tea), sugar, a culture, and other varying products. Like many herbal products, it is both manufactured and home brewed. It is used for probiotic and antioxidant reasons. As a fermented product, kombucha may contain 0.2%-0.5% alcohol. There is no known safe level of alcohol and no known safe type of alcohol for use in pregnancy. Alcohol exposure in pregnancy can result in fetal alcohol spectrum disorders, involving a range of birth defects and life-long intellectual, learning and behavioral disorders. Alcohol found in breast milk approximates the level of alcohol found in the maternal bloodstream. Alcohol-containing products should be avoided in pregnancy and lactation.

Nux vomica is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. It comes from the raw seeds (toxic) of an evergreen tree. It has serious safety concerns and yet it is still in use. It contains strychnine, which can harm both the pregnant individual and the developing fetus. It is not recommended in lactation.

Red raspberry leaf is a leaf, brewed and ingested as a tea. It is used for reasons of preventing miscarriage, relieving nausea and stomach discomfort, toning the uterus, reducing labor pain, increasing breast milk production, and other functions. In low doses, it appears to be safe. In high doses, it can induce smooth muscle relaxation. Efficacy has not been demonstrated with labor and delivery or in increasing breast milk production.

Tabacum is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. Its full name is Nicotiana tabacum (tobacco) and it contains 2%-8% nicotine, which should be avoided in pregnancy. Nicotine is a health danger for the pregnant individual and can damage a developing fetus’ brain and lungs.

Unless otherwise scientifically demonstrated, herbal products should be considered medications with pharmacologic activity, potential adverse effects, and potential toxicity in pregnancy and lactation. It’s easy for a patient to forget about reporting any nonprescription medications during a patient-provider visit. As a provider, purposefully asking about all over-the-counter and herbal products during each visit can prompt the patient to provide this important information. Further, it may facilitate discussion about the continuation/discontinuation of products of unknown safety and unknown benefit, culminating in the serious reflection: “Is it really worth the risk?”

For further information about the safety of herbal products, consult local Poison Control Centers, MothertoBaby, MothertoBaby affiliates, and the National Institutes of Health Drugs and Lactation Database, LactMed.

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology, and represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy has worked with multiple pharmaceutical manufacturers regarding studies of medication safety in pregnancy, most recently Biohaven Pharmaceuticals, New Haven, CT.

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In recent decades, natural products have had increased consumer attention in industrialized nations. One of the challenges is that “natural” can be more of a perception than a standard. “Herbal products” is a more frequently used and perhaps a more apt term. Herbal products come in many forms, including herbs used in food preparation, teas, infusions, caplets, dried extracts, essential oils, and tinctures.

Multiple prescription medications have pharmacologically active compounds that originated from herbal products, both historically and currently. Examples include the cardiac stimulant digoxin (foxglove plant), the antimalarial quinine (Cinchona bark), and antihypertensives (Rauwolfia serpentina). Indeed, the first pharmacologically active compound, morphine, was extracted from the seed pods of opium poppies approximately 200 years ago. This demonstrated that medications could be purified from plants and that a precise dose could be determined for administration. However, herbal products are grown and harvested in varying seasonal conditions and soil types, which, over time and geography, may contribute to variability in the levels of active compound in the final products.

The importance of active compound purification and consistent precise dosage in herbal products brings up the topic of regulation. Herbal products are considered dietary supplements and as such are Food and Drug Administration regulated as a food under the 1994 Dietary Supplement Health Education Act. Regulation as a food product does not involve the same level of scrutiny as a medication. There is no requirement that manufacturers check for purity and consistency of their product’s active compound(s). Manufacturers must ensure that the claims they make about herbal products are not false or misleading. They must also support their claims with evidence. However, there is no requirement for the manufacturers to submit this evidence to the FDA. This can translate into a discrepancy between the claim on the product label and scientific evidence that the product does what it claims to do. In other words, the product may not be effective.

With uncertain efficacy, the safety of herbal products comes into focus. Very few herbal products (or their specific active compounds) have been scientifically studied for safety in pregnancy and lactation. Further, herbal products may contain contaminants. Metals such as lead and mercury occur naturally. Yet, because of human activities, both may have collected in areas where herbal products are grown. From a safety perspective, both can be concerning in pregnancy or lactation. Lead and mercury are two examples of metal contaminants. Other contaminants may include pesticides, chemicals, and bacteria or other microorganisms. Some liquid herbal products such as tinctures contain alcohol, which should be avoided in pregnancy. An additional consideration would be the potential for herbal products, including any of their known or unknown product contents, to interact with prescribed medications or anesthesia.
 

Select examples of herbal products

Astragalus is the root of an herb and it is used for reasons of boosting immunity, energy, and other functions. These and its purported promotion of breast milk flow (galactagogue) are unsupported. Safety concerns include irregular heartbeat and dizziness, rendering it unsafe for use in pregnancy and of unknown efficacy and safety in lactation.

Kombucha is an herbal product made from leaves (tea), sugar, a culture, and other varying products. Like many herbal products, it is both manufactured and home brewed. It is used for probiotic and antioxidant reasons. As a fermented product, kombucha may contain 0.2%-0.5% alcohol. There is no known safe level of alcohol and no known safe type of alcohol for use in pregnancy. Alcohol exposure in pregnancy can result in fetal alcohol spectrum disorders, involving a range of birth defects and life-long intellectual, learning and behavioral disorders. Alcohol found in breast milk approximates the level of alcohol found in the maternal bloodstream. Alcohol-containing products should be avoided in pregnancy and lactation.

Nux vomica is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. It comes from the raw seeds (toxic) of an evergreen tree. It has serious safety concerns and yet it is still in use. It contains strychnine, which can harm both the pregnant individual and the developing fetus. It is not recommended in lactation.

Red raspberry leaf is a leaf, brewed and ingested as a tea. It is used for reasons of preventing miscarriage, relieving nausea and stomach discomfort, toning the uterus, reducing labor pain, increasing breast milk production, and other functions. In low doses, it appears to be safe. In high doses, it can induce smooth muscle relaxation. Efficacy has not been demonstrated with labor and delivery or in increasing breast milk production.

Tabacum is an herbal product and is used for reasons of reducing nausea or vomiting in pregnancy. Its full name is Nicotiana tabacum (tobacco) and it contains 2%-8% nicotine, which should be avoided in pregnancy. Nicotine is a health danger for the pregnant individual and can damage a developing fetus’ brain and lungs.

Unless otherwise scientifically demonstrated, herbal products should be considered medications with pharmacologic activity, potential adverse effects, and potential toxicity in pregnancy and lactation. It’s easy for a patient to forget about reporting any nonprescription medications during a patient-provider visit. As a provider, purposefully asking about all over-the-counter and herbal products during each visit can prompt the patient to provide this important information. Further, it may facilitate discussion about the continuation/discontinuation of products of unknown safety and unknown benefit, culminating in the serious reflection: “Is it really worth the risk?”

For further information about the safety of herbal products, consult local Poison Control Centers, MothertoBaby, MothertoBaby affiliates, and the National Institutes of Health Drugs and Lactation Database, LactMed.

Dr. Hardy is a consultant on global maternal-child health and pharmacoepidemiology, and represents the Society for Birth Defects Research and Prevention and the Organization of Teratology Information Specialists at PRGLAC meetings. Dr. Hardy has worked with multiple pharmaceutical manufacturers regarding studies of medication safety in pregnancy, most recently Biohaven Pharmaceuticals, New Haven, CT.

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Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research in Obstetrics & Gynecology.

“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues wrote.

Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index (BMI) after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecological surgery between March 2016 and August 2019. Patients in the study were aged a median 61 years with a median BMI of 26 kg/m², but 32 patients with a BMI of 40 or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.

In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.

The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%), compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5 to 6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering, compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”

The analysis of patients with a BMI of 40 or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 (range, 17-60) was significantly associated with not developing a wound complication, compared with a BMI of 32 (range, 17-56) (P < .001), and that 41% of patients with a BMI of at least 40 experienced wound complications, compared with 15% of patients with a BMI of less than 40 (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% CI, 1.06-1.14).
 

Applicability of results unclear for patients with higher BMI

Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Dr. Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.

“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, who noted the median BMI of 26 for patients included in the study. A study that included only patients with a BMI of 40 or higher “would have made these results more applicable.”

The low rate of wound complications in the study could potentially be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29, compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67.

“It’s hard to cross-trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical-site infections and wound complications in the heavy patient with comorbidities is still unanswered.”

The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”

This study was funded in part by a support grant from the National Institutes of Health/National Cancer Institute Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speaker’s bureau positions with AstraZeneca, Biom’Up, Bovie Medical, C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical, JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix, UpToDate, and Verthermia. Dr. Temkin reported no relevant financial disclosures.

Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research in Obstetrics & Gynecology.

“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues wrote.

Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index (BMI) after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecological surgery between March 2016 and August 2019. Patients in the study were aged a median 61 years with a median BMI of 26 kg/m², but 32 patients with a BMI of 40 or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.

In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.

The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%), compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5 to 6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering, compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”

The analysis of patients with a BMI of 40 or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 (range, 17-60) was significantly associated with not developing a wound complication, compared with a BMI of 32 (range, 17-56) (P < .001), and that 41% of patients with a BMI of at least 40 experienced wound complications, compared with 15% of patients with a BMI of less than 40 (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% CI, 1.06-1.14).
 

Applicability of results unclear for patients with higher BMI

Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Dr. Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.

“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, who noted the median BMI of 26 for patients included in the study. A study that included only patients with a BMI of 40 or higher “would have made these results more applicable.”

The low rate of wound complications in the study could potentially be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29, compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67.

“It’s hard to cross-trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical-site infections and wound complications in the heavy patient with comorbidities is still unanswered.”

The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”

This study was funded in part by a support grant from the National Institutes of Health/National Cancer Institute Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speaker’s bureau positions with AstraZeneca, Biom’Up, Bovie Medical, C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical, JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix, UpToDate, and Verthermia. Dr. Temkin reported no relevant financial disclosures.

Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research in Obstetrics & Gynecology.

“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues wrote.

Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index (BMI) after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecological surgery between March 2016 and August 2019. Patients in the study were aged a median 61 years with a median BMI of 26 kg/m², but 32 patients with a BMI of 40 or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.

In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.

The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%), compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5 to 6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering, compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”

The analysis of patients with a BMI of 40 or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 (range, 17-60) was significantly associated with not developing a wound complication, compared with a BMI of 32 (range, 17-56) (P < .001), and that 41% of patients with a BMI of at least 40 experienced wound complications, compared with 15% of patients with a BMI of less than 40 (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% CI, 1.06-1.14).
 

Applicability of results unclear for patients with higher BMI

Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Dr. Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.

“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, who noted the median BMI of 26 for patients included in the study. A study that included only patients with a BMI of 40 or higher “would have made these results more applicable.”

The low rate of wound complications in the study could potentially be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29, compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67.

“It’s hard to cross-trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical-site infections and wound complications in the heavy patient with comorbidities is still unanswered.”

The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”

This study was funded in part by a support grant from the National Institutes of Health/National Cancer Institute Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speaker’s bureau positions with AstraZeneca, Biom’Up, Bovie Medical, C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical, JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix, UpToDate, and Verthermia. Dr. Temkin reported no relevant financial disclosures.

Dear colleagues and friends,

Welcome to another edition of the Perspectives debates. The COVID-19 crisis has directly affected our endoscopy practices, and it’s raised difficult questions about how best to balance safety with continued delivery of health care services. Dr. John Inadomi and Dr. Shahnaz Sultan address the benefits and downsides of universal testing of patients before endoscopic procedures.

I hope you find this debate helpful and informative for your endoscopy unit’s policies as we navigate these uncertain times. As always, I welcome your comments and suggestions for future topics at [email protected]. Stay safe!

Charles J. Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is an associate editor for GI & Hepatology News.

Reassurance is important to both patients and providers

The COVID-19 pandemic has been a global economic, societal, and health crisis. As health care systems shifted resources to care for the overwhelming numbers of patients infected with COVID-19 and coincident with lockdown orders issued by local and state governments, elective endoscopy came to a screeching halt. The gastrointestinal professional societies issued a joint statement advocating delays of all elective endoscopies and limiting procedures to those deemed urgent or emergent.¹

Within our GI community, there was great concern raised about the degree of aerosolization and risk of virus transmission during endoscopy and colonoscopy, the type of personal protective equipment (PPE) required to minimize infection risk, and the need for negative pressure rooms or prolonged room turnover to provide adequate air exchange. Our understanding of the role of the GI tract in infection and transmission and presentation with GI symptoms, as well as the true prevalence of asymptomatic infection, was rapidly evolving. Even though our colleagues in Asia and Europe faced the COVID-19 pandemic before we did, we still had no roadmap to navigate these issues.

Public health officials emphasized that a critical step to limit the spread of infection hinged on the availability of accurate and reliable tests. However, during the initial phase of the pandemic, priority was given to patients with symptoms or exposure because of limitations of tests, sampling tools, and reagents. As testing became more available and we began to ramp up endoscopy, the American Gastroenterological Association developed a rapid review and guideline evaluating the role of testing prior to endoscopy.² In this evidence review and guideline, the authors systematically evaluated the diagnostic accuracy of the reverse transcription polymerase chain reaction (RT-PCR) nucleic acid amplification tests (NAAT) available on the U.S. market and described a framework for how a pre-endoscopy testing strategy could help with triage and decisions around PPE use.

Specifically, they made a conditional recommendation supporting a pre-endoscopy testing strategy: “For most endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%), the AGA suggests implementing a pretesting strategy using information about prevalence and test performance (sensitivity/specificity) in combination with considerations about the benefits and downsides of the strategy.”² This is a conditional recommendation based on low certainty evidence, underscoring the limitations in the evidence for diagnostic test accuracy of the currently available tests (limited sample sizes, test accuracy only for symptomatic patients, no reference standard) and limited knowledge of the true prevalence of SARS-CoV-2 infection at the population level.

The authors of the recommendations emphasized that preprocedure testing could help decrease the risk of transmission by triage – that is, delaying the procedure of patients with positive tests who could infect other patients and health care workers. In addition, for patients with negative tests, surgical masks can be considered during endoscopy to allow preservation of N95/N99 masks that are a limited resource in many settings.

Varying strategies for reopening endoscopy have been adopted by endoscopy centers and health systems. According to one survey, most of responding U.S. endoscopy centers (87%) had developed a formal COVID-19 mitigation protocol, with only 52% of the responding centers testing all patients prior to endoscopy, which highlights the large variation of policies in clinical practice.³ In making the case for a strategy of pretesting of all patients prior to endoscopy, it’s important to emphasize that the benefits of testing outweigh any downsides and that, for health care professionals and patients alike, providing reassurance about the safety of endoscopy for everyone is an important aspect to resuming endoscopy operations.

Concerns regarding acquiring COVID-19 infection in the workplace and infecting family members was and remains a source of significant stress for endoscopy unit personnel across the U.S. Recognizing these issues, many institutions initiated a program for preprocedure COVID-19 testing for all patients undergoing endoscopy. An online survey completed by 47 endoscopy unit personnel found that, after implementation of pre-endoscopy testing, fewer personnel reported anxiety regarding contracting infection (58.1% before vs. 44.7% after; P < .001), there was less concern about infecting family members (88.4% before vs. 68.4% after; P < .05), and fewer providers reported self-isolation practices (living in a room separate from family) (21.3% before vs. 10.8% after; P < .05).⁴

Moreover, implementation of a pre-endoscopy testing strategy could decrease patient anxiety and decrease patient reluctance to complete endoscopy. With recognition of the long-term consequences of delaying endoscopic evaluation, especially for colorectal cancer screening and surveillance, improving attendance may lessen the impact on colorectal cancer–related morbidity and mortality and other GI-related conditions.⁵

A pre-endoscopy testing strategy can inform PPE decisions so that N95s and power air-purifying respirators (PAPRs) are reserved for high-risk procedures (such as EGDs in COVID-19-positive patients) with use of surgical masks or extended/reused N95s for patients who test negative. In addition, preprocedure testing can improve endoscopic efficiency eliminating the need to wait for the necessary amount of air exchange between procedures in test-negative patients. In the last 6 months, the testing landscape has changed significantly with the availability of numerous platforms that allow for more efficient processing of tests and the capability of testing saliva instead of nasopharyngeal or nasal swabs. In addition to the original RT-PCR NAAT, more rapid PCR tests, and antigen tests are available. Testing is no longer a scarce resource and for this reason, we should continue our practice of testing all patients prior to endoscopy. Further studies of the false-negative/false-positive rate of various test modalities and test-timing will be important.
 

John M. Inadomi, MD, AGAF, is with the department of medicine at the University of Utah, Salt Lake City. He has no conflicts to declare.

References

1. Gastroenterology Professional Society Guidance on Endoscopic Procedures during the COVID-19 Pandemic. American College of Gastroenterology. 2020 Apr 1.

2. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

3. Moraveji S et al. Gastroenterology. 2020 Oct 1;159(4):1568-70.e5.

4. Podboy A et al. Gastroenterology. 2020 Oct 1;1586-8.e4.

5. Dekker E et al. Gastroenterology. 2020 Dec;159(6):1998-2003.

Barriers to care should be avoided

In the AGA Institute Rapid Review and Recommendations on the Role of Pre-Procedure SARS-CoV-2 Testing and Endoscopy, the authors made a conditional recommendation for implementation of a preprocedure testing strategy, specifically for endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%).¹ The authors stated that, in settings where testing is feasible and there is less perceived burden on patients and when the benefits outweigh the downsides (such as when false positives do not significantly outnumber the true positives), an endoscopy center should implement a preprocedure testing strategy. In addition to the prevalence of SARS-CoV-2 infection, which influences both the positive and negative predictive value of testing, the authors took into account the downstream consequences of test results, the pros and cons of a testing strategy, and the availability of PPE and tests.

The authors further clarify that, in areas with either low or high prevalence of asymptomatic cases, a pre-endoscopy testing strategy may not be informative. The group made a conditional recommendation against testing in these settings, highlighting concerns around the false positive rates in low-prevalence areas and potentially limited availability of tests and false negative rates in high-prevalence areas.

Early in the pandemic, because of the limited availability of tests, symptomatic or high-risk patients were given priority for SARS-CoV-2 testing. Since that time, over 180 different commercially available SARS-CoV-2 assays have become available, and many health systems have developed their own laboratory-developed tests.² However, despite the aggressive efforts to ramp up test capacity, many endoscopy centers still struggle to obtain timely and reliable results. In light of continued challenges with testing, many endoscopy centers chose to not implement a pretesting strategy and instead proceed with N95 respirators or PAPRs for all procedures. Endoscopy centers that implemented a no-testing strategy emphasized the importance of ramping up productivity as quickly as possible and simultaneously reducing any barriers for patients.

They also highlighted reports that demonstrated a low yield of positive tests and that triaging could be performed equally well with the use of a symptom checklist or fever check. In one study from New York, among 623 asymptomatic patients tested before endoscopy during May and June, which was the height of the first surge, only 6 patients tested positive (overall percentage of SARS-CoV-2–positive tests in asymptomatic patients, 0.96%).³ Similarly, low rates of positive tests were reported in a center in Miami: Among a total of 396 PCR swabs in preparation for endoscopy, one patient had a positive PCR result (positive test rate, 0.25%).⁴

What are the implications for patients, providers, and endoscopy centers if a preprocedure testing strategy is not adopted? For individual patients, there is a potential for heightened concern about risk of infection from health care staff or other patients, but this may be offset by the decreased burden of testing. For health care professionals, it means that all procedures need to be performed with universal precautions and appropriate PPE. From an endoscopy operations perspective, there remain unanswered questions regarding room turnover and the necessity for negative pressure rooms. Symptom screening, which is locally required for all health visits, may help identify symptomatic patients, and thus, procedures for these individuals could be canceled and rescheduled or moved to negative pressure rooms (based on urgency).

Questions remain about the need to perform all procedures in negative pressure rooms or with prolonged room turnover to allow for a requisite number of air exchanges. There is general agreement among gastroenterologists that upper endoscopy is an aerosol-generating procedure. The passage of the scope near the pharynx (where the virus has a propensity for colonization and infection) may lead to aerosolization of infective particles and confer an increased risk of infection. However, it is unclear whether colonoscopy actually confers an increased risk. This would require that an asymptomatic patient would be infected with the SARS-CoV-2 virus and have viable viral particles in the colon that are released during the passage of flatus in high enough quantity to allow for aerosolization and transmission of infection. Conceptually, while there are potential risks associated with both endoscopy and colonoscopy, it is reassuring that we are not seeing published reports (or anecdotal evidence) suggesting high rates of COVID-19 infection among endoscopy staff or at endoscopy centers. Requiring prolonged room turnover between every procedure would negatively impact endoscopy efficiency and recovery of endoscopy centers.

Indeed, the aftermath of the COVID-19 pandemic will be far reaching. While telemedicine has helped mitigate some of the collateral damage, the disruption of cancer screening and surveillance programs may lead to high cancer-related morbidity and mortality. In one study evaluating the impact of COVID-19 on the U.S. cancer population, authors analyzed 6,227,474 Medicare Fee for Service claims (representing 5%-7% of the Medicare population) and found a substantial decrease in cancer screening and cancer care (therapy and surgeries).⁵ Screening for colon cancer was reduced by 75% in April.

Eliminating any potential barriers to care should be the highest priority. A requirement for patients to undergo preprocedure testing may contribute to increased anxiety and added costs and may further delay care. From a patient perspective, finding a testing facility, obtaining the test within 48-72 hours, self-isolating until the day of endoscopy, and dealing with the uncertainty of the test result may serve as additional barriers for completion of endoscopy. Moreover, the differential availability of testing may further exacerbate health inequities.

In the absence of pre-endoscopy testing for all patients, routine screening for symptoms, following COVID-19 infection precautions for all cases with strict adherence to physical distancing, and use of N95 (or PAPRs) during endoscopy may minimize viral transmission among patients and staff while maximizing patient adherence to endoscopy, ensuring resumption of endoscopic services, and ultimately mitigating some of the devastating impact of COVID-19 on population health.
 

Shahnaz Sultan, MD, MHSc, AGAF, FACG, is with the division of gastroenterology at the University of Minnesota in Minneapolis and the Center for Care Delivery and Outcomes Research at Minneapolis Veterans Affairs Healthcare System. She has no conflicts to declare.

References

1. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

2. Food and Drug Administration. Emergency Use Authorization: Coronavirus Disease 2019 (COVID-19) EUA Information. 3. Dollinger MT et al. Gastroenterology. 2020;159:1962-4.

4. Forde JJ et al. Gastroenterology. 2020;159:1538-40.

5. Patt D et al. JCO Clin Cancer Inform. 2020 Nov;4:1059-71.

Dear colleagues and friends,

Welcome to another edition of the Perspectives debates. The COVID-19 crisis has directly affected our endoscopy practices, and it’s raised difficult questions about how best to balance safety with continued delivery of health care services. Dr. John Inadomi and Dr. Shahnaz Sultan address the benefits and downsides of universal testing of patients before endoscopic procedures.

I hope you find this debate helpful and informative for your endoscopy unit’s policies as we navigate these uncertain times. As always, I welcome your comments and suggestions for future topics at [email protected]. Stay safe!

Charles J. Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is an associate editor for GI & Hepatology News.

Reassurance is important to both patients and providers

The COVID-19 pandemic has been a global economic, societal, and health crisis. As health care systems shifted resources to care for the overwhelming numbers of patients infected with COVID-19 and coincident with lockdown orders issued by local and state governments, elective endoscopy came to a screeching halt. The gastrointestinal professional societies issued a joint statement advocating delays of all elective endoscopies and limiting procedures to those deemed urgent or emergent.¹

Within our GI community, there was great concern raised about the degree of aerosolization and risk of virus transmission during endoscopy and colonoscopy, the type of personal protective equipment (PPE) required to minimize infection risk, and the need for negative pressure rooms or prolonged room turnover to provide adequate air exchange. Our understanding of the role of the GI tract in infection and transmission and presentation with GI symptoms, as well as the true prevalence of asymptomatic infection, was rapidly evolving. Even though our colleagues in Asia and Europe faced the COVID-19 pandemic before we did, we still had no roadmap to navigate these issues.

Public health officials emphasized that a critical step to limit the spread of infection hinged on the availability of accurate and reliable tests. However, during the initial phase of the pandemic, priority was given to patients with symptoms or exposure because of limitations of tests, sampling tools, and reagents. As testing became more available and we began to ramp up endoscopy, the American Gastroenterological Association developed a rapid review and guideline evaluating the role of testing prior to endoscopy.² In this evidence review and guideline, the authors systematically evaluated the diagnostic accuracy of the reverse transcription polymerase chain reaction (RT-PCR) nucleic acid amplification tests (NAAT) available on the U.S. market and described a framework for how a pre-endoscopy testing strategy could help with triage and decisions around PPE use.

Specifically, they made a conditional recommendation supporting a pre-endoscopy testing strategy: “For most endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%), the AGA suggests implementing a pretesting strategy using information about prevalence and test performance (sensitivity/specificity) in combination with considerations about the benefits and downsides of the strategy.”² This is a conditional recommendation based on low certainty evidence, underscoring the limitations in the evidence for diagnostic test accuracy of the currently available tests (limited sample sizes, test accuracy only for symptomatic patients, no reference standard) and limited knowledge of the true prevalence of SARS-CoV-2 infection at the population level.

The authors of the recommendations emphasized that preprocedure testing could help decrease the risk of transmission by triage – that is, delaying the procedure of patients with positive tests who could infect other patients and health care workers. In addition, for patients with negative tests, surgical masks can be considered during endoscopy to allow preservation of N95/N99 masks that are a limited resource in many settings.

Varying strategies for reopening endoscopy have been adopted by endoscopy centers and health systems. According to one survey, most of responding U.S. endoscopy centers (87%) had developed a formal COVID-19 mitigation protocol, with only 52% of the responding centers testing all patients prior to endoscopy, which highlights the large variation of policies in clinical practice.³ In making the case for a strategy of pretesting of all patients prior to endoscopy, it’s important to emphasize that the benefits of testing outweigh any downsides and that, for health care professionals and patients alike, providing reassurance about the safety of endoscopy for everyone is an important aspect to resuming endoscopy operations.

Concerns regarding acquiring COVID-19 infection in the workplace and infecting family members was and remains a source of significant stress for endoscopy unit personnel across the U.S. Recognizing these issues, many institutions initiated a program for preprocedure COVID-19 testing for all patients undergoing endoscopy. An online survey completed by 47 endoscopy unit personnel found that, after implementation of pre-endoscopy testing, fewer personnel reported anxiety regarding contracting infection (58.1% before vs. 44.7% after; P < .001), there was less concern about infecting family members (88.4% before vs. 68.4% after; P < .05), and fewer providers reported self-isolation practices (living in a room separate from family) (21.3% before vs. 10.8% after; P < .05).⁴

Moreover, implementation of a pre-endoscopy testing strategy could decrease patient anxiety and decrease patient reluctance to complete endoscopy. With recognition of the long-term consequences of delaying endoscopic evaluation, especially for colorectal cancer screening and surveillance, improving attendance may lessen the impact on colorectal cancer–related morbidity and mortality and other GI-related conditions.⁵

A pre-endoscopy testing strategy can inform PPE decisions so that N95s and power air-purifying respirators (PAPRs) are reserved for high-risk procedures (such as EGDs in COVID-19-positive patients) with use of surgical masks or extended/reused N95s for patients who test negative. In addition, preprocedure testing can improve endoscopic efficiency eliminating the need to wait for the necessary amount of air exchange between procedures in test-negative patients. In the last 6 months, the testing landscape has changed significantly with the availability of numerous platforms that allow for more efficient processing of tests and the capability of testing saliva instead of nasopharyngeal or nasal swabs. In addition to the original RT-PCR NAAT, more rapid PCR tests, and antigen tests are available. Testing is no longer a scarce resource and for this reason, we should continue our practice of testing all patients prior to endoscopy. Further studies of the false-negative/false-positive rate of various test modalities and test-timing will be important.
 

John M. Inadomi, MD, AGAF, is with the department of medicine at the University of Utah, Salt Lake City. He has no conflicts to declare.

References

1. Gastroenterology Professional Society Guidance on Endoscopic Procedures during the COVID-19 Pandemic. American College of Gastroenterology. 2020 Apr 1.

2. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

3. Moraveji S et al. Gastroenterology. 2020 Oct 1;159(4):1568-70.e5.

4. Podboy A et al. Gastroenterology. 2020 Oct 1;1586-8.e4.

5. Dekker E et al. Gastroenterology. 2020 Dec;159(6):1998-2003.

Barriers to care should be avoided

In the AGA Institute Rapid Review and Recommendations on the Role of Pre-Procedure SARS-CoV-2 Testing and Endoscopy, the authors made a conditional recommendation for implementation of a preprocedure testing strategy, specifically for endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%).¹ The authors stated that, in settings where testing is feasible and there is less perceived burden on patients and when the benefits outweigh the downsides (such as when false positives do not significantly outnumber the true positives), an endoscopy center should implement a preprocedure testing strategy. In addition to the prevalence of SARS-CoV-2 infection, which influences both the positive and negative predictive value of testing, the authors took into account the downstream consequences of test results, the pros and cons of a testing strategy, and the availability of PPE and tests.

The authors further clarify that, in areas with either low or high prevalence of asymptomatic cases, a pre-endoscopy testing strategy may not be informative. The group made a conditional recommendation against testing in these settings, highlighting concerns around the false positive rates in low-prevalence areas and potentially limited availability of tests and false negative rates in high-prevalence areas.

Early in the pandemic, because of the limited availability of tests, symptomatic or high-risk patients were given priority for SARS-CoV-2 testing. Since that time, over 180 different commercially available SARS-CoV-2 assays have become available, and many health systems have developed their own laboratory-developed tests.² However, despite the aggressive efforts to ramp up test capacity, many endoscopy centers still struggle to obtain timely and reliable results. In light of continued challenges with testing, many endoscopy centers chose to not implement a pretesting strategy and instead proceed with N95 respirators or PAPRs for all procedures. Endoscopy centers that implemented a no-testing strategy emphasized the importance of ramping up productivity as quickly as possible and simultaneously reducing any barriers for patients.

They also highlighted reports that demonstrated a low yield of positive tests and that triaging could be performed equally well with the use of a symptom checklist or fever check. In one study from New York, among 623 asymptomatic patients tested before endoscopy during May and June, which was the height of the first surge, only 6 patients tested positive (overall percentage of SARS-CoV-2–positive tests in asymptomatic patients, 0.96%).³ Similarly, low rates of positive tests were reported in a center in Miami: Among a total of 396 PCR swabs in preparation for endoscopy, one patient had a positive PCR result (positive test rate, 0.25%).⁴

What are the implications for patients, providers, and endoscopy centers if a preprocedure testing strategy is not adopted? For individual patients, there is a potential for heightened concern about risk of infection from health care staff or other patients, but this may be offset by the decreased burden of testing. For health care professionals, it means that all procedures need to be performed with universal precautions and appropriate PPE. From an endoscopy operations perspective, there remain unanswered questions regarding room turnover and the necessity for negative pressure rooms. Symptom screening, which is locally required for all health visits, may help identify symptomatic patients, and thus, procedures for these individuals could be canceled and rescheduled or moved to negative pressure rooms (based on urgency).

Questions remain about the need to perform all procedures in negative pressure rooms or with prolonged room turnover to allow for a requisite number of air exchanges. There is general agreement among gastroenterologists that upper endoscopy is an aerosol-generating procedure. The passage of the scope near the pharynx (where the virus has a propensity for colonization and infection) may lead to aerosolization of infective particles and confer an increased risk of infection. However, it is unclear whether colonoscopy actually confers an increased risk. This would require that an asymptomatic patient would be infected with the SARS-CoV-2 virus and have viable viral particles in the colon that are released during the passage of flatus in high enough quantity to allow for aerosolization and transmission of infection. Conceptually, while there are potential risks associated with both endoscopy and colonoscopy, it is reassuring that we are not seeing published reports (or anecdotal evidence) suggesting high rates of COVID-19 infection among endoscopy staff or at endoscopy centers. Requiring prolonged room turnover between every procedure would negatively impact endoscopy efficiency and recovery of endoscopy centers.

Indeed, the aftermath of the COVID-19 pandemic will be far reaching. While telemedicine has helped mitigate some of the collateral damage, the disruption of cancer screening and surveillance programs may lead to high cancer-related morbidity and mortality. In one study evaluating the impact of COVID-19 on the U.S. cancer population, authors analyzed 6,227,474 Medicare Fee for Service claims (representing 5%-7% of the Medicare population) and found a substantial decrease in cancer screening and cancer care (therapy and surgeries).⁵ Screening for colon cancer was reduced by 75% in April.

Eliminating any potential barriers to care should be the highest priority. A requirement for patients to undergo preprocedure testing may contribute to increased anxiety and added costs and may further delay care. From a patient perspective, finding a testing facility, obtaining the test within 48-72 hours, self-isolating until the day of endoscopy, and dealing with the uncertainty of the test result may serve as additional barriers for completion of endoscopy. Moreover, the differential availability of testing may further exacerbate health inequities.

In the absence of pre-endoscopy testing for all patients, routine screening for symptoms, following COVID-19 infection precautions for all cases with strict adherence to physical distancing, and use of N95 (or PAPRs) during endoscopy may minimize viral transmission among patients and staff while maximizing patient adherence to endoscopy, ensuring resumption of endoscopic services, and ultimately mitigating some of the devastating impact of COVID-19 on population health.
 

Shahnaz Sultan, MD, MHSc, AGAF, FACG, is with the division of gastroenterology at the University of Minnesota in Minneapolis and the Center for Care Delivery and Outcomes Research at Minneapolis Veterans Affairs Healthcare System. She has no conflicts to declare.

References

1. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

2. Food and Drug Administration. Emergency Use Authorization: Coronavirus Disease 2019 (COVID-19) EUA Information. 3. Dollinger MT et al. Gastroenterology. 2020;159:1962-4.

4. Forde JJ et al. Gastroenterology. 2020;159:1538-40.

5. Patt D et al. JCO Clin Cancer Inform. 2020 Nov;4:1059-71.

Dear colleagues and friends,

Welcome to another edition of the Perspectives debates. The COVID-19 crisis has directly affected our endoscopy practices, and it’s raised difficult questions about how best to balance safety with continued delivery of health care services. Dr. John Inadomi and Dr. Shahnaz Sultan address the benefits and downsides of universal testing of patients before endoscopic procedures.

I hope you find this debate helpful and informative for your endoscopy unit’s policies as we navigate these uncertain times. As always, I welcome your comments and suggestions for future topics at [email protected]. Stay safe!

Charles J. Kahi, MD, MS, AGAF, is a professor of medicine at Indiana University, Indianapolis. He is an associate editor for GI & Hepatology News.

Reassurance is important to both patients and providers

The COVID-19 pandemic has been a global economic, societal, and health crisis. As health care systems shifted resources to care for the overwhelming numbers of patients infected with COVID-19 and coincident with lockdown orders issued by local and state governments, elective endoscopy came to a screeching halt. The gastrointestinal professional societies issued a joint statement advocating delays of all elective endoscopies and limiting procedures to those deemed urgent or emergent.¹

Within our GI community, there was great concern raised about the degree of aerosolization and risk of virus transmission during endoscopy and colonoscopy, the type of personal protective equipment (PPE) required to minimize infection risk, and the need for negative pressure rooms or prolonged room turnover to provide adequate air exchange. Our understanding of the role of the GI tract in infection and transmission and presentation with GI symptoms, as well as the true prevalence of asymptomatic infection, was rapidly evolving. Even though our colleagues in Asia and Europe faced the COVID-19 pandemic before we did, we still had no roadmap to navigate these issues.

Public health officials emphasized that a critical step to limit the spread of infection hinged on the availability of accurate and reliable tests. However, during the initial phase of the pandemic, priority was given to patients with symptoms or exposure because of limitations of tests, sampling tools, and reagents. As testing became more available and we began to ramp up endoscopy, the American Gastroenterological Association developed a rapid review and guideline evaluating the role of testing prior to endoscopy.² In this evidence review and guideline, the authors systematically evaluated the diagnostic accuracy of the reverse transcription polymerase chain reaction (RT-PCR) nucleic acid amplification tests (NAAT) available on the U.S. market and described a framework for how a pre-endoscopy testing strategy could help with triage and decisions around PPE use.

Specifically, they made a conditional recommendation supporting a pre-endoscopy testing strategy: “For most endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%), the AGA suggests implementing a pretesting strategy using information about prevalence and test performance (sensitivity/specificity) in combination with considerations about the benefits and downsides of the strategy.”² This is a conditional recommendation based on low certainty evidence, underscoring the limitations in the evidence for diagnostic test accuracy of the currently available tests (limited sample sizes, test accuracy only for symptomatic patients, no reference standard) and limited knowledge of the true prevalence of SARS-CoV-2 infection at the population level.

The authors of the recommendations emphasized that preprocedure testing could help decrease the risk of transmission by triage – that is, delaying the procedure of patients with positive tests who could infect other patients and health care workers. In addition, for patients with negative tests, surgical masks can be considered during endoscopy to allow preservation of N95/N99 masks that are a limited resource in many settings.

Varying strategies for reopening endoscopy have been adopted by endoscopy centers and health systems. According to one survey, most of responding U.S. endoscopy centers (87%) had developed a formal COVID-19 mitigation protocol, with only 52% of the responding centers testing all patients prior to endoscopy, which highlights the large variation of policies in clinical practice.³ In making the case for a strategy of pretesting of all patients prior to endoscopy, it’s important to emphasize that the benefits of testing outweigh any downsides and that, for health care professionals and patients alike, providing reassurance about the safety of endoscopy for everyone is an important aspect to resuming endoscopy operations.

Concerns regarding acquiring COVID-19 infection in the workplace and infecting family members was and remains a source of significant stress for endoscopy unit personnel across the U.S. Recognizing these issues, many institutions initiated a program for preprocedure COVID-19 testing for all patients undergoing endoscopy. An online survey completed by 47 endoscopy unit personnel found that, after implementation of pre-endoscopy testing, fewer personnel reported anxiety regarding contracting infection (58.1% before vs. 44.7% after; P < .001), there was less concern about infecting family members (88.4% before vs. 68.4% after; P < .05), and fewer providers reported self-isolation practices (living in a room separate from family) (21.3% before vs. 10.8% after; P < .05).⁴

Moreover, implementation of a pre-endoscopy testing strategy could decrease patient anxiety and decrease patient reluctance to complete endoscopy. With recognition of the long-term consequences of delaying endoscopic evaluation, especially for colorectal cancer screening and surveillance, improving attendance may lessen the impact on colorectal cancer–related morbidity and mortality and other GI-related conditions.⁵

A pre-endoscopy testing strategy can inform PPE decisions so that N95s and power air-purifying respirators (PAPRs) are reserved for high-risk procedures (such as EGDs in COVID-19-positive patients) with use of surgical masks or extended/reused N95s for patients who test negative. In addition, preprocedure testing can improve endoscopic efficiency eliminating the need to wait for the necessary amount of air exchange between procedures in test-negative patients. In the last 6 months, the testing landscape has changed significantly with the availability of numerous platforms that allow for more efficient processing of tests and the capability of testing saliva instead of nasopharyngeal or nasal swabs. In addition to the original RT-PCR NAAT, more rapid PCR tests, and antigen tests are available. Testing is no longer a scarce resource and for this reason, we should continue our practice of testing all patients prior to endoscopy. Further studies of the false-negative/false-positive rate of various test modalities and test-timing will be important.
 

John M. Inadomi, MD, AGAF, is with the department of medicine at the University of Utah, Salt Lake City. He has no conflicts to declare.

References

1. Gastroenterology Professional Society Guidance on Endoscopic Procedures during the COVID-19 Pandemic. American College of Gastroenterology. 2020 Apr 1.

2. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

3. Moraveji S et al. Gastroenterology. 2020 Oct 1;159(4):1568-70.e5.

4. Podboy A et al. Gastroenterology. 2020 Oct 1;1586-8.e4.

5. Dekker E et al. Gastroenterology. 2020 Dec;159(6):1998-2003.

Barriers to care should be avoided

In the AGA Institute Rapid Review and Recommendations on the Role of Pre-Procedure SARS-CoV-2 Testing and Endoscopy, the authors made a conditional recommendation for implementation of a preprocedure testing strategy, specifically for endoscopy centers where the prevalence of asymptomatic SARS-CoV-2 infection is intermediate (0.5%-2%).¹ The authors stated that, in settings where testing is feasible and there is less perceived burden on patients and when the benefits outweigh the downsides (such as when false positives do not significantly outnumber the true positives), an endoscopy center should implement a preprocedure testing strategy. In addition to the prevalence of SARS-CoV-2 infection, which influences both the positive and negative predictive value of testing, the authors took into account the downstream consequences of test results, the pros and cons of a testing strategy, and the availability of PPE and tests.

The authors further clarify that, in areas with either low or high prevalence of asymptomatic cases, a pre-endoscopy testing strategy may not be informative. The group made a conditional recommendation against testing in these settings, highlighting concerns around the false positive rates in low-prevalence areas and potentially limited availability of tests and false negative rates in high-prevalence areas.

Early in the pandemic, because of the limited availability of tests, symptomatic or high-risk patients were given priority for SARS-CoV-2 testing. Since that time, over 180 different commercially available SARS-CoV-2 assays have become available, and many health systems have developed their own laboratory-developed tests.² However, despite the aggressive efforts to ramp up test capacity, many endoscopy centers still struggle to obtain timely and reliable results. In light of continued challenges with testing, many endoscopy centers chose to not implement a pretesting strategy and instead proceed with N95 respirators or PAPRs for all procedures. Endoscopy centers that implemented a no-testing strategy emphasized the importance of ramping up productivity as quickly as possible and simultaneously reducing any barriers for patients.

They also highlighted reports that demonstrated a low yield of positive tests and that triaging could be performed equally well with the use of a symptom checklist or fever check. In one study from New York, among 623 asymptomatic patients tested before endoscopy during May and June, which was the height of the first surge, only 6 patients tested positive (overall percentage of SARS-CoV-2–positive tests in asymptomatic patients, 0.96%).³ Similarly, low rates of positive tests were reported in a center in Miami: Among a total of 396 PCR swabs in preparation for endoscopy, one patient had a positive PCR result (positive test rate, 0.25%).⁴

What are the implications for patients, providers, and endoscopy centers if a preprocedure testing strategy is not adopted? For individual patients, there is a potential for heightened concern about risk of infection from health care staff or other patients, but this may be offset by the decreased burden of testing. For health care professionals, it means that all procedures need to be performed with universal precautions and appropriate PPE. From an endoscopy operations perspective, there remain unanswered questions regarding room turnover and the necessity for negative pressure rooms. Symptom screening, which is locally required for all health visits, may help identify symptomatic patients, and thus, procedures for these individuals could be canceled and rescheduled or moved to negative pressure rooms (based on urgency).

Questions remain about the need to perform all procedures in negative pressure rooms or with prolonged room turnover to allow for a requisite number of air exchanges. There is general agreement among gastroenterologists that upper endoscopy is an aerosol-generating procedure. The passage of the scope near the pharynx (where the virus has a propensity for colonization and infection) may lead to aerosolization of infective particles and confer an increased risk of infection. However, it is unclear whether colonoscopy actually confers an increased risk. This would require that an asymptomatic patient would be infected with the SARS-CoV-2 virus and have viable viral particles in the colon that are released during the passage of flatus in high enough quantity to allow for aerosolization and transmission of infection. Conceptually, while there are potential risks associated with both endoscopy and colonoscopy, it is reassuring that we are not seeing published reports (or anecdotal evidence) suggesting high rates of COVID-19 infection among endoscopy staff or at endoscopy centers. Requiring prolonged room turnover between every procedure would negatively impact endoscopy efficiency and recovery of endoscopy centers.

Indeed, the aftermath of the COVID-19 pandemic will be far reaching. While telemedicine has helped mitigate some of the collateral damage, the disruption of cancer screening and surveillance programs may lead to high cancer-related morbidity and mortality. In one study evaluating the impact of COVID-19 on the U.S. cancer population, authors analyzed 6,227,474 Medicare Fee for Service claims (representing 5%-7% of the Medicare population) and found a substantial decrease in cancer screening and cancer care (therapy and surgeries).⁵ Screening for colon cancer was reduced by 75% in April.

Eliminating any potential barriers to care should be the highest priority. A requirement for patients to undergo preprocedure testing may contribute to increased anxiety and added costs and may further delay care. From a patient perspective, finding a testing facility, obtaining the test within 48-72 hours, self-isolating until the day of endoscopy, and dealing with the uncertainty of the test result may serve as additional barriers for completion of endoscopy. Moreover, the differential availability of testing may further exacerbate health inequities.

In the absence of pre-endoscopy testing for all patients, routine screening for symptoms, following COVID-19 infection precautions for all cases with strict adherence to physical distancing, and use of N95 (or PAPRs) during endoscopy may minimize viral transmission among patients and staff while maximizing patient adherence to endoscopy, ensuring resumption of endoscopic services, and ultimately mitigating some of the devastating impact of COVID-19 on population health.
 

Shahnaz Sultan, MD, MHSc, AGAF, FACG, is with the division of gastroenterology at the University of Minnesota in Minneapolis and the Center for Care Delivery and Outcomes Research at Minneapolis Veterans Affairs Healthcare System. She has no conflicts to declare.

References

1. Sultan S et al. Gastroenterology. 2020 Nov;159(5):1935-48.e5.

2. Food and Drug Administration. Emergency Use Authorization: Coronavirus Disease 2019 (COVID-19) EUA Information. 3. Dollinger MT et al. Gastroenterology. 2020;159:1962-4.

4. Forde JJ et al. Gastroenterology. 2020;159:1538-40.

5. Patt D et al. JCO Clin Cancer Inform. 2020 Nov;4:1059-71.

Exposure to Group A streptococcus (GAS) does not appear to worsen symptoms of Tourette syndrome and other chronic tic disorders (CTDs) in children and adolescents, new research suggests.

Investigators studied over 700 children and teenagers with CTDs, one-third of whom also had attention deficit hyperactivity disorder and one-third who had obsessive-compulsive disorder (OCD).

The youngsters were followed for an average of 16 months and evaluated at 4-month intervals to see if they were infected with GAS. Tic severity was monitored through telephone interviews, in-person visits, and parental reports.

A little less than half the children experienced worsening of tics during the study period, but the researchers found no association between these exacerbations and GAS exposure.

There was also no link between GAS and worsening OCD. However, researchers did find an association between GAS exposure and an increase in hyperactivity and impulsivity in patients with ADHD.

“This study does not support GAS exposures as contributing factors for tic exacerbations in children with CTD,” the authors note.

“Specific work-up or active management of GAS infections is unlikely to help modifying the course of tics in CTD and is therefore not recommended,” they conclude.

The study was published online in Neurology.
 

‘Intense debate’

The association between GAS and CTD stems from the description of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infection (PANDAS) – a condition that is now incorporated in the pediatric acute neuropsychiatric syndromes (PANS), the authors note. Tics constitute an “accompanying feature” of this condition.

However, neither population-based nor longitudinal clinical studies “could definitely establish if tic exacerbations in CTD are associated with GAS infections,” they note.  

“The link between streptococcus and tics in children is still a matter of intense debate,” said study author Davide Martino, MD, PhD, director of the Movement Disorders Program at the University of Calgary (Alta.), in a press release.

“We wanted to look at that question, as well as a possible link between strep and behavioral symptoms like obsessive-compulsive disorder and attention deficit hyperactivity disorder,” he said.

The researchers followed 715 children with CTD (mean age 10.7 years, 76.8% male) who were drawn from 16 specialist clinics in nine countries. Almost all (90.8%) had a diagnosis of Tourette syndrome (TS); 31.7% had OCD, and 36.1% had ADHD.

Participants received a throat swab at baseline, and of these, 8.4% tested positive for GAS.

Participants were evaluated over a 16- to 18-month period, consisting of:

• Face-to-face interviews and collection of throat swabs and serum at 4-month intervals.
• Telephone interviews at 4-month intervals, which took place at 2 months between study visit.
• Weekly diaries: Parents were asked to indicate any worsening of tics and focus on detecting the earliest possible tic exacerbation.

Beyond the regularly scheduled visits, parents were instructed to report, by phone or email, any noticeable increase in tic severity and then attend an in-person visit.

Tic exacerbations were defined as an increase of greater than or equal to 6 points on the Yale Global Tic Severity Scale-Total Tic Severity Score (YGTSS-TTS), compared with the previous assessment.

OCD and ADHD symptoms were assessed according to the Yale-Brown Obsessive-Compulsive Scale and the parent-reported Swanson, Nolan, and Pelham-IV (SNAP-IV) questionnaire.

The researchers divided GAS exposures into four categories: new definite exposure; new possible exposure; ongoing definite exposure; and ongoing possible exposure.
 

Unlikely trigger

During the follow-up period, 43.1% (n = 308) of participants experienced tic exacerbations. Of these, 218 participants experienced one exacerbation, while 90 participants experienced two, three, or four exacerbations.

The researchers did not find a significant association between GAS exposure status and tic exacerbation.

Participants who did develop a GAS-associated exacerbation (n = 49) were younger at study exit (9.63 vs. 11.4 years, P < .0001) and were more likely to be male (46/49 vs. 210/259, Fisher’s = .035), compared with participants who developed a non-GAS-associated tic exacerbation (n = 259).

Additional analyses were adjusted for sex, age at onset, exposure to psychotropic medications, exposures to antibiotics, geographical regions, and number of visits in the time interval of interest. These analyses continued to yield no significant association between new or ongoing concurrent GAS exposure episodes and tic exacerbation events.

Of the children in the study, 103 had a positive throat swab, indicating a new definite GAS exposure, whereas 46 had a positive throat swab indicating an ongoing definite exposure (n = 149 visits). Of these visits, only 20 corresponded to tic exacerbations.

There was also no association between GAS exposure and OCD symptom severity. However, it was associated with longitudinal changes (between 17% and 21%, depending on GAS exposure definition) in the severity of hyperactivity-impulsivity symptoms in children with ADHD.

“It is known that immune activation may concur with tic severity in youth with CTDs and that psychosocial stress levels may predict short-term future tic severity in these patients,” the authors write.

“Our findings suggest that GAS is unlikely to be the main trigger for immune activation in these patients,” they add.
 

Brick or cornerstone?

Commenting on the study for this news organization, Margo Thienemann, MD, clinical professor of psychiatry, Stanford (Calif.) University, said that in the clinic population they treat, GAS, other pathogens, and other stresses can “each be associated with PANS symptom exacerbations.”

However, these “would not be likely to cause PANS symptoms exacerbations in the vast majority of individuals, only individuals with genetic backgrounds and immunologic dysfunctions creating susceptibility,” said Dr. Thienemann, who also directs the Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Clinic at Stanford Children’s Health. She was not involved with the study.

In an accompanying editorial, Andrea Cavanna, MD, PhD, honorary reader in neuropsychiatry, Birmingham (England) Medical School and Keith Coffman, MD, director, Tourette Syndrome Center of Excellence, Children’s Mercy Hospital, Kansas City, Mo., suggest that perhaps the “interaction of psychosocial stress and GAS infections contributes more to tic exacerbation than psychosocial stress alone.”

“Time will tell whether this study stands as another brick – a cornerstone? – in the wall that separates streptococcus from tics,” they write.

The study was supported by the European Union’s Seventh Framework Program. Dr. Martino has received honoraria for lecturing from the Movement Disorders Society, Tourette Syndrome Association of America, and Dystonia Medical Research Foundation Canada; research funding support from Dystonia Medical Research Foundation Canada, the University of Calgary (Alta.), the Michael P. Smith Family, the Owerko Foundation, Ipsen Corporate, the Parkinson Association of Alberta, and the Canadian Institutes for Health Research; and royalties from Springer-Verlag. The other authors’ disclosures are listed in the original article. Dr. Cavanna, Dr. Coffman, and Dr. Thienemann have disclosed no relevant financial relationships.

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

Exposure to Group A streptococcus (GAS) does not appear to worsen symptoms of Tourette syndrome and other chronic tic disorders (CTDs) in children and adolescents, new research suggests.

Investigators studied over 700 children and teenagers with CTDs, one-third of whom also had attention deficit hyperactivity disorder and one-third who had obsessive-compulsive disorder (OCD).

The youngsters were followed for an average of 16 months and evaluated at 4-month intervals to see if they were infected with GAS. Tic severity was monitored through telephone interviews, in-person visits, and parental reports.

A little less than half the children experienced worsening of tics during the study period, but the researchers found no association between these exacerbations and GAS exposure.

There was also no link between GAS and worsening OCD. However, researchers did find an association between GAS exposure and an increase in hyperactivity and impulsivity in patients with ADHD.

“This study does not support GAS exposures as contributing factors for tic exacerbations in children with CTD,” the authors note.

“Specific work-up or active management of GAS infections is unlikely to help modifying the course of tics in CTD and is therefore not recommended,” they conclude.

The study was published online in Neurology.
 

‘Intense debate’

The association between GAS and CTD stems from the description of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infection (PANDAS) – a condition that is now incorporated in the pediatric acute neuropsychiatric syndromes (PANS), the authors note. Tics constitute an “accompanying feature” of this condition.

However, neither population-based nor longitudinal clinical studies “could definitely establish if tic exacerbations in CTD are associated with GAS infections,” they note.  

“The link between streptococcus and tics in children is still a matter of intense debate,” said study author Davide Martino, MD, PhD, director of the Movement Disorders Program at the University of Calgary (Alta.), in a press release.

“We wanted to look at that question, as well as a possible link between strep and behavioral symptoms like obsessive-compulsive disorder and attention deficit hyperactivity disorder,” he said.

The researchers followed 715 children with CTD (mean age 10.7 years, 76.8% male) who were drawn from 16 specialist clinics in nine countries. Almost all (90.8%) had a diagnosis of Tourette syndrome (TS); 31.7% had OCD, and 36.1% had ADHD.

Participants received a throat swab at baseline, and of these, 8.4% tested positive for GAS.

Participants were evaluated over a 16- to 18-month period, consisting of:

• Face-to-face interviews and collection of throat swabs and serum at 4-month intervals.
• Telephone interviews at 4-month intervals, which took place at 2 months between study visit.
• Weekly diaries: Parents were asked to indicate any worsening of tics and focus on detecting the earliest possible tic exacerbation.

Beyond the regularly scheduled visits, parents were instructed to report, by phone or email, any noticeable increase in tic severity and then attend an in-person visit.

Tic exacerbations were defined as an increase of greater than or equal to 6 points on the Yale Global Tic Severity Scale-Total Tic Severity Score (YGTSS-TTS), compared with the previous assessment.

OCD and ADHD symptoms were assessed according to the Yale-Brown Obsessive-Compulsive Scale and the parent-reported Swanson, Nolan, and Pelham-IV (SNAP-IV) questionnaire.

The researchers divided GAS exposures into four categories: new definite exposure; new possible exposure; ongoing definite exposure; and ongoing possible exposure.
 

Unlikely trigger

During the follow-up period, 43.1% (n = 308) of participants experienced tic exacerbations. Of these, 218 participants experienced one exacerbation, while 90 participants experienced two, three, or four exacerbations.

The researchers did not find a significant association between GAS exposure status and tic exacerbation.

Participants who did develop a GAS-associated exacerbation (n = 49) were younger at study exit (9.63 vs. 11.4 years, P < .0001) and were more likely to be male (46/49 vs. 210/259, Fisher’s = .035), compared with participants who developed a non-GAS-associated tic exacerbation (n = 259).

Additional analyses were adjusted for sex, age at onset, exposure to psychotropic medications, exposures to antibiotics, geographical regions, and number of visits in the time interval of interest. These analyses continued to yield no significant association between new or ongoing concurrent GAS exposure episodes and tic exacerbation events.

Of the children in the study, 103 had a positive throat swab, indicating a new definite GAS exposure, whereas 46 had a positive throat swab indicating an ongoing definite exposure (n = 149 visits). Of these visits, only 20 corresponded to tic exacerbations.

There was also no association between GAS exposure and OCD symptom severity. However, it was associated with longitudinal changes (between 17% and 21%, depending on GAS exposure definition) in the severity of hyperactivity-impulsivity symptoms in children with ADHD.

“It is known that immune activation may concur with tic severity in youth with CTDs and that psychosocial stress levels may predict short-term future tic severity in these patients,” the authors write.

“Our findings suggest that GAS is unlikely to be the main trigger for immune activation in these patients,” they add.
 

Brick or cornerstone?

Commenting on the study for this news organization, Margo Thienemann, MD, clinical professor of psychiatry, Stanford (Calif.) University, said that in the clinic population they treat, GAS, other pathogens, and other stresses can “each be associated with PANS symptom exacerbations.”

However, these “would not be likely to cause PANS symptoms exacerbations in the vast majority of individuals, only individuals with genetic backgrounds and immunologic dysfunctions creating susceptibility,” said Dr. Thienemann, who also directs the Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Clinic at Stanford Children’s Health. She was not involved with the study.

In an accompanying editorial, Andrea Cavanna, MD, PhD, honorary reader in neuropsychiatry, Birmingham (England) Medical School and Keith Coffman, MD, director, Tourette Syndrome Center of Excellence, Children’s Mercy Hospital, Kansas City, Mo., suggest that perhaps the “interaction of psychosocial stress and GAS infections contributes more to tic exacerbation than psychosocial stress alone.”

“Time will tell whether this study stands as another brick – a cornerstone? – in the wall that separates streptococcus from tics,” they write.

The study was supported by the European Union’s Seventh Framework Program. Dr. Martino has received honoraria for lecturing from the Movement Disorders Society, Tourette Syndrome Association of America, and Dystonia Medical Research Foundation Canada; research funding support from Dystonia Medical Research Foundation Canada, the University of Calgary (Alta.), the Michael P. Smith Family, the Owerko Foundation, Ipsen Corporate, the Parkinson Association of Alberta, and the Canadian Institutes for Health Research; and royalties from Springer-Verlag. The other authors’ disclosures are listed in the original article. Dr. Cavanna, Dr. Coffman, and Dr. Thienemann have disclosed no relevant financial relationships.

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

Exposure to Group A streptococcus (GAS) does not appear to worsen symptoms of Tourette syndrome and other chronic tic disorders (CTDs) in children and adolescents, new research suggests.

Investigators studied over 700 children and teenagers with CTDs, one-third of whom also had attention deficit hyperactivity disorder and one-third who had obsessive-compulsive disorder (OCD).

The youngsters were followed for an average of 16 months and evaluated at 4-month intervals to see if they were infected with GAS. Tic severity was monitored through telephone interviews, in-person visits, and parental reports.

A little less than half the children experienced worsening of tics during the study period, but the researchers found no association between these exacerbations and GAS exposure.

There was also no link between GAS and worsening OCD. However, researchers did find an association between GAS exposure and an increase in hyperactivity and impulsivity in patients with ADHD.

“This study does not support GAS exposures as contributing factors for tic exacerbations in children with CTD,” the authors note.

“Specific work-up or active management of GAS infections is unlikely to help modifying the course of tics in CTD and is therefore not recommended,” they conclude.

The study was published online in Neurology.
 

‘Intense debate’

The association between GAS and CTD stems from the description of Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infection (PANDAS) – a condition that is now incorporated in the pediatric acute neuropsychiatric syndromes (PANS), the authors note. Tics constitute an “accompanying feature” of this condition.

However, neither population-based nor longitudinal clinical studies “could definitely establish if tic exacerbations in CTD are associated with GAS infections,” they note.  

“The link between streptococcus and tics in children is still a matter of intense debate,” said study author Davide Martino, MD, PhD, director of the Movement Disorders Program at the University of Calgary (Alta.), in a press release.

“We wanted to look at that question, as well as a possible link between strep and behavioral symptoms like obsessive-compulsive disorder and attention deficit hyperactivity disorder,” he said.

The researchers followed 715 children with CTD (mean age 10.7 years, 76.8% male) who were drawn from 16 specialist clinics in nine countries. Almost all (90.8%) had a diagnosis of Tourette syndrome (TS); 31.7% had OCD, and 36.1% had ADHD.

Participants received a throat swab at baseline, and of these, 8.4% tested positive for GAS.

Participants were evaluated over a 16- to 18-month period, consisting of:

• Face-to-face interviews and collection of throat swabs and serum at 4-month intervals.
• Telephone interviews at 4-month intervals, which took place at 2 months between study visit.
• Weekly diaries: Parents were asked to indicate any worsening of tics and focus on detecting the earliest possible tic exacerbation.

Beyond the regularly scheduled visits, parents were instructed to report, by phone or email, any noticeable increase in tic severity and then attend an in-person visit.

Tic exacerbations were defined as an increase of greater than or equal to 6 points on the Yale Global Tic Severity Scale-Total Tic Severity Score (YGTSS-TTS), compared with the previous assessment.

OCD and ADHD symptoms were assessed according to the Yale-Brown Obsessive-Compulsive Scale and the parent-reported Swanson, Nolan, and Pelham-IV (SNAP-IV) questionnaire.

The researchers divided GAS exposures into four categories: new definite exposure; new possible exposure; ongoing definite exposure; and ongoing possible exposure.
 

Unlikely trigger

During the follow-up period, 43.1% (n = 308) of participants experienced tic exacerbations. Of these, 218 participants experienced one exacerbation, while 90 participants experienced two, three, or four exacerbations.

The researchers did not find a significant association between GAS exposure status and tic exacerbation.

Participants who did develop a GAS-associated exacerbation (n = 49) were younger at study exit (9.63 vs. 11.4 years, P < .0001) and were more likely to be male (46/49 vs. 210/259, Fisher’s = .035), compared with participants who developed a non-GAS-associated tic exacerbation (n = 259).

Additional analyses were adjusted for sex, age at onset, exposure to psychotropic medications, exposures to antibiotics, geographical regions, and number of visits in the time interval of interest. These analyses continued to yield no significant association between new or ongoing concurrent GAS exposure episodes and tic exacerbation events.

Of the children in the study, 103 had a positive throat swab, indicating a new definite GAS exposure, whereas 46 had a positive throat swab indicating an ongoing definite exposure (n = 149 visits). Of these visits, only 20 corresponded to tic exacerbations.

There was also no association between GAS exposure and OCD symptom severity. However, it was associated with longitudinal changes (between 17% and 21%, depending on GAS exposure definition) in the severity of hyperactivity-impulsivity symptoms in children with ADHD.

“It is known that immune activation may concur with tic severity in youth with CTDs and that psychosocial stress levels may predict short-term future tic severity in these patients,” the authors write.

“Our findings suggest that GAS is unlikely to be the main trigger for immune activation in these patients,” they add.
 

Brick or cornerstone?

Commenting on the study for this news organization, Margo Thienemann, MD, clinical professor of psychiatry, Stanford (Calif.) University, said that in the clinic population they treat, GAS, other pathogens, and other stresses can “each be associated with PANS symptom exacerbations.”

However, these “would not be likely to cause PANS symptoms exacerbations in the vast majority of individuals, only individuals with genetic backgrounds and immunologic dysfunctions creating susceptibility,” said Dr. Thienemann, who also directs the Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Clinic at Stanford Children’s Health. She was not involved with the study.

In an accompanying editorial, Andrea Cavanna, MD, PhD, honorary reader in neuropsychiatry, Birmingham (England) Medical School and Keith Coffman, MD, director, Tourette Syndrome Center of Excellence, Children’s Mercy Hospital, Kansas City, Mo., suggest that perhaps the “interaction of psychosocial stress and GAS infections contributes more to tic exacerbation than psychosocial stress alone.”

“Time will tell whether this study stands as another brick – a cornerstone? – in the wall that separates streptococcus from tics,” they write.

The study was supported by the European Union’s Seventh Framework Program. Dr. Martino has received honoraria for lecturing from the Movement Disorders Society, Tourette Syndrome Association of America, and Dystonia Medical Research Foundation Canada; research funding support from Dystonia Medical Research Foundation Canada, the University of Calgary (Alta.), the Michael P. Smith Family, the Owerko Foundation, Ipsen Corporate, the Parkinson Association of Alberta, and the Canadian Institutes for Health Research; and royalties from Springer-Verlag. The other authors’ disclosures are listed in the original article. Dr. Cavanna, Dr. Coffman, and Dr. Thienemann have disclosed no relevant financial relationships.

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

The Society of Hospital Medicine team (myself included) is very excited to get geared up for the 2021 SHM Annual Conference, now known as SHM Converge. While we all long for a traditional in-person meeting “like the good old days”, there are some significant advantages to a virtual meeting like Converge.

The most significant advantage is the ability to review more content than ever before, as we offer a combination of live and recorded “on-demand” sessions. This allows for incredible flexibility in garnering “top-shelf” content from hospital medicine experts around the country, without having to choose from competing sessions. We are especially looking forward to new sessions this year focused on COVID-19; diversity, equity, and inclusion; and resilience.

The Converge conference will still be offering networking sessions throughout – even in the virtual conference environment. We consider networking a vital and endearing part of the value equation for SHM members. For example, we now can participate in several Special Interest Forums, since many of us have several niche interests and want to take advantage of more than one of these networking opportunities. We also carefully preserved the signature “Update in Hospital Medicine” session, as well as the scientific abstract poster reception and the Best of Research and Innovation sessions. These are long-term favorites at the annual conference and lend themselves well to virtual transformation. Some of the workshops and special sessions have exclusive audience engagement and are not offered on demand, so signing up early for these sessions is highly recommended.

SHM remains the professional home for hospitalists, and we rely on the annual conference to keep us all informed on current and forward-thinking clinical practice, practice management, leadership, academics, research, and other topics. This is one of many examples of how SHM has been able to pivot to meet the needs of hospitalists throughout the pandemic. Not only have we successfully converted “traditional” meetings into virtual meetings, but we have been able to curate and deliver content faster and more seamlessly than ever before.

Whether via The Hospitalist, the Journal of Hospital Medicine, the SHM website, or our other educational platforms, SHM has remained committed to being the single “source of truth” for all things hospital medicine. Within the tumultuous political landscape of the past year, the SHM advocacy team has been more active and engaged than ever, in advocating for a myriad of hospitalist-related legislative changes. These are just a few of the ways SHM continues to add value to hospitalist members every day.

Although we will certainly miss seeing each other in person, we are confident that the SHM team will meet and exceed expectations on content delivery and will take advantage of the virtual format to improve content access. We look forward to “seeing” you at SHM Converge this year and hope you take advantage of the enhanced delivery and access to an array of amazing content!

Dr. Scheurer is president of the Society of Hospital Medicine. She is a hospitalist and chief quality officer, MUSC Health System, Medical University of South Carolina, Charleston.

The Society of Hospital Medicine team (myself included) is very excited to get geared up for the 2021 SHM Annual Conference, now known as SHM Converge. While we all long for a traditional in-person meeting “like the good old days”, there are some significant advantages to a virtual meeting like Converge.

The most significant advantage is the ability to review more content than ever before, as we offer a combination of live and recorded “on-demand” sessions. This allows for incredible flexibility in garnering “top-shelf” content from hospital medicine experts around the country, without having to choose from competing sessions. We are especially looking forward to new sessions this year focused on COVID-19; diversity, equity, and inclusion; and resilience.

The Converge conference will still be offering networking sessions throughout – even in the virtual conference environment. We consider networking a vital and endearing part of the value equation for SHM members. For example, we now can participate in several Special Interest Forums, since many of us have several niche interests and want to take advantage of more than one of these networking opportunities. We also carefully preserved the signature “Update in Hospital Medicine” session, as well as the scientific abstract poster reception and the Best of Research and Innovation sessions. These are long-term favorites at the annual conference and lend themselves well to virtual transformation. Some of the workshops and special sessions have exclusive audience engagement and are not offered on demand, so signing up early for these sessions is highly recommended.

SHM remains the professional home for hospitalists, and we rely on the annual conference to keep us all informed on current and forward-thinking clinical practice, practice management, leadership, academics, research, and other topics. This is one of many examples of how SHM has been able to pivot to meet the needs of hospitalists throughout the pandemic. Not only have we successfully converted “traditional” meetings into virtual meetings, but we have been able to curate and deliver content faster and more seamlessly than ever before.

Whether via The Hospitalist, the Journal of Hospital Medicine, the SHM website, or our other educational platforms, SHM has remained committed to being the single “source of truth” for all things hospital medicine. Within the tumultuous political landscape of the past year, the SHM advocacy team has been more active and engaged than ever, in advocating for a myriad of hospitalist-related legislative changes. These are just a few of the ways SHM continues to add value to hospitalist members every day.

Although we will certainly miss seeing each other in person, we are confident that the SHM team will meet and exceed expectations on content delivery and will take advantage of the virtual format to improve content access. We look forward to “seeing” you at SHM Converge this year and hope you take advantage of the enhanced delivery and access to an array of amazing content!

Dr. Scheurer is president of the Society of Hospital Medicine. She is a hospitalist and chief quality officer, MUSC Health System, Medical University of South Carolina, Charleston.

The Society of Hospital Medicine team (myself included) is very excited to get geared up for the 2021 SHM Annual Conference, now known as SHM Converge. While we all long for a traditional in-person meeting “like the good old days”, there are some significant advantages to a virtual meeting like Converge.

The most significant advantage is the ability to review more content than ever before, as we offer a combination of live and recorded “on-demand” sessions. This allows for incredible flexibility in garnering “top-shelf” content from hospital medicine experts around the country, without having to choose from competing sessions. We are especially looking forward to new sessions this year focused on COVID-19; diversity, equity, and inclusion; and resilience.

The Converge conference will still be offering networking sessions throughout – even in the virtual conference environment. We consider networking a vital and endearing part of the value equation for SHM members. For example, we now can participate in several Special Interest Forums, since many of us have several niche interests and want to take advantage of more than one of these networking opportunities. We also carefully preserved the signature “Update in Hospital Medicine” session, as well as the scientific abstract poster reception and the Best of Research and Innovation sessions. These are long-term favorites at the annual conference and lend themselves well to virtual transformation. Some of the workshops and special sessions have exclusive audience engagement and are not offered on demand, so signing up early for these sessions is highly recommended.

SHM remains the professional home for hospitalists, and we rely on the annual conference to keep us all informed on current and forward-thinking clinical practice, practice management, leadership, academics, research, and other topics. This is one of many examples of how SHM has been able to pivot to meet the needs of hospitalists throughout the pandemic. Not only have we successfully converted “traditional” meetings into virtual meetings, but we have been able to curate and deliver content faster and more seamlessly than ever before.

Whether via The Hospitalist, the Journal of Hospital Medicine, the SHM website, or our other educational platforms, SHM has remained committed to being the single “source of truth” for all things hospital medicine. Within the tumultuous political landscape of the past year, the SHM advocacy team has been more active and engaged than ever, in advocating for a myriad of hospitalist-related legislative changes. These are just a few of the ways SHM continues to add value to hospitalist members every day.

Although we will certainly miss seeing each other in person, we are confident that the SHM team will meet and exceed expectations on content delivery and will take advantage of the virtual format to improve content access. We look forward to “seeing” you at SHM Converge this year and hope you take advantage of the enhanced delivery and access to an array of amazing content!

Dr. Scheurer is president of the Society of Hospital Medicine. She is a hospitalist and chief quality officer, MUSC Health System, Medical University of South Carolina, Charleston.