Rheumatology News

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

A new meta-analysis appears to show that colchicine has no benefit as a treatment for COVID-19, but its inclusion of trials studying differing patient populations and testing different outcomes led to “misleading” results, says a researcher involved in one of the trials.

The meta-analysis, which includes data from the recent Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, was published Nov. 22 in RMD Open.

Kedar Gautambhai Mehta, MBBS, MD, of the GMERS Medical College Gotri in Vadodara, India, and colleagues included outcomes from six studies of 16,148 patients with COVID-19 who received colchicine or supportive care. They evaluated the efficacy outcomes of mortality, need for ventilation, intensive care unit admission, and length of stay in hospital, as well as safety outcomes of adverse events, serious adverse events, and diarrhea.

The studies in the meta-analysis included a randomized, controlled trial (RCT) of 105 patients hospitalized with COVID-19 in Greece, the international, open-label RECOVERY RCT of 11,340 patients hospitalized with COVID-19, an RCT of 72 hospitalized patients with moderate or severe COVID-19 in Brazil, an RCT of 100 patients hospitalized with COVID-19 in Iran, the international COLCORONA trial of 4,488 patients with COVID-19 who were treated with colchicine or placebo on an outpatient basis, and the randomized COLORIT trial of 43 patients hospitalized with COVID-19 in Russia.
 

Studies “asked very different questions” about colchicine

Commenting on the meta-analysis, Michael H. Pillinger, MD, a rheumatologist and professor of medicine, biochemistry, and molecular pharmacology with New York University, said the authors combined studies “that are not comparable and that asked very different questions.” Two of the studies in the meta-analysis are very large, and four are very small, which skews the results, he explained.

“The larger studies therefore drive the outcome, and while the small studies are potentially insight providing, the large studies are the only ones worth giving our attention to in the context of the meta-analysis,” he said. The two largest studies – RECOVERY and COLCORONA – taken together show no benefit for colchicine as a treatment, even though the former demonstrated no benefit and the latter did show a benefit, explained Dr. Pillinger, a co–principal investigator for the COLCORONA trial in the United States.

The studies were designed differently and should not have been included in the same analysis, Dr. Pillinger argued. In the case of COLCORONA, early treatment with colchicine was the intervention, whereas RECOVERY focused on hospitalized patients.

“In designing [COLCORONA], the author group (of whom I was a member) expressly rejected the idea that colchicine might be useful for the sicker hospitalized patients, based on the long experience with colchicine of some of us as rheumatologists,” Dr. Pillinger said.

“In short, COLCORONA proved a benefit of colchicine in outpatient COVID-19, and its authors presumed there would be no inpatient benefit; RECOVERY went ahead and proved a lack of inpatient benefit, at least when high-dose steroids were also given,” he said. “While there is no conflict between these results, the combination of the two studies in this meta-analysis suggests there might be no benefit for colchicine overall, which is misleading and can lead physicians to reject the potential of outpatient colchicine, even for future studies.”

Dr. Pillinger said he still believes colchicine has potential value as a COVID-19 treatment option for patients with mild disease, “especially for low–vaccine rate, resource-starved countries.

“It would be unfortunate if meta-analyses such as this one would put a stop to colchicine’s use, or at least its further investigation,” he said.
 

Study details

The authors of the study assessed heterogeneity of the trials’ data across the outcomes using an I2 test. They evaluated the quality of the evidence for the outcomes using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE).

The results of their meta-analysis showed that colchicine offered no significant improvement in mortality in six studies (risk difference, –0.0; 95% confidence interval, –0.01 to 0.01; I2 = 15%). It showed no benefit with respect to requiring ventilatory support in five studies of 15,519 patients (risk ratio, 0.67; 95% CI, 0.38-1.21; I2 = 47%); being admitted to the ICU in three studies with 220 patients (RR, 0.49; 95% CI, 0.19-1.25; I2 = 34%); and length of stay while in the hospital in four studies of 11,560 patients (mean difference, –1.17; 95% CI, –3.02 to 0.67; I2 = 77%).

There was no difference in serious adverse events in three studies with 4,665 patients (RD, –0.01; 95% CI, –0.02 to 0.00; I2 = 28%) for patients who received colchicine, compared with supportive care alone. Patients who received colchicine were more likely to have a higher rate of adverse events (RR, 1.58; 95% CI, 1.07-2.33; I2 = 81%) and to experience diarrhea (RR, 1.93; 95% CI, 1.62-2.29; I2 = 0%) than were patients who received supportive care alone. The researchers note that for most outcomes, the GRADE quality of evidence was moderate.

“Our findings on colchicine should be interpreted cautiously due to the inclusion of open-labeled, randomized clinical trials,” Dr. Mehta and colleagues write. “The analysis of efficacy and safety outcomes are based on a small number of RCTs in control interventions.”

The authors reported no relevant financial relationships. Dr. Pillinger is co–principal investigator of the U.S. component of the COLCORONA trial; he reported no other relevant conflicts of interest.

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

A new meta-analysis appears to show that colchicine has no benefit as a treatment for COVID-19, but its inclusion of trials studying differing patient populations and testing different outcomes led to “misleading” results, says a researcher involved in one of the trials.

The meta-analysis, which includes data from the recent Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, was published Nov. 22 in RMD Open.

Kedar Gautambhai Mehta, MBBS, MD, of the GMERS Medical College Gotri in Vadodara, India, and colleagues included outcomes from six studies of 16,148 patients with COVID-19 who received colchicine or supportive care. They evaluated the efficacy outcomes of mortality, need for ventilation, intensive care unit admission, and length of stay in hospital, as well as safety outcomes of adverse events, serious adverse events, and diarrhea.

The studies in the meta-analysis included a randomized, controlled trial (RCT) of 105 patients hospitalized with COVID-19 in Greece, the international, open-label RECOVERY RCT of 11,340 patients hospitalized with COVID-19, an RCT of 72 hospitalized patients with moderate or severe COVID-19 in Brazil, an RCT of 100 patients hospitalized with COVID-19 in Iran, the international COLCORONA trial of 4,488 patients with COVID-19 who were treated with colchicine or placebo on an outpatient basis, and the randomized COLORIT trial of 43 patients hospitalized with COVID-19 in Russia.
 

Studies “asked very different questions” about colchicine

Commenting on the meta-analysis, Michael H. Pillinger, MD, a rheumatologist and professor of medicine, biochemistry, and molecular pharmacology with New York University, said the authors combined studies “that are not comparable and that asked very different questions.” Two of the studies in the meta-analysis are very large, and four are very small, which skews the results, he explained.

“The larger studies therefore drive the outcome, and while the small studies are potentially insight providing, the large studies are the only ones worth giving our attention to in the context of the meta-analysis,” he said. The two largest studies – RECOVERY and COLCORONA – taken together show no benefit for colchicine as a treatment, even though the former demonstrated no benefit and the latter did show a benefit, explained Dr. Pillinger, a co–principal investigator for the COLCORONA trial in the United States.

The studies were designed differently and should not have been included in the same analysis, Dr. Pillinger argued. In the case of COLCORONA, early treatment with colchicine was the intervention, whereas RECOVERY focused on hospitalized patients.

“In designing [COLCORONA], the author group (of whom I was a member) expressly rejected the idea that colchicine might be useful for the sicker hospitalized patients, based on the long experience with colchicine of some of us as rheumatologists,” Dr. Pillinger said.

“In short, COLCORONA proved a benefit of colchicine in outpatient COVID-19, and its authors presumed there would be no inpatient benefit; RECOVERY went ahead and proved a lack of inpatient benefit, at least when high-dose steroids were also given,” he said. “While there is no conflict between these results, the combination of the two studies in this meta-analysis suggests there might be no benefit for colchicine overall, which is misleading and can lead physicians to reject the potential of outpatient colchicine, even for future studies.”

Dr. Pillinger said he still believes colchicine has potential value as a COVID-19 treatment option for patients with mild disease, “especially for low–vaccine rate, resource-starved countries.

“It would be unfortunate if meta-analyses such as this one would put a stop to colchicine’s use, or at least its further investigation,” he said.
 

Study details

The authors of the study assessed heterogeneity of the trials’ data across the outcomes using an I2 test. They evaluated the quality of the evidence for the outcomes using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE).

The results of their meta-analysis showed that colchicine offered no significant improvement in mortality in six studies (risk difference, –0.0; 95% confidence interval, –0.01 to 0.01; I2 = 15%). It showed no benefit with respect to requiring ventilatory support in five studies of 15,519 patients (risk ratio, 0.67; 95% CI, 0.38-1.21; I2 = 47%); being admitted to the ICU in three studies with 220 patients (RR, 0.49; 95% CI, 0.19-1.25; I2 = 34%); and length of stay while in the hospital in four studies of 11,560 patients (mean difference, –1.17; 95% CI, –3.02 to 0.67; I2 = 77%).

There was no difference in serious adverse events in three studies with 4,665 patients (RD, –0.01; 95% CI, –0.02 to 0.00; I2 = 28%) for patients who received colchicine, compared with supportive care alone. Patients who received colchicine were more likely to have a higher rate of adverse events (RR, 1.58; 95% CI, 1.07-2.33; I2 = 81%) and to experience diarrhea (RR, 1.93; 95% CI, 1.62-2.29; I2 = 0%) than were patients who received supportive care alone. The researchers note that for most outcomes, the GRADE quality of evidence was moderate.

“Our findings on colchicine should be interpreted cautiously due to the inclusion of open-labeled, randomized clinical trials,” Dr. Mehta and colleagues write. “The analysis of efficacy and safety outcomes are based on a small number of RCTs in control interventions.”

The authors reported no relevant financial relationships. Dr. Pillinger is co–principal investigator of the U.S. component of the COLCORONA trial; he reported no other relevant conflicts of interest.

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

A new meta-analysis appears to show that colchicine has no benefit as a treatment for COVID-19, but its inclusion of trials studying differing patient populations and testing different outcomes led to “misleading” results, says a researcher involved in one of the trials.

The meta-analysis, which includes data from the recent Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, was published Nov. 22 in RMD Open.

Kedar Gautambhai Mehta, MBBS, MD, of the GMERS Medical College Gotri in Vadodara, India, and colleagues included outcomes from six studies of 16,148 patients with COVID-19 who received colchicine or supportive care. They evaluated the efficacy outcomes of mortality, need for ventilation, intensive care unit admission, and length of stay in hospital, as well as safety outcomes of adverse events, serious adverse events, and diarrhea.

The studies in the meta-analysis included a randomized, controlled trial (RCT) of 105 patients hospitalized with COVID-19 in Greece, the international, open-label RECOVERY RCT of 11,340 patients hospitalized with COVID-19, an RCT of 72 hospitalized patients with moderate or severe COVID-19 in Brazil, an RCT of 100 patients hospitalized with COVID-19 in Iran, the international COLCORONA trial of 4,488 patients with COVID-19 who were treated with colchicine or placebo on an outpatient basis, and the randomized COLORIT trial of 43 patients hospitalized with COVID-19 in Russia.
 

Studies “asked very different questions” about colchicine

Commenting on the meta-analysis, Michael H. Pillinger, MD, a rheumatologist and professor of medicine, biochemistry, and molecular pharmacology with New York University, said the authors combined studies “that are not comparable and that asked very different questions.” Two of the studies in the meta-analysis are very large, and four are very small, which skews the results, he explained.

“The larger studies therefore drive the outcome, and while the small studies are potentially insight providing, the large studies are the only ones worth giving our attention to in the context of the meta-analysis,” he said. The two largest studies – RECOVERY and COLCORONA – taken together show no benefit for colchicine as a treatment, even though the former demonstrated no benefit and the latter did show a benefit, explained Dr. Pillinger, a co–principal investigator for the COLCORONA trial in the United States.

The studies were designed differently and should not have been included in the same analysis, Dr. Pillinger argued. In the case of COLCORONA, early treatment with colchicine was the intervention, whereas RECOVERY focused on hospitalized patients.

“In designing [COLCORONA], the author group (of whom I was a member) expressly rejected the idea that colchicine might be useful for the sicker hospitalized patients, based on the long experience with colchicine of some of us as rheumatologists,” Dr. Pillinger said.

“In short, COLCORONA proved a benefit of colchicine in outpatient COVID-19, and its authors presumed there would be no inpatient benefit; RECOVERY went ahead and proved a lack of inpatient benefit, at least when high-dose steroids were also given,” he said. “While there is no conflict between these results, the combination of the two studies in this meta-analysis suggests there might be no benefit for colchicine overall, which is misleading and can lead physicians to reject the potential of outpatient colchicine, even for future studies.”

Dr. Pillinger said he still believes colchicine has potential value as a COVID-19 treatment option for patients with mild disease, “especially for low–vaccine rate, resource-starved countries.

“It would be unfortunate if meta-analyses such as this one would put a stop to colchicine’s use, or at least its further investigation,” he said.
 

Study details

The authors of the study assessed heterogeneity of the trials’ data across the outcomes using an I2 test. They evaluated the quality of the evidence for the outcomes using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE).

The results of their meta-analysis showed that colchicine offered no significant improvement in mortality in six studies (risk difference, –0.0; 95% confidence interval, –0.01 to 0.01; I2 = 15%). It showed no benefit with respect to requiring ventilatory support in five studies of 15,519 patients (risk ratio, 0.67; 95% CI, 0.38-1.21; I2 = 47%); being admitted to the ICU in three studies with 220 patients (RR, 0.49; 95% CI, 0.19-1.25; I2 = 34%); and length of stay while in the hospital in four studies of 11,560 patients (mean difference, –1.17; 95% CI, –3.02 to 0.67; I2 = 77%).

There was no difference in serious adverse events in three studies with 4,665 patients (RD, –0.01; 95% CI, –0.02 to 0.00; I2 = 28%) for patients who received colchicine, compared with supportive care alone. Patients who received colchicine were more likely to have a higher rate of adverse events (RR, 1.58; 95% CI, 1.07-2.33; I2 = 81%) and to experience diarrhea (RR, 1.93; 95% CI, 1.62-2.29; I2 = 0%) than were patients who received supportive care alone. The researchers note that for most outcomes, the GRADE quality of evidence was moderate.

“Our findings on colchicine should be interpreted cautiously due to the inclusion of open-labeled, randomized clinical trials,” Dr. Mehta and colleagues write. “The analysis of efficacy and safety outcomes are based on a small number of RCTs in control interventions.”

The authors reported no relevant financial relationships. Dr. Pillinger is co–principal investigator of the U.S. component of the COLCORONA trial; he reported no other relevant conflicts of interest.

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

In a randomized controlled trial of close to 1,000 Ugandan children and youth with latent rheumatic heart disease (RHD), those who received monthly injections of penicillin G benzathine for 2 years had less disease progression than those who did not.

RHD, a valvular heart disease caused by rheumatic fever that develops after untreated Streptococcus pyogenes infection, is the most common acquired cardiovascular disease among children and young adults.

“It is clear that secondary antibiotic prophylaxis can improve outcomes for children with echo-detected rheumatic RHD,” co–lead author of the study, Andrea Z. Beaton, MD, said in an interview.

“There is huge potential here, but we are not quite ready to advocate for this strategy as a broad public health approach,” said Dr. Beaton, a pediatric cardiologist at Cincinnati Children’s Hospital Medical Center.

“We need to understand more the practical translation of this strategy to a low-resourced public health system at scale, improve [penicillin G benzathine] supply, and improve community and health care worker knowledge of this disease.”

Dr. Beaton presented the findings at the American Heart Association scientific sessions, and the study was simultaneously published in the New England Journal of Medicine on Nov. 13, 2021.

The GOAL trial – or the Gwoko Adunu pa Lutino trial, meaning “protect the heart of a child” – screened 102,200 children and adolescents aged 5-17. Of these kids and teenagers, 926 (0.9%) were diagnosed with latent RHD based on a confirmatory electrocardiogram.

“For now, I would say, if you are screening, then kids found to have latent RHD should be put on prophylaxis,” Dr. Beaton said.

“I think this is also a powerful call for more research [severely lacking in RHD],” to improve risk stratification, determine how to implement screening and prophylaxis programs, and develop new and better approaches for RHD prevention and care.

“This essential trial partially addresses the clinical equipoise that has developed regarding penicillin administration in latent RHD,” said Gabriele Rossi, MD, MPH, who was not involved with this research.

It showed that, out of the final 818 participants included in the modified intention-to-treat analysis, a total of 3 (0.8%) in the prophylaxis group had echocardiographic progression at 2 years, compared with 33 participants (8.2%) in the control group (risk difference, −7.5 percentage points; 95% confidence interval, −10.2 to −4.7; P < .001).

“This is a significant difference,” Dr. Rossi, from Médecins Sans Frontières (Doctors Without Borders), Brussels, said in an interview, noting that, however, it is not known what happens after 2 years.

The authors estimated that 13 children or adolescents with latent rheumatic heart disease would need to be treated to prevent disease progression in one person at 2 years, which is “acceptable,” he continued.

However, “screening, diagnosis, clinical follow-up, treatment, and program management [would] require substantial strengthening of health systems and the workforce, which is still far from being realizable in many African and low-income country settings,” Dr. Rossi noted.

Related study in Italy

Previously, Dr. Rossi and colleagues conducted a trial, published in 2019, that showed it was feasible to screen for asymptomatic RHD among refugee/migrant children and youths in Rome.

From February 2016 to January 2018, they screened more than 650 refugee/migrant children and adolescents who were younger than 18. They came largely from Egypt (65%) but also from 22 other countries and were often unaccompanied or with just one parent.

The number needed to screen was 5 to identify a child/youth with borderline RHD and around 40 to identify a child/youth with definite RHD.

Dr. Rossi noted that local resurgences of RHD have also been also documented in high-income countries such as Europe, Australia, New Zealand, Canada, and the United States, often among disadvantaged indigenous people, as described in a 2018 Letter to the Editor in the New England Journal of Medicine.

Dr. Beaton noted that a review of 10-year data (2008-2018) from 22 U.S. pediatric institutions showed that in the United States the prevalence of RHD “is higher in immigrant children from RHD endemic areas, but because of total numbers, more RHD cases than not are domestic.” Children living in more deprived communities are at risk for more severe disease, and the burden in U.S. territories is also quite high.
 

Screening and secondary prophylaxis

The aim of the current GOAL study was to evaluate if screening and treatment with penicillin G benzathine could detect and prevent progression of latent rheumatic heart disease in 5- to 17-year-olds living in Gulu, Uganda. The trial was conducted from July 2018 to October 2020.

“School education and community sensitization was done prior to the trial,” through radio shows or school-based education, Dr. Beaton explained. About 99% of the children/adolescents/families agreed to be screened.

The group has been conducting echo screening research in Uganda for 10 years, she noted. They have developed peer group and case manager strategies to aid participant retention, as they describe in an article about the study protocol.

The screening echocardiograms were interpreted by about 30 providers and four cardiologists reviewed confirmatory echocardiograms.

Two participants in the prophylaxis group had serious adverse events that were attributable to receipt of prophylaxis, including one episode of a mild anaphylactic reaction (representing <0.1% of all administered doses of prophylaxis).

Once children and adolescents have moderate/severe RHD, there is not much that can be done in lower- and middle-income countries, where surgery for this is uncommon, Dr. Beaton explained. Around 30% of children and adolescents with this condition who come to clinical attention in Uganda die within 9 months.
 

Further research

Dr. Beaton and colleagues have just started a trial to investigate the burden of RHD among Native American youth, which has not been studied since the 1970s.

They also have an ongoing study looking at the efficacy of a pragmatic, community-based sore throat program to prevent RHD.

“Unfortunately, this strategy has not worked well in low-to-middle income countries, for a variety of reasons so far,” Dr. Beaton noted, and the cost-effectiveness of this preventive strategy is questionable.

The trial was supported by the Thrasher Research Fund, Gift of Life International, Children’s National Hospital Foundation (Zachary Blumenfeld Fund and Race for Every Child [Team Jocelyn]), the Elias-Ginsburg Family, Wiley Rein, Philips Foundation, AT&T Foundation, Heart Healers International, the Karp Family Foundation, Huron Philanthropies, and the Cincinnati Children’s Hospital Heart Institute Research Core. Dr. Beaton and Dr. Rossi disclosed no relevant financial relationships.

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

In a randomized controlled trial of close to 1,000 Ugandan children and youth with latent rheumatic heart disease (RHD), those who received monthly injections of penicillin G benzathine for 2 years had less disease progression than those who did not.

RHD, a valvular heart disease caused by rheumatic fever that develops after untreated Streptococcus pyogenes infection, is the most common acquired cardiovascular disease among children and young adults.

“It is clear that secondary antibiotic prophylaxis can improve outcomes for children with echo-detected rheumatic RHD,” co–lead author of the study, Andrea Z. Beaton, MD, said in an interview.

“There is huge potential here, but we are not quite ready to advocate for this strategy as a broad public health approach,” said Dr. Beaton, a pediatric cardiologist at Cincinnati Children’s Hospital Medical Center.

“We need to understand more the practical translation of this strategy to a low-resourced public health system at scale, improve [penicillin G benzathine] supply, and improve community and health care worker knowledge of this disease.”

Dr. Beaton presented the findings at the American Heart Association scientific sessions, and the study was simultaneously published in the New England Journal of Medicine on Nov. 13, 2021.

The GOAL trial – or the Gwoko Adunu pa Lutino trial, meaning “protect the heart of a child” – screened 102,200 children and adolescents aged 5-17. Of these kids and teenagers, 926 (0.9%) were diagnosed with latent RHD based on a confirmatory electrocardiogram.

“For now, I would say, if you are screening, then kids found to have latent RHD should be put on prophylaxis,” Dr. Beaton said.

“I think this is also a powerful call for more research [severely lacking in RHD],” to improve risk stratification, determine how to implement screening and prophylaxis programs, and develop new and better approaches for RHD prevention and care.

“This essential trial partially addresses the clinical equipoise that has developed regarding penicillin administration in latent RHD,” said Gabriele Rossi, MD, MPH, who was not involved with this research.

It showed that, out of the final 818 participants included in the modified intention-to-treat analysis, a total of 3 (0.8%) in the prophylaxis group had echocardiographic progression at 2 years, compared with 33 participants (8.2%) in the control group (risk difference, −7.5 percentage points; 95% confidence interval, −10.2 to −4.7; P < .001).

“This is a significant difference,” Dr. Rossi, from Médecins Sans Frontières (Doctors Without Borders), Brussels, said in an interview, noting that, however, it is not known what happens after 2 years.

The authors estimated that 13 children or adolescents with latent rheumatic heart disease would need to be treated to prevent disease progression in one person at 2 years, which is “acceptable,” he continued.

However, “screening, diagnosis, clinical follow-up, treatment, and program management [would] require substantial strengthening of health systems and the workforce, which is still far from being realizable in many African and low-income country settings,” Dr. Rossi noted.

Related study in Italy

Previously, Dr. Rossi and colleagues conducted a trial, published in 2019, that showed it was feasible to screen for asymptomatic RHD among refugee/migrant children and youths in Rome.

From February 2016 to January 2018, they screened more than 650 refugee/migrant children and adolescents who were younger than 18. They came largely from Egypt (65%) but also from 22 other countries and were often unaccompanied or with just one parent.

The number needed to screen was 5 to identify a child/youth with borderline RHD and around 40 to identify a child/youth with definite RHD.

Dr. Rossi noted that local resurgences of RHD have also been also documented in high-income countries such as Europe, Australia, New Zealand, Canada, and the United States, often among disadvantaged indigenous people, as described in a 2018 Letter to the Editor in the New England Journal of Medicine.

Dr. Beaton noted that a review of 10-year data (2008-2018) from 22 U.S. pediatric institutions showed that in the United States the prevalence of RHD “is higher in immigrant children from RHD endemic areas, but because of total numbers, more RHD cases than not are domestic.” Children living in more deprived communities are at risk for more severe disease, and the burden in U.S. territories is also quite high.
 

Screening and secondary prophylaxis

The aim of the current GOAL study was to evaluate if screening and treatment with penicillin G benzathine could detect and prevent progression of latent rheumatic heart disease in 5- to 17-year-olds living in Gulu, Uganda. The trial was conducted from July 2018 to October 2020.

“School education and community sensitization was done prior to the trial,” through radio shows or school-based education, Dr. Beaton explained. About 99% of the children/adolescents/families agreed to be screened.

The group has been conducting echo screening research in Uganda for 10 years, she noted. They have developed peer group and case manager strategies to aid participant retention, as they describe in an article about the study protocol.

The screening echocardiograms were interpreted by about 30 providers and four cardiologists reviewed confirmatory echocardiograms.

Two participants in the prophylaxis group had serious adverse events that were attributable to receipt of prophylaxis, including one episode of a mild anaphylactic reaction (representing <0.1% of all administered doses of prophylaxis).

Once children and adolescents have moderate/severe RHD, there is not much that can be done in lower- and middle-income countries, where surgery for this is uncommon, Dr. Beaton explained. Around 30% of children and adolescents with this condition who come to clinical attention in Uganda die within 9 months.
 

Further research

Dr. Beaton and colleagues have just started a trial to investigate the burden of RHD among Native American youth, which has not been studied since the 1970s.

They also have an ongoing study looking at the efficacy of a pragmatic, community-based sore throat program to prevent RHD.

“Unfortunately, this strategy has not worked well in low-to-middle income countries, for a variety of reasons so far,” Dr. Beaton noted, and the cost-effectiveness of this preventive strategy is questionable.

The trial was supported by the Thrasher Research Fund, Gift of Life International, Children’s National Hospital Foundation (Zachary Blumenfeld Fund and Race for Every Child [Team Jocelyn]), the Elias-Ginsburg Family, Wiley Rein, Philips Foundation, AT&T Foundation, Heart Healers International, the Karp Family Foundation, Huron Philanthropies, and the Cincinnati Children’s Hospital Heart Institute Research Core. Dr. Beaton and Dr. Rossi disclosed no relevant financial relationships.

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

In a randomized controlled trial of close to 1,000 Ugandan children and youth with latent rheumatic heart disease (RHD), those who received monthly injections of penicillin G benzathine for 2 years had less disease progression than those who did not.

RHD, a valvular heart disease caused by rheumatic fever that develops after untreated Streptococcus pyogenes infection, is the most common acquired cardiovascular disease among children and young adults.

“It is clear that secondary antibiotic prophylaxis can improve outcomes for children with echo-detected rheumatic RHD,” co–lead author of the study, Andrea Z. Beaton, MD, said in an interview.

“There is huge potential here, but we are not quite ready to advocate for this strategy as a broad public health approach,” said Dr. Beaton, a pediatric cardiologist at Cincinnati Children’s Hospital Medical Center.

“We need to understand more the practical translation of this strategy to a low-resourced public health system at scale, improve [penicillin G benzathine] supply, and improve community and health care worker knowledge of this disease.”

Dr. Beaton presented the findings at the American Heart Association scientific sessions, and the study was simultaneously published in the New England Journal of Medicine on Nov. 13, 2021.

The GOAL trial – or the Gwoko Adunu pa Lutino trial, meaning “protect the heart of a child” – screened 102,200 children and adolescents aged 5-17. Of these kids and teenagers, 926 (0.9%) were diagnosed with latent RHD based on a confirmatory electrocardiogram.

“For now, I would say, if you are screening, then kids found to have latent RHD should be put on prophylaxis,” Dr. Beaton said.

“I think this is also a powerful call for more research [severely lacking in RHD],” to improve risk stratification, determine how to implement screening and prophylaxis programs, and develop new and better approaches for RHD prevention and care.

“This essential trial partially addresses the clinical equipoise that has developed regarding penicillin administration in latent RHD,” said Gabriele Rossi, MD, MPH, who was not involved with this research.

It showed that, out of the final 818 participants included in the modified intention-to-treat analysis, a total of 3 (0.8%) in the prophylaxis group had echocardiographic progression at 2 years, compared with 33 participants (8.2%) in the control group (risk difference, −7.5 percentage points; 95% confidence interval, −10.2 to −4.7; P < .001).

“This is a significant difference,” Dr. Rossi, from Médecins Sans Frontières (Doctors Without Borders), Brussels, said in an interview, noting that, however, it is not known what happens after 2 years.

The authors estimated that 13 children or adolescents with latent rheumatic heart disease would need to be treated to prevent disease progression in one person at 2 years, which is “acceptable,” he continued.

However, “screening, diagnosis, clinical follow-up, treatment, and program management [would] require substantial strengthening of health systems and the workforce, which is still far from being realizable in many African and low-income country settings,” Dr. Rossi noted.

Related study in Italy

Previously, Dr. Rossi and colleagues conducted a trial, published in 2019, that showed it was feasible to screen for asymptomatic RHD among refugee/migrant children and youths in Rome.

From February 2016 to January 2018, they screened more than 650 refugee/migrant children and adolescents who were younger than 18. They came largely from Egypt (65%) but also from 22 other countries and were often unaccompanied or with just one parent.

The number needed to screen was 5 to identify a child/youth with borderline RHD and around 40 to identify a child/youth with definite RHD.

Dr. Rossi noted that local resurgences of RHD have also been also documented in high-income countries such as Europe, Australia, New Zealand, Canada, and the United States, often among disadvantaged indigenous people, as described in a 2018 Letter to the Editor in the New England Journal of Medicine.

Dr. Beaton noted that a review of 10-year data (2008-2018) from 22 U.S. pediatric institutions showed that in the United States the prevalence of RHD “is higher in immigrant children from RHD endemic areas, but because of total numbers, more RHD cases than not are domestic.” Children living in more deprived communities are at risk for more severe disease, and the burden in U.S. territories is also quite high.
 

Screening and secondary prophylaxis

The aim of the current GOAL study was to evaluate if screening and treatment with penicillin G benzathine could detect and prevent progression of latent rheumatic heart disease in 5- to 17-year-olds living in Gulu, Uganda. The trial was conducted from July 2018 to October 2020.

“School education and community sensitization was done prior to the trial,” through radio shows or school-based education, Dr. Beaton explained. About 99% of the children/adolescents/families agreed to be screened.

The group has been conducting echo screening research in Uganda for 10 years, she noted. They have developed peer group and case manager strategies to aid participant retention, as they describe in an article about the study protocol.

The screening echocardiograms were interpreted by about 30 providers and four cardiologists reviewed confirmatory echocardiograms.

Two participants in the prophylaxis group had serious adverse events that were attributable to receipt of prophylaxis, including one episode of a mild anaphylactic reaction (representing <0.1% of all administered doses of prophylaxis).

Once children and adolescents have moderate/severe RHD, there is not much that can be done in lower- and middle-income countries, where surgery for this is uncommon, Dr. Beaton explained. Around 30% of children and adolescents with this condition who come to clinical attention in Uganda die within 9 months.
 

Further research

Dr. Beaton and colleagues have just started a trial to investigate the burden of RHD among Native American youth, which has not been studied since the 1970s.

They also have an ongoing study looking at the efficacy of a pragmatic, community-based sore throat program to prevent RHD.

“Unfortunately, this strategy has not worked well in low-to-middle income countries, for a variety of reasons so far,” Dr. Beaton noted, and the cost-effectiveness of this preventive strategy is questionable.

The trial was supported by the Thrasher Research Fund, Gift of Life International, Children’s National Hospital Foundation (Zachary Blumenfeld Fund and Race for Every Child [Team Jocelyn]), the Elias-Ginsburg Family, Wiley Rein, Philips Foundation, AT&T Foundation, Heart Healers International, the Karp Family Foundation, Huron Philanthropies, and the Cincinnati Children’s Hospital Heart Institute Research Core. Dr. Beaton and Dr. Rossi disclosed no relevant financial relationships.

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

Patients with giant cell arteritis (GCA) remained in remission longer when they took secukinumab (Cosentyx) during a 6-month–long taper of glucocorticoids, a monoclonal antibody drug that inhibits interleukin-17A, compared with placebo, according to phase 2 trial results presented at the virtual annual meeting of the American College of Rheumatology.

The mainstay of GCA treatment is glucocorticoids, although IL-6 inhibition with tocilizumab (Actemra) has recently become another option, Jens Thiel, MD, vice director of the Clinic for Rheumatology and Clinical Immunology at University Hospital Freiburg (Germany), told attendees.

“Secukinumab has shown significant improvements in the signs and symptoms of IL-17A-driven medical conditions such as psoriasis and psoriatic arthritis, and it has a very favorable long-term safety profile,” Dr. Thiel said. “There is experimental and preclinical data that points toward the role of IL-17A in the pathogenesis of giant cell arteritis, and therefore IL-17A inhibition, blocking vascular inflammation, is potentially a new therapeutic target for GCA.”

Christopher R. Palma, MD, ScM, assistant professor in the division of allergy, immunology, and rheumatology at the University of Rochester (N.Y.), said in an interview that the trial’s preliminary findings were exciting because they suggest that IL-17A is likely to be an effective strategy for treating GCA. ”This aligns with known pathophysiology of GCA, where IL-17A is an important part of pathology of disease,” Dr. Palma said.

In the randomized, controlled, double-blind trial, researchers enrolled 52 patients, all at least 50 years old, who had never taken a biologic for GCA. Most of the participants (80.8%) had new-onset GCA, diagnosed within the previous 6 weeks, and 19.2% had relapsing GCA. The participants received either 300 mg of secukinumab or placebo every week for 5 weeks, and then every 4 weeks for 48 total weeks. At baseline, all participants also began a 26-week taper of prednisolone from a dose of 25-60 mg/day at baseline to 0 at week 27. The primary endpoint was the proportion of participants in sustained remission through week 28.

Among the 27 participants taking secukinumab and the 25 taking placebo, 37 completed the study treatment (71%). At week 28, those still in remission included 70.1% of participants taking secukinumab and 20.3% of those taking placebo (odds ratio [OR], 9.3). Through week 52, the proportion of participants in remission included 59.3% of the secukinumab group and 8% of the placebo group.

Determination of flare was based on signs and symptoms along with a C-reactive protein level of more than 10 mg/L or an increased erythrocyte sedimentation rate. Dr. Thiel did not provide more details on these parameters or on how flares were determined, but reported that participants taking secukinumab did not reach a median time to first flare, compared to a median 197 days in the placebo group.

All the participants taking secukinumab and 96% of those taking placebo experienced treatment-emergent adverse events, with serious adverse events occurring in 22.2% of those taking secukinumab and 44% of those taking placebo. Two patients in each group discontinued the treatment because of adverse events, and one participant in each group died from causes determined to be unrelated to the treatment.

The trial’s effect size was large, but Dr. Palma noted that the study’s generalizability is limited by prednisolone tapering in the placebo arm because that’s not reflective of most clinical practice for treatment of GCA.

“We would be unlikely to mimic this trial design as we know rates of disease flare and recurrence are high without long-term therapy of some kind,” Dr. Palma said. ”The real challenge will be in assessing relative benefit and risk among many possible therapies and how IL-17A–directed therapies fit in. Obviously, a head-to-head trial design would help answer many of these questions.”

Dr. Palma said it’s too early to recommend widespread off-label use of secukinumab for GCA, but he would encourage his patients with GCA to consider participating in a phase 3 trial of the drug.

Novartis, which markets secukinumab, funded the research. Dr. Thiel has received speaking and/or advising fees from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, and Novartis, and research grants from Bristol-Myers Squibb and Novartis. His coauthors had disclosures for a wide range of pharmaceutical companies. Dr. Palma has received research funding from AbbVie, Incyte, and Regeneron.

Patients with giant cell arteritis (GCA) remained in remission longer when they took secukinumab (Cosentyx) during a 6-month–long taper of glucocorticoids, a monoclonal antibody drug that inhibits interleukin-17A, compared with placebo, according to phase 2 trial results presented at the virtual annual meeting of the American College of Rheumatology.

The mainstay of GCA treatment is glucocorticoids, although IL-6 inhibition with tocilizumab (Actemra) has recently become another option, Jens Thiel, MD, vice director of the Clinic for Rheumatology and Clinical Immunology at University Hospital Freiburg (Germany), told attendees.

“Secukinumab has shown significant improvements in the signs and symptoms of IL-17A-driven medical conditions such as psoriasis and psoriatic arthritis, and it has a very favorable long-term safety profile,” Dr. Thiel said. “There is experimental and preclinical data that points toward the role of IL-17A in the pathogenesis of giant cell arteritis, and therefore IL-17A inhibition, blocking vascular inflammation, is potentially a new therapeutic target for GCA.”

Christopher R. Palma, MD, ScM, assistant professor in the division of allergy, immunology, and rheumatology at the University of Rochester (N.Y.), said in an interview that the trial’s preliminary findings were exciting because they suggest that IL-17A is likely to be an effective strategy for treating GCA. ”This aligns with known pathophysiology of GCA, where IL-17A is an important part of pathology of disease,” Dr. Palma said.

In the randomized, controlled, double-blind trial, researchers enrolled 52 patients, all at least 50 years old, who had never taken a biologic for GCA. Most of the participants (80.8%) had new-onset GCA, diagnosed within the previous 6 weeks, and 19.2% had relapsing GCA. The participants received either 300 mg of secukinumab or placebo every week for 5 weeks, and then every 4 weeks for 48 total weeks. At baseline, all participants also began a 26-week taper of prednisolone from a dose of 25-60 mg/day at baseline to 0 at week 27. The primary endpoint was the proportion of participants in sustained remission through week 28.

Among the 27 participants taking secukinumab and the 25 taking placebo, 37 completed the study treatment (71%). At week 28, those still in remission included 70.1% of participants taking secukinumab and 20.3% of those taking placebo (odds ratio [OR], 9.3). Through week 52, the proportion of participants in remission included 59.3% of the secukinumab group and 8% of the placebo group.

Determination of flare was based on signs and symptoms along with a C-reactive protein level of more than 10 mg/L or an increased erythrocyte sedimentation rate. Dr. Thiel did not provide more details on these parameters or on how flares were determined, but reported that participants taking secukinumab did not reach a median time to first flare, compared to a median 197 days in the placebo group.

All the participants taking secukinumab and 96% of those taking placebo experienced treatment-emergent adverse events, with serious adverse events occurring in 22.2% of those taking secukinumab and 44% of those taking placebo. Two patients in each group discontinued the treatment because of adverse events, and one participant in each group died from causes determined to be unrelated to the treatment.

The trial’s effect size was large, but Dr. Palma noted that the study’s generalizability is limited by prednisolone tapering in the placebo arm because that’s not reflective of most clinical practice for treatment of GCA.

“We would be unlikely to mimic this trial design as we know rates of disease flare and recurrence are high without long-term therapy of some kind,” Dr. Palma said. ”The real challenge will be in assessing relative benefit and risk among many possible therapies and how IL-17A–directed therapies fit in. Obviously, a head-to-head trial design would help answer many of these questions.”

Dr. Palma said it’s too early to recommend widespread off-label use of secukinumab for GCA, but he would encourage his patients with GCA to consider participating in a phase 3 trial of the drug.

Novartis, which markets secukinumab, funded the research. Dr. Thiel has received speaking and/or advising fees from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, and Novartis, and research grants from Bristol-Myers Squibb and Novartis. His coauthors had disclosures for a wide range of pharmaceutical companies. Dr. Palma has received research funding from AbbVie, Incyte, and Regeneron.

Patients with giant cell arteritis (GCA) remained in remission longer when they took secukinumab (Cosentyx) during a 6-month–long taper of glucocorticoids, a monoclonal antibody drug that inhibits interleukin-17A, compared with placebo, according to phase 2 trial results presented at the virtual annual meeting of the American College of Rheumatology.

The mainstay of GCA treatment is glucocorticoids, although IL-6 inhibition with tocilizumab (Actemra) has recently become another option, Jens Thiel, MD, vice director of the Clinic for Rheumatology and Clinical Immunology at University Hospital Freiburg (Germany), told attendees.

“Secukinumab has shown significant improvements in the signs and symptoms of IL-17A-driven medical conditions such as psoriasis and psoriatic arthritis, and it has a very favorable long-term safety profile,” Dr. Thiel said. “There is experimental and preclinical data that points toward the role of IL-17A in the pathogenesis of giant cell arteritis, and therefore IL-17A inhibition, blocking vascular inflammation, is potentially a new therapeutic target for GCA.”

Christopher R. Palma, MD, ScM, assistant professor in the division of allergy, immunology, and rheumatology at the University of Rochester (N.Y.), said in an interview that the trial’s preliminary findings were exciting because they suggest that IL-17A is likely to be an effective strategy for treating GCA. ”This aligns with known pathophysiology of GCA, where IL-17A is an important part of pathology of disease,” Dr. Palma said.

In the randomized, controlled, double-blind trial, researchers enrolled 52 patients, all at least 50 years old, who had never taken a biologic for GCA. Most of the participants (80.8%) had new-onset GCA, diagnosed within the previous 6 weeks, and 19.2% had relapsing GCA. The participants received either 300 mg of secukinumab or placebo every week for 5 weeks, and then every 4 weeks for 48 total weeks. At baseline, all participants also began a 26-week taper of prednisolone from a dose of 25-60 mg/day at baseline to 0 at week 27. The primary endpoint was the proportion of participants in sustained remission through week 28.

Among the 27 participants taking secukinumab and the 25 taking placebo, 37 completed the study treatment (71%). At week 28, those still in remission included 70.1% of participants taking secukinumab and 20.3% of those taking placebo (odds ratio [OR], 9.3). Through week 52, the proportion of participants in remission included 59.3% of the secukinumab group and 8% of the placebo group.

Determination of flare was based on signs and symptoms along with a C-reactive protein level of more than 10 mg/L or an increased erythrocyte sedimentation rate. Dr. Thiel did not provide more details on these parameters or on how flares were determined, but reported that participants taking secukinumab did not reach a median time to first flare, compared to a median 197 days in the placebo group.

All the participants taking secukinumab and 96% of those taking placebo experienced treatment-emergent adverse events, with serious adverse events occurring in 22.2% of those taking secukinumab and 44% of those taking placebo. Two patients in each group discontinued the treatment because of adverse events, and one participant in each group died from causes determined to be unrelated to the treatment.

The trial’s effect size was large, but Dr. Palma noted that the study’s generalizability is limited by prednisolone tapering in the placebo arm because that’s not reflective of most clinical practice for treatment of GCA.

“We would be unlikely to mimic this trial design as we know rates of disease flare and recurrence are high without long-term therapy of some kind,” Dr. Palma said. ”The real challenge will be in assessing relative benefit and risk among many possible therapies and how IL-17A–directed therapies fit in. Obviously, a head-to-head trial design would help answer many of these questions.”

Dr. Palma said it’s too early to recommend widespread off-label use of secukinumab for GCA, but he would encourage his patients with GCA to consider participating in a phase 3 trial of the drug.

Novartis, which markets secukinumab, funded the research. Dr. Thiel has received speaking and/or advising fees from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, and Novartis, and research grants from Bristol-Myers Squibb and Novartis. His coauthors had disclosures for a wide range of pharmaceutical companies. Dr. Palma has received research funding from AbbVie, Incyte, and Regeneron.

Health experts are warning the United States could be headed for another COVID-19 surge just as we enter the holiday season, following a massive new wave of infections in Europe – a troubling pattern seen throughout the pandemic.

Eighteen months into the global health crisis that has killed 5.1 million people worldwide including more than 767,000 Americans, Europe has become the epicenter of the global health crisis once again.

And some infectious disease specialists say the United States may be next.

“It’s déjà vu, yet again,” says Eric Topol, M.D., founder and director of the Scripps Research Translational Institute. In a new analysis published in The Guardian, the professor of molecular medicine argues that it’s “wishful thinking” for U.S. authorities to believe the nation is “immune” to what’s happening in Europe.

Dr. Topol is also editor-in-chief of Medscape, MDedge’s sister site for medical professionals.

Three times over the past 18 months coronavirus surges in the United States followed similar spikes in Europe, where COVID-19 deaths grew by 10% this month.

Dr. Topol argues another wave may be in store for the states, as European countries implement new lockdowns. COVID-19 spikes are hitting some regions of the continent hard, including areas with high vaccination rates and strict control measures.

Eastern Europe and Russia, where vaccination rates are low, have experienced the worst of it. But even western countries, such as Germany, Austria and the United Kingdom, are reporting some of the highest daily infection figures in the world today.

Countries are responding in increasingly drastic ways.

In Russia, President Vladimir Putin ordered tens of thousands of workers to stay home earlier this month.

In the Dutch city of Utrecht, traditional Christmas celebrations have been canceled as the country is headed for a partial lockdown.

Austria announced a 20-day lockdown beginning Nov. 22 and on Nov. 19 leaders there announced that all 9 million residents will be required to be vaccinated by February. Leaders there are telling unvaccinated individuals to stay at home and out of restaurants, cafes, and other shops in hard-hit regions of the country.

And in Germany, where daily new-infection rates now stand at 50,000, officials have introduced stricter mask mandates and made proof of vaccination or past infection mandatory for entry to many venues. Berlin is also eyeing proposals to shut down the city’s traditional Christmas markets while authorities in Cologne have already called off holiday celebrations, after the ceremonial head of festivities tested positive for COVID-19. Bavaria canceled its popular Christmas markets and will order lockdowns in particularly vulnerable districts, while unvaccinated people will face serious restrictions on where they can go.

Former FDA Commissioner Scott Gottlieb, MD, says what’s happening across the European continent is troubling.

But he also believes it’s possible the United States may be better prepared to head off a similar surge this time around, with increased testing, vaccination and new therapies such as monoclonal antibodies, and antiviral therapeutics.

“Germany’s challenges are [a] caution to [the] world, the COVID pandemic isn’t over globally, won’t be for long time,” he says. “But [the] U.S. is further along than many other countries, in part because we already suffered more spread, in part because we’re making progress on vaccines, therapeutics, testing.”

Other experts agree the United States may not be as vulnerable to another wave of COVID-19 in coming weeks but have stopped short of suggesting we’re out of the woods.

“I don’t think that what we’re seeing in Europe necessarily means that we’re in for a huge surge of serious illness and death the way that we saw last year here in the states,” says David Dowdy, MD, PhD, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health and a general internist with Baltimore Medical Services.

“But I think anyone who says that they can predict the course of the pandemic for the next few months or few years has been proven wrong in the past and will probably be proven wrong in the future,” Dr. Dowdy says. “None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness.”
 

Looking back, and forward

What’s happening in Europe today mirrors past COVID-19 spikes that presaged big upticks in cases, hospitalizations, and deaths in the United States.

When the pandemic first hit Europe in March 2020, then-President Donald Trump downplayed the threat of the virus despite the warnings of his own advisors and independent public health experts who said COVID-19 could have dire impacts without an aggressive federal action plan.

By late spring the United States had become the epicenter of the pandemic, when case totals eclipsed those of other countries and New York City became a hot zone, according to data compiled by the Johns Hopkins Coronavirus Resource Center. Over the summer, spread of the disease slowed in New York, after tough control measures were instituted, but steadily increased in other states.

Then, later in the year, the Alpha variant of the virus took hold in the United Kingdom and the United States was again unprepared. By winter, the number of cases accelerated in every state in a major second surge that kept millions of Americans from traveling and gathering for the winter holidays.

With the rollout of COVID vaccines last December, cases in the United States – and in many parts of the world – began to fall. Some experts even suggested we’d turned a corner on the pandemic.

But then, last spring and summer, the Delta variant popped up in India and spread to the United Kingdom in a third major wave of COVID. Once again, the United States was unprepared, with 4 in 10 Americans refusing the vaccine and even some vaccinated individuals succumbing to breakthrough Delta infections.

The resulting Delta surge swept the country, preventing many businesses and schools from fully reopening and stressing hospitals in some areas of the country – particularly southern states – with new influxes of COVID-19 patients.

Now, Europe is facing another rise in COVID, with about 350 cases per 100,000 people and many countries hitting new record highs.
 

What’s driving the European resurgence?

So, what’s behind the new COVID-19 wave in Europe and what might it mean for the United States?

Shaun Truelove, PhD, an infectious disease epidemiologist and faculty member of the Johns Hopkins School of Public Health, says experts are examining several likely factors:

Waning immunity from the vaccines. Data from Johns Hopkins shows infections rising in nations with lower vaccination rates.

The impact of the Delta variant, which is three times more transmissible than the original virus and can even sicken some vaccinated individuals.

The spread of COVID-19 among teens and children; the easing of precautions (such as masking and social distancing); differences in the types of vaccines used in European nations and the United States.

“These are all possibilities,” says Dr. Truelove. “There are so many factors and so it’s difficult to pinpoint exactly what’s driving it and what effect each of those things might be having.”

As a result, it’s difficult to predict and prepare for what might lie ahead for the United States, he says.

“There’s a ton of uncertainty and we’re trying to understand what’s going to happen here over the next 6 months,” he says.

Even so, Dr. Truelove adds that what’s happening overseas might not be “super predictive” of a new wave of COVID in the United States.

For one thing, he says, the Pfizer and Moderna vaccines, the two mRNA vaccines used predominantly in the United States, are far more effective – 94-95% – than the Oxford/AstraZeneca COVID shot (63%) widely administered across Europe.

Secondly, European countries have imposed much stronger and stricter control measures throughout the pandemic than the United States. That might actually be driving the new surges because fewer unvaccinated people have been exposed to the virus, which means they have lower “natural immunity” from prior COVID infection.

Dr. Truelove explains: “Stronger and stricter control measures … have the consequence of leaving a lot more susceptible individuals in the population, [because] the stronger the controls, the fewer people get infected. And so, you have more individuals remaining in the population who are more susceptible and at risk of getting infected in the future.”

By contrast, he notes, a “large chunk” of the United States has not put strict lockdowns in place.

“So, what we’ve seen over the past couple months with the Delta wave is that in a lot of those states with lower vaccination coverage and lower controls this virus has really burned through a lot of the susceptible population. As a result, we’re seeing the curves coming down and what really looks like a lot of the built-up immunity in these states, especially southern states.”

But whether these differences will be enough for the United States to dodge another COVID-19 bullet this winter is uncertain.

“I don’t want to say that the [Europe] surge is NOT a predictor of what might come in the U.S., because I think that it very well could be,” Dr. Truelove says. “And so, people need to be aware of that, and be cautious and be sure get their vaccines and everything else.

“But I’m hopeful that because of some of the differences that maybe we’ll have a little bit of a different situation.”
 

The takeaway: How best to prepare?

Dr. Dowdy agrees that Europe’s current troubles might not necessarily mean a major new winter surge in the United States.

But he also points out that cases are beginning to head up again in New England, the Midwest, and other regions of the country that are just experiencing the first chill of winter.

“After reaching a low point about 3 weeks ago, cases due to COVID-19 have started to rise again in the United States,” he says. “Cases were falling consistently until mid-October, but over the last 3 weeks, cases have started to rise again in most states.

“Cases in Eastern and Central Europe have more than doubled during that time, meaning that the possibility of a winter surge here is very real.”

Even so, Dr. Dowdy believes the rising rates of vaccination could limit the number of Americans who will be hospitalized with severe disease or die this winter.

Still, he warns against being too optimistic, as Americans travel and get together for the winter holidays.

None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness, Dr. Dowdy says.”

The upshot?

“People need to realize that it’s not quite over,” Dr. Truelove says. “We still have a substantial amount of infection in our country. We’re still above 200 cases per million [and] 500,000 incident cases per week or so. That’s a lot of death and a lot of hospitalizations. So, we still have to be concerned and do our best to reduce transmission … by wearing masks, getting vaccinated, getting a booster shot, and getting your children vaccinated.”

Johns Hopkins social and behavioral scientist Rupali Limaye, PhD, MPH, adds that while COVID vaccines have been a “game changer” in the pandemic, more than a third of Americans have yet to receive one.

“That’s really what we need to be messaging around -- that people can still get COVID, there can still be breakthrough infections,” says Dr. Limaye, a health communications scholar. “But the great news is if you have been vaccinated, you are very much less likely, I think it’s 12 times, to be hospitalized or have severe COVID compared to those that are un-vaccinated.”

Dr. Topol agrees, adding: “Now is the time for the U.S. to heed the European signal for the first time, to pull out all the stops. Promote primary vaccination and boosters like there’s no tomorrow. Aggressively counter the pervasive misinformation and disinformation. Accelerate and expand the vaccine mandates ...

“Instead of succumbing to yet another major rise in cases and their sequelae, this is a chance for America to finally rise to the occasion, showing an ability to lead and execute.”

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

Health experts are warning the United States could be headed for another COVID-19 surge just as we enter the holiday season, following a massive new wave of infections in Europe – a troubling pattern seen throughout the pandemic.

Eighteen months into the global health crisis that has killed 5.1 million people worldwide including more than 767,000 Americans, Europe has become the epicenter of the global health crisis once again.

And some infectious disease specialists say the United States may be next.

“It’s déjà vu, yet again,” says Eric Topol, M.D., founder and director of the Scripps Research Translational Institute. In a new analysis published in The Guardian, the professor of molecular medicine argues that it’s “wishful thinking” for U.S. authorities to believe the nation is “immune” to what’s happening in Europe.

Dr. Topol is also editor-in-chief of Medscape, MDedge’s sister site for medical professionals.

Three times over the past 18 months coronavirus surges in the United States followed similar spikes in Europe, where COVID-19 deaths grew by 10% this month.

Dr. Topol argues another wave may be in store for the states, as European countries implement new lockdowns. COVID-19 spikes are hitting some regions of the continent hard, including areas with high vaccination rates and strict control measures.

Eastern Europe and Russia, where vaccination rates are low, have experienced the worst of it. But even western countries, such as Germany, Austria and the United Kingdom, are reporting some of the highest daily infection figures in the world today.

Countries are responding in increasingly drastic ways.

In Russia, President Vladimir Putin ordered tens of thousands of workers to stay home earlier this month.

In the Dutch city of Utrecht, traditional Christmas celebrations have been canceled as the country is headed for a partial lockdown.

Austria announced a 20-day lockdown beginning Nov. 22 and on Nov. 19 leaders there announced that all 9 million residents will be required to be vaccinated by February. Leaders there are telling unvaccinated individuals to stay at home and out of restaurants, cafes, and other shops in hard-hit regions of the country.

And in Germany, where daily new-infection rates now stand at 50,000, officials have introduced stricter mask mandates and made proof of vaccination or past infection mandatory for entry to many venues. Berlin is also eyeing proposals to shut down the city’s traditional Christmas markets while authorities in Cologne have already called off holiday celebrations, after the ceremonial head of festivities tested positive for COVID-19. Bavaria canceled its popular Christmas markets and will order lockdowns in particularly vulnerable districts, while unvaccinated people will face serious restrictions on where they can go.

Former FDA Commissioner Scott Gottlieb, MD, says what’s happening across the European continent is troubling.

But he also believes it’s possible the United States may be better prepared to head off a similar surge this time around, with increased testing, vaccination and new therapies such as monoclonal antibodies, and antiviral therapeutics.

“Germany’s challenges are [a] caution to [the] world, the COVID pandemic isn’t over globally, won’t be for long time,” he says. “But [the] U.S. is further along than many other countries, in part because we already suffered more spread, in part because we’re making progress on vaccines, therapeutics, testing.”

Other experts agree the United States may not be as vulnerable to another wave of COVID-19 in coming weeks but have stopped short of suggesting we’re out of the woods.

“I don’t think that what we’re seeing in Europe necessarily means that we’re in for a huge surge of serious illness and death the way that we saw last year here in the states,” says David Dowdy, MD, PhD, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health and a general internist with Baltimore Medical Services.

“But I think anyone who says that they can predict the course of the pandemic for the next few months or few years has been proven wrong in the past and will probably be proven wrong in the future,” Dr. Dowdy says. “None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness.”
 

Looking back, and forward

What’s happening in Europe today mirrors past COVID-19 spikes that presaged big upticks in cases, hospitalizations, and deaths in the United States.

When the pandemic first hit Europe in March 2020, then-President Donald Trump downplayed the threat of the virus despite the warnings of his own advisors and independent public health experts who said COVID-19 could have dire impacts without an aggressive federal action plan.

By late spring the United States had become the epicenter of the pandemic, when case totals eclipsed those of other countries and New York City became a hot zone, according to data compiled by the Johns Hopkins Coronavirus Resource Center. Over the summer, spread of the disease slowed in New York, after tough control measures were instituted, but steadily increased in other states.

Then, later in the year, the Alpha variant of the virus took hold in the United Kingdom and the United States was again unprepared. By winter, the number of cases accelerated in every state in a major second surge that kept millions of Americans from traveling and gathering for the winter holidays.

With the rollout of COVID vaccines last December, cases in the United States – and in many parts of the world – began to fall. Some experts even suggested we’d turned a corner on the pandemic.

But then, last spring and summer, the Delta variant popped up in India and spread to the United Kingdom in a third major wave of COVID. Once again, the United States was unprepared, with 4 in 10 Americans refusing the vaccine and even some vaccinated individuals succumbing to breakthrough Delta infections.

The resulting Delta surge swept the country, preventing many businesses and schools from fully reopening and stressing hospitals in some areas of the country – particularly southern states – with new influxes of COVID-19 patients.

Now, Europe is facing another rise in COVID, with about 350 cases per 100,000 people and many countries hitting new record highs.
 

What’s driving the European resurgence?

So, what’s behind the new COVID-19 wave in Europe and what might it mean for the United States?

Shaun Truelove, PhD, an infectious disease epidemiologist and faculty member of the Johns Hopkins School of Public Health, says experts are examining several likely factors:

Waning immunity from the vaccines. Data from Johns Hopkins shows infections rising in nations with lower vaccination rates.

The impact of the Delta variant, which is three times more transmissible than the original virus and can even sicken some vaccinated individuals.

The spread of COVID-19 among teens and children; the easing of precautions (such as masking and social distancing); differences in the types of vaccines used in European nations and the United States.

“These are all possibilities,” says Dr. Truelove. “There are so many factors and so it’s difficult to pinpoint exactly what’s driving it and what effect each of those things might be having.”

As a result, it’s difficult to predict and prepare for what might lie ahead for the United States, he says.

“There’s a ton of uncertainty and we’re trying to understand what’s going to happen here over the next 6 months,” he says.

Even so, Dr. Truelove adds that what’s happening overseas might not be “super predictive” of a new wave of COVID in the United States.

For one thing, he says, the Pfizer and Moderna vaccines, the two mRNA vaccines used predominantly in the United States, are far more effective – 94-95% – than the Oxford/AstraZeneca COVID shot (63%) widely administered across Europe.

Secondly, European countries have imposed much stronger and stricter control measures throughout the pandemic than the United States. That might actually be driving the new surges because fewer unvaccinated people have been exposed to the virus, which means they have lower “natural immunity” from prior COVID infection.

Dr. Truelove explains: “Stronger and stricter control measures … have the consequence of leaving a lot more susceptible individuals in the population, [because] the stronger the controls, the fewer people get infected. And so, you have more individuals remaining in the population who are more susceptible and at risk of getting infected in the future.”

By contrast, he notes, a “large chunk” of the United States has not put strict lockdowns in place.

“So, what we’ve seen over the past couple months with the Delta wave is that in a lot of those states with lower vaccination coverage and lower controls this virus has really burned through a lot of the susceptible population. As a result, we’re seeing the curves coming down and what really looks like a lot of the built-up immunity in these states, especially southern states.”

But whether these differences will be enough for the United States to dodge another COVID-19 bullet this winter is uncertain.

“I don’t want to say that the [Europe] surge is NOT a predictor of what might come in the U.S., because I think that it very well could be,” Dr. Truelove says. “And so, people need to be aware of that, and be cautious and be sure get their vaccines and everything else.

“But I’m hopeful that because of some of the differences that maybe we’ll have a little bit of a different situation.”
 

The takeaway: How best to prepare?

Dr. Dowdy agrees that Europe’s current troubles might not necessarily mean a major new winter surge in the United States.

But he also points out that cases are beginning to head up again in New England, the Midwest, and other regions of the country that are just experiencing the first chill of winter.

“After reaching a low point about 3 weeks ago, cases due to COVID-19 have started to rise again in the United States,” he says. “Cases were falling consistently until mid-October, but over the last 3 weeks, cases have started to rise again in most states.

“Cases in Eastern and Central Europe have more than doubled during that time, meaning that the possibility of a winter surge here is very real.”

Even so, Dr. Dowdy believes the rising rates of vaccination could limit the number of Americans who will be hospitalized with severe disease or die this winter.

Still, he warns against being too optimistic, as Americans travel and get together for the winter holidays.

None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness, Dr. Dowdy says.”

The upshot?

“People need to realize that it’s not quite over,” Dr. Truelove says. “We still have a substantial amount of infection in our country. We’re still above 200 cases per million [and] 500,000 incident cases per week or so. That’s a lot of death and a lot of hospitalizations. So, we still have to be concerned and do our best to reduce transmission … by wearing masks, getting vaccinated, getting a booster shot, and getting your children vaccinated.”

Johns Hopkins social and behavioral scientist Rupali Limaye, PhD, MPH, adds that while COVID vaccines have been a “game changer” in the pandemic, more than a third of Americans have yet to receive one.

“That’s really what we need to be messaging around -- that people can still get COVID, there can still be breakthrough infections,” says Dr. Limaye, a health communications scholar. “But the great news is if you have been vaccinated, you are very much less likely, I think it’s 12 times, to be hospitalized or have severe COVID compared to those that are un-vaccinated.”

Dr. Topol agrees, adding: “Now is the time for the U.S. to heed the European signal for the first time, to pull out all the stops. Promote primary vaccination and boosters like there’s no tomorrow. Aggressively counter the pervasive misinformation and disinformation. Accelerate and expand the vaccine mandates ...

“Instead of succumbing to yet another major rise in cases and their sequelae, this is a chance for America to finally rise to the occasion, showing an ability to lead and execute.”

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

Health experts are warning the United States could be headed for another COVID-19 surge just as we enter the holiday season, following a massive new wave of infections in Europe – a troubling pattern seen throughout the pandemic.

Eighteen months into the global health crisis that has killed 5.1 million people worldwide including more than 767,000 Americans, Europe has become the epicenter of the global health crisis once again.

And some infectious disease specialists say the United States may be next.

“It’s déjà vu, yet again,” says Eric Topol, M.D., founder and director of the Scripps Research Translational Institute. In a new analysis published in The Guardian, the professor of molecular medicine argues that it’s “wishful thinking” for U.S. authorities to believe the nation is “immune” to what’s happening in Europe.

Dr. Topol is also editor-in-chief of Medscape, MDedge’s sister site for medical professionals.

Three times over the past 18 months coronavirus surges in the United States followed similar spikes in Europe, where COVID-19 deaths grew by 10% this month.

Dr. Topol argues another wave may be in store for the states, as European countries implement new lockdowns. COVID-19 spikes are hitting some regions of the continent hard, including areas with high vaccination rates and strict control measures.

Eastern Europe and Russia, where vaccination rates are low, have experienced the worst of it. But even western countries, such as Germany, Austria and the United Kingdom, are reporting some of the highest daily infection figures in the world today.

Countries are responding in increasingly drastic ways.

In Russia, President Vladimir Putin ordered tens of thousands of workers to stay home earlier this month.

In the Dutch city of Utrecht, traditional Christmas celebrations have been canceled as the country is headed for a partial lockdown.

Austria announced a 20-day lockdown beginning Nov. 22 and on Nov. 19 leaders there announced that all 9 million residents will be required to be vaccinated by February. Leaders there are telling unvaccinated individuals to stay at home and out of restaurants, cafes, and other shops in hard-hit regions of the country.

And in Germany, where daily new-infection rates now stand at 50,000, officials have introduced stricter mask mandates and made proof of vaccination or past infection mandatory for entry to many venues. Berlin is also eyeing proposals to shut down the city’s traditional Christmas markets while authorities in Cologne have already called off holiday celebrations, after the ceremonial head of festivities tested positive for COVID-19. Bavaria canceled its popular Christmas markets and will order lockdowns in particularly vulnerable districts, while unvaccinated people will face serious restrictions on where they can go.

Former FDA Commissioner Scott Gottlieb, MD, says what’s happening across the European continent is troubling.

But he also believes it’s possible the United States may be better prepared to head off a similar surge this time around, with increased testing, vaccination and new therapies such as monoclonal antibodies, and antiviral therapeutics.

“Germany’s challenges are [a] caution to [the] world, the COVID pandemic isn’t over globally, won’t be for long time,” he says. “But [the] U.S. is further along than many other countries, in part because we already suffered more spread, in part because we’re making progress on vaccines, therapeutics, testing.”

Other experts agree the United States may not be as vulnerable to another wave of COVID-19 in coming weeks but have stopped short of suggesting we’re out of the woods.

“I don’t think that what we’re seeing in Europe necessarily means that we’re in for a huge surge of serious illness and death the way that we saw last year here in the states,” says David Dowdy, MD, PhD, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health and a general internist with Baltimore Medical Services.

“But I think anyone who says that they can predict the course of the pandemic for the next few months or few years has been proven wrong in the past and will probably be proven wrong in the future,” Dr. Dowdy says. “None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness.”
 

Looking back, and forward

What’s happening in Europe today mirrors past COVID-19 spikes that presaged big upticks in cases, hospitalizations, and deaths in the United States.

When the pandemic first hit Europe in March 2020, then-President Donald Trump downplayed the threat of the virus despite the warnings of his own advisors and independent public health experts who said COVID-19 could have dire impacts without an aggressive federal action plan.

By late spring the United States had become the epicenter of the pandemic, when case totals eclipsed those of other countries and New York City became a hot zone, according to data compiled by the Johns Hopkins Coronavirus Resource Center. Over the summer, spread of the disease slowed in New York, after tough control measures were instituted, but steadily increased in other states.

Then, later in the year, the Alpha variant of the virus took hold in the United Kingdom and the United States was again unprepared. By winter, the number of cases accelerated in every state in a major second surge that kept millions of Americans from traveling and gathering for the winter holidays.

With the rollout of COVID vaccines last December, cases in the United States – and in many parts of the world – began to fall. Some experts even suggested we’d turned a corner on the pandemic.

But then, last spring and summer, the Delta variant popped up in India and spread to the United Kingdom in a third major wave of COVID. Once again, the United States was unprepared, with 4 in 10 Americans refusing the vaccine and even some vaccinated individuals succumbing to breakthrough Delta infections.

The resulting Delta surge swept the country, preventing many businesses and schools from fully reopening and stressing hospitals in some areas of the country – particularly southern states – with new influxes of COVID-19 patients.

Now, Europe is facing another rise in COVID, with about 350 cases per 100,000 people and many countries hitting new record highs.
 

What’s driving the European resurgence?

So, what’s behind the new COVID-19 wave in Europe and what might it mean for the United States?

Shaun Truelove, PhD, an infectious disease epidemiologist and faculty member of the Johns Hopkins School of Public Health, says experts are examining several likely factors:

Waning immunity from the vaccines. Data from Johns Hopkins shows infections rising in nations with lower vaccination rates.

The impact of the Delta variant, which is three times more transmissible than the original virus and can even sicken some vaccinated individuals.

The spread of COVID-19 among teens and children; the easing of precautions (such as masking and social distancing); differences in the types of vaccines used in European nations and the United States.

“These are all possibilities,” says Dr. Truelove. “There are so many factors and so it’s difficult to pinpoint exactly what’s driving it and what effect each of those things might be having.”

As a result, it’s difficult to predict and prepare for what might lie ahead for the United States, he says.

“There’s a ton of uncertainty and we’re trying to understand what’s going to happen here over the next 6 months,” he says.

Even so, Dr. Truelove adds that what’s happening overseas might not be “super predictive” of a new wave of COVID in the United States.

For one thing, he says, the Pfizer and Moderna vaccines, the two mRNA vaccines used predominantly in the United States, are far more effective – 94-95% – than the Oxford/AstraZeneca COVID shot (63%) widely administered across Europe.

Secondly, European countries have imposed much stronger and stricter control measures throughout the pandemic than the United States. That might actually be driving the new surges because fewer unvaccinated people have been exposed to the virus, which means they have lower “natural immunity” from prior COVID infection.

Dr. Truelove explains: “Stronger and stricter control measures … have the consequence of leaving a lot more susceptible individuals in the population, [because] the stronger the controls, the fewer people get infected. And so, you have more individuals remaining in the population who are more susceptible and at risk of getting infected in the future.”

By contrast, he notes, a “large chunk” of the United States has not put strict lockdowns in place.

“So, what we’ve seen over the past couple months with the Delta wave is that in a lot of those states with lower vaccination coverage and lower controls this virus has really burned through a lot of the susceptible population. As a result, we’re seeing the curves coming down and what really looks like a lot of the built-up immunity in these states, especially southern states.”

But whether these differences will be enough for the United States to dodge another COVID-19 bullet this winter is uncertain.

“I don’t want to say that the [Europe] surge is NOT a predictor of what might come in the U.S., because I think that it very well could be,” Dr. Truelove says. “And so, people need to be aware of that, and be cautious and be sure get their vaccines and everything else.

“But I’m hopeful that because of some of the differences that maybe we’ll have a little bit of a different situation.”
 

The takeaway: How best to prepare?

Dr. Dowdy agrees that Europe’s current troubles might not necessarily mean a major new winter surge in the United States.

But he also points out that cases are beginning to head up again in New England, the Midwest, and other regions of the country that are just experiencing the first chill of winter.

“After reaching a low point about 3 weeks ago, cases due to COVID-19 have started to rise again in the United States,” he says. “Cases were falling consistently until mid-October, but over the last 3 weeks, cases have started to rise again in most states.

“Cases in Eastern and Central Europe have more than doubled during that time, meaning that the possibility of a winter surge here is very real.”

Even so, Dr. Dowdy believes the rising rates of vaccination could limit the number of Americans who will be hospitalized with severe disease or die this winter.

Still, he warns against being too optimistic, as Americans travel and get together for the winter holidays.

None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness, Dr. Dowdy says.”

The upshot?

“People need to realize that it’s not quite over,” Dr. Truelove says. “We still have a substantial amount of infection in our country. We’re still above 200 cases per million [and] 500,000 incident cases per week or so. That’s a lot of death and a lot of hospitalizations. So, we still have to be concerned and do our best to reduce transmission … by wearing masks, getting vaccinated, getting a booster shot, and getting your children vaccinated.”

Johns Hopkins social and behavioral scientist Rupali Limaye, PhD, MPH, adds that while COVID vaccines have been a “game changer” in the pandemic, more than a third of Americans have yet to receive one.

“That’s really what we need to be messaging around -- that people can still get COVID, there can still be breakthrough infections,” says Dr. Limaye, a health communications scholar. “But the great news is if you have been vaccinated, you are very much less likely, I think it’s 12 times, to be hospitalized or have severe COVID compared to those that are un-vaccinated.”

Dr. Topol agrees, adding: “Now is the time for the U.S. to heed the European signal for the first time, to pull out all the stops. Promote primary vaccination and boosters like there’s no tomorrow. Aggressively counter the pervasive misinformation and disinformation. Accelerate and expand the vaccine mandates ...

“Instead of succumbing to yet another major rise in cases and their sequelae, this is a chance for America to finally rise to the occasion, showing an ability to lead and execute.”

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

Smartphones are part and parcel to everyday life, including medicine. Here’s how to handle that.

Joe Lindsey, a 48-year old Colorado-based journalist, has dealt with complex hearing loss for about 15 years. which has led to countless doctor’s visits, treatments, and even surgery in hopes of finding improvement. As time went on and Mr. Lindsey’s hearing deteriorated, he began recording his appointments in order to retain important information.

Mr. Lindsey had positive intentions, but not every patient does.

With smartphones everywhere, recording medical appointments can be fraught with downsides too. While there are clear-cut reasons for recording doctor visits, patients’ goals and how they carry out the taping are key. Audio only? Or also video? With the physician’s knowledge and permission, or without?

These are the legal and ethical weeds doctors find themselves in today, so it’s important to understand all sides of the issue.

The medical world is divided on its sentiments about patients recording their visits. The American Medical Association, in fact, failed to make progress on a recent policy (resolution 007) proposal to encourage that any “audio or video recording made during a medical encounter should require both physician and patient notification and consent.” Rather than voting on the resolution, the AMA house of delegates tabled it and chose to gather more information on the issue.

In most cases, patients are recording their visits in good faith, says Jeffrey Segal, MD, JD, the CEO and founder of Medical Justice, a risk mitigation and reputation management firm for healthcare clinicians. “When it comes to ‘Team, let’s record this,’ I’m a fan,” he says. “The most common reason patients record visits is that there’s a lot of information transferred from the doctor to the patient, and there’s just not enough time to absorb it all.”

While the option is there for patients to take notes, in the give-and-take nature of conversation, this can get difficult. “If they record the visit, they can then digest it all down the road,” says Dr. Segal. “A compliant patient is one who understands what’s expected. That’s the charitable explanation for recording, and I support it.”

It’s that question of good intent, however, that concerns some physicians in today’s highly litigious society. “The worry is that there’s a small subset of patients with an ulterior motive,” says Dr. Segal.

“Some patients do record in case of an event down the road,” he adds. “They want the recording to potentially talk to a lawyer, or to file a board complaint.”

Laws in the United States surrounding recordings are confusing, with variations from state to state. Currently, 39 U.S. states allow for one-party consent — meaning a patient can record a visit without consenting with the physician.

Monica Verduzco-Gutierrez, MD, professor and chair of rehabilitation medicine at University of Texas Health, San Antonio, resides in Texas, which is one of the 39 one-consent states. “Physicians must be aware of this fact and consider how it might be used against them,” she says. “A good practice is to set expectations with the patient from the start. Also, know your hospital’s policy — some may have boundaries surrounding recordings.”

The first step is to know what type of state you practice in. Regardless of whether you are in a one- or two-party consent state — but especially a one-party state — it’s a smart move to add a sign at your office saying that you support the recording of visits, provided the patient is open and transparent about it. “Let the patient know that if they plan to record, they should ask your permission,” says Dr. Segal. “Let them know it’s not appropriate if they haven’t received your permission.” 

There are, of course, the occasional horror stories involving surreptitious recordings. “I remember a case where a patient left a phone actively recording in his bag of clothing, which went into the OR with him,” he says. “The background conversation was not flattering to the patient, who happened to be an employee of the hospital. When he came to and listened to the recording, he sued, winning his case.”
 

The age of video and telehealth

What about the rare situation when a patient pulls out a phone and begins to videotape a conversation? It can be a big slippery slope. “Patients can abuse a video recording with editing, and the recording becomes one-dimensional, which is unfair to the physician,” adds Dr. Segal.

Patients sometimes have other motives as well. “I’m aware of occasions where a doctor/patient visit got heated and the patient took out the phone to video record, sharing it to social media,” says Dr. Segal. “Once someone uses a phone to take video, just stop the conversation. Tell the patient, ‘We’re having a disagreement,’ and that it’s time to put an end to it.”

He adds that from the physician side, a video can be a protagonist in a conversation. “Frankly, a camera on your face changes the nature of things,” Dr. Segal says. “It’s much easier to have the phone sitting in a corner, quietly recording.”

Other scenarios might involve a patient’s family member accompanying the patient and bringing out their phone to record. “Doctors should consider how this might be used against them — it can blow up,” says Dr. Verduzco-Gutierrez. “Draw boundaries on this behavior, using your hospital’s policy if it has one.”

In today’s pandemic landscape, this is particularly important, she adds. “There’s generally more mistrust in the medical system right now,” says Dr. Verduzco-Gutierrez. “People are getting misinformation from sources that aren’t credible, and then want to record their visits because they aren’t receiving the treatment they want, for instance.”

COVID has also added the tricky element of telehealth, which has exploded since 2020. “You don’t know what a patient is doing on the other side of the screen,” Dr. Verduzco-Gutierrez explains. “Face-to-face, you might see them with their phones out, but anything goes with telehealth. You have to be open and communicative with your patients about your policies from the start to avoid any negative connotations.”
 

How taping can help patients

Mr. Lindsey, the Colorado journalist, is far from alone in his desire to use visit recordings in order to retain valuable information — and with good reason. According to the Dartmouth Institute for Health Policy and Clinical Practice’s Open Recordings Project, at least 1 in 10 patients records their doctor’s visits.

“I realized I was missing things and in a medical setting, that matters,” Mr. Lindsey says. “Last year, once COVID hit and we all began wearing masks, I lost my ability to read lips, one of my coping mechanisms. It became even more important that I had a backup recording to ensure I understood everything.”

Even if a patient doesn’t have hearing loss like Mr. Lindsey, having an audio record of a visit can be useful. According to a 2018 study on patient recall of key information 1 week out from their visits, 49% of decisions and recommendations were recalled accurately without prompting; 36% recalled with a prompt; and 15% recalled erroneously or not at all.

This squares with the personal experiences of Dr. Verduzco-Gutierrez. “I even see this with my mom, who doesn’t remember many details of her doctor’s visits when I ask her,” she says. “This can definitely impact treatment.”
 

For better or worse

Dr. Verduzco-Gutierrez says that often it comes down to how a patient learns best. “I teach my residents to keep this in mind and to ask the patient in advance what works best for them,” she says. “If a patient is a visual learner, they might want to take notes or have access to the appointment notes after the visit. If they will learn and retain the information best with an audio recording, then offer that option.”

Mr. Lindsey makes it a habit to inform his physicians that he will be making an audio recording of his visits. “I always let them know that I’m recording for accuracy and not to catch them in some sort of falsehood,” he says. “I can get the doctor’s notes, but those are often short and to the point; I can get more information by going back over the recording.”

To date, Mr. Lindsey hasn’t experienced any pushback from his physicians. “No one has balked at the idea or acted surprised that I want to do it,” he explains. “I think most doctors appreciate that we have a tool we can make use of for better care.”

In past coverage of the topic, some healthcare providers weighed in with support for recordings, usually citing personal reasons. “I am so very grateful for the physicians that allowed me to record the medical appointments that I attended with my parents,” said one. “As their adult daughter, I was painfully aware that my parents struggled to process and understand all of the new information coming their way.”

Another expressed support as well, stating that as a patient, he prefers recordings to notes, because the latter “bears little resemblance to the content of the meeting and discussion with the physician. If the patient straightforwardly asks for permission to record, then why not honor the good intent expressed thereby?” 

More often than not, patients have good intentions when they decide to hit the  record button in a medical visit. A little preparation goes a long way, however, says Dr. Segal: “Assume you’re being recorded, and act accordingly.”

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

Smartphones are part and parcel to everyday life, including medicine. Here’s how to handle that.

Joe Lindsey, a 48-year old Colorado-based journalist, has dealt with complex hearing loss for about 15 years. which has led to countless doctor’s visits, treatments, and even surgery in hopes of finding improvement. As time went on and Mr. Lindsey’s hearing deteriorated, he began recording his appointments in order to retain important information.

Mr. Lindsey had positive intentions, but not every patient does.

With smartphones everywhere, recording medical appointments can be fraught with downsides too. While there are clear-cut reasons for recording doctor visits, patients’ goals and how they carry out the taping are key. Audio only? Or also video? With the physician’s knowledge and permission, or without?

These are the legal and ethical weeds doctors find themselves in today, so it’s important to understand all sides of the issue.

The medical world is divided on its sentiments about patients recording their visits. The American Medical Association, in fact, failed to make progress on a recent policy (resolution 007) proposal to encourage that any “audio or video recording made during a medical encounter should require both physician and patient notification and consent.” Rather than voting on the resolution, the AMA house of delegates tabled it and chose to gather more information on the issue.

In most cases, patients are recording their visits in good faith, says Jeffrey Segal, MD, JD, the CEO and founder of Medical Justice, a risk mitigation and reputation management firm for healthcare clinicians. “When it comes to ‘Team, let’s record this,’ I’m a fan,” he says. “The most common reason patients record visits is that there’s a lot of information transferred from the doctor to the patient, and there’s just not enough time to absorb it all.”

While the option is there for patients to take notes, in the give-and-take nature of conversation, this can get difficult. “If they record the visit, they can then digest it all down the road,” says Dr. Segal. “A compliant patient is one who understands what’s expected. That’s the charitable explanation for recording, and I support it.”

It’s that question of good intent, however, that concerns some physicians in today’s highly litigious society. “The worry is that there’s a small subset of patients with an ulterior motive,” says Dr. Segal.

“Some patients do record in case of an event down the road,” he adds. “They want the recording to potentially talk to a lawyer, or to file a board complaint.”

Laws in the United States surrounding recordings are confusing, with variations from state to state. Currently, 39 U.S. states allow for one-party consent — meaning a patient can record a visit without consenting with the physician.

Monica Verduzco-Gutierrez, MD, professor and chair of rehabilitation medicine at University of Texas Health, San Antonio, resides in Texas, which is one of the 39 one-consent states. “Physicians must be aware of this fact and consider how it might be used against them,” she says. “A good practice is to set expectations with the patient from the start. Also, know your hospital’s policy — some may have boundaries surrounding recordings.”

The first step is to know what type of state you practice in. Regardless of whether you are in a one- or two-party consent state — but especially a one-party state — it’s a smart move to add a sign at your office saying that you support the recording of visits, provided the patient is open and transparent about it. “Let the patient know that if they plan to record, they should ask your permission,” says Dr. Segal. “Let them know it’s not appropriate if they haven’t received your permission.” 

There are, of course, the occasional horror stories involving surreptitious recordings. “I remember a case where a patient left a phone actively recording in his bag of clothing, which went into the OR with him,” he says. “The background conversation was not flattering to the patient, who happened to be an employee of the hospital. When he came to and listened to the recording, he sued, winning his case.”
 

The age of video and telehealth

What about the rare situation when a patient pulls out a phone and begins to videotape a conversation? It can be a big slippery slope. “Patients can abuse a video recording with editing, and the recording becomes one-dimensional, which is unfair to the physician,” adds Dr. Segal.

Patients sometimes have other motives as well. “I’m aware of occasions where a doctor/patient visit got heated and the patient took out the phone to video record, sharing it to social media,” says Dr. Segal. “Once someone uses a phone to take video, just stop the conversation. Tell the patient, ‘We’re having a disagreement,’ and that it’s time to put an end to it.”

He adds that from the physician side, a video can be a protagonist in a conversation. “Frankly, a camera on your face changes the nature of things,” Dr. Segal says. “It’s much easier to have the phone sitting in a corner, quietly recording.”

Other scenarios might involve a patient’s family member accompanying the patient and bringing out their phone to record. “Doctors should consider how this might be used against them — it can blow up,” says Dr. Verduzco-Gutierrez. “Draw boundaries on this behavior, using your hospital’s policy if it has one.”

In today’s pandemic landscape, this is particularly important, she adds. “There’s generally more mistrust in the medical system right now,” says Dr. Verduzco-Gutierrez. “People are getting misinformation from sources that aren’t credible, and then want to record their visits because they aren’t receiving the treatment they want, for instance.”

COVID has also added the tricky element of telehealth, which has exploded since 2020. “You don’t know what a patient is doing on the other side of the screen,” Dr. Verduzco-Gutierrez explains. “Face-to-face, you might see them with their phones out, but anything goes with telehealth. You have to be open and communicative with your patients about your policies from the start to avoid any negative connotations.”
 

How taping can help patients

Mr. Lindsey, the Colorado journalist, is far from alone in his desire to use visit recordings in order to retain valuable information — and with good reason. According to the Dartmouth Institute for Health Policy and Clinical Practice’s Open Recordings Project, at least 1 in 10 patients records their doctor’s visits.

“I realized I was missing things and in a medical setting, that matters,” Mr. Lindsey says. “Last year, once COVID hit and we all began wearing masks, I lost my ability to read lips, one of my coping mechanisms. It became even more important that I had a backup recording to ensure I understood everything.”

Even if a patient doesn’t have hearing loss like Mr. Lindsey, having an audio record of a visit can be useful. According to a 2018 study on patient recall of key information 1 week out from their visits, 49% of decisions and recommendations were recalled accurately without prompting; 36% recalled with a prompt; and 15% recalled erroneously or not at all.

This squares with the personal experiences of Dr. Verduzco-Gutierrez. “I even see this with my mom, who doesn’t remember many details of her doctor’s visits when I ask her,” she says. “This can definitely impact treatment.”
 

For better or worse

Dr. Verduzco-Gutierrez says that often it comes down to how a patient learns best. “I teach my residents to keep this in mind and to ask the patient in advance what works best for them,” she says. “If a patient is a visual learner, they might want to take notes or have access to the appointment notes after the visit. If they will learn and retain the information best with an audio recording, then offer that option.”

Mr. Lindsey makes it a habit to inform his physicians that he will be making an audio recording of his visits. “I always let them know that I’m recording for accuracy and not to catch them in some sort of falsehood,” he says. “I can get the doctor’s notes, but those are often short and to the point; I can get more information by going back over the recording.”

To date, Mr. Lindsey hasn’t experienced any pushback from his physicians. “No one has balked at the idea or acted surprised that I want to do it,” he explains. “I think most doctors appreciate that we have a tool we can make use of for better care.”

In past coverage of the topic, some healthcare providers weighed in with support for recordings, usually citing personal reasons. “I am so very grateful for the physicians that allowed me to record the medical appointments that I attended with my parents,” said one. “As their adult daughter, I was painfully aware that my parents struggled to process and understand all of the new information coming their way.”

Another expressed support as well, stating that as a patient, he prefers recordings to notes, because the latter “bears little resemblance to the content of the meeting and discussion with the physician. If the patient straightforwardly asks for permission to record, then why not honor the good intent expressed thereby?” 

More often than not, patients have good intentions when they decide to hit the  record button in a medical visit. A little preparation goes a long way, however, says Dr. Segal: “Assume you’re being recorded, and act accordingly.”

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

Smartphones are part and parcel to everyday life, including medicine. Here’s how to handle that.

Joe Lindsey, a 48-year old Colorado-based journalist, has dealt with complex hearing loss for about 15 years. which has led to countless doctor’s visits, treatments, and even surgery in hopes of finding improvement. As time went on and Mr. Lindsey’s hearing deteriorated, he began recording his appointments in order to retain important information.

Mr. Lindsey had positive intentions, but not every patient does.

With smartphones everywhere, recording medical appointments can be fraught with downsides too. While there are clear-cut reasons for recording doctor visits, patients’ goals and how they carry out the taping are key. Audio only? Or also video? With the physician’s knowledge and permission, or without?

These are the legal and ethical weeds doctors find themselves in today, so it’s important to understand all sides of the issue.

The medical world is divided on its sentiments about patients recording their visits. The American Medical Association, in fact, failed to make progress on a recent policy (resolution 007) proposal to encourage that any “audio or video recording made during a medical encounter should require both physician and patient notification and consent.” Rather than voting on the resolution, the AMA house of delegates tabled it and chose to gather more information on the issue.

In most cases, patients are recording their visits in good faith, says Jeffrey Segal, MD, JD, the CEO and founder of Medical Justice, a risk mitigation and reputation management firm for healthcare clinicians. “When it comes to ‘Team, let’s record this,’ I’m a fan,” he says. “The most common reason patients record visits is that there’s a lot of information transferred from the doctor to the patient, and there’s just not enough time to absorb it all.”

While the option is there for patients to take notes, in the give-and-take nature of conversation, this can get difficult. “If they record the visit, they can then digest it all down the road,” says Dr. Segal. “A compliant patient is one who understands what’s expected. That’s the charitable explanation for recording, and I support it.”

It’s that question of good intent, however, that concerns some physicians in today’s highly litigious society. “The worry is that there’s a small subset of patients with an ulterior motive,” says Dr. Segal.

“Some patients do record in case of an event down the road,” he adds. “They want the recording to potentially talk to a lawyer, or to file a board complaint.”

Laws in the United States surrounding recordings are confusing, with variations from state to state. Currently, 39 U.S. states allow for one-party consent — meaning a patient can record a visit without consenting with the physician.

Monica Verduzco-Gutierrez, MD, professor and chair of rehabilitation medicine at University of Texas Health, San Antonio, resides in Texas, which is one of the 39 one-consent states. “Physicians must be aware of this fact and consider how it might be used against them,” she says. “A good practice is to set expectations with the patient from the start. Also, know your hospital’s policy — some may have boundaries surrounding recordings.”

The first step is to know what type of state you practice in. Regardless of whether you are in a one- or two-party consent state — but especially a one-party state — it’s a smart move to add a sign at your office saying that you support the recording of visits, provided the patient is open and transparent about it. “Let the patient know that if they plan to record, they should ask your permission,” says Dr. Segal. “Let them know it’s not appropriate if they haven’t received your permission.” 

There are, of course, the occasional horror stories involving surreptitious recordings. “I remember a case where a patient left a phone actively recording in his bag of clothing, which went into the OR with him,” he says. “The background conversation was not flattering to the patient, who happened to be an employee of the hospital. When he came to and listened to the recording, he sued, winning his case.”
 

The age of video and telehealth

What about the rare situation when a patient pulls out a phone and begins to videotape a conversation? It can be a big slippery slope. “Patients can abuse a video recording with editing, and the recording becomes one-dimensional, which is unfair to the physician,” adds Dr. Segal.

Patients sometimes have other motives as well. “I’m aware of occasions where a doctor/patient visit got heated and the patient took out the phone to video record, sharing it to social media,” says Dr. Segal. “Once someone uses a phone to take video, just stop the conversation. Tell the patient, ‘We’re having a disagreement,’ and that it’s time to put an end to it.”

He adds that from the physician side, a video can be a protagonist in a conversation. “Frankly, a camera on your face changes the nature of things,” Dr. Segal says. “It’s much easier to have the phone sitting in a corner, quietly recording.”

Other scenarios might involve a patient’s family member accompanying the patient and bringing out their phone to record. “Doctors should consider how this might be used against them — it can blow up,” says Dr. Verduzco-Gutierrez. “Draw boundaries on this behavior, using your hospital’s policy if it has one.”

In today’s pandemic landscape, this is particularly important, she adds. “There’s generally more mistrust in the medical system right now,” says Dr. Verduzco-Gutierrez. “People are getting misinformation from sources that aren’t credible, and then want to record their visits because they aren’t receiving the treatment they want, for instance.”

COVID has also added the tricky element of telehealth, which has exploded since 2020. “You don’t know what a patient is doing on the other side of the screen,” Dr. Verduzco-Gutierrez explains. “Face-to-face, you might see them with their phones out, but anything goes with telehealth. You have to be open and communicative with your patients about your policies from the start to avoid any negative connotations.”
 

How taping can help patients

Mr. Lindsey, the Colorado journalist, is far from alone in his desire to use visit recordings in order to retain valuable information — and with good reason. According to the Dartmouth Institute for Health Policy and Clinical Practice’s Open Recordings Project, at least 1 in 10 patients records their doctor’s visits.

“I realized I was missing things and in a medical setting, that matters,” Mr. Lindsey says. “Last year, once COVID hit and we all began wearing masks, I lost my ability to read lips, one of my coping mechanisms. It became even more important that I had a backup recording to ensure I understood everything.”

Even if a patient doesn’t have hearing loss like Mr. Lindsey, having an audio record of a visit can be useful. According to a 2018 study on patient recall of key information 1 week out from their visits, 49% of decisions and recommendations were recalled accurately without prompting; 36% recalled with a prompt; and 15% recalled erroneously or not at all.

This squares with the personal experiences of Dr. Verduzco-Gutierrez. “I even see this with my mom, who doesn’t remember many details of her doctor’s visits when I ask her,” she says. “This can definitely impact treatment.”
 

For better or worse

Dr. Verduzco-Gutierrez says that often it comes down to how a patient learns best. “I teach my residents to keep this in mind and to ask the patient in advance what works best for them,” she says. “If a patient is a visual learner, they might want to take notes or have access to the appointment notes after the visit. If they will learn and retain the information best with an audio recording, then offer that option.”

Mr. Lindsey makes it a habit to inform his physicians that he will be making an audio recording of his visits. “I always let them know that I’m recording for accuracy and not to catch them in some sort of falsehood,” he says. “I can get the doctor’s notes, but those are often short and to the point; I can get more information by going back over the recording.”

To date, Mr. Lindsey hasn’t experienced any pushback from his physicians. “No one has balked at the idea or acted surprised that I want to do it,” he explains. “I think most doctors appreciate that we have a tool we can make use of for better care.”

In past coverage of the topic, some healthcare providers weighed in with support for recordings, usually citing personal reasons. “I am so very grateful for the physicians that allowed me to record the medical appointments that I attended with my parents,” said one. “As their adult daughter, I was painfully aware that my parents struggled to process and understand all of the new information coming their way.”

Another expressed support as well, stating that as a patient, he prefers recordings to notes, because the latter “bears little resemblance to the content of the meeting and discussion with the physician. If the patient straightforwardly asks for permission to record, then why not honor the good intent expressed thereby?” 

More often than not, patients have good intentions when they decide to hit the  record button in a medical visit. A little preparation goes a long way, however, says Dr. Segal: “Assume you’re being recorded, and act accordingly.”

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

Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

• Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
• Assimilate the evidence and create a repository of best practices, resources, and interventions.
• Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
• Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

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

Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

• Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
• Assimilate the evidence and create a repository of best practices, resources, and interventions.
• Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
• Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

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

Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

• Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
• Assimilate the evidence and create a repository of best practices, resources, and interventions.
• Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
• Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

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

Everyone over the age of 18 should be allowed to receive a booster of their COVID-19 vaccines, according to a panel of experts that advises CDC on its vaccine recommendations.

The Advisory Committee on Immunization Practices, or ACIP, recommended that all adults be eligible for a third dose of a Pfizer or Moderna mRNA vaccine, at least 6 months after their second dose.

They also strengthened a recommendation that everyone over the age of 50 should get a third dose, whether or not they have an underlying health condition that may increase their risk from a COVID-19 infection.

The committee voted 11 to 0 in favor of both policies.

CDC Director Rochelle Walensky, MD, must now sign off on both policies, which she is expected to do.

More than 70 million adults are now eligible for booster shots in the United States, but only about 31 million people have received one.  About half of those who have been boosted are over the age of 65.

In a recent survey, the Kaiser Family Foundation found that about 4 in 10 younger adults said they were unsure if they qualified for a booster.

Under the current policy, boosters are recommended for everyone age 65 and older.  But people who are younger than age 65 are eligible for boosters if they have an underlying health condition or live or work in a high-risk situation—something individuals have to determine on their own.  Experts said that shading of the policy had created confusion that was holding people back.

Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials, noted that public health officials have been swamped with calls from people who are trying to figure out if they are eligible to get a booster dose.

He said that in a call the evening of Nov. 18 with state health departments, “There was not a single state that voiced opposition to this move,” he told the ACIP.

Dr. Shah said that the current guidelines were well intentioned, but “in pursuit of precision, they create confusion.”

“Our concern is that eligible individuals are not receiving boosters right now as a result of this confusion,” he said.

The committee based its decision on the results of a new study of boosters in Pfizer vaccine recipients, as well as reassuring safety information that’s being collected through the CDC and FDA’s monitoring systems.

Pfizer presented the early results from a study of 10,000 people who had all received two doses of its vaccine.   Half of the study participants received a third shot, or booster. The other half got a placebo.

The study is ongoing, but so far, six of the people in the booster group have gotten a COVID-19 infection with symptoms compared to 123 people who got COVID-19 in the placebo group, making boosters 95% effective at keeping people from getting sick.  Most people in the study had gotten their original doses about 10 months earlier. They’ve been followed for about 10 weeks since their booster.  Importantly, there were no study participants hospitalized for COVID-19 infections in either the placebo or booster group, indicating that the first two doses were still very effective at preventing severe outcomes from infection.

The majority of side effects after a third Pfizer dose were mild and temporary.  Side effects like sore arms, swelling, fever, headache, and fatigue were more common in the booster group — affecting about 1 in 4 people who got a third shot.  Vaccination side effects were less common after boosters than have been seen after the second dose of the vaccine.

Some cases of myocarditis and pericarditis have been reported after people received vaccine boosters, but the risk for this heart inflammation appears to be extremely low, about two cases for every million doses given.  There were 54 cases of myocarditis reported so far to the Vaccine Adverse Event Reporting System, or VAERS.  So far, only 12 have met the case definition and are considered related to vaccination.  Most of the reported cases are still being studied.

Everyone over the age of 18 should be allowed to receive a booster of their COVID-19 vaccines, according to a panel of experts that advises CDC on its vaccine recommendations.

The Advisory Committee on Immunization Practices, or ACIP, recommended that all adults be eligible for a third dose of a Pfizer or Moderna mRNA vaccine, at least 6 months after their second dose.

They also strengthened a recommendation that everyone over the age of 50 should get a third dose, whether or not they have an underlying health condition that may increase their risk from a COVID-19 infection.

The committee voted 11 to 0 in favor of both policies.

CDC Director Rochelle Walensky, MD, must now sign off on both policies, which she is expected to do.

More than 70 million adults are now eligible for booster shots in the United States, but only about 31 million people have received one.  About half of those who have been boosted are over the age of 65.

In a recent survey, the Kaiser Family Foundation found that about 4 in 10 younger adults said they were unsure if they qualified for a booster.

Under the current policy, boosters are recommended for everyone age 65 and older.  But people who are younger than age 65 are eligible for boosters if they have an underlying health condition or live or work in a high-risk situation—something individuals have to determine on their own.  Experts said that shading of the policy had created confusion that was holding people back.

Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials, noted that public health officials have been swamped with calls from people who are trying to figure out if they are eligible to get a booster dose.

He said that in a call the evening of Nov. 18 with state health departments, “There was not a single state that voiced opposition to this move,” he told the ACIP.

Dr. Shah said that the current guidelines were well intentioned, but “in pursuit of precision, they create confusion.”

“Our concern is that eligible individuals are not receiving boosters right now as a result of this confusion,” he said.

The committee based its decision on the results of a new study of boosters in Pfizer vaccine recipients, as well as reassuring safety information that’s being collected through the CDC and FDA’s monitoring systems.

Pfizer presented the early results from a study of 10,000 people who had all received two doses of its vaccine.   Half of the study participants received a third shot, or booster. The other half got a placebo.

The study is ongoing, but so far, six of the people in the booster group have gotten a COVID-19 infection with symptoms compared to 123 people who got COVID-19 in the placebo group, making boosters 95% effective at keeping people from getting sick.  Most people in the study had gotten their original doses about 10 months earlier. They’ve been followed for about 10 weeks since their booster.  Importantly, there were no study participants hospitalized for COVID-19 infections in either the placebo or booster group, indicating that the first two doses were still very effective at preventing severe outcomes from infection.

The majority of side effects after a third Pfizer dose were mild and temporary.  Side effects like sore arms, swelling, fever, headache, and fatigue were more common in the booster group — affecting about 1 in 4 people who got a third shot.  Vaccination side effects were less common after boosters than have been seen after the second dose of the vaccine.

Some cases of myocarditis and pericarditis have been reported after people received vaccine boosters, but the risk for this heart inflammation appears to be extremely low, about two cases for every million doses given.  There were 54 cases of myocarditis reported so far to the Vaccine Adverse Event Reporting System, or VAERS.  So far, only 12 have met the case definition and are considered related to vaccination.  Most of the reported cases are still being studied.