Journal of Clinical Outcomes Management

A genetic risk factor could explain why some people lose their senses of smell and taste when they get infected with COVID-19, according to a new study published in the journal Nature Genetics

The finding could eventually help the 1.6 million people in the United States who still can’t smell or have had a change in their ability to smell more than 6 months after getting the coronavirus. The exact cause related to COVID-19 is still unknown, but researchers believe it could be because of damage in a part of the nose called the olfactory epithelium.

“How we get from infection to smell loss remains unclear,” Justin Turner, MD, an associate professor of otolaryngology at Vanderbilt University, Nashville, Tenn., told NBC News. Dr. Turner was not part of the research team.

“Early data suggest that supporting cells of the olfactory epithelium are the ones mostly being infected by the virus, and presumably this leads to the death of the neurons themselves,” he said. “But we don’t really, really know why and when that happens, and why it seems to preferentially happen in certain individuals.”

Researchers at 23andMe, a genomics and biotechnology company, did the study as part of a larger COVID-19 project, which includes people in the United States and the United Kingdom. They analyzed data from nearly 70,000 people who took online surveys after receiving a positive coronavirus test. Among those, 68% reported a loss of smell or taste as a symptom.

The study team compared the genetic differences between those who lost their sense of smell and taste and those who didn’t. They found that a location near two olfactory genes – UGT2A1 and UGT2A2 – is associated with COVID-19 loss of smell and taste. The genetic risk factor makes it 11% more likely for a person with COVID-19 to lose their sense of smell or taste.

The research team also found that women were 11% more likely than men to report a loss of smell and taste. About 73% of those who reported a loss of smell and taste were ages 26-35.

The researchers aren’t sure how the genes are involved, though they suspect that infected cells could lead to smell loss. Typically, the genes are expressed in tissue inside the nose involved with smell and play a role in processing things that have an odor. To use the findings, researchers need to learn more about the genes, how they are expressed, and what their functions are, NBC News reported.

The findings could help lead to treatments. Other research has shown that the loss of taste and smell is related to a “failure to protect the sensory cells of the nose and tongue from viral infection,” Danielle Reed, PhD, associate director of the Monell Chemical Senses Center in Philadelphia, told NBC News. She was not part of the research team but studies person-to-person differences in the loss of these senses because of COVID-19.

“This study suggests a different direction,” she said. “The pathways that break down the chemicals that cause taste and smell in the first place might be over or underactive, reducing or distorting the ability to taste and smell.”

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

A genetic risk factor could explain why some people lose their senses of smell and taste when they get infected with COVID-19, according to a new study published in the journal Nature Genetics

The finding could eventually help the 1.6 million people in the United States who still can’t smell or have had a change in their ability to smell more than 6 months after getting the coronavirus. The exact cause related to COVID-19 is still unknown, but researchers believe it could be because of damage in a part of the nose called the olfactory epithelium.

“How we get from infection to smell loss remains unclear,” Justin Turner, MD, an associate professor of otolaryngology at Vanderbilt University, Nashville, Tenn., told NBC News. Dr. Turner was not part of the research team.

“Early data suggest that supporting cells of the olfactory epithelium are the ones mostly being infected by the virus, and presumably this leads to the death of the neurons themselves,” he said. “But we don’t really, really know why and when that happens, and why it seems to preferentially happen in certain individuals.”

Researchers at 23andMe, a genomics and biotechnology company, did the study as part of a larger COVID-19 project, which includes people in the United States and the United Kingdom. They analyzed data from nearly 70,000 people who took online surveys after receiving a positive coronavirus test. Among those, 68% reported a loss of smell or taste as a symptom.

The study team compared the genetic differences between those who lost their sense of smell and taste and those who didn’t. They found that a location near two olfactory genes – UGT2A1 and UGT2A2 – is associated with COVID-19 loss of smell and taste. The genetic risk factor makes it 11% more likely for a person with COVID-19 to lose their sense of smell or taste.

The research team also found that women were 11% more likely than men to report a loss of smell and taste. About 73% of those who reported a loss of smell and taste were ages 26-35.

The researchers aren’t sure how the genes are involved, though they suspect that infected cells could lead to smell loss. Typically, the genes are expressed in tissue inside the nose involved with smell and play a role in processing things that have an odor. To use the findings, researchers need to learn more about the genes, how they are expressed, and what their functions are, NBC News reported.

The findings could help lead to treatments. Other research has shown that the loss of taste and smell is related to a “failure to protect the sensory cells of the nose and tongue from viral infection,” Danielle Reed, PhD, associate director of the Monell Chemical Senses Center in Philadelphia, told NBC News. She was not part of the research team but studies person-to-person differences in the loss of these senses because of COVID-19.

“This study suggests a different direction,” she said. “The pathways that break down the chemicals that cause taste and smell in the first place might be over or underactive, reducing or distorting the ability to taste and smell.”

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

A genetic risk factor could explain why some people lose their senses of smell and taste when they get infected with COVID-19, according to a new study published in the journal Nature Genetics

The finding could eventually help the 1.6 million people in the United States who still can’t smell or have had a change in their ability to smell more than 6 months after getting the coronavirus. The exact cause related to COVID-19 is still unknown, but researchers believe it could be because of damage in a part of the nose called the olfactory epithelium.

“How we get from infection to smell loss remains unclear,” Justin Turner, MD, an associate professor of otolaryngology at Vanderbilt University, Nashville, Tenn., told NBC News. Dr. Turner was not part of the research team.

“Early data suggest that supporting cells of the olfactory epithelium are the ones mostly being infected by the virus, and presumably this leads to the death of the neurons themselves,” he said. “But we don’t really, really know why and when that happens, and why it seems to preferentially happen in certain individuals.”

Researchers at 23andMe, a genomics and biotechnology company, did the study as part of a larger COVID-19 project, which includes people in the United States and the United Kingdom. They analyzed data from nearly 70,000 people who took online surveys after receiving a positive coronavirus test. Among those, 68% reported a loss of smell or taste as a symptom.

The study team compared the genetic differences between those who lost their sense of smell and taste and those who didn’t. They found that a location near two olfactory genes – UGT2A1 and UGT2A2 – is associated with COVID-19 loss of smell and taste. The genetic risk factor makes it 11% more likely for a person with COVID-19 to lose their sense of smell or taste.

The research team also found that women were 11% more likely than men to report a loss of smell and taste. About 73% of those who reported a loss of smell and taste were ages 26-35.

The researchers aren’t sure how the genes are involved, though they suspect that infected cells could lead to smell loss. Typically, the genes are expressed in tissue inside the nose involved with smell and play a role in processing things that have an odor. To use the findings, researchers need to learn more about the genes, how they are expressed, and what their functions are, NBC News reported.

The findings could help lead to treatments. Other research has shown that the loss of taste and smell is related to a “failure to protect the sensory cells of the nose and tongue from viral infection,” Danielle Reed, PhD, associate director of the Monell Chemical Senses Center in Philadelphia, told NBC News. She was not part of the research team but studies person-to-person differences in the loss of these senses because of COVID-19.

“This study suggests a different direction,” she said. “The pathways that break down the chemicals that cause taste and smell in the first place might be over or underactive, reducing or distorting the ability to taste and smell.”

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

A fourth shot of the COVID-19 vaccine boosts antibodies but doesn’t provide enough protection to prevent infections from the Omicron variant, according to new research at an Israeli hospital.

The preliminary results, released on Jan. 17, challenge the idea of giving a second booster dose to slow the spread of the coronavirus, according to USA Today.

“Despite increased antibody levels, the fourth vaccine only offers a partial defense against the virus,” Gili Regev-Yochay, MD, director of the hospital’s infection prevention and control units, told reporters.

“The vaccines, which were more effective against previous variants, offer less protection versus Omicron,” she said.

In a clinical trial, 274 medical workers at Sheba Medical Center near Tel Aviv received a fourth vaccine dose in December – 154 got the Pfizer vaccine and 120 got the Moderna vaccine – after previously getting three Pfizer shots.

Both groups received a boost in antibodies that was “slightly higher” than after the third shot, Dr. Regev-Yochay said. But when compared with a control group that didn’t receive the fourth dose, the extra boost didn’t prevent the spread of Omicron.

“We see many infected with Omicron who received the fourth dose,” Dr. Regev-Yochay said. “Granted, a bit less than in the control group, but still a lot of infections.”

Some public health officials in Israel say the campaign for fourth doses is still worthwhile, according to The Times of Israel. The vaccine still works well against the Alpha and Delta variants, Dr. Regev-Yochay said, and a fourth shot should go to older adults and those who face higher risks for severe COVID-19.

Hours after releasing the preliminary results, Sheba Medical Center published a statement calling for “continuing the vaccination drive for risk groups at this time, even though the vaccine doesn’t provide optimal protection against getting infected with the variant.” News outlets reported that the hospital was pressured into issuing the statement after Israel’s Health Ministry didn’t like the release of the early study results, The Times of Israel reported.

The second booster “returns the level of antibodies to what it was at the beginning of the third booster,” Nachman Ash, MD, director of Israel’s Health Ministry, told Channel 13 TV in Israel, according to The Associated Press.

“That has great importance, especially among the older population,” he said.

As of Sunday, more than 500,000 people in Israel had received fourth doses since the country began offering them last month to medical workers, immunocompromised patients, and people ages 60 years and older, the AP reported. At the same time, the country has faced a recent coronavirus surge that has led to record-breaking numbers of cases and rising hospitalizations.

On Tuesday, the Israeli government said it would shorten the mandatory quarantine period from 7 days to 5 days, the AP reported.

“This decision will enable us to continue safeguarding public health on the one hand and to keep the economy going at this time on the other, even though it is difficult, so that we can get through this wave safely,” Prime Minister Naftali Bennett said.

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

A fourth shot of the COVID-19 vaccine boosts antibodies but doesn’t provide enough protection to prevent infections from the Omicron variant, according to new research at an Israeli hospital.

The preliminary results, released on Jan. 17, challenge the idea of giving a second booster dose to slow the spread of the coronavirus, according to USA Today.

“Despite increased antibody levels, the fourth vaccine only offers a partial defense against the virus,” Gili Regev-Yochay, MD, director of the hospital’s infection prevention and control units, told reporters.

“The vaccines, which were more effective against previous variants, offer less protection versus Omicron,” she said.

In a clinical trial, 274 medical workers at Sheba Medical Center near Tel Aviv received a fourth vaccine dose in December – 154 got the Pfizer vaccine and 120 got the Moderna vaccine – after previously getting three Pfizer shots.

Both groups received a boost in antibodies that was “slightly higher” than after the third shot, Dr. Regev-Yochay said. But when compared with a control group that didn’t receive the fourth dose, the extra boost didn’t prevent the spread of Omicron.

“We see many infected with Omicron who received the fourth dose,” Dr. Regev-Yochay said. “Granted, a bit less than in the control group, but still a lot of infections.”

Some public health officials in Israel say the campaign for fourth doses is still worthwhile, according to The Times of Israel. The vaccine still works well against the Alpha and Delta variants, Dr. Regev-Yochay said, and a fourth shot should go to older adults and those who face higher risks for severe COVID-19.

Hours after releasing the preliminary results, Sheba Medical Center published a statement calling for “continuing the vaccination drive for risk groups at this time, even though the vaccine doesn’t provide optimal protection against getting infected with the variant.” News outlets reported that the hospital was pressured into issuing the statement after Israel’s Health Ministry didn’t like the release of the early study results, The Times of Israel reported.

The second booster “returns the level of antibodies to what it was at the beginning of the third booster,” Nachman Ash, MD, director of Israel’s Health Ministry, told Channel 13 TV in Israel, according to The Associated Press.

“That has great importance, especially among the older population,” he said.

As of Sunday, more than 500,000 people in Israel had received fourth doses since the country began offering them last month to medical workers, immunocompromised patients, and people ages 60 years and older, the AP reported. At the same time, the country has faced a recent coronavirus surge that has led to record-breaking numbers of cases and rising hospitalizations.

On Tuesday, the Israeli government said it would shorten the mandatory quarantine period from 7 days to 5 days, the AP reported.

“This decision will enable us to continue safeguarding public health on the one hand and to keep the economy going at this time on the other, even though it is difficult, so that we can get through this wave safely,” Prime Minister Naftali Bennett said.

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

A fourth shot of the COVID-19 vaccine boosts antibodies but doesn’t provide enough protection to prevent infections from the Omicron variant, according to new research at an Israeli hospital.

The preliminary results, released on Jan. 17, challenge the idea of giving a second booster dose to slow the spread of the coronavirus, according to USA Today.

“Despite increased antibody levels, the fourth vaccine only offers a partial defense against the virus,” Gili Regev-Yochay, MD, director of the hospital’s infection prevention and control units, told reporters.

“The vaccines, which were more effective against previous variants, offer less protection versus Omicron,” she said.

In a clinical trial, 274 medical workers at Sheba Medical Center near Tel Aviv received a fourth vaccine dose in December – 154 got the Pfizer vaccine and 120 got the Moderna vaccine – after previously getting three Pfizer shots.

Both groups received a boost in antibodies that was “slightly higher” than after the third shot, Dr. Regev-Yochay said. But when compared with a control group that didn’t receive the fourth dose, the extra boost didn’t prevent the spread of Omicron.

“We see many infected with Omicron who received the fourth dose,” Dr. Regev-Yochay said. “Granted, a bit less than in the control group, but still a lot of infections.”

Some public health officials in Israel say the campaign for fourth doses is still worthwhile, according to The Times of Israel. The vaccine still works well against the Alpha and Delta variants, Dr. Regev-Yochay said, and a fourth shot should go to older adults and those who face higher risks for severe COVID-19.

Hours after releasing the preliminary results, Sheba Medical Center published a statement calling for “continuing the vaccination drive for risk groups at this time, even though the vaccine doesn’t provide optimal protection against getting infected with the variant.” News outlets reported that the hospital was pressured into issuing the statement after Israel’s Health Ministry didn’t like the release of the early study results, The Times of Israel reported.

The second booster “returns the level of antibodies to what it was at the beginning of the third booster,” Nachman Ash, MD, director of Israel’s Health Ministry, told Channel 13 TV in Israel, according to The Associated Press.

“That has great importance, especially among the older population,” he said.

As of Sunday, more than 500,000 people in Israel had received fourth doses since the country began offering them last month to medical workers, immunocompromised patients, and people ages 60 years and older, the AP reported. At the same time, the country has faced a recent coronavirus surge that has led to record-breaking numbers of cases and rising hospitalizations.

On Tuesday, the Israeli government said it would shorten the mandatory quarantine period from 7 days to 5 days, the AP reported.

“This decision will enable us to continue safeguarding public health on the one hand and to keep the economy going at this time on the other, even though it is difficult, so that we can get through this wave safely,” Prime Minister Naftali Bennett said.

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

Another record week for COVID-19 brought almost 1 million new cases to the children of the United States, according to new data from the American Academy of Pediatrics and the Children’s Hospital Association.

The pre-Omicron high for new cases in a week – 252,000 during the Delta surge of the late summer and early fall – has been surpassed each of the last 3 weeks and now stands at 981,000 (Jan. 7-13), according to the AAP/CHA weekly COVID-19 report. Over the 3-week stretch from Dec. 17 to Jan. 13, weekly cases increased by 394%.

Hospitalizations also climbed to new heights, as daily admissions reached 1.23 per 100,000 children on Jan. 14, an increase of 547% since Nov. 30, when the rate was 0.19 per 100,000. Before Omicron, the highest rate for children was 0.47 per 100,000, based on data from the Centers for Disease Control and Prevention.

The inpatient population count, meanwhile, has followed suit. On Jan. 16, there were 3,822 children hospitalized in pediatric inpatient beds with laboratory-confirmed COVID-19, which is 523% higher than the 613 children who were hospitalized on Nov. 14, according to the Department of Health & Human Services. In the last week, though, the population was up by just 10%.

The one thing that has not surged in the last few weeks is vaccination. Among children aged 5-11 years, the weekly count of those who have received at least one dose dropped by 34% over the last 5 weeks, falling from 527,000 for Dec.11-17 to 347,000 during Jan. 8-14, the CDC said on the COVID Data Tracker, which also noted that just 18.4% of this age group is fully vaccinated.

The situation was reversed in children aged 12-15, who were up by 36% over that same time, but their numbers were much smaller: 78,000 for the week of Dec. 11-17 and 106,000 for Jan. 8-14. Those aged 16-17 were up by just 4% over that 5-week span, the CDC data show.

Over the course of the entire pandemic, almost 9.5 million cases of COVID-19 in children have been reported, and children represent 17.8% of all cases reported in 49 states (excluding New York but including New York City), the District of Columbia, Puerto Rico, and Guam, the AAP and CHA said in their report.

Three states (Alabama, Nebraska, and Texas) stopped public reporting over the summer, but many states count individuals up to age 19 as children, and others (South Carolina, Tennessee, and West Virginia) go up to age 20, the AAP and CHA noted. The CDC, by comparison, puts the number of cases for those aged 0-17 at 8.3 million, but that estimate is based on only 51 million of the nearly 67 million U.S. cases as of Jan. 18.

Another record week for COVID-19 brought almost 1 million new cases to the children of the United States, according to new data from the American Academy of Pediatrics and the Children’s Hospital Association.

The pre-Omicron high for new cases in a week – 252,000 during the Delta surge of the late summer and early fall – has been surpassed each of the last 3 weeks and now stands at 981,000 (Jan. 7-13), according to the AAP/CHA weekly COVID-19 report. Over the 3-week stretch from Dec. 17 to Jan. 13, weekly cases increased by 394%.

Hospitalizations also climbed to new heights, as daily admissions reached 1.23 per 100,000 children on Jan. 14, an increase of 547% since Nov. 30, when the rate was 0.19 per 100,000. Before Omicron, the highest rate for children was 0.47 per 100,000, based on data from the Centers for Disease Control and Prevention.

The inpatient population count, meanwhile, has followed suit. On Jan. 16, there were 3,822 children hospitalized in pediatric inpatient beds with laboratory-confirmed COVID-19, which is 523% higher than the 613 children who were hospitalized on Nov. 14, according to the Department of Health & Human Services. In the last week, though, the population was up by just 10%.

The one thing that has not surged in the last few weeks is vaccination. Among children aged 5-11 years, the weekly count of those who have received at least one dose dropped by 34% over the last 5 weeks, falling from 527,000 for Dec.11-17 to 347,000 during Jan. 8-14, the CDC said on the COVID Data Tracker, which also noted that just 18.4% of this age group is fully vaccinated.

The situation was reversed in children aged 12-15, who were up by 36% over that same time, but their numbers were much smaller: 78,000 for the week of Dec. 11-17 and 106,000 for Jan. 8-14. Those aged 16-17 were up by just 4% over that 5-week span, the CDC data show.

Over the course of the entire pandemic, almost 9.5 million cases of COVID-19 in children have been reported, and children represent 17.8% of all cases reported in 49 states (excluding New York but including New York City), the District of Columbia, Puerto Rico, and Guam, the AAP and CHA said in their report.

Three states (Alabama, Nebraska, and Texas) stopped public reporting over the summer, but many states count individuals up to age 19 as children, and others (South Carolina, Tennessee, and West Virginia) go up to age 20, the AAP and CHA noted. The CDC, by comparison, puts the number of cases for those aged 0-17 at 8.3 million, but that estimate is based on only 51 million of the nearly 67 million U.S. cases as of Jan. 18.

Another record week for COVID-19 brought almost 1 million new cases to the children of the United States, according to new data from the American Academy of Pediatrics and the Children’s Hospital Association.

The pre-Omicron high for new cases in a week – 252,000 during the Delta surge of the late summer and early fall – has been surpassed each of the last 3 weeks and now stands at 981,000 (Jan. 7-13), according to the AAP/CHA weekly COVID-19 report. Over the 3-week stretch from Dec. 17 to Jan. 13, weekly cases increased by 394%.

Hospitalizations also climbed to new heights, as daily admissions reached 1.23 per 100,000 children on Jan. 14, an increase of 547% since Nov. 30, when the rate was 0.19 per 100,000. Before Omicron, the highest rate for children was 0.47 per 100,000, based on data from the Centers for Disease Control and Prevention.

The inpatient population count, meanwhile, has followed suit. On Jan. 16, there were 3,822 children hospitalized in pediatric inpatient beds with laboratory-confirmed COVID-19, which is 523% higher than the 613 children who were hospitalized on Nov. 14, according to the Department of Health & Human Services. In the last week, though, the population was up by just 10%.

The one thing that has not surged in the last few weeks is vaccination. Among children aged 5-11 years, the weekly count of those who have received at least one dose dropped by 34% over the last 5 weeks, falling from 527,000 for Dec.11-17 to 347,000 during Jan. 8-14, the CDC said on the COVID Data Tracker, which also noted that just 18.4% of this age group is fully vaccinated.

The situation was reversed in children aged 12-15, who were up by 36% over that same time, but their numbers were much smaller: 78,000 for the week of Dec. 11-17 and 106,000 for Jan. 8-14. Those aged 16-17 were up by just 4% over that 5-week span, the CDC data show.

Over the course of the entire pandemic, almost 9.5 million cases of COVID-19 in children have been reported, and children represent 17.8% of all cases reported in 49 states (excluding New York but including New York City), the District of Columbia, Puerto Rico, and Guam, the AAP and CHA said in their report.

Three states (Alabama, Nebraska, and Texas) stopped public reporting over the summer, but many states count individuals up to age 19 as children, and others (South Carolina, Tennessee, and West Virginia) go up to age 20, the AAP and CHA noted. The CDC, by comparison, puts the number of cases for those aged 0-17 at 8.3 million, but that estimate is based on only 51 million of the nearly 67 million U.S. cases as of Jan. 18.

With the country looking increasingly to rapid testing as an off-ramp from the COVID-19 pandemic, a new study shows that the performance of the tests in children falls below standards set by regulatory agencies in the United States and elsewhere for diagnostic accuracy.

Experts said the findings, from a meta-analysis by researchers in the United Kingdom and Germany, underscore that, while a positive result on a rapid test is almost certainly an indicator of infection, negative results often are unreliable and can lead to a false sense of security.

“Real-life performance of current antigen tests for professional use in pediatric populations is below the minimum performance criteria set by WHO, the United States Food and Drug Administration, or the Medicines and Healthcare products Regulatory Agency (U.K.),” according to Naomi Fujita-Rohwerder, PhD, a research associate at the Cologne-based German Institute for Quality and Efficiency in Health Care (IQWiG), and her colleagues, whose study appears in BMJ Evidence-Based Medicine.

The researchers said that the study suggests that performance of rapid testing in a pediatric population is comparable to that in adults. However, they said they could not identify any studies investigating self-testing in children, which also could affect test performance.

Egon Ozer, MD, PhD, director of the center for pathogen genomics and microbial evolution at Northwestern University in Chicago, said the finding that specificity was high but sensitivity was middling “suggests that we should be very careful about interpreting negative antigen test results in children and recognize that there is a fair amount of uncertainty in the tests in this situation.”

Researchers from IQWiG, which examines the advantages and disadvantages of medical interventions, and the University of Manchester (England), conducted the systematic review and meta-analysis, which they described as the first of its kind to evaluate the diagnostic accuracy of rapid point-of-care tests for current SARS-CoV-2 infections in children.

They compiled information from 17 studies with a total 6,355 participants. They compared all antigen tests to reverse-transcription polymerase chain reaction (PCR). The studies compared eight antigen tests from six different brands. The rapid antigen tests, available from pharmacies and online stores, are widely used for self-testing in schools and testing toddlers before kindergarten.

The pooled diagnostic sensitivity of antigen tests was 64.2% and specificity was 99.1%.

Dr. Ozer noted that the analysis “was not able to address important outstanding questions such as the likelihood of transmitting infection with a false-negative antigen test versus a true-negative antigen test or how much repeated testing can increase the sensitivity.”

“In Europe, we don’t know how most tests perform in real life,” Dr. Fujita-Rohwerder said. “And even in countries like the United States, where market access is more stringent, we don’t know whether self-testing performed by children or sample collection in toddlers by laypersons has a significant impact on the diagnostic accuracy. Also, diagnostic accuracy estimates reported in our study may not apply to the current omicron or future variants of SARS-CoV-2 or vaccinated children. Hopefully, these essential gaps in the evidence will get addressed soon.”

Dr. Ozer said one takeaway from this study is negative antigen tests should not be considered a “free pass” in children, especially if the child is symptomatic, has been recently exposed to COVID-19, or is planning to spend time with individuals with conditions that place them at high risk for complications of COVID-19 infection. “In such cases, consider getting PCR testing or at least performing a repeat antigen test 36-48 hours after the first negative,” he said.

Dr. Fujita-Rohwerder said the low diagnostic sensitivity may affect the use of the tests. The gaps in evidence her group found in their study point to research needed to support evidence-based decision-making. “In particular, evidence is needed on real-life performance of tests in schools, self-testing performed by children, and kindergarten, [particularly] sample collection in toddlers by laypersons,” she said.

However, she stressed, testing is only a single measure. “Effectively reducing the spread of SARS-CoV-2 during the current pandemic requires multilayered mitigation measures,” she said. “Rapid testing represents one single layer. It can have its use at the population level, even though the sensitivity of antigen tests is lower than expected. However, antigen-based rapid testing is not a magic bullet: If your kid tests negative, do not disregard other mitigation measures.”

Edward Campbell, PhD, a virologist at Loyola University of Chicago, who serves on the board of LaGrange Elementary School District 102 outside Chicago, said the findings were unsurprising.

“This study generally looks consistent with what is known for adults. These rapid antigen tests are less sensitive than other tests,” said Dr. Campbell, who also runs a testing company for private schools in the Chicago area using reverse transcription-loop-mediated isothermal amplification technology. Even so, he said, “These tests are still effective at identifying people who are infectious to some degree. Never miss an opportunity to test.”

Dr. Fujita-Rohwerder disclosed no relevant financial conflicts of interest. Dr. Campbell owns Safeguard Surveillance.

With the country looking increasingly to rapid testing as an off-ramp from the COVID-19 pandemic, a new study shows that the performance of the tests in children falls below standards set by regulatory agencies in the United States and elsewhere for diagnostic accuracy.

Experts said the findings, from a meta-analysis by researchers in the United Kingdom and Germany, underscore that, while a positive result on a rapid test is almost certainly an indicator of infection, negative results often are unreliable and can lead to a false sense of security.

“Real-life performance of current antigen tests for professional use in pediatric populations is below the minimum performance criteria set by WHO, the United States Food and Drug Administration, or the Medicines and Healthcare products Regulatory Agency (U.K.),” according to Naomi Fujita-Rohwerder, PhD, a research associate at the Cologne-based German Institute for Quality and Efficiency in Health Care (IQWiG), and her colleagues, whose study appears in BMJ Evidence-Based Medicine.

The researchers said that the study suggests that performance of rapid testing in a pediatric population is comparable to that in adults. However, they said they could not identify any studies investigating self-testing in children, which also could affect test performance.

Egon Ozer, MD, PhD, director of the center for pathogen genomics and microbial evolution at Northwestern University in Chicago, said the finding that specificity was high but sensitivity was middling “suggests that we should be very careful about interpreting negative antigen test results in children and recognize that there is a fair amount of uncertainty in the tests in this situation.”

Researchers from IQWiG, which examines the advantages and disadvantages of medical interventions, and the University of Manchester (England), conducted the systematic review and meta-analysis, which they described as the first of its kind to evaluate the diagnostic accuracy of rapid point-of-care tests for current SARS-CoV-2 infections in children.

They compiled information from 17 studies with a total 6,355 participants. They compared all antigen tests to reverse-transcription polymerase chain reaction (PCR). The studies compared eight antigen tests from six different brands. The rapid antigen tests, available from pharmacies and online stores, are widely used for self-testing in schools and testing toddlers before kindergarten.

The pooled diagnostic sensitivity of antigen tests was 64.2% and specificity was 99.1%.

Dr. Ozer noted that the analysis “was not able to address important outstanding questions such as the likelihood of transmitting infection with a false-negative antigen test versus a true-negative antigen test or how much repeated testing can increase the sensitivity.”

“In Europe, we don’t know how most tests perform in real life,” Dr. Fujita-Rohwerder said. “And even in countries like the United States, where market access is more stringent, we don’t know whether self-testing performed by children or sample collection in toddlers by laypersons has a significant impact on the diagnostic accuracy. Also, diagnostic accuracy estimates reported in our study may not apply to the current omicron or future variants of SARS-CoV-2 or vaccinated children. Hopefully, these essential gaps in the evidence will get addressed soon.”

Dr. Ozer said one takeaway from this study is negative antigen tests should not be considered a “free pass” in children, especially if the child is symptomatic, has been recently exposed to COVID-19, or is planning to spend time with individuals with conditions that place them at high risk for complications of COVID-19 infection. “In such cases, consider getting PCR testing or at least performing a repeat antigen test 36-48 hours after the first negative,” he said.

Dr. Fujita-Rohwerder said the low diagnostic sensitivity may affect the use of the tests. The gaps in evidence her group found in their study point to research needed to support evidence-based decision-making. “In particular, evidence is needed on real-life performance of tests in schools, self-testing performed by children, and kindergarten, [particularly] sample collection in toddlers by laypersons,” she said.

However, she stressed, testing is only a single measure. “Effectively reducing the spread of SARS-CoV-2 during the current pandemic requires multilayered mitigation measures,” she said. “Rapid testing represents one single layer. It can have its use at the population level, even though the sensitivity of antigen tests is lower than expected. However, antigen-based rapid testing is not a magic bullet: If your kid tests negative, do not disregard other mitigation measures.”

Edward Campbell, PhD, a virologist at Loyola University of Chicago, who serves on the board of LaGrange Elementary School District 102 outside Chicago, said the findings were unsurprising.

“This study generally looks consistent with what is known for adults. These rapid antigen tests are less sensitive than other tests,” said Dr. Campbell, who also runs a testing company for private schools in the Chicago area using reverse transcription-loop-mediated isothermal amplification technology. Even so, he said, “These tests are still effective at identifying people who are infectious to some degree. Never miss an opportunity to test.”

Dr. Fujita-Rohwerder disclosed no relevant financial conflicts of interest. Dr. Campbell owns Safeguard Surveillance.

With the country looking increasingly to rapid testing as an off-ramp from the COVID-19 pandemic, a new study shows that the performance of the tests in children falls below standards set by regulatory agencies in the United States and elsewhere for diagnostic accuracy.

Experts said the findings, from a meta-analysis by researchers in the United Kingdom and Germany, underscore that, while a positive result on a rapid test is almost certainly an indicator of infection, negative results often are unreliable and can lead to a false sense of security.

“Real-life performance of current antigen tests for professional use in pediatric populations is below the minimum performance criteria set by WHO, the United States Food and Drug Administration, or the Medicines and Healthcare products Regulatory Agency (U.K.),” according to Naomi Fujita-Rohwerder, PhD, a research associate at the Cologne-based German Institute for Quality and Efficiency in Health Care (IQWiG), and her colleagues, whose study appears in BMJ Evidence-Based Medicine.

The researchers said that the study suggests that performance of rapid testing in a pediatric population is comparable to that in adults. However, they said they could not identify any studies investigating self-testing in children, which also could affect test performance.

Egon Ozer, MD, PhD, director of the center for pathogen genomics and microbial evolution at Northwestern University in Chicago, said the finding that specificity was high but sensitivity was middling “suggests that we should be very careful about interpreting negative antigen test results in children and recognize that there is a fair amount of uncertainty in the tests in this situation.”

Researchers from IQWiG, which examines the advantages and disadvantages of medical interventions, and the University of Manchester (England), conducted the systematic review and meta-analysis, which they described as the first of its kind to evaluate the diagnostic accuracy of rapid point-of-care tests for current SARS-CoV-2 infections in children.

They compiled information from 17 studies with a total 6,355 participants. They compared all antigen tests to reverse-transcription polymerase chain reaction (PCR). The studies compared eight antigen tests from six different brands. The rapid antigen tests, available from pharmacies and online stores, are widely used for self-testing in schools and testing toddlers before kindergarten.

The pooled diagnostic sensitivity of antigen tests was 64.2% and specificity was 99.1%.

Dr. Ozer noted that the analysis “was not able to address important outstanding questions such as the likelihood of transmitting infection with a false-negative antigen test versus a true-negative antigen test or how much repeated testing can increase the sensitivity.”

“In Europe, we don’t know how most tests perform in real life,” Dr. Fujita-Rohwerder said. “And even in countries like the United States, where market access is more stringent, we don’t know whether self-testing performed by children or sample collection in toddlers by laypersons has a significant impact on the diagnostic accuracy. Also, diagnostic accuracy estimates reported in our study may not apply to the current omicron or future variants of SARS-CoV-2 or vaccinated children. Hopefully, these essential gaps in the evidence will get addressed soon.”

Dr. Ozer said one takeaway from this study is negative antigen tests should not be considered a “free pass” in children, especially if the child is symptomatic, has been recently exposed to COVID-19, or is planning to spend time with individuals with conditions that place them at high risk for complications of COVID-19 infection. “In such cases, consider getting PCR testing or at least performing a repeat antigen test 36-48 hours after the first negative,” he said.

Dr. Fujita-Rohwerder said the low diagnostic sensitivity may affect the use of the tests. The gaps in evidence her group found in their study point to research needed to support evidence-based decision-making. “In particular, evidence is needed on real-life performance of tests in schools, self-testing performed by children, and kindergarten, [particularly] sample collection in toddlers by laypersons,” she said.

However, she stressed, testing is only a single measure. “Effectively reducing the spread of SARS-CoV-2 during the current pandemic requires multilayered mitigation measures,” she said. “Rapid testing represents one single layer. It can have its use at the population level, even though the sensitivity of antigen tests is lower than expected. However, antigen-based rapid testing is not a magic bullet: If your kid tests negative, do not disregard other mitigation measures.”

Edward Campbell, PhD, a virologist at Loyola University of Chicago, who serves on the board of LaGrange Elementary School District 102 outside Chicago, said the findings were unsurprising.

“This study generally looks consistent with what is known for adults. These rapid antigen tests are less sensitive than other tests,” said Dr. Campbell, who also runs a testing company for private schools in the Chicago area using reverse transcription-loop-mediated isothermal amplification technology. Even so, he said, “These tests are still effective at identifying people who are infectious to some degree. Never miss an opportunity to test.”

Dr. Fujita-Rohwerder disclosed no relevant financial conflicts of interest. Dr. Campbell owns Safeguard Surveillance.

Americans can now have free COVID-19 rapid tests delivered directly to their homes.

The Biden administration’s new no-cost, at-home testing program launched Jan. 18, a day ahead of schedule.

The administration said 500 million tests are available to be delivered to homes across the country. This accounts for half of the president’s recent pledge to purchase 1 billion free at-home COVID-19 tests to distribute to the American public.

On a Jan. 14 call with reporters, senior White House officials offered some details about the new program.

Here’s what we know so far.

How do I order my free tests?

Americans can visit COVIDtests.gov to order their rapid at-home tests. You can also order directly from the U.S. Postal Service website. After you order, you’ll receive a confirmation email that promises to send tracking information once your order ships.

What information do I need to order the tests?

You only need your name and home mailing address.

There is also an option to provide your email address to get updates on the status of your order.

What if someone needs help ordering the tests?

There will be a free call-in line for people needing more help, including those having trouble accessing the internet, according to White House officials.

What tests will be available?

There are nine at-home tests available through FDA emergency use authorization. According to the Frequently Asked Questions section of COVIDtests.gov, "You will not be able to choose the  brand  you order as part of this program.”

How long will it take to get the tests once I order them?

Tests are expected to ship 7 to 12 days after you order them.

But White House officials say that the time frame will likely shorten as the program gains steam.

How many can I order?

There’s a limit of four tests per residential mailing address.

For larger families, White House officials suggest trying other free testing options, like visiting COVID-19 testing sites or your local health center.

Is this a one-time opportunity?

The White House doesn’t say, but officials did mention that if you run out of your four free tests, there are many other ways to access free at-home tests, such as COVID-19 testing sites, pharmacies, and community health centers.

The free tests available through COVIDtests.gov are in addition to an estimated 375 million at-home rapid tests on the market in the U.S. this month.

When should people use a rapid at-home test?

The CDC and experts with other public health groups agree that Americans should consider using at-home rapid tests in the following situations:

• If they begin to have symptoms consistent with COVID-19;
• At least 5 days after close contact with someone who has COVID;
• If someone is indoors with a group of people who are at risk of severe disease or are unvaccinated.

Are at-home rapid tests accurate?

The U.S. Department of Health and Human Services and other federal officials confirmed through studies that all tests distributed through this program can detect the Omicron variant. These agencies also confirmed that their performance is consistent with the FDA’s emergency use authorization.

Is the website designed to handle high demand?

After the original website to sign up for health insurance under the Affordable Care Act crashed repeatedly at launch, the government says it has prepared for high demand for ordering at-home rapid tests.

The U.S. Digital Service (USDS), an organization founded after Healthcare.gov, has partnered with the Postal Service to plan for the launch.

The Postal Service has expanded its staffing, similar to what’s done during the holidays.

All orders in the continental United States will be shipped through first-class mail, with shipments to Alaska, Hawaii, U.S. territories, and military and overseas addresses sent through priority mail.

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

Americans can now have free COVID-19 rapid tests delivered directly to their homes.

The Biden administration’s new no-cost, at-home testing program launched Jan. 18, a day ahead of schedule.

The administration said 500 million tests are available to be delivered to homes across the country. This accounts for half of the president’s recent pledge to purchase 1 billion free at-home COVID-19 tests to distribute to the American public.

On a Jan. 14 call with reporters, senior White House officials offered some details about the new program.

Here’s what we know so far.

How do I order my free tests?

Americans can visit COVIDtests.gov to order their rapid at-home tests. You can also order directly from the U.S. Postal Service website. After you order, you’ll receive a confirmation email that promises to send tracking information once your order ships.

What information do I need to order the tests?

You only need your name and home mailing address.

There is also an option to provide your email address to get updates on the status of your order.

What if someone needs help ordering the tests?

There will be a free call-in line for people needing more help, including those having trouble accessing the internet, according to White House officials.

What tests will be available?

There are nine at-home tests available through FDA emergency use authorization. According to the Frequently Asked Questions section of COVIDtests.gov, "You will not be able to choose the  brand  you order as part of this program.”

How long will it take to get the tests once I order them?

Tests are expected to ship 7 to 12 days after you order them.

But White House officials say that the time frame will likely shorten as the program gains steam.

How many can I order?

There’s a limit of four tests per residential mailing address.

For larger families, White House officials suggest trying other free testing options, like visiting COVID-19 testing sites or your local health center.

Is this a one-time opportunity?

The White House doesn’t say, but officials did mention that if you run out of your four free tests, there are many other ways to access free at-home tests, such as COVID-19 testing sites, pharmacies, and community health centers.

The free tests available through COVIDtests.gov are in addition to an estimated 375 million at-home rapid tests on the market in the U.S. this month.

When should people use a rapid at-home test?

The CDC and experts with other public health groups agree that Americans should consider using at-home rapid tests in the following situations:

• If they begin to have symptoms consistent with COVID-19;
• At least 5 days after close contact with someone who has COVID;
• If someone is indoors with a group of people who are at risk of severe disease or are unvaccinated.

Are at-home rapid tests accurate?

The U.S. Department of Health and Human Services and other federal officials confirmed through studies that all tests distributed through this program can detect the Omicron variant. These agencies also confirmed that their performance is consistent with the FDA’s emergency use authorization.

Is the website designed to handle high demand?

After the original website to sign up for health insurance under the Affordable Care Act crashed repeatedly at launch, the government says it has prepared for high demand for ordering at-home rapid tests.

The U.S. Digital Service (USDS), an organization founded after Healthcare.gov, has partnered with the Postal Service to plan for the launch.

The Postal Service has expanded its staffing, similar to what’s done during the holidays.

All orders in the continental United States will be shipped through first-class mail, with shipments to Alaska, Hawaii, U.S. territories, and military and overseas addresses sent through priority mail.

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

Americans can now have free COVID-19 rapid tests delivered directly to their homes.

The Biden administration’s new no-cost, at-home testing program launched Jan. 18, a day ahead of schedule.

The administration said 500 million tests are available to be delivered to homes across the country. This accounts for half of the president’s recent pledge to purchase 1 billion free at-home COVID-19 tests to distribute to the American public.

On a Jan. 14 call with reporters, senior White House officials offered some details about the new program.

Here’s what we know so far.

How do I order my free tests?

Americans can visit COVIDtests.gov to order their rapid at-home tests. You can also order directly from the U.S. Postal Service website. After you order, you’ll receive a confirmation email that promises to send tracking information once your order ships.

What information do I need to order the tests?

You only need your name and home mailing address.

There is also an option to provide your email address to get updates on the status of your order.

What if someone needs help ordering the tests?

There will be a free call-in line for people needing more help, including those having trouble accessing the internet, according to White House officials.

What tests will be available?

There are nine at-home tests available through FDA emergency use authorization. According to the Frequently Asked Questions section of COVIDtests.gov, "You will not be able to choose the  brand  you order as part of this program.”

How long will it take to get the tests once I order them?

Tests are expected to ship 7 to 12 days after you order them.

But White House officials say that the time frame will likely shorten as the program gains steam.

How many can I order?

There’s a limit of four tests per residential mailing address.

For larger families, White House officials suggest trying other free testing options, like visiting COVID-19 testing sites or your local health center.

Is this a one-time opportunity?

The White House doesn’t say, but officials did mention that if you run out of your four free tests, there are many other ways to access free at-home tests, such as COVID-19 testing sites, pharmacies, and community health centers.

The free tests available through COVIDtests.gov are in addition to an estimated 375 million at-home rapid tests on the market in the U.S. this month.

When should people use a rapid at-home test?

The CDC and experts with other public health groups agree that Americans should consider using at-home rapid tests in the following situations:

• If they begin to have symptoms consistent with COVID-19;
• At least 5 days after close contact with someone who has COVID;
• If someone is indoors with a group of people who are at risk of severe disease or are unvaccinated.

Are at-home rapid tests accurate?

The U.S. Department of Health and Human Services and other federal officials confirmed through studies that all tests distributed through this program can detect the Omicron variant. These agencies also confirmed that their performance is consistent with the FDA’s emergency use authorization.

Is the website designed to handle high demand?

After the original website to sign up for health insurance under the Affordable Care Act crashed repeatedly at launch, the government says it has prepared for high demand for ordering at-home rapid tests.

The U.S. Digital Service (USDS), an organization founded after Healthcare.gov, has partnered with the Postal Service to plan for the launch.

The Postal Service has expanded its staffing, similar to what’s done during the holidays.

All orders in the continental United States will be shipped through first-class mail, with shipments to Alaska, Hawaii, U.S. territories, and military and overseas addresses sent through priority mail.

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

Antibiotics were administered to newborns at low risk for early-onset sepsis as frequently as to newborns with EOS risk factors, based on data from approximately 7,500 infants.

EOS remains a significant cause of morbidity and mortality, and predicting which newborns are at risk remains a challenge for neonatal care that often drives high rates of antibiotic use, Dustin D. Flannery, DO, of Children’s Hospital of Philadelphia and colleagues wrote.

Antibiotic exposures are associated with short- and long-term adverse effects in both preterm and term infants, which highlights the need for improved risk assessment in this population, the researchers said.

“A robust estimate of EOS risk in relation to delivery characteristics among infants of all gestational ages at birth could significantly contribute to newborn clinical management by identifying newborns unlikely to benefit from empirical antibiotic therapy,” they emphasized.

In a study published in Pediatrics, the researchers identified 7,540 infants born between Jan. 1, 2009, and Dec. 31, 2014, at two high-risk perinatal units in Philadelphia. Gestational age ranged from 22 to 43 weeks. Criteria for low risk of EOS were determined via an algorithm that included cesarean delivery (with or without labor or membrane rupture), and no antepartum concerns for intra-amniotic infection or nonreassuring fetal status.

A total of 6,428 infants did not meet the low-risk criteria; another 1,121 infants met the low-risk criteria. The primary outcome of EOS was defined as growth of a pathogen in at least 1 blood and/or cerebrospinal fluid culture obtained at 72 hours or less after birth. Overall, 41 infants who did not meet the low-risk criteria developed EOS; none of the infants who met the low-risk criteria developed EOS. Secondary outcomes included initiation of empirical antibiotics at 72 hours or less after birth and the duration of antibiotic use.

Although fewer low-risk infants received antibiotics, compared with infants with EOS (80.4% vs. 91.0%, P < .001), the duration of antibiotic use was not significantly different between the groups, with an adjusted difference of 0.6 hours.

Among infants who did not meet low-risk criteria, 157 were started on antibiotics for each case of EOS, the researchers noted in their discussion of the findings. “Because no cases of EOS were identified in the low-risk group, this proportion could not be calculated but suggests that antibiotic exposure in this group was disproportionately higher for incidence of EOS.”

The study findings were limited by several factors including the possible lack of generalizability to other centers and the use of data from a period before more refined EOS strategies, the researchers noted. Other limitations include the inability to assess the effect of lab results on antibiotic use, a lack of data on the exact indication for delivery, and potential misclassification bias.

Risk assessment tools should not be used alone, but should be used to inform clinical decision-making, the researchers emphasized. However, the results were strengthened by the inclusion of moderately preterm infants, who are rarely studied, and the clinical utility of the risk algorithm used in the study. “The implications of our study include potential adjustments to sepsis risk assessment in term infants, and confirmation and enhancement of previous studies that identify a subset of lower-risk preterm infants,” who may be spared empirical or prolonged antibiotic exposure, they concluded.
 

Data inform intelligent antibiotic use

“Early-onset sepsis is predominantly caused by exposure of the fetus or neonate to ascending maternal colonization or infection by gastrointestinal or genitourinary bacteria,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview. “Scenarios where there is limited neonatal exposure to these organisms would decrease the risk of development of EOS, therefore it is not surprising that delivery characteristics of low-risk deliveries as defined by investigators – the absence of labor, absence of intra-amniotic infection, rupture of membranes at time of delivery, and cesarean delivery – would have resulted in decreased likelihood of EOS.”

Inappropriate antibiotic use contributes to the development of resistant and more virulent strains of bacteria. A growing body of literature also suggests that early antibiotic usage in newborns may affect the neonatal gut microbiome, which is important for development of the neonatal immune system. Early alterations of the microbiome may have long-term implications,” Dr. Krishna said.

“Understanding the delivery characteristics that increase the risk of EOS are crucial to optimizing the use of antibiotics and thereby minimize potential harm to newborns,” she said. “Studies such as the current study are needed develop EOS prediction tools to improve antibiotic utilization.” More research is needed not only to adequately predict EOS, but to explore how antibiotics affect the neonatal microbiome, and how clinicians can circumvent potential adverse implications with antibiotic use to improve long-term health, Dr. Krishna concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Antibiotics were administered to newborns at low risk for early-onset sepsis as frequently as to newborns with EOS risk factors, based on data from approximately 7,500 infants.

EOS remains a significant cause of morbidity and mortality, and predicting which newborns are at risk remains a challenge for neonatal care that often drives high rates of antibiotic use, Dustin D. Flannery, DO, of Children’s Hospital of Philadelphia and colleagues wrote.

Antibiotic exposures are associated with short- and long-term adverse effects in both preterm and term infants, which highlights the need for improved risk assessment in this population, the researchers said.

“A robust estimate of EOS risk in relation to delivery characteristics among infants of all gestational ages at birth could significantly contribute to newborn clinical management by identifying newborns unlikely to benefit from empirical antibiotic therapy,” they emphasized.

In a study published in Pediatrics, the researchers identified 7,540 infants born between Jan. 1, 2009, and Dec. 31, 2014, at two high-risk perinatal units in Philadelphia. Gestational age ranged from 22 to 43 weeks. Criteria for low risk of EOS were determined via an algorithm that included cesarean delivery (with or without labor or membrane rupture), and no antepartum concerns for intra-amniotic infection or nonreassuring fetal status.

A total of 6,428 infants did not meet the low-risk criteria; another 1,121 infants met the low-risk criteria. The primary outcome of EOS was defined as growth of a pathogen in at least 1 blood and/or cerebrospinal fluid culture obtained at 72 hours or less after birth. Overall, 41 infants who did not meet the low-risk criteria developed EOS; none of the infants who met the low-risk criteria developed EOS. Secondary outcomes included initiation of empirical antibiotics at 72 hours or less after birth and the duration of antibiotic use.

Although fewer low-risk infants received antibiotics, compared with infants with EOS (80.4% vs. 91.0%, P < .001), the duration of antibiotic use was not significantly different between the groups, with an adjusted difference of 0.6 hours.

Among infants who did not meet low-risk criteria, 157 were started on antibiotics for each case of EOS, the researchers noted in their discussion of the findings. “Because no cases of EOS were identified in the low-risk group, this proportion could not be calculated but suggests that antibiotic exposure in this group was disproportionately higher for incidence of EOS.”

The study findings were limited by several factors including the possible lack of generalizability to other centers and the use of data from a period before more refined EOS strategies, the researchers noted. Other limitations include the inability to assess the effect of lab results on antibiotic use, a lack of data on the exact indication for delivery, and potential misclassification bias.

Risk assessment tools should not be used alone, but should be used to inform clinical decision-making, the researchers emphasized. However, the results were strengthened by the inclusion of moderately preterm infants, who are rarely studied, and the clinical utility of the risk algorithm used in the study. “The implications of our study include potential adjustments to sepsis risk assessment in term infants, and confirmation and enhancement of previous studies that identify a subset of lower-risk preterm infants,” who may be spared empirical or prolonged antibiotic exposure, they concluded.
 

Data inform intelligent antibiotic use

“Early-onset sepsis is predominantly caused by exposure of the fetus or neonate to ascending maternal colonization or infection by gastrointestinal or genitourinary bacteria,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview. “Scenarios where there is limited neonatal exposure to these organisms would decrease the risk of development of EOS, therefore it is not surprising that delivery characteristics of low-risk deliveries as defined by investigators – the absence of labor, absence of intra-amniotic infection, rupture of membranes at time of delivery, and cesarean delivery – would have resulted in decreased likelihood of EOS.”

Inappropriate antibiotic use contributes to the development of resistant and more virulent strains of bacteria. A growing body of literature also suggests that early antibiotic usage in newborns may affect the neonatal gut microbiome, which is important for development of the neonatal immune system. Early alterations of the microbiome may have long-term implications,” Dr. Krishna said.

“Understanding the delivery characteristics that increase the risk of EOS are crucial to optimizing the use of antibiotics and thereby minimize potential harm to newborns,” she said. “Studies such as the current study are needed develop EOS prediction tools to improve antibiotic utilization.” More research is needed not only to adequately predict EOS, but to explore how antibiotics affect the neonatal microbiome, and how clinicians can circumvent potential adverse implications with antibiotic use to improve long-term health, Dr. Krishna concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

Antibiotics were administered to newborns at low risk for early-onset sepsis as frequently as to newborns with EOS risk factors, based on data from approximately 7,500 infants.

EOS remains a significant cause of morbidity and mortality, and predicting which newborns are at risk remains a challenge for neonatal care that often drives high rates of antibiotic use, Dustin D. Flannery, DO, of Children’s Hospital of Philadelphia and colleagues wrote.

Antibiotic exposures are associated with short- and long-term adverse effects in both preterm and term infants, which highlights the need for improved risk assessment in this population, the researchers said.

“A robust estimate of EOS risk in relation to delivery characteristics among infants of all gestational ages at birth could significantly contribute to newborn clinical management by identifying newborns unlikely to benefit from empirical antibiotic therapy,” they emphasized.

In a study published in Pediatrics, the researchers identified 7,540 infants born between Jan. 1, 2009, and Dec. 31, 2014, at two high-risk perinatal units in Philadelphia. Gestational age ranged from 22 to 43 weeks. Criteria for low risk of EOS were determined via an algorithm that included cesarean delivery (with or without labor or membrane rupture), and no antepartum concerns for intra-amniotic infection or nonreassuring fetal status.

A total of 6,428 infants did not meet the low-risk criteria; another 1,121 infants met the low-risk criteria. The primary outcome of EOS was defined as growth of a pathogen in at least 1 blood and/or cerebrospinal fluid culture obtained at 72 hours or less after birth. Overall, 41 infants who did not meet the low-risk criteria developed EOS; none of the infants who met the low-risk criteria developed EOS. Secondary outcomes included initiation of empirical antibiotics at 72 hours or less after birth and the duration of antibiotic use.

Although fewer low-risk infants received antibiotics, compared with infants with EOS (80.4% vs. 91.0%, P < .001), the duration of antibiotic use was not significantly different between the groups, with an adjusted difference of 0.6 hours.

Among infants who did not meet low-risk criteria, 157 were started on antibiotics for each case of EOS, the researchers noted in their discussion of the findings. “Because no cases of EOS were identified in the low-risk group, this proportion could not be calculated but suggests that antibiotic exposure in this group was disproportionately higher for incidence of EOS.”

The study findings were limited by several factors including the possible lack of generalizability to other centers and the use of data from a period before more refined EOS strategies, the researchers noted. Other limitations include the inability to assess the effect of lab results on antibiotic use, a lack of data on the exact indication for delivery, and potential misclassification bias.

Risk assessment tools should not be used alone, but should be used to inform clinical decision-making, the researchers emphasized. However, the results were strengthened by the inclusion of moderately preterm infants, who are rarely studied, and the clinical utility of the risk algorithm used in the study. “The implications of our study include potential adjustments to sepsis risk assessment in term infants, and confirmation and enhancement of previous studies that identify a subset of lower-risk preterm infants,” who may be spared empirical or prolonged antibiotic exposure, they concluded.
 

Data inform intelligent antibiotic use

“Early-onset sepsis is predominantly caused by exposure of the fetus or neonate to ascending maternal colonization or infection by gastrointestinal or genitourinary bacteria,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview. “Scenarios where there is limited neonatal exposure to these organisms would decrease the risk of development of EOS, therefore it is not surprising that delivery characteristics of low-risk deliveries as defined by investigators – the absence of labor, absence of intra-amniotic infection, rupture of membranes at time of delivery, and cesarean delivery – would have resulted in decreased likelihood of EOS.”

Inappropriate antibiotic use contributes to the development of resistant and more virulent strains of bacteria. A growing body of literature also suggests that early antibiotic usage in newborns may affect the neonatal gut microbiome, which is important for development of the neonatal immune system. Early alterations of the microbiome may have long-term implications,” Dr. Krishna said.

“Understanding the delivery characteristics that increase the risk of EOS are crucial to optimizing the use of antibiotics and thereby minimize potential harm to newborns,” she said. “Studies such as the current study are needed develop EOS prediction tools to improve antibiotic utilization.” More research is needed not only to adequately predict EOS, but to explore how antibiotics affect the neonatal microbiome, and how clinicians can circumvent potential adverse implications with antibiotic use to improve long-term health, Dr. Krishna concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose and serves on the editorial advisory board of Ob.Gyn. News.

When it comes to antidepressant prescribing, less may be more, new research suggests.

A new review suggests antidepressants are overprescribed and that the efficacy of these agents is questionable, leading researchers to recommend that, when physicians prescribe these medications, it should be for shorter periods.

“Antidepressants have never been shown to have a clinically significant difference from placebo in the treatment of depression,” study co\investigator Mark Horowitz, GDPsych, PhD, division of psychiatry, University College London, said in an interview.

HconQ/ThinkStock

He added antidepressants “exert profound adverse effects on the body and brain” and can be difficult to stop because of physical dependence that occurs when the brain adapts to them.

“The best way to take people off these drugs is to do so gradually enough that the unpleasant effects are minimized and in a way that means the reductions in dose get smaller and smaller as the total dose gets lower,” Dr. Horowitz said.

However, at least one expert urged caution in interpreting the review’s findings.

“The reality is that millions of people do benefit from these medications, and this review minimizes those benefits,” Philip Muskin, MD, chief of consultation-liaison for psychiatry and professor of psychiatry, Columbia University Medical Center and New York–Presbyterian Hospital, said when approached for comment.

The findings were published online Dec. 20, 2021, in the Drug and Therapeutics Bulletin.
 

Personal experience

Prescribing of newer-generation antidepressants, such as SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), is increasing, with an estimated one in six adults in the United Kingdom receiving at least one prescription in 2019-2020, the investigators noted.

Dr. Horowitz noted a personal motivation for conducting the review. “As well as being an academic psychiatrist, I’m also a patient who has been prescribed antidepressants since age 21, when my mood was poor, due to life circumstances.”

The antidepressant “didn’t have particularly helpful effects,” but Dr. Horowitz continued taking it for 18 years. “I was told it was helpful and internalized that message. I came to understand that much of the information around antidepressants came from the drug companies that manufactured them or from academics paid by these companies.”

Dr. Horowitz is currently discontinuing his medication – a tapering process now in its third year. He said he has come to realize, in retrospect, that symptoms not initially attributed to the drug, such as fatigue, impaired concentration, and impaired memory, have improved since reducing the medication.

“That experience sensitized me to look for these symptoms in my patients and I see them; but most of my patients were told by their doctors that the cause of those problems was the depression or anxiety itself and not the drug,” he said.

Dr. Horowitz collaborated with Michael Wilcock, DTB, Pharmacy, Royal Cornwall Hospitals, NHS Trust, Truro, England, in conducting the review “to provide an independent assessment of benefits and harms of antidepressants.”

“Much of the evidence of the efficacy of antidepressants comes from randomized placebo-controlled trials,” Dr. Horowitz said. Several meta-analyses of these studies showed a difference of about two points between the agent and the placebo on the Hamilton Depression Rating Scale (HAM-D).

“Although this might be statistically significant, it does not meet the threshold for a clinical significance – those aren’t the same thing,” Dr. Horowitz said. Some analyses suggest that a “minimally clinically important difference” on the HAM-D would range from 3 to 6 points.

The findings in adolescents and children are “even less convincing,” the investigators noted, citing a Cochrane review.

“This is especially concerning because the number of children and adolescents being treated with antidepressants is rapidly increasing,” Dr. Horowitz said.

Additionally, the short duration of most trials, typically 6-12 weeks, is “largely uninformative for the clinical treatment of depression.”
 

Relapse or withdrawal?

The researchers reviewed the adverse effects of long-term antidepressant use, including daytime sleepiness, dry mouth, profuse sweating, weight gain, sexual dysfunction, restlessness, and feeling “foggy or detached.”

“Antidepressants have toxic effects on the brain and cause brain damage when they artificially increase serotonin and modify brain chemistry, which is why people become sick for years after stopping,” Dr. Horowitz said. “When the drug is reduced or stopped, the brain has difficulty dealing with the sudden drop in neurotransmitters, and withdrawal symptoms result, similar to stopping caffeine, nicotine, or opioids.”

He added it is not necessarily the original condition of depression or anxiety that is recurring but rather withdrawal, which can last for months or even years after medication discontinuation.

“Unfortunately, doctors have been taught that there are minimal withdrawal symptoms, euphemized as ‘discontinuation symptoms,’ and so when patients have reported withdrawal symptoms, they have been told it is a return of their underlying condition,” Dr. Horowitz said.

“This has led to many patients being incorrectly told that they need to get back on their antidepressants,” he added.

He likened this approach to “telling people that the need to continue smoking because when they stop, they get more anxiety.” Rather, the “correct response would be that they simply need to taper off the antidepressant more carefully,” he said.
 

Helpful in the short term

Patients should be informed prior to initiation of antidepressant treatment about the risk of withdrawal effects if they stop the drug, the investigators advise. They reference the Royal College of Psychiatrists’ updated guidance, which recommends slow tapering over a period long enough to mitigate withdrawal symptoms to “tolerable levels.”

The guidance suggests that patients start with a small “test reduction.” Withdrawal symptoms should be monitored for the following 2-4 weeks, using a symptom checklist such as the Discontinuation Emergent Signs and Symptoms Scale, with subsequent reductions based on the tolerability of the process.

Gradual dose reductions and very small final doses may necessitate the use of formulations of medication other than those commonly available in tablet forms, the researchers noted. During the tapering process, patients may benefit from increased psychosocial support.

Dr. Horowitz noted that antidepressants can be helpful on a short-term basis, and likened their use to the use of a cast to stabilize a broken arm.

“It’s useful for a short period. But if you leave someone in a plastic cast permanently, their arm will shrivel and you will disable them. These drugs should be prescribed minimally, and for the shortest possible period of time,” he said.

Dr. Horowitz recommended the recent draft National Institute for Health and Care Excellence depression guidance that recommends multiple other options beyond antidepressants, including cognitive-behavioral therapy, problem solving, counseling, and exercise.
 

Lack of balance

Dr. Muskin commented that the review is helpful in guiding clinicians on how to approach tapering of antidepressants and making patients aware of discontinuation symptoms.

However, “a lot of people will read this who need treatment, but they won’t get treated because they’ll take away the message that ‘drugs don’t work,’ ” he said.

“As it is, there is already stigma and prejudice toward psychiatric illness and using medications for treatment,” said Dr. Muskin, who was not involved with the research.

The current review “isn’t balanced, in terms of the efficacy of these drugs – both for the spectrum of depressive disorders and for panic or anxiety disorder. And there is nowhere that the authors say these drugs help people,” he added.

Moreover, the investigators’ assertion that long-term use of antidepressants causes harm is incorrect, he said.

“Yes, there are ongoing side effects that impose a burden, but that’s not the same as harm. And while the side effects are sometimes burdensome, ongoing depression is also terribly burdensome,” Dr. Muskin concluded.

Dr. Horowitz, Dr. Wilcock, and Dr. Muskin have reported no relevant financial relationships.

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

When it comes to antidepressant prescribing, less may be more, new research suggests.

A new review suggests antidepressants are overprescribed and that the efficacy of these agents is questionable, leading researchers to recommend that, when physicians prescribe these medications, it should be for shorter periods.

“Antidepressants have never been shown to have a clinically significant difference from placebo in the treatment of depression,” study co\investigator Mark Horowitz, GDPsych, PhD, division of psychiatry, University College London, said in an interview.

HconQ/ThinkStock

He added antidepressants “exert profound adverse effects on the body and brain” and can be difficult to stop because of physical dependence that occurs when the brain adapts to them.

“The best way to take people off these drugs is to do so gradually enough that the unpleasant effects are minimized and in a way that means the reductions in dose get smaller and smaller as the total dose gets lower,” Dr. Horowitz said.

However, at least one expert urged caution in interpreting the review’s findings.

“The reality is that millions of people do benefit from these medications, and this review minimizes those benefits,” Philip Muskin, MD, chief of consultation-liaison for psychiatry and professor of psychiatry, Columbia University Medical Center and New York–Presbyterian Hospital, said when approached for comment.

The findings were published online Dec. 20, 2021, in the Drug and Therapeutics Bulletin.
 

Personal experience

Prescribing of newer-generation antidepressants, such as SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), is increasing, with an estimated one in six adults in the United Kingdom receiving at least one prescription in 2019-2020, the investigators noted.

Dr. Horowitz noted a personal motivation for conducting the review. “As well as being an academic psychiatrist, I’m also a patient who has been prescribed antidepressants since age 21, when my mood was poor, due to life circumstances.”

The antidepressant “didn’t have particularly helpful effects,” but Dr. Horowitz continued taking it for 18 years. “I was told it was helpful and internalized that message. I came to understand that much of the information around antidepressants came from the drug companies that manufactured them or from academics paid by these companies.”

Dr. Horowitz is currently discontinuing his medication – a tapering process now in its third year. He said he has come to realize, in retrospect, that symptoms not initially attributed to the drug, such as fatigue, impaired concentration, and impaired memory, have improved since reducing the medication.

“That experience sensitized me to look for these symptoms in my patients and I see them; but most of my patients were told by their doctors that the cause of those problems was the depression or anxiety itself and not the drug,” he said.

Dr. Horowitz collaborated with Michael Wilcock, DTB, Pharmacy, Royal Cornwall Hospitals, NHS Trust, Truro, England, in conducting the review “to provide an independent assessment of benefits and harms of antidepressants.”

“Much of the evidence of the efficacy of antidepressants comes from randomized placebo-controlled trials,” Dr. Horowitz said. Several meta-analyses of these studies showed a difference of about two points between the agent and the placebo on the Hamilton Depression Rating Scale (HAM-D).

“Although this might be statistically significant, it does not meet the threshold for a clinical significance – those aren’t the same thing,” Dr. Horowitz said. Some analyses suggest that a “minimally clinically important difference” on the HAM-D would range from 3 to 6 points.

The findings in adolescents and children are “even less convincing,” the investigators noted, citing a Cochrane review.

“This is especially concerning because the number of children and adolescents being treated with antidepressants is rapidly increasing,” Dr. Horowitz said.

Additionally, the short duration of most trials, typically 6-12 weeks, is “largely uninformative for the clinical treatment of depression.”
 

Relapse or withdrawal?

The researchers reviewed the adverse effects of long-term antidepressant use, including daytime sleepiness, dry mouth, profuse sweating, weight gain, sexual dysfunction, restlessness, and feeling “foggy or detached.”

“Antidepressants have toxic effects on the brain and cause brain damage when they artificially increase serotonin and modify brain chemistry, which is why people become sick for years after stopping,” Dr. Horowitz said. “When the drug is reduced or stopped, the brain has difficulty dealing with the sudden drop in neurotransmitters, and withdrawal symptoms result, similar to stopping caffeine, nicotine, or opioids.”

He added it is not necessarily the original condition of depression or anxiety that is recurring but rather withdrawal, which can last for months or even years after medication discontinuation.

“Unfortunately, doctors have been taught that there are minimal withdrawal symptoms, euphemized as ‘discontinuation symptoms,’ and so when patients have reported withdrawal symptoms, they have been told it is a return of their underlying condition,” Dr. Horowitz said.

“This has led to many patients being incorrectly told that they need to get back on their antidepressants,” he added.

He likened this approach to “telling people that the need to continue smoking because when they stop, they get more anxiety.” Rather, the “correct response would be that they simply need to taper off the antidepressant more carefully,” he said.
 

Helpful in the short term

Patients should be informed prior to initiation of antidepressant treatment about the risk of withdrawal effects if they stop the drug, the investigators advise. They reference the Royal College of Psychiatrists’ updated guidance, which recommends slow tapering over a period long enough to mitigate withdrawal symptoms to “tolerable levels.”

The guidance suggests that patients start with a small “test reduction.” Withdrawal symptoms should be monitored for the following 2-4 weeks, using a symptom checklist such as the Discontinuation Emergent Signs and Symptoms Scale, with subsequent reductions based on the tolerability of the process.

Gradual dose reductions and very small final doses may necessitate the use of formulations of medication other than those commonly available in tablet forms, the researchers noted. During the tapering process, patients may benefit from increased psychosocial support.

Dr. Horowitz noted that antidepressants can be helpful on a short-term basis, and likened their use to the use of a cast to stabilize a broken arm.

“It’s useful for a short period. But if you leave someone in a plastic cast permanently, their arm will shrivel and you will disable them. These drugs should be prescribed minimally, and for the shortest possible period of time,” he said.

Dr. Horowitz recommended the recent draft National Institute for Health and Care Excellence depression guidance that recommends multiple other options beyond antidepressants, including cognitive-behavioral therapy, problem solving, counseling, and exercise.
 

Lack of balance

Dr. Muskin commented that the review is helpful in guiding clinicians on how to approach tapering of antidepressants and making patients aware of discontinuation symptoms.

However, “a lot of people will read this who need treatment, but they won’t get treated because they’ll take away the message that ‘drugs don’t work,’ ” he said.

“As it is, there is already stigma and prejudice toward psychiatric illness and using medications for treatment,” said Dr. Muskin, who was not involved with the research.

The current review “isn’t balanced, in terms of the efficacy of these drugs – both for the spectrum of depressive disorders and for panic or anxiety disorder. And there is nowhere that the authors say these drugs help people,” he added.

Moreover, the investigators’ assertion that long-term use of antidepressants causes harm is incorrect, he said.

“Yes, there are ongoing side effects that impose a burden, but that’s not the same as harm. And while the side effects are sometimes burdensome, ongoing depression is also terribly burdensome,” Dr. Muskin concluded.

Dr. Horowitz, Dr. Wilcock, and Dr. Muskin have reported no relevant financial relationships.

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

When it comes to antidepressant prescribing, less may be more, new research suggests.

A new review suggests antidepressants are overprescribed and that the efficacy of these agents is questionable, leading researchers to recommend that, when physicians prescribe these medications, it should be for shorter periods.

“Antidepressants have never been shown to have a clinically significant difference from placebo in the treatment of depression,” study co\investigator Mark Horowitz, GDPsych, PhD, division of psychiatry, University College London, said in an interview.

HconQ/ThinkStock

He added antidepressants “exert profound adverse effects on the body and brain” and can be difficult to stop because of physical dependence that occurs when the brain adapts to them.

“The best way to take people off these drugs is to do so gradually enough that the unpleasant effects are minimized and in a way that means the reductions in dose get smaller and smaller as the total dose gets lower,” Dr. Horowitz said.

However, at least one expert urged caution in interpreting the review’s findings.

“The reality is that millions of people do benefit from these medications, and this review minimizes those benefits,” Philip Muskin, MD, chief of consultation-liaison for psychiatry and professor of psychiatry, Columbia University Medical Center and New York–Presbyterian Hospital, said when approached for comment.

The findings were published online Dec. 20, 2021, in the Drug and Therapeutics Bulletin.
 

Personal experience

Prescribing of newer-generation antidepressants, such as SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), is increasing, with an estimated one in six adults in the United Kingdom receiving at least one prescription in 2019-2020, the investigators noted.

Dr. Horowitz noted a personal motivation for conducting the review. “As well as being an academic psychiatrist, I’m also a patient who has been prescribed antidepressants since age 21, when my mood was poor, due to life circumstances.”

The antidepressant “didn’t have particularly helpful effects,” but Dr. Horowitz continued taking it for 18 years. “I was told it was helpful and internalized that message. I came to understand that much of the information around antidepressants came from the drug companies that manufactured them or from academics paid by these companies.”

Dr. Horowitz is currently discontinuing his medication – a tapering process now in its third year. He said he has come to realize, in retrospect, that symptoms not initially attributed to the drug, such as fatigue, impaired concentration, and impaired memory, have improved since reducing the medication.

“That experience sensitized me to look for these symptoms in my patients and I see them; but most of my patients were told by their doctors that the cause of those problems was the depression or anxiety itself and not the drug,” he said.

Dr. Horowitz collaborated with Michael Wilcock, DTB, Pharmacy, Royal Cornwall Hospitals, NHS Trust, Truro, England, in conducting the review “to provide an independent assessment of benefits and harms of antidepressants.”

“Much of the evidence of the efficacy of antidepressants comes from randomized placebo-controlled trials,” Dr. Horowitz said. Several meta-analyses of these studies showed a difference of about two points between the agent and the placebo on the Hamilton Depression Rating Scale (HAM-D).

“Although this might be statistically significant, it does not meet the threshold for a clinical significance – those aren’t the same thing,” Dr. Horowitz said. Some analyses suggest that a “minimally clinically important difference” on the HAM-D would range from 3 to 6 points.

The findings in adolescents and children are “even less convincing,” the investigators noted, citing a Cochrane review.

“This is especially concerning because the number of children and adolescents being treated with antidepressants is rapidly increasing,” Dr. Horowitz said.

Additionally, the short duration of most trials, typically 6-12 weeks, is “largely uninformative for the clinical treatment of depression.”
 

Relapse or withdrawal?

The researchers reviewed the adverse effects of long-term antidepressant use, including daytime sleepiness, dry mouth, profuse sweating, weight gain, sexual dysfunction, restlessness, and feeling “foggy or detached.”

“Antidepressants have toxic effects on the brain and cause brain damage when they artificially increase serotonin and modify brain chemistry, which is why people become sick for years after stopping,” Dr. Horowitz said. “When the drug is reduced or stopped, the brain has difficulty dealing with the sudden drop in neurotransmitters, and withdrawal symptoms result, similar to stopping caffeine, nicotine, or opioids.”

He added it is not necessarily the original condition of depression or anxiety that is recurring but rather withdrawal, which can last for months or even years after medication discontinuation.

“Unfortunately, doctors have been taught that there are minimal withdrawal symptoms, euphemized as ‘discontinuation symptoms,’ and so when patients have reported withdrawal symptoms, they have been told it is a return of their underlying condition,” Dr. Horowitz said.

“This has led to many patients being incorrectly told that they need to get back on their antidepressants,” he added.

He likened this approach to “telling people that the need to continue smoking because when they stop, they get more anxiety.” Rather, the “correct response would be that they simply need to taper off the antidepressant more carefully,” he said.
 

Helpful in the short term

Patients should be informed prior to initiation of antidepressant treatment about the risk of withdrawal effects if they stop the drug, the investigators advise. They reference the Royal College of Psychiatrists’ updated guidance, which recommends slow tapering over a period long enough to mitigate withdrawal symptoms to “tolerable levels.”

The guidance suggests that patients start with a small “test reduction.” Withdrawal symptoms should be monitored for the following 2-4 weeks, using a symptom checklist such as the Discontinuation Emergent Signs and Symptoms Scale, with subsequent reductions based on the tolerability of the process.

Gradual dose reductions and very small final doses may necessitate the use of formulations of medication other than those commonly available in tablet forms, the researchers noted. During the tapering process, patients may benefit from increased psychosocial support.

Dr. Horowitz noted that antidepressants can be helpful on a short-term basis, and likened their use to the use of a cast to stabilize a broken arm.

“It’s useful for a short period. But if you leave someone in a plastic cast permanently, their arm will shrivel and you will disable them. These drugs should be prescribed minimally, and for the shortest possible period of time,” he said.

Dr. Horowitz recommended the recent draft National Institute for Health and Care Excellence depression guidance that recommends multiple other options beyond antidepressants, including cognitive-behavioral therapy, problem solving, counseling, and exercise.
 

Lack of balance

Dr. Muskin commented that the review is helpful in guiding clinicians on how to approach tapering of antidepressants and making patients aware of discontinuation symptoms.

However, “a lot of people will read this who need treatment, but they won’t get treated because they’ll take away the message that ‘drugs don’t work,’ ” he said.

“As it is, there is already stigma and prejudice toward psychiatric illness and using medications for treatment,” said Dr. Muskin, who was not involved with the research.

The current review “isn’t balanced, in terms of the efficacy of these drugs – both for the spectrum of depressive disorders and for panic or anxiety disorder. And there is nowhere that the authors say these drugs help people,” he added.

Moreover, the investigators’ assertion that long-term use of antidepressants causes harm is incorrect, he said.

“Yes, there are ongoing side effects that impose a burden, but that’s not the same as harm. And while the side effects are sometimes burdensome, ongoing depression is also terribly burdensome,” Dr. Muskin concluded.

Dr. Horowitz, Dr. Wilcock, and Dr. Muskin have reported no relevant financial relationships.

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

Americans will be able to order free, at-home rapid COVID-19 tests online at COVIDTests.gov starting Jan. 19.

The tests will ship within 7 to 12 days after being ordered, senior officials from President Joe Biden’s administration said Jan. 14. The U.S. Postal Service will handle the shipping and delivery through first-class mail.

People will input their name and mailing address on the website and can share an email address to receive updates on the order, according to NPR. People won’t need to pay shipping costs or enter a credit card number to order tests, according to the website’s homepage.

The website will be offered in both English and Spanish. The Biden administration will also set up a phone number so those without internet access can place orders.

Officials didn’t share a specific time that the website will open, according to he New York Times  — simply that it will go live sometime on Jan. 19. Each household will be limited to ordering four tests.

Starting Jan. 15, people with private insurance were able to seek reimbursement for tests they purchase on their own. At the same time, some insurers have said it could take weeks to set up a system for smooth reimbursement, the newspaper reported.

Last week’s announcement is the latest step in the president’s pledge to get coronavirus tests to Americans. In December, Biden said his administration would purchase 500 million tests and distribute them to Americans for free. On Jan. 13, he announced that the administration would buy another 500 million tests, bringing the total to 1 billion.

So far, the administration has signed contracts to produce 420 million tests, the newspaper reported. With the website opening this week and the lag in shipping, the tests will likely arrive by the end of January at the earliest, which could be after the peak of the current coronavirus surge in some parts of the country.

At-home tests have been in high demand, with some pharmacies, retailers, and websites reporting no stock in recent weeks. People have lined up at community testing sites for hours to get tested as the national average of daily cases has climbed above 800,000 last week.

Some consumers have also been confused about how or when to use at-home tests. On Jan. 14, Biden administration officials said that people should use rapid tests for three reasons:

• If they begin to experience COVID-19 symptoms;
• When it has been five or more days after being exposed to someone who tests positive;
• If they are gathering indoors with a high-risk person and want to check if they are negative.

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

Americans will be able to order free, at-home rapid COVID-19 tests online at COVIDTests.gov starting Jan. 19.

The tests will ship within 7 to 12 days after being ordered, senior officials from President Joe Biden’s administration said Jan. 14. The U.S. Postal Service will handle the shipping and delivery through first-class mail.

People will input their name and mailing address on the website and can share an email address to receive updates on the order, according to NPR. People won’t need to pay shipping costs or enter a credit card number to order tests, according to the website’s homepage.

The website will be offered in both English and Spanish. The Biden administration will also set up a phone number so those without internet access can place orders.

Officials didn’t share a specific time that the website will open, according to he New York Times  — simply that it will go live sometime on Jan. 19. Each household will be limited to ordering four tests.

Starting Jan. 15, people with private insurance were able to seek reimbursement for tests they purchase on their own. At the same time, some insurers have said it could take weeks to set up a system for smooth reimbursement, the newspaper reported.

Last week’s announcement is the latest step in the president’s pledge to get coronavirus tests to Americans. In December, Biden said his administration would purchase 500 million tests and distribute them to Americans for free. On Jan. 13, he announced that the administration would buy another 500 million tests, bringing the total to 1 billion.

So far, the administration has signed contracts to produce 420 million tests, the newspaper reported. With the website opening this week and the lag in shipping, the tests will likely arrive by the end of January at the earliest, which could be after the peak of the current coronavirus surge in some parts of the country.

At-home tests have been in high demand, with some pharmacies, retailers, and websites reporting no stock in recent weeks. People have lined up at community testing sites for hours to get tested as the national average of daily cases has climbed above 800,000 last week.

Some consumers have also been confused about how or when to use at-home tests. On Jan. 14, Biden administration officials said that people should use rapid tests for three reasons:

• If they begin to experience COVID-19 symptoms;
• When it has been five or more days after being exposed to someone who tests positive;
• If they are gathering indoors with a high-risk person and want to check if they are negative.

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

Americans will be able to order free, at-home rapid COVID-19 tests online at COVIDTests.gov starting Jan. 19.

The tests will ship within 7 to 12 days after being ordered, senior officials from President Joe Biden’s administration said Jan. 14. The U.S. Postal Service will handle the shipping and delivery through first-class mail.

People will input their name and mailing address on the website and can share an email address to receive updates on the order, according to NPR. People won’t need to pay shipping costs or enter a credit card number to order tests, according to the website’s homepage.

The website will be offered in both English and Spanish. The Biden administration will also set up a phone number so those without internet access can place orders.

Officials didn’t share a specific time that the website will open, according to he New York Times  — simply that it will go live sometime on Jan. 19. Each household will be limited to ordering four tests.

Starting Jan. 15, people with private insurance were able to seek reimbursement for tests they purchase on their own. At the same time, some insurers have said it could take weeks to set up a system for smooth reimbursement, the newspaper reported.

Last week’s announcement is the latest step in the president’s pledge to get coronavirus tests to Americans. In December, Biden said his administration would purchase 500 million tests and distribute them to Americans for free. On Jan. 13, he announced that the administration would buy another 500 million tests, bringing the total to 1 billion.

So far, the administration has signed contracts to produce 420 million tests, the newspaper reported. With the website opening this week and the lag in shipping, the tests will likely arrive by the end of January at the earliest, which could be after the peak of the current coronavirus surge in some parts of the country.

At-home tests have been in high demand, with some pharmacies, retailers, and websites reporting no stock in recent weeks. People have lined up at community testing sites for hours to get tested as the national average of daily cases has climbed above 800,000 last week.

Some consumers have also been confused about how or when to use at-home tests. On Jan. 14, Biden administration officials said that people should use rapid tests for three reasons:

• If they begin to experience COVID-19 symptoms;
• When it has been five or more days after being exposed to someone who tests positive;
• If they are gathering indoors with a high-risk person and want to check if they are negative.

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

A pair of updated clinical guidelines from the American College of Physicians on the diagnosis and management of diverticulitis emphasized reduced use of antibiotics, outpatient management, and informed decision-making prior to elective surgery.

The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”

Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.

The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.

In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
 

Guidance on diagnosis and management

In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.

Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.

The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.

All three recommendations are conditional, with low-certainty evidence, according to the authors.
 

Colonoscopy for diagnostic evaluation and interventions

In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.

Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.

A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.

The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.

The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.

This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
 

Update confirms best practices

“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”

Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.

Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.

Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
 

Curbing antibiotic use

It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.

“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”

“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”

As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”

The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.

A pair of updated clinical guidelines from the American College of Physicians on the diagnosis and management of diverticulitis emphasized reduced use of antibiotics, outpatient management, and informed decision-making prior to elective surgery.

The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”

Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.

The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.

In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
 

Guidance on diagnosis and management

In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.

Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.

The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.

All three recommendations are conditional, with low-certainty evidence, according to the authors.
 

Colonoscopy for diagnostic evaluation and interventions

In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.

Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.

A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.

The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.

The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.

This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
 

Update confirms best practices

“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”

Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.

Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.

Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
 

Curbing antibiotic use

It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.

“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”

“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”

As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”

The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.

A pair of updated clinical guidelines from the American College of Physicians on the diagnosis and management of diverticulitis emphasized reduced use of antibiotics, outpatient management, and informed decision-making prior to elective surgery.

The estimated prevalence of acute colonic diverticulitis in the United States appears to be on the rise, wrote Amir Qaseem, MD, and members of the ACP Clinical Guidelines Committee. “Approximately 200,000 hospitalizations for acute left-sided colonic diverticulitis occur in the United States each year, with annual costs of more than $8 billion. Timely and correct diagnosis of acute left-sided colonic diverticulitis is essential for the selection of the most appropriate management options.”

Diverticulitis is becoming increasingly common in patients treated by internal medicine physicians, according to the ACP, and the new clinical guidelines specify a course of treatment focused on outpatient management and minimal medications.

The guidelines, published in Annals of Internal Medicine, were based on a systematic review of evidence from studies published between Jan. 1, 1990, and June 1, 2020. Notably, right-sided diverticulitis was excluded because it is rare in Western countries and involves a different natural history and management options, the authors wrote.

In the guidelines, uncomplicated diverticulitis refers to localized inflammation, and complicated diverticulitis refers to “inflammation associated with an abscess, a phlegmon, a fistula, an obstruction, bleeding, or perforation.”
 

Guidance on diagnosis and management

In the first guideline, “Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis”, the authors provided three recommendations. First, they recommended that clinicians use abdominal CT imaging in cases of diagnostic uncertainty for patients with suspected acute left-sided colonic diverticulitis. The evidence showed that abdominal CT was associated with appropriate management in patients with suspected acute left-sided colonic diverticulitis, and that misdiagnosis with CT was rare.

Second, the authors of this guidance recommended management of most patients with acute left-sided colonic diverticulitis in an outpatient setting. Evidence showed that the risk for elective surgery and for recurrence were not significantly different based on inpatient or outpatient management.

The third recommendation advised clinicians to manage most patients without antibiotics. This recommendation was based on data showing no significant difference in quality of life at 3, 6, 12, or 24 months; no difference in diverticulitis-related complications; and no difference in the need for surgery in patients treated with antibiotics and those not treated with antibiotics.

All three recommendations are conditional, with low-certainty evidence, according to the authors.
 

Colonoscopy for diagnostic evaluation and interventions

In the second guideline, “Colonoscopy for Diagnostic Evaluation and Interventions to Prevent Recurrence After Acute Left-Sided Colonic Diverticulitis, the authors advised clinicians to refer patients for a colonoscopy after an initial episode of complicated left-sided colonic diverticulitis if they have not had a recent colonoscopy.

Although acute diverticulitis is usually uncomplicated, approximately 12% of cases are considered complicated, and these patients may have a higher prevalence of colorectal cancer, the authors noted. This recommendation was conditional, with low-certainty evidence. Additional diagnostic colonoscopy is not needed for patients who are up to date on recommended colorectal cancer screening, according to this guideline.

A second recommendation, given as a strong recommendation with high-certainty evidence, advised against using mesalamine to prevent recurrent diverticulitis. Evidence showed that use of mesalamine at doses ranging from 1.2 g/day to 4.8 g/day made no difference in recurrent diverticulitis risk compared with placebo. Mesalamine has no demonstrated clinical benefits, and has been associated with epigastric pain, nausea, diarrhea, dizziness, rash, and renal and hepatic impairment, the authors wrote.

The third recommendation advised the discussion of elective surgery with patients with a history of uncomplicated diverticulitis that persists or recurs frequently. Surgery also may be an option for patients with complicated diverticulitis, according to the guideline. However, “this recommendation does not apply to patients with uncomplicated diverticulitis that is not persistent or frequently recurring,” the authors wrote.

The decision to pursue elective surgery should be informed and personalized according to potential benefits, harms, costs, and patient preferences, they said. This recommendation is conditional, with low-certainty evidence.

This new guideline was designed “to guide care based on the best available evidence and may not apply to all patients or individual clinical situations,” the authors emphasized. “It should not be used as a replacement for a clinician’s judgment.”
 

Update confirms best practices

“Concerns about inappropriate antimicrobial therapy use and the delay in seeking preventative care such as a colonoscopy have led to poorer outcomes for patients,” ACP president George Abraham, MD, said in an interview. These concerns about a lack of antimicrobial stewardship and of care not being representative of ‘high value care’ “supported the need to reinforce best practices.”

Although most clinicians are aware of the nature of the recommendations in their own clinical practices, “a systematic review helped confirm and codify best practice that everyone can confidently incorporate into their daily decision-making,” Dr. Abraham said.

Compared with previous guidelines, “the single biggest difference is the fact that antimicrobial therapy is not indicated in mild, uncomplicated diverticulitis; we hope this will lead to lesser and more judicious antimicrobial prescribing,” Dr. Abraham emphasized.

Like all guidelines, the current guidelines are meant to be advisory, not mandatory; “they do not replace good clinical judgment and individual patient care decision-making,” Dr. Abraham said. “These guidelines are useful when they are widely read by clinicians, including physicians and advanced practice clinicians, and incorporated into their daily practice.”
 

Curbing antibiotic use

It is important for clinicians to recognize that uncomplicated diverticulitis in selected patients does not require initial antibiotics, David A. Johnson, MD, chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said in an interview. “This paradigm shift began with the AGA guidelines in 2015, and was more recently updated with the 2021 best practice recommendations,” first published in Gastroenterology.

“I was surprised to see this current guideline not mentioning that, if antibiotics are to be used, that amoxicillin-clavulanate alone should be favored over combination of fluoroquinolones and metronidazole,” Dr. Johnson noted. “Furthermore, the U.S. Food and Drug Administration has advised that fluoroquinolones should be reserved for conditions with no alternative treatment options.”

“The initial management approach for the AGA guidelines and best practice are comparable with these most recent ACP recommendations,” said Dr. Johnson. However, “I would suggest that clinicians treating diverticulitis also review the AGA best practice recommendations, which build out important other important points for diverticulitis management including timeframes for colonoscopy, strong effect of genetics, dietary effects, recurrence rates, and the role of surgery.”

As for research gaps, “further data on cost savings would be helpful,” as savings may be likely with significant reduction without antibiotics and imaging in select patients, Dr. Johnson said. “Cost savings and risk reduction of adverse implications of antibiotic and radiation risks should be included in these analyses.”

The guidelines were based on systematic reviews conducted by the Evidence-based Practice Center at Brown University, Providence, R.I., funded by the Agency for Healthcare Research and Quality. The development of the guidelines was supported by the ACP operating budget. The authors, Dr. Abraham, and Dr. Johnson had no financial conflicts to disclose.

Fed up with personal attacks on the nation’s top infectious disease expert, scores of leading scientists and physicians have signed an open letter defending Anthony Fauci, MD, for his years of service to the public and his leadership on the pandemic.

“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.

Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.

“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.

Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).

At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”

Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
 

‘Sagacious counsel’

The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.

“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.

“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.

“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”

“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.

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

Fed up with personal attacks on the nation’s top infectious disease expert, scores of leading scientists and physicians have signed an open letter defending Anthony Fauci, MD, for his years of service to the public and his leadership on the pandemic.

“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.

Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.

“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.

Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).

At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”

Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
 

‘Sagacious counsel’

The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.

“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.

“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.

“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”

“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.

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

Fed up with personal attacks on the nation’s top infectious disease expert, scores of leading scientists and physicians have signed an open letter defending Anthony Fauci, MD, for his years of service to the public and his leadership on the pandemic.

“We deplore the personal attacks on Dr. Fauci. The criticism is inaccurate, unscientific, ill-founded in the facts and, increasingly, motivated by partisan politics,” reads the letter of support, initiated by Ezekiel Emanuel, MD, and signed by almost 300 scientists and public health and medical professionals, including Nobel Laureates, a former Republican senator, and leadership of medical societies and institutions.

Dr. Fauci has led the National Institute for Allergy and Infectious Diseases since 1984 and serves as President Biden’s top medical advisor on the pandemic.

“Dr. Anthony Fauci has served the U.S.A. with wisdom and integrity for nearly 40 years. Through HIV, Ebola, and now COVID, he has unswervingly served the United States guiding the country to very successful outcomes. He has our unreserved respect and trust as a scientist and a national leader,” the letter reads.

Dr. Fauci has repeatedly faced harsh criticism from congressional Republicans, especially Sen. Rand Paul (R-Ky.) and Sen. Roger Marshall (R-Kan.).

At a particularly contentious congressional hearing earlier this week on the federal government’s response to Omicron, Dr. Fauci fought back, telling Sen. Marshall, “You’re so misinformed, it’s extraordinary.”

Dr. Fauci, who has received death threats and harassment of his family, told Sen. Rand that his “completely untrue” statements and rhetoric “kindles the crazies out there.”
 

‘Sagacious counsel’

The personal attacks on Dr. Fauci are a “distraction from what should be the national focus – working together to finally overcome a pandemic that is killing about 500,000 people a year. We are grateful for Dr. Fauci’s dedication and tireless efforts to help the country through this pandemic and other health crises,” the letter reads.

“Throughout the COVID-19 pandemic, Dr. Fauci has provided the American political leadership and the public with sagacious counsel in these most difficult of times. His advice has been as well informed as data and the rapidly evolving circumstances allowed,” it states.

“Importantly,” Dr. Fauci has given his advice with “humility, being clear about what we know and what is unknown, but requires judgment. He has consistently emphasized the importance of mask-wearing, social distancing, and vaccination. These are standard and necessary public health measures that we all support,” the letter states.

“We are grateful that Dr. Fauci has consistently stated the science in a way that represents the facts as they emerge, without unwarranted speculation.”

“Sadly, in these politically polarized times where misinformation contaminates the United States’ response to the pandemic, routine public health measures have become unnecessarily controversial, undermining the effectiveness of our country’s response,” the letter reads.

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