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Monkeypox presentations, prevention strategies shifting
New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.
Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.
Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.
Shift away from White men
Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.
“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.
In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.
“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.
No sustained spread outside MSM
Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.
However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.
“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”
She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.
“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.
Severe cases among immunocompromised
Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.
Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”
Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.
She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.
Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”
Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.
Differences from past epidemics
Dr. Titanji said the current outbreak has some differences from historic outbreaks.
The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.
There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.
The scope of suspected cases has also broadened, with changing clinical features.
“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.
Expanding the case definition will help identify who should be tested.
“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”
Vaccine strategy has evolved
Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.
Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”
It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.
Early data from the CDC indicate that the Jynneos vaccine is effective.
In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.
“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.
Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”
Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.
Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.
Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.
Shift away from White men
Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.
“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.
In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.
“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.
No sustained spread outside MSM
Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.
However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.
“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”
She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.
“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.
Severe cases among immunocompromised
Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.
Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”
Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.
She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.
Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”
Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.
Differences from past epidemics
Dr. Titanji said the current outbreak has some differences from historic outbreaks.
The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.
There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.
The scope of suspected cases has also broadened, with changing clinical features.
“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.
Expanding the case definition will help identify who should be tested.
“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”
Vaccine strategy has evolved
Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.
Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”
It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.
Early data from the CDC indicate that the Jynneos vaccine is effective.
In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.
“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.
Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”
Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.
Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.
Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.
Shift away from White men
Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.
“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.
In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.
“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.
No sustained spread outside MSM
Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.
However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.
“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”
She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.
“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.
Severe cases among immunocompromised
Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.
Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”
Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.
She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.
Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”
Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.
Differences from past epidemics
Dr. Titanji said the current outbreak has some differences from historic outbreaks.
The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.
There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.
The scope of suspected cases has also broadened, with changing clinical features.
“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.
Expanding the case definition will help identify who should be tested.
“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”
Vaccine strategy has evolved
Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.
Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”
It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.
Early data from the CDC indicate that the Jynneos vaccine is effective.
In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.
“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.
Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”
Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM IDWEEK 2022
C. diff recurrence drops with highly targeted ridinilazole
WASHINGTON – (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.
According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.
Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.
Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.
Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.
Of the 759 patients enrolled, 745 were included in the modified intention-to-treat population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).
Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.
“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.
Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.
“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”
Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.
“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.
Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.
Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”
Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”
Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.
Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.
The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON – (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.
According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.
Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.
Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.
Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.
Of the 759 patients enrolled, 745 were included in the modified intention-to-treat population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).
Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.
“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.
Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.
“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”
Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.
“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.
Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.
Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”
Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”
Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.
Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.
The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON – (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.
According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.
Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.
Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.
Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.
Of the 759 patients enrolled, 745 were included in the modified intention-to-treat population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).
Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.
“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.
Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.
“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”
Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.
“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.
Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.
Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”
Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”
Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.
Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.
The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT IDWEEK 2022
Cleaning indoor air ‘next frontier’ for COVID, public health
The COVID-19 pandemic is driving attention to clean indoor air like never before.
“Indoor air is that next frontier when it comes to thinking about public health for humanity,” said Ashish Jha, MD, MPH, who heads the White House COVID response team.
“This once-in-a-century pandemic has given us a moment. A moment when we can drive significant structural changes in the air that we all breathe,” he said.
The threat is immediate, Dr. Jha said, explaining that the return of influenza this year and other circulating respiratory viruses on top of COVID cases could overwhelm the health system.
“We have to bring the burden of respiratory pathogens down and the single biggest structural change we can make as a society is to do for indoor air what we’ve done for water quality,” he said.
Recent federal actions
Dr. Jha pointed to White House actions toward that end.
On Oct. 11, the White House launched a new website asking building owners and operators to sign a pledge for clean air and agree to four principles:
- Create an action plan.
- Optimize fresh air ventilation.
- Enhance air filtration and cleaning.
- Communicate with building occupants to increase awareness.
Those who pledge can download a badge to feature on their websites.
In March, the White House launched the Clean Air in Buildings Challenge as a call to action for building owners and operators to improve ventilation, filtration, and facilities for cleaner indoor air.
The government has provided funds that can be used in schools, public buildings, and other locations to improve indoor air quality, including $350 billion for state and local governments and $122 billion for schools, through the American Rescue Plan.
The Department of Energy is offering one-on-one consultations to schools to drive air quality.
Calculate your ‘indoor age’
Joseph Allen, DSc, MPH, director of the Healthy Buildings program and an associate professor at Harvard’s T. H. Chan School of Public Health in Boston, said that the indoor environment has an outsized effect on public health.
He asked people to multiply their age times 0.9 to calculate their “indoor age.”
Dr. Allen, 47, said that for him that number is 42 years spent inside spaces.
When most people realize they spend 90% of their time indoors, a startling possibility comes into play: “The person who manages your building has a greater impact on your health than your doctor,” he said. “Think about that.”
Dr. Allen led a team that published a report on four strategies every building should pursue to reduce COVID and other respiratory illnesses:
- Give every building a tune-up. “We do this for our cars, we don’t do it for our buildings,” Dr. Allen said.
- Maximize outdoor ventilation.
- Upgrade filtration. “We need to move away from filters designed to protect equipment to filters designed to protect people. MERV 13 is the new minimum.”
- Supplement with portable air cleaners.
It’s not a complete list, he said; “It’s where you should start.”
Indoor air innovations
Others are suggesting innovations in schools and businesses.
Denver (Colorado) Public School Superintendent Alex Marrero, EdD, said that the system is implementing an air quality dashboard to display performance on factors such as carbon dioxide levels, particulate matter, and volatile organic compounds in schools.
“When you’re deciding what school you’re going to visit or even enroll in, you’ll have a snapshot of what we’re able to gather. Hopefully we’ll have something up before the end of the school year,” he said.
Shelly L. Miller, PhD, professor of mechanical engineering in the environmental engineering program at the University of Colorado Boulder, said that germicidal ultraviolet disinfection, used currently in water quality, holds promise for cleaning the COVID virus and other pathogens from indoor air.
“We were looking at germicidal UV way back in the 2000s for an outbreak of tuberculosis. We continue to see that it’s effective for measles. Why can’t we put a little more emphasis on these technologies?” Dr. Miller asks, acknowledging that there is a lack of expertise in designing such systems and in training and maintenance.
“It’s not for everybody, but it’s for a lot more places than we’re using it now,” she said.
Legislation like 1970 Clean Air Act needed?
Richard Corsi, PhD, dean of the College of Engineering at the University of California, Davis, said that education is lacking on the subject and indoor air quality is taught as a class in only a few universities, including his own.
He suggested starting the education even much earlier, in high school biology, chemistry, and physics courses.
Relative to other fields, he said, research and funding for indoor air quality “has been anemic.”
Work on outdoor air quality has seen dramatic improvements over the years because of the 52-year-old Clean Air Act, he noted.
“We need something akin to the Clean Air Act for indoor air quality,” Dr. Corsi said.
The speakers declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The COVID-19 pandemic is driving attention to clean indoor air like never before.
“Indoor air is that next frontier when it comes to thinking about public health for humanity,” said Ashish Jha, MD, MPH, who heads the White House COVID response team.
“This once-in-a-century pandemic has given us a moment. A moment when we can drive significant structural changes in the air that we all breathe,” he said.
The threat is immediate, Dr. Jha said, explaining that the return of influenza this year and other circulating respiratory viruses on top of COVID cases could overwhelm the health system.
“We have to bring the burden of respiratory pathogens down and the single biggest structural change we can make as a society is to do for indoor air what we’ve done for water quality,” he said.
Recent federal actions
Dr. Jha pointed to White House actions toward that end.
On Oct. 11, the White House launched a new website asking building owners and operators to sign a pledge for clean air and agree to four principles:
- Create an action plan.
- Optimize fresh air ventilation.
- Enhance air filtration and cleaning.
- Communicate with building occupants to increase awareness.
Those who pledge can download a badge to feature on their websites.
In March, the White House launched the Clean Air in Buildings Challenge as a call to action for building owners and operators to improve ventilation, filtration, and facilities for cleaner indoor air.
The government has provided funds that can be used in schools, public buildings, and other locations to improve indoor air quality, including $350 billion for state and local governments and $122 billion for schools, through the American Rescue Plan.
The Department of Energy is offering one-on-one consultations to schools to drive air quality.
Calculate your ‘indoor age’
Joseph Allen, DSc, MPH, director of the Healthy Buildings program and an associate professor at Harvard’s T. H. Chan School of Public Health in Boston, said that the indoor environment has an outsized effect on public health.
He asked people to multiply their age times 0.9 to calculate their “indoor age.”
Dr. Allen, 47, said that for him that number is 42 years spent inside spaces.
When most people realize they spend 90% of their time indoors, a startling possibility comes into play: “The person who manages your building has a greater impact on your health than your doctor,” he said. “Think about that.”
Dr. Allen led a team that published a report on four strategies every building should pursue to reduce COVID and other respiratory illnesses:
- Give every building a tune-up. “We do this for our cars, we don’t do it for our buildings,” Dr. Allen said.
- Maximize outdoor ventilation.
- Upgrade filtration. “We need to move away from filters designed to protect equipment to filters designed to protect people. MERV 13 is the new minimum.”
- Supplement with portable air cleaners.
It’s not a complete list, he said; “It’s where you should start.”
Indoor air innovations
Others are suggesting innovations in schools and businesses.
Denver (Colorado) Public School Superintendent Alex Marrero, EdD, said that the system is implementing an air quality dashboard to display performance on factors such as carbon dioxide levels, particulate matter, and volatile organic compounds in schools.
“When you’re deciding what school you’re going to visit or even enroll in, you’ll have a snapshot of what we’re able to gather. Hopefully we’ll have something up before the end of the school year,” he said.
Shelly L. Miller, PhD, professor of mechanical engineering in the environmental engineering program at the University of Colorado Boulder, said that germicidal ultraviolet disinfection, used currently in water quality, holds promise for cleaning the COVID virus and other pathogens from indoor air.
“We were looking at germicidal UV way back in the 2000s for an outbreak of tuberculosis. We continue to see that it’s effective for measles. Why can’t we put a little more emphasis on these technologies?” Dr. Miller asks, acknowledging that there is a lack of expertise in designing such systems and in training and maintenance.
“It’s not for everybody, but it’s for a lot more places than we’re using it now,” she said.
Legislation like 1970 Clean Air Act needed?
Richard Corsi, PhD, dean of the College of Engineering at the University of California, Davis, said that education is lacking on the subject and indoor air quality is taught as a class in only a few universities, including his own.
He suggested starting the education even much earlier, in high school biology, chemistry, and physics courses.
Relative to other fields, he said, research and funding for indoor air quality “has been anemic.”
Work on outdoor air quality has seen dramatic improvements over the years because of the 52-year-old Clean Air Act, he noted.
“We need something akin to the Clean Air Act for indoor air quality,” Dr. Corsi said.
The speakers declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The COVID-19 pandemic is driving attention to clean indoor air like never before.
“Indoor air is that next frontier when it comes to thinking about public health for humanity,” said Ashish Jha, MD, MPH, who heads the White House COVID response team.
“This once-in-a-century pandemic has given us a moment. A moment when we can drive significant structural changes in the air that we all breathe,” he said.
The threat is immediate, Dr. Jha said, explaining that the return of influenza this year and other circulating respiratory viruses on top of COVID cases could overwhelm the health system.
“We have to bring the burden of respiratory pathogens down and the single biggest structural change we can make as a society is to do for indoor air what we’ve done for water quality,” he said.
Recent federal actions
Dr. Jha pointed to White House actions toward that end.
On Oct. 11, the White House launched a new website asking building owners and operators to sign a pledge for clean air and agree to four principles:
- Create an action plan.
- Optimize fresh air ventilation.
- Enhance air filtration and cleaning.
- Communicate with building occupants to increase awareness.
Those who pledge can download a badge to feature on their websites.
In March, the White House launched the Clean Air in Buildings Challenge as a call to action for building owners and operators to improve ventilation, filtration, and facilities for cleaner indoor air.
The government has provided funds that can be used in schools, public buildings, and other locations to improve indoor air quality, including $350 billion for state and local governments and $122 billion for schools, through the American Rescue Plan.
The Department of Energy is offering one-on-one consultations to schools to drive air quality.
Calculate your ‘indoor age’
Joseph Allen, DSc, MPH, director of the Healthy Buildings program and an associate professor at Harvard’s T. H. Chan School of Public Health in Boston, said that the indoor environment has an outsized effect on public health.
He asked people to multiply their age times 0.9 to calculate their “indoor age.”
Dr. Allen, 47, said that for him that number is 42 years spent inside spaces.
When most people realize they spend 90% of their time indoors, a startling possibility comes into play: “The person who manages your building has a greater impact on your health than your doctor,” he said. “Think about that.”
Dr. Allen led a team that published a report on four strategies every building should pursue to reduce COVID and other respiratory illnesses:
- Give every building a tune-up. “We do this for our cars, we don’t do it for our buildings,” Dr. Allen said.
- Maximize outdoor ventilation.
- Upgrade filtration. “We need to move away from filters designed to protect equipment to filters designed to protect people. MERV 13 is the new minimum.”
- Supplement with portable air cleaners.
It’s not a complete list, he said; “It’s where you should start.”
Indoor air innovations
Others are suggesting innovations in schools and businesses.
Denver (Colorado) Public School Superintendent Alex Marrero, EdD, said that the system is implementing an air quality dashboard to display performance on factors such as carbon dioxide levels, particulate matter, and volatile organic compounds in schools.
“When you’re deciding what school you’re going to visit or even enroll in, you’ll have a snapshot of what we’re able to gather. Hopefully we’ll have something up before the end of the school year,” he said.
Shelly L. Miller, PhD, professor of mechanical engineering in the environmental engineering program at the University of Colorado Boulder, said that germicidal ultraviolet disinfection, used currently in water quality, holds promise for cleaning the COVID virus and other pathogens from indoor air.
“We were looking at germicidal UV way back in the 2000s for an outbreak of tuberculosis. We continue to see that it’s effective for measles. Why can’t we put a little more emphasis on these technologies?” Dr. Miller asks, acknowledging that there is a lack of expertise in designing such systems and in training and maintenance.
“It’s not for everybody, but it’s for a lot more places than we’re using it now,” she said.
Legislation like 1970 Clean Air Act needed?
Richard Corsi, PhD, dean of the College of Engineering at the University of California, Davis, said that education is lacking on the subject and indoor air quality is taught as a class in only a few universities, including his own.
He suggested starting the education even much earlier, in high school biology, chemistry, and physics courses.
Relative to other fields, he said, research and funding for indoor air quality “has been anemic.”
Work on outdoor air quality has seen dramatic improvements over the years because of the 52-year-old Clean Air Act, he noted.
“We need something akin to the Clean Air Act for indoor air quality,” Dr. Corsi said.
The speakers declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pregnant, postpartum women with disabilities at higher risk for violence
Pregnant or postpartum women with disabilities are at relatively high risk of experiencing violence, often from the people closest to them, new research suggests.
The researchers set out to measure risk of interpersonal violence, which the World Health Organization defines as “the intentional use of physical force or power against an individual by an intimate partner, family member, or other community member.”
Hilary K. Brown, PhD, with the department of health & society, University of Toronto, led the study published online in Obstetrics and Gynecology.
Large, population-based dataset
The population study included people 15-49 years old with births in Ontario from 2004 to 2019. They included 147,414 people with physical disabilities; 47,459 people with intellectual disabilities; 2,557 with developmental disabilities; and 9,598 with multiple disabilities.
The control group was 1,594,441 million people without disabilities.
The outcome measured was “any emergency department visit, hospital admission, or death related to physical, sexual, or psychological violence between fertilization and 365 days post partum.”
Researchers found that the adjusted relative risk of interpersonal violence for those with disabilities, compared with those with no disabilities was 1.40 (95% confidence interval, 1.31-1.50) in those with physical disabilities; 2.39 (95% CI, 1.98-2.88) in those with intellectual or developmental disabilities; and 1.96 (95% CI, 1.66-2.30) in those with multiple disabilities.
History of violence means higher risk
Those with a history of interpersonal violence and a disability were at particularly high risk for perinatal violence.
The authors note that pregnancy is a high-risk period for interpersonal violence for all women, particularly by an intimate partner.
“More than 30% of intimate partner violence begins during pregnancy, and preexisting violence tends to escalate perinatally,” they write.
The authors cite previous research that found women with disabilities experience higher rates of abuse overall and by an intimate partner – two to four times rates reported by those without disabilities.
Opportunities for provider intervention
Since the period surrounding pregnancy is a time of increased contact with medical providers and resources, there may be opportunities for identifying abuse and providing interventions.
Those might include better screening, access to violence-related information and services, and education of health care professionals to support people with disabilities. For example, “Tools used for violence screening perinatally do not include items about forms of violence that are unique to individuals with disabilities, such as refusal to assist with activities of daily living.”
The authors add: “[G]iven that the strongest risk factor for interpersonal violence in the perinatal period, particularly in those with disabilities, was a prepregnancy history of interpersonal violence, our findings suggest that more could be done before pregnancy to offer screening and support at the index encounter.”
Violence can lead to adverse outcomes
Implications are important as the violence can result in barriers to care and adverse perinatal outcomes.
Jeanne L. Alhusen, PhD, CRNP, RN, University of Virginia Medical Center professor of nursing and associate dean for research, was not part of this research but wrote a paper earlier this year on the subject and had similar conclusions.
She said before this study by Brown et al., “our understanding of the risk of violence by disability type throughout the perinatal period, on a population-based level, was quite limited.”
With the size of this dataset, she said, this paper provides critical information for health care providers. It extends physicians’ ability to examine risk of violence by disability type as well as these patients’ risk of experiencing different types of violence.
She pointed out that the Pregnancy Risk Assessment Monitoring System (PRAMS) recently incorporated a disability supplement that allows better understanding of pregnancy risks in people with disabilities.
“It will be critical that U.S. states continue to incorporate the disability questions into their PRAMS administration [because] without that information, persons with disabilities will continue to experience unconscionable inequities,” she said.
Barriers to equitable care
Dr. Alhusen added that people with disabilities experience significant barriers in accessing equitable care – both at the provider and the system level.
She said it is critical that we recognize and address the sexual and reproductive health needs of all persons with disability. “This includes screening every person for violence and [ensuring] the tools we utilize are accessible and include items specific to disability-related abuse. In our qualitative studies, we have heard from pregnant persons that they were never screened or that they were screened with their abusive partner sitting next to them.”
Screening questions to ask
The American College of Obstetricians and Gynecologists provides examples of screening questions that are specific to people with disabilities such as asking if a partner has ever prevented the individual from using an assistive device (for example, a wheelchair, cane, or respirator) or refused to help with an important personal need, such as taking medication or getting out of bed.
“For many reasons, people with disabilities are less likely to disclose violence, and health care professionals are less likely to ask them about it,” said coauthor of the current study, Yona Lunsky, PhD, clinician-scientist, Centre for Addiction and Mental Health, Toronto, in a statement. Based on the findings, she said, she hopes clinicians will see the need to develop disability-informed screening tools to capture abuse and identify the appropriate resources for this population before, during, and after pregnancy.
Coauthor Dr. Natasha Saunders receives an honorarium from the BMJ Group (Archives of Diseases in Childhood). Coauthor Dr. Simone N. Vigod receives royalties from UpToDate for authorship of materials related to depression and pregnancy. The other authors did not report any potential conflicts of interest. Dr. Alhusen reported no relevant financial relationships.
Pregnant or postpartum women with disabilities are at relatively high risk of experiencing violence, often from the people closest to them, new research suggests.
The researchers set out to measure risk of interpersonal violence, which the World Health Organization defines as “the intentional use of physical force or power against an individual by an intimate partner, family member, or other community member.”
Hilary K. Brown, PhD, with the department of health & society, University of Toronto, led the study published online in Obstetrics and Gynecology.
Large, population-based dataset
The population study included people 15-49 years old with births in Ontario from 2004 to 2019. They included 147,414 people with physical disabilities; 47,459 people with intellectual disabilities; 2,557 with developmental disabilities; and 9,598 with multiple disabilities.
The control group was 1,594,441 million people without disabilities.
The outcome measured was “any emergency department visit, hospital admission, or death related to physical, sexual, or psychological violence between fertilization and 365 days post partum.”
Researchers found that the adjusted relative risk of interpersonal violence for those with disabilities, compared with those with no disabilities was 1.40 (95% confidence interval, 1.31-1.50) in those with physical disabilities; 2.39 (95% CI, 1.98-2.88) in those with intellectual or developmental disabilities; and 1.96 (95% CI, 1.66-2.30) in those with multiple disabilities.
History of violence means higher risk
Those with a history of interpersonal violence and a disability were at particularly high risk for perinatal violence.
The authors note that pregnancy is a high-risk period for interpersonal violence for all women, particularly by an intimate partner.
“More than 30% of intimate partner violence begins during pregnancy, and preexisting violence tends to escalate perinatally,” they write.
The authors cite previous research that found women with disabilities experience higher rates of abuse overall and by an intimate partner – two to four times rates reported by those without disabilities.
Opportunities for provider intervention
Since the period surrounding pregnancy is a time of increased contact with medical providers and resources, there may be opportunities for identifying abuse and providing interventions.
Those might include better screening, access to violence-related information and services, and education of health care professionals to support people with disabilities. For example, “Tools used for violence screening perinatally do not include items about forms of violence that are unique to individuals with disabilities, such as refusal to assist with activities of daily living.”
The authors add: “[G]iven that the strongest risk factor for interpersonal violence in the perinatal period, particularly in those with disabilities, was a prepregnancy history of interpersonal violence, our findings suggest that more could be done before pregnancy to offer screening and support at the index encounter.”
Violence can lead to adverse outcomes
Implications are important as the violence can result in barriers to care and adverse perinatal outcomes.
Jeanne L. Alhusen, PhD, CRNP, RN, University of Virginia Medical Center professor of nursing and associate dean for research, was not part of this research but wrote a paper earlier this year on the subject and had similar conclusions.
She said before this study by Brown et al., “our understanding of the risk of violence by disability type throughout the perinatal period, on a population-based level, was quite limited.”
With the size of this dataset, she said, this paper provides critical information for health care providers. It extends physicians’ ability to examine risk of violence by disability type as well as these patients’ risk of experiencing different types of violence.
She pointed out that the Pregnancy Risk Assessment Monitoring System (PRAMS) recently incorporated a disability supplement that allows better understanding of pregnancy risks in people with disabilities.
“It will be critical that U.S. states continue to incorporate the disability questions into their PRAMS administration [because] without that information, persons with disabilities will continue to experience unconscionable inequities,” she said.
Barriers to equitable care
Dr. Alhusen added that people with disabilities experience significant barriers in accessing equitable care – both at the provider and the system level.
She said it is critical that we recognize and address the sexual and reproductive health needs of all persons with disability. “This includes screening every person for violence and [ensuring] the tools we utilize are accessible and include items specific to disability-related abuse. In our qualitative studies, we have heard from pregnant persons that they were never screened or that they were screened with their abusive partner sitting next to them.”
Screening questions to ask
The American College of Obstetricians and Gynecologists provides examples of screening questions that are specific to people with disabilities such as asking if a partner has ever prevented the individual from using an assistive device (for example, a wheelchair, cane, or respirator) or refused to help with an important personal need, such as taking medication or getting out of bed.
“For many reasons, people with disabilities are less likely to disclose violence, and health care professionals are less likely to ask them about it,” said coauthor of the current study, Yona Lunsky, PhD, clinician-scientist, Centre for Addiction and Mental Health, Toronto, in a statement. Based on the findings, she said, she hopes clinicians will see the need to develop disability-informed screening tools to capture abuse and identify the appropriate resources for this population before, during, and after pregnancy.
Coauthor Dr. Natasha Saunders receives an honorarium from the BMJ Group (Archives of Diseases in Childhood). Coauthor Dr. Simone N. Vigod receives royalties from UpToDate for authorship of materials related to depression and pregnancy. The other authors did not report any potential conflicts of interest. Dr. Alhusen reported no relevant financial relationships.
Pregnant or postpartum women with disabilities are at relatively high risk of experiencing violence, often from the people closest to them, new research suggests.
The researchers set out to measure risk of interpersonal violence, which the World Health Organization defines as “the intentional use of physical force or power against an individual by an intimate partner, family member, or other community member.”
Hilary K. Brown, PhD, with the department of health & society, University of Toronto, led the study published online in Obstetrics and Gynecology.
Large, population-based dataset
The population study included people 15-49 years old with births in Ontario from 2004 to 2019. They included 147,414 people with physical disabilities; 47,459 people with intellectual disabilities; 2,557 with developmental disabilities; and 9,598 with multiple disabilities.
The control group was 1,594,441 million people without disabilities.
The outcome measured was “any emergency department visit, hospital admission, or death related to physical, sexual, or psychological violence between fertilization and 365 days post partum.”
Researchers found that the adjusted relative risk of interpersonal violence for those with disabilities, compared with those with no disabilities was 1.40 (95% confidence interval, 1.31-1.50) in those with physical disabilities; 2.39 (95% CI, 1.98-2.88) in those with intellectual or developmental disabilities; and 1.96 (95% CI, 1.66-2.30) in those with multiple disabilities.
History of violence means higher risk
Those with a history of interpersonal violence and a disability were at particularly high risk for perinatal violence.
The authors note that pregnancy is a high-risk period for interpersonal violence for all women, particularly by an intimate partner.
“More than 30% of intimate partner violence begins during pregnancy, and preexisting violence tends to escalate perinatally,” they write.
The authors cite previous research that found women with disabilities experience higher rates of abuse overall and by an intimate partner – two to four times rates reported by those without disabilities.
Opportunities for provider intervention
Since the period surrounding pregnancy is a time of increased contact with medical providers and resources, there may be opportunities for identifying abuse and providing interventions.
Those might include better screening, access to violence-related information and services, and education of health care professionals to support people with disabilities. For example, “Tools used for violence screening perinatally do not include items about forms of violence that are unique to individuals with disabilities, such as refusal to assist with activities of daily living.”
The authors add: “[G]iven that the strongest risk factor for interpersonal violence in the perinatal period, particularly in those with disabilities, was a prepregnancy history of interpersonal violence, our findings suggest that more could be done before pregnancy to offer screening and support at the index encounter.”
Violence can lead to adverse outcomes
Implications are important as the violence can result in barriers to care and adverse perinatal outcomes.
Jeanne L. Alhusen, PhD, CRNP, RN, University of Virginia Medical Center professor of nursing and associate dean for research, was not part of this research but wrote a paper earlier this year on the subject and had similar conclusions.
She said before this study by Brown et al., “our understanding of the risk of violence by disability type throughout the perinatal period, on a population-based level, was quite limited.”
With the size of this dataset, she said, this paper provides critical information for health care providers. It extends physicians’ ability to examine risk of violence by disability type as well as these patients’ risk of experiencing different types of violence.
She pointed out that the Pregnancy Risk Assessment Monitoring System (PRAMS) recently incorporated a disability supplement that allows better understanding of pregnancy risks in people with disabilities.
“It will be critical that U.S. states continue to incorporate the disability questions into their PRAMS administration [because] without that information, persons with disabilities will continue to experience unconscionable inequities,” she said.
Barriers to equitable care
Dr. Alhusen added that people with disabilities experience significant barriers in accessing equitable care – both at the provider and the system level.
She said it is critical that we recognize and address the sexual and reproductive health needs of all persons with disability. “This includes screening every person for violence and [ensuring] the tools we utilize are accessible and include items specific to disability-related abuse. In our qualitative studies, we have heard from pregnant persons that they were never screened or that they were screened with their abusive partner sitting next to them.”
Screening questions to ask
The American College of Obstetricians and Gynecologists provides examples of screening questions that are specific to people with disabilities such as asking if a partner has ever prevented the individual from using an assistive device (for example, a wheelchair, cane, or respirator) or refused to help with an important personal need, such as taking medication or getting out of bed.
“For many reasons, people with disabilities are less likely to disclose violence, and health care professionals are less likely to ask them about it,” said coauthor of the current study, Yona Lunsky, PhD, clinician-scientist, Centre for Addiction and Mental Health, Toronto, in a statement. Based on the findings, she said, she hopes clinicians will see the need to develop disability-informed screening tools to capture abuse and identify the appropriate resources for this population before, during, and after pregnancy.
Coauthor Dr. Natasha Saunders receives an honorarium from the BMJ Group (Archives of Diseases in Childhood). Coauthor Dr. Simone N. Vigod receives royalties from UpToDate for authorship of materials related to depression and pregnancy. The other authors did not report any potential conflicts of interest. Dr. Alhusen reported no relevant financial relationships.
FROM OBSTETRICS AND GYNECOLOGY
Three COVID scenarios that could spell trouble for the fall
As the United States enters a third fall with COVID-19, the virus for many is seemingly gone – or at least out of mind. But for those keeping watch, it is far from forgotten as deaths and infections continue to mount at a lower but steady pace.
What does that mean for the upcoming months? Experts predict different scenarios, some more dire than others – with one more encouraging.
In the United States, more than 300 people still die every day from COVID and more than 44,000 new daily cases are reported, according to the Centers for Disease Control and Prevention.
But progress is undeniable. The stark daily death tolls of 2020 have plummeted. Vaccines and treatments have dramatically reduced severe illness, and mask requirements have mostly turned to personal preference.
among them more-resistant variants coupled with waning immunity, the potential for a “twindemic” with a flu/COVID onslaught, and underuse of lifesaving vaccines and treatments.
Variants loom/waning immunity
Omicron variant BA.5 still makes up about 80% of infections in the United States, followed by BA4.6, according to the CDC, but other subvariants are emerging and showing signs of resistance to current antiviral treatments.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in San Diego, said about COVID this fall: “There will be another wave, magnitude unknown.”
He said subvariants XBB and BQ.1.1 “have extreme levels of immune evasion and both could pose a challenge,” explaining that XBB is more likely to cause trouble than BQ.1.1 because it is even more resistant to natural or vaccine-induced immunity.
Dr. Topol pointed to new research on those variants in a preprint posted on bioRxiv. The authors’ conclusion: “These results suggest that current herd immunity and BA.5 vaccine boosters may not provide sufficiently broad protection against infection.”
Another variant to watch, some experts say, is Omicron subvariant BA.2.75.2, which has shown resistance to antiviral treatments. It is also growing at a rather alarming rate, says Michael Sweat, PhD, director of the Medical University of South Carolina Center for Global Health in Charleston. That subvariant currently makes up under 2% of U.S. cases but has spread to at least 55 countries and 43 U.S. states after first appearing at the end of last year globally and in mid-June in the United States.
A non–peer-reviewed preprint study from Sweden found that the variant in blood samples was neutralized on average “at titers approximately 6.5 times lower than BA.5, making BA.2.75.2 the most [neutralization-resistant] variant evaluated to date.”
Katelyn Jetelina, PhD, assistant professor in the department of epidemiology at University of Texas Health Science Center, Houston, said in an interview the U.S. waves often follow Europe’s, and Europe has seen a recent spike in cases and hospitalizations not related to Omicron subvariants, but to weather changes, waning immunity, and changes in behavior.
The World Health Organization reported on Oct. 5 that, while cases were down in every other region of the world, Europe’s numbers stand out, with an 8% increase in cases from the week before.
Dr. Jetelina cited events such as Oktoberfest in Germany, which ended in the first week of October after drawing nearly 6 million people over 2 weeks, as a potential contributor, and people heading indoors as weather patterns change in Europe.
Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said in an interview he is less worried about the documented variants we know about than he is about the potential for a new immune-escape variety yet to emerge.
“Right now we know the Chinese are gearing up to open up the country, and because they have low immunity and little infection, we expect in China there will be a lot of spread of Omicron,” he said. “It’s possible because of the number of infections we could see a new variant.”
Dr. Mokdad said waning immunity could also leave populations vulnerable to variants.
“Even if you get infected, after about 5 months, you’re susceptible again. Remember, most of the infections from Omicron happened in January or February 2022, and we had two waves after that,” he said.
The new bivalent vaccines tweaked to target some Omicron variants will help, Dr. Mokdad said, but he noted, “people are very reluctant to take it.”
Jennifer Nuzzo, DrPH, professor of epidemiology and director of the Pandemic Center at Brown University, Providence, R.I., worries that in the United States we have less ability this year to track variants as funding has receded for testing kits and testing sites. Most people are testing at home – which doesn’t show up in the numbers – and the United States is relying more on other countries’ data to spot trends.
“I think we’re just going to have less visibility into the circulation of this virus,” she said in an interview.
‘Twindemic’: COVID and flu
Dr. Jetelina noted Australia and New Zealand just wrapped up a flu season that saw flu numbers returning to normal after a sharp drop in the last 2 years, and North America typically follows suit.
“We do expect flu will be here in the United States and probably at levels that we saw prepandemic. We’re all holding our breath to see how our health systems hold up with COVID-19 and flu. We haven’t really experienced that yet,” she said.
There is some disagreement, however, about the possibility of a so-called “twindemic” of influenza and COVID.
Richard Webby, PhD, an infectious disease specialist at St. Jude Children’s Research Hospital in Memphis, said in an interview he thinks the possibility of both viruses spiking at the same time is unlikely.
“That’s not to say we won’t get flu and COVID activity in the same winter,” he explained, “but I think both roaring at the same time is unlikely.”
As an indicator, he said, at the beginning of the flu season last year in the Northern Hemisphere, flu activity started to pick up, but when the Omicron variant came along, “flu just wasn’t able to compete in that same environment and flu numbers dropped right off.” Previous literature suggests that when one virus is spiking it’s hard for another respiratory virus to take hold.
Vaccine, treatment underuse
Another threat is vaccines, boosters, and treatments sitting on shelves.
Dr. Sweat referred to frustration with vaccine uptake that seems to be “frozen in amber.”
As of Oct. 4, only 5.3% of people in the United States who were eligible had received the updated booster launched in early September.
Dr. Nuzzo said boosters for people at least 65 years old will be key to severity of COVID this season.
“I think that’s probably the biggest factor going into the fall and winter,” she said.
Only 38% of people at least 50 years old and 45% of those at least 65 years old had gotten a second booster as of early October.
“If we do nothing else, we have to increase booster uptake in that group,” Dr. Nuzzo said.
She said the treatment nirmatrelvir/ritonavir (Paxlovid, Pfizer) for treating mild to moderate COVID-19 in patients at high risk for severe disease is greatly underused, often because providers aren’t prescribing it because they don’t think it helps, are worried about drug interactions, or are worried about its “rebound” effect.
Dr. Nuzzo urged greater use of the drug and education on how to manage drug interactions.
“We have very strong data that it does help keep people out of hospital. Sure, there may be a rebound, but that pales in comparison to the risk of being hospitalized,” she said.
Calm COVID season?
Not all predictions are dire. There is another little-talked-about scenario, Dr. Sweat said – that we could be in for a calm COVID season, and those who seem to be only mildly concerned about COVID may find those thoughts justified in the numbers.
Omicron blew through with such strength, he noted, that it may have left wide immunity in its wake. Because variants seem to be staying in the Omicron family, that may signal optimism.
“If the next variant is a descendant of the Omicron lineage, I would suspect that all these people who just got infected will have some protection, not perfect, but quite a bit of protection,” Dr. Sweat said.
Dr. Topol, Dr. Nuzzo, Dr. Sweat, Dr. Webby, Dr. Mokdad, and Dr. Jetelina reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
As the United States enters a third fall with COVID-19, the virus for many is seemingly gone – or at least out of mind. But for those keeping watch, it is far from forgotten as deaths and infections continue to mount at a lower but steady pace.
What does that mean for the upcoming months? Experts predict different scenarios, some more dire than others – with one more encouraging.
In the United States, more than 300 people still die every day from COVID and more than 44,000 new daily cases are reported, according to the Centers for Disease Control and Prevention.
But progress is undeniable. The stark daily death tolls of 2020 have plummeted. Vaccines and treatments have dramatically reduced severe illness, and mask requirements have mostly turned to personal preference.
among them more-resistant variants coupled with waning immunity, the potential for a “twindemic” with a flu/COVID onslaught, and underuse of lifesaving vaccines and treatments.
Variants loom/waning immunity
Omicron variant BA.5 still makes up about 80% of infections in the United States, followed by BA4.6, according to the CDC, but other subvariants are emerging and showing signs of resistance to current antiviral treatments.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in San Diego, said about COVID this fall: “There will be another wave, magnitude unknown.”
He said subvariants XBB and BQ.1.1 “have extreme levels of immune evasion and both could pose a challenge,” explaining that XBB is more likely to cause trouble than BQ.1.1 because it is even more resistant to natural or vaccine-induced immunity.
Dr. Topol pointed to new research on those variants in a preprint posted on bioRxiv. The authors’ conclusion: “These results suggest that current herd immunity and BA.5 vaccine boosters may not provide sufficiently broad protection against infection.”
Another variant to watch, some experts say, is Omicron subvariant BA.2.75.2, which has shown resistance to antiviral treatments. It is also growing at a rather alarming rate, says Michael Sweat, PhD, director of the Medical University of South Carolina Center for Global Health in Charleston. That subvariant currently makes up under 2% of U.S. cases but has spread to at least 55 countries and 43 U.S. states after first appearing at the end of last year globally and in mid-June in the United States.
A non–peer-reviewed preprint study from Sweden found that the variant in blood samples was neutralized on average “at titers approximately 6.5 times lower than BA.5, making BA.2.75.2 the most [neutralization-resistant] variant evaluated to date.”
Katelyn Jetelina, PhD, assistant professor in the department of epidemiology at University of Texas Health Science Center, Houston, said in an interview the U.S. waves often follow Europe’s, and Europe has seen a recent spike in cases and hospitalizations not related to Omicron subvariants, but to weather changes, waning immunity, and changes in behavior.
The World Health Organization reported on Oct. 5 that, while cases were down in every other region of the world, Europe’s numbers stand out, with an 8% increase in cases from the week before.
Dr. Jetelina cited events such as Oktoberfest in Germany, which ended in the first week of October after drawing nearly 6 million people over 2 weeks, as a potential contributor, and people heading indoors as weather patterns change in Europe.
Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said in an interview he is less worried about the documented variants we know about than he is about the potential for a new immune-escape variety yet to emerge.
“Right now we know the Chinese are gearing up to open up the country, and because they have low immunity and little infection, we expect in China there will be a lot of spread of Omicron,” he said. “It’s possible because of the number of infections we could see a new variant.”
Dr. Mokdad said waning immunity could also leave populations vulnerable to variants.
“Even if you get infected, after about 5 months, you’re susceptible again. Remember, most of the infections from Omicron happened in January or February 2022, and we had two waves after that,” he said.
The new bivalent vaccines tweaked to target some Omicron variants will help, Dr. Mokdad said, but he noted, “people are very reluctant to take it.”
Jennifer Nuzzo, DrPH, professor of epidemiology and director of the Pandemic Center at Brown University, Providence, R.I., worries that in the United States we have less ability this year to track variants as funding has receded for testing kits and testing sites. Most people are testing at home – which doesn’t show up in the numbers – and the United States is relying more on other countries’ data to spot trends.
“I think we’re just going to have less visibility into the circulation of this virus,” she said in an interview.
‘Twindemic’: COVID and flu
Dr. Jetelina noted Australia and New Zealand just wrapped up a flu season that saw flu numbers returning to normal after a sharp drop in the last 2 years, and North America typically follows suit.
“We do expect flu will be here in the United States and probably at levels that we saw prepandemic. We’re all holding our breath to see how our health systems hold up with COVID-19 and flu. We haven’t really experienced that yet,” she said.
There is some disagreement, however, about the possibility of a so-called “twindemic” of influenza and COVID.
Richard Webby, PhD, an infectious disease specialist at St. Jude Children’s Research Hospital in Memphis, said in an interview he thinks the possibility of both viruses spiking at the same time is unlikely.
“That’s not to say we won’t get flu and COVID activity in the same winter,” he explained, “but I think both roaring at the same time is unlikely.”
As an indicator, he said, at the beginning of the flu season last year in the Northern Hemisphere, flu activity started to pick up, but when the Omicron variant came along, “flu just wasn’t able to compete in that same environment and flu numbers dropped right off.” Previous literature suggests that when one virus is spiking it’s hard for another respiratory virus to take hold.
Vaccine, treatment underuse
Another threat is vaccines, boosters, and treatments sitting on shelves.
Dr. Sweat referred to frustration with vaccine uptake that seems to be “frozen in amber.”
As of Oct. 4, only 5.3% of people in the United States who were eligible had received the updated booster launched in early September.
Dr. Nuzzo said boosters for people at least 65 years old will be key to severity of COVID this season.
“I think that’s probably the biggest factor going into the fall and winter,” she said.
Only 38% of people at least 50 years old and 45% of those at least 65 years old had gotten a second booster as of early October.
“If we do nothing else, we have to increase booster uptake in that group,” Dr. Nuzzo said.
She said the treatment nirmatrelvir/ritonavir (Paxlovid, Pfizer) for treating mild to moderate COVID-19 in patients at high risk for severe disease is greatly underused, often because providers aren’t prescribing it because they don’t think it helps, are worried about drug interactions, or are worried about its “rebound” effect.
Dr. Nuzzo urged greater use of the drug and education on how to manage drug interactions.
“We have very strong data that it does help keep people out of hospital. Sure, there may be a rebound, but that pales in comparison to the risk of being hospitalized,” she said.
Calm COVID season?
Not all predictions are dire. There is another little-talked-about scenario, Dr. Sweat said – that we could be in for a calm COVID season, and those who seem to be only mildly concerned about COVID may find those thoughts justified in the numbers.
Omicron blew through with such strength, he noted, that it may have left wide immunity in its wake. Because variants seem to be staying in the Omicron family, that may signal optimism.
“If the next variant is a descendant of the Omicron lineage, I would suspect that all these people who just got infected will have some protection, not perfect, but quite a bit of protection,” Dr. Sweat said.
Dr. Topol, Dr. Nuzzo, Dr. Sweat, Dr. Webby, Dr. Mokdad, and Dr. Jetelina reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
As the United States enters a third fall with COVID-19, the virus for many is seemingly gone – or at least out of mind. But for those keeping watch, it is far from forgotten as deaths and infections continue to mount at a lower but steady pace.
What does that mean for the upcoming months? Experts predict different scenarios, some more dire than others – with one more encouraging.
In the United States, more than 300 people still die every day from COVID and more than 44,000 new daily cases are reported, according to the Centers for Disease Control and Prevention.
But progress is undeniable. The stark daily death tolls of 2020 have plummeted. Vaccines and treatments have dramatically reduced severe illness, and mask requirements have mostly turned to personal preference.
among them more-resistant variants coupled with waning immunity, the potential for a “twindemic” with a flu/COVID onslaught, and underuse of lifesaving vaccines and treatments.
Variants loom/waning immunity
Omicron variant BA.5 still makes up about 80% of infections in the United States, followed by BA4.6, according to the CDC, but other subvariants are emerging and showing signs of resistance to current antiviral treatments.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in San Diego, said about COVID this fall: “There will be another wave, magnitude unknown.”
He said subvariants XBB and BQ.1.1 “have extreme levels of immune evasion and both could pose a challenge,” explaining that XBB is more likely to cause trouble than BQ.1.1 because it is even more resistant to natural or vaccine-induced immunity.
Dr. Topol pointed to new research on those variants in a preprint posted on bioRxiv. The authors’ conclusion: “These results suggest that current herd immunity and BA.5 vaccine boosters may not provide sufficiently broad protection against infection.”
Another variant to watch, some experts say, is Omicron subvariant BA.2.75.2, which has shown resistance to antiviral treatments. It is also growing at a rather alarming rate, says Michael Sweat, PhD, director of the Medical University of South Carolina Center for Global Health in Charleston. That subvariant currently makes up under 2% of U.S. cases but has spread to at least 55 countries and 43 U.S. states after first appearing at the end of last year globally and in mid-June in the United States.
A non–peer-reviewed preprint study from Sweden found that the variant in blood samples was neutralized on average “at titers approximately 6.5 times lower than BA.5, making BA.2.75.2 the most [neutralization-resistant] variant evaluated to date.”
Katelyn Jetelina, PhD, assistant professor in the department of epidemiology at University of Texas Health Science Center, Houston, said in an interview the U.S. waves often follow Europe’s, and Europe has seen a recent spike in cases and hospitalizations not related to Omicron subvariants, but to weather changes, waning immunity, and changes in behavior.
The World Health Organization reported on Oct. 5 that, while cases were down in every other region of the world, Europe’s numbers stand out, with an 8% increase in cases from the week before.
Dr. Jetelina cited events such as Oktoberfest in Germany, which ended in the first week of October after drawing nearly 6 million people over 2 weeks, as a potential contributor, and people heading indoors as weather patterns change in Europe.
Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said in an interview he is less worried about the documented variants we know about than he is about the potential for a new immune-escape variety yet to emerge.
“Right now we know the Chinese are gearing up to open up the country, and because they have low immunity and little infection, we expect in China there will be a lot of spread of Omicron,” he said. “It’s possible because of the number of infections we could see a new variant.”
Dr. Mokdad said waning immunity could also leave populations vulnerable to variants.
“Even if you get infected, after about 5 months, you’re susceptible again. Remember, most of the infections from Omicron happened in January or February 2022, and we had two waves after that,” he said.
The new bivalent vaccines tweaked to target some Omicron variants will help, Dr. Mokdad said, but he noted, “people are very reluctant to take it.”
Jennifer Nuzzo, DrPH, professor of epidemiology and director of the Pandemic Center at Brown University, Providence, R.I., worries that in the United States we have less ability this year to track variants as funding has receded for testing kits and testing sites. Most people are testing at home – which doesn’t show up in the numbers – and the United States is relying more on other countries’ data to spot trends.
“I think we’re just going to have less visibility into the circulation of this virus,” she said in an interview.
‘Twindemic’: COVID and flu
Dr. Jetelina noted Australia and New Zealand just wrapped up a flu season that saw flu numbers returning to normal after a sharp drop in the last 2 years, and North America typically follows suit.
“We do expect flu will be here in the United States and probably at levels that we saw prepandemic. We’re all holding our breath to see how our health systems hold up with COVID-19 and flu. We haven’t really experienced that yet,” she said.
There is some disagreement, however, about the possibility of a so-called “twindemic” of influenza and COVID.
Richard Webby, PhD, an infectious disease specialist at St. Jude Children’s Research Hospital in Memphis, said in an interview he thinks the possibility of both viruses spiking at the same time is unlikely.
“That’s not to say we won’t get flu and COVID activity in the same winter,” he explained, “but I think both roaring at the same time is unlikely.”
As an indicator, he said, at the beginning of the flu season last year in the Northern Hemisphere, flu activity started to pick up, but when the Omicron variant came along, “flu just wasn’t able to compete in that same environment and flu numbers dropped right off.” Previous literature suggests that when one virus is spiking it’s hard for another respiratory virus to take hold.
Vaccine, treatment underuse
Another threat is vaccines, boosters, and treatments sitting on shelves.
Dr. Sweat referred to frustration with vaccine uptake that seems to be “frozen in amber.”
As of Oct. 4, only 5.3% of people in the United States who were eligible had received the updated booster launched in early September.
Dr. Nuzzo said boosters for people at least 65 years old will be key to severity of COVID this season.
“I think that’s probably the biggest factor going into the fall and winter,” she said.
Only 38% of people at least 50 years old and 45% of those at least 65 years old had gotten a second booster as of early October.
“If we do nothing else, we have to increase booster uptake in that group,” Dr. Nuzzo said.
She said the treatment nirmatrelvir/ritonavir (Paxlovid, Pfizer) for treating mild to moderate COVID-19 in patients at high risk for severe disease is greatly underused, often because providers aren’t prescribing it because they don’t think it helps, are worried about drug interactions, or are worried about its “rebound” effect.
Dr. Nuzzo urged greater use of the drug and education on how to manage drug interactions.
“We have very strong data that it does help keep people out of hospital. Sure, there may be a rebound, but that pales in comparison to the risk of being hospitalized,” she said.
Calm COVID season?
Not all predictions are dire. There is another little-talked-about scenario, Dr. Sweat said – that we could be in for a calm COVID season, and those who seem to be only mildly concerned about COVID may find those thoughts justified in the numbers.
Omicron blew through with such strength, he noted, that it may have left wide immunity in its wake. Because variants seem to be staying in the Omicron family, that may signal optimism.
“If the next variant is a descendant of the Omicron lineage, I would suspect that all these people who just got infected will have some protection, not perfect, but quite a bit of protection,” Dr. Sweat said.
Dr. Topol, Dr. Nuzzo, Dr. Sweat, Dr. Webby, Dr. Mokdad, and Dr. Jetelina reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Models stratify hysterectomy risk with benign conditions
New models can help predict whether women having a hysterectomy for benign conditions are likely to have major complications, according to researchers.
The models, which use routinely collected data, are meant to aid surgeons in counseling women before surgery and help guide shared decision-making. The tools may lead to referrals for centers with greater surgical experience or may result in seeking nonsurgical treatment options, the researchers indicate.
The tools are not applicable to patients having hysterectomy for malignant disease.
Findings of the study, led by Krupa Madhvani, MD, of Barts and the London School of Medicine and Dentistry in London, are published online in the Canadian Medical Association Journal.
Calculators complement surgeons’ intuition
“Our aim was to generate prediction models that can be used in conjunction with a surgeon’s intuition to enhance preoperative patient counseling and match the advances made in the technical aspects of surgery,” the authors write.
“Internal–external cross-validation and external validation showed moderate discrimination,” they note.
The study included 68,599 patients who had laparoscopic hysterectomies and 125,971 patients who had an abdominal hysterectomy, all English National Health System patients between 2011 and 2018.
Among their findings were that major complications occurred in 4.4% of laparoscopic and 4.9% of abdominal hysterectomies. Major complications in this study included ureteric, gastrointestinal, and vascular injury and wound complications.
Adhesions biggest predictors of complications
Adhesions were most predictive of complications – with double the odds – in both models (laparoscopic: odds ratio, 1.92; 95% confidence interval, 1.73-2.13; abdominal: OR, 2.46; 95% CI, 2.27-2.66). That finding was consistent with previous literature.
“Adhesions should be suspected if there is a previous history of laparotomy, cesarean section, pelvic infection, or endometriosis, and can be reliably diagnosed preoperatively using ultrasonography,” the authors write. “As the global rate of cesarean sections continues to rise, this will undoubtedly remain a key determinant of major complications.”
Other factors that best predicted complications included adenomyosis in the laparoscopic model, and Asian ethnicity and diabetes in the abdominal model. Diabetes was not a predictive factor for complications in laparoscopic hysterectomy as it was in a previous study.
Obesity was not a significant predictor of major complications for either form of hysterectomy.
Factors protective against major complications included younger age and diagnosed menstrual disorders or benign adnexal mass (both models) and diagnosis of fibroids in the abdominal model.
Models miss surgeon experience
Jon Ivar Einarsson MD, PhD, MPH, founder of the division of minimally invasive gynecologic surgery at Brigham and Women’s Hospital, Boston, said it’s good to have these models to estimate risk as “there’s possibly a tendency to underestimate the risk by the surgeon.”
However, he told this publication that, though these models are based on a very large data set, the models are missing some key variables – often a problem with database studies – that are more indicative of complications. The most important factor missing, he said, is surgeon experience.
“We’ve shown in our publications that there’s a correlation between that and the risk of complications,“ Dr. Einarsson said.
Among other variables missing, he noted, are some that the authors list when acknowledging the limitations: severity of endometriosis and severity of adhesions.
He said his team wouldn’t use such models because they rely on their own data for gauging risk. He encourages other surgeons to track their own data and outcomes as well.
“I think the external validity here is nonexistent because we’re dealing with a different patient population in a different country with different surgeons [who] have various degrees of expertise,” Dr. Einarsson said.
“But if surgeons have not collected their own data, then this could be useful,” he said.
Links to online calculators
The online calculator can be found at www.evidencio.com (laparoscopic, www.evidencio.com/models/show/2551; abdominal, www.evidencio.com/models/show/2552).
The large, national multi-institutional database helps with generalizability of findings, the authors write. Additionally, patients had a unique identifier number so if patients were admitted to a different hospital after surgery, they were not lost to follow-up.
Limitations, in addition to those mentioned, include gaps in detailed clinical information, such as exact body mass index, and location, type, and size of leiomyoma, the authors write.
“Further research should focus on improving the discriminatory ability of these tools by including factors other than patient characteristics, including surgeon volume, as this has been shown to reduce complications,” they write.
Dr. Madhvani has received article-processing fees from Elly Charity (East London International Women’s Health Charity). No other competing interests were declared. Dr. Einarsson reports no relevant financial relationships. The acquisition of the data was funded by the British Society for Gynaecological Endoscopy. They were not involved in the study design, analysis, interpretation of data, the writing of the report, or the decision to submit the article for publication. Coauthor Khalid Khan, MD is a distinguished investigator funded by the Beatriz Galindo Program grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Government of Spain.
New models can help predict whether women having a hysterectomy for benign conditions are likely to have major complications, according to researchers.
The models, which use routinely collected data, are meant to aid surgeons in counseling women before surgery and help guide shared decision-making. The tools may lead to referrals for centers with greater surgical experience or may result in seeking nonsurgical treatment options, the researchers indicate.
The tools are not applicable to patients having hysterectomy for malignant disease.
Findings of the study, led by Krupa Madhvani, MD, of Barts and the London School of Medicine and Dentistry in London, are published online in the Canadian Medical Association Journal.
Calculators complement surgeons’ intuition
“Our aim was to generate prediction models that can be used in conjunction with a surgeon’s intuition to enhance preoperative patient counseling and match the advances made in the technical aspects of surgery,” the authors write.
“Internal–external cross-validation and external validation showed moderate discrimination,” they note.
The study included 68,599 patients who had laparoscopic hysterectomies and 125,971 patients who had an abdominal hysterectomy, all English National Health System patients between 2011 and 2018.
Among their findings were that major complications occurred in 4.4% of laparoscopic and 4.9% of abdominal hysterectomies. Major complications in this study included ureteric, gastrointestinal, and vascular injury and wound complications.
Adhesions biggest predictors of complications
Adhesions were most predictive of complications – with double the odds – in both models (laparoscopic: odds ratio, 1.92; 95% confidence interval, 1.73-2.13; abdominal: OR, 2.46; 95% CI, 2.27-2.66). That finding was consistent with previous literature.
“Adhesions should be suspected if there is a previous history of laparotomy, cesarean section, pelvic infection, or endometriosis, and can be reliably diagnosed preoperatively using ultrasonography,” the authors write. “As the global rate of cesarean sections continues to rise, this will undoubtedly remain a key determinant of major complications.”
Other factors that best predicted complications included adenomyosis in the laparoscopic model, and Asian ethnicity and diabetes in the abdominal model. Diabetes was not a predictive factor for complications in laparoscopic hysterectomy as it was in a previous study.
Obesity was not a significant predictor of major complications for either form of hysterectomy.
Factors protective against major complications included younger age and diagnosed menstrual disorders or benign adnexal mass (both models) and diagnosis of fibroids in the abdominal model.
Models miss surgeon experience
Jon Ivar Einarsson MD, PhD, MPH, founder of the division of minimally invasive gynecologic surgery at Brigham and Women’s Hospital, Boston, said it’s good to have these models to estimate risk as “there’s possibly a tendency to underestimate the risk by the surgeon.”
However, he told this publication that, though these models are based on a very large data set, the models are missing some key variables – often a problem with database studies – that are more indicative of complications. The most important factor missing, he said, is surgeon experience.
“We’ve shown in our publications that there’s a correlation between that and the risk of complications,“ Dr. Einarsson said.
Among other variables missing, he noted, are some that the authors list when acknowledging the limitations: severity of endometriosis and severity of adhesions.
He said his team wouldn’t use such models because they rely on their own data for gauging risk. He encourages other surgeons to track their own data and outcomes as well.
“I think the external validity here is nonexistent because we’re dealing with a different patient population in a different country with different surgeons [who] have various degrees of expertise,” Dr. Einarsson said.
“But if surgeons have not collected their own data, then this could be useful,” he said.
Links to online calculators
The online calculator can be found at www.evidencio.com (laparoscopic, www.evidencio.com/models/show/2551; abdominal, www.evidencio.com/models/show/2552).
The large, national multi-institutional database helps with generalizability of findings, the authors write. Additionally, patients had a unique identifier number so if patients were admitted to a different hospital after surgery, they were not lost to follow-up.
Limitations, in addition to those mentioned, include gaps in detailed clinical information, such as exact body mass index, and location, type, and size of leiomyoma, the authors write.
“Further research should focus on improving the discriminatory ability of these tools by including factors other than patient characteristics, including surgeon volume, as this has been shown to reduce complications,” they write.
Dr. Madhvani has received article-processing fees from Elly Charity (East London International Women’s Health Charity). No other competing interests were declared. Dr. Einarsson reports no relevant financial relationships. The acquisition of the data was funded by the British Society for Gynaecological Endoscopy. They were not involved in the study design, analysis, interpretation of data, the writing of the report, or the decision to submit the article for publication. Coauthor Khalid Khan, MD is a distinguished investigator funded by the Beatriz Galindo Program grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Government of Spain.
New models can help predict whether women having a hysterectomy for benign conditions are likely to have major complications, according to researchers.
The models, which use routinely collected data, are meant to aid surgeons in counseling women before surgery and help guide shared decision-making. The tools may lead to referrals for centers with greater surgical experience or may result in seeking nonsurgical treatment options, the researchers indicate.
The tools are not applicable to patients having hysterectomy for malignant disease.
Findings of the study, led by Krupa Madhvani, MD, of Barts and the London School of Medicine and Dentistry in London, are published online in the Canadian Medical Association Journal.
Calculators complement surgeons’ intuition
“Our aim was to generate prediction models that can be used in conjunction with a surgeon’s intuition to enhance preoperative patient counseling and match the advances made in the technical aspects of surgery,” the authors write.
“Internal–external cross-validation and external validation showed moderate discrimination,” they note.
The study included 68,599 patients who had laparoscopic hysterectomies and 125,971 patients who had an abdominal hysterectomy, all English National Health System patients between 2011 and 2018.
Among their findings were that major complications occurred in 4.4% of laparoscopic and 4.9% of abdominal hysterectomies. Major complications in this study included ureteric, gastrointestinal, and vascular injury and wound complications.
Adhesions biggest predictors of complications
Adhesions were most predictive of complications – with double the odds – in both models (laparoscopic: odds ratio, 1.92; 95% confidence interval, 1.73-2.13; abdominal: OR, 2.46; 95% CI, 2.27-2.66). That finding was consistent with previous literature.
“Adhesions should be suspected if there is a previous history of laparotomy, cesarean section, pelvic infection, or endometriosis, and can be reliably diagnosed preoperatively using ultrasonography,” the authors write. “As the global rate of cesarean sections continues to rise, this will undoubtedly remain a key determinant of major complications.”
Other factors that best predicted complications included adenomyosis in the laparoscopic model, and Asian ethnicity and diabetes in the abdominal model. Diabetes was not a predictive factor for complications in laparoscopic hysterectomy as it was in a previous study.
Obesity was not a significant predictor of major complications for either form of hysterectomy.
Factors protective against major complications included younger age and diagnosed menstrual disorders or benign adnexal mass (both models) and diagnosis of fibroids in the abdominal model.
Models miss surgeon experience
Jon Ivar Einarsson MD, PhD, MPH, founder of the division of minimally invasive gynecologic surgery at Brigham and Women’s Hospital, Boston, said it’s good to have these models to estimate risk as “there’s possibly a tendency to underestimate the risk by the surgeon.”
However, he told this publication that, though these models are based on a very large data set, the models are missing some key variables – often a problem with database studies – that are more indicative of complications. The most important factor missing, he said, is surgeon experience.
“We’ve shown in our publications that there’s a correlation between that and the risk of complications,“ Dr. Einarsson said.
Among other variables missing, he noted, are some that the authors list when acknowledging the limitations: severity of endometriosis and severity of adhesions.
He said his team wouldn’t use such models because they rely on their own data for gauging risk. He encourages other surgeons to track their own data and outcomes as well.
“I think the external validity here is nonexistent because we’re dealing with a different patient population in a different country with different surgeons [who] have various degrees of expertise,” Dr. Einarsson said.
“But if surgeons have not collected their own data, then this could be useful,” he said.
Links to online calculators
The online calculator can be found at www.evidencio.com (laparoscopic, www.evidencio.com/models/show/2551; abdominal, www.evidencio.com/models/show/2552).
The large, national multi-institutional database helps with generalizability of findings, the authors write. Additionally, patients had a unique identifier number so if patients were admitted to a different hospital after surgery, they were not lost to follow-up.
Limitations, in addition to those mentioned, include gaps in detailed clinical information, such as exact body mass index, and location, type, and size of leiomyoma, the authors write.
“Further research should focus on improving the discriminatory ability of these tools by including factors other than patient characteristics, including surgeon volume, as this has been shown to reduce complications,” they write.
Dr. Madhvani has received article-processing fees from Elly Charity (East London International Women’s Health Charity). No other competing interests were declared. Dr. Einarsson reports no relevant financial relationships. The acquisition of the data was funded by the British Society for Gynaecological Endoscopy. They were not involved in the study design, analysis, interpretation of data, the writing of the report, or the decision to submit the article for publication. Coauthor Khalid Khan, MD is a distinguished investigator funded by the Beatriz Galindo Program grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Government of Spain.
FROM CANADIAN MEDICAL ASSOCIATION JOURNAL
Training program linked to less hand eczema for hairdressers
The study was conducted in Denmark, where about 40% of hairdressers develop occupational hand eczema (OHE), according to researchers. Hairdressers globally are exposed to wet work and myriad skin irritants and allergens, including dyes, permanent-wave solutions, persulfates, preservatives, and fragrances. The study, which was funded by the Danish hairdressers and beauticians union, was published in Contact Dermatitis.
Lead author Martin Havmose, BSc, of the National Allergy Research Center, department of dermatology and allergy, University of Copenhagen, Hellerup, Denmark, and colleagues wrote that prevention is critical, inasmuch as eczema can cut careers short and have lasting health effects.
Up to 70% of hairdressers experience some sort of work-related skin damage in their careers, as reported by this news organization.
Hand eczema also is common among hairdressers in the United States, Mark Denis Davis, MD, chair of dermatology at the Mayo Clinic in Rochester, Minn., told this news organization. It can be quite debilitating, itchy, and painful, he said.
“Often it is associated with painful fissuring, cracks in the skin, particularly involving the fingers. It may also be unsightly,” he said.
Dr. Davis said he hears anecdotally in his practice that many hairdressers are reluctant to wear gloves because of the touch and dexterity needed in their work.
The researchers evaluated the risk of OHE and compliance with skin protection measures among hairdressers who were trained before Denmark rolled out a nationwide skin protection program in hairdressing vocational schools in 2011.
Questionnaires were sent in May 2009 to all hairdressers (96.4% women; average age, 26) who had graduated from 1985 to 2007; in May 2020, questionnaires were sent to all hairdressers who had graduated from 2008 to 2018.
The average time worked in the trade was 8 years, and 28.8% no longer worked as hairdressers, data show.
The response rate was 66.6% (305/460) for the 2009 survey and 29.9% (363/1215) for the 2020 survey.
Prevalence of OHE dropped after program
The prevalence of OHE during career time dropped from 42.8% to 29% (adjusted odds ratio, 0.55; 95% confidence interval [CI], 0.40-0.77) between the two surveys.
In addition, the incidence rate of OHE decreased from 57.5 (95% CI, 48.4-68.4) to 42.0 (95% CI, 34.6-50.9) per 1,000 person-years (incidence rate ratio, 0.73; 95% CI, 0.560.95) in that period.
There was an increase in the use of gloves between the two surveys. There was more glove use when the hairdressers engaged in wet work and handled dyes, products with bleach, and permanent-wave solutions (P < .05).
The nationwide program educates hairdressing apprentices on contact allergy/urticaria, how to prevent occupational skin disease, and skin biology. Teaching materials focus on 11 recommendations, 7 of which are related to glove use.
“The lack of primary prevention of OHE in hairdressing vocational schools may be a missed opportunity in the prevention of the disease,” the authors concluded.
Dr. Davis said hairdressers with hand eczema should know that in the short term, topical corticosteroids can be used to decrease the inflammation of the skin.
He highlighted the following advice from the authors:
- Gloves should be used when washing, dyeing, bleaching, and creating perms.
- Disposable gloves should never be reused.
- Gloves should be used only as long as necessary.
- Rings should not be worn at work.
- Cotton gloves should be worn underneath protective gloves.
- For clients who are having their hair both cut and dyed, the hair should be cut before it is dyed.
- Nitrile gloves should be used without rubber accelerators.
“In the longer term,” said Dr. Davis, “the most important thing is to avoid exposure to the precipitating factors, such as wet work – working with water, which irritates the skin – and avoiding any allergens that are contributing to the eczema.”
The study was funded by an unrestricted grant from the Danish hairdressers and beauticians union. Two coauthors have links to industry, as listed in the original article. Dr. Davis reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The study was conducted in Denmark, where about 40% of hairdressers develop occupational hand eczema (OHE), according to researchers. Hairdressers globally are exposed to wet work and myriad skin irritants and allergens, including dyes, permanent-wave solutions, persulfates, preservatives, and fragrances. The study, which was funded by the Danish hairdressers and beauticians union, was published in Contact Dermatitis.
Lead author Martin Havmose, BSc, of the National Allergy Research Center, department of dermatology and allergy, University of Copenhagen, Hellerup, Denmark, and colleagues wrote that prevention is critical, inasmuch as eczema can cut careers short and have lasting health effects.
Up to 70% of hairdressers experience some sort of work-related skin damage in their careers, as reported by this news organization.
Hand eczema also is common among hairdressers in the United States, Mark Denis Davis, MD, chair of dermatology at the Mayo Clinic in Rochester, Minn., told this news organization. It can be quite debilitating, itchy, and painful, he said.
“Often it is associated with painful fissuring, cracks in the skin, particularly involving the fingers. It may also be unsightly,” he said.
Dr. Davis said he hears anecdotally in his practice that many hairdressers are reluctant to wear gloves because of the touch and dexterity needed in their work.
The researchers evaluated the risk of OHE and compliance with skin protection measures among hairdressers who were trained before Denmark rolled out a nationwide skin protection program in hairdressing vocational schools in 2011.
Questionnaires were sent in May 2009 to all hairdressers (96.4% women; average age, 26) who had graduated from 1985 to 2007; in May 2020, questionnaires were sent to all hairdressers who had graduated from 2008 to 2018.
The average time worked in the trade was 8 years, and 28.8% no longer worked as hairdressers, data show.
The response rate was 66.6% (305/460) for the 2009 survey and 29.9% (363/1215) for the 2020 survey.
Prevalence of OHE dropped after program
The prevalence of OHE during career time dropped from 42.8% to 29% (adjusted odds ratio, 0.55; 95% confidence interval [CI], 0.40-0.77) between the two surveys.
In addition, the incidence rate of OHE decreased from 57.5 (95% CI, 48.4-68.4) to 42.0 (95% CI, 34.6-50.9) per 1,000 person-years (incidence rate ratio, 0.73; 95% CI, 0.560.95) in that period.
There was an increase in the use of gloves between the two surveys. There was more glove use when the hairdressers engaged in wet work and handled dyes, products with bleach, and permanent-wave solutions (P < .05).
The nationwide program educates hairdressing apprentices on contact allergy/urticaria, how to prevent occupational skin disease, and skin biology. Teaching materials focus on 11 recommendations, 7 of which are related to glove use.
“The lack of primary prevention of OHE in hairdressing vocational schools may be a missed opportunity in the prevention of the disease,” the authors concluded.
Dr. Davis said hairdressers with hand eczema should know that in the short term, topical corticosteroids can be used to decrease the inflammation of the skin.
He highlighted the following advice from the authors:
- Gloves should be used when washing, dyeing, bleaching, and creating perms.
- Disposable gloves should never be reused.
- Gloves should be used only as long as necessary.
- Rings should not be worn at work.
- Cotton gloves should be worn underneath protective gloves.
- For clients who are having their hair both cut and dyed, the hair should be cut before it is dyed.
- Nitrile gloves should be used without rubber accelerators.
“In the longer term,” said Dr. Davis, “the most important thing is to avoid exposure to the precipitating factors, such as wet work – working with water, which irritates the skin – and avoiding any allergens that are contributing to the eczema.”
The study was funded by an unrestricted grant from the Danish hairdressers and beauticians union. Two coauthors have links to industry, as listed in the original article. Dr. Davis reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The study was conducted in Denmark, where about 40% of hairdressers develop occupational hand eczema (OHE), according to researchers. Hairdressers globally are exposed to wet work and myriad skin irritants and allergens, including dyes, permanent-wave solutions, persulfates, preservatives, and fragrances. The study, which was funded by the Danish hairdressers and beauticians union, was published in Contact Dermatitis.
Lead author Martin Havmose, BSc, of the National Allergy Research Center, department of dermatology and allergy, University of Copenhagen, Hellerup, Denmark, and colleagues wrote that prevention is critical, inasmuch as eczema can cut careers short and have lasting health effects.
Up to 70% of hairdressers experience some sort of work-related skin damage in their careers, as reported by this news organization.
Hand eczema also is common among hairdressers in the United States, Mark Denis Davis, MD, chair of dermatology at the Mayo Clinic in Rochester, Minn., told this news organization. It can be quite debilitating, itchy, and painful, he said.
“Often it is associated with painful fissuring, cracks in the skin, particularly involving the fingers. It may also be unsightly,” he said.
Dr. Davis said he hears anecdotally in his practice that many hairdressers are reluctant to wear gloves because of the touch and dexterity needed in their work.
The researchers evaluated the risk of OHE and compliance with skin protection measures among hairdressers who were trained before Denmark rolled out a nationwide skin protection program in hairdressing vocational schools in 2011.
Questionnaires were sent in May 2009 to all hairdressers (96.4% women; average age, 26) who had graduated from 1985 to 2007; in May 2020, questionnaires were sent to all hairdressers who had graduated from 2008 to 2018.
The average time worked in the trade was 8 years, and 28.8% no longer worked as hairdressers, data show.
The response rate was 66.6% (305/460) for the 2009 survey and 29.9% (363/1215) for the 2020 survey.
Prevalence of OHE dropped after program
The prevalence of OHE during career time dropped from 42.8% to 29% (adjusted odds ratio, 0.55; 95% confidence interval [CI], 0.40-0.77) between the two surveys.
In addition, the incidence rate of OHE decreased from 57.5 (95% CI, 48.4-68.4) to 42.0 (95% CI, 34.6-50.9) per 1,000 person-years (incidence rate ratio, 0.73; 95% CI, 0.560.95) in that period.
There was an increase in the use of gloves between the two surveys. There was more glove use when the hairdressers engaged in wet work and handled dyes, products with bleach, and permanent-wave solutions (P < .05).
The nationwide program educates hairdressing apprentices on contact allergy/urticaria, how to prevent occupational skin disease, and skin biology. Teaching materials focus on 11 recommendations, 7 of which are related to glove use.
“The lack of primary prevention of OHE in hairdressing vocational schools may be a missed opportunity in the prevention of the disease,” the authors concluded.
Dr. Davis said hairdressers with hand eczema should know that in the short term, topical corticosteroids can be used to decrease the inflammation of the skin.
He highlighted the following advice from the authors:
- Gloves should be used when washing, dyeing, bleaching, and creating perms.
- Disposable gloves should never be reused.
- Gloves should be used only as long as necessary.
- Rings should not be worn at work.
- Cotton gloves should be worn underneath protective gloves.
- For clients who are having their hair both cut and dyed, the hair should be cut before it is dyed.
- Nitrile gloves should be used without rubber accelerators.
“In the longer term,” said Dr. Davis, “the most important thing is to avoid exposure to the precipitating factors, such as wet work – working with water, which irritates the skin – and avoiding any allergens that are contributing to the eczema.”
The study was funded by an unrestricted grant from the Danish hairdressers and beauticians union. Two coauthors have links to industry, as listed in the original article. Dr. Davis reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CONTACT DERMATITIS
Apremilast may have some cardiometabolic benefits in patients with psoriasis
The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.
It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.
Fat reductions maintained at 1-year mark
The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.
As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.
“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”
Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.
The trial does help answer the question of whether apremilast can induce weight loss, he said, something that earlier trials suggested. “This trial confirms that, which is exciting,” he said. The reduction in both visceral and subcutaneous fat “deserves a lot further study.”
Several questions remain, Dr. Garshick said. Both he and Dr. Gelfand pointed to the need for large, placebo-controlled trials. “We still don’t know which medications may be preferrable in psoriasis to reduce [cardiovascular] risk if any at all,” Dr. Garshick said.
Seventy patients enrolled
In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.
Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m2. Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).
There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.
“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”
This study highlights the importance of screening, Dr. Garshick said.
He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.
Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.
Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.
It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.
Fat reductions maintained at 1-year mark
The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.
As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.
“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”
Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.
The trial does help answer the question of whether apremilast can induce weight loss, he said, something that earlier trials suggested. “This trial confirms that, which is exciting,” he said. The reduction in both visceral and subcutaneous fat “deserves a lot further study.”
Several questions remain, Dr. Garshick said. Both he and Dr. Gelfand pointed to the need for large, placebo-controlled trials. “We still don’t know which medications may be preferrable in psoriasis to reduce [cardiovascular] risk if any at all,” Dr. Garshick said.
Seventy patients enrolled
In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.
Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m2. Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).
There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.
“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”
This study highlights the importance of screening, Dr. Garshick said.
He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.
Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.
Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.
It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.
Fat reductions maintained at 1-year mark
The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.
As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.
“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”
Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.
The trial does help answer the question of whether apremilast can induce weight loss, he said, something that earlier trials suggested. “This trial confirms that, which is exciting,” he said. The reduction in both visceral and subcutaneous fat “deserves a lot further study.”
Several questions remain, Dr. Garshick said. Both he and Dr. Gelfand pointed to the need for large, placebo-controlled trials. “We still don’t know which medications may be preferrable in psoriasis to reduce [cardiovascular] risk if any at all,” Dr. Garshick said.
Seventy patients enrolled
In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.
Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m2. Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).
There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.
“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”
This study highlights the importance of screening, Dr. Garshick said.
He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.
Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.
Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA DERMATOLOGY
Presence of community health workers linked with better results in patients with T2D
The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.
The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.
Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.
Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”
Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.
The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.
A1c drops with more progress in the intervention
The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.
Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.
Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.
Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
Advantages of community workers
In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.
The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.
“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.
Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.
He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.
“They understand the culture, not just the language,” he said. “They have the trust of the community.”
It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.
The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.
“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.
Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
Other study strengths
The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.
The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.
“It becomes an alliance between the community health worker and the patient,” he continued.
Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”
The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.
The study authors and Dr. Correa reported no relevant financial relationships.
The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.
The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.
Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.
Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”
Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.
The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.
A1c drops with more progress in the intervention
The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.
Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.
Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.
Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
Advantages of community workers
In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.
The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.
“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.
Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.
He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.
“They understand the culture, not just the language,” he said. “They have the trust of the community.”
It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.
The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.
“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.
Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
Other study strengths
The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.
The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.
“It becomes an alliance between the community health worker and the patient,” he continued.
Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”
The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.
The study authors and Dr. Correa reported no relevant financial relationships.
The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.
The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.
Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.
Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”
Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.
The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.
A1c drops with more progress in the intervention
The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.
Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.
Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.
Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
Advantages of community workers
In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.
The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.
“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.
Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.
He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.
“They understand the culture, not just the language,” he said. “They have the trust of the community.”
It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.
The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.
“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.
Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
Other study strengths
The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.
The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.
“It becomes an alliance between the community health worker and the patient,” he continued.
Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”
The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.
The study authors and Dr. Correa reported no relevant financial relationships.
FROM ANNALS OF FAMILY MEDICINE
Children with sickle cell anemia not getting treatments, screening
Fewer than half of children aged 2-16 years with sickle cell anemia are receiving recommended annual screening for stroke, a common complication of the disease, according to a new Vital Signs report from the Centers for Disease Control and Prevention.
Many of these children also are not receiving the recommended medication, hydroxyurea, which can reduce pain and acute chest syndrome and improve anemia and quality of life, according to the report released Sept. 20.
Sickle cell anemia (SCA) is the most severe form of sickle cell disease (SCD), which is a red blood cell disorder that primarily affects Black and African American people in the United States. It is associated with severe complications such as stroke, vison damage, frequent infections, and delayed growth, and a reduction in lifespan of more than 20 years.
SCD affects approximately 100,000 Americans and SCA accounts for about 75% of those cases.
Physician remembers her patients’ pain
In a briefing to reporters in advance of the report’s release, Debra Houry, MD, MPH, the CDC’s acting principal deputy director, recalled “long, tough nights with these young sickle cell warriors” in her career as an emergency department physician.
“[S]eeing children and teens suffering from the severe pain that often accompanies sickle cell anemia was heartbreaking,” she said.
She asked health care providers to confront racism as they build better systems for ensuring optimal treatment for children and adolescents with SCA.
“Health care providers can educate themselves, their colleagues, and their institutions about the specialized needs of people with sickle cell anemia, including how racism inhibits optimal care,” Dr. Houry said.
She said people with SCA report difficulty accessing care and when they do, they often report feeling stigmatized.
Lead author of the report, Laura Schieve, PhD, an epidemiologist with CDC’s National Center on Birth Defects and Developmental Disabilities, and colleagues looked at data from more than 3,300 children with SCA who were continuously enrolled in Medicaid during 2019. The data came from the IBM MarketScan Multi-State Medicaid Database.
Key recommendations issued in 2014
In 2014, the National Heart, Lung, and Blood Institute (NHLBI) issued two key recommendations to prevent or reduce complications in children and adolescents with SCA.
One was annual screening of children and adolescents aged 2-16 years with transcranial Doppler (TCD) ultrasound to identify those at risk for stroke. The second was offering hydroxyurea therapy, which keeps red blood cells from sickling and blocking small blood vessels, to children and adolescents who were at least 9 months old to reduce pain and the risk for several life-threatening complications.
The researchers, however, found that in 2019, only 47% and 38% of children and adolescents aged 2-9 and 10-16 years, respectively, had TCD screening and 38% and 53% of children and adolescents aged 2-9 years and 10-16 years, respectively, used hydroxyurea.
“These complications are preventable – not inevitable. We must do more to help lessen the pain and complications associated with this disease by increasing the number of children who are screened for stroke and using the medication that can help reduce painful episodes,” said Karen Remley, MD, MPH, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a press release.
Bridging the gap
Providers, parents, health systems, and governmental agencies all have roles in bringing evidence-based recommended care to young SCA patients, Dr. Houry noted.
Community organizations can also help connect families with resources and tools to increase understanding.
Dr. Schieve pointed to access barriers in that families may have trouble traveling to specialized centers where the TCD screening is given. In addition, appointments for the screening may be limited.
Children taking hydroxyurea must be monitored for the proper dosage of medication, she explained, and that can be logistically challenging as well.
Providers report they often don’t get timely information back from TCD screening programs to keep up with which children need their annual screening.
Overall, the nation lacks providers with expertise in SCD and that can lead to symptoms being dismissed, Dr. Schieve said.
Hematologists and others have a role in advocating for patients with governmental entities to raise awareness of this issue, she added.
It’s also important that electronic health records give prompts and provide information so that all providers who care for a child can track screening and medication for the condition, Dr. Schieve and Dr. Houry said.
New funding for sickle cell data collection
Recent funding to the CDC Sickle Cell Data Collection Program may help more people get appropriate care, Dr. Houry said.
The program is currently active in 11 states and collects data from people all over the United States with SCD to study trends and treatment access for those with the disease.
The data help drive decisions such as where new sickle cell clinics are needed.
“We will expand to more states serving more people affected by this disease,” Dr. Houry said.
The authors declared no relevant financial relationships.
Fewer than half of children aged 2-16 years with sickle cell anemia are receiving recommended annual screening for stroke, a common complication of the disease, according to a new Vital Signs report from the Centers for Disease Control and Prevention.
Many of these children also are not receiving the recommended medication, hydroxyurea, which can reduce pain and acute chest syndrome and improve anemia and quality of life, according to the report released Sept. 20.
Sickle cell anemia (SCA) is the most severe form of sickle cell disease (SCD), which is a red blood cell disorder that primarily affects Black and African American people in the United States. It is associated with severe complications such as stroke, vison damage, frequent infections, and delayed growth, and a reduction in lifespan of more than 20 years.
SCD affects approximately 100,000 Americans and SCA accounts for about 75% of those cases.
Physician remembers her patients’ pain
In a briefing to reporters in advance of the report’s release, Debra Houry, MD, MPH, the CDC’s acting principal deputy director, recalled “long, tough nights with these young sickle cell warriors” in her career as an emergency department physician.
“[S]eeing children and teens suffering from the severe pain that often accompanies sickle cell anemia was heartbreaking,” she said.
She asked health care providers to confront racism as they build better systems for ensuring optimal treatment for children and adolescents with SCA.
“Health care providers can educate themselves, their colleagues, and their institutions about the specialized needs of people with sickle cell anemia, including how racism inhibits optimal care,” Dr. Houry said.
She said people with SCA report difficulty accessing care and when they do, they often report feeling stigmatized.
Lead author of the report, Laura Schieve, PhD, an epidemiologist with CDC’s National Center on Birth Defects and Developmental Disabilities, and colleagues looked at data from more than 3,300 children with SCA who were continuously enrolled in Medicaid during 2019. The data came from the IBM MarketScan Multi-State Medicaid Database.
Key recommendations issued in 2014
In 2014, the National Heart, Lung, and Blood Institute (NHLBI) issued two key recommendations to prevent or reduce complications in children and adolescents with SCA.
One was annual screening of children and adolescents aged 2-16 years with transcranial Doppler (TCD) ultrasound to identify those at risk for stroke. The second was offering hydroxyurea therapy, which keeps red blood cells from sickling and blocking small blood vessels, to children and adolescents who were at least 9 months old to reduce pain and the risk for several life-threatening complications.
The researchers, however, found that in 2019, only 47% and 38% of children and adolescents aged 2-9 and 10-16 years, respectively, had TCD screening and 38% and 53% of children and adolescents aged 2-9 years and 10-16 years, respectively, used hydroxyurea.
“These complications are preventable – not inevitable. We must do more to help lessen the pain and complications associated with this disease by increasing the number of children who are screened for stroke and using the medication that can help reduce painful episodes,” said Karen Remley, MD, MPH, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a press release.
Bridging the gap
Providers, parents, health systems, and governmental agencies all have roles in bringing evidence-based recommended care to young SCA patients, Dr. Houry noted.
Community organizations can also help connect families with resources and tools to increase understanding.
Dr. Schieve pointed to access barriers in that families may have trouble traveling to specialized centers where the TCD screening is given. In addition, appointments for the screening may be limited.
Children taking hydroxyurea must be monitored for the proper dosage of medication, she explained, and that can be logistically challenging as well.
Providers report they often don’t get timely information back from TCD screening programs to keep up with which children need their annual screening.
Overall, the nation lacks providers with expertise in SCD and that can lead to symptoms being dismissed, Dr. Schieve said.
Hematologists and others have a role in advocating for patients with governmental entities to raise awareness of this issue, she added.
It’s also important that electronic health records give prompts and provide information so that all providers who care for a child can track screening and medication for the condition, Dr. Schieve and Dr. Houry said.
New funding for sickle cell data collection
Recent funding to the CDC Sickle Cell Data Collection Program may help more people get appropriate care, Dr. Houry said.
The program is currently active in 11 states and collects data from people all over the United States with SCD to study trends and treatment access for those with the disease.
The data help drive decisions such as where new sickle cell clinics are needed.
“We will expand to more states serving more people affected by this disease,” Dr. Houry said.
The authors declared no relevant financial relationships.
Fewer than half of children aged 2-16 years with sickle cell anemia are receiving recommended annual screening for stroke, a common complication of the disease, according to a new Vital Signs report from the Centers for Disease Control and Prevention.
Many of these children also are not receiving the recommended medication, hydroxyurea, which can reduce pain and acute chest syndrome and improve anemia and quality of life, according to the report released Sept. 20.
Sickle cell anemia (SCA) is the most severe form of sickle cell disease (SCD), which is a red blood cell disorder that primarily affects Black and African American people in the United States. It is associated with severe complications such as stroke, vison damage, frequent infections, and delayed growth, and a reduction in lifespan of more than 20 years.
SCD affects approximately 100,000 Americans and SCA accounts for about 75% of those cases.
Physician remembers her patients’ pain
In a briefing to reporters in advance of the report’s release, Debra Houry, MD, MPH, the CDC’s acting principal deputy director, recalled “long, tough nights with these young sickle cell warriors” in her career as an emergency department physician.
“[S]eeing children and teens suffering from the severe pain that often accompanies sickle cell anemia was heartbreaking,” she said.
She asked health care providers to confront racism as they build better systems for ensuring optimal treatment for children and adolescents with SCA.
“Health care providers can educate themselves, their colleagues, and their institutions about the specialized needs of people with sickle cell anemia, including how racism inhibits optimal care,” Dr. Houry said.
She said people with SCA report difficulty accessing care and when they do, they often report feeling stigmatized.
Lead author of the report, Laura Schieve, PhD, an epidemiologist with CDC’s National Center on Birth Defects and Developmental Disabilities, and colleagues looked at data from more than 3,300 children with SCA who were continuously enrolled in Medicaid during 2019. The data came from the IBM MarketScan Multi-State Medicaid Database.
Key recommendations issued in 2014
In 2014, the National Heart, Lung, and Blood Institute (NHLBI) issued two key recommendations to prevent or reduce complications in children and adolescents with SCA.
One was annual screening of children and adolescents aged 2-16 years with transcranial Doppler (TCD) ultrasound to identify those at risk for stroke. The second was offering hydroxyurea therapy, which keeps red blood cells from sickling and blocking small blood vessels, to children and adolescents who were at least 9 months old to reduce pain and the risk for several life-threatening complications.
The researchers, however, found that in 2019, only 47% and 38% of children and adolescents aged 2-9 and 10-16 years, respectively, had TCD screening and 38% and 53% of children and adolescents aged 2-9 years and 10-16 years, respectively, used hydroxyurea.
“These complications are preventable – not inevitable. We must do more to help lessen the pain and complications associated with this disease by increasing the number of children who are screened for stroke and using the medication that can help reduce painful episodes,” said Karen Remley, MD, MPH, director of CDC’s National Center on Birth Defects and Developmental Disabilities, said in a press release.
Bridging the gap
Providers, parents, health systems, and governmental agencies all have roles in bringing evidence-based recommended care to young SCA patients, Dr. Houry noted.
Community organizations can also help connect families with resources and tools to increase understanding.
Dr. Schieve pointed to access barriers in that families may have trouble traveling to specialized centers where the TCD screening is given. In addition, appointments for the screening may be limited.
Children taking hydroxyurea must be monitored for the proper dosage of medication, she explained, and that can be logistically challenging as well.
Providers report they often don’t get timely information back from TCD screening programs to keep up with which children need their annual screening.
Overall, the nation lacks providers with expertise in SCD and that can lead to symptoms being dismissed, Dr. Schieve said.
Hematologists and others have a role in advocating for patients with governmental entities to raise awareness of this issue, she added.
It’s also important that electronic health records give prompts and provide information so that all providers who care for a child can track screening and medication for the condition, Dr. Schieve and Dr. Houry said.
New funding for sickle cell data collection
Recent funding to the CDC Sickle Cell Data Collection Program may help more people get appropriate care, Dr. Houry said.
The program is currently active in 11 states and collects data from people all over the United States with SCD to study trends and treatment access for those with the disease.
The data help drive decisions such as where new sickle cell clinics are needed.
“We will expand to more states serving more people affected by this disease,” Dr. Houry said.
The authors declared no relevant financial relationships.
FROM THE MMWR