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Influenza vaccine may offer much more than flu prevention
in new findings that suggest the vaccine itself, and not just avoidance of the virus, may be beneficial.
“We postulate that influenza vaccination may have a protective effect against stroke that may be partly independent of influenza prevention,” study investigator Francisco J. de Abajo, MD, PhD, MPH, of the University of Alcalá, Madrid, said in an interview.
“Although the study is observational and this finding can also be explained by unmeasured confounding factors, we feel that a direct biological effect of vaccine cannot be ruled out and this finding opens new avenues for investigation.”
The study was published online in Neurology.
‘Not a spurious association’
While there is a well-established link between seasonal influenza and increased ischemic stroke risk, the role of flu vaccination in stroke prevention is unclear.
In the nested case-control study, researchers evaluated data from primary care practices in Spain between 2001 and 2015. They identified 14,322 patients with first-time ischemic stroke. Of these, 9,542 had noncardioembolic stroke and 4,780 had cardioembolic stroke.
Each case was matched with five controls from the population of age- and sex-matched controls without stroke (n = 71,610).
Those in the stroke group had a slightly higher rate of flu vaccination than controls, at 41.4% versus 40.5% (odds ratio, 1.05).
Adjusted analysis revealed those who received flu vaccination were less likely to experience ischemic stroke within 15-30 days of vaccination (OR, 0.79) and, to a lesser degree, over up to 150 days (OR, 0.92).
The reduced risk associated with the flu vaccine was observed with both types of ischemic stroke and appeared to offer stroke protection outside of flu season.
The reduced risk was also found in subgroup comparisons in men, women, those aged over and under 65 years, and those with intermediate and high vascular risk.
Importantly, a separate analysis of pneumococcal vaccination did not show a similar reduction in stroke risk (adjusted OR, 1.08).
“The lack of protection found with the pneumococcal vaccine actually reinforces the hypothesis that the protection of influenza vaccine is not a spurious association, as both vaccines might share the same biases and confounding factors,” Dr. de Abajo said.
Anti-inflammatory effect?
Influenza infection is known to induce a systemic inflammatory response that “can precipitate atheroma plaque rupture mediated by elevated concentrations of reactive proteins and cytokines,” the investigators noted, and so, avoiding infection could prevent those effects.
The results are consistent with other studies that have shown similar findings, including recent data from the INTERSTROKE trial. However, the reduced risk observed in the current study even in years without a flu epidemic expands on previous findings.
“This finding suggests that other mechanisms different from the prevention of influenza infection – e.g., a direct biological effect – could account for the risk reduction found,” the investigators wrote.
In terms of the nature of that effect, Dr. de Abajo noted that, “at this stage, we can only speculate.
“Having said that, there are some pieces of evidence that suggest influenza vaccination may release anti-inflammatory mediators that can stabilize the atheroma plaque. This is an interesting hypothesis that should be addressed in the near future,” he added.
‘More than just flu prevention’
In an accompanying editorial, Dixon Yang, MD, and Mitchell S.V. Elkind, MD, agree that the findings point to intriguing potential unexpected benefits of the vaccine.
“This case-control study ... importantly suggests the influenza vaccine is more than just about preventing the flu,” they wrote.
Dr. Elkind said in an interview that the mechanism could indeed involve an anti-inflammatory effect.
“There is some evidence that antibiotics also have anti-inflammatory properties that might reduce risk of stroke or the brain damage from a stroke,” he noted. “So, it is plausible that some of the effect of the vaccine on reducing risk of stroke may be through a reduction in inflammation.”
Dr. Elkind noted that the magnitude of the reduction observed with the vaccine, though not substantial, is important. “The magnitude of effect for any one individual may be modest, but it is in the ballpark of the effect of other commonly used approaches to stroke prevention, such as taking an aspirin a day, which reduces risk of stroke by about 20%. But because influenza is so common, the impact of even a small effect for an individual can have a large impact at the population level. So, the results are of public health significance.”
The study received support from the Biomedical Research Foundation of the Prince of Asturias University Hospital and the Institute of Health Carlos III in Madrid. Dr. Elkind has reported receiving ancillary funding but no personal compensation from Roche for a federally funded trial of stroke prevention.
A version of this article first appeared on Medscape.com.
in new findings that suggest the vaccine itself, and not just avoidance of the virus, may be beneficial.
“We postulate that influenza vaccination may have a protective effect against stroke that may be partly independent of influenza prevention,” study investigator Francisco J. de Abajo, MD, PhD, MPH, of the University of Alcalá, Madrid, said in an interview.
“Although the study is observational and this finding can also be explained by unmeasured confounding factors, we feel that a direct biological effect of vaccine cannot be ruled out and this finding opens new avenues for investigation.”
The study was published online in Neurology.
‘Not a spurious association’
While there is a well-established link between seasonal influenza and increased ischemic stroke risk, the role of flu vaccination in stroke prevention is unclear.
In the nested case-control study, researchers evaluated data from primary care practices in Spain between 2001 and 2015. They identified 14,322 patients with first-time ischemic stroke. Of these, 9,542 had noncardioembolic stroke and 4,780 had cardioembolic stroke.
Each case was matched with five controls from the population of age- and sex-matched controls without stroke (n = 71,610).
Those in the stroke group had a slightly higher rate of flu vaccination than controls, at 41.4% versus 40.5% (odds ratio, 1.05).
Adjusted analysis revealed those who received flu vaccination were less likely to experience ischemic stroke within 15-30 days of vaccination (OR, 0.79) and, to a lesser degree, over up to 150 days (OR, 0.92).
The reduced risk associated with the flu vaccine was observed with both types of ischemic stroke and appeared to offer stroke protection outside of flu season.
The reduced risk was also found in subgroup comparisons in men, women, those aged over and under 65 years, and those with intermediate and high vascular risk.
Importantly, a separate analysis of pneumococcal vaccination did not show a similar reduction in stroke risk (adjusted OR, 1.08).
“The lack of protection found with the pneumococcal vaccine actually reinforces the hypothesis that the protection of influenza vaccine is not a spurious association, as both vaccines might share the same biases and confounding factors,” Dr. de Abajo said.
Anti-inflammatory effect?
Influenza infection is known to induce a systemic inflammatory response that “can precipitate atheroma plaque rupture mediated by elevated concentrations of reactive proteins and cytokines,” the investigators noted, and so, avoiding infection could prevent those effects.
The results are consistent with other studies that have shown similar findings, including recent data from the INTERSTROKE trial. However, the reduced risk observed in the current study even in years without a flu epidemic expands on previous findings.
“This finding suggests that other mechanisms different from the prevention of influenza infection – e.g., a direct biological effect – could account for the risk reduction found,” the investigators wrote.
In terms of the nature of that effect, Dr. de Abajo noted that, “at this stage, we can only speculate.
“Having said that, there are some pieces of evidence that suggest influenza vaccination may release anti-inflammatory mediators that can stabilize the atheroma plaque. This is an interesting hypothesis that should be addressed in the near future,” he added.
‘More than just flu prevention’
In an accompanying editorial, Dixon Yang, MD, and Mitchell S.V. Elkind, MD, agree that the findings point to intriguing potential unexpected benefits of the vaccine.
“This case-control study ... importantly suggests the influenza vaccine is more than just about preventing the flu,” they wrote.
Dr. Elkind said in an interview that the mechanism could indeed involve an anti-inflammatory effect.
“There is some evidence that antibiotics also have anti-inflammatory properties that might reduce risk of stroke or the brain damage from a stroke,” he noted. “So, it is plausible that some of the effect of the vaccine on reducing risk of stroke may be through a reduction in inflammation.”
Dr. Elkind noted that the magnitude of the reduction observed with the vaccine, though not substantial, is important. “The magnitude of effect for any one individual may be modest, but it is in the ballpark of the effect of other commonly used approaches to stroke prevention, such as taking an aspirin a day, which reduces risk of stroke by about 20%. But because influenza is so common, the impact of even a small effect for an individual can have a large impact at the population level. So, the results are of public health significance.”
The study received support from the Biomedical Research Foundation of the Prince of Asturias University Hospital and the Institute of Health Carlos III in Madrid. Dr. Elkind has reported receiving ancillary funding but no personal compensation from Roche for a federally funded trial of stroke prevention.
A version of this article first appeared on Medscape.com.
in new findings that suggest the vaccine itself, and not just avoidance of the virus, may be beneficial.
“We postulate that influenza vaccination may have a protective effect against stroke that may be partly independent of influenza prevention,” study investigator Francisco J. de Abajo, MD, PhD, MPH, of the University of Alcalá, Madrid, said in an interview.
“Although the study is observational and this finding can also be explained by unmeasured confounding factors, we feel that a direct biological effect of vaccine cannot be ruled out and this finding opens new avenues for investigation.”
The study was published online in Neurology.
‘Not a spurious association’
While there is a well-established link between seasonal influenza and increased ischemic stroke risk, the role of flu vaccination in stroke prevention is unclear.
In the nested case-control study, researchers evaluated data from primary care practices in Spain between 2001 and 2015. They identified 14,322 patients with first-time ischemic stroke. Of these, 9,542 had noncardioembolic stroke and 4,780 had cardioembolic stroke.
Each case was matched with five controls from the population of age- and sex-matched controls without stroke (n = 71,610).
Those in the stroke group had a slightly higher rate of flu vaccination than controls, at 41.4% versus 40.5% (odds ratio, 1.05).
Adjusted analysis revealed those who received flu vaccination were less likely to experience ischemic stroke within 15-30 days of vaccination (OR, 0.79) and, to a lesser degree, over up to 150 days (OR, 0.92).
The reduced risk associated with the flu vaccine was observed with both types of ischemic stroke and appeared to offer stroke protection outside of flu season.
The reduced risk was also found in subgroup comparisons in men, women, those aged over and under 65 years, and those with intermediate and high vascular risk.
Importantly, a separate analysis of pneumococcal vaccination did not show a similar reduction in stroke risk (adjusted OR, 1.08).
“The lack of protection found with the pneumococcal vaccine actually reinforces the hypothesis that the protection of influenza vaccine is not a spurious association, as both vaccines might share the same biases and confounding factors,” Dr. de Abajo said.
Anti-inflammatory effect?
Influenza infection is known to induce a systemic inflammatory response that “can precipitate atheroma plaque rupture mediated by elevated concentrations of reactive proteins and cytokines,” the investigators noted, and so, avoiding infection could prevent those effects.
The results are consistent with other studies that have shown similar findings, including recent data from the INTERSTROKE trial. However, the reduced risk observed in the current study even in years without a flu epidemic expands on previous findings.
“This finding suggests that other mechanisms different from the prevention of influenza infection – e.g., a direct biological effect – could account for the risk reduction found,” the investigators wrote.
In terms of the nature of that effect, Dr. de Abajo noted that, “at this stage, we can only speculate.
“Having said that, there are some pieces of evidence that suggest influenza vaccination may release anti-inflammatory mediators that can stabilize the atheroma plaque. This is an interesting hypothesis that should be addressed in the near future,” he added.
‘More than just flu prevention’
In an accompanying editorial, Dixon Yang, MD, and Mitchell S.V. Elkind, MD, agree that the findings point to intriguing potential unexpected benefits of the vaccine.
“This case-control study ... importantly suggests the influenza vaccine is more than just about preventing the flu,” they wrote.
Dr. Elkind said in an interview that the mechanism could indeed involve an anti-inflammatory effect.
“There is some evidence that antibiotics also have anti-inflammatory properties that might reduce risk of stroke or the brain damage from a stroke,” he noted. “So, it is plausible that some of the effect of the vaccine on reducing risk of stroke may be through a reduction in inflammation.”
Dr. Elkind noted that the magnitude of the reduction observed with the vaccine, though not substantial, is important. “The magnitude of effect for any one individual may be modest, but it is in the ballpark of the effect of other commonly used approaches to stroke prevention, such as taking an aspirin a day, which reduces risk of stroke by about 20%. But because influenza is so common, the impact of even a small effect for an individual can have a large impact at the population level. So, the results are of public health significance.”
The study received support from the Biomedical Research Foundation of the Prince of Asturias University Hospital and the Institute of Health Carlos III in Madrid. Dr. Elkind has reported receiving ancillary funding but no personal compensation from Roche for a federally funded trial of stroke prevention.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
CDC says 44% of people hospitalized with COVID had third dose or booster
, the Centers for Disease Control and Prevention says.
Unvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.
The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.
“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”
Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.
The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.
A version of this article first appeared on WebMD.com.
, the Centers for Disease Control and Prevention says.
Unvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.
The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.
“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”
Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.
The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.
A version of this article first appeared on WebMD.com.
, the Centers for Disease Control and Prevention says.
Unvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.
The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.
“Adults should stay up to date with COVID-19 vaccination, including booster doses,” the CDC said. “Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status.”
Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.
The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.
A version of this article first appeared on WebMD.com.
FROM MMWR
After index colonoscopy, what’s the CRC risk in 40- to 49-year-olds vs. 50- to 59-year-olds?
New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.
However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.
“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.
“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.
The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.
The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.
The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.
The median follow-up for both age groups was roughly 7 years.
“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.
When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.
AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).
The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.
The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.
Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.
The authors have no conflicts of interest to report.
A version of this article first appeared on Medscape.com.
New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.
However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.
“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.
“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.
The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.
The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.
The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.
The median follow-up for both age groups was roughly 7 years.
“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.
When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.
AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).
The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.
The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.
Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.
The authors have no conflicts of interest to report.
A version of this article first appeared on Medscape.com.
New data suggest that for individuals who do not have an adenoma detected on an index colonoscopy, the risk of developing an advanced neoplasia (AN) and colorectal cancer (CRC) is lower in those who are aged 40-49 years, compared with those who are 50-59 years old.
However, there is no difference between the two age groups in detection rates of nonadvanced adenoma (NAA) or advanced adenoma (AA), the same study found.
“The primary goal of this study was to investigate the risk of metachronous AN associated with conventional adenoma detected on the index colonoscopy,” explain the authors, led by Gene Ma, MD, Kaiser Permanente Northern California, San Jose.
“The lack of good-quality evidence to inform surveillance in the 40-49 year old population has resulted in inconsistent surveillance patterns in clinical practice, leading to variation in the quality of care, including both inadequate and excessive colonoscopic surveillance,” Dr. Ma and colleagues observe.
The findings from this study “expand our understanding of the risk of AN and CRC in younger individuals and suggest that the current multi-society guidelines for surveillance may be applicable for individuals 40-49 years of age,” the authors conclude.
The study was published online in The American Journal of Gastroenterology, and included 2,396 individuals between 40 and 49 years of age and 8,978 individuals between 50 and 59 years of age.
The colonoscopy was carried out for screening in 40.2% in the younger age group versus 34.8% in the older age group and was prompted by a positive fecal immunochemical test in 3.3% of the younger age group versus 32% of the older age group.
The median follow-up for both age groups was roughly 7 years.
“When comparing the 40-49 years group to the 50-59 years group, index colonoscopy detected no adenoma in 62.9% versus 40.1% (P < .0001); NAA in 25.4% versus 39.0% (P <.001), and AA in 11.6% versus 21.0% (P < .0001), respectively,” Dr. Ma and colleagues report.
When the two age groups were compared for surveillance colonoscopy, no adenoma was detected in 67% of the younger age group versus 54.7% of the older age group (P < .0001), whereas NAA was detected in 25.4% of the 40- to 49-year-olds versus 38.4% of the 50- to 59-year-olds (P < .0001). AA was detected in 3.5% versus 6.95 (P < .0001) of persons in each of the two age groups, respectively.
AN was detected on surveillance colonoscopy after index colonoscopy in 2.2% of the younger age group and twice that percentage, at 4.4%, in the older age group (P = .0003). On surveillance colonoscopy, NAA was found in 4.6% of the younger age group, compared with 7% of the older age group (P = .03), whereas AA was found in 7.9% of the 40- to 49-year-olds, compared with 11.7% of the 50- to 59-year-olds (P = .06).
The median time until surveillance colonoscopy was similar in both age groups when either NAA or AA was found on index colonoscopy, the authors note. In addition, the median time until the detection of AN was similar whether NAA or AA was detected on index colonoscopy, they add.
The overall crude cumulative incidence of AN was lower in the younger age group when no adenoma was detected on index colonoscopy (P = .0003) as well as when NAA was detected, which would be consistent with recommendations from current guidelines for surveillance colonoscopy after adenoma detection. However, there was no difference between the two age groups in the overall cumulative incidence of AN when AA was detected on index colonoscopy.
Overall, the risk for metachronous AN in persons aged 40-49 years was lower when no adenoma was detected on index colonoscopy, but there was no difference between the two age groups when NAA or AA was detected again on index colonoscopy. Similarly, those aged 40-49 years of age had a lower risk for AA or CRC when no adenoma was detected on index colonoscopy – but again, there was no difference in the risk for AA or CRC when either NAA or AA was detected on index colonoscopy.
The authors have no conflicts of interest to report.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
Isotretinoin prescribers need better education on emergency contraception
, in a survey of 57 clinicians.
Pregnancies among patients on isotretinoin have declined since the iPLEDGE risk management program was introduced in 2005, but from 2011 to 2017, 210 to 310 pregnancies were reported to the Food and Drug Administration every year, wrote Catherine E. Smiley of Penn State University, Hershey, Pa., and coauthors Melissa Butt, DrPH, and Andrea L. Zaenglein, MD, of Penn State.
For patients on isotretinoin, EC “becomes critical when abstinence fails or contraception is not used properly,” but EC merits only a brief mention in iPLEDGE materials for patients and providers, they noted.
Patients on isotretinoin who choose abstinence as their form of birth control are the group at greatest risk for pregnancy, Dr. Zaenglein, professor of dermatology and pediatric dermatology, Penn State University, said in an interview. “However, the iPLEDGE program fails to educate patients adequately on emergency contraception,” she explained.
To assess pediatric dermatologists’ understanding of EC and their contraception counseling practices for isotretinoin patients, the researchers surveyed 57 pediatric dermatologists who prescribed isotretinoin as part of their practices. The findings were published in Pediatric Dermatology.Respondents included 53 practicing dermatologists, 2 residents, and 2 fellows. Approximately one-third (31.6%) had been in practice for 6-10 years, almost 23% had been in practice for 3-5 years, and almost 20% had been in practice for 21 or more years. Almost two-thirds practiced pediatric dermatology only.
Overall, 58% of the respondents strongly agreed that they provided contraception counseling to patients at their initial visit for isotretinoin, but only 7% and 3.5% reported providing EC counseling at initial and follow-up visits, respectively. More than half (58%) said they did not counsel patients on the side effects of EC.
As for provider education, 7.1% of respondents said they had received formal education on EC counseling, 25% reported receiving informal education on EC counseling, and 68% said they received no education on EC counseling.
A total of 32% of respondents said they were at least somewhat confident in how to obtain EC in their state.
EC is an effective form of contraception if used after unprotected intercourse, and discounts can reduce the price to as low as $9.69, the researchers wrote in their discussion. “Given that most providers in this study did not receive formal education on EC, and most do not provide EC counseling to their patients of reproductive potential on isotretinoin, EC education should be a core competency in dermatology residency education on isotretinoin prescribing,” the researchers noted. In addition, EC counseling in the iPLEDGE program should be improved by including more information in education materials and reminding patients that EC is an option, they said.
The study findings were limited by several factors including the small sample size and the multiple-choice format that prevented respondents to share rationales for their responses, the researchers noted.
However, the results highlight the need to improve EC education among pediatric dermatologists to better inform patients considering isotretinoin, especially those choosing abstinence as a method of birth control, they emphasized.
“This study is very important at this specific time for two reasons,” Dr. Zaenglein said in an interview. “The first is that with the recent disastrous rollout of the new iPLEDGE changes, there have been many calls to reform the REMS program. For the first time in the 22-year history of the program, the isotretinoin manufacturers, who manage the iPLEDGE program as an unidentified group (the IPMG), have been forced by the FDA to meet with the AAD iPLEDGE Task Force,” said Dr. Zaenglein, a member of the task force.
“The task force is currently advocating for common sense changes to iPLEDGE and I think enhancing education on emergency contraception is vital to the goal of the program, stated as ‘to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure,’ ” she added. For many patients who previously became pregnant on isotretinoin, Plan B, an over-the-counter, FDA-approved form of contraception, might have prevented that pregnancy if the patients received adequate education on EC, she said.
The current study is especially relevant now, said Dr. Zaenglein. “With the reversal of Roe v. Wade, access to abortion is restricted or completely banned in many states, which makes educating our patients on how to prevent pregnancy even more important.”
Dr. Zaenglein said she was “somewhat surprised” by how many respondents were not educating their isotretinoin patients on EC. “However, these results follow a known trend among dermatologists. Only 50% of dermatologists prescribe oral contraceptives for acne, despite its being an FDA-approved treatment for the most common dermatologic condition we see in adolescents and young adults,” she noted.
“In general, dermatologists, and subsequently dermatology residents, are poorly educated on issues of reproductive health and how they are relevant to dermatologic care,” she added.
Dr. Zaenglein’s take home message: “Dermatologists should educate all patients of childbearing potential taking isotretinoin on how to acquire and use emergency contraception at every visit.” As for additional research, she said that since the study was conducted with pediatric dermatologists, “it would be very interesting to see if general dermatologists had the same lack of comfort in educating patients on emergency contraception and what their standard counseling practices are.”
The study received no outside funding. Dr. Zaenglein is a member of the AAD’s iPLEDGE Work Group and serves as an editor-in-chief of Pediatric Dermatology.
, in a survey of 57 clinicians.
Pregnancies among patients on isotretinoin have declined since the iPLEDGE risk management program was introduced in 2005, but from 2011 to 2017, 210 to 310 pregnancies were reported to the Food and Drug Administration every year, wrote Catherine E. Smiley of Penn State University, Hershey, Pa., and coauthors Melissa Butt, DrPH, and Andrea L. Zaenglein, MD, of Penn State.
For patients on isotretinoin, EC “becomes critical when abstinence fails or contraception is not used properly,” but EC merits only a brief mention in iPLEDGE materials for patients and providers, they noted.
Patients on isotretinoin who choose abstinence as their form of birth control are the group at greatest risk for pregnancy, Dr. Zaenglein, professor of dermatology and pediatric dermatology, Penn State University, said in an interview. “However, the iPLEDGE program fails to educate patients adequately on emergency contraception,” she explained.
To assess pediatric dermatologists’ understanding of EC and their contraception counseling practices for isotretinoin patients, the researchers surveyed 57 pediatric dermatologists who prescribed isotretinoin as part of their practices. The findings were published in Pediatric Dermatology.Respondents included 53 practicing dermatologists, 2 residents, and 2 fellows. Approximately one-third (31.6%) had been in practice for 6-10 years, almost 23% had been in practice for 3-5 years, and almost 20% had been in practice for 21 or more years. Almost two-thirds practiced pediatric dermatology only.
Overall, 58% of the respondents strongly agreed that they provided contraception counseling to patients at their initial visit for isotretinoin, but only 7% and 3.5% reported providing EC counseling at initial and follow-up visits, respectively. More than half (58%) said they did not counsel patients on the side effects of EC.
As for provider education, 7.1% of respondents said they had received formal education on EC counseling, 25% reported receiving informal education on EC counseling, and 68% said they received no education on EC counseling.
A total of 32% of respondents said they were at least somewhat confident in how to obtain EC in their state.
EC is an effective form of contraception if used after unprotected intercourse, and discounts can reduce the price to as low as $9.69, the researchers wrote in their discussion. “Given that most providers in this study did not receive formal education on EC, and most do not provide EC counseling to their patients of reproductive potential on isotretinoin, EC education should be a core competency in dermatology residency education on isotretinoin prescribing,” the researchers noted. In addition, EC counseling in the iPLEDGE program should be improved by including more information in education materials and reminding patients that EC is an option, they said.
The study findings were limited by several factors including the small sample size and the multiple-choice format that prevented respondents to share rationales for their responses, the researchers noted.
However, the results highlight the need to improve EC education among pediatric dermatologists to better inform patients considering isotretinoin, especially those choosing abstinence as a method of birth control, they emphasized.
“This study is very important at this specific time for two reasons,” Dr. Zaenglein said in an interview. “The first is that with the recent disastrous rollout of the new iPLEDGE changes, there have been many calls to reform the REMS program. For the first time in the 22-year history of the program, the isotretinoin manufacturers, who manage the iPLEDGE program as an unidentified group (the IPMG), have been forced by the FDA to meet with the AAD iPLEDGE Task Force,” said Dr. Zaenglein, a member of the task force.
“The task force is currently advocating for common sense changes to iPLEDGE and I think enhancing education on emergency contraception is vital to the goal of the program, stated as ‘to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure,’ ” she added. For many patients who previously became pregnant on isotretinoin, Plan B, an over-the-counter, FDA-approved form of contraception, might have prevented that pregnancy if the patients received adequate education on EC, she said.
The current study is especially relevant now, said Dr. Zaenglein. “With the reversal of Roe v. Wade, access to abortion is restricted or completely banned in many states, which makes educating our patients on how to prevent pregnancy even more important.”
Dr. Zaenglein said she was “somewhat surprised” by how many respondents were not educating their isotretinoin patients on EC. “However, these results follow a known trend among dermatologists. Only 50% of dermatologists prescribe oral contraceptives for acne, despite its being an FDA-approved treatment for the most common dermatologic condition we see in adolescents and young adults,” she noted.
“In general, dermatologists, and subsequently dermatology residents, are poorly educated on issues of reproductive health and how they are relevant to dermatologic care,” she added.
Dr. Zaenglein’s take home message: “Dermatologists should educate all patients of childbearing potential taking isotretinoin on how to acquire and use emergency contraception at every visit.” As for additional research, she said that since the study was conducted with pediatric dermatologists, “it would be very interesting to see if general dermatologists had the same lack of comfort in educating patients on emergency contraception and what their standard counseling practices are.”
The study received no outside funding. Dr. Zaenglein is a member of the AAD’s iPLEDGE Work Group and serves as an editor-in-chief of Pediatric Dermatology.
, in a survey of 57 clinicians.
Pregnancies among patients on isotretinoin have declined since the iPLEDGE risk management program was introduced in 2005, but from 2011 to 2017, 210 to 310 pregnancies were reported to the Food and Drug Administration every year, wrote Catherine E. Smiley of Penn State University, Hershey, Pa., and coauthors Melissa Butt, DrPH, and Andrea L. Zaenglein, MD, of Penn State.
For patients on isotretinoin, EC “becomes critical when abstinence fails or contraception is not used properly,” but EC merits only a brief mention in iPLEDGE materials for patients and providers, they noted.
Patients on isotretinoin who choose abstinence as their form of birth control are the group at greatest risk for pregnancy, Dr. Zaenglein, professor of dermatology and pediatric dermatology, Penn State University, said in an interview. “However, the iPLEDGE program fails to educate patients adequately on emergency contraception,” she explained.
To assess pediatric dermatologists’ understanding of EC and their contraception counseling practices for isotretinoin patients, the researchers surveyed 57 pediatric dermatologists who prescribed isotretinoin as part of their practices. The findings were published in Pediatric Dermatology.Respondents included 53 practicing dermatologists, 2 residents, and 2 fellows. Approximately one-third (31.6%) had been in practice for 6-10 years, almost 23% had been in practice for 3-5 years, and almost 20% had been in practice for 21 or more years. Almost two-thirds practiced pediatric dermatology only.
Overall, 58% of the respondents strongly agreed that they provided contraception counseling to patients at their initial visit for isotretinoin, but only 7% and 3.5% reported providing EC counseling at initial and follow-up visits, respectively. More than half (58%) said they did not counsel patients on the side effects of EC.
As for provider education, 7.1% of respondents said they had received formal education on EC counseling, 25% reported receiving informal education on EC counseling, and 68% said they received no education on EC counseling.
A total of 32% of respondents said they were at least somewhat confident in how to obtain EC in their state.
EC is an effective form of contraception if used after unprotected intercourse, and discounts can reduce the price to as low as $9.69, the researchers wrote in their discussion. “Given that most providers in this study did not receive formal education on EC, and most do not provide EC counseling to their patients of reproductive potential on isotretinoin, EC education should be a core competency in dermatology residency education on isotretinoin prescribing,” the researchers noted. In addition, EC counseling in the iPLEDGE program should be improved by including more information in education materials and reminding patients that EC is an option, they said.
The study findings were limited by several factors including the small sample size and the multiple-choice format that prevented respondents to share rationales for their responses, the researchers noted.
However, the results highlight the need to improve EC education among pediatric dermatologists to better inform patients considering isotretinoin, especially those choosing abstinence as a method of birth control, they emphasized.
“This study is very important at this specific time for two reasons,” Dr. Zaenglein said in an interview. “The first is that with the recent disastrous rollout of the new iPLEDGE changes, there have been many calls to reform the REMS program. For the first time in the 22-year history of the program, the isotretinoin manufacturers, who manage the iPLEDGE program as an unidentified group (the IPMG), have been forced by the FDA to meet with the AAD iPLEDGE Task Force,” said Dr. Zaenglein, a member of the task force.
“The task force is currently advocating for common sense changes to iPLEDGE and I think enhancing education on emergency contraception is vital to the goal of the program, stated as ‘to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure,’ ” she added. For many patients who previously became pregnant on isotretinoin, Plan B, an over-the-counter, FDA-approved form of contraception, might have prevented that pregnancy if the patients received adequate education on EC, she said.
The current study is especially relevant now, said Dr. Zaenglein. “With the reversal of Roe v. Wade, access to abortion is restricted or completely banned in many states, which makes educating our patients on how to prevent pregnancy even more important.”
Dr. Zaenglein said she was “somewhat surprised” by how many respondents were not educating their isotretinoin patients on EC. “However, these results follow a known trend among dermatologists. Only 50% of dermatologists prescribe oral contraceptives for acne, despite its being an FDA-approved treatment for the most common dermatologic condition we see in adolescents and young adults,” she noted.
“In general, dermatologists, and subsequently dermatology residents, are poorly educated on issues of reproductive health and how they are relevant to dermatologic care,” she added.
Dr. Zaenglein’s take home message: “Dermatologists should educate all patients of childbearing potential taking isotretinoin on how to acquire and use emergency contraception at every visit.” As for additional research, she said that since the study was conducted with pediatric dermatologists, “it would be very interesting to see if general dermatologists had the same lack of comfort in educating patients on emergency contraception and what their standard counseling practices are.”
The study received no outside funding. Dr. Zaenglein is a member of the AAD’s iPLEDGE Work Group and serves as an editor-in-chief of Pediatric Dermatology.
FROM PEDIATRIC DERMATOLOGY
Zeroing in on genes involved in Crohn’s disease
Researchers have identified genetic variants in 10 genes that increase susceptibility to Crohn’s disease (CD), a form of inflammatory bowel disease (IBD). Some of the variants had not previously been connected to CD.
Because they’re so common, most people will have some of the genetic variants that increase susceptibility to IBD, first author Aleksejs Sazonovs, PhD, research associate at the Wellcome Sanger Institute, Hinxton, United Kingdom, said in a news release.
“These common variants may increase a person’s risk by 10%, for example, but this increased risk doesn’t necessarily lead to disease,” Dr. Sazonovs explains.
However, some rare variants can render an individual four or five times more likely to develop IBD, “so it’s especially important to locate these and understand the biological processes they disrupt,” Dr. Sazonovs adds.
The study was published online in Nature Genetics.
Genome-wide association studies (GWASs) of CD, and of IBD more generally, have identified more than 200 loci that contribute to disease risk.
To complement GWAS data and to better define actionable biological targets in protein-coding genes, the researchers analyzed large-scale exome sequencing data from more than 30,000 patients with CD and 80,000 control persons from more than 35 centers in the International IBD Genetics Consortium.
Their findings, they say, “directly implicate” genetic variants in 10 genes in general-onset CD, four of which lie within established CD GWAS loci.
They also implicate genetic variation in six genes in regions of the genome that had not previously been connected to CD.
Of note, say the researchers, many of these newly associated genes appear to be linked to the roles that mesenchymal cells (MCs) play in intestinal homeostasis, “a pathway not previously implicated by genetic studies.”
“In addition to reiterating the central role of innate and adaptive immune cells, as well as autophagy in CD pathogenesis, these newly associated genes highlight the emerging role of mesenchymal cells in the development and maintenance of intestinal inflammation,” they add.
The researchers note that previous studies have demonstrated that the biology of MCs is disrupted in IBD. The current findings of coding variants in these genes demonstrate that these cells and functions “causally contribute to disease susceptibility,” they write.
The association of these pathways with CD pathogenesis provides a rationale for developing therapeutic modalities that can “reestablish the balance to the mesenchymal niche, as it is believed that genetic evidence for a drug target has a measurable impact on drug development,” they add.
The researchers plan to extend this research to ulcerative colitis and to increase the scale of sampling.
“We’ve already begun working on our next study, which will use exome sequence data from more than 650,000 individuals and give us unprecedented ability to derive insights into the aberrant biology underpinning inflammatory bowel disease,” Carl Anderson, PhD, senior investigator at the Wellcome Sanger Institute, says in the release.
Support for the study was funded by the National Institutes of Health, the Wellcome Trust, and the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Sazonovs reports no relevant financial relationships. Dr. Anderson has received consultancy fees from Genomics PLC and BridgeBio and lecture fees from GlaxoSmithKline.
A version of this article first appeared on Medscape.com.
Researchers have identified genetic variants in 10 genes that increase susceptibility to Crohn’s disease (CD), a form of inflammatory bowel disease (IBD). Some of the variants had not previously been connected to CD.
Because they’re so common, most people will have some of the genetic variants that increase susceptibility to IBD, first author Aleksejs Sazonovs, PhD, research associate at the Wellcome Sanger Institute, Hinxton, United Kingdom, said in a news release.
“These common variants may increase a person’s risk by 10%, for example, but this increased risk doesn’t necessarily lead to disease,” Dr. Sazonovs explains.
However, some rare variants can render an individual four or five times more likely to develop IBD, “so it’s especially important to locate these and understand the biological processes they disrupt,” Dr. Sazonovs adds.
The study was published online in Nature Genetics.
Genome-wide association studies (GWASs) of CD, and of IBD more generally, have identified more than 200 loci that contribute to disease risk.
To complement GWAS data and to better define actionable biological targets in protein-coding genes, the researchers analyzed large-scale exome sequencing data from more than 30,000 patients with CD and 80,000 control persons from more than 35 centers in the International IBD Genetics Consortium.
Their findings, they say, “directly implicate” genetic variants in 10 genes in general-onset CD, four of which lie within established CD GWAS loci.
They also implicate genetic variation in six genes in regions of the genome that had not previously been connected to CD.
Of note, say the researchers, many of these newly associated genes appear to be linked to the roles that mesenchymal cells (MCs) play in intestinal homeostasis, “a pathway not previously implicated by genetic studies.”
“In addition to reiterating the central role of innate and adaptive immune cells, as well as autophagy in CD pathogenesis, these newly associated genes highlight the emerging role of mesenchymal cells in the development and maintenance of intestinal inflammation,” they add.
The researchers note that previous studies have demonstrated that the biology of MCs is disrupted in IBD. The current findings of coding variants in these genes demonstrate that these cells and functions “causally contribute to disease susceptibility,” they write.
The association of these pathways with CD pathogenesis provides a rationale for developing therapeutic modalities that can “reestablish the balance to the mesenchymal niche, as it is believed that genetic evidence for a drug target has a measurable impact on drug development,” they add.
The researchers plan to extend this research to ulcerative colitis and to increase the scale of sampling.
“We’ve already begun working on our next study, which will use exome sequence data from more than 650,000 individuals and give us unprecedented ability to derive insights into the aberrant biology underpinning inflammatory bowel disease,” Carl Anderson, PhD, senior investigator at the Wellcome Sanger Institute, says in the release.
Support for the study was funded by the National Institutes of Health, the Wellcome Trust, and the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Sazonovs reports no relevant financial relationships. Dr. Anderson has received consultancy fees from Genomics PLC and BridgeBio and lecture fees from GlaxoSmithKline.
A version of this article first appeared on Medscape.com.
Researchers have identified genetic variants in 10 genes that increase susceptibility to Crohn’s disease (CD), a form of inflammatory bowel disease (IBD). Some of the variants had not previously been connected to CD.
Because they’re so common, most people will have some of the genetic variants that increase susceptibility to IBD, first author Aleksejs Sazonovs, PhD, research associate at the Wellcome Sanger Institute, Hinxton, United Kingdom, said in a news release.
“These common variants may increase a person’s risk by 10%, for example, but this increased risk doesn’t necessarily lead to disease,” Dr. Sazonovs explains.
However, some rare variants can render an individual four or five times more likely to develop IBD, “so it’s especially important to locate these and understand the biological processes they disrupt,” Dr. Sazonovs adds.
The study was published online in Nature Genetics.
Genome-wide association studies (GWASs) of CD, and of IBD more generally, have identified more than 200 loci that contribute to disease risk.
To complement GWAS data and to better define actionable biological targets in protein-coding genes, the researchers analyzed large-scale exome sequencing data from more than 30,000 patients with CD and 80,000 control persons from more than 35 centers in the International IBD Genetics Consortium.
Their findings, they say, “directly implicate” genetic variants in 10 genes in general-onset CD, four of which lie within established CD GWAS loci.
They also implicate genetic variation in six genes in regions of the genome that had not previously been connected to CD.
Of note, say the researchers, many of these newly associated genes appear to be linked to the roles that mesenchymal cells (MCs) play in intestinal homeostasis, “a pathway not previously implicated by genetic studies.”
“In addition to reiterating the central role of innate and adaptive immune cells, as well as autophagy in CD pathogenesis, these newly associated genes highlight the emerging role of mesenchymal cells in the development and maintenance of intestinal inflammation,” they add.
The researchers note that previous studies have demonstrated that the biology of MCs is disrupted in IBD. The current findings of coding variants in these genes demonstrate that these cells and functions “causally contribute to disease susceptibility,” they write.
The association of these pathways with CD pathogenesis provides a rationale for developing therapeutic modalities that can “reestablish the balance to the mesenchymal niche, as it is believed that genetic evidence for a drug target has a measurable impact on drug development,” they add.
The researchers plan to extend this research to ulcerative colitis and to increase the scale of sampling.
“We’ve already begun working on our next study, which will use exome sequence data from more than 650,000 individuals and give us unprecedented ability to derive insights into the aberrant biology underpinning inflammatory bowel disease,” Carl Anderson, PhD, senior investigator at the Wellcome Sanger Institute, says in the release.
Support for the study was funded by the National Institutes of Health, the Wellcome Trust, and the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Sazonovs reports no relevant financial relationships. Dr. Anderson has received consultancy fees from Genomics PLC and BridgeBio and lecture fees from GlaxoSmithKline.
A version of this article first appeared on Medscape.com.
FROM NATURE GENETICS
New study supports safety of COVID-19 boosters during pregnancy
Doctors and health professionals continue to recommend COVID-19 vaccine boosters or third doses for adolescents and adults more than 5 months after their initial vaccinations with the Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 primary vaccine series or more than 2 months after receiving the Janssen JNJ-78436735 vaccine, Alisa Kachikis, MD, of the University of Washington, Seattle, and colleagues wrote in JAMA Network Open.
Although multiple studies have shown that the COVID-19 primary series is safe and well tolerated in pregnant and lactating women, information on the safety and tolerability of boosters are lacking, the researchers noted.
“COVID-19 will be with us for a while, and it is important to continue to provide data on COVID-19 vaccines in these groups, particularly because there still are many questions about the vaccine, and because pregnant individuals have been, understandably, more hesitant to receive COVID-19 vaccines,” Dr. Kachikis said in an interview. “The findings of this study that COVID-19 booster doses are well tolerated among pregnant and lactating individuals are especially pertinent with the new COVID-19 boosters available this fall.”
In the new study, the researchers reviewed data from 17,014 participants who were part of an ongoing online prospective study of COVID-19 vaccines in pregnant and lactating individuals. Data were collected between October 2021 and April 2022 through an online survey.
The study population included 2,009 participants (11.8%) who were pregnant at the time of their booster or third dose, 10,279 (60.4%) who were lactating, and 4,726 (27.8%) who were neither pregnant nor lactating. The mean age of the participants was 33.3 years; 92.1% self-identified as White, 94.5% self-identified as non-Hispanic, and 99.7% self-identified as female.
The receipt of a booster was similar across trimesters; 26.4%, 36.5%, and 37.1% of participants received boosters or third doses in the first, second, and third trimester, respectively. The primary outcome was self-reported vaccine reactions within 24 hours of the dose.
Overall, 82.8% of the respondents reported a reaction at the site of the injection, such as redness, pain, or swelling, and 67.9% reported at least one systemic symptom, such as aches and pains, headache, chills, or fever. The most frequently reported symptoms across all groups were injection-site pain (82.2%) and fatigue (54.4%).
The pregnant women were significantly more likely than nonpregnant or nonlactating individuals to report any local reaction at the injection site (adjusted odds ratio, 1.2; P = .01), but less likely to report any systemic reaction (aOR, 0.7; P < .001).
The majority (97.6%) of the pregnant respondents and 96.0% of those lactating reported no obstetric or lactation concerns after vaccination.
Overall, a majority of the respondents reported that recommendations from public health authorities were helpful in their decision to receive a COVID-19 booster or third dose (90.0% of pregnant respondents, 89.9% of lactating respondents, and 88.1% of those neither pregnant nor lactating).
Although vaccine uptake in the current study population was high (91.1% overall and 95.0% of those pregnant), “the importance of the health care professional’s recommendation is pertinent given the ongoing increased vaccine hesitancy among pregnant individuals in the context of the COVID-19 vaccine,” the researchers emphasized.
The study findings were limited by several factors including the reliance on self-reports and a convenience sample composed mainly of health care workers because of their vaccine eligibility at the time the study started, which limits generalizability, the researchers noted. Analyses on the pregnancy outcomes of those who were pregnant when vaccinated are in progress.
The results were strengthened by the large study population that included participants from all 50 states and several territories, and ability to compare results between pregnant and lactating individuals with those who were neither pregnant nor lactating, but were of childbearing age, they said.
The results support the safety of COVID-19 boosters for pregnant and breastfeeding individuals, and these data are important to inform discussions between patients and clinicians to boost vaccine uptake and acceptance in this population, they concluded.
“Our earlier data analysis showed that pregnant and lactating individuals did very well with the initial COVID-19 vaccine series, so it was not very surprising that they also did well with COVID-19 booster or third doses,” Dr. Kachikis said in an interview.
There are two takeaway messages for clinicians, she said: “First, pregnant and lactating individuals tolerated the COVID-19 booster well. The second is that clinicians are very important when it comes to vaccine acceptance.”
“In our study, we found that, while pregnant participants were more likely to report that they were hesitant to receive the booster, they also were more likely to have discussed the COVID-19 booster with their health care provider, and to have received a recommendation to receive the booster. So, spending a little bit of extra time with patients discussing COVID-19 boosters and recommending them can make a significant difference,” she said.
The message of the study is highly reassuring for pregnant and lactating individuals, Dr. Kachikis added. “Most of the participants reported that they had fewer symptoms with the COVID-19 booster compared to the primary vaccine series, which is good news, especially since a new COVID-19 booster is being recommended for the fall.”
Reassuring findings for doctors and patients
The current study is especially timely, as updated COVID-19 boosters have now been recommended for most individuals by the Centers for Disease Control and Prevention, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
The findings support previous studies on the tolerability of COVID-19 vaccinations in pregnant and lactating persons, said Dr. Badell, who was not involved in the study.
The reassuring message for clinicians is that COVID-19 booster vaccinations are similarly well tolerated in pregnancy and lactation as they are in nonpregnant individuals, said Dr. Badell. “Given the risks of COVID infections in pregnancy and neonates, reassuring data on the tolerability and safety of vaccination in this population is very important.” Also, the researchers found that all three cohorts reported that recommendations from public or medical health authorities helped them make a decision about vaccination; “thus the more data to support these recommendations, the better,” she emphasized.
If you are pregnant or breastfeeding, the message from the study is that COVID-19 booster vaccinations are similarly well tolerated by those who are pregnant or breastfeeding and those who are not, said Dr. Badell.
“This study provides additional support for the strong recommendation to encourage not only COVID-19 vaccination in pregnancy and lactation, but booster vaccinations specifically,” and pregnant and breastfeeding individuals should not be excluded from the new CDC recommendations for COVID-19 boosters, she said.
Future research suggestions
Next steps for research include evaluating the obstetrical and neonatal outcomes in pregnancy and lactation following COVID- 19 boosters, Dr. Badell added.
Dr. Kachikis suggested studies try to answer the remaining questions about COVID-19 vaccines and the immunity of pregnant and lactating persons, particularly since they were excluded from the early clinical trials in 2020.
The study was supported by the National Institute of Allergy and Infectious Diseases, a Women’s Reproductive Health Research Award, and the National Center for Advancing Translational Sciences of the National Institutes of Health. \Dr. Kachikis disclosed serving as a research consultant for Pfizer and GlaxoSmithKline and as an unpaid consultant for GlaxoSmithKline unrelated to the current study, as well as grant support from Merck and Pfizer unrelated to the current study. Dr. Badell had no financial conflicts to disclose.
Doctors and health professionals continue to recommend COVID-19 vaccine boosters or third doses for adolescents and adults more than 5 months after their initial vaccinations with the Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 primary vaccine series or more than 2 months after receiving the Janssen JNJ-78436735 vaccine, Alisa Kachikis, MD, of the University of Washington, Seattle, and colleagues wrote in JAMA Network Open.
Although multiple studies have shown that the COVID-19 primary series is safe and well tolerated in pregnant and lactating women, information on the safety and tolerability of boosters are lacking, the researchers noted.
“COVID-19 will be with us for a while, and it is important to continue to provide data on COVID-19 vaccines in these groups, particularly because there still are many questions about the vaccine, and because pregnant individuals have been, understandably, more hesitant to receive COVID-19 vaccines,” Dr. Kachikis said in an interview. “The findings of this study that COVID-19 booster doses are well tolerated among pregnant and lactating individuals are especially pertinent with the new COVID-19 boosters available this fall.”
In the new study, the researchers reviewed data from 17,014 participants who were part of an ongoing online prospective study of COVID-19 vaccines in pregnant and lactating individuals. Data were collected between October 2021 and April 2022 through an online survey.
The study population included 2,009 participants (11.8%) who were pregnant at the time of their booster or third dose, 10,279 (60.4%) who were lactating, and 4,726 (27.8%) who were neither pregnant nor lactating. The mean age of the participants was 33.3 years; 92.1% self-identified as White, 94.5% self-identified as non-Hispanic, and 99.7% self-identified as female.
The receipt of a booster was similar across trimesters; 26.4%, 36.5%, and 37.1% of participants received boosters or third doses in the first, second, and third trimester, respectively. The primary outcome was self-reported vaccine reactions within 24 hours of the dose.
Overall, 82.8% of the respondents reported a reaction at the site of the injection, such as redness, pain, or swelling, and 67.9% reported at least one systemic symptom, such as aches and pains, headache, chills, or fever. The most frequently reported symptoms across all groups were injection-site pain (82.2%) and fatigue (54.4%).
The pregnant women were significantly more likely than nonpregnant or nonlactating individuals to report any local reaction at the injection site (adjusted odds ratio, 1.2; P = .01), but less likely to report any systemic reaction (aOR, 0.7; P < .001).
The majority (97.6%) of the pregnant respondents and 96.0% of those lactating reported no obstetric or lactation concerns after vaccination.
Overall, a majority of the respondents reported that recommendations from public health authorities were helpful in their decision to receive a COVID-19 booster or third dose (90.0% of pregnant respondents, 89.9% of lactating respondents, and 88.1% of those neither pregnant nor lactating).
Although vaccine uptake in the current study population was high (91.1% overall and 95.0% of those pregnant), “the importance of the health care professional’s recommendation is pertinent given the ongoing increased vaccine hesitancy among pregnant individuals in the context of the COVID-19 vaccine,” the researchers emphasized.
The study findings were limited by several factors including the reliance on self-reports and a convenience sample composed mainly of health care workers because of their vaccine eligibility at the time the study started, which limits generalizability, the researchers noted. Analyses on the pregnancy outcomes of those who were pregnant when vaccinated are in progress.
The results were strengthened by the large study population that included participants from all 50 states and several territories, and ability to compare results between pregnant and lactating individuals with those who were neither pregnant nor lactating, but were of childbearing age, they said.
The results support the safety of COVID-19 boosters for pregnant and breastfeeding individuals, and these data are important to inform discussions between patients and clinicians to boost vaccine uptake and acceptance in this population, they concluded.
“Our earlier data analysis showed that pregnant and lactating individuals did very well with the initial COVID-19 vaccine series, so it was not very surprising that they also did well with COVID-19 booster or third doses,” Dr. Kachikis said in an interview.
There are two takeaway messages for clinicians, she said: “First, pregnant and lactating individuals tolerated the COVID-19 booster well. The second is that clinicians are very important when it comes to vaccine acceptance.”
“In our study, we found that, while pregnant participants were more likely to report that they were hesitant to receive the booster, they also were more likely to have discussed the COVID-19 booster with their health care provider, and to have received a recommendation to receive the booster. So, spending a little bit of extra time with patients discussing COVID-19 boosters and recommending them can make a significant difference,” she said.
The message of the study is highly reassuring for pregnant and lactating individuals, Dr. Kachikis added. “Most of the participants reported that they had fewer symptoms with the COVID-19 booster compared to the primary vaccine series, which is good news, especially since a new COVID-19 booster is being recommended for the fall.”
Reassuring findings for doctors and patients
The current study is especially timely, as updated COVID-19 boosters have now been recommended for most individuals by the Centers for Disease Control and Prevention, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
The findings support previous studies on the tolerability of COVID-19 vaccinations in pregnant and lactating persons, said Dr. Badell, who was not involved in the study.
The reassuring message for clinicians is that COVID-19 booster vaccinations are similarly well tolerated in pregnancy and lactation as they are in nonpregnant individuals, said Dr. Badell. “Given the risks of COVID infections in pregnancy and neonates, reassuring data on the tolerability and safety of vaccination in this population is very important.” Also, the researchers found that all three cohorts reported that recommendations from public or medical health authorities helped them make a decision about vaccination; “thus the more data to support these recommendations, the better,” she emphasized.
If you are pregnant or breastfeeding, the message from the study is that COVID-19 booster vaccinations are similarly well tolerated by those who are pregnant or breastfeeding and those who are not, said Dr. Badell.
“This study provides additional support for the strong recommendation to encourage not only COVID-19 vaccination in pregnancy and lactation, but booster vaccinations specifically,” and pregnant and breastfeeding individuals should not be excluded from the new CDC recommendations for COVID-19 boosters, she said.
Future research suggestions
Next steps for research include evaluating the obstetrical and neonatal outcomes in pregnancy and lactation following COVID- 19 boosters, Dr. Badell added.
Dr. Kachikis suggested studies try to answer the remaining questions about COVID-19 vaccines and the immunity of pregnant and lactating persons, particularly since they were excluded from the early clinical trials in 2020.
The study was supported by the National Institute of Allergy and Infectious Diseases, a Women’s Reproductive Health Research Award, and the National Center for Advancing Translational Sciences of the National Institutes of Health. \Dr. Kachikis disclosed serving as a research consultant for Pfizer and GlaxoSmithKline and as an unpaid consultant for GlaxoSmithKline unrelated to the current study, as well as grant support from Merck and Pfizer unrelated to the current study. Dr. Badell had no financial conflicts to disclose.
Doctors and health professionals continue to recommend COVID-19 vaccine boosters or third doses for adolescents and adults more than 5 months after their initial vaccinations with the Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 primary vaccine series or more than 2 months after receiving the Janssen JNJ-78436735 vaccine, Alisa Kachikis, MD, of the University of Washington, Seattle, and colleagues wrote in JAMA Network Open.
Although multiple studies have shown that the COVID-19 primary series is safe and well tolerated in pregnant and lactating women, information on the safety and tolerability of boosters are lacking, the researchers noted.
“COVID-19 will be with us for a while, and it is important to continue to provide data on COVID-19 vaccines in these groups, particularly because there still are many questions about the vaccine, and because pregnant individuals have been, understandably, more hesitant to receive COVID-19 vaccines,” Dr. Kachikis said in an interview. “The findings of this study that COVID-19 booster doses are well tolerated among pregnant and lactating individuals are especially pertinent with the new COVID-19 boosters available this fall.”
In the new study, the researchers reviewed data from 17,014 participants who were part of an ongoing online prospective study of COVID-19 vaccines in pregnant and lactating individuals. Data were collected between October 2021 and April 2022 through an online survey.
The study population included 2,009 participants (11.8%) who were pregnant at the time of their booster or third dose, 10,279 (60.4%) who were lactating, and 4,726 (27.8%) who were neither pregnant nor lactating. The mean age of the participants was 33.3 years; 92.1% self-identified as White, 94.5% self-identified as non-Hispanic, and 99.7% self-identified as female.
The receipt of a booster was similar across trimesters; 26.4%, 36.5%, and 37.1% of participants received boosters or third doses in the first, second, and third trimester, respectively. The primary outcome was self-reported vaccine reactions within 24 hours of the dose.
Overall, 82.8% of the respondents reported a reaction at the site of the injection, such as redness, pain, or swelling, and 67.9% reported at least one systemic symptom, such as aches and pains, headache, chills, or fever. The most frequently reported symptoms across all groups were injection-site pain (82.2%) and fatigue (54.4%).
The pregnant women were significantly more likely than nonpregnant or nonlactating individuals to report any local reaction at the injection site (adjusted odds ratio, 1.2; P = .01), but less likely to report any systemic reaction (aOR, 0.7; P < .001).
The majority (97.6%) of the pregnant respondents and 96.0% of those lactating reported no obstetric or lactation concerns after vaccination.
Overall, a majority of the respondents reported that recommendations from public health authorities were helpful in their decision to receive a COVID-19 booster or third dose (90.0% of pregnant respondents, 89.9% of lactating respondents, and 88.1% of those neither pregnant nor lactating).
Although vaccine uptake in the current study population was high (91.1% overall and 95.0% of those pregnant), “the importance of the health care professional’s recommendation is pertinent given the ongoing increased vaccine hesitancy among pregnant individuals in the context of the COVID-19 vaccine,” the researchers emphasized.
The study findings were limited by several factors including the reliance on self-reports and a convenience sample composed mainly of health care workers because of their vaccine eligibility at the time the study started, which limits generalizability, the researchers noted. Analyses on the pregnancy outcomes of those who were pregnant when vaccinated are in progress.
The results were strengthened by the large study population that included participants from all 50 states and several territories, and ability to compare results between pregnant and lactating individuals with those who were neither pregnant nor lactating, but were of childbearing age, they said.
The results support the safety of COVID-19 boosters for pregnant and breastfeeding individuals, and these data are important to inform discussions between patients and clinicians to boost vaccine uptake and acceptance in this population, they concluded.
“Our earlier data analysis showed that pregnant and lactating individuals did very well with the initial COVID-19 vaccine series, so it was not very surprising that they also did well with COVID-19 booster or third doses,” Dr. Kachikis said in an interview.
There are two takeaway messages for clinicians, she said: “First, pregnant and lactating individuals tolerated the COVID-19 booster well. The second is that clinicians are very important when it comes to vaccine acceptance.”
“In our study, we found that, while pregnant participants were more likely to report that they were hesitant to receive the booster, they also were more likely to have discussed the COVID-19 booster with their health care provider, and to have received a recommendation to receive the booster. So, spending a little bit of extra time with patients discussing COVID-19 boosters and recommending them can make a significant difference,” she said.
The message of the study is highly reassuring for pregnant and lactating individuals, Dr. Kachikis added. “Most of the participants reported that they had fewer symptoms with the COVID-19 booster compared to the primary vaccine series, which is good news, especially since a new COVID-19 booster is being recommended for the fall.”
Reassuring findings for doctors and patients
The current study is especially timely, as updated COVID-19 boosters have now been recommended for most individuals by the Centers for Disease Control and Prevention, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
The findings support previous studies on the tolerability of COVID-19 vaccinations in pregnant and lactating persons, said Dr. Badell, who was not involved in the study.
The reassuring message for clinicians is that COVID-19 booster vaccinations are similarly well tolerated in pregnancy and lactation as they are in nonpregnant individuals, said Dr. Badell. “Given the risks of COVID infections in pregnancy and neonates, reassuring data on the tolerability and safety of vaccination in this population is very important.” Also, the researchers found that all three cohorts reported that recommendations from public or medical health authorities helped them make a decision about vaccination; “thus the more data to support these recommendations, the better,” she emphasized.
If you are pregnant or breastfeeding, the message from the study is that COVID-19 booster vaccinations are similarly well tolerated by those who are pregnant or breastfeeding and those who are not, said Dr. Badell.
“This study provides additional support for the strong recommendation to encourage not only COVID-19 vaccination in pregnancy and lactation, but booster vaccinations specifically,” and pregnant and breastfeeding individuals should not be excluded from the new CDC recommendations for COVID-19 boosters, she said.
Future research suggestions
Next steps for research include evaluating the obstetrical and neonatal outcomes in pregnancy and lactation following COVID- 19 boosters, Dr. Badell added.
Dr. Kachikis suggested studies try to answer the remaining questions about COVID-19 vaccines and the immunity of pregnant and lactating persons, particularly since they were excluded from the early clinical trials in 2020.
The study was supported by the National Institute of Allergy and Infectious Diseases, a Women’s Reproductive Health Research Award, and the National Center for Advancing Translational Sciences of the National Institutes of Health. \Dr. Kachikis disclosed serving as a research consultant for Pfizer and GlaxoSmithKline and as an unpaid consultant for GlaxoSmithKline unrelated to the current study, as well as grant support from Merck and Pfizer unrelated to the current study. Dr. Badell had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Ultrasound offers noninvasive alternative for monitoring ulcerative colitis
Intestinal ultrasound (IUS) findings correlate strongly with endoscopy results in patients with ulcerative colitis (UC), with treatment responses detected as soon as 8 weeks after starting tofacitinib, a longitudinal prospective study has found.
IUS accurately detected improvements and remission across a variety of scoring methodologies, suggesting that it may be a cost-effective, noninvasive alternative to endoscopic monitoring, reported lead author Floris de Voogd, MD, of Amsterdam University Medical Centers, and colleagues.
“Endoscopy is generally considered as the gold standard for the diagnosis and follow-up of patients with UC,” the investigators wrote in Gastroenterology. “However, endoscopy is an invasive and costly modality and therefore less attractive to perform frequently during the disease course.”
Whereas noninvasive fecal biomarkers are a more economical method of monitoring inflammation and treatment responses, they fail to characterize disease extent and fall short in detecting early endoscopic responses, the investigators added.
The present study aimed to determine if IUS could offer more clinical insight by measuring bowel wall thickness. Thirty patients were enrolled with moderate to severe UC, all with an endoscopic Mayo score of at least 2. Twenty-seven of these patients were evaluable through follow-up, having undergone both IUS and endoscopy at baseline and 8 weeks after starting tofacitinib.
At both time points, IUS findings correlated significantly with endoscopic Mayo score (EMS), UC endoscopic index for severity, and Robarts Histopathology Index, with correlation coefficients of 0.68, 0.73, and 0.49, respectively. Remission according to EMS was defined as a score of 0, and improvement was defined as a score of 1 or less.
Patients with EMS improvement showed lower median bowel wall thickness in the sigmoid colon after 8 weeks of treatment than did patients without improvement (1.8 mm vs. 4.5 mm; P < .0001); patients who were in EMS remission after 8 weeks also had lower median bowel wall thickness of the sigmoid colon (1.4 mm vs. 4.0 mm; P = .016).
The investigators also sought to define cutoff values for bowel wall thickness. The most accurate cutoff values for identifying endoscopic remission and improvement were 2.8 mm (area under the receiver operating curve, 0.87; 95% confidence interval, 0.74-1.00; P = .006) and 3.9 mm (AUROC, 0.92; 95% CI, 0.82-1.00; P < .0001), respectively. Treatment response was best identified by a 32% threshold reduction in thickness (AUROC, 0.87; 95% CI, 0.74-1.00; P = .002).
“Intestinal ultrasound, with bowel wall thickness as the single most important parameter is accurate to determine treatment response to tofacitinib in patients with moderate-severe UC when compared against endoscopy,” the investigators concluded.
Michael Dolinger, MD, MBA, assistant professor of pediatrics and the associate pediatric gastroenterology fellowship program director at the Icahn School of Medicine at Mount Sinai, New York, said the study is noteworthy because it is the first of its kind to show that IUS can accurately monitor treatment responses in UC.
“This study is what we’re looking for now, and in the future,” Dr. Dolinger said in an interview. “We’re looking for noninvasive biomarkers to predict early responses so that we know as clinicians ... if our medicines are working or if we need to pivot and switch effectively.”
For patients, this can mean feeling better quicker while reducing burden of care, he added.
“We can use this study to predict patient responses without having to potentially rescope them in 8 weeks using a 5-minute point-of-care test in the clinic,” Dr. Dolinger said. “It’s huge to be able to say that for patients with colitis, and to provide reassurance that not only are they potentially feeling better, but the medicine is working to change and heal their bowel wall really quickly as well.”
Dr. Dolinger speaks from clinical experience. Over the past 2 years, he and his colleagues at Mount Sinai have been implementing IUS for patients with both UC and Crohn’s disease.
“It’s become part of our standard of care,” Dr. Dolinger said. “This is now emerging in the United States and will soon take hold. There is a lot of interest.”
Dr. Dolinger is one of just a few American physicians credentialed by the International Bowel Ultrasound Group, an organization based out of Europe, Israel, and Canada. Formalized training and certification are necessary, Dr. Dolinger noted, to ensure that this new clinical approach maintains consistency as it is rolled out across the United States.
“We have the unique opportunity to do something from the ground up quickly, but also correctly, meaning that we can train everyone to speak the same language and do the same standardized exams so that all the findings and research are relatable,” Dr. Dolinger said.
He advised interested physicians to contact their local inflammatory bowel disease center to find out if training is available, and if it is, devoting “a lot of time” to the learning process.
“If you’re going to use this potentially as a clinical decision-making tool without using other invasive procedures, you really want to make sure what you’re doing is accurate and correct,” Dr. Dolinger said.
The investigators disclosed relationships with AbbVie, Merck, Takeda, and others. Dr. Dolinger disclosed a relationship with NeuroLogica, a subsidiary of Samsung Electronics.
Intestinal ultrasound (IUS) findings correlate strongly with endoscopy results in patients with ulcerative colitis (UC), with treatment responses detected as soon as 8 weeks after starting tofacitinib, a longitudinal prospective study has found.
IUS accurately detected improvements and remission across a variety of scoring methodologies, suggesting that it may be a cost-effective, noninvasive alternative to endoscopic monitoring, reported lead author Floris de Voogd, MD, of Amsterdam University Medical Centers, and colleagues.
“Endoscopy is generally considered as the gold standard for the diagnosis and follow-up of patients with UC,” the investigators wrote in Gastroenterology. “However, endoscopy is an invasive and costly modality and therefore less attractive to perform frequently during the disease course.”
Whereas noninvasive fecal biomarkers are a more economical method of monitoring inflammation and treatment responses, they fail to characterize disease extent and fall short in detecting early endoscopic responses, the investigators added.
The present study aimed to determine if IUS could offer more clinical insight by measuring bowel wall thickness. Thirty patients were enrolled with moderate to severe UC, all with an endoscopic Mayo score of at least 2. Twenty-seven of these patients were evaluable through follow-up, having undergone both IUS and endoscopy at baseline and 8 weeks after starting tofacitinib.
At both time points, IUS findings correlated significantly with endoscopic Mayo score (EMS), UC endoscopic index for severity, and Robarts Histopathology Index, with correlation coefficients of 0.68, 0.73, and 0.49, respectively. Remission according to EMS was defined as a score of 0, and improvement was defined as a score of 1 or less.
Patients with EMS improvement showed lower median bowel wall thickness in the sigmoid colon after 8 weeks of treatment than did patients without improvement (1.8 mm vs. 4.5 mm; P < .0001); patients who were in EMS remission after 8 weeks also had lower median bowel wall thickness of the sigmoid colon (1.4 mm vs. 4.0 mm; P = .016).
The investigators also sought to define cutoff values for bowel wall thickness. The most accurate cutoff values for identifying endoscopic remission and improvement were 2.8 mm (area under the receiver operating curve, 0.87; 95% confidence interval, 0.74-1.00; P = .006) and 3.9 mm (AUROC, 0.92; 95% CI, 0.82-1.00; P < .0001), respectively. Treatment response was best identified by a 32% threshold reduction in thickness (AUROC, 0.87; 95% CI, 0.74-1.00; P = .002).
“Intestinal ultrasound, with bowel wall thickness as the single most important parameter is accurate to determine treatment response to tofacitinib in patients with moderate-severe UC when compared against endoscopy,” the investigators concluded.
Michael Dolinger, MD, MBA, assistant professor of pediatrics and the associate pediatric gastroenterology fellowship program director at the Icahn School of Medicine at Mount Sinai, New York, said the study is noteworthy because it is the first of its kind to show that IUS can accurately monitor treatment responses in UC.
“This study is what we’re looking for now, and in the future,” Dr. Dolinger said in an interview. “We’re looking for noninvasive biomarkers to predict early responses so that we know as clinicians ... if our medicines are working or if we need to pivot and switch effectively.”
For patients, this can mean feeling better quicker while reducing burden of care, he added.
“We can use this study to predict patient responses without having to potentially rescope them in 8 weeks using a 5-minute point-of-care test in the clinic,” Dr. Dolinger said. “It’s huge to be able to say that for patients with colitis, and to provide reassurance that not only are they potentially feeling better, but the medicine is working to change and heal their bowel wall really quickly as well.”
Dr. Dolinger speaks from clinical experience. Over the past 2 years, he and his colleagues at Mount Sinai have been implementing IUS for patients with both UC and Crohn’s disease.
“It’s become part of our standard of care,” Dr. Dolinger said. “This is now emerging in the United States and will soon take hold. There is a lot of interest.”
Dr. Dolinger is one of just a few American physicians credentialed by the International Bowel Ultrasound Group, an organization based out of Europe, Israel, and Canada. Formalized training and certification are necessary, Dr. Dolinger noted, to ensure that this new clinical approach maintains consistency as it is rolled out across the United States.
“We have the unique opportunity to do something from the ground up quickly, but also correctly, meaning that we can train everyone to speak the same language and do the same standardized exams so that all the findings and research are relatable,” Dr. Dolinger said.
He advised interested physicians to contact their local inflammatory bowel disease center to find out if training is available, and if it is, devoting “a lot of time” to the learning process.
“If you’re going to use this potentially as a clinical decision-making tool without using other invasive procedures, you really want to make sure what you’re doing is accurate and correct,” Dr. Dolinger said.
The investigators disclosed relationships with AbbVie, Merck, Takeda, and others. Dr. Dolinger disclosed a relationship with NeuroLogica, a subsidiary of Samsung Electronics.
Intestinal ultrasound (IUS) findings correlate strongly with endoscopy results in patients with ulcerative colitis (UC), with treatment responses detected as soon as 8 weeks after starting tofacitinib, a longitudinal prospective study has found.
IUS accurately detected improvements and remission across a variety of scoring methodologies, suggesting that it may be a cost-effective, noninvasive alternative to endoscopic monitoring, reported lead author Floris de Voogd, MD, of Amsterdam University Medical Centers, and colleagues.
“Endoscopy is generally considered as the gold standard for the diagnosis and follow-up of patients with UC,” the investigators wrote in Gastroenterology. “However, endoscopy is an invasive and costly modality and therefore less attractive to perform frequently during the disease course.”
Whereas noninvasive fecal biomarkers are a more economical method of monitoring inflammation and treatment responses, they fail to characterize disease extent and fall short in detecting early endoscopic responses, the investigators added.
The present study aimed to determine if IUS could offer more clinical insight by measuring bowel wall thickness. Thirty patients were enrolled with moderate to severe UC, all with an endoscopic Mayo score of at least 2. Twenty-seven of these patients were evaluable through follow-up, having undergone both IUS and endoscopy at baseline and 8 weeks after starting tofacitinib.
At both time points, IUS findings correlated significantly with endoscopic Mayo score (EMS), UC endoscopic index for severity, and Robarts Histopathology Index, with correlation coefficients of 0.68, 0.73, and 0.49, respectively. Remission according to EMS was defined as a score of 0, and improvement was defined as a score of 1 or less.
Patients with EMS improvement showed lower median bowel wall thickness in the sigmoid colon after 8 weeks of treatment than did patients without improvement (1.8 mm vs. 4.5 mm; P < .0001); patients who were in EMS remission after 8 weeks also had lower median bowel wall thickness of the sigmoid colon (1.4 mm vs. 4.0 mm; P = .016).
The investigators also sought to define cutoff values for bowel wall thickness. The most accurate cutoff values for identifying endoscopic remission and improvement were 2.8 mm (area under the receiver operating curve, 0.87; 95% confidence interval, 0.74-1.00; P = .006) and 3.9 mm (AUROC, 0.92; 95% CI, 0.82-1.00; P < .0001), respectively. Treatment response was best identified by a 32% threshold reduction in thickness (AUROC, 0.87; 95% CI, 0.74-1.00; P = .002).
“Intestinal ultrasound, with bowel wall thickness as the single most important parameter is accurate to determine treatment response to tofacitinib in patients with moderate-severe UC when compared against endoscopy,” the investigators concluded.
Michael Dolinger, MD, MBA, assistant professor of pediatrics and the associate pediatric gastroenterology fellowship program director at the Icahn School of Medicine at Mount Sinai, New York, said the study is noteworthy because it is the first of its kind to show that IUS can accurately monitor treatment responses in UC.
“This study is what we’re looking for now, and in the future,” Dr. Dolinger said in an interview. “We’re looking for noninvasive biomarkers to predict early responses so that we know as clinicians ... if our medicines are working or if we need to pivot and switch effectively.”
For patients, this can mean feeling better quicker while reducing burden of care, he added.
“We can use this study to predict patient responses without having to potentially rescope them in 8 weeks using a 5-minute point-of-care test in the clinic,” Dr. Dolinger said. “It’s huge to be able to say that for patients with colitis, and to provide reassurance that not only are they potentially feeling better, but the medicine is working to change and heal their bowel wall really quickly as well.”
Dr. Dolinger speaks from clinical experience. Over the past 2 years, he and his colleagues at Mount Sinai have been implementing IUS for patients with both UC and Crohn’s disease.
“It’s become part of our standard of care,” Dr. Dolinger said. “This is now emerging in the United States and will soon take hold. There is a lot of interest.”
Dr. Dolinger is one of just a few American physicians credentialed by the International Bowel Ultrasound Group, an organization based out of Europe, Israel, and Canada. Formalized training and certification are necessary, Dr. Dolinger noted, to ensure that this new clinical approach maintains consistency as it is rolled out across the United States.
“We have the unique opportunity to do something from the ground up quickly, but also correctly, meaning that we can train everyone to speak the same language and do the same standardized exams so that all the findings and research are relatable,” Dr. Dolinger said.
He advised interested physicians to contact their local inflammatory bowel disease center to find out if training is available, and if it is, devoting “a lot of time” to the learning process.
“If you’re going to use this potentially as a clinical decision-making tool without using other invasive procedures, you really want to make sure what you’re doing is accurate and correct,” Dr. Dolinger said.
The investigators disclosed relationships with AbbVie, Merck, Takeda, and others. Dr. Dolinger disclosed a relationship with NeuroLogica, a subsidiary of Samsung Electronics.
FROM GASTROENTEROLOGY
Unvaccinated 10 times more likely to be hospitalized for Omicron
The data, which included almost 200,000 COVID-19–associated hospitalizations across 13 states, also showed that vaccinated, hospitalized patients were more often older and already dealing with other health conditions, compared with unvaccinated, hospitalized patients, reported lead author Fiona P. Havers, MD, of the CDC, Atlanta.
“Unlike previously published reports and web pages … this study reports hospitalization rates by vaccination status and clinical and demographic characteristics of hospitalized patients, beginning with the period when vaccines first became available, and includes comparisons of unvaccinated persons, persons vaccinated with a primary series without a booster dose, and those vaccinated with a primary series and at least 1 booster dose,” the investigators wrote in JAMA Internal Medicine.
In total, the investigators reviewed 192,509 hospitalizations involving patients 18 years and older. The study period spanned from Jan. 1, 2021, to April 30, 2022. Data were reported month by month, showing that the relative monthly hospitalization rate peaked in May 2021, when it was 17.7 times higher for unvaccinated versus vaccinated individuals (with or without a booster).
To account for differences in clinical course between Delta and Omicron, the investigators also analyzed data sorted into two time periods: July-December 2021 (Delta predominant) and January-April 2022 (Omicron BA.1 predominant). These analyses revealed the greater hospitalization risk presented by Delta. Specifically, unvaccinated people were 12.2 times more likely to be hospitalized for Delta than vaccinated people, with or without a booster, versus 6.8 times for Omicron BA.1.
Study shows power of the booster
A closer look at the Omicron BA.1 data showed the power of a booster dose. From January to April 2022, individuals who were fully vaccinated with a booster dose were 10.5 times less likely than unvaccinated individuals to be hospitalized for Omicron BA.1. Plus, boosted people were 2.5 times less likely to be hospitalized for Omicron BA.1 than people who got vaccinated but skipped the booster.
“The high hospitalization rates in unvaccinated compared with vaccinated persons with and without a booster dose underscores the importance of COVID-19 vaccinations in preventing hospitalizations and suggests that increasing vaccination coverage, including booster dose coverage, can prevent hospitalizations, serious illness, and death,” the investigators wrote.
The study also revealed that vaccinated hospitalized patients were significantly older, on average, than unvaccinated hospitalized patients (median, 70 vs. 58 years; P < .001). They were also significantly more likely to have three or more underlying medical conditions (77.8% vs. 51.6%; P < .001)
“A greater proportion of hospitalized cases among vaccinated persons occurred in individuals with medical fragility who were older, more likely to reside in long-term care facilities, and have three or more underlying medical conditions, including immunosuppressive conditions,” the investigators wrote.
New variants outpacing data, vaccines remain essential
While data from April 2022 alone showed a 3.5-fold higher rate of hospitalization among unvaccinated versus vaccinated individuals with or without a booster, newer data suggest that emerging strains of Omicron are putting more people in the hospital.
A recent report by the CDC showed weekly hospitalization rates climbing from March 20 to May 31, 2022, which coincided with predominance of the newer Omicron BA.2 variant. While unvaccinated people were still around 3.5 times more likely to be hospitalized than vaccinated people, overall hospitalization rates jumped 3-fold for people 65 years and older, and 1.7-fold for adults younger than 65. Adding further complexity to this constantly evolving situation is that Omicron BA.2 has since been joined by the BA.4 and BA.5 lineages, for which vaccines are now available.
In the paper published in JAMA Internal Medicine, the CDC report, and in a comment for this article, the CDC offered the same take-home message: Get vaccinated.
“These findings reinforce previous research illustrating how vaccination provides protection from hospitalization due to COVID-19,” a CDC spokesperson said. “COVID-19 vaccines are proven to help prevent serious COVID-19 illness, and everyone ages 6 months and older should stay up to date with COVID-19 vaccines.”
The study published in JAMA Internal Medicine was supported by the CDC. The investigators disclosed additional relationships with Sanofi, GSK, MedImmune, and others.
The data, which included almost 200,000 COVID-19–associated hospitalizations across 13 states, also showed that vaccinated, hospitalized patients were more often older and already dealing with other health conditions, compared with unvaccinated, hospitalized patients, reported lead author Fiona P. Havers, MD, of the CDC, Atlanta.
“Unlike previously published reports and web pages … this study reports hospitalization rates by vaccination status and clinical and demographic characteristics of hospitalized patients, beginning with the period when vaccines first became available, and includes comparisons of unvaccinated persons, persons vaccinated with a primary series without a booster dose, and those vaccinated with a primary series and at least 1 booster dose,” the investigators wrote in JAMA Internal Medicine.
In total, the investigators reviewed 192,509 hospitalizations involving patients 18 years and older. The study period spanned from Jan. 1, 2021, to April 30, 2022. Data were reported month by month, showing that the relative monthly hospitalization rate peaked in May 2021, when it was 17.7 times higher for unvaccinated versus vaccinated individuals (with or without a booster).
To account for differences in clinical course between Delta and Omicron, the investigators also analyzed data sorted into two time periods: July-December 2021 (Delta predominant) and January-April 2022 (Omicron BA.1 predominant). These analyses revealed the greater hospitalization risk presented by Delta. Specifically, unvaccinated people were 12.2 times more likely to be hospitalized for Delta than vaccinated people, with or without a booster, versus 6.8 times for Omicron BA.1.
Study shows power of the booster
A closer look at the Omicron BA.1 data showed the power of a booster dose. From January to April 2022, individuals who were fully vaccinated with a booster dose were 10.5 times less likely than unvaccinated individuals to be hospitalized for Omicron BA.1. Plus, boosted people were 2.5 times less likely to be hospitalized for Omicron BA.1 than people who got vaccinated but skipped the booster.
“The high hospitalization rates in unvaccinated compared with vaccinated persons with and without a booster dose underscores the importance of COVID-19 vaccinations in preventing hospitalizations and suggests that increasing vaccination coverage, including booster dose coverage, can prevent hospitalizations, serious illness, and death,” the investigators wrote.
The study also revealed that vaccinated hospitalized patients were significantly older, on average, than unvaccinated hospitalized patients (median, 70 vs. 58 years; P < .001). They were also significantly more likely to have three or more underlying medical conditions (77.8% vs. 51.6%; P < .001)
“A greater proportion of hospitalized cases among vaccinated persons occurred in individuals with medical fragility who were older, more likely to reside in long-term care facilities, and have three or more underlying medical conditions, including immunosuppressive conditions,” the investigators wrote.
New variants outpacing data, vaccines remain essential
While data from April 2022 alone showed a 3.5-fold higher rate of hospitalization among unvaccinated versus vaccinated individuals with or without a booster, newer data suggest that emerging strains of Omicron are putting more people in the hospital.
A recent report by the CDC showed weekly hospitalization rates climbing from March 20 to May 31, 2022, which coincided with predominance of the newer Omicron BA.2 variant. While unvaccinated people were still around 3.5 times more likely to be hospitalized than vaccinated people, overall hospitalization rates jumped 3-fold for people 65 years and older, and 1.7-fold for adults younger than 65. Adding further complexity to this constantly evolving situation is that Omicron BA.2 has since been joined by the BA.4 and BA.5 lineages, for which vaccines are now available.
In the paper published in JAMA Internal Medicine, the CDC report, and in a comment for this article, the CDC offered the same take-home message: Get vaccinated.
“These findings reinforce previous research illustrating how vaccination provides protection from hospitalization due to COVID-19,” a CDC spokesperson said. “COVID-19 vaccines are proven to help prevent serious COVID-19 illness, and everyone ages 6 months and older should stay up to date with COVID-19 vaccines.”
The study published in JAMA Internal Medicine was supported by the CDC. The investigators disclosed additional relationships with Sanofi, GSK, MedImmune, and others.
The data, which included almost 200,000 COVID-19–associated hospitalizations across 13 states, also showed that vaccinated, hospitalized patients were more often older and already dealing with other health conditions, compared with unvaccinated, hospitalized patients, reported lead author Fiona P. Havers, MD, of the CDC, Atlanta.
“Unlike previously published reports and web pages … this study reports hospitalization rates by vaccination status and clinical and demographic characteristics of hospitalized patients, beginning with the period when vaccines first became available, and includes comparisons of unvaccinated persons, persons vaccinated with a primary series without a booster dose, and those vaccinated with a primary series and at least 1 booster dose,” the investigators wrote in JAMA Internal Medicine.
In total, the investigators reviewed 192,509 hospitalizations involving patients 18 years and older. The study period spanned from Jan. 1, 2021, to April 30, 2022. Data were reported month by month, showing that the relative monthly hospitalization rate peaked in May 2021, when it was 17.7 times higher for unvaccinated versus vaccinated individuals (with or without a booster).
To account for differences in clinical course between Delta and Omicron, the investigators also analyzed data sorted into two time periods: July-December 2021 (Delta predominant) and January-April 2022 (Omicron BA.1 predominant). These analyses revealed the greater hospitalization risk presented by Delta. Specifically, unvaccinated people were 12.2 times more likely to be hospitalized for Delta than vaccinated people, with or without a booster, versus 6.8 times for Omicron BA.1.
Study shows power of the booster
A closer look at the Omicron BA.1 data showed the power of a booster dose. From January to April 2022, individuals who were fully vaccinated with a booster dose were 10.5 times less likely than unvaccinated individuals to be hospitalized for Omicron BA.1. Plus, boosted people were 2.5 times less likely to be hospitalized for Omicron BA.1 than people who got vaccinated but skipped the booster.
“The high hospitalization rates in unvaccinated compared with vaccinated persons with and without a booster dose underscores the importance of COVID-19 vaccinations in preventing hospitalizations and suggests that increasing vaccination coverage, including booster dose coverage, can prevent hospitalizations, serious illness, and death,” the investigators wrote.
The study also revealed that vaccinated hospitalized patients were significantly older, on average, than unvaccinated hospitalized patients (median, 70 vs. 58 years; P < .001). They were also significantly more likely to have three or more underlying medical conditions (77.8% vs. 51.6%; P < .001)
“A greater proportion of hospitalized cases among vaccinated persons occurred in individuals with medical fragility who were older, more likely to reside in long-term care facilities, and have three or more underlying medical conditions, including immunosuppressive conditions,” the investigators wrote.
New variants outpacing data, vaccines remain essential
While data from April 2022 alone showed a 3.5-fold higher rate of hospitalization among unvaccinated versus vaccinated individuals with or without a booster, newer data suggest that emerging strains of Omicron are putting more people in the hospital.
A recent report by the CDC showed weekly hospitalization rates climbing from March 20 to May 31, 2022, which coincided with predominance of the newer Omicron BA.2 variant. While unvaccinated people were still around 3.5 times more likely to be hospitalized than vaccinated people, overall hospitalization rates jumped 3-fold for people 65 years and older, and 1.7-fold for adults younger than 65. Adding further complexity to this constantly evolving situation is that Omicron BA.2 has since been joined by the BA.4 and BA.5 lineages, for which vaccines are now available.
In the paper published in JAMA Internal Medicine, the CDC report, and in a comment for this article, the CDC offered the same take-home message: Get vaccinated.
“These findings reinforce previous research illustrating how vaccination provides protection from hospitalization due to COVID-19,” a CDC spokesperson said. “COVID-19 vaccines are proven to help prevent serious COVID-19 illness, and everyone ages 6 months and older should stay up to date with COVID-19 vaccines.”
The study published in JAMA Internal Medicine was supported by the CDC. The investigators disclosed additional relationships with Sanofi, GSK, MedImmune, and others.
FROM JAMA INTERNAL MEDICINE
Shoulder lesion
A punch biopsy of the lesion was performed and the results were consistent with a dermatofibroma, which is a benign growth.
Dermatofibromas may manifest as a pink papule on fair-skinned individuals or a darker brown papule in patients of color. Clinically, the texture can be helpful to discern an etiology—dermatofibromas may dimple when pinched laterally, while melanocytic nevi or melanomas tend to be somewhat softer on palpation. Cutaneous sarcoma, while exceedingly rare, may be firmer and chaotic, and varied with multiple colors and topographical changes.
The dermoscopic pattern of a dermatofibroma includes central scar-like areas, a peripheral pigment network, occasional shiny white lines, and confluent circular brown macules. Other less frequent dermoscopic structures may also be seen. A prospective study of the dermoscopic morphology of 412 dermatofibromas found 10 distinct dermoscopic patterns, but also noted that 25% of the dermatofibromas exhibited an atypical pattern.1 Atypical pigment, multiple scar-like areas, and dotted vessels can occur in a dermatofibroma, as well as in a Spitz nevus, and melanoma. Thus, such findings should prompt a biopsy.
Dermatofibromas are safe to observe, but they can be surgically excised if they cause pain or cosmetic concerns.
This patient was reassured to know that the lesion would not require surgical intervention and was unlikely to enlarge or change significantly over time.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
1. Zaballos P, Puig S, Llambrich A, Malvehy J. Dermoscopy of dermatofibromas: a prospective morphological study of 412 cases. Arch Dermatol. 2008;144:75-83. doi: 10.1001/archdermatol.2007.8
A punch biopsy of the lesion was performed and the results were consistent with a dermatofibroma, which is a benign growth.
Dermatofibromas may manifest as a pink papule on fair-skinned individuals or a darker brown papule in patients of color. Clinically, the texture can be helpful to discern an etiology—dermatofibromas may dimple when pinched laterally, while melanocytic nevi or melanomas tend to be somewhat softer on palpation. Cutaneous sarcoma, while exceedingly rare, may be firmer and chaotic, and varied with multiple colors and topographical changes.
The dermoscopic pattern of a dermatofibroma includes central scar-like areas, a peripheral pigment network, occasional shiny white lines, and confluent circular brown macules. Other less frequent dermoscopic structures may also be seen. A prospective study of the dermoscopic morphology of 412 dermatofibromas found 10 distinct dermoscopic patterns, but also noted that 25% of the dermatofibromas exhibited an atypical pattern.1 Atypical pigment, multiple scar-like areas, and dotted vessels can occur in a dermatofibroma, as well as in a Spitz nevus, and melanoma. Thus, such findings should prompt a biopsy.
Dermatofibromas are safe to observe, but they can be surgically excised if they cause pain or cosmetic concerns.
This patient was reassured to know that the lesion would not require surgical intervention and was unlikely to enlarge or change significantly over time.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
A punch biopsy of the lesion was performed and the results were consistent with a dermatofibroma, which is a benign growth.
Dermatofibromas may manifest as a pink papule on fair-skinned individuals or a darker brown papule in patients of color. Clinically, the texture can be helpful to discern an etiology—dermatofibromas may dimple when pinched laterally, while melanocytic nevi or melanomas tend to be somewhat softer on palpation. Cutaneous sarcoma, while exceedingly rare, may be firmer and chaotic, and varied with multiple colors and topographical changes.
The dermoscopic pattern of a dermatofibroma includes central scar-like areas, a peripheral pigment network, occasional shiny white lines, and confluent circular brown macules. Other less frequent dermoscopic structures may also be seen. A prospective study of the dermoscopic morphology of 412 dermatofibromas found 10 distinct dermoscopic patterns, but also noted that 25% of the dermatofibromas exhibited an atypical pattern.1 Atypical pigment, multiple scar-like areas, and dotted vessels can occur in a dermatofibroma, as well as in a Spitz nevus, and melanoma. Thus, such findings should prompt a biopsy.
Dermatofibromas are safe to observe, but they can be surgically excised if they cause pain or cosmetic concerns.
This patient was reassured to know that the lesion would not require surgical intervention and was unlikely to enlarge or change significantly over time.
Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.
1. Zaballos P, Puig S, Llambrich A, Malvehy J. Dermoscopy of dermatofibromas: a prospective morphological study of 412 cases. Arch Dermatol. 2008;144:75-83. doi: 10.1001/archdermatol.2007.8
1. Zaballos P, Puig S, Llambrich A, Malvehy J. Dermoscopy of dermatofibromas: a prospective morphological study of 412 cases. Arch Dermatol. 2008;144:75-83. doi: 10.1001/archdermatol.2007.8
AI and reality – diagnosing otitis media is a real challenge
Let’s pretend for a moment that you receive a call from one of your college roommates who thanks to his family connections has become a venture capitalist in California. His group is considering investing in a start-up that is developing a handheld instrument that it claims will use artificial intelligence to diagnose ear infections far more accurately than the human eye. He wonders if you would like to help him evaluate the company’s proposal and offers you a small percentage of the profits for your efforts should they choose to invest.
Your former roommate has done enough research on his own to understand that otitis media makes up a large chunk of a pediatrician’s workload and that making an accurate diagnosis can often be difficult in a struggling child. He describes his own experience watching a frustrated pediatrician attempting to remove wax from his child’s ear and eventually prescribing antibiotics “to be safe.”
You agree and review the prospectus, which includes a paper from a peer-reviewed journal. What you discover is that the investigators used more than 600 high-resolution images of tympanic membranes taken “during operative myringotomy and tympanostomy tube placement” and the findings at tympanocentesis to train a neural network.
Once trained, the model they developed could differentiate with 95% accuracy between an image of a tympanic membrane that covered a normal middle ear from one that merely contained fluid and from one that contained infected fluid. When these same images were shown to 39 clinicians, more than half of which were pediatricians and included both faculty-level staff and trainees, the average diagnostic accuracy was 65%.
The prospectus includes prediction that this technology could easily be developed into a handheld instrument similar to a traditional otoscope, which could then be linked to the operator’s smartphone, giving the clinician an instant treat or no-treat answer.
Now, remember you have nothing to lose except maybe a friendship. How would you advise your old college roommate?
My advice to your college buddy would be one of caution! Yes, there is a potential big upside because there is a real need for a device that could provide a diagnostic accuracy that this AI model promises. While I suspect that AI will always be more accurate in diagnosis using static images, I bet that most people, clinicians and nonclinicians, could improve their accuracy by linking photos with diagnoses with an hour of practice.
However, evaluating a high-resolution photograph taken through an operative scope inserted into the cerumenless ear canal of a sedated, afrebrile child is several orders of magnitude less difficult than the real-world environment in which the diagnosis of otitis media is usually made.
If the venture capitalists were still interested in getting into the otitis media marketplace, you might suggest they look into companies that have already developed image capture otoscopes. At this point I could only find one on the Internet that was portable and it certainly isn’t small-child friendly. Once we have a tool that can capture images in real-world situations, the next step is to train AI systems to interpret them using the approach these researchers have developed. I bet it can be done. It will be only a matter of time ... and money.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Let’s pretend for a moment that you receive a call from one of your college roommates who thanks to his family connections has become a venture capitalist in California. His group is considering investing in a start-up that is developing a handheld instrument that it claims will use artificial intelligence to diagnose ear infections far more accurately than the human eye. He wonders if you would like to help him evaluate the company’s proposal and offers you a small percentage of the profits for your efforts should they choose to invest.
Your former roommate has done enough research on his own to understand that otitis media makes up a large chunk of a pediatrician’s workload and that making an accurate diagnosis can often be difficult in a struggling child. He describes his own experience watching a frustrated pediatrician attempting to remove wax from his child’s ear and eventually prescribing antibiotics “to be safe.”
You agree and review the prospectus, which includes a paper from a peer-reviewed journal. What you discover is that the investigators used more than 600 high-resolution images of tympanic membranes taken “during operative myringotomy and tympanostomy tube placement” and the findings at tympanocentesis to train a neural network.
Once trained, the model they developed could differentiate with 95% accuracy between an image of a tympanic membrane that covered a normal middle ear from one that merely contained fluid and from one that contained infected fluid. When these same images were shown to 39 clinicians, more than half of which were pediatricians and included both faculty-level staff and trainees, the average diagnostic accuracy was 65%.
The prospectus includes prediction that this technology could easily be developed into a handheld instrument similar to a traditional otoscope, which could then be linked to the operator’s smartphone, giving the clinician an instant treat or no-treat answer.
Now, remember you have nothing to lose except maybe a friendship. How would you advise your old college roommate?
My advice to your college buddy would be one of caution! Yes, there is a potential big upside because there is a real need for a device that could provide a diagnostic accuracy that this AI model promises. While I suspect that AI will always be more accurate in diagnosis using static images, I bet that most people, clinicians and nonclinicians, could improve their accuracy by linking photos with diagnoses with an hour of practice.
However, evaluating a high-resolution photograph taken through an operative scope inserted into the cerumenless ear canal of a sedated, afrebrile child is several orders of magnitude less difficult than the real-world environment in which the diagnosis of otitis media is usually made.
If the venture capitalists were still interested in getting into the otitis media marketplace, you might suggest they look into companies that have already developed image capture otoscopes. At this point I could only find one on the Internet that was portable and it certainly isn’t small-child friendly. Once we have a tool that can capture images in real-world situations, the next step is to train AI systems to interpret them using the approach these researchers have developed. I bet it can be done. It will be only a matter of time ... and money.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Let’s pretend for a moment that you receive a call from one of your college roommates who thanks to his family connections has become a venture capitalist in California. His group is considering investing in a start-up that is developing a handheld instrument that it claims will use artificial intelligence to diagnose ear infections far more accurately than the human eye. He wonders if you would like to help him evaluate the company’s proposal and offers you a small percentage of the profits for your efforts should they choose to invest.
Your former roommate has done enough research on his own to understand that otitis media makes up a large chunk of a pediatrician’s workload and that making an accurate diagnosis can often be difficult in a struggling child. He describes his own experience watching a frustrated pediatrician attempting to remove wax from his child’s ear and eventually prescribing antibiotics “to be safe.”
You agree and review the prospectus, which includes a paper from a peer-reviewed journal. What you discover is that the investigators used more than 600 high-resolution images of tympanic membranes taken “during operative myringotomy and tympanostomy tube placement” and the findings at tympanocentesis to train a neural network.
Once trained, the model they developed could differentiate with 95% accuracy between an image of a tympanic membrane that covered a normal middle ear from one that merely contained fluid and from one that contained infected fluid. When these same images were shown to 39 clinicians, more than half of which were pediatricians and included both faculty-level staff and trainees, the average diagnostic accuracy was 65%.
The prospectus includes prediction that this technology could easily be developed into a handheld instrument similar to a traditional otoscope, which could then be linked to the operator’s smartphone, giving the clinician an instant treat or no-treat answer.
Now, remember you have nothing to lose except maybe a friendship. How would you advise your old college roommate?
My advice to your college buddy would be one of caution! Yes, there is a potential big upside because there is a real need for a device that could provide a diagnostic accuracy that this AI model promises. While I suspect that AI will always be more accurate in diagnosis using static images, I bet that most people, clinicians and nonclinicians, could improve their accuracy by linking photos with diagnoses with an hour of practice.
However, evaluating a high-resolution photograph taken through an operative scope inserted into the cerumenless ear canal of a sedated, afrebrile child is several orders of magnitude less difficult than the real-world environment in which the diagnosis of otitis media is usually made.
If the venture capitalists were still interested in getting into the otitis media marketplace, you might suggest they look into companies that have already developed image capture otoscopes. At this point I could only find one on the Internet that was portable and it certainly isn’t small-child friendly. Once we have a tool that can capture images in real-world situations, the next step is to train AI systems to interpret them using the approach these researchers have developed. I bet it can be done. It will be only a matter of time ... and money.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.