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azzed
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bullturds
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cocaine
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cocainees
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crackwhore
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cum
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cumsluted
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cunthunterer
cunthunteres
cunthuntering
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cunthunters
cunting
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cuntlicked
cuntlicker
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dagos
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damn
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damneder
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dickbag
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dickbags
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dickdippered
dickdipperer
dickdipperes
dickdippering
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dicker
dickes
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dickfaceed
dickfaceer
dickfacees
dickfaceing
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dickflippered
dickflipperer
dickflipperes
dickflippering
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dickheaded
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dickheadser
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dingleed
dingleer
dinglees
dingleing
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dipship
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dipshipes
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dizzyed
dizzyer
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dizzying
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dizzys
doggiestyleed
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dopeyer
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drunker
drunkes
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dumass
dumassed
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dumasses
dumassing
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dumasss
dumbass
dumbassed
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dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
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dyke
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dykeer
dykees
dykeing
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erotic
eroticed
eroticer
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erotics
extacy
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extacying
extacyly
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extasy
extasyed
extasyer
extasyes
extasying
extasyly
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facked
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faged
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fagged
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faggoted
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fagoted
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faiged
faiger
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faigts
fannybandit
fannybandited
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fannybandits
farted
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fartknockered
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fartly
farts
felch
felched
felcher
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fellateer
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fellateing
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fellatio
fellatioed
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feltched
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floozy
floozyed
floozyer
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foad
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freexes
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friggaer
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fuckined
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fuckinged
fuckinger
fuckinges
fuckinging
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fuckings
fuckining
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How often does risk-reducing salpingo-oophorectomy identify cancer?
Among women with BRCA mutations who underwent risk-reducing bilateral salpingo-oophorectomy, the procedure led to a cancer diagnosis in 3%, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
Of 269 patients, 8 (3%) received a cancer diagnosis. In five cases, the cancer was diagnosed on final pathology, and three had immediate conversion to staging.
The data suggest that gynecologists as well as gynecologic oncologists may perform the procedure, but gynecologists may be less likely to obtain pelvic washings in accordance with guidelines for this indication.
said study author Coralee Toal, MD, of UPMC Magee-Womans Hospital in Pittsburgh. “It is often a diagnosis that is found at the time of pathology, so the initial procedure would not have been changed either way.”
Still, doctors who perform the procedure should follow recommended practices such as obtaining pelvic washings and identifying patients for the procedure within target age ranges, Dr. Toal said.
BRCA1 and BRCA2 mutations confer an increased risk of ovarian and breast cancer, but there is no effective form of ovarian cancer screening. Women with a known mutation may have a bilateral salpingo-oophorectomy to reduce the risk of cancer. The recommended age range for the procedure is 35-40 years for women with BRCA1 mutations and 40-45 years for women with BRCA2 mutations.
When the procedure is performed for this indication, various recommendations apply that may differ from those when the procedure is performed under different circumstances.
During risk-reducing bilateral salpingo-oophorectomy, the surgeon should thoroughly evaluate the abdominal cavity, obtain pelvic washings for cytology, remove at least 2 cm of the infundibulopelvic ligament, and divide the fallopian tube at the uterine cornua.
To assess the incidence of occult ovarian cancer at the time of risk-reducing bilateral salpingo-oophorectomy and surgeon adherence to recommended practices, Dr. Toal and colleagues performed a retrospective chart review.
They included patients who had a known BRCA mutation and underwent a risk-reducing bilateral salpingo-oophorectomy between July 2007 and September 2018. They excluded patients who had a suspicious adnexal mass before the procedure but not a known diagnosis, as well as patients with another malignancy or genetic syndrome.
The researchers evaluated adherence to recommendations by reviewing operative reports.
In all, they reviewed data from 269 patients. In 220 cases, a gynecologic oncologist performed the procedure, and in 49 cases a gynecologist performed the procedure.
Patients tended to be older than would be expected, said Dr. Toal. Patients with BRCA1 mutations had an average age of 46 years, and patients with BRCA2 mutations had an average age of 49 years.
Patients who received a cancer diagnosis were significantly older on average, compared with the other patients: 58 years versus 48 years.
Pelvic washings were performed during 95% of the procedures performed by a gynecologic oncologist, compared with 63% of the procedures performed by a gynecologist. In addition, patients who had the procedure performed by a gynecologist were significantly older than those who had the procedure performed by a gynecologic oncologist (49 vs. 47 years).
Miles Murphy, MD, president of the Society of Gynecologic Surgeons, asked how doctors should weigh the possibility of risk-reducing oophorectomy at the time of benign hysterectomy in patients without a family history of female cancer.
It could be that genetic testing would be appropriate for some of those patients, Dr. Toal said. It is “important to take a thorough family history to make sure that you are identifying anybody who may benefit from genetic counseling and genetic testing, where you might identify an otherwise not known mutation prior to an otherwise benign or routine surgery,” Dr. Toal said. “Then you would have the opportunity to perform this.”
For patients without known mutations, however, “we do know the benefit of ovaries remaining in situ ... including cardiac health,” she said. “You have to remember that people can die of a broken hip as well. The risk of osteoporosis and those things is not zero and in fact may be much higher than their ovarian cancer risk.”
One of the study authors is a surgeon educator for Covidien and Medtronic.
SOURCE: Newcomb LK et al. SGS 2020, Abstract 18.
Among women with BRCA mutations who underwent risk-reducing bilateral salpingo-oophorectomy, the procedure led to a cancer diagnosis in 3%, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
Of 269 patients, 8 (3%) received a cancer diagnosis. In five cases, the cancer was diagnosed on final pathology, and three had immediate conversion to staging.
The data suggest that gynecologists as well as gynecologic oncologists may perform the procedure, but gynecologists may be less likely to obtain pelvic washings in accordance with guidelines for this indication.
said study author Coralee Toal, MD, of UPMC Magee-Womans Hospital in Pittsburgh. “It is often a diagnosis that is found at the time of pathology, so the initial procedure would not have been changed either way.”
Still, doctors who perform the procedure should follow recommended practices such as obtaining pelvic washings and identifying patients for the procedure within target age ranges, Dr. Toal said.
BRCA1 and BRCA2 mutations confer an increased risk of ovarian and breast cancer, but there is no effective form of ovarian cancer screening. Women with a known mutation may have a bilateral salpingo-oophorectomy to reduce the risk of cancer. The recommended age range for the procedure is 35-40 years for women with BRCA1 mutations and 40-45 years for women with BRCA2 mutations.
When the procedure is performed for this indication, various recommendations apply that may differ from those when the procedure is performed under different circumstances.
During risk-reducing bilateral salpingo-oophorectomy, the surgeon should thoroughly evaluate the abdominal cavity, obtain pelvic washings for cytology, remove at least 2 cm of the infundibulopelvic ligament, and divide the fallopian tube at the uterine cornua.
To assess the incidence of occult ovarian cancer at the time of risk-reducing bilateral salpingo-oophorectomy and surgeon adherence to recommended practices, Dr. Toal and colleagues performed a retrospective chart review.
They included patients who had a known BRCA mutation and underwent a risk-reducing bilateral salpingo-oophorectomy between July 2007 and September 2018. They excluded patients who had a suspicious adnexal mass before the procedure but not a known diagnosis, as well as patients with another malignancy or genetic syndrome.
The researchers evaluated adherence to recommendations by reviewing operative reports.
In all, they reviewed data from 269 patients. In 220 cases, a gynecologic oncologist performed the procedure, and in 49 cases a gynecologist performed the procedure.
Patients tended to be older than would be expected, said Dr. Toal. Patients with BRCA1 mutations had an average age of 46 years, and patients with BRCA2 mutations had an average age of 49 years.
Patients who received a cancer diagnosis were significantly older on average, compared with the other patients: 58 years versus 48 years.
Pelvic washings were performed during 95% of the procedures performed by a gynecologic oncologist, compared with 63% of the procedures performed by a gynecologist. In addition, patients who had the procedure performed by a gynecologist were significantly older than those who had the procedure performed by a gynecologic oncologist (49 vs. 47 years).
Miles Murphy, MD, president of the Society of Gynecologic Surgeons, asked how doctors should weigh the possibility of risk-reducing oophorectomy at the time of benign hysterectomy in patients without a family history of female cancer.
It could be that genetic testing would be appropriate for some of those patients, Dr. Toal said. It is “important to take a thorough family history to make sure that you are identifying anybody who may benefit from genetic counseling and genetic testing, where you might identify an otherwise not known mutation prior to an otherwise benign or routine surgery,” Dr. Toal said. “Then you would have the opportunity to perform this.”
For patients without known mutations, however, “we do know the benefit of ovaries remaining in situ ... including cardiac health,” she said. “You have to remember that people can die of a broken hip as well. The risk of osteoporosis and those things is not zero and in fact may be much higher than their ovarian cancer risk.”
One of the study authors is a surgeon educator for Covidien and Medtronic.
SOURCE: Newcomb LK et al. SGS 2020, Abstract 18.
Among women with BRCA mutations who underwent risk-reducing bilateral salpingo-oophorectomy, the procedure led to a cancer diagnosis in 3%, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
Of 269 patients, 8 (3%) received a cancer diagnosis. In five cases, the cancer was diagnosed on final pathology, and three had immediate conversion to staging.
The data suggest that gynecologists as well as gynecologic oncologists may perform the procedure, but gynecologists may be less likely to obtain pelvic washings in accordance with guidelines for this indication.
said study author Coralee Toal, MD, of UPMC Magee-Womans Hospital in Pittsburgh. “It is often a diagnosis that is found at the time of pathology, so the initial procedure would not have been changed either way.”
Still, doctors who perform the procedure should follow recommended practices such as obtaining pelvic washings and identifying patients for the procedure within target age ranges, Dr. Toal said.
BRCA1 and BRCA2 mutations confer an increased risk of ovarian and breast cancer, but there is no effective form of ovarian cancer screening. Women with a known mutation may have a bilateral salpingo-oophorectomy to reduce the risk of cancer. The recommended age range for the procedure is 35-40 years for women with BRCA1 mutations and 40-45 years for women with BRCA2 mutations.
When the procedure is performed for this indication, various recommendations apply that may differ from those when the procedure is performed under different circumstances.
During risk-reducing bilateral salpingo-oophorectomy, the surgeon should thoroughly evaluate the abdominal cavity, obtain pelvic washings for cytology, remove at least 2 cm of the infundibulopelvic ligament, and divide the fallopian tube at the uterine cornua.
To assess the incidence of occult ovarian cancer at the time of risk-reducing bilateral salpingo-oophorectomy and surgeon adherence to recommended practices, Dr. Toal and colleagues performed a retrospective chart review.
They included patients who had a known BRCA mutation and underwent a risk-reducing bilateral salpingo-oophorectomy between July 2007 and September 2018. They excluded patients who had a suspicious adnexal mass before the procedure but not a known diagnosis, as well as patients with another malignancy or genetic syndrome.
The researchers evaluated adherence to recommendations by reviewing operative reports.
In all, they reviewed data from 269 patients. In 220 cases, a gynecologic oncologist performed the procedure, and in 49 cases a gynecologist performed the procedure.
Patients tended to be older than would be expected, said Dr. Toal. Patients with BRCA1 mutations had an average age of 46 years, and patients with BRCA2 mutations had an average age of 49 years.
Patients who received a cancer diagnosis were significantly older on average, compared with the other patients: 58 years versus 48 years.
Pelvic washings were performed during 95% of the procedures performed by a gynecologic oncologist, compared with 63% of the procedures performed by a gynecologist. In addition, patients who had the procedure performed by a gynecologist were significantly older than those who had the procedure performed by a gynecologic oncologist (49 vs. 47 years).
Miles Murphy, MD, president of the Society of Gynecologic Surgeons, asked how doctors should weigh the possibility of risk-reducing oophorectomy at the time of benign hysterectomy in patients without a family history of female cancer.
It could be that genetic testing would be appropriate for some of those patients, Dr. Toal said. It is “important to take a thorough family history to make sure that you are identifying anybody who may benefit from genetic counseling and genetic testing, where you might identify an otherwise not known mutation prior to an otherwise benign or routine surgery,” Dr. Toal said. “Then you would have the opportunity to perform this.”
For patients without known mutations, however, “we do know the benefit of ovaries remaining in situ ... including cardiac health,” she said. “You have to remember that people can die of a broken hip as well. The risk of osteoporosis and those things is not zero and in fact may be much higher than their ovarian cancer risk.”
One of the study authors is a surgeon educator for Covidien and Medtronic.
SOURCE: Newcomb LK et al. SGS 2020, Abstract 18.
FROM SGS 2020
AAP report aims to educate providers on female genital mutilation/cutting
Although female genital mutilation or cutting (FGM/C) is outlawed in much of the world, it still occurs for cultural reasons despite having no medical benefit, according to a clinical report from the American Academy of Pediatrics.
FGM/C is mainly performed on children and adolescents, but most of the research and teaching to date has addressed the impact of FGM/C on women of childbearing age and management during pregnancy and post partum, wrote Janine Young, MD, of the University of Colorado Denver in Aurora and colleagues. They are members of the AAP section on global health, committee on medical liability and risk management, or the committee on bioethics.
Published in Pediatrics, the report provides “the first comprehensive summary of FGM/C in children and includes education regarding a standard-of-care approach for examination of external female genitalia at all health supervision examinations, diagnosis, complications, management, treatment, culturally sensitive discussion and counseling approaches, and legal and ethical considerations,” they wrote.
The World Health Organization categorizes FGM/C into four subtypes. “Type I includes cutting of the glans or part of the body of the clitoris and/or prepuce; type II includes excision of the clitoris and labia minora, with or without excision of the labia majora; type III, infibulation, includes cutting and apposing the labia minora and/or majora over the urethral meatus and vaginal opening to significantly narrow it and may include clitoral excision; and type IV includes piercing, scraping, nicking, stretching, or otherwise injuring the external female genitalia without removing any genital tissue and includes practices that do not fall into the other three categories,” the authors wrote. Of these, type III is associated with the greatest long-term morbidity.
Data suggest that the prevalence and type of FGM/C varies by region, with the highest prevalence of type III in East Africa, where 82%-99% of girls reported FGM/C and 34%-79% of these cases involved type III, the authors reported.
Generally, pediatric health care providers in the United States have limited knowledge of FGM/C in the absence of any required courses on diagnosis or treatment for most primary care specialties. However, clinicians should be aware of possible risk factors, including a mother or sibling with a history of FGM/C, or patients with a country of origin, birth country, or travel history to a country where FGM/C is practiced, Dr. Young and associates noted.
They recommend that but acknowledged the challenges in raising the topic and addressing it in a culturally sensitive way. “Experts suggest that health care providers ask the patient or parent the term they use to name female genital cutting” and avoid the term mutilation, which may be offensive or misunderstood.
Many girls who have undergone FGM/C were too young to remember, the authors note. “Instead, it is advisable that the FGM/C clinical history taking include both the girl and parent or guardian once rapport has been established.”
Review potential medical complications if FGM/C is identified, and plans should be made for follow-up visits to monitor development of complications, the authors said. In addition, engage in a culturally sensitive discussion with teenagers, who may or may not have known about their FGM/C. In some cases, parents and caregivers may not have known about the FGM/C, which may be a community practice in some cultures with decisions made by other family members or authority figures.
“It is important for health care providers to assess each patient individually and make no assumptions about her and her parents’ beliefs regarding FGM/C,” Dr. Young and associates emphasized. “Mothers and fathers may or may not hold discordant views about FGM/C, and some clinical experts suggest that mothers who have themselves undergone FGM/C may nonetheless oppose subjecting their daughters to this practice. Instead, treating patients and caregivers with respect, sensitivity, and professionalism will encourage them to return and supports health-seeking behavior.”
The report presents 11 specific recommendations, including that health care providers should not perform any type of FGM/C and actively counsel families against such practices. In addition, children should have external genitalia checked at all health supervision examinations (with the consent of the guardian and/or child), and an assessment for FGM/C should be documented in the health records of patients with risk factors.
Notably, “[i]f genital examination findings are equivocal for the presence of FGM/C and risk factors for FGM/ C are present, a specialist trained in identification of FGM/C should be consulted,” Dr. Young and associates recommended. They also recommended defibulation for all girls and teenagers with type III FGM/C, especially for those with complications, and the procedure should be performed by an experienced pediatric gynecologist, gynecologist, urologist, or urogynecologist.
Finally, “[i]f FGM/C is suspected to have occurred in the United States, or as vacation cutting after immigration to the United States, the child should be evaluated for potential abuse. ... Expressed intention to engage in FGM/C, either in the United States or abroad, should also prompt a report to CPS [child protective services] if the child’s parent or caregiver cannot be dissuaded,” the authors wrote.
The report also includes case examples and expert analyses from legal and medical ethics experts to provide additional guidance for clinicians.
“This work seeks to educate pediatric health care providers on the occurrence of FGM/C, and the broader applications to the patients/population it impacts as well as the intersecting issues of diagnosis, complications, treatment, counseling needs, and the ethical and legal implications,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.
However, challenges in implementing the recommendations “relate to the complexity of the issue and also the need for greater education of primary providers,” Dr. Jay said. “The overall message for providers, I believe, is a greater understanding of the practice [of FGM/C] as most providers have limited knowledge of this practice in the United States.”
“I believe the case-based presentations allow for a better understanding of how best to approach patients and families,” she added.
Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said, “I think one of largest barriers to implementing the strategies [from] this report is the limited knowledge of FGM/C by most clinicians.”
“In general, many pediatricians are uncomfortable with genital examinations,” she said in an interview. “I suspect most feel uncomfortable with identifying FGM/C versus other genital pathology and may not have ready access to FGM/C experts. Additionally, having these difficult conversations with families about this sensitive topic may be challenging,” said Dr. Curran. “Fortunately, this report is incredibly comprehensive, providing extensive background into FGM/C, effectively using diagrams and pictures, and explaining the legal and ethical issues that arise in the care of these patients.”
“Ultimately, I think there will need to be more education within medical training and further research into FGM/C,” Dr. Curran added. “Clinicians should be knowledgeable about FGM/C, including prevalence, identification, health complications, and treatment, as well as legal and ethical implications.” However, “in addition to knowledge, clinicians must be able to navigate counseling patients and their families around this culturally sensitive topic.”
The report is thorough and well written, yet “there still remains significant gaps in knowledge about FGM/C in children and adolescents,” she said. “I think future research into prevalence, along with the health effects of FGM/C, including its impact on mental and sexual health, in the pediatric population will be essential.”
The study received no outside funding. Coauthor Christa Johnson-Agbakwu, MD, disclosed a grant relationship with Arizona State University from the 2018 copyright of “Female Genital Mutilation/Cutting (FGM/C): A Visual Reference and Learning Tool for Health Care Professionals.” The other researchers had no financial conflicts to disclose. Dr. Jay and Dr. Curran had no relevant financial conflicts to disclose. They are members of the Pediatric News editorial advisory board.
SOURCE: Young J et al. Pediatrics. 2020 Jul 27. doi: 10.1542/peds.2020-1012.
Although female genital mutilation or cutting (FGM/C) is outlawed in much of the world, it still occurs for cultural reasons despite having no medical benefit, according to a clinical report from the American Academy of Pediatrics.
FGM/C is mainly performed on children and adolescents, but most of the research and teaching to date has addressed the impact of FGM/C on women of childbearing age and management during pregnancy and post partum, wrote Janine Young, MD, of the University of Colorado Denver in Aurora and colleagues. They are members of the AAP section on global health, committee on medical liability and risk management, or the committee on bioethics.
Published in Pediatrics, the report provides “the first comprehensive summary of FGM/C in children and includes education regarding a standard-of-care approach for examination of external female genitalia at all health supervision examinations, diagnosis, complications, management, treatment, culturally sensitive discussion and counseling approaches, and legal and ethical considerations,” they wrote.
The World Health Organization categorizes FGM/C into four subtypes. “Type I includes cutting of the glans or part of the body of the clitoris and/or prepuce; type II includes excision of the clitoris and labia minora, with or without excision of the labia majora; type III, infibulation, includes cutting and apposing the labia minora and/or majora over the urethral meatus and vaginal opening to significantly narrow it and may include clitoral excision; and type IV includes piercing, scraping, nicking, stretching, or otherwise injuring the external female genitalia without removing any genital tissue and includes practices that do not fall into the other three categories,” the authors wrote. Of these, type III is associated with the greatest long-term morbidity.
Data suggest that the prevalence and type of FGM/C varies by region, with the highest prevalence of type III in East Africa, where 82%-99% of girls reported FGM/C and 34%-79% of these cases involved type III, the authors reported.
Generally, pediatric health care providers in the United States have limited knowledge of FGM/C in the absence of any required courses on diagnosis or treatment for most primary care specialties. However, clinicians should be aware of possible risk factors, including a mother or sibling with a history of FGM/C, or patients with a country of origin, birth country, or travel history to a country where FGM/C is practiced, Dr. Young and associates noted.
They recommend that but acknowledged the challenges in raising the topic and addressing it in a culturally sensitive way. “Experts suggest that health care providers ask the patient or parent the term they use to name female genital cutting” and avoid the term mutilation, which may be offensive or misunderstood.
Many girls who have undergone FGM/C were too young to remember, the authors note. “Instead, it is advisable that the FGM/C clinical history taking include both the girl and parent or guardian once rapport has been established.”
Review potential medical complications if FGM/C is identified, and plans should be made for follow-up visits to monitor development of complications, the authors said. In addition, engage in a culturally sensitive discussion with teenagers, who may or may not have known about their FGM/C. In some cases, parents and caregivers may not have known about the FGM/C, which may be a community practice in some cultures with decisions made by other family members or authority figures.
“It is important for health care providers to assess each patient individually and make no assumptions about her and her parents’ beliefs regarding FGM/C,” Dr. Young and associates emphasized. “Mothers and fathers may or may not hold discordant views about FGM/C, and some clinical experts suggest that mothers who have themselves undergone FGM/C may nonetheless oppose subjecting their daughters to this practice. Instead, treating patients and caregivers with respect, sensitivity, and professionalism will encourage them to return and supports health-seeking behavior.”
The report presents 11 specific recommendations, including that health care providers should not perform any type of FGM/C and actively counsel families against such practices. In addition, children should have external genitalia checked at all health supervision examinations (with the consent of the guardian and/or child), and an assessment for FGM/C should be documented in the health records of patients with risk factors.
Notably, “[i]f genital examination findings are equivocal for the presence of FGM/C and risk factors for FGM/ C are present, a specialist trained in identification of FGM/C should be consulted,” Dr. Young and associates recommended. They also recommended defibulation for all girls and teenagers with type III FGM/C, especially for those with complications, and the procedure should be performed by an experienced pediatric gynecologist, gynecologist, urologist, or urogynecologist.
Finally, “[i]f FGM/C is suspected to have occurred in the United States, or as vacation cutting after immigration to the United States, the child should be evaluated for potential abuse. ... Expressed intention to engage in FGM/C, either in the United States or abroad, should also prompt a report to CPS [child protective services] if the child’s parent or caregiver cannot be dissuaded,” the authors wrote.
The report also includes case examples and expert analyses from legal and medical ethics experts to provide additional guidance for clinicians.
“This work seeks to educate pediatric health care providers on the occurrence of FGM/C, and the broader applications to the patients/population it impacts as well as the intersecting issues of diagnosis, complications, treatment, counseling needs, and the ethical and legal implications,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.
However, challenges in implementing the recommendations “relate to the complexity of the issue and also the need for greater education of primary providers,” Dr. Jay said. “The overall message for providers, I believe, is a greater understanding of the practice [of FGM/C] as most providers have limited knowledge of this practice in the United States.”
“I believe the case-based presentations allow for a better understanding of how best to approach patients and families,” she added.
Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said, “I think one of largest barriers to implementing the strategies [from] this report is the limited knowledge of FGM/C by most clinicians.”
“In general, many pediatricians are uncomfortable with genital examinations,” she said in an interview. “I suspect most feel uncomfortable with identifying FGM/C versus other genital pathology and may not have ready access to FGM/C experts. Additionally, having these difficult conversations with families about this sensitive topic may be challenging,” said Dr. Curran. “Fortunately, this report is incredibly comprehensive, providing extensive background into FGM/C, effectively using diagrams and pictures, and explaining the legal and ethical issues that arise in the care of these patients.”
“Ultimately, I think there will need to be more education within medical training and further research into FGM/C,” Dr. Curran added. “Clinicians should be knowledgeable about FGM/C, including prevalence, identification, health complications, and treatment, as well as legal and ethical implications.” However, “in addition to knowledge, clinicians must be able to navigate counseling patients and their families around this culturally sensitive topic.”
The report is thorough and well written, yet “there still remains significant gaps in knowledge about FGM/C in children and adolescents,” she said. “I think future research into prevalence, along with the health effects of FGM/C, including its impact on mental and sexual health, in the pediatric population will be essential.”
The study received no outside funding. Coauthor Christa Johnson-Agbakwu, MD, disclosed a grant relationship with Arizona State University from the 2018 copyright of “Female Genital Mutilation/Cutting (FGM/C): A Visual Reference and Learning Tool for Health Care Professionals.” The other researchers had no financial conflicts to disclose. Dr. Jay and Dr. Curran had no relevant financial conflicts to disclose. They are members of the Pediatric News editorial advisory board.
SOURCE: Young J et al. Pediatrics. 2020 Jul 27. doi: 10.1542/peds.2020-1012.
Although female genital mutilation or cutting (FGM/C) is outlawed in much of the world, it still occurs for cultural reasons despite having no medical benefit, according to a clinical report from the American Academy of Pediatrics.
FGM/C is mainly performed on children and adolescents, but most of the research and teaching to date has addressed the impact of FGM/C on women of childbearing age and management during pregnancy and post partum, wrote Janine Young, MD, of the University of Colorado Denver in Aurora and colleagues. They are members of the AAP section on global health, committee on medical liability and risk management, or the committee on bioethics.
Published in Pediatrics, the report provides “the first comprehensive summary of FGM/C in children and includes education regarding a standard-of-care approach for examination of external female genitalia at all health supervision examinations, diagnosis, complications, management, treatment, culturally sensitive discussion and counseling approaches, and legal and ethical considerations,” they wrote.
The World Health Organization categorizes FGM/C into four subtypes. “Type I includes cutting of the glans or part of the body of the clitoris and/or prepuce; type II includes excision of the clitoris and labia minora, with or without excision of the labia majora; type III, infibulation, includes cutting and apposing the labia minora and/or majora over the urethral meatus and vaginal opening to significantly narrow it and may include clitoral excision; and type IV includes piercing, scraping, nicking, stretching, or otherwise injuring the external female genitalia without removing any genital tissue and includes practices that do not fall into the other three categories,” the authors wrote. Of these, type III is associated with the greatest long-term morbidity.
Data suggest that the prevalence and type of FGM/C varies by region, with the highest prevalence of type III in East Africa, where 82%-99% of girls reported FGM/C and 34%-79% of these cases involved type III, the authors reported.
Generally, pediatric health care providers in the United States have limited knowledge of FGM/C in the absence of any required courses on diagnosis or treatment for most primary care specialties. However, clinicians should be aware of possible risk factors, including a mother or sibling with a history of FGM/C, or patients with a country of origin, birth country, or travel history to a country where FGM/C is practiced, Dr. Young and associates noted.
They recommend that but acknowledged the challenges in raising the topic and addressing it in a culturally sensitive way. “Experts suggest that health care providers ask the patient or parent the term they use to name female genital cutting” and avoid the term mutilation, which may be offensive or misunderstood.
Many girls who have undergone FGM/C were too young to remember, the authors note. “Instead, it is advisable that the FGM/C clinical history taking include both the girl and parent or guardian once rapport has been established.”
Review potential medical complications if FGM/C is identified, and plans should be made for follow-up visits to monitor development of complications, the authors said. In addition, engage in a culturally sensitive discussion with teenagers, who may or may not have known about their FGM/C. In some cases, parents and caregivers may not have known about the FGM/C, which may be a community practice in some cultures with decisions made by other family members or authority figures.
“It is important for health care providers to assess each patient individually and make no assumptions about her and her parents’ beliefs regarding FGM/C,” Dr. Young and associates emphasized. “Mothers and fathers may or may not hold discordant views about FGM/C, and some clinical experts suggest that mothers who have themselves undergone FGM/C may nonetheless oppose subjecting their daughters to this practice. Instead, treating patients and caregivers with respect, sensitivity, and professionalism will encourage them to return and supports health-seeking behavior.”
The report presents 11 specific recommendations, including that health care providers should not perform any type of FGM/C and actively counsel families against such practices. In addition, children should have external genitalia checked at all health supervision examinations (with the consent of the guardian and/or child), and an assessment for FGM/C should be documented in the health records of patients with risk factors.
Notably, “[i]f genital examination findings are equivocal for the presence of FGM/C and risk factors for FGM/ C are present, a specialist trained in identification of FGM/C should be consulted,” Dr. Young and associates recommended. They also recommended defibulation for all girls and teenagers with type III FGM/C, especially for those with complications, and the procedure should be performed by an experienced pediatric gynecologist, gynecologist, urologist, or urogynecologist.
Finally, “[i]f FGM/C is suspected to have occurred in the United States, or as vacation cutting after immigration to the United States, the child should be evaluated for potential abuse. ... Expressed intention to engage in FGM/C, either in the United States or abroad, should also prompt a report to CPS [child protective services] if the child’s parent or caregiver cannot be dissuaded,” the authors wrote.
The report also includes case examples and expert analyses from legal and medical ethics experts to provide additional guidance for clinicians.
“This work seeks to educate pediatric health care providers on the occurrence of FGM/C, and the broader applications to the patients/population it impacts as well as the intersecting issues of diagnosis, complications, treatment, counseling needs, and the ethical and legal implications,” M. Susan Jay, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview.
However, challenges in implementing the recommendations “relate to the complexity of the issue and also the need for greater education of primary providers,” Dr. Jay said. “The overall message for providers, I believe, is a greater understanding of the practice [of FGM/C] as most providers have limited knowledge of this practice in the United States.”
“I believe the case-based presentations allow for a better understanding of how best to approach patients and families,” she added.
Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said, “I think one of largest barriers to implementing the strategies [from] this report is the limited knowledge of FGM/C by most clinicians.”
“In general, many pediatricians are uncomfortable with genital examinations,” she said in an interview. “I suspect most feel uncomfortable with identifying FGM/C versus other genital pathology and may not have ready access to FGM/C experts. Additionally, having these difficult conversations with families about this sensitive topic may be challenging,” said Dr. Curran. “Fortunately, this report is incredibly comprehensive, providing extensive background into FGM/C, effectively using diagrams and pictures, and explaining the legal and ethical issues that arise in the care of these patients.”
“Ultimately, I think there will need to be more education within medical training and further research into FGM/C,” Dr. Curran added. “Clinicians should be knowledgeable about FGM/C, including prevalence, identification, health complications, and treatment, as well as legal and ethical implications.” However, “in addition to knowledge, clinicians must be able to navigate counseling patients and their families around this culturally sensitive topic.”
The report is thorough and well written, yet “there still remains significant gaps in knowledge about FGM/C in children and adolescents,” she said. “I think future research into prevalence, along with the health effects of FGM/C, including its impact on mental and sexual health, in the pediatric population will be essential.”
The study received no outside funding. Coauthor Christa Johnson-Agbakwu, MD, disclosed a grant relationship with Arizona State University from the 2018 copyright of “Female Genital Mutilation/Cutting (FGM/C): A Visual Reference and Learning Tool for Health Care Professionals.” The other researchers had no financial conflicts to disclose. Dr. Jay and Dr. Curran had no relevant financial conflicts to disclose. They are members of the Pediatric News editorial advisory board.
SOURCE: Young J et al. Pediatrics. 2020 Jul 27. doi: 10.1542/peds.2020-1012.
FROM PEDIATRICS
Range of interventions reduces likelihood of infection after hysterectomy
Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
“Implementation of Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.
To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.
Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.
The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.
Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.
Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).
“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”
After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.
In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.
The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.
“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.
In addition, the study “pertains to one of CMS’s major programs to reduce and prevent health care-associated infections,” Dr. Park said at the virtual meeting. Several CMS quality indicators in 2020 relate to gynecologic surgery, including postoperative wound dehiscence rate, catheter-related UTI rate, and surgical site infection related to hysterectomy. The CMS will reduce hospital payments to institutions in the worst performing quartile for hospital-acquired infection scores by 1%.
Dr. Uppal advised that hospitals need four things to achieve similar results: a commitment from the team and leadership to reduce infections; patience; making it easy for doctors to implement the new interventions; and periodic feedback.
The process may be tedious but worth it in the end, he said.
Dr. Uppal disclosed salary support from Blue Cross Blue Shield of Michigan. A coauthor disclosed salary support from the company plus royalties from UpToDate. Dr. Park disclosed speaking for Allergan and royalties from UpToDate.
SOURCE: Uppal S et al. SGS 2020, Abstract 16.
Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
“Implementation of Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.
To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.
Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.
The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.
Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.
Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).
“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”
After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.
In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.
The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.
“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.
In addition, the study “pertains to one of CMS’s major programs to reduce and prevent health care-associated infections,” Dr. Park said at the virtual meeting. Several CMS quality indicators in 2020 relate to gynecologic surgery, including postoperative wound dehiscence rate, catheter-related UTI rate, and surgical site infection related to hysterectomy. The CMS will reduce hospital payments to institutions in the worst performing quartile for hospital-acquired infection scores by 1%.
Dr. Uppal advised that hospitals need four things to achieve similar results: a commitment from the team and leadership to reduce infections; patience; making it easy for doctors to implement the new interventions; and periodic feedback.
The process may be tedious but worth it in the end, he said.
Dr. Uppal disclosed salary support from Blue Cross Blue Shield of Michigan. A coauthor disclosed salary support from the company plus royalties from UpToDate. Dr. Park disclosed speaking for Allergan and royalties from UpToDate.
SOURCE: Uppal S et al. SGS 2020, Abstract 16.
Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
“Implementation of Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.
To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.
Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.
The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.
Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.
Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).
“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”
After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.
In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.
The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.
“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.
In addition, the study “pertains to one of CMS’s major programs to reduce and prevent health care-associated infections,” Dr. Park said at the virtual meeting. Several CMS quality indicators in 2020 relate to gynecologic surgery, including postoperative wound dehiscence rate, catheter-related UTI rate, and surgical site infection related to hysterectomy. The CMS will reduce hospital payments to institutions in the worst performing quartile for hospital-acquired infection scores by 1%.
Dr. Uppal advised that hospitals need four things to achieve similar results: a commitment from the team and leadership to reduce infections; patience; making it easy for doctors to implement the new interventions; and periodic feedback.
The process may be tedious but worth it in the end, he said.
Dr. Uppal disclosed salary support from Blue Cross Blue Shield of Michigan. A coauthor disclosed salary support from the company plus royalties from UpToDate. Dr. Park disclosed speaking for Allergan and royalties from UpToDate.
SOURCE: Uppal S et al. SGS 2020, Abstract 16.
FROM SGS 2020
More data needed to better understand COVID-19 skin manifestations
Qing Zhao, MD, Xiaokai Fang, MD, and their colleagues at the Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venereology, in Jinan, China, reported the results of a literature review of 44 articles published through May 2020 that included 507 patients with cutaneous manifestations of COVID-19. The review was published in the Journal of The European Academy of Dermatology and Venereology.
Nearly all of the patients (96%) were from Europe, and more than half were women (60%), with an average age of 49 years. Most patients had multiple skin symptoms, with the most common being erythema (44%), chilblain-like lesions (20%), urticaria-like lesions (16%), vesicular manifestations (13%), livedo/necrosis (6%), and petechiae (almost 2%). The authors described erythema as being present in specific sites, such as the trunk, extremities, flexural regions, face, and mucous membranes. Slightly less than half of all patients had significant pruritus.
Data on systemic COVID-19 symptoms were available for 431 patients and included fever in about two-thirds of patients and cough in almost 70%, with dyspnea in almost half of patients. Almost 60% had fatigue, and almost 60% had asthenia. Information about the onset of skin symptoms was available in 88 patients; of these patients, lesions were seen an average of almost 10 days after systemic symptoms appeared and, in almost 15%, were the first symptoms noted.
Histopathologic exams were done for only 23 patients and, in all cases, showed “inflammatory features without specific pathological changes, such as lymphocyte infiltration.” In one study, reverse transcription polymerase chain reaction testing of skin biopsy specimens tested negative for SARS-CoV-2.
Expression of ACE2, the receptor of SARS-CoV-2, in the skin was evaluated in six of the studies. “Higher ACE2 expression was identified in keratinocytes, mainly in differentiating keratinocytes and basal cells compared to the other cells of skin tissues,” the authors wrote. These results were confirmed with immunohistochemistry, which, they said, found “ACE2-positive keratinocytes in the stratum basal, the stratum spinosum, and the stratum granulosum of epiderma.” They added that this provides evidence “for percutaneous infection or the entry of virus into patients through skin tissues,” but cautioned that more research is needed.
The authors acknowledged that there are still many unanswered questions about COVID-19, and that more clinical data and research are needed, to improve the understanding of the cutaneous manifestations associated with COVID-19.
In an interview, Alisa N. Femia, MD, director of inpatient dermatology in the department of dermatology at New York University, said that the cutaneous signs described in the review align well with what she has seen in patients with COVID-19.
At this point, it is unclear whether cutaneous manifestations of COVID-19 are a result of SARS-CoV-2 invading the skin or an immune response related to SARS-CoV-2, noted Dr. Femia, who was not involved in the research. One method of entry could be through transmitting virus present on the skin to another part of the body where infection is more likely.
While it is possible COVID-19 could be contracted through the skin, she noted, it is much more likely an individual would be infected by SARS-CoV-2 through more traditionally understood means of transmission, such as through respiratory droplets in person-to-person contact. “I think we are far away from drawing that conclusion, that one could touch a surface or a person who has COVID and contract it through their skin,” Dr. Femia said. “The skin has a lot of other ways to protect against that from occurring,” she added.
“SAR-CoV-2 obviously enters through the ACE2 receptor, which is fairly ubiquitous, and it has been seen in keratinocytes,” she said. “But the skin is one of our biggest barriers ... and further, studies to date have shown that that receptor is expressed in relatively low levels of the keratinocytes.”
Pathogenesis of different cutaneous manifestations may be different, Dr. Femia said. For example, urticaria and morbilliform eruption were described by the authors of the review as more benign eruptions, but pathogenesis may differ from that of so-called COVID toes and from the pathogenesis of purpura and ulcerations seen in patients with more severe disease, she noted. It is plausible, she added, that purpura and ulcerations may be a “direct invasion of SARS-CoV-2 into endothelial cells,” which creates secondary processes “that ultimately destroy the skin.”
Urticaria and morbilliform eruptions, on the other hand, “are more simply that the immune system is recognizing COVID, and in doing so, is also recognizing some antigens in the skin and creating a hypersensitive response to the skin” and has “nothing to do with the SARS-CoV-2 virus actually being in that location,” she said.
It is important to differentiate between patients who have skin manifestations attributed to COVID-19 and those with manifestations independent of COVID-19, which is difficult, Dr. Femia noted. A patient with COVID-19 and a cutaneous manifestation may be having a reaction to a medication. “It’s important to have a critical eye and to remember that, when we see these manifestations, we should always be investigating whether there was an alternative cause so that we can better learn what exactly we should be attributing to this infection,” she said
Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said the authors of the review had presented interesting work, but made some “assumptions that need to be proven.” Dr. Friedman also was not involved in the research, but agreed in an interview with the assessment that it is unlikely SARS-CoV-2 would penetrate the skin. While some viruses – such as the poxvirus that causes molluscum contagiosum and the herpes simplex virus – invade keratinocytes specifically, there is a particular clinical phenotype that results that is associated with changes in the epidermis. However, “the skin manifestations of COVID-19 do not fit with direct skin invasion, [but] rather the immune response to systemic disease,” he said.
“[I]n terms of systemic invasion through the skin, it is possible, but this study certainly doesn’t show that. The presence/expression of ACE2 in the epidermis doesn’t translate to route of infection,” Dr. Friedman said..
The study received financial support from Shandong First Medical University, the Innovation Project of Shandong Academy of Medical Sciences and the Shandong Province Taishan Scholar Project. The authors report no relevant financial disclosures. Dr. Femia and Dr. Friedman had no relevant financial disclosures.
SOURCE: Zhao Q et al. J Eur Acad Dermatol Venereol. 2020 Jun 28. doi: 10.1111/jdv.16778.
Qing Zhao, MD, Xiaokai Fang, MD, and their colleagues at the Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venereology, in Jinan, China, reported the results of a literature review of 44 articles published through May 2020 that included 507 patients with cutaneous manifestations of COVID-19. The review was published in the Journal of The European Academy of Dermatology and Venereology.
Nearly all of the patients (96%) were from Europe, and more than half were women (60%), with an average age of 49 years. Most patients had multiple skin symptoms, with the most common being erythema (44%), chilblain-like lesions (20%), urticaria-like lesions (16%), vesicular manifestations (13%), livedo/necrosis (6%), and petechiae (almost 2%). The authors described erythema as being present in specific sites, such as the trunk, extremities, flexural regions, face, and mucous membranes. Slightly less than half of all patients had significant pruritus.
Data on systemic COVID-19 symptoms were available for 431 patients and included fever in about two-thirds of patients and cough in almost 70%, with dyspnea in almost half of patients. Almost 60% had fatigue, and almost 60% had asthenia. Information about the onset of skin symptoms was available in 88 patients; of these patients, lesions were seen an average of almost 10 days after systemic symptoms appeared and, in almost 15%, were the first symptoms noted.
Histopathologic exams were done for only 23 patients and, in all cases, showed “inflammatory features without specific pathological changes, such as lymphocyte infiltration.” In one study, reverse transcription polymerase chain reaction testing of skin biopsy specimens tested negative for SARS-CoV-2.
Expression of ACE2, the receptor of SARS-CoV-2, in the skin was evaluated in six of the studies. “Higher ACE2 expression was identified in keratinocytes, mainly in differentiating keratinocytes and basal cells compared to the other cells of skin tissues,” the authors wrote. These results were confirmed with immunohistochemistry, which, they said, found “ACE2-positive keratinocytes in the stratum basal, the stratum spinosum, and the stratum granulosum of epiderma.” They added that this provides evidence “for percutaneous infection or the entry of virus into patients through skin tissues,” but cautioned that more research is needed.
The authors acknowledged that there are still many unanswered questions about COVID-19, and that more clinical data and research are needed, to improve the understanding of the cutaneous manifestations associated with COVID-19.
In an interview, Alisa N. Femia, MD, director of inpatient dermatology in the department of dermatology at New York University, said that the cutaneous signs described in the review align well with what she has seen in patients with COVID-19.
At this point, it is unclear whether cutaneous manifestations of COVID-19 are a result of SARS-CoV-2 invading the skin or an immune response related to SARS-CoV-2, noted Dr. Femia, who was not involved in the research. One method of entry could be through transmitting virus present on the skin to another part of the body where infection is more likely.
While it is possible COVID-19 could be contracted through the skin, she noted, it is much more likely an individual would be infected by SARS-CoV-2 through more traditionally understood means of transmission, such as through respiratory droplets in person-to-person contact. “I think we are far away from drawing that conclusion, that one could touch a surface or a person who has COVID and contract it through their skin,” Dr. Femia said. “The skin has a lot of other ways to protect against that from occurring,” she added.
“SAR-CoV-2 obviously enters through the ACE2 receptor, which is fairly ubiquitous, and it has been seen in keratinocytes,” she said. “But the skin is one of our biggest barriers ... and further, studies to date have shown that that receptor is expressed in relatively low levels of the keratinocytes.”
Pathogenesis of different cutaneous manifestations may be different, Dr. Femia said. For example, urticaria and morbilliform eruption were described by the authors of the review as more benign eruptions, but pathogenesis may differ from that of so-called COVID toes and from the pathogenesis of purpura and ulcerations seen in patients with more severe disease, she noted. It is plausible, she added, that purpura and ulcerations may be a “direct invasion of SARS-CoV-2 into endothelial cells,” which creates secondary processes “that ultimately destroy the skin.”
Urticaria and morbilliform eruptions, on the other hand, “are more simply that the immune system is recognizing COVID, and in doing so, is also recognizing some antigens in the skin and creating a hypersensitive response to the skin” and has “nothing to do with the SARS-CoV-2 virus actually being in that location,” she said.
It is important to differentiate between patients who have skin manifestations attributed to COVID-19 and those with manifestations independent of COVID-19, which is difficult, Dr. Femia noted. A patient with COVID-19 and a cutaneous manifestation may be having a reaction to a medication. “It’s important to have a critical eye and to remember that, when we see these manifestations, we should always be investigating whether there was an alternative cause so that we can better learn what exactly we should be attributing to this infection,” she said
Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said the authors of the review had presented interesting work, but made some “assumptions that need to be proven.” Dr. Friedman also was not involved in the research, but agreed in an interview with the assessment that it is unlikely SARS-CoV-2 would penetrate the skin. While some viruses – such as the poxvirus that causes molluscum contagiosum and the herpes simplex virus – invade keratinocytes specifically, there is a particular clinical phenotype that results that is associated with changes in the epidermis. However, “the skin manifestations of COVID-19 do not fit with direct skin invasion, [but] rather the immune response to systemic disease,” he said.
“[I]n terms of systemic invasion through the skin, it is possible, but this study certainly doesn’t show that. The presence/expression of ACE2 in the epidermis doesn’t translate to route of infection,” Dr. Friedman said..
The study received financial support from Shandong First Medical University, the Innovation Project of Shandong Academy of Medical Sciences and the Shandong Province Taishan Scholar Project. The authors report no relevant financial disclosures. Dr. Femia and Dr. Friedman had no relevant financial disclosures.
SOURCE: Zhao Q et al. J Eur Acad Dermatol Venereol. 2020 Jun 28. doi: 10.1111/jdv.16778.
Qing Zhao, MD, Xiaokai Fang, MD, and their colleagues at the Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venereology, in Jinan, China, reported the results of a literature review of 44 articles published through May 2020 that included 507 patients with cutaneous manifestations of COVID-19. The review was published in the Journal of The European Academy of Dermatology and Venereology.
Nearly all of the patients (96%) were from Europe, and more than half were women (60%), with an average age of 49 years. Most patients had multiple skin symptoms, with the most common being erythema (44%), chilblain-like lesions (20%), urticaria-like lesions (16%), vesicular manifestations (13%), livedo/necrosis (6%), and petechiae (almost 2%). The authors described erythema as being present in specific sites, such as the trunk, extremities, flexural regions, face, and mucous membranes. Slightly less than half of all patients had significant pruritus.
Data on systemic COVID-19 symptoms were available for 431 patients and included fever in about two-thirds of patients and cough in almost 70%, with dyspnea in almost half of patients. Almost 60% had fatigue, and almost 60% had asthenia. Information about the onset of skin symptoms was available in 88 patients; of these patients, lesions were seen an average of almost 10 days after systemic symptoms appeared and, in almost 15%, were the first symptoms noted.
Histopathologic exams were done for only 23 patients and, in all cases, showed “inflammatory features without specific pathological changes, such as lymphocyte infiltration.” In one study, reverse transcription polymerase chain reaction testing of skin biopsy specimens tested negative for SARS-CoV-2.
Expression of ACE2, the receptor of SARS-CoV-2, in the skin was evaluated in six of the studies. “Higher ACE2 expression was identified in keratinocytes, mainly in differentiating keratinocytes and basal cells compared to the other cells of skin tissues,” the authors wrote. These results were confirmed with immunohistochemistry, which, they said, found “ACE2-positive keratinocytes in the stratum basal, the stratum spinosum, and the stratum granulosum of epiderma.” They added that this provides evidence “for percutaneous infection or the entry of virus into patients through skin tissues,” but cautioned that more research is needed.
The authors acknowledged that there are still many unanswered questions about COVID-19, and that more clinical data and research are needed, to improve the understanding of the cutaneous manifestations associated with COVID-19.
In an interview, Alisa N. Femia, MD, director of inpatient dermatology in the department of dermatology at New York University, said that the cutaneous signs described in the review align well with what she has seen in patients with COVID-19.
At this point, it is unclear whether cutaneous manifestations of COVID-19 are a result of SARS-CoV-2 invading the skin or an immune response related to SARS-CoV-2, noted Dr. Femia, who was not involved in the research. One method of entry could be through transmitting virus present on the skin to another part of the body where infection is more likely.
While it is possible COVID-19 could be contracted through the skin, she noted, it is much more likely an individual would be infected by SARS-CoV-2 through more traditionally understood means of transmission, such as through respiratory droplets in person-to-person contact. “I think we are far away from drawing that conclusion, that one could touch a surface or a person who has COVID and contract it through their skin,” Dr. Femia said. “The skin has a lot of other ways to protect against that from occurring,” she added.
“SAR-CoV-2 obviously enters through the ACE2 receptor, which is fairly ubiquitous, and it has been seen in keratinocytes,” she said. “But the skin is one of our biggest barriers ... and further, studies to date have shown that that receptor is expressed in relatively low levels of the keratinocytes.”
Pathogenesis of different cutaneous manifestations may be different, Dr. Femia said. For example, urticaria and morbilliform eruption were described by the authors of the review as more benign eruptions, but pathogenesis may differ from that of so-called COVID toes and from the pathogenesis of purpura and ulcerations seen in patients with more severe disease, she noted. It is plausible, she added, that purpura and ulcerations may be a “direct invasion of SARS-CoV-2 into endothelial cells,” which creates secondary processes “that ultimately destroy the skin.”
Urticaria and morbilliform eruptions, on the other hand, “are more simply that the immune system is recognizing COVID, and in doing so, is also recognizing some antigens in the skin and creating a hypersensitive response to the skin” and has “nothing to do with the SARS-CoV-2 virus actually being in that location,” she said.
It is important to differentiate between patients who have skin manifestations attributed to COVID-19 and those with manifestations independent of COVID-19, which is difficult, Dr. Femia noted. A patient with COVID-19 and a cutaneous manifestation may be having a reaction to a medication. “It’s important to have a critical eye and to remember that, when we see these manifestations, we should always be investigating whether there was an alternative cause so that we can better learn what exactly we should be attributing to this infection,” she said
Adam Friedman, MD, professor and interim chair of dermatology at George Washington University, Washington, said the authors of the review had presented interesting work, but made some “assumptions that need to be proven.” Dr. Friedman also was not involved in the research, but agreed in an interview with the assessment that it is unlikely SARS-CoV-2 would penetrate the skin. While some viruses – such as the poxvirus that causes molluscum contagiosum and the herpes simplex virus – invade keratinocytes specifically, there is a particular clinical phenotype that results that is associated with changes in the epidermis. However, “the skin manifestations of COVID-19 do not fit with direct skin invasion, [but] rather the immune response to systemic disease,” he said.
“[I]n terms of systemic invasion through the skin, it is possible, but this study certainly doesn’t show that. The presence/expression of ACE2 in the epidermis doesn’t translate to route of infection,” Dr. Friedman said..
The study received financial support from Shandong First Medical University, the Innovation Project of Shandong Academy of Medical Sciences and the Shandong Province Taishan Scholar Project. The authors report no relevant financial disclosures. Dr. Femia and Dr. Friedman had no relevant financial disclosures.
SOURCE: Zhao Q et al. J Eur Acad Dermatol Venereol. 2020 Jun 28. doi: 10.1111/jdv.16778.
FROM THE JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
Are you SARS-CoV-2 vaccine hesitant?
When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”
How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.”
Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?
In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.
For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.
Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.
The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
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.” Email him at pdnews@mdedge.com.
When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”
How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.”
Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?
In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.
For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.
Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.
The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
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.” Email him at pdnews@mdedge.com.
When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”
How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.”
Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?
In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.
For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.
Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.
The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
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.” Email him at pdnews@mdedge.com.
COVID-19 bits and pieces
It turns out that a pandemic, at least this COVID-19 version, can be a challenge for folks like me who are seldom at a loss for words. The pandemic has so overwhelmed every corner of our lives that it is hard to think of another topic on which to pontificate and still not tromp on someone’s political toes. One can always write about the pandemic itself, and I’ve tried that, but as the curtain is gradually being pulled back on this crafty little germ one runs the risk of making an observation today that will be disproved in a week or 2. However, I can’t suppress my urge to write, and so I have decided to share a few brief random observations. Of course they are related to the pandemic. And of course I realize that there is a better than fifty percent chance that they will be proved wrong by the time you read my next Letters from Maine.
Under the radar
Two of the many mysteries about SARS-CoV-2 involve young children who as a group appear to be less easily infected than adults and even when infected seem to be less likely to spread the disease to other people, particularly adults. One explanation posited by some researchers in France is that young children are less likely to have symptoms such as cough and are less powerful speakers and so might be less likely to spew out a significant number of infected aerosolized droplets (“How to Reopen Schools: What Science and Other Countries Teach Us.” By Pam Belluck, Apoorva Mandavill, and Benedict Carey. New York Times, July 11, 2020). While there are probably several factors to explain this observation, one may be that young children are short, seldom taller than an adult waistline. I suspect the majority of aerosols they emit fall and inactivate harmlessly to the floor several feet below an adult’s nose and mouth. Regardless of the explanation, it appears to be good news for the opening of schools, at least for the early grades.
Forget the deep cleaning
There has been a glut of news stories about reopening schools, and many of these stories are accompanied by images of school custodians with buckets, mops, spray bottles, and sponges scouring desks and walls. The most recent image in our local newspaper was of someone scrubbing the underside of a desk. I know it’s taking the World Health Organization an unconscionable period of time to acknowledge that SARS-CoV-2 is airborne, but the rest of us should have gotten the message long ago and been directing our attention to air handling and ventilation. The urge to scrub and deep clean is a hard habit to break, but this nasty bug is not like influenza or a flesh eating bacteria in which deep cleaning might help. A better image to attach to a story on school reopening would be one of a custodian with a screwdriver struggling to pry open a classroom window that had been painted shut a decade ago.
Managing the inevitable
Middlebury College in Vermont and Bowdoin College here in Brunswick, Maine, are similar in many respects because they are small and situated in relatively isolated small New England towns with good track records for pandemic management. Middlebury has elected to invite all its 2,750 students back to campus, whereas Bowdoin has decided to allow only incoming first years and transfer students (for a total of about 600) to return. Both schools will institute similar testing and social distancing protocols and restrict students from access to their respective towns (“A Tale of 2 Colleges.” By Bill Burger. Inside Higher Ed, June 29,2020). It will be an interesting experiment. I’m voting for Middlebury and not because my son and daughter-in-law are alums, but because I think Middlebury seems to have acknowledged that no matter how diligent one is in creating a SARS-CoV-2–free environment at the outset, these are college kids and there will be some cases on both campuses. It is on how those inevitable realities are managed and contained that an institution should be judged.
Patience
Unfortunately,
We always have been a restless and impatient population eager to get moving and it has driven us to greatness. Hopefully, patience will be a lesson that we will learn, along with many others.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.” Email him at pdnews@mdedge.com.
It turns out that a pandemic, at least this COVID-19 version, can be a challenge for folks like me who are seldom at a loss for words. The pandemic has so overwhelmed every corner of our lives that it is hard to think of another topic on which to pontificate and still not tromp on someone’s political toes. One can always write about the pandemic itself, and I’ve tried that, but as the curtain is gradually being pulled back on this crafty little germ one runs the risk of making an observation today that will be disproved in a week or 2. However, I can’t suppress my urge to write, and so I have decided to share a few brief random observations. Of course they are related to the pandemic. And of course I realize that there is a better than fifty percent chance that they will be proved wrong by the time you read my next Letters from Maine.
Under the radar
Two of the many mysteries about SARS-CoV-2 involve young children who as a group appear to be less easily infected than adults and even when infected seem to be less likely to spread the disease to other people, particularly adults. One explanation posited by some researchers in France is that young children are less likely to have symptoms such as cough and are less powerful speakers and so might be less likely to spew out a significant number of infected aerosolized droplets (“How to Reopen Schools: What Science and Other Countries Teach Us.” By Pam Belluck, Apoorva Mandavill, and Benedict Carey. New York Times, July 11, 2020). While there are probably several factors to explain this observation, one may be that young children are short, seldom taller than an adult waistline. I suspect the majority of aerosols they emit fall and inactivate harmlessly to the floor several feet below an adult’s nose and mouth. Regardless of the explanation, it appears to be good news for the opening of schools, at least for the early grades.
Forget the deep cleaning
There has been a glut of news stories about reopening schools, and many of these stories are accompanied by images of school custodians with buckets, mops, spray bottles, and sponges scouring desks and walls. The most recent image in our local newspaper was of someone scrubbing the underside of a desk. I know it’s taking the World Health Organization an unconscionable period of time to acknowledge that SARS-CoV-2 is airborne, but the rest of us should have gotten the message long ago and been directing our attention to air handling and ventilation. The urge to scrub and deep clean is a hard habit to break, but this nasty bug is not like influenza or a flesh eating bacteria in which deep cleaning might help. A better image to attach to a story on school reopening would be one of a custodian with a screwdriver struggling to pry open a classroom window that had been painted shut a decade ago.
Managing the inevitable
Middlebury College in Vermont and Bowdoin College here in Brunswick, Maine, are similar in many respects because they are small and situated in relatively isolated small New England towns with good track records for pandemic management. Middlebury has elected to invite all its 2,750 students back to campus, whereas Bowdoin has decided to allow only incoming first years and transfer students (for a total of about 600) to return. Both schools will institute similar testing and social distancing protocols and restrict students from access to their respective towns (“A Tale of 2 Colleges.” By Bill Burger. Inside Higher Ed, June 29,2020). It will be an interesting experiment. I’m voting for Middlebury and not because my son and daughter-in-law are alums, but because I think Middlebury seems to have acknowledged that no matter how diligent one is in creating a SARS-CoV-2–free environment at the outset, these are college kids and there will be some cases on both campuses. It is on how those inevitable realities are managed and contained that an institution should be judged.
Patience
Unfortunately,
We always have been a restless and impatient population eager to get moving and it has driven us to greatness. Hopefully, patience will be a lesson that we will learn, along with many others.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.” Email him at pdnews@mdedge.com.
It turns out that a pandemic, at least this COVID-19 version, can be a challenge for folks like me who are seldom at a loss for words. The pandemic has so overwhelmed every corner of our lives that it is hard to think of another topic on which to pontificate and still not tromp on someone’s political toes. One can always write about the pandemic itself, and I’ve tried that, but as the curtain is gradually being pulled back on this crafty little germ one runs the risk of making an observation today that will be disproved in a week or 2. However, I can’t suppress my urge to write, and so I have decided to share a few brief random observations. Of course they are related to the pandemic. And of course I realize that there is a better than fifty percent chance that they will be proved wrong by the time you read my next Letters from Maine.
Under the radar
Two of the many mysteries about SARS-CoV-2 involve young children who as a group appear to be less easily infected than adults and even when infected seem to be less likely to spread the disease to other people, particularly adults. One explanation posited by some researchers in France is that young children are less likely to have symptoms such as cough and are less powerful speakers and so might be less likely to spew out a significant number of infected aerosolized droplets (“How to Reopen Schools: What Science and Other Countries Teach Us.” By Pam Belluck, Apoorva Mandavill, and Benedict Carey. New York Times, July 11, 2020). While there are probably several factors to explain this observation, one may be that young children are short, seldom taller than an adult waistline. I suspect the majority of aerosols they emit fall and inactivate harmlessly to the floor several feet below an adult’s nose and mouth. Regardless of the explanation, it appears to be good news for the opening of schools, at least for the early grades.
Forget the deep cleaning
There has been a glut of news stories about reopening schools, and many of these stories are accompanied by images of school custodians with buckets, mops, spray bottles, and sponges scouring desks and walls. The most recent image in our local newspaper was of someone scrubbing the underside of a desk. I know it’s taking the World Health Organization an unconscionable period of time to acknowledge that SARS-CoV-2 is airborne, but the rest of us should have gotten the message long ago and been directing our attention to air handling and ventilation. The urge to scrub and deep clean is a hard habit to break, but this nasty bug is not like influenza or a flesh eating bacteria in which deep cleaning might help. A better image to attach to a story on school reopening would be one of a custodian with a screwdriver struggling to pry open a classroom window that had been painted shut a decade ago.
Managing the inevitable
Middlebury College in Vermont and Bowdoin College here in Brunswick, Maine, are similar in many respects because they are small and situated in relatively isolated small New England towns with good track records for pandemic management. Middlebury has elected to invite all its 2,750 students back to campus, whereas Bowdoin has decided to allow only incoming first years and transfer students (for a total of about 600) to return. Both schools will institute similar testing and social distancing protocols and restrict students from access to their respective towns (“A Tale of 2 Colleges.” By Bill Burger. Inside Higher Ed, June 29,2020). It will be an interesting experiment. I’m voting for Middlebury and not because my son and daughter-in-law are alums, but because I think Middlebury seems to have acknowledged that no matter how diligent one is in creating a SARS-CoV-2–free environment at the outset, these are college kids and there will be some cases on both campuses. It is on how those inevitable realities are managed and contained that an institution should be judged.
Patience
Unfortunately,
We always have been a restless and impatient population eager to get moving and it has driven us to greatness. Hopefully, patience will be a lesson that we will learn, along with many others.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.” Email him at pdnews@mdedge.com.
Vaccines for maternal and fetal health
Biomedical science is ever changing, and what may be believed in one era – for instance, bloodletting can cure disease or lobotomies can treat psychiatric disorders – may not be accepted in the next. However, one medical advance stands out in terms of maintaining and sustaining our health: vaccines. The data comparing morbidity and mortality before and after widespread vaccination are staggering. Before the smallpox vaccine, nearly 49,000 people were infected and more than 1,500 died annually from smallpox; by 1977, the vaccine eradicated the disease in the United States.1 Polio caused paralytic disease in more than 16,000 people per year in the United States, including, perhaps most famously, President Franklin Roosevelt. After development of the polio vaccine, cases and deaths dropped to zero.2
Despite the evidence indicating the effectiveness of vaccines to reduce disease and death, rates of vaccination in the United States remain low among adults, ranging from about 23% for pneumococcal disease to 45% for seasonal influenza.3 Childhood immunization in 2017 hovered around 70% for those receiving all the recommended vaccines.4 Clearly there is room for improvement.
A woman’s ob.gyn. may be the only medical professional she sees regularly, and her annual well visit may be the only time she receives information regarding her weight and blood pressure, or reviews her current medications. For women who are planning pregnancy, pregnant, or post partum, ob.gyn. consultations present unique opportunities to increase patient engagement in healthy behaviors, such as diet, exercise, and regular sleep, because women are highly motivated to do what is best for their babies.
Immunization during pregnancy not only reduces the mother’s risk of severe disease, which can lead to complications, defects, and fetal or perinatal death, but also has been shown to improve the neonate’s ability to fight infection and may reduce vertical transmission of certain diseases. In this era of COVID-19 where we have no vaccine but we have evidence that pregnant women may be at greater risk for severe disease,5 routine immunizations are vital to maternal and fetal health.
We have invited Laura E. Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York, to address the importance of vaccination and the role of the ob.gyn. in advocating for this life-saving preventive health measure. Dr. Riley disclosed she is an author for Up to Date and was a consultant to GlaxoSmithKline about a cytomegalovirus vaccine.
Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore County, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at obnews@mdedge.com.
References
1. MMWR Morb Mortal Wkly Rep. 1999 Apr 2;48(12);243-8.
2. JAMA. 2007 Nov 14;298(18):2155-63.
3. MMWR Morb Mortal Wkly Rep. 2017 May 5;66(11);1-28.
4. CDC National Center for Health Statistics FastStats on Immunization.
5. MMWR Morb Mortal Wkly Rep. 2020 Jun 26;69(25);769-75.
Biomedical science is ever changing, and what may be believed in one era – for instance, bloodletting can cure disease or lobotomies can treat psychiatric disorders – may not be accepted in the next. However, one medical advance stands out in terms of maintaining and sustaining our health: vaccines. The data comparing morbidity and mortality before and after widespread vaccination are staggering. Before the smallpox vaccine, nearly 49,000 people were infected and more than 1,500 died annually from smallpox; by 1977, the vaccine eradicated the disease in the United States.1 Polio caused paralytic disease in more than 16,000 people per year in the United States, including, perhaps most famously, President Franklin Roosevelt. After development of the polio vaccine, cases and deaths dropped to zero.2
Despite the evidence indicating the effectiveness of vaccines to reduce disease and death, rates of vaccination in the United States remain low among adults, ranging from about 23% for pneumococcal disease to 45% for seasonal influenza.3 Childhood immunization in 2017 hovered around 70% for those receiving all the recommended vaccines.4 Clearly there is room for improvement.
A woman’s ob.gyn. may be the only medical professional she sees regularly, and her annual well visit may be the only time she receives information regarding her weight and blood pressure, or reviews her current medications. For women who are planning pregnancy, pregnant, or post partum, ob.gyn. consultations present unique opportunities to increase patient engagement in healthy behaviors, such as diet, exercise, and regular sleep, because women are highly motivated to do what is best for their babies.
Immunization during pregnancy not only reduces the mother’s risk of severe disease, which can lead to complications, defects, and fetal or perinatal death, but also has been shown to improve the neonate’s ability to fight infection and may reduce vertical transmission of certain diseases. In this era of COVID-19 where we have no vaccine but we have evidence that pregnant women may be at greater risk for severe disease,5 routine immunizations are vital to maternal and fetal health.
We have invited Laura E. Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York, to address the importance of vaccination and the role of the ob.gyn. in advocating for this life-saving preventive health measure. Dr. Riley disclosed she is an author for Up to Date and was a consultant to GlaxoSmithKline about a cytomegalovirus vaccine.
Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore County, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at obnews@mdedge.com.
References
1. MMWR Morb Mortal Wkly Rep. 1999 Apr 2;48(12);243-8.
2. JAMA. 2007 Nov 14;298(18):2155-63.
3. MMWR Morb Mortal Wkly Rep. 2017 May 5;66(11);1-28.
4. CDC National Center for Health Statistics FastStats on Immunization.
5. MMWR Morb Mortal Wkly Rep. 2020 Jun 26;69(25);769-75.
Biomedical science is ever changing, and what may be believed in one era – for instance, bloodletting can cure disease or lobotomies can treat psychiatric disorders – may not be accepted in the next. However, one medical advance stands out in terms of maintaining and sustaining our health: vaccines. The data comparing morbidity and mortality before and after widespread vaccination are staggering. Before the smallpox vaccine, nearly 49,000 people were infected and more than 1,500 died annually from smallpox; by 1977, the vaccine eradicated the disease in the United States.1 Polio caused paralytic disease in more than 16,000 people per year in the United States, including, perhaps most famously, President Franklin Roosevelt. After development of the polio vaccine, cases and deaths dropped to zero.2
Despite the evidence indicating the effectiveness of vaccines to reduce disease and death, rates of vaccination in the United States remain low among adults, ranging from about 23% for pneumococcal disease to 45% for seasonal influenza.3 Childhood immunization in 2017 hovered around 70% for those receiving all the recommended vaccines.4 Clearly there is room for improvement.
A woman’s ob.gyn. may be the only medical professional she sees regularly, and her annual well visit may be the only time she receives information regarding her weight and blood pressure, or reviews her current medications. For women who are planning pregnancy, pregnant, or post partum, ob.gyn. consultations present unique opportunities to increase patient engagement in healthy behaviors, such as diet, exercise, and regular sleep, because women are highly motivated to do what is best for their babies.
Immunization during pregnancy not only reduces the mother’s risk of severe disease, which can lead to complications, defects, and fetal or perinatal death, but also has been shown to improve the neonate’s ability to fight infection and may reduce vertical transmission of certain diseases. In this era of COVID-19 where we have no vaccine but we have evidence that pregnant women may be at greater risk for severe disease,5 routine immunizations are vital to maternal and fetal health.
We have invited Laura E. Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York, to address the importance of vaccination and the role of the ob.gyn. in advocating for this life-saving preventive health measure. Dr. Riley disclosed she is an author for Up to Date and was a consultant to GlaxoSmithKline about a cytomegalovirus vaccine.
Dr. Reece, who specializes in maternal-fetal medicine, is executive vice president for medical affairs at the University of Maryland, Baltimore County, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. He is the medical editor of this column. He said he had no relevant financial disclosures. Contact him at obnews@mdedge.com.
References
1. MMWR Morb Mortal Wkly Rep. 1999 Apr 2;48(12);243-8.
2. JAMA. 2007 Nov 14;298(18):2155-63.
3. MMWR Morb Mortal Wkly Rep. 2017 May 5;66(11);1-28.
4. CDC National Center for Health Statistics FastStats on Immunization.
5. MMWR Morb Mortal Wkly Rep. 2020 Jun 26;69(25);769-75.
Maternal immunization is a priority
Maternal immunization remains a priority for ob.gyns. – an opportunity to provide protection against serious infectious diseases for both the mother and the baby. With influenza vaccination rates in pregnant women still hovering around 50% and the emerging public health problem of vaccine hesitancy, we must fully embrace our responsibility to recommend immunizations and to effectively communicate what is known about their efficacy and safety. Ideally, we should offer them as well.
One reason for the low rates of influenza vaccination – one of the two vaccinations routinely recommended for all pregnant women in the United States – is that pregnant women do not always know the importance of the vaccine. This is actionable: Data clearly show that the physician’s recommendation makes a difference and that a clinician’s offer to administer the vaccination has an even greater impact.
A 2017 Centers for Disease Control and Prevention analysis of data from Internet panel surveys1 shows that women who reported receiving both a clinician recommendation and offer of vaccination had higher coverage during the 2015-2016 and 2016-2017 influenza seasons (63.7% and 70.5%) than did women who reported receiving a clinician recommendation but no offer (37.5% and 43.7%) and women who reported receiving no recommendation for vaccination (12.8% and 14.8%).
The analysis suggests there are consistently missed opportunities: Fewer than 70% (67.3%) of pregnant women in the 2016-2017 flu season reported receiving a clinician recommendation for and offer of vaccination. This is similar to the prior three flu seasons, according to the CDC.
This year, with the COVID-19 pandemic ensuing, the prevention of severe influenza illness – and other vaccine-preventable illnesses – takes on even greater importance. It is not known what the impact of two potentially devastating respiratory infections could be for pregnant individuals. Therefore, maximal protection against at least influenza will be critical.
Influenza and Tdap
Poor outcomes and disproportionately high death rates for pregnant women were observed in both the influenza pandemic of 1918-1919 and the 1957 “Asian flu” pandemic. Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), but it was the H1N1 influenza pandemic of 2009 that reinforced its value and led our field to more fully embrace influenza vaccination as a priority for prenatal care.
Surprisingly, most of the pregnant women who became severely ill from the H1N1 virus were young and healthy and did not have a coexisting condition known to increase risk, such as asthma or diabetes. In an analysis of California epidemiologic data, 2 only one-third of 94 pregnant women who were hospitalized with 2009 H1N1 influenza had established risk factors for complications from influenza, compared with almost two-thirds of nonpregnant women of reproductive age.
Nationally, 75 deaths of pregnant women were confirmed as because of H1N1 and 34 were possibly related to H1N1, most of which (64.3%) occurred in the third trimester.3 Records of the 1957 pandemic similarly show that pregnant women in the second and third trimesters were particularly affected.
That healthy pregnant women became so ill during the H1N1 pandemic raised several flags. For one, it became clearer that pregnancy is its own significant risk factor for severe illness from the influenza virus. Physiological changes believed to make a pregnant woman more susceptible to becoming ill include decreased lung capacity, increased nasal congestion, reduced colloid oncotic pressure, and changes in the immune system. The morbidity and mortality from H1N1 influenza also increased our drive as a specialty to convince women that vaccination is an important strategy in each influenza season.
The flu vaccine can be administered at any point during pregnancy. There is no evidence that the safety profile is any different during one trimester than another.
Patients should be reassured that vaccines recommended in pregnancy have undergone rigorous testing and that the influenza vaccine has been given to millions of pregnant women over decades. They also should understand that contracting influenza has risks for the fetus; research has demonstrated that pregnant women who contract influenza are at greater risk of spontaneous abortion as well as preterm birth and low birth weight.4
In addition, the issue of flu vaccine efficacy needs to be properly teased apart. Women read every year that the vaccine is not effective, so we need to discuss with patients what efficacy means. Does the vaccine prevent illness altogether, or does it prevent severe illness? For the most part, whereas influenza vaccines often do not offer an exact match for the year’s circulating strains – and therefore may not prevent all illness – data show that the vaccine can prevent severe illness.5 That is a worthy outcome.
Also worthy is the impact of influenza vaccination on the newborn. That maternal immunization also protects the baby – it can reduce the risk for influenza in infants under 6 months of age – is underappreciated and should be part of patient counseling. There is clear evidence that maternal immunization boosts the concentration of maternal antibodies that can cross the placenta and that infants benefit from this passive antibody protection.6
The Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), the second vaccine routinely recommended during each pregnancy, is administered as early as possible during the third trimester precisely for this reason – to boost maternal immune response and maximize the passive transfer of antibodies to the newborn. The target is the prevention of pertussis and associated hospitalizations and death during the first 2 months of life in an era when sporadic and unpredictable outbreaks of the infection are occurring.
Data from the CDC of morbidity and mortality from pertussis in children (2001-2011) prior to routine maternal vaccination show that the highest rates of pediatric hospitalizations and deaths occurred in newborns. Research has demonstrated that the Tdap vaccine is highly effective in preventing infections and hospitalizations in newborns: Case-control and cohort studies in the United Kingdom7,8 have shown vaccine effectiveness of 91%-93%, and similar research9 done in the U.S. has demonstrated effectiveness of 78%-85%.
The Tdap vaccine is recommended for pregnant women at 27-36 weeks of gestation – in each pregnancy. The reason for revaccination with each pregnancy is that antibody levels do not remain high for too long; at 8 months post immunization, research has shown, maternal antibody levels have begun to wane.
The vaccine also is recommended for all individuals who will be in close contact with infants younger than 12 months (for example, parents, grandparents, and child-care providers) and who have not previously received it. However, “cocooning” the newborn is effective only when the mother also is immunized – a point that ob.gyns. need to better explain to their patients so that they understand the purpose of this strategy.
Other vaccines in pregnancy and post partum
As described in the American College of Obstetricians and Gynecologists’ committee opinion on maternal immunization, 4 it is the responsibility of the ob.gyn. or obstetric care provider to routinely assess the immunization status of every pregnant patient and recommend additional vaccines for those patients who have conditions or social/behavioral practices that put them at higher risk of acquiring vaccine-preventable diseases.
Patients who have asthma or diabetes, who smoke, or who have never been vaccinated for the prevention of pneumococcal disease should receive the PPV23 pneumococcal vaccine, for instance. For pregnant women with immune deficiencies such as HIV, the PCV13 vaccine followed by PPV23 is recommended. There are approximately 500,000 cases of invasive pneumococcal disease in the United States each year, resulting in 40,000 deaths, and many multidrug-resistant strains of Streptococcus pneumoniae.
Hepatitis A and B vaccines – both recombinant vaccines with no safety concerns – also can be given during pregnancy and are officially recommended for women who have high-risk exposures. In the case of hepatitis A, high risk entails traveling to countries where the disease is endemic. High-risk behavior for hepatitis B includes sex work or being the household contact or sexual partner of a person positive for hepatitis B surface antigen.
Other travel-related vaccines, such as Japanese encephalitis, yellow fever, smallpox, and inactivated polio vaccine, can be considered in pregnancy, but decisions should be driven by more in-depth conversations about potential risks and benefits. Unlike for other vaccinations, there are limited data on the safety of travel-related immunizations in pregnancy. Sometimes, the question of whether travel is advisable in the middle of pregnancy – whether potential risks are worth taking – is a valid question to pose in conversations with patients.
Standard obstetric practice includes assessment of rubella susceptibility at the beginning of pregnancy. In some locations such as New York, measles susceptibility is also routinely evaluated. After delivery, seronegative women should be vaccinated with MMR (measles, mumps, and rubella) vaccine prior to discharge. In recent years, with the growing problem of vaccine refusal and an increasingly mobile and global society, we’re seeing sporadic outbreaks of measles and rubella – diseases that were once eradicated.
Measles in particular is highly contagious and requires a herd immunity threshold of 92%-94% to prevent sustained spread of the disease. Postpartum immunization has important maternal and pediatric implications for subsequent pregnancies, before which vaccination is often missed.
Both the MMR vaccine and the varicella vaccine (another vaccine that can be initiated post partum) are live vaccines and therefore contraindicated during pregnancy but should be administered post partum, including to people who are breastfeeding.
Other immunizations that hold some promise to protect either the mother or fetus/neonate or both are in various stages of development or testing. These include vaccines for cytomegalovirus, malaria, respiratory syncytial virus, and group B streptococcus.
A word about COVID-19
In mid-July there were more than 120 vaccine candidates for COVID-19 in various phases of study and a host of questions. Will a vaccine be efficacious? Will it prevent severe illness, or illness altogether? And will it be safe for pregnant women?
Vaccines work by manipulating the immune system, and it is important to appreciate the possibility that there may be unique pregnancy-related issues to consider with future COVID-19 vaccines – issues that could influence the effectiveness, safety, and timing of vaccination – and to understand that with any new immunization, there will likely be reluctance on the part of pregnant women who routinely prioritize fetal safety over their own health.
Pregnant women have been excluded from COVID-19 vaccine trials, but there may come a time when experts decide that a vaccine against COVID-19 is beneficial in pregnancy. Thus far, we know that the disease is clearly different from influenza. A growing knowledge of the impact of COVID-19 on the health of pregnant women, particularly the risk of developing severe illness, will be important for the future of COVID-19 immunization, as many women will not want to accept any potential risk of a vaccine unless they believe there is a significant benefit.
References
1. MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66(38):1016-22.
2. N Engl J Med. 2010 Jan 7;362(1):27-35.
3. Obstet Gynecol. 2015 Sep;126(3):486-90.
4. Obstet Gynecol. 2018 Jun;131(6):e214-e217.
5. MMWR Morb Mortal Wkly Rep. 2019 Feb 15;68(6):135-9.
6. Obstet Gynecol. 2019 Apr;133(4):739-53.
7. Lancet. 2014 Oct 25;384(9953):1521-8.
8. Clin Infect Dis. 2015 Feb 1;60(3):333-7.
9. Clin Infect Dis. 2017 Jan 1;64(1):9-14.
Maternal immunization remains a priority for ob.gyns. – an opportunity to provide protection against serious infectious diseases for both the mother and the baby. With influenza vaccination rates in pregnant women still hovering around 50% and the emerging public health problem of vaccine hesitancy, we must fully embrace our responsibility to recommend immunizations and to effectively communicate what is known about their efficacy and safety. Ideally, we should offer them as well.
One reason for the low rates of influenza vaccination – one of the two vaccinations routinely recommended for all pregnant women in the United States – is that pregnant women do not always know the importance of the vaccine. This is actionable: Data clearly show that the physician’s recommendation makes a difference and that a clinician’s offer to administer the vaccination has an even greater impact.
A 2017 Centers for Disease Control and Prevention analysis of data from Internet panel surveys1 shows that women who reported receiving both a clinician recommendation and offer of vaccination had higher coverage during the 2015-2016 and 2016-2017 influenza seasons (63.7% and 70.5%) than did women who reported receiving a clinician recommendation but no offer (37.5% and 43.7%) and women who reported receiving no recommendation for vaccination (12.8% and 14.8%).
The analysis suggests there are consistently missed opportunities: Fewer than 70% (67.3%) of pregnant women in the 2016-2017 flu season reported receiving a clinician recommendation for and offer of vaccination. This is similar to the prior three flu seasons, according to the CDC.
This year, with the COVID-19 pandemic ensuing, the prevention of severe influenza illness – and other vaccine-preventable illnesses – takes on even greater importance. It is not known what the impact of two potentially devastating respiratory infections could be for pregnant individuals. Therefore, maximal protection against at least influenza will be critical.
Influenza and Tdap
Poor outcomes and disproportionately high death rates for pregnant women were observed in both the influenza pandemic of 1918-1919 and the 1957 “Asian flu” pandemic. Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), but it was the H1N1 influenza pandemic of 2009 that reinforced its value and led our field to more fully embrace influenza vaccination as a priority for prenatal care.
Surprisingly, most of the pregnant women who became severely ill from the H1N1 virus were young and healthy and did not have a coexisting condition known to increase risk, such as asthma or diabetes. In an analysis of California epidemiologic data, 2 only one-third of 94 pregnant women who were hospitalized with 2009 H1N1 influenza had established risk factors for complications from influenza, compared with almost two-thirds of nonpregnant women of reproductive age.
Nationally, 75 deaths of pregnant women were confirmed as because of H1N1 and 34 were possibly related to H1N1, most of which (64.3%) occurred in the third trimester.3 Records of the 1957 pandemic similarly show that pregnant women in the second and third trimesters were particularly affected.
That healthy pregnant women became so ill during the H1N1 pandemic raised several flags. For one, it became clearer that pregnancy is its own significant risk factor for severe illness from the influenza virus. Physiological changes believed to make a pregnant woman more susceptible to becoming ill include decreased lung capacity, increased nasal congestion, reduced colloid oncotic pressure, and changes in the immune system. The morbidity and mortality from H1N1 influenza also increased our drive as a specialty to convince women that vaccination is an important strategy in each influenza season.
The flu vaccine can be administered at any point during pregnancy. There is no evidence that the safety profile is any different during one trimester than another.
Patients should be reassured that vaccines recommended in pregnancy have undergone rigorous testing and that the influenza vaccine has been given to millions of pregnant women over decades. They also should understand that contracting influenza has risks for the fetus; research has demonstrated that pregnant women who contract influenza are at greater risk of spontaneous abortion as well as preterm birth and low birth weight.4
In addition, the issue of flu vaccine efficacy needs to be properly teased apart. Women read every year that the vaccine is not effective, so we need to discuss with patients what efficacy means. Does the vaccine prevent illness altogether, or does it prevent severe illness? For the most part, whereas influenza vaccines often do not offer an exact match for the year’s circulating strains – and therefore may not prevent all illness – data show that the vaccine can prevent severe illness.5 That is a worthy outcome.
Also worthy is the impact of influenza vaccination on the newborn. That maternal immunization also protects the baby – it can reduce the risk for influenza in infants under 6 months of age – is underappreciated and should be part of patient counseling. There is clear evidence that maternal immunization boosts the concentration of maternal antibodies that can cross the placenta and that infants benefit from this passive antibody protection.6
The Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), the second vaccine routinely recommended during each pregnancy, is administered as early as possible during the third trimester precisely for this reason – to boost maternal immune response and maximize the passive transfer of antibodies to the newborn. The target is the prevention of pertussis and associated hospitalizations and death during the first 2 months of life in an era when sporadic and unpredictable outbreaks of the infection are occurring.
Data from the CDC of morbidity and mortality from pertussis in children (2001-2011) prior to routine maternal vaccination show that the highest rates of pediatric hospitalizations and deaths occurred in newborns. Research has demonstrated that the Tdap vaccine is highly effective in preventing infections and hospitalizations in newborns: Case-control and cohort studies in the United Kingdom7,8 have shown vaccine effectiveness of 91%-93%, and similar research9 done in the U.S. has demonstrated effectiveness of 78%-85%.
The Tdap vaccine is recommended for pregnant women at 27-36 weeks of gestation – in each pregnancy. The reason for revaccination with each pregnancy is that antibody levels do not remain high for too long; at 8 months post immunization, research has shown, maternal antibody levels have begun to wane.
The vaccine also is recommended for all individuals who will be in close contact with infants younger than 12 months (for example, parents, grandparents, and child-care providers) and who have not previously received it. However, “cocooning” the newborn is effective only when the mother also is immunized – a point that ob.gyns. need to better explain to their patients so that they understand the purpose of this strategy.
Other vaccines in pregnancy and post partum
As described in the American College of Obstetricians and Gynecologists’ committee opinion on maternal immunization, 4 it is the responsibility of the ob.gyn. or obstetric care provider to routinely assess the immunization status of every pregnant patient and recommend additional vaccines for those patients who have conditions or social/behavioral practices that put them at higher risk of acquiring vaccine-preventable diseases.
Patients who have asthma or diabetes, who smoke, or who have never been vaccinated for the prevention of pneumococcal disease should receive the PPV23 pneumococcal vaccine, for instance. For pregnant women with immune deficiencies such as HIV, the PCV13 vaccine followed by PPV23 is recommended. There are approximately 500,000 cases of invasive pneumococcal disease in the United States each year, resulting in 40,000 deaths, and many multidrug-resistant strains of Streptococcus pneumoniae.
Hepatitis A and B vaccines – both recombinant vaccines with no safety concerns – also can be given during pregnancy and are officially recommended for women who have high-risk exposures. In the case of hepatitis A, high risk entails traveling to countries where the disease is endemic. High-risk behavior for hepatitis B includes sex work or being the household contact or sexual partner of a person positive for hepatitis B surface antigen.
Other travel-related vaccines, such as Japanese encephalitis, yellow fever, smallpox, and inactivated polio vaccine, can be considered in pregnancy, but decisions should be driven by more in-depth conversations about potential risks and benefits. Unlike for other vaccinations, there are limited data on the safety of travel-related immunizations in pregnancy. Sometimes, the question of whether travel is advisable in the middle of pregnancy – whether potential risks are worth taking – is a valid question to pose in conversations with patients.
Standard obstetric practice includes assessment of rubella susceptibility at the beginning of pregnancy. In some locations such as New York, measles susceptibility is also routinely evaluated. After delivery, seronegative women should be vaccinated with MMR (measles, mumps, and rubella) vaccine prior to discharge. In recent years, with the growing problem of vaccine refusal and an increasingly mobile and global society, we’re seeing sporadic outbreaks of measles and rubella – diseases that were once eradicated.
Measles in particular is highly contagious and requires a herd immunity threshold of 92%-94% to prevent sustained spread of the disease. Postpartum immunization has important maternal and pediatric implications for subsequent pregnancies, before which vaccination is often missed.
Both the MMR vaccine and the varicella vaccine (another vaccine that can be initiated post partum) are live vaccines and therefore contraindicated during pregnancy but should be administered post partum, including to people who are breastfeeding.
Other immunizations that hold some promise to protect either the mother or fetus/neonate or both are in various stages of development or testing. These include vaccines for cytomegalovirus, malaria, respiratory syncytial virus, and group B streptococcus.
A word about COVID-19
In mid-July there were more than 120 vaccine candidates for COVID-19 in various phases of study and a host of questions. Will a vaccine be efficacious? Will it prevent severe illness, or illness altogether? And will it be safe for pregnant women?
Vaccines work by manipulating the immune system, and it is important to appreciate the possibility that there may be unique pregnancy-related issues to consider with future COVID-19 vaccines – issues that could influence the effectiveness, safety, and timing of vaccination – and to understand that with any new immunization, there will likely be reluctance on the part of pregnant women who routinely prioritize fetal safety over their own health.
Pregnant women have been excluded from COVID-19 vaccine trials, but there may come a time when experts decide that a vaccine against COVID-19 is beneficial in pregnancy. Thus far, we know that the disease is clearly different from influenza. A growing knowledge of the impact of COVID-19 on the health of pregnant women, particularly the risk of developing severe illness, will be important for the future of COVID-19 immunization, as many women will not want to accept any potential risk of a vaccine unless they believe there is a significant benefit.
References
1. MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66(38):1016-22.
2. N Engl J Med. 2010 Jan 7;362(1):27-35.
3. Obstet Gynecol. 2015 Sep;126(3):486-90.
4. Obstet Gynecol. 2018 Jun;131(6):e214-e217.
5. MMWR Morb Mortal Wkly Rep. 2019 Feb 15;68(6):135-9.
6. Obstet Gynecol. 2019 Apr;133(4):739-53.
7. Lancet. 2014 Oct 25;384(9953):1521-8.
8. Clin Infect Dis. 2015 Feb 1;60(3):333-7.
9. Clin Infect Dis. 2017 Jan 1;64(1):9-14.
Maternal immunization remains a priority for ob.gyns. – an opportunity to provide protection against serious infectious diseases for both the mother and the baby. With influenza vaccination rates in pregnant women still hovering around 50% and the emerging public health problem of vaccine hesitancy, we must fully embrace our responsibility to recommend immunizations and to effectively communicate what is known about their efficacy and safety. Ideally, we should offer them as well.
One reason for the low rates of influenza vaccination – one of the two vaccinations routinely recommended for all pregnant women in the United States – is that pregnant women do not always know the importance of the vaccine. This is actionable: Data clearly show that the physician’s recommendation makes a difference and that a clinician’s offer to administer the vaccination has an even greater impact.
A 2017 Centers for Disease Control and Prevention analysis of data from Internet panel surveys1 shows that women who reported receiving both a clinician recommendation and offer of vaccination had higher coverage during the 2015-2016 and 2016-2017 influenza seasons (63.7% and 70.5%) than did women who reported receiving a clinician recommendation but no offer (37.5% and 43.7%) and women who reported receiving no recommendation for vaccination (12.8% and 14.8%).
The analysis suggests there are consistently missed opportunities: Fewer than 70% (67.3%) of pregnant women in the 2016-2017 flu season reported receiving a clinician recommendation for and offer of vaccination. This is similar to the prior three flu seasons, according to the CDC.
This year, with the COVID-19 pandemic ensuing, the prevention of severe influenza illness – and other vaccine-preventable illnesses – takes on even greater importance. It is not known what the impact of two potentially devastating respiratory infections could be for pregnant individuals. Therefore, maximal protection against at least influenza will be critical.
Influenza and Tdap
Poor outcomes and disproportionately high death rates for pregnant women were observed in both the influenza pandemic of 1918-1919 and the 1957 “Asian flu” pandemic. Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), but it was the H1N1 influenza pandemic of 2009 that reinforced its value and led our field to more fully embrace influenza vaccination as a priority for prenatal care.
Surprisingly, most of the pregnant women who became severely ill from the H1N1 virus were young and healthy and did not have a coexisting condition known to increase risk, such as asthma or diabetes. In an analysis of California epidemiologic data, 2 only one-third of 94 pregnant women who were hospitalized with 2009 H1N1 influenza had established risk factors for complications from influenza, compared with almost two-thirds of nonpregnant women of reproductive age.
Nationally, 75 deaths of pregnant women were confirmed as because of H1N1 and 34 were possibly related to H1N1, most of which (64.3%) occurred in the third trimester.3 Records of the 1957 pandemic similarly show that pregnant women in the second and third trimesters were particularly affected.
That healthy pregnant women became so ill during the H1N1 pandemic raised several flags. For one, it became clearer that pregnancy is its own significant risk factor for severe illness from the influenza virus. Physiological changes believed to make a pregnant woman more susceptible to becoming ill include decreased lung capacity, increased nasal congestion, reduced colloid oncotic pressure, and changes in the immune system. The morbidity and mortality from H1N1 influenza also increased our drive as a specialty to convince women that vaccination is an important strategy in each influenza season.
The flu vaccine can be administered at any point during pregnancy. There is no evidence that the safety profile is any different during one trimester than another.
Patients should be reassured that vaccines recommended in pregnancy have undergone rigorous testing and that the influenza vaccine has been given to millions of pregnant women over decades. They also should understand that contracting influenza has risks for the fetus; research has demonstrated that pregnant women who contract influenza are at greater risk of spontaneous abortion as well as preterm birth and low birth weight.4
In addition, the issue of flu vaccine efficacy needs to be properly teased apart. Women read every year that the vaccine is not effective, so we need to discuss with patients what efficacy means. Does the vaccine prevent illness altogether, or does it prevent severe illness? For the most part, whereas influenza vaccines often do not offer an exact match for the year’s circulating strains – and therefore may not prevent all illness – data show that the vaccine can prevent severe illness.5 That is a worthy outcome.
Also worthy is the impact of influenza vaccination on the newborn. That maternal immunization also protects the baby – it can reduce the risk for influenza in infants under 6 months of age – is underappreciated and should be part of patient counseling. There is clear evidence that maternal immunization boosts the concentration of maternal antibodies that can cross the placenta and that infants benefit from this passive antibody protection.6
The Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), the second vaccine routinely recommended during each pregnancy, is administered as early as possible during the third trimester precisely for this reason – to boost maternal immune response and maximize the passive transfer of antibodies to the newborn. The target is the prevention of pertussis and associated hospitalizations and death during the first 2 months of life in an era when sporadic and unpredictable outbreaks of the infection are occurring.
Data from the CDC of morbidity and mortality from pertussis in children (2001-2011) prior to routine maternal vaccination show that the highest rates of pediatric hospitalizations and deaths occurred in newborns. Research has demonstrated that the Tdap vaccine is highly effective in preventing infections and hospitalizations in newborns: Case-control and cohort studies in the United Kingdom7,8 have shown vaccine effectiveness of 91%-93%, and similar research9 done in the U.S. has demonstrated effectiveness of 78%-85%.
The Tdap vaccine is recommended for pregnant women at 27-36 weeks of gestation – in each pregnancy. The reason for revaccination with each pregnancy is that antibody levels do not remain high for too long; at 8 months post immunization, research has shown, maternal antibody levels have begun to wane.
The vaccine also is recommended for all individuals who will be in close contact with infants younger than 12 months (for example, parents, grandparents, and child-care providers) and who have not previously received it. However, “cocooning” the newborn is effective only when the mother also is immunized – a point that ob.gyns. need to better explain to their patients so that they understand the purpose of this strategy.
Other vaccines in pregnancy and post partum
As described in the American College of Obstetricians and Gynecologists’ committee opinion on maternal immunization, 4 it is the responsibility of the ob.gyn. or obstetric care provider to routinely assess the immunization status of every pregnant patient and recommend additional vaccines for those patients who have conditions or social/behavioral practices that put them at higher risk of acquiring vaccine-preventable diseases.
Patients who have asthma or diabetes, who smoke, or who have never been vaccinated for the prevention of pneumococcal disease should receive the PPV23 pneumococcal vaccine, for instance. For pregnant women with immune deficiencies such as HIV, the PCV13 vaccine followed by PPV23 is recommended. There are approximately 500,000 cases of invasive pneumococcal disease in the United States each year, resulting in 40,000 deaths, and many multidrug-resistant strains of Streptococcus pneumoniae.
Hepatitis A and B vaccines – both recombinant vaccines with no safety concerns – also can be given during pregnancy and are officially recommended for women who have high-risk exposures. In the case of hepatitis A, high risk entails traveling to countries where the disease is endemic. High-risk behavior for hepatitis B includes sex work or being the household contact or sexual partner of a person positive for hepatitis B surface antigen.
Other travel-related vaccines, such as Japanese encephalitis, yellow fever, smallpox, and inactivated polio vaccine, can be considered in pregnancy, but decisions should be driven by more in-depth conversations about potential risks and benefits. Unlike for other vaccinations, there are limited data on the safety of travel-related immunizations in pregnancy. Sometimes, the question of whether travel is advisable in the middle of pregnancy – whether potential risks are worth taking – is a valid question to pose in conversations with patients.
Standard obstetric practice includes assessment of rubella susceptibility at the beginning of pregnancy. In some locations such as New York, measles susceptibility is also routinely evaluated. After delivery, seronegative women should be vaccinated with MMR (measles, mumps, and rubella) vaccine prior to discharge. In recent years, with the growing problem of vaccine refusal and an increasingly mobile and global society, we’re seeing sporadic outbreaks of measles and rubella – diseases that were once eradicated.
Measles in particular is highly contagious and requires a herd immunity threshold of 92%-94% to prevent sustained spread of the disease. Postpartum immunization has important maternal and pediatric implications for subsequent pregnancies, before which vaccination is often missed.
Both the MMR vaccine and the varicella vaccine (another vaccine that can be initiated post partum) are live vaccines and therefore contraindicated during pregnancy but should be administered post partum, including to people who are breastfeeding.
Other immunizations that hold some promise to protect either the mother or fetus/neonate or both are in various stages of development or testing. These include vaccines for cytomegalovirus, malaria, respiratory syncytial virus, and group B streptococcus.
A word about COVID-19
In mid-July there were more than 120 vaccine candidates for COVID-19 in various phases of study and a host of questions. Will a vaccine be efficacious? Will it prevent severe illness, or illness altogether? And will it be safe for pregnant women?
Vaccines work by manipulating the immune system, and it is important to appreciate the possibility that there may be unique pregnancy-related issues to consider with future COVID-19 vaccines – issues that could influence the effectiveness, safety, and timing of vaccination – and to understand that with any new immunization, there will likely be reluctance on the part of pregnant women who routinely prioritize fetal safety over their own health.
Pregnant women have been excluded from COVID-19 vaccine trials, but there may come a time when experts decide that a vaccine against COVID-19 is beneficial in pregnancy. Thus far, we know that the disease is clearly different from influenza. A growing knowledge of the impact of COVID-19 on the health of pregnant women, particularly the risk of developing severe illness, will be important for the future of COVID-19 immunization, as many women will not want to accept any potential risk of a vaccine unless they believe there is a significant benefit.
References
1. MMWR Morb Mortal Wkly Rep. 2017 Sep 29;66(38):1016-22.
2. N Engl J Med. 2010 Jan 7;362(1):27-35.
3. Obstet Gynecol. 2015 Sep;126(3):486-90.
4. Obstet Gynecol. 2018 Jun;131(6):e214-e217.
5. MMWR Morb Mortal Wkly Rep. 2019 Feb 15;68(6):135-9.
6. Obstet Gynecol. 2019 Apr;133(4):739-53.
7. Lancet. 2014 Oct 25;384(9953):1521-8.
8. Clin Infect Dis. 2015 Feb 1;60(3):333-7.
9. Clin Infect Dis. 2017 Jan 1;64(1):9-14.
Higher death rate seen in cancer patients with nosocomial COVID-19
, according to researchers.
In an observational study of patients with COVID-19 and cancer, 19% of patients had COVID-19 acquired during a non-COVID-related hospital stay, and 81% had community-acquired COVID-19.
At a median follow-up of 23 days, the overall mortality rate was 28%. However, the all-cause mortality rate in patients with nosocomial COVID-19 was more than double that of patients with community-acquired COVID-19, at 47% and 23%, respectively.
Arielle Elkrief, MD, of the University of Montreal, reported these results during the AACR virtual meeting: COVID-19 and Cancer.
“This is the first report that describes a high rate of hospital-acquired COVID-19 in patients with cancer, at a rate of 19%,” Dr. Elkrief said. “This was associated with high mortality in both univariate and multivariate analyses.”
The study included 250 adults and 3 children with COVID-19 and cancer who were identified between March 3 and May 23, 2020. They ranged in age from 4 to 95 years, but the median age was 73 years.
All patients had either laboratory-confirmed (95%) or presumed COVID-19 (5%) and invasive cancer. The most common cancer types were similar to those seen in the general population. Lung and breast cancer were the most common, followed by lymphoma, prostate cancer, and colorectal cancer. Most patients were on active anticancer therapy, most often chemotherapy.
Most patients (n = 236) were residents of Quebec, but 17 patients were residents of British Columbia.
“It is important to note that Quebec was one of the most heavily affected areas in North America at the time of the study,” Dr. Elkrief said.
Outcomes by group
There were 206 patients (81%) who had community-acquired COVID-19 and 47 (19%) who had nosocomial COVID-19. The two groups were similar with respect to sex, performance status, and cancer stage. A small trend toward more patients on active therapy was seen in the nosocomial group, but the difference did not reach statistical significance.
The median overall survival was 27 days in the nosocomial group and 71 days in the community-acquired group (hazard ratio, 2.2; P = .002).
A multivariate analysis showed that nosocomial infection was “strongly and independently associated with death,” Dr. Elkrief said. “Other risk factors for poor prognosis included age, poor [performance] status, and advanced stage of cancer.”
There were no significant differences between the hospital-acquired and community-acquired groups for other outcomes, including oxygen requirements (43% and 47%, respectively), ICU admission (13% and 11%), need for mechanical ventilation (6% and 5%), or length of stay (median, 9.5 days and 8.5 days).
The low rate of ICU admission, considering the mortality rate of 28%, “could reflect that patients with cancer are less likely to be admitted to the ICU,” Dr. Elkrief noted.
Applying the findings to practice
The findings reinforce the importance of adherence to stringent infection control guidelines to protect vulnerable patients, such as those with cancer, Dr. Elkrief said.
In ambulatory settings, this means decreasing in-person visits through increased use of teleconsultations, and for those who need to be seen in person, screening for symptoms or use of polymerase chain reaction testing should be used when resources are available, she said.
“Similar principles apply to chemotherapy treatment units,” Dr. Elkrief said. She added that staff must avoid cross-contamination between COVID and COVID-free zones, and that “dedicated personnel and equipment should be maintained and separate between these two zones.
“Adequate protective personal equipment and strict hand hygiene protocols are also of utmost importance,” Dr. Elkrief said. “The threat of COVID-19 is not behind us, and so we continue to enforce these strategies to protect our patients.”
Session moderator Gypsyamber D’Souza, PhD, an infectious disease epidemiologist at Johns Hopkins University in Baltimore, raised the question of whether the high nosocomial infection and death rate in this study was related to patients having more severe disease because of underlying comorbidities.
Dr. Elkrief explained that the overall mortality rate was indeed higher than the 13% reported in other studies, and it may reflect an overrepresentation of hospitalized or more severely ill patients in the cohort.
However, the investigators made every effort to include all patients with both cancer and COVID-19 by using systematic screening of inpatient and outpatients lists and registries.
Further, the multivariate analysis included both inpatients and outpatients and adjusted for known negative prognostic factors for COVID-19 outcomes. These included increasing age, poor performance status, and different comorbidities.
The finding that nosocomial infection was an independent predictor of death “pushed us to look at nosocomial infection as a new independent risk factor,” Dr. Elkrief said.
Dr. Elkrief reported grant support from AstraZeneca. Dr. D’Souza did not report any disclosures.
SOURCE: Elkrief A et al. AACR: COVID and Cancer, Abstract S12-01.
, according to researchers.
In an observational study of patients with COVID-19 and cancer, 19% of patients had COVID-19 acquired during a non-COVID-related hospital stay, and 81% had community-acquired COVID-19.
At a median follow-up of 23 days, the overall mortality rate was 28%. However, the all-cause mortality rate in patients with nosocomial COVID-19 was more than double that of patients with community-acquired COVID-19, at 47% and 23%, respectively.
Arielle Elkrief, MD, of the University of Montreal, reported these results during the AACR virtual meeting: COVID-19 and Cancer.
“This is the first report that describes a high rate of hospital-acquired COVID-19 in patients with cancer, at a rate of 19%,” Dr. Elkrief said. “This was associated with high mortality in both univariate and multivariate analyses.”
The study included 250 adults and 3 children with COVID-19 and cancer who were identified between March 3 and May 23, 2020. They ranged in age from 4 to 95 years, but the median age was 73 years.
All patients had either laboratory-confirmed (95%) or presumed COVID-19 (5%) and invasive cancer. The most common cancer types were similar to those seen in the general population. Lung and breast cancer were the most common, followed by lymphoma, prostate cancer, and colorectal cancer. Most patients were on active anticancer therapy, most often chemotherapy.
Most patients (n = 236) were residents of Quebec, but 17 patients were residents of British Columbia.
“It is important to note that Quebec was one of the most heavily affected areas in North America at the time of the study,” Dr. Elkrief said.
Outcomes by group
There were 206 patients (81%) who had community-acquired COVID-19 and 47 (19%) who had nosocomial COVID-19. The two groups were similar with respect to sex, performance status, and cancer stage. A small trend toward more patients on active therapy was seen in the nosocomial group, but the difference did not reach statistical significance.
The median overall survival was 27 days in the nosocomial group and 71 days in the community-acquired group (hazard ratio, 2.2; P = .002).
A multivariate analysis showed that nosocomial infection was “strongly and independently associated with death,” Dr. Elkrief said. “Other risk factors for poor prognosis included age, poor [performance] status, and advanced stage of cancer.”
There were no significant differences between the hospital-acquired and community-acquired groups for other outcomes, including oxygen requirements (43% and 47%, respectively), ICU admission (13% and 11%), need for mechanical ventilation (6% and 5%), or length of stay (median, 9.5 days and 8.5 days).
The low rate of ICU admission, considering the mortality rate of 28%, “could reflect that patients with cancer are less likely to be admitted to the ICU,” Dr. Elkrief noted.
Applying the findings to practice
The findings reinforce the importance of adherence to stringent infection control guidelines to protect vulnerable patients, such as those with cancer, Dr. Elkrief said.
In ambulatory settings, this means decreasing in-person visits through increased use of teleconsultations, and for those who need to be seen in person, screening for symptoms or use of polymerase chain reaction testing should be used when resources are available, she said.
“Similar principles apply to chemotherapy treatment units,” Dr. Elkrief said. She added that staff must avoid cross-contamination between COVID and COVID-free zones, and that “dedicated personnel and equipment should be maintained and separate between these two zones.
“Adequate protective personal equipment and strict hand hygiene protocols are also of utmost importance,” Dr. Elkrief said. “The threat of COVID-19 is not behind us, and so we continue to enforce these strategies to protect our patients.”
Session moderator Gypsyamber D’Souza, PhD, an infectious disease epidemiologist at Johns Hopkins University in Baltimore, raised the question of whether the high nosocomial infection and death rate in this study was related to patients having more severe disease because of underlying comorbidities.
Dr. Elkrief explained that the overall mortality rate was indeed higher than the 13% reported in other studies, and it may reflect an overrepresentation of hospitalized or more severely ill patients in the cohort.
However, the investigators made every effort to include all patients with both cancer and COVID-19 by using systematic screening of inpatient and outpatients lists and registries.
Further, the multivariate analysis included both inpatients and outpatients and adjusted for known negative prognostic factors for COVID-19 outcomes. These included increasing age, poor performance status, and different comorbidities.
The finding that nosocomial infection was an independent predictor of death “pushed us to look at nosocomial infection as a new independent risk factor,” Dr. Elkrief said.
Dr. Elkrief reported grant support from AstraZeneca. Dr. D’Souza did not report any disclosures.
SOURCE: Elkrief A et al. AACR: COVID and Cancer, Abstract S12-01.
, according to researchers.
In an observational study of patients with COVID-19 and cancer, 19% of patients had COVID-19 acquired during a non-COVID-related hospital stay, and 81% had community-acquired COVID-19.
At a median follow-up of 23 days, the overall mortality rate was 28%. However, the all-cause mortality rate in patients with nosocomial COVID-19 was more than double that of patients with community-acquired COVID-19, at 47% and 23%, respectively.
Arielle Elkrief, MD, of the University of Montreal, reported these results during the AACR virtual meeting: COVID-19 and Cancer.
“This is the first report that describes a high rate of hospital-acquired COVID-19 in patients with cancer, at a rate of 19%,” Dr. Elkrief said. “This was associated with high mortality in both univariate and multivariate analyses.”
The study included 250 adults and 3 children with COVID-19 and cancer who were identified between March 3 and May 23, 2020. They ranged in age from 4 to 95 years, but the median age was 73 years.
All patients had either laboratory-confirmed (95%) or presumed COVID-19 (5%) and invasive cancer. The most common cancer types were similar to those seen in the general population. Lung and breast cancer were the most common, followed by lymphoma, prostate cancer, and colorectal cancer. Most patients were on active anticancer therapy, most often chemotherapy.
Most patients (n = 236) were residents of Quebec, but 17 patients were residents of British Columbia.
“It is important to note that Quebec was one of the most heavily affected areas in North America at the time of the study,” Dr. Elkrief said.
Outcomes by group
There were 206 patients (81%) who had community-acquired COVID-19 and 47 (19%) who had nosocomial COVID-19. The two groups were similar with respect to sex, performance status, and cancer stage. A small trend toward more patients on active therapy was seen in the nosocomial group, but the difference did not reach statistical significance.
The median overall survival was 27 days in the nosocomial group and 71 days in the community-acquired group (hazard ratio, 2.2; P = .002).
A multivariate analysis showed that nosocomial infection was “strongly and independently associated with death,” Dr. Elkrief said. “Other risk factors for poor prognosis included age, poor [performance] status, and advanced stage of cancer.”
There were no significant differences between the hospital-acquired and community-acquired groups for other outcomes, including oxygen requirements (43% and 47%, respectively), ICU admission (13% and 11%), need for mechanical ventilation (6% and 5%), or length of stay (median, 9.5 days and 8.5 days).
The low rate of ICU admission, considering the mortality rate of 28%, “could reflect that patients with cancer are less likely to be admitted to the ICU,” Dr. Elkrief noted.
Applying the findings to practice
The findings reinforce the importance of adherence to stringent infection control guidelines to protect vulnerable patients, such as those with cancer, Dr. Elkrief said.
In ambulatory settings, this means decreasing in-person visits through increased use of teleconsultations, and for those who need to be seen in person, screening for symptoms or use of polymerase chain reaction testing should be used when resources are available, she said.
“Similar principles apply to chemotherapy treatment units,” Dr. Elkrief said. She added that staff must avoid cross-contamination between COVID and COVID-free zones, and that “dedicated personnel and equipment should be maintained and separate between these two zones.
“Adequate protective personal equipment and strict hand hygiene protocols are also of utmost importance,” Dr. Elkrief said. “The threat of COVID-19 is not behind us, and so we continue to enforce these strategies to protect our patients.”
Session moderator Gypsyamber D’Souza, PhD, an infectious disease epidemiologist at Johns Hopkins University in Baltimore, raised the question of whether the high nosocomial infection and death rate in this study was related to patients having more severe disease because of underlying comorbidities.
Dr. Elkrief explained that the overall mortality rate was indeed higher than the 13% reported in other studies, and it may reflect an overrepresentation of hospitalized or more severely ill patients in the cohort.
However, the investigators made every effort to include all patients with both cancer and COVID-19 by using systematic screening of inpatient and outpatients lists and registries.
Further, the multivariate analysis included both inpatients and outpatients and adjusted for known negative prognostic factors for COVID-19 outcomes. These included increasing age, poor performance status, and different comorbidities.
The finding that nosocomial infection was an independent predictor of death “pushed us to look at nosocomial infection as a new independent risk factor,” Dr. Elkrief said.
Dr. Elkrief reported grant support from AstraZeneca. Dr. D’Souza did not report any disclosures.
SOURCE: Elkrief A et al. AACR: COVID and Cancer, Abstract S12-01.
FROM AACR: COVID-19 AND CANCER
Low vitamin D linked to increased COVID-19 risk
Low plasma vitamin D levels emerged as an independent risk factor for COVID-19 infection and hospitalization in a large, population-based study.
Participants positive for COVID-19 were 50% more likely to have low vs normal 25(OH)D levels in a multivariate analysis that controlled for other confounders, for example.
The take home message for physicians is to “test patients’ vitamin D levels and keep them optimal for the overall health – as well as for a better immunoresponse to COVID-19,” senior author Milana Frenkel-Morgenstern, PhD, head of the Cancer Genomics and BioComputing of Complex Diseases Lab at Bar-Ilan University in Ramat Gan, Israel, said in an interview.
The study was published online July 23 in The FEBS Journal.
Previous and ongoing studies are evaluating a potential role for vitamin D to prevent or minimize the severity of SARS-CoV-2 infection, building on years of research addressing vitamin D for other viral respiratory infections. The evidence to date regarding COVID-19, primarily observational studies, has yielded mixed results.
Multiple experts weighed in on the controversy in a previous report. Many point out the limitations of observational data, particularly when it comes to ruling out other factors that could affect the severity of COVID-19 infection. In addition, in a video report, JoAnn E. Manson, MD, DrPH, of Harvard Medical School in Boston, cited an observational study from three South Asian hospitals that found more severe COVID-19 patients had lower vitamin D levels, as well as other “compelling evidence” suggesting an association.
Dr. Frenkel-Morgenstern and colleagues studied data for 7,807 people, of whom 10.1% were COVID-19 positive. They assessed electronic health records for demographics, potential confounders, and outcomes between February 1 and April 30.
Participants positive for COVID-19 tended to be younger and were more likely to be men and live in a lower socioeconomic area, compared with the participants who were negative for COVID-19, in a univariate analysis.
Key findings
A higher proportion of COVID-19–positive patients had low plasma 25(OH)D concentrations, about 90% versus 85% of participants who were negative for COVID-19. The difference was statistically significant (P < .001). Furthermore, the increased likelihood for low vitamin D levels among those positive for COVID-19 held in a multivariate analysis that controlled for demographics and psychiatric and somatic disorders (adjusted odds ratio, 1.50). The difference remained statistically significant (P < .001).
The study also was noteworthy for what it did not find among participants with COVID-19. For example, the prevalence of dementia, cardiovascular disease, chronic lung disorders, and hypertension were significantly higher among the COVID-19 negative participants.
“Severe social contacts restrictions that were imposed on all the population and were even more emphasized in this highly vulnerable population” could explain these findings, the researchers noted.
“We assume that following the Israeli Ministry of Health instructions, patients with chronic medical conditions significantly reduced their social contacts” and thereby reduced their infection risk.
In contrast to previous reports, obesity was not a significant factor associated with increased likelihood for COVID-19 infection or hospitalization in the current study.
The researchers also linked low plasma 25(OH)D level to an increased likelihood of hospitalization for COVID-19 infection (crude OR, 2.09; P < .05).
After controlling for demographics and chronic disorders, the aOR decreased to 1.95 (P = .061) in a multivariate analysis. The only factor that remained statistically significant for hospitalization was age over 50 years (aOR, 2.71; P < .001).
Implications and future plans
The large number of participants and the “real world,” population-based design are strengths of the study. Considering potential confounders is another strength, the researchers noted. The retrospective database design was a limitation.
Going forward, Dr. Frenkel-Morgenstern and colleagues will “try to decipher the potential role of vitamin D in prevention and/or treatment of COVID-19” through three additional studies, she said. Also, they would like to conduct a meta-analysis to combine data from different countries to further explore the potential role of vitamin D in COVID-19.
“A compelling case”
“This is a strong study – large, adjusted for confounders, consistent with the biology and other clinical studies of vitamin D, infections, and COVID-19,” Wayne Jonas, MD, a practicing family physician and executive director of Samueli Integrative Health Programs, said in an interview.
Because the research was retrospective and observational, a causative link between vitamin D levels and COVID-19 risk cannot be interpreted from the findings. “That would need a prospective, randomized study,” said Dr. Jonas, who was not involved with the current study.
However, “the study makes a compelling case for possibly screening vitamin D levels for judging risk of COVID infection and hospitalization,” Dr. Jonas said, “and the compelling need for a large, randomized vitamin D supplement study to see if it can help prevent infection.”
“Given that vitamin D is largely safe, such a study could be done quickly and on healthy people with minimal risk for harm,” he added.
More confounders likely?
“I think the study is of interest,” Naveed Sattar, PhD, professor of metabolic medicine at the University of Glasgow, who also was not affiliated with the research, said in an interview.
“Whilst the authors adjusted for some confounders, there is a strong potential for residual confounding,” said Dr. Sattar, a coauthor of a UK Biobank study that did not find an association between vitamin D stages and COVID-19 infection in multivariate models.
For example, Dr. Sattar said, “Robust adjustment for social class is important since both Vitamin D levels and COVID-19 severity are both strongly associated with social class.” Further, it remains unknown when and what time of year the vitamin D concentrations were measured in the current study.
“In the end, only a robust randomized trial can tell us whether vitamin D supplementation helps lessen COVID-19 severity,” Dr. Sattar added. “I am not hopeful we will find this is the case – but I am glad some such trials are [ongoing].”
Dr. Frenkel-Morgenstern received a COVID-19 Data Sciences Institute grant to support this work. Dr. Frenkel-Morgenstern, Dr. Jonas, and Dr. Sattar have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Low plasma vitamin D levels emerged as an independent risk factor for COVID-19 infection and hospitalization in a large, population-based study.
Participants positive for COVID-19 were 50% more likely to have low vs normal 25(OH)D levels in a multivariate analysis that controlled for other confounders, for example.
The take home message for physicians is to “test patients’ vitamin D levels and keep them optimal for the overall health – as well as for a better immunoresponse to COVID-19,” senior author Milana Frenkel-Morgenstern, PhD, head of the Cancer Genomics and BioComputing of Complex Diseases Lab at Bar-Ilan University in Ramat Gan, Israel, said in an interview.
The study was published online July 23 in The FEBS Journal.
Previous and ongoing studies are evaluating a potential role for vitamin D to prevent or minimize the severity of SARS-CoV-2 infection, building on years of research addressing vitamin D for other viral respiratory infections. The evidence to date regarding COVID-19, primarily observational studies, has yielded mixed results.
Multiple experts weighed in on the controversy in a previous report. Many point out the limitations of observational data, particularly when it comes to ruling out other factors that could affect the severity of COVID-19 infection. In addition, in a video report, JoAnn E. Manson, MD, DrPH, of Harvard Medical School in Boston, cited an observational study from three South Asian hospitals that found more severe COVID-19 patients had lower vitamin D levels, as well as other “compelling evidence” suggesting an association.
Dr. Frenkel-Morgenstern and colleagues studied data for 7,807 people, of whom 10.1% were COVID-19 positive. They assessed electronic health records for demographics, potential confounders, and outcomes between February 1 and April 30.
Participants positive for COVID-19 tended to be younger and were more likely to be men and live in a lower socioeconomic area, compared with the participants who were negative for COVID-19, in a univariate analysis.
Key findings
A higher proportion of COVID-19–positive patients had low plasma 25(OH)D concentrations, about 90% versus 85% of participants who were negative for COVID-19. The difference was statistically significant (P < .001). Furthermore, the increased likelihood for low vitamin D levels among those positive for COVID-19 held in a multivariate analysis that controlled for demographics and psychiatric and somatic disorders (adjusted odds ratio, 1.50). The difference remained statistically significant (P < .001).
The study also was noteworthy for what it did not find among participants with COVID-19. For example, the prevalence of dementia, cardiovascular disease, chronic lung disorders, and hypertension were significantly higher among the COVID-19 negative participants.
“Severe social contacts restrictions that were imposed on all the population and were even more emphasized in this highly vulnerable population” could explain these findings, the researchers noted.
“We assume that following the Israeli Ministry of Health instructions, patients with chronic medical conditions significantly reduced their social contacts” and thereby reduced their infection risk.
In contrast to previous reports, obesity was not a significant factor associated with increased likelihood for COVID-19 infection or hospitalization in the current study.
The researchers also linked low plasma 25(OH)D level to an increased likelihood of hospitalization for COVID-19 infection (crude OR, 2.09; P < .05).
After controlling for demographics and chronic disorders, the aOR decreased to 1.95 (P = .061) in a multivariate analysis. The only factor that remained statistically significant for hospitalization was age over 50 years (aOR, 2.71; P < .001).
Implications and future plans
The large number of participants and the “real world,” population-based design are strengths of the study. Considering potential confounders is another strength, the researchers noted. The retrospective database design was a limitation.
Going forward, Dr. Frenkel-Morgenstern and colleagues will “try to decipher the potential role of vitamin D in prevention and/or treatment of COVID-19” through three additional studies, she said. Also, they would like to conduct a meta-analysis to combine data from different countries to further explore the potential role of vitamin D in COVID-19.
“A compelling case”
“This is a strong study – large, adjusted for confounders, consistent with the biology and other clinical studies of vitamin D, infections, and COVID-19,” Wayne Jonas, MD, a practicing family physician and executive director of Samueli Integrative Health Programs, said in an interview.
Because the research was retrospective and observational, a causative link between vitamin D levels and COVID-19 risk cannot be interpreted from the findings. “That would need a prospective, randomized study,” said Dr. Jonas, who was not involved with the current study.
However, “the study makes a compelling case for possibly screening vitamin D levels for judging risk of COVID infection and hospitalization,” Dr. Jonas said, “and the compelling need for a large, randomized vitamin D supplement study to see if it can help prevent infection.”
“Given that vitamin D is largely safe, such a study could be done quickly and on healthy people with minimal risk for harm,” he added.
More confounders likely?
“I think the study is of interest,” Naveed Sattar, PhD, professor of metabolic medicine at the University of Glasgow, who also was not affiliated with the research, said in an interview.
“Whilst the authors adjusted for some confounders, there is a strong potential for residual confounding,” said Dr. Sattar, a coauthor of a UK Biobank study that did not find an association between vitamin D stages and COVID-19 infection in multivariate models.
For example, Dr. Sattar said, “Robust adjustment for social class is important since both Vitamin D levels and COVID-19 severity are both strongly associated with social class.” Further, it remains unknown when and what time of year the vitamin D concentrations were measured in the current study.
“In the end, only a robust randomized trial can tell us whether vitamin D supplementation helps lessen COVID-19 severity,” Dr. Sattar added. “I am not hopeful we will find this is the case – but I am glad some such trials are [ongoing].”
Dr. Frenkel-Morgenstern received a COVID-19 Data Sciences Institute grant to support this work. Dr. Frenkel-Morgenstern, Dr. Jonas, and Dr. Sattar have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Low plasma vitamin D levels emerged as an independent risk factor for COVID-19 infection and hospitalization in a large, population-based study.
Participants positive for COVID-19 were 50% more likely to have low vs normal 25(OH)D levels in a multivariate analysis that controlled for other confounders, for example.
The take home message for physicians is to “test patients’ vitamin D levels and keep them optimal for the overall health – as well as for a better immunoresponse to COVID-19,” senior author Milana Frenkel-Morgenstern, PhD, head of the Cancer Genomics and BioComputing of Complex Diseases Lab at Bar-Ilan University in Ramat Gan, Israel, said in an interview.
The study was published online July 23 in The FEBS Journal.
Previous and ongoing studies are evaluating a potential role for vitamin D to prevent or minimize the severity of SARS-CoV-2 infection, building on years of research addressing vitamin D for other viral respiratory infections. The evidence to date regarding COVID-19, primarily observational studies, has yielded mixed results.
Multiple experts weighed in on the controversy in a previous report. Many point out the limitations of observational data, particularly when it comes to ruling out other factors that could affect the severity of COVID-19 infection. In addition, in a video report, JoAnn E. Manson, MD, DrPH, of Harvard Medical School in Boston, cited an observational study from three South Asian hospitals that found more severe COVID-19 patients had lower vitamin D levels, as well as other “compelling evidence” suggesting an association.
Dr. Frenkel-Morgenstern and colleagues studied data for 7,807 people, of whom 10.1% were COVID-19 positive. They assessed electronic health records for demographics, potential confounders, and outcomes between February 1 and April 30.
Participants positive for COVID-19 tended to be younger and were more likely to be men and live in a lower socioeconomic area, compared with the participants who were negative for COVID-19, in a univariate analysis.
Key findings
A higher proportion of COVID-19–positive patients had low plasma 25(OH)D concentrations, about 90% versus 85% of participants who were negative for COVID-19. The difference was statistically significant (P < .001). Furthermore, the increased likelihood for low vitamin D levels among those positive for COVID-19 held in a multivariate analysis that controlled for demographics and psychiatric and somatic disorders (adjusted odds ratio, 1.50). The difference remained statistically significant (P < .001).
The study also was noteworthy for what it did not find among participants with COVID-19. For example, the prevalence of dementia, cardiovascular disease, chronic lung disorders, and hypertension were significantly higher among the COVID-19 negative participants.
“Severe social contacts restrictions that were imposed on all the population and were even more emphasized in this highly vulnerable population” could explain these findings, the researchers noted.
“We assume that following the Israeli Ministry of Health instructions, patients with chronic medical conditions significantly reduced their social contacts” and thereby reduced their infection risk.
In contrast to previous reports, obesity was not a significant factor associated with increased likelihood for COVID-19 infection or hospitalization in the current study.
The researchers also linked low plasma 25(OH)D level to an increased likelihood of hospitalization for COVID-19 infection (crude OR, 2.09; P < .05).
After controlling for demographics and chronic disorders, the aOR decreased to 1.95 (P = .061) in a multivariate analysis. The only factor that remained statistically significant for hospitalization was age over 50 years (aOR, 2.71; P < .001).
Implications and future plans
The large number of participants and the “real world,” population-based design are strengths of the study. Considering potential confounders is another strength, the researchers noted. The retrospective database design was a limitation.
Going forward, Dr. Frenkel-Morgenstern and colleagues will “try to decipher the potential role of vitamin D in prevention and/or treatment of COVID-19” through three additional studies, she said. Also, they would like to conduct a meta-analysis to combine data from different countries to further explore the potential role of vitamin D in COVID-19.
“A compelling case”
“This is a strong study – large, adjusted for confounders, consistent with the biology and other clinical studies of vitamin D, infections, and COVID-19,” Wayne Jonas, MD, a practicing family physician and executive director of Samueli Integrative Health Programs, said in an interview.
Because the research was retrospective and observational, a causative link between vitamin D levels and COVID-19 risk cannot be interpreted from the findings. “That would need a prospective, randomized study,” said Dr. Jonas, who was not involved with the current study.
However, “the study makes a compelling case for possibly screening vitamin D levels for judging risk of COVID infection and hospitalization,” Dr. Jonas said, “and the compelling need for a large, randomized vitamin D supplement study to see if it can help prevent infection.”
“Given that vitamin D is largely safe, such a study could be done quickly and on healthy people with minimal risk for harm,” he added.
More confounders likely?
“I think the study is of interest,” Naveed Sattar, PhD, professor of metabolic medicine at the University of Glasgow, who also was not affiliated with the research, said in an interview.
“Whilst the authors adjusted for some confounders, there is a strong potential for residual confounding,” said Dr. Sattar, a coauthor of a UK Biobank study that did not find an association between vitamin D stages and COVID-19 infection in multivariate models.
For example, Dr. Sattar said, “Robust adjustment for social class is important since both Vitamin D levels and COVID-19 severity are both strongly associated with social class.” Further, it remains unknown when and what time of year the vitamin D concentrations were measured in the current study.
“In the end, only a robust randomized trial can tell us whether vitamin D supplementation helps lessen COVID-19 severity,” Dr. Sattar added. “I am not hopeful we will find this is the case – but I am glad some such trials are [ongoing].”
Dr. Frenkel-Morgenstern received a COVID-19 Data Sciences Institute grant to support this work. Dr. Frenkel-Morgenstern, Dr. Jonas, and Dr. Sattar have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.