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AGA introduces pathway to navigate IBD care
Inflammatory bowel disease (IBD) treatment remains a challenge in part because care is often fragmented among providers in different specialties, according to the American Gastroenterological Association. To address the need for provider coordination, the AGA has issued a new referral pathway for IBD care, published in Gastroenterology.
“The goal of this pathway is to offer guidance to primary care, emergency department, and gastroenterology providers, by helping identify patients at risk of or diagnosed with IBD and provide direction on initiating appropriate patient referrals,” wrote lead author Jami Kinnucan, MD, of the University of Michigan, Ann Arbor, and members of the AGA workgroup.
In particular, the pathway focuses on gaps in IBD care related to inflammatory issues, mental health, and nutrition. The work group included not only gastroenterologists, but also a primary care physician, mental/behavioral health specialist, registered dietitian/nutritionist, critical care specialist, nurse practitioner, physician group representative, and a patient advocacy representative.
The pathway identifies the top three areas where IBD patients usually present with symptoms: the emergency department, primary care office, and gastroenterology office.
The work group developed a list of key characteristics associated with increased morbidity, established IBD, or IBD-related complications that can be separated into high-risk, moderate-risk, and low-risk groups to help clinicians determine the timing of and need for referrals.
The pathway uses a sample patient presenting with GI symptoms such as bloody diarrhea; GI bleeding; anemia; fecal urgency; fever; abdominal pain; weight loss; and pain, swelling, or redness in the joints. Clinicians then apply the key characteristics to triage the patients into the risk groups.
High-risk characteristics include history of perianal or severe rectal disease, or deep ulcers in the GI mucosa; two or more emergency department visits for GI problems within the past 6 months, severe anemia, inadequate response to outpatient IBD therapy, history of IBD-related surgery, and malnourishment.
Moderate-risk characteristics include anemia without clinical symptoms, chronic corticosteroid use, and no emergency department or other GI medical visits within the past year.
Low-risk characteristics include chronic narcotic use, one or more comorbidities (such as heart failure, active hepatitis B, oncologic malignancy, lupus, GI infections, primary sclerosing cholangitis, viral hepatitis, and celiac disease), one or more relevant mental health conditions (such as depression, anxiety, or chronic pain), and nonadherence to IBD medical therapies.
“Referrals should be based on the highest level of risk present, in the event that a patient has characteristics that fall in more than one risk category,” the work group wrote.
To further guide clinicians in referring patients with possible or diagnosed IBD to gastroenterology specialists and to mental health and nutrition specialists, the work group developed an IBD Characteristics Assessment Checklist and a Referral Feedback form to accompany the pathway.
The checklist is designed for use by any health care professional to help identify whether a patient needs to be referred based on the key characteristics; the feedback form gives gastroenterologists a template to communicate with referring physicians about comanagement strategies for the patient.
The pathway also includes more details on how clinicians can tackle barriers to mental health and nutrition care for IBD patients.
“Until further evaluations are conducted, the work group encourages the immediate use of the pathway to begin addressing the needed improvements for IBD care coordination and communication between the different IBD providers,” the authors wrote.
Dr. Kinnucan disclosed serving as a consultant for AbbVie, Janssen, and Pfizer and serving on the Patient Education Committee of the Crohn’s and Colitis Foundation.
SOURCE: Kinnucan J et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.03.064.
Inflammatory bowel disease (IBD) treatment remains a challenge in part because care is often fragmented among providers in different specialties, according to the American Gastroenterological Association. To address the need for provider coordination, the AGA has issued a new referral pathway for IBD care, published in Gastroenterology.
“The goal of this pathway is to offer guidance to primary care, emergency department, and gastroenterology providers, by helping identify patients at risk of or diagnosed with IBD and provide direction on initiating appropriate patient referrals,” wrote lead author Jami Kinnucan, MD, of the University of Michigan, Ann Arbor, and members of the AGA workgroup.
In particular, the pathway focuses on gaps in IBD care related to inflammatory issues, mental health, and nutrition. The work group included not only gastroenterologists, but also a primary care physician, mental/behavioral health specialist, registered dietitian/nutritionist, critical care specialist, nurse practitioner, physician group representative, and a patient advocacy representative.
The pathway identifies the top three areas where IBD patients usually present with symptoms: the emergency department, primary care office, and gastroenterology office.
The work group developed a list of key characteristics associated with increased morbidity, established IBD, or IBD-related complications that can be separated into high-risk, moderate-risk, and low-risk groups to help clinicians determine the timing of and need for referrals.
The pathway uses a sample patient presenting with GI symptoms such as bloody diarrhea; GI bleeding; anemia; fecal urgency; fever; abdominal pain; weight loss; and pain, swelling, or redness in the joints. Clinicians then apply the key characteristics to triage the patients into the risk groups.
High-risk characteristics include history of perianal or severe rectal disease, or deep ulcers in the GI mucosa; two or more emergency department visits for GI problems within the past 6 months, severe anemia, inadequate response to outpatient IBD therapy, history of IBD-related surgery, and malnourishment.
Moderate-risk characteristics include anemia without clinical symptoms, chronic corticosteroid use, and no emergency department or other GI medical visits within the past year.
Low-risk characteristics include chronic narcotic use, one or more comorbidities (such as heart failure, active hepatitis B, oncologic malignancy, lupus, GI infections, primary sclerosing cholangitis, viral hepatitis, and celiac disease), one or more relevant mental health conditions (such as depression, anxiety, or chronic pain), and nonadherence to IBD medical therapies.
“Referrals should be based on the highest level of risk present, in the event that a patient has characteristics that fall in more than one risk category,” the work group wrote.
To further guide clinicians in referring patients with possible or diagnosed IBD to gastroenterology specialists and to mental health and nutrition specialists, the work group developed an IBD Characteristics Assessment Checklist and a Referral Feedback form to accompany the pathway.
The checklist is designed for use by any health care professional to help identify whether a patient needs to be referred based on the key characteristics; the feedback form gives gastroenterologists a template to communicate with referring physicians about comanagement strategies for the patient.
The pathway also includes more details on how clinicians can tackle barriers to mental health and nutrition care for IBD patients.
“Until further evaluations are conducted, the work group encourages the immediate use of the pathway to begin addressing the needed improvements for IBD care coordination and communication between the different IBD providers,” the authors wrote.
Dr. Kinnucan disclosed serving as a consultant for AbbVie, Janssen, and Pfizer and serving on the Patient Education Committee of the Crohn’s and Colitis Foundation.
SOURCE: Kinnucan J et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.03.064.
Inflammatory bowel disease (IBD) treatment remains a challenge in part because care is often fragmented among providers in different specialties, according to the American Gastroenterological Association. To address the need for provider coordination, the AGA has issued a new referral pathway for IBD care, published in Gastroenterology.
“The goal of this pathway is to offer guidance to primary care, emergency department, and gastroenterology providers, by helping identify patients at risk of or diagnosed with IBD and provide direction on initiating appropriate patient referrals,” wrote lead author Jami Kinnucan, MD, of the University of Michigan, Ann Arbor, and members of the AGA workgroup.
In particular, the pathway focuses on gaps in IBD care related to inflammatory issues, mental health, and nutrition. The work group included not only gastroenterologists, but also a primary care physician, mental/behavioral health specialist, registered dietitian/nutritionist, critical care specialist, nurse practitioner, physician group representative, and a patient advocacy representative.
The pathway identifies the top three areas where IBD patients usually present with symptoms: the emergency department, primary care office, and gastroenterology office.
The work group developed a list of key characteristics associated with increased morbidity, established IBD, or IBD-related complications that can be separated into high-risk, moderate-risk, and low-risk groups to help clinicians determine the timing of and need for referrals.
The pathway uses a sample patient presenting with GI symptoms such as bloody diarrhea; GI bleeding; anemia; fecal urgency; fever; abdominal pain; weight loss; and pain, swelling, or redness in the joints. Clinicians then apply the key characteristics to triage the patients into the risk groups.
High-risk characteristics include history of perianal or severe rectal disease, or deep ulcers in the GI mucosa; two or more emergency department visits for GI problems within the past 6 months, severe anemia, inadequate response to outpatient IBD therapy, history of IBD-related surgery, and malnourishment.
Moderate-risk characteristics include anemia without clinical symptoms, chronic corticosteroid use, and no emergency department or other GI medical visits within the past year.
Low-risk characteristics include chronic narcotic use, one or more comorbidities (such as heart failure, active hepatitis B, oncologic malignancy, lupus, GI infections, primary sclerosing cholangitis, viral hepatitis, and celiac disease), one or more relevant mental health conditions (such as depression, anxiety, or chronic pain), and nonadherence to IBD medical therapies.
“Referrals should be based on the highest level of risk present, in the event that a patient has characteristics that fall in more than one risk category,” the work group wrote.
To further guide clinicians in referring patients with possible or diagnosed IBD to gastroenterology specialists and to mental health and nutrition specialists, the work group developed an IBD Characteristics Assessment Checklist and a Referral Feedback form to accompany the pathway.
The checklist is designed for use by any health care professional to help identify whether a patient needs to be referred based on the key characteristics; the feedback form gives gastroenterologists a template to communicate with referring physicians about comanagement strategies for the patient.
The pathway also includes more details on how clinicians can tackle barriers to mental health and nutrition care for IBD patients.
“Until further evaluations are conducted, the work group encourages the immediate use of the pathway to begin addressing the needed improvements for IBD care coordination and communication between the different IBD providers,” the authors wrote.
Dr. Kinnucan disclosed serving as a consultant for AbbVie, Janssen, and Pfizer and serving on the Patient Education Committee of the Crohn’s and Colitis Foundation.
SOURCE: Kinnucan J et al. Gastroenterology. 2019. doi: 10.1053/j.gastro.2019.03.064.
FROM GASTROENTEROLOGY
Diverse vaginal microbiome may signal risk for preterm birth
in an analysis of approximately 12,000 samples, according to a study published in Nature Medicine.
Preterm births, defined as less than 37 weeks’ gestation, remain the second most common cause of neonatal death worldwide, but few strategies exist to prevent and predict preterm birth (PTB) wrote Jennifer M. Fettweis, MD, of Virginia Commonwealth University, Richmond, and her colleagues. In the United States, women of African ancestry are at significantly greater risk for PTB.
A highly diverse vaginal microbiome is thought to be associated with an increased risk of inflammation, infection, and PTB, “however, many asymptomatic healthy women have diverse vaginal microbiota,” the researchers said.
To identify vaginal microbiota distinct to women who experienced PTB, the researchers analyzed data from the Multi-Omic Microbiome Study: Pregnancy Initiative (MOMS-PI), part of the National Institutes of Health–sponsored Integrative Human Microbiome Project. The MOMS-PI study included 12,039 samples of vaginal flora from 597 pregnancies; the analysis included 45 singleton pregnancies that met the criteria for spontaneous PTB (23-36 weeks, 6 days of gestation) and 90 case-matched full-term singleton pregnancies (greater than or equal to 39 weeks). Approximately 78% of the women were of African descent in both groups, and their average age was 26 years in both groups.
Overall, the diversity of the vaginal microbiome was greater among women who experienced PTB, compared with term birth (TB). Women who experienced PTB had less Lactobacillus crispatus, but more bacterial vaginosis–associated bacterium-1 (BVAB1), Prevotella cluster 2, and Sneathia amnii, compared with TB women.
Of note, vaginal cytokine data showed that proinflammatory cytokines, which may be associated with the induction of labor, may be prompted by inflammation in the vaginal microbiome, Dr. Fettweis and her associates said. “We observed that vaginal IP-10/CXCL10 levels were inversely correlated with BVAB1 in PTB, inversely correlated with L. crispatus in TB, and positively correlated with L. iners in TB, suggesting complex host-microbiome interactions in pregnancy,” they said.
“Further studies are needed to determine whether the signatures of PTB reported in the present study replicate in other cohorts of women of African ancestry, to examine whether the observed differences in vaginal microbiome composition between women of different ancestries has a direct causal link to the ethnic and racial disparities in PTB rates, and to establish whether population-specific microbial markers can be ultimately integrated into a generalizable spectrum of vaginal microbiome states linked to the risk for PTB,” Dr. Fettweis and her associates said.
In a companion study also published in Nature Medicine, Myrna G. Serrano, MD, also of Virginia Commonwealth University, and her colleagues as part of the MOMS-PI initially determined that vaginal microbiome profiles varied between 613 pregnant and 1,969 nonpregnant women in that “pregnant women had significantly higher prevalence of the four most common Lactobacillus vagitypes (L. crispatus, L. iners, L. gasseri, and L. jensenii) and a commensurately lower prevalence of vagitypes dominated by other taxa.” The primary driver of the differences was L. iners.
They then compared vaginal microbiome data from 300 pregnant and 300 nonpregnant case-matched women of African, Hispanic, or European ancestry, as well as 90 pregnant women (49 of African ancestry and 41 of European) ancestry.
In the subset of 300 pregnant and 300 nonpregnant women, the vaginal microbiome of the pregnant women overall became more dominated by Lactobacillus early in pregnancy. Further stratification by race showed that pregnant women of African and Hispanic ancestry had significantly higher levels of four types of Lactobacillus than their nonpregnant counterparts, but no significant difference was seen between pregnant and nonpregnant women of European ancestry.
“It appears that changes occurring during pregnancy may render the reproductive tracts of women of all racial backgrounds more hospitable to taxa of Lactobacillus and less favorable for Gardnerella vaginalis and other taxa associated with BV [bacterial vaginosis] and dysbiosis,” the researchers said.
“Interestingly, BVAB1, which has been associated with dysbiotic vaginal conditions and risk of PTB, and which is present as a major vagitype largely in women of African ancestry, is not noticeably decreased in prevalence in pregnancy,” Dr. Serrano and her associates said. “Thus, BVAB1, for reasons yet to be determined, is apparently resistant to factors sculpting the microbiome in pregnant women, possibly explaining in part the enhanced risk for PTB experienced by women of African ancestry.”
In a look at the 49 pregnant women of African ancestry and 41 of European ancestry, those of African ancestry had “significantly lower representation of the L. crispatus, L. gasseri and L. jensenii vagitypes, and higher representation of L. iners and BVAB1 vagitypes. Variability in women of African ancestry was driven by BVAB1 and L. iners, whereas variability in women of non-African ancestry was driven by L. crispatus and L. iners. Again, pregnancy had no significant effect on prevalence of the BVAB1 vagitype. Prevalence of Lactobacillus-dominated profiles in women of African ancestry was lower in the first than in later trimesters, whereas women of European ancestry had a higher prevalence of Lactobacillus vagitypes throughout pregnancy.”
The presence of vaginal microbiome profiles associated with adverse pregnancy outcomes highlights the need for further studies that take advantage of this information, Dr. Serrano and her associates said. “That the vaginal microbiomes known to confer higher risk of poor health and adverse outcomes of pregnancy are more highly associated with women of African and Hispanic ancestry, but that pregnancy tends to drive these microbiomes toward more favorable microbiota, suggests that an external intervention that favors this trend might be beneficial for these populations,” they concluded. “What remains is to verify the most favorable microbiome and the most effective strategy for intervention.”
Dr. Fettweis had no financial conflicts to disclose; two coauthors are full-time employees at Pacific Biosciences. Dr. Serrano and her coauthors had no relevant financial disclosures. Dr. Serrano’s study received grants from the National Institutes of Health and other sources, as well as support from the Common Fund, the National Center for Complementary and Integrative Health, the Office of Research on Women’s Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases.
SOURCES: Fettweis J et al. Nature Medicine 2019 May 29. doi: 10.1038/s41591-019-0450-2; Serrano M et al. Nature Medicine. 2019 May 29. doi: 10.1038/s41591-019-0465-8.
in an analysis of approximately 12,000 samples, according to a study published in Nature Medicine.
Preterm births, defined as less than 37 weeks’ gestation, remain the second most common cause of neonatal death worldwide, but few strategies exist to prevent and predict preterm birth (PTB) wrote Jennifer M. Fettweis, MD, of Virginia Commonwealth University, Richmond, and her colleagues. In the United States, women of African ancestry are at significantly greater risk for PTB.
A highly diverse vaginal microbiome is thought to be associated with an increased risk of inflammation, infection, and PTB, “however, many asymptomatic healthy women have diverse vaginal microbiota,” the researchers said.
To identify vaginal microbiota distinct to women who experienced PTB, the researchers analyzed data from the Multi-Omic Microbiome Study: Pregnancy Initiative (MOMS-PI), part of the National Institutes of Health–sponsored Integrative Human Microbiome Project. The MOMS-PI study included 12,039 samples of vaginal flora from 597 pregnancies; the analysis included 45 singleton pregnancies that met the criteria for spontaneous PTB (23-36 weeks, 6 days of gestation) and 90 case-matched full-term singleton pregnancies (greater than or equal to 39 weeks). Approximately 78% of the women were of African descent in both groups, and their average age was 26 years in both groups.
Overall, the diversity of the vaginal microbiome was greater among women who experienced PTB, compared with term birth (TB). Women who experienced PTB had less Lactobacillus crispatus, but more bacterial vaginosis–associated bacterium-1 (BVAB1), Prevotella cluster 2, and Sneathia amnii, compared with TB women.
Of note, vaginal cytokine data showed that proinflammatory cytokines, which may be associated with the induction of labor, may be prompted by inflammation in the vaginal microbiome, Dr. Fettweis and her associates said. “We observed that vaginal IP-10/CXCL10 levels were inversely correlated with BVAB1 in PTB, inversely correlated with L. crispatus in TB, and positively correlated with L. iners in TB, suggesting complex host-microbiome interactions in pregnancy,” they said.
“Further studies are needed to determine whether the signatures of PTB reported in the present study replicate in other cohorts of women of African ancestry, to examine whether the observed differences in vaginal microbiome composition between women of different ancestries has a direct causal link to the ethnic and racial disparities in PTB rates, and to establish whether population-specific microbial markers can be ultimately integrated into a generalizable spectrum of vaginal microbiome states linked to the risk for PTB,” Dr. Fettweis and her associates said.
In a companion study also published in Nature Medicine, Myrna G. Serrano, MD, also of Virginia Commonwealth University, and her colleagues as part of the MOMS-PI initially determined that vaginal microbiome profiles varied between 613 pregnant and 1,969 nonpregnant women in that “pregnant women had significantly higher prevalence of the four most common Lactobacillus vagitypes (L. crispatus, L. iners, L. gasseri, and L. jensenii) and a commensurately lower prevalence of vagitypes dominated by other taxa.” The primary driver of the differences was L. iners.
They then compared vaginal microbiome data from 300 pregnant and 300 nonpregnant case-matched women of African, Hispanic, or European ancestry, as well as 90 pregnant women (49 of African ancestry and 41 of European) ancestry.
In the subset of 300 pregnant and 300 nonpregnant women, the vaginal microbiome of the pregnant women overall became more dominated by Lactobacillus early in pregnancy. Further stratification by race showed that pregnant women of African and Hispanic ancestry had significantly higher levels of four types of Lactobacillus than their nonpregnant counterparts, but no significant difference was seen between pregnant and nonpregnant women of European ancestry.
“It appears that changes occurring during pregnancy may render the reproductive tracts of women of all racial backgrounds more hospitable to taxa of Lactobacillus and less favorable for Gardnerella vaginalis and other taxa associated with BV [bacterial vaginosis] and dysbiosis,” the researchers said.
“Interestingly, BVAB1, which has been associated with dysbiotic vaginal conditions and risk of PTB, and which is present as a major vagitype largely in women of African ancestry, is not noticeably decreased in prevalence in pregnancy,” Dr. Serrano and her associates said. “Thus, BVAB1, for reasons yet to be determined, is apparently resistant to factors sculpting the microbiome in pregnant women, possibly explaining in part the enhanced risk for PTB experienced by women of African ancestry.”
In a look at the 49 pregnant women of African ancestry and 41 of European ancestry, those of African ancestry had “significantly lower representation of the L. crispatus, L. gasseri and L. jensenii vagitypes, and higher representation of L. iners and BVAB1 vagitypes. Variability in women of African ancestry was driven by BVAB1 and L. iners, whereas variability in women of non-African ancestry was driven by L. crispatus and L. iners. Again, pregnancy had no significant effect on prevalence of the BVAB1 vagitype. Prevalence of Lactobacillus-dominated profiles in women of African ancestry was lower in the first than in later trimesters, whereas women of European ancestry had a higher prevalence of Lactobacillus vagitypes throughout pregnancy.”
The presence of vaginal microbiome profiles associated with adverse pregnancy outcomes highlights the need for further studies that take advantage of this information, Dr. Serrano and her associates said. “That the vaginal microbiomes known to confer higher risk of poor health and adverse outcomes of pregnancy are more highly associated with women of African and Hispanic ancestry, but that pregnancy tends to drive these microbiomes toward more favorable microbiota, suggests that an external intervention that favors this trend might be beneficial for these populations,” they concluded. “What remains is to verify the most favorable microbiome and the most effective strategy for intervention.”
Dr. Fettweis had no financial conflicts to disclose; two coauthors are full-time employees at Pacific Biosciences. Dr. Serrano and her coauthors had no relevant financial disclosures. Dr. Serrano’s study received grants from the National Institutes of Health and other sources, as well as support from the Common Fund, the National Center for Complementary and Integrative Health, the Office of Research on Women’s Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases.
SOURCES: Fettweis J et al. Nature Medicine 2019 May 29. doi: 10.1038/s41591-019-0450-2; Serrano M et al. Nature Medicine. 2019 May 29. doi: 10.1038/s41591-019-0465-8.
in an analysis of approximately 12,000 samples, according to a study published in Nature Medicine.
Preterm births, defined as less than 37 weeks’ gestation, remain the second most common cause of neonatal death worldwide, but few strategies exist to prevent and predict preterm birth (PTB) wrote Jennifer M. Fettweis, MD, of Virginia Commonwealth University, Richmond, and her colleagues. In the United States, women of African ancestry are at significantly greater risk for PTB.
A highly diverse vaginal microbiome is thought to be associated with an increased risk of inflammation, infection, and PTB, “however, many asymptomatic healthy women have diverse vaginal microbiota,” the researchers said.
To identify vaginal microbiota distinct to women who experienced PTB, the researchers analyzed data from the Multi-Omic Microbiome Study: Pregnancy Initiative (MOMS-PI), part of the National Institutes of Health–sponsored Integrative Human Microbiome Project. The MOMS-PI study included 12,039 samples of vaginal flora from 597 pregnancies; the analysis included 45 singleton pregnancies that met the criteria for spontaneous PTB (23-36 weeks, 6 days of gestation) and 90 case-matched full-term singleton pregnancies (greater than or equal to 39 weeks). Approximately 78% of the women were of African descent in both groups, and their average age was 26 years in both groups.
Overall, the diversity of the vaginal microbiome was greater among women who experienced PTB, compared with term birth (TB). Women who experienced PTB had less Lactobacillus crispatus, but more bacterial vaginosis–associated bacterium-1 (BVAB1), Prevotella cluster 2, and Sneathia amnii, compared with TB women.
Of note, vaginal cytokine data showed that proinflammatory cytokines, which may be associated with the induction of labor, may be prompted by inflammation in the vaginal microbiome, Dr. Fettweis and her associates said. “We observed that vaginal IP-10/CXCL10 levels were inversely correlated with BVAB1 in PTB, inversely correlated with L. crispatus in TB, and positively correlated with L. iners in TB, suggesting complex host-microbiome interactions in pregnancy,” they said.
“Further studies are needed to determine whether the signatures of PTB reported in the present study replicate in other cohorts of women of African ancestry, to examine whether the observed differences in vaginal microbiome composition between women of different ancestries has a direct causal link to the ethnic and racial disparities in PTB rates, and to establish whether population-specific microbial markers can be ultimately integrated into a generalizable spectrum of vaginal microbiome states linked to the risk for PTB,” Dr. Fettweis and her associates said.
In a companion study also published in Nature Medicine, Myrna G. Serrano, MD, also of Virginia Commonwealth University, and her colleagues as part of the MOMS-PI initially determined that vaginal microbiome profiles varied between 613 pregnant and 1,969 nonpregnant women in that “pregnant women had significantly higher prevalence of the four most common Lactobacillus vagitypes (L. crispatus, L. iners, L. gasseri, and L. jensenii) and a commensurately lower prevalence of vagitypes dominated by other taxa.” The primary driver of the differences was L. iners.
They then compared vaginal microbiome data from 300 pregnant and 300 nonpregnant case-matched women of African, Hispanic, or European ancestry, as well as 90 pregnant women (49 of African ancestry and 41 of European) ancestry.
In the subset of 300 pregnant and 300 nonpregnant women, the vaginal microbiome of the pregnant women overall became more dominated by Lactobacillus early in pregnancy. Further stratification by race showed that pregnant women of African and Hispanic ancestry had significantly higher levels of four types of Lactobacillus than their nonpregnant counterparts, but no significant difference was seen between pregnant and nonpregnant women of European ancestry.
“It appears that changes occurring during pregnancy may render the reproductive tracts of women of all racial backgrounds more hospitable to taxa of Lactobacillus and less favorable for Gardnerella vaginalis and other taxa associated with BV [bacterial vaginosis] and dysbiosis,” the researchers said.
“Interestingly, BVAB1, which has been associated with dysbiotic vaginal conditions and risk of PTB, and which is present as a major vagitype largely in women of African ancestry, is not noticeably decreased in prevalence in pregnancy,” Dr. Serrano and her associates said. “Thus, BVAB1, for reasons yet to be determined, is apparently resistant to factors sculpting the microbiome in pregnant women, possibly explaining in part the enhanced risk for PTB experienced by women of African ancestry.”
In a look at the 49 pregnant women of African ancestry and 41 of European ancestry, those of African ancestry had “significantly lower representation of the L. crispatus, L. gasseri and L. jensenii vagitypes, and higher representation of L. iners and BVAB1 vagitypes. Variability in women of African ancestry was driven by BVAB1 and L. iners, whereas variability in women of non-African ancestry was driven by L. crispatus and L. iners. Again, pregnancy had no significant effect on prevalence of the BVAB1 vagitype. Prevalence of Lactobacillus-dominated profiles in women of African ancestry was lower in the first than in later trimesters, whereas women of European ancestry had a higher prevalence of Lactobacillus vagitypes throughout pregnancy.”
The presence of vaginal microbiome profiles associated with adverse pregnancy outcomes highlights the need for further studies that take advantage of this information, Dr. Serrano and her associates said. “That the vaginal microbiomes known to confer higher risk of poor health and adverse outcomes of pregnancy are more highly associated with women of African and Hispanic ancestry, but that pregnancy tends to drive these microbiomes toward more favorable microbiota, suggests that an external intervention that favors this trend might be beneficial for these populations,” they concluded. “What remains is to verify the most favorable microbiome and the most effective strategy for intervention.”
Dr. Fettweis had no financial conflicts to disclose; two coauthors are full-time employees at Pacific Biosciences. Dr. Serrano and her coauthors had no relevant financial disclosures. Dr. Serrano’s study received grants from the National Institutes of Health and other sources, as well as support from the Common Fund, the National Center for Complementary and Integrative Health, the Office of Research on Women’s Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases.
SOURCES: Fettweis J et al. Nature Medicine 2019 May 29. doi: 10.1038/s41591-019-0450-2; Serrano M et al. Nature Medicine. 2019 May 29. doi: 10.1038/s41591-019-0465-8.
FROM NATURE MEDICINE
Review clarifies depression, anxiety risk among hidradenitis suppurativa patients
and meta-analysis of more than 40,000 adults.
Previous studies of psychiatric comorbidities in HS patients have suggested an increased rate of depression, anxiety, and suicide risk, but have varied in methodology. “Therefore, the exact magnitude of the prevalence and odds of depression and anxiety in patients with HS is unclear,” wrote Myrela O. Machado, MD, of the division of dermatology, Women’s College Hospital, Toronto, and colleagues.
In a review of PubMed/MEDLINE, Embase, and PsycINFO electronic databases through July 2018, the researchers identified 10 studies comprising 40,307 adults with HS. The overall prevalence of depression was 16.9%, and in the studies that included a comparison group, the odds ratio for depression was 1.84 for HS patients, compared with controls who did not have HS. The overall prevalence of anxiety was 4.9%, but data were insufficient to determine an odds ratio for anxiety. The study was published in JAMA Dermatology.
All 10 studies assessed depression; 4 assessed anxiety. In subgroup analyses, the prevalence of depression was 11.9% in studies with a diagnosis based on clinical criteria and 26.8% in studies that used a screening instrument. The prevalence was 25.9% for outpatients with HS.
“Although our findings indicate that depression and anxiety may be common among people with HS, whether there is a causal relationship in those associations remains to be proved,” the researchers wrote.
However, they noted, “the consequences of depression and anxiety on HS-related outcomes have recently received more attention.”
The study findings were limited by several factors including the lack of data from structured diagnostic interviews, variation in methodological quality, and variation in comparison groups across studies, as well as a high level of heterogeneity across studies, the researchers noted. However, the results support the need to recognize and treat psychiatric conditions in HS patients, and to develop new management strategies, they said.
Dr. Machado had no financial conflicts to disclose. Several coauthors disclosed relationships with Galderma, LEO Pharma, Janssen, Novartis, AbbVie, Celgene, Naos, Lilly, Sanofi, Valeant, and La Roche-Posay.
SOURCE: Machado M et al. JAMA Dermatol. 2019 June 5. doi: 10.1001/jamadermatol.2019.0759.
and meta-analysis of more than 40,000 adults.
Previous studies of psychiatric comorbidities in HS patients have suggested an increased rate of depression, anxiety, and suicide risk, but have varied in methodology. “Therefore, the exact magnitude of the prevalence and odds of depression and anxiety in patients with HS is unclear,” wrote Myrela O. Machado, MD, of the division of dermatology, Women’s College Hospital, Toronto, and colleagues.
In a review of PubMed/MEDLINE, Embase, and PsycINFO electronic databases through July 2018, the researchers identified 10 studies comprising 40,307 adults with HS. The overall prevalence of depression was 16.9%, and in the studies that included a comparison group, the odds ratio for depression was 1.84 for HS patients, compared with controls who did not have HS. The overall prevalence of anxiety was 4.9%, but data were insufficient to determine an odds ratio for anxiety. The study was published in JAMA Dermatology.
All 10 studies assessed depression; 4 assessed anxiety. In subgroup analyses, the prevalence of depression was 11.9% in studies with a diagnosis based on clinical criteria and 26.8% in studies that used a screening instrument. The prevalence was 25.9% for outpatients with HS.
“Although our findings indicate that depression and anxiety may be common among people with HS, whether there is a causal relationship in those associations remains to be proved,” the researchers wrote.
However, they noted, “the consequences of depression and anxiety on HS-related outcomes have recently received more attention.”
The study findings were limited by several factors including the lack of data from structured diagnostic interviews, variation in methodological quality, and variation in comparison groups across studies, as well as a high level of heterogeneity across studies, the researchers noted. However, the results support the need to recognize and treat psychiatric conditions in HS patients, and to develop new management strategies, they said.
Dr. Machado had no financial conflicts to disclose. Several coauthors disclosed relationships with Galderma, LEO Pharma, Janssen, Novartis, AbbVie, Celgene, Naos, Lilly, Sanofi, Valeant, and La Roche-Posay.
SOURCE: Machado M et al. JAMA Dermatol. 2019 June 5. doi: 10.1001/jamadermatol.2019.0759.
and meta-analysis of more than 40,000 adults.
Previous studies of psychiatric comorbidities in HS patients have suggested an increased rate of depression, anxiety, and suicide risk, but have varied in methodology. “Therefore, the exact magnitude of the prevalence and odds of depression and anxiety in patients with HS is unclear,” wrote Myrela O. Machado, MD, of the division of dermatology, Women’s College Hospital, Toronto, and colleagues.
In a review of PubMed/MEDLINE, Embase, and PsycINFO electronic databases through July 2018, the researchers identified 10 studies comprising 40,307 adults with HS. The overall prevalence of depression was 16.9%, and in the studies that included a comparison group, the odds ratio for depression was 1.84 for HS patients, compared with controls who did not have HS. The overall prevalence of anxiety was 4.9%, but data were insufficient to determine an odds ratio for anxiety. The study was published in JAMA Dermatology.
All 10 studies assessed depression; 4 assessed anxiety. In subgroup analyses, the prevalence of depression was 11.9% in studies with a diagnosis based on clinical criteria and 26.8% in studies that used a screening instrument. The prevalence was 25.9% for outpatients with HS.
“Although our findings indicate that depression and anxiety may be common among people with HS, whether there is a causal relationship in those associations remains to be proved,” the researchers wrote.
However, they noted, “the consequences of depression and anxiety on HS-related outcomes have recently received more attention.”
The study findings were limited by several factors including the lack of data from structured diagnostic interviews, variation in methodological quality, and variation in comparison groups across studies, as well as a high level of heterogeneity across studies, the researchers noted. However, the results support the need to recognize and treat psychiatric conditions in HS patients, and to develop new management strategies, they said.
Dr. Machado had no financial conflicts to disclose. Several coauthors disclosed relationships with Galderma, LEO Pharma, Janssen, Novartis, AbbVie, Celgene, Naos, Lilly, Sanofi, Valeant, and La Roche-Posay.
SOURCE: Machado M et al. JAMA Dermatol. 2019 June 5. doi: 10.1001/jamadermatol.2019.0759.
FROM JAMA DERMATOLOGY
Peanut desensitization comes at cost of anaphylaxis
based on a meta-analysis from more than 1,000 patients published in the Lancet.
In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).
Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).
In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).
Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.
The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.
The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.
However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.
The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.
Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.
SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.
“The key criticism of this systematic review is inherent in its method because studies with different designs were grouped together,” Graham Roberts, MD, and Elizabeth Angier, MD, wrote in an accompanying editorial. In addition, the studies chosen did not account for the development of long-term peanut tolerance after the therapy was discontinued.
Also, the researchers did not factor in the variation in patterns of anaphylactic events, with patients in the treatment groups having events at home in conjunction with daily peanut doses, while the control patients would have had events mainly away from home.
“Unfortunately, the trials have not provided information about which participants benefited most from the intervention,” they wrote.
“Trading treatment-related side effects at home for allergic reactions to accidental exposures out of the house [i.e., in social situations] might beneficial for some patients,” they added. However, more research is needed to determine which patients would benefit from different treatment options at home and outside the home. The less effective but safer option of epicutaneous immunotherapy might be preferred by some patients. And early introduction of peanut products during infancy may prevent many cases of peanut allergy.
Dr. Roberts and Dr. Angier are at the University of Southampton (England). Both are members of the European Academy of Allergy and Clinical Immunology Allergen Immunotherapy Guidelines Group, which has recently published guidelines on immunotherapy. They wrote an editorial to accompany the article by Chu et al (Lancet. 2019 June 1;393:2180-1). They had no financial conflicts to disclose.
“The key criticism of this systematic review is inherent in its method because studies with different designs were grouped together,” Graham Roberts, MD, and Elizabeth Angier, MD, wrote in an accompanying editorial. In addition, the studies chosen did not account for the development of long-term peanut tolerance after the therapy was discontinued.
Also, the researchers did not factor in the variation in patterns of anaphylactic events, with patients in the treatment groups having events at home in conjunction with daily peanut doses, while the control patients would have had events mainly away from home.
“Unfortunately, the trials have not provided information about which participants benefited most from the intervention,” they wrote.
“Trading treatment-related side effects at home for allergic reactions to accidental exposures out of the house [i.e., in social situations] might beneficial for some patients,” they added. However, more research is needed to determine which patients would benefit from different treatment options at home and outside the home. The less effective but safer option of epicutaneous immunotherapy might be preferred by some patients. And early introduction of peanut products during infancy may prevent many cases of peanut allergy.
Dr. Roberts and Dr. Angier are at the University of Southampton (England). Both are members of the European Academy of Allergy and Clinical Immunology Allergen Immunotherapy Guidelines Group, which has recently published guidelines on immunotherapy. They wrote an editorial to accompany the article by Chu et al (Lancet. 2019 June 1;393:2180-1). They had no financial conflicts to disclose.
“The key criticism of this systematic review is inherent in its method because studies with different designs were grouped together,” Graham Roberts, MD, and Elizabeth Angier, MD, wrote in an accompanying editorial. In addition, the studies chosen did not account for the development of long-term peanut tolerance after the therapy was discontinued.
Also, the researchers did not factor in the variation in patterns of anaphylactic events, with patients in the treatment groups having events at home in conjunction with daily peanut doses, while the control patients would have had events mainly away from home.
“Unfortunately, the trials have not provided information about which participants benefited most from the intervention,” they wrote.
“Trading treatment-related side effects at home for allergic reactions to accidental exposures out of the house [i.e., in social situations] might beneficial for some patients,” they added. However, more research is needed to determine which patients would benefit from different treatment options at home and outside the home. The less effective but safer option of epicutaneous immunotherapy might be preferred by some patients. And early introduction of peanut products during infancy may prevent many cases of peanut allergy.
Dr. Roberts and Dr. Angier are at the University of Southampton (England). Both are members of the European Academy of Allergy and Clinical Immunology Allergen Immunotherapy Guidelines Group, which has recently published guidelines on immunotherapy. They wrote an editorial to accompany the article by Chu et al (Lancet. 2019 June 1;393:2180-1). They had no financial conflicts to disclose.
based on a meta-analysis from more than 1,000 patients published in the Lancet.
In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).
Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).
In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).
Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.
The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.
The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.
However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.
The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.
Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.
SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.
based on a meta-analysis from more than 1,000 patients published in the Lancet.
In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).
Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).
In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).
Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.
The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.
The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.
However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.
The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.
Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.
SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.
FROM THE LANCET
New tickborne virus emerges in China
A new virus has been associated with febrile illness in China in patients with histories of tick bites. The data on the discovery, isolation, and characterization of the virus were reported in the New England Journal of Medicine.
The segmented RNA virus now known as Alongshan virus (ALSV) “belongs to the unclassified jingmenvirus group in the family Flaviviridae, which includes the genera flavivirus, pestivirus, hepacivirus, and pegivirus,” wrote Ze-Dong Wang, PhD, of Foshan (China) University, and colleagues.
The index patient with ALSV was a 42-year-old female farmer from the town of Alongshan, China, who presented to a regional hospital in April 2017 with fever, headache, and a history of tick bites. The initial clinical features were similar to those seen in tickborne diseases, but a blood sample showed no RNA or antibodies for tickborne encephalitis virus. Investigators obtained a blood specimen from the index patient 4 days after the onset of illness. After culturing the sample, the investigators extracted the viral RNA genome and sequenced it.
Sequence analysis found that the new pathogen was related to segmented viruses in the jingmenvirus group of the family Flaviviridae; however, “comparison of the amino acids further confirmed that ALSV is genetically distinct from other jingmenviruses,” the investigators said.
The investigators identified 374 patients who presented to the hospital with fever, headache, and a history of tick bites during May 2017–September 2017; 86 patients had confirmed ALSV infections via nested reverse-transcription polymerase chain reaction testing. Of these, 63 were men and 84 were farmers or forestry workers. Although ticks were common in the patients’ environments, no other evidence of tickborne diseases was noted. The patients ranged in age from 24 to 77 years, and the average duration of the infection was 3-7 days.
Symptoms were nonspecific and included fever, headache, fatigue, nausea, cough, and sore throat. All 86 patients were treated with intravenous ribavirin (0.5 g/day), and intramuscular benzylpenicillin sodium (2 million U/day) for 3-5 days. The median hospital stay was 11 days, and no deaths or long-term clinical complications occurred in the confirmed ALSV patients.
ALSV is similar to other jingmenviruses, but is distinct from other infections in part because of the absence of a rash or jaundice, the investigators said.
Although the investigators said they suspected the disease was carried by ticks, they would not rule out mosquitoes as a possible carrier because ALSV RNA was found in mosquitoes in a Northeastern province of China, and the RNA from those mosquitoes was found to be genetically related to the RNA assessed in this study.
Overall, “our findings suggest that ALSV may be the cause of a previously unknown febrile disease, and more studies should be conducted to determine the geographic distribution of this disease outside its current areas of identification,” they said.
The research was supported by the National Key Research and Development Program of China and the National Natural Science Foundation of China.
SOURCE: Wang Z et al. N Engl J Med. 2019 May 29. doi: 10.1056/NEJMoa1805068.
New technology and genomic surveys will continue to help identify emerging pathogens, however, “they may provide limited value in understanding the mechanisms of disease emergence,” wrote Nikos Vasilakis, PhD, and David H. Walker, MD, in an accompanying editorial. An active surveillance program allowed the investigators of the previously unknown tickborne pathogen in China to identify a group of patients with similar history. The new pathogen was classified as one of the jingmenviruses, which “reveal that RNA virus segmentation is an evolutionary process that has occurred in previously unanticipated circumstances.” This study by Wang et al. shows that these viruses are not limited to arthropod hosts but can be dangerous to humans.
The new pathogen had likely been evolving for some time before it was discovered, the editorialists said. “The key to making such discoveries is the study of ill persons, isolation of the etiologic agent, use of tools that will reveal the nature of the agent (e.g., electron microscopy), and application of the appropriate tools for definitive characterization (e.g., sequencing of the RNA genome),” they emphasized. However, to mitigate outbreaks, “proactive, real-time surveillance” may be more cost effective than extensive genomic surveys, they noted (N Engl J Med. 2019 May 29. doi: 10.1056/NEJMe1901212).
Dr. Vasilakis and Dr. Walker are affiliated with the department of pathology, Center for Biodefense and Emerging Infectious Diseases, Center for Tropical Diseases, and the Institute for Human Infections and Immunity, University of Texas Medical Branch, Galveston. They had no financial conflicts to disclose.
New technology and genomic surveys will continue to help identify emerging pathogens, however, “they may provide limited value in understanding the mechanisms of disease emergence,” wrote Nikos Vasilakis, PhD, and David H. Walker, MD, in an accompanying editorial. An active surveillance program allowed the investigators of the previously unknown tickborne pathogen in China to identify a group of patients with similar history. The new pathogen was classified as one of the jingmenviruses, which “reveal that RNA virus segmentation is an evolutionary process that has occurred in previously unanticipated circumstances.” This study by Wang et al. shows that these viruses are not limited to arthropod hosts but can be dangerous to humans.
The new pathogen had likely been evolving for some time before it was discovered, the editorialists said. “The key to making such discoveries is the study of ill persons, isolation of the etiologic agent, use of tools that will reveal the nature of the agent (e.g., electron microscopy), and application of the appropriate tools for definitive characterization (e.g., sequencing of the RNA genome),” they emphasized. However, to mitigate outbreaks, “proactive, real-time surveillance” may be more cost effective than extensive genomic surveys, they noted (N Engl J Med. 2019 May 29. doi: 10.1056/NEJMe1901212).
Dr. Vasilakis and Dr. Walker are affiliated with the department of pathology, Center for Biodefense and Emerging Infectious Diseases, Center for Tropical Diseases, and the Institute for Human Infections and Immunity, University of Texas Medical Branch, Galveston. They had no financial conflicts to disclose.
New technology and genomic surveys will continue to help identify emerging pathogens, however, “they may provide limited value in understanding the mechanisms of disease emergence,” wrote Nikos Vasilakis, PhD, and David H. Walker, MD, in an accompanying editorial. An active surveillance program allowed the investigators of the previously unknown tickborne pathogen in China to identify a group of patients with similar history. The new pathogen was classified as one of the jingmenviruses, which “reveal that RNA virus segmentation is an evolutionary process that has occurred in previously unanticipated circumstances.” This study by Wang et al. shows that these viruses are not limited to arthropod hosts but can be dangerous to humans.
The new pathogen had likely been evolving for some time before it was discovered, the editorialists said. “The key to making such discoveries is the study of ill persons, isolation of the etiologic agent, use of tools that will reveal the nature of the agent (e.g., electron microscopy), and application of the appropriate tools for definitive characterization (e.g., sequencing of the RNA genome),” they emphasized. However, to mitigate outbreaks, “proactive, real-time surveillance” may be more cost effective than extensive genomic surveys, they noted (N Engl J Med. 2019 May 29. doi: 10.1056/NEJMe1901212).
Dr. Vasilakis and Dr. Walker are affiliated with the department of pathology, Center for Biodefense and Emerging Infectious Diseases, Center for Tropical Diseases, and the Institute for Human Infections and Immunity, University of Texas Medical Branch, Galveston. They had no financial conflicts to disclose.
A new virus has been associated with febrile illness in China in patients with histories of tick bites. The data on the discovery, isolation, and characterization of the virus were reported in the New England Journal of Medicine.
The segmented RNA virus now known as Alongshan virus (ALSV) “belongs to the unclassified jingmenvirus group in the family Flaviviridae, which includes the genera flavivirus, pestivirus, hepacivirus, and pegivirus,” wrote Ze-Dong Wang, PhD, of Foshan (China) University, and colleagues.
The index patient with ALSV was a 42-year-old female farmer from the town of Alongshan, China, who presented to a regional hospital in April 2017 with fever, headache, and a history of tick bites. The initial clinical features were similar to those seen in tickborne diseases, but a blood sample showed no RNA or antibodies for tickborne encephalitis virus. Investigators obtained a blood specimen from the index patient 4 days after the onset of illness. After culturing the sample, the investigators extracted the viral RNA genome and sequenced it.
Sequence analysis found that the new pathogen was related to segmented viruses in the jingmenvirus group of the family Flaviviridae; however, “comparison of the amino acids further confirmed that ALSV is genetically distinct from other jingmenviruses,” the investigators said.
The investigators identified 374 patients who presented to the hospital with fever, headache, and a history of tick bites during May 2017–September 2017; 86 patients had confirmed ALSV infections via nested reverse-transcription polymerase chain reaction testing. Of these, 63 were men and 84 were farmers or forestry workers. Although ticks were common in the patients’ environments, no other evidence of tickborne diseases was noted. The patients ranged in age from 24 to 77 years, and the average duration of the infection was 3-7 days.
Symptoms were nonspecific and included fever, headache, fatigue, nausea, cough, and sore throat. All 86 patients were treated with intravenous ribavirin (0.5 g/day), and intramuscular benzylpenicillin sodium (2 million U/day) for 3-5 days. The median hospital stay was 11 days, and no deaths or long-term clinical complications occurred in the confirmed ALSV patients.
ALSV is similar to other jingmenviruses, but is distinct from other infections in part because of the absence of a rash or jaundice, the investigators said.
Although the investigators said they suspected the disease was carried by ticks, they would not rule out mosquitoes as a possible carrier because ALSV RNA was found in mosquitoes in a Northeastern province of China, and the RNA from those mosquitoes was found to be genetically related to the RNA assessed in this study.
Overall, “our findings suggest that ALSV may be the cause of a previously unknown febrile disease, and more studies should be conducted to determine the geographic distribution of this disease outside its current areas of identification,” they said.
The research was supported by the National Key Research and Development Program of China and the National Natural Science Foundation of China.
SOURCE: Wang Z et al. N Engl J Med. 2019 May 29. doi: 10.1056/NEJMoa1805068.
A new virus has been associated with febrile illness in China in patients with histories of tick bites. The data on the discovery, isolation, and characterization of the virus were reported in the New England Journal of Medicine.
The segmented RNA virus now known as Alongshan virus (ALSV) “belongs to the unclassified jingmenvirus group in the family Flaviviridae, which includes the genera flavivirus, pestivirus, hepacivirus, and pegivirus,” wrote Ze-Dong Wang, PhD, of Foshan (China) University, and colleagues.
The index patient with ALSV was a 42-year-old female farmer from the town of Alongshan, China, who presented to a regional hospital in April 2017 with fever, headache, and a history of tick bites. The initial clinical features were similar to those seen in tickborne diseases, but a blood sample showed no RNA or antibodies for tickborne encephalitis virus. Investigators obtained a blood specimen from the index patient 4 days after the onset of illness. After culturing the sample, the investigators extracted the viral RNA genome and sequenced it.
Sequence analysis found that the new pathogen was related to segmented viruses in the jingmenvirus group of the family Flaviviridae; however, “comparison of the amino acids further confirmed that ALSV is genetically distinct from other jingmenviruses,” the investigators said.
The investigators identified 374 patients who presented to the hospital with fever, headache, and a history of tick bites during May 2017–September 2017; 86 patients had confirmed ALSV infections via nested reverse-transcription polymerase chain reaction testing. Of these, 63 were men and 84 were farmers or forestry workers. Although ticks were common in the patients’ environments, no other evidence of tickborne diseases was noted. The patients ranged in age from 24 to 77 years, and the average duration of the infection was 3-7 days.
Symptoms were nonspecific and included fever, headache, fatigue, nausea, cough, and sore throat. All 86 patients were treated with intravenous ribavirin (0.5 g/day), and intramuscular benzylpenicillin sodium (2 million U/day) for 3-5 days. The median hospital stay was 11 days, and no deaths or long-term clinical complications occurred in the confirmed ALSV patients.
ALSV is similar to other jingmenviruses, but is distinct from other infections in part because of the absence of a rash or jaundice, the investigators said.
Although the investigators said they suspected the disease was carried by ticks, they would not rule out mosquitoes as a possible carrier because ALSV RNA was found in mosquitoes in a Northeastern province of China, and the RNA from those mosquitoes was found to be genetically related to the RNA assessed in this study.
Overall, “our findings suggest that ALSV may be the cause of a previously unknown febrile disease, and more studies should be conducted to determine the geographic distribution of this disease outside its current areas of identification,” they said.
The research was supported by the National Key Research and Development Program of China and the National Natural Science Foundation of China.
SOURCE: Wang Z et al. N Engl J Med. 2019 May 29. doi: 10.1056/NEJMoa1805068.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Severe respiratory failure strikes healthy teens on trimethoprim-sulfamethoxazole
TMP-SMX, a frequently prescribed antibiotic, has been associated with “idiosyncratic adverse drug reactions, including cutaneous reactions and hypersensitivity syndromes,” but pulmonary complications are rare, especially in children, wrote Jenna O. Miller, MD, of the University of Missouri–Kansas City and colleagues.
In a case series published in Pediatrics, the researchers described the patients, who were aged 13-18 years; the 18-year-old was male, the others were female. Four of the patients (three females, one male) were taking TMP-SMX for acne vulgaris. One of these patients, a 13-year-old girl, underwent a bilateral lung and heart transplant after developing interstitial lung disease and died as a result of solid organ transplant complications. The other death occurred in a 15-year-old girl who was taking TMP-SMX to treat a urinary tract infection. This patient developed interstitial lung disease and died of complications from the disease while awaiting a lung transplant.
“In all cases, patients were transferred to academic medical facilities, and pediatric pulmonologists and infectious diseases specialists performed extensive evaluations,” the researchers wrote. The patients did not improve when the drug was discontinued, and four of the five were considered or listed for organ transplants. The spectrum of disease was varied among the patients, and the pathophysiology remains poorly understood.
Although no clinical test could confirm causality between TMP-SMX and ARDS in the five teens, “the extensive negative workup, paired with recent TMP-SMX exposure and similarity among these cases, raises the possibility that the observed ARDS was TMP-SMX triggered,” they wrote.
The researchers had no financial conflicts to disclose.
SOURCE: Miller JO et al. Pediatrics. 2019 May 29. doi: 10.1542/peds.2018.3242.
TMP-SMX, a frequently prescribed antibiotic, has been associated with “idiosyncratic adverse drug reactions, including cutaneous reactions and hypersensitivity syndromes,” but pulmonary complications are rare, especially in children, wrote Jenna O. Miller, MD, of the University of Missouri–Kansas City and colleagues.
In a case series published in Pediatrics, the researchers described the patients, who were aged 13-18 years; the 18-year-old was male, the others were female. Four of the patients (three females, one male) were taking TMP-SMX for acne vulgaris. One of these patients, a 13-year-old girl, underwent a bilateral lung and heart transplant after developing interstitial lung disease and died as a result of solid organ transplant complications. The other death occurred in a 15-year-old girl who was taking TMP-SMX to treat a urinary tract infection. This patient developed interstitial lung disease and died of complications from the disease while awaiting a lung transplant.
“In all cases, patients were transferred to academic medical facilities, and pediatric pulmonologists and infectious diseases specialists performed extensive evaluations,” the researchers wrote. The patients did not improve when the drug was discontinued, and four of the five were considered or listed for organ transplants. The spectrum of disease was varied among the patients, and the pathophysiology remains poorly understood.
Although no clinical test could confirm causality between TMP-SMX and ARDS in the five teens, “the extensive negative workup, paired with recent TMP-SMX exposure and similarity among these cases, raises the possibility that the observed ARDS was TMP-SMX triggered,” they wrote.
The researchers had no financial conflicts to disclose.
SOURCE: Miller JO et al. Pediatrics. 2019 May 29. doi: 10.1542/peds.2018.3242.
TMP-SMX, a frequently prescribed antibiotic, has been associated with “idiosyncratic adverse drug reactions, including cutaneous reactions and hypersensitivity syndromes,” but pulmonary complications are rare, especially in children, wrote Jenna O. Miller, MD, of the University of Missouri–Kansas City and colleagues.
In a case series published in Pediatrics, the researchers described the patients, who were aged 13-18 years; the 18-year-old was male, the others were female. Four of the patients (three females, one male) were taking TMP-SMX for acne vulgaris. One of these patients, a 13-year-old girl, underwent a bilateral lung and heart transplant after developing interstitial lung disease and died as a result of solid organ transplant complications. The other death occurred in a 15-year-old girl who was taking TMP-SMX to treat a urinary tract infection. This patient developed interstitial lung disease and died of complications from the disease while awaiting a lung transplant.
“In all cases, patients were transferred to academic medical facilities, and pediatric pulmonologists and infectious diseases specialists performed extensive evaluations,” the researchers wrote. The patients did not improve when the drug was discontinued, and four of the five were considered or listed for organ transplants. The spectrum of disease was varied among the patients, and the pathophysiology remains poorly understood.
Although no clinical test could confirm causality between TMP-SMX and ARDS in the five teens, “the extensive negative workup, paired with recent TMP-SMX exposure and similarity among these cases, raises the possibility that the observed ARDS was TMP-SMX triggered,” they wrote.
The researchers had no financial conflicts to disclose.
SOURCE: Miller JO et al. Pediatrics. 2019 May 29. doi: 10.1542/peds.2018.3242.
FROM PEDIATRICS
Team sports may mitigate tough childhoods
Individuals who experienced adverse childhood experiences but also played team sports as teens were less likely to have mental health problems in adulthood than those with childhood challenges who did not play sports, based on data from nearly 5,000 individuals.
Physical and mental health problems are more prominent throughout life among those exposed to adverse childhood experiences (ACEs), and physical activity in general and team sports in particular have been shown to improve mental health, wrote Molly C. Easterlin, MD, of the University of California, Los Angeles, and colleagues.
In a study published in JAMA Pediatrics, the researchers used data from the National Longitudinal Study of Adolescent to Adult Health to compare the development of depression, anxiety, or depressive symptoms among those with childhood ACEs who did and did not participate in team sports in adolescence.
Overall, team sports participation was significantly associated with reduced odds of depression (adjusted odds ratio, 0.76), anxiety (aOR, 0.70), and depressive symptoms (aOR, 0.85) in young adulthood for individuals with ACEs, compared with those with ACEs who did not play team sports.
Of 9,668 adolescents in the study, 4,888 individuals reported one or more ACEs and 2,084 reported two or more ACEs. The researchers compared data from the 1994-1995 school year when participants were in grades 7-12 and in 2008 to assess their mental health as young adults (aged 24-32 years).
No significant differences in associations appeared between sports participation and mental health between males and females.
The results were limited by several factors including the study design that did not allow for causality and the potential social desirability bias that might lead to underreporting ACEs, Dr. Easterlin and associates noted.
Nonetheless, “given that participation in team sports was associated with improved adult mental health among those with ACEs, and parents might consider enrolling their children with ACEs in team sports,” they wrote.
Dr. Easterlin is supported by the Cedars-Sinai Medical Center via the UCLA National Clinician Scholars Program. The authors reported no conflicts of interest.
SOURCE: Easterlin MC et al. JAMA Pediatr. 2019 May 28. doi: 10.1001/jamapediatrics.2019.1212.
Approximately half of children suffer an adverse childhood experience (ACE) that can negatively affect their mental health throughout life, and “team sports can be an avenue to interrupt these negative sequelae and address the important public health burden of depression,” wrote Amanda E. Paluch, PhD; Nia Heard-Garris, MD, MSc; and Mercedes R. Carnethon, PhD.
However, a significant socioeconomic disparity in team sports for children continues to grow in the United States, driven in part by a youth sports industry and culture that caters to high-income families looking to improve their children’s performance. “Although unintentional, these expenses leave behind lower-income children,” many of whom may be at increased risk for ACEs, the editorialists noted. Many inexpensive, community-based recreation leagues, especially in low-income areas, are often underfunded and unable to update facilities and attract more participants.
The benefits of team sports appear to go beyond the physical, as the study by Easterlin et al. suggests that feeling accepted and connected as part of a team has an impact on mental health. Also, the winning and losing of sports helps build emotional resilience that carries over to other areas of life, the editorialists added.
“Optimizing the opportunities for sports during adolescence requires relatively few resources and is a low-cost way to improve quality of life and reduce the population burden of mental health disorders, especially for adolescents and young adults with histories of ACEs,” they concluded.
Dr. Paluch and Dr. Carnethon are affiliated with the department of preventive medicine and Dr. Heard-Garris is affiliated with the department of pediatrics at Northwestern University, Chicago. They commented on the study by Easterlin et al (JAMA Pediatr. 2019 May 28. doi:10.1001/jamapediatrics.2019.1209). They reported no conflicts of interest.
Approximately half of children suffer an adverse childhood experience (ACE) that can negatively affect their mental health throughout life, and “team sports can be an avenue to interrupt these negative sequelae and address the important public health burden of depression,” wrote Amanda E. Paluch, PhD; Nia Heard-Garris, MD, MSc; and Mercedes R. Carnethon, PhD.
However, a significant socioeconomic disparity in team sports for children continues to grow in the United States, driven in part by a youth sports industry and culture that caters to high-income families looking to improve their children’s performance. “Although unintentional, these expenses leave behind lower-income children,” many of whom may be at increased risk for ACEs, the editorialists noted. Many inexpensive, community-based recreation leagues, especially in low-income areas, are often underfunded and unable to update facilities and attract more participants.
The benefits of team sports appear to go beyond the physical, as the study by Easterlin et al. suggests that feeling accepted and connected as part of a team has an impact on mental health. Also, the winning and losing of sports helps build emotional resilience that carries over to other areas of life, the editorialists added.
“Optimizing the opportunities for sports during adolescence requires relatively few resources and is a low-cost way to improve quality of life and reduce the population burden of mental health disorders, especially for adolescents and young adults with histories of ACEs,” they concluded.
Dr. Paluch and Dr. Carnethon are affiliated with the department of preventive medicine and Dr. Heard-Garris is affiliated with the department of pediatrics at Northwestern University, Chicago. They commented on the study by Easterlin et al (JAMA Pediatr. 2019 May 28. doi:10.1001/jamapediatrics.2019.1209). They reported no conflicts of interest.
Approximately half of children suffer an adverse childhood experience (ACE) that can negatively affect their mental health throughout life, and “team sports can be an avenue to interrupt these negative sequelae and address the important public health burden of depression,” wrote Amanda E. Paluch, PhD; Nia Heard-Garris, MD, MSc; and Mercedes R. Carnethon, PhD.
However, a significant socioeconomic disparity in team sports for children continues to grow in the United States, driven in part by a youth sports industry and culture that caters to high-income families looking to improve their children’s performance. “Although unintentional, these expenses leave behind lower-income children,” many of whom may be at increased risk for ACEs, the editorialists noted. Many inexpensive, community-based recreation leagues, especially in low-income areas, are often underfunded and unable to update facilities and attract more participants.
The benefits of team sports appear to go beyond the physical, as the study by Easterlin et al. suggests that feeling accepted and connected as part of a team has an impact on mental health. Also, the winning and losing of sports helps build emotional resilience that carries over to other areas of life, the editorialists added.
“Optimizing the opportunities for sports during adolescence requires relatively few resources and is a low-cost way to improve quality of life and reduce the population burden of mental health disorders, especially for adolescents and young adults with histories of ACEs,” they concluded.
Dr. Paluch and Dr. Carnethon are affiliated with the department of preventive medicine and Dr. Heard-Garris is affiliated with the department of pediatrics at Northwestern University, Chicago. They commented on the study by Easterlin et al (JAMA Pediatr. 2019 May 28. doi:10.1001/jamapediatrics.2019.1209). They reported no conflicts of interest.
Individuals who experienced adverse childhood experiences but also played team sports as teens were less likely to have mental health problems in adulthood than those with childhood challenges who did not play sports, based on data from nearly 5,000 individuals.
Physical and mental health problems are more prominent throughout life among those exposed to adverse childhood experiences (ACEs), and physical activity in general and team sports in particular have been shown to improve mental health, wrote Molly C. Easterlin, MD, of the University of California, Los Angeles, and colleagues.
In a study published in JAMA Pediatrics, the researchers used data from the National Longitudinal Study of Adolescent to Adult Health to compare the development of depression, anxiety, or depressive symptoms among those with childhood ACEs who did and did not participate in team sports in adolescence.
Overall, team sports participation was significantly associated with reduced odds of depression (adjusted odds ratio, 0.76), anxiety (aOR, 0.70), and depressive symptoms (aOR, 0.85) in young adulthood for individuals with ACEs, compared with those with ACEs who did not play team sports.
Of 9,668 adolescents in the study, 4,888 individuals reported one or more ACEs and 2,084 reported two or more ACEs. The researchers compared data from the 1994-1995 school year when participants were in grades 7-12 and in 2008 to assess their mental health as young adults (aged 24-32 years).
No significant differences in associations appeared between sports participation and mental health between males and females.
The results were limited by several factors including the study design that did not allow for causality and the potential social desirability bias that might lead to underreporting ACEs, Dr. Easterlin and associates noted.
Nonetheless, “given that participation in team sports was associated with improved adult mental health among those with ACEs, and parents might consider enrolling their children with ACEs in team sports,” they wrote.
Dr. Easterlin is supported by the Cedars-Sinai Medical Center via the UCLA National Clinician Scholars Program. The authors reported no conflicts of interest.
SOURCE: Easterlin MC et al. JAMA Pediatr. 2019 May 28. doi: 10.1001/jamapediatrics.2019.1212.
Individuals who experienced adverse childhood experiences but also played team sports as teens were less likely to have mental health problems in adulthood than those with childhood challenges who did not play sports, based on data from nearly 5,000 individuals.
Physical and mental health problems are more prominent throughout life among those exposed to adverse childhood experiences (ACEs), and physical activity in general and team sports in particular have been shown to improve mental health, wrote Molly C. Easterlin, MD, of the University of California, Los Angeles, and colleagues.
In a study published in JAMA Pediatrics, the researchers used data from the National Longitudinal Study of Adolescent to Adult Health to compare the development of depression, anxiety, or depressive symptoms among those with childhood ACEs who did and did not participate in team sports in adolescence.
Overall, team sports participation was significantly associated with reduced odds of depression (adjusted odds ratio, 0.76), anxiety (aOR, 0.70), and depressive symptoms (aOR, 0.85) in young adulthood for individuals with ACEs, compared with those with ACEs who did not play team sports.
Of 9,668 adolescents in the study, 4,888 individuals reported one or more ACEs and 2,084 reported two or more ACEs. The researchers compared data from the 1994-1995 school year when participants were in grades 7-12 and in 2008 to assess their mental health as young adults (aged 24-32 years).
No significant differences in associations appeared between sports participation and mental health between males and females.
The results were limited by several factors including the study design that did not allow for causality and the potential social desirability bias that might lead to underreporting ACEs, Dr. Easterlin and associates noted.
Nonetheless, “given that participation in team sports was associated with improved adult mental health among those with ACEs, and parents might consider enrolling their children with ACEs in team sports,” they wrote.
Dr. Easterlin is supported by the Cedars-Sinai Medical Center via the UCLA National Clinician Scholars Program. The authors reported no conflicts of interest.
SOURCE: Easterlin MC et al. JAMA Pediatr. 2019 May 28. doi: 10.1001/jamapediatrics.2019.1212.
FROM JAMA PEDIATRICS
FDA permits marketing of Zika diagnostic test
A Zika virus test initially authorized only for emergency use has now been approved for use in nonemergency situations, according to a statement from the Food and Drug Administration.
The ZIKV Detect 2.0 IgM Capture ELISA (enzyme-linked immunosorbent assay) is now authorized for use in patients with clinical signs and symptoms consistent with Zika virus infection, as well as those who meet the Centers for Disease Control and Prevention epidemiologic criteria, including residence in or travel to a region deemed high risk because of active Zika transmission.
The test is designed to identify Zika antibodies in the blood, and the FDA cited a review of clinical trial data and analytic data to support the test’s safety and effectiveness.
“Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions,” the FDA stated.
The ZIKV Detect 2.0 IgM Capture ELISA, initially approved in 2016, had been authorized by the FDA only for emergency use, along with other tests for detecting Zika virus, under the under the FDA’s Emergency Use Authorization (EUA) authority.
The FDA granted marketing authorization to test manufacturer InBios International.
The FDA is communicating with four EUA holders to gather information to evaluate whether the FDA should revoke the EUAs for these specific tests. The marketing authorization of ZIKV Detect 2.0 IgM Capture ELISA does not impact the availability of the other 14 Zika nucleic acid diagnostics available under EUAs.
The Zika virus, typically transmitted by an infected mosquito, is especially a risk for pregnant women as the fetus may experience neurologic complications and microcephaly as a result of infection.
A Zika virus test initially authorized only for emergency use has now been approved for use in nonemergency situations, according to a statement from the Food and Drug Administration.
The ZIKV Detect 2.0 IgM Capture ELISA (enzyme-linked immunosorbent assay) is now authorized for use in patients with clinical signs and symptoms consistent with Zika virus infection, as well as those who meet the Centers for Disease Control and Prevention epidemiologic criteria, including residence in or travel to a region deemed high risk because of active Zika transmission.
The test is designed to identify Zika antibodies in the blood, and the FDA cited a review of clinical trial data and analytic data to support the test’s safety and effectiveness.
“Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions,” the FDA stated.
The ZIKV Detect 2.0 IgM Capture ELISA, initially approved in 2016, had been authorized by the FDA only for emergency use, along with other tests for detecting Zika virus, under the under the FDA’s Emergency Use Authorization (EUA) authority.
The FDA granted marketing authorization to test manufacturer InBios International.
The FDA is communicating with four EUA holders to gather information to evaluate whether the FDA should revoke the EUAs for these specific tests. The marketing authorization of ZIKV Detect 2.0 IgM Capture ELISA does not impact the availability of the other 14 Zika nucleic acid diagnostics available under EUAs.
The Zika virus, typically transmitted by an infected mosquito, is especially a risk for pregnant women as the fetus may experience neurologic complications and microcephaly as a result of infection.
A Zika virus test initially authorized only for emergency use has now been approved for use in nonemergency situations, according to a statement from the Food and Drug Administration.
The ZIKV Detect 2.0 IgM Capture ELISA (enzyme-linked immunosorbent assay) is now authorized for use in patients with clinical signs and symptoms consistent with Zika virus infection, as well as those who meet the Centers for Disease Control and Prevention epidemiologic criteria, including residence in or travel to a region deemed high risk because of active Zika transmission.
The test is designed to identify Zika antibodies in the blood, and the FDA cited a review of clinical trial data and analytic data to support the test’s safety and effectiveness.
“Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions,” the FDA stated.
The ZIKV Detect 2.0 IgM Capture ELISA, initially approved in 2016, had been authorized by the FDA only for emergency use, along with other tests for detecting Zika virus, under the under the FDA’s Emergency Use Authorization (EUA) authority.
The FDA granted marketing authorization to test manufacturer InBios International.
The FDA is communicating with four EUA holders to gather information to evaluate whether the FDA should revoke the EUAs for these specific tests. The marketing authorization of ZIKV Detect 2.0 IgM Capture ELISA does not impact the availability of the other 14 Zika nucleic acid diagnostics available under EUAs.
The Zika virus, typically transmitted by an infected mosquito, is especially a risk for pregnant women as the fetus may experience neurologic complications and microcephaly as a result of infection.
Keep sports fun, keep kids playing
according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.
In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.
The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.
“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.
You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.
They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.
“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”
“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”
“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.
They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.
“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”
Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.
The report authors had no financial conflicts to disclose.
SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.
“I think it is quite timely with the obesity epidemic and lack of PE in schools to highlight how important physical activity is for children, and organized sports is one of the ways to accomplish that,” Andrew Gregory, MD, said in an interview.
“I think the summary of both benefits and risks is well informed and complete,” he said.
However, “I think most pediatricians and parents are aware of the physical benefits of exercise, but many may be unaware of the psychological and social benefits,” Dr. Gregory noted. “It is also important that parents and coaches understand that bullying and hazing have no place in organized sports and should not be tolerated.”
“I think the most important thing for clinicians to pass on is that the benefits of organized sports far outweigh the risks,” he said. The challenge is, “How do we better incorporate organized sports into schools and community organizations so that more children have access?”
Dr. Gregory is an associate professor of orthopaedics, neurosurgery & pediatrics at Vanderbilt University in Nashville, Tenn., and serves as codirector of the Vanderbilt Sports Concussion Center. He had no financial conflicts to disclose.
“I think it is quite timely with the obesity epidemic and lack of PE in schools to highlight how important physical activity is for children, and organized sports is one of the ways to accomplish that,” Andrew Gregory, MD, said in an interview.
“I think the summary of both benefits and risks is well informed and complete,” he said.
However, “I think most pediatricians and parents are aware of the physical benefits of exercise, but many may be unaware of the psychological and social benefits,” Dr. Gregory noted. “It is also important that parents and coaches understand that bullying and hazing have no place in organized sports and should not be tolerated.”
“I think the most important thing for clinicians to pass on is that the benefits of organized sports far outweigh the risks,” he said. The challenge is, “How do we better incorporate organized sports into schools and community organizations so that more children have access?”
Dr. Gregory is an associate professor of orthopaedics, neurosurgery & pediatrics at Vanderbilt University in Nashville, Tenn., and serves as codirector of the Vanderbilt Sports Concussion Center. He had no financial conflicts to disclose.
“I think it is quite timely with the obesity epidemic and lack of PE in schools to highlight how important physical activity is for children, and organized sports is one of the ways to accomplish that,” Andrew Gregory, MD, said in an interview.
“I think the summary of both benefits and risks is well informed and complete,” he said.
However, “I think most pediatricians and parents are aware of the physical benefits of exercise, but many may be unaware of the psychological and social benefits,” Dr. Gregory noted. “It is also important that parents and coaches understand that bullying and hazing have no place in organized sports and should not be tolerated.”
“I think the most important thing for clinicians to pass on is that the benefits of organized sports far outweigh the risks,” he said. The challenge is, “How do we better incorporate organized sports into schools and community organizations so that more children have access?”
Dr. Gregory is an associate professor of orthopaedics, neurosurgery & pediatrics at Vanderbilt University in Nashville, Tenn., and serves as codirector of the Vanderbilt Sports Concussion Center. He had no financial conflicts to disclose.
according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.
In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.
The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.
“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.
You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.
They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.
“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”
“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”
“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.
They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.
“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”
Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.
The report authors had no financial conflicts to disclose.
SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.
according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.
In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.
The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.
“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.
You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.
They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.
“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”
“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”
“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.
They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.
“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”
Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.
The report authors had no financial conflicts to disclose.
SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.
FROM PEDIATRICS
Hormone use linked to hair loss in transgender adults
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point: Use of hormone therapy had a significant impact on scalp and hair loss in trans men who used masculinizing hormones.
Major finding: Scalp hair loss or hair thinning was reported by 65% of trans women, 43% of trans men, and 35% of nonbinary individuals.
Study details: The data come from a cross-sectional study including 991 adults self-identifying as gender minorities.
Disclosures: The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
Source: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.