Heidi Splete

Primary cutaneous melanomas more than 2 mm thick can be excised with 2-cm margins with outcomes similar to excision with 4-cm margins, based on data from a randomized, multicenter trial of 936 patients.

“Over time, and in light of the findings of several randomized studies, less extensive surgery for primary melanoma with tumor thickness greater than 2 mm has become more established,” and most recent guidelines recommend a 2-cm margin for these tumors, wrote Deborah Utjés, MD, of the Karolinska Institute in Stockholm and colleagues.

To reinforce the safety and effectiveness of the 2-cm margin, the researchers conducted an open-label, randomized trial of clinically staged melanoma patients aged 75 years and younger with localized cutaneous melanomas thicker than 2 mm, from January 1992 to May 2004. Patients were treated in Denmark, Estonia, Norway, and Sweden. The findings were published in the Lancet.

Patients were randomized to treatment with a 2-cm (471) or 4-cm excision margin (465). The melanomas were located on the trunk, upper extremities, or lower extremities.

The primary outcome of overall survival was similar between the groups. Over a median 20-year follow-up period, the death rate was approximately 50% in each group (49% in the 2-cm group and 51% in the 4-cm group). Disease-specific survival rates were similar as well. Of the 621 reported deaths, 397 were attributed to melanoma: 192 (48%) in the 2-cm group and 205 (52%) in the 4-cm group.

The study findings were limited by several factors, including a lower-than-expected number of patients, lack of nodal staging during the study period, and a focus only on the surgical margin without recording data on pathological excision margins.

However, the extended follow-up supports the safe use of the 2-cm margin for the treatment of melanomas thicker than 2 mm, the investigators wrote. In addition, results from an ongoing trial comparing 1-cm and 2-cm margins for melanomas at least 1 mm thick may yield more evidence to support still narrower surgical margins for some cutaneous melanomas.

The study notes that guidelines from organizations that include the American National Comprehensive Cancer Network and the American Academy of Dermatology recommend the 2-cm margin for tumors that are thicker than 2 mm.

The study was supported by the Swedish Cancer Society, Stockholm Cancer Society, Swedish Society for Medical Research, and the Stockholm County Council, and by funds from Radiumhemmet Research and Wallström. The authors reported no disclosures.

SOURCE: Utjés D et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31132-8.

Primary cutaneous melanomas more than 2 mm thick can be excised with 2-cm margins with outcomes similar to excision with 4-cm margins, based on data from a randomized, multicenter trial of 936 patients.

“Over time, and in light of the findings of several randomized studies, less extensive surgery for primary melanoma with tumor thickness greater than 2 mm has become more established,” and most recent guidelines recommend a 2-cm margin for these tumors, wrote Deborah Utjés, MD, of the Karolinska Institute in Stockholm and colleagues.

To reinforce the safety and effectiveness of the 2-cm margin, the researchers conducted an open-label, randomized trial of clinically staged melanoma patients aged 75 years and younger with localized cutaneous melanomas thicker than 2 mm, from January 1992 to May 2004. Patients were treated in Denmark, Estonia, Norway, and Sweden. The findings were published in the Lancet.

Patients were randomized to treatment with a 2-cm (471) or 4-cm excision margin (465). The melanomas were located on the trunk, upper extremities, or lower extremities.

The primary outcome of overall survival was similar between the groups. Over a median 20-year follow-up period, the death rate was approximately 50% in each group (49% in the 2-cm group and 51% in the 4-cm group). Disease-specific survival rates were similar as well. Of the 621 reported deaths, 397 were attributed to melanoma: 192 (48%) in the 2-cm group and 205 (52%) in the 4-cm group.

The study findings were limited by several factors, including a lower-than-expected number of patients, lack of nodal staging during the study period, and a focus only on the surgical margin without recording data on pathological excision margins.

However, the extended follow-up supports the safe use of the 2-cm margin for the treatment of melanomas thicker than 2 mm, the investigators wrote. In addition, results from an ongoing trial comparing 1-cm and 2-cm margins for melanomas at least 1 mm thick may yield more evidence to support still narrower surgical margins for some cutaneous melanomas.

The study notes that guidelines from organizations that include the American National Comprehensive Cancer Network and the American Academy of Dermatology recommend the 2-cm margin for tumors that are thicker than 2 mm.

The study was supported by the Swedish Cancer Society, Stockholm Cancer Society, Swedish Society for Medical Research, and the Stockholm County Council, and by funds from Radiumhemmet Research and Wallström. The authors reported no disclosures.

SOURCE: Utjés D et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31132-8.

Primary cutaneous melanomas more than 2 mm thick can be excised with 2-cm margins with outcomes similar to excision with 4-cm margins, based on data from a randomized, multicenter trial of 936 patients.

“Over time, and in light of the findings of several randomized studies, less extensive surgery for primary melanoma with tumor thickness greater than 2 mm has become more established,” and most recent guidelines recommend a 2-cm margin for these tumors, wrote Deborah Utjés, MD, of the Karolinska Institute in Stockholm and colleagues.

To reinforce the safety and effectiveness of the 2-cm margin, the researchers conducted an open-label, randomized trial of clinically staged melanoma patients aged 75 years and younger with localized cutaneous melanomas thicker than 2 mm, from January 1992 to May 2004. Patients were treated in Denmark, Estonia, Norway, and Sweden. The findings were published in the Lancet.

Patients were randomized to treatment with a 2-cm (471) or 4-cm excision margin (465). The melanomas were located on the trunk, upper extremities, or lower extremities.

The primary outcome of overall survival was similar between the groups. Over a median 20-year follow-up period, the death rate was approximately 50% in each group (49% in the 2-cm group and 51% in the 4-cm group). Disease-specific survival rates were similar as well. Of the 621 reported deaths, 397 were attributed to melanoma: 192 (48%) in the 2-cm group and 205 (52%) in the 4-cm group.

The study findings were limited by several factors, including a lower-than-expected number of patients, lack of nodal staging during the study period, and a focus only on the surgical margin without recording data on pathological excision margins.

However, the extended follow-up supports the safe use of the 2-cm margin for the treatment of melanomas thicker than 2 mm, the investigators wrote. In addition, results from an ongoing trial comparing 1-cm and 2-cm margins for melanomas at least 1 mm thick may yield more evidence to support still narrower surgical margins for some cutaneous melanomas.

The study notes that guidelines from organizations that include the American National Comprehensive Cancer Network and the American Academy of Dermatology recommend the 2-cm margin for tumors that are thicker than 2 mm.

The study was supported by the Swedish Cancer Society, Stockholm Cancer Society, Swedish Society for Medical Research, and the Stockholm County Council, and by funds from Radiumhemmet Research and Wallström. The authors reported no disclosures.

SOURCE: Utjés D et al. Lancet. 2019 Jul 4. doi: 10.1016/S0140-6736(19)31132-8.

Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

Higher levels of eicosapentaenoic acid, a type of omega-3 polyunsaturated fatty acid, were associated with a significantly reduced risk of heart failure in a large, multi-ethnic cohort of adults in the United States.

Despite the potential benefits of omega-3s eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for heart health, their use has been controversial, although data in a mouse model showed that dietary EPA was protective against heart failure, wrote Robert C. Block, MD, of the University of Rochester (N.Y.), and colleagues. Their report is in the Journal of the American College of Cardiology.

To examine the impact of EPA on heart failure in humans, the researchers used data from the Multi-Ethnic Study of Atherosclerosis (MESA), a longitudinal cohort study of U.S. adults, including those who are African American, Hispanic, Asian, and white.

The researchers included 6,562 MESA participants aged 45-84 years from six communities. Participants underwent a baseline exam between July 2000 and July 2002 that included phospholipid measurements used to identify plasma EPA percentage, and they completed study visits approximately every other year for a median follow-up of 13 years.

A total of 292 heart failure events occurred during the follow-up period: 128 with reduced ejection fraction (EF less than 45%), 110 with preserved ejection fraction (EF at least 45%), and 54 with unknown EF status.

The percent EPA for individuals without heart failure was significantly higher compared with those with heart failure (0.76% vs. 0.69%, P =.005). The association remained significant after the researchers controlled for age, sex, race, body mass index, smoking, diabetes, blood pressure, lipids and lipid-lowering drugs, albuminuria, and the lead fatty acid (defined as the fatty acid with the largest in-cluster correlation).


An EPA level greater than 2.5% was considered sufficient to prevent heart failure based on prior definitions. A total of 73% of the participants had insufficient EPA (less than 1.0%), 2.4% had marginal levels (1.0%-2.5%), and 4.5% had sufficient levels. However, given that EPA levels can be easily and safely increased with the consumption of seafood or fish oil capsules, increasing EPA is a feasible heart failure prevention strategy, the researchers said.

The study included 2,532 white, 1,794 black, 1,442 Hispanic, and 794 Chinese participants. Overall, the fewest Hispanic participants met the criteria for sufficient EPA (1.4%), followed by black (4.4%), white (4.9%), and Chinese participants (9.8%).

The study findings were limited by several factors, including relatively few participants with preserved ejection fractions and sufficient EPA levels, as well as the inability to account for changes in omega-3 levels and other risk factors over time, the researchers noted.

“We consider this study to strongly determine a benefit of EPA exists, but insufficient to determine whether a threshold for %EPA exists near 3%,” they said. They proposed a follow-up study including individuals with higher levels of EPA to better detect a protective effect.

Lead author Dr. Block had no financial conflicts to disclose. Several coauthors received honoraria from Amarin Pharmaceuticals. The study was funded in part by the National Heart, Lung, and Blood Institute.

Higher levels of eicosapentaenoic acid, a type of omega-3 polyunsaturated fatty acid, were associated with a significantly reduced risk of heart failure in a large, multi-ethnic cohort of adults in the United States.

Despite the potential benefits of omega-3s eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for heart health, their use has been controversial, although data in a mouse model showed that dietary EPA was protective against heart failure, wrote Robert C. Block, MD, of the University of Rochester (N.Y.), and colleagues. Their report is in the Journal of the American College of Cardiology.

To examine the impact of EPA on heart failure in humans, the researchers used data from the Multi-Ethnic Study of Atherosclerosis (MESA), a longitudinal cohort study of U.S. adults, including those who are African American, Hispanic, Asian, and white.

The researchers included 6,562 MESA participants aged 45-84 years from six communities. Participants underwent a baseline exam between July 2000 and July 2002 that included phospholipid measurements used to identify plasma EPA percentage, and they completed study visits approximately every other year for a median follow-up of 13 years.

A total of 292 heart failure events occurred during the follow-up period: 128 with reduced ejection fraction (EF less than 45%), 110 with preserved ejection fraction (EF at least 45%), and 54 with unknown EF status.

The percent EPA for individuals without heart failure was significantly higher compared with those with heart failure (0.76% vs. 0.69%, P =.005). The association remained significant after the researchers controlled for age, sex, race, body mass index, smoking, diabetes, blood pressure, lipids and lipid-lowering drugs, albuminuria, and the lead fatty acid (defined as the fatty acid with the largest in-cluster correlation).


An EPA level greater than 2.5% was considered sufficient to prevent heart failure based on prior definitions. A total of 73% of the participants had insufficient EPA (less than 1.0%), 2.4% had marginal levels (1.0%-2.5%), and 4.5% had sufficient levels. However, given that EPA levels can be easily and safely increased with the consumption of seafood or fish oil capsules, increasing EPA is a feasible heart failure prevention strategy, the researchers said.

The study included 2,532 white, 1,794 black, 1,442 Hispanic, and 794 Chinese participants. Overall, the fewest Hispanic participants met the criteria for sufficient EPA (1.4%), followed by black (4.4%), white (4.9%), and Chinese participants (9.8%).

The study findings were limited by several factors, including relatively few participants with preserved ejection fractions and sufficient EPA levels, as well as the inability to account for changes in omega-3 levels and other risk factors over time, the researchers noted.

“We consider this study to strongly determine a benefit of EPA exists, but insufficient to determine whether a threshold for %EPA exists near 3%,” they said. They proposed a follow-up study including individuals with higher levels of EPA to better detect a protective effect.

Lead author Dr. Block had no financial conflicts to disclose. Several coauthors received honoraria from Amarin Pharmaceuticals. The study was funded in part by the National Heart, Lung, and Blood Institute.

Higher levels of eicosapentaenoic acid, a type of omega-3 polyunsaturated fatty acid, were associated with a significantly reduced risk of heart failure in a large, multi-ethnic cohort of adults in the United States.

Despite the potential benefits of omega-3s eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for heart health, their use has been controversial, although data in a mouse model showed that dietary EPA was protective against heart failure, wrote Robert C. Block, MD, of the University of Rochester (N.Y.), and colleagues. Their report is in the Journal of the American College of Cardiology.

To examine the impact of EPA on heart failure in humans, the researchers used data from the Multi-Ethnic Study of Atherosclerosis (MESA), a longitudinal cohort study of U.S. adults, including those who are African American, Hispanic, Asian, and white.

The researchers included 6,562 MESA participants aged 45-84 years from six communities. Participants underwent a baseline exam between July 2000 and July 2002 that included phospholipid measurements used to identify plasma EPA percentage, and they completed study visits approximately every other year for a median follow-up of 13 years.

A total of 292 heart failure events occurred during the follow-up period: 128 with reduced ejection fraction (EF less than 45%), 110 with preserved ejection fraction (EF at least 45%), and 54 with unknown EF status.

The percent EPA for individuals without heart failure was significantly higher compared with those with heart failure (0.76% vs. 0.69%, P =.005). The association remained significant after the researchers controlled for age, sex, race, body mass index, smoking, diabetes, blood pressure, lipids and lipid-lowering drugs, albuminuria, and the lead fatty acid (defined as the fatty acid with the largest in-cluster correlation).


An EPA level greater than 2.5% was considered sufficient to prevent heart failure based on prior definitions. A total of 73% of the participants had insufficient EPA (less than 1.0%), 2.4% had marginal levels (1.0%-2.5%), and 4.5% had sufficient levels. However, given that EPA levels can be easily and safely increased with the consumption of seafood or fish oil capsules, increasing EPA is a feasible heart failure prevention strategy, the researchers said.

The study included 2,532 white, 1,794 black, 1,442 Hispanic, and 794 Chinese participants. Overall, the fewest Hispanic participants met the criteria for sufficient EPA (1.4%), followed by black (4.4%), white (4.9%), and Chinese participants (9.8%).

The study findings were limited by several factors, including relatively few participants with preserved ejection fractions and sufficient EPA levels, as well as the inability to account for changes in omega-3 levels and other risk factors over time, the researchers noted.

“We consider this study to strongly determine a benefit of EPA exists, but insufficient to determine whether a threshold for %EPA exists near 3%,” they said. They proposed a follow-up study including individuals with higher levels of EPA to better detect a protective effect.

Lead author Dr. Block had no financial conflicts to disclose. Several coauthors received honoraria from Amarin Pharmaceuticals. The study was funded in part by the National Heart, Lung, and Blood Institute.

Isotretinoin use may increase vulnerability to psychiatric conditions, but available evidence does not support a causal relationship, on the basis of data from a retrospective study of 17,829 psychiatric adverse events reported to the Food and Drug Administration over 2 decades.

“Although one study highlighted consistent reporting of depression and suicide in patients taking isotretinoin in the United States from 1982 to 2000, few studies have examined reports of psychiatric adverse events at the national level since 2000,” wrote Sean Singer of Harvard University, Boston, and his colleagues.

In a study published in JAMA Dermatology, the researchers reviewed data from the FDA’s Adverse Event Reporting System between 1997 and 2017.

A total of 17,829 psychiatric adverse events in which isotretinoin was the primary suspect drug were reported during the study period. The researchers classified the events into 12 categories; the most common were depressive disorders (42%), emotional lability (17%), and anxiety (14%). The number of reported psychiatric adverse events was similar between men and women (8,936 and 8,362 events, respectively).

The researchers also identified 2,278 reports of suicidal ideation, 602 reports of attempted suicide, and 368 reports of completed suicide.

In addition, the researchers examined data from the iPLEDGE program and found completed suicide rates of 8.4 per 100,000 patients in 2009 and 5.6 per 100,000 patients in 2010. However, these rates were lower than national suicide rates in the general population of 11.8 per 100,000 people in 2009 and 12.1 per 100,000 people in 2010.

Patient age was available for 13,553 adverse event reports, and patients aged 10-19 years accounted for 53% of the reports overall and 58% of completed suicides for which age was reported.

The high number of psychiatric adverse events in the youngest age group “could reflect more isotretinoin prescriptions in this age group or may suggest that teenagers are particularly vulnerable to psychiatric adverse events while taking isotretinoin,” the researchers said.

The findings were limited by several factors, including the reliance on proper clinician reports to the Adverse Event Reporting System database and the separation of some psychiatric terms into categories that may reflect symptoms of other psychiatric diagnoses, the researchers said.

However, “Our data showed high numbers of reports of emotional lability, anxiety disorders, insomnia, self-injurious behavior, and psychotic disorders with isotretinoin as the primary suspect drug,” they noted.

“Although no causal link has been established between isotretinoin and psychiatric adverse events, it is important to recognize that there are data that suggest patients using this drug may be vulnerable to a number of psychiatric conditions” and that monthly iPLEDGE visits are an opportunity to screen patients for these conditions, they said.

They also stressed that “the risk of psychiatric adverse events in patients taking isotretinoin must be considered in the context of a known increased risk of suicidal ideation in patients with acne independent of isotretinoin therapy.”

Mr. Singer had no financial conflicts to disclose. Study coauthor John S. Barbieri, MD, disclosed partial salary support from Pfizer and grand support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and Arash Mostaghimi, MD, disclosed personal fees from Pfizer.

SOURCE: Singer S et al. JAMA Dermatol. 2019. Jul 3. doi: 10.1001/jamadermatol.2019.1416.

Isotretinoin use may increase vulnerability to psychiatric conditions, but available evidence does not support a causal relationship, on the basis of data from a retrospective study of 17,829 psychiatric adverse events reported to the Food and Drug Administration over 2 decades.

“Although one study highlighted consistent reporting of depression and suicide in patients taking isotretinoin in the United States from 1982 to 2000, few studies have examined reports of psychiatric adverse events at the national level since 2000,” wrote Sean Singer of Harvard University, Boston, and his colleagues.

In a study published in JAMA Dermatology, the researchers reviewed data from the FDA’s Adverse Event Reporting System between 1997 and 2017.

A total of 17,829 psychiatric adverse events in which isotretinoin was the primary suspect drug were reported during the study period. The researchers classified the events into 12 categories; the most common were depressive disorders (42%), emotional lability (17%), and anxiety (14%). The number of reported psychiatric adverse events was similar between men and women (8,936 and 8,362 events, respectively).

The researchers also identified 2,278 reports of suicidal ideation, 602 reports of attempted suicide, and 368 reports of completed suicide.

In addition, the researchers examined data from the iPLEDGE program and found completed suicide rates of 8.4 per 100,000 patients in 2009 and 5.6 per 100,000 patients in 2010. However, these rates were lower than national suicide rates in the general population of 11.8 per 100,000 people in 2009 and 12.1 per 100,000 people in 2010.

Patient age was available for 13,553 adverse event reports, and patients aged 10-19 years accounted for 53% of the reports overall and 58% of completed suicides for which age was reported.

The high number of psychiatric adverse events in the youngest age group “could reflect more isotretinoin prescriptions in this age group or may suggest that teenagers are particularly vulnerable to psychiatric adverse events while taking isotretinoin,” the researchers said.

The findings were limited by several factors, including the reliance on proper clinician reports to the Adverse Event Reporting System database and the separation of some psychiatric terms into categories that may reflect symptoms of other psychiatric diagnoses, the researchers said.

However, “Our data showed high numbers of reports of emotional lability, anxiety disorders, insomnia, self-injurious behavior, and psychotic disorders with isotretinoin as the primary suspect drug,” they noted.

“Although no causal link has been established between isotretinoin and psychiatric adverse events, it is important to recognize that there are data that suggest patients using this drug may be vulnerable to a number of psychiatric conditions” and that monthly iPLEDGE visits are an opportunity to screen patients for these conditions, they said.

They also stressed that “the risk of psychiatric adverse events in patients taking isotretinoin must be considered in the context of a known increased risk of suicidal ideation in patients with acne independent of isotretinoin therapy.”

Mr. Singer had no financial conflicts to disclose. Study coauthor John S. Barbieri, MD, disclosed partial salary support from Pfizer and grand support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and Arash Mostaghimi, MD, disclosed personal fees from Pfizer.

SOURCE: Singer S et al. JAMA Dermatol. 2019. Jul 3. doi: 10.1001/jamadermatol.2019.1416.

Isotretinoin use may increase vulnerability to psychiatric conditions, but available evidence does not support a causal relationship, on the basis of data from a retrospective study of 17,829 psychiatric adverse events reported to the Food and Drug Administration over 2 decades.

“Although one study highlighted consistent reporting of depression and suicide in patients taking isotretinoin in the United States from 1982 to 2000, few studies have examined reports of psychiatric adverse events at the national level since 2000,” wrote Sean Singer of Harvard University, Boston, and his colleagues.

In a study published in JAMA Dermatology, the researchers reviewed data from the FDA’s Adverse Event Reporting System between 1997 and 2017.

A total of 17,829 psychiatric adverse events in which isotretinoin was the primary suspect drug were reported during the study period. The researchers classified the events into 12 categories; the most common were depressive disorders (42%), emotional lability (17%), and anxiety (14%). The number of reported psychiatric adverse events was similar between men and women (8,936 and 8,362 events, respectively).

The researchers also identified 2,278 reports of suicidal ideation, 602 reports of attempted suicide, and 368 reports of completed suicide.

In addition, the researchers examined data from the iPLEDGE program and found completed suicide rates of 8.4 per 100,000 patients in 2009 and 5.6 per 100,000 patients in 2010. However, these rates were lower than national suicide rates in the general population of 11.8 per 100,000 people in 2009 and 12.1 per 100,000 people in 2010.

Patient age was available for 13,553 adverse event reports, and patients aged 10-19 years accounted for 53% of the reports overall and 58% of completed suicides for which age was reported.

The high number of psychiatric adverse events in the youngest age group “could reflect more isotretinoin prescriptions in this age group or may suggest that teenagers are particularly vulnerable to psychiatric adverse events while taking isotretinoin,” the researchers said.

The findings were limited by several factors, including the reliance on proper clinician reports to the Adverse Event Reporting System database and the separation of some psychiatric terms into categories that may reflect symptoms of other psychiatric diagnoses, the researchers said.

However, “Our data showed high numbers of reports of emotional lability, anxiety disorders, insomnia, self-injurious behavior, and psychotic disorders with isotretinoin as the primary suspect drug,” they noted.

“Although no causal link has been established between isotretinoin and psychiatric adverse events, it is important to recognize that there are data that suggest patients using this drug may be vulnerable to a number of psychiatric conditions” and that monthly iPLEDGE visits are an opportunity to screen patients for these conditions, they said.

They also stressed that “the risk of psychiatric adverse events in patients taking isotretinoin must be considered in the context of a known increased risk of suicidal ideation in patients with acne independent of isotretinoin therapy.”

Mr. Singer had no financial conflicts to disclose. Study coauthor John S. Barbieri, MD, disclosed partial salary support from Pfizer and grand support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and Arash Mostaghimi, MD, disclosed personal fees from Pfizer.

SOURCE: Singer S et al. JAMA Dermatol. 2019. Jul 3. doi: 10.1001/jamadermatol.2019.1416.

High rates of both incarceration and reduced household income are significantly associated with drug-related deaths in the United States, based a regression analysis of several decades of data.

“More than half a million drug-related deaths have occurred in the USA in the past three and half decades, however, no studies have investigated the association between these deaths and the expansion of the incarcerated population,” wrote Elias Nosrati, PhD, of the University of Oxford (England) and colleagues.

The researchers reviewed previously unavailable data on jail and prison incarceration at the county level from the nonprofit Vera Institute of Justice in New York, as well as mortality data from the U.S. National Vital Statistics System. The analysis was published in the Lancet Public Health.

After adjustment for multiple confounding variables, each standard deviation in admission rates to local jails (an average of 7,018 per 100,000 population) was associated with a significant 1.5% increase in drug-related deaths, and each standard deviation in admission rates to state prisons (an average of 254.6 per 100,000 population) was associated with a significant 2.6% increase in drug-related deaths, reported Dr. Nosrati and colleagues.

“On average, high incarceration rates correspond to 1.9 excess deaths per 100,000 county residents, corresponding to a treatment effect equal to a 53.5% increase in the mortality rate from drug use disorders,” the researchers wrote. In addition, each standard-deviation decrease in median household income was associated with a 12.8% increase in drug-related deaths within counties.

The findings were limited by several factors, including the observational nature of the study, the potential skewing of results because of missing data from some counties, and the inability to examine support for individuals released from jail or prison, the researchers noted.

However, the results suggest that, “when coupled with economic hardship, the operations of the prison and jail systems constitute an upstream determinant of despair, whereby regular exposures to neighborhood violence, unstable social and family relationships, and psychosocial stress trigger destructive behaviours,” they wrote.

In an accompanying comment, James LePage, PhD, wrote that current laws regarding trespassing, loitering, and vagrancy “unfairly criminalize individuals of low economic status and homeless individuals” by increasing their likelihood of interaction with the legal system and thus increasing the incarceration rate in this population.

“Future studies should focus on racial and ethnic biases in arrests and sentencing, and the subsequent effect on drug-related mortality,” wrote Dr. LePage of the VA North Texas Health Care System in Dallas.

Neither the researchers in the main study nor Dr. LePage had financial conflicts to disclose.

SOURCE: Nosrati E et al. Lancet Public Health. 2019 Jul 3;4:e326-33.

High rates of both incarceration and reduced household income are significantly associated with drug-related deaths in the United States, based a regression analysis of several decades of data.

“More than half a million drug-related deaths have occurred in the USA in the past three and half decades, however, no studies have investigated the association between these deaths and the expansion of the incarcerated population,” wrote Elias Nosrati, PhD, of the University of Oxford (England) and colleagues.

The researchers reviewed previously unavailable data on jail and prison incarceration at the county level from the nonprofit Vera Institute of Justice in New York, as well as mortality data from the U.S. National Vital Statistics System. The analysis was published in the Lancet Public Health.

After adjustment for multiple confounding variables, each standard deviation in admission rates to local jails (an average of 7,018 per 100,000 population) was associated with a significant 1.5% increase in drug-related deaths, and each standard deviation in admission rates to state prisons (an average of 254.6 per 100,000 population) was associated with a significant 2.6% increase in drug-related deaths, reported Dr. Nosrati and colleagues.

“On average, high incarceration rates correspond to 1.9 excess deaths per 100,000 county residents, corresponding to a treatment effect equal to a 53.5% increase in the mortality rate from drug use disorders,” the researchers wrote. In addition, each standard-deviation decrease in median household income was associated with a 12.8% increase in drug-related deaths within counties.

The findings were limited by several factors, including the observational nature of the study, the potential skewing of results because of missing data from some counties, and the inability to examine support for individuals released from jail or prison, the researchers noted.

However, the results suggest that, “when coupled with economic hardship, the operations of the prison and jail systems constitute an upstream determinant of despair, whereby regular exposures to neighborhood violence, unstable social and family relationships, and psychosocial stress trigger destructive behaviours,” they wrote.

In an accompanying comment, James LePage, PhD, wrote that current laws regarding trespassing, loitering, and vagrancy “unfairly criminalize individuals of low economic status and homeless individuals” by increasing their likelihood of interaction with the legal system and thus increasing the incarceration rate in this population.

“Future studies should focus on racial and ethnic biases in arrests and sentencing, and the subsequent effect on drug-related mortality,” wrote Dr. LePage of the VA North Texas Health Care System in Dallas.

Neither the researchers in the main study nor Dr. LePage had financial conflicts to disclose.

SOURCE: Nosrati E et al. Lancet Public Health. 2019 Jul 3;4:e326-33.

High rates of both incarceration and reduced household income are significantly associated with drug-related deaths in the United States, based a regression analysis of several decades of data.

“More than half a million drug-related deaths have occurred in the USA in the past three and half decades, however, no studies have investigated the association between these deaths and the expansion of the incarcerated population,” wrote Elias Nosrati, PhD, of the University of Oxford (England) and colleagues.

The researchers reviewed previously unavailable data on jail and prison incarceration at the county level from the nonprofit Vera Institute of Justice in New York, as well as mortality data from the U.S. National Vital Statistics System. The analysis was published in the Lancet Public Health.

After adjustment for multiple confounding variables, each standard deviation in admission rates to local jails (an average of 7,018 per 100,000 population) was associated with a significant 1.5% increase in drug-related deaths, and each standard deviation in admission rates to state prisons (an average of 254.6 per 100,000 population) was associated with a significant 2.6% increase in drug-related deaths, reported Dr. Nosrati and colleagues.

“On average, high incarceration rates correspond to 1.9 excess deaths per 100,000 county residents, corresponding to a treatment effect equal to a 53.5% increase in the mortality rate from drug use disorders,” the researchers wrote. In addition, each standard-deviation decrease in median household income was associated with a 12.8% increase in drug-related deaths within counties.

The findings were limited by several factors, including the observational nature of the study, the potential skewing of results because of missing data from some counties, and the inability to examine support for individuals released from jail or prison, the researchers noted.

However, the results suggest that, “when coupled with economic hardship, the operations of the prison and jail systems constitute an upstream determinant of despair, whereby regular exposures to neighborhood violence, unstable social and family relationships, and psychosocial stress trigger destructive behaviours,” they wrote.

In an accompanying comment, James LePage, PhD, wrote that current laws regarding trespassing, loitering, and vagrancy “unfairly criminalize individuals of low economic status and homeless individuals” by increasing their likelihood of interaction with the legal system and thus increasing the incarceration rate in this population.

“Future studies should focus on racial and ethnic biases in arrests and sentencing, and the subsequent effect on drug-related mortality,” wrote Dr. LePage of the VA North Texas Health Care System in Dallas.

Neither the researchers in the main study nor Dr. LePage had financial conflicts to disclose.

SOURCE: Nosrati E et al. Lancet Public Health. 2019 Jul 3;4:e326-33.

MADRID – Influenza vaccination is similarly effective for individuals taking a tumor necrosis factor (TNF) inhibitor and healthy controls, but the number needed to vaccinate to prevent one case of influenza for patients taking a TNF inhibitor is much lower, according to data from a study presented at the European Congress of Rheumatology.

Mitchel L. Zoler/MDedge News

The number needed to vaccinate (NNV) to prevent one case of influenza among healthy control patients was 71, compared with an NNV of 10 for patients taking the TNF inhibitor adalimumab (Humira), reported Giovanni Adami, MD, and colleagues at the University of Verona (Italy).

While TNF inhibitors “are known to increase the risk of infection by suppressing the activity of the immune system,” it has not been clear whether the response to vaccination is impaired in patients treated with a TNF inhibitor, Dr. Adami said.

Dr. Adami and colleagues reviewed data from 15,132 adult patients exposed to adalimumab in global rheumatoid arthritis clinical trials and 71,221 healthy controls from clinical trials of influenza vaccines. Overall, the rate of influenza infection was similarly reduced with vaccination in both groups. The rate in healthy individuals went from 2.3% for those unvaccinated to 0.9% for those vaccinated; for TNF inhibitor–treated patients, the rate was 14.4% for those unvaccinated versus 4.5% for those vaccinated.

“It is not surprising that the number needed to vaccinate is dramatically lower in patients treated with immunosuppressors, compared to healthy individuals,” Dr. Adami noted. “As a matter of fact, patients treated with such drugs are at higher risk of infections, namely they have a greater absolute risk of influenza. Nevertheless, [it] is quite surprising that the relative risk reduction is similar between TNF inhibitor–treated patients and healthy controls, meaning that the vaccination is efficacious in both the cohorts.”

The researchers also calculated the cost to prevent one case of influenza, using a cost of approximately 16.5 euro per vaccine. (Dr. Adami also cited an average U.S. cost of about $40/vaccine). Using this method, they estimated a cost for vaccination of 1,174 euro (roughly $1,340) to prevent one influenza infection in the general population, and a cost of about 165 euro (roughly $188) to vaccinate enough people treated with a TNF inhibitor to prevent one infection.

Dr. Adami advised clinicians to remember the low NNV for TNF inhibitor–treated patients with regard to influenza vaccination. “A direct disclosure of the NNV for these patients might help adherence to vaccinations,” he said.

Next steps for research should include extending the real-world effectiveness analysis to other medications and other diseases, such as zoster vaccination in patients treated with Janus kinase inhibitors, Dr. Adami said.

Dr. Adami had no financial conflicts to disclose. Several coauthors disclosed relationships with companies including Abiogen Pharma, Grünenthal, Amgen, Janssen-Cilag, Mundipharma, and Pfizer.

Mitchel L. Zoler contributed to this report.

SOURCE: Adami G et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):192-3. Abstract OP0230, doi: 10.1136/annrheumdis-2019-eular.3088

MADRID – Influenza vaccination is similarly effective for individuals taking a tumor necrosis factor (TNF) inhibitor and healthy controls, but the number needed to vaccinate to prevent one case of influenza for patients taking a TNF inhibitor is much lower, according to data from a study presented at the European Congress of Rheumatology.

Mitchel L. Zoler/MDedge News

The number needed to vaccinate (NNV) to prevent one case of influenza among healthy control patients was 71, compared with an NNV of 10 for patients taking the TNF inhibitor adalimumab (Humira), reported Giovanni Adami, MD, and colleagues at the University of Verona (Italy).

While TNF inhibitors “are known to increase the risk of infection by suppressing the activity of the immune system,” it has not been clear whether the response to vaccination is impaired in patients treated with a TNF inhibitor, Dr. Adami said.

Dr. Adami and colleagues reviewed data from 15,132 adult patients exposed to adalimumab in global rheumatoid arthritis clinical trials and 71,221 healthy controls from clinical trials of influenza vaccines. Overall, the rate of influenza infection was similarly reduced with vaccination in both groups. The rate in healthy individuals went from 2.3% for those unvaccinated to 0.9% for those vaccinated; for TNF inhibitor–treated patients, the rate was 14.4% for those unvaccinated versus 4.5% for those vaccinated.

“It is not surprising that the number needed to vaccinate is dramatically lower in patients treated with immunosuppressors, compared to healthy individuals,” Dr. Adami noted. “As a matter of fact, patients treated with such drugs are at higher risk of infections, namely they have a greater absolute risk of influenza. Nevertheless, [it] is quite surprising that the relative risk reduction is similar between TNF inhibitor–treated patients and healthy controls, meaning that the vaccination is efficacious in both the cohorts.”

The researchers also calculated the cost to prevent one case of influenza, using a cost of approximately 16.5 euro per vaccine. (Dr. Adami also cited an average U.S. cost of about $40/vaccine). Using this method, they estimated a cost for vaccination of 1,174 euro (roughly $1,340) to prevent one influenza infection in the general population, and a cost of about 165 euro (roughly $188) to vaccinate enough people treated with a TNF inhibitor to prevent one infection.

Dr. Adami advised clinicians to remember the low NNV for TNF inhibitor–treated patients with regard to influenza vaccination. “A direct disclosure of the NNV for these patients might help adherence to vaccinations,” he said.

Next steps for research should include extending the real-world effectiveness analysis to other medications and other diseases, such as zoster vaccination in patients treated with Janus kinase inhibitors, Dr. Adami said.

Dr. Adami had no financial conflicts to disclose. Several coauthors disclosed relationships with companies including Abiogen Pharma, Grünenthal, Amgen, Janssen-Cilag, Mundipharma, and Pfizer.

Mitchel L. Zoler contributed to this report.

SOURCE: Adami G et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):192-3. Abstract OP0230, doi: 10.1136/annrheumdis-2019-eular.3088

MADRID – Influenza vaccination is similarly effective for individuals taking a tumor necrosis factor (TNF) inhibitor and healthy controls, but the number needed to vaccinate to prevent one case of influenza for patients taking a TNF inhibitor is much lower, according to data from a study presented at the European Congress of Rheumatology.

Mitchel L. Zoler/MDedge News

The number needed to vaccinate (NNV) to prevent one case of influenza among healthy control patients was 71, compared with an NNV of 10 for patients taking the TNF inhibitor adalimumab (Humira), reported Giovanni Adami, MD, and colleagues at the University of Verona (Italy).

While TNF inhibitors “are known to increase the risk of infection by suppressing the activity of the immune system,” it has not been clear whether the response to vaccination is impaired in patients treated with a TNF inhibitor, Dr. Adami said.

Dr. Adami and colleagues reviewed data from 15,132 adult patients exposed to adalimumab in global rheumatoid arthritis clinical trials and 71,221 healthy controls from clinical trials of influenza vaccines. Overall, the rate of influenza infection was similarly reduced with vaccination in both groups. The rate in healthy individuals went from 2.3% for those unvaccinated to 0.9% for those vaccinated; for TNF inhibitor–treated patients, the rate was 14.4% for those unvaccinated versus 4.5% for those vaccinated.

“It is not surprising that the number needed to vaccinate is dramatically lower in patients treated with immunosuppressors, compared to healthy individuals,” Dr. Adami noted. “As a matter of fact, patients treated with such drugs are at higher risk of infections, namely they have a greater absolute risk of influenza. Nevertheless, [it] is quite surprising that the relative risk reduction is similar between TNF inhibitor–treated patients and healthy controls, meaning that the vaccination is efficacious in both the cohorts.”

The researchers also calculated the cost to prevent one case of influenza, using a cost of approximately 16.5 euro per vaccine. (Dr. Adami also cited an average U.S. cost of about $40/vaccine). Using this method, they estimated a cost for vaccination of 1,174 euro (roughly $1,340) to prevent one influenza infection in the general population, and a cost of about 165 euro (roughly $188) to vaccinate enough people treated with a TNF inhibitor to prevent one infection.

Dr. Adami advised clinicians to remember the low NNV for TNF inhibitor–treated patients with regard to influenza vaccination. “A direct disclosure of the NNV for these patients might help adherence to vaccinations,” he said.

Next steps for research should include extending the real-world effectiveness analysis to other medications and other diseases, such as zoster vaccination in patients treated with Janus kinase inhibitors, Dr. Adami said.

Dr. Adami had no financial conflicts to disclose. Several coauthors disclosed relationships with companies including Abiogen Pharma, Grünenthal, Amgen, Janssen-Cilag, Mundipharma, and Pfizer.

Mitchel L. Zoler contributed to this report.

SOURCE: Adami G et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):192-3. Abstract OP0230, doi: 10.1136/annrheumdis-2019-eular.3088

The ratio of the forced expiratory volume in 1 second to the forced vital capacity (FEV₁:FVC) at the recommended threshold of 0.70 effectively diagnosed individuals at risk for clinically significant COPD, a longitudinal study of more than 24,000 individuals has found.

Guidelines from respiratory societies have long recommended a diagnosis of airflow obstruction when the FEV₁:FVC is less than 0.70, but no rigorous, population-based studies have been conducted to support this recommendation, wrote Surya P. Bhatt, MD, of the University of Alabama at Birmingham, and colleagues.

“The selection of a threshold for defining airflow obstruction has major implications for patient care and public health as the prevalence of airflow obstruction can vary by as much as 33% depending on which threshold is selected,” they said.

In a study published in JAMA, the researchers reviewed data from 24,207 participants in the National Heart, Lung, and Blood Institute Pooled Cohorts Study to assess the accuracy of different thresholds in predicting COPD events in a large, multiethnic, U.S. population. All participants underwent spirometry; the average age at spirometry was 63 years, and 54% of the patients were women. Patients were enrolled during 1987-2000 and received follow-up longitudinally through 2016.

Overall, 3,925 participants experienced COPD-related events during an average of 15 years of follow-up (more than 340,757 person-years). These events included 3,563 hospitalizations and 447 deaths related to COPD.

The researchers compared three thresholds for FEV₁:FVC ratios: a fixed optimal threshold of 0.71, a lower limit of normal (LLN) defined as 0.034, and the currently recommended 0.70.

The optimal 0.71 was not significantly different from the recommended 0.70 but was significantly more accurate than the LLN of 0.034. In addition, the 0.70 value was the optimal predictor in a subgroup analysis of ever-smokers and in multivariate analysis.

The findings were limited by several factors including the use of prebronchodilator spirometry, lack of adjustment for medication use, and limitation of outcomes to COPD mortality or clinical events mainly caused by COPD, which might exclude patients with mild to moderate disease, the researchers noted.

However, the study “provides population-based evidence to support 0.70 as the optimal FEV₁:FVC threshold for defining clinically significant airflow obstruction,” to help clinicians identify patients at increased risk for significant COPD, they said.

Lead author Dr. Bhatt disclosed a National Institutes of Health grant, consulting fees from Sunovion and research funds from Proterix Bio. The study was supported by grants from multiple agencies of the National Institutes of Health, including the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging.

SOURCE: Bhatt SP et al. JAMA. 2019. 321:2438-47.

The ratio of the forced expiratory volume in 1 second to the forced vital capacity (FEV₁:FVC) at the recommended threshold of 0.70 effectively diagnosed individuals at risk for clinically significant COPD, a longitudinal study of more than 24,000 individuals has found.

Guidelines from respiratory societies have long recommended a diagnosis of airflow obstruction when the FEV₁:FVC is less than 0.70, but no rigorous, population-based studies have been conducted to support this recommendation, wrote Surya P. Bhatt, MD, of the University of Alabama at Birmingham, and colleagues.

“The selection of a threshold for defining airflow obstruction has major implications for patient care and public health as the prevalence of airflow obstruction can vary by as much as 33% depending on which threshold is selected,” they said.

In a study published in JAMA, the researchers reviewed data from 24,207 participants in the National Heart, Lung, and Blood Institute Pooled Cohorts Study to assess the accuracy of different thresholds in predicting COPD events in a large, multiethnic, U.S. population. All participants underwent spirometry; the average age at spirometry was 63 years, and 54% of the patients were women. Patients were enrolled during 1987-2000 and received follow-up longitudinally through 2016.

Overall, 3,925 participants experienced COPD-related events during an average of 15 years of follow-up (more than 340,757 person-years). These events included 3,563 hospitalizations and 447 deaths related to COPD.

The researchers compared three thresholds for FEV₁:FVC ratios: a fixed optimal threshold of 0.71, a lower limit of normal (LLN) defined as 0.034, and the currently recommended 0.70.

The optimal 0.71 was not significantly different from the recommended 0.70 but was significantly more accurate than the LLN of 0.034. In addition, the 0.70 value was the optimal predictor in a subgroup analysis of ever-smokers and in multivariate analysis.

The findings were limited by several factors including the use of prebronchodilator spirometry, lack of adjustment for medication use, and limitation of outcomes to COPD mortality or clinical events mainly caused by COPD, which might exclude patients with mild to moderate disease, the researchers noted.

However, the study “provides population-based evidence to support 0.70 as the optimal FEV₁:FVC threshold for defining clinically significant airflow obstruction,” to help clinicians identify patients at increased risk for significant COPD, they said.

Lead author Dr. Bhatt disclosed a National Institutes of Health grant, consulting fees from Sunovion and research funds from Proterix Bio. The study was supported by grants from multiple agencies of the National Institutes of Health, including the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging.

SOURCE: Bhatt SP et al. JAMA. 2019. 321:2438-47.

The ratio of the forced expiratory volume in 1 second to the forced vital capacity (FEV₁:FVC) at the recommended threshold of 0.70 effectively diagnosed individuals at risk for clinically significant COPD, a longitudinal study of more than 24,000 individuals has found.

Guidelines from respiratory societies have long recommended a diagnosis of airflow obstruction when the FEV₁:FVC is less than 0.70, but no rigorous, population-based studies have been conducted to support this recommendation, wrote Surya P. Bhatt, MD, of the University of Alabama at Birmingham, and colleagues.

“The selection of a threshold for defining airflow obstruction has major implications for patient care and public health as the prevalence of airflow obstruction can vary by as much as 33% depending on which threshold is selected,” they said.

In a study published in JAMA, the researchers reviewed data from 24,207 participants in the National Heart, Lung, and Blood Institute Pooled Cohorts Study to assess the accuracy of different thresholds in predicting COPD events in a large, multiethnic, U.S. population. All participants underwent spirometry; the average age at spirometry was 63 years, and 54% of the patients were women. Patients were enrolled during 1987-2000 and received follow-up longitudinally through 2016.

Overall, 3,925 participants experienced COPD-related events during an average of 15 years of follow-up (more than 340,757 person-years). These events included 3,563 hospitalizations and 447 deaths related to COPD.

The researchers compared three thresholds for FEV₁:FVC ratios: a fixed optimal threshold of 0.71, a lower limit of normal (LLN) defined as 0.034, and the currently recommended 0.70.

The optimal 0.71 was not significantly different from the recommended 0.70 but was significantly more accurate than the LLN of 0.034. In addition, the 0.70 value was the optimal predictor in a subgroup analysis of ever-smokers and in multivariate analysis.

The findings were limited by several factors including the use of prebronchodilator spirometry, lack of adjustment for medication use, and limitation of outcomes to COPD mortality or clinical events mainly caused by COPD, which might exclude patients with mild to moderate disease, the researchers noted.

However, the study “provides population-based evidence to support 0.70 as the optimal FEV₁:FVC threshold for defining clinically significant airflow obstruction,” to help clinicians identify patients at increased risk for significant COPD, they said.

Lead author Dr. Bhatt disclosed a National Institutes of Health grant, consulting fees from Sunovion and research funds from Proterix Bio. The study was supported by grants from multiple agencies of the National Institutes of Health, including the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging.

SOURCE: Bhatt SP et al. JAMA. 2019. 321:2438-47.

Current and former smokers are at significantly increased risk for acute complications after Mohs surgery, based on data from a retrospective case-control study of 1,008 adult patients.

Terroa/iStock/Getty Images

The increased risk of complications for smokers following many types of surgery is well documented; however, “the effect of smoking in the specific setting of cutaneous tissue transfer is not well characterized in the literature describing outcomes after Mohs reconstruction,” wrote Chang Ye Wang, MD, of St. Louis University, Missouri, and colleagues.

To determine the impact of smoking on acute and long-term complications, the researchers reviewed data from 1,008 adults (396 women and 612 men) who underwent Mohs surgery between July 1, 2012, and June 30, 2016, at a single center. The study population included 128 current smokers, 385 former smokers, and 495 never smokers. The age of the patients ranged from 21 years to 90 years, with a median of 70 years. The results were published in JAMA Facial Plastic Surgery.

The overall rate of acute complications was 4.1%, and the most common complication was infection, in 19 cases; others were 10 cases of flap or graft necrosis, 10 cases of wound dehiscence, and 6 of cases of hematoma or uncontrolled bleeding; some patients experienced more than one of these complications. The risk of acute complications increased for current smokers (odds ratio 9.58) and former smokers (OR, 3.64) in a multivariate analysis. Increased risk of acute complications also was associated with a larger defect (OR, 2.25) and use of free cartilage graft (OR, 8.19).

The researchers defined acute complications as “any postsurgical infection, dehiscence, hematoma, uncontrolled bleeding, and tissue necrosis that required medical counseling or intervention,” and long-term complications as “any postsurgical functional defect or unsatisfactory cosmesis that prompted the patient to request an additional procedural intervention or the surgeon to offer it.”

The overall rate of long-term complications was 7.4%. A procedure in the center of the face was associated with a 25% increased risk of long-term complications (OR, 25.4). Other factors associated with an increased risk of long-term complications were the use of interpolation flap or flap-graft combination (OR, 3.49), larger flaps (OR, 1.42), and presence of basal cell carcinomas or other basaloid tumors (OR, 3.43). Smoking was not associated with an increased risk of long-term complications, and an older age was associated with a decreased risk of long-term complications (OR, 0.66).

The findings were limited by the retrospective study design and unblinded data collection, as well as a lack of photographs of all patients at matching time points, the researchers said. However, the results are consistent with previous studies and “may allow the surgeon to better quantify the magnitude of risk and provide helpful information for patient counseling,” they added.

The researchers had no financial conflicts to disclose.

SOURCE: Wang CY et al. JAMA Facial Plast. Surg. 2019 June 13. doi: 10.1001/jamafacial.2019.0243.

Current and former smokers are at significantly increased risk for acute complications after Mohs surgery, based on data from a retrospective case-control study of 1,008 adult patients.

Terroa/iStock/Getty Images

The increased risk of complications for smokers following many types of surgery is well documented; however, “the effect of smoking in the specific setting of cutaneous tissue transfer is not well characterized in the literature describing outcomes after Mohs reconstruction,” wrote Chang Ye Wang, MD, of St. Louis University, Missouri, and colleagues.

To determine the impact of smoking on acute and long-term complications, the researchers reviewed data from 1,008 adults (396 women and 612 men) who underwent Mohs surgery between July 1, 2012, and June 30, 2016, at a single center. The study population included 128 current smokers, 385 former smokers, and 495 never smokers. The age of the patients ranged from 21 years to 90 years, with a median of 70 years. The results were published in JAMA Facial Plastic Surgery.

The overall rate of acute complications was 4.1%, and the most common complication was infection, in 19 cases; others were 10 cases of flap or graft necrosis, 10 cases of wound dehiscence, and 6 of cases of hematoma or uncontrolled bleeding; some patients experienced more than one of these complications. The risk of acute complications increased for current smokers (odds ratio 9.58) and former smokers (OR, 3.64) in a multivariate analysis. Increased risk of acute complications also was associated with a larger defect (OR, 2.25) and use of free cartilage graft (OR, 8.19).

The researchers defined acute complications as “any postsurgical infection, dehiscence, hematoma, uncontrolled bleeding, and tissue necrosis that required medical counseling or intervention,” and long-term complications as “any postsurgical functional defect or unsatisfactory cosmesis that prompted the patient to request an additional procedural intervention or the surgeon to offer it.”

The overall rate of long-term complications was 7.4%. A procedure in the center of the face was associated with a 25% increased risk of long-term complications (OR, 25.4). Other factors associated with an increased risk of long-term complications were the use of interpolation flap or flap-graft combination (OR, 3.49), larger flaps (OR, 1.42), and presence of basal cell carcinomas or other basaloid tumors (OR, 3.43). Smoking was not associated with an increased risk of long-term complications, and an older age was associated with a decreased risk of long-term complications (OR, 0.66).

The findings were limited by the retrospective study design and unblinded data collection, as well as a lack of photographs of all patients at matching time points, the researchers said. However, the results are consistent with previous studies and “may allow the surgeon to better quantify the magnitude of risk and provide helpful information for patient counseling,” they added.

The researchers had no financial conflicts to disclose.

SOURCE: Wang CY et al. JAMA Facial Plast. Surg. 2019 June 13. doi: 10.1001/jamafacial.2019.0243.

Current and former smokers are at significantly increased risk for acute complications after Mohs surgery, based on data from a retrospective case-control study of 1,008 adult patients.

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The increased risk of complications for smokers following many types of surgery is well documented; however, “the effect of smoking in the specific setting of cutaneous tissue transfer is not well characterized in the literature describing outcomes after Mohs reconstruction,” wrote Chang Ye Wang, MD, of St. Louis University, Missouri, and colleagues.

To determine the impact of smoking on acute and long-term complications, the researchers reviewed data from 1,008 adults (396 women and 612 men) who underwent Mohs surgery between July 1, 2012, and June 30, 2016, at a single center. The study population included 128 current smokers, 385 former smokers, and 495 never smokers. The age of the patients ranged from 21 years to 90 years, with a median of 70 years. The results were published in JAMA Facial Plastic Surgery.

The overall rate of acute complications was 4.1%, and the most common complication was infection, in 19 cases; others were 10 cases of flap or graft necrosis, 10 cases of wound dehiscence, and 6 of cases of hematoma or uncontrolled bleeding; some patients experienced more than one of these complications. The risk of acute complications increased for current smokers (odds ratio 9.58) and former smokers (OR, 3.64) in a multivariate analysis. Increased risk of acute complications also was associated with a larger defect (OR, 2.25) and use of free cartilage graft (OR, 8.19).

The researchers defined acute complications as “any postsurgical infection, dehiscence, hematoma, uncontrolled bleeding, and tissue necrosis that required medical counseling or intervention,” and long-term complications as “any postsurgical functional defect or unsatisfactory cosmesis that prompted the patient to request an additional procedural intervention or the surgeon to offer it.”

The overall rate of long-term complications was 7.4%. A procedure in the center of the face was associated with a 25% increased risk of long-term complications (OR, 25.4). Other factors associated with an increased risk of long-term complications were the use of interpolation flap or flap-graft combination (OR, 3.49), larger flaps (OR, 1.42), and presence of basal cell carcinomas or other basaloid tumors (OR, 3.43). Smoking was not associated with an increased risk of long-term complications, and an older age was associated with a decreased risk of long-term complications (OR, 0.66).

The findings were limited by the retrospective study design and unblinded data collection, as well as a lack of photographs of all patients at matching time points, the researchers said. However, the results are consistent with previous studies and “may allow the surgeon to better quantify the magnitude of risk and provide helpful information for patient counseling,” they added.

The researchers had no financial conflicts to disclose.

SOURCE: Wang CY et al. JAMA Facial Plast. Surg. 2019 June 13. doi: 10.1001/jamafacial.2019.0243.

A booster dose of meningococcal B (MenB) vaccine is necessary to sustain protection for persons aged 10 years and older at increased risk, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

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The committee voted unanimously in favor of a booster dose of MenB vaccine 1 year after completion of the primary series, with additional boosters every 2-3 years “for as long as risk remains” for high-risk persons, including microbiologists and persons with complement deficiency, complement inhibitor use, or asplenia.

The committee also voted unanimously in favor of a one-time MenB booster for individuals aged 10 years and older who are at least a year beyond completion of a MenB primary series and deemed at increased risk by public health officials in an outbreak situation.

In addition, “a booster dose interval of 6 months or more may be considered by public health officials depending on the specific outbreak, vaccine strategy, and projected duration of elevated risk” according to the language, which was included in the unanimously approved statement “Meningococcal Vaccination: Recommendations of The Advisory Committee on Immunization Practices.”

The updated statement on meningococcal vaccination was developed in 2019 “to consolidate all existing ACIP recommendations for MenACWY and MenB vaccines in a single document,” said Sarah Mbaeyi, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, who presented immunogenicity data and the proposed recommendations.

The statement includes the recommendation of a MenB primary series for individuals aged 16-23 years based on shared clinical decision making. Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn., noted the importance of ongoing data collection, and said clinicians must make clear to patients that, “if they want protection, they need the booster.”

Approximately 7% of serogroup B cases in the United States are related to disease outbreaks, mainly among college students, Dr. Mbaeyi said. All 13 universities that experienced outbreaks between 2013 and 2019 have implemented a MenB primary series, and one university has implemented an off-label booster program.

The work group concluded that a MenB booster dose is necessary to sustain protection against serogroup B disease in persons at increased risk during an outbreak, and that the potential benefits outweighed the harms given the seriousness of meningococcal disease.

Paul Hunter, MD, of the City of Milwaukee Health Department, noted that “the booster recommendation gives more flexibility” in an outbreak response.

The committee also voted unanimously to approve the Vaccines for Children resolution for the meningococcal vaccine that updates language to align with the new recommendations.

The ACIP members had no financial conflicts to disclose.

A booster dose of meningococcal B (MenB) vaccine is necessary to sustain protection for persons aged 10 years and older at increased risk, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Choreograph/Thinkstock

The committee voted unanimously in favor of a booster dose of MenB vaccine 1 year after completion of the primary series, with additional boosters every 2-3 years “for as long as risk remains” for high-risk persons, including microbiologists and persons with complement deficiency, complement inhibitor use, or asplenia.

The committee also voted unanimously in favor of a one-time MenB booster for individuals aged 10 years and older who are at least a year beyond completion of a MenB primary series and deemed at increased risk by public health officials in an outbreak situation.

In addition, “a booster dose interval of 6 months or more may be considered by public health officials depending on the specific outbreak, vaccine strategy, and projected duration of elevated risk” according to the language, which was included in the unanimously approved statement “Meningococcal Vaccination: Recommendations of The Advisory Committee on Immunization Practices.”

The updated statement on meningococcal vaccination was developed in 2019 “to consolidate all existing ACIP recommendations for MenACWY and MenB vaccines in a single document,” said Sarah Mbaeyi, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, who presented immunogenicity data and the proposed recommendations.

The statement includes the recommendation of a MenB primary series for individuals aged 16-23 years based on shared clinical decision making. Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn., noted the importance of ongoing data collection, and said clinicians must make clear to patients that, “if they want protection, they need the booster.”

Approximately 7% of serogroup B cases in the United States are related to disease outbreaks, mainly among college students, Dr. Mbaeyi said. All 13 universities that experienced outbreaks between 2013 and 2019 have implemented a MenB primary series, and one university has implemented an off-label booster program.

The work group concluded that a MenB booster dose is necessary to sustain protection against serogroup B disease in persons at increased risk during an outbreak, and that the potential benefits outweighed the harms given the seriousness of meningococcal disease.

Paul Hunter, MD, of the City of Milwaukee Health Department, noted that “the booster recommendation gives more flexibility” in an outbreak response.

The committee also voted unanimously to approve the Vaccines for Children resolution for the meningococcal vaccine that updates language to align with the new recommendations.

The ACIP members had no financial conflicts to disclose.

A booster dose of meningococcal B (MenB) vaccine is necessary to sustain protection for persons aged 10 years and older at increased risk, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Choreograph/Thinkstock

The committee voted unanimously in favor of a booster dose of MenB vaccine 1 year after completion of the primary series, with additional boosters every 2-3 years “for as long as risk remains” for high-risk persons, including microbiologists and persons with complement deficiency, complement inhibitor use, or asplenia.

The committee also voted unanimously in favor of a one-time MenB booster for individuals aged 10 years and older who are at least a year beyond completion of a MenB primary series and deemed at increased risk by public health officials in an outbreak situation.

In addition, “a booster dose interval of 6 months or more may be considered by public health officials depending on the specific outbreak, vaccine strategy, and projected duration of elevated risk” according to the language, which was included in the unanimously approved statement “Meningococcal Vaccination: Recommendations of The Advisory Committee on Immunization Practices.”

The updated statement on meningococcal vaccination was developed in 2019 “to consolidate all existing ACIP recommendations for MenACWY and MenB vaccines in a single document,” said Sarah Mbaeyi, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, who presented immunogenicity data and the proposed recommendations.

The statement includes the recommendation of a MenB primary series for individuals aged 16-23 years based on shared clinical decision making. Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn., noted the importance of ongoing data collection, and said clinicians must make clear to patients that, “if they want protection, they need the booster.”

Approximately 7% of serogroup B cases in the United States are related to disease outbreaks, mainly among college students, Dr. Mbaeyi said. All 13 universities that experienced outbreaks between 2013 and 2019 have implemented a MenB primary series, and one university has implemented an off-label booster program.

The work group concluded that a MenB booster dose is necessary to sustain protection against serogroup B disease in persons at increased risk during an outbreak, and that the potential benefits outweighed the harms given the seriousness of meningococcal disease.

Paul Hunter, MD, of the City of Milwaukee Health Department, noted that “the booster recommendation gives more flexibility” in an outbreak response.

The committee also voted unanimously to approve the Vaccines for Children resolution for the meningococcal vaccine that updates language to align with the new recommendations.

The ACIP members had no financial conflicts to disclose.

Outbreaks of cryptosporidiosis increased in the United States by an average of 13% each year between 2009 and 2017, based on data from the Centers for Disease Control and Prevention.

In a study published in the CDC’s Morbidity and Mortality Weekly Report, researchers reviewed data from 444 reported outbreaks submitted to the CDC’s National Outbreak Reporting System totaling 7,465 cases, including 287 hospitalizations and one death.

The outbreaks during this period were most commonly associated with pools and water parks (35%), exposure to cattle (15%), and child care settings (13%). Another 3% of outbreaks were associated with drinking unpasteurized milk or apple cider. An outbreak was defined as two or more cases linked to a common source.

The profuse, watery diarrhea associated with infection from the cryptosporidium parasite can last for 3 weeks in healthy individuals and can cause life-threatening malnutrition in the immunocompromised, wrote Radhika Gharpure, DVM, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, and colleagues.

The overall number of outbreaks peaked during July and August each year; the number associated with pools and water parks peaked between June and August, the number associated with cattle peaked between March and May, and the number associated with child care settings peaked between July and September.

The results were limited by several factors including likely underestimation of the number of outbreaks, the use of multipathogen testing panels that could have inflated the number of outbreaks, and the variation in the ability of jurisdictions to detect, investigate, and report outbreaks, the researchers noted. CryptoNet, a molecularly-based surveillance system, has shown potential to track disease transmission, they said.

However, primary prevention is important to prevent the spread of disease, and strategies include refraining from swimming when one has diarrhea and for 2 weeks after resolution of diarrhea, not sending children to child care when they have diarrhea, and washing hands thoroughly after contact with animals, the researchers said.

“If a cryptosporidiosis outbreak occurs, substantial decontamination measures are needed, including hyperchlorinating public treated recreational water venues (e.g., swimming pools at a hotel, apartment complex, or water park) and using hydrogen peroxide to disinfect surfaces in child care settings to inactivate Cryptosporidium oocysts,” they emphasized.

The researchers had no financial conflicts to disclose.

SOURCE: Gharpure R et al. MMWR. 2019 June 28. 68:568-72.

Outbreaks of cryptosporidiosis increased in the United States by an average of 13% each year between 2009 and 2017, based on data from the Centers for Disease Control and Prevention.

In a study published in the CDC’s Morbidity and Mortality Weekly Report, researchers reviewed data from 444 reported outbreaks submitted to the CDC’s National Outbreak Reporting System totaling 7,465 cases, including 287 hospitalizations and one death.

The outbreaks during this period were most commonly associated with pools and water parks (35%), exposure to cattle (15%), and child care settings (13%). Another 3% of outbreaks were associated with drinking unpasteurized milk or apple cider. An outbreak was defined as two or more cases linked to a common source.

The profuse, watery diarrhea associated with infection from the cryptosporidium parasite can last for 3 weeks in healthy individuals and can cause life-threatening malnutrition in the immunocompromised, wrote Radhika Gharpure, DVM, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, and colleagues.

The overall number of outbreaks peaked during July and August each year; the number associated with pools and water parks peaked between June and August, the number associated with cattle peaked between March and May, and the number associated with child care settings peaked between July and September.

The results were limited by several factors including likely underestimation of the number of outbreaks, the use of multipathogen testing panels that could have inflated the number of outbreaks, and the variation in the ability of jurisdictions to detect, investigate, and report outbreaks, the researchers noted. CryptoNet, a molecularly-based surveillance system, has shown potential to track disease transmission, they said.

However, primary prevention is important to prevent the spread of disease, and strategies include refraining from swimming when one has diarrhea and for 2 weeks after resolution of diarrhea, not sending children to child care when they have diarrhea, and washing hands thoroughly after contact with animals, the researchers said.

“If a cryptosporidiosis outbreak occurs, substantial decontamination measures are needed, including hyperchlorinating public treated recreational water venues (e.g., swimming pools at a hotel, apartment complex, or water park) and using hydrogen peroxide to disinfect surfaces in child care settings to inactivate Cryptosporidium oocysts,” they emphasized.

The researchers had no financial conflicts to disclose.

SOURCE: Gharpure R et al. MMWR. 2019 June 28. 68:568-72.

Outbreaks of cryptosporidiosis increased in the United States by an average of 13% each year between 2009 and 2017, based on data from the Centers for Disease Control and Prevention.

In a study published in the CDC’s Morbidity and Mortality Weekly Report, researchers reviewed data from 444 reported outbreaks submitted to the CDC’s National Outbreak Reporting System totaling 7,465 cases, including 287 hospitalizations and one death.

The outbreaks during this period were most commonly associated with pools and water parks (35%), exposure to cattle (15%), and child care settings (13%). Another 3% of outbreaks were associated with drinking unpasteurized milk or apple cider. An outbreak was defined as two or more cases linked to a common source.

The profuse, watery diarrhea associated with infection from the cryptosporidium parasite can last for 3 weeks in healthy individuals and can cause life-threatening malnutrition in the immunocompromised, wrote Radhika Gharpure, DVM, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, and colleagues.

The overall number of outbreaks peaked during July and August each year; the number associated with pools and water parks peaked between June and August, the number associated with cattle peaked between March and May, and the number associated with child care settings peaked between July and September.

The results were limited by several factors including likely underestimation of the number of outbreaks, the use of multipathogen testing panels that could have inflated the number of outbreaks, and the variation in the ability of jurisdictions to detect, investigate, and report outbreaks, the researchers noted. CryptoNet, a molecularly-based surveillance system, has shown potential to track disease transmission, they said.

However, primary prevention is important to prevent the spread of disease, and strategies include refraining from swimming when one has diarrhea and for 2 weeks after resolution of diarrhea, not sending children to child care when they have diarrhea, and washing hands thoroughly after contact with animals, the researchers said.

“If a cryptosporidiosis outbreak occurs, substantial decontamination measures are needed, including hyperchlorinating public treated recreational water venues (e.g., swimming pools at a hotel, apartment complex, or water park) and using hydrogen peroxide to disinfect surfaces in child care settings to inactivate Cryptosporidium oocysts,” they emphasized.

The researchers had no financial conflicts to disclose.

SOURCE: Gharpure R et al. MMWR. 2019 June 28. 68:568-72.