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Suicidality risk high in transgender youth, varies by gender identity subtype
, new research suggests.
The study, which included more than 2,000 adolescents and was published in the October 14 issue of Pediatrics, provides new insights into suicide risk in gender identity subgroups, according to the investigators.
“Limited measures of gender identity may have led to inaccurate estimates of suicidality among transgender females in previous studies,” wrote Brian C. Thoma, PhD, and his colleagues at the University of Pittsburgh. The researchers noted that transgender females and nonbinary adolescents assigned male at birth are frequently combined in studies.
“However, our results indicate transgender females have higher risk for suicidal ideation and attempt compared with cisgender adolescents, whereas nonbinary adolescents assigned male at birth do not,” they wrote. “It is possible that estimates of suicidality that aggregate all transgender adolescents assigned male at birth into one group underestimate rates of suicidality among transgender females.”
The study, which analyzed results from a cross-sectional online survey from July to October 2018, was comprised of 2,020 adolescents, including 1,134 transgender adolescents.
The researchers divided respondents into seven categories: Cisgender males, cisgender females, transgender males, transgender females, nonbinary adolescents assigned female at birth, nonbinary adolescents assigned male at birth, and questioning gender identity. They then assessed non-suicidal self-injury (NSSI) and lifetime suicidality.
Compared to cisgender youth, transgender adolescents overall were more likely to report all outcomes: passive death wish (odds ratio [OR]=2.60), suicidal ideation (OR=2.20), suicide plan (OR=1.82), suicide attempt (OR=1.65), attempt requiring medical care (OR=2.01), and NSSI (OR=2.88).
Using cisgender males as reference after adjustment for all demographics, “cisgender females, transgender males, and nonbinary adolescents assigned female at birth had higher odds of each suicidality outcome” (OR= 1.49-5.85; OR=2.72-12.12; OR=1.84-8.59, respectively), the authors reported. “Transgender females had higher odds of each outcome [OR=2.73-6.30] except for suicide attempt requiring medical care. Nonbinary adolescents assigned male at birth had higher odds of suicide attempt requiring medical care [OR=10.13] and NSSI [OR=3.79]. Adolescents questioning their gender identity had higher odds of all outcomes [OR=3.23-7.59] except for suicide attempt.”
When compared to cisgender females as reference, however, only transgender males and transgender females had higher odds of suicidal ideation and attempts.
The overall findings were unsurprising since the higher rates of suicidality among transgender youth have already been documented, but the classification of participants was interesting, Gerald Montano, DO, an assistant professor of pediatrics at the University of Pittsburgh School of Medicine, said in an interview. Dr Montano was not involved in the study.
“It’s always been a challenge because, in the past, they always lumped transgender youth along with lesbian, gay, and bisexual youth,” Dr Montano said. This study is one of the few to go into more detail in considering participants’ gender identity, which was wise given that suicidal risk may differ accordingly.
The biggest take-home message of this study is the importance of screening for suicidality after informing adolescent patients of the limits of confidentiality, Dr Montano said.
“I think it’s very important for the physician to be aware of the reasons for those thoughts of suicide,” he continued. “A lot of it has to do with their gender identity and from discrimination and stigma from the general population.”
The research was funded by the University of Pittsburgh Central Research Development Fund and the National Institutes of Health. The authors reported no conflicts of interest.
SOURCE: Thoma BC et al, Pediatrics, October 14, 2019. DOI: 10.1542/peds.2019-1183
, new research suggests.
The study, which included more than 2,000 adolescents and was published in the October 14 issue of Pediatrics, provides new insights into suicide risk in gender identity subgroups, according to the investigators.
“Limited measures of gender identity may have led to inaccurate estimates of suicidality among transgender females in previous studies,” wrote Brian C. Thoma, PhD, and his colleagues at the University of Pittsburgh. The researchers noted that transgender females and nonbinary adolescents assigned male at birth are frequently combined in studies.
“However, our results indicate transgender females have higher risk for suicidal ideation and attempt compared with cisgender adolescents, whereas nonbinary adolescents assigned male at birth do not,” they wrote. “It is possible that estimates of suicidality that aggregate all transgender adolescents assigned male at birth into one group underestimate rates of suicidality among transgender females.”
The study, which analyzed results from a cross-sectional online survey from July to October 2018, was comprised of 2,020 adolescents, including 1,134 transgender adolescents.
The researchers divided respondents into seven categories: Cisgender males, cisgender females, transgender males, transgender females, nonbinary adolescents assigned female at birth, nonbinary adolescents assigned male at birth, and questioning gender identity. They then assessed non-suicidal self-injury (NSSI) and lifetime suicidality.
Compared to cisgender youth, transgender adolescents overall were more likely to report all outcomes: passive death wish (odds ratio [OR]=2.60), suicidal ideation (OR=2.20), suicide plan (OR=1.82), suicide attempt (OR=1.65), attempt requiring medical care (OR=2.01), and NSSI (OR=2.88).
Using cisgender males as reference after adjustment for all demographics, “cisgender females, transgender males, and nonbinary adolescents assigned female at birth had higher odds of each suicidality outcome” (OR= 1.49-5.85; OR=2.72-12.12; OR=1.84-8.59, respectively), the authors reported. “Transgender females had higher odds of each outcome [OR=2.73-6.30] except for suicide attempt requiring medical care. Nonbinary adolescents assigned male at birth had higher odds of suicide attempt requiring medical care [OR=10.13] and NSSI [OR=3.79]. Adolescents questioning their gender identity had higher odds of all outcomes [OR=3.23-7.59] except for suicide attempt.”
When compared to cisgender females as reference, however, only transgender males and transgender females had higher odds of suicidal ideation and attempts.
The overall findings were unsurprising since the higher rates of suicidality among transgender youth have already been documented, but the classification of participants was interesting, Gerald Montano, DO, an assistant professor of pediatrics at the University of Pittsburgh School of Medicine, said in an interview. Dr Montano was not involved in the study.
“It’s always been a challenge because, in the past, they always lumped transgender youth along with lesbian, gay, and bisexual youth,” Dr Montano said. This study is one of the few to go into more detail in considering participants’ gender identity, which was wise given that suicidal risk may differ accordingly.
The biggest take-home message of this study is the importance of screening for suicidality after informing adolescent patients of the limits of confidentiality, Dr Montano said.
“I think it’s very important for the physician to be aware of the reasons for those thoughts of suicide,” he continued. “A lot of it has to do with their gender identity and from discrimination and stigma from the general population.”
The research was funded by the University of Pittsburgh Central Research Development Fund and the National Institutes of Health. The authors reported no conflicts of interest.
SOURCE: Thoma BC et al, Pediatrics, October 14, 2019. DOI: 10.1542/peds.2019-1183
, new research suggests.
The study, which included more than 2,000 adolescents and was published in the October 14 issue of Pediatrics, provides new insights into suicide risk in gender identity subgroups, according to the investigators.
“Limited measures of gender identity may have led to inaccurate estimates of suicidality among transgender females in previous studies,” wrote Brian C. Thoma, PhD, and his colleagues at the University of Pittsburgh. The researchers noted that transgender females and nonbinary adolescents assigned male at birth are frequently combined in studies.
“However, our results indicate transgender females have higher risk for suicidal ideation and attempt compared with cisgender adolescents, whereas nonbinary adolescents assigned male at birth do not,” they wrote. “It is possible that estimates of suicidality that aggregate all transgender adolescents assigned male at birth into one group underestimate rates of suicidality among transgender females.”
The study, which analyzed results from a cross-sectional online survey from July to October 2018, was comprised of 2,020 adolescents, including 1,134 transgender adolescents.
The researchers divided respondents into seven categories: Cisgender males, cisgender females, transgender males, transgender females, nonbinary adolescents assigned female at birth, nonbinary adolescents assigned male at birth, and questioning gender identity. They then assessed non-suicidal self-injury (NSSI) and lifetime suicidality.
Compared to cisgender youth, transgender adolescents overall were more likely to report all outcomes: passive death wish (odds ratio [OR]=2.60), suicidal ideation (OR=2.20), suicide plan (OR=1.82), suicide attempt (OR=1.65), attempt requiring medical care (OR=2.01), and NSSI (OR=2.88).
Using cisgender males as reference after adjustment for all demographics, “cisgender females, transgender males, and nonbinary adolescents assigned female at birth had higher odds of each suicidality outcome” (OR= 1.49-5.85; OR=2.72-12.12; OR=1.84-8.59, respectively), the authors reported. “Transgender females had higher odds of each outcome [OR=2.73-6.30] except for suicide attempt requiring medical care. Nonbinary adolescents assigned male at birth had higher odds of suicide attempt requiring medical care [OR=10.13] and NSSI [OR=3.79]. Adolescents questioning their gender identity had higher odds of all outcomes [OR=3.23-7.59] except for suicide attempt.”
When compared to cisgender females as reference, however, only transgender males and transgender females had higher odds of suicidal ideation and attempts.
The overall findings were unsurprising since the higher rates of suicidality among transgender youth have already been documented, but the classification of participants was interesting, Gerald Montano, DO, an assistant professor of pediatrics at the University of Pittsburgh School of Medicine, said in an interview. Dr Montano was not involved in the study.
“It’s always been a challenge because, in the past, they always lumped transgender youth along with lesbian, gay, and bisexual youth,” Dr Montano said. This study is one of the few to go into more detail in considering participants’ gender identity, which was wise given that suicidal risk may differ accordingly.
The biggest take-home message of this study is the importance of screening for suicidality after informing adolescent patients of the limits of confidentiality, Dr Montano said.
“I think it’s very important for the physician to be aware of the reasons for those thoughts of suicide,” he continued. “A lot of it has to do with their gender identity and from discrimination and stigma from the general population.”
The research was funded by the University of Pittsburgh Central Research Development Fund and the National Institutes of Health. The authors reported no conflicts of interest.
SOURCE: Thoma BC et al, Pediatrics, October 14, 2019. DOI: 10.1542/peds.2019-1183
FROM PEDIATRICS
Key clinical point: Transgender adolescents should be screened for suicidality.
Major finding: Transgender youth as well as nonbinary adolescents assigned female at birth are at markedly high risk for suicidal ideation and attempt.
Study details: The findings are based on a cross-sectional survey of 2,020 U.S. adolescents, including 1,134 transgender or gender-diverse adolescents.
Disclosures: The research was funded by the University of Pittsburgh Central Research Development Fund and the National Institutes of Health. The authors reported no conflicts of interest.
Source: Thoma BC et al. Pediatrics. October 14, 2019. DOI: 10.1542/peds.2019-1183
Too few pregnant women receive both influenza and Tdap vaccines
according to a Morbidity and Mortality Weekly Report published by the Centers for Disease Control and Prevention.
The CDC recommends that all pregnant women receive the Tdap vaccine, preferably between 27 and 36 weeks’ gestation. The flu vaccine is recommended for all women at any point in pregnancy if the pregnancy falls within flu season. Women do not need a second flu shot if they received the vaccine before pregnancy in the same influenza season. Both vaccines provide protection to infants after birth.
“Clinicians caring for women who are pregnant have a huge role in helping women understand risks and benefits and the value of vaccines,” Anne Schuchat, MD, principal deputy director of the CDC, Atlanta, said in a telebriefing about the new report. “A lot of women are worried about taking any extra medicine or getting shots during pregnancy, and clinicians can let them know about the large data available showing the safety of the vaccine as well as the effectiveness. We also think it’s important to let people know about the risk of not vaccinating.”
Pregnant women are at higher risk for influenza complications and represent a disproportionate number of flu-related hospitalizations. From the 2010-2011 to 2017-2018 influenza seasons, 24%-34% of influenza hospitalizations each season were pregnant women aged 15-44, yet only 9% of women in this age group are pregnant at any point each year, according to the report.
Similarly, infants under 6 months have the greatest risk of hospitalization from influenza, and half of pertussis hospitalizations and 69% of pertussis deaths occur in infants under 2 months old. But a fetus receives protective maternal antibodies from flu and pertussis vaccines about 2 weeks after the mother is vaccinated.
Influenza hospitalization is 40% lower among pregnant women vaccinated against flu and 72% lower in infants under 6 months who received maternal influenza antibodies during gestation. Similarly, Tdap vaccination during the third trimester of pregnancy reduces pertussis infection risk by 78% and pertussis hospitalization by 91% in infants under 2 months.
“Infant protection can motivate pregnant women to receive recommended vaccines, and intention to vaccinate is higher among women who perceive more serious consequences of influenza or pertussis disease for their own or their infant’s health,” Megan C. Lindley, MPH, of the CDC’s Immunization Services Division, and colleagues wrote in the MMWR report.
In March-April 2019, Ms. Lindley and associates conducted an Internet survey about flu and Tdap immunizations among women aged 18-49 who had been pregnant at any point since August 1, 2018. A total of 2,626 women completed the survey of 2,762 invitations (95% response rate).
Among 817 women who knew their Tdap status during pregnancy, 55% received the Tdap vaccine. Among 2,097 women who reported a pregnancy between October 2018 and January 2019, 54% received the flu vaccine before or during pregnancy.
But many women received one vaccine without the other: 65% of women surveyed had not received both vaccines during pregnancy. Higher immunization rates occurred among women whose clinicians recommended the vaccines: 66% received a flu shot and 71% received Tdap.
“We’re learning a lot about improved communication between clinicians and patients. One thing we suggest is to begin the conversations early.” Dr Schuchat said. “If you begin talking early in the pregnancy about the things you’ll be looking forward to and provide information, by the time it is flu season or it is that third trimester, they’re prepared to make a good choice.”
Most women surveyed (75%) said their providers did offer a flu or Tdap vaccine in the office or a referral for one. Yet more than 30% of these women did not get the recommended vaccine.
The most common reason for not getting the Tdap during pregnancy, cited by 38% of women who didn’t receive it, was not knowing about the recommendation. Those who did not receive flu vaccination, however, cited concerns about effectiveness (18%) or safety for the baby (16%). A similar proportion of women cited safety concerns for not getting the Tdap (17%).
Sharing information early and engaging respectfully with patients are key to successful provider recommendations, Dr Schuchat said.
“It’s really important for clinicians to begin by listening to women, asking, ‘Can I answer your questions? What are the concerns that you have?’ ” she said. “We find that, when a clinician validates a patient’s concerns and really shows that they’re listening, they can build trust and respect.”
Providers’ sharing their personal experience can help as well, Dr Schuchat added. Clinicians can let patients know if they themselves, or their partner, received the vaccines during pregnancy.
Rates for turning down vaccines were higher for black women: 47% received the flu vaccine after a recommendation, compared with 69% of white women. Among those receiving a Tdap recommendation, 53% of black women accepted it, compared with 77% of white women and 66% of Latina women. The authors noted a past study showing black adults had a higher distrust of flu vaccination, their doctor, and CDC information than white adults.
“Differential effects of provider vaccination offers or referrals might also be explained by less patient-centered provider communication with black patients,” Ms. Lindley and associates wrote.
SOURCE: Lindley MC. MMWR Morb Mortal Wkly Rep. 2019 Oct 8. doi: 10.15585/mmwr.mm6840e1.
according to a Morbidity and Mortality Weekly Report published by the Centers for Disease Control and Prevention.
The CDC recommends that all pregnant women receive the Tdap vaccine, preferably between 27 and 36 weeks’ gestation. The flu vaccine is recommended for all women at any point in pregnancy if the pregnancy falls within flu season. Women do not need a second flu shot if they received the vaccine before pregnancy in the same influenza season. Both vaccines provide protection to infants after birth.
“Clinicians caring for women who are pregnant have a huge role in helping women understand risks and benefits and the value of vaccines,” Anne Schuchat, MD, principal deputy director of the CDC, Atlanta, said in a telebriefing about the new report. “A lot of women are worried about taking any extra medicine or getting shots during pregnancy, and clinicians can let them know about the large data available showing the safety of the vaccine as well as the effectiveness. We also think it’s important to let people know about the risk of not vaccinating.”
Pregnant women are at higher risk for influenza complications and represent a disproportionate number of flu-related hospitalizations. From the 2010-2011 to 2017-2018 influenza seasons, 24%-34% of influenza hospitalizations each season were pregnant women aged 15-44, yet only 9% of women in this age group are pregnant at any point each year, according to the report.
Similarly, infants under 6 months have the greatest risk of hospitalization from influenza, and half of pertussis hospitalizations and 69% of pertussis deaths occur in infants under 2 months old. But a fetus receives protective maternal antibodies from flu and pertussis vaccines about 2 weeks after the mother is vaccinated.
Influenza hospitalization is 40% lower among pregnant women vaccinated against flu and 72% lower in infants under 6 months who received maternal influenza antibodies during gestation. Similarly, Tdap vaccination during the third trimester of pregnancy reduces pertussis infection risk by 78% and pertussis hospitalization by 91% in infants under 2 months.
“Infant protection can motivate pregnant women to receive recommended vaccines, and intention to vaccinate is higher among women who perceive more serious consequences of influenza or pertussis disease for their own or their infant’s health,” Megan C. Lindley, MPH, of the CDC’s Immunization Services Division, and colleagues wrote in the MMWR report.
In March-April 2019, Ms. Lindley and associates conducted an Internet survey about flu and Tdap immunizations among women aged 18-49 who had been pregnant at any point since August 1, 2018. A total of 2,626 women completed the survey of 2,762 invitations (95% response rate).
Among 817 women who knew their Tdap status during pregnancy, 55% received the Tdap vaccine. Among 2,097 women who reported a pregnancy between October 2018 and January 2019, 54% received the flu vaccine before or during pregnancy.
But many women received one vaccine without the other: 65% of women surveyed had not received both vaccines during pregnancy. Higher immunization rates occurred among women whose clinicians recommended the vaccines: 66% received a flu shot and 71% received Tdap.
“We’re learning a lot about improved communication between clinicians and patients. One thing we suggest is to begin the conversations early.” Dr Schuchat said. “If you begin talking early in the pregnancy about the things you’ll be looking forward to and provide information, by the time it is flu season or it is that third trimester, they’re prepared to make a good choice.”
Most women surveyed (75%) said their providers did offer a flu or Tdap vaccine in the office or a referral for one. Yet more than 30% of these women did not get the recommended vaccine.
The most common reason for not getting the Tdap during pregnancy, cited by 38% of women who didn’t receive it, was not knowing about the recommendation. Those who did not receive flu vaccination, however, cited concerns about effectiveness (18%) or safety for the baby (16%). A similar proportion of women cited safety concerns for not getting the Tdap (17%).
Sharing information early and engaging respectfully with patients are key to successful provider recommendations, Dr Schuchat said.
“It’s really important for clinicians to begin by listening to women, asking, ‘Can I answer your questions? What are the concerns that you have?’ ” she said. “We find that, when a clinician validates a patient’s concerns and really shows that they’re listening, they can build trust and respect.”
Providers’ sharing their personal experience can help as well, Dr Schuchat added. Clinicians can let patients know if they themselves, or their partner, received the vaccines during pregnancy.
Rates for turning down vaccines were higher for black women: 47% received the flu vaccine after a recommendation, compared with 69% of white women. Among those receiving a Tdap recommendation, 53% of black women accepted it, compared with 77% of white women and 66% of Latina women. The authors noted a past study showing black adults had a higher distrust of flu vaccination, their doctor, and CDC information than white adults.
“Differential effects of provider vaccination offers or referrals might also be explained by less patient-centered provider communication with black patients,” Ms. Lindley and associates wrote.
SOURCE: Lindley MC. MMWR Morb Mortal Wkly Rep. 2019 Oct 8. doi: 10.15585/mmwr.mm6840e1.
according to a Morbidity and Mortality Weekly Report published by the Centers for Disease Control and Prevention.
The CDC recommends that all pregnant women receive the Tdap vaccine, preferably between 27 and 36 weeks’ gestation. The flu vaccine is recommended for all women at any point in pregnancy if the pregnancy falls within flu season. Women do not need a second flu shot if they received the vaccine before pregnancy in the same influenza season. Both vaccines provide protection to infants after birth.
“Clinicians caring for women who are pregnant have a huge role in helping women understand risks and benefits and the value of vaccines,” Anne Schuchat, MD, principal deputy director of the CDC, Atlanta, said in a telebriefing about the new report. “A lot of women are worried about taking any extra medicine or getting shots during pregnancy, and clinicians can let them know about the large data available showing the safety of the vaccine as well as the effectiveness. We also think it’s important to let people know about the risk of not vaccinating.”
Pregnant women are at higher risk for influenza complications and represent a disproportionate number of flu-related hospitalizations. From the 2010-2011 to 2017-2018 influenza seasons, 24%-34% of influenza hospitalizations each season were pregnant women aged 15-44, yet only 9% of women in this age group are pregnant at any point each year, according to the report.
Similarly, infants under 6 months have the greatest risk of hospitalization from influenza, and half of pertussis hospitalizations and 69% of pertussis deaths occur in infants under 2 months old. But a fetus receives protective maternal antibodies from flu and pertussis vaccines about 2 weeks after the mother is vaccinated.
Influenza hospitalization is 40% lower among pregnant women vaccinated against flu and 72% lower in infants under 6 months who received maternal influenza antibodies during gestation. Similarly, Tdap vaccination during the third trimester of pregnancy reduces pertussis infection risk by 78% and pertussis hospitalization by 91% in infants under 2 months.
“Infant protection can motivate pregnant women to receive recommended vaccines, and intention to vaccinate is higher among women who perceive more serious consequences of influenza or pertussis disease for their own or their infant’s health,” Megan C. Lindley, MPH, of the CDC’s Immunization Services Division, and colleagues wrote in the MMWR report.
In March-April 2019, Ms. Lindley and associates conducted an Internet survey about flu and Tdap immunizations among women aged 18-49 who had been pregnant at any point since August 1, 2018. A total of 2,626 women completed the survey of 2,762 invitations (95% response rate).
Among 817 women who knew their Tdap status during pregnancy, 55% received the Tdap vaccine. Among 2,097 women who reported a pregnancy between October 2018 and January 2019, 54% received the flu vaccine before or during pregnancy.
But many women received one vaccine without the other: 65% of women surveyed had not received both vaccines during pregnancy. Higher immunization rates occurred among women whose clinicians recommended the vaccines: 66% received a flu shot and 71% received Tdap.
“We’re learning a lot about improved communication between clinicians and patients. One thing we suggest is to begin the conversations early.” Dr Schuchat said. “If you begin talking early in the pregnancy about the things you’ll be looking forward to and provide information, by the time it is flu season or it is that third trimester, they’re prepared to make a good choice.”
Most women surveyed (75%) said their providers did offer a flu or Tdap vaccine in the office or a referral for one. Yet more than 30% of these women did not get the recommended vaccine.
The most common reason for not getting the Tdap during pregnancy, cited by 38% of women who didn’t receive it, was not knowing about the recommendation. Those who did not receive flu vaccination, however, cited concerns about effectiveness (18%) or safety for the baby (16%). A similar proportion of women cited safety concerns for not getting the Tdap (17%).
Sharing information early and engaging respectfully with patients are key to successful provider recommendations, Dr Schuchat said.
“It’s really important for clinicians to begin by listening to women, asking, ‘Can I answer your questions? What are the concerns that you have?’ ” she said. “We find that, when a clinician validates a patient’s concerns and really shows that they’re listening, they can build trust and respect.”
Providers’ sharing their personal experience can help as well, Dr Schuchat added. Clinicians can let patients know if they themselves, or their partner, received the vaccines during pregnancy.
Rates for turning down vaccines were higher for black women: 47% received the flu vaccine after a recommendation, compared with 69% of white women. Among those receiving a Tdap recommendation, 53% of black women accepted it, compared with 77% of white women and 66% of Latina women. The authors noted a past study showing black adults had a higher distrust of flu vaccination, their doctor, and CDC information than white adults.
“Differential effects of provider vaccination offers or referrals might also be explained by less patient-centered provider communication with black patients,” Ms. Lindley and associates wrote.
SOURCE: Lindley MC. MMWR Morb Mortal Wkly Rep. 2019 Oct 8. doi: 10.15585/mmwr.mm6840e1.
FROM MMWR TELEBRIEFING
High maternal lead levels linked to children’s obesity
Children born to mothers with high blood levels of lead have an increased risk of being overweight or obese, particularly if their mothers are also overweight, according to new research.
Adequate maternal plasma levels of folate, however, mitigated this risk.
“When considered simultaneously, maternal lead exposure, rather than early childhood lead exposure, contributed to overweight/obesity risk in a dose-response fashion across multiple developmental stages (preschool age, school age and early adolescence) and amplified intergenerational overweight/obesity risk (additively with maternal overweight/obesity),” Guoying Wang, MD, PhD, of Johns Hopkins Bloomberg School of Public Health, Baltimore, and associates, reported in JAMA Network Open.
“These findings support the hypothesis that the obesity epidemic could be related to environmental chemical exposures in utero and raise the possibility that optimal maternal folate supplementation may help counteract the adverse effects of environmental lead exposure,” the authors wrote.
The prospective urban, low-income cohort study, which ran from 2002 to 2013, involved 1,442 mother-child pairs who joined the study when the children were born and attended follow-up visits at Boston Medical Center. The mean age of the mothers was 29 years, and the children were, on average, 8 years old at follow-up. Half the children were male; 67% of mothers were black, and 20% were Latina.
The researchers collected maternal blood samples within 24-72 hours after birth to measure red blood cell lead levels and plasma folate levels. Children’s whole-blood lead levels were measured during the first lead screening of their well child visits, at a median 10 months of age. Researchers tracked children’s body mass index Z-score and defined overweight/obesity as exceeding the 85th national percentile for their age and sex.
Detectable lead was present in all the mothers’ blood samples. The median maternal red blood cell lead level was 2.5 mcg/dL, although black mothers tended to have higher lead exposure than that of other racial groups. Median maternal plasma folate level was 32 nmol/L. Children’s blood lead levels were a median 1.4 mcg/dL, and their median BMI Z-score was 0.78.
Children whose mothers had red blood cell lead levels of 5.0 mcg/dL or greater (16%) had 65% greater odds of being overweight or obese compared with children whose mothers’ lead level was less than 2 mcg/dL, after adjustment for maternal education, race/ethnicity, smoking status, parity, diabetes, hypertensive disorder, preterm birth, fetal growth, and breastfeeding status (odds ratio [OR], 1.65; 95% confidence internal [CI], 1.18-2.32). Only 5.2% of children had whole-blood lead levels of 5 mcg/dL or greater.
“Mothers with the highest red blood cell lead levels were older and multiparous, were more likely to be black and nonsmokers, had lower plasma folate levels and were more likely to have prepregnancy overweight/obesity and diabetes,” the authors reported.
The dose-response association did not lose significance when the researchers adjusted for children’s blood lead levels, maternal age, cesarean delivery, term births only, and black race. Nor did it change in a subset of children when the researchers adjusted for children’s physical activity.
The strength of the association increased when mothers also had a BMI greater than the average/healthy range. Children were more than four times more likely to be overweight or obese if their mothers were overweight or obese and had lead levels greater than 5.0 mcg/dL, compared with nonoverweight mothers with levels below 2 mcg/dL (OR, 4.24; 95% CI, 2.64-6.82).
Among children whose mothers were overweight/obese and had high blood lead levels, however, high folate levels appeared protective against obesity. These children had a 41% lower risk of being overweight or obese, compared with others in their group, if their mothers had plasma folate levels of at least 20 nmol/L (OR, 0.59 CI, 0.36-0.95; P = .03).
According to an invited commentary, “approximately 140,000 new chemicals and pesticides have appeared since 1950,” with “universal human exposure to approximately 5,000 of those,” wrote Marco Sanchez-Guerra, PhD, of the National Institute of Perinatology in Mexico City, and coauthors Andres Cardenas, PhD, of the University of California, Berkeley, and Citlalli Osorio-Yáñez, PhD, of the National Autonomous University of Mexico in Mexico City. Yet fewer than half of those chemicals have been tested for safety or toxic effect, the editorialists wrote, and scientists know little of their potential reproductive harm.
Dr. Sanchez-Guerra, Dr. Cardenas, and Dr. Osorio-Yáñez agreed with the study authors that elevated lead exposures, especially from gasoline before lead was removed in the United States in 1975, may partly explain the current epidemic of obesity.
“Identifying preventable prenatal causes of obesity is a cornerstone in the fight against the obesity epidemic,” the editorialists said. While most recommendations center on changes to diet and physical activity, environmental factors during pregnancy could be involved in childhood obesity as well.
“The study by Wang et al. opens the door to new questions about whether adequate folate intake might modify the adverse effects of other chemical exposures,” they continued, noting other research suggesting a protective effect from folate against health effects of air pollution exposure. “These efforts could yield substantial public health benefits and represent novel tools in fighting the obesity epidemic,” they concluded.
The research was funded by the National Institutes of Health and the U.S. Department of Health and Human Services. Neither the study authors nor the editorialists had industry financial disclosures.
SOURCES: Wang G et al. JAMA Netw Open. 2019;2(10):e1912343. doi: 10.1001/jamanetworkopen.2019.12343; Sanchez-Guerra M et al. JAMA Netw Open. 2019;2(10):e1912334. doi: 10.1001/jamanetworkopen.2019.12334.
Children born to mothers with high blood levels of lead have an increased risk of being overweight or obese, particularly if their mothers are also overweight, according to new research.
Adequate maternal plasma levels of folate, however, mitigated this risk.
“When considered simultaneously, maternal lead exposure, rather than early childhood lead exposure, contributed to overweight/obesity risk in a dose-response fashion across multiple developmental stages (preschool age, school age and early adolescence) and amplified intergenerational overweight/obesity risk (additively with maternal overweight/obesity),” Guoying Wang, MD, PhD, of Johns Hopkins Bloomberg School of Public Health, Baltimore, and associates, reported in JAMA Network Open.
“These findings support the hypothesis that the obesity epidemic could be related to environmental chemical exposures in utero and raise the possibility that optimal maternal folate supplementation may help counteract the adverse effects of environmental lead exposure,” the authors wrote.
The prospective urban, low-income cohort study, which ran from 2002 to 2013, involved 1,442 mother-child pairs who joined the study when the children were born and attended follow-up visits at Boston Medical Center. The mean age of the mothers was 29 years, and the children were, on average, 8 years old at follow-up. Half the children were male; 67% of mothers were black, and 20% were Latina.
The researchers collected maternal blood samples within 24-72 hours after birth to measure red blood cell lead levels and plasma folate levels. Children’s whole-blood lead levels were measured during the first lead screening of their well child visits, at a median 10 months of age. Researchers tracked children’s body mass index Z-score and defined overweight/obesity as exceeding the 85th national percentile for their age and sex.
Detectable lead was present in all the mothers’ blood samples. The median maternal red blood cell lead level was 2.5 mcg/dL, although black mothers tended to have higher lead exposure than that of other racial groups. Median maternal plasma folate level was 32 nmol/L. Children’s blood lead levels were a median 1.4 mcg/dL, and their median BMI Z-score was 0.78.
Children whose mothers had red blood cell lead levels of 5.0 mcg/dL or greater (16%) had 65% greater odds of being overweight or obese compared with children whose mothers’ lead level was less than 2 mcg/dL, after adjustment for maternal education, race/ethnicity, smoking status, parity, diabetes, hypertensive disorder, preterm birth, fetal growth, and breastfeeding status (odds ratio [OR], 1.65; 95% confidence internal [CI], 1.18-2.32). Only 5.2% of children had whole-blood lead levels of 5 mcg/dL or greater.
“Mothers with the highest red blood cell lead levels were older and multiparous, were more likely to be black and nonsmokers, had lower plasma folate levels and were more likely to have prepregnancy overweight/obesity and diabetes,” the authors reported.
The dose-response association did not lose significance when the researchers adjusted for children’s blood lead levels, maternal age, cesarean delivery, term births only, and black race. Nor did it change in a subset of children when the researchers adjusted for children’s physical activity.
The strength of the association increased when mothers also had a BMI greater than the average/healthy range. Children were more than four times more likely to be overweight or obese if their mothers were overweight or obese and had lead levels greater than 5.0 mcg/dL, compared with nonoverweight mothers with levels below 2 mcg/dL (OR, 4.24; 95% CI, 2.64-6.82).
Among children whose mothers were overweight/obese and had high blood lead levels, however, high folate levels appeared protective against obesity. These children had a 41% lower risk of being overweight or obese, compared with others in their group, if their mothers had plasma folate levels of at least 20 nmol/L (OR, 0.59 CI, 0.36-0.95; P = .03).
According to an invited commentary, “approximately 140,000 new chemicals and pesticides have appeared since 1950,” with “universal human exposure to approximately 5,000 of those,” wrote Marco Sanchez-Guerra, PhD, of the National Institute of Perinatology in Mexico City, and coauthors Andres Cardenas, PhD, of the University of California, Berkeley, and Citlalli Osorio-Yáñez, PhD, of the National Autonomous University of Mexico in Mexico City. Yet fewer than half of those chemicals have been tested for safety or toxic effect, the editorialists wrote, and scientists know little of their potential reproductive harm.
Dr. Sanchez-Guerra, Dr. Cardenas, and Dr. Osorio-Yáñez agreed with the study authors that elevated lead exposures, especially from gasoline before lead was removed in the United States in 1975, may partly explain the current epidemic of obesity.
“Identifying preventable prenatal causes of obesity is a cornerstone in the fight against the obesity epidemic,” the editorialists said. While most recommendations center on changes to diet and physical activity, environmental factors during pregnancy could be involved in childhood obesity as well.
“The study by Wang et al. opens the door to new questions about whether adequate folate intake might modify the adverse effects of other chemical exposures,” they continued, noting other research suggesting a protective effect from folate against health effects of air pollution exposure. “These efforts could yield substantial public health benefits and represent novel tools in fighting the obesity epidemic,” they concluded.
The research was funded by the National Institutes of Health and the U.S. Department of Health and Human Services. Neither the study authors nor the editorialists had industry financial disclosures.
SOURCES: Wang G et al. JAMA Netw Open. 2019;2(10):e1912343. doi: 10.1001/jamanetworkopen.2019.12343; Sanchez-Guerra M et al. JAMA Netw Open. 2019;2(10):e1912334. doi: 10.1001/jamanetworkopen.2019.12334.
Children born to mothers with high blood levels of lead have an increased risk of being overweight or obese, particularly if their mothers are also overweight, according to new research.
Adequate maternal plasma levels of folate, however, mitigated this risk.
“When considered simultaneously, maternal lead exposure, rather than early childhood lead exposure, contributed to overweight/obesity risk in a dose-response fashion across multiple developmental stages (preschool age, school age and early adolescence) and amplified intergenerational overweight/obesity risk (additively with maternal overweight/obesity),” Guoying Wang, MD, PhD, of Johns Hopkins Bloomberg School of Public Health, Baltimore, and associates, reported in JAMA Network Open.
“These findings support the hypothesis that the obesity epidemic could be related to environmental chemical exposures in utero and raise the possibility that optimal maternal folate supplementation may help counteract the adverse effects of environmental lead exposure,” the authors wrote.
The prospective urban, low-income cohort study, which ran from 2002 to 2013, involved 1,442 mother-child pairs who joined the study when the children were born and attended follow-up visits at Boston Medical Center. The mean age of the mothers was 29 years, and the children were, on average, 8 years old at follow-up. Half the children were male; 67% of mothers were black, and 20% were Latina.
The researchers collected maternal blood samples within 24-72 hours after birth to measure red blood cell lead levels and plasma folate levels. Children’s whole-blood lead levels were measured during the first lead screening of their well child visits, at a median 10 months of age. Researchers tracked children’s body mass index Z-score and defined overweight/obesity as exceeding the 85th national percentile for their age and sex.
Detectable lead was present in all the mothers’ blood samples. The median maternal red blood cell lead level was 2.5 mcg/dL, although black mothers tended to have higher lead exposure than that of other racial groups. Median maternal plasma folate level was 32 nmol/L. Children’s blood lead levels were a median 1.4 mcg/dL, and their median BMI Z-score was 0.78.
Children whose mothers had red blood cell lead levels of 5.0 mcg/dL or greater (16%) had 65% greater odds of being overweight or obese compared with children whose mothers’ lead level was less than 2 mcg/dL, after adjustment for maternal education, race/ethnicity, smoking status, parity, diabetes, hypertensive disorder, preterm birth, fetal growth, and breastfeeding status (odds ratio [OR], 1.65; 95% confidence internal [CI], 1.18-2.32). Only 5.2% of children had whole-blood lead levels of 5 mcg/dL or greater.
“Mothers with the highest red blood cell lead levels were older and multiparous, were more likely to be black and nonsmokers, had lower plasma folate levels and were more likely to have prepregnancy overweight/obesity and diabetes,” the authors reported.
The dose-response association did not lose significance when the researchers adjusted for children’s blood lead levels, maternal age, cesarean delivery, term births only, and black race. Nor did it change in a subset of children when the researchers adjusted for children’s physical activity.
The strength of the association increased when mothers also had a BMI greater than the average/healthy range. Children were more than four times more likely to be overweight or obese if their mothers were overweight or obese and had lead levels greater than 5.0 mcg/dL, compared with nonoverweight mothers with levels below 2 mcg/dL (OR, 4.24; 95% CI, 2.64-6.82).
Among children whose mothers were overweight/obese and had high blood lead levels, however, high folate levels appeared protective against obesity. These children had a 41% lower risk of being overweight or obese, compared with others in their group, if their mothers had plasma folate levels of at least 20 nmol/L (OR, 0.59 CI, 0.36-0.95; P = .03).
According to an invited commentary, “approximately 140,000 new chemicals and pesticides have appeared since 1950,” with “universal human exposure to approximately 5,000 of those,” wrote Marco Sanchez-Guerra, PhD, of the National Institute of Perinatology in Mexico City, and coauthors Andres Cardenas, PhD, of the University of California, Berkeley, and Citlalli Osorio-Yáñez, PhD, of the National Autonomous University of Mexico in Mexico City. Yet fewer than half of those chemicals have been tested for safety or toxic effect, the editorialists wrote, and scientists know little of their potential reproductive harm.
Dr. Sanchez-Guerra, Dr. Cardenas, and Dr. Osorio-Yáñez agreed with the study authors that elevated lead exposures, especially from gasoline before lead was removed in the United States in 1975, may partly explain the current epidemic of obesity.
“Identifying preventable prenatal causes of obesity is a cornerstone in the fight against the obesity epidemic,” the editorialists said. While most recommendations center on changes to diet and physical activity, environmental factors during pregnancy could be involved in childhood obesity as well.
“The study by Wang et al. opens the door to new questions about whether adequate folate intake might modify the adverse effects of other chemical exposures,” they continued, noting other research suggesting a protective effect from folate against health effects of air pollution exposure. “These efforts could yield substantial public health benefits and represent novel tools in fighting the obesity epidemic,” they concluded.
The research was funded by the National Institutes of Health and the U.S. Department of Health and Human Services. Neither the study authors nor the editorialists had industry financial disclosures.
SOURCES: Wang G et al. JAMA Netw Open. 2019;2(10):e1912343. doi: 10.1001/jamanetworkopen.2019.12343; Sanchez-Guerra M et al. JAMA Netw Open. 2019;2(10):e1912334. doi: 10.1001/jamanetworkopen.2019.12334.
FROM JAMA NETWORK OPEN
Impact of climate change on mortality underlined by global study
Regardless of where people live in the world, air pollution is linked to increased rates of cardiovascular disease, respiratory problems, and all-cause mortality, according to one of the largest studies ever to assess the effects of inhalable particulate matter (PM), published Aug. 21 in the New England Journal of Medicine.
“These data reinforce the evidence of a link between mortality and PM concentration established in regional and local studies,” reported Cong Liu of the Huazhong University of Science and Technology in Wuhan, China, and an international team of researchers.
“Many people are experiencing worse allergy and asthma symptoms in the setting of increased heat and worse air quality,” Caren G. Solomon, MD, of Harvard Medical School, Boston, said in an interview. “It is often not appreciated that these are complications of climate change.”
Other such complications include heat-related illnesses and severe weather events, as well as the less visible manifestations, such as shifts in the epidemiology of vector-borne infectious disease, Dr. Solomon and colleagues wrote in an editorial accompanying Mr. Liu’s study.
“The stark reality is that high levels of greenhouse gases caused by the combustion of fossil fuels – and the resulting rise in temperature and sea levels and intensification of extreme weather – are having profound consequences for human health and health systems,” Dr. Solomon and colleagues wrote (N Engl J Med. 2019;381:773-4.).
In the new air pollution study, Mr. Liu and colleagues analyzed 59.6 million deaths from 652 cities across 24 countries, “thereby greatly increasing the generalizability of the association and decreasing the likelihood that the reported associations are subject to confounding bias,” wrote John R. Balmes, MD, of the University of California, San Francisco, and the University of California, Berkeley, in an editorial about the study (N Engl J Med. 2019;381:774-6).
The researchers compared air pollution data from 1986-2015 from the Multi-City Multi-Country (MCC) Collaborative Research Network to mortality data reported from individual countries. They assessed PM with an aerodynamic diameter of 10 mcg or less (PM10; n = 598 cities) and PM with an aerodynamic diameter of 2.5 mcg or less (PM2.5; n=499 cities).
Mr. Liu’s team used a time-series analysis – a standard upon which the majority of air pollution research relies. These studies “include daily measures of health events (e.g., daily mortality), regressed against concentrations of PM (e.g., 24-hour average PM2.5) and weather variables (e.g., daily average temperature) for a given geographic area,” Dr. Balmes wrote. “The population serves as its own control, and confounding by population characteristics is negligible because these are stable over short time frames.”
The researchers found a 0.44% increase in daily all-cause mortality for each 10-mcg/m3 increase in the 2-day moving average (current and previous day) of PM10. The same increase was linked to a 0.36% increase in daily cardiovascular mortality and a 0.47% increase in daily respiratory mortality. Similarly, a 10-mcg/m3 increase in the PM2.5 average was linked to 0.68% increase in all-cause mortality, a 0.55% increase in cardiovascular mortality, and 0.74% increase in respiratory mortality.
Locations with higher annual mean temperatures showed stronger associations, and all these associations remained statistically significant after the researchers adjusted for gaseous pollutants.
Although the majority of countries and cities included in the study came from the northern hemisphere, the researchers noted that the magnitude of effect they found, particularly for PM10 concentrations, matched up with that seen in previous studies of multiple cities or countries.
Still, they found “significant evidence of spatial heterogeneity in the associations between PM concentration and daily mortality across countries and regions.” Among the factors that could contribute to those variations are “different PM components, long-term air pollution levels, population susceptibility, and different lengths of study periods,” they speculated.
What makes this study remarkable – despite decades of previous similar studies – is its size and the implications of a curvilinear shape in its concentration-response relation, according to Dr. Balmes.
“The current study of PM data from many regions around the world provides the strongest evidence to date that higher levels of exposure may be associated with a lower per-unit risk,” Dr. Balmes wrote. “Regions that have lower exposures had a higher per-unit risk. This finding has profound policy implications, especially given that no threshold of effect was found. Even high-income countries, such as the United States, with relatively good air quality could still see public health benefits from further reduction of ambient PM concentrations.”
The policy implications, however, extend well beyond clean air regulations because the findings represent just one aspect of climate change’s negative effects on health, which are “frighteningly broad,” Dr. Solomon and colleagues wrote.
“As climate change continues to alter disease patterns and disrupt health systems, its effects on human health will become harder to ignore,” they wrote. “We, as a medical community, have the responsibility and the opportunity to mobilize the urgent, large-scale climate action required to protect health – as well as the ingenuity to develop novel and bold interventions to avert the most catastrophic outcomes.”
The new research and associated commentary marked the introduction of a new NEJM topic on climate change effects on health and health systems.
SOURCE: Liu C et al. N Engl J Med. 2019;381:705-15.
This article was updated 8/22/19.
The negative effects of climate change on global public health are already playing out around us, but scientific research shows that they will only get worse – unless we begin addressing the issue in earnest now.
At the macro level nationally, effective policy is actually being stripped away right now. “[While] scientists tell us we have little time to wait if we hope to avoid the most devastating effects of climate change, leaders in Washington, D.C., are attacking science and rolling back Obama-era rules from the Environmental Protection Agency,” such as working to weaken vehicle fuel-efficiency standards, relaxing methane emissions rules, ending mercury emissions regulation and taking other actions that will only increase air pollution.
“If these EPA rollbacks are successful, they will diminish our ability to mitigate health effects and diseases related to the burning of fossil fuels and the immense toll they take on our families. ... If we stop supporting and listening to the best available science, if we allow more pollution to be emitted, and if we start limiting the EPA’s ability to monitor and enforce pollution standards, then we put at risk everyone’s health – and especially the health and future of our children.”
Engaging in advocacy and communicating to our representatives that we want stronger regulations is one way people can personally take action, but we can take immediate actions in our everyday lives too. Rather than dwelling on the despair of helplessness and hopelessness that grips many people when it comes to climate change, this moment can be reframed as an opportunity for people to make decisions that immediately begin improving their health — and also happen to be good for the planet.
“To me, the most urgent challenge when it comes to health and climate change is the reality that, when climate change comes up, in the U.S. audience, the first thing that should come into people’s minds is that we need to do this now because we need to protect our children’s health. ... Too many people either don’t get that it matters to health at all, or they don’t get that the actions we need to take are exactly what we need to do to address the health problems that have been nearly impossible to deal with.”
For example, problems like rising child obesity and type 2 diabetes rates have plagued public health, yet people can make changes that reduce obesity and diabetes risk that also decrease their carbon footprints, he said. “One of the best ways to deal with obesity is to eat more plants, and it turns out that’s really good for the climate” Additionally, getting people out of cars and walking and cycling can reduce individuals’ risk of diabetes – while simultaneously decreasing air pollution. “We need to be doing these things regardless of climate change, and if parents and children understood that the pathway to a healthier future was through tackling climate change, we would see a transformation.”
The value of local policy actions should be emphasized, such as ones that call for a reduction in a city’s use of concrete – which increases localized heat – and constructing more efficient buildings. Healthcare providers have an opportunity – and responsibility – not only to recognize this reality but to help their patients recognize it too.
“We can also use our roles as trusted advisers to inform and motivate actions that are increasingly necessary to protect the health of the communities we serve.” They also need to be vigilant about conditions that will worsen as the planet heats up: For example, medications such as diuretics carry more risks in higher temperatures, and patients taking them need to know that.
The need to address climate change matters because we face the challenge of protecting the world’s most vulnerable people.
“One of the great things about climate change is if it causes us to rethink about what we need to do to protect the future, it’s going to help our health today. ... If we can use that as the motivator, then maybe we can stop arguing and start thinking about climate as a positive issue, as a more personal issue we can all participate in and be willing to invest in.”
Gina McCarthy, MS, was administrator of the Environmental Protection Agency during 2013-2017, and Aaron Bernstein, MD, MPH, is a pediatrician at Boston Children’s Hospital. Both are from the Center for Climate, Health, and the Global Environment (Harvard C-CHANGE) at the Harvard T.H. Chan School of Public Health in Boston. Their comments came from their perspective (N Engl J Med. 2019 Aug 22. doi: 10.1056/NEJMp1909643) published in NEJM along with this article and editorial and a phone interview. They reported not having any disclosures.
The negative effects of climate change on global public health are already playing out around us, but scientific research shows that they will only get worse – unless we begin addressing the issue in earnest now.
At the macro level nationally, effective policy is actually being stripped away right now. “[While] scientists tell us we have little time to wait if we hope to avoid the most devastating effects of climate change, leaders in Washington, D.C., are attacking science and rolling back Obama-era rules from the Environmental Protection Agency,” such as working to weaken vehicle fuel-efficiency standards, relaxing methane emissions rules, ending mercury emissions regulation and taking other actions that will only increase air pollution.
“If these EPA rollbacks are successful, they will diminish our ability to mitigate health effects and diseases related to the burning of fossil fuels and the immense toll they take on our families. ... If we stop supporting and listening to the best available science, if we allow more pollution to be emitted, and if we start limiting the EPA’s ability to monitor and enforce pollution standards, then we put at risk everyone’s health – and especially the health and future of our children.”
Engaging in advocacy and communicating to our representatives that we want stronger regulations is one way people can personally take action, but we can take immediate actions in our everyday lives too. Rather than dwelling on the despair of helplessness and hopelessness that grips many people when it comes to climate change, this moment can be reframed as an opportunity for people to make decisions that immediately begin improving their health — and also happen to be good for the planet.
“To me, the most urgent challenge when it comes to health and climate change is the reality that, when climate change comes up, in the U.S. audience, the first thing that should come into people’s minds is that we need to do this now because we need to protect our children’s health. ... Too many people either don’t get that it matters to health at all, or they don’t get that the actions we need to take are exactly what we need to do to address the health problems that have been nearly impossible to deal with.”
For example, problems like rising child obesity and type 2 diabetes rates have plagued public health, yet people can make changes that reduce obesity and diabetes risk that also decrease their carbon footprints, he said. “One of the best ways to deal with obesity is to eat more plants, and it turns out that’s really good for the climate” Additionally, getting people out of cars and walking and cycling can reduce individuals’ risk of diabetes – while simultaneously decreasing air pollution. “We need to be doing these things regardless of climate change, and if parents and children understood that the pathway to a healthier future was through tackling climate change, we would see a transformation.”
The value of local policy actions should be emphasized, such as ones that call for a reduction in a city’s use of concrete – which increases localized heat – and constructing more efficient buildings. Healthcare providers have an opportunity – and responsibility – not only to recognize this reality but to help their patients recognize it too.
“We can also use our roles as trusted advisers to inform and motivate actions that are increasingly necessary to protect the health of the communities we serve.” They also need to be vigilant about conditions that will worsen as the planet heats up: For example, medications such as diuretics carry more risks in higher temperatures, and patients taking them need to know that.
The need to address climate change matters because we face the challenge of protecting the world’s most vulnerable people.
“One of the great things about climate change is if it causes us to rethink about what we need to do to protect the future, it’s going to help our health today. ... If we can use that as the motivator, then maybe we can stop arguing and start thinking about climate as a positive issue, as a more personal issue we can all participate in and be willing to invest in.”
Gina McCarthy, MS, was administrator of the Environmental Protection Agency during 2013-2017, and Aaron Bernstein, MD, MPH, is a pediatrician at Boston Children’s Hospital. Both are from the Center for Climate, Health, and the Global Environment (Harvard C-CHANGE) at the Harvard T.H. Chan School of Public Health in Boston. Their comments came from their perspective (N Engl J Med. 2019 Aug 22. doi: 10.1056/NEJMp1909643) published in NEJM along with this article and editorial and a phone interview. They reported not having any disclosures.
The negative effects of climate change on global public health are already playing out around us, but scientific research shows that they will only get worse – unless we begin addressing the issue in earnest now.
At the macro level nationally, effective policy is actually being stripped away right now. “[While] scientists tell us we have little time to wait if we hope to avoid the most devastating effects of climate change, leaders in Washington, D.C., are attacking science and rolling back Obama-era rules from the Environmental Protection Agency,” such as working to weaken vehicle fuel-efficiency standards, relaxing methane emissions rules, ending mercury emissions regulation and taking other actions that will only increase air pollution.
“If these EPA rollbacks are successful, they will diminish our ability to mitigate health effects and diseases related to the burning of fossil fuels and the immense toll they take on our families. ... If we stop supporting and listening to the best available science, if we allow more pollution to be emitted, and if we start limiting the EPA’s ability to monitor and enforce pollution standards, then we put at risk everyone’s health – and especially the health and future of our children.”
Engaging in advocacy and communicating to our representatives that we want stronger regulations is one way people can personally take action, but we can take immediate actions in our everyday lives too. Rather than dwelling on the despair of helplessness and hopelessness that grips many people when it comes to climate change, this moment can be reframed as an opportunity for people to make decisions that immediately begin improving their health — and also happen to be good for the planet.
“To me, the most urgent challenge when it comes to health and climate change is the reality that, when climate change comes up, in the U.S. audience, the first thing that should come into people’s minds is that we need to do this now because we need to protect our children’s health. ... Too many people either don’t get that it matters to health at all, or they don’t get that the actions we need to take are exactly what we need to do to address the health problems that have been nearly impossible to deal with.”
For example, problems like rising child obesity and type 2 diabetes rates have plagued public health, yet people can make changes that reduce obesity and diabetes risk that also decrease their carbon footprints, he said. “One of the best ways to deal with obesity is to eat more plants, and it turns out that’s really good for the climate” Additionally, getting people out of cars and walking and cycling can reduce individuals’ risk of diabetes – while simultaneously decreasing air pollution. “We need to be doing these things regardless of climate change, and if parents and children understood that the pathway to a healthier future was through tackling climate change, we would see a transformation.”
The value of local policy actions should be emphasized, such as ones that call for a reduction in a city’s use of concrete – which increases localized heat – and constructing more efficient buildings. Healthcare providers have an opportunity – and responsibility – not only to recognize this reality but to help their patients recognize it too.
“We can also use our roles as trusted advisers to inform and motivate actions that are increasingly necessary to protect the health of the communities we serve.” They also need to be vigilant about conditions that will worsen as the planet heats up: For example, medications such as diuretics carry more risks in higher temperatures, and patients taking them need to know that.
The need to address climate change matters because we face the challenge of protecting the world’s most vulnerable people.
“One of the great things about climate change is if it causes us to rethink about what we need to do to protect the future, it’s going to help our health today. ... If we can use that as the motivator, then maybe we can stop arguing and start thinking about climate as a positive issue, as a more personal issue we can all participate in and be willing to invest in.”
Gina McCarthy, MS, was administrator of the Environmental Protection Agency during 2013-2017, and Aaron Bernstein, MD, MPH, is a pediatrician at Boston Children’s Hospital. Both are from the Center for Climate, Health, and the Global Environment (Harvard C-CHANGE) at the Harvard T.H. Chan School of Public Health in Boston. Their comments came from their perspective (N Engl J Med. 2019 Aug 22. doi: 10.1056/NEJMp1909643) published in NEJM along with this article and editorial and a phone interview. They reported not having any disclosures.
Regardless of where people live in the world, air pollution is linked to increased rates of cardiovascular disease, respiratory problems, and all-cause mortality, according to one of the largest studies ever to assess the effects of inhalable particulate matter (PM), published Aug. 21 in the New England Journal of Medicine.
“These data reinforce the evidence of a link between mortality and PM concentration established in regional and local studies,” reported Cong Liu of the Huazhong University of Science and Technology in Wuhan, China, and an international team of researchers.
“Many people are experiencing worse allergy and asthma symptoms in the setting of increased heat and worse air quality,” Caren G. Solomon, MD, of Harvard Medical School, Boston, said in an interview. “It is often not appreciated that these are complications of climate change.”
Other such complications include heat-related illnesses and severe weather events, as well as the less visible manifestations, such as shifts in the epidemiology of vector-borne infectious disease, Dr. Solomon and colleagues wrote in an editorial accompanying Mr. Liu’s study.
“The stark reality is that high levels of greenhouse gases caused by the combustion of fossil fuels – and the resulting rise in temperature and sea levels and intensification of extreme weather – are having profound consequences for human health and health systems,” Dr. Solomon and colleagues wrote (N Engl J Med. 2019;381:773-4.).
In the new air pollution study, Mr. Liu and colleagues analyzed 59.6 million deaths from 652 cities across 24 countries, “thereby greatly increasing the generalizability of the association and decreasing the likelihood that the reported associations are subject to confounding bias,” wrote John R. Balmes, MD, of the University of California, San Francisco, and the University of California, Berkeley, in an editorial about the study (N Engl J Med. 2019;381:774-6).
The researchers compared air pollution data from 1986-2015 from the Multi-City Multi-Country (MCC) Collaborative Research Network to mortality data reported from individual countries. They assessed PM with an aerodynamic diameter of 10 mcg or less (PM10; n = 598 cities) and PM with an aerodynamic diameter of 2.5 mcg or less (PM2.5; n=499 cities).
Mr. Liu’s team used a time-series analysis – a standard upon which the majority of air pollution research relies. These studies “include daily measures of health events (e.g., daily mortality), regressed against concentrations of PM (e.g., 24-hour average PM2.5) and weather variables (e.g., daily average temperature) for a given geographic area,” Dr. Balmes wrote. “The population serves as its own control, and confounding by population characteristics is negligible because these are stable over short time frames.”
The researchers found a 0.44% increase in daily all-cause mortality for each 10-mcg/m3 increase in the 2-day moving average (current and previous day) of PM10. The same increase was linked to a 0.36% increase in daily cardiovascular mortality and a 0.47% increase in daily respiratory mortality. Similarly, a 10-mcg/m3 increase in the PM2.5 average was linked to 0.68% increase in all-cause mortality, a 0.55% increase in cardiovascular mortality, and 0.74% increase in respiratory mortality.
Locations with higher annual mean temperatures showed stronger associations, and all these associations remained statistically significant after the researchers adjusted for gaseous pollutants.
Although the majority of countries and cities included in the study came from the northern hemisphere, the researchers noted that the magnitude of effect they found, particularly for PM10 concentrations, matched up with that seen in previous studies of multiple cities or countries.
Still, they found “significant evidence of spatial heterogeneity in the associations between PM concentration and daily mortality across countries and regions.” Among the factors that could contribute to those variations are “different PM components, long-term air pollution levels, population susceptibility, and different lengths of study periods,” they speculated.
What makes this study remarkable – despite decades of previous similar studies – is its size and the implications of a curvilinear shape in its concentration-response relation, according to Dr. Balmes.
“The current study of PM data from many regions around the world provides the strongest evidence to date that higher levels of exposure may be associated with a lower per-unit risk,” Dr. Balmes wrote. “Regions that have lower exposures had a higher per-unit risk. This finding has profound policy implications, especially given that no threshold of effect was found. Even high-income countries, such as the United States, with relatively good air quality could still see public health benefits from further reduction of ambient PM concentrations.”
The policy implications, however, extend well beyond clean air regulations because the findings represent just one aspect of climate change’s negative effects on health, which are “frighteningly broad,” Dr. Solomon and colleagues wrote.
“As climate change continues to alter disease patterns and disrupt health systems, its effects on human health will become harder to ignore,” they wrote. “We, as a medical community, have the responsibility and the opportunity to mobilize the urgent, large-scale climate action required to protect health – as well as the ingenuity to develop novel and bold interventions to avert the most catastrophic outcomes.”
The new research and associated commentary marked the introduction of a new NEJM topic on climate change effects on health and health systems.
SOURCE: Liu C et al. N Engl J Med. 2019;381:705-15.
This article was updated 8/22/19.
Regardless of where people live in the world, air pollution is linked to increased rates of cardiovascular disease, respiratory problems, and all-cause mortality, according to one of the largest studies ever to assess the effects of inhalable particulate matter (PM), published Aug. 21 in the New England Journal of Medicine.
“These data reinforce the evidence of a link between mortality and PM concentration established in regional and local studies,” reported Cong Liu of the Huazhong University of Science and Technology in Wuhan, China, and an international team of researchers.
“Many people are experiencing worse allergy and asthma symptoms in the setting of increased heat and worse air quality,” Caren G. Solomon, MD, of Harvard Medical School, Boston, said in an interview. “It is often not appreciated that these are complications of climate change.”
Other such complications include heat-related illnesses and severe weather events, as well as the less visible manifestations, such as shifts in the epidemiology of vector-borne infectious disease, Dr. Solomon and colleagues wrote in an editorial accompanying Mr. Liu’s study.
“The stark reality is that high levels of greenhouse gases caused by the combustion of fossil fuels – and the resulting rise in temperature and sea levels and intensification of extreme weather – are having profound consequences for human health and health systems,” Dr. Solomon and colleagues wrote (N Engl J Med. 2019;381:773-4.).
In the new air pollution study, Mr. Liu and colleagues analyzed 59.6 million deaths from 652 cities across 24 countries, “thereby greatly increasing the generalizability of the association and decreasing the likelihood that the reported associations are subject to confounding bias,” wrote John R. Balmes, MD, of the University of California, San Francisco, and the University of California, Berkeley, in an editorial about the study (N Engl J Med. 2019;381:774-6).
The researchers compared air pollution data from 1986-2015 from the Multi-City Multi-Country (MCC) Collaborative Research Network to mortality data reported from individual countries. They assessed PM with an aerodynamic diameter of 10 mcg or less (PM10; n = 598 cities) and PM with an aerodynamic diameter of 2.5 mcg or less (PM2.5; n=499 cities).
Mr. Liu’s team used a time-series analysis – a standard upon which the majority of air pollution research relies. These studies “include daily measures of health events (e.g., daily mortality), regressed against concentrations of PM (e.g., 24-hour average PM2.5) and weather variables (e.g., daily average temperature) for a given geographic area,” Dr. Balmes wrote. “The population serves as its own control, and confounding by population characteristics is negligible because these are stable over short time frames.”
The researchers found a 0.44% increase in daily all-cause mortality for each 10-mcg/m3 increase in the 2-day moving average (current and previous day) of PM10. The same increase was linked to a 0.36% increase in daily cardiovascular mortality and a 0.47% increase in daily respiratory mortality. Similarly, a 10-mcg/m3 increase in the PM2.5 average was linked to 0.68% increase in all-cause mortality, a 0.55% increase in cardiovascular mortality, and 0.74% increase in respiratory mortality.
Locations with higher annual mean temperatures showed stronger associations, and all these associations remained statistically significant after the researchers adjusted for gaseous pollutants.
Although the majority of countries and cities included in the study came from the northern hemisphere, the researchers noted that the magnitude of effect they found, particularly for PM10 concentrations, matched up with that seen in previous studies of multiple cities or countries.
Still, they found “significant evidence of spatial heterogeneity in the associations between PM concentration and daily mortality across countries and regions.” Among the factors that could contribute to those variations are “different PM components, long-term air pollution levels, population susceptibility, and different lengths of study periods,” they speculated.
What makes this study remarkable – despite decades of previous similar studies – is its size and the implications of a curvilinear shape in its concentration-response relation, according to Dr. Balmes.
“The current study of PM data from many regions around the world provides the strongest evidence to date that higher levels of exposure may be associated with a lower per-unit risk,” Dr. Balmes wrote. “Regions that have lower exposures had a higher per-unit risk. This finding has profound policy implications, especially given that no threshold of effect was found. Even high-income countries, such as the United States, with relatively good air quality could still see public health benefits from further reduction of ambient PM concentrations.”
The policy implications, however, extend well beyond clean air regulations because the findings represent just one aspect of climate change’s negative effects on health, which are “frighteningly broad,” Dr. Solomon and colleagues wrote.
“As climate change continues to alter disease patterns and disrupt health systems, its effects on human health will become harder to ignore,” they wrote. “We, as a medical community, have the responsibility and the opportunity to mobilize the urgent, large-scale climate action required to protect health – as well as the ingenuity to develop novel and bold interventions to avert the most catastrophic outcomes.”
The new research and associated commentary marked the introduction of a new NEJM topic on climate change effects on health and health systems.
SOURCE: Liu C et al. N Engl J Med. 2019;381:705-15.
This article was updated 8/22/19.
FROM NEJM
Women underrepresented as oncology trial corresponding authors
Fewer than one in five oncologic phase 3 randomized controlled trials (RCTs) had female corresponding authors, but the proportion of women in this authorship role appears to be gradually increasing, investigators report.
“Through identification of the factors associated with gender disparities in RCT leadership, we hope that the academic oncology community will work to better understand and address the underlying reasons for such imbalances,” wrote Ethan B. Ludmir, MD, of the University of Texas MD Anderson Cancer Center, Houston, and associates. The report is in JAMA Oncology.
The authors searched ClinicalTrials.gov in late 2017 for all oncologic phase 3 RCTs. Of the 1,239 they initially turned up, the authors narrowed them down to the 598 that used multiple arms to test a therapeutic intervention, underwent peer review, and published results of primary endpoints. Among the trials, all published between 2003 and 2018, 17.9% had female corresponding authors.
Industry-funded trials, which comprised 77.8% of the sample, had half as many female corresponding authors (14.4%) as those not funded by industry (30.1%) (P less than .001), “possibly reflecting gender biases that are enhanced in the context of industry relationships with academic medicine,” the authors wrote. The opposite trend appeared in cooperative group trials, a quarter of which (25.9%) had female corresponding authors, compared with 14.3% of noncooperative trials (P = .001).
Trials for breast cancer and head and neck cancer were most likely to have female corresponding authors, while the trials with the lowest rates were those for gastrointestinal, genitourinary, and hematologic cancers (P less than .001). The researchers also found gender disparities in the type of intervention tested: Radiotherapy and supportive care studies were more likely to have female corresponding authors, yet none of the surgical trials had any (P less than .001).
In addition, female corresponding authorship was more likely when the institutions were based in the United States (n = 329) than when they were overseas (P = .001). Women were corresponding authors in 22.5% of U.S. studies and 20% of Canadian studies but only 12% of European trials and 2.3% of Asian trials (P = .001).
Within the United States, more than a third of studies from institutions in the Southeast had female corresponding authors (34.1%), followed by those in the Midwest (27.5%) and West (25.9%). Southwestern institutions were least likely to have female corresponding authors (8.7%). Approximately twice as many studies came from Northeastern institutions as from other regions (n = 112), but only 18.8% of these had female corresponding authors (P = .03).
The frequency of female corresponding authors has been increasing, however: The authors calculated a 1.2% increase each year, “echoing data showing an approximate 1.0% annual increase in the number of female academic hematologist-oncologists,” they noted. “However, the absolute female corresponding author rate for these trials is still lower than the percentage of female academic oncologists in this general study period, ranging from 27% in 2000 to 39% in 2015.”
SOURCE: Ludmir EB et al. JAMA Oncology. 8 Aug 2019. doi: 10.1001/jamaoncol.2019.2196.
Fewer than one in five oncologic phase 3 randomized controlled trials (RCTs) had female corresponding authors, but the proportion of women in this authorship role appears to be gradually increasing, investigators report.
“Through identification of the factors associated with gender disparities in RCT leadership, we hope that the academic oncology community will work to better understand and address the underlying reasons for such imbalances,” wrote Ethan B. Ludmir, MD, of the University of Texas MD Anderson Cancer Center, Houston, and associates. The report is in JAMA Oncology.
The authors searched ClinicalTrials.gov in late 2017 for all oncologic phase 3 RCTs. Of the 1,239 they initially turned up, the authors narrowed them down to the 598 that used multiple arms to test a therapeutic intervention, underwent peer review, and published results of primary endpoints. Among the trials, all published between 2003 and 2018, 17.9% had female corresponding authors.
Industry-funded trials, which comprised 77.8% of the sample, had half as many female corresponding authors (14.4%) as those not funded by industry (30.1%) (P less than .001), “possibly reflecting gender biases that are enhanced in the context of industry relationships with academic medicine,” the authors wrote. The opposite trend appeared in cooperative group trials, a quarter of which (25.9%) had female corresponding authors, compared with 14.3% of noncooperative trials (P = .001).
Trials for breast cancer and head and neck cancer were most likely to have female corresponding authors, while the trials with the lowest rates were those for gastrointestinal, genitourinary, and hematologic cancers (P less than .001). The researchers also found gender disparities in the type of intervention tested: Radiotherapy and supportive care studies were more likely to have female corresponding authors, yet none of the surgical trials had any (P less than .001).
In addition, female corresponding authorship was more likely when the institutions were based in the United States (n = 329) than when they were overseas (P = .001). Women were corresponding authors in 22.5% of U.S. studies and 20% of Canadian studies but only 12% of European trials and 2.3% of Asian trials (P = .001).
Within the United States, more than a third of studies from institutions in the Southeast had female corresponding authors (34.1%), followed by those in the Midwest (27.5%) and West (25.9%). Southwestern institutions were least likely to have female corresponding authors (8.7%). Approximately twice as many studies came from Northeastern institutions as from other regions (n = 112), but only 18.8% of these had female corresponding authors (P = .03).
The frequency of female corresponding authors has been increasing, however: The authors calculated a 1.2% increase each year, “echoing data showing an approximate 1.0% annual increase in the number of female academic hematologist-oncologists,” they noted. “However, the absolute female corresponding author rate for these trials is still lower than the percentage of female academic oncologists in this general study period, ranging from 27% in 2000 to 39% in 2015.”
SOURCE: Ludmir EB et al. JAMA Oncology. 8 Aug 2019. doi: 10.1001/jamaoncol.2019.2196.
Fewer than one in five oncologic phase 3 randomized controlled trials (RCTs) had female corresponding authors, but the proportion of women in this authorship role appears to be gradually increasing, investigators report.
“Through identification of the factors associated with gender disparities in RCT leadership, we hope that the academic oncology community will work to better understand and address the underlying reasons for such imbalances,” wrote Ethan B. Ludmir, MD, of the University of Texas MD Anderson Cancer Center, Houston, and associates. The report is in JAMA Oncology.
The authors searched ClinicalTrials.gov in late 2017 for all oncologic phase 3 RCTs. Of the 1,239 they initially turned up, the authors narrowed them down to the 598 that used multiple arms to test a therapeutic intervention, underwent peer review, and published results of primary endpoints. Among the trials, all published between 2003 and 2018, 17.9% had female corresponding authors.
Industry-funded trials, which comprised 77.8% of the sample, had half as many female corresponding authors (14.4%) as those not funded by industry (30.1%) (P less than .001), “possibly reflecting gender biases that are enhanced in the context of industry relationships with academic medicine,” the authors wrote. The opposite trend appeared in cooperative group trials, a quarter of which (25.9%) had female corresponding authors, compared with 14.3% of noncooperative trials (P = .001).
Trials for breast cancer and head and neck cancer were most likely to have female corresponding authors, while the trials with the lowest rates were those for gastrointestinal, genitourinary, and hematologic cancers (P less than .001). The researchers also found gender disparities in the type of intervention tested: Radiotherapy and supportive care studies were more likely to have female corresponding authors, yet none of the surgical trials had any (P less than .001).
In addition, female corresponding authorship was more likely when the institutions were based in the United States (n = 329) than when they were overseas (P = .001). Women were corresponding authors in 22.5% of U.S. studies and 20% of Canadian studies but only 12% of European trials and 2.3% of Asian trials (P = .001).
Within the United States, more than a third of studies from institutions in the Southeast had female corresponding authors (34.1%), followed by those in the Midwest (27.5%) and West (25.9%). Southwestern institutions were least likely to have female corresponding authors (8.7%). Approximately twice as many studies came from Northeastern institutions as from other regions (n = 112), but only 18.8% of these had female corresponding authors (P = .03).
The frequency of female corresponding authors has been increasing, however: The authors calculated a 1.2% increase each year, “echoing data showing an approximate 1.0% annual increase in the number of female academic hematologist-oncologists,” they noted. “However, the absolute female corresponding author rate for these trials is still lower than the percentage of female academic oncologists in this general study period, ranging from 27% in 2000 to 39% in 2015.”
SOURCE: Ludmir EB et al. JAMA Oncology. 8 Aug 2019. doi: 10.1001/jamaoncol.2019.2196.
FROM JAMA ONCOLOGY
Lancet joins movement to reject ‘manels’
The Lancet Group’s 18 medical journals have committed to ensuring that their editorial advisory boards include at least 50% female members by the end of 2019 as just one component of the diversity and gender parity initiative unveiled Aug. 8.
“The case for gender equity and diversity is clear: Teams that are diverse in terms of gender, ethnicity, and social background produce better health science, are more highly cited, generate a broader range of ideas and innovations, and better represent society,” group editors wrote in their comment (Lancet. 2019 Aug 10;394:452-3). They emphasized the importance of increasing inclusion in science “across gender, ethnicity, geography, and other social categories.”
The Diversity Pledge states the group’s commitment “to increasing diversity and inclusion in research and publishing, and in particular to increasing the representation of women and colleagues from low-income and middle-income countries among our editorial advisers, peer reviewers, and authors.”
The No All-Male Panel Policy echoes a call from the National Institutes of Health for ending the “Manel Tradition,” as NIH Director Francis S. Collins, MD, PhD, wrote in early June. Recognizing the need “to combat cultural forces that tolerate gender harassment and limit the advancement of women,” Dr. Collins pledged to decline speaking invitations if “attention to inclusiveness” is not clear in the event’s agenda.
Discussion of “manels” – all-male panels – and the decision to boycott them has been picking up speed in scientific, medical and even business circles over the past several years. The BBC highlighted a popular blog that shamed events with all-male panels in 2015, and a 2018 study more formally concluded that male scientists had considerably more opportunities to speak and present at the world’s largest geophysical conference.
One business and development leader even included space on his website to allow other leaders to pledge not to “serve on a panel of two people or more unless there is at least one woman on the panel, not including the chair.” More than 2,000 leaders from across the globe already have signed.
Six months ago, the Lancet published a special theme issue on women in science, medicine, and global health. The editors noted in the issue that women comprise fewer than a third of authors and reviewers in high-impact medical journals – just one example of the underrepresentation of women and people in color in medical publishing. The group is now revamping their systems to address the disparities.
“An upcoming update of our online submission system will have a field for self-selected gender, so we can better track representation across genders among authors, reviewers, editors, and editorial advisers, along with country of origin,” the editors wrote.
But they acknowledged that their efforts are just one piece of the academic ecosystem and called on others’ participation. “We encourage other publishers, journals, and members of the science community to contribute to these pledges.”
SOURCE: Lancet. 2019 Aug 10;394:452-3.
The Lancet Group’s 18 medical journals have committed to ensuring that their editorial advisory boards include at least 50% female members by the end of 2019 as just one component of the diversity and gender parity initiative unveiled Aug. 8.
“The case for gender equity and diversity is clear: Teams that are diverse in terms of gender, ethnicity, and social background produce better health science, are more highly cited, generate a broader range of ideas and innovations, and better represent society,” group editors wrote in their comment (Lancet. 2019 Aug 10;394:452-3). They emphasized the importance of increasing inclusion in science “across gender, ethnicity, geography, and other social categories.”
The Diversity Pledge states the group’s commitment “to increasing diversity and inclusion in research and publishing, and in particular to increasing the representation of women and colleagues from low-income and middle-income countries among our editorial advisers, peer reviewers, and authors.”
The No All-Male Panel Policy echoes a call from the National Institutes of Health for ending the “Manel Tradition,” as NIH Director Francis S. Collins, MD, PhD, wrote in early June. Recognizing the need “to combat cultural forces that tolerate gender harassment and limit the advancement of women,” Dr. Collins pledged to decline speaking invitations if “attention to inclusiveness” is not clear in the event’s agenda.
Discussion of “manels” – all-male panels – and the decision to boycott them has been picking up speed in scientific, medical and even business circles over the past several years. The BBC highlighted a popular blog that shamed events with all-male panels in 2015, and a 2018 study more formally concluded that male scientists had considerably more opportunities to speak and present at the world’s largest geophysical conference.
One business and development leader even included space on his website to allow other leaders to pledge not to “serve on a panel of two people or more unless there is at least one woman on the panel, not including the chair.” More than 2,000 leaders from across the globe already have signed.
Six months ago, the Lancet published a special theme issue on women in science, medicine, and global health. The editors noted in the issue that women comprise fewer than a third of authors and reviewers in high-impact medical journals – just one example of the underrepresentation of women and people in color in medical publishing. The group is now revamping their systems to address the disparities.
“An upcoming update of our online submission system will have a field for self-selected gender, so we can better track representation across genders among authors, reviewers, editors, and editorial advisers, along with country of origin,” the editors wrote.
But they acknowledged that their efforts are just one piece of the academic ecosystem and called on others’ participation. “We encourage other publishers, journals, and members of the science community to contribute to these pledges.”
SOURCE: Lancet. 2019 Aug 10;394:452-3.
The Lancet Group’s 18 medical journals have committed to ensuring that their editorial advisory boards include at least 50% female members by the end of 2019 as just one component of the diversity and gender parity initiative unveiled Aug. 8.
“The case for gender equity and diversity is clear: Teams that are diverse in terms of gender, ethnicity, and social background produce better health science, are more highly cited, generate a broader range of ideas and innovations, and better represent society,” group editors wrote in their comment (Lancet. 2019 Aug 10;394:452-3). They emphasized the importance of increasing inclusion in science “across gender, ethnicity, geography, and other social categories.”
The Diversity Pledge states the group’s commitment “to increasing diversity and inclusion in research and publishing, and in particular to increasing the representation of women and colleagues from low-income and middle-income countries among our editorial advisers, peer reviewers, and authors.”
The No All-Male Panel Policy echoes a call from the National Institutes of Health for ending the “Manel Tradition,” as NIH Director Francis S. Collins, MD, PhD, wrote in early June. Recognizing the need “to combat cultural forces that tolerate gender harassment and limit the advancement of women,” Dr. Collins pledged to decline speaking invitations if “attention to inclusiveness” is not clear in the event’s agenda.
Discussion of “manels” – all-male panels – and the decision to boycott them has been picking up speed in scientific, medical and even business circles over the past several years. The BBC highlighted a popular blog that shamed events with all-male panels in 2015, and a 2018 study more formally concluded that male scientists had considerably more opportunities to speak and present at the world’s largest geophysical conference.
One business and development leader even included space on his website to allow other leaders to pledge not to “serve on a panel of two people or more unless there is at least one woman on the panel, not including the chair.” More than 2,000 leaders from across the globe already have signed.
Six months ago, the Lancet published a special theme issue on women in science, medicine, and global health. The editors noted in the issue that women comprise fewer than a third of authors and reviewers in high-impact medical journals – just one example of the underrepresentation of women and people in color in medical publishing. The group is now revamping their systems to address the disparities.
“An upcoming update of our online submission system will have a field for self-selected gender, so we can better track representation across genders among authors, reviewers, editors, and editorial advisers, along with country of origin,” the editors wrote.
But they acknowledged that their efforts are just one piece of the academic ecosystem and called on others’ participation. “We encourage other publishers, journals, and members of the science community to contribute to these pledges.”
SOURCE: Lancet. 2019 Aug 10;394:452-3.
FROM THE LANCET
New RSV vaccine immunogenicity improved with protein engineering
Development of an effective respiratory syncytial virus (RSV) vaccine is feasible using a new technology that can contribute to development of other vaccines as well, according to results of a proof-of-concept study in Science.
The new method of protein engineering preserves the RSV antigen protein’s prefusion structure, including the epitope, thereby inducing antibodies that better “match,” and neutralize, the actual pathogen.
“Protein-based RSV vaccines have had a particularly complicated history, especially those in which the primary immunogen has been the fusion (F) glycoprotein, which exists in two major conformational states: prefusion (pre-F) and postfusion (post-F),” lead author Michelle Crank, MD, of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases in Bethesda, Md., and her colleagues explained in the paper.
Since the failure of the whole-inactivated RSV vaccine in the 1960s, researchers have focused on F subunit vaccine candidates, but these contain only post-F or “structurally undefined” F protein.
“Although the products are immunogenic, a substantial proportion of antibodies elicited are non- or poorly neutralizing, and field trials have shown no or minimal efficacy,” the authors wrote.
But now researchers have an “atomic-level understanding of F conformational states, antigenic sites, and the specificity of the human B cell repertoire and serum antibody response to infection.” Having developed a way to engineer proteins to retain the F protein’s prefusion conformation, the researchers developed the DS-Cav1 vaccine with an F protein from RSV subtype A.
In their phase 1, randomized, open-label clinical trial, the researchers tested the safety, tolerability and immunogenicity of DS-Cav1. The trial involved 90 healthy adults, aged 18-50, who had no abnormal findings in clinical lab tests, their medical history, or a physical exam.
The participants received two intramuscular doses, 12 weeks apart, of either 50 mcg, 150 mcg or 500 mcg of the vaccine. In each of these dosage groups, half the participants received a vaccine with 0.5 mcg of alum as an adjuvant, and half received a vaccine without any adjuvants. Each of the six randomized dosage-adjuvant groups had 15 participants.
The investigators report on safety and immunogenicity through 28 days after the first vaccine dose among the first 40 participants enrolled, each randomly assigned into four groups of 10 for the 50 mcg and 150 mcg doses with and without the adjuvant. Their primary immunogenicity endpoint was neutralizing activity from the vaccine.
Neutralizing activity with RSV A was seven times higher with 50 mcg and 12-15 times higher with 150 mcg at week 4 than at baseline (P less than .001).
“These increases in neutralizing activity were higher than those previously reported for F protein subunit vaccines and exceeded the threefold increase in neutralization reported after experimental human challenge with RSV,” the authors noted. Neutralization levels remained 5-10 times higher than baseline at week 12 (P less than .001).
Even with RSV B, neutralizing activity from DS-Cav1 was 4-6 times greater with 50 mcg and 9 times greater with 150 mcg, both with and without alum (P less than .001).
“The boost in neutralizing activity to subtype B after a single immunization with a subtype A–based F vaccine reflected the high conservation of F between subtypes and suggested that multiple prior infections by both RSV A and B subtypes establishes a broad preexisting B-cell repertoire,” the authors wrote.
The adjuvant had no clinically significant effect on immunogenicity, and no serious adverse events occurred in the groups.
The findings reveal that DS-Cav1 induces antibodies far more functionally effective than seen in previous RSV vaccines while opening the door to using similar techniques with other vaccines, the authors wrote. “We are now entering an era of vaccinology in which new technologies provide avenues to define the structural basis of antigenicity and to rapidly isolate and characterize human monoclonal antibodies,” the researchers wrote, marking “a step toward a future of precision vaccines.”
The research was funded by the National Institutes of Health and the Bill & Melinda Gates Foundation. Several of the study authors are inventors on patents for stabilizing the RSV F protein.
Development of an effective respiratory syncytial virus (RSV) vaccine is feasible using a new technology that can contribute to development of other vaccines as well, according to results of a proof-of-concept study in Science.
The new method of protein engineering preserves the RSV antigen protein’s prefusion structure, including the epitope, thereby inducing antibodies that better “match,” and neutralize, the actual pathogen.
“Protein-based RSV vaccines have had a particularly complicated history, especially those in which the primary immunogen has been the fusion (F) glycoprotein, which exists in two major conformational states: prefusion (pre-F) and postfusion (post-F),” lead author Michelle Crank, MD, of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases in Bethesda, Md., and her colleagues explained in the paper.
Since the failure of the whole-inactivated RSV vaccine in the 1960s, researchers have focused on F subunit vaccine candidates, but these contain only post-F or “structurally undefined” F protein.
“Although the products are immunogenic, a substantial proportion of antibodies elicited are non- or poorly neutralizing, and field trials have shown no or minimal efficacy,” the authors wrote.
But now researchers have an “atomic-level understanding of F conformational states, antigenic sites, and the specificity of the human B cell repertoire and serum antibody response to infection.” Having developed a way to engineer proteins to retain the F protein’s prefusion conformation, the researchers developed the DS-Cav1 vaccine with an F protein from RSV subtype A.
In their phase 1, randomized, open-label clinical trial, the researchers tested the safety, tolerability and immunogenicity of DS-Cav1. The trial involved 90 healthy adults, aged 18-50, who had no abnormal findings in clinical lab tests, their medical history, or a physical exam.
The participants received two intramuscular doses, 12 weeks apart, of either 50 mcg, 150 mcg or 500 mcg of the vaccine. In each of these dosage groups, half the participants received a vaccine with 0.5 mcg of alum as an adjuvant, and half received a vaccine without any adjuvants. Each of the six randomized dosage-adjuvant groups had 15 participants.
The investigators report on safety and immunogenicity through 28 days after the first vaccine dose among the first 40 participants enrolled, each randomly assigned into four groups of 10 for the 50 mcg and 150 mcg doses with and without the adjuvant. Their primary immunogenicity endpoint was neutralizing activity from the vaccine.
Neutralizing activity with RSV A was seven times higher with 50 mcg and 12-15 times higher with 150 mcg at week 4 than at baseline (P less than .001).
“These increases in neutralizing activity were higher than those previously reported for F protein subunit vaccines and exceeded the threefold increase in neutralization reported after experimental human challenge with RSV,” the authors noted. Neutralization levels remained 5-10 times higher than baseline at week 12 (P less than .001).
Even with RSV B, neutralizing activity from DS-Cav1 was 4-6 times greater with 50 mcg and 9 times greater with 150 mcg, both with and without alum (P less than .001).
“The boost in neutralizing activity to subtype B after a single immunization with a subtype A–based F vaccine reflected the high conservation of F between subtypes and suggested that multiple prior infections by both RSV A and B subtypes establishes a broad preexisting B-cell repertoire,” the authors wrote.
The adjuvant had no clinically significant effect on immunogenicity, and no serious adverse events occurred in the groups.
The findings reveal that DS-Cav1 induces antibodies far more functionally effective than seen in previous RSV vaccines while opening the door to using similar techniques with other vaccines, the authors wrote. “We are now entering an era of vaccinology in which new technologies provide avenues to define the structural basis of antigenicity and to rapidly isolate and characterize human monoclonal antibodies,” the researchers wrote, marking “a step toward a future of precision vaccines.”
The research was funded by the National Institutes of Health and the Bill & Melinda Gates Foundation. Several of the study authors are inventors on patents for stabilizing the RSV F protein.
Development of an effective respiratory syncytial virus (RSV) vaccine is feasible using a new technology that can contribute to development of other vaccines as well, according to results of a proof-of-concept study in Science.
The new method of protein engineering preserves the RSV antigen protein’s prefusion structure, including the epitope, thereby inducing antibodies that better “match,” and neutralize, the actual pathogen.
“Protein-based RSV vaccines have had a particularly complicated history, especially those in which the primary immunogen has been the fusion (F) glycoprotein, which exists in two major conformational states: prefusion (pre-F) and postfusion (post-F),” lead author Michelle Crank, MD, of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases in Bethesda, Md., and her colleagues explained in the paper.
Since the failure of the whole-inactivated RSV vaccine in the 1960s, researchers have focused on F subunit vaccine candidates, but these contain only post-F or “structurally undefined” F protein.
“Although the products are immunogenic, a substantial proportion of antibodies elicited are non- or poorly neutralizing, and field trials have shown no or minimal efficacy,” the authors wrote.
But now researchers have an “atomic-level understanding of F conformational states, antigenic sites, and the specificity of the human B cell repertoire and serum antibody response to infection.” Having developed a way to engineer proteins to retain the F protein’s prefusion conformation, the researchers developed the DS-Cav1 vaccine with an F protein from RSV subtype A.
In their phase 1, randomized, open-label clinical trial, the researchers tested the safety, tolerability and immunogenicity of DS-Cav1. The trial involved 90 healthy adults, aged 18-50, who had no abnormal findings in clinical lab tests, their medical history, or a physical exam.
The participants received two intramuscular doses, 12 weeks apart, of either 50 mcg, 150 mcg or 500 mcg of the vaccine. In each of these dosage groups, half the participants received a vaccine with 0.5 mcg of alum as an adjuvant, and half received a vaccine without any adjuvants. Each of the six randomized dosage-adjuvant groups had 15 participants.
The investigators report on safety and immunogenicity through 28 days after the first vaccine dose among the first 40 participants enrolled, each randomly assigned into four groups of 10 for the 50 mcg and 150 mcg doses with and without the adjuvant. Their primary immunogenicity endpoint was neutralizing activity from the vaccine.
Neutralizing activity with RSV A was seven times higher with 50 mcg and 12-15 times higher with 150 mcg at week 4 than at baseline (P less than .001).
“These increases in neutralizing activity were higher than those previously reported for F protein subunit vaccines and exceeded the threefold increase in neutralization reported after experimental human challenge with RSV,” the authors noted. Neutralization levels remained 5-10 times higher than baseline at week 12 (P less than .001).
Even with RSV B, neutralizing activity from DS-Cav1 was 4-6 times greater with 50 mcg and 9 times greater with 150 mcg, both with and without alum (P less than .001).
“The boost in neutralizing activity to subtype B after a single immunization with a subtype A–based F vaccine reflected the high conservation of F between subtypes and suggested that multiple prior infections by both RSV A and B subtypes establishes a broad preexisting B-cell repertoire,” the authors wrote.
The adjuvant had no clinically significant effect on immunogenicity, and no serious adverse events occurred in the groups.
The findings reveal that DS-Cav1 induces antibodies far more functionally effective than seen in previous RSV vaccines while opening the door to using similar techniques with other vaccines, the authors wrote. “We are now entering an era of vaccinology in which new technologies provide avenues to define the structural basis of antigenicity and to rapidly isolate and characterize human monoclonal antibodies,” the researchers wrote, marking “a step toward a future of precision vaccines.”
The research was funded by the National Institutes of Health and the Bill & Melinda Gates Foundation. Several of the study authors are inventors on patents for stabilizing the RSV F protein.
FROM SCIENCE
Key clinical point:
Major finding: Epitope-neutralizing activity is 5-10 times greater 12 weeks after baseline with a 50 mcg or 150 mcg with and without alum adjuvant.
Study details: The findings are based on a prespecified interim analysis of 90 healthy adult participants in a phase 1, randomized, trial of DS-Cav1.
Disclosures: The research was funded by the National Institutes of Health and the Bill & Melinda Gates Foundation. Several authors are inventors on patents for stabilizing the RSV F protein.
Source: Crank MC et al. Science. 2019;365(6452):505-9.
Semen cryopreservation viable for young transgender patients in small study
as transgender women, according to results of a small retrospective cohort study.
The lack of data on this topic, however, makes it difficult to determine how long an individual must be off gender-affirming therapy before spermatogenesis resumes, if it resumes, and what the long-term effects of gender-affirming therapy are.
“This information is critical to address as part of a multidisciplinary fertility discussion with youth and their guardians so that an informed decision can be made regarding fertility preservation use,” wrote Emily P. Barnard, DO, of UPMC Magee-Womens Hospital in Pittsburgh and her associates.
The researchers retrospectively collected data on transgender patients who sought fertility preservation between 2015 and 2018.
The 11 white transgender women (sex assigned male at birth) who followed up on adolescent medicine or pediatric endocrinology referrals for fertility preservation received their consultations between ages 16 and 24, with 19 years having been the median age at which they occurred. Gender dysphoria onset happened at a median age of 12 for the patients, who were evaluated for it at a median age of 17.
All but one patient submitted at least one semen sample, and eight ultimately cryopreserved their semen.
The eight samples from gender-affirming therapy–naive patients had abnormal morphology, with the median morphology having been 6% versus the normal range of greater than 13.0%. Otherwise, the samples collected were normal, but the authors noted that established semen analysis parameters don’t exist for adolescents and young adults.
All eight patients who had their semen cryopreserved, began gonadotropin-releasing hormone (GnRH) agonist therapy after cryopreservation, and four of those patients concurrently began taking estradiol.
One patient had already been taking intramuscular leuprolide acetate every 6 months and discontinued it to attempt fertility preservation. Spermatogenesis returned after 5 months of azoospermia, albeit with abnormal morphology (9%).
Another patient had been taking spironolactone and estradiol for 26 months before ceasing therapy to attempt fertility preservation. She remained azoospermic 4 months after stopping therapy and then moved forward with an orchiectomy.
“For many transgender patients, the potential need to discontinue GnRH agonist or gender-affirming therapy to allow for resumption of spermatogenesis may be a significant barrier to pursuing fertility preservation because cessation of therapy may result in exacerbation of gender dysphoria and progression of undesired male secondary sex characteristics,” the researchers wrote. “For individuals for whom this risk is not acceptable or if azoospermia is noted on semen analysis, there are several alternate options, including electroejaculation, testicular sperm extraction, and testicular tissue cryopreservation,” they continued. Electroejaculation with a transrectal probe is an option particularly for those who cannot masturbate or feel uncomfortable doing so, the authors explained.
For those who have not previously received gender-affirming therapy, the fertility preservation “process can be completed quickly, with collections occurring every 2 to 3 days to preserve several samples before initiating GnRH agonist or gender-affirming therapy,” they concluded.
SOURCE: Barnard EP et al. Pediatrics. 2019 Aug 5. doi: 10.1542/peds.2018-3943.
The lack of long-term data on various gender-affirming medical interventions, particularly hormone therapies, for transgender adolescents and young adults has led professional medical organizations to recommend patients receive fertility counseling before beginning any such therapies.
Yet few data exist on fertility preservation either. The study by Barnard et al. is the first to examine semen cryopreservation outcomes in adolescents and young adults assigned male at birth and asserting a female gender identity.
“There is often urgency to start medical affirming interventions (MAI) among transgender and gender-diverse adolescents and young adults (TGD-AYA) due to gender dysphoria and related psychological sequelae,” wrote Jason Rafferty, MD, MPH, in an accompanying editorial. “However, starting MAI immediately and delaying fertility services may lead to increased overall morbidity for some patients.”
Although multiple professional organizations recommend fertility counseling before MAI initiation, many transgender patients are not following this advice. Dr. Rafferty noted one study found only 20% of TGD-AYA discussed fertility with their physicians before beginning MAI, and only 13% discussed possible effects of MAI on fertility – yet 60% wanted to learn more.
“Barnard et al. review data suggesting TGD-AYA have low interest in fertility services, but many TGD-AYA questioned whether this may later change,” Dr. Rafferty wrote. “After starting MAIs, TGD-AYA report being more emotionally capable of considering future parenting because of increasing comfort with their bodies and romantic relationships.”
Various barriers also exist for TGD-AYA interested in fertility services, such as cost, lack of insurance coverage, low availability of services, increased dysphoria from the procedures, stereotypes, stigma, and interest in starting MAI as soon as possible.
“Under a reproductive justice framework, autonomy around family planning is a right that should not be limited by structural or systemic barriers,” Dr. Rafferty wrote. “Overall, there is a clinical and ethical imperative to better understand and provide access to fertility services for TGD-AYA.”
Jason Rafferty, MD, MPH, is a pediatrician and child psychiatrist who practices at the gender and sexuality clinic in Riverside and at the Adolescent Healthcare Center at Hasbro Children’s Hospital in Providence, R.I. His comments are summarized from an accompanying editorial (Pediatrics 2019 Aug 5. doi: 10.1542/peds.2019-2000).
The lack of long-term data on various gender-affirming medical interventions, particularly hormone therapies, for transgender adolescents and young adults has led professional medical organizations to recommend patients receive fertility counseling before beginning any such therapies.
Yet few data exist on fertility preservation either. The study by Barnard et al. is the first to examine semen cryopreservation outcomes in adolescents and young adults assigned male at birth and asserting a female gender identity.
“There is often urgency to start medical affirming interventions (MAI) among transgender and gender-diverse adolescents and young adults (TGD-AYA) due to gender dysphoria and related psychological sequelae,” wrote Jason Rafferty, MD, MPH, in an accompanying editorial. “However, starting MAI immediately and delaying fertility services may lead to increased overall morbidity for some patients.”
Although multiple professional organizations recommend fertility counseling before MAI initiation, many transgender patients are not following this advice. Dr. Rafferty noted one study found only 20% of TGD-AYA discussed fertility with their physicians before beginning MAI, and only 13% discussed possible effects of MAI on fertility – yet 60% wanted to learn more.
“Barnard et al. review data suggesting TGD-AYA have low interest in fertility services, but many TGD-AYA questioned whether this may later change,” Dr. Rafferty wrote. “After starting MAIs, TGD-AYA report being more emotionally capable of considering future parenting because of increasing comfort with their bodies and romantic relationships.”
Various barriers also exist for TGD-AYA interested in fertility services, such as cost, lack of insurance coverage, low availability of services, increased dysphoria from the procedures, stereotypes, stigma, and interest in starting MAI as soon as possible.
“Under a reproductive justice framework, autonomy around family planning is a right that should not be limited by structural or systemic barriers,” Dr. Rafferty wrote. “Overall, there is a clinical and ethical imperative to better understand and provide access to fertility services for TGD-AYA.”
Jason Rafferty, MD, MPH, is a pediatrician and child psychiatrist who practices at the gender and sexuality clinic in Riverside and at the Adolescent Healthcare Center at Hasbro Children’s Hospital in Providence, R.I. His comments are summarized from an accompanying editorial (Pediatrics 2019 Aug 5. doi: 10.1542/peds.2019-2000).
The lack of long-term data on various gender-affirming medical interventions, particularly hormone therapies, for transgender adolescents and young adults has led professional medical organizations to recommend patients receive fertility counseling before beginning any such therapies.
Yet few data exist on fertility preservation either. The study by Barnard et al. is the first to examine semen cryopreservation outcomes in adolescents and young adults assigned male at birth and asserting a female gender identity.
“There is often urgency to start medical affirming interventions (MAI) among transgender and gender-diverse adolescents and young adults (TGD-AYA) due to gender dysphoria and related psychological sequelae,” wrote Jason Rafferty, MD, MPH, in an accompanying editorial. “However, starting MAI immediately and delaying fertility services may lead to increased overall morbidity for some patients.”
Although multiple professional organizations recommend fertility counseling before MAI initiation, many transgender patients are not following this advice. Dr. Rafferty noted one study found only 20% of TGD-AYA discussed fertility with their physicians before beginning MAI, and only 13% discussed possible effects of MAI on fertility – yet 60% wanted to learn more.
“Barnard et al. review data suggesting TGD-AYA have low interest in fertility services, but many TGD-AYA questioned whether this may later change,” Dr. Rafferty wrote. “After starting MAIs, TGD-AYA report being more emotionally capable of considering future parenting because of increasing comfort with their bodies and romantic relationships.”
Various barriers also exist for TGD-AYA interested in fertility services, such as cost, lack of insurance coverage, low availability of services, increased dysphoria from the procedures, stereotypes, stigma, and interest in starting MAI as soon as possible.
“Under a reproductive justice framework, autonomy around family planning is a right that should not be limited by structural or systemic barriers,” Dr. Rafferty wrote. “Overall, there is a clinical and ethical imperative to better understand and provide access to fertility services for TGD-AYA.”
Jason Rafferty, MD, MPH, is a pediatrician and child psychiatrist who practices at the gender and sexuality clinic in Riverside and at the Adolescent Healthcare Center at Hasbro Children’s Hospital in Providence, R.I. His comments are summarized from an accompanying editorial (Pediatrics 2019 Aug 5. doi: 10.1542/peds.2019-2000).
as transgender women, according to results of a small retrospective cohort study.
The lack of data on this topic, however, makes it difficult to determine how long an individual must be off gender-affirming therapy before spermatogenesis resumes, if it resumes, and what the long-term effects of gender-affirming therapy are.
“This information is critical to address as part of a multidisciplinary fertility discussion with youth and their guardians so that an informed decision can be made regarding fertility preservation use,” wrote Emily P. Barnard, DO, of UPMC Magee-Womens Hospital in Pittsburgh and her associates.
The researchers retrospectively collected data on transgender patients who sought fertility preservation between 2015 and 2018.
The 11 white transgender women (sex assigned male at birth) who followed up on adolescent medicine or pediatric endocrinology referrals for fertility preservation received their consultations between ages 16 and 24, with 19 years having been the median age at which they occurred. Gender dysphoria onset happened at a median age of 12 for the patients, who were evaluated for it at a median age of 17.
All but one patient submitted at least one semen sample, and eight ultimately cryopreserved their semen.
The eight samples from gender-affirming therapy–naive patients had abnormal morphology, with the median morphology having been 6% versus the normal range of greater than 13.0%. Otherwise, the samples collected were normal, but the authors noted that established semen analysis parameters don’t exist for adolescents and young adults.
All eight patients who had their semen cryopreserved, began gonadotropin-releasing hormone (GnRH) agonist therapy after cryopreservation, and four of those patients concurrently began taking estradiol.
One patient had already been taking intramuscular leuprolide acetate every 6 months and discontinued it to attempt fertility preservation. Spermatogenesis returned after 5 months of azoospermia, albeit with abnormal morphology (9%).
Another patient had been taking spironolactone and estradiol for 26 months before ceasing therapy to attempt fertility preservation. She remained azoospermic 4 months after stopping therapy and then moved forward with an orchiectomy.
“For many transgender patients, the potential need to discontinue GnRH agonist or gender-affirming therapy to allow for resumption of spermatogenesis may be a significant barrier to pursuing fertility preservation because cessation of therapy may result in exacerbation of gender dysphoria and progression of undesired male secondary sex characteristics,” the researchers wrote. “For individuals for whom this risk is not acceptable or if azoospermia is noted on semen analysis, there are several alternate options, including electroejaculation, testicular sperm extraction, and testicular tissue cryopreservation,” they continued. Electroejaculation with a transrectal probe is an option particularly for those who cannot masturbate or feel uncomfortable doing so, the authors explained.
For those who have not previously received gender-affirming therapy, the fertility preservation “process can be completed quickly, with collections occurring every 2 to 3 days to preserve several samples before initiating GnRH agonist or gender-affirming therapy,” they concluded.
SOURCE: Barnard EP et al. Pediatrics. 2019 Aug 5. doi: 10.1542/peds.2018-3943.
as transgender women, according to results of a small retrospective cohort study.
The lack of data on this topic, however, makes it difficult to determine how long an individual must be off gender-affirming therapy before spermatogenesis resumes, if it resumes, and what the long-term effects of gender-affirming therapy are.
“This information is critical to address as part of a multidisciplinary fertility discussion with youth and their guardians so that an informed decision can be made regarding fertility preservation use,” wrote Emily P. Barnard, DO, of UPMC Magee-Womens Hospital in Pittsburgh and her associates.
The researchers retrospectively collected data on transgender patients who sought fertility preservation between 2015 and 2018.
The 11 white transgender women (sex assigned male at birth) who followed up on adolescent medicine or pediatric endocrinology referrals for fertility preservation received their consultations between ages 16 and 24, with 19 years having been the median age at which they occurred. Gender dysphoria onset happened at a median age of 12 for the patients, who were evaluated for it at a median age of 17.
All but one patient submitted at least one semen sample, and eight ultimately cryopreserved their semen.
The eight samples from gender-affirming therapy–naive patients had abnormal morphology, with the median morphology having been 6% versus the normal range of greater than 13.0%. Otherwise, the samples collected were normal, but the authors noted that established semen analysis parameters don’t exist for adolescents and young adults.
All eight patients who had their semen cryopreserved, began gonadotropin-releasing hormone (GnRH) agonist therapy after cryopreservation, and four of those patients concurrently began taking estradiol.
One patient had already been taking intramuscular leuprolide acetate every 6 months and discontinued it to attempt fertility preservation. Spermatogenesis returned after 5 months of azoospermia, albeit with abnormal morphology (9%).
Another patient had been taking spironolactone and estradiol for 26 months before ceasing therapy to attempt fertility preservation. She remained azoospermic 4 months after stopping therapy and then moved forward with an orchiectomy.
“For many transgender patients, the potential need to discontinue GnRH agonist or gender-affirming therapy to allow for resumption of spermatogenesis may be a significant barrier to pursuing fertility preservation because cessation of therapy may result in exacerbation of gender dysphoria and progression of undesired male secondary sex characteristics,” the researchers wrote. “For individuals for whom this risk is not acceptable or if azoospermia is noted on semen analysis, there are several alternate options, including electroejaculation, testicular sperm extraction, and testicular tissue cryopreservation,” they continued. Electroejaculation with a transrectal probe is an option particularly for those who cannot masturbate or feel uncomfortable doing so, the authors explained.
For those who have not previously received gender-affirming therapy, the fertility preservation “process can be completed quickly, with collections occurring every 2 to 3 days to preserve several samples before initiating GnRH agonist or gender-affirming therapy,” they concluded.
SOURCE: Barnard EP et al. Pediatrics. 2019 Aug 5. doi: 10.1542/peds.2018-3943.
FROM PEDIATRICS
Pharmacist stigma a barrier to rural buprenorphine access
SAN ANTONIO – Most attention paid to barriers for medication-assisted treatment of opioid use disorder has focused on prescribers and patients, but pharmacists are “a neglected link in the chain,” according to Hannah Cooper, ScD, an assistant professor of behavioral sciences and health education at Emory University, Atlanta.
“Pharmacy-based dispensing of buprenorphine is one of the medication’s major advances over methadone,” Dr. Cooper told attendees at the annual meeting of the College on Problems of Drug Dependence. Yet, early interviews she and her colleagues conducted with rural Kentucky pharmacist colleagues in the CARE2HOPE study “revealed that pharmacy-level barriers might also curtail access to buprenorphine.”
Little research has examined those barriers, but Dr. Cooper noted. Further, anecdotal evidence has suggested that wholesaler concerns about Drug Enforcement Administration restrictions on dispensing buprenorphine has caused shortages at pharmacies.
Dr. Cooper and colleagues, therefore, designed a qualitative study aimed at learning about pharmacists’ attitudes and dispensing practices related to buprenorphine. They also looked at whether DEA limits actually exist on dispensing the drug. They interviewed 14 pharmacists operating 15 pharmacies across all 12 counties in two rural Kentucky health districts. Eleven of the pharmacists worked in independent pharmacies; the others worked at chains. Six pharmacies dispensed more than 100 buprenorphine prescriptions a month, five dispensed only several dozen a month, and four refused to dispense it at all.
Perceptions of federal restrictions
“Variations in buprenorphine dispensing did not solely reflect underlying variations in local need or prescribing practices,” Dr. Cooper said. At 12 of the 15 pharmacies, limits on buprenorphine resulted from a perceived DEA “cap” on dispensing the drug or “because of distrust in buprenorphine itself, its prescribers and its patients.”
The perceived cap from the DEA was shrouded in uncertainty: 10 of the pharmacists said the DEA capped the percentage of controlled substances pharmacists could dispense that were opioids, yet the pharmacists did not know what that percentage was.
Five of those interviewed said the cap often significantly cut short how many buprenorphine prescriptions they would dispense. Since they did not know how much the cap was, they internally set arbitrary limits, such as dispensing two prescriptions per day, to avoid risk of the DEA investigating their pharmacy.
Yet, those limits could not meet patient demand, so several pharmacists rationed buprenorphine only to local residents or long-term customers, causing additional problems. That practice strained relationships with prescribers, who then had to call multiple pharmacies to find one that would dispense the drug to new patients. It also put pharmacy staff at risk when a rejection angered a customer and “undermined local recovery efforts,” Dr. Cooper said.
Five other pharmacists, however, did not ration their buprenorphine and did not worry about exceeding the DEA cap.
No numerical cap appears to exist, but DEA regulations and the SUPPORT for Patients and Communities Act do require internal opioid surveillance systems at wholesalers that flag suspicious orders of controlled substances, including buprenorphine. And they enforce it: An $80 million settlement in 2013 resulted from the DEA’s charge that Walgreens distribution centers did not report suspicious drug orders.
Stigma among some pharmacists
Six of the pharmacists had low trust in buprenorphine and in those who prescribed it and used it, Dr. Cooper reported. Three would not dispense the drug at all, and two would not take new buprenorphine patients.
One such pharmacist told researchers: “It is supposed to be the drug to help them [recover.] They want Suboxone worse than they do the hydrocodone. … It’s not what it’s designed to be.”
Those pharmacists also reported believing that malpractice was common among prescribers, who, for example, did not provide required counseling to patients or did not quickly wean them off buprenorphine. The pharmacists perceived the physicians prescribing buprenorphine as doing so only to make more money, just as they had done by prescribing opioids in the first place.
Those pharmacists also believed the patients themselves sold buprenorphine to make money and that opioid use disorder was a choice. They told researchers that dispensing buprenorphine would bring more drug users to their stores and subsequently hurt business.
Yet, those beliefs were not universal among the pharmacists. Eight believed buprenorphine was an appropriate opioid use disorder treatment and had positive attitudes toward patients. Unlike those who viewed the disorder as a choice, those pharmacists saw it as a disease and viewed the patients admirably for their commitment to recovery.
Though a small, qualitative study, those findings suggest a need to more closely examine how pharmacies affect access to medication to treat opioid use disorder, Dr. Cooper said.
“In an epicenter of the U.S. opioid epidemic, policies and stigma curtail access to buprenorphine,” she told attendees. “DEA regulations, the SUPPORT Act, and related lawsuits have led wholesalers to develop proprietary caps that force some pharmacists to ration the number of buprenorphine prescriptions they filled.” Some pharmacists will not dispense the drug at all, while others “limited dispensing to known or local patients and prescribers, a practice that pharmacists recognized hurt patients who had to travel far to reach prescribers.”
The research was funded by the National Institutes of Health through CARE2HOPE, Rural Health Project, and the Emory Center for AIDS Research. The authors reported no disclosures.
SAN ANTONIO – Most attention paid to barriers for medication-assisted treatment of opioid use disorder has focused on prescribers and patients, but pharmacists are “a neglected link in the chain,” according to Hannah Cooper, ScD, an assistant professor of behavioral sciences and health education at Emory University, Atlanta.
“Pharmacy-based dispensing of buprenorphine is one of the medication’s major advances over methadone,” Dr. Cooper told attendees at the annual meeting of the College on Problems of Drug Dependence. Yet, early interviews she and her colleagues conducted with rural Kentucky pharmacist colleagues in the CARE2HOPE study “revealed that pharmacy-level barriers might also curtail access to buprenorphine.”
Little research has examined those barriers, but Dr. Cooper noted. Further, anecdotal evidence has suggested that wholesaler concerns about Drug Enforcement Administration restrictions on dispensing buprenorphine has caused shortages at pharmacies.
Dr. Cooper and colleagues, therefore, designed a qualitative study aimed at learning about pharmacists’ attitudes and dispensing practices related to buprenorphine. They also looked at whether DEA limits actually exist on dispensing the drug. They interviewed 14 pharmacists operating 15 pharmacies across all 12 counties in two rural Kentucky health districts. Eleven of the pharmacists worked in independent pharmacies; the others worked at chains. Six pharmacies dispensed more than 100 buprenorphine prescriptions a month, five dispensed only several dozen a month, and four refused to dispense it at all.
Perceptions of federal restrictions
“Variations in buprenorphine dispensing did not solely reflect underlying variations in local need or prescribing practices,” Dr. Cooper said. At 12 of the 15 pharmacies, limits on buprenorphine resulted from a perceived DEA “cap” on dispensing the drug or “because of distrust in buprenorphine itself, its prescribers and its patients.”
The perceived cap from the DEA was shrouded in uncertainty: 10 of the pharmacists said the DEA capped the percentage of controlled substances pharmacists could dispense that were opioids, yet the pharmacists did not know what that percentage was.
Five of those interviewed said the cap often significantly cut short how many buprenorphine prescriptions they would dispense. Since they did not know how much the cap was, they internally set arbitrary limits, such as dispensing two prescriptions per day, to avoid risk of the DEA investigating their pharmacy.
Yet, those limits could not meet patient demand, so several pharmacists rationed buprenorphine only to local residents or long-term customers, causing additional problems. That practice strained relationships with prescribers, who then had to call multiple pharmacies to find one that would dispense the drug to new patients. It also put pharmacy staff at risk when a rejection angered a customer and “undermined local recovery efforts,” Dr. Cooper said.
Five other pharmacists, however, did not ration their buprenorphine and did not worry about exceeding the DEA cap.
No numerical cap appears to exist, but DEA regulations and the SUPPORT for Patients and Communities Act do require internal opioid surveillance systems at wholesalers that flag suspicious orders of controlled substances, including buprenorphine. And they enforce it: An $80 million settlement in 2013 resulted from the DEA’s charge that Walgreens distribution centers did not report suspicious drug orders.
Stigma among some pharmacists
Six of the pharmacists had low trust in buprenorphine and in those who prescribed it and used it, Dr. Cooper reported. Three would not dispense the drug at all, and two would not take new buprenorphine patients.
One such pharmacist told researchers: “It is supposed to be the drug to help them [recover.] They want Suboxone worse than they do the hydrocodone. … It’s not what it’s designed to be.”
Those pharmacists also reported believing that malpractice was common among prescribers, who, for example, did not provide required counseling to patients or did not quickly wean them off buprenorphine. The pharmacists perceived the physicians prescribing buprenorphine as doing so only to make more money, just as they had done by prescribing opioids in the first place.
Those pharmacists also believed the patients themselves sold buprenorphine to make money and that opioid use disorder was a choice. They told researchers that dispensing buprenorphine would bring more drug users to their stores and subsequently hurt business.
Yet, those beliefs were not universal among the pharmacists. Eight believed buprenorphine was an appropriate opioid use disorder treatment and had positive attitudes toward patients. Unlike those who viewed the disorder as a choice, those pharmacists saw it as a disease and viewed the patients admirably for their commitment to recovery.
Though a small, qualitative study, those findings suggest a need to more closely examine how pharmacies affect access to medication to treat opioid use disorder, Dr. Cooper said.
“In an epicenter of the U.S. opioid epidemic, policies and stigma curtail access to buprenorphine,” she told attendees. “DEA regulations, the SUPPORT Act, and related lawsuits have led wholesalers to develop proprietary caps that force some pharmacists to ration the number of buprenorphine prescriptions they filled.” Some pharmacists will not dispense the drug at all, while others “limited dispensing to known or local patients and prescribers, a practice that pharmacists recognized hurt patients who had to travel far to reach prescribers.”
The research was funded by the National Institutes of Health through CARE2HOPE, Rural Health Project, and the Emory Center for AIDS Research. The authors reported no disclosures.
SAN ANTONIO – Most attention paid to barriers for medication-assisted treatment of opioid use disorder has focused on prescribers and patients, but pharmacists are “a neglected link in the chain,” according to Hannah Cooper, ScD, an assistant professor of behavioral sciences and health education at Emory University, Atlanta.
“Pharmacy-based dispensing of buprenorphine is one of the medication’s major advances over methadone,” Dr. Cooper told attendees at the annual meeting of the College on Problems of Drug Dependence. Yet, early interviews she and her colleagues conducted with rural Kentucky pharmacist colleagues in the CARE2HOPE study “revealed that pharmacy-level barriers might also curtail access to buprenorphine.”
Little research has examined those barriers, but Dr. Cooper noted. Further, anecdotal evidence has suggested that wholesaler concerns about Drug Enforcement Administration restrictions on dispensing buprenorphine has caused shortages at pharmacies.
Dr. Cooper and colleagues, therefore, designed a qualitative study aimed at learning about pharmacists’ attitudes and dispensing practices related to buprenorphine. They also looked at whether DEA limits actually exist on dispensing the drug. They interviewed 14 pharmacists operating 15 pharmacies across all 12 counties in two rural Kentucky health districts. Eleven of the pharmacists worked in independent pharmacies; the others worked at chains. Six pharmacies dispensed more than 100 buprenorphine prescriptions a month, five dispensed only several dozen a month, and four refused to dispense it at all.
Perceptions of federal restrictions
“Variations in buprenorphine dispensing did not solely reflect underlying variations in local need or prescribing practices,” Dr. Cooper said. At 12 of the 15 pharmacies, limits on buprenorphine resulted from a perceived DEA “cap” on dispensing the drug or “because of distrust in buprenorphine itself, its prescribers and its patients.”
The perceived cap from the DEA was shrouded in uncertainty: 10 of the pharmacists said the DEA capped the percentage of controlled substances pharmacists could dispense that were opioids, yet the pharmacists did not know what that percentage was.
Five of those interviewed said the cap often significantly cut short how many buprenorphine prescriptions they would dispense. Since they did not know how much the cap was, they internally set arbitrary limits, such as dispensing two prescriptions per day, to avoid risk of the DEA investigating their pharmacy.
Yet, those limits could not meet patient demand, so several pharmacists rationed buprenorphine only to local residents or long-term customers, causing additional problems. That practice strained relationships with prescribers, who then had to call multiple pharmacies to find one that would dispense the drug to new patients. It also put pharmacy staff at risk when a rejection angered a customer and “undermined local recovery efforts,” Dr. Cooper said.
Five other pharmacists, however, did not ration their buprenorphine and did not worry about exceeding the DEA cap.
No numerical cap appears to exist, but DEA regulations and the SUPPORT for Patients and Communities Act do require internal opioid surveillance systems at wholesalers that flag suspicious orders of controlled substances, including buprenorphine. And they enforce it: An $80 million settlement in 2013 resulted from the DEA’s charge that Walgreens distribution centers did not report suspicious drug orders.
Stigma among some pharmacists
Six of the pharmacists had low trust in buprenorphine and in those who prescribed it and used it, Dr. Cooper reported. Three would not dispense the drug at all, and two would not take new buprenorphine patients.
One such pharmacist told researchers: “It is supposed to be the drug to help them [recover.] They want Suboxone worse than they do the hydrocodone. … It’s not what it’s designed to be.”
Those pharmacists also reported believing that malpractice was common among prescribers, who, for example, did not provide required counseling to patients or did not quickly wean them off buprenorphine. The pharmacists perceived the physicians prescribing buprenorphine as doing so only to make more money, just as they had done by prescribing opioids in the first place.
Those pharmacists also believed the patients themselves sold buprenorphine to make money and that opioid use disorder was a choice. They told researchers that dispensing buprenorphine would bring more drug users to their stores and subsequently hurt business.
Yet, those beliefs were not universal among the pharmacists. Eight believed buprenorphine was an appropriate opioid use disorder treatment and had positive attitudes toward patients. Unlike those who viewed the disorder as a choice, those pharmacists saw it as a disease and viewed the patients admirably for their commitment to recovery.
Though a small, qualitative study, those findings suggest a need to more closely examine how pharmacies affect access to medication to treat opioid use disorder, Dr. Cooper said.
“In an epicenter of the U.S. opioid epidemic, policies and stigma curtail access to buprenorphine,” she told attendees. “DEA regulations, the SUPPORT Act, and related lawsuits have led wholesalers to develop proprietary caps that force some pharmacists to ration the number of buprenorphine prescriptions they filled.” Some pharmacists will not dispense the drug at all, while others “limited dispensing to known or local patients and prescribers, a practice that pharmacists recognized hurt patients who had to travel far to reach prescribers.”
The research was funded by the National Institutes of Health through CARE2HOPE, Rural Health Project, and the Emory Center for AIDS Research. The authors reported no disclosures.
REPORTING FROM CPDD 2019
Mindfulness-based relapse prevention tied to lower anxiety, depression
SAN ANTONIO – A mindfulness-based relapse prevention program resulted in significantly greater declines in anxiety and depressive symptoms among participants in an opioid addiction treatment program than those seen in patients who received treatment as usual, suggest results of a small nonrandomized controlled trial. Relapse rates trended downward with mindfulness but were not significantly different from the treatment-as-usual (TAU) group.
“Mindfulness-based relapse prevention (MBRP) can be successfully implemented in an outpatient setting with as good as or better results as treatment as usual,” Keith J. Zullig, PhD, MSPH, chair and professor in the department of social and behavioral sciences at the West Virginia University School of Public Health in Morgantown, said at the annual meeting of the College on Problems of Drug Dependence.
Though relapse rates did not show a statistically significant drop with mindfulness treatment compared with treatment as usual, the downward trend suggests that it is worthwhile to conduct a larger scale study, Dr. Zullig said.
, he added.
The researchers recruited 60 participants from a Comprehensive Opioid Addiction Treatment program who had been substance free for at least 90 consecutive days. Participants chose whether to enter the MBRP group or the treatment-as-usual group.
The treatment-as-usual group attended biweekly 60-minute sessions with a cognitive-based therapy process group led by a licensed therapist for 36 weeks. The MBRP group involved 24 weeks of biweekly attendance at 60-minute sessions, also led by a licensed therapist, followed by 12 weeks in the treatment-as-usual group.
The MBRP instruction involved the following:
- Mindful skill building
- Breathing
- Meditation
- Mindful movement (“gentle yoga practiced with mindful awareness of the body”)
- Using all the senses
- Increasing awareness of breath, body sensations, thoughts, and emotional energy
- Mindfulness in everyday life
- Daily home practice of formal mindfulness meditation for 30 minutes per day, 5-6 days a week
- Discussing practice/exercises both in and outside class
Researchers tracked retention rates, any prohibited substance relapse, and four self-reported measures at 12, 24, and 36 weeks’ follow-up. The self-reported measures looked at craving, with the Desire for Drug Questionnaire; anxiety, with the Overall Anxiety Severity and Impairment Scale, range 0-20); depression, with the Overall Depression Severity and Impairment Scale, range 0-20; and mindfulness, with the Five Facet Mindfulness Questionnaire.
Participants in both groups were statistically similar in gender, employment, education, insurance, and marital status at baseline.
Of the 24 patients who entered the MBRP program, 14 completed the full 24 weeks of intervention and 12 subsequent weeks. Among the 36 participants who entered the treatment-as-usual group, 20 completed the 36 weeks.
Retention was 75% in both groups at 24 weeks, but retention from 24 to 36 weeks was nonsignificantly greater in the mindfulness group (93% vs. 91% treatment as usual).
Relapse at both 24 and 36 weeks was lower among those using mindfulness but without a statistically significant difference. At 24 weeks, 44% of the treatment-as-usual participants had relapsed at least once, compared with 33% of the MBRP participants (intent to treat).
At 36 weeks (n = 37), 45% of the 22 remaining in the treatment-as-usual group had relapsed, compared with 40% of the 15 in the MBRP group. However, 20% of those in MBRP (3 of 15) relapsed between the 24 and 36 week follow-ups, compared with 5% (1 of 22) in the treatment-as-usual group, still a nonsignificant difference.
Anxiety scores were higher at baseline in the MBRP group (11 MBRP vs. 7.25 TAU) but were similar in both groups at 36 weeks (5.79 MBRP vs. 5.6 TAU). Depression scores also were higher at baseline in the MBRP (8 vs. 6.3) but ended slightly lower than the treatment-as-usual group at 36 weeks (3.71 MBRP vs. 4.35 TAU). The reductions in depression and anxiety scores for the MBRP group were significantly greater than in the treatment-as-usual group.
Mindfulness scores were not significantly different at baseline between the groups but were significantly higher at 36 weeks in the mindfulness groups (3.47 vs. 3.3, range 1-5).
“Relapse rates were trending lower in the MBRP group although not statistically significant,” Dr. Zullig said. “Significant decreases occurred in craving in both MBRP and treatment-as-usual groups.”
The Centers for Disease Control and Prevention funded the research. The authors had no disclosures.
SAN ANTONIO – A mindfulness-based relapse prevention program resulted in significantly greater declines in anxiety and depressive symptoms among participants in an opioid addiction treatment program than those seen in patients who received treatment as usual, suggest results of a small nonrandomized controlled trial. Relapse rates trended downward with mindfulness but were not significantly different from the treatment-as-usual (TAU) group.
“Mindfulness-based relapse prevention (MBRP) can be successfully implemented in an outpatient setting with as good as or better results as treatment as usual,” Keith J. Zullig, PhD, MSPH, chair and professor in the department of social and behavioral sciences at the West Virginia University School of Public Health in Morgantown, said at the annual meeting of the College on Problems of Drug Dependence.
Though relapse rates did not show a statistically significant drop with mindfulness treatment compared with treatment as usual, the downward trend suggests that it is worthwhile to conduct a larger scale study, Dr. Zullig said.
, he added.
The researchers recruited 60 participants from a Comprehensive Opioid Addiction Treatment program who had been substance free for at least 90 consecutive days. Participants chose whether to enter the MBRP group or the treatment-as-usual group.
The treatment-as-usual group attended biweekly 60-minute sessions with a cognitive-based therapy process group led by a licensed therapist for 36 weeks. The MBRP group involved 24 weeks of biweekly attendance at 60-minute sessions, also led by a licensed therapist, followed by 12 weeks in the treatment-as-usual group.
The MBRP instruction involved the following:
- Mindful skill building
- Breathing
- Meditation
- Mindful movement (“gentle yoga practiced with mindful awareness of the body”)
- Using all the senses
- Increasing awareness of breath, body sensations, thoughts, and emotional energy
- Mindfulness in everyday life
- Daily home practice of formal mindfulness meditation for 30 minutes per day, 5-6 days a week
- Discussing practice/exercises both in and outside class
Researchers tracked retention rates, any prohibited substance relapse, and four self-reported measures at 12, 24, and 36 weeks’ follow-up. The self-reported measures looked at craving, with the Desire for Drug Questionnaire; anxiety, with the Overall Anxiety Severity and Impairment Scale, range 0-20); depression, with the Overall Depression Severity and Impairment Scale, range 0-20; and mindfulness, with the Five Facet Mindfulness Questionnaire.
Participants in both groups were statistically similar in gender, employment, education, insurance, and marital status at baseline.
Of the 24 patients who entered the MBRP program, 14 completed the full 24 weeks of intervention and 12 subsequent weeks. Among the 36 participants who entered the treatment-as-usual group, 20 completed the 36 weeks.
Retention was 75% in both groups at 24 weeks, but retention from 24 to 36 weeks was nonsignificantly greater in the mindfulness group (93% vs. 91% treatment as usual).
Relapse at both 24 and 36 weeks was lower among those using mindfulness but without a statistically significant difference. At 24 weeks, 44% of the treatment-as-usual participants had relapsed at least once, compared with 33% of the MBRP participants (intent to treat).
At 36 weeks (n = 37), 45% of the 22 remaining in the treatment-as-usual group had relapsed, compared with 40% of the 15 in the MBRP group. However, 20% of those in MBRP (3 of 15) relapsed between the 24 and 36 week follow-ups, compared with 5% (1 of 22) in the treatment-as-usual group, still a nonsignificant difference.
Anxiety scores were higher at baseline in the MBRP group (11 MBRP vs. 7.25 TAU) but were similar in both groups at 36 weeks (5.79 MBRP vs. 5.6 TAU). Depression scores also were higher at baseline in the MBRP (8 vs. 6.3) but ended slightly lower than the treatment-as-usual group at 36 weeks (3.71 MBRP vs. 4.35 TAU). The reductions in depression and anxiety scores for the MBRP group were significantly greater than in the treatment-as-usual group.
Mindfulness scores were not significantly different at baseline between the groups but were significantly higher at 36 weeks in the mindfulness groups (3.47 vs. 3.3, range 1-5).
“Relapse rates were trending lower in the MBRP group although not statistically significant,” Dr. Zullig said. “Significant decreases occurred in craving in both MBRP and treatment-as-usual groups.”
The Centers for Disease Control and Prevention funded the research. The authors had no disclosures.
SAN ANTONIO – A mindfulness-based relapse prevention program resulted in significantly greater declines in anxiety and depressive symptoms among participants in an opioid addiction treatment program than those seen in patients who received treatment as usual, suggest results of a small nonrandomized controlled trial. Relapse rates trended downward with mindfulness but were not significantly different from the treatment-as-usual (TAU) group.
“Mindfulness-based relapse prevention (MBRP) can be successfully implemented in an outpatient setting with as good as or better results as treatment as usual,” Keith J. Zullig, PhD, MSPH, chair and professor in the department of social and behavioral sciences at the West Virginia University School of Public Health in Morgantown, said at the annual meeting of the College on Problems of Drug Dependence.
Though relapse rates did not show a statistically significant drop with mindfulness treatment compared with treatment as usual, the downward trend suggests that it is worthwhile to conduct a larger scale study, Dr. Zullig said.
, he added.
The researchers recruited 60 participants from a Comprehensive Opioid Addiction Treatment program who had been substance free for at least 90 consecutive days. Participants chose whether to enter the MBRP group or the treatment-as-usual group.
The treatment-as-usual group attended biweekly 60-minute sessions with a cognitive-based therapy process group led by a licensed therapist for 36 weeks. The MBRP group involved 24 weeks of biweekly attendance at 60-minute sessions, also led by a licensed therapist, followed by 12 weeks in the treatment-as-usual group.
The MBRP instruction involved the following:
- Mindful skill building
- Breathing
- Meditation
- Mindful movement (“gentle yoga practiced with mindful awareness of the body”)
- Using all the senses
- Increasing awareness of breath, body sensations, thoughts, and emotional energy
- Mindfulness in everyday life
- Daily home practice of formal mindfulness meditation for 30 minutes per day, 5-6 days a week
- Discussing practice/exercises both in and outside class
Researchers tracked retention rates, any prohibited substance relapse, and four self-reported measures at 12, 24, and 36 weeks’ follow-up. The self-reported measures looked at craving, with the Desire for Drug Questionnaire; anxiety, with the Overall Anxiety Severity and Impairment Scale, range 0-20); depression, with the Overall Depression Severity and Impairment Scale, range 0-20; and mindfulness, with the Five Facet Mindfulness Questionnaire.
Participants in both groups were statistically similar in gender, employment, education, insurance, and marital status at baseline.
Of the 24 patients who entered the MBRP program, 14 completed the full 24 weeks of intervention and 12 subsequent weeks. Among the 36 participants who entered the treatment-as-usual group, 20 completed the 36 weeks.
Retention was 75% in both groups at 24 weeks, but retention from 24 to 36 weeks was nonsignificantly greater in the mindfulness group (93% vs. 91% treatment as usual).
Relapse at both 24 and 36 weeks was lower among those using mindfulness but without a statistically significant difference. At 24 weeks, 44% of the treatment-as-usual participants had relapsed at least once, compared with 33% of the MBRP participants (intent to treat).
At 36 weeks (n = 37), 45% of the 22 remaining in the treatment-as-usual group had relapsed, compared with 40% of the 15 in the MBRP group. However, 20% of those in MBRP (3 of 15) relapsed between the 24 and 36 week follow-ups, compared with 5% (1 of 22) in the treatment-as-usual group, still a nonsignificant difference.
Anxiety scores were higher at baseline in the MBRP group (11 MBRP vs. 7.25 TAU) but were similar in both groups at 36 weeks (5.79 MBRP vs. 5.6 TAU). Depression scores also were higher at baseline in the MBRP (8 vs. 6.3) but ended slightly lower than the treatment-as-usual group at 36 weeks (3.71 MBRP vs. 4.35 TAU). The reductions in depression and anxiety scores for the MBRP group were significantly greater than in the treatment-as-usual group.
Mindfulness scores were not significantly different at baseline between the groups but were significantly higher at 36 weeks in the mindfulness groups (3.47 vs. 3.3, range 1-5).
“Relapse rates were trending lower in the MBRP group although not statistically significant,” Dr. Zullig said. “Significant decreases occurred in craving in both MBRP and treatment-as-usual groups.”
The Centers for Disease Control and Prevention funded the research. The authors had no disclosures.
REPORTING FROM CPDD 2019