Randy Dotinga

A new analysis of 18 hair products used by black women finds that they contain 45 endocrine-disrupting or asthma-associated chemicals, a finding that could help explain why this population suffers from higher rates of chemical exposure and hormone-related health conditions.

“We found multiples of our targeted chemicals in all of our products,” said study lead author Jessica S. Helm, PhD, of the Silent Spring Institute, Newton, Mass., in an interview. “We’re concerned about the additive effect of multiple products being used together.”

The study was published online April 24 in the journal Environmental Research.

According to the study, previous research has found that, compared with white women, U.S. black women have higher urinary levels of chemicals like phthalates and parabens. Black women also have higher rates of asthma and hormone-related health conditions like uterine fibroids and infertility, Dr. Helms said.

The researchers launched their study to better understand the possible role of hair care products in raising chemical levels in black women, Dr. Helm said.

The researchers tested 18 types of hair care products shown by a 2004-2005 survey to be popular among black women: hot oil treatments, anti-frizz products and polishes, leave-in conditioners, root stimulators, hair lotions, and relaxers. Researchers had purchased the products in 2008.

The researchers detected 45 of 66 target chemicals in the samples, including some that are banned in the European Union or regulated in California based on health concerns, according to Dr. Helms.

Most of the products contained parabens and phthalates (both 78%), UV filters (72%), and cyclosiloxanes (67%).

 

All products contained at least 1 of 19 targeted fragrances, while “hair lotions, root stimulators, and hair relaxers contained multiple fragrance chemicals per product, with an average of five to eight targeted fragrance chemicals detected per product versus an average of two in the anti-frizz products.”

How do the findings compare with previous research? “They’re roughly consistent with what’s been found before, but potentially on the higher end,” Dr. Helms said. “For some of these chemicals, there’s not a lot of data from the past.”

Most of the chemicals aren’t listed on product labels, Dr. Helm said. “It’s possible that some of the ingredients were unintentionally added as part of manufacturing or other processes.”

Dr. Helm urged physicians to consider the connections between hair care products and chemical exposure. “Maybe there’s an opportunity to use fewer products,” she said.

 

Dr. Helm acknowledged that it is difficult to find hair care products that don’t include fragrance. She recommends the use of products made from plants or organic ingredients, and she pointed to a Silver Spring Institute–affiliated app called DetoxMe that offers suggestions about reducing chemical exposure from consumer products.

The study was funded by the Rose Foundation, the Goldman Fund, and Hurricane Voices Breast Cancer Foundation. The authors report no relevant disclosures.

cenews@mdedge.com

SOURCE: Helm JS et al. Environ Res. 2018 Apr 25. doi: 10.1016/j.envres.2018.03.030.

A new analysis of 18 hair products used by black women finds that they contain 45 endocrine-disrupting or asthma-associated chemicals, a finding that could help explain why this population suffers from higher rates of chemical exposure and hormone-related health conditions.

“We found multiples of our targeted chemicals in all of our products,” said study lead author Jessica S. Helm, PhD, of the Silent Spring Institute, Newton, Mass., in an interview. “We’re concerned about the additive effect of multiple products being used together.”

The study was published online April 24 in the journal Environmental Research.

According to the study, previous research has found that, compared with white women, U.S. black women have higher urinary levels of chemicals like phthalates and parabens. Black women also have higher rates of asthma and hormone-related health conditions like uterine fibroids and infertility, Dr. Helms said.

The researchers launched their study to better understand the possible role of hair care products in raising chemical levels in black women, Dr. Helm said.

The researchers tested 18 types of hair care products shown by a 2004-2005 survey to be popular among black women: hot oil treatments, anti-frizz products and polishes, leave-in conditioners, root stimulators, hair lotions, and relaxers. Researchers had purchased the products in 2008.

The researchers detected 45 of 66 target chemicals in the samples, including some that are banned in the European Union or regulated in California based on health concerns, according to Dr. Helms.

Most of the products contained parabens and phthalates (both 78%), UV filters (72%), and cyclosiloxanes (67%).

 

All products contained at least 1 of 19 targeted fragrances, while “hair lotions, root stimulators, and hair relaxers contained multiple fragrance chemicals per product, with an average of five to eight targeted fragrance chemicals detected per product versus an average of two in the anti-frizz products.”

How do the findings compare with previous research? “They’re roughly consistent with what’s been found before, but potentially on the higher end,” Dr. Helms said. “For some of these chemicals, there’s not a lot of data from the past.”

Most of the chemicals aren’t listed on product labels, Dr. Helm said. “It’s possible that some of the ingredients were unintentionally added as part of manufacturing or other processes.”

Dr. Helm urged physicians to consider the connections between hair care products and chemical exposure. “Maybe there’s an opportunity to use fewer products,” she said.

 

Dr. Helm acknowledged that it is difficult to find hair care products that don’t include fragrance. She recommends the use of products made from plants or organic ingredients, and she pointed to a Silver Spring Institute–affiliated app called DetoxMe that offers suggestions about reducing chemical exposure from consumer products.

The study was funded by the Rose Foundation, the Goldman Fund, and Hurricane Voices Breast Cancer Foundation. The authors report no relevant disclosures.

cenews@mdedge.com

SOURCE: Helm JS et al. Environ Res. 2018 Apr 25. doi: 10.1016/j.envres.2018.03.030.

A new analysis of 18 hair products used by black women finds that they contain 45 endocrine-disrupting or asthma-associated chemicals, a finding that could help explain why this population suffers from higher rates of chemical exposure and hormone-related health conditions.

“We found multiples of our targeted chemicals in all of our products,” said study lead author Jessica S. Helm, PhD, of the Silent Spring Institute, Newton, Mass., in an interview. “We’re concerned about the additive effect of multiple products being used together.”

The study was published online April 24 in the journal Environmental Research.

According to the study, previous research has found that, compared with white women, U.S. black women have higher urinary levels of chemicals like phthalates and parabens. Black women also have higher rates of asthma and hormone-related health conditions like uterine fibroids and infertility, Dr. Helms said.

The researchers launched their study to better understand the possible role of hair care products in raising chemical levels in black women, Dr. Helm said.

The researchers tested 18 types of hair care products shown by a 2004-2005 survey to be popular among black women: hot oil treatments, anti-frizz products and polishes, leave-in conditioners, root stimulators, hair lotions, and relaxers. Researchers had purchased the products in 2008.

The researchers detected 45 of 66 target chemicals in the samples, including some that are banned in the European Union or regulated in California based on health concerns, according to Dr. Helms.

Most of the products contained parabens and phthalates (both 78%), UV filters (72%), and cyclosiloxanes (67%).

 

All products contained at least 1 of 19 targeted fragrances, while “hair lotions, root stimulators, and hair relaxers contained multiple fragrance chemicals per product, with an average of five to eight targeted fragrance chemicals detected per product versus an average of two in the anti-frizz products.”

How do the findings compare with previous research? “They’re roughly consistent with what’s been found before, but potentially on the higher end,” Dr. Helms said. “For some of these chemicals, there’s not a lot of data from the past.”

Most of the chemicals aren’t listed on product labels, Dr. Helm said. “It’s possible that some of the ingredients were unintentionally added as part of manufacturing or other processes.”

Dr. Helm urged physicians to consider the connections between hair care products and chemical exposure. “Maybe there’s an opportunity to use fewer products,” she said.

 

Dr. Helm acknowledged that it is difficult to find hair care products that don’t include fragrance. She recommends the use of products made from plants or organic ingredients, and she pointed to a Silver Spring Institute–affiliated app called DetoxMe that offers suggestions about reducing chemical exposure from consumer products.

The study was funded by the Rose Foundation, the Goldman Fund, and Hurricane Voices Breast Cancer Foundation. The authors report no relevant disclosures.

cenews@mdedge.com

SOURCE: Helm JS et al. Environ Res. 2018 Apr 25. doi: 10.1016/j.envres.2018.03.030.

Innovative compensation systems aimed at achieving fairness, consistency, and transparency in salaries among surgeons in academic medical centers can go a long way to closing the gender pay gap.

At the University of Alabama at Birmingham, research showed that a newly adopted compensation system – one not even designed to address gender disparities – boosted the salaries of female surgeons from 46% to 72% of the salaries of their male colleagues. A gender salary gap also narrowed at Oregon Health & Sciences University, Portland, after a new compensation policy was put into place.

The Oregon findings reveal that “gender bias did exist, and a universal compensation plan did assist in leveling the playing field as far as salaries go,” said study coauthor Kenneth S. Azarow, MD, interim chair of surgery at OHSU, in an interview.

The two studies were presented at the annual meeting of the American Surgical Association.

Recent studies have revealed significant gaps in the salaries of female physicians, compared with their male counterparts. The challenge in this kind of study is to fairly compare salaries by adjusting for hours worked, time taken for family obligations, negotiated starting salary, and other factors that play into salary level.

A 2016 analysis of 590 surgeons at 24 medical schools found that men made a mean of $323,000 a year, compared with $270,000 among women. The gap persisted after adjustment for factors like years of experience and publication history at $280,000 (women) and $312,000 (men). The pay gap among 744 surgical subspecialists was even wider at $343,000 (men) versus $267,000 (women). After adjustment, male surgical subspecialists made $329,000, while women made $285,000 (JAMA Intern Med. 2016;176[9]:1294-304).

In 2015, the administration at Oregon Health & Sciences University instituted a school-wide “Faculty First” compensation plan. It aligns faculty pay – based on specialty and academic rank – with 3-year rolling median salaries in the Western region as reported by the Association of American Medical Colleges.

 

A study of compensation at OHSU led by Heather E. Hoops, MD, examined the salaries earned by certain department of surgery faculty during 2009-2017 and promotion and retention rates during 1998-2007. The study excluded instructors, the chair of the department, and some other faculty members whose salaries were based on specific bonuses.

The researchers found that prior to the change in 2015, the 24 female faculty made significantly less than the 62 men (P = .004). After the “Faculty First” initiative was implemented in 2015, salaries for both genders grew significantly and gender salary gap was virtually closed after that time.

The researchers found no gender disparity in time to promotion among the faculty. No significant difference was found in the rate of departure between male and female faculty (P = .73), although women who were not promoted tended to leave more quickly than their male counterparts.

“Objective compensation plans may work by mitigating gender-based implicit bias in the salary negotiation process and differences in salary negotiation style between females and males,” Dr. Hoops and her coauthors wrote. “However, objective compensation plans do not supplant the need for other institutional interventions, such as implicit bias training and objective and transparent promotion criteria, to improve gender equality among surgeons.”

 

In the other study, University of Alabama at Birmingham researchers analyzed surgeon salaries earned during 2014-2017. In 2017, the university switched some surgeons to a new compensation system based on work revenue value units with incentives.

Of the surgeons at the institution, 31 men and 11 women were eligible for the new compensation system. Before it was put into place, female surgeons made 46% of the salaries of men with similar revenue value unit production. “Female surgeons are now earning 72% of what their male colleagues earn,” the researchers reported.

In an interview, study lead author Melanie Morris, MD, said the new pay system unexpectedly reduced the gender pay gap. “The rationale for this department compensation plan was to create a fair and transparent compensation system for all faculty,” she said. “In doing so, this plan unintentionally led to these described changes to equalize an unrecognized disparity. We are proud of the result and recognize there is still more work to do. Each institution should know their own data to see if a gender pay disparity exists and devise a plan to address it.”

 

OHSU Department of Surgery funded the Oregon study. The study authors report no disclosures. The University of Alabama at Birmingham study reports no funding. The study authors report no disclosures.

The complete manuscript of these studies and their presentation at the American Surgical Association’s 138th Annual Meeting, April 2018, in Phoenix, is anticipated to be published in the Annals of Surgery pending editorial review.

SOURCE: Morris MS et al. ASA Annual Meeting 2018, Abstract 4. Hoops HE et al. ASA Annual Meeting 2018, Abstract 9.

Innovative compensation systems aimed at achieving fairness, consistency, and transparency in salaries among surgeons in academic medical centers can go a long way to closing the gender pay gap.

At the University of Alabama at Birmingham, research showed that a newly adopted compensation system – one not even designed to address gender disparities – boosted the salaries of female surgeons from 46% to 72% of the salaries of their male colleagues. A gender salary gap also narrowed at Oregon Health & Sciences University, Portland, after a new compensation policy was put into place.

The Oregon findings reveal that “gender bias did exist, and a universal compensation plan did assist in leveling the playing field as far as salaries go,” said study coauthor Kenneth S. Azarow, MD, interim chair of surgery at OHSU, in an interview.

The two studies were presented at the annual meeting of the American Surgical Association.

Recent studies have revealed significant gaps in the salaries of female physicians, compared with their male counterparts. The challenge in this kind of study is to fairly compare salaries by adjusting for hours worked, time taken for family obligations, negotiated starting salary, and other factors that play into salary level.

A 2016 analysis of 590 surgeons at 24 medical schools found that men made a mean of $323,000 a year, compared with $270,000 among women. The gap persisted after adjustment for factors like years of experience and publication history at $280,000 (women) and $312,000 (men). The pay gap among 744 surgical subspecialists was even wider at $343,000 (men) versus $267,000 (women). After adjustment, male surgical subspecialists made $329,000, while women made $285,000 (JAMA Intern Med. 2016;176[9]:1294-304).

In 2015, the administration at Oregon Health & Sciences University instituted a school-wide “Faculty First” compensation plan. It aligns faculty pay – based on specialty and academic rank – with 3-year rolling median salaries in the Western region as reported by the Association of American Medical Colleges.

 

A study of compensation at OHSU led by Heather E. Hoops, MD, examined the salaries earned by certain department of surgery faculty during 2009-2017 and promotion and retention rates during 1998-2007. The study excluded instructors, the chair of the department, and some other faculty members whose salaries were based on specific bonuses.

The researchers found that prior to the change in 2015, the 24 female faculty made significantly less than the 62 men (P = .004). After the “Faculty First” initiative was implemented in 2015, salaries for both genders grew significantly and gender salary gap was virtually closed after that time.

The researchers found no gender disparity in time to promotion among the faculty. No significant difference was found in the rate of departure between male and female faculty (P = .73), although women who were not promoted tended to leave more quickly than their male counterparts.

“Objective compensation plans may work by mitigating gender-based implicit bias in the salary negotiation process and differences in salary negotiation style between females and males,” Dr. Hoops and her coauthors wrote. “However, objective compensation plans do not supplant the need for other institutional interventions, such as implicit bias training and objective and transparent promotion criteria, to improve gender equality among surgeons.”

 

In the other study, University of Alabama at Birmingham researchers analyzed surgeon salaries earned during 2014-2017. In 2017, the university switched some surgeons to a new compensation system based on work revenue value units with incentives.

Of the surgeons at the institution, 31 men and 11 women were eligible for the new compensation system. Before it was put into place, female surgeons made 46% of the salaries of men with similar revenue value unit production. “Female surgeons are now earning 72% of what their male colleagues earn,” the researchers reported.

In an interview, study lead author Melanie Morris, MD, said the new pay system unexpectedly reduced the gender pay gap. “The rationale for this department compensation plan was to create a fair and transparent compensation system for all faculty,” she said. “In doing so, this plan unintentionally led to these described changes to equalize an unrecognized disparity. We are proud of the result and recognize there is still more work to do. Each institution should know their own data to see if a gender pay disparity exists and devise a plan to address it.”

 

OHSU Department of Surgery funded the Oregon study. The study authors report no disclosures. The University of Alabama at Birmingham study reports no funding. The study authors report no disclosures.

The complete manuscript of these studies and their presentation at the American Surgical Association’s 138th Annual Meeting, April 2018, in Phoenix, is anticipated to be published in the Annals of Surgery pending editorial review.

SOURCE: Morris MS et al. ASA Annual Meeting 2018, Abstract 4. Hoops HE et al. ASA Annual Meeting 2018, Abstract 9.

Innovative compensation systems aimed at achieving fairness, consistency, and transparency in salaries among surgeons in academic medical centers can go a long way to closing the gender pay gap.

At the University of Alabama at Birmingham, research showed that a newly adopted compensation system – one not even designed to address gender disparities – boosted the salaries of female surgeons from 46% to 72% of the salaries of their male colleagues. A gender salary gap also narrowed at Oregon Health & Sciences University, Portland, after a new compensation policy was put into place.

The Oregon findings reveal that “gender bias did exist, and a universal compensation plan did assist in leveling the playing field as far as salaries go,” said study coauthor Kenneth S. Azarow, MD, interim chair of surgery at OHSU, in an interview.

The two studies were presented at the annual meeting of the American Surgical Association.

Recent studies have revealed significant gaps in the salaries of female physicians, compared with their male counterparts. The challenge in this kind of study is to fairly compare salaries by adjusting for hours worked, time taken for family obligations, negotiated starting salary, and other factors that play into salary level.

A 2016 analysis of 590 surgeons at 24 medical schools found that men made a mean of $323,000 a year, compared with $270,000 among women. The gap persisted after adjustment for factors like years of experience and publication history at $280,000 (women) and $312,000 (men). The pay gap among 744 surgical subspecialists was even wider at $343,000 (men) versus $267,000 (women). After adjustment, male surgical subspecialists made $329,000, while women made $285,000 (JAMA Intern Med. 2016;176[9]:1294-304).

In 2015, the administration at Oregon Health & Sciences University instituted a school-wide “Faculty First” compensation plan. It aligns faculty pay – based on specialty and academic rank – with 3-year rolling median salaries in the Western region as reported by the Association of American Medical Colleges.

 

A study of compensation at OHSU led by Heather E. Hoops, MD, examined the salaries earned by certain department of surgery faculty during 2009-2017 and promotion and retention rates during 1998-2007. The study excluded instructors, the chair of the department, and some other faculty members whose salaries were based on specific bonuses.

The researchers found that prior to the change in 2015, the 24 female faculty made significantly less than the 62 men (P = .004). After the “Faculty First” initiative was implemented in 2015, salaries for both genders grew significantly and gender salary gap was virtually closed after that time.

The researchers found no gender disparity in time to promotion among the faculty. No significant difference was found in the rate of departure between male and female faculty (P = .73), although women who were not promoted tended to leave more quickly than their male counterparts.

“Objective compensation plans may work by mitigating gender-based implicit bias in the salary negotiation process and differences in salary negotiation style between females and males,” Dr. Hoops and her coauthors wrote. “However, objective compensation plans do not supplant the need for other institutional interventions, such as implicit bias training and objective and transparent promotion criteria, to improve gender equality among surgeons.”

 

In the other study, University of Alabama at Birmingham researchers analyzed surgeon salaries earned during 2014-2017. In 2017, the university switched some surgeons to a new compensation system based on work revenue value units with incentives.

Of the surgeons at the institution, 31 men and 11 women were eligible for the new compensation system. Before it was put into place, female surgeons made 46% of the salaries of men with similar revenue value unit production. “Female surgeons are now earning 72% of what their male colleagues earn,” the researchers reported.

In an interview, study lead author Melanie Morris, MD, said the new pay system unexpectedly reduced the gender pay gap. “The rationale for this department compensation plan was to create a fair and transparent compensation system for all faculty,” she said. “In doing so, this plan unintentionally led to these described changes to equalize an unrecognized disparity. We are proud of the result and recognize there is still more work to do. Each institution should know their own data to see if a gender pay disparity exists and devise a plan to address it.”

 

OHSU Department of Surgery funded the Oregon study. The study authors report no disclosures. The University of Alabama at Birmingham study reports no funding. The study authors report no disclosures.

The complete manuscript of these studies and their presentation at the American Surgical Association’s 138th Annual Meeting, April 2018, in Phoenix, is anticipated to be published in the Annals of Surgery pending editorial review.

SOURCE: Morris MS et al. ASA Annual Meeting 2018, Abstract 4. Hoops HE et al. ASA Annual Meeting 2018, Abstract 9.

 

A Danish cohort study provides more evidence of a significant link between HIV infection and two types of skin cancer.

Danish researchers report that HIV-positive patients as a whole faced a higher risk of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), with incidence rate ratios (IRRs) of 1.79 and 5.40, respectively, when compared with a background population, who were HIV-negative.

“The risk of SCC seemed to increase with increasing level of immunosuppression while the increased risk of BCC was restricted to patients reporting MSM [men who have sex with men] as route of infection,” wrote the authors, led by Silje Haukali Omland, MD, PhD, of the department of dermato-venereology, Copenhagen University Hospital.

The Danish nationwide cohort study, which matched each HIV patient with 5 age- and sex-matched individuals from the background population, was published online March 26 in the Journal of the American Academy of Dermatology.

The results are similar to those published elsewhere, as is the finding that HIV-positive patients do not face a higher risk of malignant melanoma. “The results here confirm prior studies and support heightened vigilance for skin conditions, such as SCC and BCC in HIV patients,” said Michael J. Silverberg, PhD, of Kaiser Permanente Division of Research, in an interview after reviewing the study findings. He was not a study author.

Researchers have long noted a connection between various types of cancer and HIV infection. But, as noted in a 2013 study led by Dr. Silverberg, research into links between HIV and non-melanoma skin cancers has been sparse and inconclusive. That study of white adults found higher adjusted rate ratios for SCC (2.6) and BCC (2.1) among those who were HIV-positive compared with those who were HIV-negative (J Natl Cancer Inst. 2013 Mar 6;105[5]:350-60).

In the Danish study, researchers tracked sex-and age-matched cohorts of HIV-infected (4,280) and non-HIV-infected patients (21,399) aged 16 years or older from study inclusion through as late as 2014. All the HIV-positive subjects had taken antiretroviral medications. The researchers also compared the HIV-positive patients to their non-HIV-infected siblings.

 

Overall, those who were HIV-positive were more likely to develop BCC (IRR, 1.79, 95% CI, 1.43-2.22), and males who reported sex with men had an even higher risk (IRR, 2.30, 95% CI, 1.76-3.02).

As for SCC, the IRR was 5.40 (95% CI, 3.07-9.52) among those who were HIV-positive, compared with the background population, and the researchers found evidence that risk increased with level of immunosuppression. Those who indicated heterosexual and male homosexual transmission had similar rates of SCC.

The rates of BCC or SCC were not higher among siblings of HIV-positive patients.

In addition, the risk of melanoma was not increased among those who were HIV-positive subjects or their siblings, when compared with the background group. However, the researchers noted that the study turned up a low number of HIV-positive subjects with melanoma, potentially throwing off the results.

 

The researchers noted that the inclusion of siblings in the study suggests that sun exposure in childhood was not a confounding factor. Presumably, they wrote, the siblings had similar levels of exposure as children, although exposure to sun bed tanning could differ between siblings.

“Study methods appear very strong and consistent with other work done in the area,” Dr. Silverberg said in the interview. As for possible causes of the disparities, he noted that exposure to the sun or to tanning beds could explain the greater risk of BCC among men who have sex with men. “For SCC, there may be a biological link, as studies have suggested a link with human papillomavirus for that particular cancer,” he added.

No study funding was reported. The study authors reported disclosures that included grants, research grants, speaker fees, and/or advisory board honoraria from several drug manufacturers. Dr. Silverberg has no relevant disclosures.

SOURCE: Omland S et al. J Am Acad Dermatol. 2018 Mar 24. pii: S0190-9622(18)30475-4. doi: 10.1016/j.jaad.2018.03.024.

 

A Danish cohort study provides more evidence of a significant link between HIV infection and two types of skin cancer.

Danish researchers report that HIV-positive patients as a whole faced a higher risk of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), with incidence rate ratios (IRRs) of 1.79 and 5.40, respectively, when compared with a background population, who were HIV-negative.

“The risk of SCC seemed to increase with increasing level of immunosuppression while the increased risk of BCC was restricted to patients reporting MSM [men who have sex with men] as route of infection,” wrote the authors, led by Silje Haukali Omland, MD, PhD, of the department of dermato-venereology, Copenhagen University Hospital.

The Danish nationwide cohort study, which matched each HIV patient with 5 age- and sex-matched individuals from the background population, was published online March 26 in the Journal of the American Academy of Dermatology.

The results are similar to those published elsewhere, as is the finding that HIV-positive patients do not face a higher risk of malignant melanoma. “The results here confirm prior studies and support heightened vigilance for skin conditions, such as SCC and BCC in HIV patients,” said Michael J. Silverberg, PhD, of Kaiser Permanente Division of Research, in an interview after reviewing the study findings. He was not a study author.

Researchers have long noted a connection between various types of cancer and HIV infection. But, as noted in a 2013 study led by Dr. Silverberg, research into links between HIV and non-melanoma skin cancers has been sparse and inconclusive. That study of white adults found higher adjusted rate ratios for SCC (2.6) and BCC (2.1) among those who were HIV-positive compared with those who were HIV-negative (J Natl Cancer Inst. 2013 Mar 6;105[5]:350-60).

In the Danish study, researchers tracked sex-and age-matched cohorts of HIV-infected (4,280) and non-HIV-infected patients (21,399) aged 16 years or older from study inclusion through as late as 2014. All the HIV-positive subjects had taken antiretroviral medications. The researchers also compared the HIV-positive patients to their non-HIV-infected siblings.

 

Overall, those who were HIV-positive were more likely to develop BCC (IRR, 1.79, 95% CI, 1.43-2.22), and males who reported sex with men had an even higher risk (IRR, 2.30, 95% CI, 1.76-3.02).

As for SCC, the IRR was 5.40 (95% CI, 3.07-9.52) among those who were HIV-positive, compared with the background population, and the researchers found evidence that risk increased with level of immunosuppression. Those who indicated heterosexual and male homosexual transmission had similar rates of SCC.

The rates of BCC or SCC were not higher among siblings of HIV-positive patients.

In addition, the risk of melanoma was not increased among those who were HIV-positive subjects or their siblings, when compared with the background group. However, the researchers noted that the study turned up a low number of HIV-positive subjects with melanoma, potentially throwing off the results.

 

The researchers noted that the inclusion of siblings in the study suggests that sun exposure in childhood was not a confounding factor. Presumably, they wrote, the siblings had similar levels of exposure as children, although exposure to sun bed tanning could differ between siblings.

“Study methods appear very strong and consistent with other work done in the area,” Dr. Silverberg said in the interview. As for possible causes of the disparities, he noted that exposure to the sun or to tanning beds could explain the greater risk of BCC among men who have sex with men. “For SCC, there may be a biological link, as studies have suggested a link with human papillomavirus for that particular cancer,” he added.

No study funding was reported. The study authors reported disclosures that included grants, research grants, speaker fees, and/or advisory board honoraria from several drug manufacturers. Dr. Silverberg has no relevant disclosures.

SOURCE: Omland S et al. J Am Acad Dermatol. 2018 Mar 24. pii: S0190-9622(18)30475-4. doi: 10.1016/j.jaad.2018.03.024.

 

A Danish cohort study provides more evidence of a significant link between HIV infection and two types of skin cancer.

Danish researchers report that HIV-positive patients as a whole faced a higher risk of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), with incidence rate ratios (IRRs) of 1.79 and 5.40, respectively, when compared with a background population, who were HIV-negative.

“The risk of SCC seemed to increase with increasing level of immunosuppression while the increased risk of BCC was restricted to patients reporting MSM [men who have sex with men] as route of infection,” wrote the authors, led by Silje Haukali Omland, MD, PhD, of the department of dermato-venereology, Copenhagen University Hospital.

The Danish nationwide cohort study, which matched each HIV patient with 5 age- and sex-matched individuals from the background population, was published online March 26 in the Journal of the American Academy of Dermatology.

The results are similar to those published elsewhere, as is the finding that HIV-positive patients do not face a higher risk of malignant melanoma. “The results here confirm prior studies and support heightened vigilance for skin conditions, such as SCC and BCC in HIV patients,” said Michael J. Silverberg, PhD, of Kaiser Permanente Division of Research, in an interview after reviewing the study findings. He was not a study author.

Researchers have long noted a connection between various types of cancer and HIV infection. But, as noted in a 2013 study led by Dr. Silverberg, research into links between HIV and non-melanoma skin cancers has been sparse and inconclusive. That study of white adults found higher adjusted rate ratios for SCC (2.6) and BCC (2.1) among those who were HIV-positive compared with those who were HIV-negative (J Natl Cancer Inst. 2013 Mar 6;105[5]:350-60).

In the Danish study, researchers tracked sex-and age-matched cohorts of HIV-infected (4,280) and non-HIV-infected patients (21,399) aged 16 years or older from study inclusion through as late as 2014. All the HIV-positive subjects had taken antiretroviral medications. The researchers also compared the HIV-positive patients to their non-HIV-infected siblings.

 

Overall, those who were HIV-positive were more likely to develop BCC (IRR, 1.79, 95% CI, 1.43-2.22), and males who reported sex with men had an even higher risk (IRR, 2.30, 95% CI, 1.76-3.02).

As for SCC, the IRR was 5.40 (95% CI, 3.07-9.52) among those who were HIV-positive, compared with the background population, and the researchers found evidence that risk increased with level of immunosuppression. Those who indicated heterosexual and male homosexual transmission had similar rates of SCC.

The rates of BCC or SCC were not higher among siblings of HIV-positive patients.

In addition, the risk of melanoma was not increased among those who were HIV-positive subjects or their siblings, when compared with the background group. However, the researchers noted that the study turned up a low number of HIV-positive subjects with melanoma, potentially throwing off the results.

 

The researchers noted that the inclusion of siblings in the study suggests that sun exposure in childhood was not a confounding factor. Presumably, they wrote, the siblings had similar levels of exposure as children, although exposure to sun bed tanning could differ between siblings.

“Study methods appear very strong and consistent with other work done in the area,” Dr. Silverberg said in the interview. As for possible causes of the disparities, he noted that exposure to the sun or to tanning beds could explain the greater risk of BCC among men who have sex with men. “For SCC, there may be a biological link, as studies have suggested a link with human papillomavirus for that particular cancer,” he added.

No study funding was reported. The study authors reported disclosures that included grants, research grants, speaker fees, and/or advisory board honoraria from several drug manufacturers. Dr. Silverberg has no relevant disclosures.

SOURCE: Omland S et al. J Am Acad Dermatol. 2018 Mar 24. pii: S0190-9622(18)30475-4. doi: 10.1016/j.jaad.2018.03.024.

 

A molecular host response assay, called SeptiCyte Lab, holds promise as a tool to distinguish between sepsis and noninfectious systemic inflammation (SIRS), reported researchers in an industry-funded study.

Sepsis is a complex and hard-to-diagnose condition, noted two members of the editorial advisory board of CHEST Physician^® in interviews. To make things more complicated, there’s not even a standard definition of sepsis, explained board member Nirmal S. Sharma, MD, of the University of South Florida, Tampa.

“Although newer sepsis definitions have been proposed, all of them have pitfalls and are not used universally. Additionally, the presence of inflammatory response leading to suspicion of sepsis can be due to a new infection or underlying disease processes, thus making it difficult to identify the possible cause,” said Dr. Sharma. “Culture-negative cases due to the use of antibiotics prior to suspicion/onset of sepsis can further muddle the picture. Finally, in certain subsets of patients, such as the immunocompromised and elderly, the signs of sepsis may be delayed due to inadequate/dampened immune response, thus making early diagnosis difficult.”

Blood testing can provide information about germs that are causing an infection, but “they often take several days, and we need to start the antibiotics before we have those results,” added Daniel R. Ouellette, MD, FCCP, the other board member interviewed.

The SeptiCyte Lab assay, which was approved by the FDA for use in diagnosing sepsis in 2017, was developed to help physicians distinguish sepsis from SIRS in patients during their first day of ICU treatment, noted the authors of the new study in the American Journal of Respiratory and Critical Care Medicine.

This new tool seems to overcome some of the obstacles encountered when other diagnostic methods are used to determine if a patient has sepsis.

Russell R. Miller III, MD, FCCM, and his colleagues performed their SeptiCyte Lab assay on patients’ blood samples; this involved real-time, reverse-transcription, quantitative polymerase chain reaction screening designed to analyze the relative expression levels of four genes. The testing procedure took approximately 6 hours from the draw of the blood sample, according to the study, which was recently published online.

 

The predictive sensitivity of the test was 0.97 in patients unanimously considered to have sepsis by expert panels comprising three members. Negative predictive values were at least 0.89, according to the researchers.

Overall, the findings show “good reliability,” wrote Dr. Miller of the Intermountain Medical Center in Murray, Utah, and the University of Utah, Salt Lake City, and his colleagues.

The test produced scores in four bands, with scores at or above 3.1 considered to be evidence of infection. Lower levels were considered to be evidence of noninfection.

Dr. Miller and his coauthors reported that 86% of patients unanimously considered to have sepsis had scores above 3.1. In contrast, only 30% of those considered to have SIRS had such high scores.

In addition, the study authors determined that the test was more reliable than were the clinical signs and laboratory variables that are commonly used to diagnose sepsis within 24 hours of arrival at the ICU.

Reaching a definitive sepsis diagnosis is challenging based on clinical signs alone, since various conditions mimic the signs of sepsis, noted Dr. Ouellette of Henry Ford Hospital and Wayne State University School of Medicine in Detroit.

In some cases, physicians simply assume that a patient has sepsis and begin antibiotics, he said, “but that’s not a free ride. Each [antibiotic] may produce side effects with consequences for patients. The other problem is that overuse of antibiotics leads to resistance.”

The study by Dr. Miller and his colleagues combined the results of three trials conducted from during 2011-2016 in the United States and the Netherlands in 447 subjects.

 

One trial analyzed the experiences of 198 consecutive subjects, all critically ill, who met various criteria. (They were part of a consortium trial of 7,500 patients). The second trial had 129 participants, and the third had 120. Of the total participants, 71% were white and 20% were black.

Inclusion of procalcitonin levels in the laboratory variables didn’t appear to make a significant difference. The study authors wrote that the test “differs from, and is complementary to that of procalcitonin. The latter test is cleared for predicting progression from severe sepsis to septic shock, for predicting 28-day mortality, and for managing antibiotic de-escalation.”

According to the researchers, differences in age, sex, and race/ethnicity did not significantly affect the test.

The study concludes by noting that “future studies are warranted to determine how host gene expression could most effectively be integrated into clinical decision making to ensure susceptible patients are accurately managed early in the course of disease.”

The test is “promising new technology, but I don’t think you could say it’s definitive,” noted Dr. Ouellette.“Like any test, it’s not perfect,” he explained. “That’s important because physicians wouldn’t want to guess wrong. We might err on the side of choosing to treat with antibiotics even in the face of a test that suggested they might not have infection.”

Immunexpress and the Australian Government funded the study. Fourteen authors disclosed being current or former employees of Immunexpress and/or shareholders; others reported receiving funding from the company via their institutions. Four authors declared having filed patent applications related to the study or to the diagnosis of community-acquired pneumonia upon ICU admission. Some authors reported various other disclosures.

Dr. Ouellette and Dr. Sharma said they did not have any disclosures.

SOURCE: Miller RR et al. Am J Respir Crit Care Med. 2018 Apr 6. doi: 10.1164/rccm.201712-2472OC.

 

A molecular host response assay, called SeptiCyte Lab, holds promise as a tool to distinguish between sepsis and noninfectious systemic inflammation (SIRS), reported researchers in an industry-funded study.

Sepsis is a complex and hard-to-diagnose condition, noted two members of the editorial advisory board of CHEST Physician^® in interviews. To make things more complicated, there’s not even a standard definition of sepsis, explained board member Nirmal S. Sharma, MD, of the University of South Florida, Tampa.

“Although newer sepsis definitions have been proposed, all of them have pitfalls and are not used universally. Additionally, the presence of inflammatory response leading to suspicion of sepsis can be due to a new infection or underlying disease processes, thus making it difficult to identify the possible cause,” said Dr. Sharma. “Culture-negative cases due to the use of antibiotics prior to suspicion/onset of sepsis can further muddle the picture. Finally, in certain subsets of patients, such as the immunocompromised and elderly, the signs of sepsis may be delayed due to inadequate/dampened immune response, thus making early diagnosis difficult.”

Blood testing can provide information about germs that are causing an infection, but “they often take several days, and we need to start the antibiotics before we have those results,” added Daniel R. Ouellette, MD, FCCP, the other board member interviewed.

The SeptiCyte Lab assay, which was approved by the FDA for use in diagnosing sepsis in 2017, was developed to help physicians distinguish sepsis from SIRS in patients during their first day of ICU treatment, noted the authors of the new study in the American Journal of Respiratory and Critical Care Medicine.

This new tool seems to overcome some of the obstacles encountered when other diagnostic methods are used to determine if a patient has sepsis.

Russell R. Miller III, MD, FCCM, and his colleagues performed their SeptiCyte Lab assay on patients’ blood samples; this involved real-time, reverse-transcription, quantitative polymerase chain reaction screening designed to analyze the relative expression levels of four genes. The testing procedure took approximately 6 hours from the draw of the blood sample, according to the study, which was recently published online.

 

The predictive sensitivity of the test was 0.97 in patients unanimously considered to have sepsis by expert panels comprising three members. Negative predictive values were at least 0.89, according to the researchers.

Overall, the findings show “good reliability,” wrote Dr. Miller of the Intermountain Medical Center in Murray, Utah, and the University of Utah, Salt Lake City, and his colleagues.

The test produced scores in four bands, with scores at or above 3.1 considered to be evidence of infection. Lower levels were considered to be evidence of noninfection.

Dr. Miller and his coauthors reported that 86% of patients unanimously considered to have sepsis had scores above 3.1. In contrast, only 30% of those considered to have SIRS had such high scores.

In addition, the study authors determined that the test was more reliable than were the clinical signs and laboratory variables that are commonly used to diagnose sepsis within 24 hours of arrival at the ICU.

Reaching a definitive sepsis diagnosis is challenging based on clinical signs alone, since various conditions mimic the signs of sepsis, noted Dr. Ouellette of Henry Ford Hospital and Wayne State University School of Medicine in Detroit.

In some cases, physicians simply assume that a patient has sepsis and begin antibiotics, he said, “but that’s not a free ride. Each [antibiotic] may produce side effects with consequences for patients. The other problem is that overuse of antibiotics leads to resistance.”

The study by Dr. Miller and his colleagues combined the results of three trials conducted from during 2011-2016 in the United States and the Netherlands in 447 subjects.

 

One trial analyzed the experiences of 198 consecutive subjects, all critically ill, who met various criteria. (They were part of a consortium trial of 7,500 patients). The second trial had 129 participants, and the third had 120. Of the total participants, 71% were white and 20% were black.

Inclusion of procalcitonin levels in the laboratory variables didn’t appear to make a significant difference. The study authors wrote that the test “differs from, and is complementary to that of procalcitonin. The latter test is cleared for predicting progression from severe sepsis to septic shock, for predicting 28-day mortality, and for managing antibiotic de-escalation.”

According to the researchers, differences in age, sex, and race/ethnicity did not significantly affect the test.

The study concludes by noting that “future studies are warranted to determine how host gene expression could most effectively be integrated into clinical decision making to ensure susceptible patients are accurately managed early in the course of disease.”

The test is “promising new technology, but I don’t think you could say it’s definitive,” noted Dr. Ouellette.“Like any test, it’s not perfect,” he explained. “That’s important because physicians wouldn’t want to guess wrong. We might err on the side of choosing to treat with antibiotics even in the face of a test that suggested they might not have infection.”

Immunexpress and the Australian Government funded the study. Fourteen authors disclosed being current or former employees of Immunexpress and/or shareholders; others reported receiving funding from the company via their institutions. Four authors declared having filed patent applications related to the study or to the diagnosis of community-acquired pneumonia upon ICU admission. Some authors reported various other disclosures.

Dr. Ouellette and Dr. Sharma said they did not have any disclosures.

SOURCE: Miller RR et al. Am J Respir Crit Care Med. 2018 Apr 6. doi: 10.1164/rccm.201712-2472OC.

 

A molecular host response assay, called SeptiCyte Lab, holds promise as a tool to distinguish between sepsis and noninfectious systemic inflammation (SIRS), reported researchers in an industry-funded study.

Sepsis is a complex and hard-to-diagnose condition, noted two members of the editorial advisory board of CHEST Physician^® in interviews. To make things more complicated, there’s not even a standard definition of sepsis, explained board member Nirmal S. Sharma, MD, of the University of South Florida, Tampa.

“Although newer sepsis definitions have been proposed, all of them have pitfalls and are not used universally. Additionally, the presence of inflammatory response leading to suspicion of sepsis can be due to a new infection or underlying disease processes, thus making it difficult to identify the possible cause,” said Dr. Sharma. “Culture-negative cases due to the use of antibiotics prior to suspicion/onset of sepsis can further muddle the picture. Finally, in certain subsets of patients, such as the immunocompromised and elderly, the signs of sepsis may be delayed due to inadequate/dampened immune response, thus making early diagnosis difficult.”

Blood testing can provide information about germs that are causing an infection, but “they often take several days, and we need to start the antibiotics before we have those results,” added Daniel R. Ouellette, MD, FCCP, the other board member interviewed.

The SeptiCyte Lab assay, which was approved by the FDA for use in diagnosing sepsis in 2017, was developed to help physicians distinguish sepsis from SIRS in patients during their first day of ICU treatment, noted the authors of the new study in the American Journal of Respiratory and Critical Care Medicine.

This new tool seems to overcome some of the obstacles encountered when other diagnostic methods are used to determine if a patient has sepsis.

Russell R. Miller III, MD, FCCM, and his colleagues performed their SeptiCyte Lab assay on patients’ blood samples; this involved real-time, reverse-transcription, quantitative polymerase chain reaction screening designed to analyze the relative expression levels of four genes. The testing procedure took approximately 6 hours from the draw of the blood sample, according to the study, which was recently published online.

 

The predictive sensitivity of the test was 0.97 in patients unanimously considered to have sepsis by expert panels comprising three members. Negative predictive values were at least 0.89, according to the researchers.

Overall, the findings show “good reliability,” wrote Dr. Miller of the Intermountain Medical Center in Murray, Utah, and the University of Utah, Salt Lake City, and his colleagues.

The test produced scores in four bands, with scores at or above 3.1 considered to be evidence of infection. Lower levels were considered to be evidence of noninfection.

Dr. Miller and his coauthors reported that 86% of patients unanimously considered to have sepsis had scores above 3.1. In contrast, only 30% of those considered to have SIRS had such high scores.

In addition, the study authors determined that the test was more reliable than were the clinical signs and laboratory variables that are commonly used to diagnose sepsis within 24 hours of arrival at the ICU.

Reaching a definitive sepsis diagnosis is challenging based on clinical signs alone, since various conditions mimic the signs of sepsis, noted Dr. Ouellette of Henry Ford Hospital and Wayne State University School of Medicine in Detroit.

In some cases, physicians simply assume that a patient has sepsis and begin antibiotics, he said, “but that’s not a free ride. Each [antibiotic] may produce side effects with consequences for patients. The other problem is that overuse of antibiotics leads to resistance.”

The study by Dr. Miller and his colleagues combined the results of three trials conducted from during 2011-2016 in the United States and the Netherlands in 447 subjects.

 

One trial analyzed the experiences of 198 consecutive subjects, all critically ill, who met various criteria. (They were part of a consortium trial of 7,500 patients). The second trial had 129 participants, and the third had 120. Of the total participants, 71% were white and 20% were black.

Inclusion of procalcitonin levels in the laboratory variables didn’t appear to make a significant difference. The study authors wrote that the test “differs from, and is complementary to that of procalcitonin. The latter test is cleared for predicting progression from severe sepsis to septic shock, for predicting 28-day mortality, and for managing antibiotic de-escalation.”

According to the researchers, differences in age, sex, and race/ethnicity did not significantly affect the test.

The study concludes by noting that “future studies are warranted to determine how host gene expression could most effectively be integrated into clinical decision making to ensure susceptible patients are accurately managed early in the course of disease.”

The test is “promising new technology, but I don’t think you could say it’s definitive,” noted Dr. Ouellette.“Like any test, it’s not perfect,” he explained. “That’s important because physicians wouldn’t want to guess wrong. We might err on the side of choosing to treat with antibiotics even in the face of a test that suggested they might not have infection.”

Immunexpress and the Australian Government funded the study. Fourteen authors disclosed being current or former employees of Immunexpress and/or shareholders; others reported receiving funding from the company via their institutions. Four authors declared having filed patent applications related to the study or to the diagnosis of community-acquired pneumonia upon ICU admission. Some authors reported various other disclosures.

Dr. Ouellette and Dr. Sharma said they did not have any disclosures.

SOURCE: Miller RR et al. Am J Respir Crit Care Med. 2018 Apr 6. doi: 10.1164/rccm.201712-2472OC.

 

Autism spectrum disorder (ASD) affected an estimated 1.68 per 1,000 8-year-olds in 11 U.S. states in 2014, the highest number since monitoring began in 2000, a new federal report found.

The number suggests the ASD diagnosis rate has continued its steady rise since 2000-2002, when only 0.67 per 1,000 8-year-olds were believed to have the condition.

The report also found that while the gap in diagnosis rates between blacks and whites has dwindled, ASD prevalence “continues to vary among certain racial/ethnic groups and communities.” Indeed, the ASD rate approached 3% in some communities, according to the report published April 28 in Morbidity and Mortality Weekly Report.

The findings are based on statistics gathered by the Autism and Developmental Disabilities Monitoring Network, which uses multiple strategies to track ASD diagnoses among 8-year-olds in Arizona, Arkansas, Colorado, Georgia, Maryland, Minnesota, Missouri, New Jersey, North Carolina, Tennessee, and Wisconsin.

The network, which started its work in 2000, monitors 8-year-old children because that’s the age when ASD prevalence is thought to be at its highest.

The new report, by Jon Baio of the National Center on Birth Defects and Developmental Disabilities and his associates relied upon ASD definitions from DSM-IV-TR and DSM-5. While the definitions seem to be quite different, the report states, “the prevalence of ASD and characteristics of children identified by each case definition were similar in 2014.” Prevalence estimates in the report are only based on DSM-IV-TR criteria.

In total, the report for 2014 tracked 325,483 children aged 8 years, which accounted for 8% of the entire U.S. population in that age group. Of those, 5,473 were determined to have ASD.

 

The overall ASD prevalence was 16.8 per 1,000 (1 in 59) children. In 2000, the rate was estimated at 6.7 per 1,000. (The researchers caution that the states included in the monitoring network have changed over time.)

New Jersey had the highest prevalence of ASD (29.3 per 1,000, or 2.93%), and the difference when compared with each of the other 10 states was statistically significant (P less than .01).

The overall ASD rate was 26.6 per 1,000 for boys and 6.6 per 1,000 for girls (P less than .01). For whites, it was 17.2 per 1,000, while blacks (16.0 per 1,000) and Hispanics (14.0 per 1,000) had lower rates.

When intelligence quotient information was available, 44% of those with ASD had IQ greater than 85. Blacks (44%) and Hispanics (35%) with ASD were more likely than whites (22%) to have IQs less than or equal to 70, a sign of intellectual disability, the researcher reported.

 

Of the children with ASD, 80% had previously been diagnosed with the condition or determined to be eligible for autism services.

In light of the report findings, the authors wrote, “With prevalence of ASD reaching nearly 3% in some communities and representing an increase of 150% since 2000, ASD is an urgent public health concern that could benefit from enhanced strategies to help identify ASD earlier; to determine possible risk factors; and to address the growing behavioral, educational, residential and occupational needs of this population.”

Funding and disclosures were not reported.

SOURCE: Baio J et al. Morb Mortal Wkly Rep. 2018 Apr 27;67(6):1-28.

 

Autism spectrum disorder (ASD) affected an estimated 1.68 per 1,000 8-year-olds in 11 U.S. states in 2014, the highest number since monitoring began in 2000, a new federal report found.

The number suggests the ASD diagnosis rate has continued its steady rise since 2000-2002, when only 0.67 per 1,000 8-year-olds were believed to have the condition.

The report also found that while the gap in diagnosis rates between blacks and whites has dwindled, ASD prevalence “continues to vary among certain racial/ethnic groups and communities.” Indeed, the ASD rate approached 3% in some communities, according to the report published April 28 in Morbidity and Mortality Weekly Report.

The findings are based on statistics gathered by the Autism and Developmental Disabilities Monitoring Network, which uses multiple strategies to track ASD diagnoses among 8-year-olds in Arizona, Arkansas, Colorado, Georgia, Maryland, Minnesota, Missouri, New Jersey, North Carolina, Tennessee, and Wisconsin.

The network, which started its work in 2000, monitors 8-year-old children because that’s the age when ASD prevalence is thought to be at its highest.

The new report, by Jon Baio of the National Center on Birth Defects and Developmental Disabilities and his associates relied upon ASD definitions from DSM-IV-TR and DSM-5. While the definitions seem to be quite different, the report states, “the prevalence of ASD and characteristics of children identified by each case definition were similar in 2014.” Prevalence estimates in the report are only based on DSM-IV-TR criteria.

In total, the report for 2014 tracked 325,483 children aged 8 years, which accounted for 8% of the entire U.S. population in that age group. Of those, 5,473 were determined to have ASD.

 

The overall ASD prevalence was 16.8 per 1,000 (1 in 59) children. In 2000, the rate was estimated at 6.7 per 1,000. (The researchers caution that the states included in the monitoring network have changed over time.)

New Jersey had the highest prevalence of ASD (29.3 per 1,000, or 2.93%), and the difference when compared with each of the other 10 states was statistically significant (P less than .01).

The overall ASD rate was 26.6 per 1,000 for boys and 6.6 per 1,000 for girls (P less than .01). For whites, it was 17.2 per 1,000, while blacks (16.0 per 1,000) and Hispanics (14.0 per 1,000) had lower rates.

When intelligence quotient information was available, 44% of those with ASD had IQ greater than 85. Blacks (44%) and Hispanics (35%) with ASD were more likely than whites (22%) to have IQs less than or equal to 70, a sign of intellectual disability, the researcher reported.

 

Of the children with ASD, 80% had previously been diagnosed with the condition or determined to be eligible for autism services.

In light of the report findings, the authors wrote, “With prevalence of ASD reaching nearly 3% in some communities and representing an increase of 150% since 2000, ASD is an urgent public health concern that could benefit from enhanced strategies to help identify ASD earlier; to determine possible risk factors; and to address the growing behavioral, educational, residential and occupational needs of this population.”

Funding and disclosures were not reported.

SOURCE: Baio J et al. Morb Mortal Wkly Rep. 2018 Apr 27;67(6):1-28.

 

Autism spectrum disorder (ASD) affected an estimated 1.68 per 1,000 8-year-olds in 11 U.S. states in 2014, the highest number since monitoring began in 2000, a new federal report found.

The number suggests the ASD diagnosis rate has continued its steady rise since 2000-2002, when only 0.67 per 1,000 8-year-olds were believed to have the condition.

The report also found that while the gap in diagnosis rates between blacks and whites has dwindled, ASD prevalence “continues to vary among certain racial/ethnic groups and communities.” Indeed, the ASD rate approached 3% in some communities, according to the report published April 28 in Morbidity and Mortality Weekly Report.

The findings are based on statistics gathered by the Autism and Developmental Disabilities Monitoring Network, which uses multiple strategies to track ASD diagnoses among 8-year-olds in Arizona, Arkansas, Colorado, Georgia, Maryland, Minnesota, Missouri, New Jersey, North Carolina, Tennessee, and Wisconsin.

The network, which started its work in 2000, monitors 8-year-old children because that’s the age when ASD prevalence is thought to be at its highest.

The new report, by Jon Baio of the National Center on Birth Defects and Developmental Disabilities and his associates relied upon ASD definitions from DSM-IV-TR and DSM-5. While the definitions seem to be quite different, the report states, “the prevalence of ASD and characteristics of children identified by each case definition were similar in 2014.” Prevalence estimates in the report are only based on DSM-IV-TR criteria.

In total, the report for 2014 tracked 325,483 children aged 8 years, which accounted for 8% of the entire U.S. population in that age group. Of those, 5,473 were determined to have ASD.

 

The overall ASD prevalence was 16.8 per 1,000 (1 in 59) children. In 2000, the rate was estimated at 6.7 per 1,000. (The researchers caution that the states included in the monitoring network have changed over time.)

New Jersey had the highest prevalence of ASD (29.3 per 1,000, or 2.93%), and the difference when compared with each of the other 10 states was statistically significant (P less than .01).

The overall ASD rate was 26.6 per 1,000 for boys and 6.6 per 1,000 for girls (P less than .01). For whites, it was 17.2 per 1,000, while blacks (16.0 per 1,000) and Hispanics (14.0 per 1,000) had lower rates.

When intelligence quotient information was available, 44% of those with ASD had IQ greater than 85. Blacks (44%) and Hispanics (35%) with ASD were more likely than whites (22%) to have IQs less than or equal to 70, a sign of intellectual disability, the researcher reported.

 

Of the children with ASD, 80% had previously been diagnosed with the condition or determined to be eligible for autism services.

In light of the report findings, the authors wrote, “With prevalence of ASD reaching nearly 3% in some communities and representing an increase of 150% since 2000, ASD is an urgent public health concern that could benefit from enhanced strategies to help identify ASD earlier; to determine possible risk factors; and to address the growing behavioral, educational, residential and occupational needs of this population.”

Funding and disclosures were not reported.

SOURCE: Baio J et al. Morb Mortal Wkly Rep. 2018 Apr 27;67(6):1-28.

 

A survey conducted at the world’s largest twin celebration provides more evidence that twins share a genetic propensity toward acne, and provides information about several aggravating factors.

The study “further supports that there may be a genetic phenotypic link, though social and environmental factors may also have an influence in the disease process,” the authors wrote.

copyright Kativ/iStockphoto

The study, led by Amanda Suggs, MD, of University Hospitals Cleveland Medical Center, appears in the April issue of the Journal of Drugs in Dermatology.

Previous twin research has linked genetic factors to 80% of acne variance, with environmental factors, such as stress and low intake of produce, believed to account for the rest of the risk (J Invest Dermat. 2002;119[6]:1317-22). For the new study, researchers surveyed twins at the 2016 Twins Day Festival in Twinsburg, Ohio. Thousand of twins – and triplets and quadruplets – from around the world attend the annual event.

After incomplete surveys were discarded, the survey population included 202 identical twins (101 pairs) and 53 fraternal twins or triplets. (A set of triplets was included in addition to 25 pairs of twins.) The majority of participants were female: 23% of identical twins and 17% of the fraternal twins and triplets were male. The mean age was 29 years among the identical twins and 21 years among fraternal twins.

Identical twins were more likely to both have acne (64%) than fraternal twins (49%), which supports the results of previous studies that suggest “acne is largely attributable to genetics,” the authors observed. Among identical twins, those with acne were more likely to have polycystic ovarian syndrome (P = .045), anxiety (P = .014), and asthma (P = .026).

“Identical twin pairs with acne had a higher BMI [body mass index] and exercised less than those without,” the researchers added. These two associations were statistically significant, both for higher BMI (P = .020) and for less exercise (P = .001). “This suggests that a higher BMI and lack of exercise may contribute [along with genetics of course] to acne development. Thus, regular exercise and lower BMI may keep acne at bay,” they noted.

 

They also analyzed 56 pairs of identical twins with acne, who reported different severities, and found that the twin with more severe acne was more likely to report that sun exposure (P = .048), cosmetic product use (P = .002), and sugar intake (P = .048) aggravated their acne. Refined carbohydrates, as an aggravating factor, approached statistical significance, they said.

A separate analysis of 45 pairs of female identical twins with different degrees of acne severity produced similar findings. There were no significant difference between acne severity groups in terms of menstruation flare frequency or with oral contraceptive use. The twin with more severe acne, however, “was more likely to report aggravation of acne with sun exposure,” cosmetic use, and sugar intake, all associations which reached statistical significance. They were also more likely to report that refined carbohydrates and intake of fried foods aggravated their acne, associations that approached statistical significance.

“This twin study provides further support for reducing intake of sugar and refined carbohydrates to decrease acne severity in susceptible individuals,” the authors wrote. “For females, reducing intake of fried foods may also help,” they added.

There’s a twist to their results: The finding that those with more severe acne reported worsening symptoms with sun exposure “conflicts with prior research, which has found that acne improves with sun,” the authors wrote, adding that “perhaps the data was confounded by comedogenic sunscreen use.”
No specific study funding was reported. The study authors reported no disclosures.

SOURCE: Suggs A et al. J Drugs Dermatol. 2018 Apr;17(4):380-2.

 

A survey conducted at the world’s largest twin celebration provides more evidence that twins share a genetic propensity toward acne, and provides information about several aggravating factors.

The study “further supports that there may be a genetic phenotypic link, though social and environmental factors may also have an influence in the disease process,” the authors wrote.

copyright Kativ/iStockphoto

The study, led by Amanda Suggs, MD, of University Hospitals Cleveland Medical Center, appears in the April issue of the Journal of Drugs in Dermatology.

Previous twin research has linked genetic factors to 80% of acne variance, with environmental factors, such as stress and low intake of produce, believed to account for the rest of the risk (J Invest Dermat. 2002;119[6]:1317-22). For the new study, researchers surveyed twins at the 2016 Twins Day Festival in Twinsburg, Ohio. Thousand of twins – and triplets and quadruplets – from around the world attend the annual event.

After incomplete surveys were discarded, the survey population included 202 identical twins (101 pairs) and 53 fraternal twins or triplets. (A set of triplets was included in addition to 25 pairs of twins.) The majority of participants were female: 23% of identical twins and 17% of the fraternal twins and triplets were male. The mean age was 29 years among the identical twins and 21 years among fraternal twins.

Identical twins were more likely to both have acne (64%) than fraternal twins (49%), which supports the results of previous studies that suggest “acne is largely attributable to genetics,” the authors observed. Among identical twins, those with acne were more likely to have polycystic ovarian syndrome (P = .045), anxiety (P = .014), and asthma (P = .026).

“Identical twin pairs with acne had a higher BMI [body mass index] and exercised less than those without,” the researchers added. These two associations were statistically significant, both for higher BMI (P = .020) and for less exercise (P = .001). “This suggests that a higher BMI and lack of exercise may contribute [along with genetics of course] to acne development. Thus, regular exercise and lower BMI may keep acne at bay,” they noted.

 

They also analyzed 56 pairs of identical twins with acne, who reported different severities, and found that the twin with more severe acne was more likely to report that sun exposure (P = .048), cosmetic product use (P = .002), and sugar intake (P = .048) aggravated their acne. Refined carbohydrates, as an aggravating factor, approached statistical significance, they said.

A separate analysis of 45 pairs of female identical twins with different degrees of acne severity produced similar findings. There were no significant difference between acne severity groups in terms of menstruation flare frequency or with oral contraceptive use. The twin with more severe acne, however, “was more likely to report aggravation of acne with sun exposure,” cosmetic use, and sugar intake, all associations which reached statistical significance. They were also more likely to report that refined carbohydrates and intake of fried foods aggravated their acne, associations that approached statistical significance.

“This twin study provides further support for reducing intake of sugar and refined carbohydrates to decrease acne severity in susceptible individuals,” the authors wrote. “For females, reducing intake of fried foods may also help,” they added.

There’s a twist to their results: The finding that those with more severe acne reported worsening symptoms with sun exposure “conflicts with prior research, which has found that acne improves with sun,” the authors wrote, adding that “perhaps the data was confounded by comedogenic sunscreen use.”
No specific study funding was reported. The study authors reported no disclosures.

SOURCE: Suggs A et al. J Drugs Dermatol. 2018 Apr;17(4):380-2.

 

A survey conducted at the world’s largest twin celebration provides more evidence that twins share a genetic propensity toward acne, and provides information about several aggravating factors.

The study “further supports that there may be a genetic phenotypic link, though social and environmental factors may also have an influence in the disease process,” the authors wrote.

copyright Kativ/iStockphoto

The study, led by Amanda Suggs, MD, of University Hospitals Cleveland Medical Center, appears in the April issue of the Journal of Drugs in Dermatology.

Previous twin research has linked genetic factors to 80% of acne variance, with environmental factors, such as stress and low intake of produce, believed to account for the rest of the risk (J Invest Dermat. 2002;119[6]:1317-22). For the new study, researchers surveyed twins at the 2016 Twins Day Festival in Twinsburg, Ohio. Thousand of twins – and triplets and quadruplets – from around the world attend the annual event.

After incomplete surveys were discarded, the survey population included 202 identical twins (101 pairs) and 53 fraternal twins or triplets. (A set of triplets was included in addition to 25 pairs of twins.) The majority of participants were female: 23% of identical twins and 17% of the fraternal twins and triplets were male. The mean age was 29 years among the identical twins and 21 years among fraternal twins.

Identical twins were more likely to both have acne (64%) than fraternal twins (49%), which supports the results of previous studies that suggest “acne is largely attributable to genetics,” the authors observed. Among identical twins, those with acne were more likely to have polycystic ovarian syndrome (P = .045), anxiety (P = .014), and asthma (P = .026).

“Identical twin pairs with acne had a higher BMI [body mass index] and exercised less than those without,” the researchers added. These two associations were statistically significant, both for higher BMI (P = .020) and for less exercise (P = .001). “This suggests that a higher BMI and lack of exercise may contribute [along with genetics of course] to acne development. Thus, regular exercise and lower BMI may keep acne at bay,” they noted.

 

They also analyzed 56 pairs of identical twins with acne, who reported different severities, and found that the twin with more severe acne was more likely to report that sun exposure (P = .048), cosmetic product use (P = .002), and sugar intake (P = .048) aggravated their acne. Refined carbohydrates, as an aggravating factor, approached statistical significance, they said.

A separate analysis of 45 pairs of female identical twins with different degrees of acne severity produced similar findings. There were no significant difference between acne severity groups in terms of menstruation flare frequency or with oral contraceptive use. The twin with more severe acne, however, “was more likely to report aggravation of acne with sun exposure,” cosmetic use, and sugar intake, all associations which reached statistical significance. They were also more likely to report that refined carbohydrates and intake of fried foods aggravated their acne, associations that approached statistical significance.

“This twin study provides further support for reducing intake of sugar and refined carbohydrates to decrease acne severity in susceptible individuals,” the authors wrote. “For females, reducing intake of fried foods may also help,” they added.

There’s a twist to their results: The finding that those with more severe acne reported worsening symptoms with sun exposure “conflicts with prior research, which has found that acne improves with sun,” the authors wrote, adding that “perhaps the data was confounded by comedogenic sunscreen use.”
No specific study funding was reported. The study authors reported no disclosures.

SOURCE: Suggs A et al. J Drugs Dermatol. 2018 Apr;17(4):380-2.

 

Physicians and nurses turn to a wide variety of kinds of dressings to treat patients with diabetic foot ulcers (DFU). Now, new data from an industry-funded study suggest that an experimental nitric oxide-generating dressing holds promise as a tool to reduce diabetic foot wound size in certain cases.

Balkonsky/Thinkstock

The treatment is still in the research stage, and it’s not clear whether more studies will be conducted. For now, though, “we have a topical agent which specifically treats infection as well as increases perfusion of the ulcer,” study lead author Michael E. Edmonds, MD, a professor of diabetes and endocrinology at King’s College Hospital in London, said in an interview. “The study also showed that the agent not only improved healing but significantly reduced serious adverse events related to the ulcer, which included hospitalizations and amputations.”
 

The study appeared online April 4 in Wound Repair and Regeneration.

Researchers estimate that DFUs affect as many as 4% of patients with diabetes each year, with about a quarter developing the condition over their lifetimes.

A 2014 U.S. study found that 4%-5% percentage of patients with DFUs underwent lower limb amputations over a 12-month period. The same study also estimated that DFU-related care costs as much as $13 billion a year. (Diabetes Care. 2014 Mar;37[3]:651-8)

“There is no straightforward guideline to choose dressing,” said wound care specialist William H. Tettelbach, MD, the medical director of infection prevention, wound care, and antibiotic stewardship at Landmark Hospital in Salt Lake City, in an interview. Instead, he said, there are just some general tenets: Use an absorbing dressing for a wet ulcer, a moist dressing for a dry ulcer, and an antimicrobial dressing for a bacterial ulcer.

The new multi-center, randomized, controlled phase 2/3 study – funded by the biotech company Edixomed – examined the use of a nitric oxide–generating dressing known as EDX110. The dressing consists of a moist mesh and a second layer that keeps the first layer in place.

 

“The critical factors that delay the healing of diabetic foot ulcers are ischemia and infection,” Dr. Edmonds said. “Nitric oxide plays a crucial role in maintaining the microvascular supply and infection control in the skin, and its absence in diabetes contributes to poor ulcer healing. EDX110 generates a sustained release of nitric oxide which can treat both infection and ischemia simultaneously.”

Researchers randomly assigned patients with chronic DFUs – including some with infections – to a control group (n = 73) or a treatment group that received the experimental dressing (n = 75). The study protocol was changed partway through to allow patients with DFUs of at least 14 days duration to participate instead of just those with DFUs in place for at least 6 weeks.

The average age of patients in both groups was 59 years, and males made up 82%-87% of the total. Some had more than 1 ulcer.

All patients received standard DFU care for their institution with the exception of members of the treatment group, who were given the EDX110 dressing. Participants were treated for 12 weeks or until their ulcers healed followed by a 12-week follow-up period.

 

The institutes used a wide variety of dressings including absorbent pad, alginate, antimicrobial, foam, gauze, and other types. About a third were antimicrobial.

In the intent-to-treat population at 12 weeks, the median percentage area reduction of the ulcers was 89% in the treatment group, compared with 47% in the control group (P = .016).

The researchers reported significantly fewer serious adverse events in the treatment group, and none were reported to be linked to the various dressings used.

According to Dr. Edmonds, pricing information for the treatment is unavailable.

 

Dr. Tettelbach cautioned about the limitations of the study. For one, it doesn’t focus on chronic DFUs that can last well beyond a month and “are more problematic to heal and pose a greater relative risk of infection than acute DFUs.”

He added: “Surrogate end points such as 80% reduction in surface area at 12 weeks are difficult to extrapolate to expected closure. An open chronic ulcer is at risk for complicating infection no matter what size,” he said.

Overall, Dr. Tettelbach said, he doesn’t see the study as a “big deal,” but it’s “a welcomed addition to the wound dressing family that works using a novel mechanism of stimulating angiogenesis and antimicrobial properties.”

The biotech company Edixomed funded the study. The study authors report various disclosures or no disclosures; two disclose links to Edixomed.

SOURCE: Edmonds ME et al. Wound Repair Regen. 2018 April 4. doi: 10.1111/wrr.12630.

 

Physicians and nurses turn to a wide variety of kinds of dressings to treat patients with diabetic foot ulcers (DFU). Now, new data from an industry-funded study suggest that an experimental nitric oxide-generating dressing holds promise as a tool to reduce diabetic foot wound size in certain cases.

Balkonsky/Thinkstock

The treatment is still in the research stage, and it’s not clear whether more studies will be conducted. For now, though, “we have a topical agent which specifically treats infection as well as increases perfusion of the ulcer,” study lead author Michael E. Edmonds, MD, a professor of diabetes and endocrinology at King’s College Hospital in London, said in an interview. “The study also showed that the agent not only improved healing but significantly reduced serious adverse events related to the ulcer, which included hospitalizations and amputations.”
 

The study appeared online April 4 in Wound Repair and Regeneration.

Researchers estimate that DFUs affect as many as 4% of patients with diabetes each year, with about a quarter developing the condition over their lifetimes.

A 2014 U.S. study found that 4%-5% percentage of patients with DFUs underwent lower limb amputations over a 12-month period. The same study also estimated that DFU-related care costs as much as $13 billion a year. (Diabetes Care. 2014 Mar;37[3]:651-8)

“There is no straightforward guideline to choose dressing,” said wound care specialist William H. Tettelbach, MD, the medical director of infection prevention, wound care, and antibiotic stewardship at Landmark Hospital in Salt Lake City, in an interview. Instead, he said, there are just some general tenets: Use an absorbing dressing for a wet ulcer, a moist dressing for a dry ulcer, and an antimicrobial dressing for a bacterial ulcer.

The new multi-center, randomized, controlled phase 2/3 study – funded by the biotech company Edixomed – examined the use of a nitric oxide–generating dressing known as EDX110. The dressing consists of a moist mesh and a second layer that keeps the first layer in place.

 

“The critical factors that delay the healing of diabetic foot ulcers are ischemia and infection,” Dr. Edmonds said. “Nitric oxide plays a crucial role in maintaining the microvascular supply and infection control in the skin, and its absence in diabetes contributes to poor ulcer healing. EDX110 generates a sustained release of nitric oxide which can treat both infection and ischemia simultaneously.”

Researchers randomly assigned patients with chronic DFUs – including some with infections – to a control group (n = 73) or a treatment group that received the experimental dressing (n = 75). The study protocol was changed partway through to allow patients with DFUs of at least 14 days duration to participate instead of just those with DFUs in place for at least 6 weeks.

The average age of patients in both groups was 59 years, and males made up 82%-87% of the total. Some had more than 1 ulcer.

All patients received standard DFU care for their institution with the exception of members of the treatment group, who were given the EDX110 dressing. Participants were treated for 12 weeks or until their ulcers healed followed by a 12-week follow-up period.

 

The institutes used a wide variety of dressings including absorbent pad, alginate, antimicrobial, foam, gauze, and other types. About a third were antimicrobial.

In the intent-to-treat population at 12 weeks, the median percentage area reduction of the ulcers was 89% in the treatment group, compared with 47% in the control group (P = .016).

The researchers reported significantly fewer serious adverse events in the treatment group, and none were reported to be linked to the various dressings used.

According to Dr. Edmonds, pricing information for the treatment is unavailable.

 

Dr. Tettelbach cautioned about the limitations of the study. For one, it doesn’t focus on chronic DFUs that can last well beyond a month and “are more problematic to heal and pose a greater relative risk of infection than acute DFUs.”

He added: “Surrogate end points such as 80% reduction in surface area at 12 weeks are difficult to extrapolate to expected closure. An open chronic ulcer is at risk for complicating infection no matter what size,” he said.

Overall, Dr. Tettelbach said, he doesn’t see the study as a “big deal,” but it’s “a welcomed addition to the wound dressing family that works using a novel mechanism of stimulating angiogenesis and antimicrobial properties.”

The biotech company Edixomed funded the study. The study authors report various disclosures or no disclosures; two disclose links to Edixomed.

SOURCE: Edmonds ME et al. Wound Repair Regen. 2018 April 4. doi: 10.1111/wrr.12630.

 

Physicians and nurses turn to a wide variety of kinds of dressings to treat patients with diabetic foot ulcers (DFU). Now, new data from an industry-funded study suggest that an experimental nitric oxide-generating dressing holds promise as a tool to reduce diabetic foot wound size in certain cases.

Balkonsky/Thinkstock

The treatment is still in the research stage, and it’s not clear whether more studies will be conducted. For now, though, “we have a topical agent which specifically treats infection as well as increases perfusion of the ulcer,” study lead author Michael E. Edmonds, MD, a professor of diabetes and endocrinology at King’s College Hospital in London, said in an interview. “The study also showed that the agent not only improved healing but significantly reduced serious adverse events related to the ulcer, which included hospitalizations and amputations.”
 

The study appeared online April 4 in Wound Repair and Regeneration.

Researchers estimate that DFUs affect as many as 4% of patients with diabetes each year, with about a quarter developing the condition over their lifetimes.

A 2014 U.S. study found that 4%-5% percentage of patients with DFUs underwent lower limb amputations over a 12-month period. The same study also estimated that DFU-related care costs as much as $13 billion a year. (Diabetes Care. 2014 Mar;37[3]:651-8)

“There is no straightforward guideline to choose dressing,” said wound care specialist William H. Tettelbach, MD, the medical director of infection prevention, wound care, and antibiotic stewardship at Landmark Hospital in Salt Lake City, in an interview. Instead, he said, there are just some general tenets: Use an absorbing dressing for a wet ulcer, a moist dressing for a dry ulcer, and an antimicrobial dressing for a bacterial ulcer.

The new multi-center, randomized, controlled phase 2/3 study – funded by the biotech company Edixomed – examined the use of a nitric oxide–generating dressing known as EDX110. The dressing consists of a moist mesh and a second layer that keeps the first layer in place.

 

“The critical factors that delay the healing of diabetic foot ulcers are ischemia and infection,” Dr. Edmonds said. “Nitric oxide plays a crucial role in maintaining the microvascular supply and infection control in the skin, and its absence in diabetes contributes to poor ulcer healing. EDX110 generates a sustained release of nitric oxide which can treat both infection and ischemia simultaneously.”

Researchers randomly assigned patients with chronic DFUs – including some with infections – to a control group (n = 73) or a treatment group that received the experimental dressing (n = 75). The study protocol was changed partway through to allow patients with DFUs of at least 14 days duration to participate instead of just those with DFUs in place for at least 6 weeks.

The average age of patients in both groups was 59 years, and males made up 82%-87% of the total. Some had more than 1 ulcer.

All patients received standard DFU care for their institution with the exception of members of the treatment group, who were given the EDX110 dressing. Participants were treated for 12 weeks or until their ulcers healed followed by a 12-week follow-up period.

 

The institutes used a wide variety of dressings including absorbent pad, alginate, antimicrobial, foam, gauze, and other types. About a third were antimicrobial.

In the intent-to-treat population at 12 weeks, the median percentage area reduction of the ulcers was 89% in the treatment group, compared with 47% in the control group (P = .016).

The researchers reported significantly fewer serious adverse events in the treatment group, and none were reported to be linked to the various dressings used.

According to Dr. Edmonds, pricing information for the treatment is unavailable.

 

Dr. Tettelbach cautioned about the limitations of the study. For one, it doesn’t focus on chronic DFUs that can last well beyond a month and “are more problematic to heal and pose a greater relative risk of infection than acute DFUs.”

He added: “Surrogate end points such as 80% reduction in surface area at 12 weeks are difficult to extrapolate to expected closure. An open chronic ulcer is at risk for complicating infection no matter what size,” he said.

Overall, Dr. Tettelbach said, he doesn’t see the study as a “big deal,” but it’s “a welcomed addition to the wound dressing family that works using a novel mechanism of stimulating angiogenesis and antimicrobial properties.”

The biotech company Edixomed funded the study. The study authors report various disclosures or no disclosures; two disclose links to Edixomed.

SOURCE: Edmonds ME et al. Wound Repair Regen. 2018 April 4. doi: 10.1111/wrr.12630.

 

Most patients who responded to surveys reported being satisfied after off-label treatment with Juvéderm Voluma XC hyaluronic acid filler for infraorbital hollowing, a study finds.

Adverse effects were reported in 12% of patients.

The treatment’s “high patient satisfaction profile and a similar safety profile among other soft-tissue fillers make it an excellent adjunct in the plastic surgeon’s armamentarium,” reported Michael B. Hall, MD, and his associates at their private, ambulatory facial plastic and reconstructive surgery practice in Austin, Texas, in JAMA Facial Plastic Surgery.

According to the researchers, the Food and Drug Administration has not approved any soft-tissue fillers for the periorbital complex. At their practice, Dr. Hall and his associates treat infraorbital hollows with Juvéderm Voluma XC, which is approved by the FDA for certain types of cheek augmentation. Other studies have examined Belotero or Restylane as treatments for building volume in the periorbital area, the authors wrote, but research into cosmetic injections of Juvéderm Voluma XC is lacking.

For the new study, the researchers retrospectively analyzed the cases of 101 patients (aged 32-75 years, with average age of 54 years; 89% female; 54% Fitzpatrick skin type II; racial breakdown not reported) who were electively treated with the filler for infraorbital hollowing in 2016 and 2017. The patients received an average 1 mL of the treatment gel.

The patients were photographed and answered surveys, and they were evaluated using the Allergan Infraorbital Hollows Scale. Follow-up time averaged 12 months.

A total of 18 patients (18%) required touch-up within 3 months, and 2 required multiple touch-ups. A total of 12 subjects (12%) had adverse effects (including 3 who had more than one), which included bruising (10%), contour irregularities (2%), edema (3%) and Tyndall effect (1%). Hyaluronidase was required in 3 patients (3%), and 24 patients sought further treatment after 3 months.

 

The researchers sent two satisfaction surveys to the participants. A total of 41% responded to the FACE-Q Satisfaction With Eyes survey, and 42% responded to the FACE-Q Satisfaction With Decision survey.

Depending on the question, 70%-85% of the respondents to the Satisfaction With Eyes survey said they were “definitely” or “somewhat” satisfied with the treatment outcome.

The highest levels of dissatisfaction came in response to a questions about whether the subjects felt their eyes looked alert (not tired) or youthful. The highest levels of satisfaction were in response to questions about whether the subjects were happy with the shape, attractiveness, and openness of their eyes.

Depending on the question, 73%-85% of the subjects who took the Satisfaction With Decision survey reported that they “definitely” or “somewhat” agree with positive statements about the treatment. While differences were small, they agreed the most with a statement saying the procedure was “worth the time and effort.”

No external funding or remuneration was received. The study authors reported no relevant disclosures.
 

SOURCE: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.

 

Most patients who responded to surveys reported being satisfied after off-label treatment with Juvéderm Voluma XC hyaluronic acid filler for infraorbital hollowing, a study finds.

Adverse effects were reported in 12% of patients.

The treatment’s “high patient satisfaction profile and a similar safety profile among other soft-tissue fillers make it an excellent adjunct in the plastic surgeon’s armamentarium,” reported Michael B. Hall, MD, and his associates at their private, ambulatory facial plastic and reconstructive surgery practice in Austin, Texas, in JAMA Facial Plastic Surgery.

According to the researchers, the Food and Drug Administration has not approved any soft-tissue fillers for the periorbital complex. At their practice, Dr. Hall and his associates treat infraorbital hollows with Juvéderm Voluma XC, which is approved by the FDA for certain types of cheek augmentation. Other studies have examined Belotero or Restylane as treatments for building volume in the periorbital area, the authors wrote, but research into cosmetic injections of Juvéderm Voluma XC is lacking.

For the new study, the researchers retrospectively analyzed the cases of 101 patients (aged 32-75 years, with average age of 54 years; 89% female; 54% Fitzpatrick skin type II; racial breakdown not reported) who were electively treated with the filler for infraorbital hollowing in 2016 and 2017. The patients received an average 1 mL of the treatment gel.

The patients were photographed and answered surveys, and they were evaluated using the Allergan Infraorbital Hollows Scale. Follow-up time averaged 12 months.

A total of 18 patients (18%) required touch-up within 3 months, and 2 required multiple touch-ups. A total of 12 subjects (12%) had adverse effects (including 3 who had more than one), which included bruising (10%), contour irregularities (2%), edema (3%) and Tyndall effect (1%). Hyaluronidase was required in 3 patients (3%), and 24 patients sought further treatment after 3 months.

 

The researchers sent two satisfaction surveys to the participants. A total of 41% responded to the FACE-Q Satisfaction With Eyes survey, and 42% responded to the FACE-Q Satisfaction With Decision survey.

Depending on the question, 70%-85% of the respondents to the Satisfaction With Eyes survey said they were “definitely” or “somewhat” satisfied with the treatment outcome.

The highest levels of dissatisfaction came in response to a questions about whether the subjects felt their eyes looked alert (not tired) or youthful. The highest levels of satisfaction were in response to questions about whether the subjects were happy with the shape, attractiveness, and openness of their eyes.

Depending on the question, 73%-85% of the subjects who took the Satisfaction With Decision survey reported that they “definitely” or “somewhat” agree with positive statements about the treatment. While differences were small, they agreed the most with a statement saying the procedure was “worth the time and effort.”

No external funding or remuneration was received. The study authors reported no relevant disclosures.
 

SOURCE: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.

 

Most patients who responded to surveys reported being satisfied after off-label treatment with Juvéderm Voluma XC hyaluronic acid filler for infraorbital hollowing, a study finds.

Adverse effects were reported in 12% of patients.

The treatment’s “high patient satisfaction profile and a similar safety profile among other soft-tissue fillers make it an excellent adjunct in the plastic surgeon’s armamentarium,” reported Michael B. Hall, MD, and his associates at their private, ambulatory facial plastic and reconstructive surgery practice in Austin, Texas, in JAMA Facial Plastic Surgery.

According to the researchers, the Food and Drug Administration has not approved any soft-tissue fillers for the periorbital complex. At their practice, Dr. Hall and his associates treat infraorbital hollows with Juvéderm Voluma XC, which is approved by the FDA for certain types of cheek augmentation. Other studies have examined Belotero or Restylane as treatments for building volume in the periorbital area, the authors wrote, but research into cosmetic injections of Juvéderm Voluma XC is lacking.

For the new study, the researchers retrospectively analyzed the cases of 101 patients (aged 32-75 years, with average age of 54 years; 89% female; 54% Fitzpatrick skin type II; racial breakdown not reported) who were electively treated with the filler for infraorbital hollowing in 2016 and 2017. The patients received an average 1 mL of the treatment gel.

The patients were photographed and answered surveys, and they were evaluated using the Allergan Infraorbital Hollows Scale. Follow-up time averaged 12 months.

A total of 18 patients (18%) required touch-up within 3 months, and 2 required multiple touch-ups. A total of 12 subjects (12%) had adverse effects (including 3 who had more than one), which included bruising (10%), contour irregularities (2%), edema (3%) and Tyndall effect (1%). Hyaluronidase was required in 3 patients (3%), and 24 patients sought further treatment after 3 months.

 

The researchers sent two satisfaction surveys to the participants. A total of 41% responded to the FACE-Q Satisfaction With Eyes survey, and 42% responded to the FACE-Q Satisfaction With Decision survey.

Depending on the question, 70%-85% of the respondents to the Satisfaction With Eyes survey said they were “definitely” or “somewhat” satisfied with the treatment outcome.

The highest levels of dissatisfaction came in response to a questions about whether the subjects felt their eyes looked alert (not tired) or youthful. The highest levels of satisfaction were in response to questions about whether the subjects were happy with the shape, attractiveness, and openness of their eyes.

Depending on the question, 73%-85% of the subjects who took the Satisfaction With Decision survey reported that they “definitely” or “somewhat” agree with positive statements about the treatment. While differences were small, they agreed the most with a statement saying the procedure was “worth the time and effort.”

No external funding or remuneration was received. The study authors reported no relevant disclosures.
 

SOURCE: Hall MB et al. JAMA Facial Plast Surg. 2018 Apr 5. doi:10.1001/jamafacial.2018.0230.

 

New research provides strong statistical support for the use of dynamic multidisciplinary discussion in the diagnosis of patients who may have interstitial lung diseases (ILD).

Multidisciplinary discussion (MDD) provided a diagnosis in 80% of referred cases when referring physicians couldn’t come up with one, and it changed the diagnosis in 41% of the other cases.

The American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association adopted joint guidelines for the treatment of idiopathic pulmonary fibrosis in 2015, and the ATS and ERS updated guidelines for the classification and terminology for idiopathic interstitial pneumonias in 2013. The Lancet Respiratory Medicine published what some consider to be a landmark evaluation of multidisciplinary team agreement on diagnosis of interstitial lung disease following the adoption of these guidelines (Walsh SLF et al. 2016;4[7]:557-65). This study showed that in idiopathic pulmonary fibrosis, multidisciplinary team meetings “have a higher level of agreement on diagnoses, assign diagnoses with higher confidence more frequently, and provide diagnoses that have nonsignificant greater prognostic separation than do clinicians or radiologists in most cases,” the researchers wrote.

In the new study, MDD failed to produce a diagnosis or suggestions about a way forward in only 3.5% of patients, according to the study, which appeared March 30 in CHEST®.

“Several previous studies have demonstrated that MDD improves the accuracy of ILD diagnosis, particularly as compared with the referring physician’s initial diagnosis,” said pulmonologist Danielle Antin-Ozerkis, MD, of Yale University, New Haven, Conn., in an interview. “The current study supports the use of this team approach.”

According to Dr. Antin-Ozerkis, accurate diagnosis of ILD is crucial to treatment, but it can be challenging to achieve. The MDD approach has been recommended since 2002 by the ATS and ERS, she said.

The study authors, led by Laurens J. De Sadeleer, MD, of Belgium’s University Hospitals Leuven, define the MDD approach as one “in which expert ILD clinicians, radiologists, and pathologists integrate all available clinical data, laboratory results, high-resolution computed tomography [HRCT] findings, and lung biopsy [when performed].”

 

For the study, the researchers tracked pre-MDD and MDD diagnoses of 938 consecutive patients with possible ILD who were discussed during 2005-2015. Of these patients, referring physicians made preliminary diagnoses in 49% of cases; in the rest, physicians either failed to develop a diagnosis or offered multiple possible diagnoses.

MDD teams produced a change in diagnosis in 191 – 42% – of patients with a pre-MDD diagnosis. Another condition was diagnosed in 118 of these patients, and the MDD teams declined to classify the other 73 patients pending further investigation.

The MDD teams also were able to produce diagnoses in 80% of cases when referring physicians could not come up with diagnoses.

“Discrepancy between pre-MDD diagnosis before work-up and discussion was remarkable,” the study authors wrote, estimating that MDD added value for 70% of referred patients.

 

“We believe MDD should be a common practice in the diagnosis of every patient with suspected ILD,” the researchers said.

The study doesn’t examine the challenges of putting MDD into practice, but Dr. Antin-Ozerkis provided some perspective. “It may be difficult for physicians to take the time from a busy practice to meet with a multidisciplinary team. It can require resources to gather the data necessary to comprehensively assess each patient case. Additionally, maintaining staff with experienced pulmonologists, radiologists and pathologists may be costly.”

She added that “there are various ways in which MDD may occur,” and that the pros and cons of different methods have not been well studied. “This practice will likely evolve with the development of new biomarkers and other diagnostic strategies in IPF [idiopathic pulmonary fibrosis].”

Still, she said, “this joint undertaking is clearly vital in helping to guide clinical practice, including therapeutic decisions and discussion of prognosis. For now, any discussion between clinician, radiologist, and pathologist is of benefit.”

Research Foundation-Flanders and University Hospitals Leuven funded the study. Some study authors reported various disclosures. Dr. Antin-Ozerkis disclosed serving as an investigator on several clinical trials for IPF and other ILDs by Boehringer, Promedior, Fibrogen and Roche. She noted that payments go directly to the university with no direct payments to the investigator.

SOURCE: De Sadeleer LJ et al. Chest. 2018 Mar 30. doi: 10.1016/j.chest.2018.03.026.

 

New research provides strong statistical support for the use of dynamic multidisciplinary discussion in the diagnosis of patients who may have interstitial lung diseases (ILD).

Multidisciplinary discussion (MDD) provided a diagnosis in 80% of referred cases when referring physicians couldn’t come up with one, and it changed the diagnosis in 41% of the other cases.

The American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association adopted joint guidelines for the treatment of idiopathic pulmonary fibrosis in 2015, and the ATS and ERS updated guidelines for the classification and terminology for idiopathic interstitial pneumonias in 2013. The Lancet Respiratory Medicine published what some consider to be a landmark evaluation of multidisciplinary team agreement on diagnosis of interstitial lung disease following the adoption of these guidelines (Walsh SLF et al. 2016;4[7]:557-65). This study showed that in idiopathic pulmonary fibrosis, multidisciplinary team meetings “have a higher level of agreement on diagnoses, assign diagnoses with higher confidence more frequently, and provide diagnoses that have nonsignificant greater prognostic separation than do clinicians or radiologists in most cases,” the researchers wrote.

In the new study, MDD failed to produce a diagnosis or suggestions about a way forward in only 3.5% of patients, according to the study, which appeared March 30 in CHEST®.

“Several previous studies have demonstrated that MDD improves the accuracy of ILD diagnosis, particularly as compared with the referring physician’s initial diagnosis,” said pulmonologist Danielle Antin-Ozerkis, MD, of Yale University, New Haven, Conn., in an interview. “The current study supports the use of this team approach.”

According to Dr. Antin-Ozerkis, accurate diagnosis of ILD is crucial to treatment, but it can be challenging to achieve. The MDD approach has been recommended since 2002 by the ATS and ERS, she said.

The study authors, led by Laurens J. De Sadeleer, MD, of Belgium’s University Hospitals Leuven, define the MDD approach as one “in which expert ILD clinicians, radiologists, and pathologists integrate all available clinical data, laboratory results, high-resolution computed tomography [HRCT] findings, and lung biopsy [when performed].”

 

For the study, the researchers tracked pre-MDD and MDD diagnoses of 938 consecutive patients with possible ILD who were discussed during 2005-2015. Of these patients, referring physicians made preliminary diagnoses in 49% of cases; in the rest, physicians either failed to develop a diagnosis or offered multiple possible diagnoses.

MDD teams produced a change in diagnosis in 191 – 42% – of patients with a pre-MDD diagnosis. Another condition was diagnosed in 118 of these patients, and the MDD teams declined to classify the other 73 patients pending further investigation.

The MDD teams also were able to produce diagnoses in 80% of cases when referring physicians could not come up with diagnoses.

“Discrepancy between pre-MDD diagnosis before work-up and discussion was remarkable,” the study authors wrote, estimating that MDD added value for 70% of referred patients.

 

“We believe MDD should be a common practice in the diagnosis of every patient with suspected ILD,” the researchers said.

The study doesn’t examine the challenges of putting MDD into practice, but Dr. Antin-Ozerkis provided some perspective. “It may be difficult for physicians to take the time from a busy practice to meet with a multidisciplinary team. It can require resources to gather the data necessary to comprehensively assess each patient case. Additionally, maintaining staff with experienced pulmonologists, radiologists and pathologists may be costly.”

She added that “there are various ways in which MDD may occur,” and that the pros and cons of different methods have not been well studied. “This practice will likely evolve with the development of new biomarkers and other diagnostic strategies in IPF [idiopathic pulmonary fibrosis].”

Still, she said, “this joint undertaking is clearly vital in helping to guide clinical practice, including therapeutic decisions and discussion of prognosis. For now, any discussion between clinician, radiologist, and pathologist is of benefit.”

Research Foundation-Flanders and University Hospitals Leuven funded the study. Some study authors reported various disclosures. Dr. Antin-Ozerkis disclosed serving as an investigator on several clinical trials for IPF and other ILDs by Boehringer, Promedior, Fibrogen and Roche. She noted that payments go directly to the university with no direct payments to the investigator.

SOURCE: De Sadeleer LJ et al. Chest. 2018 Mar 30. doi: 10.1016/j.chest.2018.03.026.

 

New research provides strong statistical support for the use of dynamic multidisciplinary discussion in the diagnosis of patients who may have interstitial lung diseases (ILD).

Multidisciplinary discussion (MDD) provided a diagnosis in 80% of referred cases when referring physicians couldn’t come up with one, and it changed the diagnosis in 41% of the other cases.

The American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association adopted joint guidelines for the treatment of idiopathic pulmonary fibrosis in 2015, and the ATS and ERS updated guidelines for the classification and terminology for idiopathic interstitial pneumonias in 2013. The Lancet Respiratory Medicine published what some consider to be a landmark evaluation of multidisciplinary team agreement on diagnosis of interstitial lung disease following the adoption of these guidelines (Walsh SLF et al. 2016;4[7]:557-65). This study showed that in idiopathic pulmonary fibrosis, multidisciplinary team meetings “have a higher level of agreement on diagnoses, assign diagnoses with higher confidence more frequently, and provide diagnoses that have nonsignificant greater prognostic separation than do clinicians or radiologists in most cases,” the researchers wrote.

In the new study, MDD failed to produce a diagnosis or suggestions about a way forward in only 3.5% of patients, according to the study, which appeared March 30 in CHEST®.

“Several previous studies have demonstrated that MDD improves the accuracy of ILD diagnosis, particularly as compared with the referring physician’s initial diagnosis,” said pulmonologist Danielle Antin-Ozerkis, MD, of Yale University, New Haven, Conn., in an interview. “The current study supports the use of this team approach.”

According to Dr. Antin-Ozerkis, accurate diagnosis of ILD is crucial to treatment, but it can be challenging to achieve. The MDD approach has been recommended since 2002 by the ATS and ERS, she said.

The study authors, led by Laurens J. De Sadeleer, MD, of Belgium’s University Hospitals Leuven, define the MDD approach as one “in which expert ILD clinicians, radiologists, and pathologists integrate all available clinical data, laboratory results, high-resolution computed tomography [HRCT] findings, and lung biopsy [when performed].”

 

For the study, the researchers tracked pre-MDD and MDD diagnoses of 938 consecutive patients with possible ILD who were discussed during 2005-2015. Of these patients, referring physicians made preliminary diagnoses in 49% of cases; in the rest, physicians either failed to develop a diagnosis or offered multiple possible diagnoses.

MDD teams produced a change in diagnosis in 191 – 42% – of patients with a pre-MDD diagnosis. Another condition was diagnosed in 118 of these patients, and the MDD teams declined to classify the other 73 patients pending further investigation.

The MDD teams also were able to produce diagnoses in 80% of cases when referring physicians could not come up with diagnoses.

“Discrepancy between pre-MDD diagnosis before work-up and discussion was remarkable,” the study authors wrote, estimating that MDD added value for 70% of referred patients.

 

“We believe MDD should be a common practice in the diagnosis of every patient with suspected ILD,” the researchers said.

The study doesn’t examine the challenges of putting MDD into practice, but Dr. Antin-Ozerkis provided some perspective. “It may be difficult for physicians to take the time from a busy practice to meet with a multidisciplinary team. It can require resources to gather the data necessary to comprehensively assess each patient case. Additionally, maintaining staff with experienced pulmonologists, radiologists and pathologists may be costly.”

She added that “there are various ways in which MDD may occur,” and that the pros and cons of different methods have not been well studied. “This practice will likely evolve with the development of new biomarkers and other diagnostic strategies in IPF [idiopathic pulmonary fibrosis].”

Still, she said, “this joint undertaking is clearly vital in helping to guide clinical practice, including therapeutic decisions and discussion of prognosis. For now, any discussion between clinician, radiologist, and pathologist is of benefit.”

Research Foundation-Flanders and University Hospitals Leuven funded the study. Some study authors reported various disclosures. Dr. Antin-Ozerkis disclosed serving as an investigator on several clinical trials for IPF and other ILDs by Boehringer, Promedior, Fibrogen and Roche. She noted that payments go directly to the university with no direct payments to the investigator.

SOURCE: De Sadeleer LJ et al. Chest. 2018 Mar 30. doi: 10.1016/j.chest.2018.03.026.

 

Pregnant women are rarely included in clinical drug trials, creating a significant and potentially dangerous gap in knowledge. Now, a new draft guidance from the Food and Drug Administration broadens the discussion about these trials, suggesting issues to consider – including ethics and risks – when testing medications in pregnant women.

“The guidance opens the possibility of ethical conduct of trials in pregnant women but carefully lays out the caveats to be considered,” Christina Chambers, PhD, a perinatal epidemiologist at the University of California, San Diego, said in an interview. “With proper planning and thoughtful consultation with the relevant experts, this change in regulatory limitations will benefit pregnant women and their children.”

As Dr. Chambers noted, “we have very limited pregnancy safety data for most prescription drugs” because of the lack of clinical trials and comprehensive postmarketing studies in this population.

Attitudes have evolved toward more acceptance of including pregnant women in drug trials, according to a 2015 committee opinion from the American College of Obstetricians and Gynecologists. Still, “concerns about the potential for pregnancy in research trial participants have led to practices involving overly burdensome contraception requirements,” the opinion states. “Although changes have been made to encourage and recruit more women into research studies, a gap still exists in the available data on health and disease in women, including those who are pregnant” (Obstet Gynecol 2015;126:e100-7).

[polldaddy:9979976]

The draft guidance, released April 6 by the FDA, is “intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations,” according to posting comments in the Federal Register.

The draft notes that in some cases, the lack of data about drugs may harm pregnant women and their fetuses by leading physicians to be fearful about prescribing medication. Conversely, physicians and pregnant women are often in the dark about the risks and benefits of medications that are prescribed and used, according to the draft.

In terms of research going forward, the guidance says “development of accessible treatment options for the pregnant population is a significant public health issue.”

 

The guidance, which recommends that clinical trial sponsors consider enlisting ethicists to take part in drug development program, offers these guidelines, among others, to drugmakers:

• It is “ethically justifiable” to include pregnant women in clinical trials under specific circumstances. “Sponsors should consider meeting with the appropriate FDA review division early in the development phase to discuss when and how to include pregnant women in the drug development plan. These discussions should involve FDA experts in bioethics and maternal health.”
• “Pregnant women can be enrolled in clinical trials that involve greater than minimal risk to the fetuses if the trials offer the potential for direct clinical benefit to the enrolled pregnant women and/or their fetuses.”
• A new pregnancy during a randomized, blinded clinical trial should prompt unblinding “so that counseling may be offered based on whether the fetus has been exposed to the investigational drug, placebo, or control.”
• The pregnant woman may continue the trial if potential benefits outweigh the risks.
• In general, pregnant women should not be enrolled in phase 1 and phase 2 clinical trials. Instead, those trials should be completed first “in a nonpregnant population that include females of reproductive potential.”
• Several types of events may call for the cessation of a clinical trial that includes pregnant women, such as serious maternal or fetal adverse events.

 

The draft guidance should take note of the fact that birth defects often don’t appear for months or even longer, according to Gerald Briggs, BPharm, FCCP, clinical professor of pharmacy at the University of California, San Francisco. “Until first year of life or later, the babies need to be monitored,” he said in an interview.

Mr. Briggs, who led a 2015 report examining the role of pregnant women in phase 4 clinical drug trials, added that the document should take note of recommendations from clinical teratologists regarding the design of animal studies that should be performed prior to human trials (Am J Obstet Gynecol. 2015;213(6):810-5).

Comments on the draft guidance can be made at www.federalregister.gov and are due by June 8, 2018.

Dr. Chambers and Mr. Briggs reported no relevant disclosures.

 

Pregnant women are rarely included in clinical drug trials, creating a significant and potentially dangerous gap in knowledge. Now, a new draft guidance from the Food and Drug Administration broadens the discussion about these trials, suggesting issues to consider – including ethics and risks – when testing medications in pregnant women.

“The guidance opens the possibility of ethical conduct of trials in pregnant women but carefully lays out the caveats to be considered,” Christina Chambers, PhD, a perinatal epidemiologist at the University of California, San Diego, said in an interview. “With proper planning and thoughtful consultation with the relevant experts, this change in regulatory limitations will benefit pregnant women and their children.”

As Dr. Chambers noted, “we have very limited pregnancy safety data for most prescription drugs” because of the lack of clinical trials and comprehensive postmarketing studies in this population.

Attitudes have evolved toward more acceptance of including pregnant women in drug trials, according to a 2015 committee opinion from the American College of Obstetricians and Gynecologists. Still, “concerns about the potential for pregnancy in research trial participants have led to practices involving overly burdensome contraception requirements,” the opinion states. “Although changes have been made to encourage and recruit more women into research studies, a gap still exists in the available data on health and disease in women, including those who are pregnant” (Obstet Gynecol 2015;126:e100-7).

[polldaddy:9979976]

The draft guidance, released April 6 by the FDA, is “intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations,” according to posting comments in the Federal Register.

The draft notes that in some cases, the lack of data about drugs may harm pregnant women and their fetuses by leading physicians to be fearful about prescribing medication. Conversely, physicians and pregnant women are often in the dark about the risks and benefits of medications that are prescribed and used, according to the draft.

In terms of research going forward, the guidance says “development of accessible treatment options for the pregnant population is a significant public health issue.”

 

The guidance, which recommends that clinical trial sponsors consider enlisting ethicists to take part in drug development program, offers these guidelines, among others, to drugmakers:

• It is “ethically justifiable” to include pregnant women in clinical trials under specific circumstances. “Sponsors should consider meeting with the appropriate FDA review division early in the development phase to discuss when and how to include pregnant women in the drug development plan. These discussions should involve FDA experts in bioethics and maternal health.”
• “Pregnant women can be enrolled in clinical trials that involve greater than minimal risk to the fetuses if the trials offer the potential for direct clinical benefit to the enrolled pregnant women and/or their fetuses.”
• A new pregnancy during a randomized, blinded clinical trial should prompt unblinding “so that counseling may be offered based on whether the fetus has been exposed to the investigational drug, placebo, or control.”
• The pregnant woman may continue the trial if potential benefits outweigh the risks.
• In general, pregnant women should not be enrolled in phase 1 and phase 2 clinical trials. Instead, those trials should be completed first “in a nonpregnant population that include females of reproductive potential.”
• Several types of events may call for the cessation of a clinical trial that includes pregnant women, such as serious maternal or fetal adverse events.

 

The draft guidance should take note of the fact that birth defects often don’t appear for months or even longer, according to Gerald Briggs, BPharm, FCCP, clinical professor of pharmacy at the University of California, San Francisco. “Until first year of life or later, the babies need to be monitored,” he said in an interview.

Mr. Briggs, who led a 2015 report examining the role of pregnant women in phase 4 clinical drug trials, added that the document should take note of recommendations from clinical teratologists regarding the design of animal studies that should be performed prior to human trials (Am J Obstet Gynecol. 2015;213(6):810-5).

Comments on the draft guidance can be made at www.federalregister.gov and are due by June 8, 2018.

Dr. Chambers and Mr. Briggs reported no relevant disclosures.

 

Pregnant women are rarely included in clinical drug trials, creating a significant and potentially dangerous gap in knowledge. Now, a new draft guidance from the Food and Drug Administration broadens the discussion about these trials, suggesting issues to consider – including ethics and risks – when testing medications in pregnant women.

“The guidance opens the possibility of ethical conduct of trials in pregnant women but carefully lays out the caveats to be considered,” Christina Chambers, PhD, a perinatal epidemiologist at the University of California, San Diego, said in an interview. “With proper planning and thoughtful consultation with the relevant experts, this change in regulatory limitations will benefit pregnant women and their children.”

As Dr. Chambers noted, “we have very limited pregnancy safety data for most prescription drugs” because of the lack of clinical trials and comprehensive postmarketing studies in this population.

Attitudes have evolved toward more acceptance of including pregnant women in drug trials, according to a 2015 committee opinion from the American College of Obstetricians and Gynecologists. Still, “concerns about the potential for pregnancy in research trial participants have led to practices involving overly burdensome contraception requirements,” the opinion states. “Although changes have been made to encourage and recruit more women into research studies, a gap still exists in the available data on health and disease in women, including those who are pregnant” (Obstet Gynecol 2015;126:e100-7).

[polldaddy:9979976]

The draft guidance, released April 6 by the FDA, is “intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations,” according to posting comments in the Federal Register.

The draft notes that in some cases, the lack of data about drugs may harm pregnant women and their fetuses by leading physicians to be fearful about prescribing medication. Conversely, physicians and pregnant women are often in the dark about the risks and benefits of medications that are prescribed and used, according to the draft.

In terms of research going forward, the guidance says “development of accessible treatment options for the pregnant population is a significant public health issue.”

 

The guidance, which recommends that clinical trial sponsors consider enlisting ethicists to take part in drug development program, offers these guidelines, among others, to drugmakers:

• It is “ethically justifiable” to include pregnant women in clinical trials under specific circumstances. “Sponsors should consider meeting with the appropriate FDA review division early in the development phase to discuss when and how to include pregnant women in the drug development plan. These discussions should involve FDA experts in bioethics and maternal health.”
• “Pregnant women can be enrolled in clinical trials that involve greater than minimal risk to the fetuses if the trials offer the potential for direct clinical benefit to the enrolled pregnant women and/or their fetuses.”
• A new pregnancy during a randomized, blinded clinical trial should prompt unblinding “so that counseling may be offered based on whether the fetus has been exposed to the investigational drug, placebo, or control.”
• The pregnant woman may continue the trial if potential benefits outweigh the risks.
• In general, pregnant women should not be enrolled in phase 1 and phase 2 clinical trials. Instead, those trials should be completed first “in a nonpregnant population that include females of reproductive potential.”
• Several types of events may call for the cessation of a clinical trial that includes pregnant women, such as serious maternal or fetal adverse events.

 

The draft guidance should take note of the fact that birth defects often don’t appear for months or even longer, according to Gerald Briggs, BPharm, FCCP, clinical professor of pharmacy at the University of California, San Francisco. “Until first year of life or later, the babies need to be monitored,” he said in an interview.

Mr. Briggs, who led a 2015 report examining the role of pregnant women in phase 4 clinical drug trials, added that the document should take note of recommendations from clinical teratologists regarding the design of animal studies that should be performed prior to human trials (Am J Obstet Gynecol. 2015;213(6):810-5).

Comments on the draft guidance can be made at www.federalregister.gov and are due by June 8, 2018.

Dr. Chambers and Mr. Briggs reported no relevant disclosures.