Autologous hematopoietic cell transplantation (AHCT) was linked to improved progression-free survival, but not improved overall survival, in a retrospective cohort study including more than 1,000 mantle cell lymphoma (MCL) patients.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

Use of consolidative AHCT was associated with improved progression-free survival even after the researchers controlled for disease severity in this cohort of younger, transplantation-eligible patients treated in the rituximab era, according to Stefan K. Barta, MD, of the University of Pennsylvania, Philadelphia, and his coinvestigators.

There was no such link between AHCT and improved overall survival in a propensity score–weighted analysis, though certain subgroups did seem to have an overall survival benefit, such as patients with high-risk features, Dr. Barta and his colleagues reported in the Journal of Clinical Oncology.

By contrast, other recent studies have found an association between consolidative AHCT and improved overall survival in MCL, including another recently reported retrospective analysis of 10,000 patients in the National Cancer Database.

The lack of overall survival improvement seen in the present study may be due to effective salvage therapy with novel agents or additional transplantation, abrogating any improvement that otherwise might be attributable to AHCT, Dr. Barta and his coauthors said in a discussion of their results.

The present analysis included 1,029 transplantation-eligible adults aged 65 years or younger with a new diagnosis of MCL, who were treated between 2000 and 2015 at one of 25 medical centers. About two-thirds of the patients underwent consolidative AHCT.

With a median follow-up of 76 months, median progression-free survival was 62 months, and median overall survival was 138 months, the investigators reported.

While AHCT was linked to improved progression-free survival and overall survival in an unadjusted analysis, subsequent analyses showed only a trend toward improvement or no improvement in overall survival.

Specifically, AHCT was associated with improved progression-free survival in multivariable regression analysis, with a hazard ratio (HR) of 0.53 (95% confidence interval, 0.43-0.66; P less than .01) and in propensity score–weighted analysis (HR, 0.70; 95% CI, 0.59-0.84; P less than .05).

By contrast, AHCT was associated with a trend toward improved overall survival in the multivariable analysis (HR, 0.77; 95% CI, 0.98 to 1.01; P = .06) and no improvement in overall survival in the propensity score–weighted analysis (HR, 0.87; 95% CI, 0.69 to 1.10; P = .24).

A subgroup analysis conducted after the multivariable analysis found that overall survival improvements were seen only in patients who received CHOP-like induction or induction without cytarabine, or those who had blastoid or pleomorphic variant or who scored high on the MCL International Prognostic Index.

Randomized trials are “urgently needed” to determine the true benefit of consolidative AHCT in MCL, Dr. Barta and his coauthors said, since some subgroups likely derive minimal benefit from it, including patients with TP53 mutations or those who are minimal residual disease (MRD) negative following induction.

One such study is EA4151, an ongoing randomized, phase 3 clinical trial, which is evaluating consolidation with AHCT followed by maintenance rituximab versus maintenance rituximab alone for MCL patients in MRD-negative first complete remission.

“With this and other well-designed prospective trials as well as with well-validated predictive biomarkers, clinicians will be better able to provide a more refined, risk-adapted approach to first-line management of MCL,” the investigators said.

Dr. Barta provided no disclosures related to the research. Coauthors had disclosures related to Sanofi, AstraZeneca, Celgene, Adaptive Biotechnologies, Janssen Oncology, Seattle Genetics, Genentech, Pharmacyclics, Merck, Bristol-Myers Squibb, and others.

SOURCE: Gerson JN et al. J Clin Oncol. 2019 Jan 7. doi: 10.1200/JCO.18.00690.

Autologous hematopoietic cell transplantation (AHCT) was linked to improved progression-free survival, but not improved overall survival, in a retrospective cohort study including more than 1,000 mantle cell lymphoma (MCL) patients.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

Use of consolidative AHCT was associated with improved progression-free survival even after the researchers controlled for disease severity in this cohort of younger, transplantation-eligible patients treated in the rituximab era, according to Stefan K. Barta, MD, of the University of Pennsylvania, Philadelphia, and his coinvestigators.

There was no such link between AHCT and improved overall survival in a propensity score–weighted analysis, though certain subgroups did seem to have an overall survival benefit, such as patients with high-risk features, Dr. Barta and his colleagues reported in the Journal of Clinical Oncology.

By contrast, other recent studies have found an association between consolidative AHCT and improved overall survival in MCL, including another recently reported retrospective analysis of 10,000 patients in the National Cancer Database.

The lack of overall survival improvement seen in the present study may be due to effective salvage therapy with novel agents or additional transplantation, abrogating any improvement that otherwise might be attributable to AHCT, Dr. Barta and his coauthors said in a discussion of their results.

The present analysis included 1,029 transplantation-eligible adults aged 65 years or younger with a new diagnosis of MCL, who were treated between 2000 and 2015 at one of 25 medical centers. About two-thirds of the patients underwent consolidative AHCT.

With a median follow-up of 76 months, median progression-free survival was 62 months, and median overall survival was 138 months, the investigators reported.

While AHCT was linked to improved progression-free survival and overall survival in an unadjusted analysis, subsequent analyses showed only a trend toward improvement or no improvement in overall survival.

Specifically, AHCT was associated with improved progression-free survival in multivariable regression analysis, with a hazard ratio (HR) of 0.53 (95% confidence interval, 0.43-0.66; P less than .01) and in propensity score–weighted analysis (HR, 0.70; 95% CI, 0.59-0.84; P less than .05).

By contrast, AHCT was associated with a trend toward improved overall survival in the multivariable analysis (HR, 0.77; 95% CI, 0.98 to 1.01; P = .06) and no improvement in overall survival in the propensity score–weighted analysis (HR, 0.87; 95% CI, 0.69 to 1.10; P = .24).

A subgroup analysis conducted after the multivariable analysis found that overall survival improvements were seen only in patients who received CHOP-like induction or induction without cytarabine, or those who had blastoid or pleomorphic variant or who scored high on the MCL International Prognostic Index.

Randomized trials are “urgently needed” to determine the true benefit of consolidative AHCT in MCL, Dr. Barta and his coauthors said, since some subgroups likely derive minimal benefit from it, including patients with TP53 mutations or those who are minimal residual disease (MRD) negative following induction.

One such study is EA4151, an ongoing randomized, phase 3 clinical trial, which is evaluating consolidation with AHCT followed by maintenance rituximab versus maintenance rituximab alone for MCL patients in MRD-negative first complete remission.

“With this and other well-designed prospective trials as well as with well-validated predictive biomarkers, clinicians will be better able to provide a more refined, risk-adapted approach to first-line management of MCL,” the investigators said.

Dr. Barta provided no disclosures related to the research. Coauthors had disclosures related to Sanofi, AstraZeneca, Celgene, Adaptive Biotechnologies, Janssen Oncology, Seattle Genetics, Genentech, Pharmacyclics, Merck, Bristol-Myers Squibb, and others.

SOURCE: Gerson JN et al. J Clin Oncol. 2019 Jan 7. doi: 10.1200/JCO.18.00690.

Autologous hematopoietic cell transplantation (AHCT) was linked to improved progression-free survival, but not improved overall survival, in a retrospective cohort study including more than 1,000 mantle cell lymphoma (MCL) patients.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

Use of consolidative AHCT was associated with improved progression-free survival even after the researchers controlled for disease severity in this cohort of younger, transplantation-eligible patients treated in the rituximab era, according to Stefan K. Barta, MD, of the University of Pennsylvania, Philadelphia, and his coinvestigators.

There was no such link between AHCT and improved overall survival in a propensity score–weighted analysis, though certain subgroups did seem to have an overall survival benefit, such as patients with high-risk features, Dr. Barta and his colleagues reported in the Journal of Clinical Oncology.

By contrast, other recent studies have found an association between consolidative AHCT and improved overall survival in MCL, including another recently reported retrospective analysis of 10,000 patients in the National Cancer Database.

The lack of overall survival improvement seen in the present study may be due to effective salvage therapy with novel agents or additional transplantation, abrogating any improvement that otherwise might be attributable to AHCT, Dr. Barta and his coauthors said in a discussion of their results.

The present analysis included 1,029 transplantation-eligible adults aged 65 years or younger with a new diagnosis of MCL, who were treated between 2000 and 2015 at one of 25 medical centers. About two-thirds of the patients underwent consolidative AHCT.

With a median follow-up of 76 months, median progression-free survival was 62 months, and median overall survival was 138 months, the investigators reported.

While AHCT was linked to improved progression-free survival and overall survival in an unadjusted analysis, subsequent analyses showed only a trend toward improvement or no improvement in overall survival.

Specifically, AHCT was associated with improved progression-free survival in multivariable regression analysis, with a hazard ratio (HR) of 0.53 (95% confidence interval, 0.43-0.66; P less than .01) and in propensity score–weighted analysis (HR, 0.70; 95% CI, 0.59-0.84; P less than .05).

By contrast, AHCT was associated with a trend toward improved overall survival in the multivariable analysis (HR, 0.77; 95% CI, 0.98 to 1.01; P = .06) and no improvement in overall survival in the propensity score–weighted analysis (HR, 0.87; 95% CI, 0.69 to 1.10; P = .24).

A subgroup analysis conducted after the multivariable analysis found that overall survival improvements were seen only in patients who received CHOP-like induction or induction without cytarabine, or those who had blastoid or pleomorphic variant or who scored high on the MCL International Prognostic Index.

Randomized trials are “urgently needed” to determine the true benefit of consolidative AHCT in MCL, Dr. Barta and his coauthors said, since some subgroups likely derive minimal benefit from it, including patients with TP53 mutations or those who are minimal residual disease (MRD) negative following induction.

One such study is EA4151, an ongoing randomized, phase 3 clinical trial, which is evaluating consolidation with AHCT followed by maintenance rituximab versus maintenance rituximab alone for MCL patients in MRD-negative first complete remission.

“With this and other well-designed prospective trials as well as with well-validated predictive biomarkers, clinicians will be better able to provide a more refined, risk-adapted approach to first-line management of MCL,” the investigators said.

Dr. Barta provided no disclosures related to the research. Coauthors had disclosures related to Sanofi, AstraZeneca, Celgene, Adaptive Biotechnologies, Janssen Oncology, Seattle Genetics, Genentech, Pharmacyclics, Merck, Bristol-Myers Squibb, and others.

SOURCE: Gerson JN et al. J Clin Oncol. 2019 Jan 7. doi: 10.1200/JCO.18.00690.

As winter settles in for most of the United States, there are some people who do not have access to adequate shelter from the cold. Currently, there are an estimated 700,000 homeless youth in the United States, which is roughly 1 out of 30 youth.¹Among homeless youth, a disproportionate number of these youth identify as lesbian, gay, bisexual, or transgender (LGBT). The reasons for these disparities are complex, although stigma and discrimination are major factors. Despite the major challenges faced by this population, medical providers can play a role in addressing homelessness among LGBT youth.

bodnarchuk/Getty Images

According to the Department of Education, homeless youth are defined as youth “who lack a fixed, regular, and adequate nighttime residence.”² Although the image of a person sleeping on a bench at a park covered with newspapers comes to mind, it may not be obvious that a youth may be homeless. Sometimes, youth may be sleeping in their cars at night and others may be staying the night at one house and then staying the next night at another house (known as “couch surfing”). Many will be utilizing homeless shelters to sleep in.

Homelessness among LGBT youth is a major problem in the United States. Although LGB (sexual minority) people comprise 2%-7% of the population,³ about one-third of homeless youth identify as LGB or questioning. Additionally, about 4% of homeless youth identify as transgender, compared with 1% of the general youth population in the United States. LGBT youth are at a higher risk for homelessness than are cisgender (gender identity matches with the assigned sex at birth), heterosexual youth. There are even disparities within LGBT youth.

Why are LGBT youth at high risk for homelessness? The most common reason is family rejection of their sexual orientation and/or gender identity.⁴ Some are directly kicked out by their families. Whereas others leave because relationships with their families have become so strained after the child has come out that the environment is no longer tolerable to live in. However, poverty and race may play a significant role in this phenomenon. There is a misperception that families of color are more homophobic or transphobic (disliking or having a prejudice against transsexual or transgender people) than white families because there is a higher proportion of LGBT homeless youth of color. However, what most likely increases the likelihood of family rejection is the strain of poverty, which people of color are more likely to experience. Chronic unemployment or unstable housing makes it very difficult for families to utilize the important skills to accept and support their LGBT child. Whenever a child comes out to their parents, it is a stressful event for the family. Family with stable physical resources (decent income, stable housing) also are more likely to have psychological resources (family cohesiveness, open communication, good parent-child relationships) to manage these types of stress. However, for those with unstable resources, they are unable to tap into their psychological resources to handle the stress of a child coming out to them.⁵ As a result, they resort to rejection. Many parents believe that rejecting their child’s sexual orientation or gender identity will protect them from stigma and discrimination, and they do not realize that rejection can harm their child.^6,7

There are other reasons LGBT youth become homeless. One is untreated mental illness and substance use, mostly likely a result from experiencing stigma and discrimination. Another is that some age out of the foster care system.⁴ Finally, some LGBT youth run away from home because of abuse from their parents, and unfortunately, LGBT youth are more likely to experience abuse from a parent than are heterosexual, cisgender youth.⁸

Furthermore, although there are homeless shelters for youth, many LGBT youth avoid going to homeless shelters out of fear for their own safety. Many homeless shelters are ill equipped to work with LGBT youth, especially in managing other homeless youth who may harass or assault another youth on the basis of their sexual orientation or gender identity.⁴ Additionally, many homeless shelters arrangements are gendered, making it difficult for transgender youth to find a shelter as they may be forced to live with people of their assigned sex of birth, putting them at an increased risk for harassment and violence.⁹

Despite the many challenges faced by homeless LGBT youth, medical providers can play a role in promoting their health and well-being. Screening for homelessness can create opportunities for medical providers to offer resources for immediate needs. Three good questions are: “During the last 12 months, was there a time when you were not able to pay the mortgage or rent on time?” “In the past 12 months, how many places [have you] lived?” and “What type of housing do you currently live in?”¹⁰ Resources for such youth would include the National Coalition for the Homeless, which contains a list of homeless shelters that are equipped to address the needs of LGBT homeless youth.

Medical providers must address some of the root causes of homelessness among LGBT youth. One of them is family rejection. Medical providers can counsel parents of LGBT youth in the importance of family support in protecting their LGBT child from adverse health outcomes. One good resource is the Family Acceptance Project, which teaches parents skills to support their LGBT child. Additionally, medical providers can work with homeless shelters and help them develop best practices for working with LGBT youth. A good place to start is Lambda Legal’s National Recommended Best Practices for Serving LGBT Homeless Youth.

Educating both families and homeless shelters are key in both preventing homelessness and mitigating the effects of homelessness on the health of LGBT youth.

Dr. Montano is assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].

References

1. “Missed opportunities: Youth homelessness in America,” Chapin Hall at the University of Chicago, 2017. voicesofyouthcount.org.

2. Homelessness & Runaway Youth. Federal Definitions. youth.gov.

3. MMWR Surveill Summ. 2016. doi: 10.15585/mmwr.ss6509a1.

4. “Serving Our Youth 2015: The Needs and Experiences of Lesbian, Gay, Bisexual, Transgender and Questioning Youth Experiencing Homelesness,” The Williams Institute with True Colors Fund, June 2015.

5. Sex Roles. 2013 Jun;68(11-12):690-702.

6. “Supportive families, healthy children: Helping families with lesbian, gay, bisexual & transgender children,” Family Acceptance Project, San Francisco State University, 2009.

7. Pediatrics. 2009 Jan. doi: 10.1542/peds.2007-3524.

8. Am J Public Health. 2011. doi: 10.2105/AJPH.2009.190009.

9. Am J Orthopsychiatry. 2014. doi: 10.1037/h0098852.

10. Pediatrics. 2018. doi: 10.1542/peds.2017-2199.

As winter settles in for most of the United States, there are some people who do not have access to adequate shelter from the cold. Currently, there are an estimated 700,000 homeless youth in the United States, which is roughly 1 out of 30 youth.¹Among homeless youth, a disproportionate number of these youth identify as lesbian, gay, bisexual, or transgender (LGBT). The reasons for these disparities are complex, although stigma and discrimination are major factors. Despite the major challenges faced by this population, medical providers can play a role in addressing homelessness among LGBT youth.

bodnarchuk/Getty Images

According to the Department of Education, homeless youth are defined as youth “who lack a fixed, regular, and adequate nighttime residence.”² Although the image of a person sleeping on a bench at a park covered with newspapers comes to mind, it may not be obvious that a youth may be homeless. Sometimes, youth may be sleeping in their cars at night and others may be staying the night at one house and then staying the next night at another house (known as “couch surfing”). Many will be utilizing homeless shelters to sleep in.

Homelessness among LGBT youth is a major problem in the United States. Although LGB (sexual minority) people comprise 2%-7% of the population,³ about one-third of homeless youth identify as LGB or questioning. Additionally, about 4% of homeless youth identify as transgender, compared with 1% of the general youth population in the United States. LGBT youth are at a higher risk for homelessness than are cisgender (gender identity matches with the assigned sex at birth), heterosexual youth. There are even disparities within LGBT youth.

Why are LGBT youth at high risk for homelessness? The most common reason is family rejection of their sexual orientation and/or gender identity.⁴ Some are directly kicked out by their families. Whereas others leave because relationships with their families have become so strained after the child has come out that the environment is no longer tolerable to live in. However, poverty and race may play a significant role in this phenomenon. There is a misperception that families of color are more homophobic or transphobic (disliking or having a prejudice against transsexual or transgender people) than white families because there is a higher proportion of LGBT homeless youth of color. However, what most likely increases the likelihood of family rejection is the strain of poverty, which people of color are more likely to experience. Chronic unemployment or unstable housing makes it very difficult for families to utilize the important skills to accept and support their LGBT child. Whenever a child comes out to their parents, it is a stressful event for the family. Family with stable physical resources (decent income, stable housing) also are more likely to have psychological resources (family cohesiveness, open communication, good parent-child relationships) to manage these types of stress. However, for those with unstable resources, they are unable to tap into their psychological resources to handle the stress of a child coming out to them.⁵ As a result, they resort to rejection. Many parents believe that rejecting their child’s sexual orientation or gender identity will protect them from stigma and discrimination, and they do not realize that rejection can harm their child.^6,7

There are other reasons LGBT youth become homeless. One is untreated mental illness and substance use, mostly likely a result from experiencing stigma and discrimination. Another is that some age out of the foster care system.⁴ Finally, some LGBT youth run away from home because of abuse from their parents, and unfortunately, LGBT youth are more likely to experience abuse from a parent than are heterosexual, cisgender youth.⁸

Furthermore, although there are homeless shelters for youth, many LGBT youth avoid going to homeless shelters out of fear for their own safety. Many homeless shelters are ill equipped to work with LGBT youth, especially in managing other homeless youth who may harass or assault another youth on the basis of their sexual orientation or gender identity.⁴ Additionally, many homeless shelters arrangements are gendered, making it difficult for transgender youth to find a shelter as they may be forced to live with people of their assigned sex of birth, putting them at an increased risk for harassment and violence.⁹

Despite the many challenges faced by homeless LGBT youth, medical providers can play a role in promoting their health and well-being. Screening for homelessness can create opportunities for medical providers to offer resources for immediate needs. Three good questions are: “During the last 12 months, was there a time when you were not able to pay the mortgage or rent on time?” “In the past 12 months, how many places [have you] lived?” and “What type of housing do you currently live in?”¹⁰ Resources for such youth would include the National Coalition for the Homeless, which contains a list of homeless shelters that are equipped to address the needs of LGBT homeless youth.

Medical providers must address some of the root causes of homelessness among LGBT youth. One of them is family rejection. Medical providers can counsel parents of LGBT youth in the importance of family support in protecting their LGBT child from adverse health outcomes. One good resource is the Family Acceptance Project, which teaches parents skills to support their LGBT child. Additionally, medical providers can work with homeless shelters and help them develop best practices for working with LGBT youth. A good place to start is Lambda Legal’s National Recommended Best Practices for Serving LGBT Homeless Youth.

Educating both families and homeless shelters are key in both preventing homelessness and mitigating the effects of homelessness on the health of LGBT youth.

Dr. Montano is assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].

References

1. “Missed opportunities: Youth homelessness in America,” Chapin Hall at the University of Chicago, 2017. voicesofyouthcount.org.

2. Homelessness & Runaway Youth. Federal Definitions. youth.gov.

3. MMWR Surveill Summ. 2016. doi: 10.15585/mmwr.ss6509a1.

4. “Serving Our Youth 2015: The Needs and Experiences of Lesbian, Gay, Bisexual, Transgender and Questioning Youth Experiencing Homelesness,” The Williams Institute with True Colors Fund, June 2015.

5. Sex Roles. 2013 Jun;68(11-12):690-702.

6. “Supportive families, healthy children: Helping families with lesbian, gay, bisexual & transgender children,” Family Acceptance Project, San Francisco State University, 2009.

7. Pediatrics. 2009 Jan. doi: 10.1542/peds.2007-3524.

8. Am J Public Health. 2011. doi: 10.2105/AJPH.2009.190009.

9. Am J Orthopsychiatry. 2014. doi: 10.1037/h0098852.

10. Pediatrics. 2018. doi: 10.1542/peds.2017-2199.

As winter settles in for most of the United States, there are some people who do not have access to adequate shelter from the cold. Currently, there are an estimated 700,000 homeless youth in the United States, which is roughly 1 out of 30 youth.¹Among homeless youth, a disproportionate number of these youth identify as lesbian, gay, bisexual, or transgender (LGBT). The reasons for these disparities are complex, although stigma and discrimination are major factors. Despite the major challenges faced by this population, medical providers can play a role in addressing homelessness among LGBT youth.

bodnarchuk/Getty Images

According to the Department of Education, homeless youth are defined as youth “who lack a fixed, regular, and adequate nighttime residence.”² Although the image of a person sleeping on a bench at a park covered with newspapers comes to mind, it may not be obvious that a youth may be homeless. Sometimes, youth may be sleeping in their cars at night and others may be staying the night at one house and then staying the next night at another house (known as “couch surfing”). Many will be utilizing homeless shelters to sleep in.

Homelessness among LGBT youth is a major problem in the United States. Although LGB (sexual minority) people comprise 2%-7% of the population,³ about one-third of homeless youth identify as LGB or questioning. Additionally, about 4% of homeless youth identify as transgender, compared with 1% of the general youth population in the United States. LGBT youth are at a higher risk for homelessness than are cisgender (gender identity matches with the assigned sex at birth), heterosexual youth. There are even disparities within LGBT youth.

Why are LGBT youth at high risk for homelessness? The most common reason is family rejection of their sexual orientation and/or gender identity.⁴ Some are directly kicked out by their families. Whereas others leave because relationships with their families have become so strained after the child has come out that the environment is no longer tolerable to live in. However, poverty and race may play a significant role in this phenomenon. There is a misperception that families of color are more homophobic or transphobic (disliking or having a prejudice against transsexual or transgender people) than white families because there is a higher proportion of LGBT homeless youth of color. However, what most likely increases the likelihood of family rejection is the strain of poverty, which people of color are more likely to experience. Chronic unemployment or unstable housing makes it very difficult for families to utilize the important skills to accept and support their LGBT child. Whenever a child comes out to their parents, it is a stressful event for the family. Family with stable physical resources (decent income, stable housing) also are more likely to have psychological resources (family cohesiveness, open communication, good parent-child relationships) to manage these types of stress. However, for those with unstable resources, they are unable to tap into their psychological resources to handle the stress of a child coming out to them.⁵ As a result, they resort to rejection. Many parents believe that rejecting their child’s sexual orientation or gender identity will protect them from stigma and discrimination, and they do not realize that rejection can harm their child.^6,7

There are other reasons LGBT youth become homeless. One is untreated mental illness and substance use, mostly likely a result from experiencing stigma and discrimination. Another is that some age out of the foster care system.⁴ Finally, some LGBT youth run away from home because of abuse from their parents, and unfortunately, LGBT youth are more likely to experience abuse from a parent than are heterosexual, cisgender youth.⁸

Furthermore, although there are homeless shelters for youth, many LGBT youth avoid going to homeless shelters out of fear for their own safety. Many homeless shelters are ill equipped to work with LGBT youth, especially in managing other homeless youth who may harass or assault another youth on the basis of their sexual orientation or gender identity.⁴ Additionally, many homeless shelters arrangements are gendered, making it difficult for transgender youth to find a shelter as they may be forced to live with people of their assigned sex of birth, putting them at an increased risk for harassment and violence.⁹

Despite the many challenges faced by homeless LGBT youth, medical providers can play a role in promoting their health and well-being. Screening for homelessness can create opportunities for medical providers to offer resources for immediate needs. Three good questions are: “During the last 12 months, was there a time when you were not able to pay the mortgage or rent on time?” “In the past 12 months, how many places [have you] lived?” and “What type of housing do you currently live in?”¹⁰ Resources for such youth would include the National Coalition for the Homeless, which contains a list of homeless shelters that are equipped to address the needs of LGBT homeless youth.

Medical providers must address some of the root causes of homelessness among LGBT youth. One of them is family rejection. Medical providers can counsel parents of LGBT youth in the importance of family support in protecting their LGBT child from adverse health outcomes. One good resource is the Family Acceptance Project, which teaches parents skills to support their LGBT child. Additionally, medical providers can work with homeless shelters and help them develop best practices for working with LGBT youth. A good place to start is Lambda Legal’s National Recommended Best Practices for Serving LGBT Homeless Youth.

Educating both families and homeless shelters are key in both preventing homelessness and mitigating the effects of homelessness on the health of LGBT youth.

Dr. Montano is assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].

References

1. “Missed opportunities: Youth homelessness in America,” Chapin Hall at the University of Chicago, 2017. voicesofyouthcount.org.

2. Homelessness & Runaway Youth. Federal Definitions. youth.gov.

3. MMWR Surveill Summ. 2016. doi: 10.15585/mmwr.ss6509a1.

4. “Serving Our Youth 2015: The Needs and Experiences of Lesbian, Gay, Bisexual, Transgender and Questioning Youth Experiencing Homelesness,” The Williams Institute with True Colors Fund, June 2015.

5. Sex Roles. 2013 Jun;68(11-12):690-702.

6. “Supportive families, healthy children: Helping families with lesbian, gay, bisexual & transgender children,” Family Acceptance Project, San Francisco State University, 2009.

7. Pediatrics. 2009 Jan. doi: 10.1542/peds.2007-3524.

8. Am J Public Health. 2011. doi: 10.2105/AJPH.2009.190009.

9. Am J Orthopsychiatry. 2014. doi: 10.1037/h0098852.

10. Pediatrics. 2018. doi: 10.1542/peds.2017-2199.

SAN DIEGO – Investigational SPK-8011 gene transfer results in safe, durable, dose-dependent Factor VIII (FVIII) expression in patients with severe or moderately severe hemophilia A, according to preliminary findings from an ongoing phase 1/2 study.

An overall reduction of 97% was seen in both the annualized bleeding rate (ABR) and annualized infusion rate (AIR) in the first 12 patients treated with SPK-8011, which is a Spark Therapeutics product that consists of a bioengineered AAV capsid expressing B domain-deleted FVIII under the control of a liver-specific promoter, principal investigator Lindsey A. George, MD, reported at the annual meeting of the American Society of Hematology.

Study subjects were men aged 18-52 years, including 11 with severe disease and 1 with moderately severe disease, who received a single infusion of either 5E11 vg/kg (2 patients), 1E12 vg/kg (3 patients), or 2E12 vg/kg (7 patients).

“All vector doses led to expression of FVIII levels adequate to prevent bleeding and allow cessation of prophylaxis,” said Dr. George, associate professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and an attending physician in the division of hematology at Children’s Hospital of Philadelphia.

In the two men in the 5E11 dose cohort, mean FVIII levels beginning 12 weeks after infusion were 13%, and neither experienced bleeding events, had elevated transaminase levels, or required steroids, she said, noting that FVIII expression remained stable for at least 66 weeks (and up to 78 weeks in one patient).

The three men in the 1E12 dose cohort had mean FVIII levels of 15% beginning at 12 weeks post infusion, and the levels were stable for at least 46 weeks.

The first patient was infused with a single dose of factor concentrate for a spontaneous joint bleed at day 159, and the second patient received multiple infusions for a traumatic bleed beginning at day 195. Both received a successful course of tapering steroids, at 12 and 7 weeks after infusion, respectively, for declining FVIII levels, Dr. George said.

The third subject had no bleeding and did not receive factor infusions or steroids, she added.

In the highest dose cohort (2E12), five of seven subjects had FVIII levels between 16% and 49%.

Steroids were required and given between 6 and 11 weeks after infusion in five of the seven patients in that cohort for either declining FVIII levels, a rise in alanine aminotransferase (ALT) above baseline, or elevated IFN-g ELISPOTs to AAV capsid. The steroids normalized ALT levels and extinguished the ELISPOT signal in all cases.

In two patients, FVIII levels showed limited stabilization, and fell to less than 6%. This was most likely due to the immune response, Dr. George explained, noting that in one of the two patients no bleeds were reported through 12 weeks of follow-up, while the other experienced four bleeds through 37 weeks of observation.

SPK-8011 was well tolerated in this study, which had cumulative follow-up of 506 weeks at the time of Dr. George’s presentation. No inhibitor formation was noted in the safety analysis and the only serious adverse event – the immune response to AAV capsid – has resolved, she said.

Data from the lowest dose cohort (5E11) are consistent with published natural history data indicating FVIII:C 12% is adequate to prevent spontaneous bleeding events, she said. However, she noted that the loss of some FVIII expression in two patients in the 2E12 dose cohort (which eventually stabilized on steroids), and the fact that five of seven subjects in this cohort required steroids, suggests a possible role for prophylactic steroid administration in patients treated with SPK-8011.

“Gene transfer for hemophilia A offers the potential for a one-time disease-altering treatment that eliminates bleed risk and could free patients from the burden of lifelong chronic therapy,” Dr. George said.

A phase 3 run-in study is planned, she added.

Spark Therapeutics sponsored the study. Dr. George reported equity ownership related to the University of Pennsylvania and consultancy for Pfizer.

[email protected]

SOURCE: High K et al., ASH 2018, Abstract 487.

SAN DIEGO – Investigational SPK-8011 gene transfer results in safe, durable, dose-dependent Factor VIII (FVIII) expression in patients with severe or moderately severe hemophilia A, according to preliminary findings from an ongoing phase 1/2 study.

An overall reduction of 97% was seen in both the annualized bleeding rate (ABR) and annualized infusion rate (AIR) in the first 12 patients treated with SPK-8011, which is a Spark Therapeutics product that consists of a bioengineered AAV capsid expressing B domain-deleted FVIII under the control of a liver-specific promoter, principal investigator Lindsey A. George, MD, reported at the annual meeting of the American Society of Hematology.

Study subjects were men aged 18-52 years, including 11 with severe disease and 1 with moderately severe disease, who received a single infusion of either 5E11 vg/kg (2 patients), 1E12 vg/kg (3 patients), or 2E12 vg/kg (7 patients).

“All vector doses led to expression of FVIII levels adequate to prevent bleeding and allow cessation of prophylaxis,” said Dr. George, associate professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and an attending physician in the division of hematology at Children’s Hospital of Philadelphia.

In the two men in the 5E11 dose cohort, mean FVIII levels beginning 12 weeks after infusion were 13%, and neither experienced bleeding events, had elevated transaminase levels, or required steroids, she said, noting that FVIII expression remained stable for at least 66 weeks (and up to 78 weeks in one patient).

The three men in the 1E12 dose cohort had mean FVIII levels of 15% beginning at 12 weeks post infusion, and the levels were stable for at least 46 weeks.

The first patient was infused with a single dose of factor concentrate for a spontaneous joint bleed at day 159, and the second patient received multiple infusions for a traumatic bleed beginning at day 195. Both received a successful course of tapering steroids, at 12 and 7 weeks after infusion, respectively, for declining FVIII levels, Dr. George said.

The third subject had no bleeding and did not receive factor infusions or steroids, she added.

In the highest dose cohort (2E12), five of seven subjects had FVIII levels between 16% and 49%.

Steroids were required and given between 6 and 11 weeks after infusion in five of the seven patients in that cohort for either declining FVIII levels, a rise in alanine aminotransferase (ALT) above baseline, or elevated IFN-g ELISPOTs to AAV capsid. The steroids normalized ALT levels and extinguished the ELISPOT signal in all cases.

In two patients, FVIII levels showed limited stabilization, and fell to less than 6%. This was most likely due to the immune response, Dr. George explained, noting that in one of the two patients no bleeds were reported through 12 weeks of follow-up, while the other experienced four bleeds through 37 weeks of observation.

SPK-8011 was well tolerated in this study, which had cumulative follow-up of 506 weeks at the time of Dr. George’s presentation. No inhibitor formation was noted in the safety analysis and the only serious adverse event – the immune response to AAV capsid – has resolved, she said.

Data from the lowest dose cohort (5E11) are consistent with published natural history data indicating FVIII:C 12% is adequate to prevent spontaneous bleeding events, she said. However, she noted that the loss of some FVIII expression in two patients in the 2E12 dose cohort (which eventually stabilized on steroids), and the fact that five of seven subjects in this cohort required steroids, suggests a possible role for prophylactic steroid administration in patients treated with SPK-8011.

“Gene transfer for hemophilia A offers the potential for a one-time disease-altering treatment that eliminates bleed risk and could free patients from the burden of lifelong chronic therapy,” Dr. George said.

A phase 3 run-in study is planned, she added.

Spark Therapeutics sponsored the study. Dr. George reported equity ownership related to the University of Pennsylvania and consultancy for Pfizer.

[email protected]

SOURCE: High K et al., ASH 2018, Abstract 487.

SAN DIEGO – Investigational SPK-8011 gene transfer results in safe, durable, dose-dependent Factor VIII (FVIII) expression in patients with severe or moderately severe hemophilia A, according to preliminary findings from an ongoing phase 1/2 study.

An overall reduction of 97% was seen in both the annualized bleeding rate (ABR) and annualized infusion rate (AIR) in the first 12 patients treated with SPK-8011, which is a Spark Therapeutics product that consists of a bioengineered AAV capsid expressing B domain-deleted FVIII under the control of a liver-specific promoter, principal investigator Lindsey A. George, MD, reported at the annual meeting of the American Society of Hematology.

Study subjects were men aged 18-52 years, including 11 with severe disease and 1 with moderately severe disease, who received a single infusion of either 5E11 vg/kg (2 patients), 1E12 vg/kg (3 patients), or 2E12 vg/kg (7 patients).

“All vector doses led to expression of FVIII levels adequate to prevent bleeding and allow cessation of prophylaxis,” said Dr. George, associate professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and an attending physician in the division of hematology at Children’s Hospital of Philadelphia.

In the two men in the 5E11 dose cohort, mean FVIII levels beginning 12 weeks after infusion were 13%, and neither experienced bleeding events, had elevated transaminase levels, or required steroids, she said, noting that FVIII expression remained stable for at least 66 weeks (and up to 78 weeks in one patient).

The three men in the 1E12 dose cohort had mean FVIII levels of 15% beginning at 12 weeks post infusion, and the levels were stable for at least 46 weeks.

The first patient was infused with a single dose of factor concentrate for a spontaneous joint bleed at day 159, and the second patient received multiple infusions for a traumatic bleed beginning at day 195. Both received a successful course of tapering steroids, at 12 and 7 weeks after infusion, respectively, for declining FVIII levels, Dr. George said.

The third subject had no bleeding and did not receive factor infusions or steroids, she added.

In the highest dose cohort (2E12), five of seven subjects had FVIII levels between 16% and 49%.

Steroids were required and given between 6 and 11 weeks after infusion in five of the seven patients in that cohort for either declining FVIII levels, a rise in alanine aminotransferase (ALT) above baseline, or elevated IFN-g ELISPOTs to AAV capsid. The steroids normalized ALT levels and extinguished the ELISPOT signal in all cases.

In two patients, FVIII levels showed limited stabilization, and fell to less than 6%. This was most likely due to the immune response, Dr. George explained, noting that in one of the two patients no bleeds were reported through 12 weeks of follow-up, while the other experienced four bleeds through 37 weeks of observation.

SPK-8011 was well tolerated in this study, which had cumulative follow-up of 506 weeks at the time of Dr. George’s presentation. No inhibitor formation was noted in the safety analysis and the only serious adverse event – the immune response to AAV capsid – has resolved, she said.

Data from the lowest dose cohort (5E11) are consistent with published natural history data indicating FVIII:C 12% is adequate to prevent spontaneous bleeding events, she said. However, she noted that the loss of some FVIII expression in two patients in the 2E12 dose cohort (which eventually stabilized on steroids), and the fact that five of seven subjects in this cohort required steroids, suggests a possible role for prophylactic steroid administration in patients treated with SPK-8011.

“Gene transfer for hemophilia A offers the potential for a one-time disease-altering treatment that eliminates bleed risk and could free patients from the burden of lifelong chronic therapy,” Dr. George said.

A phase 3 run-in study is planned, she added.

Spark Therapeutics sponsored the study. Dr. George reported equity ownership related to the University of Pennsylvania and consultancy for Pfizer.

[email protected]

SOURCE: High K et al., ASH 2018, Abstract 487.

The Food and Drug Administration has granted breakthrough therapy designation to zanubrutinib as a treatment for adults with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Zanubrutinib (BGB-3111) is a Bruton’s tyrosine kinase inhibitor being developed by BeiGene as a potential treatment for B-cell malignancies.

Researchers have evaluated zanubrutinib in a phase 2 trial (NCT03206970) of patients with relapsed/refractory MCL. Results from this trial were presented at the 2018 annual meeting of the American Society of Hematology (Abstract 148).

As of March 27, 2018, 86 patients had been enrolled in the trial and received treatment. They had a median of two prior lines of therapy and they received zanubrutinib at 160 mg twice daily.

Eighty-five patients were evaluable for efficacy. The overall response rate was 83.5% (71/85), and the complete response rate was 58.8% (50/85). At a median follow-up of 24.1 weeks, the median duration of response and median progression-free survival had not been reached. The estimated 24-week progression-free survival rate was 82%. The most common adverse events (AEs) in this trial were decrease in neutrophil count (31.4%), rash (29.1%), upper respiratory tract infection (29.1%), and decrease in platelet count (22.1%). Common grade 3 or higher AEs included neutrophil count decrease (11.6%) and lung infection (5.8%).

Four patients had fatal treatment-emergent AEs. One death was caused by a traffic accident, one was due to cerebral hemorrhage, and one resulted from pneumonia. The fourth death occurred in a patient with infection, but the cause of death was unknown.

Breakthrough therapy designation is designed to expedite the development and review of a therapy for a serious or life-threatening disease, following preliminary clinical evidence indicating it demonstrates substantial improvement over existing therapies.

[email protected]

The Food and Drug Administration has granted breakthrough therapy designation to zanubrutinib as a treatment for adults with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Zanubrutinib (BGB-3111) is a Bruton’s tyrosine kinase inhibitor being developed by BeiGene as a potential treatment for B-cell malignancies.

Researchers have evaluated zanubrutinib in a phase 2 trial (NCT03206970) of patients with relapsed/refractory MCL. Results from this trial were presented at the 2018 annual meeting of the American Society of Hematology (Abstract 148).

As of March 27, 2018, 86 patients had been enrolled in the trial and received treatment. They had a median of two prior lines of therapy and they received zanubrutinib at 160 mg twice daily.

Eighty-five patients were evaluable for efficacy. The overall response rate was 83.5% (71/85), and the complete response rate was 58.8% (50/85). At a median follow-up of 24.1 weeks, the median duration of response and median progression-free survival had not been reached. The estimated 24-week progression-free survival rate was 82%. The most common adverse events (AEs) in this trial were decrease in neutrophil count (31.4%), rash (29.1%), upper respiratory tract infection (29.1%), and decrease in platelet count (22.1%). Common grade 3 or higher AEs included neutrophil count decrease (11.6%) and lung infection (5.8%).

Four patients had fatal treatment-emergent AEs. One death was caused by a traffic accident, one was due to cerebral hemorrhage, and one resulted from pneumonia. The fourth death occurred in a patient with infection, but the cause of death was unknown.

Breakthrough therapy designation is designed to expedite the development and review of a therapy for a serious or life-threatening disease, following preliminary clinical evidence indicating it demonstrates substantial improvement over existing therapies.

[email protected]

The Food and Drug Administration has granted breakthrough therapy designation to zanubrutinib as a treatment for adults with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Zanubrutinib (BGB-3111) is a Bruton’s tyrosine kinase inhibitor being developed by BeiGene as a potential treatment for B-cell malignancies.

Researchers have evaluated zanubrutinib in a phase 2 trial (NCT03206970) of patients with relapsed/refractory MCL. Results from this trial were presented at the 2018 annual meeting of the American Society of Hematology (Abstract 148).

As of March 27, 2018, 86 patients had been enrolled in the trial and received treatment. They had a median of two prior lines of therapy and they received zanubrutinib at 160 mg twice daily.

Eighty-five patients were evaluable for efficacy. The overall response rate was 83.5% (71/85), and the complete response rate was 58.8% (50/85). At a median follow-up of 24.1 weeks, the median duration of response and median progression-free survival had not been reached. The estimated 24-week progression-free survival rate was 82%. The most common adverse events (AEs) in this trial were decrease in neutrophil count (31.4%), rash (29.1%), upper respiratory tract infection (29.1%), and decrease in platelet count (22.1%). Common grade 3 or higher AEs included neutrophil count decrease (11.6%) and lung infection (5.8%).

Four patients had fatal treatment-emergent AEs. One death was caused by a traffic accident, one was due to cerebral hemorrhage, and one resulted from pneumonia. The fourth death occurred in a patient with infection, but the cause of death was unknown.

Breakthrough therapy designation is designed to expedite the development and review of a therapy for a serious or life-threatening disease, following preliminary clinical evidence indicating it demonstrates substantial improvement over existing therapies.

[email protected]

Diagnosis of any mental disorder significantly increased the risk for all other mental disorders, based on data from a population-based cohort study of almost 6 million individuals followed for nearly 84 million person-years.

Comorbidity among mental disorders has been acknowledged, but comprehensive data on comorbidities across all subsets of disease and a comprehensive risk assessment has been lacking, wrote Oleguer Plana-Ripoll, PhD, of Aarhus University in Denmark, and his colleagues.

In a study published in JAMA Psychiatry, the researchers included all individuals born in Denmark between Jan. 1, 1900, and Dec. 31, 2015, who were living in Denmark between Jan. 1, 2000, and Dec. 31, 2016. They used national health registries to identify mental disorders, and diagnoses were based on the International Statistical Classification of Diseases and Related Health Problems. The study population included 2,958,293 men and 2,982,485 women with an average age of 32 years at the start of the follow-up period; participants were followed for a total of 83.9 million person-years. Mental disorders were categorized in groups, and groups were paired for risk assessment.

Overall, the risk of developing all other mental disorders increased with the diagnosis of one mental disorder, most prominently in the first year after diagnosis, but the risk persisted for at least 15 years. In one model controlling for age, calendar time, and sex, hazard ratios ranged from 2.0 for prior intellectual disabilities paired with later eating disorders to 48.6 for prior developmental disorders paired with later intellectual disabilities.

The large sample size allowed for focus on absolute risk and the study was accompanied by an interactive website (http://www.nbepi.com) that allows clinicians (and potentially patients) to monitor possible emerging mental health comorbidities.

As one example of absolute risk assessment, the researchers determined that 40% of men and 50% of women diagnosed with a mood disorder before age 20 years would develop an incident neurotic disorder as defined by the 10th revision of the International Statistical Classification of Diseases and Related Health Problems within the next 15 years. “The provision of absolute risk estimates may facilitate the clinical translation of our findings, and lay the groundwork for future studies related to personalized medicine and the primary prevention of comorbidity,” Dr. Plana-Ripoll and his colleagues wrote.

The researchers acknowledged the study’s limitation of comorbidities to pairs of disorders versus three or more, the use of groups of disorders rather than specific disorders, and the limitation to mental disorders treated in secondary care settings. However, the data support findings from previous studies and “provide new insights into the complex nature of comorbidity and the comprehensive nature of the analysis will provide an important foundation for future research,” they said.

The research was supported by the Danish National Research Foundation. Dr. Plana-Ripoll had no financial conflicts to disclose. Some coauthors disclosed grants from the National Institutes of Health, Novo Nordisk Foundation, and the European Research Council, and some coauthors disclosed financial relationships with Sanofi Aventis, Johnson & Johnson, Sage Pharmaceuticals, Shire, and Takeda.

SOURCE: Plana-Ripoll O et al. JAMA Psychiatry. 2019 Jan 16. doi: 10.1001/jamapsychiatry.2018.3658.

Diagnosis of any mental disorder significantly increased the risk for all other mental disorders, based on data from a population-based cohort study of almost 6 million individuals followed for nearly 84 million person-years.

Comorbidity among mental disorders has been acknowledged, but comprehensive data on comorbidities across all subsets of disease and a comprehensive risk assessment has been lacking, wrote Oleguer Plana-Ripoll, PhD, of Aarhus University in Denmark, and his colleagues.

In a study published in JAMA Psychiatry, the researchers included all individuals born in Denmark between Jan. 1, 1900, and Dec. 31, 2015, who were living in Denmark between Jan. 1, 2000, and Dec. 31, 2016. They used national health registries to identify mental disorders, and diagnoses were based on the International Statistical Classification of Diseases and Related Health Problems. The study population included 2,958,293 men and 2,982,485 women with an average age of 32 years at the start of the follow-up period; participants were followed for a total of 83.9 million person-years. Mental disorders were categorized in groups, and groups were paired for risk assessment.

Overall, the risk of developing all other mental disorders increased with the diagnosis of one mental disorder, most prominently in the first year after diagnosis, but the risk persisted for at least 15 years. In one model controlling for age, calendar time, and sex, hazard ratios ranged from 2.0 for prior intellectual disabilities paired with later eating disorders to 48.6 for prior developmental disorders paired with later intellectual disabilities.

The large sample size allowed for focus on absolute risk and the study was accompanied by an interactive website (http://www.nbepi.com) that allows clinicians (and potentially patients) to monitor possible emerging mental health comorbidities.

As one example of absolute risk assessment, the researchers determined that 40% of men and 50% of women diagnosed with a mood disorder before age 20 years would develop an incident neurotic disorder as defined by the 10th revision of the International Statistical Classification of Diseases and Related Health Problems within the next 15 years. “The provision of absolute risk estimates may facilitate the clinical translation of our findings, and lay the groundwork for future studies related to personalized medicine and the primary prevention of comorbidity,” Dr. Plana-Ripoll and his colleagues wrote.

The researchers acknowledged the study’s limitation of comorbidities to pairs of disorders versus three or more, the use of groups of disorders rather than specific disorders, and the limitation to mental disorders treated in secondary care settings. However, the data support findings from previous studies and “provide new insights into the complex nature of comorbidity and the comprehensive nature of the analysis will provide an important foundation for future research,” they said.

The research was supported by the Danish National Research Foundation. Dr. Plana-Ripoll had no financial conflicts to disclose. Some coauthors disclosed grants from the National Institutes of Health, Novo Nordisk Foundation, and the European Research Council, and some coauthors disclosed financial relationships with Sanofi Aventis, Johnson & Johnson, Sage Pharmaceuticals, Shire, and Takeda.

SOURCE: Plana-Ripoll O et al. JAMA Psychiatry. 2019 Jan 16. doi: 10.1001/jamapsychiatry.2018.3658.

Diagnosis of any mental disorder significantly increased the risk for all other mental disorders, based on data from a population-based cohort study of almost 6 million individuals followed for nearly 84 million person-years.

Comorbidity among mental disorders has been acknowledged, but comprehensive data on comorbidities across all subsets of disease and a comprehensive risk assessment has been lacking, wrote Oleguer Plana-Ripoll, PhD, of Aarhus University in Denmark, and his colleagues.

In a study published in JAMA Psychiatry, the researchers included all individuals born in Denmark between Jan. 1, 1900, and Dec. 31, 2015, who were living in Denmark between Jan. 1, 2000, and Dec. 31, 2016. They used national health registries to identify mental disorders, and diagnoses were based on the International Statistical Classification of Diseases and Related Health Problems. The study population included 2,958,293 men and 2,982,485 women with an average age of 32 years at the start of the follow-up period; participants were followed for a total of 83.9 million person-years. Mental disorders were categorized in groups, and groups were paired for risk assessment.

Overall, the risk of developing all other mental disorders increased with the diagnosis of one mental disorder, most prominently in the first year after diagnosis, but the risk persisted for at least 15 years. In one model controlling for age, calendar time, and sex, hazard ratios ranged from 2.0 for prior intellectual disabilities paired with later eating disorders to 48.6 for prior developmental disorders paired with later intellectual disabilities.

The large sample size allowed for focus on absolute risk and the study was accompanied by an interactive website (http://www.nbepi.com) that allows clinicians (and potentially patients) to monitor possible emerging mental health comorbidities.

As one example of absolute risk assessment, the researchers determined that 40% of men and 50% of women diagnosed with a mood disorder before age 20 years would develop an incident neurotic disorder as defined by the 10th revision of the International Statistical Classification of Diseases and Related Health Problems within the next 15 years. “The provision of absolute risk estimates may facilitate the clinical translation of our findings, and lay the groundwork for future studies related to personalized medicine and the primary prevention of comorbidity,” Dr. Plana-Ripoll and his colleagues wrote.

The researchers acknowledged the study’s limitation of comorbidities to pairs of disorders versus three or more, the use of groups of disorders rather than specific disorders, and the limitation to mental disorders treated in secondary care settings. However, the data support findings from previous studies and “provide new insights into the complex nature of comorbidity and the comprehensive nature of the analysis will provide an important foundation for future research,” they said.

The research was supported by the Danish National Research Foundation. Dr. Plana-Ripoll had no financial conflicts to disclose. Some coauthors disclosed grants from the National Institutes of Health, Novo Nordisk Foundation, and the European Research Council, and some coauthors disclosed financial relationships with Sanofi Aventis, Johnson & Johnson, Sage Pharmaceuticals, Shire, and Takeda.

SOURCE: Plana-Ripoll O et al. JAMA Psychiatry. 2019 Jan 16. doi: 10.1001/jamapsychiatry.2018.3658.

To determine if a nationwide implementation of robotic minimally invasive surgery (MIS) influenced the risk of severe complications and survival among women with early-stage endometrial cancer, a group of researchers from the University of Southern Denmark studied the Danish Gynecological Cancer Database, a nationwide, mandatory prospective registration of new cases of women with endometrial cancer who received their surgical treatment in a public hospital.¹ Siv Joergensen, MD, reported results at the 47th AAGL Global Congress on Minimally Invasive Gynecology annual meeting on November 13, 2018, in Las Vegas, Nevada.

The transition to robotic MIS was undertaken in Denmark from 2008 to 2013, with the centralization of endometrial cancer treatment in 2012. Over the span of 10 years, the surgical approach to treatment changed from 97% open access surgery to 95% MIS.

For the prospective cohort study, more than 7,000 women with endometrial cancer who received a hysterectomy from January 2005 to June 2015 were grouped by those receiving surgical care before (group 1) and after (group 2) robotic MIS implementation in Denmark. A total of 5,654 women with FIGO Stage I–II endometrial cancer were included in the final study.

Severe complications were 7.3% in group 1 and 6.2% in group 2 (odds ratio, 1.38; 95% confidence interval [CI], 1.10–1.73). Five-year survival rates were significantly lower before robotic MIS was implemented (hazard ratio, 1.22; 95% CI, 1.05–1.41), and no difference was found between laparoscopic and robotic MIS.

The authors concluded that nationwide implementation of robotic MIS enabled a shift toward all types of MIS (with a 73% reduction in hysterectomies performed by laparotomy) and translated into reduced risk of severe complications and increased survival.

How do these results compare with those in the United States?

According to Erica Dun, MD, MPH, who provided commentary for Dr. Joergensen’s study, the United States adopted robotic MIS in the early 2000s. Around 2008, 14% of hysterectomies performed for early-stage endometrial cancer were done through a MIS approach.² In 2014, after a study in which Walker and colleagues found that laparoscopy was safe and feasible compared with laparotomy,³ the American College of Obstetricians and Gynecologists, jointly with the Society of Gynecologic Oncologists, stated that “MIS should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”⁴

Dr. Dun pointed out that Casarin and colleagues found in 2018 that 71.4% of surgeries performed in the United States for endometrial cancer were performed through MIS.⁵ That number rose to 86.5% MIS (72.5% robot-assisted) for centers of the National Comprehensive Cancer Network.⁶

Dr. Dun concluded that nationwide implementation of robotic MIS is feasible for gynecologic oncologists, and it is beneficial for patients.

To determine if a nationwide implementation of robotic minimally invasive surgery (MIS) influenced the risk of severe complications and survival among women with early-stage endometrial cancer, a group of researchers from the University of Southern Denmark studied the Danish Gynecological Cancer Database, a nationwide, mandatory prospective registration of new cases of women with endometrial cancer who received their surgical treatment in a public hospital.¹ Siv Joergensen, MD, reported results at the 47th AAGL Global Congress on Minimally Invasive Gynecology annual meeting on November 13, 2018, in Las Vegas, Nevada.

The transition to robotic MIS was undertaken in Denmark from 2008 to 2013, with the centralization of endometrial cancer treatment in 2012. Over the span of 10 years, the surgical approach to treatment changed from 97% open access surgery to 95% MIS.

For the prospective cohort study, more than 7,000 women with endometrial cancer who received a hysterectomy from January 2005 to June 2015 were grouped by those receiving surgical care before (group 1) and after (group 2) robotic MIS implementation in Denmark. A total of 5,654 women with FIGO Stage I–II endometrial cancer were included in the final study.

Severe complications were 7.3% in group 1 and 6.2% in group 2 (odds ratio, 1.38; 95% confidence interval [CI], 1.10–1.73). Five-year survival rates were significantly lower before robotic MIS was implemented (hazard ratio, 1.22; 95% CI, 1.05–1.41), and no difference was found between laparoscopic and robotic MIS.

The authors concluded that nationwide implementation of robotic MIS enabled a shift toward all types of MIS (with a 73% reduction in hysterectomies performed by laparotomy) and translated into reduced risk of severe complications and increased survival.

How do these results compare with those in the United States?

According to Erica Dun, MD, MPH, who provided commentary for Dr. Joergensen’s study, the United States adopted robotic MIS in the early 2000s. Around 2008, 14% of hysterectomies performed for early-stage endometrial cancer were done through a MIS approach.² In 2014, after a study in which Walker and colleagues found that laparoscopy was safe and feasible compared with laparotomy,³ the American College of Obstetricians and Gynecologists, jointly with the Society of Gynecologic Oncologists, stated that “MIS should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”⁴

Dr. Dun pointed out that Casarin and colleagues found in 2018 that 71.4% of surgeries performed in the United States for endometrial cancer were performed through MIS.⁵ That number rose to 86.5% MIS (72.5% robot-assisted) for centers of the National Comprehensive Cancer Network.⁶

Dr. Dun concluded that nationwide implementation of robotic MIS is feasible for gynecologic oncologists, and it is beneficial for patients.

To determine if a nationwide implementation of robotic minimally invasive surgery (MIS) influenced the risk of severe complications and survival among women with early-stage endometrial cancer, a group of researchers from the University of Southern Denmark studied the Danish Gynecological Cancer Database, a nationwide, mandatory prospective registration of new cases of women with endometrial cancer who received their surgical treatment in a public hospital.¹ Siv Joergensen, MD, reported results at the 47th AAGL Global Congress on Minimally Invasive Gynecology annual meeting on November 13, 2018, in Las Vegas, Nevada.

The transition to robotic MIS was undertaken in Denmark from 2008 to 2013, with the centralization of endometrial cancer treatment in 2012. Over the span of 10 years, the surgical approach to treatment changed from 97% open access surgery to 95% MIS.

For the prospective cohort study, more than 7,000 women with endometrial cancer who received a hysterectomy from January 2005 to June 2015 were grouped by those receiving surgical care before (group 1) and after (group 2) robotic MIS implementation in Denmark. A total of 5,654 women with FIGO Stage I–II endometrial cancer were included in the final study.

Severe complications were 7.3% in group 1 and 6.2% in group 2 (odds ratio, 1.38; 95% confidence interval [CI], 1.10–1.73). Five-year survival rates were significantly lower before robotic MIS was implemented (hazard ratio, 1.22; 95% CI, 1.05–1.41), and no difference was found between laparoscopic and robotic MIS.

The authors concluded that nationwide implementation of robotic MIS enabled a shift toward all types of MIS (with a 73% reduction in hysterectomies performed by laparotomy) and translated into reduced risk of severe complications and increased survival.

How do these results compare with those in the United States?

According to Erica Dun, MD, MPH, who provided commentary for Dr. Joergensen’s study, the United States adopted robotic MIS in the early 2000s. Around 2008, 14% of hysterectomies performed for early-stage endometrial cancer were done through a MIS approach.² In 2014, after a study in which Walker and colleagues found that laparoscopy was safe and feasible compared with laparotomy,³ the American College of Obstetricians and Gynecologists, jointly with the Society of Gynecologic Oncologists, stated that “MIS should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”⁴

Dr. Dun pointed out that Casarin and colleagues found in 2018 that 71.4% of surgeries performed in the United States for endometrial cancer were performed through MIS.⁵ That number rose to 86.5% MIS (72.5% robot-assisted) for centers of the National Comprehensive Cancer Network.⁶

Dr. Dun concluded that nationwide implementation of robotic MIS is feasible for gynecologic oncologists, and it is beneficial for patients.

Clinical question: How effective are intramuscular midazolam, olanzapine, ziprasidone, and haloperidol at sedating acutely agitated adults in the emergency department?

Background: Acute agitation is commonly seen in the ED and sometimes requires parenteral medications to keep patients and staff safe. Although many medications, including benzodiazepines and antipsychotics, are used, there is no consensus regarding which medications are most effective and safe for acute agitation.

Study design: Prospective observational study.

Setting: Emergency department of an inner-city Level 1 adult and pediatric trauma center.

Synopsis: This study enrolled 737 adults in the ED who presented with acute agitation and treated them with either haloperidol 5 mg, ziprasidone 20 mg, olanzapine 10 mg, midazolam 5 mg, or haloperidol 10 mg intramuscularly, based on predetermined 3-week blocks. The main outcome was the proportion of patients adequately sedated at 15 minutes, based on Altered Mental Status Scale score less than 1. A total of 650 patients (88%) were agitated from alcohol intoxication.

Dr. Jenkins is assistant professor of medicine and an academic hospitalist, University of Utah, Salt Lake City.

Clinical question: How effective are intramuscular midazolam, olanzapine, ziprasidone, and haloperidol at sedating acutely agitated adults in the emergency department?

Background: Acute agitation is commonly seen in the ED and sometimes requires parenteral medications to keep patients and staff safe. Although many medications, including benzodiazepines and antipsychotics, are used, there is no consensus regarding which medications are most effective and safe for acute agitation.

Study design: Prospective observational study.

Setting: Emergency department of an inner-city Level 1 adult and pediatric trauma center.

Synopsis: This study enrolled 737 adults in the ED who presented with acute agitation and treated them with either haloperidol 5 mg, ziprasidone 20 mg, olanzapine 10 mg, midazolam 5 mg, or haloperidol 10 mg intramuscularly, based on predetermined 3-week blocks. The main outcome was the proportion of patients adequately sedated at 15 minutes, based on Altered Mental Status Scale score less than 1. A total of 650 patients (88%) were agitated from alcohol intoxication.

Dr. Jenkins is assistant professor of medicine and an academic hospitalist, University of Utah, Salt Lake City.

Clinical question: How effective are intramuscular midazolam, olanzapine, ziprasidone, and haloperidol at sedating acutely agitated adults in the emergency department?

Background: Acute agitation is commonly seen in the ED and sometimes requires parenteral medications to keep patients and staff safe. Although many medications, including benzodiazepines and antipsychotics, are used, there is no consensus regarding which medications are most effective and safe for acute agitation.

Study design: Prospective observational study.

Setting: Emergency department of an inner-city Level 1 adult and pediatric trauma center.

Synopsis: This study enrolled 737 adults in the ED who presented with acute agitation and treated them with either haloperidol 5 mg, ziprasidone 20 mg, olanzapine 10 mg, midazolam 5 mg, or haloperidol 10 mg intramuscularly, based on predetermined 3-week blocks. The main outcome was the proportion of patients adequately sedated at 15 minutes, based on Altered Mental Status Scale score less than 1. A total of 650 patients (88%) were agitated from alcohol intoxication.

Dr. Jenkins is assistant professor of medicine and an academic hospitalist, University of Utah, Salt Lake City.

Discussing confidentiality is essential to the appropriate health care of adolescents, especially prior to discussing sensitive subjects, reported John S. Santelli, MD, MPH, of Mailman School of Public Health, Columbia University, New York, N.Y., and his associates.

Rawpixel/Thinkstock

“Previous research has shown that when adolescents and young adults (AYAs) are not assured of confidentiality, they are less willing to discuss sensitive topics with their providers,” they wrote. The report is in Pediatrics.

According to national guidelines, although discussions concerning confidentiality can begin with parents in early adolescence, over time, the goal should be to allow fully for alone time for the AYA with you without parents present in the room.

You have a unique opportunity to help parents understand confidentiality and aid them in transitioning over time, with full respect and support for the developing adolescent-provider relationship, so that it can be fully realized by the time the adolescent reaches 13 years of age.

Using a nationally representative age-, race/ethnicity-, and income-matched sample of AYAs, the authors surveyed youth aged 13-26 years concerning preventive services received and discussions held with health care providers. Of the 1,918 individuals who completed the survey, the authors’ analysis was limited to the 1,509 (79%) youth who had seen their providers in the past 2 years.

The study focused on 11 youth-provider discussion topics. For 10 of the 11 topics, less than half of the young people said they had a discussion on the topic with a health care provider on their last visit. The most commonly discussed topics overall included mental health/emotional issues (55%), drug or alcohol use (46%), tobacco use (44%), and school performance (43%); the least common were gun safety (14%), sexual orientation (20%), and sexual or physical abuse (21%). There were more discussions concerning birth control among young women (from 26% at ages 13-14 to 54% by ages 23-26) compared with young men (13% at ages 13-14 to 12% by ages 23-26).

On average, young women reported discussing just 3.7 of the 11 topics during their last preventive care visit; young men similarly reported an average of 3.6 topics. Overall, the mean number of youth-provider discussions declined over time from 4.1 at ages 13-14 and 4.4 at ages 15-18 to 2.6 by ages 23-26.

Compared with white youth, who reported 3.3 topics at their last visit, Hispanic and African American youth reported discussing 4.2 topics. Similar differences were seen when comparing rural (2.7 topics) and urban or suburban youth (3.8 topics) or incomes greater than $75,000 (3.6 topics) compared with incomes of $25,000 or less (4.2 topics).

Youth who previously discussed confidentiality also reported discussing more topics (4.4), compared with those who had not talked about confidentiality (2.9).

Before the implementation of the Patient Protection and Affordable Care Act (ACA), which requires the provision of prevention services without cost sharing, less than half of adolescents visited a medical provider for annual preventive care visits, other studies have shown.

Although professional guidelines for adolescent preventive care recommend youth access to confidential services, “young people report that health care encounters often do not include an explanation of confidentiality by their health care provider.” Without the assurance of confidentiality, adolescents are more likely to not seek care or to opt not to disclose risky behaviors.

Current systems tend to rely on parent reporting regarding uses of services, and there is no mechanism in place for collection of data on discussion of sensitive health topics. The authors also noted a lack of time available for dialogue during visits as well as an absence of screening questionnaires prior to visits that might invite opportunities to disclose information on sensitive topics.

“Young people who reported ever having talked about confidentiality with their regular provider were more likely to engage in health discussions with providers,” emphasized Dr. Santelli and his associates. “The use of a health checklist and/or questionnaire and having spent more time with their provider during the visit were consistently associated with more of these discussions.”

You can build rapport with AYAs during preventive care visits that include screening and counseling. Immunizations, screening, and treatment of sexually transmitted infections, and dispensing of reproductive and sexual health services, including contraception, offer good opportunities for these discussions. Other sensitive topics are tobacco, alcohol, and drug use; depression and mental health; and obesity and physical activity.

Dr. Santelli and his associates consider the results of their research to serve as a “valuable addition to the literature.” They did, however, note several limitations. Because the data are cross-sectional, they cannot demonstrate causality. The use of self-report data may have contributed to underreporting of risk behaviors because adolescents were interviewed directly following parents on the same computer. Survey questions did account for the existence of youth-provider discussions, but the researchers were not able to measure the impact or quality of the resulting conversations.

It is important to note that because providers were not interviewed, the time pressures and other expected barriers were not fully accounted for in this research, Dr. Santelli and his colleagues cautioned. “Future research should ask specifically about provider-level barriers to providing preventive care to better understand their impact,” they advised.

Ultimately, the clinicians who are providing care to youth and their families will need support in implementing such changes, especially where education in the importance of discussion confidentiality and private time are concerned, they added.

The authors had no relevant financial disclosures. The study was funded by an unrestricted research grant from the Merck Foundation.

SOURCE: Santelli J et. al. Pediatrics. 2019. doi: 10.1542/peds.2018-1403.

Discussing confidentiality is essential to the appropriate health care of adolescents, especially prior to discussing sensitive subjects, reported John S. Santelli, MD, MPH, of Mailman School of Public Health, Columbia University, New York, N.Y., and his associates.

Rawpixel/Thinkstock

“Previous research has shown that when adolescents and young adults (AYAs) are not assured of confidentiality, they are less willing to discuss sensitive topics with their providers,” they wrote. The report is in Pediatrics.

According to national guidelines, although discussions concerning confidentiality can begin with parents in early adolescence, over time, the goal should be to allow fully for alone time for the AYA with you without parents present in the room.

You have a unique opportunity to help parents understand confidentiality and aid them in transitioning over time, with full respect and support for the developing adolescent-provider relationship, so that it can be fully realized by the time the adolescent reaches 13 years of age.

Using a nationally representative age-, race/ethnicity-, and income-matched sample of AYAs, the authors surveyed youth aged 13-26 years concerning preventive services received and discussions held with health care providers. Of the 1,918 individuals who completed the survey, the authors’ analysis was limited to the 1,509 (79%) youth who had seen their providers in the past 2 years.

The study focused on 11 youth-provider discussion topics. For 10 of the 11 topics, less than half of the young people said they had a discussion on the topic with a health care provider on their last visit. The most commonly discussed topics overall included mental health/emotional issues (55%), drug or alcohol use (46%), tobacco use (44%), and school performance (43%); the least common were gun safety (14%), sexual orientation (20%), and sexual or physical abuse (21%). There were more discussions concerning birth control among young women (from 26% at ages 13-14 to 54% by ages 23-26) compared with young men (13% at ages 13-14 to 12% by ages 23-26).

On average, young women reported discussing just 3.7 of the 11 topics during their last preventive care visit; young men similarly reported an average of 3.6 topics. Overall, the mean number of youth-provider discussions declined over time from 4.1 at ages 13-14 and 4.4 at ages 15-18 to 2.6 by ages 23-26.

Compared with white youth, who reported 3.3 topics at their last visit, Hispanic and African American youth reported discussing 4.2 topics. Similar differences were seen when comparing rural (2.7 topics) and urban or suburban youth (3.8 topics) or incomes greater than $75,000 (3.6 topics) compared with incomes of $25,000 or less (4.2 topics).

Youth who previously discussed confidentiality also reported discussing more topics (4.4), compared with those who had not talked about confidentiality (2.9).

Before the implementation of the Patient Protection and Affordable Care Act (ACA), which requires the provision of prevention services without cost sharing, less than half of adolescents visited a medical provider for annual preventive care visits, other studies have shown.

Although professional guidelines for adolescent preventive care recommend youth access to confidential services, “young people report that health care encounters often do not include an explanation of confidentiality by their health care provider.” Without the assurance of confidentiality, adolescents are more likely to not seek care or to opt not to disclose risky behaviors.

Current systems tend to rely on parent reporting regarding uses of services, and there is no mechanism in place for collection of data on discussion of sensitive health topics. The authors also noted a lack of time available for dialogue during visits as well as an absence of screening questionnaires prior to visits that might invite opportunities to disclose information on sensitive topics.

“Young people who reported ever having talked about confidentiality with their regular provider were more likely to engage in health discussions with providers,” emphasized Dr. Santelli and his associates. “The use of a health checklist and/or questionnaire and having spent more time with their provider during the visit were consistently associated with more of these discussions.”

You can build rapport with AYAs during preventive care visits that include screening and counseling. Immunizations, screening, and treatment of sexually transmitted infections, and dispensing of reproductive and sexual health services, including contraception, offer good opportunities for these discussions. Other sensitive topics are tobacco, alcohol, and drug use; depression and mental health; and obesity and physical activity.

Dr. Santelli and his associates consider the results of their research to serve as a “valuable addition to the literature.” They did, however, note several limitations. Because the data are cross-sectional, they cannot demonstrate causality. The use of self-report data may have contributed to underreporting of risk behaviors because adolescents were interviewed directly following parents on the same computer. Survey questions did account for the existence of youth-provider discussions, but the researchers were not able to measure the impact or quality of the resulting conversations.

It is important to note that because providers were not interviewed, the time pressures and other expected barriers were not fully accounted for in this research, Dr. Santelli and his colleagues cautioned. “Future research should ask specifically about provider-level barriers to providing preventive care to better understand their impact,” they advised.

Ultimately, the clinicians who are providing care to youth and their families will need support in implementing such changes, especially where education in the importance of discussion confidentiality and private time are concerned, they added.

The authors had no relevant financial disclosures. The study was funded by an unrestricted research grant from the Merck Foundation.

SOURCE: Santelli J et. al. Pediatrics. 2019. doi: 10.1542/peds.2018-1403.

Discussing confidentiality is essential to the appropriate health care of adolescents, especially prior to discussing sensitive subjects, reported John S. Santelli, MD, MPH, of Mailman School of Public Health, Columbia University, New York, N.Y., and his associates.

Rawpixel/Thinkstock

“Previous research has shown that when adolescents and young adults (AYAs) are not assured of confidentiality, they are less willing to discuss sensitive topics with their providers,” they wrote. The report is in Pediatrics.

According to national guidelines, although discussions concerning confidentiality can begin with parents in early adolescence, over time, the goal should be to allow fully for alone time for the AYA with you without parents present in the room.

You have a unique opportunity to help parents understand confidentiality and aid them in transitioning over time, with full respect and support for the developing adolescent-provider relationship, so that it can be fully realized by the time the adolescent reaches 13 years of age.

Using a nationally representative age-, race/ethnicity-, and income-matched sample of AYAs, the authors surveyed youth aged 13-26 years concerning preventive services received and discussions held with health care providers. Of the 1,918 individuals who completed the survey, the authors’ analysis was limited to the 1,509 (79%) youth who had seen their providers in the past 2 years.

The study focused on 11 youth-provider discussion topics. For 10 of the 11 topics, less than half of the young people said they had a discussion on the topic with a health care provider on their last visit. The most commonly discussed topics overall included mental health/emotional issues (55%), drug or alcohol use (46%), tobacco use (44%), and school performance (43%); the least common were gun safety (14%), sexual orientation (20%), and sexual or physical abuse (21%). There were more discussions concerning birth control among young women (from 26% at ages 13-14 to 54% by ages 23-26) compared with young men (13% at ages 13-14 to 12% by ages 23-26).

On average, young women reported discussing just 3.7 of the 11 topics during their last preventive care visit; young men similarly reported an average of 3.6 topics. Overall, the mean number of youth-provider discussions declined over time from 4.1 at ages 13-14 and 4.4 at ages 15-18 to 2.6 by ages 23-26.

Compared with white youth, who reported 3.3 topics at their last visit, Hispanic and African American youth reported discussing 4.2 topics. Similar differences were seen when comparing rural (2.7 topics) and urban or suburban youth (3.8 topics) or incomes greater than $75,000 (3.6 topics) compared with incomes of $25,000 or less (4.2 topics).

Youth who previously discussed confidentiality also reported discussing more topics (4.4), compared with those who had not talked about confidentiality (2.9).

Before the implementation of the Patient Protection and Affordable Care Act (ACA), which requires the provision of prevention services without cost sharing, less than half of adolescents visited a medical provider for annual preventive care visits, other studies have shown.

Although professional guidelines for adolescent preventive care recommend youth access to confidential services, “young people report that health care encounters often do not include an explanation of confidentiality by their health care provider.” Without the assurance of confidentiality, adolescents are more likely to not seek care or to opt not to disclose risky behaviors.

Current systems tend to rely on parent reporting regarding uses of services, and there is no mechanism in place for collection of data on discussion of sensitive health topics. The authors also noted a lack of time available for dialogue during visits as well as an absence of screening questionnaires prior to visits that might invite opportunities to disclose information on sensitive topics.

“Young people who reported ever having talked about confidentiality with their regular provider were more likely to engage in health discussions with providers,” emphasized Dr. Santelli and his associates. “The use of a health checklist and/or questionnaire and having spent more time with their provider during the visit were consistently associated with more of these discussions.”

You can build rapport with AYAs during preventive care visits that include screening and counseling. Immunizations, screening, and treatment of sexually transmitted infections, and dispensing of reproductive and sexual health services, including contraception, offer good opportunities for these discussions. Other sensitive topics are tobacco, alcohol, and drug use; depression and mental health; and obesity and physical activity.

Dr. Santelli and his associates consider the results of their research to serve as a “valuable addition to the literature.” They did, however, note several limitations. Because the data are cross-sectional, they cannot demonstrate causality. The use of self-report data may have contributed to underreporting of risk behaviors because adolescents were interviewed directly following parents on the same computer. Survey questions did account for the existence of youth-provider discussions, but the researchers were not able to measure the impact or quality of the resulting conversations.

It is important to note that because providers were not interviewed, the time pressures and other expected barriers were not fully accounted for in this research, Dr. Santelli and his colleagues cautioned. “Future research should ask specifically about provider-level barriers to providing preventive care to better understand their impact,” they advised.

Ultimately, the clinicians who are providing care to youth and their families will need support in implementing such changes, especially where education in the importance of discussion confidentiality and private time are concerned, they added.

The authors had no relevant financial disclosures. The study was funded by an unrestricted research grant from the Merck Foundation.

SOURCE: Santelli J et. al. Pediatrics. 2019. doi: 10.1542/peds.2018-1403.

The Food and Drug Administration has smoothed the way to OTC naloxone by releasing “drug facts label” templates for manufacturers to use when submitting their products for consideration.

Drug facts labels (DFLs) are required for all OTC drugs, and it’s usually up to manufacturers to develop and test their own to ensure that consumers understand how to use their products.

“Some stakeholders have identified the requirement ... as a barrier to development of OTC naloxone products,” so the agency developed two DFLs on its own – one for nasal spray naloxone, the other for auto-injectors – and completed the necessary label comprehension testing, according to an announcement from FDA Commissioner Scott Gottlieb, MD.

There’s not much else manufactures have to do, except deal with the details of their own products. They “can now focus their efforts on ... how well consumers understand the product-specific information that hasn’t been already tested in the model” DFLs, according to the announcement.

As deaths from opioid abuse continue to climb, the FDA is committed to increasing access to naloxone, which currently requires a prescription. The new DFLs “should jump-start the development of OTC naloxone products ... I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible,” Dr. Gottlieb said.

Comprehension was assessed in more than 700 people, including heroin and prescription opioid users, their friends and families, and adolescents. “Overall, the study demonstrated that” the DFLs are “well-understood by consumers” and acceptable “for use by manufacturers in support of their ... development programs,” according to the announcement.

In a press statement, the American Medical Association applauded the agency’s move “to provide labeling that would allow for over-the-counter availability of naloxone, a move that will save people from opioid-related overdose ... The action should spur efforts by naloxone manufacturers to submit applications for their products to receive over-the-counter status.”

[email protected]

The Food and Drug Administration has smoothed the way to OTC naloxone by releasing “drug facts label” templates for manufacturers to use when submitting their products for consideration.

Drug facts labels (DFLs) are required for all OTC drugs, and it’s usually up to manufacturers to develop and test their own to ensure that consumers understand how to use their products.

“Some stakeholders have identified the requirement ... as a barrier to development of OTC naloxone products,” so the agency developed two DFLs on its own – one for nasal spray naloxone, the other for auto-injectors – and completed the necessary label comprehension testing, according to an announcement from FDA Commissioner Scott Gottlieb, MD.

There’s not much else manufactures have to do, except deal with the details of their own products. They “can now focus their efforts on ... how well consumers understand the product-specific information that hasn’t been already tested in the model” DFLs, according to the announcement.

As deaths from opioid abuse continue to climb, the FDA is committed to increasing access to naloxone, which currently requires a prescription. The new DFLs “should jump-start the development of OTC naloxone products ... I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible,” Dr. Gottlieb said.

Comprehension was assessed in more than 700 people, including heroin and prescription opioid users, their friends and families, and adolescents. “Overall, the study demonstrated that” the DFLs are “well-understood by consumers” and acceptable “for use by manufacturers in support of their ... development programs,” according to the announcement.

In a press statement, the American Medical Association applauded the agency’s move “to provide labeling that would allow for over-the-counter availability of naloxone, a move that will save people from opioid-related overdose ... The action should spur efforts by naloxone manufacturers to submit applications for their products to receive over-the-counter status.”

[email protected]

The Food and Drug Administration has smoothed the way to OTC naloxone by releasing “drug facts label” templates for manufacturers to use when submitting their products for consideration.

Drug facts labels (DFLs) are required for all OTC drugs, and it’s usually up to manufacturers to develop and test their own to ensure that consumers understand how to use their products.

“Some stakeholders have identified the requirement ... as a barrier to development of OTC naloxone products,” so the agency developed two DFLs on its own – one for nasal spray naloxone, the other for auto-injectors – and completed the necessary label comprehension testing, according to an announcement from FDA Commissioner Scott Gottlieb, MD.

There’s not much else manufactures have to do, except deal with the details of their own products. They “can now focus their efforts on ... how well consumers understand the product-specific information that hasn’t been already tested in the model” DFLs, according to the announcement.

As deaths from opioid abuse continue to climb, the FDA is committed to increasing access to naloxone, which currently requires a prescription. The new DFLs “should jump-start the development of OTC naloxone products ... I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible,” Dr. Gottlieb said.

Comprehension was assessed in more than 700 people, including heroin and prescription opioid users, their friends and families, and adolescents. “Overall, the study demonstrated that” the DFLs are “well-understood by consumers” and acceptable “for use by manufacturers in support of their ... development programs,” according to the announcement.

In a press statement, the American Medical Association applauded the agency’s move “to provide labeling that would allow for over-the-counter availability of naloxone, a move that will save people from opioid-related overdose ... The action should spur efforts by naloxone manufacturers to submit applications for their products to receive over-the-counter status.”

[email protected]

Anti-vaccination protesters targeted Monique A. Tello, MD, MPH, in late summer 2018 by leaving bad online ratings and writing false and defamatory comments in her online profiles. Dr. Tell wrote about her experience in a blog post where she opened up about how difficult the process has been, and how she has found support in a community of her colleagues.
Apple Podcasts
Google Podcasts
Spotify

Anti-vaccination protesters targeted Monique A. Tello, MD, MPH, in late summer 2018 by leaving bad online ratings and writing false and defamatory comments in her online profiles. Dr. Tell wrote about her experience in a blog post where she opened up about how difficult the process has been, and how she has found support in a community of her colleagues.
Apple Podcasts
Google Podcasts
Spotify

Anti-vaccination protesters targeted Monique A. Tello, MD, MPH, in late summer 2018 by leaving bad online ratings and writing false and defamatory comments in her online profiles. Dr. Tell wrote about her experience in a blog post where she opened up about how difficult the process has been, and how she has found support in a community of her colleagues.
Apple Podcasts
Google Podcasts
Spotify