The rate of colorectal cancer diagnosis has risen in younger patients, with later-stage tumors predominant, according to findings from a study based on the large National Cancer Database.

Over a 10-year period, the number of colorectal cancer (CRC) cases increased by 11.4% among patients younger than 50 years, which translates to an average increase of 1.28% per year, or 136 new cases each year. By contrast, the number of newly diagnosed CRC cases in those over 50 years of age, dropped by 2.5% over the same period, according to data presented in a teleconference in advance of the annual Digestive Disease Week.

More advanced cancers were diagnosed in the younger group: stage 3, in 30.6% of patients under 50 years of age vs. 25.1% in those over that age; stage 4, in 25.6% vs. 18.2%, respectively.

“Last year, colorectal cancer was the second leading cause of cancer deaths in the U.S., second only to lung cancer. The health care system has done a great deal to heighten patient awareness and increase screenings, but these efforts have focused on people over the age of 50. Our findings show that more efforts need to be aimed at younger people, a group not normally considered at risk,” said lead author Dr. Elie Sutton. “Further, it is very concerning that within younger patients, a higher percentage were diagnosed at later stages.”

The study was based on more than 1 million CRC cases in the National Cancer Database from 2004 to 2013. Factors examined included a comparison of variables between younger-onset and older-onset CRC, such as stage at diagnosis, length of inpatient hospital stay, demographics, and 30-day and 90-day mortality.

In patients for whom data on metastatic disease were available, liver metastasis was reported in 19.4% of younger-onset patients vs. 13.8% of older-onset patients (P less than .001).

As would be expected, hospital stays were shorter for younger-onset patients, who are typically more resilient than older patients. A hospital stay of 5 days or less was recorded for 56.6% of younger-onset patients vs. 43.3% of older-onset patients (P = .001).

Short-term mortality was better for younger patients. Thirty-day mortality was 0.6% for younger-onset patients vs. 3.5% for older-onset patients (P less than .001). Ninety-day mortality was reported in 1.6% vs. 6.4%, respectively (P less than .001), and 8.5% of younger-onset patients had no insurance vs. 2.8% of older-onset patients (P less than .001).

These data are not a surprise, Dr. Sutton commented, in light of the fact that another study showed a similar trend about 5 years ago. “This means we have not adequately addressed risk of CRC in young patients under the age of 50,” he said. “Health care providers should be more vigilant and encourage screening in younger patients,” he emphasized.

Future studies will look at the trends in CRC over time. “We will continue to analyze the National Cancer Database. These insights may be helpful when revisiting colorectal cancer screening guidelines,” Dr. Sutton stated.

Dr. Sutton had no relevant financial disclosures.

The rate of colorectal cancer diagnosis has risen in younger patients, with later-stage tumors predominant, according to findings from a study based on the large National Cancer Database.

Over a 10-year period, the number of colorectal cancer (CRC) cases increased by 11.4% among patients younger than 50 years, which translates to an average increase of 1.28% per year, or 136 new cases each year. By contrast, the number of newly diagnosed CRC cases in those over 50 years of age, dropped by 2.5% over the same period, according to data presented in a teleconference in advance of the annual Digestive Disease Week.

More advanced cancers were diagnosed in the younger group: stage 3, in 30.6% of patients under 50 years of age vs. 25.1% in those over that age; stage 4, in 25.6% vs. 18.2%, respectively.

“Last year, colorectal cancer was the second leading cause of cancer deaths in the U.S., second only to lung cancer. The health care system has done a great deal to heighten patient awareness and increase screenings, but these efforts have focused on people over the age of 50. Our findings show that more efforts need to be aimed at younger people, a group not normally considered at risk,” said lead author Dr. Elie Sutton. “Further, it is very concerning that within younger patients, a higher percentage were diagnosed at later stages.”

The study was based on more than 1 million CRC cases in the National Cancer Database from 2004 to 2013. Factors examined included a comparison of variables between younger-onset and older-onset CRC, such as stage at diagnosis, length of inpatient hospital stay, demographics, and 30-day and 90-day mortality.

In patients for whom data on metastatic disease were available, liver metastasis was reported in 19.4% of younger-onset patients vs. 13.8% of older-onset patients (P less than .001).

As would be expected, hospital stays were shorter for younger-onset patients, who are typically more resilient than older patients. A hospital stay of 5 days or less was recorded for 56.6% of younger-onset patients vs. 43.3% of older-onset patients (P = .001).

Short-term mortality was better for younger patients. Thirty-day mortality was 0.6% for younger-onset patients vs. 3.5% for older-onset patients (P less than .001). Ninety-day mortality was reported in 1.6% vs. 6.4%, respectively (P less than .001), and 8.5% of younger-onset patients had no insurance vs. 2.8% of older-onset patients (P less than .001).

These data are not a surprise, Dr. Sutton commented, in light of the fact that another study showed a similar trend about 5 years ago. “This means we have not adequately addressed risk of CRC in young patients under the age of 50,” he said. “Health care providers should be more vigilant and encourage screening in younger patients,” he emphasized.

Future studies will look at the trends in CRC over time. “We will continue to analyze the National Cancer Database. These insights may be helpful when revisiting colorectal cancer screening guidelines,” Dr. Sutton stated.

Dr. Sutton had no relevant financial disclosures.

The rate of colorectal cancer diagnosis has risen in younger patients, with later-stage tumors predominant, according to findings from a study based on the large National Cancer Database.

Over a 10-year period, the number of colorectal cancer (CRC) cases increased by 11.4% among patients younger than 50 years, which translates to an average increase of 1.28% per year, or 136 new cases each year. By contrast, the number of newly diagnosed CRC cases in those over 50 years of age, dropped by 2.5% over the same period, according to data presented in a teleconference in advance of the annual Digestive Disease Week.

More advanced cancers were diagnosed in the younger group: stage 3, in 30.6% of patients under 50 years of age vs. 25.1% in those over that age; stage 4, in 25.6% vs. 18.2%, respectively.

“Last year, colorectal cancer was the second leading cause of cancer deaths in the U.S., second only to lung cancer. The health care system has done a great deal to heighten patient awareness and increase screenings, but these efforts have focused on people over the age of 50. Our findings show that more efforts need to be aimed at younger people, a group not normally considered at risk,” said lead author Dr. Elie Sutton. “Further, it is very concerning that within younger patients, a higher percentage were diagnosed at later stages.”

The study was based on more than 1 million CRC cases in the National Cancer Database from 2004 to 2013. Factors examined included a comparison of variables between younger-onset and older-onset CRC, such as stage at diagnosis, length of inpatient hospital stay, demographics, and 30-day and 90-day mortality.

In patients for whom data on metastatic disease were available, liver metastasis was reported in 19.4% of younger-onset patients vs. 13.8% of older-onset patients (P less than .001).

As would be expected, hospital stays were shorter for younger-onset patients, who are typically more resilient than older patients. A hospital stay of 5 days or less was recorded for 56.6% of younger-onset patients vs. 43.3% of older-onset patients (P = .001).

Short-term mortality was better for younger patients. Thirty-day mortality was 0.6% for younger-onset patients vs. 3.5% for older-onset patients (P less than .001). Ninety-day mortality was reported in 1.6% vs. 6.4%, respectively (P less than .001), and 8.5% of younger-onset patients had no insurance vs. 2.8% of older-onset patients (P less than .001).

These data are not a surprise, Dr. Sutton commented, in light of the fact that another study showed a similar trend about 5 years ago. “This means we have not adequately addressed risk of CRC in young patients under the age of 50,” he said. “Health care providers should be more vigilant and encourage screening in younger patients,” he emphasized.

Future studies will look at the trends in CRC over time. “We will continue to analyze the National Cancer Database. These insights may be helpful when revisiting colorectal cancer screening guidelines,” Dr. Sutton stated.

Dr. Sutton had no relevant financial disclosures.

BALTIMORE – Biopsy results from a commercially available genetic test for ruling out malignancy of thyroid nodules may not provide reliable answers to clinicians and patients.

When fine-needle aspiration biopsy of thyroid nodules comes back inconclusive, clinicians have increasingly utilized the Afirma gene expression classifier (GEC) to rule out malignancy, but a retrospective analysis of almost 200 patients with indeterminate biopsy results along with a pooled analysis of 11 previous studies has raised questions about the negative predictive value of the test.

©Sebastian Kaulitzki/Fotolia

“The Afirma GEC test has substantial variability in performance,” said Dr. Zaid Al-Qurayshi of Tulane University, New Orleans, who reported the results at the annual meeting of the American Association of Endocrine Surgeons. “This variability cannot be explained based on differences in prevalence alone, but may also be the result of intrinsic test properties.”

The Afirma GEC measures the expression of 167 genes to more precisely determine the cancer risk of an indeterminate biopsied thyroid nodule and avoid unnecessary surgery. The test costs approximately $4,800 per nodule.

The researchers undertook the study in light of an American Thyroid Association (ATA) statement last year that concluded that test results are predicated on the clinician knowing the prevalence of malignancy within each indeterminate cytologic category at his/her own institution. Without this information, the performance of the diagnostic tests may vary substantially (Thyroid. 2015;25:760-8).

The single-center, retrospective cohort analysis included 192 patients with 210 indeterminate biopsy results, 145 of whom had surgery with 154 thyroid nodules. With a malignancy prevalence of 45%, the expected negative predictive value (NPV) of the test was estimated to be 85%, Dr. Al-Qurayshi said. However, the actual observed NPV was 69%. “If the prevalence was assumed to be 25%, the expected NPV was estimated to be 94%, while the observed NPV would have been 85%,” Dr. Al-Qurayshi said.

The researchers calculated the expected NPV by adopting the sensitivity and specificity rates of the test as reported in previous studies, while they calculated the observed NPV based on the actual negative rate among the Tulane cohort, Dr. Al-Qurayshi said.

Dr. Al-Qurayshi and colleagues then compared their results with pooled data from 11 other studies of the Afirma GEC. The pooled data analysis included 1,303 patients and yielded a malignancy prevalence of 31.1%, with a range of 29%-35%, and a pooled NPV of 92%, with a range of 87%-96%, Dr. Al-Qurayshi said.

“A lot of previously published studies took the sensitivity and specificity that were previously reported for granted, and now we are showing this sensitivity is all over the place,” Dr. Al-Qurayshi said. “Now, we don’t know which is the true one, and we need a larger clinical trial first to determine the true properties. Then we can ask how the prevalence in one’s institution is affecting the performance of the test.”

In an interview, Dr. Emad Kandil, senior study coauthor, also of Tulane, said the 69% NPV of the Tulane cohort puts the diagnostic scenario “back to ground zero, which is similar to what we had prior to the use of the new commercially available genetic tests.” He added, “A larger, randomized trial of the Afirma GEC test should answer those questions.”

The seminal study for the Afirma GEC, authored by Dr. Erik Alexander of Brigham and Women’s Hospital, Boston, in 2012, reported a 92% NPV with the test (N Engl J Med. 2012;367:705-15).

“The first thought was that they had different results because their population was different,” Dr. Al-Qurayshi said. “The ATA statement noted that it is the clinician’s responsibility to determine if this test is appropriate for their population or not, but the performance of the test doesn’t just depend on the population property, but it also depends on the intrinsic testing properties.”

Dr. Kandil disclosed that he has been a primary investigator in the ENHANCE multicenter study of the Afirma GEC. The other coauthors had no financial disclosures.

BALTIMORE – Biopsy results from a commercially available genetic test for ruling out malignancy of thyroid nodules may not provide reliable answers to clinicians and patients.

When fine-needle aspiration biopsy of thyroid nodules comes back inconclusive, clinicians have increasingly utilized the Afirma gene expression classifier (GEC) to rule out malignancy, but a retrospective analysis of almost 200 patients with indeterminate biopsy results along with a pooled analysis of 11 previous studies has raised questions about the negative predictive value of the test.

©Sebastian Kaulitzki/Fotolia

“The Afirma GEC test has substantial variability in performance,” said Dr. Zaid Al-Qurayshi of Tulane University, New Orleans, who reported the results at the annual meeting of the American Association of Endocrine Surgeons. “This variability cannot be explained based on differences in prevalence alone, but may also be the result of intrinsic test properties.”

The Afirma GEC measures the expression of 167 genes to more precisely determine the cancer risk of an indeterminate biopsied thyroid nodule and avoid unnecessary surgery. The test costs approximately $4,800 per nodule.

The researchers undertook the study in light of an American Thyroid Association (ATA) statement last year that concluded that test results are predicated on the clinician knowing the prevalence of malignancy within each indeterminate cytologic category at his/her own institution. Without this information, the performance of the diagnostic tests may vary substantially (Thyroid. 2015;25:760-8).

The single-center, retrospective cohort analysis included 192 patients with 210 indeterminate biopsy results, 145 of whom had surgery with 154 thyroid nodules. With a malignancy prevalence of 45%, the expected negative predictive value (NPV) of the test was estimated to be 85%, Dr. Al-Qurayshi said. However, the actual observed NPV was 69%. “If the prevalence was assumed to be 25%, the expected NPV was estimated to be 94%, while the observed NPV would have been 85%,” Dr. Al-Qurayshi said.

The researchers calculated the expected NPV by adopting the sensitivity and specificity rates of the test as reported in previous studies, while they calculated the observed NPV based on the actual negative rate among the Tulane cohort, Dr. Al-Qurayshi said.

Dr. Al-Qurayshi and colleagues then compared their results with pooled data from 11 other studies of the Afirma GEC. The pooled data analysis included 1,303 patients and yielded a malignancy prevalence of 31.1%, with a range of 29%-35%, and a pooled NPV of 92%, with a range of 87%-96%, Dr. Al-Qurayshi said.

“A lot of previously published studies took the sensitivity and specificity that were previously reported for granted, and now we are showing this sensitivity is all over the place,” Dr. Al-Qurayshi said. “Now, we don’t know which is the true one, and we need a larger clinical trial first to determine the true properties. Then we can ask how the prevalence in one’s institution is affecting the performance of the test.”

In an interview, Dr. Emad Kandil, senior study coauthor, also of Tulane, said the 69% NPV of the Tulane cohort puts the diagnostic scenario “back to ground zero, which is similar to what we had prior to the use of the new commercially available genetic tests.” He added, “A larger, randomized trial of the Afirma GEC test should answer those questions.”

The seminal study for the Afirma GEC, authored by Dr. Erik Alexander of Brigham and Women’s Hospital, Boston, in 2012, reported a 92% NPV with the test (N Engl J Med. 2012;367:705-15).

“The first thought was that they had different results because their population was different,” Dr. Al-Qurayshi said. “The ATA statement noted that it is the clinician’s responsibility to determine if this test is appropriate for their population or not, but the performance of the test doesn’t just depend on the population property, but it also depends on the intrinsic testing properties.”

Dr. Kandil disclosed that he has been a primary investigator in the ENHANCE multicenter study of the Afirma GEC. The other coauthors had no financial disclosures.

BALTIMORE – Biopsy results from a commercially available genetic test for ruling out malignancy of thyroid nodules may not provide reliable answers to clinicians and patients.

When fine-needle aspiration biopsy of thyroid nodules comes back inconclusive, clinicians have increasingly utilized the Afirma gene expression classifier (GEC) to rule out malignancy, but a retrospective analysis of almost 200 patients with indeterminate biopsy results along with a pooled analysis of 11 previous studies has raised questions about the negative predictive value of the test.

©Sebastian Kaulitzki/Fotolia

“The Afirma GEC test has substantial variability in performance,” said Dr. Zaid Al-Qurayshi of Tulane University, New Orleans, who reported the results at the annual meeting of the American Association of Endocrine Surgeons. “This variability cannot be explained based on differences in prevalence alone, but may also be the result of intrinsic test properties.”

The Afirma GEC measures the expression of 167 genes to more precisely determine the cancer risk of an indeterminate biopsied thyroid nodule and avoid unnecessary surgery. The test costs approximately $4,800 per nodule.

The researchers undertook the study in light of an American Thyroid Association (ATA) statement last year that concluded that test results are predicated on the clinician knowing the prevalence of malignancy within each indeterminate cytologic category at his/her own institution. Without this information, the performance of the diagnostic tests may vary substantially (Thyroid. 2015;25:760-8).

The single-center, retrospective cohort analysis included 192 patients with 210 indeterminate biopsy results, 145 of whom had surgery with 154 thyroid nodules. With a malignancy prevalence of 45%, the expected negative predictive value (NPV) of the test was estimated to be 85%, Dr. Al-Qurayshi said. However, the actual observed NPV was 69%. “If the prevalence was assumed to be 25%, the expected NPV was estimated to be 94%, while the observed NPV would have been 85%,” Dr. Al-Qurayshi said.

The researchers calculated the expected NPV by adopting the sensitivity and specificity rates of the test as reported in previous studies, while they calculated the observed NPV based on the actual negative rate among the Tulane cohort, Dr. Al-Qurayshi said.

Dr. Al-Qurayshi and colleagues then compared their results with pooled data from 11 other studies of the Afirma GEC. The pooled data analysis included 1,303 patients and yielded a malignancy prevalence of 31.1%, with a range of 29%-35%, and a pooled NPV of 92%, with a range of 87%-96%, Dr. Al-Qurayshi said.

“A lot of previously published studies took the sensitivity and specificity that were previously reported for granted, and now we are showing this sensitivity is all over the place,” Dr. Al-Qurayshi said. “Now, we don’t know which is the true one, and we need a larger clinical trial first to determine the true properties. Then we can ask how the prevalence in one’s institution is affecting the performance of the test.”

In an interview, Dr. Emad Kandil, senior study coauthor, also of Tulane, said the 69% NPV of the Tulane cohort puts the diagnostic scenario “back to ground zero, which is similar to what we had prior to the use of the new commercially available genetic tests.” He added, “A larger, randomized trial of the Afirma GEC test should answer those questions.”

The seminal study for the Afirma GEC, authored by Dr. Erik Alexander of Brigham and Women’s Hospital, Boston, in 2012, reported a 92% NPV with the test (N Engl J Med. 2012;367:705-15).

“The first thought was that they had different results because their population was different,” Dr. Al-Qurayshi said. “The ATA statement noted that it is the clinician’s responsibility to determine if this test is appropriate for their population or not, but the performance of the test doesn’t just depend on the population property, but it also depends on the intrinsic testing properties.”

Dr. Kandil disclosed that he has been a primary investigator in the ENHANCE multicenter study of the Afirma GEC. The other coauthors had no financial disclosures.

There has been quite a bit of discussion and controversy lately about transgender individuals. The debate has extended to the diagnosis itself and whether it should be maintained as an official entity. The previous edition of the Diagnostic and Statistical Manual included the diagnosis of gender identity disorder, which was modified to the current diagnosis of gender dysphoria that describes individuals who show a persistent desire to be the “other” gender and/or an insistence that their gender is different from their birth sex.

One question at the heart of this discussion is the degree to which psychiatric symptoms and disorders are inherent in the gender dysphoria itself or whether most, if not all, of the noted links to things like anxiety, depression, and suicidal behavior stem from the hostility and abuse that many of these youth endure.

As has been reported in the Pediatric News column LGBT Youth Consult, research is now focusing on the mental health of transgender youth, although the data are not entirely consistent. One recent study of 298 transgender women between the ages of 16 and 29 years, of whom nearly three-quarters had received crossgender hormones, showed quite high rates of psychiatric disorders including depression (35%), anxiety (8%), and substance abuse (11%).¹ Moderate to high levels of suicidality in the past month were found in 20% of the sample. Although one cannot conclude from this study that psychopathology is intrinsic to transgender individuals, it does suggest that difficulties can certainly persist among those who have socially transitioned to their affirmed gender.

In contrast, another study from the TransYouth Project showed much more hopeful results.² In this younger sample of 73 prepubescent children, 70% of whom were natal males and all of whom had been supported in the social transition to their affirmed gender at a relatively young age, levels of depressed symptoms were no different from those in 73 controls, and scores on an anxiety scale were only slightly elevated, but did not reach clinical or even subclinical levels as a group. The authors of this study concluded that psychiatric symptoms are not “synonymous” with being transgender. They suggest that supporting youth in their transition at earlier ages could possibly prevent the occurrence of mental health problems in the future.

There is wide acknowledgment that gender-nonconforming youth are at much heightened risk from what can be vicious and cruel maltreatment from peers and the wider community. Similarly, there is good consensus that “conversion therapy” approaches that actively try to discourage youth from their affirmed gender are misguided and unethical. What remains in question among well-meaning parents and clinicians alike, however, is at what age should social transition be supported and how encompassing should it be with regard to pronoun use, bathroom and dressing room access, clothing, and so on. Studies have shown that gender atypical behavior can be quite common in young children, with the vast majority eventually developing gender identities that are in line with their natal sex. Parents may worry that promoting a premature gender transition might expose their child to bullying and harassment that could otherwise be avoided. On the other hand, parents may worry that not supporting gender transition will be experienced as rejecting and critical, which could lead to increased feelings of depression and isolation. Although both views represent valid concerns, it is probably fair to say that among clinicians and researchers who work with transgender youth, there seems to be some movement toward more active acceptance and encouragement of a child’s gender expression at the time, with the understanding that for many, there can be continued movement in one’s gender “journey” across development.

Interestingly, these studies are being published in parallel with some neuroimaging research investigating sex differences with regard to the brain. A recent study from the Proceedings of the National Academy of Sciences found that, among many different regions that are known to show some sex differences with regard to size or connectivity to other regions, the typical human brain shows a “mosaic” pattern in which some regions look more typically male while others look more typically female.³

References

1. JAMA Pediatr. 2016 May 1;170(5):481-6.
2. Pediatrics. 2016;137(3):1-8.
3. PNAS. 2015;112(50):15468-73

Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych.

There has been quite a bit of discussion and controversy lately about transgender individuals. The debate has extended to the diagnosis itself and whether it should be maintained as an official entity. The previous edition of the Diagnostic and Statistical Manual included the diagnosis of gender identity disorder, which was modified to the current diagnosis of gender dysphoria that describes individuals who show a persistent desire to be the “other” gender and/or an insistence that their gender is different from their birth sex.

One question at the heart of this discussion is the degree to which psychiatric symptoms and disorders are inherent in the gender dysphoria itself or whether most, if not all, of the noted links to things like anxiety, depression, and suicidal behavior stem from the hostility and abuse that many of these youth endure.

As has been reported in the Pediatric News column LGBT Youth Consult, research is now focusing on the mental health of transgender youth, although the data are not entirely consistent. One recent study of 298 transgender women between the ages of 16 and 29 years, of whom nearly three-quarters had received crossgender hormones, showed quite high rates of psychiatric disorders including depression (35%), anxiety (8%), and substance abuse (11%).¹ Moderate to high levels of suicidality in the past month were found in 20% of the sample. Although one cannot conclude from this study that psychopathology is intrinsic to transgender individuals, it does suggest that difficulties can certainly persist among those who have socially transitioned to their affirmed gender.

In contrast, another study from the TransYouth Project showed much more hopeful results.² In this younger sample of 73 prepubescent children, 70% of whom were natal males and all of whom had been supported in the social transition to their affirmed gender at a relatively young age, levels of depressed symptoms were no different from those in 73 controls, and scores on an anxiety scale were only slightly elevated, but did not reach clinical or even subclinical levels as a group. The authors of this study concluded that psychiatric symptoms are not “synonymous” with being transgender. They suggest that supporting youth in their transition at earlier ages could possibly prevent the occurrence of mental health problems in the future.

There is wide acknowledgment that gender-nonconforming youth are at much heightened risk from what can be vicious and cruel maltreatment from peers and the wider community. Similarly, there is good consensus that “conversion therapy” approaches that actively try to discourage youth from their affirmed gender are misguided and unethical. What remains in question among well-meaning parents and clinicians alike, however, is at what age should social transition be supported and how encompassing should it be with regard to pronoun use, bathroom and dressing room access, clothing, and so on. Studies have shown that gender atypical behavior can be quite common in young children, with the vast majority eventually developing gender identities that are in line with their natal sex. Parents may worry that promoting a premature gender transition might expose their child to bullying and harassment that could otherwise be avoided. On the other hand, parents may worry that not supporting gender transition will be experienced as rejecting and critical, which could lead to increased feelings of depression and isolation. Although both views represent valid concerns, it is probably fair to say that among clinicians and researchers who work with transgender youth, there seems to be some movement toward more active acceptance and encouragement of a child’s gender expression at the time, with the understanding that for many, there can be continued movement in one’s gender “journey” across development.

Interestingly, these studies are being published in parallel with some neuroimaging research investigating sex differences with regard to the brain. A recent study from the Proceedings of the National Academy of Sciences found that, among many different regions that are known to show some sex differences with regard to size or connectivity to other regions, the typical human brain shows a “mosaic” pattern in which some regions look more typically male while others look more typically female.³

References

1. JAMA Pediatr. 2016 May 1;170(5):481-6.
2. Pediatrics. 2016;137(3):1-8.
3. PNAS. 2015;112(50):15468-73

Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych.

There has been quite a bit of discussion and controversy lately about transgender individuals. The debate has extended to the diagnosis itself and whether it should be maintained as an official entity. The previous edition of the Diagnostic and Statistical Manual included the diagnosis of gender identity disorder, which was modified to the current diagnosis of gender dysphoria that describes individuals who show a persistent desire to be the “other” gender and/or an insistence that their gender is different from their birth sex.

One question at the heart of this discussion is the degree to which psychiatric symptoms and disorders are inherent in the gender dysphoria itself or whether most, if not all, of the noted links to things like anxiety, depression, and suicidal behavior stem from the hostility and abuse that many of these youth endure.

As has been reported in the Pediatric News column LGBT Youth Consult, research is now focusing on the mental health of transgender youth, although the data are not entirely consistent. One recent study of 298 transgender women between the ages of 16 and 29 years, of whom nearly three-quarters had received crossgender hormones, showed quite high rates of psychiatric disorders including depression (35%), anxiety (8%), and substance abuse (11%).¹ Moderate to high levels of suicidality in the past month were found in 20% of the sample. Although one cannot conclude from this study that psychopathology is intrinsic to transgender individuals, it does suggest that difficulties can certainly persist among those who have socially transitioned to their affirmed gender.

In contrast, another study from the TransYouth Project showed much more hopeful results.² In this younger sample of 73 prepubescent children, 70% of whom were natal males and all of whom had been supported in the social transition to their affirmed gender at a relatively young age, levels of depressed symptoms were no different from those in 73 controls, and scores on an anxiety scale were only slightly elevated, but did not reach clinical or even subclinical levels as a group. The authors of this study concluded that psychiatric symptoms are not “synonymous” with being transgender. They suggest that supporting youth in their transition at earlier ages could possibly prevent the occurrence of mental health problems in the future.

There is wide acknowledgment that gender-nonconforming youth are at much heightened risk from what can be vicious and cruel maltreatment from peers and the wider community. Similarly, there is good consensus that “conversion therapy” approaches that actively try to discourage youth from their affirmed gender are misguided and unethical. What remains in question among well-meaning parents and clinicians alike, however, is at what age should social transition be supported and how encompassing should it be with regard to pronoun use, bathroom and dressing room access, clothing, and so on. Studies have shown that gender atypical behavior can be quite common in young children, with the vast majority eventually developing gender identities that are in line with their natal sex. Parents may worry that promoting a premature gender transition might expose their child to bullying and harassment that could otherwise be avoided. On the other hand, parents may worry that not supporting gender transition will be experienced as rejecting and critical, which could lead to increased feelings of depression and isolation. Although both views represent valid concerns, it is probably fair to say that among clinicians and researchers who work with transgender youth, there seems to be some movement toward more active acceptance and encouragement of a child’s gender expression at the time, with the understanding that for many, there can be continued movement in one’s gender “journey” across development.

Interestingly, these studies are being published in parallel with some neuroimaging research investigating sex differences with regard to the brain. A recent study from the Proceedings of the National Academy of Sciences found that, among many different regions that are known to show some sex differences with regard to size or connectivity to other regions, the typical human brain shows a “mosaic” pattern in which some regions look more typically male while others look more typically female.³

References

1. JAMA Pediatr. 2016 May 1;170(5):481-6.
2. Pediatrics. 2016;137(3):1-8.
3. PNAS. 2015;112(50):15468-73

Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @pedipsych.

A gas-filled gastric balloon may promote weight loss more effectively than does its water-filled cousin, according to data from a randomized study that was presented during a teleconference in advance of the annual Digestive Disease Week. A water-filled version of the device is on the market already.

The study enrolled 387 people aged 22 to 64 years old with a body mass index (BMI) from 30 to 40 kg/m² at 15 different sites. People were randomized to the Obalon Balloon System or to a sham control group. People in the treatment group were asked to swallow three capsules: one every 3 weeks until week 12.

The balloon is contained within the capsule, and after swallowing each balloon was filled with 250 cubic centimeters (slightly more than 1 cup) of a nitrogen-based gas via a small catheter. The control group also swallowed sugar-filled capsules (sham treatment).

A total of 366 patients swallowed at least two capsules and were included in the per protocol analysis: 185 in the treatment group and 181 in the control group. All patients saw a registered dietitian every 3 weeks and also followed diet, exercise, and behavior modification lifestyle changes. Obalon balloons were removed endoscopically at week 24, when participants’ weight was assessed.

The balloon-treated group had a mean weight loss of 6.8%, compared with 3.59% in the control group. At least 5% of body weight loss was achieved by 64.3% of the balloon-treated group, compared with 32% of the control group. The balloon treatment group, but not controls, showed improvements in levels of systolic blood pressure, LDL cholesterol, and triglycerides.

The finding that obese participants who swallowed the Obalon 6-Month Balloon System lost nearly 7% of their body weight and experienced improvements in other health indicators “is important because weight loss is quite difficult to achieve and a significant number of people are not successful in achieving their weight loss goals with diet changes and exercise,” said lead author Dr. Shelby Sullivan, who presented the findings.

Adverse events were mostly mild and included diarrhea, cramping, and nausea in nine patients. No hospitalizations were required for these events. One patient with a pre-existing bleeding ulcer experienced a serious adverse event, which the investigators classified as being possibly related to treatment.

“This patient had an orthopedic procedure and was taking high doses of NSAIDs. That should have been excluded in the trial,” said Dr. Sullivan of Washington University, St. Louis.

“Treatment over time, and even with the initial swallowing of the balloon capsule is quite well tolerated, with only mild symptoms compared with other balloon systems,” she said. “Anecdotally, my impression is that patients liked the therapy because it allowed them to follow lifestyle therapy as well.”

The Obalon balloon is given in stages, giving patients’ stomachs time to adjust to the balloon. Unlike liquid-filled balloons, the gas floats up in the stomach and may cause fewer symptoms than liquid-filled balloons, she suggested.

Dr. Sullivan believes that when the Obalon system is used in the real world, it may lead to even greater weight loss. “This has been seen in other sham-controlled trials,” she noted.

Patients enrolled in the trial are being followed longitudinally and those in the sham control group are allowed to cross over to the Obalon balloons on an open-label basis.

“More than 640 million people globally have obesity, and at this time, there are more overweight than underweight people in the world. Some treatments that are alternatives to diet and exercise may be risky. Obalon swallowable balloon is a new treatment option that can help patients lose almost twice as much weight compared with lifestyle changes alone,” she said.

Dr. Sullivan received funding for this study from Obalon Therapeutics.

A gas-filled gastric balloon may promote weight loss more effectively than does its water-filled cousin, according to data from a randomized study that was presented during a teleconference in advance of the annual Digestive Disease Week. A water-filled version of the device is on the market already.

The study enrolled 387 people aged 22 to 64 years old with a body mass index (BMI) from 30 to 40 kg/m² at 15 different sites. People were randomized to the Obalon Balloon System or to a sham control group. People in the treatment group were asked to swallow three capsules: one every 3 weeks until week 12.

The balloon is contained within the capsule, and after swallowing each balloon was filled with 250 cubic centimeters (slightly more than 1 cup) of a nitrogen-based gas via a small catheter. The control group also swallowed sugar-filled capsules (sham treatment).

A total of 366 patients swallowed at least two capsules and were included in the per protocol analysis: 185 in the treatment group and 181 in the control group. All patients saw a registered dietitian every 3 weeks and also followed diet, exercise, and behavior modification lifestyle changes. Obalon balloons were removed endoscopically at week 24, when participants’ weight was assessed.

The balloon-treated group had a mean weight loss of 6.8%, compared with 3.59% in the control group. At least 5% of body weight loss was achieved by 64.3% of the balloon-treated group, compared with 32% of the control group. The balloon treatment group, but not controls, showed improvements in levels of systolic blood pressure, LDL cholesterol, and triglycerides.

The finding that obese participants who swallowed the Obalon 6-Month Balloon System lost nearly 7% of their body weight and experienced improvements in other health indicators “is important because weight loss is quite difficult to achieve and a significant number of people are not successful in achieving their weight loss goals with diet changes and exercise,” said lead author Dr. Shelby Sullivan, who presented the findings.

Adverse events were mostly mild and included diarrhea, cramping, and nausea in nine patients. No hospitalizations were required for these events. One patient with a pre-existing bleeding ulcer experienced a serious adverse event, which the investigators classified as being possibly related to treatment.

“This patient had an orthopedic procedure and was taking high doses of NSAIDs. That should have been excluded in the trial,” said Dr. Sullivan of Washington University, St. Louis.

“Treatment over time, and even with the initial swallowing of the balloon capsule is quite well tolerated, with only mild symptoms compared with other balloon systems,” she said. “Anecdotally, my impression is that patients liked the therapy because it allowed them to follow lifestyle therapy as well.”

The Obalon balloon is given in stages, giving patients’ stomachs time to adjust to the balloon. Unlike liquid-filled balloons, the gas floats up in the stomach and may cause fewer symptoms than liquid-filled balloons, she suggested.

Dr. Sullivan believes that when the Obalon system is used in the real world, it may lead to even greater weight loss. “This has been seen in other sham-controlled trials,” she noted.

Patients enrolled in the trial are being followed longitudinally and those in the sham control group are allowed to cross over to the Obalon balloons on an open-label basis.

“More than 640 million people globally have obesity, and at this time, there are more overweight than underweight people in the world. Some treatments that are alternatives to diet and exercise may be risky. Obalon swallowable balloon is a new treatment option that can help patients lose almost twice as much weight compared with lifestyle changes alone,” she said.

Dr. Sullivan received funding for this study from Obalon Therapeutics.

A gas-filled gastric balloon may promote weight loss more effectively than does its water-filled cousin, according to data from a randomized study that was presented during a teleconference in advance of the annual Digestive Disease Week. A water-filled version of the device is on the market already.

The study enrolled 387 people aged 22 to 64 years old with a body mass index (BMI) from 30 to 40 kg/m² at 15 different sites. People were randomized to the Obalon Balloon System or to a sham control group. People in the treatment group were asked to swallow three capsules: one every 3 weeks until week 12.

The balloon is contained within the capsule, and after swallowing each balloon was filled with 250 cubic centimeters (slightly more than 1 cup) of a nitrogen-based gas via a small catheter. The control group also swallowed sugar-filled capsules (sham treatment).

A total of 366 patients swallowed at least two capsules and were included in the per protocol analysis: 185 in the treatment group and 181 in the control group. All patients saw a registered dietitian every 3 weeks and also followed diet, exercise, and behavior modification lifestyle changes. Obalon balloons were removed endoscopically at week 24, when participants’ weight was assessed.

The balloon-treated group had a mean weight loss of 6.8%, compared with 3.59% in the control group. At least 5% of body weight loss was achieved by 64.3% of the balloon-treated group, compared with 32% of the control group. The balloon treatment group, but not controls, showed improvements in levels of systolic blood pressure, LDL cholesterol, and triglycerides.

The finding that obese participants who swallowed the Obalon 6-Month Balloon System lost nearly 7% of their body weight and experienced improvements in other health indicators “is important because weight loss is quite difficult to achieve and a significant number of people are not successful in achieving their weight loss goals with diet changes and exercise,” said lead author Dr. Shelby Sullivan, who presented the findings.

Adverse events were mostly mild and included diarrhea, cramping, and nausea in nine patients. No hospitalizations were required for these events. One patient with a pre-existing bleeding ulcer experienced a serious adverse event, which the investigators classified as being possibly related to treatment.

“This patient had an orthopedic procedure and was taking high doses of NSAIDs. That should have been excluded in the trial,” said Dr. Sullivan of Washington University, St. Louis.

“Treatment over time, and even with the initial swallowing of the balloon capsule is quite well tolerated, with only mild symptoms compared with other balloon systems,” she said. “Anecdotally, my impression is that patients liked the therapy because it allowed them to follow lifestyle therapy as well.”

The Obalon balloon is given in stages, giving patients’ stomachs time to adjust to the balloon. Unlike liquid-filled balloons, the gas floats up in the stomach and may cause fewer symptoms than liquid-filled balloons, she suggested.

Dr. Sullivan believes that when the Obalon system is used in the real world, it may lead to even greater weight loss. “This has been seen in other sham-controlled trials,” she noted.

Patients enrolled in the trial are being followed longitudinally and those in the sham control group are allowed to cross over to the Obalon balloons on an open-label basis.

“More than 640 million people globally have obesity, and at this time, there are more overweight than underweight people in the world. Some treatments that are alternatives to diet and exercise may be risky. Obalon swallowable balloon is a new treatment option that can help patients lose almost twice as much weight compared with lifestyle changes alone,” she said.

Dr. Sullivan received funding for this study from Obalon Therapeutics.

FLORENCE, ITALY – Influenza vaccination of heart failure patients cut their rate of hospitalization for cardiovascular disease by nearly a third during the year following vaccination in a study of more than 59,000 British heart failure patients.

Influenza vaccination of heart failure patients also cut their rate of hospitalization for respiratory infections by a statistically significant 16% during the year following vaccination, Dr. Kazem Rahimi said at a meeting held by the Heart Failure Association of the ESC.

Mitchel L. Zoler/Frontline Medical News

“In the absence of randomized trials, this [observational] study of 59,202 heart failure patients provides the most compelling evidence to date for the protective effect of influenza vaccination on hospital admissions,” said Dr. Rahimi, a cardiologist and epidemiologist who is deputy director of the George Institute for Global Health at the University of Oxford (England).

The analysis also showed that influenza vaccination of heart failure patients had no significant effect on all-cause hospitalizations.

Dr. Rahimi and his associates analyzed electronic health records from primary and secondary care settings in England during 1990-2013, from which they identified 59,202 heart failure patients with records for at least 1 year of influenza vaccination and at least 1 year without vaccination. The patients averaged 75 years old and were divided equally among women and men.

To control for potential confounding factors, they used a self-control model in which hospitalizations for each heart failure patient during the year following an influenza vaccination were compared with an adjacent year for that same patient when no vaccination occurred.

The results showed that the incidence of hospitalizations for cardiovascular diseases fell by a statistically significant 30% in the year following an influenza vaccination, compared with one or more adjacent years without vaccination. The protection again hospitalization was strongest during the second month following vaccination and then gradually waned over the ensuing year; by about 10 months following vaccination the protection effect had disappeared.

The study also looked at influenza vaccine uptake by heart failure patients through the 24-year period examined. During that time, the vaccination uptake rate rose from a low of less than 10% in 1990 to a peak rate of just over 60% in 2006, after which the rate gradually declined to a rate of just under 50% in 2013. Dr. Rahimi attributed the rise in uptake during the period from 1990 to 2006 in part to incentives that primary care physicians in England began receiving to administer influenza vaccine to their patients. “Higher uptake of annual vaccination in heart failure patients may help alleviate the burden of influenza-related hospital admissions,” he said.

Dr. Rahimi had no disclosures.

[email protected]

On Twitter @mitchelzoler

FLORENCE, ITALY – Influenza vaccination of heart failure patients cut their rate of hospitalization for cardiovascular disease by nearly a third during the year following vaccination in a study of more than 59,000 British heart failure patients.

Influenza vaccination of heart failure patients also cut their rate of hospitalization for respiratory infections by a statistically significant 16% during the year following vaccination, Dr. Kazem Rahimi said at a meeting held by the Heart Failure Association of the ESC.

Mitchel L. Zoler/Frontline Medical News

“In the absence of randomized trials, this [observational] study of 59,202 heart failure patients provides the most compelling evidence to date for the protective effect of influenza vaccination on hospital admissions,” said Dr. Rahimi, a cardiologist and epidemiologist who is deputy director of the George Institute for Global Health at the University of Oxford (England).

The analysis also showed that influenza vaccination of heart failure patients had no significant effect on all-cause hospitalizations.

Dr. Rahimi and his associates analyzed electronic health records from primary and secondary care settings in England during 1990-2013, from which they identified 59,202 heart failure patients with records for at least 1 year of influenza vaccination and at least 1 year without vaccination. The patients averaged 75 years old and were divided equally among women and men.

To control for potential confounding factors, they used a self-control model in which hospitalizations for each heart failure patient during the year following an influenza vaccination were compared with an adjacent year for that same patient when no vaccination occurred.

The results showed that the incidence of hospitalizations for cardiovascular diseases fell by a statistically significant 30% in the year following an influenza vaccination, compared with one or more adjacent years without vaccination. The protection again hospitalization was strongest during the second month following vaccination and then gradually waned over the ensuing year; by about 10 months following vaccination the protection effect had disappeared.

The study also looked at influenza vaccine uptake by heart failure patients through the 24-year period examined. During that time, the vaccination uptake rate rose from a low of less than 10% in 1990 to a peak rate of just over 60% in 2006, after which the rate gradually declined to a rate of just under 50% in 2013. Dr. Rahimi attributed the rise in uptake during the period from 1990 to 2006 in part to incentives that primary care physicians in England began receiving to administer influenza vaccine to their patients. “Higher uptake of annual vaccination in heart failure patients may help alleviate the burden of influenza-related hospital admissions,” he said.

Dr. Rahimi had no disclosures.

[email protected]

On Twitter @mitchelzoler

FLORENCE, ITALY – Influenza vaccination of heart failure patients cut their rate of hospitalization for cardiovascular disease by nearly a third during the year following vaccination in a study of more than 59,000 British heart failure patients.

Influenza vaccination of heart failure patients also cut their rate of hospitalization for respiratory infections by a statistically significant 16% during the year following vaccination, Dr. Kazem Rahimi said at a meeting held by the Heart Failure Association of the ESC.

Mitchel L. Zoler/Frontline Medical News

“In the absence of randomized trials, this [observational] study of 59,202 heart failure patients provides the most compelling evidence to date for the protective effect of influenza vaccination on hospital admissions,” said Dr. Rahimi, a cardiologist and epidemiologist who is deputy director of the George Institute for Global Health at the University of Oxford (England).

The analysis also showed that influenza vaccination of heart failure patients had no significant effect on all-cause hospitalizations.

Dr. Rahimi and his associates analyzed electronic health records from primary and secondary care settings in England during 1990-2013, from which they identified 59,202 heart failure patients with records for at least 1 year of influenza vaccination and at least 1 year without vaccination. The patients averaged 75 years old and were divided equally among women and men.

To control for potential confounding factors, they used a self-control model in which hospitalizations for each heart failure patient during the year following an influenza vaccination were compared with an adjacent year for that same patient when no vaccination occurred.

The results showed that the incidence of hospitalizations for cardiovascular diseases fell by a statistically significant 30% in the year following an influenza vaccination, compared with one or more adjacent years without vaccination. The protection again hospitalization was strongest during the second month following vaccination and then gradually waned over the ensuing year; by about 10 months following vaccination the protection effect had disappeared.

The study also looked at influenza vaccine uptake by heart failure patients through the 24-year period examined. During that time, the vaccination uptake rate rose from a low of less than 10% in 1990 to a peak rate of just over 60% in 2006, after which the rate gradually declined to a rate of just under 50% in 2013. Dr. Rahimi attributed the rise in uptake during the period from 1990 to 2006 in part to incentives that primary care physicians in England began receiving to administer influenza vaccine to their patients. “Higher uptake of annual vaccination in heart failure patients may help alleviate the burden of influenza-related hospital admissions,” he said.

Dr. Rahimi had no disclosures.

[email protected]

On Twitter @mitchelzoler

Thank You for Investing in the Future of CT Surgery

Last year, the Foundation provided research and fellowship opportunities to 134 young surgeons from five continents, launched eight new programs and the Academic Excellence Award, while maintaining our core programs. We also increased revenue by almost $900,000, allowing us to grow program funding by 39 percent.

This wouldn’t have been possible without our individual donors and corporate/organizational partners.

Read the 2015 Graham Foundation Annual Report

The AATS Graham Foundation has been hard at work over this past year to advance its mission of driving leadership in research and education through clinical and research fellowship programs. These spectacular programs are only  possible with the support of our individual donors, institutional and foundation contributors, and industry partners. Read the report here.

Check out the Donor Honor Roll

Your support is key. Help us ensure the future of the specialty.

Make a gift to the Foundation or renew your commitment

Thank You for Investing in the Future of CT Surgery

Last year, the Foundation provided research and fellowship opportunities to 134 young surgeons from five continents, launched eight new programs and the Academic Excellence Award, while maintaining our core programs. We also increased revenue by almost $900,000, allowing us to grow program funding by 39 percent.

This wouldn’t have been possible without our individual donors and corporate/organizational partners.

Read the 2015 Graham Foundation Annual Report

The AATS Graham Foundation has been hard at work over this past year to advance its mission of driving leadership in research and education through clinical and research fellowship programs. These spectacular programs are only  possible with the support of our individual donors, institutional and foundation contributors, and industry partners. Read the report here.

Check out the Donor Honor Roll

Your support is key. Help us ensure the future of the specialty.

Make a gift to the Foundation or renew your commitment

Thank You for Investing in the Future of CT Surgery

Last year, the Foundation provided research and fellowship opportunities to 134 young surgeons from five continents, launched eight new programs and the Academic Excellence Award, while maintaining our core programs. We also increased revenue by almost $900,000, allowing us to grow program funding by 39 percent.

This wouldn’t have been possible without our individual donors and corporate/organizational partners.

Read the 2015 Graham Foundation Annual Report

The AATS Graham Foundation has been hard at work over this past year to advance its mission of driving leadership in research and education through clinical and research fellowship programs. These spectacular programs are only  possible with the support of our individual donors, institutional and foundation contributors, and industry partners. Read the report here.

Check out the Donor Honor Roll

Your support is key. Help us ensure the future of the specialty.

Make a gift to the Foundation or renew your commitment

CHICAGO – Combination therapy with oxandrolone and propranolol can attenuate burn-induced growth arrest and increase growth rate in severely burned children, according to findings from a prospective, randomized clinical trial.

Of 612 children with burns over at least 30% of their total body surface area (average of more than 50%), 103 were randomized to receive treatment with both oxandrolone and propranolol, 67 received oxandrolone alone, 194 received propranolol alone, and 248 served as controls. After a minimum of 1 year of treatment, the average growth rate was 5.9 cm in the control group and 7.6 cm in the group receiving combination therapy, Dr. David N. Herndon of the University of Texas Medical Branch at Galveston reported at the annual meeting of the American Surgical Association.

“The rate of growth with combination therapy was significantly greater than with either of the individual drugs alone,” Dr. Herndon said.

Further, the period of growth arrest was significantly shorter – by 84 days – among those in the combination-treatment group, compared with those in the control group.

Study subjects were children treated at Shriners Hospitals for Children – Galveston from 1997 to 2015. Boys aged 6 months to 14 years and girls aged 6 months to 12 years were included to eliminate the variable onset of postpubescent growth delay. About two-thirds in each group were boys, and the ages in the patient groups were similar. Mortality was low and was similar across the groups, as was hospital length of stay.

Dr. Herndon and his colleagues controlled for heterogeneous burn distribution between the groups in the course of their analyses, as well as age.

In children with severe, extensive burn injury, the hypercatabolic response is mediated by increased production of catecholamines and corticosteroids, coupled with decreased production of testosterone. This contributes to growth arrest and to decreased strength for up to 2 years after burn injury, he explained. Children with burns over 50% of their total body surface routinely survive acute hospitalization but, at 3 months post injury, are thin, have difficulty walking, and require occupational and physical therapy to help them perform even the simplest activities of daily living.

At 1 year, a raised inflammatory mass covers their wounds, they experience itching, and they have, in large part, stunted growth; there is severe loss of lean body mass and strength, and fracture risk is increased, Dr. Herndon said.

In previous work, he and his colleagues showed that administration of propranolol at an average dose of 4 mg/kg per day for 1 year decreased cardiac work and resting energy expenditure while increasing peripheral lean mass. Further, they found that the testosterone analog oxandrolone, given at 0.1 mg/kg twice per day for 1 year, improved lean body mass accretion and bone mineral content.

The current study was conducted to test the effects of administering both agents in combination.

“The combined use of oxandrolone and propranolol in severely burned children confers an additional benefit on growth over either treatment alone,” Dr. Herndon said, adding that the additive effects of combination therapy may be due to the effects of oxandrolone on bone growth and the anti-inflammatory effects of propranolol.

“The additional benefits point out mechanistic changes that may be eventful in the treatment of hypermetabolism generally and in inflammatory states,” he concluded.

Dr. Herndon reported having no disclosures.

[email protected]

CHICAGO – Combination therapy with oxandrolone and propranolol can attenuate burn-induced growth arrest and increase growth rate in severely burned children, according to findings from a prospective, randomized clinical trial.

Of 612 children with burns over at least 30% of their total body surface area (average of more than 50%), 103 were randomized to receive treatment with both oxandrolone and propranolol, 67 received oxandrolone alone, 194 received propranolol alone, and 248 served as controls. After a minimum of 1 year of treatment, the average growth rate was 5.9 cm in the control group and 7.6 cm in the group receiving combination therapy, Dr. David N. Herndon of the University of Texas Medical Branch at Galveston reported at the annual meeting of the American Surgical Association.

“The rate of growth with combination therapy was significantly greater than with either of the individual drugs alone,” Dr. Herndon said.

Further, the period of growth arrest was significantly shorter – by 84 days – among those in the combination-treatment group, compared with those in the control group.

Study subjects were children treated at Shriners Hospitals for Children – Galveston from 1997 to 2015. Boys aged 6 months to 14 years and girls aged 6 months to 12 years were included to eliminate the variable onset of postpubescent growth delay. About two-thirds in each group were boys, and the ages in the patient groups were similar. Mortality was low and was similar across the groups, as was hospital length of stay.

Dr. Herndon and his colleagues controlled for heterogeneous burn distribution between the groups in the course of their analyses, as well as age.

In children with severe, extensive burn injury, the hypercatabolic response is mediated by increased production of catecholamines and corticosteroids, coupled with decreased production of testosterone. This contributes to growth arrest and to decreased strength for up to 2 years after burn injury, he explained. Children with burns over 50% of their total body surface routinely survive acute hospitalization but, at 3 months post injury, are thin, have difficulty walking, and require occupational and physical therapy to help them perform even the simplest activities of daily living.

At 1 year, a raised inflammatory mass covers their wounds, they experience itching, and they have, in large part, stunted growth; there is severe loss of lean body mass and strength, and fracture risk is increased, Dr. Herndon said.

In previous work, he and his colleagues showed that administration of propranolol at an average dose of 4 mg/kg per day for 1 year decreased cardiac work and resting energy expenditure while increasing peripheral lean mass. Further, they found that the testosterone analog oxandrolone, given at 0.1 mg/kg twice per day for 1 year, improved lean body mass accretion and bone mineral content.

The current study was conducted to test the effects of administering both agents in combination.

“The combined use of oxandrolone and propranolol in severely burned children confers an additional benefit on growth over either treatment alone,” Dr. Herndon said, adding that the additive effects of combination therapy may be due to the effects of oxandrolone on bone growth and the anti-inflammatory effects of propranolol.

“The additional benefits point out mechanistic changes that may be eventful in the treatment of hypermetabolism generally and in inflammatory states,” he concluded.

Dr. Herndon reported having no disclosures.

[email protected]

CHICAGO – Combination therapy with oxandrolone and propranolol can attenuate burn-induced growth arrest and increase growth rate in severely burned children, according to findings from a prospective, randomized clinical trial.

Of 612 children with burns over at least 30% of their total body surface area (average of more than 50%), 103 were randomized to receive treatment with both oxandrolone and propranolol, 67 received oxandrolone alone, 194 received propranolol alone, and 248 served as controls. After a minimum of 1 year of treatment, the average growth rate was 5.9 cm in the control group and 7.6 cm in the group receiving combination therapy, Dr. David N. Herndon of the University of Texas Medical Branch at Galveston reported at the annual meeting of the American Surgical Association.

“The rate of growth with combination therapy was significantly greater than with either of the individual drugs alone,” Dr. Herndon said.

Further, the period of growth arrest was significantly shorter – by 84 days – among those in the combination-treatment group, compared with those in the control group.

Study subjects were children treated at Shriners Hospitals for Children – Galveston from 1997 to 2015. Boys aged 6 months to 14 years and girls aged 6 months to 12 years were included to eliminate the variable onset of postpubescent growth delay. About two-thirds in each group were boys, and the ages in the patient groups were similar. Mortality was low and was similar across the groups, as was hospital length of stay.

Dr. Herndon and his colleagues controlled for heterogeneous burn distribution between the groups in the course of their analyses, as well as age.

In children with severe, extensive burn injury, the hypercatabolic response is mediated by increased production of catecholamines and corticosteroids, coupled with decreased production of testosterone. This contributes to growth arrest and to decreased strength for up to 2 years after burn injury, he explained. Children with burns over 50% of their total body surface routinely survive acute hospitalization but, at 3 months post injury, are thin, have difficulty walking, and require occupational and physical therapy to help them perform even the simplest activities of daily living.

At 1 year, a raised inflammatory mass covers their wounds, they experience itching, and they have, in large part, stunted growth; there is severe loss of lean body mass and strength, and fracture risk is increased, Dr. Herndon said.

In previous work, he and his colleagues showed that administration of propranolol at an average dose of 4 mg/kg per day for 1 year decreased cardiac work and resting energy expenditure while increasing peripheral lean mass. Further, they found that the testosterone analog oxandrolone, given at 0.1 mg/kg twice per day for 1 year, improved lean body mass accretion and bone mineral content.

The current study was conducted to test the effects of administering both agents in combination.

“The combined use of oxandrolone and propranolol in severely burned children confers an additional benefit on growth over either treatment alone,” Dr. Herndon said, adding that the additive effects of combination therapy may be due to the effects of oxandrolone on bone growth and the anti-inflammatory effects of propranolol.

“The additional benefits point out mechanistic changes that may be eventful in the treatment of hypermetabolism generally and in inflammatory states,” he concluded.

Dr. Herndon reported having no disclosures.

[email protected]

Materials to support the families of children with serious illnesses have been developed by the National Institute of Nursing Research, which is part of the National Institutes of Health. The materials are associated with the NINR’s “Palliative Care: Conversations Matter” campaign.

“Palliative care is often associated with end of life, making it difficult for patients and their families – and even for healthcare providers – to start conversations around the subject. However, palliative care can be incredibly helpful for patients and their families at any stage during an illness. We hope these materials will improve patient and family understanding of pediatric palliative care and facilitate discussion with healthcare teams,” NINR Director Patricia A. Grady said in a written statement.

The resources, which include a fact sheet, a resource card to help families find support, and a series of family stories, are available in both Spanish and English. The NINR developed these materials with feedback from parents of seriously ill children. To learn more, click here

[email protected]

Materials to support the families of children with serious illnesses have been developed by the National Institute of Nursing Research, which is part of the National Institutes of Health. The materials are associated with the NINR’s “Palliative Care: Conversations Matter” campaign.

“Palliative care is often associated with end of life, making it difficult for patients and their families – and even for healthcare providers – to start conversations around the subject. However, palliative care can be incredibly helpful for patients and their families at any stage during an illness. We hope these materials will improve patient and family understanding of pediatric palliative care and facilitate discussion with healthcare teams,” NINR Director Patricia A. Grady said in a written statement.

The resources, which include a fact sheet, a resource card to help families find support, and a series of family stories, are available in both Spanish and English. The NINR developed these materials with feedback from parents of seriously ill children. To learn more, click here

[email protected]

Materials to support the families of children with serious illnesses have been developed by the National Institute of Nursing Research, which is part of the National Institutes of Health. The materials are associated with the NINR’s “Palliative Care: Conversations Matter” campaign.

“Palliative care is often associated with end of life, making it difficult for patients and their families – and even for healthcare providers – to start conversations around the subject. However, palliative care can be incredibly helpful for patients and their families at any stage during an illness. We hope these materials will improve patient and family understanding of pediatric palliative care and facilitate discussion with healthcare teams,” NINR Director Patricia A. Grady said in a written statement.

The resources, which include a fact sheet, a resource card to help families find support, and a series of family stories, are available in both Spanish and English. The NINR developed these materials with feedback from parents of seriously ill children. To learn more, click here

[email protected]

I think it is really cool that this publication has a series of articles on “What Cardiologists [or infection disease specialists, nephrologists, etc.] Want Hospitalists to Know.” I’m always interested to see which clinical topics made the list and which I’m already reasonably familiar with versus know little about. I’ve added this series to my list of things that are always worth the time to read, along with the “What’s New” section in UpToDate, review articles in major journals, and the Cleveland Clinic Journal of Medicine.

Not long ago, I worked with a hospitalist group that had agreed to cardiologists’ request that new hospitalists round with a cardiologist for something like three days as part of their orientation. This seems like they’ve taken the idea of “What Cardiologists Want Hospitalists to Know” a lot further than I had ever considered. I’m sure it would have value on many levels, including positioning the new hospitalist to work more effectively with the cardiologists, but I’m not sure it’s worth the cost. And I’m really concerned it sends a signal that the relationship is one way—that is, the hospitalists need to understand what the cardiologists do and want from them and not the reverse. For many reasons, I think this should be a reciprocal relationship, and it seems reasonable that new cardiologists should orient by rounding with hospitalists.

Same goes for the “… Want Hospitalists to Know” series. I’d like to see articles enumerating what hospitalists want doctors in other fields to know either in this magazine or its counterpart in the other specialty. What follows is the first of these. It is my take on non-clinical topics hospitalists want hospital leaders to know, and I’ll leave it to others to write about clinical topics.

We Aren’t on ‘Vacation’ Every Other Week

If you always think of our days off as a vacation, as in, “Those hospitalists get 26 weeks of vacation a year,” you’re making a mistake. A significant portion of our weekdays off are just like your weekends; they’re days to take a breather.

And you’re likely forgetting how many weekends we work.

And maybe lots of nights also.

You probably work more hours annually, but having more days for a breather are one offset for our weekends and nights.

Insisting Hospitalists Work an Entire Shift (12 Hours) Doesn’t Make a Lot of Sense on Slow Days

Staying around after completing clinical work yields no value. Too often, the time is spent watching YouTube or similar activities. And it means the doctor will be much more frustrated, and more likely to lobby for overtime compensation, when needing to stay beyond the scheduled end of the shift on busy days.

Avoid measuring work effort in hours. And in many cases, it is best to avoid precise determinations of when a day shift ends. At most hospitals, you do need at least one daytime doctor to stay on duty until the next shift arrives, but it rarely makes sense to have all of the hospitalists stay.

Your hospitalists need to be professional enough not to dash out the door the minute they’ve put notes on every patient’s chart. Instead, rather than leaving at the first opportunity on slow days, they could do all of the discharge preparation (med rec, discharge summary, etc.) for patients likely ready for discharge the next day; this can help a lot to discharge patients early the next day. Or they could make “secondary” rounds focused on patient satisfaction, etc.

Obs Patients Usually Are No Less Complicated—or Labor-Intensive—to Care For

It’s best to think of observation as solely a payor classification and not a good indicator of risk, complexity, or work required. Unfortunately “observation” is often thought of as shorthand for simple, not sick, easy to manage, etc. While true for a small subset of observation patients, such as younger people with a single problem such as atypical chest pain, it isn’t true for older (Medicare) patients with multiple chronic illnesses, on multiple medications, and with complex social situations.

Shouldn’t We Measure Length of Stay for All Patients in Hours Rather Than Days?

Then we could better understand throughput issues such as whether afternoon discharges for inpatients are late discharges or really very early discharges that weren’t held until the next morning.

Even High-Performing Hospitalist Groups Are Likely to Have Patient Satisfaction Scores on the Lower End of Doctors at Your Hospital

Don’t decide that just because they have much lower scores than the orthopedists, cardiologists, obstetricians, and other specialties, it is the hospitalists who are falling furthest below their potential. It may be the cardiologists who have a long way to go to achieve great scores for their specialty.

This isn’t an excuse. Just about every hospitalist group can do better and should work to make it happen. And because in nearly every hospital more HCAHPS surveys are attributed to hospitalists than any other specialty by a wide margin, our scores have a huge impact on the overall hospital averages. But you should keep in mind that, for a variety of reasons, hospitalists everywhere have physician communication scores that are lower than many or most other specialties.

To my knowledge, there isn’t a data set that provides patient satisfaction scores by specialty. And scores seem to vary a lot by geographic region, e.g., they’re nearly always higher in the South than other parts of the country. So there isn’t a good way to control for all the variables and know you’re setting appropriate improvement goals for each specialty. But your hospitalists will appreciate it if you acknowledge it may be unreasonable to set the same goals across specialties.

We’d Love Your Help Getting Rid of Pagers

Secure text messaging between all caregivers seems to be the way to go, and we will look to the hospital to make an investment in technology to make it possible and train users to ensure that by making messaging easier the volume of messages (interruptions) doesn’t just skyrocket. We, the hospitalists at your hospital, are happy to help with all of this, from vendor selection to plans for implementation. Please ask! TH

I think it is really cool that this publication has a series of articles on “What Cardiologists [or infection disease specialists, nephrologists, etc.] Want Hospitalists to Know.” I’m always interested to see which clinical topics made the list and which I’m already reasonably familiar with versus know little about. I’ve added this series to my list of things that are always worth the time to read, along with the “What’s New” section in UpToDate, review articles in major journals, and the Cleveland Clinic Journal of Medicine.

Not long ago, I worked with a hospitalist group that had agreed to cardiologists’ request that new hospitalists round with a cardiologist for something like three days as part of their orientation. This seems like they’ve taken the idea of “What Cardiologists Want Hospitalists to Know” a lot further than I had ever considered. I’m sure it would have value on many levels, including positioning the new hospitalist to work more effectively with the cardiologists, but I’m not sure it’s worth the cost. And I’m really concerned it sends a signal that the relationship is one way—that is, the hospitalists need to understand what the cardiologists do and want from them and not the reverse. For many reasons, I think this should be a reciprocal relationship, and it seems reasonable that new cardiologists should orient by rounding with hospitalists.

Same goes for the “… Want Hospitalists to Know” series. I’d like to see articles enumerating what hospitalists want doctors in other fields to know either in this magazine or its counterpart in the other specialty. What follows is the first of these. It is my take on non-clinical topics hospitalists want hospital leaders to know, and I’ll leave it to others to write about clinical topics.

We Aren’t on ‘Vacation’ Every Other Week

If you always think of our days off as a vacation, as in, “Those hospitalists get 26 weeks of vacation a year,” you’re making a mistake. A significant portion of our weekdays off are just like your weekends; they’re days to take a breather.

And you’re likely forgetting how many weekends we work.

And maybe lots of nights also.

You probably work more hours annually, but having more days for a breather are one offset for our weekends and nights.

Insisting Hospitalists Work an Entire Shift (12 Hours) Doesn’t Make a Lot of Sense on Slow Days

Staying around after completing clinical work yields no value. Too often, the time is spent watching YouTube or similar activities. And it means the doctor will be much more frustrated, and more likely to lobby for overtime compensation, when needing to stay beyond the scheduled end of the shift on busy days.

Avoid measuring work effort in hours. And in many cases, it is best to avoid precise determinations of when a day shift ends. At most hospitals, you do need at least one daytime doctor to stay on duty until the next shift arrives, but it rarely makes sense to have all of the hospitalists stay.

Your hospitalists need to be professional enough not to dash out the door the minute they’ve put notes on every patient’s chart. Instead, rather than leaving at the first opportunity on slow days, they could do all of the discharge preparation (med rec, discharge summary, etc.) for patients likely ready for discharge the next day; this can help a lot to discharge patients early the next day. Or they could make “secondary” rounds focused on patient satisfaction, etc.

Obs Patients Usually Are No Less Complicated—or Labor-Intensive—to Care For

It’s best to think of observation as solely a payor classification and not a good indicator of risk, complexity, or work required. Unfortunately “observation” is often thought of as shorthand for simple, not sick, easy to manage, etc. While true for a small subset of observation patients, such as younger people with a single problem such as atypical chest pain, it isn’t true for older (Medicare) patients with multiple chronic illnesses, on multiple medications, and with complex social situations.

Shouldn’t We Measure Length of Stay for All Patients in Hours Rather Than Days?

Then we could better understand throughput issues such as whether afternoon discharges for inpatients are late discharges or really very early discharges that weren’t held until the next morning.

Even High-Performing Hospitalist Groups Are Likely to Have Patient Satisfaction Scores on the Lower End of Doctors at Your Hospital

Don’t decide that just because they have much lower scores than the orthopedists, cardiologists, obstetricians, and other specialties, it is the hospitalists who are falling furthest below their potential. It may be the cardiologists who have a long way to go to achieve great scores for their specialty.

This isn’t an excuse. Just about every hospitalist group can do better and should work to make it happen. And because in nearly every hospital more HCAHPS surveys are attributed to hospitalists than any other specialty by a wide margin, our scores have a huge impact on the overall hospital averages. But you should keep in mind that, for a variety of reasons, hospitalists everywhere have physician communication scores that are lower than many or most other specialties.

To my knowledge, there isn’t a data set that provides patient satisfaction scores by specialty. And scores seem to vary a lot by geographic region, e.g., they’re nearly always higher in the South than other parts of the country. So there isn’t a good way to control for all the variables and know you’re setting appropriate improvement goals for each specialty. But your hospitalists will appreciate it if you acknowledge it may be unreasonable to set the same goals across specialties.

We’d Love Your Help Getting Rid of Pagers

Secure text messaging between all caregivers seems to be the way to go, and we will look to the hospital to make an investment in technology to make it possible and train users to ensure that by making messaging easier the volume of messages (interruptions) doesn’t just skyrocket. We, the hospitalists at your hospital, are happy to help with all of this, from vendor selection to plans for implementation. Please ask! TH

I think it is really cool that this publication has a series of articles on “What Cardiologists [or infection disease specialists, nephrologists, etc.] Want Hospitalists to Know.” I’m always interested to see which clinical topics made the list and which I’m already reasonably familiar with versus know little about. I’ve added this series to my list of things that are always worth the time to read, along with the “What’s New” section in UpToDate, review articles in major journals, and the Cleveland Clinic Journal of Medicine.

Not long ago, I worked with a hospitalist group that had agreed to cardiologists’ request that new hospitalists round with a cardiologist for something like three days as part of their orientation. This seems like they’ve taken the idea of “What Cardiologists Want Hospitalists to Know” a lot further than I had ever considered. I’m sure it would have value on many levels, including positioning the new hospitalist to work more effectively with the cardiologists, but I’m not sure it’s worth the cost. And I’m really concerned it sends a signal that the relationship is one way—that is, the hospitalists need to understand what the cardiologists do and want from them and not the reverse. For many reasons, I think this should be a reciprocal relationship, and it seems reasonable that new cardiologists should orient by rounding with hospitalists.

Same goes for the “… Want Hospitalists to Know” series. I’d like to see articles enumerating what hospitalists want doctors in other fields to know either in this magazine or its counterpart in the other specialty. What follows is the first of these. It is my take on non-clinical topics hospitalists want hospital leaders to know, and I’ll leave it to others to write about clinical topics.

We Aren’t on ‘Vacation’ Every Other Week

If you always think of our days off as a vacation, as in, “Those hospitalists get 26 weeks of vacation a year,” you’re making a mistake. A significant portion of our weekdays off are just like your weekends; they’re days to take a breather.

And you’re likely forgetting how many weekends we work.

And maybe lots of nights also.

You probably work more hours annually, but having more days for a breather are one offset for our weekends and nights.

Insisting Hospitalists Work an Entire Shift (12 Hours) Doesn’t Make a Lot of Sense on Slow Days

Staying around after completing clinical work yields no value. Too often, the time is spent watching YouTube or similar activities. And it means the doctor will be much more frustrated, and more likely to lobby for overtime compensation, when needing to stay beyond the scheduled end of the shift on busy days.

Avoid measuring work effort in hours. And in many cases, it is best to avoid precise determinations of when a day shift ends. At most hospitals, you do need at least one daytime doctor to stay on duty until the next shift arrives, but it rarely makes sense to have all of the hospitalists stay.

Your hospitalists need to be professional enough not to dash out the door the minute they’ve put notes on every patient’s chart. Instead, rather than leaving at the first opportunity on slow days, they could do all of the discharge preparation (med rec, discharge summary, etc.) for patients likely ready for discharge the next day; this can help a lot to discharge patients early the next day. Or they could make “secondary” rounds focused on patient satisfaction, etc.

Obs Patients Usually Are No Less Complicated—or Labor-Intensive—to Care For

It’s best to think of observation as solely a payor classification and not a good indicator of risk, complexity, or work required. Unfortunately “observation” is often thought of as shorthand for simple, not sick, easy to manage, etc. While true for a small subset of observation patients, such as younger people with a single problem such as atypical chest pain, it isn’t true for older (Medicare) patients with multiple chronic illnesses, on multiple medications, and with complex social situations.

Shouldn’t We Measure Length of Stay for All Patients in Hours Rather Than Days?

Then we could better understand throughput issues such as whether afternoon discharges for inpatients are late discharges or really very early discharges that weren’t held until the next morning.

Even High-Performing Hospitalist Groups Are Likely to Have Patient Satisfaction Scores on the Lower End of Doctors at Your Hospital

Don’t decide that just because they have much lower scores than the orthopedists, cardiologists, obstetricians, and other specialties, it is the hospitalists who are falling furthest below their potential. It may be the cardiologists who have a long way to go to achieve great scores for their specialty.

This isn’t an excuse. Just about every hospitalist group can do better and should work to make it happen. And because in nearly every hospital more HCAHPS surveys are attributed to hospitalists than any other specialty by a wide margin, our scores have a huge impact on the overall hospital averages. But you should keep in mind that, for a variety of reasons, hospitalists everywhere have physician communication scores that are lower than many or most other specialties.

To my knowledge, there isn’t a data set that provides patient satisfaction scores by specialty. And scores seem to vary a lot by geographic region, e.g., they’re nearly always higher in the South than other parts of the country. So there isn’t a good way to control for all the variables and know you’re setting appropriate improvement goals for each specialty. But your hospitalists will appreciate it if you acknowledge it may be unreasonable to set the same goals across specialties.

We’d Love Your Help Getting Rid of Pagers

Secure text messaging between all caregivers seems to be the way to go, and we will look to the hospital to make an investment in technology to make it possible and train users to ensure that by making messaging easier the volume of messages (interruptions) doesn’t just skyrocket. We, the hospitalists at your hospital, are happy to help with all of this, from vendor selection to plans for implementation. Please ask! TH

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.

The RealStar® Zika Virus RT-PCR Kit U.S. is a product of altona Diagnostics GmbH.

Under the EUA, the test can be used as a molecular diagnostic tool for the in vitro qualitative detection of RNA from the Zika virus in human serum or urine (collected alongside a patient-matched serum specimen).

The RealStar® Zika Virus RT-PCR Kit U.S. is intended for use in individuals meeting US Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (eg, clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel).

The test is authorized for use only under the EUA in CLIA-certified High Complexity Laboratories in the US or by similarly qualified non-US laboratories, by clinical laboratory personnel specifically trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The RealStar® Zika Virus RT-PCR Kit U.S. is authorized for a workflow consisting of nucleic acid extraction using the QIAamp® Viral RNA Mini Kit (QIAGEN), followed by the amplification and detection of Zika-virus-specific RNA using the RealStar® Zika Virus RT-PCR Kit U.S. on an ABI Prism® 7500 SDS/Fast SDS (Applied Biosystems), CFX96™ Real-Time PCR Detection System or CFX96™ Deep Well Real-Time PCR Detection System (both from BIO-RAD), LightCycler® 480 Instrument II (Roche), Rotor-Gene® 6000 (Corbett Research), or Rotor-Gene® Q 5/6 plex/MDxPlatform (QIAGEN).

About the EUA

The RealStar® Zika Virus RT-PCR Kit U.S. has not been FDA-cleared or approved. An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The RealStar® Zika Virus RT-PCR Kit U.S. is only authorized as long as circumstances exist to justify the authorization of the emergency use of in vitro diagnostics for the detection of Zika virus under section 564(b)(1) of the Federal Food, Drug & Cosmetic Act, 21 U.S.C.§360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Zika testing

The FDA has granted EUAs for 3 other tests designed to detect Zika virus:

• Zika Virus RNA Qualitative Real-Time RT-PCR test (Focus Diagnostics)
• Trioplex Real-time RT-PCR Assay (CDC)
• Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (CDC).

The FDA has also authorized use of the cobas® Zika test (Roche) to screen blood donations for Zika virus. The test may be used under an investigational new drug application for screening donated blood in areas with active mosquito-borne transmission of the virus.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.

The RealStar® Zika Virus RT-PCR Kit U.S. is a product of altona Diagnostics GmbH.

Under the EUA, the test can be used as a molecular diagnostic tool for the in vitro qualitative detection of RNA from the Zika virus in human serum or urine (collected alongside a patient-matched serum specimen).

The RealStar® Zika Virus RT-PCR Kit U.S. is intended for use in individuals meeting US Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (eg, clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel).

The test is authorized for use only under the EUA in CLIA-certified High Complexity Laboratories in the US or by similarly qualified non-US laboratories, by clinical laboratory personnel specifically trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The RealStar® Zika Virus RT-PCR Kit U.S. is authorized for a workflow consisting of nucleic acid extraction using the QIAamp® Viral RNA Mini Kit (QIAGEN), followed by the amplification and detection of Zika-virus-specific RNA using the RealStar® Zika Virus RT-PCR Kit U.S. on an ABI Prism® 7500 SDS/Fast SDS (Applied Biosystems), CFX96™ Real-Time PCR Detection System or CFX96™ Deep Well Real-Time PCR Detection System (both from BIO-RAD), LightCycler® 480 Instrument II (Roche), Rotor-Gene® 6000 (Corbett Research), or Rotor-Gene® Q 5/6 plex/MDxPlatform (QIAGEN).

About the EUA

The RealStar® Zika Virus RT-PCR Kit U.S. has not been FDA-cleared or approved. An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The RealStar® Zika Virus RT-PCR Kit U.S. is only authorized as long as circumstances exist to justify the authorization of the emergency use of in vitro diagnostics for the detection of Zika virus under section 564(b)(1) of the Federal Food, Drug & Cosmetic Act, 21 U.S.C.§360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Zika testing

The FDA has granted EUAs for 3 other tests designed to detect Zika virus:

• Zika Virus RNA Qualitative Real-Time RT-PCR test (Focus Diagnostics)
• Trioplex Real-time RT-PCR Assay (CDC)
• Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (CDC).

The FDA has also authorized use of the cobas® Zika test (Roche) to screen blood donations for Zika virus. The test may be used under an investigational new drug application for screening donated blood in areas with active mosquito-borne transmission of the virus.

Blood sample collection

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for another test designed to detect Zika virus infection.

The RealStar® Zika Virus RT-PCR Kit U.S. is a product of altona Diagnostics GmbH.

Under the EUA, the test can be used as a molecular diagnostic tool for the in vitro qualitative detection of RNA from the Zika virus in human serum or urine (collected alongside a patient-matched serum specimen).

The RealStar® Zika Virus RT-PCR Kit U.S. is intended for use in individuals meeting US Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (eg, clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (eg, history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel).

The test is authorized for use only under the EUA in CLIA-certified High Complexity Laboratories in the US or by similarly qualified non-US laboratories, by clinical laboratory personnel specifically trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The RealStar® Zika Virus RT-PCR Kit U.S. is authorized for a workflow consisting of nucleic acid extraction using the QIAamp® Viral RNA Mini Kit (QIAGEN), followed by the amplification and detection of Zika-virus-specific RNA using the RealStar® Zika Virus RT-PCR Kit U.S. on an ABI Prism® 7500 SDS/Fast SDS (Applied Biosystems), CFX96™ Real-Time PCR Detection System or CFX96™ Deep Well Real-Time PCR Detection System (both from BIO-RAD), LightCycler® 480 Instrument II (Roche), Rotor-Gene® 6000 (Corbett Research), or Rotor-Gene® Q 5/6 plex/MDxPlatform (QIAGEN).

About the EUA

The RealStar® Zika Virus RT-PCR Kit U.S. has not been FDA-cleared or approved. An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency.

The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The RealStar® Zika Virus RT-PCR Kit U.S. is only authorized as long as circumstances exist to justify the authorization of the emergency use of in vitro diagnostics for the detection of Zika virus under section 564(b)(1) of the Federal Food, Drug & Cosmetic Act, 21 U.S.C.§360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Zika testing

The FDA has granted EUAs for 3 other tests designed to detect Zika virus:

• Zika Virus RNA Qualitative Real-Time RT-PCR test (Focus Diagnostics)
• Trioplex Real-time RT-PCR Assay (CDC)
• Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (CDC).

The FDA has also authorized use of the cobas® Zika test (Roche) to screen blood donations for Zika virus. The test may be used under an investigational new drug application for screening donated blood in areas with active mosquito-borne transmission of the virus.