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Bundled maternal HIV, well-baby visits boost ART adherence
SEATTLE – When new moms can get their well-baby visits and HIV care together in the same office, they have better antiretroviral adherence, better viral suppression, and breast-feed longer, according to a randomized trial of 472 new moms with HIV in Cape Town, South Africa.
“It’s a simple and highly effective strategy for promoting maternal postpartum engagement” in HIV care, said lead investigator Landon Myer, MD, professor and head of epidemiology and biostatistics at the University of Cape Town.
Antiretroviral treatment management is often a routine part of prenatal care, but care splits after birth, with moms generally sent to an adult HIV clinic and babies in follow-up care at the pediatrician’s office. It’s a logistics problem for many, and women tend to prioritize the care of their infants over their own HIV.
“There’s a big push [globally] to identify interventions that can enhance women’s antiretroviral therapy (ART) adherence post partum,” Dr. Myer said.
The investigators had a hunch that bundling care would help. They randomized 234 women to centers with combined HIV and pediatric care within a week of birth and 238 to the usual split care approach. In the latter group, the mothers were referred to adult HIV services soon after delivery.
At 12 months, 77% of the women in the integrated-care group had viral loads below 50 copies/mL, versus 56% of women in the split care group. Women in the integrated group breastfed for about 9 months, versus 3 months in the control group. The findings were statistically significant.
“We were surprised by how big the differences were,” Dr. Myer said at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Mother-to-child transmission was low, at about 0.55%, and did not differ by arm. Vaccination rates, vitamin use, and other infant outcomes were also similar in both groups. Just a few women in each arm dropped out before the 12-month, postpartum visit.
The mothers were a median of 28 years old, and all had started ART during pregnancy at a median of 21 weeks gestation, with a median pre-ART T-cell count of 354 cells/microL. Three-quarters had viral suppression below 50 copies/mL at randomization. About a quarter were giving birth for the first time. Mothers in the bundled-care group were referred back to adult HIV services at the end of breastfeeding.
Dr. Myer had no disclosures. The work was funded by the National Institutes of Health.
SEATTLE – When new moms can get their well-baby visits and HIV care together in the same office, they have better antiretroviral adherence, better viral suppression, and breast-feed longer, according to a randomized trial of 472 new moms with HIV in Cape Town, South Africa.
“It’s a simple and highly effective strategy for promoting maternal postpartum engagement” in HIV care, said lead investigator Landon Myer, MD, professor and head of epidemiology and biostatistics at the University of Cape Town.
Antiretroviral treatment management is often a routine part of prenatal care, but care splits after birth, with moms generally sent to an adult HIV clinic and babies in follow-up care at the pediatrician’s office. It’s a logistics problem for many, and women tend to prioritize the care of their infants over their own HIV.
“There’s a big push [globally] to identify interventions that can enhance women’s antiretroviral therapy (ART) adherence post partum,” Dr. Myer said.
The investigators had a hunch that bundling care would help. They randomized 234 women to centers with combined HIV and pediatric care within a week of birth and 238 to the usual split care approach. In the latter group, the mothers were referred to adult HIV services soon after delivery.
At 12 months, 77% of the women in the integrated-care group had viral loads below 50 copies/mL, versus 56% of women in the split care group. Women in the integrated group breastfed for about 9 months, versus 3 months in the control group. The findings were statistically significant.
“We were surprised by how big the differences were,” Dr. Myer said at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Mother-to-child transmission was low, at about 0.55%, and did not differ by arm. Vaccination rates, vitamin use, and other infant outcomes were also similar in both groups. Just a few women in each arm dropped out before the 12-month, postpartum visit.
The mothers were a median of 28 years old, and all had started ART during pregnancy at a median of 21 weeks gestation, with a median pre-ART T-cell count of 354 cells/microL. Three-quarters had viral suppression below 50 copies/mL at randomization. About a quarter were giving birth for the first time. Mothers in the bundled-care group were referred back to adult HIV services at the end of breastfeeding.
Dr. Myer had no disclosures. The work was funded by the National Institutes of Health.
SEATTLE – When new moms can get their well-baby visits and HIV care together in the same office, they have better antiretroviral adherence, better viral suppression, and breast-feed longer, according to a randomized trial of 472 new moms with HIV in Cape Town, South Africa.
“It’s a simple and highly effective strategy for promoting maternal postpartum engagement” in HIV care, said lead investigator Landon Myer, MD, professor and head of epidemiology and biostatistics at the University of Cape Town.
Antiretroviral treatment management is often a routine part of prenatal care, but care splits after birth, with moms generally sent to an adult HIV clinic and babies in follow-up care at the pediatrician’s office. It’s a logistics problem for many, and women tend to prioritize the care of their infants over their own HIV.
“There’s a big push [globally] to identify interventions that can enhance women’s antiretroviral therapy (ART) adherence post partum,” Dr. Myer said.
The investigators had a hunch that bundling care would help. They randomized 234 women to centers with combined HIV and pediatric care within a week of birth and 238 to the usual split care approach. In the latter group, the mothers were referred to adult HIV services soon after delivery.
At 12 months, 77% of the women in the integrated-care group had viral loads below 50 copies/mL, versus 56% of women in the split care group. Women in the integrated group breastfed for about 9 months, versus 3 months in the control group. The findings were statistically significant.
“We were surprised by how big the differences were,” Dr. Myer said at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.
Mother-to-child transmission was low, at about 0.55%, and did not differ by arm. Vaccination rates, vitamin use, and other infant outcomes were also similar in both groups. Just a few women in each arm dropped out before the 12-month, postpartum visit.
The mothers were a median of 28 years old, and all had started ART during pregnancy at a median of 21 weeks gestation, with a median pre-ART T-cell count of 354 cells/microL. Three-quarters had viral suppression below 50 copies/mL at randomization. About a quarter were giving birth for the first time. Mothers in the bundled-care group were referred back to adult HIV services at the end of breastfeeding.
Dr. Myer had no disclosures. The work was funded by the National Institutes of Health.
AT CROI
Key clinical point:
Major finding: At 12 months, 77% of the women in the integrated-care group had viral loads below 50 copies/mL, versus 56% of women in the control arm. Women in the integrated group breastfed for about 9 months, versus 3 months in the split-care group.
Data source: A randomized trial of 472 new moms with HIV and their babies in Cape Town, South Africa.
Disclosures: Dr. Myer had no disclosures. The work was funded by the National Institutes of Health.
FDA approves Sovaldi, Harvoni for HCV in ages 12-plus
The Food and Drug Administration has approved the use of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C virus (HCV) in children aged 12 years and older.
The drugs – the first direct-acting, potentially curative antiviral treatments approved for children and adolescents with HCV – previously were approved for adults. The supplemental applications submitted by Gilead Sciences, which markets the drugs, were approved by the FDA on April 7 and expand the use of these drugs to pediatric patients aged 12 and up who weigh at least 77 pounds, and who have either mild or no cirrhosis; Sovaldi is indicated for those with HCV genotypes 2 or 3, and Harvoni is indicated for those with HCV genotypes 1, 4, 5, or 6.
“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press statement.
Of note, hepatitis B virus (HBV) reactivation has been reported in adults with HCV/HBV coinfection who were treated with these drugs, but who were not receiving HBV antiviral therapy; therefore, all patients should be screened for evidence of current or prior HBV infection before starting treatment with Harvoni or Sovaldi, according to the FDA statement.
The Food and Drug Administration has approved the use of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C virus (HCV) in children aged 12 years and older.
The drugs – the first direct-acting, potentially curative antiviral treatments approved for children and adolescents with HCV – previously were approved for adults. The supplemental applications submitted by Gilead Sciences, which markets the drugs, were approved by the FDA on April 7 and expand the use of these drugs to pediatric patients aged 12 and up who weigh at least 77 pounds, and who have either mild or no cirrhosis; Sovaldi is indicated for those with HCV genotypes 2 or 3, and Harvoni is indicated for those with HCV genotypes 1, 4, 5, or 6.
“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press statement.
Of note, hepatitis B virus (HBV) reactivation has been reported in adults with HCV/HBV coinfection who were treated with these drugs, but who were not receiving HBV antiviral therapy; therefore, all patients should be screened for evidence of current or prior HBV infection before starting treatment with Harvoni or Sovaldi, according to the FDA statement.
The Food and Drug Administration has approved the use of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C virus (HCV) in children aged 12 years and older.
The drugs – the first direct-acting, potentially curative antiviral treatments approved for children and adolescents with HCV – previously were approved for adults. The supplemental applications submitted by Gilead Sciences, which markets the drugs, were approved by the FDA on April 7 and expand the use of these drugs to pediatric patients aged 12 and up who weigh at least 77 pounds, and who have either mild or no cirrhosis; Sovaldi is indicated for those with HCV genotypes 2 or 3, and Harvoni is indicated for those with HCV genotypes 1, 4, 5, or 6.
“These approvals will help change the landscape for HCV treatment by addressing an unmet need in children and adolescents,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press statement.
Of note, hepatitis B virus (HBV) reactivation has been reported in adults with HCV/HBV coinfection who were treated with these drugs, but who were not receiving HBV antiviral therapy; therefore, all patients should be screened for evidence of current or prior HBV infection before starting treatment with Harvoni or Sovaldi, according to the FDA statement.
Redness and Painful Ulcerations in the Perineal Area
The Diagnosis: PELVIS Syndrome
Infantile hemangiomas (IHs) are present in up to 10% of infants by 1 year of age and are most commonly located on the face and upper extremities. Less than 10% of IHs develop in the perineum.1 Perineal IHs are benign tumors of the vascular endothelium that present as plaques and commonly are accompanied by painful ulcerations. Ulceration is more common in the diaper area secondary to irritation from urine, stool, and friction.2 Although most IHs are benign isolated findings, facial IHs have been associated with several syndromes including Sturge-Weber and PHACE (posterior fossa brain malformations, hemangiomas, arterial anomalies, cardiac anomalies and coarctation of the aorta, and eye and endocrine abnormalities) syndromes.3 Researchers also have identified an association between lumbosacral IHs and spinal dysraphism (tethered spinal cord).4
A smaller number of studies have investigated congenital anomalies related to perineal IH,1,5 specifically PELVIS syndrome. The acronym PELVIS has been used to describe a syndrome of congenital malformations including perineal hemangioma, external genital malformations, lipomyelomeningocele, vesicorenal abnormalities, imperforate anus, and skin tag.1 An alternative description of similar findings is LUMBAR (lower body hemangioma and other cutaneous defects; urogenital anomalies, ulceration; myelopathy; bony deformities; anorectal malformations, arterial anomalies; and renal anomalies).5 Researchers have suggested that both of these acronyms describe the same syndrome, and it is common for the syndrome to be incomplete.6 One study (N=11) found that perineal hemangiomas are most commonly associated with anal malformations (8 patients), followed by urinary tract abnormalities (7 patients) and malformation of the external genitalia (7 patients). A skin tag was present in 5 patients.1 The pathogenesis of PELVIS syndrome is unknown.
When an infant presents with a perineal hemangioma and physical examination suggests PELVIS syndrome, imaging should be performed to evaluate for other anomalies. Before 4 months of age, ultrasound should be utilized to investigate the presence of reno-genitourinary or spinal malformations. Magnetic resonance imaging is the preferred imaging modality in children older than 4 months.7 Management of PELVIS syndrome requires a multidisciplinary approach and early recognition of the full extent of congenital malformations. Pediatric dermatologists, urologists, endocrinologists, and neonatologists have a role in its diagnosis and treatment.
- Girard C, Bigorre M, Guillot B, et al. PELVIS syndrome. Arch Dermatol. 2006;142:884-888.
- Bruckner AL, Frieden IJ. Hemangiomas of infancy. J Am Acad Dermatol. 2003;48:477-496.
- Frieden IJ, Reese V, Cohen D. PHACE syndrome: the association of posterior fossa brain malformations, hemangiomas, arterial anomalies, coarctation of the aorta and cardiac defects, and eye abnormalities. Arch Dermatol. 1996;132:307-311.
- Albright AL, Gartner JC, Wiener ES. Lumbar cutaneous hemangiomas as indicators of tethered spinal cords. Pediatrics. 1989;83:977-980.
- Iacobas I, Burrows PE, Frieden IJ, et al. LUMBAR: association between cutaneous infantile hemangiomas of the lower body and regional congenital anomalies. J Pediatr. 2010;157:795-801.
- Frade FN, Kadlub V, Soupre S, et al. PELVIS or LUMBAR syndrome: the same entity. two case reports. Arch Pediatr. 2012;19:55-58.
- Berk DR, Bayliss SJ, Merritt DF. Management quandary: extensive perineal infantile hemangioma with associated congenital anomalies: an example of the PELVIS syndrome. J Pediatr Adolesc Gynecol. 2007;20:105-108.
The Diagnosis: PELVIS Syndrome
Infantile hemangiomas (IHs) are present in up to 10% of infants by 1 year of age and are most commonly located on the face and upper extremities. Less than 10% of IHs develop in the perineum.1 Perineal IHs are benign tumors of the vascular endothelium that present as plaques and commonly are accompanied by painful ulcerations. Ulceration is more common in the diaper area secondary to irritation from urine, stool, and friction.2 Although most IHs are benign isolated findings, facial IHs have been associated with several syndromes including Sturge-Weber and PHACE (posterior fossa brain malformations, hemangiomas, arterial anomalies, cardiac anomalies and coarctation of the aorta, and eye and endocrine abnormalities) syndromes.3 Researchers also have identified an association between lumbosacral IHs and spinal dysraphism (tethered spinal cord).4
A smaller number of studies have investigated congenital anomalies related to perineal IH,1,5 specifically PELVIS syndrome. The acronym PELVIS has been used to describe a syndrome of congenital malformations including perineal hemangioma, external genital malformations, lipomyelomeningocele, vesicorenal abnormalities, imperforate anus, and skin tag.1 An alternative description of similar findings is LUMBAR (lower body hemangioma and other cutaneous defects; urogenital anomalies, ulceration; myelopathy; bony deformities; anorectal malformations, arterial anomalies; and renal anomalies).5 Researchers have suggested that both of these acronyms describe the same syndrome, and it is common for the syndrome to be incomplete.6 One study (N=11) found that perineal hemangiomas are most commonly associated with anal malformations (8 patients), followed by urinary tract abnormalities (7 patients) and malformation of the external genitalia (7 patients). A skin tag was present in 5 patients.1 The pathogenesis of PELVIS syndrome is unknown.
When an infant presents with a perineal hemangioma and physical examination suggests PELVIS syndrome, imaging should be performed to evaluate for other anomalies. Before 4 months of age, ultrasound should be utilized to investigate the presence of reno-genitourinary or spinal malformations. Magnetic resonance imaging is the preferred imaging modality in children older than 4 months.7 Management of PELVIS syndrome requires a multidisciplinary approach and early recognition of the full extent of congenital malformations. Pediatric dermatologists, urologists, endocrinologists, and neonatologists have a role in its diagnosis and treatment.
The Diagnosis: PELVIS Syndrome
Infantile hemangiomas (IHs) are present in up to 10% of infants by 1 year of age and are most commonly located on the face and upper extremities. Less than 10% of IHs develop in the perineum.1 Perineal IHs are benign tumors of the vascular endothelium that present as plaques and commonly are accompanied by painful ulcerations. Ulceration is more common in the diaper area secondary to irritation from urine, stool, and friction.2 Although most IHs are benign isolated findings, facial IHs have been associated with several syndromes including Sturge-Weber and PHACE (posterior fossa brain malformations, hemangiomas, arterial anomalies, cardiac anomalies and coarctation of the aorta, and eye and endocrine abnormalities) syndromes.3 Researchers also have identified an association between lumbosacral IHs and spinal dysraphism (tethered spinal cord).4
A smaller number of studies have investigated congenital anomalies related to perineal IH,1,5 specifically PELVIS syndrome. The acronym PELVIS has been used to describe a syndrome of congenital malformations including perineal hemangioma, external genital malformations, lipomyelomeningocele, vesicorenal abnormalities, imperforate anus, and skin tag.1 An alternative description of similar findings is LUMBAR (lower body hemangioma and other cutaneous defects; urogenital anomalies, ulceration; myelopathy; bony deformities; anorectal malformations, arterial anomalies; and renal anomalies).5 Researchers have suggested that both of these acronyms describe the same syndrome, and it is common for the syndrome to be incomplete.6 One study (N=11) found that perineal hemangiomas are most commonly associated with anal malformations (8 patients), followed by urinary tract abnormalities (7 patients) and malformation of the external genitalia (7 patients). A skin tag was present in 5 patients.1 The pathogenesis of PELVIS syndrome is unknown.
When an infant presents with a perineal hemangioma and physical examination suggests PELVIS syndrome, imaging should be performed to evaluate for other anomalies. Before 4 months of age, ultrasound should be utilized to investigate the presence of reno-genitourinary or spinal malformations. Magnetic resonance imaging is the preferred imaging modality in children older than 4 months.7 Management of PELVIS syndrome requires a multidisciplinary approach and early recognition of the full extent of congenital malformations. Pediatric dermatologists, urologists, endocrinologists, and neonatologists have a role in its diagnosis and treatment.
- Girard C, Bigorre M, Guillot B, et al. PELVIS syndrome. Arch Dermatol. 2006;142:884-888.
- Bruckner AL, Frieden IJ. Hemangiomas of infancy. J Am Acad Dermatol. 2003;48:477-496.
- Frieden IJ, Reese V, Cohen D. PHACE syndrome: the association of posterior fossa brain malformations, hemangiomas, arterial anomalies, coarctation of the aorta and cardiac defects, and eye abnormalities. Arch Dermatol. 1996;132:307-311.
- Albright AL, Gartner JC, Wiener ES. Lumbar cutaneous hemangiomas as indicators of tethered spinal cords. Pediatrics. 1989;83:977-980.
- Iacobas I, Burrows PE, Frieden IJ, et al. LUMBAR: association between cutaneous infantile hemangiomas of the lower body and regional congenital anomalies. J Pediatr. 2010;157:795-801.
- Frade FN, Kadlub V, Soupre S, et al. PELVIS or LUMBAR syndrome: the same entity. two case reports. Arch Pediatr. 2012;19:55-58.
- Berk DR, Bayliss SJ, Merritt DF. Management quandary: extensive perineal infantile hemangioma with associated congenital anomalies: an example of the PELVIS syndrome. J Pediatr Adolesc Gynecol. 2007;20:105-108.
- Girard C, Bigorre M, Guillot B, et al. PELVIS syndrome. Arch Dermatol. 2006;142:884-888.
- Bruckner AL, Frieden IJ. Hemangiomas of infancy. J Am Acad Dermatol. 2003;48:477-496.
- Frieden IJ, Reese V, Cohen D. PHACE syndrome: the association of posterior fossa brain malformations, hemangiomas, arterial anomalies, coarctation of the aorta and cardiac defects, and eye abnormalities. Arch Dermatol. 1996;132:307-311.
- Albright AL, Gartner JC, Wiener ES. Lumbar cutaneous hemangiomas as indicators of tethered spinal cords. Pediatrics. 1989;83:977-980.
- Iacobas I, Burrows PE, Frieden IJ, et al. LUMBAR: association between cutaneous infantile hemangiomas of the lower body and regional congenital anomalies. J Pediatr. 2010;157:795-801.
- Frade FN, Kadlub V, Soupre S, et al. PELVIS or LUMBAR syndrome: the same entity. two case reports. Arch Pediatr. 2012;19:55-58.
- Berk DR, Bayliss SJ, Merritt DF. Management quandary: extensive perineal infantile hemangioma with associated congenital anomalies: an example of the PELVIS syndrome. J Pediatr Adolesc Gynecol. 2007;20:105-108.
A 7-week-old boy with ambiguous genitalia presented for evaluation of what the parents described as progressively worsening diaper rash. The patient was born at full-term after an uncomplicated gestation via normal spontaneous vaginal delivery. Examination of the external genitalia revealed microphallus with phimosis and a bifid scrotum. Two weeks after birth, the patient developed redness and painful ulcerations in the diaper area. At the time of presentation, the patient had bright red plaques along the suprapubic lines, inguinal creases, and in the perineal region. Physical examination also was notable for tender ulcerations of the inguinal creases and perineum and a perineal skin tag.
Number of U.S. Zika-infected pregnancies tops 5,100
Almost 200 cases of pregnant women with Zika virus infection were reported in the United States during the 2 weeks ending March 28, with the number split evenly between the territories and the 50 states and Washington, D.C., according to the Centers for Disease Control and Prevention.
These latest 197 cases – 98 in the territories and 99 in the states/D.C. – bring the U.S. total since the beginning of 2016 to 5,177 pregnant women with laboratory evidence of Zika virus infection: 3,461 in the U.S. territories and 1,716 in the states/D.C., the CDC reported on April 6.
Since Jan. 1, 2015, a total of 41,701 cases of Zika virus infection have been reported among all Americans: 5,197 in the states/D.C. and 36,504 in the territories. Almost all of the territorial cases (97%) have occurred in Puerto Rico, while Florida (21%), New York (20%), and California (9%) together have accounted for half of the cases in the states/D.C., the CDC said.
These are not real-time data and reflect only pregnancy outcomes for women with any laboratory evidence of possible Zika virus infection, although it is not known if Zika virus was the cause of the poor outcomes. Zika-related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, or termination with evidence of birth defects.
Almost 200 cases of pregnant women with Zika virus infection were reported in the United States during the 2 weeks ending March 28, with the number split evenly between the territories and the 50 states and Washington, D.C., according to the Centers for Disease Control and Prevention.
These latest 197 cases – 98 in the territories and 99 in the states/D.C. – bring the U.S. total since the beginning of 2016 to 5,177 pregnant women with laboratory evidence of Zika virus infection: 3,461 in the U.S. territories and 1,716 in the states/D.C., the CDC reported on April 6.
Since Jan. 1, 2015, a total of 41,701 cases of Zika virus infection have been reported among all Americans: 5,197 in the states/D.C. and 36,504 in the territories. Almost all of the territorial cases (97%) have occurred in Puerto Rico, while Florida (21%), New York (20%), and California (9%) together have accounted for half of the cases in the states/D.C., the CDC said.
These are not real-time data and reflect only pregnancy outcomes for women with any laboratory evidence of possible Zika virus infection, although it is not known if Zika virus was the cause of the poor outcomes. Zika-related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, or termination with evidence of birth defects.
Almost 200 cases of pregnant women with Zika virus infection were reported in the United States during the 2 weeks ending March 28, with the number split evenly between the territories and the 50 states and Washington, D.C., according to the Centers for Disease Control and Prevention.
These latest 197 cases – 98 in the territories and 99 in the states/D.C. – bring the U.S. total since the beginning of 2016 to 5,177 pregnant women with laboratory evidence of Zika virus infection: 3,461 in the U.S. territories and 1,716 in the states/D.C., the CDC reported on April 6.
Since Jan. 1, 2015, a total of 41,701 cases of Zika virus infection have been reported among all Americans: 5,197 in the states/D.C. and 36,504 in the territories. Almost all of the territorial cases (97%) have occurred in Puerto Rico, while Florida (21%), New York (20%), and California (9%) together have accounted for half of the cases in the states/D.C., the CDC said.
These are not real-time data and reflect only pregnancy outcomes for women with any laboratory evidence of possible Zika virus infection, although it is not known if Zika virus was the cause of the poor outcomes. Zika-related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, or termination with evidence of birth defects.
Pardon the interruption?
Your first patient of the afternoon is a 9-year-old boy who moved to town several months ago. Mercifully, the second patient of the afternoon has canceled, giving you a few more minutes to get acquainted with this young man whose chief complaint is listed as “behavior problem.” You learn quickly that this family has relocated from a town just 20 miles away because they are seeking a school that is a “better fit” for your new patient.
Due to some miscommunications, the child’s old records have not arrived at your office. The mother says that her son is not taking any medication, and she isn’t sure if he has ever been given a diagnosis. You learn that he likes to argue and is prone to violent temper tantrums. Your initial brief exam does not suggest any cognitive deficits, but he exudes an aura of anger and discontent. You tell his mother that you will be glad to try to help, but you will need his old records and another longer visit before you can make any recommendations.
Two days later you see a fourth-grader you have known since birth. He rarely comes to the office with problems, but you understand that he is a good student, a competent athlete, and socially engaged. His chief complaint for this visit is “hair loss,” but you soon discover that he has trichotillomania and has recently begun having nightmares and experiencing enuresis. All of these symptoms began a month ago with arrival of a new student in his class whose violent outbursts have become increasingly more physical. I have borrowed this child’s scenario from a similar case study in a recent supplement to the Journal of Developmental & Behavioral Pediatrics titled, “Behavioral Changes Associated with a Disruptive New Student in the Classroom,” (J Dev Behav Pediatr. Feb/Mar 2017. doi: 10.1097/DBP.0000000000000175).
The afternoon following your visit with the hair-pulling fourth-grader, you receive the new patient’s records for which you have been waiting. The circle is completed as you read that this is his third school in 18 months, and the reports of his behavior make it clear that your two patients are classmates. This scenario of coincidence could easily have occurred in a small town like Brunswick, Maine, where I practiced, but I have manufactured it to raise several questions about social priorities and professional ethics.
Forty years ago, institutions housing individuals with Down syndrome started closing and the process of integrating children with a variety of cognitive and physical disabilities into traditional classrooms began. To the surprise of some people, this mainstreaming has generally gone well. Unfortunately, funding hasn’t always caught up with the demand for services. For the most part, children readily accept their challenged classmates who look, move, and sound different. The flailing and grunting of the child with spastic choreoathetosis using a wheelchair isn’t considered an interruption because “that’s just the way she is.”
However, there seems to be an invisible line that separates those children who seem to be incapable of stopping their potentially disruptive behavior from those children we assume “ought to know better” or whose parents we believe have failed at instilling even the most basic discipline. You can certainly question the validity of those assumptions. But it is clear that your new patient’s disruptive behavior is interfering with his classmates’ education, and in some cases threatening their health. Your patient with trichotillomania is probably the canary in a very unsettled mine.
Your dilemma as the pediatrician for these two boys is the same we face as a society. How do you effectively advocate for a positive educational atmosphere for children with a variety of special needs, some of which seem to be in direct conflict? You can ask the school system to be patient as you help the disruptive child get connected with the services he needs. But you know that could take several months at a minimum. Meanwhile your hair-pulling patient and his classmates are losing valuable educational opportunities by the day.
I don’t have the answer, but I suspect that somehow it is going to come down to affordability. Counseling, psychiatrists, and one on one classroom aids don’t come cheap, nor does the tuition for a special school in another school district. But we can’t discount the value of an education free of disruption.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com
Your first patient of the afternoon is a 9-year-old boy who moved to town several months ago. Mercifully, the second patient of the afternoon has canceled, giving you a few more minutes to get acquainted with this young man whose chief complaint is listed as “behavior problem.” You learn quickly that this family has relocated from a town just 20 miles away because they are seeking a school that is a “better fit” for your new patient.
Due to some miscommunications, the child’s old records have not arrived at your office. The mother says that her son is not taking any medication, and she isn’t sure if he has ever been given a diagnosis. You learn that he likes to argue and is prone to violent temper tantrums. Your initial brief exam does not suggest any cognitive deficits, but he exudes an aura of anger and discontent. You tell his mother that you will be glad to try to help, but you will need his old records and another longer visit before you can make any recommendations.
Two days later you see a fourth-grader you have known since birth. He rarely comes to the office with problems, but you understand that he is a good student, a competent athlete, and socially engaged. His chief complaint for this visit is “hair loss,” but you soon discover that he has trichotillomania and has recently begun having nightmares and experiencing enuresis. All of these symptoms began a month ago with arrival of a new student in his class whose violent outbursts have become increasingly more physical. I have borrowed this child’s scenario from a similar case study in a recent supplement to the Journal of Developmental & Behavioral Pediatrics titled, “Behavioral Changes Associated with a Disruptive New Student in the Classroom,” (J Dev Behav Pediatr. Feb/Mar 2017. doi: 10.1097/DBP.0000000000000175).
The afternoon following your visit with the hair-pulling fourth-grader, you receive the new patient’s records for which you have been waiting. The circle is completed as you read that this is his third school in 18 months, and the reports of his behavior make it clear that your two patients are classmates. This scenario of coincidence could easily have occurred in a small town like Brunswick, Maine, where I practiced, but I have manufactured it to raise several questions about social priorities and professional ethics.
Forty years ago, institutions housing individuals with Down syndrome started closing and the process of integrating children with a variety of cognitive and physical disabilities into traditional classrooms began. To the surprise of some people, this mainstreaming has generally gone well. Unfortunately, funding hasn’t always caught up with the demand for services. For the most part, children readily accept their challenged classmates who look, move, and sound different. The flailing and grunting of the child with spastic choreoathetosis using a wheelchair isn’t considered an interruption because “that’s just the way she is.”
However, there seems to be an invisible line that separates those children who seem to be incapable of stopping their potentially disruptive behavior from those children we assume “ought to know better” or whose parents we believe have failed at instilling even the most basic discipline. You can certainly question the validity of those assumptions. But it is clear that your new patient’s disruptive behavior is interfering with his classmates’ education, and in some cases threatening their health. Your patient with trichotillomania is probably the canary in a very unsettled mine.
Your dilemma as the pediatrician for these two boys is the same we face as a society. How do you effectively advocate for a positive educational atmosphere for children with a variety of special needs, some of which seem to be in direct conflict? You can ask the school system to be patient as you help the disruptive child get connected with the services he needs. But you know that could take several months at a minimum. Meanwhile your hair-pulling patient and his classmates are losing valuable educational opportunities by the day.
I don’t have the answer, but I suspect that somehow it is going to come down to affordability. Counseling, psychiatrists, and one on one classroom aids don’t come cheap, nor does the tuition for a special school in another school district. But we can’t discount the value of an education free of disruption.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com
Your first patient of the afternoon is a 9-year-old boy who moved to town several months ago. Mercifully, the second patient of the afternoon has canceled, giving you a few more minutes to get acquainted with this young man whose chief complaint is listed as “behavior problem.” You learn quickly that this family has relocated from a town just 20 miles away because they are seeking a school that is a “better fit” for your new patient.
Due to some miscommunications, the child’s old records have not arrived at your office. The mother says that her son is not taking any medication, and she isn’t sure if he has ever been given a diagnosis. You learn that he likes to argue and is prone to violent temper tantrums. Your initial brief exam does not suggest any cognitive deficits, but he exudes an aura of anger and discontent. You tell his mother that you will be glad to try to help, but you will need his old records and another longer visit before you can make any recommendations.
Two days later you see a fourth-grader you have known since birth. He rarely comes to the office with problems, but you understand that he is a good student, a competent athlete, and socially engaged. His chief complaint for this visit is “hair loss,” but you soon discover that he has trichotillomania and has recently begun having nightmares and experiencing enuresis. All of these symptoms began a month ago with arrival of a new student in his class whose violent outbursts have become increasingly more physical. I have borrowed this child’s scenario from a similar case study in a recent supplement to the Journal of Developmental & Behavioral Pediatrics titled, “Behavioral Changes Associated with a Disruptive New Student in the Classroom,” (J Dev Behav Pediatr. Feb/Mar 2017. doi: 10.1097/DBP.0000000000000175).
The afternoon following your visit with the hair-pulling fourth-grader, you receive the new patient’s records for which you have been waiting. The circle is completed as you read that this is his third school in 18 months, and the reports of his behavior make it clear that your two patients are classmates. This scenario of coincidence could easily have occurred in a small town like Brunswick, Maine, where I practiced, but I have manufactured it to raise several questions about social priorities and professional ethics.
Forty years ago, institutions housing individuals with Down syndrome started closing and the process of integrating children with a variety of cognitive and physical disabilities into traditional classrooms began. To the surprise of some people, this mainstreaming has generally gone well. Unfortunately, funding hasn’t always caught up with the demand for services. For the most part, children readily accept their challenged classmates who look, move, and sound different. The flailing and grunting of the child with spastic choreoathetosis using a wheelchair isn’t considered an interruption because “that’s just the way she is.”
However, there seems to be an invisible line that separates those children who seem to be incapable of stopping their potentially disruptive behavior from those children we assume “ought to know better” or whose parents we believe have failed at instilling even the most basic discipline. You can certainly question the validity of those assumptions. But it is clear that your new patient’s disruptive behavior is interfering with his classmates’ education, and in some cases threatening their health. Your patient with trichotillomania is probably the canary in a very unsettled mine.
Your dilemma as the pediatrician for these two boys is the same we face as a society. How do you effectively advocate for a positive educational atmosphere for children with a variety of special needs, some of which seem to be in direct conflict? You can ask the school system to be patient as you help the disruptive child get connected with the services he needs. But you know that could take several months at a minimum. Meanwhile your hair-pulling patient and his classmates are losing valuable educational opportunities by the day.
I don’t have the answer, but I suspect that somehow it is going to come down to affordability. Counseling, psychiatrists, and one on one classroom aids don’t come cheap, nor does the tuition for a special school in another school district. But we can’t discount the value of an education free of disruption.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com
FDA approves first home genetic health risk test
The Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer genetic screening test, according to a press release on Thursday, April 6.
FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson’s, late-onset Alzheimer’s, celiac disease, and hereditary hemochromatosis, to spur patients to consult with their physicians and make more informed lifestyle decisions.
“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in the release. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
The FDA has exempted all further GHR tests developed by 23andMe from premarket review, noting future GHR tests developed by other makers, excluding those used for diagnostic purposes, may also achieve this exemption after submitting their first premarket review.
For the full details, see the original announcement.
ezimmerman@frontlinemedcom.com
On Twitter @EAZTweets
The Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer genetic screening test, according to a press release on Thursday, April 6.
FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson’s, late-onset Alzheimer’s, celiac disease, and hereditary hemochromatosis, to spur patients to consult with their physicians and make more informed lifestyle decisions.
“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in the release. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
The FDA has exempted all further GHR tests developed by 23andMe from premarket review, noting future GHR tests developed by other makers, excluding those used for diagnostic purposes, may also achieve this exemption after submitting their first premarket review.
For the full details, see the original announcement.
ezimmerman@frontlinemedcom.com
On Twitter @EAZTweets
The Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer genetic screening test, according to a press release on Thursday, April 6.
FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson’s, late-onset Alzheimer’s, celiac disease, and hereditary hemochromatosis, to spur patients to consult with their physicians and make more informed lifestyle decisions.
“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in the release. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
The FDA has exempted all further GHR tests developed by 23andMe from premarket review, noting future GHR tests developed by other makers, excluding those used for diagnostic purposes, may also achieve this exemption after submitting their first premarket review.
For the full details, see the original announcement.
ezimmerman@frontlinemedcom.com
On Twitter @EAZTweets
Large Hyperpigmented Plaques on the Trunk of a Newborn
The Diagnosis: Cutaneous Mastocytoma
Physical examination revealed a 58×51-mm hyperpigmented plaque with central pink coloration and scale on the right side of the back as well as a 39×33-mm pink plaque with a hyperpigmented border on the left side of the flank (Figure 1). At follow-up 2 weeks later, the patient's parents reported that blisters formed within both of the plaques. The blisters ruptured a few hours after forming and drained clear fluid with scant blood. Both plaques contained erosions from the ruptured bullae but remained the same size with no surrounding erythema or warmth. A 4-mm punch biopsy was performed of intact skin from the back lesion (Figure 2A). Histologic examination revealed a cellular infiltrate of monotonous bland cells that completely filled the dermis without epidermal involvement, along with occasional intermixed eosinophils. The morphology of these infiltrating cells was compatible with mast cells confirmed by strongly positive Leder staining (Figure 2B).
Mastocytosis encompasses a rare group of disorders characterized by abnormal mast cell accumulation or mast cell mediator release in various tissues. These disorders can be classified as either systemic mastocytosis with mast cell infiltration into bone marrow or other extracutaneous organs, or cutaneous mastocytosis with disease limited to the skin.1 Mutations involving activation of the c-Kit receptor in stimulating mast cell growth and development have been implicated in both systemic and cutaneous forms of the disease.2,3
Cutaneous mastocytosis is most often diagnosed in childhood and typically is characterized by spontaneous regression before puberty in a majority of cases.1,4 Under the World Health Organization classification system, cutaneous mastocytosis can be further subdivided into 3 disorders (listed in order of most to least common): urticaria pigmentosa (also known as maculopapular cutaneous mastocytosis) with typical, plaque, and nodular forms; cutaneous mastocytoma (as seen in this patient); and diffuse cutaneous mastocytosis.5 Compared to the widespread distribution of small macules and papules in urticaria pigmentosa, the cutaneous mastocytoma subtype presents with 1 to 6 brown to orange-yellow plaques or nodules measuring more than 1 cm in diameter. Cutaneous mastocytoma typically presents in infancy and is located most commonly on the trunk and extremities, though it may be found on the face or scalp. The plaques of mastocytoma often have well-defined margins, and these lesions may become bullous or demonstrate Darier sign of urtication and erythema on physical stimulation. Patients most commonly experience pruritus from mast cell degranulation and rarely exhibit systemic symptoms of mast cell mediator release; however, generalized flushing, hypotension, headaches, and gastrointestinal symptoms may occur, particularly if the lesion is vigorously rubbed.6,7 Conditions in the differential include aplasia cutis congenita, connective tissue nevus, epidermal nevus, and epidermolysis bullosa. They should not elicit a blister if rubbed, except for epidermolysis bullosa, which can easily be differentiated based on histology.
The workup for cutaneous mastocytosis in the pediatric population may include a biopsy of lesional skin, though in many cases the characteristic cutaneous manifestations are sufficient to make a diagnosis. Histologically, biopsy results often reveal abundant diffuse dermal infiltration of mast cells, which are characterized by their large pink granular cytoplasm and round dense central nuclei. In pediatric patients, mast cells typically are restricted to the dermis, and there is a low risk for hematologic abnormalities, thereby precluding the need for bone marrow examination in the absence of organomegaly or notable peripheral blood abnormalities such as severe cytopenia.5,6
Management of cutaneous mastocytosis consists of avoidance of mast cell degranulation triggers and symptomatic treatment of histamine release. Triggers include certain medications (eg, narcotic analgesics, aspirin, nonsteroidal anti-inflammatory drugs, iodinated contrast agents, antibiotics, muscle relaxants), mechanical irritation, insect stings, spicy foods, stress, or extreme temperature changes.8 Symptomatic treatment can be achieved through topical corticosteroid or oral antihistamine use. Along with decreasing pruritus, topical corticosteroids also may be helpful in decreasing time to spontaneous resolution and healing.7 The patient in this case was treated with desonide ointment 0.05% daily to both lesions as well as mupirocin ointment 2% as needed for erosions. These treatments helped reduce the patient's symptoms, but her lesions persisted over a follow-up period of 4 months.
- Valent P, Sperr WR, Schwartz LB, et al. Diagnosis and classification of mast cell proliferative disorders: delineation from immunologic diseases and non-mast cell hematopoietic neoplasms. J Allergy Clin Immunol. 2004;114:3-11.
- Bibi S, Langenfeld F, Jeanningros S, et al. Molecular defects in mastocytosis: KIT and beyond KIT. Immunol Allergy Clin North Am. 2014;34:239-262.
- Yavuz AS, Lipsky PE, Yavuz S, et al. Evidence for the involvement of a hematopoietic progenitor cell in systemic mastocytosis from single-cell analysis of mutations in the c-kit gene. Blood. 2002;100:661-665.
- Méni C, Bruneau J, Georgin-Lavialle S, et al. Paediatric mastocytosis: a systematic review of 1747 cases. Br J Dermatol. 2015;172:642-651.
- Valent P, Horny HP, Escribano L, et al. Diagnostic criteria and classification of mastocytosis: a consensus proposal. Leuk Res. 2001;25:603-625.
- Wolff K, Komar M, Petzelbauer P. Clinical and histopathological aspects of cutaneous mastocytosis. Leuk Res. 2001;25:519-528.
- Patrizi A, Tabanelli M, Neri I, et al. Topical corticosteroids versus "wait and see" in the management of solitary mastocytoma in pediatric patients: a long-term follow-up. Dermatol Ther. 2015;28:57-61.
- Bonadonna P, Lombardo C. Drug allergy in mastocytosis. Immunol Allergy Clin North Am. 2014;34:397-405.
The Diagnosis: Cutaneous Mastocytoma
Physical examination revealed a 58×51-mm hyperpigmented plaque with central pink coloration and scale on the right side of the back as well as a 39×33-mm pink plaque with a hyperpigmented border on the left side of the flank (Figure 1). At follow-up 2 weeks later, the patient's parents reported that blisters formed within both of the plaques. The blisters ruptured a few hours after forming and drained clear fluid with scant blood. Both plaques contained erosions from the ruptured bullae but remained the same size with no surrounding erythema or warmth. A 4-mm punch biopsy was performed of intact skin from the back lesion (Figure 2A). Histologic examination revealed a cellular infiltrate of monotonous bland cells that completely filled the dermis without epidermal involvement, along with occasional intermixed eosinophils. The morphology of these infiltrating cells was compatible with mast cells confirmed by strongly positive Leder staining (Figure 2B).
Mastocytosis encompasses a rare group of disorders characterized by abnormal mast cell accumulation or mast cell mediator release in various tissues. These disorders can be classified as either systemic mastocytosis with mast cell infiltration into bone marrow or other extracutaneous organs, or cutaneous mastocytosis with disease limited to the skin.1 Mutations involving activation of the c-Kit receptor in stimulating mast cell growth and development have been implicated in both systemic and cutaneous forms of the disease.2,3
Cutaneous mastocytosis is most often diagnosed in childhood and typically is characterized by spontaneous regression before puberty in a majority of cases.1,4 Under the World Health Organization classification system, cutaneous mastocytosis can be further subdivided into 3 disorders (listed in order of most to least common): urticaria pigmentosa (also known as maculopapular cutaneous mastocytosis) with typical, plaque, and nodular forms; cutaneous mastocytoma (as seen in this patient); and diffuse cutaneous mastocytosis.5 Compared to the widespread distribution of small macules and papules in urticaria pigmentosa, the cutaneous mastocytoma subtype presents with 1 to 6 brown to orange-yellow plaques or nodules measuring more than 1 cm in diameter. Cutaneous mastocytoma typically presents in infancy and is located most commonly on the trunk and extremities, though it may be found on the face or scalp. The plaques of mastocytoma often have well-defined margins, and these lesions may become bullous or demonstrate Darier sign of urtication and erythema on physical stimulation. Patients most commonly experience pruritus from mast cell degranulation and rarely exhibit systemic symptoms of mast cell mediator release; however, generalized flushing, hypotension, headaches, and gastrointestinal symptoms may occur, particularly if the lesion is vigorously rubbed.6,7 Conditions in the differential include aplasia cutis congenita, connective tissue nevus, epidermal nevus, and epidermolysis bullosa. They should not elicit a blister if rubbed, except for epidermolysis bullosa, which can easily be differentiated based on histology.
The workup for cutaneous mastocytosis in the pediatric population may include a biopsy of lesional skin, though in many cases the characteristic cutaneous manifestations are sufficient to make a diagnosis. Histologically, biopsy results often reveal abundant diffuse dermal infiltration of mast cells, which are characterized by their large pink granular cytoplasm and round dense central nuclei. In pediatric patients, mast cells typically are restricted to the dermis, and there is a low risk for hematologic abnormalities, thereby precluding the need for bone marrow examination in the absence of organomegaly or notable peripheral blood abnormalities such as severe cytopenia.5,6
Management of cutaneous mastocytosis consists of avoidance of mast cell degranulation triggers and symptomatic treatment of histamine release. Triggers include certain medications (eg, narcotic analgesics, aspirin, nonsteroidal anti-inflammatory drugs, iodinated contrast agents, antibiotics, muscle relaxants), mechanical irritation, insect stings, spicy foods, stress, or extreme temperature changes.8 Symptomatic treatment can be achieved through topical corticosteroid or oral antihistamine use. Along with decreasing pruritus, topical corticosteroids also may be helpful in decreasing time to spontaneous resolution and healing.7 The patient in this case was treated with desonide ointment 0.05% daily to both lesions as well as mupirocin ointment 2% as needed for erosions. These treatments helped reduce the patient's symptoms, but her lesions persisted over a follow-up period of 4 months.
The Diagnosis: Cutaneous Mastocytoma
Physical examination revealed a 58×51-mm hyperpigmented plaque with central pink coloration and scale on the right side of the back as well as a 39×33-mm pink plaque with a hyperpigmented border on the left side of the flank (Figure 1). At follow-up 2 weeks later, the patient's parents reported that blisters formed within both of the plaques. The blisters ruptured a few hours after forming and drained clear fluid with scant blood. Both plaques contained erosions from the ruptured bullae but remained the same size with no surrounding erythema or warmth. A 4-mm punch biopsy was performed of intact skin from the back lesion (Figure 2A). Histologic examination revealed a cellular infiltrate of monotonous bland cells that completely filled the dermis without epidermal involvement, along with occasional intermixed eosinophils. The morphology of these infiltrating cells was compatible with mast cells confirmed by strongly positive Leder staining (Figure 2B).
Mastocytosis encompasses a rare group of disorders characterized by abnormal mast cell accumulation or mast cell mediator release in various tissues. These disorders can be classified as either systemic mastocytosis with mast cell infiltration into bone marrow or other extracutaneous organs, or cutaneous mastocytosis with disease limited to the skin.1 Mutations involving activation of the c-Kit receptor in stimulating mast cell growth and development have been implicated in both systemic and cutaneous forms of the disease.2,3
Cutaneous mastocytosis is most often diagnosed in childhood and typically is characterized by spontaneous regression before puberty in a majority of cases.1,4 Under the World Health Organization classification system, cutaneous mastocytosis can be further subdivided into 3 disorders (listed in order of most to least common): urticaria pigmentosa (also known as maculopapular cutaneous mastocytosis) with typical, plaque, and nodular forms; cutaneous mastocytoma (as seen in this patient); and diffuse cutaneous mastocytosis.5 Compared to the widespread distribution of small macules and papules in urticaria pigmentosa, the cutaneous mastocytoma subtype presents with 1 to 6 brown to orange-yellow plaques or nodules measuring more than 1 cm in diameter. Cutaneous mastocytoma typically presents in infancy and is located most commonly on the trunk and extremities, though it may be found on the face or scalp. The plaques of mastocytoma often have well-defined margins, and these lesions may become bullous or demonstrate Darier sign of urtication and erythema on physical stimulation. Patients most commonly experience pruritus from mast cell degranulation and rarely exhibit systemic symptoms of mast cell mediator release; however, generalized flushing, hypotension, headaches, and gastrointestinal symptoms may occur, particularly if the lesion is vigorously rubbed.6,7 Conditions in the differential include aplasia cutis congenita, connective tissue nevus, epidermal nevus, and epidermolysis bullosa. They should not elicit a blister if rubbed, except for epidermolysis bullosa, which can easily be differentiated based on histology.
The workup for cutaneous mastocytosis in the pediatric population may include a biopsy of lesional skin, though in many cases the characteristic cutaneous manifestations are sufficient to make a diagnosis. Histologically, biopsy results often reveal abundant diffuse dermal infiltration of mast cells, which are characterized by their large pink granular cytoplasm and round dense central nuclei. In pediatric patients, mast cells typically are restricted to the dermis, and there is a low risk for hematologic abnormalities, thereby precluding the need for bone marrow examination in the absence of organomegaly or notable peripheral blood abnormalities such as severe cytopenia.5,6
Management of cutaneous mastocytosis consists of avoidance of mast cell degranulation triggers and symptomatic treatment of histamine release. Triggers include certain medications (eg, narcotic analgesics, aspirin, nonsteroidal anti-inflammatory drugs, iodinated contrast agents, antibiotics, muscle relaxants), mechanical irritation, insect stings, spicy foods, stress, or extreme temperature changes.8 Symptomatic treatment can be achieved through topical corticosteroid or oral antihistamine use. Along with decreasing pruritus, topical corticosteroids also may be helpful in decreasing time to spontaneous resolution and healing.7 The patient in this case was treated with desonide ointment 0.05% daily to both lesions as well as mupirocin ointment 2% as needed for erosions. These treatments helped reduce the patient's symptoms, but her lesions persisted over a follow-up period of 4 months.
- Valent P, Sperr WR, Schwartz LB, et al. Diagnosis and classification of mast cell proliferative disorders: delineation from immunologic diseases and non-mast cell hematopoietic neoplasms. J Allergy Clin Immunol. 2004;114:3-11.
- Bibi S, Langenfeld F, Jeanningros S, et al. Molecular defects in mastocytosis: KIT and beyond KIT. Immunol Allergy Clin North Am. 2014;34:239-262.
- Yavuz AS, Lipsky PE, Yavuz S, et al. Evidence for the involvement of a hematopoietic progenitor cell in systemic mastocytosis from single-cell analysis of mutations in the c-kit gene. Blood. 2002;100:661-665.
- Méni C, Bruneau J, Georgin-Lavialle S, et al. Paediatric mastocytosis: a systematic review of 1747 cases. Br J Dermatol. 2015;172:642-651.
- Valent P, Horny HP, Escribano L, et al. Diagnostic criteria and classification of mastocytosis: a consensus proposal. Leuk Res. 2001;25:603-625.
- Wolff K, Komar M, Petzelbauer P. Clinical and histopathological aspects of cutaneous mastocytosis. Leuk Res. 2001;25:519-528.
- Patrizi A, Tabanelli M, Neri I, et al. Topical corticosteroids versus "wait and see" in the management of solitary mastocytoma in pediatric patients: a long-term follow-up. Dermatol Ther. 2015;28:57-61.
- Bonadonna P, Lombardo C. Drug allergy in mastocytosis. Immunol Allergy Clin North Am. 2014;34:397-405.
- Valent P, Sperr WR, Schwartz LB, et al. Diagnosis and classification of mast cell proliferative disorders: delineation from immunologic diseases and non-mast cell hematopoietic neoplasms. J Allergy Clin Immunol. 2004;114:3-11.
- Bibi S, Langenfeld F, Jeanningros S, et al. Molecular defects in mastocytosis: KIT and beyond KIT. Immunol Allergy Clin North Am. 2014;34:239-262.
- Yavuz AS, Lipsky PE, Yavuz S, et al. Evidence for the involvement of a hematopoietic progenitor cell in systemic mastocytosis from single-cell analysis of mutations in the c-kit gene. Blood. 2002;100:661-665.
- Méni C, Bruneau J, Georgin-Lavialle S, et al. Paediatric mastocytosis: a systematic review of 1747 cases. Br J Dermatol. 2015;172:642-651.
- Valent P, Horny HP, Escribano L, et al. Diagnostic criteria and classification of mastocytosis: a consensus proposal. Leuk Res. 2001;25:603-625.
- Wolff K, Komar M, Petzelbauer P. Clinical and histopathological aspects of cutaneous mastocytosis. Leuk Res. 2001;25:519-528.
- Patrizi A, Tabanelli M, Neri I, et al. Topical corticosteroids versus "wait and see" in the management of solitary mastocytoma in pediatric patients: a long-term follow-up. Dermatol Ther. 2015;28:57-61.
- Bonadonna P, Lombardo C. Drug allergy in mastocytosis. Immunol Allergy Clin North Am. 2014;34:397-405.
A 4-day-old girl with no notable medical history presented with 2 pink lesions on the right side of the back and left side of the flank. Both lesions were present at birth and had not changed in size, shape, or color in the first 4 days of life. She had no constitutional symptoms. The child was a full-term newborn, and her mother experienced no pregnancy or delivery complications. She had no family history of similar skin findings.
Electronic Collaboration in Dermatology Resident Training Through Social Networking
More than 1.8 billion individuals utilize social media, a number that continues to grow as the social media market expands.1 Social media enables individuals, groups, and organizations to efficiently disperse and access information2-4 and also provides a structure that encourages collaboration between patients, staff, and physicians that cannot be achieved by other communication modalities.4-6 Expert opinions and related educational materials can be shared globally, improving collaboration between dermatologists.6 A structured social networking site for sharing training materials, research, and ideas can help bring the national dermatology community together in a new way.
Other professions have employed social networking tools to accomplish similar goals of organizing training resources; radiology has an electronic database that allows sharing of training materials and incorporates social networking capabilities.7 Their Web software provides functionality for individual file uploading and supports collaboration and sharing, all while maintaining the security of uploaded information. General surgery has already addressed similar concerns via a task force that incorporates all the essential organizations in surgical education.8 Increased satisfaction and academic abilities have been demonstrated with their collaborative curriculum.9 Gastroenterologists also utilize electronic resources; one study showed that using videos to educate patients prior to colonoscopies was superior to face-to-face education.10 In addition, video education may free up time for office staff to accomplish other tasks.
As a specialty, dermatology has not been a leader in the implementation of social networking for collaboration and training purposes. Every dermatologist is an educator. To maintain a successful practice, dermatologists must keep up-to-date on their own clinical knowledge, provide training to their staff, and educate their patients. Although there are numerous educational resources available to dermatologists, an informal survey of 30 dermatology faculty members revealed a practice gap in awareness and utilization of these expanding electronic resources.11
To better understand the needs of the specialty as a whole, we chose to focus on one aspect of dermatology education: resident training. The goal of our study was to survey dermatology residents and faculty to gain a better understanding of how they currently provide education and what online resources and social networking sites they currently use or would be willing to use. The study included 3 central hypotheses: First, residents would be less satisfied with their current curriculum and residents would report greater contributions to the curriculum relative to faculty. Second, both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Lastly, residents would be more willing than faculty to participate in social networking for educational purposes.
Methods
This study was granted institutional review board exemption. Two surveys were developed by the authors to assess the current structure and satisfaction of dermatology residency curriculum and the willingness to participate in social networking to use and share educational materials. The surveys were evaluated for relevance by the survey evaluation team of the Association of Professors of Dermatology (APD). The instrument was not pilot tested.
The surveys were electronically distributed using an online service to dermatology faculty via the APD listserve, which comprised the entirety of the APD membership in 2014. The resident survey was distributed to the dermatology residents via the American Society for Dermatologic Surgery listserve, which included all residents in training (2013-2014 academic year). Second and third invitations to complete the surveys were distributed 3 and 5 weeks later, respectively.
Resident and faculty responses were compared. Additionally, responses were stratified for large (>9 residents) and small programs (≤9 residents) for comparison. Descriptive statistics including means and medians for continuous variables and frequency tables for categorical variables were generated using research and spreadsheet software.
Results
There were 137 survey respondents; 52 of 426 (12.2%) dermatology faculty and 85 of 1539 (5.5%) dermatology residents responded to the survey. Small programs accounted for 24% of total survey responses and 76% were from large programs.
Current Curriculum
The majority of dermatology faculty (44%) and residents (35%) identified 1 to 2 faculty members as contributing to the creation and organization of their respective curricula; however, a notable percentage of residents (9%) reported that no faculty contributed to the organization of the curriculum. Residents noted that senior residents carry twice the responsibility for structuring the curriculum compared to faculty (61% vs 32% of the workload), but faculty described an even split between senior residents and faculty (47% vs 49% of the workload). Faculty believed their residents spend a similar amount of time in resident- and faculty-led instruction (38% vs 35% of their time); however, the majority of residents reported spending too little time in faculty-led instruction (53%). When residents ranked their preference for learning modes, faculty-led and self-study learning were ranked first and second by 48% and 45% of residents, respectively. Resident-led instruction was ranked last by 66% of residents. Likewise, a majority of residents (53%) described their amount of time in faculty-led instruction as too little.
When asked what subjects in dermatology were lacking at their programs, residents reported clinical trials (47%), skin of color (46%), cosmetic dermatology (34%), and aggressive skin cancer/multidisciplinary tumor board (32%). Although 11% of residents reported lacking inpatient dermatology in their curriculum, 0% of faculty reported the same. A notable percentage of faculty reported nothing was lacking compared to residents (25% vs 7%). Despite these different views between residents and faculty on their contributions to and structure of their curriculums, both faculty and residents claimed overall satisfaction (satisfied or very satisfied) with their program’s ability to optimally cover the field of dermatology in 3 years (100% and 91%, respectively).
Large Versus Small Residency Programs
When stratifying the resident responses for small versus large programs, both program sizes reported more time in resident-led instruction than faculty-led instruction. Likewise, residents in both program sizes equally preferred self-study or faculty-led instruction to resident-led instruction. Residents at small programs more often reported lacking instruction in rheumatology, immunobullous diseases, and basic science/skin biology compared to large-program residents. Compared to large-program faculty, small-program faculty reported lacking instruction in cosmetic dermatology.
Faculty at small programs reported spending too little time preparing for their faculty-led instruction compared to faculty at large programs (44% vs 12%). All (100%) of the faculty at small programs were likely to seek out study materials shared by top educators, while 77% of faculty at large programs were likely to do the same. When asked if faculty would translate what their program does well into an electronic format for sharing, 30% of large-program faculty were likely to do so compared to 11% of small-program faculty (Figure 1).
Use of Online Educational Materials and Interest in Collaboration
A majority of faculty and residents stated that they use online educational materials as supplements to traditional classroom lecture and print materials (81% vs 86%); however, almost twice as many residents stated that online educational materials were essential to their current study routines compared to faculty (39% vs 21%).
The majority of faculty (92%) and residents (84%) were either interested or very interested in a collaborative online curriculum. Both residents (85%) and faculty (81%) stated they would be likely to seek out online educational materials shared by top educators. Although both residents and faculty reported many aspects of their curriculums they thought could be beneficial to other dermatology programs (Table 1), only 27% of faculty and 19% of residents were likely to translate those strengths into a shareable electronic format. Several reasons were reported for not contributing to an online curriculum, with lack of time being the most common reason (Table 2).
Eighty percent of residents and 88% of faculty reported they were either interested or very interested in being more connected/interactive with their dermatology peers nationally (Figure 2). Likewise, 94% of residents and 87% of faculty agreed that the dermatology community could benefit from a social networking site for educational collaboration. Four times as many residents versus faculty currently use social networking sites (eg, Facebook, LinkedIn, Google Groups) as a primary mode of communication with distant professional peers. The majority of residents (52%) reported they would be likely to participate in a professional social networking site, while the majority of faculty (50%) stated they were neutral on their likelihood of participating. Both residents and faculty reported lack of time as a common reason for being unlikely to utilize a professional social networking site. Other barriers to participation are listed in Table 3.
Comment
This study showed how dermatology faculty and residents currently provide training and what online resources and social networking sites they currently use or would be willing to use. The generalizability of the conclusions is limited by the low response rate for the surveys. The results demonstrated the different views between faculty and residents and between large and small residency programs on various topics. This microcosm of dermatology training can likely be applied to other training scenarios in dermatology, including patient education; training of nurses, physician extenders, and office staff; continuing medical education for physicians; and peer-to-peer collaboration.
Hypothesis 1: Partially Proven
We hypothesized that residents would report less satisfaction with their current curriculum and would report greater resident contributions to the curriculum relative to faculty. Overall, residents and faculty reported satisfaction with their curriculums to provide up-to-date information and breadth in the field of dermatology. Despite their overall satisfaction, more residents reported lacking instruction in several dermatology subtopics compared to faculty. Additionally, residents believed they spend twice as much time structuring their curriculum compared to faculty, with some residents reporting no faculty involvement. Although residents preferred faculty-led instruction, a majority of residents reported they do not have enough faculty-led didactics. The preference for faculty-led training is likely due to the expertise of faculty compared to residents.
Hypothesis 2: Partially Proven
We also hypothesized that both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Although there was no difference in interest between residents at small versus large programs, there was a difference between faculty at small versus large programs. Small-program faculty were more interested in using shared materials than larger programs, while large-program faculty were more likely to share their educational materials. Small-program faculty reported spending too little time preparing their lectures, which is possibly due to a lack of time for preparation. Additionally, residents and faculty at smaller programs report their curriculum was lacking specific dermatology topics compared to large programs. These disparities between program sizes indicate a need for a social networking site for training collaboration in dermatology. Large programs have the ability to share what they do well, which small programs are eager to utilize.
Hypothesis 3: Not Proven
We hypothesized that residents would be more willing than faculty to participate in social networking for educational purposes. The majority of faculty and residents were interested in participating in a collaborative online curriculum and using the shared materials from top educators; however, even though such large majorities favored collaboration and sharing, only 27% of faculty and 19% of residents were likely to translate their own materials into a shareable format. Although lack of time was the most common reason for not sharing materials, electronic methods may have the potential to ultimately save time and remove the burden of content creation. The time it would take to translate selected personal training materials into a shareable form would be made up for by the time saved using another educators’ materials. Updating and customizing shared online educational materials can be much quicker and easier than educators creating materials on their own. Dermatologists would be more efficient facilitators of training via high-quality shared materials while decreasing the time burden associated with resident education.5 Another concern for not sharing or participating in a social networking site was skepticism of information security on such a network. The poor organization and information overload of online resources can compound the already existing time constraints on dermatologists, which may limit their ability to utilize such valuable resources. In addition, quality of online resources is not always guaranteed, and determining the sources that are high quality is sometimes a difficult task.6 For online materials to remain useful, there should be a peer-review process to evaluate quality and assess satisfaction.5
Solution: Create a Dermatology Task Force
A dermatology task force could facilitate the resolution of these challenges of online materials. In addition, a task force could cover the administrative support needed to ensure security and provide maintenance on social networks.
The main limitation to implementing a social network is the presence of the administrative infrastructure to jumpstart its creation. A task force incorporating the essential stakeholders in dermatology training is the first step. With inclusive representation from all of the smaller professional dermatology societies, the American Academy of Dermatology is optimally positioned to create this task force. With existing information technologies, a task force could address the concerns revealed in our survey as well as any future concerns that may arise.
The goal is a single social network for dermatologists that has the capability of improving communication and collaboration between professional peers regardless of their practice setting. Such a network is ideal for the practicing dermatologist for the purposes of staff training, patient education, and obtaining continuing medical education credit. Additionally, peer group collaboration would facilitate the understanding and completion of the evolving requirements for Maintenance of Certification from the American Board of Dermatology. The availability of quality shared materials would save time and increase efficiency of an entire dermatology practice. Materials that aid in patient education would allow office staff to dedicate their time to other tasks, thereby increasing productivity. Shared training materials would decrease the burden of staff education, providing more time for advanced hands-on training. This method of collaborative effort is capable of advancing the field of dermatology as a whole. It can overcome geographical and institutional barriers to connect dermatologists with similar interests worldwide; disseminate advances in diagnosis and treatment; and improve the quality of dermatology training of dermatologists, staff, and patients.
- Statistics and facts about social networks. Statista website. http://www.statista.com/topics/1164/social-networks/. Accessed March 22, 2017.
- Baker RC, Klein M, Samaan Z, et al. Effectiveness of an online pediatric primary care curriculum. Acad Pediatr. 2010;10:131-137.
- Dolev JC, O’Sullivan P, Berger T. The eDerm online curriculum: a randomized study of effective skin cancer teaching to medical students. J Am Acad Dermatol. 2011;65:e165-e171.
- Amir M, Sampson BP, Endly D, et al. Social networking sites: emerging and essential tools for communication in dermatology. JAMA Dermatol. 2014;150:56-60.
- Ruiz JG, Mintzer MJ, Leipzig RM. The impact of e-learning in medical education. Acad Med. 2006;81:207-212.
- Hanson AH, Krause LK, Simmons RN, et al. Dermatology education and the internet: traditional and cutting-edge resources. J Am Acad Dermatol. 2011;65:836-842.
- Rowe SP, Siddiqui A, Bonekamp D. The key image and case log application: new radiology software for teaching file creation and case logging that incorporates elements of a social network. Acad Radiol. 2014;21:916-930.
- Bell RH. Surgical council on resident education: a new organization devoted to graduate surgical education. J Am Coll Surg. 2007;204:341-346.
- Kirton OC, Reilly P, Staff I, et al. Development and implementation of an interactive, objective, and simulation-based curriculum for general surgery residents. J Surg Educ. 2012;69:718-723.
- Prakash S, Verma S, McGowan J, et al. Improving the quality of colonoscopy bowel preparation using an educational video. Can J Gastroenterol. 2013;27:696-700.
- Carroll BT. eTools for teaching dermatologic surgery. Paper presented at the Association of Professors of Dermatology 2014 Annual Meeting; September 12-13, 2014; Chicago, IL.
More than 1.8 billion individuals utilize social media, a number that continues to grow as the social media market expands.1 Social media enables individuals, groups, and organizations to efficiently disperse and access information2-4 and also provides a structure that encourages collaboration between patients, staff, and physicians that cannot be achieved by other communication modalities.4-6 Expert opinions and related educational materials can be shared globally, improving collaboration between dermatologists.6 A structured social networking site for sharing training materials, research, and ideas can help bring the national dermatology community together in a new way.
Other professions have employed social networking tools to accomplish similar goals of organizing training resources; radiology has an electronic database that allows sharing of training materials and incorporates social networking capabilities.7 Their Web software provides functionality for individual file uploading and supports collaboration and sharing, all while maintaining the security of uploaded information. General surgery has already addressed similar concerns via a task force that incorporates all the essential organizations in surgical education.8 Increased satisfaction and academic abilities have been demonstrated with their collaborative curriculum.9 Gastroenterologists also utilize electronic resources; one study showed that using videos to educate patients prior to colonoscopies was superior to face-to-face education.10 In addition, video education may free up time for office staff to accomplish other tasks.
As a specialty, dermatology has not been a leader in the implementation of social networking for collaboration and training purposes. Every dermatologist is an educator. To maintain a successful practice, dermatologists must keep up-to-date on their own clinical knowledge, provide training to their staff, and educate their patients. Although there are numerous educational resources available to dermatologists, an informal survey of 30 dermatology faculty members revealed a practice gap in awareness and utilization of these expanding electronic resources.11
To better understand the needs of the specialty as a whole, we chose to focus on one aspect of dermatology education: resident training. The goal of our study was to survey dermatology residents and faculty to gain a better understanding of how they currently provide education and what online resources and social networking sites they currently use or would be willing to use. The study included 3 central hypotheses: First, residents would be less satisfied with their current curriculum and residents would report greater contributions to the curriculum relative to faculty. Second, both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Lastly, residents would be more willing than faculty to participate in social networking for educational purposes.
Methods
This study was granted institutional review board exemption. Two surveys were developed by the authors to assess the current structure and satisfaction of dermatology residency curriculum and the willingness to participate in social networking to use and share educational materials. The surveys were evaluated for relevance by the survey evaluation team of the Association of Professors of Dermatology (APD). The instrument was not pilot tested.
The surveys were electronically distributed using an online service to dermatology faculty via the APD listserve, which comprised the entirety of the APD membership in 2014. The resident survey was distributed to the dermatology residents via the American Society for Dermatologic Surgery listserve, which included all residents in training (2013-2014 academic year). Second and third invitations to complete the surveys were distributed 3 and 5 weeks later, respectively.
Resident and faculty responses were compared. Additionally, responses were stratified for large (>9 residents) and small programs (≤9 residents) for comparison. Descriptive statistics including means and medians for continuous variables and frequency tables for categorical variables were generated using research and spreadsheet software.
Results
There were 137 survey respondents; 52 of 426 (12.2%) dermatology faculty and 85 of 1539 (5.5%) dermatology residents responded to the survey. Small programs accounted for 24% of total survey responses and 76% were from large programs.
Current Curriculum
The majority of dermatology faculty (44%) and residents (35%) identified 1 to 2 faculty members as contributing to the creation and organization of their respective curricula; however, a notable percentage of residents (9%) reported that no faculty contributed to the organization of the curriculum. Residents noted that senior residents carry twice the responsibility for structuring the curriculum compared to faculty (61% vs 32% of the workload), but faculty described an even split between senior residents and faculty (47% vs 49% of the workload). Faculty believed their residents spend a similar amount of time in resident- and faculty-led instruction (38% vs 35% of their time); however, the majority of residents reported spending too little time in faculty-led instruction (53%). When residents ranked their preference for learning modes, faculty-led and self-study learning were ranked first and second by 48% and 45% of residents, respectively. Resident-led instruction was ranked last by 66% of residents. Likewise, a majority of residents (53%) described their amount of time in faculty-led instruction as too little.
When asked what subjects in dermatology were lacking at their programs, residents reported clinical trials (47%), skin of color (46%), cosmetic dermatology (34%), and aggressive skin cancer/multidisciplinary tumor board (32%). Although 11% of residents reported lacking inpatient dermatology in their curriculum, 0% of faculty reported the same. A notable percentage of faculty reported nothing was lacking compared to residents (25% vs 7%). Despite these different views between residents and faculty on their contributions to and structure of their curriculums, both faculty and residents claimed overall satisfaction (satisfied or very satisfied) with their program’s ability to optimally cover the field of dermatology in 3 years (100% and 91%, respectively).
Large Versus Small Residency Programs
When stratifying the resident responses for small versus large programs, both program sizes reported more time in resident-led instruction than faculty-led instruction. Likewise, residents in both program sizes equally preferred self-study or faculty-led instruction to resident-led instruction. Residents at small programs more often reported lacking instruction in rheumatology, immunobullous diseases, and basic science/skin biology compared to large-program residents. Compared to large-program faculty, small-program faculty reported lacking instruction in cosmetic dermatology.
Faculty at small programs reported spending too little time preparing for their faculty-led instruction compared to faculty at large programs (44% vs 12%). All (100%) of the faculty at small programs were likely to seek out study materials shared by top educators, while 77% of faculty at large programs were likely to do the same. When asked if faculty would translate what their program does well into an electronic format for sharing, 30% of large-program faculty were likely to do so compared to 11% of small-program faculty (Figure 1).
Use of Online Educational Materials and Interest in Collaboration
A majority of faculty and residents stated that they use online educational materials as supplements to traditional classroom lecture and print materials (81% vs 86%); however, almost twice as many residents stated that online educational materials were essential to their current study routines compared to faculty (39% vs 21%).
The majority of faculty (92%) and residents (84%) were either interested or very interested in a collaborative online curriculum. Both residents (85%) and faculty (81%) stated they would be likely to seek out online educational materials shared by top educators. Although both residents and faculty reported many aspects of their curriculums they thought could be beneficial to other dermatology programs (Table 1), only 27% of faculty and 19% of residents were likely to translate those strengths into a shareable electronic format. Several reasons were reported for not contributing to an online curriculum, with lack of time being the most common reason (Table 2).
Eighty percent of residents and 88% of faculty reported they were either interested or very interested in being more connected/interactive with their dermatology peers nationally (Figure 2). Likewise, 94% of residents and 87% of faculty agreed that the dermatology community could benefit from a social networking site for educational collaboration. Four times as many residents versus faculty currently use social networking sites (eg, Facebook, LinkedIn, Google Groups) as a primary mode of communication with distant professional peers. The majority of residents (52%) reported they would be likely to participate in a professional social networking site, while the majority of faculty (50%) stated they were neutral on their likelihood of participating. Both residents and faculty reported lack of time as a common reason for being unlikely to utilize a professional social networking site. Other barriers to participation are listed in Table 3.
Comment
This study showed how dermatology faculty and residents currently provide training and what online resources and social networking sites they currently use or would be willing to use. The generalizability of the conclusions is limited by the low response rate for the surveys. The results demonstrated the different views between faculty and residents and between large and small residency programs on various topics. This microcosm of dermatology training can likely be applied to other training scenarios in dermatology, including patient education; training of nurses, physician extenders, and office staff; continuing medical education for physicians; and peer-to-peer collaboration.
Hypothesis 1: Partially Proven
We hypothesized that residents would report less satisfaction with their current curriculum and would report greater resident contributions to the curriculum relative to faculty. Overall, residents and faculty reported satisfaction with their curriculums to provide up-to-date information and breadth in the field of dermatology. Despite their overall satisfaction, more residents reported lacking instruction in several dermatology subtopics compared to faculty. Additionally, residents believed they spend twice as much time structuring their curriculum compared to faculty, with some residents reporting no faculty involvement. Although residents preferred faculty-led instruction, a majority of residents reported they do not have enough faculty-led didactics. The preference for faculty-led training is likely due to the expertise of faculty compared to residents.
Hypothesis 2: Partially Proven
We also hypothesized that both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Although there was no difference in interest between residents at small versus large programs, there was a difference between faculty at small versus large programs. Small-program faculty were more interested in using shared materials than larger programs, while large-program faculty were more likely to share their educational materials. Small-program faculty reported spending too little time preparing their lectures, which is possibly due to a lack of time for preparation. Additionally, residents and faculty at smaller programs report their curriculum was lacking specific dermatology topics compared to large programs. These disparities between program sizes indicate a need for a social networking site for training collaboration in dermatology. Large programs have the ability to share what they do well, which small programs are eager to utilize.
Hypothesis 3: Not Proven
We hypothesized that residents would be more willing than faculty to participate in social networking for educational purposes. The majority of faculty and residents were interested in participating in a collaborative online curriculum and using the shared materials from top educators; however, even though such large majorities favored collaboration and sharing, only 27% of faculty and 19% of residents were likely to translate their own materials into a shareable format. Although lack of time was the most common reason for not sharing materials, electronic methods may have the potential to ultimately save time and remove the burden of content creation. The time it would take to translate selected personal training materials into a shareable form would be made up for by the time saved using another educators’ materials. Updating and customizing shared online educational materials can be much quicker and easier than educators creating materials on their own. Dermatologists would be more efficient facilitators of training via high-quality shared materials while decreasing the time burden associated with resident education.5 Another concern for not sharing or participating in a social networking site was skepticism of information security on such a network. The poor organization and information overload of online resources can compound the already existing time constraints on dermatologists, which may limit their ability to utilize such valuable resources. In addition, quality of online resources is not always guaranteed, and determining the sources that are high quality is sometimes a difficult task.6 For online materials to remain useful, there should be a peer-review process to evaluate quality and assess satisfaction.5
Solution: Create a Dermatology Task Force
A dermatology task force could facilitate the resolution of these challenges of online materials. In addition, a task force could cover the administrative support needed to ensure security and provide maintenance on social networks.
The main limitation to implementing a social network is the presence of the administrative infrastructure to jumpstart its creation. A task force incorporating the essential stakeholders in dermatology training is the first step. With inclusive representation from all of the smaller professional dermatology societies, the American Academy of Dermatology is optimally positioned to create this task force. With existing information technologies, a task force could address the concerns revealed in our survey as well as any future concerns that may arise.
The goal is a single social network for dermatologists that has the capability of improving communication and collaboration between professional peers regardless of their practice setting. Such a network is ideal for the practicing dermatologist for the purposes of staff training, patient education, and obtaining continuing medical education credit. Additionally, peer group collaboration would facilitate the understanding and completion of the evolving requirements for Maintenance of Certification from the American Board of Dermatology. The availability of quality shared materials would save time and increase efficiency of an entire dermatology practice. Materials that aid in patient education would allow office staff to dedicate their time to other tasks, thereby increasing productivity. Shared training materials would decrease the burden of staff education, providing more time for advanced hands-on training. This method of collaborative effort is capable of advancing the field of dermatology as a whole. It can overcome geographical and institutional barriers to connect dermatologists with similar interests worldwide; disseminate advances in diagnosis and treatment; and improve the quality of dermatology training of dermatologists, staff, and patients.
More than 1.8 billion individuals utilize social media, a number that continues to grow as the social media market expands.1 Social media enables individuals, groups, and organizations to efficiently disperse and access information2-4 and also provides a structure that encourages collaboration between patients, staff, and physicians that cannot be achieved by other communication modalities.4-6 Expert opinions and related educational materials can be shared globally, improving collaboration between dermatologists.6 A structured social networking site for sharing training materials, research, and ideas can help bring the national dermatology community together in a new way.
Other professions have employed social networking tools to accomplish similar goals of organizing training resources; radiology has an electronic database that allows sharing of training materials and incorporates social networking capabilities.7 Their Web software provides functionality for individual file uploading and supports collaboration and sharing, all while maintaining the security of uploaded information. General surgery has already addressed similar concerns via a task force that incorporates all the essential organizations in surgical education.8 Increased satisfaction and academic abilities have been demonstrated with their collaborative curriculum.9 Gastroenterologists also utilize electronic resources; one study showed that using videos to educate patients prior to colonoscopies was superior to face-to-face education.10 In addition, video education may free up time for office staff to accomplish other tasks.
As a specialty, dermatology has not been a leader in the implementation of social networking for collaboration and training purposes. Every dermatologist is an educator. To maintain a successful practice, dermatologists must keep up-to-date on their own clinical knowledge, provide training to their staff, and educate their patients. Although there are numerous educational resources available to dermatologists, an informal survey of 30 dermatology faculty members revealed a practice gap in awareness and utilization of these expanding electronic resources.11
To better understand the needs of the specialty as a whole, we chose to focus on one aspect of dermatology education: resident training. The goal of our study was to survey dermatology residents and faculty to gain a better understanding of how they currently provide education and what online resources and social networking sites they currently use or would be willing to use. The study included 3 central hypotheses: First, residents would be less satisfied with their current curriculum and residents would report greater contributions to the curriculum relative to faculty. Second, both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Lastly, residents would be more willing than faculty to participate in social networking for educational purposes.
Methods
This study was granted institutional review board exemption. Two surveys were developed by the authors to assess the current structure and satisfaction of dermatology residency curriculum and the willingness to participate in social networking to use and share educational materials. The surveys were evaluated for relevance by the survey evaluation team of the Association of Professors of Dermatology (APD). The instrument was not pilot tested.
The surveys were electronically distributed using an online service to dermatology faculty via the APD listserve, which comprised the entirety of the APD membership in 2014. The resident survey was distributed to the dermatology residents via the American Society for Dermatologic Surgery listserve, which included all residents in training (2013-2014 academic year). Second and third invitations to complete the surveys were distributed 3 and 5 weeks later, respectively.
Resident and faculty responses were compared. Additionally, responses were stratified for large (>9 residents) and small programs (≤9 residents) for comparison. Descriptive statistics including means and medians for continuous variables and frequency tables for categorical variables were generated using research and spreadsheet software.
Results
There were 137 survey respondents; 52 of 426 (12.2%) dermatology faculty and 85 of 1539 (5.5%) dermatology residents responded to the survey. Small programs accounted for 24% of total survey responses and 76% were from large programs.
Current Curriculum
The majority of dermatology faculty (44%) and residents (35%) identified 1 to 2 faculty members as contributing to the creation and organization of their respective curricula; however, a notable percentage of residents (9%) reported that no faculty contributed to the organization of the curriculum. Residents noted that senior residents carry twice the responsibility for structuring the curriculum compared to faculty (61% vs 32% of the workload), but faculty described an even split between senior residents and faculty (47% vs 49% of the workload). Faculty believed their residents spend a similar amount of time in resident- and faculty-led instruction (38% vs 35% of their time); however, the majority of residents reported spending too little time in faculty-led instruction (53%). When residents ranked their preference for learning modes, faculty-led and self-study learning were ranked first and second by 48% and 45% of residents, respectively. Resident-led instruction was ranked last by 66% of residents. Likewise, a majority of residents (53%) described their amount of time in faculty-led instruction as too little.
When asked what subjects in dermatology were lacking at their programs, residents reported clinical trials (47%), skin of color (46%), cosmetic dermatology (34%), and aggressive skin cancer/multidisciplinary tumor board (32%). Although 11% of residents reported lacking inpatient dermatology in their curriculum, 0% of faculty reported the same. A notable percentage of faculty reported nothing was lacking compared to residents (25% vs 7%). Despite these different views between residents and faculty on their contributions to and structure of their curriculums, both faculty and residents claimed overall satisfaction (satisfied or very satisfied) with their program’s ability to optimally cover the field of dermatology in 3 years (100% and 91%, respectively).
Large Versus Small Residency Programs
When stratifying the resident responses for small versus large programs, both program sizes reported more time in resident-led instruction than faculty-led instruction. Likewise, residents in both program sizes equally preferred self-study or faculty-led instruction to resident-led instruction. Residents at small programs more often reported lacking instruction in rheumatology, immunobullous diseases, and basic science/skin biology compared to large-program residents. Compared to large-program faculty, small-program faculty reported lacking instruction in cosmetic dermatology.
Faculty at small programs reported spending too little time preparing for their faculty-led instruction compared to faculty at large programs (44% vs 12%). All (100%) of the faculty at small programs were likely to seek out study materials shared by top educators, while 77% of faculty at large programs were likely to do the same. When asked if faculty would translate what their program does well into an electronic format for sharing, 30% of large-program faculty were likely to do so compared to 11% of small-program faculty (Figure 1).
Use of Online Educational Materials and Interest in Collaboration
A majority of faculty and residents stated that they use online educational materials as supplements to traditional classroom lecture and print materials (81% vs 86%); however, almost twice as many residents stated that online educational materials were essential to their current study routines compared to faculty (39% vs 21%).
The majority of faculty (92%) and residents (84%) were either interested or very interested in a collaborative online curriculum. Both residents (85%) and faculty (81%) stated they would be likely to seek out online educational materials shared by top educators. Although both residents and faculty reported many aspects of their curriculums they thought could be beneficial to other dermatology programs (Table 1), only 27% of faculty and 19% of residents were likely to translate those strengths into a shareable electronic format. Several reasons were reported for not contributing to an online curriculum, with lack of time being the most common reason (Table 2).
Eighty percent of residents and 88% of faculty reported they were either interested or very interested in being more connected/interactive with their dermatology peers nationally (Figure 2). Likewise, 94% of residents and 87% of faculty agreed that the dermatology community could benefit from a social networking site for educational collaboration. Four times as many residents versus faculty currently use social networking sites (eg, Facebook, LinkedIn, Google Groups) as a primary mode of communication with distant professional peers. The majority of residents (52%) reported they would be likely to participate in a professional social networking site, while the majority of faculty (50%) stated they were neutral on their likelihood of participating. Both residents and faculty reported lack of time as a common reason for being unlikely to utilize a professional social networking site. Other barriers to participation are listed in Table 3.
Comment
This study showed how dermatology faculty and residents currently provide training and what online resources and social networking sites they currently use or would be willing to use. The generalizability of the conclusions is limited by the low response rate for the surveys. The results demonstrated the different views between faculty and residents and between large and small residency programs on various topics. This microcosm of dermatology training can likely be applied to other training scenarios in dermatology, including patient education; training of nurses, physician extenders, and office staff; continuing medical education for physicians; and peer-to-peer collaboration.
Hypothesis 1: Partially Proven
We hypothesized that residents would report less satisfaction with their current curriculum and would report greater resident contributions to the curriculum relative to faculty. Overall, residents and faculty reported satisfaction with their curriculums to provide up-to-date information and breadth in the field of dermatology. Despite their overall satisfaction, more residents reported lacking instruction in several dermatology subtopics compared to faculty. Additionally, residents believed they spend twice as much time structuring their curriculum compared to faculty, with some residents reporting no faculty involvement. Although residents preferred faculty-led instruction, a majority of residents reported they do not have enough faculty-led didactics. The preference for faculty-led training is likely due to the expertise of faculty compared to residents.
Hypothesis 2: Partially Proven
We also hypothesized that both residents and faculty of smaller programs would be more interested in collaborative educational resources relative to larger programs. Although there was no difference in interest between residents at small versus large programs, there was a difference between faculty at small versus large programs. Small-program faculty were more interested in using shared materials than larger programs, while large-program faculty were more likely to share their educational materials. Small-program faculty reported spending too little time preparing their lectures, which is possibly due to a lack of time for preparation. Additionally, residents and faculty at smaller programs report their curriculum was lacking specific dermatology topics compared to large programs. These disparities between program sizes indicate a need for a social networking site for training collaboration in dermatology. Large programs have the ability to share what they do well, which small programs are eager to utilize.
Hypothesis 3: Not Proven
We hypothesized that residents would be more willing than faculty to participate in social networking for educational purposes. The majority of faculty and residents were interested in participating in a collaborative online curriculum and using the shared materials from top educators; however, even though such large majorities favored collaboration and sharing, only 27% of faculty and 19% of residents were likely to translate their own materials into a shareable format. Although lack of time was the most common reason for not sharing materials, electronic methods may have the potential to ultimately save time and remove the burden of content creation. The time it would take to translate selected personal training materials into a shareable form would be made up for by the time saved using another educators’ materials. Updating and customizing shared online educational materials can be much quicker and easier than educators creating materials on their own. Dermatologists would be more efficient facilitators of training via high-quality shared materials while decreasing the time burden associated with resident education.5 Another concern for not sharing or participating in a social networking site was skepticism of information security on such a network. The poor organization and information overload of online resources can compound the already existing time constraints on dermatologists, which may limit their ability to utilize such valuable resources. In addition, quality of online resources is not always guaranteed, and determining the sources that are high quality is sometimes a difficult task.6 For online materials to remain useful, there should be a peer-review process to evaluate quality and assess satisfaction.5
Solution: Create a Dermatology Task Force
A dermatology task force could facilitate the resolution of these challenges of online materials. In addition, a task force could cover the administrative support needed to ensure security and provide maintenance on social networks.
The main limitation to implementing a social network is the presence of the administrative infrastructure to jumpstart its creation. A task force incorporating the essential stakeholders in dermatology training is the first step. With inclusive representation from all of the smaller professional dermatology societies, the American Academy of Dermatology is optimally positioned to create this task force. With existing information technologies, a task force could address the concerns revealed in our survey as well as any future concerns that may arise.
The goal is a single social network for dermatologists that has the capability of improving communication and collaboration between professional peers regardless of their practice setting. Such a network is ideal for the practicing dermatologist for the purposes of staff training, patient education, and obtaining continuing medical education credit. Additionally, peer group collaboration would facilitate the understanding and completion of the evolving requirements for Maintenance of Certification from the American Board of Dermatology. The availability of quality shared materials would save time and increase efficiency of an entire dermatology practice. Materials that aid in patient education would allow office staff to dedicate their time to other tasks, thereby increasing productivity. Shared training materials would decrease the burden of staff education, providing more time for advanced hands-on training. This method of collaborative effort is capable of advancing the field of dermatology as a whole. It can overcome geographical and institutional barriers to connect dermatologists with similar interests worldwide; disseminate advances in diagnosis and treatment; and improve the quality of dermatology training of dermatologists, staff, and patients.
- Statistics and facts about social networks. Statista website. http://www.statista.com/topics/1164/social-networks/. Accessed March 22, 2017.
- Baker RC, Klein M, Samaan Z, et al. Effectiveness of an online pediatric primary care curriculum. Acad Pediatr. 2010;10:131-137.
- Dolev JC, O’Sullivan P, Berger T. The eDerm online curriculum: a randomized study of effective skin cancer teaching to medical students. J Am Acad Dermatol. 2011;65:e165-e171.
- Amir M, Sampson BP, Endly D, et al. Social networking sites: emerging and essential tools for communication in dermatology. JAMA Dermatol. 2014;150:56-60.
- Ruiz JG, Mintzer MJ, Leipzig RM. The impact of e-learning in medical education. Acad Med. 2006;81:207-212.
- Hanson AH, Krause LK, Simmons RN, et al. Dermatology education and the internet: traditional and cutting-edge resources. J Am Acad Dermatol. 2011;65:836-842.
- Rowe SP, Siddiqui A, Bonekamp D. The key image and case log application: new radiology software for teaching file creation and case logging that incorporates elements of a social network. Acad Radiol. 2014;21:916-930.
- Bell RH. Surgical council on resident education: a new organization devoted to graduate surgical education. J Am Coll Surg. 2007;204:341-346.
- Kirton OC, Reilly P, Staff I, et al. Development and implementation of an interactive, objective, and simulation-based curriculum for general surgery residents. J Surg Educ. 2012;69:718-723.
- Prakash S, Verma S, McGowan J, et al. Improving the quality of colonoscopy bowel preparation using an educational video. Can J Gastroenterol. 2013;27:696-700.
- Carroll BT. eTools for teaching dermatologic surgery. Paper presented at the Association of Professors of Dermatology 2014 Annual Meeting; September 12-13, 2014; Chicago, IL.
- Statistics and facts about social networks. Statista website. http://www.statista.com/topics/1164/social-networks/. Accessed March 22, 2017.
- Baker RC, Klein M, Samaan Z, et al. Effectiveness of an online pediatric primary care curriculum. Acad Pediatr. 2010;10:131-137.
- Dolev JC, O’Sullivan P, Berger T. The eDerm online curriculum: a randomized study of effective skin cancer teaching to medical students. J Am Acad Dermatol. 2011;65:e165-e171.
- Amir M, Sampson BP, Endly D, et al. Social networking sites: emerging and essential tools for communication in dermatology. JAMA Dermatol. 2014;150:56-60.
- Ruiz JG, Mintzer MJ, Leipzig RM. The impact of e-learning in medical education. Acad Med. 2006;81:207-212.
- Hanson AH, Krause LK, Simmons RN, et al. Dermatology education and the internet: traditional and cutting-edge resources. J Am Acad Dermatol. 2011;65:836-842.
- Rowe SP, Siddiqui A, Bonekamp D. The key image and case log application: new radiology software for teaching file creation and case logging that incorporates elements of a social network. Acad Radiol. 2014;21:916-930.
- Bell RH. Surgical council on resident education: a new organization devoted to graduate surgical education. J Am Coll Surg. 2007;204:341-346.
- Kirton OC, Reilly P, Staff I, et al. Development and implementation of an interactive, objective, and simulation-based curriculum for general surgery residents. J Surg Educ. 2012;69:718-723.
- Prakash S, Verma S, McGowan J, et al. Improving the quality of colonoscopy bowel preparation using an educational video. Can J Gastroenterol. 2013;27:696-700.
- Carroll BT. eTools for teaching dermatologic surgery. Paper presented at the Association of Professors of Dermatology 2014 Annual Meeting; September 12-13, 2014; Chicago, IL.
Practice Points
- Educational collaboration between residency programs via social media can result in more well-rounded dermatologists, which will enhance patient care.
- Social media can connect dermatologists nationwide to improve patient care via collaboration.
Long-acting growth hormone moves forward based on positive phase II data
ORLANDO – An extended-release human growth hormone formulation proved safe and effective in both children and adults, offering the prospect of a less-rigorous dosing schedule and potentially better patient compliance with treatment.
The two phase II studies examined somavaratan, which is being developed by Versartis of Menlo Park, Calif. Kevin Yuen, MD, an endocrinologist at the Swedish Medical Center, Seattle, and Wayne V. Moore, MD, a pediatric endocrinologist at Children’s Mercy Hospital, Kansas City, Mo., presented the data at the annual meeting of the Endocrine Society.
“Despite the fact that human growth hormone is a proven treatment for growth hormone deficiency, daily use of our current formulations can be a factor that affects compliance,” said Dr. Yuen. He cited a 2008 study of 158 men taking growth hormone, which found that only one-third were highly compliant (Endocr Pract. 2008 Mar;14[2]:143-54). “And even among this group, there were 21 doses missed over just a 3-month period.”
The group of 55 international experts described several strategies for creating long-acting growth hormone formulations, including depot formulations, pegylation, prodrugs, noncovalent albumin binding growth hormone compounds, and growth hormone fusion proteins. These preparations are currently in various stages of development, with some already approved in Europe and Asia.
Somavaratan (VRS-317) is a fusion protein produced in Escherichia coli. The active portion is recombinant human growth hormone, which is bound to long chains of hydrophilic amino acids. This reduces renal filtration, Dr. Yuen said. The growth hormone loses some potency in this construct, but its delayed clearance, with a half-life 30-60 times longer than recombinant human growth hormone (rhGH) allows it to exert a prolonged effect in target tissue.
Of the two phase II studies of the molecule, one was conducted in 64 prepubertal children who were naive to any growth hormone treatment, and one in 36 adults with adult-onset growth hormone deficiency. The company also has made these presentations available online.
The pediatric study reported 3-year data on the cohort, which began treatment of children at a mean age of 7 years. At baseline, the children were about 2.6 standard deviations (SDs) below their expected height, and their mean IGF-1 levels, about 1.7 SDs below. They showed a mean maximum stimulated growth hormone level of 5.4 ng/mL. Although they were a mean of 7.8 years chronologically at the study’s outset, their mean bone age was 6.4 years.
The first 12 months of the study consisted of dose-ranging trials, with initial doses of 5 mg/kg each month, then 2.5 mg/kg twice a month, and then 1.15 mg/kg weekly. During the last 2 years of the study, all children were taking 3.5 mg/kg, once a month.
Within the first year, all children taking the 3.5-mg/kg dose had achieved normal IGF-1 levels, which were consistent with levels achieved in the ANSWER registry dataset of somatropin (rDNA origin) injection (Norditropin) recombinant human growth hormone (Clin Epidemiol. 2013;5:119-27).
Height velocity improved, as did height standard deviation. By year 3, patients were a mean of 1.25 SDs below expected height – a significant improvement over baseline. These findings were almost superimposable with those in the ANSWER registry. Bone age and chronological age came into alignment within the first year and that association was maintained throughout the study – again, in almost superimposable curves with the registry data.
Somavaratan exerted no untoward metabolic effects. There were no adverse changes in body mass index. At baseline, the mean hemoglobin A1c was 5.2%; this was unchanged at 3 years. No patient developed diabetes. The most commonly reported adverse event was injection site pain (48%). Injection site erythema was reported in 5% of patients, but no injection site nodules occurred.
Other adverse events were headache, extremity pain, arthralgia, and musculoskeletal pain. Although the numbers were small overall, reports did increase after all the children were switched to the 3.5-mg/kg dose. However, they occurred in 5% or less of the patient group. There were no withdrawals due to adverse events.
The second trial was a dose-ranging study conducted in 49 adults aged 23-70 years. They all had been diagnosed with adult-onset growth hormone deficiency, but had stable pituitary function. If they were on any growth hormone therapy, they underwent a 14-day washout period.
The subjects were divided and dosed by age and gender. All subjects received one injection per month for 5 months.
Cohort A comprised 21 men and women aged 35 years or older, who took 0.6 mg/kg per month. Cohort B comprised six men and women younger than 35 years, who took 0.8 mg/kg per month. Cohort C comprised eight women taking oral estrogen contraceptives. These women received 1 mg/kg per month.
The cohorts were similar in body mass index and weight, but they did differ significantly in baseline IGF-1 levels. In cohort A, the level was 0.52 SDs below normal. In cohort B, it was 2.89 SDs below normal, and in cohort C, it was 2.29 SDs below.
Overall, somavaratan induced a rapid and dramatic increase in IGF-1 that tailed off over 30 days. By day 8 after injection, IGF-1 had risen from a mean baseline of -1 SDs to more than 2 SDs above. By day 22, it had returned to baseline levels. The response to the fifth injection was identical to that of the first, Dr. Yuen said.
Response varied somewhat by cohort, with the younger, mixed-gender group responding the most dramatically, with a mean increase of about 4 SDs from baseline. This put the group above the maximum response target of 1.5 SDs.
The older, mixed-gender cohort experienced about a 3 SDs increase – also above the target level. The women taking estrogen experienced the flattest response, gaining about 2 SDs. However, the response curve was nearly identical, with a rapid, sharp increase in IGF-1 within the first week, followed by a gradual decline to baseline by 22 days.
The adverse event profile was not quite as benign as it was in the pediatric study. Virtually all patients experienced at least one adverse event. A third were mild and 58% moderate. The rest were serious, with one severe and one life-threatening event. Dr. Yuen did not discuss adverse events; these were, however, included in supplementary slides available on the Versartis Inc. slide set.
The finding of a predictable, 3-week tailing-off of efficacy, combined with the fact that patients responded so dramatically, exceeding the maximum target of a 1.5 SDs increase in IGF-1, has prompted a new dosing protocol for the somavaratan open-label extension study, which includes all the phase II completers, plus an additional 40 adult patients.
Doses will be titrated to each subject’s individual IGF-1 responses, based on the IGF-I level 7 days post dose until a maintenance dose is reached. Subjects receiving somavaratan in a previous somavaratan study will have their dose decreased by half (minimum dose of 20 mg, or 40 mg for women on estrogen).
Dr. Yuen is a member of the Versartis advisory board. Dr. Moore has received research support from the company.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – An extended-release human growth hormone formulation proved safe and effective in both children and adults, offering the prospect of a less-rigorous dosing schedule and potentially better patient compliance with treatment.
The two phase II studies examined somavaratan, which is being developed by Versartis of Menlo Park, Calif. Kevin Yuen, MD, an endocrinologist at the Swedish Medical Center, Seattle, and Wayne V. Moore, MD, a pediatric endocrinologist at Children’s Mercy Hospital, Kansas City, Mo., presented the data at the annual meeting of the Endocrine Society.
“Despite the fact that human growth hormone is a proven treatment for growth hormone deficiency, daily use of our current formulations can be a factor that affects compliance,” said Dr. Yuen. He cited a 2008 study of 158 men taking growth hormone, which found that only one-third were highly compliant (Endocr Pract. 2008 Mar;14[2]:143-54). “And even among this group, there were 21 doses missed over just a 3-month period.”
The group of 55 international experts described several strategies for creating long-acting growth hormone formulations, including depot formulations, pegylation, prodrugs, noncovalent albumin binding growth hormone compounds, and growth hormone fusion proteins. These preparations are currently in various stages of development, with some already approved in Europe and Asia.
Somavaratan (VRS-317) is a fusion protein produced in Escherichia coli. The active portion is recombinant human growth hormone, which is bound to long chains of hydrophilic amino acids. This reduces renal filtration, Dr. Yuen said. The growth hormone loses some potency in this construct, but its delayed clearance, with a half-life 30-60 times longer than recombinant human growth hormone (rhGH) allows it to exert a prolonged effect in target tissue.
Of the two phase II studies of the molecule, one was conducted in 64 prepubertal children who were naive to any growth hormone treatment, and one in 36 adults with adult-onset growth hormone deficiency. The company also has made these presentations available online.
The pediatric study reported 3-year data on the cohort, which began treatment of children at a mean age of 7 years. At baseline, the children were about 2.6 standard deviations (SDs) below their expected height, and their mean IGF-1 levels, about 1.7 SDs below. They showed a mean maximum stimulated growth hormone level of 5.4 ng/mL. Although they were a mean of 7.8 years chronologically at the study’s outset, their mean bone age was 6.4 years.
The first 12 months of the study consisted of dose-ranging trials, with initial doses of 5 mg/kg each month, then 2.5 mg/kg twice a month, and then 1.15 mg/kg weekly. During the last 2 years of the study, all children were taking 3.5 mg/kg, once a month.
Within the first year, all children taking the 3.5-mg/kg dose had achieved normal IGF-1 levels, which were consistent with levels achieved in the ANSWER registry dataset of somatropin (rDNA origin) injection (Norditropin) recombinant human growth hormone (Clin Epidemiol. 2013;5:119-27).
Height velocity improved, as did height standard deviation. By year 3, patients were a mean of 1.25 SDs below expected height – a significant improvement over baseline. These findings were almost superimposable with those in the ANSWER registry. Bone age and chronological age came into alignment within the first year and that association was maintained throughout the study – again, in almost superimposable curves with the registry data.
Somavaratan exerted no untoward metabolic effects. There were no adverse changes in body mass index. At baseline, the mean hemoglobin A1c was 5.2%; this was unchanged at 3 years. No patient developed diabetes. The most commonly reported adverse event was injection site pain (48%). Injection site erythema was reported in 5% of patients, but no injection site nodules occurred.
Other adverse events were headache, extremity pain, arthralgia, and musculoskeletal pain. Although the numbers were small overall, reports did increase after all the children were switched to the 3.5-mg/kg dose. However, they occurred in 5% or less of the patient group. There were no withdrawals due to adverse events.
The second trial was a dose-ranging study conducted in 49 adults aged 23-70 years. They all had been diagnosed with adult-onset growth hormone deficiency, but had stable pituitary function. If they were on any growth hormone therapy, they underwent a 14-day washout period.
The subjects were divided and dosed by age and gender. All subjects received one injection per month for 5 months.
Cohort A comprised 21 men and women aged 35 years or older, who took 0.6 mg/kg per month. Cohort B comprised six men and women younger than 35 years, who took 0.8 mg/kg per month. Cohort C comprised eight women taking oral estrogen contraceptives. These women received 1 mg/kg per month.
The cohorts were similar in body mass index and weight, but they did differ significantly in baseline IGF-1 levels. In cohort A, the level was 0.52 SDs below normal. In cohort B, it was 2.89 SDs below normal, and in cohort C, it was 2.29 SDs below.
Overall, somavaratan induced a rapid and dramatic increase in IGF-1 that tailed off over 30 days. By day 8 after injection, IGF-1 had risen from a mean baseline of -1 SDs to more than 2 SDs above. By day 22, it had returned to baseline levels. The response to the fifth injection was identical to that of the first, Dr. Yuen said.
Response varied somewhat by cohort, with the younger, mixed-gender group responding the most dramatically, with a mean increase of about 4 SDs from baseline. This put the group above the maximum response target of 1.5 SDs.
The older, mixed-gender cohort experienced about a 3 SDs increase – also above the target level. The women taking estrogen experienced the flattest response, gaining about 2 SDs. However, the response curve was nearly identical, with a rapid, sharp increase in IGF-1 within the first week, followed by a gradual decline to baseline by 22 days.
The adverse event profile was not quite as benign as it was in the pediatric study. Virtually all patients experienced at least one adverse event. A third were mild and 58% moderate. The rest were serious, with one severe and one life-threatening event. Dr. Yuen did not discuss adverse events; these were, however, included in supplementary slides available on the Versartis Inc. slide set.
The finding of a predictable, 3-week tailing-off of efficacy, combined with the fact that patients responded so dramatically, exceeding the maximum target of a 1.5 SDs increase in IGF-1, has prompted a new dosing protocol for the somavaratan open-label extension study, which includes all the phase II completers, plus an additional 40 adult patients.
Doses will be titrated to each subject’s individual IGF-1 responses, based on the IGF-I level 7 days post dose until a maintenance dose is reached. Subjects receiving somavaratan in a previous somavaratan study will have their dose decreased by half (minimum dose of 20 mg, or 40 mg for women on estrogen).
Dr. Yuen is a member of the Versartis advisory board. Dr. Moore has received research support from the company.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – An extended-release human growth hormone formulation proved safe and effective in both children and adults, offering the prospect of a less-rigorous dosing schedule and potentially better patient compliance with treatment.
The two phase II studies examined somavaratan, which is being developed by Versartis of Menlo Park, Calif. Kevin Yuen, MD, an endocrinologist at the Swedish Medical Center, Seattle, and Wayne V. Moore, MD, a pediatric endocrinologist at Children’s Mercy Hospital, Kansas City, Mo., presented the data at the annual meeting of the Endocrine Society.
“Despite the fact that human growth hormone is a proven treatment for growth hormone deficiency, daily use of our current formulations can be a factor that affects compliance,” said Dr. Yuen. He cited a 2008 study of 158 men taking growth hormone, which found that only one-third were highly compliant (Endocr Pract. 2008 Mar;14[2]:143-54). “And even among this group, there were 21 doses missed over just a 3-month period.”
The group of 55 international experts described several strategies for creating long-acting growth hormone formulations, including depot formulations, pegylation, prodrugs, noncovalent albumin binding growth hormone compounds, and growth hormone fusion proteins. These preparations are currently in various stages of development, with some already approved in Europe and Asia.
Somavaratan (VRS-317) is a fusion protein produced in Escherichia coli. The active portion is recombinant human growth hormone, which is bound to long chains of hydrophilic amino acids. This reduces renal filtration, Dr. Yuen said. The growth hormone loses some potency in this construct, but its delayed clearance, with a half-life 30-60 times longer than recombinant human growth hormone (rhGH) allows it to exert a prolonged effect in target tissue.
Of the two phase II studies of the molecule, one was conducted in 64 prepubertal children who were naive to any growth hormone treatment, and one in 36 adults with adult-onset growth hormone deficiency. The company also has made these presentations available online.
The pediatric study reported 3-year data on the cohort, which began treatment of children at a mean age of 7 years. At baseline, the children were about 2.6 standard deviations (SDs) below their expected height, and their mean IGF-1 levels, about 1.7 SDs below. They showed a mean maximum stimulated growth hormone level of 5.4 ng/mL. Although they were a mean of 7.8 years chronologically at the study’s outset, their mean bone age was 6.4 years.
The first 12 months of the study consisted of dose-ranging trials, with initial doses of 5 mg/kg each month, then 2.5 mg/kg twice a month, and then 1.15 mg/kg weekly. During the last 2 years of the study, all children were taking 3.5 mg/kg, once a month.
Within the first year, all children taking the 3.5-mg/kg dose had achieved normal IGF-1 levels, which were consistent with levels achieved in the ANSWER registry dataset of somatropin (rDNA origin) injection (Norditropin) recombinant human growth hormone (Clin Epidemiol. 2013;5:119-27).
Height velocity improved, as did height standard deviation. By year 3, patients were a mean of 1.25 SDs below expected height – a significant improvement over baseline. These findings were almost superimposable with those in the ANSWER registry. Bone age and chronological age came into alignment within the first year and that association was maintained throughout the study – again, in almost superimposable curves with the registry data.
Somavaratan exerted no untoward metabolic effects. There were no adverse changes in body mass index. At baseline, the mean hemoglobin A1c was 5.2%; this was unchanged at 3 years. No patient developed diabetes. The most commonly reported adverse event was injection site pain (48%). Injection site erythema was reported in 5% of patients, but no injection site nodules occurred.
Other adverse events were headache, extremity pain, arthralgia, and musculoskeletal pain. Although the numbers were small overall, reports did increase after all the children were switched to the 3.5-mg/kg dose. However, they occurred in 5% or less of the patient group. There were no withdrawals due to adverse events.
The second trial was a dose-ranging study conducted in 49 adults aged 23-70 years. They all had been diagnosed with adult-onset growth hormone deficiency, but had stable pituitary function. If they were on any growth hormone therapy, they underwent a 14-day washout period.
The subjects were divided and dosed by age and gender. All subjects received one injection per month for 5 months.
Cohort A comprised 21 men and women aged 35 years or older, who took 0.6 mg/kg per month. Cohort B comprised six men and women younger than 35 years, who took 0.8 mg/kg per month. Cohort C comprised eight women taking oral estrogen contraceptives. These women received 1 mg/kg per month.
The cohorts were similar in body mass index and weight, but they did differ significantly in baseline IGF-1 levels. In cohort A, the level was 0.52 SDs below normal. In cohort B, it was 2.89 SDs below normal, and in cohort C, it was 2.29 SDs below.
Overall, somavaratan induced a rapid and dramatic increase in IGF-1 that tailed off over 30 days. By day 8 after injection, IGF-1 had risen from a mean baseline of -1 SDs to more than 2 SDs above. By day 22, it had returned to baseline levels. The response to the fifth injection was identical to that of the first, Dr. Yuen said.
Response varied somewhat by cohort, with the younger, mixed-gender group responding the most dramatically, with a mean increase of about 4 SDs from baseline. This put the group above the maximum response target of 1.5 SDs.
The older, mixed-gender cohort experienced about a 3 SDs increase – also above the target level. The women taking estrogen experienced the flattest response, gaining about 2 SDs. However, the response curve was nearly identical, with a rapid, sharp increase in IGF-1 within the first week, followed by a gradual decline to baseline by 22 days.
The adverse event profile was not quite as benign as it was in the pediatric study. Virtually all patients experienced at least one adverse event. A third were mild and 58% moderate. The rest were serious, with one severe and one life-threatening event. Dr. Yuen did not discuss adverse events; these were, however, included in supplementary slides available on the Versartis Inc. slide set.
The finding of a predictable, 3-week tailing-off of efficacy, combined with the fact that patients responded so dramatically, exceeding the maximum target of a 1.5 SDs increase in IGF-1, has prompted a new dosing protocol for the somavaratan open-label extension study, which includes all the phase II completers, plus an additional 40 adult patients.
Doses will be titrated to each subject’s individual IGF-1 responses, based on the IGF-I level 7 days post dose until a maintenance dose is reached. Subjects receiving somavaratan in a previous somavaratan study will have their dose decreased by half (minimum dose of 20 mg, or 40 mg for women on estrogen).
Dr. Yuen is a member of the Versartis advisory board. Dr. Moore has received research support from the company.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
AT ENDO 2017
Key clinical point:
Major finding: In the 64-patient pediatric study, the molecule raised growth velocity and IGF-1 levels by several standard deviations. In the 48-patient adult study, it raised IGF-1 levels by up to 4 standard deviations.
Data source: A 64-patient pediatric dose-ranging study and a 48-patient adult study.
Disclosures: Versartis sponsored the studies. Dr. Yuen is on the company’s advisory board. Dr. Moore has received research support from the company.
Data-driven HR, RR parameters might help reduce alarm fatigue
Clinical question: Can alarm fatigue in pediatric inpatient settings be safely mitigated by modifying alarm limits with data-driven vital sign reference ranges?
Background: The management of patient alarms in the hospital is a significant safety issue, with the large majority of alarms (85%-99%) either false or not clinically significant. This leads to provider desensitization or alarm fatigue, which has been shown to contribute to adverse events.
In 2014, the Joint Commission made the issue of alarm system safety and alarm fatigue a priority for hospitals.1 Multiple studies have been published addressing alarm fatigue in hospitalized adult patients, but this issue is less well studied in pediatrics, including little guidance on optimizing alarm parameters. Widely used reference ranges and guides are based on limited evidence, primarily based on observational data in healthy outpatients or consensus data.
A 2013 study used vital sign data from hospitalized children to develop percentile curves for heart rate (HR) and respiratory rate (RR) and estimated that 54% of vital sign measurements in hospitalized children are out of range using currently accepted reference ranges.2
To safely decrease the number of out-of-range vital sign measurements resulting from current reference ranges, this study used data from non–critically ill hospitalized children to develop HR and RR percentile charts, and then performed retrospective safety analysis by evaluating effects of modifying the alarm limits on identification of cardiorespiratory arrests (CRA) and rapid response team (RRT) activations.
Study Design: Retrospective, cross-sectional study.
Setting: Single-site, 311-bed quaternary-care academic hospital, both general medical and surgical units.
Synopsis: Vital signs were extracted from the institution’s electronic health record (EHR) for all general medical and surgical patients discharged between Jan. 1, 3013, and May 3, 2014, excluding critically ill children and physiologically implausible vital signs. Two different sets were used, a training set (patients discharged between Jan. 1, 2013, and Dec. 31, 2013) and a validation set (Jan. 1, 2014-May 3, 2014). One HR and RR pair was randomly selected for each 4-hour interval during hospitalization, with a maximum of 10 HR and RR pairs per patient. Age-stratified percentiles were calculated using this data. The 5th and 95th percentile limits using the study data were compared with the 5th and 95th percentile values in the 2013 study, and the reference ranges currently in use at the institution (2004 National Institutes of Health ranges).2
The training set used 62,508 vital sign measurements for 7,202 patients to calculate percentiles for HR and RR among 14 different age groups. The validation set consisted of 82,993 vital sign measurements for 2,287 patients. Using the 5th and 95th percentiles for HR and RR resulted in 24,045 (55.6%) fewer out-of-range measurements in the validation set compared to NIH reference ranges (45% fewer HR values, 61% fewer RR values). This finding, as well as the vital sign percentile ranges, was consistent with the data published in the 2013 study.2
Data for all 148 out-of-ICU RRT and CRA events during the same time period were reviewed using manual chart review. Evaluating vital signs within the 12 hours preceding the events, 144 patients had out-of-range HR or RR measurements using NIH ranges. One hundred thirty-six (94.4%) of these 144 patients also had out-of-range measurements using the study-derived 5th and 95th percentile values.
Manual chart review of the remaining eight patients who had normal HR or RR demonstrated that the RRT or CRA interventions occurred for clinical indications that did no rely on HR or RR measurement (for example, desaturations, difficulty breathing, hematemesis), so the data-driven parameters did not miss any of these events.
Bottom line: In this retrospective study, using data-driven HR and RR parameters was at least as safe as the NIH-published reference ranges currently in use in this hospital. In addition to maintaining safety related to RRT and CRA events, use of the data-driven parameters resulted in 55.6% fewer out-of-range vital sign measurements in the studied population. This may reduce the frequency of false alarms and improve alarm fatigue, and should be studied prospectively in the future.
Citation: Goel VV, Poole SF, Longhurst CA, et al. Safety analysis of proposed data-driven physiologic alarm parameters for hospitalized children. J Hosp Med. 2016;11(12):817-823.
Dr. Galloway is a pediatric hospitalist at Sanford Children’s Hospital in Sioux Falls, S.D., assistant professor of pediatrics at the University of South Dakota Sanford School of Medicine, and vice chief of the division of hospital pediatrics at USD SSOM and Sanford Children’s Hospital.
References
1. The Joint Commission. Alarm system safety. Available at: https://www.jointcommission.org/assets/1/18/R3_Report_Issue_5_12_2_13_Final.pdf. Published December 11, 2013.
2. Bonafide CP, Brady PW, Keren R, Conway PH, Marsolo K, Daymont C. Development of heart and respiratory rate percentile curves for hospitalized children. Pediatrics. 2013;131(4):e1150-1157.
Clinical question: Can alarm fatigue in pediatric inpatient settings be safely mitigated by modifying alarm limits with data-driven vital sign reference ranges?
Background: The management of patient alarms in the hospital is a significant safety issue, with the large majority of alarms (85%-99%) either false or not clinically significant. This leads to provider desensitization or alarm fatigue, which has been shown to contribute to adverse events.
In 2014, the Joint Commission made the issue of alarm system safety and alarm fatigue a priority for hospitals.1 Multiple studies have been published addressing alarm fatigue in hospitalized adult patients, but this issue is less well studied in pediatrics, including little guidance on optimizing alarm parameters. Widely used reference ranges and guides are based on limited evidence, primarily based on observational data in healthy outpatients or consensus data.
A 2013 study used vital sign data from hospitalized children to develop percentile curves for heart rate (HR) and respiratory rate (RR) and estimated that 54% of vital sign measurements in hospitalized children are out of range using currently accepted reference ranges.2
To safely decrease the number of out-of-range vital sign measurements resulting from current reference ranges, this study used data from non–critically ill hospitalized children to develop HR and RR percentile charts, and then performed retrospective safety analysis by evaluating effects of modifying the alarm limits on identification of cardiorespiratory arrests (CRA) and rapid response team (RRT) activations.
Study Design: Retrospective, cross-sectional study.
Setting: Single-site, 311-bed quaternary-care academic hospital, both general medical and surgical units.
Synopsis: Vital signs were extracted from the institution’s electronic health record (EHR) for all general medical and surgical patients discharged between Jan. 1, 3013, and May 3, 2014, excluding critically ill children and physiologically implausible vital signs. Two different sets were used, a training set (patients discharged between Jan. 1, 2013, and Dec. 31, 2013) and a validation set (Jan. 1, 2014-May 3, 2014). One HR and RR pair was randomly selected for each 4-hour interval during hospitalization, with a maximum of 10 HR and RR pairs per patient. Age-stratified percentiles were calculated using this data. The 5th and 95th percentile limits using the study data were compared with the 5th and 95th percentile values in the 2013 study, and the reference ranges currently in use at the institution (2004 National Institutes of Health ranges).2
The training set used 62,508 vital sign measurements for 7,202 patients to calculate percentiles for HR and RR among 14 different age groups. The validation set consisted of 82,993 vital sign measurements for 2,287 patients. Using the 5th and 95th percentiles for HR and RR resulted in 24,045 (55.6%) fewer out-of-range measurements in the validation set compared to NIH reference ranges (45% fewer HR values, 61% fewer RR values). This finding, as well as the vital sign percentile ranges, was consistent with the data published in the 2013 study.2
Data for all 148 out-of-ICU RRT and CRA events during the same time period were reviewed using manual chart review. Evaluating vital signs within the 12 hours preceding the events, 144 patients had out-of-range HR or RR measurements using NIH ranges. One hundred thirty-six (94.4%) of these 144 patients also had out-of-range measurements using the study-derived 5th and 95th percentile values.
Manual chart review of the remaining eight patients who had normal HR or RR demonstrated that the RRT or CRA interventions occurred for clinical indications that did no rely on HR or RR measurement (for example, desaturations, difficulty breathing, hematemesis), so the data-driven parameters did not miss any of these events.
Bottom line: In this retrospective study, using data-driven HR and RR parameters was at least as safe as the NIH-published reference ranges currently in use in this hospital. In addition to maintaining safety related to RRT and CRA events, use of the data-driven parameters resulted in 55.6% fewer out-of-range vital sign measurements in the studied population. This may reduce the frequency of false alarms and improve alarm fatigue, and should be studied prospectively in the future.
Citation: Goel VV, Poole SF, Longhurst CA, et al. Safety analysis of proposed data-driven physiologic alarm parameters for hospitalized children. J Hosp Med. 2016;11(12):817-823.
Dr. Galloway is a pediatric hospitalist at Sanford Children’s Hospital in Sioux Falls, S.D., assistant professor of pediatrics at the University of South Dakota Sanford School of Medicine, and vice chief of the division of hospital pediatrics at USD SSOM and Sanford Children’s Hospital.
References
1. The Joint Commission. Alarm system safety. Available at: https://www.jointcommission.org/assets/1/18/R3_Report_Issue_5_12_2_13_Final.pdf. Published December 11, 2013.
2. Bonafide CP, Brady PW, Keren R, Conway PH, Marsolo K, Daymont C. Development of heart and respiratory rate percentile curves for hospitalized children. Pediatrics. 2013;131(4):e1150-1157.
Clinical question: Can alarm fatigue in pediatric inpatient settings be safely mitigated by modifying alarm limits with data-driven vital sign reference ranges?
Background: The management of patient alarms in the hospital is a significant safety issue, with the large majority of alarms (85%-99%) either false or not clinically significant. This leads to provider desensitization or alarm fatigue, which has been shown to contribute to adverse events.
In 2014, the Joint Commission made the issue of alarm system safety and alarm fatigue a priority for hospitals.1 Multiple studies have been published addressing alarm fatigue in hospitalized adult patients, but this issue is less well studied in pediatrics, including little guidance on optimizing alarm parameters. Widely used reference ranges and guides are based on limited evidence, primarily based on observational data in healthy outpatients or consensus data.
A 2013 study used vital sign data from hospitalized children to develop percentile curves for heart rate (HR) and respiratory rate (RR) and estimated that 54% of vital sign measurements in hospitalized children are out of range using currently accepted reference ranges.2
To safely decrease the number of out-of-range vital sign measurements resulting from current reference ranges, this study used data from non–critically ill hospitalized children to develop HR and RR percentile charts, and then performed retrospective safety analysis by evaluating effects of modifying the alarm limits on identification of cardiorespiratory arrests (CRA) and rapid response team (RRT) activations.
Study Design: Retrospective, cross-sectional study.
Setting: Single-site, 311-bed quaternary-care academic hospital, both general medical and surgical units.
Synopsis: Vital signs were extracted from the institution’s electronic health record (EHR) for all general medical and surgical patients discharged between Jan. 1, 3013, and May 3, 2014, excluding critically ill children and physiologically implausible vital signs. Two different sets were used, a training set (patients discharged between Jan. 1, 2013, and Dec. 31, 2013) and a validation set (Jan. 1, 2014-May 3, 2014). One HR and RR pair was randomly selected for each 4-hour interval during hospitalization, with a maximum of 10 HR and RR pairs per patient. Age-stratified percentiles were calculated using this data. The 5th and 95th percentile limits using the study data were compared with the 5th and 95th percentile values in the 2013 study, and the reference ranges currently in use at the institution (2004 National Institutes of Health ranges).2
The training set used 62,508 vital sign measurements for 7,202 patients to calculate percentiles for HR and RR among 14 different age groups. The validation set consisted of 82,993 vital sign measurements for 2,287 patients. Using the 5th and 95th percentiles for HR and RR resulted in 24,045 (55.6%) fewer out-of-range measurements in the validation set compared to NIH reference ranges (45% fewer HR values, 61% fewer RR values). This finding, as well as the vital sign percentile ranges, was consistent with the data published in the 2013 study.2
Data for all 148 out-of-ICU RRT and CRA events during the same time period were reviewed using manual chart review. Evaluating vital signs within the 12 hours preceding the events, 144 patients had out-of-range HR or RR measurements using NIH ranges. One hundred thirty-six (94.4%) of these 144 patients also had out-of-range measurements using the study-derived 5th and 95th percentile values.
Manual chart review of the remaining eight patients who had normal HR or RR demonstrated that the RRT or CRA interventions occurred for clinical indications that did no rely on HR or RR measurement (for example, desaturations, difficulty breathing, hematemesis), so the data-driven parameters did not miss any of these events.
Bottom line: In this retrospective study, using data-driven HR and RR parameters was at least as safe as the NIH-published reference ranges currently in use in this hospital. In addition to maintaining safety related to RRT and CRA events, use of the data-driven parameters resulted in 55.6% fewer out-of-range vital sign measurements in the studied population. This may reduce the frequency of false alarms and improve alarm fatigue, and should be studied prospectively in the future.
Citation: Goel VV, Poole SF, Longhurst CA, et al. Safety analysis of proposed data-driven physiologic alarm parameters for hospitalized children. J Hosp Med. 2016;11(12):817-823.
Dr. Galloway is a pediatric hospitalist at Sanford Children’s Hospital in Sioux Falls, S.D., assistant professor of pediatrics at the University of South Dakota Sanford School of Medicine, and vice chief of the division of hospital pediatrics at USD SSOM and Sanford Children’s Hospital.
References
1. The Joint Commission. Alarm system safety. Available at: https://www.jointcommission.org/assets/1/18/R3_Report_Issue_5_12_2_13_Final.pdf. Published December 11, 2013.
2. Bonafide CP, Brady PW, Keren R, Conway PH, Marsolo K, Daymont C. Development of heart and respiratory rate percentile curves for hospitalized children. Pediatrics. 2013;131(4):e1150-1157.