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Pediatric migraine linked to multiple comorbidities
Pediatric headache and migraine are associated with a variety of conditions including respiratory, gastrointestinal, neurologic, and mood disorders, according to findings published in the Journal of Pediatrics.
In a study of 9,329 pediatric patients from the Philadelphia Neurodevelopmental Cohort, at the University of Pennsylvania, children with any headache type were more likely to have cardiovascular (odds ratio, 1.4; 95% confidence interval, 1.1-1.7) and gastrointestinal (OR, 1.2; 95% CI, 1.1-1.4) problems than did those without headache. In addition, they were more likely to have attention deficit hyperactivity disorder (OR, 1.2; 95% CI, 1.1-1.4), wrote Tarannum M. Lateef, MD, MPH, of the Center for Neuroscience and Behavioral Medicine at Children’s National Medical Center in Washington, and her coauthors.
Study participants were aged 8-21 years and were enrolled in the cohort from November 2009 to November 2011. Physical conditions were identified using EMRs and interviews and were later grouped together by general category.
Patients were asked about lifetime headache and migraine symptoms including sensitivity to light and noise, gastrointestinal symptoms, unilateral pain, throbbing and pulsation, and interference at school or work. Migraine was defined as headache accompanied by any three of these symptoms. Mental disorders were identified using an abbreviated version of the Kiddie-Schedule for Affective Disorders and Schizophrenia, reported Dr. Lateef and her associates.
Lifetime prevalence of any headache was 45.5%, and 22.6% for migraine. Migraine was more common in female patients (25.5%) than in male patients (19.4%).
Compared with nonmigraine headache patients, those with migraine more frequently had neurologic/central nervous system disorders (OR, 1.7; 95% CI, 1.4-2.0), developmental disorders (OR, 1.3; 95% CI, 1.1-1.6), respiratory problems (OR, 1.3; 95% CI, 1.1-1.6), anxiety (OR, 1.6; 95% CI, 1.3-2), mood disorders (OR, 2; 95% CI, 1.6-2.3), and behavioral disorders (OR, 1.3; 95% CI, 1.1-1.6).
The results suggest that “headache, particularly migraine, is associated with respiratory and other neurologic and developmental disorders, as well as with anxiety and mood disorders,” the authors wrote.
“Comorbidity may be an important index of heterogeneity … that can guide clinical management, genetic investigation, and future research on shared pathophysiology” with other disorders, they concluded.
No disclosures were reported.
SOURCE: Lateef T et al. J Pediatr. 2018 Oct 29. doi: 10.1016/j.jpeds.2018.09.033.
Pediatric headache and migraine are associated with a variety of conditions including respiratory, gastrointestinal, neurologic, and mood disorders, according to findings published in the Journal of Pediatrics.
In a study of 9,329 pediatric patients from the Philadelphia Neurodevelopmental Cohort, at the University of Pennsylvania, children with any headache type were more likely to have cardiovascular (odds ratio, 1.4; 95% confidence interval, 1.1-1.7) and gastrointestinal (OR, 1.2; 95% CI, 1.1-1.4) problems than did those without headache. In addition, they were more likely to have attention deficit hyperactivity disorder (OR, 1.2; 95% CI, 1.1-1.4), wrote Tarannum M. Lateef, MD, MPH, of the Center for Neuroscience and Behavioral Medicine at Children’s National Medical Center in Washington, and her coauthors.
Study participants were aged 8-21 years and were enrolled in the cohort from November 2009 to November 2011. Physical conditions were identified using EMRs and interviews and were later grouped together by general category.
Patients were asked about lifetime headache and migraine symptoms including sensitivity to light and noise, gastrointestinal symptoms, unilateral pain, throbbing and pulsation, and interference at school or work. Migraine was defined as headache accompanied by any three of these symptoms. Mental disorders were identified using an abbreviated version of the Kiddie-Schedule for Affective Disorders and Schizophrenia, reported Dr. Lateef and her associates.
Lifetime prevalence of any headache was 45.5%, and 22.6% for migraine. Migraine was more common in female patients (25.5%) than in male patients (19.4%).
Compared with nonmigraine headache patients, those with migraine more frequently had neurologic/central nervous system disorders (OR, 1.7; 95% CI, 1.4-2.0), developmental disorders (OR, 1.3; 95% CI, 1.1-1.6), respiratory problems (OR, 1.3; 95% CI, 1.1-1.6), anxiety (OR, 1.6; 95% CI, 1.3-2), mood disorders (OR, 2; 95% CI, 1.6-2.3), and behavioral disorders (OR, 1.3; 95% CI, 1.1-1.6).
The results suggest that “headache, particularly migraine, is associated with respiratory and other neurologic and developmental disorders, as well as with anxiety and mood disorders,” the authors wrote.
“Comorbidity may be an important index of heterogeneity … that can guide clinical management, genetic investigation, and future research on shared pathophysiology” with other disorders, they concluded.
No disclosures were reported.
SOURCE: Lateef T et al. J Pediatr. 2018 Oct 29. doi: 10.1016/j.jpeds.2018.09.033.
Pediatric headache and migraine are associated with a variety of conditions including respiratory, gastrointestinal, neurologic, and mood disorders, according to findings published in the Journal of Pediatrics.
In a study of 9,329 pediatric patients from the Philadelphia Neurodevelopmental Cohort, at the University of Pennsylvania, children with any headache type were more likely to have cardiovascular (odds ratio, 1.4; 95% confidence interval, 1.1-1.7) and gastrointestinal (OR, 1.2; 95% CI, 1.1-1.4) problems than did those without headache. In addition, they were more likely to have attention deficit hyperactivity disorder (OR, 1.2; 95% CI, 1.1-1.4), wrote Tarannum M. Lateef, MD, MPH, of the Center for Neuroscience and Behavioral Medicine at Children’s National Medical Center in Washington, and her coauthors.
Study participants were aged 8-21 years and were enrolled in the cohort from November 2009 to November 2011. Physical conditions were identified using EMRs and interviews and were later grouped together by general category.
Patients were asked about lifetime headache and migraine symptoms including sensitivity to light and noise, gastrointestinal symptoms, unilateral pain, throbbing and pulsation, and interference at school or work. Migraine was defined as headache accompanied by any three of these symptoms. Mental disorders were identified using an abbreviated version of the Kiddie-Schedule for Affective Disorders and Schizophrenia, reported Dr. Lateef and her associates.
Lifetime prevalence of any headache was 45.5%, and 22.6% for migraine. Migraine was more common in female patients (25.5%) than in male patients (19.4%).
Compared with nonmigraine headache patients, those with migraine more frequently had neurologic/central nervous system disorders (OR, 1.7; 95% CI, 1.4-2.0), developmental disorders (OR, 1.3; 95% CI, 1.1-1.6), respiratory problems (OR, 1.3; 95% CI, 1.1-1.6), anxiety (OR, 1.6; 95% CI, 1.3-2), mood disorders (OR, 2; 95% CI, 1.6-2.3), and behavioral disorders (OR, 1.3; 95% CI, 1.1-1.6).
The results suggest that “headache, particularly migraine, is associated with respiratory and other neurologic and developmental disorders, as well as with anxiety and mood disorders,” the authors wrote.
“Comorbidity may be an important index of heterogeneity … that can guide clinical management, genetic investigation, and future research on shared pathophysiology” with other disorders, they concluded.
No disclosures were reported.
SOURCE: Lateef T et al. J Pediatr. 2018 Oct 29. doi: 10.1016/j.jpeds.2018.09.033.
FROM THE JOURNAL OF PEDIATRICS
Key clinical point: Pediatric headache and migraine are associated with respiratory, neurologic, developmental, anxiety, and mood disorders.
Major finding: Patients with migraine more frequently had neurologic/central nervous system disorders (odds ratio, 1.7; 95% confidence interval, 1.4-2), developmental disorders (OR, 1.3; 95% CI, 1.1-1.6), respiratory problems (OR, 1.3; 95% CI, 1.1-1.6), anxiety (OR, 1.6; 95% CI, 1.3-2), mood disorders (OR, 2; 95% CI, 1.6-2.3), and behavioral disorders (OR, 1.3; 95% CI, 1.1-1.6).
Study details: A study of 9,329 patients aged 8-21 years from the Philadelphia Neurodevelopmental Cohort.
Disclosures: No disclosures were reported.
Source: Lateef T et al. J Pediatr. 2018 Oct 29. doi: 10.1016/j.jpeds.2018.09.033.
Risk factors identified for urinary retention after lap hernia repair
was more likely in patients aged more than 60 years, patients with benign prostatic hyperplasia, and patients with a decreased body mass index, according to findings published in the Journal of Surgical Research.
The researchers note that, while laparoscopic TEP is growing in popularity for inguinal hernia repair, postop urinary retention (POUR) is estimated at 2%-30%, but for open procedures, it is estimated at 0.4%-3%. POUR is linked to the development of urinary tract infections and also hospital readmissions. Since TEP may eventually become the norm, the study authors suggest that identifying patients at higher risk for POUR would contribute to the safety and quality of care for this operation.
In a retrospective chart review of 578 patients who had the procedure between 2009 and 2016, patients over age 60 years, patients with benign prostatic hyperplasia, and those with a body mass index (BMI) of less than or equal to 25.8 kg/m2 were more likely to develop postoperative urinary retention (POUR). Patients with these risk factors were also more likely to develop a urinary tract infection within 30 days, reported Daniel Roadman, a medical student in the department of surgery at Medical College of Wisconsin in Milwaukee, and coauthors.
Investigators conducted a retrospective chart review of patients 18 years of age or older with a direct, indirect, and/or femoral inguinal hernia. POUR was defined as “inability to void spontaneously prior to hospital discharge, requiring straight or indwelling catheter placement,” the authors wrote.
Patients were required to void before being discharged. For patients unable to void, an indwelling catheter was placed and removed the following morning. Patients still unable to void at this point were discharged with an indwelling catheter and scheduled for follow-up within 1 week.
POUR occurred in 64 of the 578 patients (11.1%), and was significantly associated with benign prostatic hyperplasia, age of 60 years or older, development of urinary tract infection (UTI) within 30 days, and decreased BMI. Patients with POUR had increased incidence of UTI (6.3%), compared with patients without POUR (0.6%; P less than .0001).
Among patients who developed POUR, 54 (84.3%) were admitted for overnight observation with a stay of approximately 1.5 days. Three of these patients (5.6%) had a straight catheterization, and 51 (94.4%) had an indwelling urinary catheter placed. Two patients developed a UTI.
Of the 10 patients discharged home, six (60%) returned to the emergency department for catheterization; two (33.3%) patients had straight catheterization, and four (66.7%) were discharged home with an indwelling catheter. Two of these patients developed a UTI. In both groups, all patients who developed a UTI had an indwelling catheter placed, Mr. Roadman and colleagues reported.
During the study period, institutional protocol changed from routine intraoperative urinary catheterization to catheterization per surgeon discretion, though this did not affect POUR incidence.
“This is the first study to show a significant increase in UTI within 30 days after POUR,” the authors wrote. “Urinary stasis within the bladder due to the inability to void could lead to increased bacterial load and risk of infection.”
“It is important for providers, especially surgeons, to understand the risk of POUR and therefore increased risk of UTI after laparoscopic TEP inguinal hernia repair,” they added. “Identifying patients at higher risk … can help with patient education and expectations.”
No disclosures were reported by the study authors.
SOURCE: Roadman D et al. J Surg Res. 2018;11(231):309-15.
was more likely in patients aged more than 60 years, patients with benign prostatic hyperplasia, and patients with a decreased body mass index, according to findings published in the Journal of Surgical Research.
The researchers note that, while laparoscopic TEP is growing in popularity for inguinal hernia repair, postop urinary retention (POUR) is estimated at 2%-30%, but for open procedures, it is estimated at 0.4%-3%. POUR is linked to the development of urinary tract infections and also hospital readmissions. Since TEP may eventually become the norm, the study authors suggest that identifying patients at higher risk for POUR would contribute to the safety and quality of care for this operation.
In a retrospective chart review of 578 patients who had the procedure between 2009 and 2016, patients over age 60 years, patients with benign prostatic hyperplasia, and those with a body mass index (BMI) of less than or equal to 25.8 kg/m2 were more likely to develop postoperative urinary retention (POUR). Patients with these risk factors were also more likely to develop a urinary tract infection within 30 days, reported Daniel Roadman, a medical student in the department of surgery at Medical College of Wisconsin in Milwaukee, and coauthors.
Investigators conducted a retrospective chart review of patients 18 years of age or older with a direct, indirect, and/or femoral inguinal hernia. POUR was defined as “inability to void spontaneously prior to hospital discharge, requiring straight or indwelling catheter placement,” the authors wrote.
Patients were required to void before being discharged. For patients unable to void, an indwelling catheter was placed and removed the following morning. Patients still unable to void at this point were discharged with an indwelling catheter and scheduled for follow-up within 1 week.
POUR occurred in 64 of the 578 patients (11.1%), and was significantly associated with benign prostatic hyperplasia, age of 60 years or older, development of urinary tract infection (UTI) within 30 days, and decreased BMI. Patients with POUR had increased incidence of UTI (6.3%), compared with patients without POUR (0.6%; P less than .0001).
Among patients who developed POUR, 54 (84.3%) were admitted for overnight observation with a stay of approximately 1.5 days. Three of these patients (5.6%) had a straight catheterization, and 51 (94.4%) had an indwelling urinary catheter placed. Two patients developed a UTI.
Of the 10 patients discharged home, six (60%) returned to the emergency department for catheterization; two (33.3%) patients had straight catheterization, and four (66.7%) were discharged home with an indwelling catheter. Two of these patients developed a UTI. In both groups, all patients who developed a UTI had an indwelling catheter placed, Mr. Roadman and colleagues reported.
During the study period, institutional protocol changed from routine intraoperative urinary catheterization to catheterization per surgeon discretion, though this did not affect POUR incidence.
“This is the first study to show a significant increase in UTI within 30 days after POUR,” the authors wrote. “Urinary stasis within the bladder due to the inability to void could lead to increased bacterial load and risk of infection.”
“It is important for providers, especially surgeons, to understand the risk of POUR and therefore increased risk of UTI after laparoscopic TEP inguinal hernia repair,” they added. “Identifying patients at higher risk … can help with patient education and expectations.”
No disclosures were reported by the study authors.
SOURCE: Roadman D et al. J Surg Res. 2018;11(231):309-15.
was more likely in patients aged more than 60 years, patients with benign prostatic hyperplasia, and patients with a decreased body mass index, according to findings published in the Journal of Surgical Research.
The researchers note that, while laparoscopic TEP is growing in popularity for inguinal hernia repair, postop urinary retention (POUR) is estimated at 2%-30%, but for open procedures, it is estimated at 0.4%-3%. POUR is linked to the development of urinary tract infections and also hospital readmissions. Since TEP may eventually become the norm, the study authors suggest that identifying patients at higher risk for POUR would contribute to the safety and quality of care for this operation.
In a retrospective chart review of 578 patients who had the procedure between 2009 and 2016, patients over age 60 years, patients with benign prostatic hyperplasia, and those with a body mass index (BMI) of less than or equal to 25.8 kg/m2 were more likely to develop postoperative urinary retention (POUR). Patients with these risk factors were also more likely to develop a urinary tract infection within 30 days, reported Daniel Roadman, a medical student in the department of surgery at Medical College of Wisconsin in Milwaukee, and coauthors.
Investigators conducted a retrospective chart review of patients 18 years of age or older with a direct, indirect, and/or femoral inguinal hernia. POUR was defined as “inability to void spontaneously prior to hospital discharge, requiring straight or indwelling catheter placement,” the authors wrote.
Patients were required to void before being discharged. For patients unable to void, an indwelling catheter was placed and removed the following morning. Patients still unable to void at this point were discharged with an indwelling catheter and scheduled for follow-up within 1 week.
POUR occurred in 64 of the 578 patients (11.1%), and was significantly associated with benign prostatic hyperplasia, age of 60 years or older, development of urinary tract infection (UTI) within 30 days, and decreased BMI. Patients with POUR had increased incidence of UTI (6.3%), compared with patients without POUR (0.6%; P less than .0001).
Among patients who developed POUR, 54 (84.3%) were admitted for overnight observation with a stay of approximately 1.5 days. Three of these patients (5.6%) had a straight catheterization, and 51 (94.4%) had an indwelling urinary catheter placed. Two patients developed a UTI.
Of the 10 patients discharged home, six (60%) returned to the emergency department for catheterization; two (33.3%) patients had straight catheterization, and four (66.7%) were discharged home with an indwelling catheter. Two of these patients developed a UTI. In both groups, all patients who developed a UTI had an indwelling catheter placed, Mr. Roadman and colleagues reported.
During the study period, institutional protocol changed from routine intraoperative urinary catheterization to catheterization per surgeon discretion, though this did not affect POUR incidence.
“This is the first study to show a significant increase in UTI within 30 days after POUR,” the authors wrote. “Urinary stasis within the bladder due to the inability to void could lead to increased bacterial load and risk of infection.”
“It is important for providers, especially surgeons, to understand the risk of POUR and therefore increased risk of UTI after laparoscopic TEP inguinal hernia repair,” they added. “Identifying patients at higher risk … can help with patient education and expectations.”
No disclosures were reported by the study authors.
SOURCE: Roadman D et al. J Surg Res. 2018;11(231):309-15.
FROM THE JOURNAL OF SURGICAL RESEARCH
Key clinical point: Postoperative urinary retention was more likely to occur in patients more than 60 years of age and patients with benign prostatic hyperplasia.
Major finding: POUR occurred in 64 of the 578 patients (11.1%), and was significantly associated with benign prostatic hyperplasia, age of 60 years or older, development of urinary tract infection (UTI) within 30 days, and decreased BMI.
Study details: A retrospective chart review of 578 patients who had laparoscopic total extraperitoneal inguinal hernia repair between 2009 and 2016.
Disclosures: No disclosures were reported.
Source: Roadman D et al. J Surg Res. 2018;11(231):309-15.
Adalimumab safety profile similar in children and adults
The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.
In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.
All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.
Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.
Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.
Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.
The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.
AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.
SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.
The findings of this study underscore the importance of being “aware of the safety profile of this widely used biologic medication,” Philip J. Hashkes, MD, MSc, wrote in an accompanying editorial.
“The major finding was that the safety profile is similar to that seen in adults,” he added. “Although almost all patients developed adverse effects, especially infections, most were usual pediatric infections (including the serious infections) with very few opportunistic infections.” Patients with Crohn’s disease had more serious adverse effects and infections.
Future research should go a step further and focus on “post-marketing surveillance in ‘real life’ settings,” he concluded.
Dr. Hashkes is a pediatric rheumatologist at the Cleveland Clinic. His editorial in response to the article by Horneff et al. appeared in the Journal of Pediatrics (J Pediatr. 2018 Oct;201:2-3).
The findings of this study underscore the importance of being “aware of the safety profile of this widely used biologic medication,” Philip J. Hashkes, MD, MSc, wrote in an accompanying editorial.
“The major finding was that the safety profile is similar to that seen in adults,” he added. “Although almost all patients developed adverse effects, especially infections, most were usual pediatric infections (including the serious infections) with very few opportunistic infections.” Patients with Crohn’s disease had more serious adverse effects and infections.
Future research should go a step further and focus on “post-marketing surveillance in ‘real life’ settings,” he concluded.
Dr. Hashkes is a pediatric rheumatologist at the Cleveland Clinic. His editorial in response to the article by Horneff et al. appeared in the Journal of Pediatrics (J Pediatr. 2018 Oct;201:2-3).
The findings of this study underscore the importance of being “aware of the safety profile of this widely used biologic medication,” Philip J. Hashkes, MD, MSc, wrote in an accompanying editorial.
“The major finding was that the safety profile is similar to that seen in adults,” he added. “Although almost all patients developed adverse effects, especially infections, most were usual pediatric infections (including the serious infections) with very few opportunistic infections.” Patients with Crohn’s disease had more serious adverse effects and infections.
Future research should go a step further and focus on “post-marketing surveillance in ‘real life’ settings,” he concluded.
Dr. Hashkes is a pediatric rheumatologist at the Cleveland Clinic. His editorial in response to the article by Horneff et al. appeared in the Journal of Pediatrics (J Pediatr. 2018 Oct;201:2-3).
The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.
In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.
All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.
Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.
Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.
Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.
The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.
AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.
SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.
The safety profile for adalimumab in children is similar to that of adults, according to findings published in the Journal of Pediatrics.
In an analysis of data from seven clinical trials from 2002-2015, the most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY). Serious infections were the most frequent adverse events across indications (8% of all patients; 4 events per 100 PY), reported Gerd Horneff, MD, of the department of general pediatrics at Asklepios Klinik Sankt Augustin (Germany), and his coauthors.
All of the clinical trials were funded by AbbVie, and included 577 pediatric patients with juvenile idiopathic arthritis (JIA), psoriasis, or Crohn’s disease. Patients received subcutaneous injection of adalimumab at a dosage of either 40 mg/0.8 mL or 20 mg/0.4 mL.
Adverse events that occurred after the first adalimumab dose and up to 70 days after the last dose were included. Serious adverse events were defined as “events that were fatal or immediately life-threatening; required inpatient or prolonged hospitalization; resulted in persistent or significant disability/incapacity, congenital anomaly, or spontaneous or elective abortion; or required medical or surgical intervention to prevent a serious outcome,” the authors said.
Infections occurred in 82% of JIA patients (151 events per 100 PY), 74% of patients with psoriasis (169 events per 100 PY), and 76% of patients with CD (132 events per 100 PY). The most common events for JIA, psoriasis, and Crohn’s were injection-site pain (22% of patients; 75 events per 100 PY), headache (30% of patients; 47 events per 100 PY), and worsening of Crohn’s disease (55% of patients; 37 events per 100 PY), respectively.
Serious adverse events occurred in 29% of patients. Rates for JIA, psoriasis, and Crohn’s were 14, 7, and 32 events per 100 PY, respectively. Serious infections were the most common serious adverse event, with rates of 3, 1, and 7 events per 100 PY for JIA, psoriasis, and Crohn’s disease, respectively. Pneumonia was the most commonly reported serious infection (1% of patients; 1 event per 100 PY). One death, due to an accidental fall, occurred in an adolescent patient with psoriasis.
The study findings add to “a more complete understanding of the established safety profile of adalimumab,” and suggest that in pediatric patients, “the overall safety profile was comparable and consistent with that in adults,” Dr. Horneff and his associates added.
AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.
SOURCE: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.
FROM THE JOURNAL OF PEDIATRICS
Key clinical point:
Major finding: The most common adverse events across indications were upper respiratory tract infection (24 events per 100 patient-years), nasopharyngitis (17 events per 100 PY), and headache (20 events per 100 PY).
Study details: An analysis of data for 577 pediatric patients from seven clinical trials between September 2002 and December 2015.
Disclosures: AbbVie funded the study. Dr. Horneff has received grants from AbbVie, Chugai, Novartis, Pfizer, and Roche. Seven of the investigators are or were employees of AbbVie and may own AbbVie stock and stock options. Two of the investigators disclosed ties with a number of pharmaceutical companies.
Source: Horneff G et al. J Pediatr. 2018 Oct. doi: 10.1016/j.jpeds.2018.05.042.
Dual-frequency ultrasound promising for refractory rosacea
, according to a new study in Dermatologic Surgery.
In the study, a retrospective medical record analysis of 42 rosacea patients, DFU improved symptoms, including erythema index (EI) and transepithelial water loss (TEWL), and also improved outcomes on the patient self-assessment (PSA), reported Jun Yeong Park, MD, and coauthors, from the department of dermatology, Hallym University Sacred Heart Hospital in Anyang, South Korea.
Of the 42 patients, 26 had erythematotelangiectatic rosacea, 14 had papulopustular rosacea, and 2 had mixed disease; their mean age was 48 years, and they had had rosacea for a mean of 2 years. Patients had started DFU treatment between September 2016 and December 2016, and were not taking oral medication (besides antihistamines), topical ointments, or other laser treatments at the time. Most had been treated with various systemic therapies, topical therapies, or lasers, but had not had adequate improvement of flushing and erythema.
Patients received DFU treatment of the entire face twice per week for the first week, followed by one-week intervals, for a total of 12 weeks. Each treatment session lasted 10 minutes, and included DFU frequencies of 3/4.5 MHz at an ultrasound intensity of 2.0W/cm2 for 5 minutes, followed by 4.5 MHz at an intensity of 2.0W/cm2. Responses to treatment were based on EI, TEWL values (measured on three different sites on each cheek according to guidelines established by the European Group for Efficacy Measurements on Cosmetics and Other Topical Products), and PSA. PSA was completed on a scale of 0 (absent) to 4 (severe) for erythema, itching sensation, and burning sensation.
At 12 weeks follow-up, the mean EI dropped from 16.3 at baseline to 12.7 at 12 weeks (P less than .01). Mean TEWL values dropped from a baseline of 35.8 g m–1 h–1 to 22.8 g m–1 h–1 at 12 weeks (P less than .01).
When evaluated by rosacea subtype, a slightly higher reduction in the group with papulopustular rosacea was seen for EI and TEWL, compared with those with the erythematotelangiectatic subtype, but the differences were not statistically significant for either, the authors reported.
Between baseline and 12 weeks, the PSA values for erythema decreased from 2.6 to 1.1. Itching and burning grades also decreased, from 2.4 to 0.4 and from 2.4 to 0.3, respectively.
The findings verify that there were “improvements in the barrier function of patients with refractory rosacea, based on the TEWL level before and after treatment,” the authors noted. “Therefore, DFU may be an additional treatment option for rosacea that is resistant to other treatments.”
This study is the first to evaluate DFU in patients with refractory rosacea “who did not show signs of recovery after undergoing previous therapies,” they noted.
No disclosures were reported.
SOURCE: Park J et al. Dermatol Surg 2018 Sep;44(9):1209-15. doi: 10.1097/DSS.0000000000001552.
, according to a new study in Dermatologic Surgery.
In the study, a retrospective medical record analysis of 42 rosacea patients, DFU improved symptoms, including erythema index (EI) and transepithelial water loss (TEWL), and also improved outcomes on the patient self-assessment (PSA), reported Jun Yeong Park, MD, and coauthors, from the department of dermatology, Hallym University Sacred Heart Hospital in Anyang, South Korea.
Of the 42 patients, 26 had erythematotelangiectatic rosacea, 14 had papulopustular rosacea, and 2 had mixed disease; their mean age was 48 years, and they had had rosacea for a mean of 2 years. Patients had started DFU treatment between September 2016 and December 2016, and were not taking oral medication (besides antihistamines), topical ointments, or other laser treatments at the time. Most had been treated with various systemic therapies, topical therapies, or lasers, but had not had adequate improvement of flushing and erythema.
Patients received DFU treatment of the entire face twice per week for the first week, followed by one-week intervals, for a total of 12 weeks. Each treatment session lasted 10 minutes, and included DFU frequencies of 3/4.5 MHz at an ultrasound intensity of 2.0W/cm2 for 5 minutes, followed by 4.5 MHz at an intensity of 2.0W/cm2. Responses to treatment were based on EI, TEWL values (measured on three different sites on each cheek according to guidelines established by the European Group for Efficacy Measurements on Cosmetics and Other Topical Products), and PSA. PSA was completed on a scale of 0 (absent) to 4 (severe) for erythema, itching sensation, and burning sensation.
At 12 weeks follow-up, the mean EI dropped from 16.3 at baseline to 12.7 at 12 weeks (P less than .01). Mean TEWL values dropped from a baseline of 35.8 g m–1 h–1 to 22.8 g m–1 h–1 at 12 weeks (P less than .01).
When evaluated by rosacea subtype, a slightly higher reduction in the group with papulopustular rosacea was seen for EI and TEWL, compared with those with the erythematotelangiectatic subtype, but the differences were not statistically significant for either, the authors reported.
Between baseline and 12 weeks, the PSA values for erythema decreased from 2.6 to 1.1. Itching and burning grades also decreased, from 2.4 to 0.4 and from 2.4 to 0.3, respectively.
The findings verify that there were “improvements in the barrier function of patients with refractory rosacea, based on the TEWL level before and after treatment,” the authors noted. “Therefore, DFU may be an additional treatment option for rosacea that is resistant to other treatments.”
This study is the first to evaluate DFU in patients with refractory rosacea “who did not show signs of recovery after undergoing previous therapies,” they noted.
No disclosures were reported.
SOURCE: Park J et al. Dermatol Surg 2018 Sep;44(9):1209-15. doi: 10.1097/DSS.0000000000001552.
, according to a new study in Dermatologic Surgery.
In the study, a retrospective medical record analysis of 42 rosacea patients, DFU improved symptoms, including erythema index (EI) and transepithelial water loss (TEWL), and also improved outcomes on the patient self-assessment (PSA), reported Jun Yeong Park, MD, and coauthors, from the department of dermatology, Hallym University Sacred Heart Hospital in Anyang, South Korea.
Of the 42 patients, 26 had erythematotelangiectatic rosacea, 14 had papulopustular rosacea, and 2 had mixed disease; their mean age was 48 years, and they had had rosacea for a mean of 2 years. Patients had started DFU treatment between September 2016 and December 2016, and were not taking oral medication (besides antihistamines), topical ointments, or other laser treatments at the time. Most had been treated with various systemic therapies, topical therapies, or lasers, but had not had adequate improvement of flushing and erythema.
Patients received DFU treatment of the entire face twice per week for the first week, followed by one-week intervals, for a total of 12 weeks. Each treatment session lasted 10 minutes, and included DFU frequencies of 3/4.5 MHz at an ultrasound intensity of 2.0W/cm2 for 5 minutes, followed by 4.5 MHz at an intensity of 2.0W/cm2. Responses to treatment were based on EI, TEWL values (measured on three different sites on each cheek according to guidelines established by the European Group for Efficacy Measurements on Cosmetics and Other Topical Products), and PSA. PSA was completed on a scale of 0 (absent) to 4 (severe) for erythema, itching sensation, and burning sensation.
At 12 weeks follow-up, the mean EI dropped from 16.3 at baseline to 12.7 at 12 weeks (P less than .01). Mean TEWL values dropped from a baseline of 35.8 g m–1 h–1 to 22.8 g m–1 h–1 at 12 weeks (P less than .01).
When evaluated by rosacea subtype, a slightly higher reduction in the group with papulopustular rosacea was seen for EI and TEWL, compared with those with the erythematotelangiectatic subtype, but the differences were not statistically significant for either, the authors reported.
Between baseline and 12 weeks, the PSA values for erythema decreased from 2.6 to 1.1. Itching and burning grades also decreased, from 2.4 to 0.4 and from 2.4 to 0.3, respectively.
The findings verify that there were “improvements in the barrier function of patients with refractory rosacea, based on the TEWL level before and after treatment,” the authors noted. “Therefore, DFU may be an additional treatment option for rosacea that is resistant to other treatments.”
This study is the first to evaluate DFU in patients with refractory rosacea “who did not show signs of recovery after undergoing previous therapies,” they noted.
No disclosures were reported.
SOURCE: Park J et al. Dermatol Surg 2018 Sep;44(9):1209-15. doi: 10.1097/DSS.0000000000001552.
Key clinical point: Dual-frequency ultrasound may be an effective option for treatment-resistant rosacea.
Major finding: In 12 weeks, the erythema index dropped from 16.3 to 12.7 (P less than .01), along with drops in patient self assessment measures for erythema, itching, and burning.
Study details: A retrospective electronic medical records analysis of 42 rosacea patients.
Disclosures: No disclosures were reported.
Source: Park J et al. Dermatol Surg 2018 Sep;44(9):1209-15. doi: 10.1097/DSS.0000000000001552.
AAP guidelines emphasize gender-affirmative care
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
FROM PEDATRICS
Extended propranolol use boosts success in high-risk infantile hemangioma
Extending oral propranolol treatment up to 12 months of age increased the success rate for high-risk infantile hemangioma, according to results published in Pediatrics.
Previous studies of oral propranol for infantile hemangiomas (IH) have revealed its efficacy, although there is no consensus on the optimal treatment duration. Nonetheless, treatment up to 12 months of age has been proposed if patients don’t respond after 6 months. Infants with high-risk hemangiomas, however, have been excluded from previous studies, authors of the current study explained.
In an open-label study of patients aged 35-150 days the success rate of oral propranolol was 47% after 6 months of treatment. The rate increased to 76% after the initial treatment period, reported Eulalia Baselga, MD, of the department of dermatology at Hospital de la Santa Creu i Sant Pau in Barcelona, and coauthors.
Investigators studied 45 patients from 10 hospitals in Spain and Poland between June 2015 and February 2017. The patients had high-risk IH in the proliferative phase. High-risk hemangiomas were defined as those that were life threatening, at risk for functional impact, disfiguring, or ulcerated nonresponsive to standard wound care measures.
Oral propranolol was administered twice daily at a dosage of 3 mg/kg per day. During the initial treatment period (ITP), patients received propranolol for a minimum of 6 months, and if treatment was not successful, it continued until success or up to 12 months of age.
Patients who achieved success in the initial phase were managed for 3 months with no treatment, and if there was rebound growth, treatment was restarted for up to 6 months at the provider’s discretion.
Treatment was considered a success if the target hemangioma resolved and there was no functional impact. The IH was considered resolved if it disappeared, even if there were minimal telangiectasias, erythema, skin thickening, soft tissue swelling, or the presence of sequelae.
Treatment success was achieved by 21 (47%) patients after 6 months and by 34 (76%) patients by the end of the ITP. Functional impact was determined using the Hemangioma Severity and Hemangioma Dynamic Complication scales. Adverse events, reported by 80% of patients, were resolved by the end of the study and included respiratory syncytial virus bronchiolitis, ulcerated hemangioma, pneumonia and respiratory failure, inguinal hernia, upper respiratory tract infection, dehydration, bronchitis, choking, and thermal burn. Although no patients experienced adverse events that resulted in discontinuation of treatment, 35 events led to temporary discontinuation, primarily due to respiratory events, the authors reported.
The results indicate that “oral propranolol is effective in treating high-risk IH with a favorable safety profile,” the authors concluded.
The study was funded by the Institut de Recherche Pierre Fabre Several authors were employed by or had other relationships with Pierre Fabre. The other authors had no conflicts of interest.
SOURCE: Baselga E et al. Pediatrics. 2018. doi: 10.1542/peds.2017-3866.
Extending oral propranolol treatment up to 12 months of age increased the success rate for high-risk infantile hemangioma, according to results published in Pediatrics.
Previous studies of oral propranol for infantile hemangiomas (IH) have revealed its efficacy, although there is no consensus on the optimal treatment duration. Nonetheless, treatment up to 12 months of age has been proposed if patients don’t respond after 6 months. Infants with high-risk hemangiomas, however, have been excluded from previous studies, authors of the current study explained.
In an open-label study of patients aged 35-150 days the success rate of oral propranolol was 47% after 6 months of treatment. The rate increased to 76% after the initial treatment period, reported Eulalia Baselga, MD, of the department of dermatology at Hospital de la Santa Creu i Sant Pau in Barcelona, and coauthors.
Investigators studied 45 patients from 10 hospitals in Spain and Poland between June 2015 and February 2017. The patients had high-risk IH in the proliferative phase. High-risk hemangiomas were defined as those that were life threatening, at risk for functional impact, disfiguring, or ulcerated nonresponsive to standard wound care measures.
Oral propranolol was administered twice daily at a dosage of 3 mg/kg per day. During the initial treatment period (ITP), patients received propranolol for a minimum of 6 months, and if treatment was not successful, it continued until success or up to 12 months of age.
Patients who achieved success in the initial phase were managed for 3 months with no treatment, and if there was rebound growth, treatment was restarted for up to 6 months at the provider’s discretion.
Treatment was considered a success if the target hemangioma resolved and there was no functional impact. The IH was considered resolved if it disappeared, even if there were minimal telangiectasias, erythema, skin thickening, soft tissue swelling, or the presence of sequelae.
Treatment success was achieved by 21 (47%) patients after 6 months and by 34 (76%) patients by the end of the ITP. Functional impact was determined using the Hemangioma Severity and Hemangioma Dynamic Complication scales. Adverse events, reported by 80% of patients, were resolved by the end of the study and included respiratory syncytial virus bronchiolitis, ulcerated hemangioma, pneumonia and respiratory failure, inguinal hernia, upper respiratory tract infection, dehydration, bronchitis, choking, and thermal burn. Although no patients experienced adverse events that resulted in discontinuation of treatment, 35 events led to temporary discontinuation, primarily due to respiratory events, the authors reported.
The results indicate that “oral propranolol is effective in treating high-risk IH with a favorable safety profile,” the authors concluded.
The study was funded by the Institut de Recherche Pierre Fabre Several authors were employed by or had other relationships with Pierre Fabre. The other authors had no conflicts of interest.
SOURCE: Baselga E et al. Pediatrics. 2018. doi: 10.1542/peds.2017-3866.
Extending oral propranolol treatment up to 12 months of age increased the success rate for high-risk infantile hemangioma, according to results published in Pediatrics.
Previous studies of oral propranol for infantile hemangiomas (IH) have revealed its efficacy, although there is no consensus on the optimal treatment duration. Nonetheless, treatment up to 12 months of age has been proposed if patients don’t respond after 6 months. Infants with high-risk hemangiomas, however, have been excluded from previous studies, authors of the current study explained.
In an open-label study of patients aged 35-150 days the success rate of oral propranolol was 47% after 6 months of treatment. The rate increased to 76% after the initial treatment period, reported Eulalia Baselga, MD, of the department of dermatology at Hospital de la Santa Creu i Sant Pau in Barcelona, and coauthors.
Investigators studied 45 patients from 10 hospitals in Spain and Poland between June 2015 and February 2017. The patients had high-risk IH in the proliferative phase. High-risk hemangiomas were defined as those that were life threatening, at risk for functional impact, disfiguring, or ulcerated nonresponsive to standard wound care measures.
Oral propranolol was administered twice daily at a dosage of 3 mg/kg per day. During the initial treatment period (ITP), patients received propranolol for a minimum of 6 months, and if treatment was not successful, it continued until success or up to 12 months of age.
Patients who achieved success in the initial phase were managed for 3 months with no treatment, and if there was rebound growth, treatment was restarted for up to 6 months at the provider’s discretion.
Treatment was considered a success if the target hemangioma resolved and there was no functional impact. The IH was considered resolved if it disappeared, even if there were minimal telangiectasias, erythema, skin thickening, soft tissue swelling, or the presence of sequelae.
Treatment success was achieved by 21 (47%) patients after 6 months and by 34 (76%) patients by the end of the ITP. Functional impact was determined using the Hemangioma Severity and Hemangioma Dynamic Complication scales. Adverse events, reported by 80% of patients, were resolved by the end of the study and included respiratory syncytial virus bronchiolitis, ulcerated hemangioma, pneumonia and respiratory failure, inguinal hernia, upper respiratory tract infection, dehydration, bronchitis, choking, and thermal burn. Although no patients experienced adverse events that resulted in discontinuation of treatment, 35 events led to temporary discontinuation, primarily due to respiratory events, the authors reported.
The results indicate that “oral propranolol is effective in treating high-risk IH with a favorable safety profile,” the authors concluded.
The study was funded by the Institut de Recherche Pierre Fabre Several authors were employed by or had other relationships with Pierre Fabre. The other authors had no conflicts of interest.
SOURCE: Baselga E et al. Pediatrics. 2018. doi: 10.1542/peds.2017-3866.
FROM PEDIATRICS
Key clinical point:
Major finding: After 6 months of treatment, the success rate was 47%, and it rose to 76% at the end of the treatment period.
Study details: A phase 3 study of 45 patients aged 35-150 days with high-risk IH.
Disclosures: The study was funded by the Institut de Recherche Pierre Fabre Several authors were employed by or had other relationships with Pierre Fabre. The other authors had no conflicts of interest.
Source: Baselga E et al. Pediatrics. 2018. doi: 10.1542/peds.2017-3866
Community-based therapy improved asthma outcomes in African American teens
, according to results published in Pediatrics.
In a study of 167 African American patients aged 12-16 years, the 84 randomly assigned to Multisystemic Therapy–Health Care (MST-HC) had greater improvement in forced expiratory volume in 1 second (FEV1) over time, compared with the 83 patients randomly assigned to family support (FS) therapy (beta = 0.097, t[164.27] = 2.52; P = .01). Improvements in secondary outcomes also were observed in this group, reported Sylvie Naar, PhD, of Florida State University, Tallahassee, and her coauthors.
They studied African American adolescents with moderate to severe persistent asthma who resided in a home setting with a caregiver and were at high risk for poorly controlled asthma. Families were randomized to either MST-HC (84 patients) or FS (83 patients) based on severity of urgent care use, and follow-up was completed 7 and 12 months after baseline assessment. Families were paid $50 for each assessment.
FEV1 was the primary outcome. Secondary outcomes were medication adherence, symptom severity and frequency, inpatient hospitalizations, and ED visits. Medication adherence was evaluated via the Family Asthma Management System Scale (FAMSS) and the Daily Phone Diary (DPD). Other outcomes were confirmed via medical records.
Patients in the FS control group received weekly home-based counseling for up to 6 months. Patients in the MST-HC treatment group were first engaged in a motivational session with a therapist and evaluated for asthma management with interviews and observations within the home and community. Once possible contributing factors to poor asthma management (such as medication underuse or low parental monitoring) were identified, targeted interventions such as skills training, behavioral and family therapy, or communication training with school and medical staff were chosen, and treatment goals continually monitored and modified, the authors said.
The mean length of treatment until termination in the MST-HC group was 5 months, and the mean number of sessions was 27. In the FS group, mean length of treatment was 4 months, and the mean number of sessions was 11.
FEV1 for the MST-HC group improved from 2.05 at baseline to 2.25 at 7 months (a 10% improvement), and to 2.37 (a 16% improvement) at 12 months, compared with an improvement from 2.21 to 2.31 at 7 months (a 4% improvement) and 2.33 (a 5% improvement) at 12 months in the control group, the authors reported.
At 12 months, FAMSS adherence scores improved from 4.19 to 5.24 in the MST-HC group and from 4.61 to 4.72 in the control group.
DPD adherence scores improved from a mean of 0.33 at baseline to 0.69 for the MST-HC group, and from 0.43 to 0.46 in the FS group.
At 12 months, the mean frequency of asthma symptoms in the MST-HC group improved from 2.75 at baseline to 1.43, compared with a decline of 2.67 to 2.58 in the control group. The mean number of hospitalizations in the MST-HC group improved from 0.87 to 0.24, compared with a change from 0.66 to 0.34 in the control group.
The study results are “especially noteworthy because African American adolescents experience greater morbidity and mortality from asthma than white adolescents even when controlling for socioeconomic variables,” Dr. Naar and her associates wrote. Future research should focus on the “transportability” of MST-HC treatment to community settings, which is “ready to be studied in effectiveness and implementation trials.”
The study was supported by a National Institutes of Health grant. Coauthor Phillippe Cunningham, PhD, is a co-owner of Evidence-Based Services, a network partner organization that is licensed to disseminate Multisystemic Therapy for drug court and juvenile delinquency settings. The other authors said they have no potential conflicts of interest.
SOURCE: Naar S et al. Pediatrics. 2018. doi: 10.1542/peds.2017-3737.
, according to results published in Pediatrics.
In a study of 167 African American patients aged 12-16 years, the 84 randomly assigned to Multisystemic Therapy–Health Care (MST-HC) had greater improvement in forced expiratory volume in 1 second (FEV1) over time, compared with the 83 patients randomly assigned to family support (FS) therapy (beta = 0.097, t[164.27] = 2.52; P = .01). Improvements in secondary outcomes also were observed in this group, reported Sylvie Naar, PhD, of Florida State University, Tallahassee, and her coauthors.
They studied African American adolescents with moderate to severe persistent asthma who resided in a home setting with a caregiver and were at high risk for poorly controlled asthma. Families were randomized to either MST-HC (84 patients) or FS (83 patients) based on severity of urgent care use, and follow-up was completed 7 and 12 months after baseline assessment. Families were paid $50 for each assessment.
FEV1 was the primary outcome. Secondary outcomes were medication adherence, symptom severity and frequency, inpatient hospitalizations, and ED visits. Medication adherence was evaluated via the Family Asthma Management System Scale (FAMSS) and the Daily Phone Diary (DPD). Other outcomes were confirmed via medical records.
Patients in the FS control group received weekly home-based counseling for up to 6 months. Patients in the MST-HC treatment group were first engaged in a motivational session with a therapist and evaluated for asthma management with interviews and observations within the home and community. Once possible contributing factors to poor asthma management (such as medication underuse or low parental monitoring) were identified, targeted interventions such as skills training, behavioral and family therapy, or communication training with school and medical staff were chosen, and treatment goals continually monitored and modified, the authors said.
The mean length of treatment until termination in the MST-HC group was 5 months, and the mean number of sessions was 27. In the FS group, mean length of treatment was 4 months, and the mean number of sessions was 11.
FEV1 for the MST-HC group improved from 2.05 at baseline to 2.25 at 7 months (a 10% improvement), and to 2.37 (a 16% improvement) at 12 months, compared with an improvement from 2.21 to 2.31 at 7 months (a 4% improvement) and 2.33 (a 5% improvement) at 12 months in the control group, the authors reported.
At 12 months, FAMSS adherence scores improved from 4.19 to 5.24 in the MST-HC group and from 4.61 to 4.72 in the control group.
DPD adherence scores improved from a mean of 0.33 at baseline to 0.69 for the MST-HC group, and from 0.43 to 0.46 in the FS group.
At 12 months, the mean frequency of asthma symptoms in the MST-HC group improved from 2.75 at baseline to 1.43, compared with a decline of 2.67 to 2.58 in the control group. The mean number of hospitalizations in the MST-HC group improved from 0.87 to 0.24, compared with a change from 0.66 to 0.34 in the control group.
The study results are “especially noteworthy because African American adolescents experience greater morbidity and mortality from asthma than white adolescents even when controlling for socioeconomic variables,” Dr. Naar and her associates wrote. Future research should focus on the “transportability” of MST-HC treatment to community settings, which is “ready to be studied in effectiveness and implementation trials.”
The study was supported by a National Institutes of Health grant. Coauthor Phillippe Cunningham, PhD, is a co-owner of Evidence-Based Services, a network partner organization that is licensed to disseminate Multisystemic Therapy for drug court and juvenile delinquency settings. The other authors said they have no potential conflicts of interest.
SOURCE: Naar S et al. Pediatrics. 2018. doi: 10.1542/peds.2017-3737.
, according to results published in Pediatrics.
In a study of 167 African American patients aged 12-16 years, the 84 randomly assigned to Multisystemic Therapy–Health Care (MST-HC) had greater improvement in forced expiratory volume in 1 second (FEV1) over time, compared with the 83 patients randomly assigned to family support (FS) therapy (beta = 0.097, t[164.27] = 2.52; P = .01). Improvements in secondary outcomes also were observed in this group, reported Sylvie Naar, PhD, of Florida State University, Tallahassee, and her coauthors.
They studied African American adolescents with moderate to severe persistent asthma who resided in a home setting with a caregiver and were at high risk for poorly controlled asthma. Families were randomized to either MST-HC (84 patients) or FS (83 patients) based on severity of urgent care use, and follow-up was completed 7 and 12 months after baseline assessment. Families were paid $50 for each assessment.
FEV1 was the primary outcome. Secondary outcomes were medication adherence, symptom severity and frequency, inpatient hospitalizations, and ED visits. Medication adherence was evaluated via the Family Asthma Management System Scale (FAMSS) and the Daily Phone Diary (DPD). Other outcomes were confirmed via medical records.
Patients in the FS control group received weekly home-based counseling for up to 6 months. Patients in the MST-HC treatment group were first engaged in a motivational session with a therapist and evaluated for asthma management with interviews and observations within the home and community. Once possible contributing factors to poor asthma management (such as medication underuse or low parental monitoring) were identified, targeted interventions such as skills training, behavioral and family therapy, or communication training with school and medical staff were chosen, and treatment goals continually monitored and modified, the authors said.
The mean length of treatment until termination in the MST-HC group was 5 months, and the mean number of sessions was 27. In the FS group, mean length of treatment was 4 months, and the mean number of sessions was 11.
FEV1 for the MST-HC group improved from 2.05 at baseline to 2.25 at 7 months (a 10% improvement), and to 2.37 (a 16% improvement) at 12 months, compared with an improvement from 2.21 to 2.31 at 7 months (a 4% improvement) and 2.33 (a 5% improvement) at 12 months in the control group, the authors reported.
At 12 months, FAMSS adherence scores improved from 4.19 to 5.24 in the MST-HC group and from 4.61 to 4.72 in the control group.
DPD adherence scores improved from a mean of 0.33 at baseline to 0.69 for the MST-HC group, and from 0.43 to 0.46 in the FS group.
At 12 months, the mean frequency of asthma symptoms in the MST-HC group improved from 2.75 at baseline to 1.43, compared with a decline of 2.67 to 2.58 in the control group. The mean number of hospitalizations in the MST-HC group improved from 0.87 to 0.24, compared with a change from 0.66 to 0.34 in the control group.
The study results are “especially noteworthy because African American adolescents experience greater morbidity and mortality from asthma than white adolescents even when controlling for socioeconomic variables,” Dr. Naar and her associates wrote. Future research should focus on the “transportability” of MST-HC treatment to community settings, which is “ready to be studied in effectiveness and implementation trials.”
The study was supported by a National Institutes of Health grant. Coauthor Phillippe Cunningham, PhD, is a co-owner of Evidence-Based Services, a network partner organization that is licensed to disseminate Multisystemic Therapy for drug court and juvenile delinquency settings. The other authors said they have no potential conflicts of interest.
SOURCE: Naar S et al. Pediatrics. 2018. doi: 10.1542/peds.2017-3737.
FROM PEDIATRICS
Key clinical point: Multisystemic Therapy–Health Care (MST-HC) significantly improved outcomes in African American adolescents with moderate to severe asthma.
Major finding: Patients randomly assigned to MST-HC treatment had greater improvement in FEV1 over time, compared with controls (beta = 0.097; t(164.27) = 2.52; P = .01).
Study details: A study of 167 African American patients aged 12-16 years, randomly assigned to either MST-HC or FS.
Disclosures: The study was supported by a National Institutes of Health grant. Coauthor Phillippe Cunningham, PhD, is a co-owner of Evidence-Based Services, a network partner organization that is licensed to disseminate multisystemic therapy for drug court and juvenile delinquency settings. The other authors said they have no potential conflicts of interest.
Source: Naar S et al. Pediatrics. 2018. doi: 10.1542/peds.2017-3737.
Rivaroxaban has ‘favorable’ benefit-risk profile
Both low-dose and full-dose rivaroxaban had superior benefit-risk profiles for extended venous thromboembolism (VTE) treatment when compared to aspirin, according to investigators.
The team found the combined outcome of recurrent VTE and major bleeding was less likely to occur in patients treated with rivaroxaban at 20 mg or 10 mg than in patients treated with aspirin.
Paolo Prandoni, MD, of the University of Padua in Italy, and his colleagues reported these results in Thrombosis Research.
The investigators analyzed data from the EINSTEIN-CHOICE trial, a double-blind, randomized study of 3,365 patients age 18 or older with deep vein thrombosis (DVT) or pulmonary embolism (PE) who had previously received anticoagulant treatment for 6 to 12 months.
Patients were given once-daily rivaroxaban at a low dose (10 mg), once-daily rivaroxaban at the full dose (20 mg), or once-daily aspirin at a dose of 100 mg.
The incidence of the combined outcome of recurrent VTE and major bleeding was 2.8% lower in the 20 mg rivaroxaban arm and 3.4% lower in the 10 mg rivaroxaban arm than in the aspirin arm.
The cumulative incidence of recurrent VTE was 1.9% in the 20 mg rivaroxaban arm, 1.6% in the 10 mg rivaroxaban arm, and 5.0% in the aspirin arm.
The cumulative incidence of major bleeding was 0.7%, 0.4%, and 0.5%, respectively.
Benefit-risk profile
Benefit and risk were calculated using “excess numbers of events,” or the difference in cumulative incidences in a hypothetical population of 10,000 VTE patients treated for 1 year.
Excess numbers of events were defined as the number of patients in this hypothetical population who would experience a particular event when treated with rivaroxaban (at either dose), minus that in the same population treated with aspirin.
In patients treated with 20 mg of rivaroxaban instead of aspirin, there would be 123 fewer episodes of PE (95% confidence interval [CI], 21-226) and 198 fewer episodes of DVT (95% CI, 62-333).
In patients given 10 mg of rivaroxaban instead of aspirin, there would be 121 fewer episodes of PE (95% CI, 4-238) and 217 fewer episodes of DVT (95% CI, 92-342).
Net clinical benefit was defined as the composite of symptomatic recurrent VTE and major bleeding events. It occurred in 23 patients in the 20 mg rivaroxaban arm, 17 patients in the 10 mg rivaroxaban arm, and 53 patients in the aspirin arm.
For 10,000 patients treated for 1 year with rivaroxaban instead of aspirin, there would be 284 fewer net clinical benefit outcomes for the 20 mg dose (95% CI, 106-462) and 339 fewer (95% CI, 165-512) for the 10 mg dose.
This means that one additional symptomatic recurrent VTE or major bleed would be avoided for every 36 patients treated with rivaroxaban at 20 mg or every 30 patients treated with rivaroxaban at 10 mg.
The investigators therefore concluded that rivaroxaban “provides a clinically important benefit in terms of reduction in recurrent VTE” and has a favorable benefit-risk profile relative to aspirin.
In fact, the team said there is “no longer a place” for extended VTE treatment with aspirin.
Bayer AG funded this study. Dr. Prandoni reported financial relationships with Bayer, Sanofi, Daiichi Sankyo, and Pfizer.
Both low-dose and full-dose rivaroxaban had superior benefit-risk profiles for extended venous thromboembolism (VTE) treatment when compared to aspirin, according to investigators.
The team found the combined outcome of recurrent VTE and major bleeding was less likely to occur in patients treated with rivaroxaban at 20 mg or 10 mg than in patients treated with aspirin.
Paolo Prandoni, MD, of the University of Padua in Italy, and his colleagues reported these results in Thrombosis Research.
The investigators analyzed data from the EINSTEIN-CHOICE trial, a double-blind, randomized study of 3,365 patients age 18 or older with deep vein thrombosis (DVT) or pulmonary embolism (PE) who had previously received anticoagulant treatment for 6 to 12 months.
Patients were given once-daily rivaroxaban at a low dose (10 mg), once-daily rivaroxaban at the full dose (20 mg), or once-daily aspirin at a dose of 100 mg.
The incidence of the combined outcome of recurrent VTE and major bleeding was 2.8% lower in the 20 mg rivaroxaban arm and 3.4% lower in the 10 mg rivaroxaban arm than in the aspirin arm.
The cumulative incidence of recurrent VTE was 1.9% in the 20 mg rivaroxaban arm, 1.6% in the 10 mg rivaroxaban arm, and 5.0% in the aspirin arm.
The cumulative incidence of major bleeding was 0.7%, 0.4%, and 0.5%, respectively.
Benefit-risk profile
Benefit and risk were calculated using “excess numbers of events,” or the difference in cumulative incidences in a hypothetical population of 10,000 VTE patients treated for 1 year.
Excess numbers of events were defined as the number of patients in this hypothetical population who would experience a particular event when treated with rivaroxaban (at either dose), minus that in the same population treated with aspirin.
In patients treated with 20 mg of rivaroxaban instead of aspirin, there would be 123 fewer episodes of PE (95% confidence interval [CI], 21-226) and 198 fewer episodes of DVT (95% CI, 62-333).
In patients given 10 mg of rivaroxaban instead of aspirin, there would be 121 fewer episodes of PE (95% CI, 4-238) and 217 fewer episodes of DVT (95% CI, 92-342).
Net clinical benefit was defined as the composite of symptomatic recurrent VTE and major bleeding events. It occurred in 23 patients in the 20 mg rivaroxaban arm, 17 patients in the 10 mg rivaroxaban arm, and 53 patients in the aspirin arm.
For 10,000 patients treated for 1 year with rivaroxaban instead of aspirin, there would be 284 fewer net clinical benefit outcomes for the 20 mg dose (95% CI, 106-462) and 339 fewer (95% CI, 165-512) for the 10 mg dose.
This means that one additional symptomatic recurrent VTE or major bleed would be avoided for every 36 patients treated with rivaroxaban at 20 mg or every 30 patients treated with rivaroxaban at 10 mg.
The investigators therefore concluded that rivaroxaban “provides a clinically important benefit in terms of reduction in recurrent VTE” and has a favorable benefit-risk profile relative to aspirin.
In fact, the team said there is “no longer a place” for extended VTE treatment with aspirin.
Bayer AG funded this study. Dr. Prandoni reported financial relationships with Bayer, Sanofi, Daiichi Sankyo, and Pfizer.
Both low-dose and full-dose rivaroxaban had superior benefit-risk profiles for extended venous thromboembolism (VTE) treatment when compared to aspirin, according to investigators.
The team found the combined outcome of recurrent VTE and major bleeding was less likely to occur in patients treated with rivaroxaban at 20 mg or 10 mg than in patients treated with aspirin.
Paolo Prandoni, MD, of the University of Padua in Italy, and his colleagues reported these results in Thrombosis Research.
The investigators analyzed data from the EINSTEIN-CHOICE trial, a double-blind, randomized study of 3,365 patients age 18 or older with deep vein thrombosis (DVT) or pulmonary embolism (PE) who had previously received anticoagulant treatment for 6 to 12 months.
Patients were given once-daily rivaroxaban at a low dose (10 mg), once-daily rivaroxaban at the full dose (20 mg), or once-daily aspirin at a dose of 100 mg.
The incidence of the combined outcome of recurrent VTE and major bleeding was 2.8% lower in the 20 mg rivaroxaban arm and 3.4% lower in the 10 mg rivaroxaban arm than in the aspirin arm.
The cumulative incidence of recurrent VTE was 1.9% in the 20 mg rivaroxaban arm, 1.6% in the 10 mg rivaroxaban arm, and 5.0% in the aspirin arm.
The cumulative incidence of major bleeding was 0.7%, 0.4%, and 0.5%, respectively.
Benefit-risk profile
Benefit and risk were calculated using “excess numbers of events,” or the difference in cumulative incidences in a hypothetical population of 10,000 VTE patients treated for 1 year.
Excess numbers of events were defined as the number of patients in this hypothetical population who would experience a particular event when treated with rivaroxaban (at either dose), minus that in the same population treated with aspirin.
In patients treated with 20 mg of rivaroxaban instead of aspirin, there would be 123 fewer episodes of PE (95% confidence interval [CI], 21-226) and 198 fewer episodes of DVT (95% CI, 62-333).
In patients given 10 mg of rivaroxaban instead of aspirin, there would be 121 fewer episodes of PE (95% CI, 4-238) and 217 fewer episodes of DVT (95% CI, 92-342).
Net clinical benefit was defined as the composite of symptomatic recurrent VTE and major bleeding events. It occurred in 23 patients in the 20 mg rivaroxaban arm, 17 patients in the 10 mg rivaroxaban arm, and 53 patients in the aspirin arm.
For 10,000 patients treated for 1 year with rivaroxaban instead of aspirin, there would be 284 fewer net clinical benefit outcomes for the 20 mg dose (95% CI, 106-462) and 339 fewer (95% CI, 165-512) for the 10 mg dose.
This means that one additional symptomatic recurrent VTE or major bleed would be avoided for every 36 patients treated with rivaroxaban at 20 mg or every 30 patients treated with rivaroxaban at 10 mg.
The investigators therefore concluded that rivaroxaban “provides a clinically important benefit in terms of reduction in recurrent VTE” and has a favorable benefit-risk profile relative to aspirin.
In fact, the team said there is “no longer a place” for extended VTE treatment with aspirin.
Bayer AG funded this study. Dr. Prandoni reported financial relationships with Bayer, Sanofi, Daiichi Sankyo, and Pfizer.
Rivaroxaban superior to aspirin for extended VTE treatment
Both low-dose and full-dose rivaroxaban had superior benefit-risk profiles for extended venous thromboembolism (VTE) treatment compared with aspirin, according to results published in Thrombosis Research.
Incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower for patients treated with rivaroxaban at 20 mg and 10 mg, respectively, than for those treated with aspirin, reported Paolo Prandoni, MD, of the department of cardiothoracic and vascular sciences at the University of Padua, Italy, and his coauthors.
Investigators analyzed data from the EINSTEIN-CHOICE trial, a double-blind, randomized study of 3,365 patients aged 18 years or older with deep vein thrombosis or pulmonary embolism who had previously received anticoagulant treatment for 6-12 months. Patients were given either once-daily rivaroxaban at a low dose (10 mg), once-daily rivaroxaban at full dose (20 mg), or once- daily aspirin at a dose of 100 mg.
Benefit and risk were calculated using “excess numbers of events,” or the difference in cumulative incidences in a hypothetical population of 10,000 VTE patients treated for 1 year. Excess numbers of events were defined as the number of patients in this hypothetical population who would experience a particular event when treated with rivaroxaban (at either dose), minus that in the same population treated with aspirin.
The cumulative incidences of recurrent VTE in the full-dose rivaroxaban, low-dose rivaroxaban, and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively. The cumulative incidences of major bleeding in these groups were 0.7%, 0.4% and 0.5%, respectively.
In patients treated with 20 mg of rivaroxaban instead of aspirin, there would be 123 fewer episodes of pulmonary embolism (95% confidence interval, 21-226) and 198 fewer episodes of deep vein thrombosis (95% CI, 62-333).
In patients given 10 mg of rivaroxaban instead of aspirin, there would be 121 fewer episodes of pulmonary embolism (95% CI, 4-238) and 217 fewer episodes of deep vein thrombosis (95% CI, 92-342), Dr. Prandoni and his colleagues wrote.
Net clinical benefit was defined as the composite of symptomatic recurrent VTE and major bleeding events, and occurred in 23 patients in the full-dose rivaroxaban group, 17 patients in the low-dose rivaroxaban group, and 53 patients in the aspirin group.
For 10,000 patients treated for 1 year with rivaroxaban instead of aspirin, there would be 284 fewer net clinical benefit outcomes for the 20-mg dose (95% CI, 106-462) and 339 fewer (95% CI, 165-512) for the 10-mg dose. “Thus, compared with aspirin, one additional symptomatic recurrent VTE or major bleed would be avoided for every 36 or 30 patients treated with rivaroxaban 20 mg or 10 mg, respectively,” the investigators wrote.
The findings indicate that there is “no longer a place” for extended VTE treatment with aspirin, the investigators said.
“Extended anticoagulation with once daily rivaroxaban ... provides a clinically important benefit in terms of reduction in recurrent VTE,” they wrote. “Regardless of which dose is chosen ... rivaroxaban has a favourable benefit-risk profile relative to aspirin.”
Bayer AG funded the study. Dr. Prandoni reported financial relationships with Bayer, Sanofi, Daiichi Sankyo, and Pfizer.
SOURCE: Prandoni P et al. Thromb Res. 2018 Aug;168:121-9.
Both low-dose and full-dose rivaroxaban had superior benefit-risk profiles for extended venous thromboembolism (VTE) treatment compared with aspirin, according to results published in Thrombosis Research.
Incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower for patients treated with rivaroxaban at 20 mg and 10 mg, respectively, than for those treated with aspirin, reported Paolo Prandoni, MD, of the department of cardiothoracic and vascular sciences at the University of Padua, Italy, and his coauthors.
Investigators analyzed data from the EINSTEIN-CHOICE trial, a double-blind, randomized study of 3,365 patients aged 18 years or older with deep vein thrombosis or pulmonary embolism who had previously received anticoagulant treatment for 6-12 months. Patients were given either once-daily rivaroxaban at a low dose (10 mg), once-daily rivaroxaban at full dose (20 mg), or once- daily aspirin at a dose of 100 mg.
Benefit and risk were calculated using “excess numbers of events,” or the difference in cumulative incidences in a hypothetical population of 10,000 VTE patients treated for 1 year. Excess numbers of events were defined as the number of patients in this hypothetical population who would experience a particular event when treated with rivaroxaban (at either dose), minus that in the same population treated with aspirin.
The cumulative incidences of recurrent VTE in the full-dose rivaroxaban, low-dose rivaroxaban, and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively. The cumulative incidences of major bleeding in these groups were 0.7%, 0.4% and 0.5%, respectively.
In patients treated with 20 mg of rivaroxaban instead of aspirin, there would be 123 fewer episodes of pulmonary embolism (95% confidence interval, 21-226) and 198 fewer episodes of deep vein thrombosis (95% CI, 62-333).
In patients given 10 mg of rivaroxaban instead of aspirin, there would be 121 fewer episodes of pulmonary embolism (95% CI, 4-238) and 217 fewer episodes of deep vein thrombosis (95% CI, 92-342), Dr. Prandoni and his colleagues wrote.
Net clinical benefit was defined as the composite of symptomatic recurrent VTE and major bleeding events, and occurred in 23 patients in the full-dose rivaroxaban group, 17 patients in the low-dose rivaroxaban group, and 53 patients in the aspirin group.
For 10,000 patients treated for 1 year with rivaroxaban instead of aspirin, there would be 284 fewer net clinical benefit outcomes for the 20-mg dose (95% CI, 106-462) and 339 fewer (95% CI, 165-512) for the 10-mg dose. “Thus, compared with aspirin, one additional symptomatic recurrent VTE or major bleed would be avoided for every 36 or 30 patients treated with rivaroxaban 20 mg or 10 mg, respectively,” the investigators wrote.
The findings indicate that there is “no longer a place” for extended VTE treatment with aspirin, the investigators said.
“Extended anticoagulation with once daily rivaroxaban ... provides a clinically important benefit in terms of reduction in recurrent VTE,” they wrote. “Regardless of which dose is chosen ... rivaroxaban has a favourable benefit-risk profile relative to aspirin.”
Bayer AG funded the study. Dr. Prandoni reported financial relationships with Bayer, Sanofi, Daiichi Sankyo, and Pfizer.
SOURCE: Prandoni P et al. Thromb Res. 2018 Aug;168:121-9.
Both low-dose and full-dose rivaroxaban had superior benefit-risk profiles for extended venous thromboembolism (VTE) treatment compared with aspirin, according to results published in Thrombosis Research.
Incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower for patients treated with rivaroxaban at 20 mg and 10 mg, respectively, than for those treated with aspirin, reported Paolo Prandoni, MD, of the department of cardiothoracic and vascular sciences at the University of Padua, Italy, and his coauthors.
Investigators analyzed data from the EINSTEIN-CHOICE trial, a double-blind, randomized study of 3,365 patients aged 18 years or older with deep vein thrombosis or pulmonary embolism who had previously received anticoagulant treatment for 6-12 months. Patients were given either once-daily rivaroxaban at a low dose (10 mg), once-daily rivaroxaban at full dose (20 mg), or once- daily aspirin at a dose of 100 mg.
Benefit and risk were calculated using “excess numbers of events,” or the difference in cumulative incidences in a hypothetical population of 10,000 VTE patients treated for 1 year. Excess numbers of events were defined as the number of patients in this hypothetical population who would experience a particular event when treated with rivaroxaban (at either dose), minus that in the same population treated with aspirin.
The cumulative incidences of recurrent VTE in the full-dose rivaroxaban, low-dose rivaroxaban, and aspirin groups were 1.9%, 1.6%, and 5.0%, respectively. The cumulative incidences of major bleeding in these groups were 0.7%, 0.4% and 0.5%, respectively.
In patients treated with 20 mg of rivaroxaban instead of aspirin, there would be 123 fewer episodes of pulmonary embolism (95% confidence interval, 21-226) and 198 fewer episodes of deep vein thrombosis (95% CI, 62-333).
In patients given 10 mg of rivaroxaban instead of aspirin, there would be 121 fewer episodes of pulmonary embolism (95% CI, 4-238) and 217 fewer episodes of deep vein thrombosis (95% CI, 92-342), Dr. Prandoni and his colleagues wrote.
Net clinical benefit was defined as the composite of symptomatic recurrent VTE and major bleeding events, and occurred in 23 patients in the full-dose rivaroxaban group, 17 patients in the low-dose rivaroxaban group, and 53 patients in the aspirin group.
For 10,000 patients treated for 1 year with rivaroxaban instead of aspirin, there would be 284 fewer net clinical benefit outcomes for the 20-mg dose (95% CI, 106-462) and 339 fewer (95% CI, 165-512) for the 10-mg dose. “Thus, compared with aspirin, one additional symptomatic recurrent VTE or major bleed would be avoided for every 36 or 30 patients treated with rivaroxaban 20 mg or 10 mg, respectively,” the investigators wrote.
The findings indicate that there is “no longer a place” for extended VTE treatment with aspirin, the investigators said.
“Extended anticoagulation with once daily rivaroxaban ... provides a clinically important benefit in terms of reduction in recurrent VTE,” they wrote. “Regardless of which dose is chosen ... rivaroxaban has a favourable benefit-risk profile relative to aspirin.”
Bayer AG funded the study. Dr. Prandoni reported financial relationships with Bayer, Sanofi, Daiichi Sankyo, and Pfizer.
SOURCE: Prandoni P et al. Thromb Res. 2018 Aug;168:121-9.
FROM THROMBOSIS RESEARCH
Key clinical point:
Major finding: Incidences of the combined outcome of recurrent VTE and major bleeding were 2.8% and 3.4% lower in the rivaroxaban 20-mg and 10-mg groups, respectively, than in the aspirin group.
Study details: Analysis of data from 3,365 patients in the EINSTEIN-CHOICE trial, a double-blind, randomized study comparing rivaroxaban with aspirin for extended treatment of VTE.
Disclosures: Bayer AG funded the study. Dr. Prandoni disclosed financial relationships with Bayer, Sanofi, Daiichi Sankyo, and Pfizer.
Source: Prandoni P et al. Thromb Res. 2018 Aug;168:121-9.
Little overlap between surgical M&M and AHRQ on adverse events
Limited overlap in adverse events identified by surgical morbidity and mortality (M&M) conferences and by Agency for Healthcare Research and Quality patient safety indicators (PSIs) demonstrates that the two processes tend to capture different, but equally important, measures, according to study results published in the Journal of the American College of Surgeons.
Just 18 of 149 (12.1%) PSI-defined events were identified by both processes in a retrospective, observational study of complications at the UC Davis Medical Center’s department of surgery. Most events (62.4%) were identified by only the M&M review, while 25.5% were identified by only the PSIs, reported Jamie E. Anderson, MD, MPH, of the department of surgery at UC Davis Medical Center in Sacramento and coauthors.
The study authors identified 6,563 surgical hospitalizations in the year 2016, of which 647 (9.9%) had at least one event that was either submitted for review for a departmental M&M conference, identified as a PSI event from administrative data, or both. Cases in patients aged less than 18 years were excluded.
Hospital administrative data were reported using ICD-10 CM/PCS codes. Investigators identified all PSI cases, which included pressure ulcer, retained surgical item, iatrogenic pneumothorax, central venous catheter–related blood stream infection, postoperative hip fracture, perioperative hematoma or hemorrhage requiring a procedure, postoperative acute kidney injury requiring dialysis, postoperative respiratory failure, perioperative pulmonary embolism or deep venous thrombosis, postoperative sepsis, postoperative wound dehiscence, and unrecognized abdominopelvic accidental puncture or laceration.
Complications submitted to the M&M conference were reviewed for PSI-defined events, and included events from general surgery, bariatric surgery, burn, cardiothoracic, colorectal, surgical oncology, plastic, vascular, transplant, and trauma. PSI-defined events were then reviewed to verify whether they counted as “true” PSI events and further classified as a documentation error, intentional exclusion, or inherent limitation of the PSI, the authors reported.
Of 6,563 surgical hospitalizations, 647 had at least one complication identified by M&M, PSI, or both. Of these, 116 had at least one PSI-defined event identified by either M&M or PSI. The remaining hospitalizations had unrelated complications and were excluded from analysis.
Of the 116 hospitalizations, there were 149 PSI-defined events, of which 18 (12.1%) were identified by both methods. Most events (62.4%) were identified by only the M&M review, and 25.5% were identified by only the PSIs. Perioperative hemorrhage/hematoma and postoperative sepsis were most likely to be identified by both.
Of the 93 PSI-defined events captured by only M&M, 11 (11.8%) met AHRQ criteria and were considered “true” events, or “false negatives.” All 38 events identified by PSI alone were correctly identified as true PSI events, Dr. Anderson and colleagues reported.
The findings indicate that the AHRQ PSI and surgical M&M conference “should be considered complementary approaches for identifying complications,” the authors wrote.
The PSI data captured central venous catheter–related blood stream infection and pressure ulcers, but the M&M conferences did not include these outcomes. The M&M reviewed more cases of postoperative sepsis, abdominopelvic accidental laceration, and the one case of retained surgical item.
“These two processes of identifying complications have different purposes, and each approach captured different events,” they added.
The M&M conference “balances clinician education and quality improvement with an underlying theme of accountability,” they said, with increased emphasis on examining adverse events in the context of systems-based practices. PSI, on the other hand, is intended as a “resource-nonintensive means” to help hospitals identify preventable events and facilitate quality improvement, they said.
“In an era in which there are numerous mechanisms to measure surgical quality, the traditional M&M conference is still relevant for identifying and discussing surgical complications,” the authors concluded. “We believe that our center’s existing M&M case-finding process is fundamentally sound, but it could be improved by including all PSI-flagged hospitalizations in our M&M process. This may result in review of some false-positive records, but it will enable our department to address certain potentially preventable complications that are currently overlooked.”
Two of the study coauthors received salary support from the AHRQ to support the agency’s Quality Indicator Program, one of whom serves on the agency’s Quality Indicators Expert Workgroup. No other disclosures were reported.
SOURCE: Anderson J et al. J Am Coll Surg. 2018 Jul 5. doi: 10.1016/j.jamcollsurg.2018.06.008.
Limited overlap in adverse events identified by surgical morbidity and mortality (M&M) conferences and by Agency for Healthcare Research and Quality patient safety indicators (PSIs) demonstrates that the two processes tend to capture different, but equally important, measures, according to study results published in the Journal of the American College of Surgeons.
Just 18 of 149 (12.1%) PSI-defined events were identified by both processes in a retrospective, observational study of complications at the UC Davis Medical Center’s department of surgery. Most events (62.4%) were identified by only the M&M review, while 25.5% were identified by only the PSIs, reported Jamie E. Anderson, MD, MPH, of the department of surgery at UC Davis Medical Center in Sacramento and coauthors.
The study authors identified 6,563 surgical hospitalizations in the year 2016, of which 647 (9.9%) had at least one event that was either submitted for review for a departmental M&M conference, identified as a PSI event from administrative data, or both. Cases in patients aged less than 18 years were excluded.
Hospital administrative data were reported using ICD-10 CM/PCS codes. Investigators identified all PSI cases, which included pressure ulcer, retained surgical item, iatrogenic pneumothorax, central venous catheter–related blood stream infection, postoperative hip fracture, perioperative hematoma or hemorrhage requiring a procedure, postoperative acute kidney injury requiring dialysis, postoperative respiratory failure, perioperative pulmonary embolism or deep venous thrombosis, postoperative sepsis, postoperative wound dehiscence, and unrecognized abdominopelvic accidental puncture or laceration.
Complications submitted to the M&M conference were reviewed for PSI-defined events, and included events from general surgery, bariatric surgery, burn, cardiothoracic, colorectal, surgical oncology, plastic, vascular, transplant, and trauma. PSI-defined events were then reviewed to verify whether they counted as “true” PSI events and further classified as a documentation error, intentional exclusion, or inherent limitation of the PSI, the authors reported.
Of 6,563 surgical hospitalizations, 647 had at least one complication identified by M&M, PSI, or both. Of these, 116 had at least one PSI-defined event identified by either M&M or PSI. The remaining hospitalizations had unrelated complications and were excluded from analysis.
Of the 116 hospitalizations, there were 149 PSI-defined events, of which 18 (12.1%) were identified by both methods. Most events (62.4%) were identified by only the M&M review, and 25.5% were identified by only the PSIs. Perioperative hemorrhage/hematoma and postoperative sepsis were most likely to be identified by both.
Of the 93 PSI-defined events captured by only M&M, 11 (11.8%) met AHRQ criteria and were considered “true” events, or “false negatives.” All 38 events identified by PSI alone were correctly identified as true PSI events, Dr. Anderson and colleagues reported.
The findings indicate that the AHRQ PSI and surgical M&M conference “should be considered complementary approaches for identifying complications,” the authors wrote.
The PSI data captured central venous catheter–related blood stream infection and pressure ulcers, but the M&M conferences did not include these outcomes. The M&M reviewed more cases of postoperative sepsis, abdominopelvic accidental laceration, and the one case of retained surgical item.
“These two processes of identifying complications have different purposes, and each approach captured different events,” they added.
The M&M conference “balances clinician education and quality improvement with an underlying theme of accountability,” they said, with increased emphasis on examining adverse events in the context of systems-based practices. PSI, on the other hand, is intended as a “resource-nonintensive means” to help hospitals identify preventable events and facilitate quality improvement, they said.
“In an era in which there are numerous mechanisms to measure surgical quality, the traditional M&M conference is still relevant for identifying and discussing surgical complications,” the authors concluded. “We believe that our center’s existing M&M case-finding process is fundamentally sound, but it could be improved by including all PSI-flagged hospitalizations in our M&M process. This may result in review of some false-positive records, but it will enable our department to address certain potentially preventable complications that are currently overlooked.”
Two of the study coauthors received salary support from the AHRQ to support the agency’s Quality Indicator Program, one of whom serves on the agency’s Quality Indicators Expert Workgroup. No other disclosures were reported.
SOURCE: Anderson J et al. J Am Coll Surg. 2018 Jul 5. doi: 10.1016/j.jamcollsurg.2018.06.008.
Limited overlap in adverse events identified by surgical morbidity and mortality (M&M) conferences and by Agency for Healthcare Research and Quality patient safety indicators (PSIs) demonstrates that the two processes tend to capture different, but equally important, measures, according to study results published in the Journal of the American College of Surgeons.
Just 18 of 149 (12.1%) PSI-defined events were identified by both processes in a retrospective, observational study of complications at the UC Davis Medical Center’s department of surgery. Most events (62.4%) were identified by only the M&M review, while 25.5% were identified by only the PSIs, reported Jamie E. Anderson, MD, MPH, of the department of surgery at UC Davis Medical Center in Sacramento and coauthors.
The study authors identified 6,563 surgical hospitalizations in the year 2016, of which 647 (9.9%) had at least one event that was either submitted for review for a departmental M&M conference, identified as a PSI event from administrative data, or both. Cases in patients aged less than 18 years were excluded.
Hospital administrative data were reported using ICD-10 CM/PCS codes. Investigators identified all PSI cases, which included pressure ulcer, retained surgical item, iatrogenic pneumothorax, central venous catheter–related blood stream infection, postoperative hip fracture, perioperative hematoma or hemorrhage requiring a procedure, postoperative acute kidney injury requiring dialysis, postoperative respiratory failure, perioperative pulmonary embolism or deep venous thrombosis, postoperative sepsis, postoperative wound dehiscence, and unrecognized abdominopelvic accidental puncture or laceration.
Complications submitted to the M&M conference were reviewed for PSI-defined events, and included events from general surgery, bariatric surgery, burn, cardiothoracic, colorectal, surgical oncology, plastic, vascular, transplant, and trauma. PSI-defined events were then reviewed to verify whether they counted as “true” PSI events and further classified as a documentation error, intentional exclusion, or inherent limitation of the PSI, the authors reported.
Of 6,563 surgical hospitalizations, 647 had at least one complication identified by M&M, PSI, or both. Of these, 116 had at least one PSI-defined event identified by either M&M or PSI. The remaining hospitalizations had unrelated complications and were excluded from analysis.
Of the 116 hospitalizations, there were 149 PSI-defined events, of which 18 (12.1%) were identified by both methods. Most events (62.4%) were identified by only the M&M review, and 25.5% were identified by only the PSIs. Perioperative hemorrhage/hematoma and postoperative sepsis were most likely to be identified by both.
Of the 93 PSI-defined events captured by only M&M, 11 (11.8%) met AHRQ criteria and were considered “true” events, or “false negatives.” All 38 events identified by PSI alone were correctly identified as true PSI events, Dr. Anderson and colleagues reported.
The findings indicate that the AHRQ PSI and surgical M&M conference “should be considered complementary approaches for identifying complications,” the authors wrote.
The PSI data captured central venous catheter–related blood stream infection and pressure ulcers, but the M&M conferences did not include these outcomes. The M&M reviewed more cases of postoperative sepsis, abdominopelvic accidental laceration, and the one case of retained surgical item.
“These two processes of identifying complications have different purposes, and each approach captured different events,” they added.
The M&M conference “balances clinician education and quality improvement with an underlying theme of accountability,” they said, with increased emphasis on examining adverse events in the context of systems-based practices. PSI, on the other hand, is intended as a “resource-nonintensive means” to help hospitals identify preventable events and facilitate quality improvement, they said.
“In an era in which there are numerous mechanisms to measure surgical quality, the traditional M&M conference is still relevant for identifying and discussing surgical complications,” the authors concluded. “We believe that our center’s existing M&M case-finding process is fundamentally sound, but it could be improved by including all PSI-flagged hospitalizations in our M&M process. This may result in review of some false-positive records, but it will enable our department to address certain potentially preventable complications that are currently overlooked.”
Two of the study coauthors received salary support from the AHRQ to support the agency’s Quality Indicator Program, one of whom serves on the agency’s Quality Indicators Expert Workgroup. No other disclosures were reported.
SOURCE: Anderson J et al. J Am Coll Surg. 2018 Jul 5. doi: 10.1016/j.jamcollsurg.2018.06.008.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Key clinical point: Surgical morbidity and mortality conferences and AHRQ patient safety indicators should be considered complementary measures of adverse events because of a limited overlap in identifying adverse events.
Major finding: Eighteen of 149 (12.1%) PSI-defined events were identified by both processes; most (62.4%) were identified by only M&M review, and 25.5% by only PSI.
Study details: A retrospective observational study of all complications in 2016 at the UC Davis Medical Center department of surgery.
Disclosures: Two of the study coauthors received salary support from the AHRQ to support the agency’s Quality Indicator Program, one of whom serves on the agency’s Quality Indicators Expert Workgroup. No other disclosures were reported.
Source: Anderson J et al. J Am Coll Surg. 2018 Jul 5. doi: 10.1016/j.jamcollsurg.2018.06.008.
