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Self-harm on rise in U.S. among girls aged 10-14
The rate of self-inflicted injuries has increased significantly among young girls since 2009, according to a study of emergency department visits for self-inflicted injuries from 2001 to 2015.
In a research letter, Melissa C. Mercado, PhD, and her associates reached that conclusion based on data from 43,138 emergency department visits for self-inflicted injury among young people aged 10-24 years, which were captured by the National Electronic Injury Surveillance System–All Injury Program (JAMA. 2017;318[19]:1931-3. doi: 10.1001/jama.2017.13317).
From 2001 to 2008, the overall weighted, age-adjusted rate of self-inflicted injury showed no statistically significant trend upward or downward, reported Dr. Mercado of the National Center for Injury Prevention and Control, Atlanta, and her associates. From 2009 to 2015, however, the rate increased by a significant 5.7% per year, reaching 303.7 per 100,000 population in 2015, compared with 201.6 in 2001.
This increase was even more pronounced among girls, rising by 8.4% per year from 2008 to 2015 in all females but by 18.8% per year in those aged 10-14 years. In adolescent females aged 15-19, the rate of self-inflicted injury rose 7.2% per year from 2008 to 2015. In young women aged 20-24 years, the rate rose 2% per year from 2001 to 2015.
Meanwhile, the rates of self-inflicted injury for males were stable across all time periods and age groups.
“Self-inflicted injury is one of the strongest risk factors for suicide – the second-leading cause of death among those aged 10 to 24 years during 2015,” Dr. Mercado and her coauthors wrote.
The most common method of self-inflicted injury for females was poisoning. As with the overall rates of injury in females, the rates of this method of harm were stable until 2007, then increased by 5.3% until 2015. Self-inflicted injuries among females using a sharp object increased by 7.1% each year from 2001 to 2015, but the rates of blunt-object injuries were stable from 2006 to 2015.
The authors wrote that the finding of an increase in self-harm among females was consistent with youth suicide data, which also show an increase after 2006, particularly among girls and female adolescents aged 10-14 years.
Dr. Mercado and her associates called for the implementation of evidence-based, comprehensive suicide and self-harm prevention strategies. “These strategies include strengthening access to and delivery of care for suicidal youth within health systems and creating protective environments, promoting youth connectedness, teaching coping and problem-solving skills, and identifying and supporting at-risk youth within communities.”
The study was conducted under the auspices of the National Center for Injury Prevention and Control, which is part of the Centers for Disease Control and Prevention. The findings, however, do not necessarily represent the views of the CDC. No conflicts of interest were declared.
The rate of self-inflicted injuries has increased significantly among young girls since 2009, according to a study of emergency department visits for self-inflicted injuries from 2001 to 2015.
In a research letter, Melissa C. Mercado, PhD, and her associates reached that conclusion based on data from 43,138 emergency department visits for self-inflicted injury among young people aged 10-24 years, which were captured by the National Electronic Injury Surveillance System–All Injury Program (JAMA. 2017;318[19]:1931-3. doi: 10.1001/jama.2017.13317).
From 2001 to 2008, the overall weighted, age-adjusted rate of self-inflicted injury showed no statistically significant trend upward or downward, reported Dr. Mercado of the National Center for Injury Prevention and Control, Atlanta, and her associates. From 2009 to 2015, however, the rate increased by a significant 5.7% per year, reaching 303.7 per 100,000 population in 2015, compared with 201.6 in 2001.
This increase was even more pronounced among girls, rising by 8.4% per year from 2008 to 2015 in all females but by 18.8% per year in those aged 10-14 years. In adolescent females aged 15-19, the rate of self-inflicted injury rose 7.2% per year from 2008 to 2015. In young women aged 20-24 years, the rate rose 2% per year from 2001 to 2015.
Meanwhile, the rates of self-inflicted injury for males were stable across all time periods and age groups.
“Self-inflicted injury is one of the strongest risk factors for suicide – the second-leading cause of death among those aged 10 to 24 years during 2015,” Dr. Mercado and her coauthors wrote.
The most common method of self-inflicted injury for females was poisoning. As with the overall rates of injury in females, the rates of this method of harm were stable until 2007, then increased by 5.3% until 2015. Self-inflicted injuries among females using a sharp object increased by 7.1% each year from 2001 to 2015, but the rates of blunt-object injuries were stable from 2006 to 2015.
The authors wrote that the finding of an increase in self-harm among females was consistent with youth suicide data, which also show an increase after 2006, particularly among girls and female adolescents aged 10-14 years.
Dr. Mercado and her associates called for the implementation of evidence-based, comprehensive suicide and self-harm prevention strategies. “These strategies include strengthening access to and delivery of care for suicidal youth within health systems and creating protective environments, promoting youth connectedness, teaching coping and problem-solving skills, and identifying and supporting at-risk youth within communities.”
The study was conducted under the auspices of the National Center for Injury Prevention and Control, which is part of the Centers for Disease Control and Prevention. The findings, however, do not necessarily represent the views of the CDC. No conflicts of interest were declared.
The rate of self-inflicted injuries has increased significantly among young girls since 2009, according to a study of emergency department visits for self-inflicted injuries from 2001 to 2015.
In a research letter, Melissa C. Mercado, PhD, and her associates reached that conclusion based on data from 43,138 emergency department visits for self-inflicted injury among young people aged 10-24 years, which were captured by the National Electronic Injury Surveillance System–All Injury Program (JAMA. 2017;318[19]:1931-3. doi: 10.1001/jama.2017.13317).
From 2001 to 2008, the overall weighted, age-adjusted rate of self-inflicted injury showed no statistically significant trend upward or downward, reported Dr. Mercado of the National Center for Injury Prevention and Control, Atlanta, and her associates. From 2009 to 2015, however, the rate increased by a significant 5.7% per year, reaching 303.7 per 100,000 population in 2015, compared with 201.6 in 2001.
This increase was even more pronounced among girls, rising by 8.4% per year from 2008 to 2015 in all females but by 18.8% per year in those aged 10-14 years. In adolescent females aged 15-19, the rate of self-inflicted injury rose 7.2% per year from 2008 to 2015. In young women aged 20-24 years, the rate rose 2% per year from 2001 to 2015.
Meanwhile, the rates of self-inflicted injury for males were stable across all time periods and age groups.
“Self-inflicted injury is one of the strongest risk factors for suicide – the second-leading cause of death among those aged 10 to 24 years during 2015,” Dr. Mercado and her coauthors wrote.
The most common method of self-inflicted injury for females was poisoning. As with the overall rates of injury in females, the rates of this method of harm were stable until 2007, then increased by 5.3% until 2015. Self-inflicted injuries among females using a sharp object increased by 7.1% each year from 2001 to 2015, but the rates of blunt-object injuries were stable from 2006 to 2015.
The authors wrote that the finding of an increase in self-harm among females was consistent with youth suicide data, which also show an increase after 2006, particularly among girls and female adolescents aged 10-14 years.
Dr. Mercado and her associates called for the implementation of evidence-based, comprehensive suicide and self-harm prevention strategies. “These strategies include strengthening access to and delivery of care for suicidal youth within health systems and creating protective environments, promoting youth connectedness, teaching coping and problem-solving skills, and identifying and supporting at-risk youth within communities.”
The study was conducted under the auspices of the National Center for Injury Prevention and Control, which is part of the Centers for Disease Control and Prevention. The findings, however, do not necessarily represent the views of the CDC. No conflicts of interest were declared.
FROM JAMA
Key clinical point: Rates of self-inflicted injury rose significantly in young women between 2009 and 2015, particularly in those aged 10-14 years.
Major finding: The rate of emergency department visits for self-inflicted injury rose 18.8% per year from 2009 to 2015 in females aged 10-14 years.
Data source: Analysis of data from 43,138 emergency department visits of young people aged 10-24 years for self-inflicted injury.
Disclosures: The study was conducted under the auspices of the Centers for Disease Control and Prevention, but the findings do not necessarily represent the views of the CDC. No conflicts of interest were declared.
Prenatal vitamin D supplementation plagued by lack of evidence
Prenatal vitamin D supplementation may reduce the risk of small for gestational age and early wheeze in infants, but most of the evidence comes from small, low-quality trials, according to a systematic review and meta-analysis.
Researchers reported on a meta-analysis of 43 randomized controlled trials, involving 8,406 participants, which examined the effects of vitamin D supplementation during pregnancy (BMJ. 2017;359:j5237. doi: 10.1136/bmj.j5237).
The most commonly reported outcomes involved fetal growth and preterm birth. A pooling of 37 comparisons suggested that vitamin D supplementation increased mean birth weight by an average of 58 g, compared with low-dose vitamin D, no vitamin D, or placebo.
Two high-quality trials using a regular dose of vitamin D, which were conducted in high-income countries, found a 19% reduction in the risk of persistent/recurrent wheeze by age 3, which the authors said was consistent with other data suggesting a beneficial effect of vitamin D in adults with asthma. However, there were no other respiratory effects, such as on the risk of upper or lower respiratory tract infections.
There were few studies that reported on maternal clinical outcomes, and those that did showed no evidence of benefit.
“Though some observational studies have shown associations between maternal vitamin D deficiency and gestational diabetes and preeclampsia, we did not find robust corroborating evidence from randomised controlled trials,” wrote Daniel E. Roth, MD, and his colleagues at the Hospital for Sick Children, Toronto, and the University of Toronto.
They did report significantly higher maternal and cord blood concentrations of 25-hydroxyvitamin D in the intervention groups, compared with controls.
The median sample size of the studies was 133, and the researchers found that only 8 of the 43 trials had an overall low risk of bias. They also noted that there were wide variations in baseline maternal vitamin D levels.
“Though trials of prenatal vitamin D supplementation are being published at an accelerating pace, randomised controlled trials published up to 2017 were generally small, low quality, and rarely designed to examine clinical outcomes,” the researchers wrote.
The study was supported by the Hospital for Sick Children. No conflicts of interest were declared.
Prenatal vitamin D supplementation may reduce the risk of small for gestational age and early wheeze in infants, but most of the evidence comes from small, low-quality trials, according to a systematic review and meta-analysis.
Researchers reported on a meta-analysis of 43 randomized controlled trials, involving 8,406 participants, which examined the effects of vitamin D supplementation during pregnancy (BMJ. 2017;359:j5237. doi: 10.1136/bmj.j5237).
The most commonly reported outcomes involved fetal growth and preterm birth. A pooling of 37 comparisons suggested that vitamin D supplementation increased mean birth weight by an average of 58 g, compared with low-dose vitamin D, no vitamin D, or placebo.
Two high-quality trials using a regular dose of vitamin D, which were conducted in high-income countries, found a 19% reduction in the risk of persistent/recurrent wheeze by age 3, which the authors said was consistent with other data suggesting a beneficial effect of vitamin D in adults with asthma. However, there were no other respiratory effects, such as on the risk of upper or lower respiratory tract infections.
There were few studies that reported on maternal clinical outcomes, and those that did showed no evidence of benefit.
“Though some observational studies have shown associations between maternal vitamin D deficiency and gestational diabetes and preeclampsia, we did not find robust corroborating evidence from randomised controlled trials,” wrote Daniel E. Roth, MD, and his colleagues at the Hospital for Sick Children, Toronto, and the University of Toronto.
They did report significantly higher maternal and cord blood concentrations of 25-hydroxyvitamin D in the intervention groups, compared with controls.
The median sample size of the studies was 133, and the researchers found that only 8 of the 43 trials had an overall low risk of bias. They also noted that there were wide variations in baseline maternal vitamin D levels.
“Though trials of prenatal vitamin D supplementation are being published at an accelerating pace, randomised controlled trials published up to 2017 were generally small, low quality, and rarely designed to examine clinical outcomes,” the researchers wrote.
The study was supported by the Hospital for Sick Children. No conflicts of interest were declared.
Prenatal vitamin D supplementation may reduce the risk of small for gestational age and early wheeze in infants, but most of the evidence comes from small, low-quality trials, according to a systematic review and meta-analysis.
Researchers reported on a meta-analysis of 43 randomized controlled trials, involving 8,406 participants, which examined the effects of vitamin D supplementation during pregnancy (BMJ. 2017;359:j5237. doi: 10.1136/bmj.j5237).
The most commonly reported outcomes involved fetal growth and preterm birth. A pooling of 37 comparisons suggested that vitamin D supplementation increased mean birth weight by an average of 58 g, compared with low-dose vitamin D, no vitamin D, or placebo.
Two high-quality trials using a regular dose of vitamin D, which were conducted in high-income countries, found a 19% reduction in the risk of persistent/recurrent wheeze by age 3, which the authors said was consistent with other data suggesting a beneficial effect of vitamin D in adults with asthma. However, there were no other respiratory effects, such as on the risk of upper or lower respiratory tract infections.
There were few studies that reported on maternal clinical outcomes, and those that did showed no evidence of benefit.
“Though some observational studies have shown associations between maternal vitamin D deficiency and gestational diabetes and preeclampsia, we did not find robust corroborating evidence from randomised controlled trials,” wrote Daniel E. Roth, MD, and his colleagues at the Hospital for Sick Children, Toronto, and the University of Toronto.
They did report significantly higher maternal and cord blood concentrations of 25-hydroxyvitamin D in the intervention groups, compared with controls.
The median sample size of the studies was 133, and the researchers found that only 8 of the 43 trials had an overall low risk of bias. They also noted that there were wide variations in baseline maternal vitamin D levels.
“Though trials of prenatal vitamin D supplementation are being published at an accelerating pace, randomised controlled trials published up to 2017 were generally small, low quality, and rarely designed to examine clinical outcomes,” the researchers wrote.
The study was supported by the Hospital for Sick Children. No conflicts of interest were declared.
FROM BMJ
Key clinical point:
Major finding: Prenatal vitamin D supplementation is associated with a 40% reduction in the risk of having an SGA infant.
Data source: A systematic review and meta-analysis of 43 randomized controlled trials.
Disclosures: The study was supported by the Hospital for Sick Children, Toronto. No conflicts of interest were declared.
Fecal microbiota transplants by oral capsule noninferior to colonoscopy
Fecal microbiota transplantation (FMT) using oral capsules as the delivery method has been shown to be noninferior to delivery using colonoscopy for the treatment of Clostridium difficile infection, but with a significantly lower price tag.
In an unblended noninferiority trial, published in the Nov. 28 issue of JAMA, 116 adults with at least three documented episodes of C. difficile infection were randomized to either 360 mL of fecal slurry delivered to the cecum via colonoscopy or to 40 capsules of processed fecal microbiota swallowed under direct observation.
Dina Kao, MD, of the department of medicine at the University of Alberta, Edmonton, and coauthors commented that the response rate with the capsules was higher than that seen in other studies of fecal microbiota capsules, which they suggested may partly be due to the larger amount of donor stool used in the study: 80-100 g, compared with 17 g and 25 g used in other studies.
“The higher efficacy observed in this study suggests a dose-dependent response to FMT, and a benefit of bowel lavage prior to FMT, because residual vancomycin was detected up to 8 days despite its discontinuation,” they wrote.
Both treatment modalities achieved similar quality of life improvements. Both groups reported major improvements in domains including physical and emotional health, physical and social functioning, and general health, with no significant differences between the two arms of the study.
The cost per treatment in the colonoscopy group was $874 per patient, compared with $308 per patient in the capsule group.
“Although colonoscopy delivery is more invasive, resource intensive, costly, and inconvenient for patients, it has the advantage of identifying alternative diagnoses,” the authors wrote. “Conversely, when FMT is given by oral capsules, it can be administered in an office setting, which could substantially reduce cost and wait time.”
Both groups also showed significantly improved gut microbiota diversity, which approached that of the donor just 1 week after administration of the treatment.
While 30% of patients characterized FMTs as “unpleasant, gross, or disgusting,” 79% of participants said the unpleasantness was the same or less than anticipated, and 97% said they would undergo the same treatment by the same delivery method again if needed.
However, significantly more patients in the capsule group described their experience as “not at all unpleasant,” compared with the colonoscopy group (66% vs. 44%; 95% CI, 3%-40%; P = .01).
There were no colonic perforations seen in the colonoscopy group, and no infectious complications relating to the treatment in either group. One patient in each group died of underlying cardiopulmonary illness that was unrelated to the treatment, and the rate of minor adverse events was 5.4% in the capsule group and 12.5% in the colonoscopy group.
The authors acknowledged that the lack of a placebo group in the study meant they were not able to measure the size of the effect of fecal microbiota transplantation by either route. One earlier trial had also shown a placebo response rate of 45%.
The study was funded by Alberta Health Services and the University of Alberta Hospital Foundation. Four authors declared grants and other funding from the study funder and the pharmaceutical industry.
Clostridium difficile infection costs the U.S. health care system an estimated $1.5 billion each year, with 450,000 cases reported annually, 20% of which involve a recurrence of the infection. Fecal microbiota transplantation is increasingly being used as a treatment, but more widespread adoption is limited partly by the logistical difficulties of delivery.
This study offers encouraging data on delivery of fecal microbiota transplants via capsule, which may reduce barriers to adoption of this treatment; however, there are still some questions to be answered about the treatment’s efficacy, such as the timing of delivery and the relative importance of stool components.
There are also other approaches that should be considered in future research on C. difficile infection, including the use of vancomycin tapers with and without “chasers” of fidaxomicin/rifaximin, the use of defined microbial communities, and the use of sterile, fecal-derived products, which may even supplant standard fecal microbial transplants in the future.
Krishna Rao, MD, Vincent B. Young, MD, PhD, and Preeti N. Malani, MD, are with the division of infectious diseases in the department of internal medicine at the University of Michigan, Ann Arbor. These comments are taken from an accompanying editorial (JAMA. 2017 Nov 28;381:1979-80. doi: 10.1001/jama.2017.17969). Dr. Young reported consulting fees from Vedanta, Merck, and Finch Therapeutics and grants from MedImmune. No other disclosures were reported.
Clostridium difficile infection costs the U.S. health care system an estimated $1.5 billion each year, with 450,000 cases reported annually, 20% of which involve a recurrence of the infection. Fecal microbiota transplantation is increasingly being used as a treatment, but more widespread adoption is limited partly by the logistical difficulties of delivery.
This study offers encouraging data on delivery of fecal microbiota transplants via capsule, which may reduce barriers to adoption of this treatment; however, there are still some questions to be answered about the treatment’s efficacy, such as the timing of delivery and the relative importance of stool components.
There are also other approaches that should be considered in future research on C. difficile infection, including the use of vancomycin tapers with and without “chasers” of fidaxomicin/rifaximin, the use of defined microbial communities, and the use of sterile, fecal-derived products, which may even supplant standard fecal microbial transplants in the future.
Krishna Rao, MD, Vincent B. Young, MD, PhD, and Preeti N. Malani, MD, are with the division of infectious diseases in the department of internal medicine at the University of Michigan, Ann Arbor. These comments are taken from an accompanying editorial (JAMA. 2017 Nov 28;381:1979-80. doi: 10.1001/jama.2017.17969). Dr. Young reported consulting fees from Vedanta, Merck, and Finch Therapeutics and grants from MedImmune. No other disclosures were reported.
Clostridium difficile infection costs the U.S. health care system an estimated $1.5 billion each year, with 450,000 cases reported annually, 20% of which involve a recurrence of the infection. Fecal microbiota transplantation is increasingly being used as a treatment, but more widespread adoption is limited partly by the logistical difficulties of delivery.
This study offers encouraging data on delivery of fecal microbiota transplants via capsule, which may reduce barriers to adoption of this treatment; however, there are still some questions to be answered about the treatment’s efficacy, such as the timing of delivery and the relative importance of stool components.
There are also other approaches that should be considered in future research on C. difficile infection, including the use of vancomycin tapers with and without “chasers” of fidaxomicin/rifaximin, the use of defined microbial communities, and the use of sterile, fecal-derived products, which may even supplant standard fecal microbial transplants in the future.
Krishna Rao, MD, Vincent B. Young, MD, PhD, and Preeti N. Malani, MD, are with the division of infectious diseases in the department of internal medicine at the University of Michigan, Ann Arbor. These comments are taken from an accompanying editorial (JAMA. 2017 Nov 28;381:1979-80. doi: 10.1001/jama.2017.17969). Dr. Young reported consulting fees from Vedanta, Merck, and Finch Therapeutics and grants from MedImmune. No other disclosures were reported.
Fecal microbiota transplantation (FMT) using oral capsules as the delivery method has been shown to be noninferior to delivery using colonoscopy for the treatment of Clostridium difficile infection, but with a significantly lower price tag.
In an unblended noninferiority trial, published in the Nov. 28 issue of JAMA, 116 adults with at least three documented episodes of C. difficile infection were randomized to either 360 mL of fecal slurry delivered to the cecum via colonoscopy or to 40 capsules of processed fecal microbiota swallowed under direct observation.
Dina Kao, MD, of the department of medicine at the University of Alberta, Edmonton, and coauthors commented that the response rate with the capsules was higher than that seen in other studies of fecal microbiota capsules, which they suggested may partly be due to the larger amount of donor stool used in the study: 80-100 g, compared with 17 g and 25 g used in other studies.
“The higher efficacy observed in this study suggests a dose-dependent response to FMT, and a benefit of bowel lavage prior to FMT, because residual vancomycin was detected up to 8 days despite its discontinuation,” they wrote.
Both treatment modalities achieved similar quality of life improvements. Both groups reported major improvements in domains including physical and emotional health, physical and social functioning, and general health, with no significant differences between the two arms of the study.
The cost per treatment in the colonoscopy group was $874 per patient, compared with $308 per patient in the capsule group.
“Although colonoscopy delivery is more invasive, resource intensive, costly, and inconvenient for patients, it has the advantage of identifying alternative diagnoses,” the authors wrote. “Conversely, when FMT is given by oral capsules, it can be administered in an office setting, which could substantially reduce cost and wait time.”
Both groups also showed significantly improved gut microbiota diversity, which approached that of the donor just 1 week after administration of the treatment.
While 30% of patients characterized FMTs as “unpleasant, gross, or disgusting,” 79% of participants said the unpleasantness was the same or less than anticipated, and 97% said they would undergo the same treatment by the same delivery method again if needed.
However, significantly more patients in the capsule group described their experience as “not at all unpleasant,” compared with the colonoscopy group (66% vs. 44%; 95% CI, 3%-40%; P = .01).
There were no colonic perforations seen in the colonoscopy group, and no infectious complications relating to the treatment in either group. One patient in each group died of underlying cardiopulmonary illness that was unrelated to the treatment, and the rate of minor adverse events was 5.4% in the capsule group and 12.5% in the colonoscopy group.
The authors acknowledged that the lack of a placebo group in the study meant they were not able to measure the size of the effect of fecal microbiota transplantation by either route. One earlier trial had also shown a placebo response rate of 45%.
The study was funded by Alberta Health Services and the University of Alberta Hospital Foundation. Four authors declared grants and other funding from the study funder and the pharmaceutical industry.
Fecal microbiota transplantation (FMT) using oral capsules as the delivery method has been shown to be noninferior to delivery using colonoscopy for the treatment of Clostridium difficile infection, but with a significantly lower price tag.
In an unblended noninferiority trial, published in the Nov. 28 issue of JAMA, 116 adults with at least three documented episodes of C. difficile infection were randomized to either 360 mL of fecal slurry delivered to the cecum via colonoscopy or to 40 capsules of processed fecal microbiota swallowed under direct observation.
Dina Kao, MD, of the department of medicine at the University of Alberta, Edmonton, and coauthors commented that the response rate with the capsules was higher than that seen in other studies of fecal microbiota capsules, which they suggested may partly be due to the larger amount of donor stool used in the study: 80-100 g, compared with 17 g and 25 g used in other studies.
“The higher efficacy observed in this study suggests a dose-dependent response to FMT, and a benefit of bowel lavage prior to FMT, because residual vancomycin was detected up to 8 days despite its discontinuation,” they wrote.
Both treatment modalities achieved similar quality of life improvements. Both groups reported major improvements in domains including physical and emotional health, physical and social functioning, and general health, with no significant differences between the two arms of the study.
The cost per treatment in the colonoscopy group was $874 per patient, compared with $308 per patient in the capsule group.
“Although colonoscopy delivery is more invasive, resource intensive, costly, and inconvenient for patients, it has the advantage of identifying alternative diagnoses,” the authors wrote. “Conversely, when FMT is given by oral capsules, it can be administered in an office setting, which could substantially reduce cost and wait time.”
Both groups also showed significantly improved gut microbiota diversity, which approached that of the donor just 1 week after administration of the treatment.
While 30% of patients characterized FMTs as “unpleasant, gross, or disgusting,” 79% of participants said the unpleasantness was the same or less than anticipated, and 97% said they would undergo the same treatment by the same delivery method again if needed.
However, significantly more patients in the capsule group described their experience as “not at all unpleasant,” compared with the colonoscopy group (66% vs. 44%; 95% CI, 3%-40%; P = .01).
There were no colonic perforations seen in the colonoscopy group, and no infectious complications relating to the treatment in either group. One patient in each group died of underlying cardiopulmonary illness that was unrelated to the treatment, and the rate of minor adverse events was 5.4% in the capsule group and 12.5% in the colonoscopy group.
The authors acknowledged that the lack of a placebo group in the study meant they were not able to measure the size of the effect of fecal microbiota transplantation by either route. One earlier trial had also shown a placebo response rate of 45%.
The study was funded by Alberta Health Services and the University of Alberta Hospital Foundation. Four authors declared grants and other funding from the study funder and the pharmaceutical industry.
FROM JAMA
Key clinical point: Delivering fecal microbiota transplants using oral capsules is noninferior to delivery via colonoscopy in the treatment of Clostridium difficile infection.
Major finding: The rates of resolution of recurrent C. difficile infection with fecal microbiota transplants are similar for delivery via oral capsule or via colonoscopy.
Data source: A randomized, unblended noninferiority trial in 116 adults with recurrent C. difficile infection.
Disclosures: The study was funded by Alberta Health Services and the University of Alberta Hospital Foundation. Four authors declared grants and other funding from the study funder and the pharmaceutical industry.
Tezacaftor-ivacaftor combo shows promise in cystic fibrosis
A new drug that targets the cystic fibrosis transmembrane conductance regulator protein could significantly improve lung function and other symptoms in patients with cystic fibrosis.
In a phase 3 double-blind, placebo controlled crossover trial, researchers examined the effects of tezacaftor – a cystic fibrosis transmembrane conductance regulator (CFTR) corrector – in combination with the CFTR potentiator ivacaftor, compared with ivacaftor alone or placebo.
“The addition of the CFTR corrector tezacaftor was hypothesized to enhance clinical benefit in patients with these mutations by increasing overall CFTR function,” wrote Dr. Steven M. Rowe of the division of pulmonary, allergy, and critical care medicine at the University of Alabama at Birmingham, and his coauthors. “This combination treatment is particularly important for restoring activity to those carrying two copies of the Phe508del CFTR mutation, as shown for the approved corrector-potentiator combination lumacaftor-ivacaftor, and may provide benefit to patients with other CFTR mutations.”
After two 8-week treatment periods in which patients were randomized to two of the three regimens, separated by an 8-week washout period, researchers saw significant improvements in predicted forced expiratory volume in 1 second (FEV1), both with tezacaftor-ivacaftor and ivacaftor alone, compared with placebo (N Engl J Med. 2017 Nov 23;377:2024-35. doi: 10.1056/NEJMoa1709847).
From baseline to the average of week 4 and 8, the combination of tezacaftor-ivacaftor was associated with a 6.8-percentage-point absolute change, and there was a 4.7-percentage-point improvement with ivacaftor alone compared with placebo. The difference between the tezacaftor-ivacaftor combination and ivacaftor monotherapy was also statistically significant in favor of the combination treatment.
Researchers also saw significant improvements in the secondary endpoint of absolute change in the Cystic Fibrosis Questionnaire–Revised score; the combination treatment was associated with an 11.1 point improvement compared with placebo, and monotherapy achieved a 9.7-point improvement. In the combination therapy group, 65% of patients achieved a clinically important difference of 4 points or greater, compared with 58% of patients in the monotherapy group and 33% of patients in the placebo group.
“These findings confirm the benefits of potentiator therapy in patients with residual CFTR function mutations and the added benefit conferred by corrector-potentiator combination therapy in this population,” the authors wrote.
The investigators also saw a lower rate of pulmonary exacerbations in the combined therapy group, but this did not reach statistical significance.
The rate of adverse events was similar across all three groups. Most were considered mild or moderate in severity and were largely clinical manifestations of cystic fibrosis.
Vertex Pharmaceuticals, which manufactures tezacaftor and ivacaftor, funded the study. Twelve of the thirteen authors reported receiving various kinds of support from Vertex, including personal fees, grant support, and nonfinancial support. Several authors reported ties to other industry sources.
This NEJM article came out with a companion article reporting phase 3 tezacaftor-ivacaftor results in homozygous CFTR Phe508del patients. Tezacaftor is a CFTR corrector developed by a company that has another corrector on the market, called lumacaftor. Lumacaftor is formulated with ivacaftor and available in the United States for patients age 6 and above who have two copies of Phe508del. It is exciting that another combination therapy has been developed that appears to be very effective and can be used for a second group of patients. This era of personalized medicine is extremely exciting, and we look forward to future therapies for all CFTR mutations.
This NEJM article came out with a companion article reporting phase 3 tezacaftor-ivacaftor results in homozygous CFTR Phe508del patients. Tezacaftor is a CFTR corrector developed by a company that has another corrector on the market, called lumacaftor. Lumacaftor is formulated with ivacaftor and available in the United States for patients age 6 and above who have two copies of Phe508del. It is exciting that another combination therapy has been developed that appears to be very effective and can be used for a second group of patients. This era of personalized medicine is extremely exciting, and we look forward to future therapies for all CFTR mutations.
This NEJM article came out with a companion article reporting phase 3 tezacaftor-ivacaftor results in homozygous CFTR Phe508del patients. Tezacaftor is a CFTR corrector developed by a company that has another corrector on the market, called lumacaftor. Lumacaftor is formulated with ivacaftor and available in the United States for patients age 6 and above who have two copies of Phe508del. It is exciting that another combination therapy has been developed that appears to be very effective and can be used for a second group of patients. This era of personalized medicine is extremely exciting, and we look forward to future therapies for all CFTR mutations.
A new drug that targets the cystic fibrosis transmembrane conductance regulator protein could significantly improve lung function and other symptoms in patients with cystic fibrosis.
In a phase 3 double-blind, placebo controlled crossover trial, researchers examined the effects of tezacaftor – a cystic fibrosis transmembrane conductance regulator (CFTR) corrector – in combination with the CFTR potentiator ivacaftor, compared with ivacaftor alone or placebo.
“The addition of the CFTR corrector tezacaftor was hypothesized to enhance clinical benefit in patients with these mutations by increasing overall CFTR function,” wrote Dr. Steven M. Rowe of the division of pulmonary, allergy, and critical care medicine at the University of Alabama at Birmingham, and his coauthors. “This combination treatment is particularly important for restoring activity to those carrying two copies of the Phe508del CFTR mutation, as shown for the approved corrector-potentiator combination lumacaftor-ivacaftor, and may provide benefit to patients with other CFTR mutations.”
After two 8-week treatment periods in which patients were randomized to two of the three regimens, separated by an 8-week washout period, researchers saw significant improvements in predicted forced expiratory volume in 1 second (FEV1), both with tezacaftor-ivacaftor and ivacaftor alone, compared with placebo (N Engl J Med. 2017 Nov 23;377:2024-35. doi: 10.1056/NEJMoa1709847).
From baseline to the average of week 4 and 8, the combination of tezacaftor-ivacaftor was associated with a 6.8-percentage-point absolute change, and there was a 4.7-percentage-point improvement with ivacaftor alone compared with placebo. The difference between the tezacaftor-ivacaftor combination and ivacaftor monotherapy was also statistically significant in favor of the combination treatment.
Researchers also saw significant improvements in the secondary endpoint of absolute change in the Cystic Fibrosis Questionnaire–Revised score; the combination treatment was associated with an 11.1 point improvement compared with placebo, and monotherapy achieved a 9.7-point improvement. In the combination therapy group, 65% of patients achieved a clinically important difference of 4 points or greater, compared with 58% of patients in the monotherapy group and 33% of patients in the placebo group.
“These findings confirm the benefits of potentiator therapy in patients with residual CFTR function mutations and the added benefit conferred by corrector-potentiator combination therapy in this population,” the authors wrote.
The investigators also saw a lower rate of pulmonary exacerbations in the combined therapy group, but this did not reach statistical significance.
The rate of adverse events was similar across all three groups. Most were considered mild or moderate in severity and were largely clinical manifestations of cystic fibrosis.
Vertex Pharmaceuticals, which manufactures tezacaftor and ivacaftor, funded the study. Twelve of the thirteen authors reported receiving various kinds of support from Vertex, including personal fees, grant support, and nonfinancial support. Several authors reported ties to other industry sources.
A new drug that targets the cystic fibrosis transmembrane conductance regulator protein could significantly improve lung function and other symptoms in patients with cystic fibrosis.
In a phase 3 double-blind, placebo controlled crossover trial, researchers examined the effects of tezacaftor – a cystic fibrosis transmembrane conductance regulator (CFTR) corrector – in combination with the CFTR potentiator ivacaftor, compared with ivacaftor alone or placebo.
“The addition of the CFTR corrector tezacaftor was hypothesized to enhance clinical benefit in patients with these mutations by increasing overall CFTR function,” wrote Dr. Steven M. Rowe of the division of pulmonary, allergy, and critical care medicine at the University of Alabama at Birmingham, and his coauthors. “This combination treatment is particularly important for restoring activity to those carrying two copies of the Phe508del CFTR mutation, as shown for the approved corrector-potentiator combination lumacaftor-ivacaftor, and may provide benefit to patients with other CFTR mutations.”
After two 8-week treatment periods in which patients were randomized to two of the three regimens, separated by an 8-week washout period, researchers saw significant improvements in predicted forced expiratory volume in 1 second (FEV1), both with tezacaftor-ivacaftor and ivacaftor alone, compared with placebo (N Engl J Med. 2017 Nov 23;377:2024-35. doi: 10.1056/NEJMoa1709847).
From baseline to the average of week 4 and 8, the combination of tezacaftor-ivacaftor was associated with a 6.8-percentage-point absolute change, and there was a 4.7-percentage-point improvement with ivacaftor alone compared with placebo. The difference between the tezacaftor-ivacaftor combination and ivacaftor monotherapy was also statistically significant in favor of the combination treatment.
Researchers also saw significant improvements in the secondary endpoint of absolute change in the Cystic Fibrosis Questionnaire–Revised score; the combination treatment was associated with an 11.1 point improvement compared with placebo, and monotherapy achieved a 9.7-point improvement. In the combination therapy group, 65% of patients achieved a clinically important difference of 4 points or greater, compared with 58% of patients in the monotherapy group and 33% of patients in the placebo group.
“These findings confirm the benefits of potentiator therapy in patients with residual CFTR function mutations and the added benefit conferred by corrector-potentiator combination therapy in this population,” the authors wrote.
The investigators also saw a lower rate of pulmonary exacerbations in the combined therapy group, but this did not reach statistical significance.
The rate of adverse events was similar across all three groups. Most were considered mild or moderate in severity and were largely clinical manifestations of cystic fibrosis.
Vertex Pharmaceuticals, which manufactures tezacaftor and ivacaftor, funded the study. Twelve of the thirteen authors reported receiving various kinds of support from Vertex, including personal fees, grant support, and nonfinancial support. Several authors reported ties to other industry sources.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: The combination of tezacaftor and ivacaftor is associated with significant improvements in lung function in cystic fibrosis, compared with placebo or ivacaftor alone.
Major finding: Combined treatment with tezacaftor-ivacaftor was associated with a 6.8-percentage-point absolute change in FEV1 compared with placebo.
Data source: A phase 3 double-blind, placebo controlled, randomized crossover trial of 248 patients with cystic fibrosis.
Disclosures: Vertex Pharmaceuticals, which manufactures tezacaftor and ivacaftor, funded the study. Twelve of the thirteen authors reported receiving various kinds of support from Vertex, including personal fees, grant support, and nonfinancial support. Several authors reported ties to other industry sources.
Safety-net hospitals would be hurt by hospital-wide 30-day readmission penalties
Considering all readmissions within 30 days of discharge in the Hospital Readmissions Reduction Program would modestly increase the number of hospitals eligible for penalties and would have a bigger impact on safety-net hospitals, based on a study of two years of Medicare claims data from 3,443 hospitals.
“Transition to a hospital-wide measure would require an adjustment in the penalty formula to keep penalties in the same range for most hospitals and without a change in procedures would have a deleterious effect on safety-net hospitals,” according to Rachael B. Zuckerman, PhD, from the Department of Health and Human Services, Washington, and her co-authors.
Analyzing 6,807,899 admissions for hospital-wide readmission measures and 4,392,658 admissions for condition-specific measures, the researchers found that a condition-specific approach would result in 3,238 hospitals being eligible for penalties for at least one condition. A hospital-wide measure of readmissions would result in 76 additional hospitals being eligible for penalties based on one year of admissions data, and 128 additional hospitals based on 3 years of admissions data (NEJM 2017, 377:1551-58. DOI: 10.1056/NEJMsa1701791).
Moving to a hospital-wide measure of readmissions also would significantly increase mean annual penalty rates across all hospitals by 0.89% of base diagnosis-related group (DRG) payments or $393,000; 43% of hospitals would be penalized under this standard.
“Moving to the hospital-wide readmission measure would also substantially increase the disparity between safety-net and other hospitals: the mean penalty as a percentage of base DRG payments would be 0.41 percentage points ($198,000) higher among safety net hospitals,” the authors wrote.
“Since safety-net hospitals tend to perform slightly worse on the hospital-wide measure, they are more likely to receive a penalty, which would increase the disparity in penalties between the two groups.”
The study was supported by the Department of Health and Human Services. One author declared grants from funding bodies and universities outside the submitted work. One author is an associate editor of the New England Journal of Medicine. One author was an employee of the Department of Health and Human Services at the time of the study. No other conflicts of interest were declared.
Considering all readmissions within 30 days of discharge in the Hospital Readmissions Reduction Program would modestly increase the number of hospitals eligible for penalties and would have a bigger impact on safety-net hospitals, based on a study of two years of Medicare claims data from 3,443 hospitals.
“Transition to a hospital-wide measure would require an adjustment in the penalty formula to keep penalties in the same range for most hospitals and without a change in procedures would have a deleterious effect on safety-net hospitals,” according to Rachael B. Zuckerman, PhD, from the Department of Health and Human Services, Washington, and her co-authors.
Analyzing 6,807,899 admissions for hospital-wide readmission measures and 4,392,658 admissions for condition-specific measures, the researchers found that a condition-specific approach would result in 3,238 hospitals being eligible for penalties for at least one condition. A hospital-wide measure of readmissions would result in 76 additional hospitals being eligible for penalties based on one year of admissions data, and 128 additional hospitals based on 3 years of admissions data (NEJM 2017, 377:1551-58. DOI: 10.1056/NEJMsa1701791).
Moving to a hospital-wide measure of readmissions also would significantly increase mean annual penalty rates across all hospitals by 0.89% of base diagnosis-related group (DRG) payments or $393,000; 43% of hospitals would be penalized under this standard.
“Moving to the hospital-wide readmission measure would also substantially increase the disparity between safety-net and other hospitals: the mean penalty as a percentage of base DRG payments would be 0.41 percentage points ($198,000) higher among safety net hospitals,” the authors wrote.
“Since safety-net hospitals tend to perform slightly worse on the hospital-wide measure, they are more likely to receive a penalty, which would increase the disparity in penalties between the two groups.”
The study was supported by the Department of Health and Human Services. One author declared grants from funding bodies and universities outside the submitted work. One author is an associate editor of the New England Journal of Medicine. One author was an employee of the Department of Health and Human Services at the time of the study. No other conflicts of interest were declared.
Considering all readmissions within 30 days of discharge in the Hospital Readmissions Reduction Program would modestly increase the number of hospitals eligible for penalties and would have a bigger impact on safety-net hospitals, based on a study of two years of Medicare claims data from 3,443 hospitals.
“Transition to a hospital-wide measure would require an adjustment in the penalty formula to keep penalties in the same range for most hospitals and without a change in procedures would have a deleterious effect on safety-net hospitals,” according to Rachael B. Zuckerman, PhD, from the Department of Health and Human Services, Washington, and her co-authors.
Analyzing 6,807,899 admissions for hospital-wide readmission measures and 4,392,658 admissions for condition-specific measures, the researchers found that a condition-specific approach would result in 3,238 hospitals being eligible for penalties for at least one condition. A hospital-wide measure of readmissions would result in 76 additional hospitals being eligible for penalties based on one year of admissions data, and 128 additional hospitals based on 3 years of admissions data (NEJM 2017, 377:1551-58. DOI: 10.1056/NEJMsa1701791).
Moving to a hospital-wide measure of readmissions also would significantly increase mean annual penalty rates across all hospitals by 0.89% of base diagnosis-related group (DRG) payments or $393,000; 43% of hospitals would be penalized under this standard.
“Moving to the hospital-wide readmission measure would also substantially increase the disparity between safety-net and other hospitals: the mean penalty as a percentage of base DRG payments would be 0.41 percentage points ($198,000) higher among safety net hospitals,” the authors wrote.
“Since safety-net hospitals tend to perform slightly worse on the hospital-wide measure, they are more likely to receive a penalty, which would increase the disparity in penalties between the two groups.”
The study was supported by the Department of Health and Human Services. One author declared grants from funding bodies and universities outside the submitted work. One author is an associate editor of the New England Journal of Medicine. One author was an employee of the Department of Health and Human Services at the time of the study. No other conflicts of interest were declared.
FROM NEJM
Key clinical point: Adopting a hospital-wide measure of 30-day readmissions for the Hospital Readmissions Reduction Program would modestly increase the number of hospitals eligible for penalties and would have a bigger impact on safety-net hospitals.
Major finding: With a hospital-wide measure of readmissions in the Hospital Readmissions Reduction Program, the mean penalty as a percentage of base DRG payments would be 0.41 percentage points ($198,000) higher among safety net hospitals.
Data source: Analysis of two years of Medicare claims data from 3,443 hospitals.
Disclosures: The study was supported by the Department of Health and Human Services. One author declared grants from funding bodies and universities outside the submitted work. One author is an associated editor of the New England Journal of Medicine. One author was an employee of the Department of Health and Human Services at the time of the study. No other conflicts of interest were declared.
OCD linked to lower education attainment
Obsessive-compulsive disorder could be detrimental to educational attainment, particularly if diagnosed before the age of 18 years, according to a study published online Nov. 15.
A Swedish population-based birth cohort study identified 15,120 individuals who had been diagnosed with obsessive-compulsive disorder (OCD, 11,482 of whom were in families with full siblings discordant for OCD.
Individuals with OCD were also 57% less likely to complete upper secondary school, 28% less likely to start a university degree, 41% less likely to finish that degree, and 48% less likely to complete postgraduate education, compared to individuals without OCD.
“The association was global rather than being limited to a particular course; patients were more likely to fail each of the core and additional courses in compulsory school and less likely to achieve each level of education, from primary school to postgraduate education,” wrote Ana Pérez-Vigil, MD, of the Center for Psychiatry Research at Karolinska Institutet, Stockholm, and her coauthors.
The authors noted that as the education impairment seemed greatest at the end of upper secondary school but reduced during university, individuals with OCD might cope better with their symptoms as they age or receive evidence-based treatment.
“These individuals might be able to find alternative routes to access university, such as the locally funded school system for adults who have failed to complete primary or secondary school (known as komvux in Sweden),” they wrote. “Thus, early educational failure does not necessarily condemn individuals to lifelong educational ostracism.”
People with OCD also were 53% less likely to be eligible to access a vocational program (95% confidence interval, 0.45-0.50) and 49% less likely to be eligible for an academic program in upper secondary school (95% CI, 0.58-0.63), compared with the general population, after adjustment for factors such as sex, year of birth, and parental age at birth of the participant.
Early diagnosis – before the age of 18 years – was associated with even worse educational outcomes, compared with those diagnosed after the age of 18.
Excluding individuals with other comorbidities such as attention-deficit/hyperactivity disorder attenuated the results slightly, but individuals with OCD still showed significantly worse educational attainment than that of the general population.
Dr. Pérez-Vigil and her coauthors said detecting and treating OCD early might help patients “fulfill their educational potential.”
Several authors of the study were supported by grants from the International OCD Foundation; the Alicia Koplowitz Foundation; the Swedish Research Council for Health, Working Life, and Welfare; and the Karolinska Institute. Two authors declared royalties from a publishing company, and one declared speaking fees and a research grant from Shire Pharmaceuticals, all of which were outside the submitted work. No other conflicts of interest were declared.
Obsessive-compulsive disorder could be detrimental to educational attainment, particularly if diagnosed before the age of 18 years, according to a study published online Nov. 15.
A Swedish population-based birth cohort study identified 15,120 individuals who had been diagnosed with obsessive-compulsive disorder (OCD, 11,482 of whom were in families with full siblings discordant for OCD.
Individuals with OCD were also 57% less likely to complete upper secondary school, 28% less likely to start a university degree, 41% less likely to finish that degree, and 48% less likely to complete postgraduate education, compared to individuals without OCD.
“The association was global rather than being limited to a particular course; patients were more likely to fail each of the core and additional courses in compulsory school and less likely to achieve each level of education, from primary school to postgraduate education,” wrote Ana Pérez-Vigil, MD, of the Center for Psychiatry Research at Karolinska Institutet, Stockholm, and her coauthors.
The authors noted that as the education impairment seemed greatest at the end of upper secondary school but reduced during university, individuals with OCD might cope better with their symptoms as they age or receive evidence-based treatment.
“These individuals might be able to find alternative routes to access university, such as the locally funded school system for adults who have failed to complete primary or secondary school (known as komvux in Sweden),” they wrote. “Thus, early educational failure does not necessarily condemn individuals to lifelong educational ostracism.”
People with OCD also were 53% less likely to be eligible to access a vocational program (95% confidence interval, 0.45-0.50) and 49% less likely to be eligible for an academic program in upper secondary school (95% CI, 0.58-0.63), compared with the general population, after adjustment for factors such as sex, year of birth, and parental age at birth of the participant.
Early diagnosis – before the age of 18 years – was associated with even worse educational outcomes, compared with those diagnosed after the age of 18.
Excluding individuals with other comorbidities such as attention-deficit/hyperactivity disorder attenuated the results slightly, but individuals with OCD still showed significantly worse educational attainment than that of the general population.
Dr. Pérez-Vigil and her coauthors said detecting and treating OCD early might help patients “fulfill their educational potential.”
Several authors of the study were supported by grants from the International OCD Foundation; the Alicia Koplowitz Foundation; the Swedish Research Council for Health, Working Life, and Welfare; and the Karolinska Institute. Two authors declared royalties from a publishing company, and one declared speaking fees and a research grant from Shire Pharmaceuticals, all of which were outside the submitted work. No other conflicts of interest were declared.
Obsessive-compulsive disorder could be detrimental to educational attainment, particularly if diagnosed before the age of 18 years, according to a study published online Nov. 15.
A Swedish population-based birth cohort study identified 15,120 individuals who had been diagnosed with obsessive-compulsive disorder (OCD, 11,482 of whom were in families with full siblings discordant for OCD.
Individuals with OCD were also 57% less likely to complete upper secondary school, 28% less likely to start a university degree, 41% less likely to finish that degree, and 48% less likely to complete postgraduate education, compared to individuals without OCD.
“The association was global rather than being limited to a particular course; patients were more likely to fail each of the core and additional courses in compulsory school and less likely to achieve each level of education, from primary school to postgraduate education,” wrote Ana Pérez-Vigil, MD, of the Center for Psychiatry Research at Karolinska Institutet, Stockholm, and her coauthors.
The authors noted that as the education impairment seemed greatest at the end of upper secondary school but reduced during university, individuals with OCD might cope better with their symptoms as they age or receive evidence-based treatment.
“These individuals might be able to find alternative routes to access university, such as the locally funded school system for adults who have failed to complete primary or secondary school (known as komvux in Sweden),” they wrote. “Thus, early educational failure does not necessarily condemn individuals to lifelong educational ostracism.”
People with OCD also were 53% less likely to be eligible to access a vocational program (95% confidence interval, 0.45-0.50) and 49% less likely to be eligible for an academic program in upper secondary school (95% CI, 0.58-0.63), compared with the general population, after adjustment for factors such as sex, year of birth, and parental age at birth of the participant.
Early diagnosis – before the age of 18 years – was associated with even worse educational outcomes, compared with those diagnosed after the age of 18.
Excluding individuals with other comorbidities such as attention-deficit/hyperactivity disorder attenuated the results slightly, but individuals with OCD still showed significantly worse educational attainment than that of the general population.
Dr. Pérez-Vigil and her coauthors said detecting and treating OCD early might help patients “fulfill their educational potential.”
Several authors of the study were supported by grants from the International OCD Foundation; the Alicia Koplowitz Foundation; the Swedish Research Council for Health, Working Life, and Welfare; and the Karolinska Institute. Two authors declared royalties from a publishing company, and one declared speaking fees and a research grant from Shire Pharmaceuticals, all of which were outside the submitted work. No other conflicts of interest were declared.
FROM JAMA PSYCHIATRY
Key clinical point: Obsessive-compulsive disorder is associated with a decrease in education attainment, particularly if diagnosed before the age of 18 years.
Major finding: Individuals with obsessive-compulsive disorder are significantly less likely to complete upper secondary school and significantly less likely to pass courses in the last year of compulsory education.
Data source: A Swedish population-based birth cohort study of 15,120 individuals who had been diagnosed with obsessive-compulsive disorder.
Disclosures: Several authors of the study were supported by grants from the International OCD Foundation; the Alicia Koplowitz Foundation; the Swedish Research Council for Health, Working Life, and Welfare; and the Karolinska Institute. Two authors declared royalties from a publishing company, and one declared speaking fees and a research grant from Shire Pharmaceuticals, all of which were outside the submitted work. No other conflicts of interest were declared.
Narcolepsy drug has potential to help Parkinson’s disease sleep problems
A treatment for narcolepsy reduced sleep problems in individuals with Parkinson’s disease who had excessive daytime sleepiness in a double-blind, randomized, placebo-controlled, phase 2a trial.
The trial results provide “class I evidence for the efficacy of sodium oxybate in treating sleep-wake disturbances in Parkinson’s disease. This finding is based on the extensive, electrophysiologically proven treatment effect that, to our knowledge, is unmatched by any other intervention reported so far,” Fabian Büchele, MD, of the department of neurology at University Hospital Zürich and his colleagues wrote in their report (JAMA Neurol. 2017 Nov 6. doi: 10.1001/jamaneurol.2017.3171).
“Sodium oxybate–related improvements of sleep and EDS [excessive daytime sleepiness] correlated significantly, whereas sodium oxybate–induced sleep disturbances predicted insufficient treatment response and AEs [adverse events],” they wrote.
The study of 12 patients used a crossover design to examine how well the sodium oxybate could improve sleep latency and scores on the Epworth Sleepiness Scale. The investigators randomized the patients to receive the central nervous system depressor sodium oxybate followed by placebo, or to placebo first and then the active drug, with a 2- to 4-week washout period in between crossovers. Sodium oxybate or placebo were taken at bedtime, and 2.5-4 hours later, with the dose individually titrated between 3 g and 9 g per night, for 6 weeks.
The treatment was associated with significant improvements, including a significant 2.9-minute increase in mean sleep latency on the intention-to-treat analysis (P = .002) and a 3.5-minute increase in the per-protocol analysis (P less than .001), as well as a 4.2-point reduction in Epworth Sleepiness Scale scores (P = .001).
Patients treated with sodium oxybate reported enhanced subjective sleep quality, shown as a 2-point mean reduction in Parkinson’s Disease Sleep Scale–2 scores and a 72.7-minute mean increase in slow-wave stage N3 sleep (and reduction in superficial stage N1 sleep).
In eight patients, there was at least a 50% clinically significant increase in mean sleep latency, and six patients had a normalization of Epworth Sleepiness Scale scores.
The sodium oxybate was fairly well tolerated, with no dropouts related to adverse events. All patients experienced adverse events, but three-quarters of these were described as not interfering with daily activities, and one-quarter as having a mild to moderate impact on daily activities. Most resolved after dose adjustment, but one-third of patients were still affected by the end of the study.
One patient dropped out during the washout phase and another was excluded from the per-protocol analysis; both of these patients developed sleep apnea during the course of the study. One patient also developed parasomnia during the study.
While the authors said that their results on efficacy and safety matched those found in trials of sodium oxybate for narcolepsy, their study was limited by small numbers, and larger follow-up trials of longer duration are needed to confirm the findings.
The study was funded by UCB Pharma, which provided the drug and placebo, and by the Clinical Research Priority Program Sleep and Health of the University of Zürich. Five authors declared speaker honoraria and grants from a range of organizations and pharmaceutical companies, including one author who had received these from UCB Pharma. No other conflicts were declared.
A treatment for narcolepsy reduced sleep problems in individuals with Parkinson’s disease who had excessive daytime sleepiness in a double-blind, randomized, placebo-controlled, phase 2a trial.
The trial results provide “class I evidence for the efficacy of sodium oxybate in treating sleep-wake disturbances in Parkinson’s disease. This finding is based on the extensive, electrophysiologically proven treatment effect that, to our knowledge, is unmatched by any other intervention reported so far,” Fabian Büchele, MD, of the department of neurology at University Hospital Zürich and his colleagues wrote in their report (JAMA Neurol. 2017 Nov 6. doi: 10.1001/jamaneurol.2017.3171).
“Sodium oxybate–related improvements of sleep and EDS [excessive daytime sleepiness] correlated significantly, whereas sodium oxybate–induced sleep disturbances predicted insufficient treatment response and AEs [adverse events],” they wrote.
The study of 12 patients used a crossover design to examine how well the sodium oxybate could improve sleep latency and scores on the Epworth Sleepiness Scale. The investigators randomized the patients to receive the central nervous system depressor sodium oxybate followed by placebo, or to placebo first and then the active drug, with a 2- to 4-week washout period in between crossovers. Sodium oxybate or placebo were taken at bedtime, and 2.5-4 hours later, with the dose individually titrated between 3 g and 9 g per night, for 6 weeks.
The treatment was associated with significant improvements, including a significant 2.9-minute increase in mean sleep latency on the intention-to-treat analysis (P = .002) and a 3.5-minute increase in the per-protocol analysis (P less than .001), as well as a 4.2-point reduction in Epworth Sleepiness Scale scores (P = .001).
Patients treated with sodium oxybate reported enhanced subjective sleep quality, shown as a 2-point mean reduction in Parkinson’s Disease Sleep Scale–2 scores and a 72.7-minute mean increase in slow-wave stage N3 sleep (and reduction in superficial stage N1 sleep).
In eight patients, there was at least a 50% clinically significant increase in mean sleep latency, and six patients had a normalization of Epworth Sleepiness Scale scores.
The sodium oxybate was fairly well tolerated, with no dropouts related to adverse events. All patients experienced adverse events, but three-quarters of these were described as not interfering with daily activities, and one-quarter as having a mild to moderate impact on daily activities. Most resolved after dose adjustment, but one-third of patients were still affected by the end of the study.
One patient dropped out during the washout phase and another was excluded from the per-protocol analysis; both of these patients developed sleep apnea during the course of the study. One patient also developed parasomnia during the study.
While the authors said that their results on efficacy and safety matched those found in trials of sodium oxybate for narcolepsy, their study was limited by small numbers, and larger follow-up trials of longer duration are needed to confirm the findings.
The study was funded by UCB Pharma, which provided the drug and placebo, and by the Clinical Research Priority Program Sleep and Health of the University of Zürich. Five authors declared speaker honoraria and grants from a range of organizations and pharmaceutical companies, including one author who had received these from UCB Pharma. No other conflicts were declared.
A treatment for narcolepsy reduced sleep problems in individuals with Parkinson’s disease who had excessive daytime sleepiness in a double-blind, randomized, placebo-controlled, phase 2a trial.
The trial results provide “class I evidence for the efficacy of sodium oxybate in treating sleep-wake disturbances in Parkinson’s disease. This finding is based on the extensive, electrophysiologically proven treatment effect that, to our knowledge, is unmatched by any other intervention reported so far,” Fabian Büchele, MD, of the department of neurology at University Hospital Zürich and his colleagues wrote in their report (JAMA Neurol. 2017 Nov 6. doi: 10.1001/jamaneurol.2017.3171).
“Sodium oxybate–related improvements of sleep and EDS [excessive daytime sleepiness] correlated significantly, whereas sodium oxybate–induced sleep disturbances predicted insufficient treatment response and AEs [adverse events],” they wrote.
The study of 12 patients used a crossover design to examine how well the sodium oxybate could improve sleep latency and scores on the Epworth Sleepiness Scale. The investigators randomized the patients to receive the central nervous system depressor sodium oxybate followed by placebo, or to placebo first and then the active drug, with a 2- to 4-week washout period in between crossovers. Sodium oxybate or placebo were taken at bedtime, and 2.5-4 hours later, with the dose individually titrated between 3 g and 9 g per night, for 6 weeks.
The treatment was associated with significant improvements, including a significant 2.9-minute increase in mean sleep latency on the intention-to-treat analysis (P = .002) and a 3.5-minute increase in the per-protocol analysis (P less than .001), as well as a 4.2-point reduction in Epworth Sleepiness Scale scores (P = .001).
Patients treated with sodium oxybate reported enhanced subjective sleep quality, shown as a 2-point mean reduction in Parkinson’s Disease Sleep Scale–2 scores and a 72.7-minute mean increase in slow-wave stage N3 sleep (and reduction in superficial stage N1 sleep).
In eight patients, there was at least a 50% clinically significant increase in mean sleep latency, and six patients had a normalization of Epworth Sleepiness Scale scores.
The sodium oxybate was fairly well tolerated, with no dropouts related to adverse events. All patients experienced adverse events, but three-quarters of these were described as not interfering with daily activities, and one-quarter as having a mild to moderate impact on daily activities. Most resolved after dose adjustment, but one-third of patients were still affected by the end of the study.
One patient dropped out during the washout phase and another was excluded from the per-protocol analysis; both of these patients developed sleep apnea during the course of the study. One patient also developed parasomnia during the study.
While the authors said that their results on efficacy and safety matched those found in trials of sodium oxybate for narcolepsy, their study was limited by small numbers, and larger follow-up trials of longer duration are needed to confirm the findings.
The study was funded by UCB Pharma, which provided the drug and placebo, and by the Clinical Research Priority Program Sleep and Health of the University of Zürich. Five authors declared speaker honoraria and grants from a range of organizations and pharmaceutical companies, including one author who had received these from UCB Pharma. No other conflicts were declared.
FROM JAMA NEUROLOGY
Key clinical point: Sodium oxybate may reduce sleep-wake disturbances of Parkinson’s disease.
Major finding:
Data source: Randomized, placebo-controlled, crossover phase 2a trial in 12 patients with Parkinson’s disease.
Disclosures: The study was funded by UCB Pharma, which provided the drug and placebo, and by the Clinical Research Priority Program Sleep and Health of the University of Zürich. Five authors declared speaker honoraria and grants from a range of organizations and pharmaceutical companies, including one author who had received these from UCB Pharma. No other conflicts were declared.
Shorter hospital stays with robotic thoracic surgery
Robotic thoracic surgery is associated with shorter hospital stays, shorter duration of chest tube usage, and lower postoperative pain intensity than open thoracotomy, new data suggests.
In a paper published in Surgical Endoscopy, researchers reported the results of a retrospective study comparing the outcomes from 38 individuals who underwent robotic thoracic surgery using the da Vinci System with those of 38 patients who underwent open thoracic surgery.
They saw significantly shorter hospital stays associated with robotic surgery, compared with open surgery (6.9 days vs. 8.0 days, respectively; P = .02), as well as a shorter duration of chest tube use (2.9 plus or minus 2.0 days vs. 4.9 plus or minus 2.2 days; P less than .001).
While robotic surgery did not result in significant reductions in postoperative pain intensity when patients coughed, pain intensity for patients at rest on days 4 and 5 after surgery was significantly lower among those who had undergone robotic surgery than among those who had undergone open surgery (Surg Endosc. 2017. doi: 10.1007/s00464-017-5464-6). On day 4, those who had undergone robotic surgery reported a mean pain score of 0.5 on a scale of 1-10, while those who underwent open surgery had a mean pain score of 1.1 (P = .04). On day 5, the mean pain scores were 0.7 in the robotic-surgery group and 1.6 in the open-surgery group (P = .003).
However, there was no difference in postoperative opioid use between the two groups. The robotic-surgery group showed a trend toward more postoperative nausea, but this did not reach statistical significance.
Most of the surgeries in the study were performed to remove malignant or benign tumors. Among both groups, 68% of patients received epidural analgesia, and 32% received systemic opioid-based postoperative analgesia.
“Current evidence shows that more than 70% of stage I lung cancers are still being performed by open technique,” wrote Christopher Darr, from the West German Lung Center at University Hospital Essen (Germany), and his coauthors. “However, the safety and the feasibility of robotic anatomic lung resection have been shown in several case series. Robotic thoracic surgery is gaining popularity as benefits can be suggested, such as improved ergonomics, three-dimensional optics, and simplifying operative procedure.”
One author declared financial support for meetings and presentations from Intuitive Surgical, the company that developed the da Vinci System. No other conflicts of interest were declared.
Robotic thoracic surgery is associated with shorter hospital stays, shorter duration of chest tube usage, and lower postoperative pain intensity than open thoracotomy, new data suggests.
In a paper published in Surgical Endoscopy, researchers reported the results of a retrospective study comparing the outcomes from 38 individuals who underwent robotic thoracic surgery using the da Vinci System with those of 38 patients who underwent open thoracic surgery.
They saw significantly shorter hospital stays associated with robotic surgery, compared with open surgery (6.9 days vs. 8.0 days, respectively; P = .02), as well as a shorter duration of chest tube use (2.9 plus or minus 2.0 days vs. 4.9 plus or minus 2.2 days; P less than .001).
While robotic surgery did not result in significant reductions in postoperative pain intensity when patients coughed, pain intensity for patients at rest on days 4 and 5 after surgery was significantly lower among those who had undergone robotic surgery than among those who had undergone open surgery (Surg Endosc. 2017. doi: 10.1007/s00464-017-5464-6). On day 4, those who had undergone robotic surgery reported a mean pain score of 0.5 on a scale of 1-10, while those who underwent open surgery had a mean pain score of 1.1 (P = .04). On day 5, the mean pain scores were 0.7 in the robotic-surgery group and 1.6 in the open-surgery group (P = .003).
However, there was no difference in postoperative opioid use between the two groups. The robotic-surgery group showed a trend toward more postoperative nausea, but this did not reach statistical significance.
Most of the surgeries in the study were performed to remove malignant or benign tumors. Among both groups, 68% of patients received epidural analgesia, and 32% received systemic opioid-based postoperative analgesia.
“Current evidence shows that more than 70% of stage I lung cancers are still being performed by open technique,” wrote Christopher Darr, from the West German Lung Center at University Hospital Essen (Germany), and his coauthors. “However, the safety and the feasibility of robotic anatomic lung resection have been shown in several case series. Robotic thoracic surgery is gaining popularity as benefits can be suggested, such as improved ergonomics, three-dimensional optics, and simplifying operative procedure.”
One author declared financial support for meetings and presentations from Intuitive Surgical, the company that developed the da Vinci System. No other conflicts of interest were declared.
Robotic thoracic surgery is associated with shorter hospital stays, shorter duration of chest tube usage, and lower postoperative pain intensity than open thoracotomy, new data suggests.
In a paper published in Surgical Endoscopy, researchers reported the results of a retrospective study comparing the outcomes from 38 individuals who underwent robotic thoracic surgery using the da Vinci System with those of 38 patients who underwent open thoracic surgery.
They saw significantly shorter hospital stays associated with robotic surgery, compared with open surgery (6.9 days vs. 8.0 days, respectively; P = .02), as well as a shorter duration of chest tube use (2.9 plus or minus 2.0 days vs. 4.9 plus or minus 2.2 days; P less than .001).
While robotic surgery did not result in significant reductions in postoperative pain intensity when patients coughed, pain intensity for patients at rest on days 4 and 5 after surgery was significantly lower among those who had undergone robotic surgery than among those who had undergone open surgery (Surg Endosc. 2017. doi: 10.1007/s00464-017-5464-6). On day 4, those who had undergone robotic surgery reported a mean pain score of 0.5 on a scale of 1-10, while those who underwent open surgery had a mean pain score of 1.1 (P = .04). On day 5, the mean pain scores were 0.7 in the robotic-surgery group and 1.6 in the open-surgery group (P = .003).
However, there was no difference in postoperative opioid use between the two groups. The robotic-surgery group showed a trend toward more postoperative nausea, but this did not reach statistical significance.
Most of the surgeries in the study were performed to remove malignant or benign tumors. Among both groups, 68% of patients received epidural analgesia, and 32% received systemic opioid-based postoperative analgesia.
“Current evidence shows that more than 70% of stage I lung cancers are still being performed by open technique,” wrote Christopher Darr, from the West German Lung Center at University Hospital Essen (Germany), and his coauthors. “However, the safety and the feasibility of robotic anatomic lung resection have been shown in several case series. Robotic thoracic surgery is gaining popularity as benefits can be suggested, such as improved ergonomics, three-dimensional optics, and simplifying operative procedure.”
One author declared financial support for meetings and presentations from Intuitive Surgical, the company that developed the da Vinci System. No other conflicts of interest were declared.
FROM SURGICAL ENDOSCOPY
Key clinical point: Robotic thoracic surgery is associated with shorter hospital stays and shorter duration of chest tube use, compared with open surgery.
Major finding: Patients who underwent robotic thoracic surgery had a mean hospital stay of 6.9 days, compared with 8 days for those who underwent open thoracic surgery.
Data source: Retrospective study of 38 patients who underwent robotic thoracic surgery and 38 who underwent open thoracic surgery.
Disclosures: One investigator declared financial support from Intuitive Surgical, the company that developed the da Vinci System, for meetings and presentations. No other conflicts of interest were declared.
HPV vaccination cuts incidence of juvenile respiratory papillomatosis
Introduction of a national human papillomavirus vaccination program in Australia has been associated with declines in the incidence of juvenile-onset recurrent respiratory papillomatosis, according to a nationwide study.
Juvenile-onset recurrent respiratory papillomatosis (JORRP) is a rare condition characterized by recurring growths in the larynx that often require multiple operations to remove. The disease typically emerges around age 3-4 years and most cases are thought to be caused by human papillomavirus (HPV) subtypes 6 and 11, which are acquired from the mother during birth.
Overall, just 15 cases were reported during the course of the study; 7 in the 1st year, 3 in the 2nd year, 2 each in the 3rd and 4th years, and 1 case in the last year. The annual rates declined from 0.16 per 100,000 children aged 0-14 years in 2012 to 0.02 per 100,000 in 2016.
Of the cases identified, none of the mothers had been vaccinated against HPV before pregnancy and 20% had a history of genital warts. Seven cases were genotyped; 4 were HPV-6 and 3 were HPV-11, and 13 of the 15 cases were born vaginally.
“Our data strongly suggest that the previously documented impact of quadrivalent HPV vaccination in dramatically reducing the prevalence of HPV-6 and HPV-11 genital infection in the Australian population is translating to a reduction in the risk of transmission to infants intrapartum and subsequent development in some of these children of JORRP,” wrote Daniel Novakovic, MD, of the University of Sydney Medical School, and his coinvestigators.
The authors noted that their initial estimate of infection rates was lower than that seen in other studies, such as the 0.5 per 100,000 rate seen in private health insurance data, and the 1.0 per 100,000 seen with Medicaid data in the United States.
Given that the study period started nearly 5 years after the vaccination program began, they suggested that this lower prevalence may reflect the early impact of the vaccine, particularly given that the prevalence of genital warts had already dramatically declined by that point.
However they also stressed that their study relied on clinicians actively reporting cases, and that given surveillance only began after the introduction of the vaccination program, no data were available on the incidence before that point.
The study was supported by a research grant from Merck and by the Australian Paediatric Surveillance Unit, which is supported by the Australian Government Department of Health. Three authors declared research funding from Merck/Seqirus for HPV studies. Two authors declared funding, speaking fees, and other support from a range of pharmaceutical companies. No other conflicts of interest were declared.
Introduction of a national human papillomavirus vaccination program in Australia has been associated with declines in the incidence of juvenile-onset recurrent respiratory papillomatosis, according to a nationwide study.
Juvenile-onset recurrent respiratory papillomatosis (JORRP) is a rare condition characterized by recurring growths in the larynx that often require multiple operations to remove. The disease typically emerges around age 3-4 years and most cases are thought to be caused by human papillomavirus (HPV) subtypes 6 and 11, which are acquired from the mother during birth.
Overall, just 15 cases were reported during the course of the study; 7 in the 1st year, 3 in the 2nd year, 2 each in the 3rd and 4th years, and 1 case in the last year. The annual rates declined from 0.16 per 100,000 children aged 0-14 years in 2012 to 0.02 per 100,000 in 2016.
Of the cases identified, none of the mothers had been vaccinated against HPV before pregnancy and 20% had a history of genital warts. Seven cases were genotyped; 4 were HPV-6 and 3 were HPV-11, and 13 of the 15 cases were born vaginally.
“Our data strongly suggest that the previously documented impact of quadrivalent HPV vaccination in dramatically reducing the prevalence of HPV-6 and HPV-11 genital infection in the Australian population is translating to a reduction in the risk of transmission to infants intrapartum and subsequent development in some of these children of JORRP,” wrote Daniel Novakovic, MD, of the University of Sydney Medical School, and his coinvestigators.
The authors noted that their initial estimate of infection rates was lower than that seen in other studies, such as the 0.5 per 100,000 rate seen in private health insurance data, and the 1.0 per 100,000 seen with Medicaid data in the United States.
Given that the study period started nearly 5 years after the vaccination program began, they suggested that this lower prevalence may reflect the early impact of the vaccine, particularly given that the prevalence of genital warts had already dramatically declined by that point.
However they also stressed that their study relied on clinicians actively reporting cases, and that given surveillance only began after the introduction of the vaccination program, no data were available on the incidence before that point.
The study was supported by a research grant from Merck and by the Australian Paediatric Surveillance Unit, which is supported by the Australian Government Department of Health. Three authors declared research funding from Merck/Seqirus for HPV studies. Two authors declared funding, speaking fees, and other support from a range of pharmaceutical companies. No other conflicts of interest were declared.
Introduction of a national human papillomavirus vaccination program in Australia has been associated with declines in the incidence of juvenile-onset recurrent respiratory papillomatosis, according to a nationwide study.
Juvenile-onset recurrent respiratory papillomatosis (JORRP) is a rare condition characterized by recurring growths in the larynx that often require multiple operations to remove. The disease typically emerges around age 3-4 years and most cases are thought to be caused by human papillomavirus (HPV) subtypes 6 and 11, which are acquired from the mother during birth.
Overall, just 15 cases were reported during the course of the study; 7 in the 1st year, 3 in the 2nd year, 2 each in the 3rd and 4th years, and 1 case in the last year. The annual rates declined from 0.16 per 100,000 children aged 0-14 years in 2012 to 0.02 per 100,000 in 2016.
Of the cases identified, none of the mothers had been vaccinated against HPV before pregnancy and 20% had a history of genital warts. Seven cases were genotyped; 4 were HPV-6 and 3 were HPV-11, and 13 of the 15 cases were born vaginally.
“Our data strongly suggest that the previously documented impact of quadrivalent HPV vaccination in dramatically reducing the prevalence of HPV-6 and HPV-11 genital infection in the Australian population is translating to a reduction in the risk of transmission to infants intrapartum and subsequent development in some of these children of JORRP,” wrote Daniel Novakovic, MD, of the University of Sydney Medical School, and his coinvestigators.
The authors noted that their initial estimate of infection rates was lower than that seen in other studies, such as the 0.5 per 100,000 rate seen in private health insurance data, and the 1.0 per 100,000 seen with Medicaid data in the United States.
Given that the study period started nearly 5 years after the vaccination program began, they suggested that this lower prevalence may reflect the early impact of the vaccine, particularly given that the prevalence of genital warts had already dramatically declined by that point.
However they also stressed that their study relied on clinicians actively reporting cases, and that given surveillance only began after the introduction of the vaccination program, no data were available on the incidence before that point.
The study was supported by a research grant from Merck and by the Australian Paediatric Surveillance Unit, which is supported by the Australian Government Department of Health. Three authors declared research funding from Merck/Seqirus for HPV studies. Two authors declared funding, speaking fees, and other support from a range of pharmaceutical companies. No other conflicts of interest were declared.
FROM THE JOURNAL OF INFECTIOUS DISEASES
Key clinical point: The introduction of a human papillomavirus vaccination program in Australia has seen a decline in the incidence of juvenile-onset recurrent respiratory papillomatosis.
Major finding: The incidence of juvenile recurrent respiratory papillomatosis decreased from 0.16 per 100,000 children aged 0-14 years to 0.02 per 100,000 over 5 years shortly after the national HPV vaccination program was introduced.
Data source: Prospective study using data from the Australian Paediatric Surveillance Unit.
Disclosures: The study was supported by a research grant from Merck and by the Australian Paediatric Surveillance Unit, which is supported by the Australian Government Department of Health. Three authors declared research funding from Merck/Seqirus for HPV studies. Two authors declared funding, speaking fees, and other support from a range of pharmaceutical companies. No other conflicts of interest were declared.
Exercise program speeds healing of venous leg ulcers
A supervised exercise program for patients with venous leg ulcers has shown improved healing times over compression therapy alone, according to a paper published online on Oct. 27 in the British Journal of Dermatology.
In a parallel group feasibility trial, researchers randomized 39 patients with venous ulcers either to a 12-week program of supervised exercise three times a week plus compression therapy (18 patients), or compression therapy alone (21 patients). The exercise program combined aerobic, resistance, and flexibility exercises.
This group showed a median ulcer healing time of 13 weeks (3.9-52 weeks), compared with 34.7 weeks (4.3-52 weeks) for the compression therapy–only group, although the median ulcer size was similar between the two groups at 12 months. At last follow-up of 12 months, 83% of the ulcers in the exercise group had healed, compared with 60% in the control group (Br J Dermatol. 2017 Oct 27. doi: 10.1111/bjd.16089).
The intervention group had a slightly higher quality of life at baseline, as measured by the EQ-5D utility score, and this difference was maintained throughout the study.
Nearly three-quarters (72%) of the exercise group participants went to all the scheduled exercise sessions, with an overall attendance rate of 79%, which the authors noted was high considering many were old, frail, and had no previous exercise experience.
“This was achieved without employing any specific adherence-enhancing components or provision of behavioral change support, which could have potentially improved attendance rates and the effect of the intervention even further,” wrote Markos Klonizakis, DPhil, from the Centre for Sport and Exercise Science at Sheffield (England) Hallam University, and his coinvestigators.
There were no serious adverse events, and only two exercise-related adverse events in the intervention group – both excessive discharge from the ulcer – which resulted in postponement of the exercise sessions for those two individuals.
The exercise regimen was associated with modest reductions in weight, while those in the control group showed an overall increase in weight.
Researchers also assessed the relative costs of the two interventions by getting participants to keep a diary of their use of National Health Service resources, health care visits, prescriptions, and other out-of-pocket expenses.
They calculated that the total mean National Health Service cost per participant for the exercise intervention was £813.27, and £2,298.57 for the control group who received compression therapy only.
The investigators noted that their initial plan had been met with some skepticism from clinicians and patients, some of whom felt that exercise would have a detrimental rather than positive effect on venous ulcer healing.
“Our results suggest that there may be significant potential benefit in healing rates and that, if this were confirmed in a full trial, the introduction of supervised exercise for venous leg ulcers may well also be cost-saving for the National Health Service.”
The study was funded by the National Institute for Health Research. No conflicts of interest were declared.
A supervised exercise program for patients with venous leg ulcers has shown improved healing times over compression therapy alone, according to a paper published online on Oct. 27 in the British Journal of Dermatology.
In a parallel group feasibility trial, researchers randomized 39 patients with venous ulcers either to a 12-week program of supervised exercise three times a week plus compression therapy (18 patients), or compression therapy alone (21 patients). The exercise program combined aerobic, resistance, and flexibility exercises.
This group showed a median ulcer healing time of 13 weeks (3.9-52 weeks), compared with 34.7 weeks (4.3-52 weeks) for the compression therapy–only group, although the median ulcer size was similar between the two groups at 12 months. At last follow-up of 12 months, 83% of the ulcers in the exercise group had healed, compared with 60% in the control group (Br J Dermatol. 2017 Oct 27. doi: 10.1111/bjd.16089).
The intervention group had a slightly higher quality of life at baseline, as measured by the EQ-5D utility score, and this difference was maintained throughout the study.
Nearly three-quarters (72%) of the exercise group participants went to all the scheduled exercise sessions, with an overall attendance rate of 79%, which the authors noted was high considering many were old, frail, and had no previous exercise experience.
“This was achieved without employing any specific adherence-enhancing components or provision of behavioral change support, which could have potentially improved attendance rates and the effect of the intervention even further,” wrote Markos Klonizakis, DPhil, from the Centre for Sport and Exercise Science at Sheffield (England) Hallam University, and his coinvestigators.
There were no serious adverse events, and only two exercise-related adverse events in the intervention group – both excessive discharge from the ulcer – which resulted in postponement of the exercise sessions for those two individuals.
The exercise regimen was associated with modest reductions in weight, while those in the control group showed an overall increase in weight.
Researchers also assessed the relative costs of the two interventions by getting participants to keep a diary of their use of National Health Service resources, health care visits, prescriptions, and other out-of-pocket expenses.
They calculated that the total mean National Health Service cost per participant for the exercise intervention was £813.27, and £2,298.57 for the control group who received compression therapy only.
The investigators noted that their initial plan had been met with some skepticism from clinicians and patients, some of whom felt that exercise would have a detrimental rather than positive effect on venous ulcer healing.
“Our results suggest that there may be significant potential benefit in healing rates and that, if this were confirmed in a full trial, the introduction of supervised exercise for venous leg ulcers may well also be cost-saving for the National Health Service.”
The study was funded by the National Institute for Health Research. No conflicts of interest were declared.
A supervised exercise program for patients with venous leg ulcers has shown improved healing times over compression therapy alone, according to a paper published online on Oct. 27 in the British Journal of Dermatology.
In a parallel group feasibility trial, researchers randomized 39 patients with venous ulcers either to a 12-week program of supervised exercise three times a week plus compression therapy (18 patients), or compression therapy alone (21 patients). The exercise program combined aerobic, resistance, and flexibility exercises.
This group showed a median ulcer healing time of 13 weeks (3.9-52 weeks), compared with 34.7 weeks (4.3-52 weeks) for the compression therapy–only group, although the median ulcer size was similar between the two groups at 12 months. At last follow-up of 12 months, 83% of the ulcers in the exercise group had healed, compared with 60% in the control group (Br J Dermatol. 2017 Oct 27. doi: 10.1111/bjd.16089).
The intervention group had a slightly higher quality of life at baseline, as measured by the EQ-5D utility score, and this difference was maintained throughout the study.
Nearly three-quarters (72%) of the exercise group participants went to all the scheduled exercise sessions, with an overall attendance rate of 79%, which the authors noted was high considering many were old, frail, and had no previous exercise experience.
“This was achieved without employing any specific adherence-enhancing components or provision of behavioral change support, which could have potentially improved attendance rates and the effect of the intervention even further,” wrote Markos Klonizakis, DPhil, from the Centre for Sport and Exercise Science at Sheffield (England) Hallam University, and his coinvestigators.
There were no serious adverse events, and only two exercise-related adverse events in the intervention group – both excessive discharge from the ulcer – which resulted in postponement of the exercise sessions for those two individuals.
The exercise regimen was associated with modest reductions in weight, while those in the control group showed an overall increase in weight.
Researchers also assessed the relative costs of the two interventions by getting participants to keep a diary of their use of National Health Service resources, health care visits, prescriptions, and other out-of-pocket expenses.
They calculated that the total mean National Health Service cost per participant for the exercise intervention was £813.27, and £2,298.57 for the control group who received compression therapy only.
The investigators noted that their initial plan had been met with some skepticism from clinicians and patients, some of whom felt that exercise would have a detrimental rather than positive effect on venous ulcer healing.
“Our results suggest that there may be significant potential benefit in healing rates and that, if this were confirmed in a full trial, the introduction of supervised exercise for venous leg ulcers may well also be cost-saving for the National Health Service.”
The study was funded by the National Institute for Health Research. No conflicts of interest were declared.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point: A supervised exercise program for patients with venous leg ulcers has shown significantly improved healing times over compression therapy alone.
Major finding: Patients who underwent a program of supervised exercise in addition to compression therapy showed a median ulcer healing time of 13 weeks, compared with 35 weeks for patients who received compression therapy alone.
Data source: A randomized, parallel group feasibility trial in 39 patients with venous ulcers.
Disclosures: The study was funded by the National Institute for Health Research. No conflicts of interest were declared.