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E-cigarettes: A health threat or cessation tool?
DENVER –
“So far, the evidence regarding e-cigarettes’ effectiveness for smoking cessation is equivocal at best,” Alison Breland, PhD, said at the annual meeting of the Teratology Society.
But Dr. Breland noted that there is significant controversy around this topic. “I can tell you that, at the conferences I go to, where there are lots of people studying nicotine and tobacco, scientists are fighting with each other over this question,” said Dr. Breland, a psychologist and project director at the Center for the Study of Tobacco Products at Virginia Commonwealth University in Richmond.
That being said, she noted that this meta-analysis has generated unusually harsh printed comments from its critics.
“We could argue about the methodology of the studies all day. If you think all the studies are garbage then you won’t believe the odds ratio, either. But I think right now the evidence shows that e-cigarettes don’t seem to help people quit,” she said. “That may change in the future with testing of different kinds of devices.”
To be useful for smoking cessation, she explained, a device would need to consistently deliver enough nicotine to enable the smoker to fend off withdrawal symptoms but not so much that the wish to quit evaporates. It’s a matter of finding the sweet spot in what is technically termed device nicotine flux.
There is a great deal of misconception about e-cigarettes, Dr. Breland said, some of it promoted through misleading product advertising. She sought to set the record straight.
How e-cigarettes work
What are e-cigarettes? They are basically nicotine delivery devices. They use electricity to power a heating element that aerosolizes a liquid containing varying concentrations of nicotine; solvents, such as propylene glycol and vegetable glycerins; and flavorants. As a class, e-cigarettes are rapidly evolving. A vast array of devices are marketed with wide differences in design, materials, construction, amount of nicotine delivered, and electrical power – which, along with puff duration, is a key factor in how much nicotine gets into a user’s blood.
“Most of the devices have a battery, but it’s important to know that some of them can be plugged directly into a USB port on a computer,” Dr. Breland said.
E-cigarettes don’t generate a vapor, as is widely believed. It’s an aerosol, and it contains toxic byproducts. On the plus side, unlike combustible cigarettes, e-cigarettes don’t deliver carbon monoxide.
A vast array of flavorant mixtures are sold, including some that are clearly designed to be attractive to children, with names like “blue cotton candy” and “Apple Jacks.”
User demographics
Who is using e-cigarettes? Primarily adolescents and young adults in prime reproductive age. National surveys indicate e-cigarettes are now the most widely used tobacco product among U.S. high school students, well ahead of combustible cigarettes.
Of particular concern, data from the Centers for Disease Control and Prevention’s National Health Interview Survey indicate that, among 18- to 24-year-olds who use e-cigarettes, about 40% also currently use conventional cigarettes, about 20% are former cigarette smokers, and about 40% are never smokers – that is, have never smoked combustible cigarettes (MMWR Morb Mortal Wkly Rep. 2016;65:1177. doi: 10.15585/mmwr.mm6542a7).
“We don’t know what’s going to happen to these never smokers who are currently using e-cigarettes. Are they starting on a lifetime of nicotine dependence via e-cigarettes, or perhaps even worse, are they going to transition to combustible cigarettes? There’s more and more evidence showing that’s happening,” Dr. Breland said.
The CDC survey also showed that 59% of adult users of e-cigarettes are what Dr. Breland called “dualies,” individuals who also smoke conventional cigarettes.
“That really diminishes any potential benefit of e-cigarettes,” she said.
Impact on pregnancy
What is known about the impact of e-cigarettes on pregnancy and birth outcomes? Almost nothing at this point. E-cigarettes deliver nicotine to the bloodstream, and nicotine is known to cause unwelcome, long-term changes in fetal brain development and in that of adolescents as well. The other aerosolized toxicants have not been well studied. A few small surveys conducted in obstetric practices indicate some pregnant women perceive e-cigarettes as posing only minor health risks and safer than combustible cigarettes. And some pregnant women are using e-cigarettes.
“I think it’s notable that we’re not finding exclusive e-cigarette users. It’s early in the study, but so far the dual users are smoking the same number of cigarettes per day as cigarette-only users, and they have the same expired carbon monoxide levels. It makes me feel concerned in particular about dual use in pregnancy,” she said.
Regulation
One audience member asked what the point of allowing e-cigarettes is since, under a best-case scenario, their effectiveness as a smoking cessation tool is similar to a nicotine patch, and smokers already have access to the patch as well as nicotine gum.
Dr. Breland replied that the patch and gum deliver nicotine very slowly, so they are not as satisfying as smoking.
“The hope with e-cigarettes is that, since they get nicotine into your blood pretty fast – similar to a cigarette – they can more effectively suppress your withdrawal,” she said. “Whether or not that’s true isn’t known yet.”
The Food and Drug Administration has the authority to regulate e-cigarettes through several different mechanisms but, in late July 2017, announced a delay in issuing new regulations that would likely have removed many of the devices and flavorings from the marketplace.
Dr. Breland’s research is supported by the National Institute on Drug Abuse and the Food and Drug Administration. She reported having no financial conflicts of interest.
DENVER –
“So far, the evidence regarding e-cigarettes’ effectiveness for smoking cessation is equivocal at best,” Alison Breland, PhD, said at the annual meeting of the Teratology Society.
But Dr. Breland noted that there is significant controversy around this topic. “I can tell you that, at the conferences I go to, where there are lots of people studying nicotine and tobacco, scientists are fighting with each other over this question,” said Dr. Breland, a psychologist and project director at the Center for the Study of Tobacco Products at Virginia Commonwealth University in Richmond.
That being said, she noted that this meta-analysis has generated unusually harsh printed comments from its critics.
“We could argue about the methodology of the studies all day. If you think all the studies are garbage then you won’t believe the odds ratio, either. But I think right now the evidence shows that e-cigarettes don’t seem to help people quit,” she said. “That may change in the future with testing of different kinds of devices.”
To be useful for smoking cessation, she explained, a device would need to consistently deliver enough nicotine to enable the smoker to fend off withdrawal symptoms but not so much that the wish to quit evaporates. It’s a matter of finding the sweet spot in what is technically termed device nicotine flux.
There is a great deal of misconception about e-cigarettes, Dr. Breland said, some of it promoted through misleading product advertising. She sought to set the record straight.
How e-cigarettes work
What are e-cigarettes? They are basically nicotine delivery devices. They use electricity to power a heating element that aerosolizes a liquid containing varying concentrations of nicotine; solvents, such as propylene glycol and vegetable glycerins; and flavorants. As a class, e-cigarettes are rapidly evolving. A vast array of devices are marketed with wide differences in design, materials, construction, amount of nicotine delivered, and electrical power – which, along with puff duration, is a key factor in how much nicotine gets into a user’s blood.
“Most of the devices have a battery, but it’s important to know that some of them can be plugged directly into a USB port on a computer,” Dr. Breland said.
E-cigarettes don’t generate a vapor, as is widely believed. It’s an aerosol, and it contains toxic byproducts. On the plus side, unlike combustible cigarettes, e-cigarettes don’t deliver carbon monoxide.
A vast array of flavorant mixtures are sold, including some that are clearly designed to be attractive to children, with names like “blue cotton candy” and “Apple Jacks.”
User demographics
Who is using e-cigarettes? Primarily adolescents and young adults in prime reproductive age. National surveys indicate e-cigarettes are now the most widely used tobacco product among U.S. high school students, well ahead of combustible cigarettes.
Of particular concern, data from the Centers for Disease Control and Prevention’s National Health Interview Survey indicate that, among 18- to 24-year-olds who use e-cigarettes, about 40% also currently use conventional cigarettes, about 20% are former cigarette smokers, and about 40% are never smokers – that is, have never smoked combustible cigarettes (MMWR Morb Mortal Wkly Rep. 2016;65:1177. doi: 10.15585/mmwr.mm6542a7).
“We don’t know what’s going to happen to these never smokers who are currently using e-cigarettes. Are they starting on a lifetime of nicotine dependence via e-cigarettes, or perhaps even worse, are they going to transition to combustible cigarettes? There’s more and more evidence showing that’s happening,” Dr. Breland said.
The CDC survey also showed that 59% of adult users of e-cigarettes are what Dr. Breland called “dualies,” individuals who also smoke conventional cigarettes.
“That really diminishes any potential benefit of e-cigarettes,” she said.
Impact on pregnancy
What is known about the impact of e-cigarettes on pregnancy and birth outcomes? Almost nothing at this point. E-cigarettes deliver nicotine to the bloodstream, and nicotine is known to cause unwelcome, long-term changes in fetal brain development and in that of adolescents as well. The other aerosolized toxicants have not been well studied. A few small surveys conducted in obstetric practices indicate some pregnant women perceive e-cigarettes as posing only minor health risks and safer than combustible cigarettes. And some pregnant women are using e-cigarettes.
“I think it’s notable that we’re not finding exclusive e-cigarette users. It’s early in the study, but so far the dual users are smoking the same number of cigarettes per day as cigarette-only users, and they have the same expired carbon monoxide levels. It makes me feel concerned in particular about dual use in pregnancy,” she said.
Regulation
One audience member asked what the point of allowing e-cigarettes is since, under a best-case scenario, their effectiveness as a smoking cessation tool is similar to a nicotine patch, and smokers already have access to the patch as well as nicotine gum.
Dr. Breland replied that the patch and gum deliver nicotine very slowly, so they are not as satisfying as smoking.
“The hope with e-cigarettes is that, since they get nicotine into your blood pretty fast – similar to a cigarette – they can more effectively suppress your withdrawal,” she said. “Whether or not that’s true isn’t known yet.”
The Food and Drug Administration has the authority to regulate e-cigarettes through several different mechanisms but, in late July 2017, announced a delay in issuing new regulations that would likely have removed many of the devices and flavorings from the marketplace.
Dr. Breland’s research is supported by the National Institute on Drug Abuse and the Food and Drug Administration. She reported having no financial conflicts of interest.
DENVER –
“So far, the evidence regarding e-cigarettes’ effectiveness for smoking cessation is equivocal at best,” Alison Breland, PhD, said at the annual meeting of the Teratology Society.
But Dr. Breland noted that there is significant controversy around this topic. “I can tell you that, at the conferences I go to, where there are lots of people studying nicotine and tobacco, scientists are fighting with each other over this question,” said Dr. Breland, a psychologist and project director at the Center for the Study of Tobacco Products at Virginia Commonwealth University in Richmond.
That being said, she noted that this meta-analysis has generated unusually harsh printed comments from its critics.
“We could argue about the methodology of the studies all day. If you think all the studies are garbage then you won’t believe the odds ratio, either. But I think right now the evidence shows that e-cigarettes don’t seem to help people quit,” she said. “That may change in the future with testing of different kinds of devices.”
To be useful for smoking cessation, she explained, a device would need to consistently deliver enough nicotine to enable the smoker to fend off withdrawal symptoms but not so much that the wish to quit evaporates. It’s a matter of finding the sweet spot in what is technically termed device nicotine flux.
There is a great deal of misconception about e-cigarettes, Dr. Breland said, some of it promoted through misleading product advertising. She sought to set the record straight.
How e-cigarettes work
What are e-cigarettes? They are basically nicotine delivery devices. They use electricity to power a heating element that aerosolizes a liquid containing varying concentrations of nicotine; solvents, such as propylene glycol and vegetable glycerins; and flavorants. As a class, e-cigarettes are rapidly evolving. A vast array of devices are marketed with wide differences in design, materials, construction, amount of nicotine delivered, and electrical power – which, along with puff duration, is a key factor in how much nicotine gets into a user’s blood.
“Most of the devices have a battery, but it’s important to know that some of them can be plugged directly into a USB port on a computer,” Dr. Breland said.
E-cigarettes don’t generate a vapor, as is widely believed. It’s an aerosol, and it contains toxic byproducts. On the plus side, unlike combustible cigarettes, e-cigarettes don’t deliver carbon monoxide.
A vast array of flavorant mixtures are sold, including some that are clearly designed to be attractive to children, with names like “blue cotton candy” and “Apple Jacks.”
User demographics
Who is using e-cigarettes? Primarily adolescents and young adults in prime reproductive age. National surveys indicate e-cigarettes are now the most widely used tobacco product among U.S. high school students, well ahead of combustible cigarettes.
Of particular concern, data from the Centers for Disease Control and Prevention’s National Health Interview Survey indicate that, among 18- to 24-year-olds who use e-cigarettes, about 40% also currently use conventional cigarettes, about 20% are former cigarette smokers, and about 40% are never smokers – that is, have never smoked combustible cigarettes (MMWR Morb Mortal Wkly Rep. 2016;65:1177. doi: 10.15585/mmwr.mm6542a7).
“We don’t know what’s going to happen to these never smokers who are currently using e-cigarettes. Are they starting on a lifetime of nicotine dependence via e-cigarettes, or perhaps even worse, are they going to transition to combustible cigarettes? There’s more and more evidence showing that’s happening,” Dr. Breland said.
The CDC survey also showed that 59% of adult users of e-cigarettes are what Dr. Breland called “dualies,” individuals who also smoke conventional cigarettes.
“That really diminishes any potential benefit of e-cigarettes,” she said.
Impact on pregnancy
What is known about the impact of e-cigarettes on pregnancy and birth outcomes? Almost nothing at this point. E-cigarettes deliver nicotine to the bloodstream, and nicotine is known to cause unwelcome, long-term changes in fetal brain development and in that of adolescents as well. The other aerosolized toxicants have not been well studied. A few small surveys conducted in obstetric practices indicate some pregnant women perceive e-cigarettes as posing only minor health risks and safer than combustible cigarettes. And some pregnant women are using e-cigarettes.
“I think it’s notable that we’re not finding exclusive e-cigarette users. It’s early in the study, but so far the dual users are smoking the same number of cigarettes per day as cigarette-only users, and they have the same expired carbon monoxide levels. It makes me feel concerned in particular about dual use in pregnancy,” she said.
Regulation
One audience member asked what the point of allowing e-cigarettes is since, under a best-case scenario, their effectiveness as a smoking cessation tool is similar to a nicotine patch, and smokers already have access to the patch as well as nicotine gum.
Dr. Breland replied that the patch and gum deliver nicotine very slowly, so they are not as satisfying as smoking.
“The hope with e-cigarettes is that, since they get nicotine into your blood pretty fast – similar to a cigarette – they can more effectively suppress your withdrawal,” she said. “Whether or not that’s true isn’t known yet.”
The Food and Drug Administration has the authority to regulate e-cigarettes through several different mechanisms but, in late July 2017, announced a delay in issuing new regulations that would likely have removed many of the devices and flavorings from the marketplace.
Dr. Breland’s research is supported by the National Institute on Drug Abuse and the Food and Drug Administration. She reported having no financial conflicts of interest.
EXPERT ANALYSIS FROM TERATOLOGY SOCIETY 2017
Wide variability found in invasive mediastinal staging rates for lung cancer
COLORADO SPRINGS – Significant variability exists between hospitals in Washington state in their rates of invasive mediastinal staging for lung cancer, Farhood Farjah, MD, reported at the annual meeting of the Western Thoracic Surgical Association.
“We found evidence of a fivefold variation in hospital-level rates of invasive mediastinal staging not explained by chance or case mix,” according to Dr. Farjah of the University of Washington, Seattle.
“This has led to substantial concerns about quality of thoracic surgical care in the community at large,” he noted.
The Washington study is the first to show hospital-by-hospital variation in rates of invasive mediastinal staging.
Invasive mediastinal staging for lung cancer is considered important because imaging is known to have a substantial false-negative rate, and staging results have a profound impact on treatment recommendations, which can range from surgery alone to additional chemoradiation therapy.
Yet the meaning of the hospital-level huge variability in practice observed in the Washington study remains unclear.
“Our understanding of the underutilization of invasive mediastinal staging is further complicated by the fact that patterns of invasive mediastinal staging are highly variable across hospitals staffed by at least one board-certified thoracic surgeon with a noncardiac practice,” Dr. Farjah explained. “This variability could be a marker of poor-quality care. However, because the guidelines are not supported by level 1 evidence, it’s equally plausible that this variability might represent uncertainty or even disagreement with the practice guidelines – and specifically about the appropriate indication for invasive staging.”
He presented a retrospective cohort study of 406 patients whose non–small cell lung cancer was resected during July 2011–December 2013 at one of five Washington hospitals, each with at least one board-certified thoracic surgeon with a noncardiac practice on staff. The four participating community hospitals and one academic medical center were involved in a National Cancer Institute–funded, physician-led quality improvement initiative.
Overall, 66% of the 406 patients underwent any form of invasive mediastinal staging: 85% by mediastinoscopy only; 12% by mediastinoscopy plus endobronchial ultrasound-guided nodal aspiration (EBUS); 3% by EBUS only; and the remaining handful by mediastinoscopy, EBUS, and esophageal ultrasound-guided nodal aspiration. The invasive staging was performed at the time of resection in 64% of cases. A median of three nodal stations were sampled.
After statistical adjustment for random variation and between-hospital differences in clinical stage, rates of invasive staging were all over the map. While an overall mean of 66% of the lung cancer patients underwent invasive mediastinal staging, the rates at the five hospitals were 94%, 84%, 31%, 80%, and 17%.
Dr. Farjah and his coinvestigators are now conducting provider interviews and focus groups in an effort to understand what drove the participating surgeons’ wide variability in performing invasive mediastinal staging.
Discussant Jane Yanagawa, MD, of the University of California, Los Angeles, commented, “I think this is a really interesting study because, historically, lower rates of mediastinoscopy are assumed to be a reflection of low-quality care – and you suggest that might not be the case, that it might be more complicated than that.”
Dr. Yanagawa sketched one fairly common scenario that might represent a surgeon’s reasonable avoidance of guideline-recommended invasive mediastinal staging: a patient who by all preoperative imaging appears to have stage IA lung cancer and wishes to avoid the morbidity, time, and cost of needle biopsy, instead choosing to go straight to the operating room for a diagnosis by wedge resection, followed by a completion lobectomy based upon the frozen section results. Could such a pathway account for the variability seen in the Washington study?
“I think it could have,” Dr. Farjah replied. “I would say that’s probably one driver of variability.”
As for the generalizability of the findings of a five-hospital study carried out in a single state, Dr. Farjah said he thinks the results are applicable to any academic or community hospital with at least one board-certified thoracic surgeon with a noncardiac practice.
He reported having no financial conflicts of interest regarding the study.
M. Patricia Rivera, MD, FCCP, comments: Staging of lung cancer is essential to select the best treatment strategy for a given patient. However, despite multiple guideline recommendations
M. Patricia Rivera, MD, FCCP, comments: Staging of lung cancer is essential to select the best treatment strategy for a given patient. However, despite multiple guideline recommendations
M. Patricia Rivera, MD, FCCP, comments: Staging of lung cancer is essential to select the best treatment strategy for a given patient. However, despite multiple guideline recommendations
COLORADO SPRINGS – Significant variability exists between hospitals in Washington state in their rates of invasive mediastinal staging for lung cancer, Farhood Farjah, MD, reported at the annual meeting of the Western Thoracic Surgical Association.
“We found evidence of a fivefold variation in hospital-level rates of invasive mediastinal staging not explained by chance or case mix,” according to Dr. Farjah of the University of Washington, Seattle.
“This has led to substantial concerns about quality of thoracic surgical care in the community at large,” he noted.
The Washington study is the first to show hospital-by-hospital variation in rates of invasive mediastinal staging.
Invasive mediastinal staging for lung cancer is considered important because imaging is known to have a substantial false-negative rate, and staging results have a profound impact on treatment recommendations, which can range from surgery alone to additional chemoradiation therapy.
Yet the meaning of the hospital-level huge variability in practice observed in the Washington study remains unclear.
“Our understanding of the underutilization of invasive mediastinal staging is further complicated by the fact that patterns of invasive mediastinal staging are highly variable across hospitals staffed by at least one board-certified thoracic surgeon with a noncardiac practice,” Dr. Farjah explained. “This variability could be a marker of poor-quality care. However, because the guidelines are not supported by level 1 evidence, it’s equally plausible that this variability might represent uncertainty or even disagreement with the practice guidelines – and specifically about the appropriate indication for invasive staging.”
He presented a retrospective cohort study of 406 patients whose non–small cell lung cancer was resected during July 2011–December 2013 at one of five Washington hospitals, each with at least one board-certified thoracic surgeon with a noncardiac practice on staff. The four participating community hospitals and one academic medical center were involved in a National Cancer Institute–funded, physician-led quality improvement initiative.
Overall, 66% of the 406 patients underwent any form of invasive mediastinal staging: 85% by mediastinoscopy only; 12% by mediastinoscopy plus endobronchial ultrasound-guided nodal aspiration (EBUS); 3% by EBUS only; and the remaining handful by mediastinoscopy, EBUS, and esophageal ultrasound-guided nodal aspiration. The invasive staging was performed at the time of resection in 64% of cases. A median of three nodal stations were sampled.
After statistical adjustment for random variation and between-hospital differences in clinical stage, rates of invasive staging were all over the map. While an overall mean of 66% of the lung cancer patients underwent invasive mediastinal staging, the rates at the five hospitals were 94%, 84%, 31%, 80%, and 17%.
Dr. Farjah and his coinvestigators are now conducting provider interviews and focus groups in an effort to understand what drove the participating surgeons’ wide variability in performing invasive mediastinal staging.
Discussant Jane Yanagawa, MD, of the University of California, Los Angeles, commented, “I think this is a really interesting study because, historically, lower rates of mediastinoscopy are assumed to be a reflection of low-quality care – and you suggest that might not be the case, that it might be more complicated than that.”
Dr. Yanagawa sketched one fairly common scenario that might represent a surgeon’s reasonable avoidance of guideline-recommended invasive mediastinal staging: a patient who by all preoperative imaging appears to have stage IA lung cancer and wishes to avoid the morbidity, time, and cost of needle biopsy, instead choosing to go straight to the operating room for a diagnosis by wedge resection, followed by a completion lobectomy based upon the frozen section results. Could such a pathway account for the variability seen in the Washington study?
“I think it could have,” Dr. Farjah replied. “I would say that’s probably one driver of variability.”
As for the generalizability of the findings of a five-hospital study carried out in a single state, Dr. Farjah said he thinks the results are applicable to any academic or community hospital with at least one board-certified thoracic surgeon with a noncardiac practice.
He reported having no financial conflicts of interest regarding the study.
COLORADO SPRINGS – Significant variability exists between hospitals in Washington state in their rates of invasive mediastinal staging for lung cancer, Farhood Farjah, MD, reported at the annual meeting of the Western Thoracic Surgical Association.
“We found evidence of a fivefold variation in hospital-level rates of invasive mediastinal staging not explained by chance or case mix,” according to Dr. Farjah of the University of Washington, Seattle.
“This has led to substantial concerns about quality of thoracic surgical care in the community at large,” he noted.
The Washington study is the first to show hospital-by-hospital variation in rates of invasive mediastinal staging.
Invasive mediastinal staging for lung cancer is considered important because imaging is known to have a substantial false-negative rate, and staging results have a profound impact on treatment recommendations, which can range from surgery alone to additional chemoradiation therapy.
Yet the meaning of the hospital-level huge variability in practice observed in the Washington study remains unclear.
“Our understanding of the underutilization of invasive mediastinal staging is further complicated by the fact that patterns of invasive mediastinal staging are highly variable across hospitals staffed by at least one board-certified thoracic surgeon with a noncardiac practice,” Dr. Farjah explained. “This variability could be a marker of poor-quality care. However, because the guidelines are not supported by level 1 evidence, it’s equally plausible that this variability might represent uncertainty or even disagreement with the practice guidelines – and specifically about the appropriate indication for invasive staging.”
He presented a retrospective cohort study of 406 patients whose non–small cell lung cancer was resected during July 2011–December 2013 at one of five Washington hospitals, each with at least one board-certified thoracic surgeon with a noncardiac practice on staff. The four participating community hospitals and one academic medical center were involved in a National Cancer Institute–funded, physician-led quality improvement initiative.
Overall, 66% of the 406 patients underwent any form of invasive mediastinal staging: 85% by mediastinoscopy only; 12% by mediastinoscopy plus endobronchial ultrasound-guided nodal aspiration (EBUS); 3% by EBUS only; and the remaining handful by mediastinoscopy, EBUS, and esophageal ultrasound-guided nodal aspiration. The invasive staging was performed at the time of resection in 64% of cases. A median of three nodal stations were sampled.
After statistical adjustment for random variation and between-hospital differences in clinical stage, rates of invasive staging were all over the map. While an overall mean of 66% of the lung cancer patients underwent invasive mediastinal staging, the rates at the five hospitals were 94%, 84%, 31%, 80%, and 17%.
Dr. Farjah and his coinvestigators are now conducting provider interviews and focus groups in an effort to understand what drove the participating surgeons’ wide variability in performing invasive mediastinal staging.
Discussant Jane Yanagawa, MD, of the University of California, Los Angeles, commented, “I think this is a really interesting study because, historically, lower rates of mediastinoscopy are assumed to be a reflection of low-quality care – and you suggest that might not be the case, that it might be more complicated than that.”
Dr. Yanagawa sketched one fairly common scenario that might represent a surgeon’s reasonable avoidance of guideline-recommended invasive mediastinal staging: a patient who by all preoperative imaging appears to have stage IA lung cancer and wishes to avoid the morbidity, time, and cost of needle biopsy, instead choosing to go straight to the operating room for a diagnosis by wedge resection, followed by a completion lobectomy based upon the frozen section results. Could such a pathway account for the variability seen in the Washington study?
“I think it could have,” Dr. Farjah replied. “I would say that’s probably one driver of variability.”
As for the generalizability of the findings of a five-hospital study carried out in a single state, Dr. Farjah said he thinks the results are applicable to any academic or community hospital with at least one board-certified thoracic surgeon with a noncardiac practice.
He reported having no financial conflicts of interest regarding the study.
AT THE WTSA ANNUAL MEETING
Key clinical point:
Major finding: Rates of invasive mediastinal staging after adjustment for clinical stage ranged from a low of 17% at one hospital to as high as 94% at another.
Data source: This retrospective cohort study included 406 patients.
Disclosures: Dr. Farjah reported having no financial conflicts of interest.
Short, simple antibiotic courses effective in latent TB
Latent tuberculosis infection can be safely and effectively treated with 3- and 4-month medication regimens, including those using once-weekly dosing, according to results from a new meta-analysis.
The findings, published online July 31 in Annals of Internal Medicine, bolster evidence that shorter antibiotic regimens using rifamycins alone or in combination with other drugs are a viable alternative to the longer courses (Ann Intern Med. 2017;167:248-55).
For their research, Dominik Zenner, MD, an epidemiologist with Public Health England in London, and his colleagues updated a meta-analysis they published in 2014. The team added 8 new randomized studies to the 53 that had been included in the earlier paper (Ann Intern Med. 2014 Sep;161:419-28).
Using pairwise comparisons and a Bayesian network analysis, Dr. Zenner and his colleagues found comparable efficacy among isoniazid regimens of 6 months or more; rifampicin-isoniazid regimens of 3 or 4 months, rifampicin-only regimens, and rifampicin-pyrazinamide regimens, compared with placebo (P less than .05 for all).
Importantly, a rifapentine-based regimen in which patients took a weekly dose for 12 weeks was as effective as the others.
“We think that you can get away with shorter regimens,” Dr. Zenner said in an interview. Although 3- to 4-month courses are already recommended in some countries, including the United Kingdom, for most patients with latent TB, “clinicians in some settings have been quite slow to adopt them,” he said.
The U.S. Centers for Disease Control and Prevention currently recommend multiple treatment strategies for latent TB, depending on patient characteristics. These include 6 or 9 months of isoniazid; 3 months of once-weekly isoniazid and rifapentine; or 4 months of daily rifampin.
In the meta-analysis, rifamycin-only regimens performed as well as did those regimens that also used isoniazid, the study showed, suggesting that, for most patients who can safely be treated with rifamycins, “there is no added gain of using isoniazid,” Dr. Zenner said.
He noted that the longer isoniazid-alone regimens are nonetheless effective and appropriate for some, including people who might have potential drug interactions, such as HIV patients taking antiretroviral medications.
About 2 billion people worldwide are estimated to have latent TB, and most will not go on to develop active TB. However, because latent TB acts as the reservoir for active TB, screening of high-risk groups and close contacts of TB patients and treating latent infections is a public health priority.
But many of these asymptomatic patients will get lost between a positive screen result and successful treatment completion, Dr. Zenner said.
“We have huge drop-offs in the cascade of treatment, and treatment completion is one of the worries,” he said. “Whether it makes a huge difference in compliance to take only 12 doses is not sufficiently studied, but it does make a lot of sense. By reducing the pill burden, as we call it, we think that we will see quite good adherence rates – but that’s a subject of further detailed study.”
The investigators noted as a limitation of their study that hepatotoxicity outcomes were not available for all studies and that some of the included trials had a potential for bias. They did not see statistically significant differences in treatment efficacy between regimens in HIV-positive and HIV-negative patients, but noted in their analysis that “efficacy may have been weaker in HIV-positive populations.”
The U.K. National Institute for Health Research provided some funding for Dr. Zenner and his colleagues’ study. One coauthor, Helen Stagg, PhD, reported nonfinancial support from Sanofi during the study, and financial support from Otsuka for unrelated work.
Latent tuberculosis infection can be safely and effectively treated with 3- and 4-month medication regimens, including those using once-weekly dosing, according to results from a new meta-analysis.
The findings, published online July 31 in Annals of Internal Medicine, bolster evidence that shorter antibiotic regimens using rifamycins alone or in combination with other drugs are a viable alternative to the longer courses (Ann Intern Med. 2017;167:248-55).
For their research, Dominik Zenner, MD, an epidemiologist with Public Health England in London, and his colleagues updated a meta-analysis they published in 2014. The team added 8 new randomized studies to the 53 that had been included in the earlier paper (Ann Intern Med. 2014 Sep;161:419-28).
Using pairwise comparisons and a Bayesian network analysis, Dr. Zenner and his colleagues found comparable efficacy among isoniazid regimens of 6 months or more; rifampicin-isoniazid regimens of 3 or 4 months, rifampicin-only regimens, and rifampicin-pyrazinamide regimens, compared with placebo (P less than .05 for all).
Importantly, a rifapentine-based regimen in which patients took a weekly dose for 12 weeks was as effective as the others.
“We think that you can get away with shorter regimens,” Dr. Zenner said in an interview. Although 3- to 4-month courses are already recommended in some countries, including the United Kingdom, for most patients with latent TB, “clinicians in some settings have been quite slow to adopt them,” he said.
The U.S. Centers for Disease Control and Prevention currently recommend multiple treatment strategies for latent TB, depending on patient characteristics. These include 6 or 9 months of isoniazid; 3 months of once-weekly isoniazid and rifapentine; or 4 months of daily rifampin.
In the meta-analysis, rifamycin-only regimens performed as well as did those regimens that also used isoniazid, the study showed, suggesting that, for most patients who can safely be treated with rifamycins, “there is no added gain of using isoniazid,” Dr. Zenner said.
He noted that the longer isoniazid-alone regimens are nonetheless effective and appropriate for some, including people who might have potential drug interactions, such as HIV patients taking antiretroviral medications.
About 2 billion people worldwide are estimated to have latent TB, and most will not go on to develop active TB. However, because latent TB acts as the reservoir for active TB, screening of high-risk groups and close contacts of TB patients and treating latent infections is a public health priority.
But many of these asymptomatic patients will get lost between a positive screen result and successful treatment completion, Dr. Zenner said.
“We have huge drop-offs in the cascade of treatment, and treatment completion is one of the worries,” he said. “Whether it makes a huge difference in compliance to take only 12 doses is not sufficiently studied, but it does make a lot of sense. By reducing the pill burden, as we call it, we think that we will see quite good adherence rates – but that’s a subject of further detailed study.”
The investigators noted as a limitation of their study that hepatotoxicity outcomes were not available for all studies and that some of the included trials had a potential for bias. They did not see statistically significant differences in treatment efficacy between regimens in HIV-positive and HIV-negative patients, but noted in their analysis that “efficacy may have been weaker in HIV-positive populations.”
The U.K. National Institute for Health Research provided some funding for Dr. Zenner and his colleagues’ study. One coauthor, Helen Stagg, PhD, reported nonfinancial support from Sanofi during the study, and financial support from Otsuka for unrelated work.
Latent tuberculosis infection can be safely and effectively treated with 3- and 4-month medication regimens, including those using once-weekly dosing, according to results from a new meta-analysis.
The findings, published online July 31 in Annals of Internal Medicine, bolster evidence that shorter antibiotic regimens using rifamycins alone or in combination with other drugs are a viable alternative to the longer courses (Ann Intern Med. 2017;167:248-55).
For their research, Dominik Zenner, MD, an epidemiologist with Public Health England in London, and his colleagues updated a meta-analysis they published in 2014. The team added 8 new randomized studies to the 53 that had been included in the earlier paper (Ann Intern Med. 2014 Sep;161:419-28).
Using pairwise comparisons and a Bayesian network analysis, Dr. Zenner and his colleagues found comparable efficacy among isoniazid regimens of 6 months or more; rifampicin-isoniazid regimens of 3 or 4 months, rifampicin-only regimens, and rifampicin-pyrazinamide regimens, compared with placebo (P less than .05 for all).
Importantly, a rifapentine-based regimen in which patients took a weekly dose for 12 weeks was as effective as the others.
“We think that you can get away with shorter regimens,” Dr. Zenner said in an interview. Although 3- to 4-month courses are already recommended in some countries, including the United Kingdom, for most patients with latent TB, “clinicians in some settings have been quite slow to adopt them,” he said.
The U.S. Centers for Disease Control and Prevention currently recommend multiple treatment strategies for latent TB, depending on patient characteristics. These include 6 or 9 months of isoniazid; 3 months of once-weekly isoniazid and rifapentine; or 4 months of daily rifampin.
In the meta-analysis, rifamycin-only regimens performed as well as did those regimens that also used isoniazid, the study showed, suggesting that, for most patients who can safely be treated with rifamycins, “there is no added gain of using isoniazid,” Dr. Zenner said.
He noted that the longer isoniazid-alone regimens are nonetheless effective and appropriate for some, including people who might have potential drug interactions, such as HIV patients taking antiretroviral medications.
About 2 billion people worldwide are estimated to have latent TB, and most will not go on to develop active TB. However, because latent TB acts as the reservoir for active TB, screening of high-risk groups and close contacts of TB patients and treating latent infections is a public health priority.
But many of these asymptomatic patients will get lost between a positive screen result and successful treatment completion, Dr. Zenner said.
“We have huge drop-offs in the cascade of treatment, and treatment completion is one of the worries,” he said. “Whether it makes a huge difference in compliance to take only 12 doses is not sufficiently studied, but it does make a lot of sense. By reducing the pill burden, as we call it, we think that we will see quite good adherence rates – but that’s a subject of further detailed study.”
The investigators noted as a limitation of their study that hepatotoxicity outcomes were not available for all studies and that some of the included trials had a potential for bias. They did not see statistically significant differences in treatment efficacy between regimens in HIV-positive and HIV-negative patients, but noted in their analysis that “efficacy may have been weaker in HIV-positive populations.”
The U.K. National Institute for Health Research provided some funding for Dr. Zenner and his colleagues’ study. One coauthor, Helen Stagg, PhD, reported nonfinancial support from Sanofi during the study, and financial support from Otsuka for unrelated work.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Rifamycin-only treatment of latent TB works as well as combination regimens, and shorter dosing schedules show no loss in efficacy vs. longer ones.
Major finding: Rifamycin-only regimens, rifampicin-isoniazid regimens of 3 or 4 months, rifampicin-pyrazinamide regimens were all effective, compared with placebo and with isoniazid regimens of 6, 12 and 72 months.
Data source: A network meta-analysis of 61 randomized trials, 8 of them published in last 3 years
Disclosures: The National Institute for Health Research (UK) funded some co-authors; one co-author disclosed a financial relationship with a pharmaceutical firm.
Statewide QI learning collaboratives improve asthma care
Care of children with asthma can be improved using statewide quality improvement (QI) learning collaboratives, said Judith C. Dolins, of the American Academy of Pediatrics (AAP), Elk Grove Village, Ill., and her associates.
AAP chapters demonstrated this through their implementation of the Chapter Quality Network (CQN) project, which was supported by the national organization. This project sought to encourage practice changes in asthma care in a number of states using statewide QI learning collaboratives and lead practices to implement the National Heart, Lung, and Blood Institute’s (NHLBI) 2007 asthma guidelines over the course of four time periods, which the researchers referred to as waves. In nine states, 19 AAP chapters engaged 180 practices to participate, and involved 749 pediatricians treating 45,431 patients (Pediatrics. 2017. doi: 10.1542/peds.2016-1612).
Across all waves, practices had reasonably high baseline use of the stepwise approach (81%-89%) and a controller medication for patients with persistent asthma (74%-88%). The patients with a current written asthma action plan increased from 49%-57% to 75%-91%. Physicians’ and parents’ ratings of asthma in children as “well controlled” rose modestly from 58%-63% to 71%-74% and from 67%-73% to 78%-87%, respectively. Patients receiving self-management materials increased from 57%-62% to 62%-88%.
Here’s how the project worked. The CQN had three linked frameworks.: One provided a methodology for spreading practice changes, another outlined the elements of care, and a third provided a framework so the practices could test, implement, and adapt changes.
A national AAP leadership team of experts in asthma care, QI, and primary care practice systems developed a set of key drivers and interventions, and an implementation guide that included resources, tools and methods, and a set of measures for the chapters. They also designed reporting tools and a curriculum fostering QI learning by chapter leaders. Then, in a state chapter leadership learning network and a practice collaborative model in each state, there were “multiple in-person learning sessions and defined action periods, best practices, and tests of change that were spread and incorporated” for the chapters to use, according to the study report.
Chapters in each state had monthly webinars and two in-person learning sessions for participating practices. They also reviewed data reports at the state and practice level and provided coaching for practices.
Practices were asked to “incorporate optimal NHLBI asthma care practices, including assessment of control, a stepwise approach to treatment, appropriate use of controller medication, and an updated asthma action plan for self-management.” Other interventions included use of an asthma encounter form (which collected 16 measures, including outcome and process measures that were entered into a national database at least monthly); introduction of population registries; workflow assessment; motivational interviews; plan-do-study-act cycles for QI; and review of data for QI.
All the physicians were eligible to earn MOC part 4 credit and continuing medical education credit, and 80% of the physicians did get MOC credit across the 4 waves.
“Our findings are notable for achieving improvement in asthma care through training multiple state coordinating entities instead of directly leading the learning collaborative itself. Few other projects have achieved this level of results in pediatric practice improvement in asthma care on such a widespread scale across multiple states. This project may serve as a model for other statewide and national organizations attempting to achieve improvements in population health through support and training for statewide organizations that, in turn, support individual health care providers and practices,” Ms. Dolins and her associates said. “Although none of the waves achieved the preset goal of 90%, all showed substantial improvement and remarkable consistency in the rate of improvement. We, therefore, regarded the project as an overall success.”
The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
We can do a better job of taking care of our patients. And in no other area is there more room for quality improvement (QI) than in ambulatory care. In the article by Dolins et al., substantial improvements were reported in outpatient management meeting the standard of care for asthma. In my experience, doing so not only gives children a better functional outcome but also saves costs by avoiding unnecessary ED visits and hospitalization and generates new dollars for pediatric offices through the additional services they provide. We have seen similar improvements in our own work in South Carolina and Tennessee. The practices that have wanted to become involved in our asthma QI are those that are already doing a better than average job. Yet, they still generate substantial additional improvements.
The AAP study relied heavily on national experts and standards. Although their input is valued, the true advantage of QI is the opportunity for pediatricians and their staff at the service delivery level to generate their own changes within the context of a learning collaborative. True improvement and innovation is facilitated by allowing flexibility at the local level and sharing the ideas that result. Those that design the QI efforts of the future need to make sure they allow for local expertise rather than leaning too heavily on centrally predetermined change concepts.
Part IV Maintenance of Certification requirements from the American Board of Pediatrics help provide momentum for successful pediatric QI. The National Improvement Partnership Network has formed pediatric outpatient learning collaboratives to share ideas. As we identify more successes with ambulatory care QI, as more and more organizations like AAP state chapters become involved, as all practices – rather than just the best – recognize the obligation to promote quality, we have a tremendous opportunity to improve the developmental and health outcomes of the children. QI can promote work and cost efficiencies that facilitate our work as pediatricians, making our lives more productive and rewarding.
Francis E. Rushton Jr, MD, is a pediatrician and medical director of South Carolina’s QTIP (Quality Through Innovation in Pediatrics) network and the Quality Director for PHIIT (Pediatric Health Improvement In Tennessee). He reported not having any relevant financial disclosures.
We can do a better job of taking care of our patients. And in no other area is there more room for quality improvement (QI) than in ambulatory care. In the article by Dolins et al., substantial improvements were reported in outpatient management meeting the standard of care for asthma. In my experience, doing so not only gives children a better functional outcome but also saves costs by avoiding unnecessary ED visits and hospitalization and generates new dollars for pediatric offices through the additional services they provide. We have seen similar improvements in our own work in South Carolina and Tennessee. The practices that have wanted to become involved in our asthma QI are those that are already doing a better than average job. Yet, they still generate substantial additional improvements.
The AAP study relied heavily on national experts and standards. Although their input is valued, the true advantage of QI is the opportunity for pediatricians and their staff at the service delivery level to generate their own changes within the context of a learning collaborative. True improvement and innovation is facilitated by allowing flexibility at the local level and sharing the ideas that result. Those that design the QI efforts of the future need to make sure they allow for local expertise rather than leaning too heavily on centrally predetermined change concepts.
Part IV Maintenance of Certification requirements from the American Board of Pediatrics help provide momentum for successful pediatric QI. The National Improvement Partnership Network has formed pediatric outpatient learning collaboratives to share ideas. As we identify more successes with ambulatory care QI, as more and more organizations like AAP state chapters become involved, as all practices – rather than just the best – recognize the obligation to promote quality, we have a tremendous opportunity to improve the developmental and health outcomes of the children. QI can promote work and cost efficiencies that facilitate our work as pediatricians, making our lives more productive and rewarding.
Francis E. Rushton Jr, MD, is a pediatrician and medical director of South Carolina’s QTIP (Quality Through Innovation in Pediatrics) network and the Quality Director for PHIIT (Pediatric Health Improvement In Tennessee). He reported not having any relevant financial disclosures.
We can do a better job of taking care of our patients. And in no other area is there more room for quality improvement (QI) than in ambulatory care. In the article by Dolins et al., substantial improvements were reported in outpatient management meeting the standard of care for asthma. In my experience, doing so not only gives children a better functional outcome but also saves costs by avoiding unnecessary ED visits and hospitalization and generates new dollars for pediatric offices through the additional services they provide. We have seen similar improvements in our own work in South Carolina and Tennessee. The practices that have wanted to become involved in our asthma QI are those that are already doing a better than average job. Yet, they still generate substantial additional improvements.
The AAP study relied heavily on national experts and standards. Although their input is valued, the true advantage of QI is the opportunity for pediatricians and their staff at the service delivery level to generate their own changes within the context of a learning collaborative. True improvement and innovation is facilitated by allowing flexibility at the local level and sharing the ideas that result. Those that design the QI efforts of the future need to make sure they allow for local expertise rather than leaning too heavily on centrally predetermined change concepts.
Part IV Maintenance of Certification requirements from the American Board of Pediatrics help provide momentum for successful pediatric QI. The National Improvement Partnership Network has formed pediatric outpatient learning collaboratives to share ideas. As we identify more successes with ambulatory care QI, as more and more organizations like AAP state chapters become involved, as all practices – rather than just the best – recognize the obligation to promote quality, we have a tremendous opportunity to improve the developmental and health outcomes of the children. QI can promote work and cost efficiencies that facilitate our work as pediatricians, making our lives more productive and rewarding.
Francis E. Rushton Jr, MD, is a pediatrician and medical director of South Carolina’s QTIP (Quality Through Innovation in Pediatrics) network and the Quality Director for PHIIT (Pediatric Health Improvement In Tennessee). He reported not having any relevant financial disclosures.
Care of children with asthma can be improved using statewide quality improvement (QI) learning collaboratives, said Judith C. Dolins, of the American Academy of Pediatrics (AAP), Elk Grove Village, Ill., and her associates.
AAP chapters demonstrated this through their implementation of the Chapter Quality Network (CQN) project, which was supported by the national organization. This project sought to encourage practice changes in asthma care in a number of states using statewide QI learning collaboratives and lead practices to implement the National Heart, Lung, and Blood Institute’s (NHLBI) 2007 asthma guidelines over the course of four time periods, which the researchers referred to as waves. In nine states, 19 AAP chapters engaged 180 practices to participate, and involved 749 pediatricians treating 45,431 patients (Pediatrics. 2017. doi: 10.1542/peds.2016-1612).
Across all waves, practices had reasonably high baseline use of the stepwise approach (81%-89%) and a controller medication for patients with persistent asthma (74%-88%). The patients with a current written asthma action plan increased from 49%-57% to 75%-91%. Physicians’ and parents’ ratings of asthma in children as “well controlled” rose modestly from 58%-63% to 71%-74% and from 67%-73% to 78%-87%, respectively. Patients receiving self-management materials increased from 57%-62% to 62%-88%.
Here’s how the project worked. The CQN had three linked frameworks.: One provided a methodology for spreading practice changes, another outlined the elements of care, and a third provided a framework so the practices could test, implement, and adapt changes.
A national AAP leadership team of experts in asthma care, QI, and primary care practice systems developed a set of key drivers and interventions, and an implementation guide that included resources, tools and methods, and a set of measures for the chapters. They also designed reporting tools and a curriculum fostering QI learning by chapter leaders. Then, in a state chapter leadership learning network and a practice collaborative model in each state, there were “multiple in-person learning sessions and defined action periods, best practices, and tests of change that were spread and incorporated” for the chapters to use, according to the study report.
Chapters in each state had monthly webinars and two in-person learning sessions for participating practices. They also reviewed data reports at the state and practice level and provided coaching for practices.
Practices were asked to “incorporate optimal NHLBI asthma care practices, including assessment of control, a stepwise approach to treatment, appropriate use of controller medication, and an updated asthma action plan for self-management.” Other interventions included use of an asthma encounter form (which collected 16 measures, including outcome and process measures that were entered into a national database at least monthly); introduction of population registries; workflow assessment; motivational interviews; plan-do-study-act cycles for QI; and review of data for QI.
All the physicians were eligible to earn MOC part 4 credit and continuing medical education credit, and 80% of the physicians did get MOC credit across the 4 waves.
“Our findings are notable for achieving improvement in asthma care through training multiple state coordinating entities instead of directly leading the learning collaborative itself. Few other projects have achieved this level of results in pediatric practice improvement in asthma care on such a widespread scale across multiple states. This project may serve as a model for other statewide and national organizations attempting to achieve improvements in population health through support and training for statewide organizations that, in turn, support individual health care providers and practices,” Ms. Dolins and her associates said. “Although none of the waves achieved the preset goal of 90%, all showed substantial improvement and remarkable consistency in the rate of improvement. We, therefore, regarded the project as an overall success.”
The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
Care of children with asthma can be improved using statewide quality improvement (QI) learning collaboratives, said Judith C. Dolins, of the American Academy of Pediatrics (AAP), Elk Grove Village, Ill., and her associates.
AAP chapters demonstrated this through their implementation of the Chapter Quality Network (CQN) project, which was supported by the national organization. This project sought to encourage practice changes in asthma care in a number of states using statewide QI learning collaboratives and lead practices to implement the National Heart, Lung, and Blood Institute’s (NHLBI) 2007 asthma guidelines over the course of four time periods, which the researchers referred to as waves. In nine states, 19 AAP chapters engaged 180 practices to participate, and involved 749 pediatricians treating 45,431 patients (Pediatrics. 2017. doi: 10.1542/peds.2016-1612).
Across all waves, practices had reasonably high baseline use of the stepwise approach (81%-89%) and a controller medication for patients with persistent asthma (74%-88%). The patients with a current written asthma action plan increased from 49%-57% to 75%-91%. Physicians’ and parents’ ratings of asthma in children as “well controlled” rose modestly from 58%-63% to 71%-74% and from 67%-73% to 78%-87%, respectively. Patients receiving self-management materials increased from 57%-62% to 62%-88%.
Here’s how the project worked. The CQN had three linked frameworks.: One provided a methodology for spreading practice changes, another outlined the elements of care, and a third provided a framework so the practices could test, implement, and adapt changes.
A national AAP leadership team of experts in asthma care, QI, and primary care practice systems developed a set of key drivers and interventions, and an implementation guide that included resources, tools and methods, and a set of measures for the chapters. They also designed reporting tools and a curriculum fostering QI learning by chapter leaders. Then, in a state chapter leadership learning network and a practice collaborative model in each state, there were “multiple in-person learning sessions and defined action periods, best practices, and tests of change that were spread and incorporated” for the chapters to use, according to the study report.
Chapters in each state had monthly webinars and two in-person learning sessions for participating practices. They also reviewed data reports at the state and practice level and provided coaching for practices.
Practices were asked to “incorporate optimal NHLBI asthma care practices, including assessment of control, a stepwise approach to treatment, appropriate use of controller medication, and an updated asthma action plan for self-management.” Other interventions included use of an asthma encounter form (which collected 16 measures, including outcome and process measures that were entered into a national database at least monthly); introduction of population registries; workflow assessment; motivational interviews; plan-do-study-act cycles for QI; and review of data for QI.
All the physicians were eligible to earn MOC part 4 credit and continuing medical education credit, and 80% of the physicians did get MOC credit across the 4 waves.
“Our findings are notable for achieving improvement in asthma care through training multiple state coordinating entities instead of directly leading the learning collaborative itself. Few other projects have achieved this level of results in pediatric practice improvement in asthma care on such a widespread scale across multiple states. This project may serve as a model for other statewide and national organizations attempting to achieve improvements in population health through support and training for statewide organizations that, in turn, support individual health care providers and practices,” Ms. Dolins and her associates said. “Although none of the waves achieved the preset goal of 90%, all showed substantial improvement and remarkable consistency in the rate of improvement. We, therefore, regarded the project as an overall success.”
The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
FROM PEDIATRICS
Key clinical point:
Major finding: In wave 4, during which data were collected for 9 months, the rate of optimal asthma care at each encounter improved from 38% to 72%.
Data source: In nine states, 19 AAP chapters engaged 180 practices to participate in quality improvement learning collaboratives, which involved 749 pediatricians treating 45,431 patients.
Disclosures: The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
Add-on azithromycin cuts asthma exacerbations
Adults with persistent symptomatic asthma who took azithromycin as an add-on therapy experienced fewer exacerbations and had improved quality of life, compared with their peers who took a placebo, a multicenter, randomized trial demonstrated.
“Macrolide antibiotics have antibacterial, antiviral, and anti-inflammatory effects, and are reported to be beneficial in both eosinophilic and noneosinophilic subtypes,” a group of Australian researchers wrote online July 4 in The Lancet (doi: org/10.1016/S0140-6736[17]31281-3). “Systematic reviews of randomized, controlled trials report benefits of macrolides on asthma symptoms but [we] are unable to draw conclusions about the effects on other endpoints, including exacerbations, due to lack of data, heterogeneity of results, and inadequate study design and sample size.”
The researchers observed a significant reduction in the incidence of total asthma exacerbations in the azithromycin-treated group: 1.07/patient-year, compared with 1.86/patient year in the placebo group, which translated into an incidence rate ratio of 0.59 (P less than .0001). Specifically, 127 patients in the placebo group (61%) experienced at least one asthma exacerbation compared with 94 patients in the azithromycin group (44%; P less than .0001). A significant improvement in asthma-related quality of life was also seen among patients in the azithromycin group (adjusted mean difference of 0.36; P = .001).
Though the mechanism of the antiviral effect of macrolides is not yet determined, Dr. Gibson and his associates noted that respiratory viral infection is associated with severe exacerbations in eosinophilic asthma and causes most respiratory infections. “There is a known interaction between eosinophilic airway inflammation, exacerbation rate, and impaired innate antiviral immunity,” they wrote. “Since we observed a benefit of azithromycin on both asthma exacerbations and respiratory infections, we speculate that azithromycin might be acting to prevent viral-induced episodes in asthma.”
“Given the major impact of asthma exacerbations on patients and the community and the ongoing risk posed by these events in patients who remain symptomatic on maintenance therapy, we consider that azithromycin is a valuable addition to existing regimens for treating asthma,” the researchers concluded. “The long-term effects of this therapy on community microbial resistance require further evaluation.”
The overall rates and types of serious adverse events seen in both groups were not significantly different from each other, with serious adverse events having occurred in 16 (8%) patients treated with azithromycin and 26 (13%) patients given the placebo.
The study was funded by the National Health and Medical Research Council of Australia and the John Hunter Hospital Charitable Trust. The authors reported having no financial conflicts directly related to the study.
Since microbial resistance is a well known side effect of antibiotic use, add-on therapy with azithromycin in asthma needs to be restricted to those patients with the highest unmet medical need (for example, frequent exacerbators) and to time periods with the greatest risk of exacerbations (such as winter). Biomarkers that predict the therapeutic response to macrolides might facilitate optimal patient selection. Further research is needed to elucidate the most important mechanism of action of these pleiotropic drugs. Macrolides have anti-inflammatory, antibacterial, and antiviral effects. However, the authors did not observe a reduction in inflammatory cell counts in sputum to support a definite anti-inflammatory effect. Azithromycin also was effective in patients with and without potentially pathogenic microorganisms in sputum cultures at baseline. Since azithromycin reduced both asthma exacerbations and respiratory infections, the benefits of azithromycin might be caused by preventing viral-induced attacks in asthma. Azithromycin stimulates phagocytosis of microbes and dead cells by macrophages (i.e., efferocytosis), an effect that is likely to be independent of the nature of the accompanying neutrophilic or eosinophilic airway inflammation.
Gibson and colleagues have clearly shown that add-on therapy with azithromycin is effective and safe in adult patients with uncontrolled asthma despite treatment with inhaled corticosteroids and long-acting beta-agonists. Azithromycin benefited patients with both eosinophilic and noneosinophilic asthma. However, the effects of long-term therapy with macrolides on community microbial resistance remain a public health concern. Future studies with potentially safer nonantibiotic macrolides in uncontrolled severe asthma are warranted. Since the antimicrobial effects probably contribute to the overall efficacy of macrolides, the beneficial effects of nonantibiotic macrolides might be intermediate between macrolide antibiotics and placebo.
This text is excerpted from a commentary published online July 4 in The Lancet (doi. org/10.1016/S0140-6736[17]31547-7). Guy Brusselle, MD, is with the department of respiratory medicine at Ghent (Belgium) University Hospital and Ian Pavord, MD, is with the University of Oxford’s Nuffield Department of Medicine, England. Both authors disclosed having received honoraria and other financial support from numerous pharmaceutical companies.
Since microbial resistance is a well known side effect of antibiotic use, add-on therapy with azithromycin in asthma needs to be restricted to those patients with the highest unmet medical need (for example, frequent exacerbators) and to time periods with the greatest risk of exacerbations (such as winter). Biomarkers that predict the therapeutic response to macrolides might facilitate optimal patient selection. Further research is needed to elucidate the most important mechanism of action of these pleiotropic drugs. Macrolides have anti-inflammatory, antibacterial, and antiviral effects. However, the authors did not observe a reduction in inflammatory cell counts in sputum to support a definite anti-inflammatory effect. Azithromycin also was effective in patients with and without potentially pathogenic microorganisms in sputum cultures at baseline. Since azithromycin reduced both asthma exacerbations and respiratory infections, the benefits of azithromycin might be caused by preventing viral-induced attacks in asthma. Azithromycin stimulates phagocytosis of microbes and dead cells by macrophages (i.e., efferocytosis), an effect that is likely to be independent of the nature of the accompanying neutrophilic or eosinophilic airway inflammation.
Gibson and colleagues have clearly shown that add-on therapy with azithromycin is effective and safe in adult patients with uncontrolled asthma despite treatment with inhaled corticosteroids and long-acting beta-agonists. Azithromycin benefited patients with both eosinophilic and noneosinophilic asthma. However, the effects of long-term therapy with macrolides on community microbial resistance remain a public health concern. Future studies with potentially safer nonantibiotic macrolides in uncontrolled severe asthma are warranted. Since the antimicrobial effects probably contribute to the overall efficacy of macrolides, the beneficial effects of nonantibiotic macrolides might be intermediate between macrolide antibiotics and placebo.
This text is excerpted from a commentary published online July 4 in The Lancet (doi. org/10.1016/S0140-6736[17]31547-7). Guy Brusselle, MD, is with the department of respiratory medicine at Ghent (Belgium) University Hospital and Ian Pavord, MD, is with the University of Oxford’s Nuffield Department of Medicine, England. Both authors disclosed having received honoraria and other financial support from numerous pharmaceutical companies.
Since microbial resistance is a well known side effect of antibiotic use, add-on therapy with azithromycin in asthma needs to be restricted to those patients with the highest unmet medical need (for example, frequent exacerbators) and to time periods with the greatest risk of exacerbations (such as winter). Biomarkers that predict the therapeutic response to macrolides might facilitate optimal patient selection. Further research is needed to elucidate the most important mechanism of action of these pleiotropic drugs. Macrolides have anti-inflammatory, antibacterial, and antiviral effects. However, the authors did not observe a reduction in inflammatory cell counts in sputum to support a definite anti-inflammatory effect. Azithromycin also was effective in patients with and without potentially pathogenic microorganisms in sputum cultures at baseline. Since azithromycin reduced both asthma exacerbations and respiratory infections, the benefits of azithromycin might be caused by preventing viral-induced attacks in asthma. Azithromycin stimulates phagocytosis of microbes and dead cells by macrophages (i.e., efferocytosis), an effect that is likely to be independent of the nature of the accompanying neutrophilic or eosinophilic airway inflammation.
Gibson and colleagues have clearly shown that add-on therapy with azithromycin is effective and safe in adult patients with uncontrolled asthma despite treatment with inhaled corticosteroids and long-acting beta-agonists. Azithromycin benefited patients with both eosinophilic and noneosinophilic asthma. However, the effects of long-term therapy with macrolides on community microbial resistance remain a public health concern. Future studies with potentially safer nonantibiotic macrolides in uncontrolled severe asthma are warranted. Since the antimicrobial effects probably contribute to the overall efficacy of macrolides, the beneficial effects of nonantibiotic macrolides might be intermediate between macrolide antibiotics and placebo.
This text is excerpted from a commentary published online July 4 in The Lancet (doi. org/10.1016/S0140-6736[17]31547-7). Guy Brusselle, MD, is with the department of respiratory medicine at Ghent (Belgium) University Hospital and Ian Pavord, MD, is with the University of Oxford’s Nuffield Department of Medicine, England. Both authors disclosed having received honoraria and other financial support from numerous pharmaceutical companies.
Adults with persistent symptomatic asthma who took azithromycin as an add-on therapy experienced fewer exacerbations and had improved quality of life, compared with their peers who took a placebo, a multicenter, randomized trial demonstrated.
“Macrolide antibiotics have antibacterial, antiviral, and anti-inflammatory effects, and are reported to be beneficial in both eosinophilic and noneosinophilic subtypes,” a group of Australian researchers wrote online July 4 in The Lancet (doi: org/10.1016/S0140-6736[17]31281-3). “Systematic reviews of randomized, controlled trials report benefits of macrolides on asthma symptoms but [we] are unable to draw conclusions about the effects on other endpoints, including exacerbations, due to lack of data, heterogeneity of results, and inadequate study design and sample size.”
The researchers observed a significant reduction in the incidence of total asthma exacerbations in the azithromycin-treated group: 1.07/patient-year, compared with 1.86/patient year in the placebo group, which translated into an incidence rate ratio of 0.59 (P less than .0001). Specifically, 127 patients in the placebo group (61%) experienced at least one asthma exacerbation compared with 94 patients in the azithromycin group (44%; P less than .0001). A significant improvement in asthma-related quality of life was also seen among patients in the azithromycin group (adjusted mean difference of 0.36; P = .001).
Though the mechanism of the antiviral effect of macrolides is not yet determined, Dr. Gibson and his associates noted that respiratory viral infection is associated with severe exacerbations in eosinophilic asthma and causes most respiratory infections. “There is a known interaction between eosinophilic airway inflammation, exacerbation rate, and impaired innate antiviral immunity,” they wrote. “Since we observed a benefit of azithromycin on both asthma exacerbations and respiratory infections, we speculate that azithromycin might be acting to prevent viral-induced episodes in asthma.”
“Given the major impact of asthma exacerbations on patients and the community and the ongoing risk posed by these events in patients who remain symptomatic on maintenance therapy, we consider that azithromycin is a valuable addition to existing regimens for treating asthma,” the researchers concluded. “The long-term effects of this therapy on community microbial resistance require further evaluation.”
The overall rates and types of serious adverse events seen in both groups were not significantly different from each other, with serious adverse events having occurred in 16 (8%) patients treated with azithromycin and 26 (13%) patients given the placebo.
The study was funded by the National Health and Medical Research Council of Australia and the John Hunter Hospital Charitable Trust. The authors reported having no financial conflicts directly related to the study.
Adults with persistent symptomatic asthma who took azithromycin as an add-on therapy experienced fewer exacerbations and had improved quality of life, compared with their peers who took a placebo, a multicenter, randomized trial demonstrated.
“Macrolide antibiotics have antibacterial, antiviral, and anti-inflammatory effects, and are reported to be beneficial in both eosinophilic and noneosinophilic subtypes,” a group of Australian researchers wrote online July 4 in The Lancet (doi: org/10.1016/S0140-6736[17]31281-3). “Systematic reviews of randomized, controlled trials report benefits of macrolides on asthma symptoms but [we] are unable to draw conclusions about the effects on other endpoints, including exacerbations, due to lack of data, heterogeneity of results, and inadequate study design and sample size.”
The researchers observed a significant reduction in the incidence of total asthma exacerbations in the azithromycin-treated group: 1.07/patient-year, compared with 1.86/patient year in the placebo group, which translated into an incidence rate ratio of 0.59 (P less than .0001). Specifically, 127 patients in the placebo group (61%) experienced at least one asthma exacerbation compared with 94 patients in the azithromycin group (44%; P less than .0001). A significant improvement in asthma-related quality of life was also seen among patients in the azithromycin group (adjusted mean difference of 0.36; P = .001).
Though the mechanism of the antiviral effect of macrolides is not yet determined, Dr. Gibson and his associates noted that respiratory viral infection is associated with severe exacerbations in eosinophilic asthma and causes most respiratory infections. “There is a known interaction between eosinophilic airway inflammation, exacerbation rate, and impaired innate antiviral immunity,” they wrote. “Since we observed a benefit of azithromycin on both asthma exacerbations and respiratory infections, we speculate that azithromycin might be acting to prevent viral-induced episodes in asthma.”
“Given the major impact of asthma exacerbations on patients and the community and the ongoing risk posed by these events in patients who remain symptomatic on maintenance therapy, we consider that azithromycin is a valuable addition to existing regimens for treating asthma,” the researchers concluded. “The long-term effects of this therapy on community microbial resistance require further evaluation.”
The overall rates and types of serious adverse events seen in both groups were not significantly different from each other, with serious adverse events having occurred in 16 (8%) patients treated with azithromycin and 26 (13%) patients given the placebo.
The study was funded by the National Health and Medical Research Council of Australia and the John Hunter Hospital Charitable Trust. The authors reported having no financial conflicts directly related to the study.
FROM THE LANCET
Key clinical point:
Major finding: Azithromycin reduced the incidence of total asthma exacerbations, compared with placebo (1.07/patient-year vs. 1.86/patient-year, respectively, for an incidence rate ratio of 0.59; P less than .0001).
Data source: A randomized, placebo-controlled, multicenter trial of 420 adults with persistent, uncontrolled asthma.
Disclosures: The study was funded by the National Health and Medical Research Council of Australia and the John Hunter Hospital Charitable Trust. The authors reported having no financial conflicts directly related to the study.
Study: No increased mortality with ACA-prompted readmission declines
Concerns that efforts to reduce 30-day hospital readmission rates under the Affordable Care Act’s Hospital Readmission Reduction Program might lead to unintended increases in mortality rates appear to be unfounded, according to a review of more than 6.7 million hospitalizations for heart failure, acute myocardial infarction, or pneumonia between 2008 and 2014.
In fact, reductions in 30-day readmission rates among Medicare fee-for-service beneficiaries are weakly but significantly correlated with reductions in hospital 30-day mortality rates after discharge, according to Kumar Dharmarajan, MD, of Yale New Haven (Conn.) Health, and colleagues (JAMA 2017 Jul 18;318[3]:270-8. doi: 10.1001/jama.2017.8444).
From 2008 to 2014, the RARRs declined in aggregate across hospitals (–0.053% for heart failure, –0.044% for acute MI, and –0.033% for pneumonia).
“In contrast, monthly aggregate trends across hospitals in 30-day risk-adjusted mortality rates after discharge varied by admitting condition” the investigators said.
For heart failure, acute MI, and pneumonia, there was an increase of 0.008%, a decrease of 0.003%, and an increase of 0.001%, respectively, they said. However, paired monthly trends in 30-day RARRs and 30-day RAMRs after discharge “identified concomitant reduction in readmission and mortality rates within hospitals.”
Correlation coefficients of the paired monthly trends for heart failure, acute MI, and pneumonia in 2008-2014 were 0.066, 0.067, and 0.108, respectively.
“Paired trends in hospital 30-day risk-adjusted readmission rates and both 90-day risk-adjusted mortality rates after discharge and 90-day risk-adjusted mortality rates after the admission date also identified concomitant reductions in readmission and mortality rates within hospitals,” the authors wrote.
The findings “do not support increasing postdischarge mortality related to reducing hospital readmissions,” they concluded.
The authors work under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures. Dr. Dharmarajan reported serving as a consultant and scientific advisory board member for Clover Health at the time this research was performed. He is supported by grants from the National Institute on Aging and the American Federation for Aging Research, and the Yale Claude D. Pepper Older Americans Independence Center.
The findings by Dharmarajan and colleagues are “certainly good news,” Karen E. Joynt Maddox, MD, wrote in an editorial.
The study provides support for strategies that hospitals are using to reduce readmissions, and also underscores the importance of evaluating unintended consequences of policy changes such as the Affordable Care Act’s Hospital Readmissions Reduction Program (HRRP), she said (JAMA. 2017 Jul 18;318[3]:243-4).
The study did not address the possibility that attention to reducing readmissions has taken priority over reducing mortality, which could have the unintended consequence of slowing improvements in mortality, she noted, suggesting that for this and other reasons it may be “time to reexamine and reengineer the HRRP to avoid unintended consequences and to ensure that its incentives are fully aligned with the ultimate goal of improving the health outcomes of patients.
“Only with full knowledge of the advantages and disadvantages of a particular policy decision can policy makers and advocates work to craft statutes and rules that maximize benefits while minimizing harms,” she wrote.
Dr. Joynt Maddox is with Brigham and Women’s Hospital, Boston. She is supported by a grant from the National Heart, Lung, and Blood Institute.
The findings by Dharmarajan and colleagues are “certainly good news,” Karen E. Joynt Maddox, MD, wrote in an editorial.
The study provides support for strategies that hospitals are using to reduce readmissions, and also underscores the importance of evaluating unintended consequences of policy changes such as the Affordable Care Act’s Hospital Readmissions Reduction Program (HRRP), she said (JAMA. 2017 Jul 18;318[3]:243-4).
The study did not address the possibility that attention to reducing readmissions has taken priority over reducing mortality, which could have the unintended consequence of slowing improvements in mortality, she noted, suggesting that for this and other reasons it may be “time to reexamine and reengineer the HRRP to avoid unintended consequences and to ensure that its incentives are fully aligned with the ultimate goal of improving the health outcomes of patients.
“Only with full knowledge of the advantages and disadvantages of a particular policy decision can policy makers and advocates work to craft statutes and rules that maximize benefits while minimizing harms,” she wrote.
Dr. Joynt Maddox is with Brigham and Women’s Hospital, Boston. She is supported by a grant from the National Heart, Lung, and Blood Institute.
The findings by Dharmarajan and colleagues are “certainly good news,” Karen E. Joynt Maddox, MD, wrote in an editorial.
The study provides support for strategies that hospitals are using to reduce readmissions, and also underscores the importance of evaluating unintended consequences of policy changes such as the Affordable Care Act’s Hospital Readmissions Reduction Program (HRRP), she said (JAMA. 2017 Jul 18;318[3]:243-4).
The study did not address the possibility that attention to reducing readmissions has taken priority over reducing mortality, which could have the unintended consequence of slowing improvements in mortality, she noted, suggesting that for this and other reasons it may be “time to reexamine and reengineer the HRRP to avoid unintended consequences and to ensure that its incentives are fully aligned with the ultimate goal of improving the health outcomes of patients.
“Only with full knowledge of the advantages and disadvantages of a particular policy decision can policy makers and advocates work to craft statutes and rules that maximize benefits while minimizing harms,” she wrote.
Dr. Joynt Maddox is with Brigham and Women’s Hospital, Boston. She is supported by a grant from the National Heart, Lung, and Blood Institute.
Concerns that efforts to reduce 30-day hospital readmission rates under the Affordable Care Act’s Hospital Readmission Reduction Program might lead to unintended increases in mortality rates appear to be unfounded, according to a review of more than 6.7 million hospitalizations for heart failure, acute myocardial infarction, or pneumonia between 2008 and 2014.
In fact, reductions in 30-day readmission rates among Medicare fee-for-service beneficiaries are weakly but significantly correlated with reductions in hospital 30-day mortality rates after discharge, according to Kumar Dharmarajan, MD, of Yale New Haven (Conn.) Health, and colleagues (JAMA 2017 Jul 18;318[3]:270-8. doi: 10.1001/jama.2017.8444).
From 2008 to 2014, the RARRs declined in aggregate across hospitals (–0.053% for heart failure, –0.044% for acute MI, and –0.033% for pneumonia).
“In contrast, monthly aggregate trends across hospitals in 30-day risk-adjusted mortality rates after discharge varied by admitting condition” the investigators said.
For heart failure, acute MI, and pneumonia, there was an increase of 0.008%, a decrease of 0.003%, and an increase of 0.001%, respectively, they said. However, paired monthly trends in 30-day RARRs and 30-day RAMRs after discharge “identified concomitant reduction in readmission and mortality rates within hospitals.”
Correlation coefficients of the paired monthly trends for heart failure, acute MI, and pneumonia in 2008-2014 were 0.066, 0.067, and 0.108, respectively.
“Paired trends in hospital 30-day risk-adjusted readmission rates and both 90-day risk-adjusted mortality rates after discharge and 90-day risk-adjusted mortality rates after the admission date also identified concomitant reductions in readmission and mortality rates within hospitals,” the authors wrote.
The findings “do not support increasing postdischarge mortality related to reducing hospital readmissions,” they concluded.
The authors work under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures. Dr. Dharmarajan reported serving as a consultant and scientific advisory board member for Clover Health at the time this research was performed. He is supported by grants from the National Institute on Aging and the American Federation for Aging Research, and the Yale Claude D. Pepper Older Americans Independence Center.
Concerns that efforts to reduce 30-day hospital readmission rates under the Affordable Care Act’s Hospital Readmission Reduction Program might lead to unintended increases in mortality rates appear to be unfounded, according to a review of more than 6.7 million hospitalizations for heart failure, acute myocardial infarction, or pneumonia between 2008 and 2014.
In fact, reductions in 30-day readmission rates among Medicare fee-for-service beneficiaries are weakly but significantly correlated with reductions in hospital 30-day mortality rates after discharge, according to Kumar Dharmarajan, MD, of Yale New Haven (Conn.) Health, and colleagues (JAMA 2017 Jul 18;318[3]:270-8. doi: 10.1001/jama.2017.8444).
From 2008 to 2014, the RARRs declined in aggregate across hospitals (–0.053% for heart failure, –0.044% for acute MI, and –0.033% for pneumonia).
“In contrast, monthly aggregate trends across hospitals in 30-day risk-adjusted mortality rates after discharge varied by admitting condition” the investigators said.
For heart failure, acute MI, and pneumonia, there was an increase of 0.008%, a decrease of 0.003%, and an increase of 0.001%, respectively, they said. However, paired monthly trends in 30-day RARRs and 30-day RAMRs after discharge “identified concomitant reduction in readmission and mortality rates within hospitals.”
Correlation coefficients of the paired monthly trends for heart failure, acute MI, and pneumonia in 2008-2014 were 0.066, 0.067, and 0.108, respectively.
“Paired trends in hospital 30-day risk-adjusted readmission rates and both 90-day risk-adjusted mortality rates after discharge and 90-day risk-adjusted mortality rates after the admission date also identified concomitant reductions in readmission and mortality rates within hospitals,” the authors wrote.
The findings “do not support increasing postdischarge mortality related to reducing hospital readmissions,” they concluded.
The authors work under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures. Dr. Dharmarajan reported serving as a consultant and scientific advisory board member for Clover Health at the time this research was performed. He is supported by grants from the National Institute on Aging and the American Federation for Aging Research, and the Yale Claude D. Pepper Older Americans Independence Center.
FROM JAMA
Key clinical point:
Major finding: Correlation coefficients of the paired monthly trends for heart failure, acute myocardial infarction, and pneumonia in 2008-2014 were 0.066, 0.067, and 0.108, respectively.
Data source: A retrospective review of more than 6.7 million hospitalized Medicare fee-for-service beneficiaries.
Disclosures: The authors work under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures. Dr. Dharmarajan reported serving as a consultant and scientific advisory board member for Clover Health at the time this research was performed. He is supported by grants from the National Institute on Aging and the American Federation for Aging Research, and the Yale Claude D. Pepper Older Americans Independence Center.
High-dose vitamin D fails against young children’s upper respiratory infections
A daily dose of 2,000 IU of vitamin D had no impact on reducing wintertime upper respiratory tract infections in young children, compared with a 400 IU dose, based on a study of 703 children aged 1-5 years. The report was published July 18 in JAMA.
“Vitamin D increases the synthesis of the antimicrobial peptide cathelicidin in respiratory epithelium, which has been shown to reduce disease severity and replication of the influenza virus in vitro,” but studies on the effect of vitamin D on upper respiratory infections have been limited, wrote Mary Aglipay of St. Michael’s Hospital, Toronto, and her colleagues.
The average number of laboratory-confirmed cases of upper respiratory tract infections per child was not significantly different between the high-dose and low-dose groups (1.05 vs. 1.03).
The median time to the first laboratory-confirmed infection was similar between the groups: 3.95 months in the high-dose group and 3.29 months in the low-dose group. In addition, the number of parent-reported upper respiratory tract infections was similar between the high-dose and low-dose groups (625 vs. 600).
Serum 25-hydroxyvitamin D levels also remained comparable between the high-dose and low-dose groups at the study’s end (48.7 ng/mL vs. 36.8 ng/mL).
The results were limited by several factors, including the lack of a placebo group and the high baseline vitamin D levels in the children at the end of the summer, the researchers noted.
However, “these findings do not support the routine use of high-dose vitamin D supplementation in children for the prevention of viral upper respiratory tract infection,” they said.
The study was supported by the Canadian Institutes of Health Research, Institute of Human Development, Child and Youth Health, and Institute of Nutrition, Metabolism and Diabetes, and the Thrasher Research Fund. The vitamin D formulations were donated by Ddrops. Ms. Aglipay had no financial conflicts to disclose. One coauthor, Muhammad Mamdani, MPH, had ties to a number of pharmaceutical companies.
A daily dose of 2,000 IU of vitamin D had no impact on reducing wintertime upper respiratory tract infections in young children, compared with a 400 IU dose, based on a study of 703 children aged 1-5 years. The report was published July 18 in JAMA.
“Vitamin D increases the synthesis of the antimicrobial peptide cathelicidin in respiratory epithelium, which has been shown to reduce disease severity and replication of the influenza virus in vitro,” but studies on the effect of vitamin D on upper respiratory infections have been limited, wrote Mary Aglipay of St. Michael’s Hospital, Toronto, and her colleagues.
The average number of laboratory-confirmed cases of upper respiratory tract infections per child was not significantly different between the high-dose and low-dose groups (1.05 vs. 1.03).
The median time to the first laboratory-confirmed infection was similar between the groups: 3.95 months in the high-dose group and 3.29 months in the low-dose group. In addition, the number of parent-reported upper respiratory tract infections was similar between the high-dose and low-dose groups (625 vs. 600).
Serum 25-hydroxyvitamin D levels also remained comparable between the high-dose and low-dose groups at the study’s end (48.7 ng/mL vs. 36.8 ng/mL).
The results were limited by several factors, including the lack of a placebo group and the high baseline vitamin D levels in the children at the end of the summer, the researchers noted.
However, “these findings do not support the routine use of high-dose vitamin D supplementation in children for the prevention of viral upper respiratory tract infection,” they said.
The study was supported by the Canadian Institutes of Health Research, Institute of Human Development, Child and Youth Health, and Institute of Nutrition, Metabolism and Diabetes, and the Thrasher Research Fund. The vitamin D formulations were donated by Ddrops. Ms. Aglipay had no financial conflicts to disclose. One coauthor, Muhammad Mamdani, MPH, had ties to a number of pharmaceutical companies.
A daily dose of 2,000 IU of vitamin D had no impact on reducing wintertime upper respiratory tract infections in young children, compared with a 400 IU dose, based on a study of 703 children aged 1-5 years. The report was published July 18 in JAMA.
“Vitamin D increases the synthesis of the antimicrobial peptide cathelicidin in respiratory epithelium, which has been shown to reduce disease severity and replication of the influenza virus in vitro,” but studies on the effect of vitamin D on upper respiratory infections have been limited, wrote Mary Aglipay of St. Michael’s Hospital, Toronto, and her colleagues.
The average number of laboratory-confirmed cases of upper respiratory tract infections per child was not significantly different between the high-dose and low-dose groups (1.05 vs. 1.03).
The median time to the first laboratory-confirmed infection was similar between the groups: 3.95 months in the high-dose group and 3.29 months in the low-dose group. In addition, the number of parent-reported upper respiratory tract infections was similar between the high-dose and low-dose groups (625 vs. 600).
Serum 25-hydroxyvitamin D levels also remained comparable between the high-dose and low-dose groups at the study’s end (48.7 ng/mL vs. 36.8 ng/mL).
The results were limited by several factors, including the lack of a placebo group and the high baseline vitamin D levels in the children at the end of the summer, the researchers noted.
However, “these findings do not support the routine use of high-dose vitamin D supplementation in children for the prevention of viral upper respiratory tract infection,” they said.
The study was supported by the Canadian Institutes of Health Research, Institute of Human Development, Child and Youth Health, and Institute of Nutrition, Metabolism and Diabetes, and the Thrasher Research Fund. The vitamin D formulations were donated by Ddrops. Ms. Aglipay had no financial conflicts to disclose. One coauthor, Muhammad Mamdani, MPH, had ties to a number of pharmaceutical companies.
FROM JAMA
Key clinical point:
Major finding: The average number of laboratory-confirmed upper respiratory tract infections per child was not significantly different between the high-dose and low-dose groups (1.05 vs. 1.03).
Data source: A study of 703 healthy children aged 1-5 years randomized to 2,000 IU or 400 IU of vitamin D.
Disclosures: The study was supported by the Canadian Institutes of Health Research, Institute of Human Development, Child and Youth Health, and Institute of Nutrition, Metabolism and Diabetes, and the Thrasher Research Fund. The vitamin D formulations were donated by Ddrops. Ms. Aglipay had no financial conflicts to disclose. One coauthor, Muhammad Mamdani, MPH, had ties to a number of pharmaceutical companies.
Immune signature shows good prognostic performance in early-stage NSCLC
A new tumor immune-related gene signature may help take the guesswork out of prognostication in patients with early-stage non–small cell lung cancer (NSCLC), according to a retrospective cohort study.
“Various components of the immune system have been shown to be a determining factor during cancer initiation and progression,” note the investigators, who were led by Bailiang Li, PhD, of Stanford (Calif.) University. “Recent immunotherapies targeting specific immune checkpoints such as programmed death 1 or programmed death ligand 1 have demonstrated a remarkable, durable response in NSCLC. Certain histopathologic patterns, such as intratumoral infiltration by cytotoxic lymphocytes, have also been associated with better prognoses in several cancer types, including NSCLC.”
For the study, the investigators developed and validated an immune-related gene signature using frozen tumors from 2,414 patients with stage I or II nonsquamous NSCLC from 19 public cohorts who underwent resection with negative margins and did not receive any neoadjuvant or adjuvant therapy.
The new signature contained 25 gene pairs consisting of 40 unique immune-related genes, Dr. Li and associates report (JAMA Oncol. 2017 Jul 6. doi: 10.1001/jamaoncol.2017.1609).
Processes such as chemotaxis were enriched among the included genes.
The signature significantly stratified patients into groups that have high and low risks of death during follow-up, both across and within subsets with stage I, IA, IB, or II disease. Relative to counterparts falling into the signature-defined low-risk group, those falling into the signature-defined high-risk group had roughly twice the risk of death after adjustment for clinical and pathologic characteristics, with a hazard ratio range of 1.72 (P less than .001) to 2.36 (P less than .001).
Accuracy of the immune signature exceeded that of two commercialized gene signatures for estimating survival in similar validation cohorts (mean concordance index [C-index], 0.64 vs 0.53 and 0.61).
Moreover, the combination of the immune signature with clinical factors outperformed the signature alone (mean C-index, 0.70 vs 0.63) and another commercialized clinical-molecular combination signature (mean C-index, 0.68 vs 0.65).
“The proposed immune-related gene pair–based signature is a promising prognostic biomarker in nonsquamous NSCLC, including early-stage disease,” concluded the investigators. “Prospective studies are needed to further validate its analytical accuracy for estimating prognoses and to test its clinical utility in individualized management of nonsquamous NSCLC.”
M. Patricia Rivera, MD, FCCP, comments: As lung cancer screening implementation increases, it is expected that the prevalence of early-stage non–small cell lung cancer (NSCLC) will increase.
Currently, adjuvant therapy is reserved for patients with tumors greater than 4 cm or those with N1 disease. Having reliable biomarkers to identify patients at a high risk for recurrence after surgical resection is a significant clinical advantage in order to guide adjuvant therapy. The clinical-immune signature described in this study is an exciting and promising biomarker for estimating overall survival in NSCLC.
M. Patricia Rivera, MD, FCCP, comments: As lung cancer screening implementation increases, it is expected that the prevalence of early-stage non–small cell lung cancer (NSCLC) will increase.
Currently, adjuvant therapy is reserved for patients with tumors greater than 4 cm or those with N1 disease. Having reliable biomarkers to identify patients at a high risk for recurrence after surgical resection is a significant clinical advantage in order to guide adjuvant therapy. The clinical-immune signature described in this study is an exciting and promising biomarker for estimating overall survival in NSCLC.
M. Patricia Rivera, MD, FCCP, comments: As lung cancer screening implementation increases, it is expected that the prevalence of early-stage non–small cell lung cancer (NSCLC) will increase.
Currently, adjuvant therapy is reserved for patients with tumors greater than 4 cm or those with N1 disease. Having reliable biomarkers to identify patients at a high risk for recurrence after surgical resection is a significant clinical advantage in order to guide adjuvant therapy. The clinical-immune signature described in this study is an exciting and promising biomarker for estimating overall survival in NSCLC.
A new tumor immune-related gene signature may help take the guesswork out of prognostication in patients with early-stage non–small cell lung cancer (NSCLC), according to a retrospective cohort study.
“Various components of the immune system have been shown to be a determining factor during cancer initiation and progression,” note the investigators, who were led by Bailiang Li, PhD, of Stanford (Calif.) University. “Recent immunotherapies targeting specific immune checkpoints such as programmed death 1 or programmed death ligand 1 have demonstrated a remarkable, durable response in NSCLC. Certain histopathologic patterns, such as intratumoral infiltration by cytotoxic lymphocytes, have also been associated with better prognoses in several cancer types, including NSCLC.”
For the study, the investigators developed and validated an immune-related gene signature using frozen tumors from 2,414 patients with stage I or II nonsquamous NSCLC from 19 public cohorts who underwent resection with negative margins and did not receive any neoadjuvant or adjuvant therapy.
The new signature contained 25 gene pairs consisting of 40 unique immune-related genes, Dr. Li and associates report (JAMA Oncol. 2017 Jul 6. doi: 10.1001/jamaoncol.2017.1609).
Processes such as chemotaxis were enriched among the included genes.
The signature significantly stratified patients into groups that have high and low risks of death during follow-up, both across and within subsets with stage I, IA, IB, or II disease. Relative to counterparts falling into the signature-defined low-risk group, those falling into the signature-defined high-risk group had roughly twice the risk of death after adjustment for clinical and pathologic characteristics, with a hazard ratio range of 1.72 (P less than .001) to 2.36 (P less than .001).
Accuracy of the immune signature exceeded that of two commercialized gene signatures for estimating survival in similar validation cohorts (mean concordance index [C-index], 0.64 vs 0.53 and 0.61).
Moreover, the combination of the immune signature with clinical factors outperformed the signature alone (mean C-index, 0.70 vs 0.63) and another commercialized clinical-molecular combination signature (mean C-index, 0.68 vs 0.65).
“The proposed immune-related gene pair–based signature is a promising prognostic biomarker in nonsquamous NSCLC, including early-stage disease,” concluded the investigators. “Prospective studies are needed to further validate its analytical accuracy for estimating prognoses and to test its clinical utility in individualized management of nonsquamous NSCLC.”
A new tumor immune-related gene signature may help take the guesswork out of prognostication in patients with early-stage non–small cell lung cancer (NSCLC), according to a retrospective cohort study.
“Various components of the immune system have been shown to be a determining factor during cancer initiation and progression,” note the investigators, who were led by Bailiang Li, PhD, of Stanford (Calif.) University. “Recent immunotherapies targeting specific immune checkpoints such as programmed death 1 or programmed death ligand 1 have demonstrated a remarkable, durable response in NSCLC. Certain histopathologic patterns, such as intratumoral infiltration by cytotoxic lymphocytes, have also been associated with better prognoses in several cancer types, including NSCLC.”
For the study, the investigators developed and validated an immune-related gene signature using frozen tumors from 2,414 patients with stage I or II nonsquamous NSCLC from 19 public cohorts who underwent resection with negative margins and did not receive any neoadjuvant or adjuvant therapy.
The new signature contained 25 gene pairs consisting of 40 unique immune-related genes, Dr. Li and associates report (JAMA Oncol. 2017 Jul 6. doi: 10.1001/jamaoncol.2017.1609).
Processes such as chemotaxis were enriched among the included genes.
The signature significantly stratified patients into groups that have high and low risks of death during follow-up, both across and within subsets with stage I, IA, IB, or II disease. Relative to counterparts falling into the signature-defined low-risk group, those falling into the signature-defined high-risk group had roughly twice the risk of death after adjustment for clinical and pathologic characteristics, with a hazard ratio range of 1.72 (P less than .001) to 2.36 (P less than .001).
Accuracy of the immune signature exceeded that of two commercialized gene signatures for estimating survival in similar validation cohorts (mean concordance index [C-index], 0.64 vs 0.53 and 0.61).
Moreover, the combination of the immune signature with clinical factors outperformed the signature alone (mean C-index, 0.70 vs 0.63) and another commercialized clinical-molecular combination signature (mean C-index, 0.68 vs 0.65).
“The proposed immune-related gene pair–based signature is a promising prognostic biomarker in nonsquamous NSCLC, including early-stage disease,” concluded the investigators. “Prospective studies are needed to further validate its analytical accuracy for estimating prognoses and to test its clinical utility in individualized management of nonsquamous NSCLC.”
FROM JAMA ONCOLOGY
Key clinical point:
Major finding: Compared with peers in the signature-defined low-risk group, patients in the signature-defined high-risk group had roughly twice the adjusted risk of death (hazard ratio range, 1.72-2.36).
Data source: A retrospective cohort study using frozen tumors from 2,414 patients with stage I or II nonsquamous NSCLC who underwent complete resection and did not receive adjuvant or neoadjuvant therapy.
Disclosures: The investigators reported that they had no relevant disclosures. The study was supported in part by the National Institutes of Health.
Vaccine reduced risk for flu visits by 42%
Last year’s influenza vaccination reduced the overall risk for flu-related medical visits by 42%, according to the Centers for Disease Control and Prevention.
In an article summarizing influenza activity in the United States during October 2016–May 2017, investigators said that most of the viral strains antigenically characterized at the CDC “were similar to the reference viruses representing the recommended components for the 2016-2017 vaccine.”
The 2017-2018 influenza vaccine has been updated to include an additional influenza A (H1N1) component. This change was recommended by the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, based on data from global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, human serology studies, antiviral susceptibility, and the availability of candidate influenza viruses (MMWR. 2017;66[25]:668-76).
Preliminary data show that, during the 2016-2017 flu season, there were 18,184 laboratory-confirmed, flu-related hospitalizations, for an overall incidence of 65 per 100,000 population, more than double that for the 2015-2017 season (31/100,000). Broken down by age groups, the rates per 100,000 population in this past season were 44 at ages 0-4 years, 17 at ages 5-17 years, 20 at ages 18-49 years, and 65 at ages 50-64 years, compared with 291 at ages 65 years and older. Finalized estimates of the number of influenza illnesses, medical visits, and hospitalizations averted by vaccination during the 2016-2017 season will be published in December, the investigators said.
Last year’s influenza vaccination reduced the overall risk for flu-related medical visits by 42%, according to the Centers for Disease Control and Prevention.
In an article summarizing influenza activity in the United States during October 2016–May 2017, investigators said that most of the viral strains antigenically characterized at the CDC “were similar to the reference viruses representing the recommended components for the 2016-2017 vaccine.”
The 2017-2018 influenza vaccine has been updated to include an additional influenza A (H1N1) component. This change was recommended by the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, based on data from global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, human serology studies, antiviral susceptibility, and the availability of candidate influenza viruses (MMWR. 2017;66[25]:668-76).
Preliminary data show that, during the 2016-2017 flu season, there were 18,184 laboratory-confirmed, flu-related hospitalizations, for an overall incidence of 65 per 100,000 population, more than double that for the 2015-2017 season (31/100,000). Broken down by age groups, the rates per 100,000 population in this past season were 44 at ages 0-4 years, 17 at ages 5-17 years, 20 at ages 18-49 years, and 65 at ages 50-64 years, compared with 291 at ages 65 years and older. Finalized estimates of the number of influenza illnesses, medical visits, and hospitalizations averted by vaccination during the 2016-2017 season will be published in December, the investigators said.
Last year’s influenza vaccination reduced the overall risk for flu-related medical visits by 42%, according to the Centers for Disease Control and Prevention.
In an article summarizing influenza activity in the United States during October 2016–May 2017, investigators said that most of the viral strains antigenically characterized at the CDC “were similar to the reference viruses representing the recommended components for the 2016-2017 vaccine.”
The 2017-2018 influenza vaccine has been updated to include an additional influenza A (H1N1) component. This change was recommended by the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, based on data from global influenza virologic and epidemiologic surveillance, genetic and antigenic characterization, human serology studies, antiviral susceptibility, and the availability of candidate influenza viruses (MMWR. 2017;66[25]:668-76).
Preliminary data show that, during the 2016-2017 flu season, there were 18,184 laboratory-confirmed, flu-related hospitalizations, for an overall incidence of 65 per 100,000 population, more than double that for the 2015-2017 season (31/100,000). Broken down by age groups, the rates per 100,000 population in this past season were 44 at ages 0-4 years, 17 at ages 5-17 years, 20 at ages 18-49 years, and 65 at ages 50-64 years, compared with 291 at ages 65 years and older. Finalized estimates of the number of influenza illnesses, medical visits, and hospitalizations averted by vaccination during the 2016-2017 season will be published in December, the investigators said.
FROM MORBIDITY AND MORTALITY WEEKLY REPORT
Key clinical point: Last year’s influenza vaccination reduced the overall risk for flu-related medical visits by 42%.
Major finding: During the 2016-2017 flu season, there were 18,184 laboratory-confirmed, flu-related hospitalizations, for an overall incidence of 65 per 100,000 population.
Data source: A review of data submitted to the Centers for Disease Control and Prevention regarding the 2016-2017 influenza season.
Disclosures: This study was supported by the CDC. Dr. Blanton and her associates reported having no relevant financial disclosures.
Cancer immunotherapy seen repigmenting gray hair
Patients on immunotherapy treatments for lung cancer have experienced repigmentation of their formerly gray hair, according to a new report. Moreover, researchers say, all but one of the patients experiencing this effect also responded well to the therapy, suggesting that hair repigmentation could potentially serve as a marker of treatment response.
In a case series published online July 12 in JAMA Dermatology (2017. doi: 10.1001/jamadermatol.2017.2106), Noelia Rivera, MD, of the Universitat Autònoma de Barcelona and her colleagues report findings from 14 patients (13 male, mean age 65) receiving anti–programmed cell death 1 (anti–PD-1) and anti–programmed cell death ligand 1 (anti–PD-L1) therapies to treat squamous cell lung cancer or lung adenocarcinoma, with most (11) receiving nivolumab (Opdivo). All but one patient experienced a diffuse darkening of the hair to resemble its previous color, while the remaining patient’s repigmentation occurred in patches.
Dr. Rivera and her colleagues wrote in their analysis that gray hair follicles “still preserve a reduced number of differentiated and functioning melanocytes located in the hair bulb. This reduced number of melanocytes may explain the possibility of [repigmentation] under appropriate conditions.” But, there are competing theories as to why this should occur with cancer immunotherapy, they noted. One is that the drugs’ inhibition of proinflammatory cytokines acts as negative regulators of melanogenesis. Another is that melanocytes in hair follicles are activated through inflammatory mediators. Of the patients with hair repigmentation in the study, only one, who was being treated with nivolumab for lung squamous cell carcinoma, had disease progression. This patient was discontinued after four treatment sessions and died. The other 13 patients saw either stable disease or a partial response.
The study received no outside funding, but two investigators disclosed financial relationships with pharmaceutical manufacturers.
Patients on immunotherapy treatments for lung cancer have experienced repigmentation of their formerly gray hair, according to a new report. Moreover, researchers say, all but one of the patients experiencing this effect also responded well to the therapy, suggesting that hair repigmentation could potentially serve as a marker of treatment response.
In a case series published online July 12 in JAMA Dermatology (2017. doi: 10.1001/jamadermatol.2017.2106), Noelia Rivera, MD, of the Universitat Autònoma de Barcelona and her colleagues report findings from 14 patients (13 male, mean age 65) receiving anti–programmed cell death 1 (anti–PD-1) and anti–programmed cell death ligand 1 (anti–PD-L1) therapies to treat squamous cell lung cancer or lung adenocarcinoma, with most (11) receiving nivolumab (Opdivo). All but one patient experienced a diffuse darkening of the hair to resemble its previous color, while the remaining patient’s repigmentation occurred in patches.
Dr. Rivera and her colleagues wrote in their analysis that gray hair follicles “still preserve a reduced number of differentiated and functioning melanocytes located in the hair bulb. This reduced number of melanocytes may explain the possibility of [repigmentation] under appropriate conditions.” But, there are competing theories as to why this should occur with cancer immunotherapy, they noted. One is that the drugs’ inhibition of proinflammatory cytokines acts as negative regulators of melanogenesis. Another is that melanocytes in hair follicles are activated through inflammatory mediators. Of the patients with hair repigmentation in the study, only one, who was being treated with nivolumab for lung squamous cell carcinoma, had disease progression. This patient was discontinued after four treatment sessions and died. The other 13 patients saw either stable disease or a partial response.
The study received no outside funding, but two investigators disclosed financial relationships with pharmaceutical manufacturers.
Patients on immunotherapy treatments for lung cancer have experienced repigmentation of their formerly gray hair, according to a new report. Moreover, researchers say, all but one of the patients experiencing this effect also responded well to the therapy, suggesting that hair repigmentation could potentially serve as a marker of treatment response.
In a case series published online July 12 in JAMA Dermatology (2017. doi: 10.1001/jamadermatol.2017.2106), Noelia Rivera, MD, of the Universitat Autònoma de Barcelona and her colleagues report findings from 14 patients (13 male, mean age 65) receiving anti–programmed cell death 1 (anti–PD-1) and anti–programmed cell death ligand 1 (anti–PD-L1) therapies to treat squamous cell lung cancer or lung adenocarcinoma, with most (11) receiving nivolumab (Opdivo). All but one patient experienced a diffuse darkening of the hair to resemble its previous color, while the remaining patient’s repigmentation occurred in patches.
Dr. Rivera and her colleagues wrote in their analysis that gray hair follicles “still preserve a reduced number of differentiated and functioning melanocytes located in the hair bulb. This reduced number of melanocytes may explain the possibility of [repigmentation] under appropriate conditions.” But, there are competing theories as to why this should occur with cancer immunotherapy, they noted. One is that the drugs’ inhibition of proinflammatory cytokines acts as negative regulators of melanogenesis. Another is that melanocytes in hair follicles are activated through inflammatory mediators. Of the patients with hair repigmentation in the study, only one, who was being treated with nivolumab for lung squamous cell carcinoma, had disease progression. This patient was discontinued after four treatment sessions and died. The other 13 patients saw either stable disease or a partial response.
The study received no outside funding, but two investigators disclosed financial relationships with pharmaceutical manufacturers.
FROM JAMA DERMATOLOGY
Key clinical point:
Major finding: Of 52 patients, 14 patients saw a diffuse restoration of their original hair color during the course of treatment. All but 1 of these also saw a robust treatment response.
Data source: A case series drawn from a single-center cohort of 52 lung cancer patients treated with anti–PD-1 and anti–PD-L1 and monitored for cutaneous effects.
Disclosures: Two coauthors disclosed financial relationships with several drug manufacturers.
