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Exercise tops NSAIDs for knee osteoarthritis
LAS VEGAS – After participating in an 8-week neuromuscular exercise therapy program, patients with mild to moderate knee osteoarthritis showed significantly greater symptomatic improvement at 12 months of follow-up than if they had been instructed to treat with analgesics and anti-inflammatory agents in the randomized EXERPHARMA trial.
“Neuromuscular exercise could be the superior choice for long-term relief of symptoms such as swelling, stiffness, and catching, while avoiding the potential side effects of analgesics and anti-inflammatory drugs,” Anders Holsgaard-Larsen, MD, said in his presentation of the 1-year study results at the World Congress on Osteoarthritis.
Ninety-three patients with mild to moderate medial knee osteoarthritis – “a group we commonly see in primary care,” he noted – were randomized to the structured 8-week neuromuscular exercise therapy program or to 8 weeks of instruction in the appropriate use of NSAIDs and acetaminophen. The exercise program entailed two hour-long, physical therapist-supervised sessions per week, which included functional, proprioceptive, strength, and endurance exercises of three or four progressive degrees of difficulty.
The initial results obtained at the conclusion of the 8-week interventions – change in knee joint load while walking – have been published (Osteoarthritis Cartilage. 2017 Apr;25[4]:470-80). There was no significant difference between the two study groups. But outcomes at the prespecified 12-month follow-up designed to capture any late improvement were a different story, Dr. Holsgaard-Larsen said at the congress sponsored by the Osteoarthritis Research Society International.
The neuromuscular exercise therapy group showed a significantly greater improvement on the Knee Injury and Osteoarthritis Scores (KOOS) symptom subscale at 12 months: a mean 10.9-point improvement from baseline, compared with a 3.3-point improvement with drug therapy.
That being said, the prespecified primary endpoint at 12 months was change on the activities of daily living subscale – and this between-group difference didn’t reach statistical significance. So technically EXERPHARMA was a negative study, according to the investigator.
That comment caused audience member Theodore P. Pincus, MD, to rise in protest.
“I might argue that perhaps we’ve gotten too focused on P-values rather than looking at the whole picture. In my opinion, your hypothesis is more validated than you seem to think,” said Dr. Pincus, professor of rheumatology at Rush University in Chicago.
The EXERPHARMA trial was funded by the Danish Rheumatism Association and other noncommercial research support. Dr. Holsgaard-Larsen reported having no financial conflicts of interest.
LAS VEGAS – After participating in an 8-week neuromuscular exercise therapy program, patients with mild to moderate knee osteoarthritis showed significantly greater symptomatic improvement at 12 months of follow-up than if they had been instructed to treat with analgesics and anti-inflammatory agents in the randomized EXERPHARMA trial.
“Neuromuscular exercise could be the superior choice for long-term relief of symptoms such as swelling, stiffness, and catching, while avoiding the potential side effects of analgesics and anti-inflammatory drugs,” Anders Holsgaard-Larsen, MD, said in his presentation of the 1-year study results at the World Congress on Osteoarthritis.
Ninety-three patients with mild to moderate medial knee osteoarthritis – “a group we commonly see in primary care,” he noted – were randomized to the structured 8-week neuromuscular exercise therapy program or to 8 weeks of instruction in the appropriate use of NSAIDs and acetaminophen. The exercise program entailed two hour-long, physical therapist-supervised sessions per week, which included functional, proprioceptive, strength, and endurance exercises of three or four progressive degrees of difficulty.
The initial results obtained at the conclusion of the 8-week interventions – change in knee joint load while walking – have been published (Osteoarthritis Cartilage. 2017 Apr;25[4]:470-80). There was no significant difference between the two study groups. But outcomes at the prespecified 12-month follow-up designed to capture any late improvement were a different story, Dr. Holsgaard-Larsen said at the congress sponsored by the Osteoarthritis Research Society International.
The neuromuscular exercise therapy group showed a significantly greater improvement on the Knee Injury and Osteoarthritis Scores (KOOS) symptom subscale at 12 months: a mean 10.9-point improvement from baseline, compared with a 3.3-point improvement with drug therapy.
That being said, the prespecified primary endpoint at 12 months was change on the activities of daily living subscale – and this between-group difference didn’t reach statistical significance. So technically EXERPHARMA was a negative study, according to the investigator.
That comment caused audience member Theodore P. Pincus, MD, to rise in protest.
“I might argue that perhaps we’ve gotten too focused on P-values rather than looking at the whole picture. In my opinion, your hypothesis is more validated than you seem to think,” said Dr. Pincus, professor of rheumatology at Rush University in Chicago.
The EXERPHARMA trial was funded by the Danish Rheumatism Association and other noncommercial research support. Dr. Holsgaard-Larsen reported having no financial conflicts of interest.
LAS VEGAS – After participating in an 8-week neuromuscular exercise therapy program, patients with mild to moderate knee osteoarthritis showed significantly greater symptomatic improvement at 12 months of follow-up than if they had been instructed to treat with analgesics and anti-inflammatory agents in the randomized EXERPHARMA trial.
“Neuromuscular exercise could be the superior choice for long-term relief of symptoms such as swelling, stiffness, and catching, while avoiding the potential side effects of analgesics and anti-inflammatory drugs,” Anders Holsgaard-Larsen, MD, said in his presentation of the 1-year study results at the World Congress on Osteoarthritis.
Ninety-three patients with mild to moderate medial knee osteoarthritis – “a group we commonly see in primary care,” he noted – were randomized to the structured 8-week neuromuscular exercise therapy program or to 8 weeks of instruction in the appropriate use of NSAIDs and acetaminophen. The exercise program entailed two hour-long, physical therapist-supervised sessions per week, which included functional, proprioceptive, strength, and endurance exercises of three or four progressive degrees of difficulty.
The initial results obtained at the conclusion of the 8-week interventions – change in knee joint load while walking – have been published (Osteoarthritis Cartilage. 2017 Apr;25[4]:470-80). There was no significant difference between the two study groups. But outcomes at the prespecified 12-month follow-up designed to capture any late improvement were a different story, Dr. Holsgaard-Larsen said at the congress sponsored by the Osteoarthritis Research Society International.
The neuromuscular exercise therapy group showed a significantly greater improvement on the Knee Injury and Osteoarthritis Scores (KOOS) symptom subscale at 12 months: a mean 10.9-point improvement from baseline, compared with a 3.3-point improvement with drug therapy.
That being said, the prespecified primary endpoint at 12 months was change on the activities of daily living subscale – and this between-group difference didn’t reach statistical significance. So technically EXERPHARMA was a negative study, according to the investigator.
That comment caused audience member Theodore P. Pincus, MD, to rise in protest.
“I might argue that perhaps we’ve gotten too focused on P-values rather than looking at the whole picture. In my opinion, your hypothesis is more validated than you seem to think,” said Dr. Pincus, professor of rheumatology at Rush University in Chicago.
The EXERPHARMA trial was funded by the Danish Rheumatism Association and other noncommercial research support. Dr. Holsgaard-Larsen reported having no financial conflicts of interest.
AT OARSI 2017
Key clinical point:
Major finding: At 12 months of follow-up, patients with knee osteoarthritis who had been assigned to an 8-week structured neuromuscular exercise therapy program had a mean 10.9-point improvement on the KOOS symptom subscale, significantly better than the 3.3-point improvement in patients assigned to primary therapy with NSAIDs and acetaminophen.
Data source: This randomized, single-blind clinical trial included 93 patients with mild to moderate knee osteoarthritis.
Disclosures: The EXERPHARMA trial was funded by the Danish Rheumatism Association and other noncommercial research support. The presenter reported having no financial conflicts of interest.
Poll: How have you changed opioid prescribing in your practice?
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[polldaddy:9772633]
[polldaddy:9772633]
GOP senators shutting out physician input on reform – ASCO CEO
WASHINGTON – Physician associations are having an easy time finding people on Capitol Hill willing to listen when it comes to health care reform, but it appears that the conversations are falling on deaf ears, according to Clifford Hudis, MD, CEO of the American Society of Clinical Oncology.
“I am dismayed that our opinions are not being valued,” Dr. Hudis said at a policy summit hosted by the National Comprehensive Cancer Network.
He was critical of the current skyrocketing prices of oncology treatments but noted that, the way the current market is set up, there is no incentive anywhere in the system to put any pressure on manufacturers.
“Right now, the market forces, such as they are, not only allow this but encourage it and probably will continue to do so for a little longer,” he said, adding that the environment is such that “a majority of Americans want the government to do something about price. Think about that for a minute. That is a call for regulation, indirectly or directly. That’s a call for oversight. It’s a call for something different from the traditional open workings of a free market.”
He noted that, at least conceptually, the Trump administration is following in the footsteps of the Obama administration with an emphasis on value over volume, shared risk, and looking for improved outcomes.
In that vein, Dr. Hudis said there are rumblings that the much-criticized Part B demonstration that would put more emphasis on value-based payments to physicians for Part B drugs could return in some form, though he had no further details.
“Our position is that physicians should be accountable for utilization, for quality of care, and not for the price of the drug at market entry,” he said, noting ASCO’s opposition to the Part B demonstration as it was originally proposed.
That demonstration also highlighted another issue of value, particularly when there are no traditional market forces in play to help exert downward pressure on prices.
Defining value is problematic, and Dr. Hudis criticized the many value frameworks – including ASCO’s – as a signal that there is not enough being done to let the market truly make its determination on what is value.
“When we superimpose something like the value framework on this, we are essentially admitting a kind of defeat,” he said. “We are admitting that there won’t be traditional bid-counterbid price setting. There will instead be a declaration of value ultimately leading to pricing.”
“They are a declaration that somebody, through opinion or formula, will start to tell you collectively what a therapy is worth,” he added. “That’s like somebody telling you what an automobile is worth. It doesn’t really work that way in the rest of your world. You make a judgment for yourself about what something is worth. … One thing I know for sure is that for most patients, most new drugs are not worth their current price.”
WASHINGTON – Physician associations are having an easy time finding people on Capitol Hill willing to listen when it comes to health care reform, but it appears that the conversations are falling on deaf ears, according to Clifford Hudis, MD, CEO of the American Society of Clinical Oncology.
“I am dismayed that our opinions are not being valued,” Dr. Hudis said at a policy summit hosted by the National Comprehensive Cancer Network.
He was critical of the current skyrocketing prices of oncology treatments but noted that, the way the current market is set up, there is no incentive anywhere in the system to put any pressure on manufacturers.
“Right now, the market forces, such as they are, not only allow this but encourage it and probably will continue to do so for a little longer,” he said, adding that the environment is such that “a majority of Americans want the government to do something about price. Think about that for a minute. That is a call for regulation, indirectly or directly. That’s a call for oversight. It’s a call for something different from the traditional open workings of a free market.”
He noted that, at least conceptually, the Trump administration is following in the footsteps of the Obama administration with an emphasis on value over volume, shared risk, and looking for improved outcomes.
In that vein, Dr. Hudis said there are rumblings that the much-criticized Part B demonstration that would put more emphasis on value-based payments to physicians for Part B drugs could return in some form, though he had no further details.
“Our position is that physicians should be accountable for utilization, for quality of care, and not for the price of the drug at market entry,” he said, noting ASCO’s opposition to the Part B demonstration as it was originally proposed.
That demonstration also highlighted another issue of value, particularly when there are no traditional market forces in play to help exert downward pressure on prices.
Defining value is problematic, and Dr. Hudis criticized the many value frameworks – including ASCO’s – as a signal that there is not enough being done to let the market truly make its determination on what is value.
“When we superimpose something like the value framework on this, we are essentially admitting a kind of defeat,” he said. “We are admitting that there won’t be traditional bid-counterbid price setting. There will instead be a declaration of value ultimately leading to pricing.”
“They are a declaration that somebody, through opinion or formula, will start to tell you collectively what a therapy is worth,” he added. “That’s like somebody telling you what an automobile is worth. It doesn’t really work that way in the rest of your world. You make a judgment for yourself about what something is worth. … One thing I know for sure is that for most patients, most new drugs are not worth their current price.”
WASHINGTON – Physician associations are having an easy time finding people on Capitol Hill willing to listen when it comes to health care reform, but it appears that the conversations are falling on deaf ears, according to Clifford Hudis, MD, CEO of the American Society of Clinical Oncology.
“I am dismayed that our opinions are not being valued,” Dr. Hudis said at a policy summit hosted by the National Comprehensive Cancer Network.
He was critical of the current skyrocketing prices of oncology treatments but noted that, the way the current market is set up, there is no incentive anywhere in the system to put any pressure on manufacturers.
“Right now, the market forces, such as they are, not only allow this but encourage it and probably will continue to do so for a little longer,” he said, adding that the environment is such that “a majority of Americans want the government to do something about price. Think about that for a minute. That is a call for regulation, indirectly or directly. That’s a call for oversight. It’s a call for something different from the traditional open workings of a free market.”
He noted that, at least conceptually, the Trump administration is following in the footsteps of the Obama administration with an emphasis on value over volume, shared risk, and looking for improved outcomes.
In that vein, Dr. Hudis said there are rumblings that the much-criticized Part B demonstration that would put more emphasis on value-based payments to physicians for Part B drugs could return in some form, though he had no further details.
“Our position is that physicians should be accountable for utilization, for quality of care, and not for the price of the drug at market entry,” he said, noting ASCO’s opposition to the Part B demonstration as it was originally proposed.
That demonstration also highlighted another issue of value, particularly when there are no traditional market forces in play to help exert downward pressure on prices.
Defining value is problematic, and Dr. Hudis criticized the many value frameworks – including ASCO’s – as a signal that there is not enough being done to let the market truly make its determination on what is value.
“When we superimpose something like the value framework on this, we are essentially admitting a kind of defeat,” he said. “We are admitting that there won’t be traditional bid-counterbid price setting. There will instead be a declaration of value ultimately leading to pricing.”
“They are a declaration that somebody, through opinion or formula, will start to tell you collectively what a therapy is worth,” he added. “That’s like somebody telling you what an automobile is worth. It doesn’t really work that way in the rest of your world. You make a judgment for yourself about what something is worth. … One thing I know for sure is that for most patients, most new drugs are not worth their current price.”
AT NCCN POLICY SUMMIT
HCV/HIV-coinfected teens rapidly progress to advanced liver disease
MADRID – Roughly one in four children with vertically transmitted hepatitis C virus (HCV)/HIV coinfection will progress to advanced hepatic fibrosis by age 20 years despite treatment with pegylated interferon plus ribavirin, Carolina Fernández McPhee, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
This rate was nearly five times higher than in matched children with vertically acquired HCV monoinfection in a multicenter retrospective study, according to Dr. McPhee of Hospital General Universitario Gregorio Marañón in Madrid.
She presented a multicenter retrospective study of liver disease progression in 71 HCV/HIV coinfected children and 71 age- and sex-matched HCV-monoinfected children. The coinfected children are being followed in CORISPES (the Spanish Cohort of HIV-infected Children), where they receive state-of-the-art care.
All was quiet through age 9 years, with no progression to liver fibrosis in either patient group. Among patients followed to age 20 years, however, 9 (24%) of 38 HCV/HIV-coinfected patients showed progression to advanced fibrosis, compared with just 3 (6%) of 54 patients with HCV only.
Of HCV/HIV coinfected patients, 73% were infected with the hard to treat viral genotypes 1 or 4, compared with 93% of patients with HCV-only.
In the study group, 22 patients with HCV/HIV and 52 patients with HCV-only underwent treatment with pegylated interferon and ribavirin. At the time of treatment, three coinfected patients already had cirrhosis, another eight had moderate to advanced fibrosis, and half had no or mild fibrosis. In contrast, only one patient with HCV monoinfection had cirrhosis, four had moderate to advanced fibrosis, and the rest – nearly 90% of the total group – had no or mild fibrosis.
At treatment initiation, 96% of the HCV/HIV group were on antiretroviral therapy, 86% showed suppression of HIV RNA, 44% had AIDS, and 32% had a CD4 count below 500 cells/mm3.
The sustained viral response rate was similar in the two groups of patients – 41% in the HCV/HIV group and 42% in HCV-only patients – despite the fact that the HCV monoinfected patients had a higher prevalence of the tough to treat genotypes.
Roughly 12 million people worldwide are coinfected with HCV and HIV.
Dr. McPhee reported having no relevant financial disclosures.
MADRID – Roughly one in four children with vertically transmitted hepatitis C virus (HCV)/HIV coinfection will progress to advanced hepatic fibrosis by age 20 years despite treatment with pegylated interferon plus ribavirin, Carolina Fernández McPhee, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
This rate was nearly five times higher than in matched children with vertically acquired HCV monoinfection in a multicenter retrospective study, according to Dr. McPhee of Hospital General Universitario Gregorio Marañón in Madrid.
She presented a multicenter retrospective study of liver disease progression in 71 HCV/HIV coinfected children and 71 age- and sex-matched HCV-monoinfected children. The coinfected children are being followed in CORISPES (the Spanish Cohort of HIV-infected Children), where they receive state-of-the-art care.
All was quiet through age 9 years, with no progression to liver fibrosis in either patient group. Among patients followed to age 20 years, however, 9 (24%) of 38 HCV/HIV-coinfected patients showed progression to advanced fibrosis, compared with just 3 (6%) of 54 patients with HCV only.
Of HCV/HIV coinfected patients, 73% were infected with the hard to treat viral genotypes 1 or 4, compared with 93% of patients with HCV-only.
In the study group, 22 patients with HCV/HIV and 52 patients with HCV-only underwent treatment with pegylated interferon and ribavirin. At the time of treatment, three coinfected patients already had cirrhosis, another eight had moderate to advanced fibrosis, and half had no or mild fibrosis. In contrast, only one patient with HCV monoinfection had cirrhosis, four had moderate to advanced fibrosis, and the rest – nearly 90% of the total group – had no or mild fibrosis.
At treatment initiation, 96% of the HCV/HIV group were on antiretroviral therapy, 86% showed suppression of HIV RNA, 44% had AIDS, and 32% had a CD4 count below 500 cells/mm3.
The sustained viral response rate was similar in the two groups of patients – 41% in the HCV/HIV group and 42% in HCV-only patients – despite the fact that the HCV monoinfected patients had a higher prevalence of the tough to treat genotypes.
Roughly 12 million people worldwide are coinfected with HCV and HIV.
Dr. McPhee reported having no relevant financial disclosures.
MADRID – Roughly one in four children with vertically transmitted hepatitis C virus (HCV)/HIV coinfection will progress to advanced hepatic fibrosis by age 20 years despite treatment with pegylated interferon plus ribavirin, Carolina Fernández McPhee, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
This rate was nearly five times higher than in matched children with vertically acquired HCV monoinfection in a multicenter retrospective study, according to Dr. McPhee of Hospital General Universitario Gregorio Marañón in Madrid.
She presented a multicenter retrospective study of liver disease progression in 71 HCV/HIV coinfected children and 71 age- and sex-matched HCV-monoinfected children. The coinfected children are being followed in CORISPES (the Spanish Cohort of HIV-infected Children), where they receive state-of-the-art care.
All was quiet through age 9 years, with no progression to liver fibrosis in either patient group. Among patients followed to age 20 years, however, 9 (24%) of 38 HCV/HIV-coinfected patients showed progression to advanced fibrosis, compared with just 3 (6%) of 54 patients with HCV only.
Of HCV/HIV coinfected patients, 73% were infected with the hard to treat viral genotypes 1 or 4, compared with 93% of patients with HCV-only.
In the study group, 22 patients with HCV/HIV and 52 patients with HCV-only underwent treatment with pegylated interferon and ribavirin. At the time of treatment, three coinfected patients already had cirrhosis, another eight had moderate to advanced fibrosis, and half had no or mild fibrosis. In contrast, only one patient with HCV monoinfection had cirrhosis, four had moderate to advanced fibrosis, and the rest – nearly 90% of the total group – had no or mild fibrosis.
At treatment initiation, 96% of the HCV/HIV group were on antiretroviral therapy, 86% showed suppression of HIV RNA, 44% had AIDS, and 32% had a CD4 count below 500 cells/mm3.
The sustained viral response rate was similar in the two groups of patients – 41% in the HCV/HIV group and 42% in HCV-only patients – despite the fact that the HCV monoinfected patients had a higher prevalence of the tough to treat genotypes.
Roughly 12 million people worldwide are coinfected with HCV and HIV.
Dr. McPhee reported having no relevant financial disclosures.
AT ESPID 2017
Key clinical point:
Major finding: By age 20 years, 24% of a group of patients with vertically transmitted HCV/HIV coinfection had progressed to advanced hepatic fibrosis, compared with 6% of patients with vertically transmitted HCV monoinfection.
Data source: This retrospective, multicenter, observational Spanish study included 71 children with vertically transmitted HCV/HIV coinfection and 71 with vertically transmitted HCV monoinfection.
Disclosures: Dr. McPhee reported having no relevant financial disclosures.
ODYSSEY: Alirocumab improves lipids but not glycemic targets in 2DM
SAN DIEGO – The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab helped correct dyslipidemia but did not improve glucose control in patients with type 2 diabetes mellitus, investigators reported at the annual scientific sessions of the American Diabetes Association.
In the international, double-blind ODYSSEY DM-Insulin trial, 24 weeks of alirocumab (Praluent, Sanofi and Regeneron) therapy cut low-density lipoprotein (LDL) cholesterol levels by an average of 49% more than placebo (P less than .0001), said Lawrence A. Leiter, MD, professor of medicine and nutritional sciences at the University of Toronto. Alirocumab also significantly reduced non–high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) levels. However, hemoglobin A1c, fasting plasma glucose, total insulin dose, and number of antihyperglycemic drugs remained nearly identical between the trial arms throughout follow-up.
About 94% of patients in each arm completed the trial. Most were in their mid-60s, white, obese, and already on a moderate or high-intensity statin, with baseline fasting plasma glucose levels of about 150 mg per dL and HbA1c levels of 7.5%. The most common treatment-associated adverse events were myalgia (4%) and arthralgia (3%). Rates of local and systemic allergic drug reactions, neurologic or neurocognitive events, and elevated transaminases were low and similar between groups, according to Dr. Leiter, who is also director of the lipid clinic at the Li Ka Shing Knowledge Institute at St. Michael’s Hospital.
Robert R. Henry, MD, who is professor of medicine at the University of California, San Diego, discussed the ODYSSEY DM-Dyslipidemia trial which compared alirocumab with usual care in patients with type 2 diabetes whose mixed dyslipidemia was inadequately controlled with maximum tolerable statin therapy. In all, 413 patients received open-label alirocumab (75 mg–150 mg) or placebo plus optional ezetimibe, fenofibrate, omega-3 fatty acids, or nicotinic acid every 2 weeks for 24 weeks. At the end of treatment, non-HDL cholesterol dropped about 33% more with alirocumab than usual care (P less than .0001). Alirocumab also produced significant declines in LDL cholesterol, apolipoprotein B, total cholesterol, and lipoprotein(a), and a 6% increase in HDL cholesterol as compared with usual care. Once again, alirocumab induced no changes in HbA1c or fasting plasma glucose levels. The most common treatment-related adverse events were urinary tract infections, diarrhea, and nasopharyngitis.
Sanofi US and Regeneron Pharmaceuticals make alirocumab and funded the trials. Dr. Leiter disclosed research grants and consulting relationships with Regeneron, Sanofi, Eli Lilly and Company, and several other pharmaceutical companies. Dr. Henry disclosed consulting and advisory relationships with Sanofi and many other pharmaceutical companies.
SAN DIEGO – The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab helped correct dyslipidemia but did not improve glucose control in patients with type 2 diabetes mellitus, investigators reported at the annual scientific sessions of the American Diabetes Association.
In the international, double-blind ODYSSEY DM-Insulin trial, 24 weeks of alirocumab (Praluent, Sanofi and Regeneron) therapy cut low-density lipoprotein (LDL) cholesterol levels by an average of 49% more than placebo (P less than .0001), said Lawrence A. Leiter, MD, professor of medicine and nutritional sciences at the University of Toronto. Alirocumab also significantly reduced non–high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) levels. However, hemoglobin A1c, fasting plasma glucose, total insulin dose, and number of antihyperglycemic drugs remained nearly identical between the trial arms throughout follow-up.
About 94% of patients in each arm completed the trial. Most were in their mid-60s, white, obese, and already on a moderate or high-intensity statin, with baseline fasting plasma glucose levels of about 150 mg per dL and HbA1c levels of 7.5%. The most common treatment-associated adverse events were myalgia (4%) and arthralgia (3%). Rates of local and systemic allergic drug reactions, neurologic or neurocognitive events, and elevated transaminases were low and similar between groups, according to Dr. Leiter, who is also director of the lipid clinic at the Li Ka Shing Knowledge Institute at St. Michael’s Hospital.
Robert R. Henry, MD, who is professor of medicine at the University of California, San Diego, discussed the ODYSSEY DM-Dyslipidemia trial which compared alirocumab with usual care in patients with type 2 diabetes whose mixed dyslipidemia was inadequately controlled with maximum tolerable statin therapy. In all, 413 patients received open-label alirocumab (75 mg–150 mg) or placebo plus optional ezetimibe, fenofibrate, omega-3 fatty acids, or nicotinic acid every 2 weeks for 24 weeks. At the end of treatment, non-HDL cholesterol dropped about 33% more with alirocumab than usual care (P less than .0001). Alirocumab also produced significant declines in LDL cholesterol, apolipoprotein B, total cholesterol, and lipoprotein(a), and a 6% increase in HDL cholesterol as compared with usual care. Once again, alirocumab induced no changes in HbA1c or fasting plasma glucose levels. The most common treatment-related adverse events were urinary tract infections, diarrhea, and nasopharyngitis.
Sanofi US and Regeneron Pharmaceuticals make alirocumab and funded the trials. Dr. Leiter disclosed research grants and consulting relationships with Regeneron, Sanofi, Eli Lilly and Company, and several other pharmaceutical companies. Dr. Henry disclosed consulting and advisory relationships with Sanofi and many other pharmaceutical companies.
SAN DIEGO – The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab helped correct dyslipidemia but did not improve glucose control in patients with type 2 diabetes mellitus, investigators reported at the annual scientific sessions of the American Diabetes Association.
In the international, double-blind ODYSSEY DM-Insulin trial, 24 weeks of alirocumab (Praluent, Sanofi and Regeneron) therapy cut low-density lipoprotein (LDL) cholesterol levels by an average of 49% more than placebo (P less than .0001), said Lawrence A. Leiter, MD, professor of medicine and nutritional sciences at the University of Toronto. Alirocumab also significantly reduced non–high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein(a) levels. However, hemoglobin A1c, fasting plasma glucose, total insulin dose, and number of antihyperglycemic drugs remained nearly identical between the trial arms throughout follow-up.
About 94% of patients in each arm completed the trial. Most were in their mid-60s, white, obese, and already on a moderate or high-intensity statin, with baseline fasting plasma glucose levels of about 150 mg per dL and HbA1c levels of 7.5%. The most common treatment-associated adverse events were myalgia (4%) and arthralgia (3%). Rates of local and systemic allergic drug reactions, neurologic or neurocognitive events, and elevated transaminases were low and similar between groups, according to Dr. Leiter, who is also director of the lipid clinic at the Li Ka Shing Knowledge Institute at St. Michael’s Hospital.
Robert R. Henry, MD, who is professor of medicine at the University of California, San Diego, discussed the ODYSSEY DM-Dyslipidemia trial which compared alirocumab with usual care in patients with type 2 diabetes whose mixed dyslipidemia was inadequately controlled with maximum tolerable statin therapy. In all, 413 patients received open-label alirocumab (75 mg–150 mg) or placebo plus optional ezetimibe, fenofibrate, omega-3 fatty acids, or nicotinic acid every 2 weeks for 24 weeks. At the end of treatment, non-HDL cholesterol dropped about 33% more with alirocumab than usual care (P less than .0001). Alirocumab also produced significant declines in LDL cholesterol, apolipoprotein B, total cholesterol, and lipoprotein(a), and a 6% increase in HDL cholesterol as compared with usual care. Once again, alirocumab induced no changes in HbA1c or fasting plasma glucose levels. The most common treatment-related adverse events were urinary tract infections, diarrhea, and nasopharyngitis.
Sanofi US and Regeneron Pharmaceuticals make alirocumab and funded the trials. Dr. Leiter disclosed research grants and consulting relationships with Regeneron, Sanofi, Eli Lilly and Company, and several other pharmaceutical companies. Dr. Henry disclosed consulting and advisory relationships with Sanofi and many other pharmaceutical companies.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point:
Major finding: After 24 weeks of treatment, average low-density lipoprotein levels fell by about 43%-49% (P less than .0001, compared with placebo, in each trial).
Data source: ODYSSEY DM-Insulin included 441 patients on insulin for type 2 diabetes who had elevated LDL levels and other cardiovascular risk factors. ODYSSEY DM-Dyslipidemia included 413 patients with type 2 diabetes and mixed dyslipidemia despite maximally tolerated statins.
Disclosures: Sanofi and Regeneron Pharmaceuticals funded the trial. Dr. Leiter disclosed research grants and consulting relationships with Regeneron, Sanofi, Eli Lilly, and several other pharmaceutical companies.
Aspirin triples major bleeding risk after age 75 years
Older adults who take aspirin daily are at greater risk for serious bleeding than previously thought, based on data from roughly 3,000 patients.
“The risk of upper gastrointestinal bleeding on antiplatelet treatment increases with age, but it is uncertain whether older age alone is a sufficient indicator of high risk to justify routine coprescription of PPIs [proton pump inhibitors],” wrote Linxin Li, DPhil, of the University of Oxford (England) and her colleagues.
To assess the rate of bleeding among older adults on long-term aspirin therapy, Dr. Li and her colleagues reviewed data from the Oxford Vascular Study, a prospective population-based study of 3,166 patients. Of those, 1,584 were younger than 75 years, with an average age of 61 years, and 1,582 were at least 75 years old, with average age of 83 years. Patients were followed at 30 days, 6 months, and 1, 5, and 10 years to determine bleeding, recurrent ischemic events, and disability (Lancet. 2017. doi: 10.1016/S0140-6736[17]30770-5).
In addition, more than twice the major upper GI bleeds were disabling or fatal in adults aged 75 years and older than in the younger patients (62% vs. 25%).
Only a third of the patients in the study were taking proton pump inhibitors (PPIs), partly because current clinical guidelines don’t specifically recommend their use and partly in the absence of an accepted definition of which patients are at high risk for upper GI bleeding, the researchers said. They estimated that the number needed to treat with PPIs to prevent a major GI bleed after 5 years decreased with age: “80 for patients younger than 65 years, 75 for patients aged 65-74 years, 23 for patients aged 75-84 years, and 21 for patients aged 85 years or older.” In addition, the number needed to treat with PPIs to prevent a disabling or fatal upper GI bleed after 5 years was 338 for patients younger than 65 years but dropped to 25 for patients aged 85 years and older.
The findings were limited by the observational nature of the study and inability to show that increased risk of bleeding was caused by aspirin alone, the researchers said. However, based on the data, “age 75 years would be an appropriate threshold to start a PPI both in patients newly initiated on antiplatelet drugs and in patients on established treatment,” they wrote.
The study data were taken from the Oxford Vascular Study, which was funded by the National Institute of Health Research and several other research institutions. Corresponding author Peter Rothwell, MD, disclosed financial relationships with Bayer.
In patients with stroke with a cardiac source of embolism who qualify for oral anticoagulation, we obsess about the association between benefit and bleeding risk. Specific risk scores were developed to assess the bleeding risk for patients with atrial fibrillation who qualified for anticoagulation. However, similar risk scores are not applied for patients who undergo long-term prevention with antiplatelet therapy.
On the basis of this study’s results, the benefit-risk association in long-term antiplatelet therapy should be evaluated every 3-5 years in patients older than 75 years, and PPIs should be used in patients on antiplatelet therapy who are at least 75 years old or in patients with a history of gastrointestinal bleeds.
Hans-Christoph Diener, MD, of the department of neurology at the University Duisburg-Essen in Essen, Germany, made these remarks in an accompanying editorial (Lancet. 2017 Jun 13. doi: 10.1016/S0140-6736[17]31507-6). He disclosed relationships with multiple companies, including AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck, and Novartis.
In patients with stroke with a cardiac source of embolism who qualify for oral anticoagulation, we obsess about the association between benefit and bleeding risk. Specific risk scores were developed to assess the bleeding risk for patients with atrial fibrillation who qualified for anticoagulation. However, similar risk scores are not applied for patients who undergo long-term prevention with antiplatelet therapy.
On the basis of this study’s results, the benefit-risk association in long-term antiplatelet therapy should be evaluated every 3-5 years in patients older than 75 years, and PPIs should be used in patients on antiplatelet therapy who are at least 75 years old or in patients with a history of gastrointestinal bleeds.
Hans-Christoph Diener, MD, of the department of neurology at the University Duisburg-Essen in Essen, Germany, made these remarks in an accompanying editorial (Lancet. 2017 Jun 13. doi: 10.1016/S0140-6736[17]31507-6). He disclosed relationships with multiple companies, including AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck, and Novartis.
In patients with stroke with a cardiac source of embolism who qualify for oral anticoagulation, we obsess about the association between benefit and bleeding risk. Specific risk scores were developed to assess the bleeding risk for patients with atrial fibrillation who qualified for anticoagulation. However, similar risk scores are not applied for patients who undergo long-term prevention with antiplatelet therapy.
On the basis of this study’s results, the benefit-risk association in long-term antiplatelet therapy should be evaluated every 3-5 years in patients older than 75 years, and PPIs should be used in patients on antiplatelet therapy who are at least 75 years old or in patients with a history of gastrointestinal bleeds.
Hans-Christoph Diener, MD, of the department of neurology at the University Duisburg-Essen in Essen, Germany, made these remarks in an accompanying editorial (Lancet. 2017 Jun 13. doi: 10.1016/S0140-6736[17]31507-6). He disclosed relationships with multiple companies, including AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck, and Novartis.
Older adults who take aspirin daily are at greater risk for serious bleeding than previously thought, based on data from roughly 3,000 patients.
“The risk of upper gastrointestinal bleeding on antiplatelet treatment increases with age, but it is uncertain whether older age alone is a sufficient indicator of high risk to justify routine coprescription of PPIs [proton pump inhibitors],” wrote Linxin Li, DPhil, of the University of Oxford (England) and her colleagues.
To assess the rate of bleeding among older adults on long-term aspirin therapy, Dr. Li and her colleagues reviewed data from the Oxford Vascular Study, a prospective population-based study of 3,166 patients. Of those, 1,584 were younger than 75 years, with an average age of 61 years, and 1,582 were at least 75 years old, with average age of 83 years. Patients were followed at 30 days, 6 months, and 1, 5, and 10 years to determine bleeding, recurrent ischemic events, and disability (Lancet. 2017. doi: 10.1016/S0140-6736[17]30770-5).
In addition, more than twice the major upper GI bleeds were disabling or fatal in adults aged 75 years and older than in the younger patients (62% vs. 25%).
Only a third of the patients in the study were taking proton pump inhibitors (PPIs), partly because current clinical guidelines don’t specifically recommend their use and partly in the absence of an accepted definition of which patients are at high risk for upper GI bleeding, the researchers said. They estimated that the number needed to treat with PPIs to prevent a major GI bleed after 5 years decreased with age: “80 for patients younger than 65 years, 75 for patients aged 65-74 years, 23 for patients aged 75-84 years, and 21 for patients aged 85 years or older.” In addition, the number needed to treat with PPIs to prevent a disabling or fatal upper GI bleed after 5 years was 338 for patients younger than 65 years but dropped to 25 for patients aged 85 years and older.
The findings were limited by the observational nature of the study and inability to show that increased risk of bleeding was caused by aspirin alone, the researchers said. However, based on the data, “age 75 years would be an appropriate threshold to start a PPI both in patients newly initiated on antiplatelet drugs and in patients on established treatment,” they wrote.
The study data were taken from the Oxford Vascular Study, which was funded by the National Institute of Health Research and several other research institutions. Corresponding author Peter Rothwell, MD, disclosed financial relationships with Bayer.
Older adults who take aspirin daily are at greater risk for serious bleeding than previously thought, based on data from roughly 3,000 patients.
“The risk of upper gastrointestinal bleeding on antiplatelet treatment increases with age, but it is uncertain whether older age alone is a sufficient indicator of high risk to justify routine coprescription of PPIs [proton pump inhibitors],” wrote Linxin Li, DPhil, of the University of Oxford (England) and her colleagues.
To assess the rate of bleeding among older adults on long-term aspirin therapy, Dr. Li and her colleagues reviewed data from the Oxford Vascular Study, a prospective population-based study of 3,166 patients. Of those, 1,584 were younger than 75 years, with an average age of 61 years, and 1,582 were at least 75 years old, with average age of 83 years. Patients were followed at 30 days, 6 months, and 1, 5, and 10 years to determine bleeding, recurrent ischemic events, and disability (Lancet. 2017. doi: 10.1016/S0140-6736[17]30770-5).
In addition, more than twice the major upper GI bleeds were disabling or fatal in adults aged 75 years and older than in the younger patients (62% vs. 25%).
Only a third of the patients in the study were taking proton pump inhibitors (PPIs), partly because current clinical guidelines don’t specifically recommend their use and partly in the absence of an accepted definition of which patients are at high risk for upper GI bleeding, the researchers said. They estimated that the number needed to treat with PPIs to prevent a major GI bleed after 5 years decreased with age: “80 for patients younger than 65 years, 75 for patients aged 65-74 years, 23 for patients aged 75-84 years, and 21 for patients aged 85 years or older.” In addition, the number needed to treat with PPIs to prevent a disabling or fatal upper GI bleed after 5 years was 338 for patients younger than 65 years but dropped to 25 for patients aged 85 years and older.
The findings were limited by the observational nature of the study and inability to show that increased risk of bleeding was caused by aspirin alone, the researchers said. However, based on the data, “age 75 years would be an appropriate threshold to start a PPI both in patients newly initiated on antiplatelet drugs and in patients on established treatment,” they wrote.
The study data were taken from the Oxford Vascular Study, which was funded by the National Institute of Health Research and several other research institutions. Corresponding author Peter Rothwell, MD, disclosed financial relationships with Bayer.
FROM THE LANCET
Key clinical point:
Major finding: The annual rate of life-threatening or fatal bleeding episodes was less than 0.5% for patients younger than 65 years but rose to 1.5% in those aged 75-84 years and 2.5% in those aged 85 years and older.
Data source: A prospective, population-based cohort study of 3,166 adults who had one transient ischemic attack, ischemic stroke, or MI and who were treated with antiplatelet drugs.
Disclosures: The study data were taken from the Oxford Vascular Study, which was funded by the Wellcome Trust, Wolfson Foundation, British Heart Foundation, Dunhill Medical Trust, the National Institute of Health Research (NIHR), and the NIHR Oxford Biomedical Research Centre. Corresponding author Peter Rothwell, MD, disclosed financial relationships with Bayer.
USPSTF recommends screening children, adolescents for obesity
Children and adolescents aged 6 years and older should be screened for obesity and referred to comprehensive, intensive behavioral interventions with at least 26 hours of intervention contact, according to a U.S. Preventive Services Task Force Recommendation Statement that was published online June 20 in JAMA.
This updated recommendation is largely consistent with the previous 2010 recommendation “but includes the word ‘adolescents’ to further clarify the population to which this recommendation applies,” according to a press release accompanying the Recommendation Statement and the Evidence Report on which it is based.
The behavioral interventions that proved most beneficial included at least 26 hours of contact over a period of 2-12 months. Those that included 52 or more hours of contact achieved even greater weight loss, as well as some improvements in cardiovascular and metabolic risk factors (JAMA. 2017 Jun 20. doi: 10.1001/jama.2017.6803).
In general, children and adolescents who received intensive behavioral intervention showed absolute reductions in BMI z scores of 0.20 and maintained their baseline weight within approximately 5 pounds, while control subjects showed small or no reductions in BMI z scores and typically gained a mean of 5-17 pounds.
The components of these comprehensive interventions varied, but the most successful ones included sessions involving both the child and the parent (separately, together, or both); offered both family and group sessions; provided education regarding healthy eating, exercising, and reading food labels; encouraged stimulus-control measures such as limiting access to unhealthy foods and limiting screen time (that is, physical inactivity); and included supervised physical activity. Additional beneficial components are assisting patients to identify and accomplish goals, self-monitor, and problem-solve, as well as teaching them coping skills and addressing their body image.
In contrast to behavioral interventions, pharmacotherapy was not endorsed by the USPSTF. The current evidence was deemed inadequate to determine whether the slight weight loss achieved with pharmacotherapy is clinically significant and whether it outweighs the harms of the medications.
The two agents currently used in this regard are metformin, which is not Food and Drug Administration–approved for this purpose, and orlistat, which is approved for patients aged 12 years and older. Orlistat in particular frequently causes adverse events including fatty or oily stools, abdominal pain or cramping, flatus with stool discharge, and fecal incontinence, Dr. Grossman and his associates said.
The USPSTF is an independent voluntary group supported by the U.S. Agency for Healthcare Research and Quality as mandated by Congress. The authors’ conflicts of interest are available at https://www.uspreventiveservicestaskforce.org/Page/Name/conflict-of-interest-disclosures.
Letter to the Editor
It is not surprising that there are so many overweight and obese children, despite the fact that in order to prevent bad feelings, children have to be much more overweight than adults to be classified as obese or overweight.
If one is waiting until age 6 years to screen for obesity, that horse will be long out of the barn. The problem begins when the rapid weight gain of infants does not slow down in the 2nd and 3rd years of life. This is also when bad food choices and eating habits often begin.
The other problem is that body mass index is a terrible tool and so is any indicator that tries to define obesity using only height and weight. None of these distinguish between the muscular child and the slender child with a large belly. Waist to height or body volume measurements are far better indicators.
Lastly, parents have come to see the mildly overweight child as the norm because so many children are. Until parents see pictures of children from a few decades ago and are educated as to what normal looks like, we will have great difficulty making a dent in this problem.
Richard H. Feuille Jr., MD
This USPSTF recommendation simply confirms what pediatric clinicians always do in the everyday care for children and adolescents: monitor growth, counsel on healthy lifestyles, and refer for specialized care when appropriate.
Intensive behavioral interventions are impractical for many families and frequently aren’t covered by insurance. At best, implementing this recommendation will have only a modest effect on obesity in the United States. At worst, it could divert attention and resources away from population-health approaches to prevention and toward weight management programs that are not well equipped to meet the demand and very often don’t exist within local communities.
Improving neighborhood walkability, increasing the availability of healthy foods, and providing safe physical spaces would be more effective at reducing childhood obesity, as would improving school nutrition and curtailing the marketing of sugar-sweetened drinks and other unhealthy foods to children.
Rachel L. J. Thornton, MD, PhD, Raquel G. Hernandez, MD, MPH; Tina L. Cheng, MD, MPH, are in the department of pediatrics at Johns Hopkins University, Baltimore. They reported having no relevant financial disclosures. They made these remarks in an editorial accompanying the USPSTF report (JAMA. 2017;317:2378-80).
This USPSTF recommendation simply confirms what pediatric clinicians always do in the everyday care for children and adolescents: monitor growth, counsel on healthy lifestyles, and refer for specialized care when appropriate.
Intensive behavioral interventions are impractical for many families and frequently aren’t covered by insurance. At best, implementing this recommendation will have only a modest effect on obesity in the United States. At worst, it could divert attention and resources away from population-health approaches to prevention and toward weight management programs that are not well equipped to meet the demand and very often don’t exist within local communities.
Improving neighborhood walkability, increasing the availability of healthy foods, and providing safe physical spaces would be more effective at reducing childhood obesity, as would improving school nutrition and curtailing the marketing of sugar-sweetened drinks and other unhealthy foods to children.
Rachel L. J. Thornton, MD, PhD, Raquel G. Hernandez, MD, MPH; Tina L. Cheng, MD, MPH, are in the department of pediatrics at Johns Hopkins University, Baltimore. They reported having no relevant financial disclosures. They made these remarks in an editorial accompanying the USPSTF report (JAMA. 2017;317:2378-80).
This USPSTF recommendation simply confirms what pediatric clinicians always do in the everyday care for children and adolescents: monitor growth, counsel on healthy lifestyles, and refer for specialized care when appropriate.
Intensive behavioral interventions are impractical for many families and frequently aren’t covered by insurance. At best, implementing this recommendation will have only a modest effect on obesity in the United States. At worst, it could divert attention and resources away from population-health approaches to prevention and toward weight management programs that are not well equipped to meet the demand and very often don’t exist within local communities.
Improving neighborhood walkability, increasing the availability of healthy foods, and providing safe physical spaces would be more effective at reducing childhood obesity, as would improving school nutrition and curtailing the marketing of sugar-sweetened drinks and other unhealthy foods to children.
Rachel L. J. Thornton, MD, PhD, Raquel G. Hernandez, MD, MPH; Tina L. Cheng, MD, MPH, are in the department of pediatrics at Johns Hopkins University, Baltimore. They reported having no relevant financial disclosures. They made these remarks in an editorial accompanying the USPSTF report (JAMA. 2017;317:2378-80).
Children and adolescents aged 6 years and older should be screened for obesity and referred to comprehensive, intensive behavioral interventions with at least 26 hours of intervention contact, according to a U.S. Preventive Services Task Force Recommendation Statement that was published online June 20 in JAMA.
This updated recommendation is largely consistent with the previous 2010 recommendation “but includes the word ‘adolescents’ to further clarify the population to which this recommendation applies,” according to a press release accompanying the Recommendation Statement and the Evidence Report on which it is based.
The behavioral interventions that proved most beneficial included at least 26 hours of contact over a period of 2-12 months. Those that included 52 or more hours of contact achieved even greater weight loss, as well as some improvements in cardiovascular and metabolic risk factors (JAMA. 2017 Jun 20. doi: 10.1001/jama.2017.6803).
In general, children and adolescents who received intensive behavioral intervention showed absolute reductions in BMI z scores of 0.20 and maintained their baseline weight within approximately 5 pounds, while control subjects showed small or no reductions in BMI z scores and typically gained a mean of 5-17 pounds.
The components of these comprehensive interventions varied, but the most successful ones included sessions involving both the child and the parent (separately, together, or both); offered both family and group sessions; provided education regarding healthy eating, exercising, and reading food labels; encouraged stimulus-control measures such as limiting access to unhealthy foods and limiting screen time (that is, physical inactivity); and included supervised physical activity. Additional beneficial components are assisting patients to identify and accomplish goals, self-monitor, and problem-solve, as well as teaching them coping skills and addressing their body image.
In contrast to behavioral interventions, pharmacotherapy was not endorsed by the USPSTF. The current evidence was deemed inadequate to determine whether the slight weight loss achieved with pharmacotherapy is clinically significant and whether it outweighs the harms of the medications.
The two agents currently used in this regard are metformin, which is not Food and Drug Administration–approved for this purpose, and orlistat, which is approved for patients aged 12 years and older. Orlistat in particular frequently causes adverse events including fatty or oily stools, abdominal pain or cramping, flatus with stool discharge, and fecal incontinence, Dr. Grossman and his associates said.
The USPSTF is an independent voluntary group supported by the U.S. Agency for Healthcare Research and Quality as mandated by Congress. The authors’ conflicts of interest are available at https://www.uspreventiveservicestaskforce.org/Page/Name/conflict-of-interest-disclosures.
Letter to the Editor
It is not surprising that there are so many overweight and obese children, despite the fact that in order to prevent bad feelings, children have to be much more overweight than adults to be classified as obese or overweight.
If one is waiting until age 6 years to screen for obesity, that horse will be long out of the barn. The problem begins when the rapid weight gain of infants does not slow down in the 2nd and 3rd years of life. This is also when bad food choices and eating habits often begin.
The other problem is that body mass index is a terrible tool and so is any indicator that tries to define obesity using only height and weight. None of these distinguish between the muscular child and the slender child with a large belly. Waist to height or body volume measurements are far better indicators.
Lastly, parents have come to see the mildly overweight child as the norm because so many children are. Until parents see pictures of children from a few decades ago and are educated as to what normal looks like, we will have great difficulty making a dent in this problem.
Richard H. Feuille Jr., MD
Children and adolescents aged 6 years and older should be screened for obesity and referred to comprehensive, intensive behavioral interventions with at least 26 hours of intervention contact, according to a U.S. Preventive Services Task Force Recommendation Statement that was published online June 20 in JAMA.
This updated recommendation is largely consistent with the previous 2010 recommendation “but includes the word ‘adolescents’ to further clarify the population to which this recommendation applies,” according to a press release accompanying the Recommendation Statement and the Evidence Report on which it is based.
The behavioral interventions that proved most beneficial included at least 26 hours of contact over a period of 2-12 months. Those that included 52 or more hours of contact achieved even greater weight loss, as well as some improvements in cardiovascular and metabolic risk factors (JAMA. 2017 Jun 20. doi: 10.1001/jama.2017.6803).
In general, children and adolescents who received intensive behavioral intervention showed absolute reductions in BMI z scores of 0.20 and maintained their baseline weight within approximately 5 pounds, while control subjects showed small or no reductions in BMI z scores and typically gained a mean of 5-17 pounds.
The components of these comprehensive interventions varied, but the most successful ones included sessions involving both the child and the parent (separately, together, or both); offered both family and group sessions; provided education regarding healthy eating, exercising, and reading food labels; encouraged stimulus-control measures such as limiting access to unhealthy foods and limiting screen time (that is, physical inactivity); and included supervised physical activity. Additional beneficial components are assisting patients to identify and accomplish goals, self-monitor, and problem-solve, as well as teaching them coping skills and addressing their body image.
In contrast to behavioral interventions, pharmacotherapy was not endorsed by the USPSTF. The current evidence was deemed inadequate to determine whether the slight weight loss achieved with pharmacotherapy is clinically significant and whether it outweighs the harms of the medications.
The two agents currently used in this regard are metformin, which is not Food and Drug Administration–approved for this purpose, and orlistat, which is approved for patients aged 12 years and older. Orlistat in particular frequently causes adverse events including fatty or oily stools, abdominal pain or cramping, flatus with stool discharge, and fecal incontinence, Dr. Grossman and his associates said.
The USPSTF is an independent voluntary group supported by the U.S. Agency for Healthcare Research and Quality as mandated by Congress. The authors’ conflicts of interest are available at https://www.uspreventiveservicestaskforce.org/Page/Name/conflict-of-interest-disclosures.
Letter to the Editor
It is not surprising that there are so many overweight and obese children, despite the fact that in order to prevent bad feelings, children have to be much more overweight than adults to be classified as obese or overweight.
If one is waiting until age 6 years to screen for obesity, that horse will be long out of the barn. The problem begins when the rapid weight gain of infants does not slow down in the 2nd and 3rd years of life. This is also when bad food choices and eating habits often begin.
The other problem is that body mass index is a terrible tool and so is any indicator that tries to define obesity using only height and weight. None of these distinguish between the muscular child and the slender child with a large belly. Waist to height or body volume measurements are far better indicators.
Lastly, parents have come to see the mildly overweight child as the norm because so many children are. Until parents see pictures of children from a few decades ago and are educated as to what normal looks like, we will have great difficulty making a dent in this problem.
Richard H. Feuille Jr., MD
FROM JAMA
Key clinical point: with at least 26 hours of contact.
Major finding: Children and adolescents who received intensive behavioral intervention showed absolute reductions in BMI z scores of 0.20 and maintained their baseline weight within approximately 5 pounds, while control subjects showed small or no reductions in BMI z scores and typically gained a mean of 5-17 pounds.
Data source: A review of the literature since the previous USPSTF recommendation statement in 2010, including 45 studies of lifestyle-based interventions involving 7,099 overweight and obese children.
Disclosures: The USPSTF is an independent voluntary group supported by the U.S. Agency for Healthcare Research and Quality as mandated by Congress. The authors’ conflicts of interest are available at www.uspreventiveservicestaskforce.org.
MMR vaccine cut hospitalizations for unrelated respiratory infections
, said Giuseppe La Torre of the Sapienza University of Rome and his associates.
The 2-year retrospective database study included 11,004 children, 21% of whom did not receive the MMR vaccine; 49% received one dose, and 30% received two doses. There were 12 hospitalizations for measles (9 in unvaccinated children, 3 in those who received one dose, and none in those who received two doses), 2 hospitalizations for mumps (1 among vaccinated and 1 among unvaccinated children), and no hospitalizations for rubella (P less than .001).
There were 414 hospitalizations for all infectious diseases, 11% in unvaccinated children, 1.5% in those who had received one dose of vaccine, and 1% in those who had received two doses (P less than .001). MMR vaccine also was highly protective against hospitalizations for all infectious diseases (HR, 0.29).
Of 809 hospitalizations for respiratory diseases, 18% involved children who had not been vaccinated, 4% involved children who had received one dose, and 5.5% involved children vaccinated with two doses (P less than .001). MMR likewise was highly protective against hospitalizations for respiratory diseases (HR, 0.18).
Read more in the journal Human Vaccines & Immunotherapeutics (2017 Jun 12. doi: 10.1080/21645515.2017.1330733).
, said Giuseppe La Torre of the Sapienza University of Rome and his associates.
The 2-year retrospective database study included 11,004 children, 21% of whom did not receive the MMR vaccine; 49% received one dose, and 30% received two doses. There were 12 hospitalizations for measles (9 in unvaccinated children, 3 in those who received one dose, and none in those who received two doses), 2 hospitalizations for mumps (1 among vaccinated and 1 among unvaccinated children), and no hospitalizations for rubella (P less than .001).
There were 414 hospitalizations for all infectious diseases, 11% in unvaccinated children, 1.5% in those who had received one dose of vaccine, and 1% in those who had received two doses (P less than .001). MMR vaccine also was highly protective against hospitalizations for all infectious diseases (HR, 0.29).
Of 809 hospitalizations for respiratory diseases, 18% involved children who had not been vaccinated, 4% involved children who had received one dose, and 5.5% involved children vaccinated with two doses (P less than .001). MMR likewise was highly protective against hospitalizations for respiratory diseases (HR, 0.18).
Read more in the journal Human Vaccines & Immunotherapeutics (2017 Jun 12. doi: 10.1080/21645515.2017.1330733).
, said Giuseppe La Torre of the Sapienza University of Rome and his associates.
The 2-year retrospective database study included 11,004 children, 21% of whom did not receive the MMR vaccine; 49% received one dose, and 30% received two doses. There were 12 hospitalizations for measles (9 in unvaccinated children, 3 in those who received one dose, and none in those who received two doses), 2 hospitalizations for mumps (1 among vaccinated and 1 among unvaccinated children), and no hospitalizations for rubella (P less than .001).
There were 414 hospitalizations for all infectious diseases, 11% in unvaccinated children, 1.5% in those who had received one dose of vaccine, and 1% in those who had received two doses (P less than .001). MMR vaccine also was highly protective against hospitalizations for all infectious diseases (HR, 0.29).
Of 809 hospitalizations for respiratory diseases, 18% involved children who had not been vaccinated, 4% involved children who had received one dose, and 5.5% involved children vaccinated with two doses (P less than .001). MMR likewise was highly protective against hospitalizations for respiratory diseases (HR, 0.18).
Read more in the journal Human Vaccines & Immunotherapeutics (2017 Jun 12. doi: 10.1080/21645515.2017.1330733).
FROM HUMAN VACCINES & IMMUNOTHERAPEUTICS
Massive blood transfusions increase risk with CRS/HIPEC
Massive allogenic blood transfusion during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) increased the risk of major complications and reduced overall survival in a review of 936 cases at St. George Hospital near Sydney, Australia.
CRS/HIPEC is a long, complex procedure for peritoneal carcinomatosis, pseudomyxoma peritonei, peritoneal mesothelioma, and other abdominal cancers. The abdomen is opened, the cancer is debulked as much as possible, and the cavity is filled with heated chemotherapy drugs. Because CRS/HIPEC often requires multivisceral resection and dissection in multiple abdominal regions, up to 77% of patients require intraoperative transfusions, and up to 37% require massive allogenic blood transfusions (MABT) with five or more units.
Blood transfusions are known to be associated with poorer cancer surgery outcomes, but their effect in CRS/HIPEC hasn’t been much studied, which is “surprising given the extent to which blood products are used in” the procedure, said investigators led by Akshat Saxena, MD, a surgeon at St. George Hospital (J Gastrointest Surg. 2017 May 30. doi: 10.1007/s11605-017-3444-8).
Based on their findings, the researchers concluded that “there is a real need to evaluate new strategies to reduce the rate of MABT during CRS/HIPEC.”
The procedures in the study were performed from 1996 to 2016. The in-hospital mortality rate was 0.3% in patients who did not have MABT but 4.4% among the 337 patients (36%) who did. Even after adjusting for confounders on multivariate analysis, including the fact that MABT patients had more extensive disease and longer surgeries, MABT significantly increased the risk of in-hospital mortality (relative risk, 7.72; P = .021). In patients requiring MABT had a 5-year survival of 5%. In patients not requiring MABT, 5-year survival was at 36%. The difference remained significant on multivariate analysis.
MABT patients also had twice the risk of life-threatening complications and complications requiring surgical, endoscopic, or radiological intervention (62% versus 30%; RR, 2.05; P less than .001). MABT patients were more likely to stay in the ICU for 4 or more days and in the hospital for 28 or more days.
Worse overall survival with MABT was driven at least in part by patients who had CRS/HIPEC for colorectal cancer peritoneal carcinomatosis and pseudomyxoma peritonei. MABT did not seem to contribute to lower survival in patients who had the procedure for appendiceal or ovarian cancer. “It seems that the impact of long-term immunomodulation induced by blood transfusion” – the suspected mechanism through which transfusions cause problems – “varies according to the disease subtype. This warrants further investigation,” the investigators said.
Several strategies have been tried to reduce the need for transfusions during CRS/HIPEC. The study team previously reported that preemptive clotting factor replacement helps. Others have had success with preemptive tranexamic acid and cryoprecipitate to address low serum fibrinogen levels during CRS/HIPEC. “Further evaluation of both these strategies is warranted,” the researchers said.
Funding source and disclosure information were not included in the study report.
Massive allogenic blood transfusion during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) increased the risk of major complications and reduced overall survival in a review of 936 cases at St. George Hospital near Sydney, Australia.
CRS/HIPEC is a long, complex procedure for peritoneal carcinomatosis, pseudomyxoma peritonei, peritoneal mesothelioma, and other abdominal cancers. The abdomen is opened, the cancer is debulked as much as possible, and the cavity is filled with heated chemotherapy drugs. Because CRS/HIPEC often requires multivisceral resection and dissection in multiple abdominal regions, up to 77% of patients require intraoperative transfusions, and up to 37% require massive allogenic blood transfusions (MABT) with five or more units.
Blood transfusions are known to be associated with poorer cancer surgery outcomes, but their effect in CRS/HIPEC hasn’t been much studied, which is “surprising given the extent to which blood products are used in” the procedure, said investigators led by Akshat Saxena, MD, a surgeon at St. George Hospital (J Gastrointest Surg. 2017 May 30. doi: 10.1007/s11605-017-3444-8).
Based on their findings, the researchers concluded that “there is a real need to evaluate new strategies to reduce the rate of MABT during CRS/HIPEC.”
The procedures in the study were performed from 1996 to 2016. The in-hospital mortality rate was 0.3% in patients who did not have MABT but 4.4% among the 337 patients (36%) who did. Even after adjusting for confounders on multivariate analysis, including the fact that MABT patients had more extensive disease and longer surgeries, MABT significantly increased the risk of in-hospital mortality (relative risk, 7.72; P = .021). In patients requiring MABT had a 5-year survival of 5%. In patients not requiring MABT, 5-year survival was at 36%. The difference remained significant on multivariate analysis.
MABT patients also had twice the risk of life-threatening complications and complications requiring surgical, endoscopic, or radiological intervention (62% versus 30%; RR, 2.05; P less than .001). MABT patients were more likely to stay in the ICU for 4 or more days and in the hospital for 28 or more days.
Worse overall survival with MABT was driven at least in part by patients who had CRS/HIPEC for colorectal cancer peritoneal carcinomatosis and pseudomyxoma peritonei. MABT did not seem to contribute to lower survival in patients who had the procedure for appendiceal or ovarian cancer. “It seems that the impact of long-term immunomodulation induced by blood transfusion” – the suspected mechanism through which transfusions cause problems – “varies according to the disease subtype. This warrants further investigation,” the investigators said.
Several strategies have been tried to reduce the need for transfusions during CRS/HIPEC. The study team previously reported that preemptive clotting factor replacement helps. Others have had success with preemptive tranexamic acid and cryoprecipitate to address low serum fibrinogen levels during CRS/HIPEC. “Further evaluation of both these strategies is warranted,” the researchers said.
Funding source and disclosure information were not included in the study report.
Massive allogenic blood transfusion during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) increased the risk of major complications and reduced overall survival in a review of 936 cases at St. George Hospital near Sydney, Australia.
CRS/HIPEC is a long, complex procedure for peritoneal carcinomatosis, pseudomyxoma peritonei, peritoneal mesothelioma, and other abdominal cancers. The abdomen is opened, the cancer is debulked as much as possible, and the cavity is filled with heated chemotherapy drugs. Because CRS/HIPEC often requires multivisceral resection and dissection in multiple abdominal regions, up to 77% of patients require intraoperative transfusions, and up to 37% require massive allogenic blood transfusions (MABT) with five or more units.
Blood transfusions are known to be associated with poorer cancer surgery outcomes, but their effect in CRS/HIPEC hasn’t been much studied, which is “surprising given the extent to which blood products are used in” the procedure, said investigators led by Akshat Saxena, MD, a surgeon at St. George Hospital (J Gastrointest Surg. 2017 May 30. doi: 10.1007/s11605-017-3444-8).
Based on their findings, the researchers concluded that “there is a real need to evaluate new strategies to reduce the rate of MABT during CRS/HIPEC.”
The procedures in the study were performed from 1996 to 2016. The in-hospital mortality rate was 0.3% in patients who did not have MABT but 4.4% among the 337 patients (36%) who did. Even after adjusting for confounders on multivariate analysis, including the fact that MABT patients had more extensive disease and longer surgeries, MABT significantly increased the risk of in-hospital mortality (relative risk, 7.72; P = .021). In patients requiring MABT had a 5-year survival of 5%. In patients not requiring MABT, 5-year survival was at 36%. The difference remained significant on multivariate analysis.
MABT patients also had twice the risk of life-threatening complications and complications requiring surgical, endoscopic, or radiological intervention (62% versus 30%; RR, 2.05; P less than .001). MABT patients were more likely to stay in the ICU for 4 or more days and in the hospital for 28 or more days.
Worse overall survival with MABT was driven at least in part by patients who had CRS/HIPEC for colorectal cancer peritoneal carcinomatosis and pseudomyxoma peritonei. MABT did not seem to contribute to lower survival in patients who had the procedure for appendiceal or ovarian cancer. “It seems that the impact of long-term immunomodulation induced by blood transfusion” – the suspected mechanism through which transfusions cause problems – “varies according to the disease subtype. This warrants further investigation,” the investigators said.
Several strategies have been tried to reduce the need for transfusions during CRS/HIPEC. The study team previously reported that preemptive clotting factor replacement helps. Others have had success with preemptive tranexamic acid and cryoprecipitate to address low serum fibrinogen levels during CRS/HIPEC. “Further evaluation of both these strategies is warranted,” the researchers said.
Funding source and disclosure information were not included in the study report.
FROM THE JOURNAL OF GASTROINTESTINAL SURGERY
Key clinical point:
Major finding: Even after adjusting for confounders, MABT significantly increased the risk of in-hospital mortality (RR, 7.72; P = .021).
Data source: A single institution review of 936 cases.
Disclosures: Funding source and disclosure information were not included in the study report.
Sneak Peek: Journal of Hospital Medicine – July 2017
BACKGROUND: Medicare patients account for approximately 50% of hospital days. Hospitalization in older adults often results in poor outcomes.
OBJECTIVE: To test the feasibility and impact of using Assessing Care of Vulnerable Elders (ACOVE) quality indicators (QIs) as a therapeutic intervention to improve care of hospitalized older adults.
SETTING: Large tertiary hospital in the greater New York Metropolitan area.
PATIENTS: Hospitalized patients, 75 and over, admitted to medical units.
INTERVENTION: A checklist, comprised of four ACOVE QIs, administered during daily interdisciplinary rounds: venous thrombosis prophylaxis (VTE) (QI 1), indwelling bladder catheters (QI 2), mobilization (QI 3), and delirium evaluation (QI 4).
MEASUREMENTS: Variables were extracted from electronic medical records with QI compliance as the primary outcome, and length of stay (LOS), discharge disposition, and readmissions as secondary outcomes. Generalized linear mixed models for binary clustered data were used to estimate compliance rates for each group (intervention group or control group) in the postintervention period, along with their corresponding 95% confidence intervals.
RESULTS: Of the 2,396 patients, 530 were on an intervention unit. In those patients not already compliant with VTE, the compliance rate was 57% in intervention vs. 39% in control (P less than .0056). For indwelling catheters, mobilization, and delirium evaluation, overall compliance was significantly higher in the intervention group 72.2% vs. 54.4% (P = .1061), 62.9% vs. 48.2% (P less than .0001), and 27.9% vs. 21.7% (P = .0027), respectively.
CONCLUSIONS: The study demonstrates the feasibility and effectiveness of integrating ACOVE QIs to improve the quality of care in hospitalized older adults.
Also in JHM
Use of simulation to assess incoming interns’ recognition of opportunities to choose wisely
AUTHORS: Kathleen M. Wiest, Jeanne M. Farnan, MD, MHPE, Ellen Byrne, Lukas Matern, Melissa Cappaert, MA, Kristen Hirsch, Vineet M. Arora, MD, MAPP
Clinician attitudes regarding ICD deactivation in DNR/DNI patients
AUTHORS: Andrew J. Bradley, MD, Adam D. Marks, MD, MPH
Using standardized patients to assess hospitalist communication skills
AUTHORS: Dennis T. Chang, MD, Micah Mann, MD, Terry Sommer, BFA, Robert Fallar, PhD, Alan Weinberg, MS, Erica Friedman, MD
Techniques and behaviors associated with exemplary inpatient general medicine teaching: An exploratory qualitative study
AUTHORS: Nathan Houchens, MD, Molly Harrod, PhD, Stephanie Moody, PhD, Karen E. Fowler, MPH, Sanjay Saint, MD, MPH
A simple algorithm for predicting bacteremia using food consumption and shaking chills: A prospective observational study
AUTHORS: Takayuki Komatsu, MD, PhD, Erika Takahashi, MD, Kentaro Mishima, MD, Takeo Toyoda, MD, Fumihiro Saitoh, MD, Akari Yasuda, RN, Joe Matsuoka, PhD, Manabu Sugita, MD, PhD, Joel Branch, MD, Makoto Aoki, MD, Lawrence M. Tierney Jr., MD, Kenji Inoue, MD, PhD
For more articles and subscription information, visit www.journalofhospitalmedicine.com.
BACKGROUND: Medicare patients account for approximately 50% of hospital days. Hospitalization in older adults often results in poor outcomes.
OBJECTIVE: To test the feasibility and impact of using Assessing Care of Vulnerable Elders (ACOVE) quality indicators (QIs) as a therapeutic intervention to improve care of hospitalized older adults.
SETTING: Large tertiary hospital in the greater New York Metropolitan area.
PATIENTS: Hospitalized patients, 75 and over, admitted to medical units.
INTERVENTION: A checklist, comprised of four ACOVE QIs, administered during daily interdisciplinary rounds: venous thrombosis prophylaxis (VTE) (QI 1), indwelling bladder catheters (QI 2), mobilization (QI 3), and delirium evaluation (QI 4).
MEASUREMENTS: Variables were extracted from electronic medical records with QI compliance as the primary outcome, and length of stay (LOS), discharge disposition, and readmissions as secondary outcomes. Generalized linear mixed models for binary clustered data were used to estimate compliance rates for each group (intervention group or control group) in the postintervention period, along with their corresponding 95% confidence intervals.
RESULTS: Of the 2,396 patients, 530 were on an intervention unit. In those patients not already compliant with VTE, the compliance rate was 57% in intervention vs. 39% in control (P less than .0056). For indwelling catheters, mobilization, and delirium evaluation, overall compliance was significantly higher in the intervention group 72.2% vs. 54.4% (P = .1061), 62.9% vs. 48.2% (P less than .0001), and 27.9% vs. 21.7% (P = .0027), respectively.
CONCLUSIONS: The study demonstrates the feasibility and effectiveness of integrating ACOVE QIs to improve the quality of care in hospitalized older adults.
Also in JHM
Use of simulation to assess incoming interns’ recognition of opportunities to choose wisely
AUTHORS: Kathleen M. Wiest, Jeanne M. Farnan, MD, MHPE, Ellen Byrne, Lukas Matern, Melissa Cappaert, MA, Kristen Hirsch, Vineet M. Arora, MD, MAPP
Clinician attitudes regarding ICD deactivation in DNR/DNI patients
AUTHORS: Andrew J. Bradley, MD, Adam D. Marks, MD, MPH
Using standardized patients to assess hospitalist communication skills
AUTHORS: Dennis T. Chang, MD, Micah Mann, MD, Terry Sommer, BFA, Robert Fallar, PhD, Alan Weinberg, MS, Erica Friedman, MD
Techniques and behaviors associated with exemplary inpatient general medicine teaching: An exploratory qualitative study
AUTHORS: Nathan Houchens, MD, Molly Harrod, PhD, Stephanie Moody, PhD, Karen E. Fowler, MPH, Sanjay Saint, MD, MPH
A simple algorithm for predicting bacteremia using food consumption and shaking chills: A prospective observational study
AUTHORS: Takayuki Komatsu, MD, PhD, Erika Takahashi, MD, Kentaro Mishima, MD, Takeo Toyoda, MD, Fumihiro Saitoh, MD, Akari Yasuda, RN, Joe Matsuoka, PhD, Manabu Sugita, MD, PhD, Joel Branch, MD, Makoto Aoki, MD, Lawrence M. Tierney Jr., MD, Kenji Inoue, MD, PhD
For more articles and subscription information, visit www.journalofhospitalmedicine.com.
BACKGROUND: Medicare patients account for approximately 50% of hospital days. Hospitalization in older adults often results in poor outcomes.
OBJECTIVE: To test the feasibility and impact of using Assessing Care of Vulnerable Elders (ACOVE) quality indicators (QIs) as a therapeutic intervention to improve care of hospitalized older adults.
SETTING: Large tertiary hospital in the greater New York Metropolitan area.
PATIENTS: Hospitalized patients, 75 and over, admitted to medical units.
INTERVENTION: A checklist, comprised of four ACOVE QIs, administered during daily interdisciplinary rounds: venous thrombosis prophylaxis (VTE) (QI 1), indwelling bladder catheters (QI 2), mobilization (QI 3), and delirium evaluation (QI 4).
MEASUREMENTS: Variables were extracted from electronic medical records with QI compliance as the primary outcome, and length of stay (LOS), discharge disposition, and readmissions as secondary outcomes. Generalized linear mixed models for binary clustered data were used to estimate compliance rates for each group (intervention group or control group) in the postintervention period, along with their corresponding 95% confidence intervals.
RESULTS: Of the 2,396 patients, 530 were on an intervention unit. In those patients not already compliant with VTE, the compliance rate was 57% in intervention vs. 39% in control (P less than .0056). For indwelling catheters, mobilization, and delirium evaluation, overall compliance was significantly higher in the intervention group 72.2% vs. 54.4% (P = .1061), 62.9% vs. 48.2% (P less than .0001), and 27.9% vs. 21.7% (P = .0027), respectively.
CONCLUSIONS: The study demonstrates the feasibility and effectiveness of integrating ACOVE QIs to improve the quality of care in hospitalized older adults.
Also in JHM
Use of simulation to assess incoming interns’ recognition of opportunities to choose wisely
AUTHORS: Kathleen M. Wiest, Jeanne M. Farnan, MD, MHPE, Ellen Byrne, Lukas Matern, Melissa Cappaert, MA, Kristen Hirsch, Vineet M. Arora, MD, MAPP
Clinician attitudes regarding ICD deactivation in DNR/DNI patients
AUTHORS: Andrew J. Bradley, MD, Adam D. Marks, MD, MPH
Using standardized patients to assess hospitalist communication skills
AUTHORS: Dennis T. Chang, MD, Micah Mann, MD, Terry Sommer, BFA, Robert Fallar, PhD, Alan Weinberg, MS, Erica Friedman, MD
Techniques and behaviors associated with exemplary inpatient general medicine teaching: An exploratory qualitative study
AUTHORS: Nathan Houchens, MD, Molly Harrod, PhD, Stephanie Moody, PhD, Karen E. Fowler, MPH, Sanjay Saint, MD, MPH
A simple algorithm for predicting bacteremia using food consumption and shaking chills: A prospective observational study
AUTHORS: Takayuki Komatsu, MD, PhD, Erika Takahashi, MD, Kentaro Mishima, MD, Takeo Toyoda, MD, Fumihiro Saitoh, MD, Akari Yasuda, RN, Joe Matsuoka, PhD, Manabu Sugita, MD, PhD, Joel Branch, MD, Makoto Aoki, MD, Lawrence M. Tierney Jr., MD, Kenji Inoue, MD, PhD
For more articles and subscription information, visit www.journalofhospitalmedicine.com.