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M. Alexander Otto began his reporting career early in 1999 covering the pharmaceutical industry for a national pharmacists' magazine and freelancing for the Washington Post and other newspapers. He then joined BNA, now part of Bloomberg News, covering health law and the protection of people and animals in medical research. Alex next worked for the McClatchy Company. Based on his work, Alex won a year-long Knight Science Journalism Fellowship to MIT in 2008-2009. He joined the company shortly thereafter. Alex has a newspaper journalism degree from Syracuse (N.Y.) University and a master's degree in medical science -- a physician assistant degree -- from George Washington University. Alex is based in Seattle.
Early tube feeding may speed discharge for elderly hip fracture patients
LAS VEGAS – Lengths of hospital stay were nearly halved in elderly hip fracture patients started on enteral nutrition within 24 hours of surgery, according to a retrospective cohort study of 100 sequential hip fracture patients at Salem (Ore.) Hospital.
The 89 patients fed by nasogastric tube within 24 hours stayed in the hospital an average of 4.43 days. The 11 fed an average of 4.36 days later stayed an average of 7.80 days.
The risk of hospital stays 5 days or longer quadrupled when enteral nutrition was delayed (RR, 4.14). Two patients (18%) died in the delayed-feeding group; eight (9%) died in the early-feeding group.
The average age in the study was 83 years old. Patients who went for more than a day without being fed – the range was 2-7 days – were a bit older with an average age of 86 years, "meaning that they were unlikely to have much in the way of reserves and were very likely to have some malnutrition at baseline," said Dr. Cynthia Wallace, medical director of Vibra Specialty Hospital in Portland, Ore., as well as a palliative care consultant at Salem Hospital.
"Association doesn’t prove causality," she said. It’s possible that those who went longer without nutrition were sicker and more confused.
Even so, "the correlation was pretty compelling." The findings argue strongly for early nutrition "whether or not it’s known absolutely" that it improves outcomes. Nutrition is essential for recovery: "If you are going to treat a patient aggressively, you need to give them nutrition. It’s just the right thing to do." It may also save a lot of money. A day in the hospital costs more than $4,000, while feedings cost about $35 a day, Dr. Wallace said at the Society of Hospital Medicine annual meeting.
"Given an ALOS [average length of stay] of 7 days without intervention, an early 3-day trial of enteral nutrition could save the hospital between $2,939 and $12,065 for an ALOS reduction of 1-4 days, respectively," she reported in the accompanying abstract. "Assuming a utility of 100%, the cost per outpatient day gained for the patient varies from $25 to $100 for a range of 4 to 1 days gained. If early enteral nutrition is responsible for the reduction in ALOS, less than 10% of 1 cent is spent to garner $1 in reduced inpatient costs."
Days go by
It’s not uncommon for elderly patients to go days without being fed. One of the reasons, Dr. Wallace said, is because there’s been an overextrapolation from studies showing that percutaneous gastrostomy tubes don’t improve quality of life or survival in end-stage dementia.
Those findings "have unintentionally influenced use of temporary feeding tubes in patients with acute issues who are otherwise receiving full medical treatment" and have resulted "in inappropriate withholding of enteral nutrition" in the elderly, she said.
"We’ve morphed the data into saying, ‘Oh, if I’ve got a patient who has some underlying dementia, I shouldn’t give them tube feeds. But the data about not doing [gastrostomy] tubes in advanced dementia has to do with people who are not undergoing acute medical treatment. That’s a very different situation from hip fractures and other acute problems in the elderly. Unfortunately, the evidence for one situation has been transposed onto a different situation, so a lot of hospitalists hesitate to initiate tube feeds," she said.
In patients who waited more than a day to get fed, "there was a lag time to even getting a nutrition consult. Nobody really quite noticed that they weren’t getting nutrition." That’s consistent "with what I’ve seen throughout my hospitalist career, and not just in hip fractures. As hospitalist doctors, we get very worked up about the medical issues, and we simply don’t attend to nutrition. We sometimes think somebody else is taking care of it," she said.
"The ages were [statistically] the same between the two groups, and there was a pretty [even] distribution of comorbidities," she noted.
Dr. Wallace said she had no relevant financial disclosures. The work received no outside funding.
LAS VEGAS – Lengths of hospital stay were nearly halved in elderly hip fracture patients started on enteral nutrition within 24 hours of surgery, according to a retrospective cohort study of 100 sequential hip fracture patients at Salem (Ore.) Hospital.
The 89 patients fed by nasogastric tube within 24 hours stayed in the hospital an average of 4.43 days. The 11 fed an average of 4.36 days later stayed an average of 7.80 days.
The risk of hospital stays 5 days or longer quadrupled when enteral nutrition was delayed (RR, 4.14). Two patients (18%) died in the delayed-feeding group; eight (9%) died in the early-feeding group.
The average age in the study was 83 years old. Patients who went for more than a day without being fed – the range was 2-7 days – were a bit older with an average age of 86 years, "meaning that they were unlikely to have much in the way of reserves and were very likely to have some malnutrition at baseline," said Dr. Cynthia Wallace, medical director of Vibra Specialty Hospital in Portland, Ore., as well as a palliative care consultant at Salem Hospital.
"Association doesn’t prove causality," she said. It’s possible that those who went longer without nutrition were sicker and more confused.
Even so, "the correlation was pretty compelling." The findings argue strongly for early nutrition "whether or not it’s known absolutely" that it improves outcomes. Nutrition is essential for recovery: "If you are going to treat a patient aggressively, you need to give them nutrition. It’s just the right thing to do." It may also save a lot of money. A day in the hospital costs more than $4,000, while feedings cost about $35 a day, Dr. Wallace said at the Society of Hospital Medicine annual meeting.
"Given an ALOS [average length of stay] of 7 days without intervention, an early 3-day trial of enteral nutrition could save the hospital between $2,939 and $12,065 for an ALOS reduction of 1-4 days, respectively," she reported in the accompanying abstract. "Assuming a utility of 100%, the cost per outpatient day gained for the patient varies from $25 to $100 for a range of 4 to 1 days gained. If early enteral nutrition is responsible for the reduction in ALOS, less than 10% of 1 cent is spent to garner $1 in reduced inpatient costs."
Days go by
It’s not uncommon for elderly patients to go days without being fed. One of the reasons, Dr. Wallace said, is because there’s been an overextrapolation from studies showing that percutaneous gastrostomy tubes don’t improve quality of life or survival in end-stage dementia.
Those findings "have unintentionally influenced use of temporary feeding tubes in patients with acute issues who are otherwise receiving full medical treatment" and have resulted "in inappropriate withholding of enteral nutrition" in the elderly, she said.
"We’ve morphed the data into saying, ‘Oh, if I’ve got a patient who has some underlying dementia, I shouldn’t give them tube feeds. But the data about not doing [gastrostomy] tubes in advanced dementia has to do with people who are not undergoing acute medical treatment. That’s a very different situation from hip fractures and other acute problems in the elderly. Unfortunately, the evidence for one situation has been transposed onto a different situation, so a lot of hospitalists hesitate to initiate tube feeds," she said.
In patients who waited more than a day to get fed, "there was a lag time to even getting a nutrition consult. Nobody really quite noticed that they weren’t getting nutrition." That’s consistent "with what I’ve seen throughout my hospitalist career, and not just in hip fractures. As hospitalist doctors, we get very worked up about the medical issues, and we simply don’t attend to nutrition. We sometimes think somebody else is taking care of it," she said.
"The ages were [statistically] the same between the two groups, and there was a pretty [even] distribution of comorbidities," she noted.
Dr. Wallace said she had no relevant financial disclosures. The work received no outside funding.
LAS VEGAS – Lengths of hospital stay were nearly halved in elderly hip fracture patients started on enteral nutrition within 24 hours of surgery, according to a retrospective cohort study of 100 sequential hip fracture patients at Salem (Ore.) Hospital.
The 89 patients fed by nasogastric tube within 24 hours stayed in the hospital an average of 4.43 days. The 11 fed an average of 4.36 days later stayed an average of 7.80 days.
The risk of hospital stays 5 days or longer quadrupled when enteral nutrition was delayed (RR, 4.14). Two patients (18%) died in the delayed-feeding group; eight (9%) died in the early-feeding group.
The average age in the study was 83 years old. Patients who went for more than a day without being fed – the range was 2-7 days – were a bit older with an average age of 86 years, "meaning that they were unlikely to have much in the way of reserves and were very likely to have some malnutrition at baseline," said Dr. Cynthia Wallace, medical director of Vibra Specialty Hospital in Portland, Ore., as well as a palliative care consultant at Salem Hospital.
"Association doesn’t prove causality," she said. It’s possible that those who went longer without nutrition were sicker and more confused.
Even so, "the correlation was pretty compelling." The findings argue strongly for early nutrition "whether or not it’s known absolutely" that it improves outcomes. Nutrition is essential for recovery: "If you are going to treat a patient aggressively, you need to give them nutrition. It’s just the right thing to do." It may also save a lot of money. A day in the hospital costs more than $4,000, while feedings cost about $35 a day, Dr. Wallace said at the Society of Hospital Medicine annual meeting.
"Given an ALOS [average length of stay] of 7 days without intervention, an early 3-day trial of enteral nutrition could save the hospital between $2,939 and $12,065 for an ALOS reduction of 1-4 days, respectively," she reported in the accompanying abstract. "Assuming a utility of 100%, the cost per outpatient day gained for the patient varies from $25 to $100 for a range of 4 to 1 days gained. If early enteral nutrition is responsible for the reduction in ALOS, less than 10% of 1 cent is spent to garner $1 in reduced inpatient costs."
Days go by
It’s not uncommon for elderly patients to go days without being fed. One of the reasons, Dr. Wallace said, is because there’s been an overextrapolation from studies showing that percutaneous gastrostomy tubes don’t improve quality of life or survival in end-stage dementia.
Those findings "have unintentionally influenced use of temporary feeding tubes in patients with acute issues who are otherwise receiving full medical treatment" and have resulted "in inappropriate withholding of enteral nutrition" in the elderly, she said.
"We’ve morphed the data into saying, ‘Oh, if I’ve got a patient who has some underlying dementia, I shouldn’t give them tube feeds. But the data about not doing [gastrostomy] tubes in advanced dementia has to do with people who are not undergoing acute medical treatment. That’s a very different situation from hip fractures and other acute problems in the elderly. Unfortunately, the evidence for one situation has been transposed onto a different situation, so a lot of hospitalists hesitate to initiate tube feeds," she said.
In patients who waited more than a day to get fed, "there was a lag time to even getting a nutrition consult. Nobody really quite noticed that they weren’t getting nutrition." That’s consistent "with what I’ve seen throughout my hospitalist career, and not just in hip fractures. As hospitalist doctors, we get very worked up about the medical issues, and we simply don’t attend to nutrition. We sometimes think somebody else is taking care of it," she said.
"The ages were [statistically] the same between the two groups, and there was a pretty [even] distribution of comorbidities," she noted.
Dr. Wallace said she had no relevant financial disclosures. The work received no outside funding.
AT HOSPITAL MEDICINE 2014
Major finding: Hospital length of stay for patients receiving enteral nutrition within 24 hours of hip surgery was 4.43 days vs 7.80 days for patients who received no enteral nutrition for more than 1 day postoperatively.
Data source: A retrospective cohort study of 89 elderly hip fracture patients.
Disclosures: The investigator reported having no relevant financial disclosures; no outside funding was involved in the project.
Quality gap in atrial fibrillation care significant
LAS VEGAS – About 40% of atrial fibrillation inpatients leave the hospital without a prescription for stroke prevention medications, according to a retrospective review from Northwestern University in Chicago.
Investigators there calculated the CHADS2(congestive heart failure, hypertension, age, diabetes, prior stroke) score of 16,106 patients discharged with atrial fibrillation diagnosed by 12-lead EKG or telemetry. Guidelines call for aspirin or anticoagulation in patients with a score of 1, and anticoagulation in patients with scores of 2-6, according to lead researcher Dr. Hiren Shah, medical director of the medicine and cardiac telemetry hospitalist unit at Northwestern Memorial Hospital in Chicago.
Even so, 41.2% of 277 patients with a CHADS2 score of 6 and 36% of of patients with a score of 5 were discharged without a prescription to prevent stroke. Additionally, 36.8% of 1,550 with a score of 4 left the hospital without such a prescription, as did 35.9% of 3,343 patients with a score of 3, 38.8% of 4,106 of patients with a score of 2 and 40.3% of 3,457 patients with a score of 1.
Among patients who were treated, about 15% with a score of 2-6 received aspirin alone, instead of warfarin or newer anticoagulants. When anticoagulation was initiated, warfarin was the most common choice.
"These data, I think, would mirror the overall population of patients throughout the country. There’s a major quality gap in atrial fibrillation. I would urge hospitalists to start quality improvement projects to address this very important clinical issue," Dr. Shah said.
The reasons for the findings are uncertain. It’s unknown if patients were started on stroke prophylaxis after discharge. The study, comprising two years of patient data starting Nov.1, 2011, also did not assess outcomes or reasons why patients went untreated.
It could be that hospitalists didn’t have time to discuss anticoagulation with patients, or didn’t calculate CHADS2 scores. They might also have overestimated bleeding risks, although if "you’re at CHADS 5 or 6, your stroke risk is 12% and 18% per year, so unless the contraindication to anticoagulation is absolute, the risk of bleeding would have to be very high for you not to choose anticoagulation," Dr. Shah said at the Society of Hospital Medicine annual meeting.
Hospitalists might also have thought that anticoagulation is an outpatient issue, "but we think the hospital is a nice point in time where you can capture these patients and evaluate them for this issue, then communicate their stroke risk to their primary care doctor," he said.
One of the solutions is a reminder in the electronic health record to do a CHADS score, so long as the system can recognize atrial fibrillation patients. Also, with the help of funding from the Society of Hospital Medicine, "we are going to have a mentored implementation program where we’ll go to hospitals and coach them on how to improve, similar to what we did for DVT/PE [deep vein thrombosis/pulmonary embolism] prophylaxis," Dr. Shah said.
Atrial fibrillation, in general, "is at the point where DVT/PE was several years ago. Prophylaxis was sporadic, and then there was a big push. We think atrial fibrillation is a similar condition that will be addressed aggressively in time by all hospitals," he said.
Dr. Shah is a speaker for Janssen Pharmaceuticals, the maker of the anticoagulant rivaroxaban (Xarelto). He is also an editorial adviser for Hospitalist News. He said his work received no outside funding.
LAS VEGAS – About 40% of atrial fibrillation inpatients leave the hospital without a prescription for stroke prevention medications, according to a retrospective review from Northwestern University in Chicago.
Investigators there calculated the CHADS2(congestive heart failure, hypertension, age, diabetes, prior stroke) score of 16,106 patients discharged with atrial fibrillation diagnosed by 12-lead EKG or telemetry. Guidelines call for aspirin or anticoagulation in patients with a score of 1, and anticoagulation in patients with scores of 2-6, according to lead researcher Dr. Hiren Shah, medical director of the medicine and cardiac telemetry hospitalist unit at Northwestern Memorial Hospital in Chicago.
Even so, 41.2% of 277 patients with a CHADS2 score of 6 and 36% of of patients with a score of 5 were discharged without a prescription to prevent stroke. Additionally, 36.8% of 1,550 with a score of 4 left the hospital without such a prescription, as did 35.9% of 3,343 patients with a score of 3, 38.8% of 4,106 of patients with a score of 2 and 40.3% of 3,457 patients with a score of 1.
Among patients who were treated, about 15% with a score of 2-6 received aspirin alone, instead of warfarin or newer anticoagulants. When anticoagulation was initiated, warfarin was the most common choice.
"These data, I think, would mirror the overall population of patients throughout the country. There’s a major quality gap in atrial fibrillation. I would urge hospitalists to start quality improvement projects to address this very important clinical issue," Dr. Shah said.
The reasons for the findings are uncertain. It’s unknown if patients were started on stroke prophylaxis after discharge. The study, comprising two years of patient data starting Nov.1, 2011, also did not assess outcomes or reasons why patients went untreated.
It could be that hospitalists didn’t have time to discuss anticoagulation with patients, or didn’t calculate CHADS2 scores. They might also have overestimated bleeding risks, although if "you’re at CHADS 5 or 6, your stroke risk is 12% and 18% per year, so unless the contraindication to anticoagulation is absolute, the risk of bleeding would have to be very high for you not to choose anticoagulation," Dr. Shah said at the Society of Hospital Medicine annual meeting.
Hospitalists might also have thought that anticoagulation is an outpatient issue, "but we think the hospital is a nice point in time where you can capture these patients and evaluate them for this issue, then communicate their stroke risk to their primary care doctor," he said.
One of the solutions is a reminder in the electronic health record to do a CHADS score, so long as the system can recognize atrial fibrillation patients. Also, with the help of funding from the Society of Hospital Medicine, "we are going to have a mentored implementation program where we’ll go to hospitals and coach them on how to improve, similar to what we did for DVT/PE [deep vein thrombosis/pulmonary embolism] prophylaxis," Dr. Shah said.
Atrial fibrillation, in general, "is at the point where DVT/PE was several years ago. Prophylaxis was sporadic, and then there was a big push. We think atrial fibrillation is a similar condition that will be addressed aggressively in time by all hospitals," he said.
Dr. Shah is a speaker for Janssen Pharmaceuticals, the maker of the anticoagulant rivaroxaban (Xarelto). He is also an editorial adviser for Hospitalist News. He said his work received no outside funding.
LAS VEGAS – About 40% of atrial fibrillation inpatients leave the hospital without a prescription for stroke prevention medications, according to a retrospective review from Northwestern University in Chicago.
Investigators there calculated the CHADS2(congestive heart failure, hypertension, age, diabetes, prior stroke) score of 16,106 patients discharged with atrial fibrillation diagnosed by 12-lead EKG or telemetry. Guidelines call for aspirin or anticoagulation in patients with a score of 1, and anticoagulation in patients with scores of 2-6, according to lead researcher Dr. Hiren Shah, medical director of the medicine and cardiac telemetry hospitalist unit at Northwestern Memorial Hospital in Chicago.
Even so, 41.2% of 277 patients with a CHADS2 score of 6 and 36% of of patients with a score of 5 were discharged without a prescription to prevent stroke. Additionally, 36.8% of 1,550 with a score of 4 left the hospital without such a prescription, as did 35.9% of 3,343 patients with a score of 3, 38.8% of 4,106 of patients with a score of 2 and 40.3% of 3,457 patients with a score of 1.
Among patients who were treated, about 15% with a score of 2-6 received aspirin alone, instead of warfarin or newer anticoagulants. When anticoagulation was initiated, warfarin was the most common choice.
"These data, I think, would mirror the overall population of patients throughout the country. There’s a major quality gap in atrial fibrillation. I would urge hospitalists to start quality improvement projects to address this very important clinical issue," Dr. Shah said.
The reasons for the findings are uncertain. It’s unknown if patients were started on stroke prophylaxis after discharge. The study, comprising two years of patient data starting Nov.1, 2011, also did not assess outcomes or reasons why patients went untreated.
It could be that hospitalists didn’t have time to discuss anticoagulation with patients, or didn’t calculate CHADS2 scores. They might also have overestimated bleeding risks, although if "you’re at CHADS 5 or 6, your stroke risk is 12% and 18% per year, so unless the contraindication to anticoagulation is absolute, the risk of bleeding would have to be very high for you not to choose anticoagulation," Dr. Shah said at the Society of Hospital Medicine annual meeting.
Hospitalists might also have thought that anticoagulation is an outpatient issue, "but we think the hospital is a nice point in time where you can capture these patients and evaluate them for this issue, then communicate their stroke risk to their primary care doctor," he said.
One of the solutions is a reminder in the electronic health record to do a CHADS score, so long as the system can recognize atrial fibrillation patients. Also, with the help of funding from the Society of Hospital Medicine, "we are going to have a mentored implementation program where we’ll go to hospitals and coach them on how to improve, similar to what we did for DVT/PE [deep vein thrombosis/pulmonary embolism] prophylaxis," Dr. Shah said.
Atrial fibrillation, in general, "is at the point where DVT/PE was several years ago. Prophylaxis was sporadic, and then there was a big push. We think atrial fibrillation is a similar condition that will be addressed aggressively in time by all hospitals," he said.
Dr. Shah is a speaker for Janssen Pharmaceuticals, the maker of the anticoagulant rivaroxaban (Xarelto). He is also an editorial adviser for Hospitalist News. He said his work received no outside funding.
AT HOSPITAL MEDICINE 2014
Major finding: A total of 36% of patients with a CHADS2 score of 5, and 41.2% with a score of 6 left the hospital without medications to prevent stroke.
Data Source: Retrospective review of more than 2 years of data for 16,000 patients hospitalized for atrial fibrillation patients
Disclosures: The lead investigator is a speaker for Janssen Pharmaceuticals, maker of rivaroxaban). He said his work received no outside funding.
Military's top doc: Iraq lessons saved lives in Boston
Dr. Jonathan Woodson fielded emails in his Pentagon office last April from nervous colleagues in Boston. His fellow vascular surgeons there wanted to know if more attacks were coming in the Marathon bombings. "When you work at the Pentagon, everyone thinks you have total situational awareness," said Dr. Woodson, assistant secretary of defense for health affairs.
His former colleagues, however, wanted tips on how to care for bombing victims, and knew that military surgeons like Dr. Woodson had answers. Before President Obama tapped him in 2010 to become the military’s top doctor and oversee the Pentagon’s $50 billion–plus medical budget, he’d scrubbed in on battlefield cases in Kosovo, Iraq, and Afghanistan, in addition to performing his vascular surgery and administrative duties at Boston University and Boston Medical Center.
"We’ve been dealing with [improvised explosive device] injuries for over a decade," said Dr. Woodson, a brigadier general in the U.S. Army Reserve. "I had trained some of the folks who worked on the bombing victims, and they knew what my techniques were."
The back-and-forth about the Boston attacks highlights how important it is for military and civilian physicians to cross-pollinate. In the past, "there’s always been a cadre of usually academic surgeons and physicians who maintain contact with the military. I think [it] is very important to formalize these connections. One of my strategic imperatives is to make sure we invest in partnerships [with] academic medical centers and key professional organizations" so that war innovations make it into civilian practice, and, in turn, are remembered for future conflicts.
"There’s the potential for this expertise to be lost," said Dr. Woodson, There’ve been many innovations in recent years, including the recognition that extensive fasciotomies can save badly damaged limbs.
At the start of Operation Iraqi Freedom in 2003, Dr. Woodson was in northern Kuwait running a makeshift U.S. military hospital out of a commandeered Kuwaiti facility. "As the troops went over the berm, we were taking the first wave of casualties," performing surgery in full chemical-attack gear. "Luckily, the incoming Scud missiles weren’t very accurate. It was a humbling experience," he said.
A young soldier was helicoptered in with a crushed leg after a hit to his armored vehicle. "We did an interposition graft to repair the popliteal artery," and, because of severe swelling, extensive fasciotomies to prevent compartment syndrome; the soldier still had his leg when he was airlifted out. Although not standard practice at the time, that case and others like it quickly demonstrated "the benefit of doing four-compartment fasciotomies early on to preserve limbs. Fasciotomies are now [used routinely] to address these injuries."
Tourniquets – which "prior to this conflict had a very bad reputation" – have proved their worth in recent battles as well, a lesson that helped save lives in Boston. Likewise, the military has learned the value of temporary vascular shunts when there’s no time for a definitive repair. "We [also] came to understand very early on the need for aggressive blood replacement," he said.
Dr. Jonathan Woodson fielded emails in his Pentagon office last April from nervous colleagues in Boston. His fellow vascular surgeons there wanted to know if more attacks were coming in the Marathon bombings. "When you work at the Pentagon, everyone thinks you have total situational awareness," said Dr. Woodson, assistant secretary of defense for health affairs.
His former colleagues, however, wanted tips on how to care for bombing victims, and knew that military surgeons like Dr. Woodson had answers. Before President Obama tapped him in 2010 to become the military’s top doctor and oversee the Pentagon’s $50 billion–plus medical budget, he’d scrubbed in on battlefield cases in Kosovo, Iraq, and Afghanistan, in addition to performing his vascular surgery and administrative duties at Boston University and Boston Medical Center.
"We’ve been dealing with [improvised explosive device] injuries for over a decade," said Dr. Woodson, a brigadier general in the U.S. Army Reserve. "I had trained some of the folks who worked on the bombing victims, and they knew what my techniques were."
The back-and-forth about the Boston attacks highlights how important it is for military and civilian physicians to cross-pollinate. In the past, "there’s always been a cadre of usually academic surgeons and physicians who maintain contact with the military. I think [it] is very important to formalize these connections. One of my strategic imperatives is to make sure we invest in partnerships [with] academic medical centers and key professional organizations" so that war innovations make it into civilian practice, and, in turn, are remembered for future conflicts.
"There’s the potential for this expertise to be lost," said Dr. Woodson, There’ve been many innovations in recent years, including the recognition that extensive fasciotomies can save badly damaged limbs.
At the start of Operation Iraqi Freedom in 2003, Dr. Woodson was in northern Kuwait running a makeshift U.S. military hospital out of a commandeered Kuwaiti facility. "As the troops went over the berm, we were taking the first wave of casualties," performing surgery in full chemical-attack gear. "Luckily, the incoming Scud missiles weren’t very accurate. It was a humbling experience," he said.
A young soldier was helicoptered in with a crushed leg after a hit to his armored vehicle. "We did an interposition graft to repair the popliteal artery," and, because of severe swelling, extensive fasciotomies to prevent compartment syndrome; the soldier still had his leg when he was airlifted out. Although not standard practice at the time, that case and others like it quickly demonstrated "the benefit of doing four-compartment fasciotomies early on to preserve limbs. Fasciotomies are now [used routinely] to address these injuries."
Tourniquets – which "prior to this conflict had a very bad reputation" – have proved their worth in recent battles as well, a lesson that helped save lives in Boston. Likewise, the military has learned the value of temporary vascular shunts when there’s no time for a definitive repair. "We [also] came to understand very early on the need for aggressive blood replacement," he said.
Dr. Jonathan Woodson fielded emails in his Pentagon office last April from nervous colleagues in Boston. His fellow vascular surgeons there wanted to know if more attacks were coming in the Marathon bombings. "When you work at the Pentagon, everyone thinks you have total situational awareness," said Dr. Woodson, assistant secretary of defense for health affairs.
His former colleagues, however, wanted tips on how to care for bombing victims, and knew that military surgeons like Dr. Woodson had answers. Before President Obama tapped him in 2010 to become the military’s top doctor and oversee the Pentagon’s $50 billion–plus medical budget, he’d scrubbed in on battlefield cases in Kosovo, Iraq, and Afghanistan, in addition to performing his vascular surgery and administrative duties at Boston University and Boston Medical Center.
"We’ve been dealing with [improvised explosive device] injuries for over a decade," said Dr. Woodson, a brigadier general in the U.S. Army Reserve. "I had trained some of the folks who worked on the bombing victims, and they knew what my techniques were."
The back-and-forth about the Boston attacks highlights how important it is for military and civilian physicians to cross-pollinate. In the past, "there’s always been a cadre of usually academic surgeons and physicians who maintain contact with the military. I think [it] is very important to formalize these connections. One of my strategic imperatives is to make sure we invest in partnerships [with] academic medical centers and key professional organizations" so that war innovations make it into civilian practice, and, in turn, are remembered for future conflicts.
"There’s the potential for this expertise to be lost," said Dr. Woodson, There’ve been many innovations in recent years, including the recognition that extensive fasciotomies can save badly damaged limbs.
At the start of Operation Iraqi Freedom in 2003, Dr. Woodson was in northern Kuwait running a makeshift U.S. military hospital out of a commandeered Kuwaiti facility. "As the troops went over the berm, we were taking the first wave of casualties," performing surgery in full chemical-attack gear. "Luckily, the incoming Scud missiles weren’t very accurate. It was a humbling experience," he said.
A young soldier was helicoptered in with a crushed leg after a hit to his armored vehicle. "We did an interposition graft to repair the popliteal artery," and, because of severe swelling, extensive fasciotomies to prevent compartment syndrome; the soldier still had his leg when he was airlifted out. Although not standard practice at the time, that case and others like it quickly demonstrated "the benefit of doing four-compartment fasciotomies early on to preserve limbs. Fasciotomies are now [used routinely] to address these injuries."
Tourniquets – which "prior to this conflict had a very bad reputation" – have proved their worth in recent battles as well, a lesson that helped save lives in Boston. Likewise, the military has learned the value of temporary vascular shunts when there’s no time for a definitive repair. "We [also] came to understand very early on the need for aggressive blood replacement," he said.
Physicians, nurses beat clinical scores for ICH outcome prediction
SAN DIEGO – Neurologists and neurology nurses predict 3-month functional outcomes following intracerebral hemorrhagic strokes better than do commonly used clinical scores, according to a prospective, observational study.
At each of the five centers participating in the study, the investigators asked one physician – usually a neurologist – and one neurology nurse on the treatment team to predict 3-month modified Rankin Scale (mRS) scores for primary intracerebral hemorrhagic (ICH) stroke patients under their care within 24 hours of admission.
The team then calculated the admission ICH score and FUNC score themselves based on imaging and other records. The results for all centers then were compared with actual 3-month mRS scores for the 100 patients included in the study.
With 1 representing a perfect correlation with actual 3-month mRS scores, the Spearman’s rank correlation for attending physicians was 0.81, for neurology nurses 0.72, for the ICH scale 0.55, and for the FUNC score –0.46 (negative because higher scores mean better outcomes).
To control for self-fulfilling prophecies among providers, the team ran the analysis again, excluding the 18 patients for whom comfort care was recommended early on. The results were similar: r = 0.78 for attendings, 0.66 for nurses, 0.48 for the ICH score, and –0.37 for the FUNC score. Results in both analyses were statistically significant. The accuracy advantage for physicians and nurses remained when predictions were examined for only the 35 patients who were alive at 3 months.
"Existing formal scales such as the ICH score and FUNC score are useful for providing general probabilities for outcomes among ICH [patient populations], but it is appropriate for trained neurologists and neuroscience nurses to use their best subjective judgment ... when counseling any individual ICH patient and their family," said lead investigator Dr. David Hwang, a neurointensivist in the neurology department at Yale University, New Haven, Conn.
The study findings matter because early predictions guide treatment. It’s the first time that stroke scores have been pitted against clinical judgment, he said at the International Stroke Conference, sponsored by the American Heart Association.
Seventy-five of the physicians were attendings, and 25% were trainees. Although attendings and neurology nurses significantly beat clinical scores, trainees did not. "The vast majority of physicians and nurses were specialists in neuroscience," Dr. Hwang noted.
Patents were, on average, 67 years old. The ICH involved a deep brain bleed in 53% and had a volume of less than 30 mL in 71%. Glasgow Coma Scale scores of 13-15 occurred in 64%.
"Our cohort contained a majority of well-appearing patients, with good exams and small bleeds," a potential limitation. But overall mortality at 3 months was 35%, which is comparable to results from large, published cohorts, Dr. Hwang said.
Even when the 18 comfort-care patients were excluded, "the self-fulfilling prophecy [may have had an] effect," but the team was trying to mimic real life in its work, where they "are the ones to figure out and give prognostic advice to patients and families," he said.
Dr. Hwang said he had no relevant disclosures. The study was funded by the American Heart Association and the National Institute of Neurological Disorders and Stroke.
SAN DIEGO – Neurologists and neurology nurses predict 3-month functional outcomes following intracerebral hemorrhagic strokes better than do commonly used clinical scores, according to a prospective, observational study.
At each of the five centers participating in the study, the investigators asked one physician – usually a neurologist – and one neurology nurse on the treatment team to predict 3-month modified Rankin Scale (mRS) scores for primary intracerebral hemorrhagic (ICH) stroke patients under their care within 24 hours of admission.
The team then calculated the admission ICH score and FUNC score themselves based on imaging and other records. The results for all centers then were compared with actual 3-month mRS scores for the 100 patients included in the study.
With 1 representing a perfect correlation with actual 3-month mRS scores, the Spearman’s rank correlation for attending physicians was 0.81, for neurology nurses 0.72, for the ICH scale 0.55, and for the FUNC score –0.46 (negative because higher scores mean better outcomes).
To control for self-fulfilling prophecies among providers, the team ran the analysis again, excluding the 18 patients for whom comfort care was recommended early on. The results were similar: r = 0.78 for attendings, 0.66 for nurses, 0.48 for the ICH score, and –0.37 for the FUNC score. Results in both analyses were statistically significant. The accuracy advantage for physicians and nurses remained when predictions were examined for only the 35 patients who were alive at 3 months.
"Existing formal scales such as the ICH score and FUNC score are useful for providing general probabilities for outcomes among ICH [patient populations], but it is appropriate for trained neurologists and neuroscience nurses to use their best subjective judgment ... when counseling any individual ICH patient and their family," said lead investigator Dr. David Hwang, a neurointensivist in the neurology department at Yale University, New Haven, Conn.
The study findings matter because early predictions guide treatment. It’s the first time that stroke scores have been pitted against clinical judgment, he said at the International Stroke Conference, sponsored by the American Heart Association.
Seventy-five of the physicians were attendings, and 25% were trainees. Although attendings and neurology nurses significantly beat clinical scores, trainees did not. "The vast majority of physicians and nurses were specialists in neuroscience," Dr. Hwang noted.
Patents were, on average, 67 years old. The ICH involved a deep brain bleed in 53% and had a volume of less than 30 mL in 71%. Glasgow Coma Scale scores of 13-15 occurred in 64%.
"Our cohort contained a majority of well-appearing patients, with good exams and small bleeds," a potential limitation. But overall mortality at 3 months was 35%, which is comparable to results from large, published cohorts, Dr. Hwang said.
Even when the 18 comfort-care patients were excluded, "the self-fulfilling prophecy [may have had an] effect," but the team was trying to mimic real life in its work, where they "are the ones to figure out and give prognostic advice to patients and families," he said.
Dr. Hwang said he had no relevant disclosures. The study was funded by the American Heart Association and the National Institute of Neurological Disorders and Stroke.
SAN DIEGO – Neurologists and neurology nurses predict 3-month functional outcomes following intracerebral hemorrhagic strokes better than do commonly used clinical scores, according to a prospective, observational study.
At each of the five centers participating in the study, the investigators asked one physician – usually a neurologist – and one neurology nurse on the treatment team to predict 3-month modified Rankin Scale (mRS) scores for primary intracerebral hemorrhagic (ICH) stroke patients under their care within 24 hours of admission.
The team then calculated the admission ICH score and FUNC score themselves based on imaging and other records. The results for all centers then were compared with actual 3-month mRS scores for the 100 patients included in the study.
With 1 representing a perfect correlation with actual 3-month mRS scores, the Spearman’s rank correlation for attending physicians was 0.81, for neurology nurses 0.72, for the ICH scale 0.55, and for the FUNC score –0.46 (negative because higher scores mean better outcomes).
To control for self-fulfilling prophecies among providers, the team ran the analysis again, excluding the 18 patients for whom comfort care was recommended early on. The results were similar: r = 0.78 for attendings, 0.66 for nurses, 0.48 for the ICH score, and –0.37 for the FUNC score. Results in both analyses were statistically significant. The accuracy advantage for physicians and nurses remained when predictions were examined for only the 35 patients who were alive at 3 months.
"Existing formal scales such as the ICH score and FUNC score are useful for providing general probabilities for outcomes among ICH [patient populations], but it is appropriate for trained neurologists and neuroscience nurses to use their best subjective judgment ... when counseling any individual ICH patient and their family," said lead investigator Dr. David Hwang, a neurointensivist in the neurology department at Yale University, New Haven, Conn.
The study findings matter because early predictions guide treatment. It’s the first time that stroke scores have been pitted against clinical judgment, he said at the International Stroke Conference, sponsored by the American Heart Association.
Seventy-five of the physicians were attendings, and 25% were trainees. Although attendings and neurology nurses significantly beat clinical scores, trainees did not. "The vast majority of physicians and nurses were specialists in neuroscience," Dr. Hwang noted.
Patents were, on average, 67 years old. The ICH involved a deep brain bleed in 53% and had a volume of less than 30 mL in 71%. Glasgow Coma Scale scores of 13-15 occurred in 64%.
"Our cohort contained a majority of well-appearing patients, with good exams and small bleeds," a potential limitation. But overall mortality at 3 months was 35%, which is comparable to results from large, published cohorts, Dr. Hwang said.
Even when the 18 comfort-care patients were excluded, "the self-fulfilling prophecy [may have had an] effect," but the team was trying to mimic real life in its work, where they "are the ones to figure out and give prognostic advice to patients and families," he said.
Dr. Hwang said he had no relevant disclosures. The study was funded by the American Heart Association and the National Institute of Neurological Disorders and Stroke.
AT THE INTERNATIONAL STROKE CONFERENCE
Major finding: With 1 representing a perfect correlation with actual 3-month mRS scores, the Spearman’s rank correlation for ICH functional outcomes predicted by attending physicians was 0.81, for predictions by neurology nurses 0.72, for ICH scale score predictions 0.55, and for the FUNC score –0.46.
Data Source: A prospective, observational study in 100 ICH patients.
Disclosures: Dr. Hwang said he had no relevant disclosures. The study was funded by the American Heart Association and the National Institute of Neurological Disorders and Stroke.
Inflammatory markers linked with IBD colon cancer risk
As C-reactive protein levels and erythrocyte sedimentation rates go up in patients with inflammatory bowel disease, the risk of colorectal cancer goes up, too, a finding that suggests a role for both as markers of colon cancer risk, Boston investigators reported in a prospective study.
The results were published online Jan. 6 in Clinical Gastroenterology and Hepatology.
The investigators divided 3,145 IBD patients into quartiles according to median C-reactive protein (CRP) levels, and 4,008 other patients into quartiles according to median erythrocyte sedimentation rates (ESR).
They followed the patients for a median of 6 years.
On multivariate analysis, there was a significant increase in the risk of colorectal cancer (CRC) across quartiles of CRP elevation (P for trend = .017).
Higher median ESR was also independently associated with higher risk of CRC across quartiles (P for trend = .007) (Clin. Gastroenterol. Hepatol. 2014 Jan. 6 [doi: 10.1016/j.cgh. 2013.12.030]).
"This association adds another clinical variable to help stratify patients into risk categories. There is an important need to identify high-risk subgroups that may benefit from continued intensive surveillance strategies while allowing for less frequent colonoscopies in patients at low risk of CRC. We believe that our findings ... suggest that an individual patient’s severity of inflammation may be helpful in further personalizing surveillance recommendations," and might even help monitor other outcomes, including treatment response, wrote the authors, led by Dr. Ashwin Ananthakrishnan, a gastroenterologist at Massachusetts General Hospital, Boston.
After adjustment for age, sex, race, IBD type, and other factors, the patients in the highest CRP quartile had more than double the risk of colorectal cancer compared with those in the lowest quartile (OR 2.72, 95% CI 0.95-7.76).
The strength of association was similar in men and women, and in Crohn’s disease and ulcerative colitis.
Similarly, patients in the highest ESR quartile had double the risk compared with those in the lowest (OR 2.06, 95% CI 1.14-3.74). The correlation was strongest in ulcerative colitis patients and men.
The median CRP values in each of the quartiles were 0.8, 2.7, 7.5, and 32.8 mg/L. In the ESR group, the median quartile values were 7, 14, 25, and 50 mm/hr.
Overall, 33 patients in the CRP cohort and 102 patients in the ESR cohort developed colorectal cancer at a median age of 55 years.
The median number of CRP measurements was three, and median number of ESR measurements six. More than half the subjects were women, most were white, and ulcerative colitis was slightly more common than was Crohn’s disease.
Adjustment for the number of colonoscopies, intensity of health care utilization, use of corticosteroids, and other factors did not change results for either the CRP or ESR cohorts.
As C-reactive protein levels and erythrocyte sedimentation rates go up in patients with inflammatory bowel disease, the risk of colorectal cancer goes up, too, a finding that suggests a role for both as markers of colon cancer risk, Boston investigators reported in a prospective study.
The results were published online Jan. 6 in Clinical Gastroenterology and Hepatology.
The investigators divided 3,145 IBD patients into quartiles according to median C-reactive protein (CRP) levels, and 4,008 other patients into quartiles according to median erythrocyte sedimentation rates (ESR).
They followed the patients for a median of 6 years.
On multivariate analysis, there was a significant increase in the risk of colorectal cancer (CRC) across quartiles of CRP elevation (P for trend = .017).
Higher median ESR was also independently associated with higher risk of CRC across quartiles (P for trend = .007) (Clin. Gastroenterol. Hepatol. 2014 Jan. 6 [doi: 10.1016/j.cgh. 2013.12.030]).
"This association adds another clinical variable to help stratify patients into risk categories. There is an important need to identify high-risk subgroups that may benefit from continued intensive surveillance strategies while allowing for less frequent colonoscopies in patients at low risk of CRC. We believe that our findings ... suggest that an individual patient’s severity of inflammation may be helpful in further personalizing surveillance recommendations," and might even help monitor other outcomes, including treatment response, wrote the authors, led by Dr. Ashwin Ananthakrishnan, a gastroenterologist at Massachusetts General Hospital, Boston.
After adjustment for age, sex, race, IBD type, and other factors, the patients in the highest CRP quartile had more than double the risk of colorectal cancer compared with those in the lowest quartile (OR 2.72, 95% CI 0.95-7.76).
The strength of association was similar in men and women, and in Crohn’s disease and ulcerative colitis.
Similarly, patients in the highest ESR quartile had double the risk compared with those in the lowest (OR 2.06, 95% CI 1.14-3.74). The correlation was strongest in ulcerative colitis patients and men.
The median CRP values in each of the quartiles were 0.8, 2.7, 7.5, and 32.8 mg/L. In the ESR group, the median quartile values were 7, 14, 25, and 50 mm/hr.
Overall, 33 patients in the CRP cohort and 102 patients in the ESR cohort developed colorectal cancer at a median age of 55 years.
The median number of CRP measurements was three, and median number of ESR measurements six. More than half the subjects were women, most were white, and ulcerative colitis was slightly more common than was Crohn’s disease.
Adjustment for the number of colonoscopies, intensity of health care utilization, use of corticosteroids, and other factors did not change results for either the CRP or ESR cohorts.
As C-reactive protein levels and erythrocyte sedimentation rates go up in patients with inflammatory bowel disease, the risk of colorectal cancer goes up, too, a finding that suggests a role for both as markers of colon cancer risk, Boston investigators reported in a prospective study.
The results were published online Jan. 6 in Clinical Gastroenterology and Hepatology.
The investigators divided 3,145 IBD patients into quartiles according to median C-reactive protein (CRP) levels, and 4,008 other patients into quartiles according to median erythrocyte sedimentation rates (ESR).
They followed the patients for a median of 6 years.
On multivariate analysis, there was a significant increase in the risk of colorectal cancer (CRC) across quartiles of CRP elevation (P for trend = .017).
Higher median ESR was also independently associated with higher risk of CRC across quartiles (P for trend = .007) (Clin. Gastroenterol. Hepatol. 2014 Jan. 6 [doi: 10.1016/j.cgh. 2013.12.030]).
"This association adds another clinical variable to help stratify patients into risk categories. There is an important need to identify high-risk subgroups that may benefit from continued intensive surveillance strategies while allowing for less frequent colonoscopies in patients at low risk of CRC. We believe that our findings ... suggest that an individual patient’s severity of inflammation may be helpful in further personalizing surveillance recommendations," and might even help monitor other outcomes, including treatment response, wrote the authors, led by Dr. Ashwin Ananthakrishnan, a gastroenterologist at Massachusetts General Hospital, Boston.
After adjustment for age, sex, race, IBD type, and other factors, the patients in the highest CRP quartile had more than double the risk of colorectal cancer compared with those in the lowest quartile (OR 2.72, 95% CI 0.95-7.76).
The strength of association was similar in men and women, and in Crohn’s disease and ulcerative colitis.
Similarly, patients in the highest ESR quartile had double the risk compared with those in the lowest (OR 2.06, 95% CI 1.14-3.74). The correlation was strongest in ulcerative colitis patients and men.
The median CRP values in each of the quartiles were 0.8, 2.7, 7.5, and 32.8 mg/L. In the ESR group, the median quartile values were 7, 14, 25, and 50 mm/hr.
Overall, 33 patients in the CRP cohort and 102 patients in the ESR cohort developed colorectal cancer at a median age of 55 years.
The median number of CRP measurements was three, and median number of ESR measurements six. More than half the subjects were women, most were white, and ulcerative colitis was slightly more common than was Crohn’s disease.
Adjustment for the number of colonoscopies, intensity of health care utilization, use of corticosteroids, and other factors did not change results for either the CRP or ESR cohorts.
Major finding: The risk of colorectal cancer is more than double for IBD patients with the highest quartile values of CRP (P for trend = .017) and ESR (P for trend = .007).
Data Source: Prospective, longitudinal study of 7,153 adult IBD patients.
Disclosures: The work was funded by the National Institutes of Health. The investigators have no disclosures.
Biphasic reaction risk rises with severity of initial anaphylactic attack
SAN DIEGO – The more severe an anaphylactic reaction, the more likely that a child will have a second reaction within several hours, according to data from a review of more than 400 children. The findings were presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Researchers found five independent predictors for biphasic reactions: age 6-9 years (OR, 3.60); time greater than 90 minutes from the onset of the initial anaphylactic reaction to emergency department presentation (OR, 2.58); wide pulse pressure at triage (OR, 2.92); treatment of the initial reaction with more than one dose of epinephrine (OR, 2.7); and administration of inhaled albuterol (Salbutamol) in the ED (OR, 2.39).
The "five clinical predictors could ultimately be used to identify patients who would benefit from prolonged ED or inpatient monitoring," noted Dr. Waleed D. Alqurashi of the University of Ottawa, and colleagues. "These findings may enable better utilization of ED resources and counseling of patients and families after anaphylactic reactions," they added.
The retrospective multicenter study included data from 484 children who visited an ED from January 2010 through December 2010 with anaphylactic reactions requiring epinephrine. Of these, 71 (15%) went on to a second reaction, most within 6 hours of the first. The median age of the children was 4.8 years, and about 65% were male.
"If any of these predictors are there, it means they need to be observed" at least 6-8 hours, said Dr. Alqurashi, an emergency medicine research fellow. "If the initial reaction was mild and treated appropriately with epinephrine, they don’t need to stay in the department for a long period of time," he said.
Of the 71 biphasic reactions, 53 (75%) occurred in the ED a median of 4.7 hours after the initial anaphylactic reaction; 18 (25%) occurred after ED discharge at a median of 18.5 hours from the first reaction. Thirty-five (49%) of the second reactions were anaphylactic, requiring epinephrine. "The other half were milder in nature," but still sometimes required oxygen or other significant interventions, Dr. Alqurashi said.
"Nobody knows exactly how often [biphasic reactions] happen," he said, although the data suggest that reactions occur about 15% of the time. The hunch is that the second reaction isn’t really an independent event, just a continuation of the first attack, he explained. "When you treat it the first time, you mask the symptoms" and the patient presents clinically again a few hours later, after the first round of medications wears off.
There were no statistical differences between children who had uniphasic and biphasic reactions in terms of the numbers of systems involved in their reactions. The majority of children in both groups had respiratory signs.
In agreement with previous studies, systemic steroids did not prevent biphasic reactions. "They were not useful. There may be a subpopulation that benefits from them, for example, people with asthma," Dr. Alqurashi said.
The investigators did not report outside funding. Dr. Alqurashi said he has no disclosures.
SAN DIEGO – The more severe an anaphylactic reaction, the more likely that a child will have a second reaction within several hours, according to data from a review of more than 400 children. The findings were presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Researchers found five independent predictors for biphasic reactions: age 6-9 years (OR, 3.60); time greater than 90 minutes from the onset of the initial anaphylactic reaction to emergency department presentation (OR, 2.58); wide pulse pressure at triage (OR, 2.92); treatment of the initial reaction with more than one dose of epinephrine (OR, 2.7); and administration of inhaled albuterol (Salbutamol) in the ED (OR, 2.39).
The "five clinical predictors could ultimately be used to identify patients who would benefit from prolonged ED or inpatient monitoring," noted Dr. Waleed D. Alqurashi of the University of Ottawa, and colleagues. "These findings may enable better utilization of ED resources and counseling of patients and families after anaphylactic reactions," they added.
The retrospective multicenter study included data from 484 children who visited an ED from January 2010 through December 2010 with anaphylactic reactions requiring epinephrine. Of these, 71 (15%) went on to a second reaction, most within 6 hours of the first. The median age of the children was 4.8 years, and about 65% were male.
"If any of these predictors are there, it means they need to be observed" at least 6-8 hours, said Dr. Alqurashi, an emergency medicine research fellow. "If the initial reaction was mild and treated appropriately with epinephrine, they don’t need to stay in the department for a long period of time," he said.
Of the 71 biphasic reactions, 53 (75%) occurred in the ED a median of 4.7 hours after the initial anaphylactic reaction; 18 (25%) occurred after ED discharge at a median of 18.5 hours from the first reaction. Thirty-five (49%) of the second reactions were anaphylactic, requiring epinephrine. "The other half were milder in nature," but still sometimes required oxygen or other significant interventions, Dr. Alqurashi said.
"Nobody knows exactly how often [biphasic reactions] happen," he said, although the data suggest that reactions occur about 15% of the time. The hunch is that the second reaction isn’t really an independent event, just a continuation of the first attack, he explained. "When you treat it the first time, you mask the symptoms" and the patient presents clinically again a few hours later, after the first round of medications wears off.
There were no statistical differences between children who had uniphasic and biphasic reactions in terms of the numbers of systems involved in their reactions. The majority of children in both groups had respiratory signs.
In agreement with previous studies, systemic steroids did not prevent biphasic reactions. "They were not useful. There may be a subpopulation that benefits from them, for example, people with asthma," Dr. Alqurashi said.
The investigators did not report outside funding. Dr. Alqurashi said he has no disclosures.
SAN DIEGO – The more severe an anaphylactic reaction, the more likely that a child will have a second reaction within several hours, according to data from a review of more than 400 children. The findings were presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Researchers found five independent predictors for biphasic reactions: age 6-9 years (OR, 3.60); time greater than 90 minutes from the onset of the initial anaphylactic reaction to emergency department presentation (OR, 2.58); wide pulse pressure at triage (OR, 2.92); treatment of the initial reaction with more than one dose of epinephrine (OR, 2.7); and administration of inhaled albuterol (Salbutamol) in the ED (OR, 2.39).
The "five clinical predictors could ultimately be used to identify patients who would benefit from prolonged ED or inpatient monitoring," noted Dr. Waleed D. Alqurashi of the University of Ottawa, and colleagues. "These findings may enable better utilization of ED resources and counseling of patients and families after anaphylactic reactions," they added.
The retrospective multicenter study included data from 484 children who visited an ED from January 2010 through December 2010 with anaphylactic reactions requiring epinephrine. Of these, 71 (15%) went on to a second reaction, most within 6 hours of the first. The median age of the children was 4.8 years, and about 65% were male.
"If any of these predictors are there, it means they need to be observed" at least 6-8 hours, said Dr. Alqurashi, an emergency medicine research fellow. "If the initial reaction was mild and treated appropriately with epinephrine, they don’t need to stay in the department for a long period of time," he said.
Of the 71 biphasic reactions, 53 (75%) occurred in the ED a median of 4.7 hours after the initial anaphylactic reaction; 18 (25%) occurred after ED discharge at a median of 18.5 hours from the first reaction. Thirty-five (49%) of the second reactions were anaphylactic, requiring epinephrine. "The other half were milder in nature," but still sometimes required oxygen or other significant interventions, Dr. Alqurashi said.
"Nobody knows exactly how often [biphasic reactions] happen," he said, although the data suggest that reactions occur about 15% of the time. The hunch is that the second reaction isn’t really an independent event, just a continuation of the first attack, he explained. "When you treat it the first time, you mask the symptoms" and the patient presents clinically again a few hours later, after the first round of medications wears off.
There were no statistical differences between children who had uniphasic and biphasic reactions in terms of the numbers of systems involved in their reactions. The majority of children in both groups had respiratory signs.
In agreement with previous studies, systemic steroids did not prevent biphasic reactions. "They were not useful. There may be a subpopulation that benefits from them, for example, people with asthma," Dr. Alqurashi said.
The investigators did not report outside funding. Dr. Alqurashi said he has no disclosures.
AT THE 2014 AAAAI ANNUAL MEETING
Major finding: The odds of biphasic reactions more than double if the first anaphylactic attack requires more than one epinephrine shot (OR, 2.92; 95% CI 1.69-5.04).
Data Source: Retrospective cohort analysis of anaphylactic reactions in 484 children.
Disclosures: The investigators did not report outside funding. The lead author had no disclosures.
Computer program calls parents when asthma scrips run low
SAN DIEGO – A newly developed computer program mines electronic medical records to find pediatric asthma patients who are about to run out of their inhaled corticosteroid inhalers, then calls their parents to help them order new ones.
It’s not a robocall. Parents don’t push buttons to signal their response. Instead, they speak to the computer, and it understands what they say, just like the automated speech-recognition telephone systems used by credit card companies, airlines, and other industries. The software was developed by team from National Jewish Health and Kaiser Permanente Colorado, both in Denver.
At 24 months, adherence – measured by medication possession ratio – was 44.5% among 452 children randomized to the calls and 35.5% among 447 who were not, a statistically significant 25% difference.
"It takes a fair amount of work to get a system like this going, but then the computer does the rest. Most adherence interventions expect busy health care providers to do something; this doesn’t add any burden to their day. Think of it as the electronic health record picking up the phone and talking with patients," said project leader Bruce Bender, Ph.D., head of pediatric behavioral health at National Jewish Health in Denver.
The system calls parents 10 days before the child is due to run out of the inhaler. "It pulls information out of the EHR, so when it talks to the parent, it references the prescribing physician, the name of the child, and the last time the inhaled corticosteroid prescription was filled." It then gives parents options to refill the prescription or talk with an asthma nurse or pharmacist, among other things, he said.
The 25% adherence improvement was consistent throughout the investigation and in subgroups stratified by age, gender, race, body mass index, or disease-related characteristics.
ED visits and admissions did not differ between the call and control groups. "We were a little bit surprised by that, because this is a bigger bump in adherence than you typically see in adherence interventions." Maybe it was because "care is already pretty good in [our system]; we keep people out of the ED pretty effectively." In both groups, there were 0.09 ED visits per person in the year before enrollment, Dr. Bender said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
"It could also be that in asthma, you really need to change the [adherence] curve more dramatically to see a change in outcomes," he said.
Children in the study were aged 3-12 years. About 10% of parents contacted declined to participate in the program; about 90% of those who did said in subsequent surveys that they liked the calls and found them helpful. Dr. Bender and his colleagues said they hope to scale up the system for cardiovascular and adult asthma patients.
If parents did not pick up the phone, the system would leave a message and try a few more times, but "we capped it at three [callbacks]. We didn’t want people to feel harassed," he said.
Eliza Corp., a computer company outside of Boston, developed the program’s software. The efforts were funded by the National Heart, Lung, and Blood institute. Dr. Bender said he has no relevant disclosures.
SAN DIEGO – A newly developed computer program mines electronic medical records to find pediatric asthma patients who are about to run out of their inhaled corticosteroid inhalers, then calls their parents to help them order new ones.
It’s not a robocall. Parents don’t push buttons to signal their response. Instead, they speak to the computer, and it understands what they say, just like the automated speech-recognition telephone systems used by credit card companies, airlines, and other industries. The software was developed by team from National Jewish Health and Kaiser Permanente Colorado, both in Denver.
At 24 months, adherence – measured by medication possession ratio – was 44.5% among 452 children randomized to the calls and 35.5% among 447 who were not, a statistically significant 25% difference.
"It takes a fair amount of work to get a system like this going, but then the computer does the rest. Most adherence interventions expect busy health care providers to do something; this doesn’t add any burden to their day. Think of it as the electronic health record picking up the phone and talking with patients," said project leader Bruce Bender, Ph.D., head of pediatric behavioral health at National Jewish Health in Denver.
The system calls parents 10 days before the child is due to run out of the inhaler. "It pulls information out of the EHR, so when it talks to the parent, it references the prescribing physician, the name of the child, and the last time the inhaled corticosteroid prescription was filled." It then gives parents options to refill the prescription or talk with an asthma nurse or pharmacist, among other things, he said.
The 25% adherence improvement was consistent throughout the investigation and in subgroups stratified by age, gender, race, body mass index, or disease-related characteristics.
ED visits and admissions did not differ between the call and control groups. "We were a little bit surprised by that, because this is a bigger bump in adherence than you typically see in adherence interventions." Maybe it was because "care is already pretty good in [our system]; we keep people out of the ED pretty effectively." In both groups, there were 0.09 ED visits per person in the year before enrollment, Dr. Bender said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
"It could also be that in asthma, you really need to change the [adherence] curve more dramatically to see a change in outcomes," he said.
Children in the study were aged 3-12 years. About 10% of parents contacted declined to participate in the program; about 90% of those who did said in subsequent surveys that they liked the calls and found them helpful. Dr. Bender and his colleagues said they hope to scale up the system for cardiovascular and adult asthma patients.
If parents did not pick up the phone, the system would leave a message and try a few more times, but "we capped it at three [callbacks]. We didn’t want people to feel harassed," he said.
Eliza Corp., a computer company outside of Boston, developed the program’s software. The efforts were funded by the National Heart, Lung, and Blood institute. Dr. Bender said he has no relevant disclosures.
SAN DIEGO – A newly developed computer program mines electronic medical records to find pediatric asthma patients who are about to run out of their inhaled corticosteroid inhalers, then calls their parents to help them order new ones.
It’s not a robocall. Parents don’t push buttons to signal their response. Instead, they speak to the computer, and it understands what they say, just like the automated speech-recognition telephone systems used by credit card companies, airlines, and other industries. The software was developed by team from National Jewish Health and Kaiser Permanente Colorado, both in Denver.
At 24 months, adherence – measured by medication possession ratio – was 44.5% among 452 children randomized to the calls and 35.5% among 447 who were not, a statistically significant 25% difference.
"It takes a fair amount of work to get a system like this going, but then the computer does the rest. Most adherence interventions expect busy health care providers to do something; this doesn’t add any burden to their day. Think of it as the electronic health record picking up the phone and talking with patients," said project leader Bruce Bender, Ph.D., head of pediatric behavioral health at National Jewish Health in Denver.
The system calls parents 10 days before the child is due to run out of the inhaler. "It pulls information out of the EHR, so when it talks to the parent, it references the prescribing physician, the name of the child, and the last time the inhaled corticosteroid prescription was filled." It then gives parents options to refill the prescription or talk with an asthma nurse or pharmacist, among other things, he said.
The 25% adherence improvement was consistent throughout the investigation and in subgroups stratified by age, gender, race, body mass index, or disease-related characteristics.
ED visits and admissions did not differ between the call and control groups. "We were a little bit surprised by that, because this is a bigger bump in adherence than you typically see in adherence interventions." Maybe it was because "care is already pretty good in [our system]; we keep people out of the ED pretty effectively." In both groups, there were 0.09 ED visits per person in the year before enrollment, Dr. Bender said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
"It could also be that in asthma, you really need to change the [adherence] curve more dramatically to see a change in outcomes," he said.
Children in the study were aged 3-12 years. About 10% of parents contacted declined to participate in the program; about 90% of those who did said in subsequent surveys that they liked the calls and found them helpful. Dr. Bender and his colleagues said they hope to scale up the system for cardiovascular and adult asthma patients.
If parents did not pick up the phone, the system would leave a message and try a few more times, but "we capped it at three [callbacks]. We didn’t want people to feel harassed," he said.
Eliza Corp., a computer company outside of Boston, developed the program’s software. The efforts were funded by the National Heart, Lung, and Blood institute. Dr. Bender said he has no relevant disclosures.
AT THE 2014 AAAAI ANNUAL MEETING
Major finding: A computer program that links electronic medical records and speech recognition software automatically calls parents when the child’s asthma inhaler is about to run out, and helps them order a new one. The program increased inhaler adherence by 25%.
Data Source: Two year trial involving 899 patients.
Disclosures: The efforts were funded by the National Heart, Lung, and Blood institute. The lead investigator has no relevant disclosures.
Phytoestrogens may prevent, treat asthma and allergy
SAN DIEGO – Could increased consumption of phytoestrogens help prevent or treat asthma and allergy?
Dr. Jessica Savage, an allergist and immunologist at Brigham and Women’s Hospital, Boston, and her colleagues correlated one-time urinary phytoestrogen measurements from 7,909 subjects in the National Health and Nutrition Examination Survey, 2003-2010, with histories of physician-diagnosed asthma and self-reported wheezing.
The investigators also considered serum total and specific IgE levels obtained from a subset of 2,218 subjects. They defined atopy as having at least one positive IgE level (0.35 kU/L or above) to an aeroallergen.
Adjusting for a wide range of potential cofounders, including age, gender, race, urinary creatinine, poverty, body mass index, smoking, and smoke exposure, they found that, for every natural log increase in urinary enterolactone, the odds of asthma decreased by 8%. Enterolactone also was significantly inversely associated with asthma prevalence and had the strongest inverse association with wheezing.
For every natural log increase in urinary o-desmethylangolensin (ODMA), there was a 7% decrease in the odds of wheeze. The odds of atopy significantly decreased with increasing ODMA levels.
"We can’t say anything about cause and effect" yet, but if the association holds up with further investigation, it might suggest a role for phytoestrogen probiotics to help treat the conditions, Dr. Savagesaid at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Phytoestrogens are plant-derived compounds. Gut bacteria convert lignans, which are particularly plentiful in flax seeds, into enterolactone, and the isoflavone daidzein, particularly plentiful in soybeans, into ODMA.
"Increased consumption of sources of phytoestrogens or probiotics to increase precursor conversion may help prevent or treat asthma and allergic disease," Dr. Savage said. "I was really surprised that the enterolactone signal is very strong both for asthma and for wheezing."
Although soy-derived compounds have been associated with better lung function and decreased lung symptoms in the past, "there’s really not a lot known about enterolactone," she said. "The idea is that somehow these metabolites are anti-inflammatory. Urinary levels are partly due to your diet and partly to having the right bacterial flora in your gut. Our findings could be explained by people just having different diets; they could also be explained by people with asthma having lower levels of the right kind of bacteria."
About half the subjects were female, and about 80% were over age 18 years; 70% of the study population was white.
Enterolactone tertiles were defined as 0.2-178; 179-644; and 645-122,000 ng/mL urine. ODMA tertiles were defined as 0.1-1.4; 1.5-12.8; and 12.9-18,500 ng/mL urine.
The study was funded by the National Institutes of Health. The investigators reported no relevant disclosures.
SAN DIEGO – Could increased consumption of phytoestrogens help prevent or treat asthma and allergy?
Dr. Jessica Savage, an allergist and immunologist at Brigham and Women’s Hospital, Boston, and her colleagues correlated one-time urinary phytoestrogen measurements from 7,909 subjects in the National Health and Nutrition Examination Survey, 2003-2010, with histories of physician-diagnosed asthma and self-reported wheezing.
The investigators also considered serum total and specific IgE levels obtained from a subset of 2,218 subjects. They defined atopy as having at least one positive IgE level (0.35 kU/L or above) to an aeroallergen.
Adjusting for a wide range of potential cofounders, including age, gender, race, urinary creatinine, poverty, body mass index, smoking, and smoke exposure, they found that, for every natural log increase in urinary enterolactone, the odds of asthma decreased by 8%. Enterolactone also was significantly inversely associated with asthma prevalence and had the strongest inverse association with wheezing.
For every natural log increase in urinary o-desmethylangolensin (ODMA), there was a 7% decrease in the odds of wheeze. The odds of atopy significantly decreased with increasing ODMA levels.
"We can’t say anything about cause and effect" yet, but if the association holds up with further investigation, it might suggest a role for phytoestrogen probiotics to help treat the conditions, Dr. Savagesaid at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Phytoestrogens are plant-derived compounds. Gut bacteria convert lignans, which are particularly plentiful in flax seeds, into enterolactone, and the isoflavone daidzein, particularly plentiful in soybeans, into ODMA.
"Increased consumption of sources of phytoestrogens or probiotics to increase precursor conversion may help prevent or treat asthma and allergic disease," Dr. Savage said. "I was really surprised that the enterolactone signal is very strong both for asthma and for wheezing."
Although soy-derived compounds have been associated with better lung function and decreased lung symptoms in the past, "there’s really not a lot known about enterolactone," she said. "The idea is that somehow these metabolites are anti-inflammatory. Urinary levels are partly due to your diet and partly to having the right bacterial flora in your gut. Our findings could be explained by people just having different diets; they could also be explained by people with asthma having lower levels of the right kind of bacteria."
About half the subjects were female, and about 80% were over age 18 years; 70% of the study population was white.
Enterolactone tertiles were defined as 0.2-178; 179-644; and 645-122,000 ng/mL urine. ODMA tertiles were defined as 0.1-1.4; 1.5-12.8; and 12.9-18,500 ng/mL urine.
The study was funded by the National Institutes of Health. The investigators reported no relevant disclosures.
SAN DIEGO – Could increased consumption of phytoestrogens help prevent or treat asthma and allergy?
Dr. Jessica Savage, an allergist and immunologist at Brigham and Women’s Hospital, Boston, and her colleagues correlated one-time urinary phytoestrogen measurements from 7,909 subjects in the National Health and Nutrition Examination Survey, 2003-2010, with histories of physician-diagnosed asthma and self-reported wheezing.
The investigators also considered serum total and specific IgE levels obtained from a subset of 2,218 subjects. They defined atopy as having at least one positive IgE level (0.35 kU/L or above) to an aeroallergen.
Adjusting for a wide range of potential cofounders, including age, gender, race, urinary creatinine, poverty, body mass index, smoking, and smoke exposure, they found that, for every natural log increase in urinary enterolactone, the odds of asthma decreased by 8%. Enterolactone also was significantly inversely associated with asthma prevalence and had the strongest inverse association with wheezing.
For every natural log increase in urinary o-desmethylangolensin (ODMA), there was a 7% decrease in the odds of wheeze. The odds of atopy significantly decreased with increasing ODMA levels.
"We can’t say anything about cause and effect" yet, but if the association holds up with further investigation, it might suggest a role for phytoestrogen probiotics to help treat the conditions, Dr. Savagesaid at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Phytoestrogens are plant-derived compounds. Gut bacteria convert lignans, which are particularly plentiful in flax seeds, into enterolactone, and the isoflavone daidzein, particularly plentiful in soybeans, into ODMA.
"Increased consumption of sources of phytoestrogens or probiotics to increase precursor conversion may help prevent or treat asthma and allergic disease," Dr. Savage said. "I was really surprised that the enterolactone signal is very strong both for asthma and for wheezing."
Although soy-derived compounds have been associated with better lung function and decreased lung symptoms in the past, "there’s really not a lot known about enterolactone," she said. "The idea is that somehow these metabolites are anti-inflammatory. Urinary levels are partly due to your diet and partly to having the right bacterial flora in your gut. Our findings could be explained by people just having different diets; they could also be explained by people with asthma having lower levels of the right kind of bacteria."
About half the subjects were female, and about 80% were over age 18 years; 70% of the study population was white.
Enterolactone tertiles were defined as 0.2-178; 179-644; and 645-122,000 ng/mL urine. ODMA tertiles were defined as 0.1-1.4; 1.5-12.8; and 12.9-18,500 ng/mL urine.
The study was funded by the National Institutes of Health. The investigators reported no relevant disclosures.
AT THE 2014 AAAAI ANNUAL MEETING
Major finding: For every natural log increase in urinary enterolactone, the odds of asthma decrease by 8%.
Data Source: The National Health and Nutrition Examination Survey 2003-2010.
Disclosures: The study was funded by the National Institutes of Health. The investigators reported no relevant disclosures.
Omalizumab reduces epinephrine need during oral immunotherapy
SAN DIEGO– Omalizumab appears to significantly reduce adverse effects from oral immunotherapy for cows’ milk allergy, allowing patients to reach maintenance doses of powdered skim milk sooner, according to the first double-blind, randomized, placebo-controlled trial to see if omalizumab makes oral immunotherapy safer.
The investigators randomized 28 milk-allergic subjects to omalizumab (Xolair) injections during oral immunotherapy (OIT) and 29 others to dummy shots for 16 months. The median age in the trial was about 10 years; 70% of the subjects were male; and most had asthma, allergic rhinitis, and other food allergies.
Milk OIT was started after 4 months, with the goal of escalating patients to a maintenance dose of 3.84 g/day of powdered skim milk.
Just one omalizumab patient needed an epinephrine shot, while nine placebo subjects needed a total of 17 epinephrine shots. Omalizumab subjects had a median of five OIT symptoms – for instance, perioral itching, tingling, or hives; mild throat symptoms; and abdominal cramps – during escalation and maintenance therapy, while the placebo group had a median of 47.5 (P =.0001).
Omalizumab subjects needed a median of 198 OIT doses to reach maintenance dosing in a median of 25.9 weeks; placebo patients needed a median of 224.5 doses to reach maintenance in a median of 30.8 weeks. The differences were significant.
"OIT is very promising" as a way to desensitize patients, but "it’s still very experimental. The major limitation is the frequency of side effects. The reactions are unpredictable and [mostly] occur at home, so there’s a real risk to this therapy. We don’t really have a good idea of who is not going to do well until they actually develop the reactions. There’s a risk that some of these kids might develop other allergic problems like eosinophilic esophagitis, or you could make them more sensitive," said lead investigator Dr. Jennifer S. Kim, a pediatric allergist and immunologist at the North Shore University Health System in Chicago.
"To make OIT safer, omalizumab is being studied. When our results were unblinded, I was happy to see that it works," she said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
There were no statistically significant baseline differences between the two study arms for age or baseline milk specific IgE (median 39.4 kUA/L omalizumab vs. 42.0 kUA/L control), milk PST wheal (median 10.0 mm omalizumab vs. 8.0 mm control), or food challenge doses at first symptoms (20 mg in both groups).
Omalizumab is a subcutaneous injection currently indicated only for allergic asthma. It was dosed according to product labelling – every 2-4 weeks depending on weight and IgE levels. "We did not really have any adverse effects from the injection," Dr. Kim said.
Powdered milk was used for OIT because it’s easier to dispense to subjects and less likely to spoil than fresh milk, among other reasons. Patients dissolved it in whatever they chose, often Gatorade. "It wasn’t peoples’ favorite thing to take on a daily basis," she said.
The results are from an interim analysis, and the study is ongoing.
The National Institutes of Health funded the project. The omalizumab used in the trial was donated by its maker, Genentech, and comarketer, Novartis. Dr. Kim said that she has no disclosures. The senior author, Dr. Hugh Sampson of Mount Sinai Hospital in New York, is an unpaid advisor to Novartis.
SAN DIEGO– Omalizumab appears to significantly reduce adverse effects from oral immunotherapy for cows’ milk allergy, allowing patients to reach maintenance doses of powdered skim milk sooner, according to the first double-blind, randomized, placebo-controlled trial to see if omalizumab makes oral immunotherapy safer.
The investigators randomized 28 milk-allergic subjects to omalizumab (Xolair) injections during oral immunotherapy (OIT) and 29 others to dummy shots for 16 months. The median age in the trial was about 10 years; 70% of the subjects were male; and most had asthma, allergic rhinitis, and other food allergies.
Milk OIT was started after 4 months, with the goal of escalating patients to a maintenance dose of 3.84 g/day of powdered skim milk.
Just one omalizumab patient needed an epinephrine shot, while nine placebo subjects needed a total of 17 epinephrine shots. Omalizumab subjects had a median of five OIT symptoms – for instance, perioral itching, tingling, or hives; mild throat symptoms; and abdominal cramps – during escalation and maintenance therapy, while the placebo group had a median of 47.5 (P =.0001).
Omalizumab subjects needed a median of 198 OIT doses to reach maintenance dosing in a median of 25.9 weeks; placebo patients needed a median of 224.5 doses to reach maintenance in a median of 30.8 weeks. The differences were significant.
"OIT is very promising" as a way to desensitize patients, but "it’s still very experimental. The major limitation is the frequency of side effects. The reactions are unpredictable and [mostly] occur at home, so there’s a real risk to this therapy. We don’t really have a good idea of who is not going to do well until they actually develop the reactions. There’s a risk that some of these kids might develop other allergic problems like eosinophilic esophagitis, or you could make them more sensitive," said lead investigator Dr. Jennifer S. Kim, a pediatric allergist and immunologist at the North Shore University Health System in Chicago.
"To make OIT safer, omalizumab is being studied. When our results were unblinded, I was happy to see that it works," she said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
There were no statistically significant baseline differences between the two study arms for age or baseline milk specific IgE (median 39.4 kUA/L omalizumab vs. 42.0 kUA/L control), milk PST wheal (median 10.0 mm omalizumab vs. 8.0 mm control), or food challenge doses at first symptoms (20 mg in both groups).
Omalizumab is a subcutaneous injection currently indicated only for allergic asthma. It was dosed according to product labelling – every 2-4 weeks depending on weight and IgE levels. "We did not really have any adverse effects from the injection," Dr. Kim said.
Powdered milk was used for OIT because it’s easier to dispense to subjects and less likely to spoil than fresh milk, among other reasons. Patients dissolved it in whatever they chose, often Gatorade. "It wasn’t peoples’ favorite thing to take on a daily basis," she said.
The results are from an interim analysis, and the study is ongoing.
The National Institutes of Health funded the project. The omalizumab used in the trial was donated by its maker, Genentech, and comarketer, Novartis. Dr. Kim said that she has no disclosures. The senior author, Dr. Hugh Sampson of Mount Sinai Hospital in New York, is an unpaid advisor to Novartis.
SAN DIEGO– Omalizumab appears to significantly reduce adverse effects from oral immunotherapy for cows’ milk allergy, allowing patients to reach maintenance doses of powdered skim milk sooner, according to the first double-blind, randomized, placebo-controlled trial to see if omalizumab makes oral immunotherapy safer.
The investigators randomized 28 milk-allergic subjects to omalizumab (Xolair) injections during oral immunotherapy (OIT) and 29 others to dummy shots for 16 months. The median age in the trial was about 10 years; 70% of the subjects were male; and most had asthma, allergic rhinitis, and other food allergies.
Milk OIT was started after 4 months, with the goal of escalating patients to a maintenance dose of 3.84 g/day of powdered skim milk.
Just one omalizumab patient needed an epinephrine shot, while nine placebo subjects needed a total of 17 epinephrine shots. Omalizumab subjects had a median of five OIT symptoms – for instance, perioral itching, tingling, or hives; mild throat symptoms; and abdominal cramps – during escalation and maintenance therapy, while the placebo group had a median of 47.5 (P =.0001).
Omalizumab subjects needed a median of 198 OIT doses to reach maintenance dosing in a median of 25.9 weeks; placebo patients needed a median of 224.5 doses to reach maintenance in a median of 30.8 weeks. The differences were significant.
"OIT is very promising" as a way to desensitize patients, but "it’s still very experimental. The major limitation is the frequency of side effects. The reactions are unpredictable and [mostly] occur at home, so there’s a real risk to this therapy. We don’t really have a good idea of who is not going to do well until they actually develop the reactions. There’s a risk that some of these kids might develop other allergic problems like eosinophilic esophagitis, or you could make them more sensitive," said lead investigator Dr. Jennifer S. Kim, a pediatric allergist and immunologist at the North Shore University Health System in Chicago.
"To make OIT safer, omalizumab is being studied. When our results were unblinded, I was happy to see that it works," she said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
There were no statistically significant baseline differences between the two study arms for age or baseline milk specific IgE (median 39.4 kUA/L omalizumab vs. 42.0 kUA/L control), milk PST wheal (median 10.0 mm omalizumab vs. 8.0 mm control), or food challenge doses at first symptoms (20 mg in both groups).
Omalizumab is a subcutaneous injection currently indicated only for allergic asthma. It was dosed according to product labelling – every 2-4 weeks depending on weight and IgE levels. "We did not really have any adverse effects from the injection," Dr. Kim said.
Powdered milk was used for OIT because it’s easier to dispense to subjects and less likely to spoil than fresh milk, among other reasons. Patients dissolved it in whatever they chose, often Gatorade. "It wasn’t peoples’ favorite thing to take on a daily basis," she said.
The results are from an interim analysis, and the study is ongoing.
The National Institutes of Health funded the project. The omalizumab used in the trial was donated by its maker, Genentech, and comarketer, Novartis. Dr. Kim said that she has no disclosures. The senior author, Dr. Hugh Sampson of Mount Sinai Hospital in New York, is an unpaid advisor to Novartis.
AT THE 2014 AAAAI ANNUAL MEETING
Major finding: During escalation and maintenance cows’ milk OIT, just 1 of 28 patients on adjunctive omalizumab needed epinephrine rescue, versus 9 of 29 subjects on adjunctive placebo.
Data Source: Randomized, double-blind, placebo-controlled trial in 57 patients, mostly children, undergoing OIT for cows’ milk allergy.
Disclosures: The National Institutes of Health funded the project. The omalizumab used in the trial was donated by its maker, Genentech, and comarketer, Novartis. Dr. Kim said that she has no disclosures.
Blood Pressure Control Tied to Decline in Stroke Mortality
Antihypertensive therapy is probably the main reason why stroke fatalities have dropped dramatically in the United States over the past 50 years, according to an American Heart Association study published Dec. 5 in Stroke.
Despite an aging and heavier population, "the accelerated decline in stroke mortality that began in the 1970s is consistent with the aggressive hypertension treatment and control strategies implemented in that period. ... The decrease in blood pressure with drug therapy ... appears to be the major determinant of reduction in the risk of stroke and stroke deaths," wrote lead author Dr. Daniel Lackland, professor of epidemiology at the Medical University of South Carolina, Charleston, and his colleagues (Stroke 2013 Dec. 5 [doi:10.1161/01.str.0000437068.30550.cf]).
Statins, diabetes drugs, public health efforts, increased research, improved imaging, and quicker and better stroke treatment, among other things, have helped, too. People have also begun to lose weight, cut salt from their diets, and eat and smoke less.
But when it comes to accounting for the stroke mortality rate reduction from 88/100,000 in 1950 to 23/100,000 in 2010 – a reduction that holds across racial, age, and gender lines – the evidence is strongest for hypertension control, the authors said.
"Although the decline in stroke mortality in the United States started at the beginning of the 20th century, decades before hypertension treatment, the slope of the decline in mortality accelerated significantly after the introduction of tolerable antihypertensive drug therapy in the 1960s," they wrote. Stroke is now the fourth leading cause of death in the United States, instead of the third, and both recurrent and first-time strokes are down. Europe has had a similar decline.
Although great racial disparities still exist in stroke mortality, particularly for blacks, "the decline in stroke mortality for all racial/ethnic groups has reduced the magnitude of the racial/ethnic gap in stroke mortality risks and likewise the variation in stroke mortality by geographic area, with particular emphasis in the Stroke Belt," Dr. Lackland and his colleagues wrote.
"The decline is real, not a statistical fluke or the result of more people dying of lung disease, the third leading cause of death," Dr. Lackland said in a statement. It’s also not due to changes in billing codes, diagnostic improvements, death certificate causes of death, or other factors the team considered. Instead, it is "one of the major public health successes of the past 50 years," the authors wrote.
The findings are based on literature reviews, morbidity and mortality reports, clinical and public health guidelines, expert opinion, and other sources.
The authors noted that "increased application of advanced neuroimaging ... might improve the diagnosis of milder, less-fatal strokes over time. This would result in an apparent decline in the stroke case-fatality rate, solely as a result of improved detection. However, this should not result in a change in stroke mortality over time unless technological advances improve the diagnosis of more severe, fatal strokes also, which seems unlikely."
Dr. Lackland said he had no relevant financial disclosures. One of the 13 authors on the paper is a speaker and consultant for Allergan and a consultant for Reata.
Antihypertensive therapy is probably the main reason why stroke fatalities have dropped dramatically in the United States over the past 50 years, according to an American Heart Association study published Dec. 5 in Stroke.
Despite an aging and heavier population, "the accelerated decline in stroke mortality that began in the 1970s is consistent with the aggressive hypertension treatment and control strategies implemented in that period. ... The decrease in blood pressure with drug therapy ... appears to be the major determinant of reduction in the risk of stroke and stroke deaths," wrote lead author Dr. Daniel Lackland, professor of epidemiology at the Medical University of South Carolina, Charleston, and his colleagues (Stroke 2013 Dec. 5 [doi:10.1161/01.str.0000437068.30550.cf]).
Statins, diabetes drugs, public health efforts, increased research, improved imaging, and quicker and better stroke treatment, among other things, have helped, too. People have also begun to lose weight, cut salt from their diets, and eat and smoke less.
But when it comes to accounting for the stroke mortality rate reduction from 88/100,000 in 1950 to 23/100,000 in 2010 – a reduction that holds across racial, age, and gender lines – the evidence is strongest for hypertension control, the authors said.
"Although the decline in stroke mortality in the United States started at the beginning of the 20th century, decades before hypertension treatment, the slope of the decline in mortality accelerated significantly after the introduction of tolerable antihypertensive drug therapy in the 1960s," they wrote. Stroke is now the fourth leading cause of death in the United States, instead of the third, and both recurrent and first-time strokes are down. Europe has had a similar decline.
Although great racial disparities still exist in stroke mortality, particularly for blacks, "the decline in stroke mortality for all racial/ethnic groups has reduced the magnitude of the racial/ethnic gap in stroke mortality risks and likewise the variation in stroke mortality by geographic area, with particular emphasis in the Stroke Belt," Dr. Lackland and his colleagues wrote.
"The decline is real, not a statistical fluke or the result of more people dying of lung disease, the third leading cause of death," Dr. Lackland said in a statement. It’s also not due to changes in billing codes, diagnostic improvements, death certificate causes of death, or other factors the team considered. Instead, it is "one of the major public health successes of the past 50 years," the authors wrote.
The findings are based on literature reviews, morbidity and mortality reports, clinical and public health guidelines, expert opinion, and other sources.
The authors noted that "increased application of advanced neuroimaging ... might improve the diagnosis of milder, less-fatal strokes over time. This would result in an apparent decline in the stroke case-fatality rate, solely as a result of improved detection. However, this should not result in a change in stroke mortality over time unless technological advances improve the diagnosis of more severe, fatal strokes also, which seems unlikely."
Dr. Lackland said he had no relevant financial disclosures. One of the 13 authors on the paper is a speaker and consultant for Allergan and a consultant for Reata.
Antihypertensive therapy is probably the main reason why stroke fatalities have dropped dramatically in the United States over the past 50 years, according to an American Heart Association study published Dec. 5 in Stroke.
Despite an aging and heavier population, "the accelerated decline in stroke mortality that began in the 1970s is consistent with the aggressive hypertension treatment and control strategies implemented in that period. ... The decrease in blood pressure with drug therapy ... appears to be the major determinant of reduction in the risk of stroke and stroke deaths," wrote lead author Dr. Daniel Lackland, professor of epidemiology at the Medical University of South Carolina, Charleston, and his colleagues (Stroke 2013 Dec. 5 [doi:10.1161/01.str.0000437068.30550.cf]).
Statins, diabetes drugs, public health efforts, increased research, improved imaging, and quicker and better stroke treatment, among other things, have helped, too. People have also begun to lose weight, cut salt from their diets, and eat and smoke less.
But when it comes to accounting for the stroke mortality rate reduction from 88/100,000 in 1950 to 23/100,000 in 2010 – a reduction that holds across racial, age, and gender lines – the evidence is strongest for hypertension control, the authors said.
"Although the decline in stroke mortality in the United States started at the beginning of the 20th century, decades before hypertension treatment, the slope of the decline in mortality accelerated significantly after the introduction of tolerable antihypertensive drug therapy in the 1960s," they wrote. Stroke is now the fourth leading cause of death in the United States, instead of the third, and both recurrent and first-time strokes are down. Europe has had a similar decline.
Although great racial disparities still exist in stroke mortality, particularly for blacks, "the decline in stroke mortality for all racial/ethnic groups has reduced the magnitude of the racial/ethnic gap in stroke mortality risks and likewise the variation in stroke mortality by geographic area, with particular emphasis in the Stroke Belt," Dr. Lackland and his colleagues wrote.
"The decline is real, not a statistical fluke or the result of more people dying of lung disease, the third leading cause of death," Dr. Lackland said in a statement. It’s also not due to changes in billing codes, diagnostic improvements, death certificate causes of death, or other factors the team considered. Instead, it is "one of the major public health successes of the past 50 years," the authors wrote.
The findings are based on literature reviews, morbidity and mortality reports, clinical and public health guidelines, expert opinion, and other sources.
The authors noted that "increased application of advanced neuroimaging ... might improve the diagnosis of milder, less-fatal strokes over time. This would result in an apparent decline in the stroke case-fatality rate, solely as a result of improved detection. However, this should not result in a change in stroke mortality over time unless technological advances improve the diagnosis of more severe, fatal strokes also, which seems unlikely."
Dr. Lackland said he had no relevant financial disclosures. One of the 13 authors on the paper is a speaker and consultant for Allergan and a consultant for Reata.
FROM STROKE