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How Hospitalists Can Team with Nursing to Improve Patient Care
Establishing mutual respect and trust between hospitalists and nurses is an important part of ensuring patient safety, whether you’re on your first job or your 20th, says Angela Beck, RN, director of critical-care services at Nebraska Medical Center in Omaha.
“Nurses are important coordinators of care,” she says. “Recognizing and valuing nurses for that is truly the most important thing for the patient, and can also help hospitalists build relationships.”
Key Partners
Forming a collaborative relationship with the nursing service might depend on where you start. At Northwestern Memorial Hospital in Chicago, the nursing service enjoys a “close and collaborative relationship” with hospitalists, according to Kristin Ramsey, RN, MSN, MPPM, NE-BC, associate chief nurse and executive director of operations. New hospitalists are oriented to the care-delivery models on the inpatient care units. In addition, hospitalists are acculturated into the hospital’s coleadership model.
—Kristin Ramsey, RN, MSN, MPPM, NE-BC, associate chief nurse and executive director of operations, Northwestern Memorial Hospital, Chicago
“We have partnered with our hospitalists to create a model in which the physician and nurse leader collaboratively lead the development of multidisciplinary, subspecialty teams to ensure quality outcomes,” Ramsey says. “The model is so successful with the hospitalists that we are now extending it to other areas in the organization.”
Round Sharing
Absent a formalized training protocol for partnering with nursing, hospitalists still can learn a great deal by listening to and communicating with the nursing staff, says Connie Ogden, RN, MSN, NEA-BC, executive director of adult acute services at Nebraska Medical Center. “Nurses are there around the clock caring for patients and may have a different insight” about patients’ evolving conditions, she says.
Care for the patient improves if everyone is on the same page, Ogden adds. That’s why it makes sense, she says, to include nurses during rounds. Beck agrees: “If nurses aren’t there to hear how the plan of care comes about, there is no reason to believe they can effectively describe it once the physician turns around and walks away to see another patient.”
In critical-care units, according to Beck, nurses can function as a bridge between patients and physicians. For example, they can help patients define and express their goals. Some of these goals can be incremental, she notes, such as “I really want to get out of bed this afternoon,” or “I really want my family here to listen to this message.”
Different Role, Same Goal
As director of adult acute services, Ogden often receives complaints from physicians about calls they receive from nurses. Often, these calls emanate from a concern for the patient (e.g. a 2 a.m. call for a Tylenol order to address a headache) or from the requirement that nurses follow policy and clarify orders. If hospitalists understand the back story of the call, their perception of its purpose can change.
Although there have been strides toward better nurse-physician collaboration, “we still have a lot of opportunities for improvement,” Beck asserts.
Establishing mutual respect and trust is not an overnight accomplishment. As Ogden explains, physicians and nurses have different roles, but they share the same goal: quality outcomes in patient care.
Gretchen Henkel is a freelance writer based in southern California.
► For more career-related articles, visit the SHM Career Center.
BEST WAYS TO IMPROVE HOSPITALIST-NURSING COLLABORATION
“A good portion of nurses are relationship builders,” says Beck, director of critical-care services at Nebraska Medical Center. She urges hospitalists on a new job to just “be physically present, in the beginning, on inpatient units” whenever possible. “Acting like you care is really important, and nurses will respond to that,” she says. “You can create an environment in which nurses’ feedback is valued.”
She also recommends, especially for new hospitalists, Dr. Peter J. Pronovost’s three-part talk “The Science of Safety,” delivered to incoming residents at Johns Hopkins University Medical Center in Baltimore, where Dr. Provonost is medical director of the quality and safety research group.—GH
Establishing mutual respect and trust between hospitalists and nurses is an important part of ensuring patient safety, whether you’re on your first job or your 20th, says Angela Beck, RN, director of critical-care services at Nebraska Medical Center in Omaha.
“Nurses are important coordinators of care,” she says. “Recognizing and valuing nurses for that is truly the most important thing for the patient, and can also help hospitalists build relationships.”
Key Partners
Forming a collaborative relationship with the nursing service might depend on where you start. At Northwestern Memorial Hospital in Chicago, the nursing service enjoys a “close and collaborative relationship” with hospitalists, according to Kristin Ramsey, RN, MSN, MPPM, NE-BC, associate chief nurse and executive director of operations. New hospitalists are oriented to the care-delivery models on the inpatient care units. In addition, hospitalists are acculturated into the hospital’s coleadership model.
—Kristin Ramsey, RN, MSN, MPPM, NE-BC, associate chief nurse and executive director of operations, Northwestern Memorial Hospital, Chicago
“We have partnered with our hospitalists to create a model in which the physician and nurse leader collaboratively lead the development of multidisciplinary, subspecialty teams to ensure quality outcomes,” Ramsey says. “The model is so successful with the hospitalists that we are now extending it to other areas in the organization.”
Round Sharing
Absent a formalized training protocol for partnering with nursing, hospitalists still can learn a great deal by listening to and communicating with the nursing staff, says Connie Ogden, RN, MSN, NEA-BC, executive director of adult acute services at Nebraska Medical Center. “Nurses are there around the clock caring for patients and may have a different insight” about patients’ evolving conditions, she says.
Care for the patient improves if everyone is on the same page, Ogden adds. That’s why it makes sense, she says, to include nurses during rounds. Beck agrees: “If nurses aren’t there to hear how the plan of care comes about, there is no reason to believe they can effectively describe it once the physician turns around and walks away to see another patient.”
In critical-care units, according to Beck, nurses can function as a bridge between patients and physicians. For example, they can help patients define and express their goals. Some of these goals can be incremental, she notes, such as “I really want to get out of bed this afternoon,” or “I really want my family here to listen to this message.”
Different Role, Same Goal
As director of adult acute services, Ogden often receives complaints from physicians about calls they receive from nurses. Often, these calls emanate from a concern for the patient (e.g. a 2 a.m. call for a Tylenol order to address a headache) or from the requirement that nurses follow policy and clarify orders. If hospitalists understand the back story of the call, their perception of its purpose can change.
Although there have been strides toward better nurse-physician collaboration, “we still have a lot of opportunities for improvement,” Beck asserts.
Establishing mutual respect and trust is not an overnight accomplishment. As Ogden explains, physicians and nurses have different roles, but they share the same goal: quality outcomes in patient care.
Gretchen Henkel is a freelance writer based in southern California.
► For more career-related articles, visit the SHM Career Center.
BEST WAYS TO IMPROVE HOSPITALIST-NURSING COLLABORATION
“A good portion of nurses are relationship builders,” says Beck, director of critical-care services at Nebraska Medical Center. She urges hospitalists on a new job to just “be physically present, in the beginning, on inpatient units” whenever possible. “Acting like you care is really important, and nurses will respond to that,” she says. “You can create an environment in which nurses’ feedback is valued.”
She also recommends, especially for new hospitalists, Dr. Peter J. Pronovost’s three-part talk “The Science of Safety,” delivered to incoming residents at Johns Hopkins University Medical Center in Baltimore, where Dr. Provonost is medical director of the quality and safety research group.—GH
Establishing mutual respect and trust between hospitalists and nurses is an important part of ensuring patient safety, whether you’re on your first job or your 20th, says Angela Beck, RN, director of critical-care services at Nebraska Medical Center in Omaha.
“Nurses are important coordinators of care,” she says. “Recognizing and valuing nurses for that is truly the most important thing for the patient, and can also help hospitalists build relationships.”
Key Partners
Forming a collaborative relationship with the nursing service might depend on where you start. At Northwestern Memorial Hospital in Chicago, the nursing service enjoys a “close and collaborative relationship” with hospitalists, according to Kristin Ramsey, RN, MSN, MPPM, NE-BC, associate chief nurse and executive director of operations. New hospitalists are oriented to the care-delivery models on the inpatient care units. In addition, hospitalists are acculturated into the hospital’s coleadership model.
—Kristin Ramsey, RN, MSN, MPPM, NE-BC, associate chief nurse and executive director of operations, Northwestern Memorial Hospital, Chicago
“We have partnered with our hospitalists to create a model in which the physician and nurse leader collaboratively lead the development of multidisciplinary, subspecialty teams to ensure quality outcomes,” Ramsey says. “The model is so successful with the hospitalists that we are now extending it to other areas in the organization.”
Round Sharing
Absent a formalized training protocol for partnering with nursing, hospitalists still can learn a great deal by listening to and communicating with the nursing staff, says Connie Ogden, RN, MSN, NEA-BC, executive director of adult acute services at Nebraska Medical Center. “Nurses are there around the clock caring for patients and may have a different insight” about patients’ evolving conditions, she says.
Care for the patient improves if everyone is on the same page, Ogden adds. That’s why it makes sense, she says, to include nurses during rounds. Beck agrees: “If nurses aren’t there to hear how the plan of care comes about, there is no reason to believe they can effectively describe it once the physician turns around and walks away to see another patient.”
In critical-care units, according to Beck, nurses can function as a bridge between patients and physicians. For example, they can help patients define and express their goals. Some of these goals can be incremental, she notes, such as “I really want to get out of bed this afternoon,” or “I really want my family here to listen to this message.”
Different Role, Same Goal
As director of adult acute services, Ogden often receives complaints from physicians about calls they receive from nurses. Often, these calls emanate from a concern for the patient (e.g. a 2 a.m. call for a Tylenol order to address a headache) or from the requirement that nurses follow policy and clarify orders. If hospitalists understand the back story of the call, their perception of its purpose can change.
Although there have been strides toward better nurse-physician collaboration, “we still have a lot of opportunities for improvement,” Beck asserts.
Establishing mutual respect and trust is not an overnight accomplishment. As Ogden explains, physicians and nurses have different roles, but they share the same goal: quality outcomes in patient care.
Gretchen Henkel is a freelance writer based in southern California.
► For more career-related articles, visit the SHM Career Center.
BEST WAYS TO IMPROVE HOSPITALIST-NURSING COLLABORATION
“A good portion of nurses are relationship builders,” says Beck, director of critical-care services at Nebraska Medical Center. She urges hospitalists on a new job to just “be physically present, in the beginning, on inpatient units” whenever possible. “Acting like you care is really important, and nurses will respond to that,” she says. “You can create an environment in which nurses’ feedback is valued.”
She also recommends, especially for new hospitalists, Dr. Peter J. Pronovost’s three-part talk “The Science of Safety,” delivered to incoming residents at Johns Hopkins University Medical Center in Baltimore, where Dr. Provonost is medical director of the quality and safety research group.—GH
Eculizumab gets accelerated approval for aHUS
The US Food and Drug Administration (FDA) has granted accelerated approval for eculizumab (Soliris) to treat patients with atypical hemolytic uremic syndrome (aHUS).
This rare and chronic disease can lead to renal failure and is associated with an increased risk of death and stroke. It accounts for 5% to 10% of all cases of hemolytic uremic syndrome and disproportionately affects children.
Eculizumab is a targeted therapy that works by inhibiting proteins that play a role in aHUS. The FDA granted accelerated approval for eculizumab based on data suggesting the drug likely confers a clinical benefit for patients with aHUS.
The FDA’s Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint that is thought to predict clinical benefit. The makers of eculizumab, Alexion Pharmaceuticals, are still required to conduct research to confirm the anticipated clinical benefit.
If this research indicates that eculizumab does provide a clinical benefit, the FDA will grant traditional approval for the drug. If research suggests eculizumab does not provide a clinical benefit, the FDA has regulatory procedures in place that could lead to removing the drug from the market.
There are no other FDA-approved treatments for aHUS. The safety and efficacy of the current standard treatment, plasma therapy (plasma exchange or fresh frozen plasma infusion), have not been studied in well-controlled trials.
Researchers have examined the safety and efficacy of eculizumab in 2 single-arm trials of 37 adult and adolescent patients with aHUS and 1 retrospective study of 19 pediatric and 11 adult patients with aHUS.
Patients treated with eculizumab in these studies experienced a favorable improvement in kidney function, including elimination of the requirement for dialysis in several patients who did not respond to plasma therapy.
Patients treated with eculizumab also exhibited improvement in platelet counts and other blood parameters that correlate with aHUS disease activity.
The most common side effects included hypertension, diarrhea, headache, anemia, vomiting, nausea, upper respiratory and urinary tract infections, and leukopenia.
Eculizumab will continue to be available only through a restricted program. Prescribers must enroll in a registration program and provide a medication guide to patients who receive the drug.
Eculizumab is marketed as Soliris by Alexion Pharmaceuticals, located in Cheshire, Connecticut. 
The US Food and Drug Administration (FDA) has granted accelerated approval for eculizumab (Soliris) to treat patients with atypical hemolytic uremic syndrome (aHUS).
This rare and chronic disease can lead to renal failure and is associated with an increased risk of death and stroke. It accounts for 5% to 10% of all cases of hemolytic uremic syndrome and disproportionately affects children.
Eculizumab is a targeted therapy that works by inhibiting proteins that play a role in aHUS. The FDA granted accelerated approval for eculizumab based on data suggesting the drug likely confers a clinical benefit for patients with aHUS.
The FDA’s Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint that is thought to predict clinical benefit. The makers of eculizumab, Alexion Pharmaceuticals, are still required to conduct research to confirm the anticipated clinical benefit.
If this research indicates that eculizumab does provide a clinical benefit, the FDA will grant traditional approval for the drug. If research suggests eculizumab does not provide a clinical benefit, the FDA has regulatory procedures in place that could lead to removing the drug from the market.
There are no other FDA-approved treatments for aHUS. The safety and efficacy of the current standard treatment, plasma therapy (plasma exchange or fresh frozen plasma infusion), have not been studied in well-controlled trials.
Researchers have examined the safety and efficacy of eculizumab in 2 single-arm trials of 37 adult and adolescent patients with aHUS and 1 retrospective study of 19 pediatric and 11 adult patients with aHUS.
Patients treated with eculizumab in these studies experienced a favorable improvement in kidney function, including elimination of the requirement for dialysis in several patients who did not respond to plasma therapy.
Patients treated with eculizumab also exhibited improvement in platelet counts and other blood parameters that correlate with aHUS disease activity.
The most common side effects included hypertension, diarrhea, headache, anemia, vomiting, nausea, upper respiratory and urinary tract infections, and leukopenia.
Eculizumab will continue to be available only through a restricted program. Prescribers must enroll in a registration program and provide a medication guide to patients who receive the drug.
Eculizumab is marketed as Soliris by Alexion Pharmaceuticals, located in Cheshire, Connecticut.
The US Food and Drug Administration (FDA) has granted accelerated approval for eculizumab (Soliris) to treat patients with atypical hemolytic uremic syndrome (aHUS).
This rare and chronic disease can lead to renal failure and is associated with an increased risk of death and stroke. It accounts for 5% to 10% of all cases of hemolytic uremic syndrome and disproportionately affects children.
Eculizumab is a targeted therapy that works by inhibiting proteins that play a role in aHUS. The FDA granted accelerated approval for eculizumab based on data suggesting the drug likely confers a clinical benefit for patients with aHUS.
The FDA’s Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint that is thought to predict clinical benefit. The makers of eculizumab, Alexion Pharmaceuticals, are still required to conduct research to confirm the anticipated clinical benefit.
If this research indicates that eculizumab does provide a clinical benefit, the FDA will grant traditional approval for the drug. If research suggests eculizumab does not provide a clinical benefit, the FDA has regulatory procedures in place that could lead to removing the drug from the market.
There are no other FDA-approved treatments for aHUS. The safety and efficacy of the current standard treatment, plasma therapy (plasma exchange or fresh frozen plasma infusion), have not been studied in well-controlled trials.
Researchers have examined the safety and efficacy of eculizumab in 2 single-arm trials of 37 adult and adolescent patients with aHUS and 1 retrospective study of 19 pediatric and 11 adult patients with aHUS.
Patients treated with eculizumab in these studies experienced a favorable improvement in kidney function, including elimination of the requirement for dialysis in several patients who did not respond to plasma therapy.
Patients treated with eculizumab also exhibited improvement in platelet counts and other blood parameters that correlate with aHUS disease activity.
The most common side effects included hypertension, diarrhea, headache, anemia, vomiting, nausea, upper respiratory and urinary tract infections, and leukopenia.
Eculizumab will continue to be available only through a restricted program. Prescribers must enroll in a registration program and provide a medication guide to patients who receive the drug.
Eculizumab is marketed as Soliris by Alexion Pharmaceuticals, located in Cheshire, Connecticut.
DPP-4 Inhibitors May Be Cardioprotective
LISBON – A new meta-analysis offers some tantalizing hints that DPP-4 inhibitors may offer some level of protection against major cardiovascular events in type 2 diabetes patients.
The analysis, which included data on more than 33,000 patients, found a consistent 31% reduction in major cardiovascular events among those who took dipeptidyl peptidase–4 (DPP-4) inhibitors, compared with those taking placebo or other treatments, Dr. Edoardo Mannucci reported at the annual meeting of the European Association for the Study of Diabetes.
Despite the positive findings, Dr. Mannucci, of the Careggi Teaching Hospital in Florence, Italy, warned against taking the data as gospel.
"The limitations here are clear," he said. "Cardiovascular events were not end points in any of these trials, and were [reported only] as major adverse events. Also, since they were not prespecified end points, there is a possibility that some of the cases could have been misclassified."
Additionally, none of the trials enrolled patients who were at a high risk of cardiovascular events. "These subjects are not very likely to be included in trials with metabolic outcomes, so we really don’t know the effect on those people."
Still, he said, the consistency of the findings "suggests the possibility of some unconventional cardiovascular protective effect that deserves further investigation."
Dr. Mannucci and his colleagues examined 42 phase III trials completed through March 2011 that included one of four DPP-4 inhibitors: saxagliptin, sitagliptin, alogliptin, and vildagliptin. (The latter two are not available in the United States.) Among placebo-controlled trials, 137 events occurred, and in comparator trials, 120 occurred.
Overall, the hazard ratios for a major cardiovascular event were 0.63 for alogliptin, 0.66 for saxagliptin, 0.74 for sitagliptin, and 0.67 for vildagliptin, compared with placebo. All the comparisons were statistically significant, he said.
In the comparator trials, none of the difference in cardiovascular events between drug regimens reached statistical significance, but the trend in favor of the DPP-4 inhibitors was similar to the findings in the placebo-controlled studies, he said.
Dr. Mannucci speculated that the lack of significance could be related to the low incidence of a major cardiovascular event in these trials, ranging from one event in an acarbose study to five each in studies with metformin and sulfonylureas.
Considering all of the 26 placebo-controlled and 16 comparator studies, the odds ratio in favor of the DPP-4 drugs was 0.69, "easily reaching statistical significance," with a P value of .006, Dr. Mannucci said.
When the trials were divided by duration, those less than 52 weeks (30) were significantly in favor of the drugs (OR, 0.62). For those 52 weeks or longer, the result was not significant (OR, 0.83).
Despite the analysis’s limitations, the unexpected observation raises intriguing questions, Dr. Mannucci said, including the possible rapidity of a cardiovascular benefit in the shorter trials. "Usually when we treat any risk factor for cardiovascular disease, we need several years to see any effect on major cardiovascular events. This is true for blood pressure, blood lipids, and blood glucose, and here we see agents that work on blood glucose and show an effect in a few months. This points to speculation that some unconventional cardioprotective effect occurs, which does not require a lot of incubation."
There are no proven mechanistic actions for the observed risk reductions, but Dr. Mannucci said that preclinical studies of the DPP-4 drugs provide some hints, including a direct myocardial effect, GLP-1 stimulation, myocardial protection from ischemia, and recruitment of endothelial cell progenitors."
"We are somewhat stretching the data here, because these trials were not designed for this end point," he acknowledged. "These findings are not fully reliable and we must admit that. But we won’t have any data with credible reliability for the next 4-5 years, so in the meanwhile, even data with some problems could give us some further information."
Dr. Carolyn Deacon, a medical physiologist at Panum Institute in Copenhagen, said that the meta-analysis offers some reassurance to those who are concerned about the cardiovascular safety of any drug. "When we get all the data for the DPP-4–inhibitor trials and the GLP-1 analogues, and examine cardiovascular events for these outcomes, we’ll know much more. But we are getting preclinical data that look positive, so we’re moving in the right direction," she noted.
The preclinical data suggest that the DPP-4 inhibitors may act directly on the heart, induce vasodilation, and improve endothelial function, Dr. Deacon added. "But right now, we cannot separate those benefits from the improved metabolic profile that the drugs induce, so I don’t want to raise hopes too much."
Dr. Mannucci disclosed relationships with Astra Zeneca, Boehringer Ingelheim, Eli Lilly Merck, Bristol-Myers Squibb, Novartis, and Takeda. Dr. Deacon disclosed a number of relationships with pharmaceutical companies involved in diabetes research.
This meta-analysis offers some reassurance to those of us who continue to be concerned about the cardiovascular safety of any drug. When we get all the data for the DPP-4–inhibitor trials and the GLP-1 analogues, and examine cardiovascular events for these outcomes, we’ll know much more. But we are getting preclinical data that look positive, so we’re moving in the right direction.
The preclinical data suggest that the DPP-4 inhibitors may act directly on the heart, induce vasodilation, and improve endothelial function. But right now, we cannot separate those benefits from the improved metabolic profile that the drugs induce, so I don’t want to raise hopes too much.
Carolyn Deacon, M.D., is a medical physiologist at Panum Institute in Copenhagen. She disclosed a number of relationships with pharmaceutical companies involved in diabetes research. Her spouse is an employee of Merck.
This meta-analysis offers some reassurance to those of us who continue to be concerned about the cardiovascular safety of any drug. When we get all the data for the DPP-4–inhibitor trials and the GLP-1 analogues, and examine cardiovascular events for these outcomes, we’ll know much more. But we are getting preclinical data that look positive, so we’re moving in the right direction.
The preclinical data suggest that the DPP-4 inhibitors may act directly on the heart, induce vasodilation, and improve endothelial function. But right now, we cannot separate those benefits from the improved metabolic profile that the drugs induce, so I don’t want to raise hopes too much.
Carolyn Deacon, M.D., is a medical physiologist at Panum Institute in Copenhagen. She disclosed a number of relationships with pharmaceutical companies involved in diabetes research. Her spouse is an employee of Merck.
This meta-analysis offers some reassurance to those of us who continue to be concerned about the cardiovascular safety of any drug. When we get all the data for the DPP-4–inhibitor trials and the GLP-1 analogues, and examine cardiovascular events for these outcomes, we’ll know much more. But we are getting preclinical data that look positive, so we’re moving in the right direction.
The preclinical data suggest that the DPP-4 inhibitors may act directly on the heart, induce vasodilation, and improve endothelial function. But right now, we cannot separate those benefits from the improved metabolic profile that the drugs induce, so I don’t want to raise hopes too much.
Carolyn Deacon, M.D., is a medical physiologist at Panum Institute in Copenhagen. She disclosed a number of relationships with pharmaceutical companies involved in diabetes research. Her spouse is an employee of Merck.
LISBON – A new meta-analysis offers some tantalizing hints that DPP-4 inhibitors may offer some level of protection against major cardiovascular events in type 2 diabetes patients.
The analysis, which included data on more than 33,000 patients, found a consistent 31% reduction in major cardiovascular events among those who took dipeptidyl peptidase–4 (DPP-4) inhibitors, compared with those taking placebo or other treatments, Dr. Edoardo Mannucci reported at the annual meeting of the European Association for the Study of Diabetes.
Despite the positive findings, Dr. Mannucci, of the Careggi Teaching Hospital in Florence, Italy, warned against taking the data as gospel.
"The limitations here are clear," he said. "Cardiovascular events were not end points in any of these trials, and were [reported only] as major adverse events. Also, since they were not prespecified end points, there is a possibility that some of the cases could have been misclassified."
Additionally, none of the trials enrolled patients who were at a high risk of cardiovascular events. "These subjects are not very likely to be included in trials with metabolic outcomes, so we really don’t know the effect on those people."
Still, he said, the consistency of the findings "suggests the possibility of some unconventional cardiovascular protective effect that deserves further investigation."
Dr. Mannucci and his colleagues examined 42 phase III trials completed through March 2011 that included one of four DPP-4 inhibitors: saxagliptin, sitagliptin, alogliptin, and vildagliptin. (The latter two are not available in the United States.) Among placebo-controlled trials, 137 events occurred, and in comparator trials, 120 occurred.
Overall, the hazard ratios for a major cardiovascular event were 0.63 for alogliptin, 0.66 for saxagliptin, 0.74 for sitagliptin, and 0.67 for vildagliptin, compared with placebo. All the comparisons were statistically significant, he said.
In the comparator trials, none of the difference in cardiovascular events between drug regimens reached statistical significance, but the trend in favor of the DPP-4 inhibitors was similar to the findings in the placebo-controlled studies, he said.
Dr. Mannucci speculated that the lack of significance could be related to the low incidence of a major cardiovascular event in these trials, ranging from one event in an acarbose study to five each in studies with metformin and sulfonylureas.
Considering all of the 26 placebo-controlled and 16 comparator studies, the odds ratio in favor of the DPP-4 drugs was 0.69, "easily reaching statistical significance," with a P value of .006, Dr. Mannucci said.
When the trials were divided by duration, those less than 52 weeks (30) were significantly in favor of the drugs (OR, 0.62). For those 52 weeks or longer, the result was not significant (OR, 0.83).
Despite the analysis’s limitations, the unexpected observation raises intriguing questions, Dr. Mannucci said, including the possible rapidity of a cardiovascular benefit in the shorter trials. "Usually when we treat any risk factor for cardiovascular disease, we need several years to see any effect on major cardiovascular events. This is true for blood pressure, blood lipids, and blood glucose, and here we see agents that work on blood glucose and show an effect in a few months. This points to speculation that some unconventional cardioprotective effect occurs, which does not require a lot of incubation."
There are no proven mechanistic actions for the observed risk reductions, but Dr. Mannucci said that preclinical studies of the DPP-4 drugs provide some hints, including a direct myocardial effect, GLP-1 stimulation, myocardial protection from ischemia, and recruitment of endothelial cell progenitors."
"We are somewhat stretching the data here, because these trials were not designed for this end point," he acknowledged. "These findings are not fully reliable and we must admit that. But we won’t have any data with credible reliability for the next 4-5 years, so in the meanwhile, even data with some problems could give us some further information."
Dr. Carolyn Deacon, a medical physiologist at Panum Institute in Copenhagen, said that the meta-analysis offers some reassurance to those who are concerned about the cardiovascular safety of any drug. "When we get all the data for the DPP-4–inhibitor trials and the GLP-1 analogues, and examine cardiovascular events for these outcomes, we’ll know much more. But we are getting preclinical data that look positive, so we’re moving in the right direction," she noted.
The preclinical data suggest that the DPP-4 inhibitors may act directly on the heart, induce vasodilation, and improve endothelial function, Dr. Deacon added. "But right now, we cannot separate those benefits from the improved metabolic profile that the drugs induce, so I don’t want to raise hopes too much."
Dr. Mannucci disclosed relationships with Astra Zeneca, Boehringer Ingelheim, Eli Lilly Merck, Bristol-Myers Squibb, Novartis, and Takeda. Dr. Deacon disclosed a number of relationships with pharmaceutical companies involved in diabetes research.
LISBON – A new meta-analysis offers some tantalizing hints that DPP-4 inhibitors may offer some level of protection against major cardiovascular events in type 2 diabetes patients.
The analysis, which included data on more than 33,000 patients, found a consistent 31% reduction in major cardiovascular events among those who took dipeptidyl peptidase–4 (DPP-4) inhibitors, compared with those taking placebo or other treatments, Dr. Edoardo Mannucci reported at the annual meeting of the European Association for the Study of Diabetes.
Despite the positive findings, Dr. Mannucci, of the Careggi Teaching Hospital in Florence, Italy, warned against taking the data as gospel.
"The limitations here are clear," he said. "Cardiovascular events were not end points in any of these trials, and were [reported only] as major adverse events. Also, since they were not prespecified end points, there is a possibility that some of the cases could have been misclassified."
Additionally, none of the trials enrolled patients who were at a high risk of cardiovascular events. "These subjects are not very likely to be included in trials with metabolic outcomes, so we really don’t know the effect on those people."
Still, he said, the consistency of the findings "suggests the possibility of some unconventional cardiovascular protective effect that deserves further investigation."
Dr. Mannucci and his colleagues examined 42 phase III trials completed through March 2011 that included one of four DPP-4 inhibitors: saxagliptin, sitagliptin, alogliptin, and vildagliptin. (The latter two are not available in the United States.) Among placebo-controlled trials, 137 events occurred, and in comparator trials, 120 occurred.
Overall, the hazard ratios for a major cardiovascular event were 0.63 for alogliptin, 0.66 for saxagliptin, 0.74 for sitagliptin, and 0.67 for vildagliptin, compared with placebo. All the comparisons were statistically significant, he said.
In the comparator trials, none of the difference in cardiovascular events between drug regimens reached statistical significance, but the trend in favor of the DPP-4 inhibitors was similar to the findings in the placebo-controlled studies, he said.
Dr. Mannucci speculated that the lack of significance could be related to the low incidence of a major cardiovascular event in these trials, ranging from one event in an acarbose study to five each in studies with metformin and sulfonylureas.
Considering all of the 26 placebo-controlled and 16 comparator studies, the odds ratio in favor of the DPP-4 drugs was 0.69, "easily reaching statistical significance," with a P value of .006, Dr. Mannucci said.
When the trials were divided by duration, those less than 52 weeks (30) were significantly in favor of the drugs (OR, 0.62). For those 52 weeks or longer, the result was not significant (OR, 0.83).
Despite the analysis’s limitations, the unexpected observation raises intriguing questions, Dr. Mannucci said, including the possible rapidity of a cardiovascular benefit in the shorter trials. "Usually when we treat any risk factor for cardiovascular disease, we need several years to see any effect on major cardiovascular events. This is true for blood pressure, blood lipids, and blood glucose, and here we see agents that work on blood glucose and show an effect in a few months. This points to speculation that some unconventional cardioprotective effect occurs, which does not require a lot of incubation."
There are no proven mechanistic actions for the observed risk reductions, but Dr. Mannucci said that preclinical studies of the DPP-4 drugs provide some hints, including a direct myocardial effect, GLP-1 stimulation, myocardial protection from ischemia, and recruitment of endothelial cell progenitors."
"We are somewhat stretching the data here, because these trials were not designed for this end point," he acknowledged. "These findings are not fully reliable and we must admit that. But we won’t have any data with credible reliability for the next 4-5 years, so in the meanwhile, even data with some problems could give us some further information."
Dr. Carolyn Deacon, a medical physiologist at Panum Institute in Copenhagen, said that the meta-analysis offers some reassurance to those who are concerned about the cardiovascular safety of any drug. "When we get all the data for the DPP-4–inhibitor trials and the GLP-1 analogues, and examine cardiovascular events for these outcomes, we’ll know much more. But we are getting preclinical data that look positive, so we’re moving in the right direction," she noted.
The preclinical data suggest that the DPP-4 inhibitors may act directly on the heart, induce vasodilation, and improve endothelial function, Dr. Deacon added. "But right now, we cannot separate those benefits from the improved metabolic profile that the drugs induce, so I don’t want to raise hopes too much."
Dr. Mannucci disclosed relationships with Astra Zeneca, Boehringer Ingelheim, Eli Lilly Merck, Bristol-Myers Squibb, Novartis, and Takeda. Dr. Deacon disclosed a number of relationships with pharmaceutical companies involved in diabetes research.
FROM THE ANNUAL MEETING OF THE EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES
Major Finding: Type 2 diabetes patients taking DPP-4 inhibitors had a statistically significant 31% reduced incidence of cardiovascular events, compared with those on placebo or comparator drugs.
Data Source: A meta-analysis of 42 phase III studies of four DPP-4–inhibiting drugs in more than 30,000 patients.
Disclosures: Dr. Mannucci disclosed relationships with Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Merck, Bristol-Myers Squibb, Novartis, and Takeda.
Diagnosis, Management of Arthritis in Children and Teens
When you assess a patient with a swollen joint, limited range of motion, and/or pain, consider a diagnosis of juvenile idiopathic arthritis.
Start with a detailed history and physical examination. Questions to ask include: How long have the symptoms been present? Was the onset acute or gradual? What is its severity? Ask the patient to rate the severity of pain. Use a 0-10 rating scale in older children and a faces scale in younger kids. Remember that not all children with oligoarticular juvenile idiopathic arthritis (JIA) experience pain.
Is there interference with school or any other activities? Are the symptoms improving or getting worse?
Also inquire about diurnal variation: Are symptoms more problematic in the morning or evening? Stiffness in the morning or following prolonged inactivity is a classic sign of arthritis in children as well as in adults. Also, what medications or other strategies has the patient tried, and how successful where they?
Inquire about associated symptoms. Fever, cutaneous eruption, weight loss, abdominal pain, diarrhea, and behavioral or visual changes are examples. Ocular inflammation is a common feature of some of the subtypes of juvenile arthritis.
Ask the patient or family about a history of trauma to rule out a fracture or significant intraarticular injury. Keep in mind that even chronic swelling of a joint sometimes may be an orthopedic issue.
One diagnosis you don’t want to miss is malignancy. You think automatically about arthritis when a child presents with joint pain, but all pediatric rheumatologists see a few children each year who turn out to have cancer instead. So be sure that pain truly is localized to the joint, and it’s not bone pain which may reflect the presence of leukemia, lymphoma, or another malignancy.
Remember arthritis is not always the primary disorder. During the initial evaluation you might see a child with inflammation of two of three joints. If you don’t ask about recurrent abdominal pain and/or low-grade fever, you may miss the fact that their arthritis is part of inflammatory bowel disease. If you have any questions about the primary vs. secondary nature of a child’s arthritis, refer the patient to a pediatric rheumatologist for further evaluation. The differential diagnosis for juvenile idiopathic arthritis (now the preferred name replacing "juvenile rheumatoid arthritis") can be lengthy.
Once a diagnosis of JIA is confirmed, a pediatric rheumatologist is best qualified to oversee ongoing care of the patient. Compared with 20 years ago, there are now a great many new agents specifically tailored to treat JIA (particularly biologics), and these medications require that those familiar with dosing schedules and side effects direct their administration. A medication that works well for one subtype of JIA may not work as well for another.
Physical and occupational therapists are critical for a successful approach to children with chronic arthritis. Their involvement helps to maintain range of motion, muscle strength, and endurance while preventing joint contractures and abnormalities of bone growth. The overall goal is to "mainstream" children back to their usual activities. However, if they participated in rugby, ice hockey, or tackle football, we will try to steer these patients to activities with a lower potential for direct trauma. We don’t want a child to be isolated from their peers.
It also is important not to overtest children with suspected arthritis. Laboratory testing is indicated if you strongly suspect an inflammatory process rather than for a child with vague aches and pains. Appropriate initial assays often include a complete blood count, urinalysis, sedimentation rate, and measurement of the C-reactive protein.
Tests such as an ANA (antinuclear antibody) and rheumatoid factor should be reserved for those children with symptoms and signs more likely to be associated with an inflammatory condition. These tests may be misleading with frequent false-positive results that cause undue anxiety for the patient and their family.
For more information on when to refer your patient, see the American College of Rheumatology’s 2010 Guidelines for the Referral of Children and Adolescents to Pediatric Rheumatologists.
Dr. Goldsmith is professor of pediatrics at Drexel University and chief of the rheumatology section at St. Christopher’s Hospital for Children, both in Philadelphia. Dr. Goldsmith said that he has no relevant financial disclosures.
This column, "Subspecialist Consult," appears regularly in Pediatric News, a publication of Elsevier.
When you assess a patient with a swollen joint, limited range of motion, and/or pain, consider a diagnosis of juvenile idiopathic arthritis.
Start with a detailed history and physical examination. Questions to ask include: How long have the symptoms been present? Was the onset acute or gradual? What is its severity? Ask the patient to rate the severity of pain. Use a 0-10 rating scale in older children and a faces scale in younger kids. Remember that not all children with oligoarticular juvenile idiopathic arthritis (JIA) experience pain.
Is there interference with school or any other activities? Are the symptoms improving or getting worse?
Also inquire about diurnal variation: Are symptoms more problematic in the morning or evening? Stiffness in the morning or following prolonged inactivity is a classic sign of arthritis in children as well as in adults. Also, what medications or other strategies has the patient tried, and how successful where they?
Inquire about associated symptoms. Fever, cutaneous eruption, weight loss, abdominal pain, diarrhea, and behavioral or visual changes are examples. Ocular inflammation is a common feature of some of the subtypes of juvenile arthritis.
Ask the patient or family about a history of trauma to rule out a fracture or significant intraarticular injury. Keep in mind that even chronic swelling of a joint sometimes may be an orthopedic issue.
One diagnosis you don’t want to miss is malignancy. You think automatically about arthritis when a child presents with joint pain, but all pediatric rheumatologists see a few children each year who turn out to have cancer instead. So be sure that pain truly is localized to the joint, and it’s not bone pain which may reflect the presence of leukemia, lymphoma, or another malignancy.
Remember arthritis is not always the primary disorder. During the initial evaluation you might see a child with inflammation of two of three joints. If you don’t ask about recurrent abdominal pain and/or low-grade fever, you may miss the fact that their arthritis is part of inflammatory bowel disease. If you have any questions about the primary vs. secondary nature of a child’s arthritis, refer the patient to a pediatric rheumatologist for further evaluation. The differential diagnosis for juvenile idiopathic arthritis (now the preferred name replacing "juvenile rheumatoid arthritis") can be lengthy.
Once a diagnosis of JIA is confirmed, a pediatric rheumatologist is best qualified to oversee ongoing care of the patient. Compared with 20 years ago, there are now a great many new agents specifically tailored to treat JIA (particularly biologics), and these medications require that those familiar with dosing schedules and side effects direct their administration. A medication that works well for one subtype of JIA may not work as well for another.
Physical and occupational therapists are critical for a successful approach to children with chronic arthritis. Their involvement helps to maintain range of motion, muscle strength, and endurance while preventing joint contractures and abnormalities of bone growth. The overall goal is to "mainstream" children back to their usual activities. However, if they participated in rugby, ice hockey, or tackle football, we will try to steer these patients to activities with a lower potential for direct trauma. We don’t want a child to be isolated from their peers.
It also is important not to overtest children with suspected arthritis. Laboratory testing is indicated if you strongly suspect an inflammatory process rather than for a child with vague aches and pains. Appropriate initial assays often include a complete blood count, urinalysis, sedimentation rate, and measurement of the C-reactive protein.
Tests such as an ANA (antinuclear antibody) and rheumatoid factor should be reserved for those children with symptoms and signs more likely to be associated with an inflammatory condition. These tests may be misleading with frequent false-positive results that cause undue anxiety for the patient and their family.
For more information on when to refer your patient, see the American College of Rheumatology’s 2010 Guidelines for the Referral of Children and Adolescents to Pediatric Rheumatologists.
Dr. Goldsmith is professor of pediatrics at Drexel University and chief of the rheumatology section at St. Christopher’s Hospital for Children, both in Philadelphia. Dr. Goldsmith said that he has no relevant financial disclosures.
This column, "Subspecialist Consult," appears regularly in Pediatric News, a publication of Elsevier.
When you assess a patient with a swollen joint, limited range of motion, and/or pain, consider a diagnosis of juvenile idiopathic arthritis.
Start with a detailed history and physical examination. Questions to ask include: How long have the symptoms been present? Was the onset acute or gradual? What is its severity? Ask the patient to rate the severity of pain. Use a 0-10 rating scale in older children and a faces scale in younger kids. Remember that not all children with oligoarticular juvenile idiopathic arthritis (JIA) experience pain.
Is there interference with school or any other activities? Are the symptoms improving or getting worse?
Also inquire about diurnal variation: Are symptoms more problematic in the morning or evening? Stiffness in the morning or following prolonged inactivity is a classic sign of arthritis in children as well as in adults. Also, what medications or other strategies has the patient tried, and how successful where they?
Inquire about associated symptoms. Fever, cutaneous eruption, weight loss, abdominal pain, diarrhea, and behavioral or visual changes are examples. Ocular inflammation is a common feature of some of the subtypes of juvenile arthritis.
Ask the patient or family about a history of trauma to rule out a fracture or significant intraarticular injury. Keep in mind that even chronic swelling of a joint sometimes may be an orthopedic issue.
One diagnosis you don’t want to miss is malignancy. You think automatically about arthritis when a child presents with joint pain, but all pediatric rheumatologists see a few children each year who turn out to have cancer instead. So be sure that pain truly is localized to the joint, and it’s not bone pain which may reflect the presence of leukemia, lymphoma, or another malignancy.
Remember arthritis is not always the primary disorder. During the initial evaluation you might see a child with inflammation of two of three joints. If you don’t ask about recurrent abdominal pain and/or low-grade fever, you may miss the fact that their arthritis is part of inflammatory bowel disease. If you have any questions about the primary vs. secondary nature of a child’s arthritis, refer the patient to a pediatric rheumatologist for further evaluation. The differential diagnosis for juvenile idiopathic arthritis (now the preferred name replacing "juvenile rheumatoid arthritis") can be lengthy.
Once a diagnosis of JIA is confirmed, a pediatric rheumatologist is best qualified to oversee ongoing care of the patient. Compared with 20 years ago, there are now a great many new agents specifically tailored to treat JIA (particularly biologics), and these medications require that those familiar with dosing schedules and side effects direct their administration. A medication that works well for one subtype of JIA may not work as well for another.
Physical and occupational therapists are critical for a successful approach to children with chronic arthritis. Their involvement helps to maintain range of motion, muscle strength, and endurance while preventing joint contractures and abnormalities of bone growth. The overall goal is to "mainstream" children back to their usual activities. However, if they participated in rugby, ice hockey, or tackle football, we will try to steer these patients to activities with a lower potential for direct trauma. We don’t want a child to be isolated from their peers.
It also is important not to overtest children with suspected arthritis. Laboratory testing is indicated if you strongly suspect an inflammatory process rather than for a child with vague aches and pains. Appropriate initial assays often include a complete blood count, urinalysis, sedimentation rate, and measurement of the C-reactive protein.
Tests such as an ANA (antinuclear antibody) and rheumatoid factor should be reserved for those children with symptoms and signs more likely to be associated with an inflammatory condition. These tests may be misleading with frequent false-positive results that cause undue anxiety for the patient and their family.
For more information on when to refer your patient, see the American College of Rheumatology’s 2010 Guidelines for the Referral of Children and Adolescents to Pediatric Rheumatologists.
Dr. Goldsmith is professor of pediatrics at Drexel University and chief of the rheumatology section at St. Christopher’s Hospital for Children, both in Philadelphia. Dr. Goldsmith said that he has no relevant financial disclosures.
This column, "Subspecialist Consult," appears regularly in Pediatric News, a publication of Elsevier.
Deadline Extension for Bundled Payments Program
The Centers for Medicare & Medicaid Services (CMS) on Aug. 23 introduced the Bundled Payments for Care Improvement Initiative, developed as part of the payment bundling provision of the Affordable Care Act (ACA). CMS has invited providers to apply to help test and develop four different models of bundling payments, which allow for great flexibility in selecting conditions, developing the care delivery structure, and determining how payments will be allocated among participating providers.
SHM learned last week that the Center for Medicare & Medicaid Innovation (CMMI) will accept nonbinding letters of intent for Model 1 of the program through Oct. 6. CMMI extended the deadline, originally set for Sept. 22, to give institutions and providers more time. Once institutions submit their letters of intent, the deadline to submit a formal application is Nov. 18.
The deadline for letters of intent for Models 2-4 remains Nov. 4, according to CMMI. The application deadline for those three models is March 15, 2012.
Felix Aguirre, MD, SFHM, vice president of medical affairs for North Hollywood, Calif.-based IPC: The Hospitalist Co., says HM group leaders should continue to monitor the process, but how involved they get depends on their individual situations and their relationship with an institution. “If you’re a private group, there’s a lot of weight on you to try to convince an acute-care facility to go down this risk-bearing road,” he says.
Dr. Aguirre says CMMI’s first three models are all “retrospective,” meaning hospitals and/or providers will be paid fees for service, and once episodic care is completed, as defined by each of the models, reconciliation will be made—and there is the real risk of having to pay back funds to CMS. In Model 4, the lone “prospective” setup, there is a single bundled payment up front “and you live and die by that money,” Dr. Aguirre says. “If it costs you a lot more to provide the service, it’s a true risk arrangement where you take a loss. Of course, if you have reduced costs by providing services a little more efficiently and you’ve saved a few dollars, you get to remain with those dollars.”
Dr. Aguirre also notes that of the four current models, Model 3 is the only one available directly to individual providers or HM groups as a risk-bearing entity, and only for post-acute-care services.
CMMI is expected to introduce at least a few more models in the coming months.
For more about CMS' bundling initiatives, visit our website.
The Centers for Medicare & Medicaid Services (CMS) on Aug. 23 introduced the Bundled Payments for Care Improvement Initiative, developed as part of the payment bundling provision of the Affordable Care Act (ACA). CMS has invited providers to apply to help test and develop four different models of bundling payments, which allow for great flexibility in selecting conditions, developing the care delivery structure, and determining how payments will be allocated among participating providers.
SHM learned last week that the Center for Medicare & Medicaid Innovation (CMMI) will accept nonbinding letters of intent for Model 1 of the program through Oct. 6. CMMI extended the deadline, originally set for Sept. 22, to give institutions and providers more time. Once institutions submit their letters of intent, the deadline to submit a formal application is Nov. 18.
The deadline for letters of intent for Models 2-4 remains Nov. 4, according to CMMI. The application deadline for those three models is March 15, 2012.
Felix Aguirre, MD, SFHM, vice president of medical affairs for North Hollywood, Calif.-based IPC: The Hospitalist Co., says HM group leaders should continue to monitor the process, but how involved they get depends on their individual situations and their relationship with an institution. “If you’re a private group, there’s a lot of weight on you to try to convince an acute-care facility to go down this risk-bearing road,” he says.
Dr. Aguirre says CMMI’s first three models are all “retrospective,” meaning hospitals and/or providers will be paid fees for service, and once episodic care is completed, as defined by each of the models, reconciliation will be made—and there is the real risk of having to pay back funds to CMS. In Model 4, the lone “prospective” setup, there is a single bundled payment up front “and you live and die by that money,” Dr. Aguirre says. “If it costs you a lot more to provide the service, it’s a true risk arrangement where you take a loss. Of course, if you have reduced costs by providing services a little more efficiently and you’ve saved a few dollars, you get to remain with those dollars.”
Dr. Aguirre also notes that of the four current models, Model 3 is the only one available directly to individual providers or HM groups as a risk-bearing entity, and only for post-acute-care services.
CMMI is expected to introduce at least a few more models in the coming months.
For more about CMS' bundling initiatives, visit our website.
The Centers for Medicare & Medicaid Services (CMS) on Aug. 23 introduced the Bundled Payments for Care Improvement Initiative, developed as part of the payment bundling provision of the Affordable Care Act (ACA). CMS has invited providers to apply to help test and develop four different models of bundling payments, which allow for great flexibility in selecting conditions, developing the care delivery structure, and determining how payments will be allocated among participating providers.
SHM learned last week that the Center for Medicare & Medicaid Innovation (CMMI) will accept nonbinding letters of intent for Model 1 of the program through Oct. 6. CMMI extended the deadline, originally set for Sept. 22, to give institutions and providers more time. Once institutions submit their letters of intent, the deadline to submit a formal application is Nov. 18.
The deadline for letters of intent for Models 2-4 remains Nov. 4, according to CMMI. The application deadline for those three models is March 15, 2012.
Felix Aguirre, MD, SFHM, vice president of medical affairs for North Hollywood, Calif.-based IPC: The Hospitalist Co., says HM group leaders should continue to monitor the process, but how involved they get depends on their individual situations and their relationship with an institution. “If you’re a private group, there’s a lot of weight on you to try to convince an acute-care facility to go down this risk-bearing road,” he says.
Dr. Aguirre says CMMI’s first three models are all “retrospective,” meaning hospitals and/or providers will be paid fees for service, and once episodic care is completed, as defined by each of the models, reconciliation will be made—and there is the real risk of having to pay back funds to CMS. In Model 4, the lone “prospective” setup, there is a single bundled payment up front “and you live and die by that money,” Dr. Aguirre says. “If it costs you a lot more to provide the service, it’s a true risk arrangement where you take a loss. Of course, if you have reduced costs by providing services a little more efficiently and you’ve saved a few dollars, you get to remain with those dollars.”
Dr. Aguirre also notes that of the four current models, Model 3 is the only one available directly to individual providers or HM groups as a risk-bearing entity, and only for post-acute-care services.
CMMI is expected to introduce at least a few more models in the coming months.
For more about CMS' bundling initiatives, visit our website.
Anticoagulant Rivaroxaban Clears FDA Panel Hurdle
An FDA advisory panel has recommended the approval of rivaroxaban (Xarelto) for stroke prevention in patients with non-valvular atrial fibrillation, but the panelists raised questions about the methodology of the trial that compared the drug to the gold standard, warfarin (Coumadin).
A final decision on the drug is expected in November.
Rivaroxaban has been developed as a once-a-day oral medication that prevents clotting by inhibiting factor Xa, a key component in the generation of thrombin. It is one medication in a line of drugs trying to position themselves to replace warfarin, which has many contraindications and requires frequent blood draws for monitoring; the new drugs would not require frequent blood draws.
Panelists questioned whether ROCKET-AF—the trial that compared rivaroxaban to warfarin—was sufficient to show noninferiority, as only 55% of the patients on warfarin had international normalized ratio (INR) levels needed for stroke prevention.
Ian Jenkins, MD, assistant professor in the division of hospital medicine at the University of California at San Diego, says that rivaroxaban “will be an option for AF, but probably not my first choice.”
Another oral warfarin alternative—dabigatran, which inhibits thrombin—is already available, he notes. And dabigatran was found to be superior to warfarin, while rivaroxaban was only found to be noninferior. But Dr. Jenkins also notes that dabigatran and rivaroxaban have not been compared head-to-head.
“The low percent of therapeutic INRs in ROCKET-AF does concern me,” Dr. Jenkins adds, “but we have to remember that the patients who will benefit the most from these medications are the ones with difficult-to-control INRs anyway.”
He also explains that patients now doing well on warfarin don’t have a “great reason” to boost their costs by trying another drug.
An FDA advisory panel has recommended the approval of rivaroxaban (Xarelto) for stroke prevention in patients with non-valvular atrial fibrillation, but the panelists raised questions about the methodology of the trial that compared the drug to the gold standard, warfarin (Coumadin).
A final decision on the drug is expected in November.
Rivaroxaban has been developed as a once-a-day oral medication that prevents clotting by inhibiting factor Xa, a key component in the generation of thrombin. It is one medication in a line of drugs trying to position themselves to replace warfarin, which has many contraindications and requires frequent blood draws for monitoring; the new drugs would not require frequent blood draws.
Panelists questioned whether ROCKET-AF—the trial that compared rivaroxaban to warfarin—was sufficient to show noninferiority, as only 55% of the patients on warfarin had international normalized ratio (INR) levels needed for stroke prevention.
Ian Jenkins, MD, assistant professor in the division of hospital medicine at the University of California at San Diego, says that rivaroxaban “will be an option for AF, but probably not my first choice.”
Another oral warfarin alternative—dabigatran, which inhibits thrombin—is already available, he notes. And dabigatran was found to be superior to warfarin, while rivaroxaban was only found to be noninferior. But Dr. Jenkins also notes that dabigatran and rivaroxaban have not been compared head-to-head.
“The low percent of therapeutic INRs in ROCKET-AF does concern me,” Dr. Jenkins adds, “but we have to remember that the patients who will benefit the most from these medications are the ones with difficult-to-control INRs anyway.”
He also explains that patients now doing well on warfarin don’t have a “great reason” to boost their costs by trying another drug.
An FDA advisory panel has recommended the approval of rivaroxaban (Xarelto) for stroke prevention in patients with non-valvular atrial fibrillation, but the panelists raised questions about the methodology of the trial that compared the drug to the gold standard, warfarin (Coumadin).
A final decision on the drug is expected in November.
Rivaroxaban has been developed as a once-a-day oral medication that prevents clotting by inhibiting factor Xa, a key component in the generation of thrombin. It is one medication in a line of drugs trying to position themselves to replace warfarin, which has many contraindications and requires frequent blood draws for monitoring; the new drugs would not require frequent blood draws.
Panelists questioned whether ROCKET-AF—the trial that compared rivaroxaban to warfarin—was sufficient to show noninferiority, as only 55% of the patients on warfarin had international normalized ratio (INR) levels needed for stroke prevention.
Ian Jenkins, MD, assistant professor in the division of hospital medicine at the University of California at San Diego, says that rivaroxaban “will be an option for AF, but probably not my first choice.”
Another oral warfarin alternative—dabigatran, which inhibits thrombin—is already available, he notes. And dabigatran was found to be superior to warfarin, while rivaroxaban was only found to be noninferior. But Dr. Jenkins also notes that dabigatran and rivaroxaban have not been compared head-to-head.
“The low percent of therapeutic INRs in ROCKET-AF does concern me,” Dr. Jenkins adds, “but we have to remember that the patients who will benefit the most from these medications are the ones with difficult-to-control INRs anyway.”
He also explains that patients now doing well on warfarin don’t have a “great reason” to boost their costs by trying another drug.
Continuous Glucose Monitor Accurate Post-Cardiac Surgery
LISBON – Although microcirculation in cardiac surgery patients is impaired during the first few hours of admission to the intensive care unit, the degree of impairment was not great enough to affect the accuracy of continuous glucose monitors in a prospective, observational study of 60 patients.
Hyperglycemia, hypoglycemia, and glucose hypervariability are all associated with increased mortality in critically ill patients following cardiac surgery. Continuous glucose monitoring (CGM) is a potential alternative to frequent, time-consuming fingerstick glucose measurements, and can provide more information about glucose trends. However, the accuracy of these systems in critically ill patients has been uncertain, said Dr. J. Hans DeVries, an endocrinologist at the University of Amsterdam.
Now, "these results support CGM use in cardiac surgery patients, with quite good sensor accuracy in patients with a low severity of illness," he said at the annual meeting of the European Association for the Study of Diabetes (EASD).
The patients had a mean age of 65 years, and 48 of the 60 were male. Nearly a third (27%) had diabetes. Thirty-two (53%) of the patients were undergoing only coronary artery bypass surgery, 16 (27%) were having just valve surgery, and 12 (20%) had both procedures. Their APACHE score predicting mortality was low, 0.01. Total ICU stay was 23 hours. Hemodynamic parameters were fairly good, with a microcirculatory function index of 2.8 (out of 3.0). The proportion of perfused vessels was high, 0.97. However, the patients’ peripheral temperature was low, 32.8 °C.
Two sensors – the Medtronic Guardian REAL-Time and the Abbott FreeStyle Navigator – were placed subcutaneously in the abdominal wall of each patient prior to surgery. The Navigator performed slightly better than did the Guardian. Microcirculation was measured by microvascular flow index (MFI), perfused vessel density (PVD), and proportion of perfused vessels (PPV) using sublingual sidestream dark-field (SDF) imaging; and tissue oxygenation (StO2) was obtained with near-infrared spectroscopy.
While StO2 and PVD were impaired in the first hours after surgery, at no point were any microcirculatory parameters significantly associated with sensor accuracy. For the Navigator CGM, lower peripheral temperature and higher APACHE IV scores were significantly associated with decreased sensor accuracy (P values of .003 and less than .001, respectively). For the Guardian, lower peripheral temperature was significantly associated with decreased sensor accuracy (P = .048).
"Further studies are needed to assess the influence of microcirculation on sensor accuracy in more severely ill patients, such as those with sepsis," Dr. DeVries concluded.
The study was supported by the EASD’s European Foundation for the Study of Diabetes. Dr. DeVries has received research support from, and is on the speakers’ bureau for Dexcom, Abbott, and Medtronic.
LISBON – Although microcirculation in cardiac surgery patients is impaired during the first few hours of admission to the intensive care unit, the degree of impairment was not great enough to affect the accuracy of continuous glucose monitors in a prospective, observational study of 60 patients.
Hyperglycemia, hypoglycemia, and glucose hypervariability are all associated with increased mortality in critically ill patients following cardiac surgery. Continuous glucose monitoring (CGM) is a potential alternative to frequent, time-consuming fingerstick glucose measurements, and can provide more information about glucose trends. However, the accuracy of these systems in critically ill patients has been uncertain, said Dr. J. Hans DeVries, an endocrinologist at the University of Amsterdam.
Now, "these results support CGM use in cardiac surgery patients, with quite good sensor accuracy in patients with a low severity of illness," he said at the annual meeting of the European Association for the Study of Diabetes (EASD).
The patients had a mean age of 65 years, and 48 of the 60 were male. Nearly a third (27%) had diabetes. Thirty-two (53%) of the patients were undergoing only coronary artery bypass surgery, 16 (27%) were having just valve surgery, and 12 (20%) had both procedures. Their APACHE score predicting mortality was low, 0.01. Total ICU stay was 23 hours. Hemodynamic parameters were fairly good, with a microcirculatory function index of 2.8 (out of 3.0). The proportion of perfused vessels was high, 0.97. However, the patients’ peripheral temperature was low, 32.8 °C.
Two sensors – the Medtronic Guardian REAL-Time and the Abbott FreeStyle Navigator – were placed subcutaneously in the abdominal wall of each patient prior to surgery. The Navigator performed slightly better than did the Guardian. Microcirculation was measured by microvascular flow index (MFI), perfused vessel density (PVD), and proportion of perfused vessels (PPV) using sublingual sidestream dark-field (SDF) imaging; and tissue oxygenation (StO2) was obtained with near-infrared spectroscopy.
While StO2 and PVD were impaired in the first hours after surgery, at no point were any microcirculatory parameters significantly associated with sensor accuracy. For the Navigator CGM, lower peripheral temperature and higher APACHE IV scores were significantly associated with decreased sensor accuracy (P values of .003 and less than .001, respectively). For the Guardian, lower peripheral temperature was significantly associated with decreased sensor accuracy (P = .048).
"Further studies are needed to assess the influence of microcirculation on sensor accuracy in more severely ill patients, such as those with sepsis," Dr. DeVries concluded.
The study was supported by the EASD’s European Foundation for the Study of Diabetes. Dr. DeVries has received research support from, and is on the speakers’ bureau for Dexcom, Abbott, and Medtronic.
LISBON – Although microcirculation in cardiac surgery patients is impaired during the first few hours of admission to the intensive care unit, the degree of impairment was not great enough to affect the accuracy of continuous glucose monitors in a prospective, observational study of 60 patients.
Hyperglycemia, hypoglycemia, and glucose hypervariability are all associated with increased mortality in critically ill patients following cardiac surgery. Continuous glucose monitoring (CGM) is a potential alternative to frequent, time-consuming fingerstick glucose measurements, and can provide more information about glucose trends. However, the accuracy of these systems in critically ill patients has been uncertain, said Dr. J. Hans DeVries, an endocrinologist at the University of Amsterdam.
Now, "these results support CGM use in cardiac surgery patients, with quite good sensor accuracy in patients with a low severity of illness," he said at the annual meeting of the European Association for the Study of Diabetes (EASD).
The patients had a mean age of 65 years, and 48 of the 60 were male. Nearly a third (27%) had diabetes. Thirty-two (53%) of the patients were undergoing only coronary artery bypass surgery, 16 (27%) were having just valve surgery, and 12 (20%) had both procedures. Their APACHE score predicting mortality was low, 0.01. Total ICU stay was 23 hours. Hemodynamic parameters were fairly good, with a microcirculatory function index of 2.8 (out of 3.0). The proportion of perfused vessels was high, 0.97. However, the patients’ peripheral temperature was low, 32.8 °C.
Two sensors – the Medtronic Guardian REAL-Time and the Abbott FreeStyle Navigator – were placed subcutaneously in the abdominal wall of each patient prior to surgery. The Navigator performed slightly better than did the Guardian. Microcirculation was measured by microvascular flow index (MFI), perfused vessel density (PVD), and proportion of perfused vessels (PPV) using sublingual sidestream dark-field (SDF) imaging; and tissue oxygenation (StO2) was obtained with near-infrared spectroscopy.
While StO2 and PVD were impaired in the first hours after surgery, at no point were any microcirculatory parameters significantly associated with sensor accuracy. For the Navigator CGM, lower peripheral temperature and higher APACHE IV scores were significantly associated with decreased sensor accuracy (P values of .003 and less than .001, respectively). For the Guardian, lower peripheral temperature was significantly associated with decreased sensor accuracy (P = .048).
"Further studies are needed to assess the influence of microcirculation on sensor accuracy in more severely ill patients, such as those with sepsis," Dr. DeVries concluded.
The study was supported by the EASD’s European Foundation for the Study of Diabetes. Dr. DeVries has received research support from, and is on the speakers’ bureau for Dexcom, Abbott, and Medtronic.
FROM THE ANNUAL MEETING OF THE EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES (EASD)
Major Finding: While StO2 and PVD were impaired in the first hours after surgery, at no point were any microcirculatory parameters significantly associated with sensor accuracy.
Data Source: Prospective, observational study of 60 patients undergoing cardiac surgery.
Disclosures: The study was supported by the EASD’s European Foundation for the Study of Diabetes. Dr. DeVries has received research support from, and is on the speakers’ bureau for Dexcom, Abbott, and Medtronic.
Household Medicine Cabinet Source of Most Pediatric Poisonings
Approximately 95% of visits related to medication poisoning in children younger than 5 years are caused by self-ingestion, based on data from nearly 500,000 emergency visits during 2001-2008, according to a study published online Sept. 16 in the Journal of Pediatrics.
"If we are to make progress in reducing childhood injury from pharmaceutical poisoning, we need to better understand the epidemic," said Dr. G. Randall Bond of the University of Cincinnati and colleagues.
The researchers reviewed case information from 453,599 children aged 5 years and younger who visited emergency departments due to possible medication poisoning via ingestion of a single product. Data were taken from the American Association of Poison Control Centers’ National Poison Data System, an electronic database of all calls to the organization’s member centers (J. Pediatr. 2011 Sept. 16 [doi:10.1016/j.jpeds.2011.07.042]).
Of the self-ingested poisonings, prescription products accounted for the largest percentage of ED visits (55%), hospital admissions (76%), and significant injuries (71%).
Opioid analgesics had the greatest increase in impact on health care resources during the study period – ED visits increased by 101%, injury rates increased by 92%, and hospital admission rates increased by 86%.
The findings were limited by the self-reported nature of the cases, but they support data from previous studies on the increasing numbers of emergency department visits by young children due to medication poisoning, Dr. Bond and his coauthors said. "The most likely explanation for these observations is a rise in the number of medications in the environment of small children," they noted.
These medications may be more accessible to children in the home because the number of opioid analgesic prescriptions has increased, according to data from the U.S. Drug Enforcement Administration’s database, the researchers noted.
When it comes to preventing medication poisonings, "the results of this study suggest that focus should shift to self-ingestion and prescription products," the researchers said. "The largest potential benefits would come from a shift in attention to packaging design changes that reduce the quantity a child could quickly and easily access in a self-ingestion episode," they added.
Of 90 unintentional deaths recorded in the database, 66 were ingestion related. Of these, opioid analgesic and cough medicines accounted for the most deaths (20).
Another recent study by Dr. Gary M. Vilke of the University of California, San Diego and colleagues provided a breakdown of more than 40,000 paramedic transport calls related to poisonings in children younger than 5 years between 2000 and 2007 (J. Emerg. Med. 2011;41:265-9).
In this retrospective study, more than half of the poisonings were due to ingestion of prescription or over-the-counter medications (56%). In addition, medications made up a majority of the poisonings in each age group: less than 1 year (40%), 1 year (46%), 2 years (66%), 3 years (68%), and 4 years (60%). The researchers also noted that 10% of the poisonings were caused by cosmetics. This study was limited by the use of a preexisting database and the inclusion only of cases in which poisoning was the chief complaint.
However, the findings reinforce the need for better education about the poisoning potential of household medications, as shown in the study by Dr. Bond and colleagues.
None of the researchers in either study had any financial conflicts to disclose.
Approximately 95% of visits related to medication poisoning in children younger than 5 years are caused by self-ingestion, based on data from nearly 500,000 emergency visits during 2001-2008, according to a study published online Sept. 16 in the Journal of Pediatrics.
"If we are to make progress in reducing childhood injury from pharmaceutical poisoning, we need to better understand the epidemic," said Dr. G. Randall Bond of the University of Cincinnati and colleagues.
The researchers reviewed case information from 453,599 children aged 5 years and younger who visited emergency departments due to possible medication poisoning via ingestion of a single product. Data were taken from the American Association of Poison Control Centers’ National Poison Data System, an electronic database of all calls to the organization’s member centers (J. Pediatr. 2011 Sept. 16 [doi:10.1016/j.jpeds.2011.07.042]).
Of the self-ingested poisonings, prescription products accounted for the largest percentage of ED visits (55%), hospital admissions (76%), and significant injuries (71%).
Opioid analgesics had the greatest increase in impact on health care resources during the study period – ED visits increased by 101%, injury rates increased by 92%, and hospital admission rates increased by 86%.
The findings were limited by the self-reported nature of the cases, but they support data from previous studies on the increasing numbers of emergency department visits by young children due to medication poisoning, Dr. Bond and his coauthors said. "The most likely explanation for these observations is a rise in the number of medications in the environment of small children," they noted.
These medications may be more accessible to children in the home because the number of opioid analgesic prescriptions has increased, according to data from the U.S. Drug Enforcement Administration’s database, the researchers noted.
When it comes to preventing medication poisonings, "the results of this study suggest that focus should shift to self-ingestion and prescription products," the researchers said. "The largest potential benefits would come from a shift in attention to packaging design changes that reduce the quantity a child could quickly and easily access in a self-ingestion episode," they added.
Of 90 unintentional deaths recorded in the database, 66 were ingestion related. Of these, opioid analgesic and cough medicines accounted for the most deaths (20).
Another recent study by Dr. Gary M. Vilke of the University of California, San Diego and colleagues provided a breakdown of more than 40,000 paramedic transport calls related to poisonings in children younger than 5 years between 2000 and 2007 (J. Emerg. Med. 2011;41:265-9).
In this retrospective study, more than half of the poisonings were due to ingestion of prescription or over-the-counter medications (56%). In addition, medications made up a majority of the poisonings in each age group: less than 1 year (40%), 1 year (46%), 2 years (66%), 3 years (68%), and 4 years (60%). The researchers also noted that 10% of the poisonings were caused by cosmetics. This study was limited by the use of a preexisting database and the inclusion only of cases in which poisoning was the chief complaint.
However, the findings reinforce the need for better education about the poisoning potential of household medications, as shown in the study by Dr. Bond and colleagues.
None of the researchers in either study had any financial conflicts to disclose.
Approximately 95% of visits related to medication poisoning in children younger than 5 years are caused by self-ingestion, based on data from nearly 500,000 emergency visits during 2001-2008, according to a study published online Sept. 16 in the Journal of Pediatrics.
"If we are to make progress in reducing childhood injury from pharmaceutical poisoning, we need to better understand the epidemic," said Dr. G. Randall Bond of the University of Cincinnati and colleagues.
The researchers reviewed case information from 453,599 children aged 5 years and younger who visited emergency departments due to possible medication poisoning via ingestion of a single product. Data were taken from the American Association of Poison Control Centers’ National Poison Data System, an electronic database of all calls to the organization’s member centers (J. Pediatr. 2011 Sept. 16 [doi:10.1016/j.jpeds.2011.07.042]).
Of the self-ingested poisonings, prescription products accounted for the largest percentage of ED visits (55%), hospital admissions (76%), and significant injuries (71%).
Opioid analgesics had the greatest increase in impact on health care resources during the study period – ED visits increased by 101%, injury rates increased by 92%, and hospital admission rates increased by 86%.
The findings were limited by the self-reported nature of the cases, but they support data from previous studies on the increasing numbers of emergency department visits by young children due to medication poisoning, Dr. Bond and his coauthors said. "The most likely explanation for these observations is a rise in the number of medications in the environment of small children," they noted.
These medications may be more accessible to children in the home because the number of opioid analgesic prescriptions has increased, according to data from the U.S. Drug Enforcement Administration’s database, the researchers noted.
When it comes to preventing medication poisonings, "the results of this study suggest that focus should shift to self-ingestion and prescription products," the researchers said. "The largest potential benefits would come from a shift in attention to packaging design changes that reduce the quantity a child could quickly and easily access in a self-ingestion episode," they added.
Of 90 unintentional deaths recorded in the database, 66 were ingestion related. Of these, opioid analgesic and cough medicines accounted for the most deaths (20).
Another recent study by Dr. Gary M. Vilke of the University of California, San Diego and colleagues provided a breakdown of more than 40,000 paramedic transport calls related to poisonings in children younger than 5 years between 2000 and 2007 (J. Emerg. Med. 2011;41:265-9).
In this retrospective study, more than half of the poisonings were due to ingestion of prescription or over-the-counter medications (56%). In addition, medications made up a majority of the poisonings in each age group: less than 1 year (40%), 1 year (46%), 2 years (66%), 3 years (68%), and 4 years (60%). The researchers also noted that 10% of the poisonings were caused by cosmetics. This study was limited by the use of a preexisting database and the inclusion only of cases in which poisoning was the chief complaint.
However, the findings reinforce the need for better education about the poisoning potential of household medications, as shown in the study by Dr. Bond and colleagues.
None of the researchers in either study had any financial conflicts to disclose.
FROM THE JOURNAL OF PEDIATRICS
Major Finding: Prescription medications accounted for 55% of emergency department visits for poisoning in children aged 5 years and younger.
Data Source: Data on 453,599 cases from the American Association of Poison Control Centers’ National Poison Data System, 2001-2008.
Disclosures: None of the researchers in either study had any financial conflicts to disclose.
Court Upholds Doctors' Right to Discuss Firearms
A U.S. District Court judge has granted a preliminary injunction that stops Florida from enforcing a new law barring physicians from asking their patients about firearms ownership, saying that the law may be unconstitutional and has a good chance of being overturned.
The injunction, granted Sept. 14 by Judge Marcia Cooke, immediately prevents the state from pursuing disciplinary action against physicians who inquire about firearms in the home and counsel on firearms-injury prevention.
The decision won praise from the American Academy of Pediatrics, which has fought the law.
"The AAP is pleased the court recognized the confidential nature of the physician-patient relationship and the critical importance of this counseling, which is a cornerstone of pediatric care," Dr. O. Marion Burton, AAP president, said in a statement. "Today’s court victory ensures that important conversations about firearm safety can continue to take place between doctors and patients."
The Florida law, passed last spring and signed by Gov. Rick Scott (R) in June, forbids licensed health care practitioners from asking about gun ownership unless the practitioner believes "in good faith" that the information is relevant to patients’ and family members’ medical care or safety. Under the law, physicians and other health care practitioners also cannot record information on firearms in patients’ medical records.
Violators of the law could be subject to state medical board disciplinary action and sanctions.
The Florida chapters of the AAP, the American College of Physicians, and the American Academy of Family Physicians, along with six individual Florida physicians, filed suit in June against the law, saying it substantially curtails their First Amendment rights to exchange information with patients about gun safety. The judge agreed.
"Plaintiffs state that, as a result of the law, they are no longer (i) asking patients about firearm ownership, (ii) following up on routine questions regarding firearm ownership, (iii) providing patient intake questionnaires that include questions about firearms, or (iv) orally counseling patients about firearm safety," Judge Cooke wrote in her injunction.
Proponents of the Florida law have argued that it represents a Second Amendment issue involving the right to bear arms. However, Judge Cooke disagreed, calling it a First Amendment – or freedom of speech – issue instead.
"A practitioner who counsels a patient on firearm safety, even when entirely irrelevant to medical care or safety, does not affect nor interfere with the patient’s right to continue to own, possess, or use firearms," she wrote.
A U.S. District Court judge has granted a preliminary injunction that stops Florida from enforcing a new law barring physicians from asking their patients about firearms ownership, saying that the law may be unconstitutional and has a good chance of being overturned.
The injunction, granted Sept. 14 by Judge Marcia Cooke, immediately prevents the state from pursuing disciplinary action against physicians who inquire about firearms in the home and counsel on firearms-injury prevention.
The decision won praise from the American Academy of Pediatrics, which has fought the law.
"The AAP is pleased the court recognized the confidential nature of the physician-patient relationship and the critical importance of this counseling, which is a cornerstone of pediatric care," Dr. O. Marion Burton, AAP president, said in a statement. "Today’s court victory ensures that important conversations about firearm safety can continue to take place between doctors and patients."
The Florida law, passed last spring and signed by Gov. Rick Scott (R) in June, forbids licensed health care practitioners from asking about gun ownership unless the practitioner believes "in good faith" that the information is relevant to patients’ and family members’ medical care or safety. Under the law, physicians and other health care practitioners also cannot record information on firearms in patients’ medical records.
Violators of the law could be subject to state medical board disciplinary action and sanctions.
The Florida chapters of the AAP, the American College of Physicians, and the American Academy of Family Physicians, along with six individual Florida physicians, filed suit in June against the law, saying it substantially curtails their First Amendment rights to exchange information with patients about gun safety. The judge agreed.
"Plaintiffs state that, as a result of the law, they are no longer (i) asking patients about firearm ownership, (ii) following up on routine questions regarding firearm ownership, (iii) providing patient intake questionnaires that include questions about firearms, or (iv) orally counseling patients about firearm safety," Judge Cooke wrote in her injunction.
Proponents of the Florida law have argued that it represents a Second Amendment issue involving the right to bear arms. However, Judge Cooke disagreed, calling it a First Amendment – or freedom of speech – issue instead.
"A practitioner who counsels a patient on firearm safety, even when entirely irrelevant to medical care or safety, does not affect nor interfere with the patient’s right to continue to own, possess, or use firearms," she wrote.
A U.S. District Court judge has granted a preliminary injunction that stops Florida from enforcing a new law barring physicians from asking their patients about firearms ownership, saying that the law may be unconstitutional and has a good chance of being overturned.
The injunction, granted Sept. 14 by Judge Marcia Cooke, immediately prevents the state from pursuing disciplinary action against physicians who inquire about firearms in the home and counsel on firearms-injury prevention.
The decision won praise from the American Academy of Pediatrics, which has fought the law.
"The AAP is pleased the court recognized the confidential nature of the physician-patient relationship and the critical importance of this counseling, which is a cornerstone of pediatric care," Dr. O. Marion Burton, AAP president, said in a statement. "Today’s court victory ensures that important conversations about firearm safety can continue to take place between doctors and patients."
The Florida law, passed last spring and signed by Gov. Rick Scott (R) in June, forbids licensed health care practitioners from asking about gun ownership unless the practitioner believes "in good faith" that the information is relevant to patients’ and family members’ medical care or safety. Under the law, physicians and other health care practitioners also cannot record information on firearms in patients’ medical records.
Violators of the law could be subject to state medical board disciplinary action and sanctions.
The Florida chapters of the AAP, the American College of Physicians, and the American Academy of Family Physicians, along with six individual Florida physicians, filed suit in June against the law, saying it substantially curtails their First Amendment rights to exchange information with patients about gun safety. The judge agreed.
"Plaintiffs state that, as a result of the law, they are no longer (i) asking patients about firearm ownership, (ii) following up on routine questions regarding firearm ownership, (iii) providing patient intake questionnaires that include questions about firearms, or (iv) orally counseling patients about firearm safety," Judge Cooke wrote in her injunction.
Proponents of the Florida law have argued that it represents a Second Amendment issue involving the right to bear arms. However, Judge Cooke disagreed, calling it a First Amendment – or freedom of speech – issue instead.
"A practitioner who counsels a patient on firearm safety, even when entirely irrelevant to medical care or safety, does not affect nor interfere with the patient’s right to continue to own, possess, or use firearms," she wrote.
Mount Sinai Team Reduces LOS, Costs with Mobile ACE Approach
With our aging population, the challenges of meeting the unique needs of frail elderly patients will continue to mount. In the current issue of the Journal of Hospital Medicine, authors from Mount Sinai Medical Center in New York City report on their adaptation of the acute care for the elderly, or ACE, approach.1 They found that by bringing geriatrics-focused, team-based care to the patient (instead of locating the patient only in the ACE unit), they were able to reduce costs by an average of $4,943 per patient.
And, beginning in year two of the study, when the team incorporated hospitalists into their model, the ACE team decreased length of stay (LOS) by 1.6 days per patient.
From ACE to MACE
Since the mid-1990s, studies have shown that the ACE unit model can be effective in meeting the unique needs of frail, elderly patients. But even at institutions where these geriatric-focused units have been established, hospitals might not have enough dedicated beds for every elderly patient.
“A geographically based unit is difficult to accomplish when you have high occupancy rates in the hospital,” says lead author Jeffrey Farber, MD, assistant professor of geriatrics and palliative medicine and director of the Mobile ACE Service at Mount Sinai.
Dr. Farber and his colleagues began their mobile ACE (MACE) approach in 2007. Their retrospective cohort study compared outcomes of 8,094 hospitalized elderly patients cared for in the traditional ACE, the general medical service, or the MACE over a three-year period. To compare ACE and MACE patient outcomes, they limited their study sample to patients who already had been seen as part of their outpatient geriatrics service. Besides the shorter LOS, the MACE model also realized a net savings of $2,081 in direct hospital costs, $9,37 in nursing costs, and $223 in pharmacy costs in year two.
The MACE team, comprised of a geriatrician-hospitalist, geriatric medicine fellow, social worker, and nurse coordinator, met daily or twice a day. The nurse coordinator identified and resolved complex family and living situations, and daily check-ins with the patients’ caregivers or family members ensured that care plans and discharge plans were clearly understood before the patient left the hospital, Dr. Farber explains.
—Jeffrey Farber, MD, assistant professor of geriatrics and palliative medicine, director, Mobile ACE Service, Mount Sinai Medical Center, New York City
Gathering pre-hospitalization history is facilitated by the linkage of the hospital’s electronic health record with that of the Mount Sinai outpatient geriatrics practice and the hospital’s affiliated nursing home. Dr. Farber admits the integrated system confers an advantage to the geriatrics service. But community-based hospitalists can increase their odds of having accurate pre-hospitalization information by concerted outreach to referral sources in their community, he says.
Commenting on the study’s results, Heidi Wald, MD, MSPH, associate professor of medicine in the division of healthcare policy research at the University of Colorado Denver School of Medicine, notes that “hospitalists are great at providing efficient care, and geriatricians are good at preserving function and mitigating harm, so it was only logical that hybrids of the two models might achieve both sets of aims.”
One model that she and her UC Denver colleagues have studied utilizes “geriatricized” hospitalists (through focused geriatrics and CME programs), which allows the physicians to feel comfortable managing the unique needs of these patients. She says that functional outcomes warrant attention in the next generation of studies in this area.
Dr. Farber’s colleague, William Hung, MD, is analyzing the data of a prospective, longitudinal study focusing on functional status and post-hospitalization follow-up.
Gretchen Henkel is a freelance writer based in southern California.
Reference
1. Farber JI, Korc-Grodzicki B, Du Q, Leipzig, RM, Siu, AL. Operational and quality outcomes of a mobile acute care for the elderly service. J Hosp Med. 2011;6(6):358-363.
With our aging population, the challenges of meeting the unique needs of frail elderly patients will continue to mount. In the current issue of the Journal of Hospital Medicine, authors from Mount Sinai Medical Center in New York City report on their adaptation of the acute care for the elderly, or ACE, approach.1 They found that by bringing geriatrics-focused, team-based care to the patient (instead of locating the patient only in the ACE unit), they were able to reduce costs by an average of $4,943 per patient.
And, beginning in year two of the study, when the team incorporated hospitalists into their model, the ACE team decreased length of stay (LOS) by 1.6 days per patient.
From ACE to MACE
Since the mid-1990s, studies have shown that the ACE unit model can be effective in meeting the unique needs of frail, elderly patients. But even at institutions where these geriatric-focused units have been established, hospitals might not have enough dedicated beds for every elderly patient.
“A geographically based unit is difficult to accomplish when you have high occupancy rates in the hospital,” says lead author Jeffrey Farber, MD, assistant professor of geriatrics and palliative medicine and director of the Mobile ACE Service at Mount Sinai.
Dr. Farber and his colleagues began their mobile ACE (MACE) approach in 2007. Their retrospective cohort study compared outcomes of 8,094 hospitalized elderly patients cared for in the traditional ACE, the general medical service, or the MACE over a three-year period. To compare ACE and MACE patient outcomes, they limited their study sample to patients who already had been seen as part of their outpatient geriatrics service. Besides the shorter LOS, the MACE model also realized a net savings of $2,081 in direct hospital costs, $9,37 in nursing costs, and $223 in pharmacy costs in year two.
The MACE team, comprised of a geriatrician-hospitalist, geriatric medicine fellow, social worker, and nurse coordinator, met daily or twice a day. The nurse coordinator identified and resolved complex family and living situations, and daily check-ins with the patients’ caregivers or family members ensured that care plans and discharge plans were clearly understood before the patient left the hospital, Dr. Farber explains.
—Jeffrey Farber, MD, assistant professor of geriatrics and palliative medicine, director, Mobile ACE Service, Mount Sinai Medical Center, New York City
Gathering pre-hospitalization history is facilitated by the linkage of the hospital’s electronic health record with that of the Mount Sinai outpatient geriatrics practice and the hospital’s affiliated nursing home. Dr. Farber admits the integrated system confers an advantage to the geriatrics service. But community-based hospitalists can increase their odds of having accurate pre-hospitalization information by concerted outreach to referral sources in their community, he says.
Commenting on the study’s results, Heidi Wald, MD, MSPH, associate professor of medicine in the division of healthcare policy research at the University of Colorado Denver School of Medicine, notes that “hospitalists are great at providing efficient care, and geriatricians are good at preserving function and mitigating harm, so it was only logical that hybrids of the two models might achieve both sets of aims.”
One model that she and her UC Denver colleagues have studied utilizes “geriatricized” hospitalists (through focused geriatrics and CME programs), which allows the physicians to feel comfortable managing the unique needs of these patients. She says that functional outcomes warrant attention in the next generation of studies in this area.
Dr. Farber’s colleague, William Hung, MD, is analyzing the data of a prospective, longitudinal study focusing on functional status and post-hospitalization follow-up.
Gretchen Henkel is a freelance writer based in southern California.
Reference
1. Farber JI, Korc-Grodzicki B, Du Q, Leipzig, RM, Siu, AL. Operational and quality outcomes of a mobile acute care for the elderly service. J Hosp Med. 2011;6(6):358-363.
With our aging population, the challenges of meeting the unique needs of frail elderly patients will continue to mount. In the current issue of the Journal of Hospital Medicine, authors from Mount Sinai Medical Center in New York City report on their adaptation of the acute care for the elderly, or ACE, approach.1 They found that by bringing geriatrics-focused, team-based care to the patient (instead of locating the patient only in the ACE unit), they were able to reduce costs by an average of $4,943 per patient.
And, beginning in year two of the study, when the team incorporated hospitalists into their model, the ACE team decreased length of stay (LOS) by 1.6 days per patient.
From ACE to MACE
Since the mid-1990s, studies have shown that the ACE unit model can be effective in meeting the unique needs of frail, elderly patients. But even at institutions where these geriatric-focused units have been established, hospitals might not have enough dedicated beds for every elderly patient.
“A geographically based unit is difficult to accomplish when you have high occupancy rates in the hospital,” says lead author Jeffrey Farber, MD, assistant professor of geriatrics and palliative medicine and director of the Mobile ACE Service at Mount Sinai.
Dr. Farber and his colleagues began their mobile ACE (MACE) approach in 2007. Their retrospective cohort study compared outcomes of 8,094 hospitalized elderly patients cared for in the traditional ACE, the general medical service, or the MACE over a three-year period. To compare ACE and MACE patient outcomes, they limited their study sample to patients who already had been seen as part of their outpatient geriatrics service. Besides the shorter LOS, the MACE model also realized a net savings of $2,081 in direct hospital costs, $9,37 in nursing costs, and $223 in pharmacy costs in year two.
The MACE team, comprised of a geriatrician-hospitalist, geriatric medicine fellow, social worker, and nurse coordinator, met daily or twice a day. The nurse coordinator identified and resolved complex family and living situations, and daily check-ins with the patients’ caregivers or family members ensured that care plans and discharge plans were clearly understood before the patient left the hospital, Dr. Farber explains.
—Jeffrey Farber, MD, assistant professor of geriatrics and palliative medicine, director, Mobile ACE Service, Mount Sinai Medical Center, New York City
Gathering pre-hospitalization history is facilitated by the linkage of the hospital’s electronic health record with that of the Mount Sinai outpatient geriatrics practice and the hospital’s affiliated nursing home. Dr. Farber admits the integrated system confers an advantage to the geriatrics service. But community-based hospitalists can increase their odds of having accurate pre-hospitalization information by concerted outreach to referral sources in their community, he says.
Commenting on the study’s results, Heidi Wald, MD, MSPH, associate professor of medicine in the division of healthcare policy research at the University of Colorado Denver School of Medicine, notes that “hospitalists are great at providing efficient care, and geriatricians are good at preserving function and mitigating harm, so it was only logical that hybrids of the two models might achieve both sets of aims.”
One model that she and her UC Denver colleagues have studied utilizes “geriatricized” hospitalists (through focused geriatrics and CME programs), which allows the physicians to feel comfortable managing the unique needs of these patients. She says that functional outcomes warrant attention in the next generation of studies in this area.
Dr. Farber’s colleague, William Hung, MD, is analyzing the data of a prospective, longitudinal study focusing on functional status and post-hospitalization follow-up.
Gretchen Henkel is a freelance writer based in southern California.
Reference
1. Farber JI, Korc-Grodzicki B, Du Q, Leipzig, RM, Siu, AL. Operational and quality outcomes of a mobile acute care for the elderly service. J Hosp Med. 2011;6(6):358-363.