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Listen Now: Patient Satisfaction Changes Related to Hospital Renovation
As patient satisfaction becomes part of the healthcare quality metric, how does hospital facility design intersect with patient experience, patient satisfaction, and care quality? Two experts, one an architect and the other a hospital medicine clinician and researcher, weigh in on the intersection of architecture and healthcare.
As patient satisfaction becomes part of the healthcare quality metric, how does hospital facility design intersect with patient experience, patient satisfaction, and care quality? Two experts, one an architect and the other a hospital medicine clinician and researcher, weigh in on the intersection of architecture and healthcare.
As patient satisfaction becomes part of the healthcare quality metric, how does hospital facility design intersect with patient experience, patient satisfaction, and care quality? Two experts, one an architect and the other a hospital medicine clinician and researcher, weigh in on the intersection of architecture and healthcare.
Press Ganey Executive Urges Physicians to Embrace Hospital Medicine Care Model
James Merlino, MD, president and CMO of Press Ganey's strategic consulting division, wants to convince physicians around the country that hospital medicine is good healthcare as a whole.
“[Hospitalists] are the holistic scorekeepers for a variety of medical conditions that a lot of physicians don’t understand and don’t treat very well,” says Dr. Merlino, whose company supports healthcare providers in improving the patient experience. “We know that when their model is allowed to foster, quality improves [and] safety improves. It’s a model that needs to be embraced so we can deliver better care for patients.”
Dr. Merlino recently talked with The Hospitalist:
Question: You say you’ve seen some specialists and primary care physicians disrespect hospitalists. Why do you believe that occurs?
Answer: It’s a relatively new model, and physicians who have patients in the hospital, nonhospitalists, don’t like to give up the autonomy and the control they feel they have or the responsibility they have to care for patients. The hospitalist model challenges that.
Q: How does healthcare develop a culture that prizes hospitalists and encourages teamwork?
A: Number one, people have to call it out and talk about it. What surprised me in one hospital I visited was [that] the hospitalists did not elevate the issue to leadership. The second thing that relates to changing physician culture is accountability of leadership. When medical staff leaders find out about this type of behavior, it must be addressed.
Q: Why does the challenge persist?
A: It’s leaders stepping up and holding people accountable for their actions. Leaders sometimes have a tendency to ignore behavior problems. When issues like lack of professionalism are identified, then medical leadership really needs to step in and deal with the individuals who are creating the problem. That is a gap in healthcare.
Q: What stops leaders from being accountable?
A: The problem is that physician leaders and other leaders tend to shy away from controversial problems. Pushing into a medical staff issue like this is complicated and difficult. Physicians are the engines of your organization. Leaders are working very hard to keep the medical staff in a steady state … and often there’s a reluctance to push into behavioral problems. TH
Visit our website for more information on multidisciplinary care.
James Merlino, MD, president and CMO of Press Ganey's strategic consulting division, wants to convince physicians around the country that hospital medicine is good healthcare as a whole.
“[Hospitalists] are the holistic scorekeepers for a variety of medical conditions that a lot of physicians don’t understand and don’t treat very well,” says Dr. Merlino, whose company supports healthcare providers in improving the patient experience. “We know that when their model is allowed to foster, quality improves [and] safety improves. It’s a model that needs to be embraced so we can deliver better care for patients.”
Dr. Merlino recently talked with The Hospitalist:
Question: You say you’ve seen some specialists and primary care physicians disrespect hospitalists. Why do you believe that occurs?
Answer: It’s a relatively new model, and physicians who have patients in the hospital, nonhospitalists, don’t like to give up the autonomy and the control they feel they have or the responsibility they have to care for patients. The hospitalist model challenges that.
Q: How does healthcare develop a culture that prizes hospitalists and encourages teamwork?
A: Number one, people have to call it out and talk about it. What surprised me in one hospital I visited was [that] the hospitalists did not elevate the issue to leadership. The second thing that relates to changing physician culture is accountability of leadership. When medical staff leaders find out about this type of behavior, it must be addressed.
Q: Why does the challenge persist?
A: It’s leaders stepping up and holding people accountable for their actions. Leaders sometimes have a tendency to ignore behavior problems. When issues like lack of professionalism are identified, then medical leadership really needs to step in and deal with the individuals who are creating the problem. That is a gap in healthcare.
Q: What stops leaders from being accountable?
A: The problem is that physician leaders and other leaders tend to shy away from controversial problems. Pushing into a medical staff issue like this is complicated and difficult. Physicians are the engines of your organization. Leaders are working very hard to keep the medical staff in a steady state … and often there’s a reluctance to push into behavioral problems. TH
Visit our website for more information on multidisciplinary care.
James Merlino, MD, president and CMO of Press Ganey's strategic consulting division, wants to convince physicians around the country that hospital medicine is good healthcare as a whole.
“[Hospitalists] are the holistic scorekeepers for a variety of medical conditions that a lot of physicians don’t understand and don’t treat very well,” says Dr. Merlino, whose company supports healthcare providers in improving the patient experience. “We know that when their model is allowed to foster, quality improves [and] safety improves. It’s a model that needs to be embraced so we can deliver better care for patients.”
Dr. Merlino recently talked with The Hospitalist:
Question: You say you’ve seen some specialists and primary care physicians disrespect hospitalists. Why do you believe that occurs?
Answer: It’s a relatively new model, and physicians who have patients in the hospital, nonhospitalists, don’t like to give up the autonomy and the control they feel they have or the responsibility they have to care for patients. The hospitalist model challenges that.
Q: How does healthcare develop a culture that prizes hospitalists and encourages teamwork?
A: Number one, people have to call it out and talk about it. What surprised me in one hospital I visited was [that] the hospitalists did not elevate the issue to leadership. The second thing that relates to changing physician culture is accountability of leadership. When medical staff leaders find out about this type of behavior, it must be addressed.
Q: Why does the challenge persist?
A: It’s leaders stepping up and holding people accountable for their actions. Leaders sometimes have a tendency to ignore behavior problems. When issues like lack of professionalism are identified, then medical leadership really needs to step in and deal with the individuals who are creating the problem. That is a gap in healthcare.
Q: What stops leaders from being accountable?
A: The problem is that physician leaders and other leaders tend to shy away from controversial problems. Pushing into a medical staff issue like this is complicated and difficult. Physicians are the engines of your organization. Leaders are working very hard to keep the medical staff in a steady state … and often there’s a reluctance to push into behavioral problems. TH
Visit our website for more information on multidisciplinary care.
Where Leading GOP Presidential Candidates Stand on Health Policies
As the long 2016 presidential election season draws on, Republican hopefuls strive to stand out among their fellow party candidates; however, many in the running remain tacit about specific policies on issues ranging from immigration to gun control and healthcare.
“Many of these candidates … do not feel like getting involved in an extensive policy discussion will influence whether they win Iowa and New Hampshire,” says Robert Blendon, ScD, professor of health policy and political analysis at the Harvard School of Public Health and Harvard Kennedy School of Government in Cambridge, Mass. “They see it as a distraction, because the people voting are not asking them.”
For physicians and others passionate about healthcare, “it’s very frustrating,” Dr. Blendon says. “People who are on the Republican side want a replacement [for the Affordable Care Act], but they are not driven—I have seen the surveys—to want to really know the details of that replacement.”
GOP candidates share many common ideas about the U.S. health system. Most say they want to allow people under age 26 to remain on their parents’ health plans and believe people with preexisting conditions should have access to coverage, generally through the creation of state-based, high-risk insurance pools. They believe expanded health savings accounts will give patients more skin in the game, and, across the board, they have vowed to “repeal and replace Obamacare.”
Listen to more of our interview with Robert Blendon, ScD
However, “with more than 10 candidates, there is going to be variation,” Dr. Blendon adds.
For instance, former Florida Governor Jeb Bush has proposed the Conservative Plan for 21st Century Health, which aims to “lower costs,” “promote innovation,” and “return power to states.”
Neurosurgeon Ben Carson originally suggested he would “abolish” Medicare and instead provide seniors with a $2,000-a-year federal subsidy to purchase private insurance. He has backtracked that idea and, in December 2015, issued a report highlighting the pillars of his health plan, which include creating “health empowerment accounts” and raising the Medicare age to 70.
New Jersey Governor Chris Christie’s plan suggests a priority for veterans, including the formation of a federal Secretary of Veterans Affairs, while Carly Fiorina says that “every healthcare provider “ought to publish its costs, its prices, its outcomes” so patients know what they are buying.
“As the field on the Republican side narrows, I think we will start to see more pressure on them to flesh those principles out a little bit more,” says Joshua Lenchus, DO, RPh, FACP, SFHM, a hospitalist at the University of Miami (Fla.) Jackson Memorial Hospital and a member of SHM’s Public Policy Committee.
Some GOP candidates, like Kentucky Senator and ophthalmologist Rand Paul, have proposed reforming medical malpractice. Some wish to make insurance portable from one job to the next, like former Arkansas Governor Mike Huckabee, or across state lines, as Ohio Governor John Kasich has proposed.
Some of these ideas, says hospitalist and SHM Public Policy Committee member Bradley Flansbaum, DO, MPH, MHM, “have been adequately dismembered, and they’re not going to carry weight.
“Buying insurance across state lines, fixing malpractice—that is not going to fix the healthcare system,” says Dr. Flansbaum, clinical professor of medicine at NYU School of Medicine in New York City.
Overall, a Republican-sponsored healthcare system will not guarantee the same level of comprehensive benefits patients have now under the ACA, Dr. Blendon says, and, in general, subsidies and tax credits will be less generous than they are today, in turn reducing federal expenditures.
Most Republican candidates are in favor of some version of free market healthcare, but Dr. Flansbaum points out that “there are so many imperfections in the market, everything from people having asymmetric information—a physician knows a lot more than a patient does—to opaque pricing,” he says. “It’s not exchanging goods like we are used to.”
Republicans are generally committed to “less federal government, less expenditures, more choices, and less expensive benefits,” in healthcare, but Dr. Blendon says the system “would not go back to 2009.”
For hospitalists interested in election-year or other healthcare policy issues, Dr. Flansbaum suggests getting involved in the SHM committee, visiting the advocacy section of the SHM website, and reaching out to local representatives and others who write and vote on laws.
“How do you affect change?” he asks. “It’s not sitting in the breakfast lounge at the hospital bellyaching to your colleagues.” TH
Editor's note: update Jan. 4, 2016.
Kelly April Tyrrell is a freelance writer in Madison, Wis.
As the long 2016 presidential election season draws on, Republican hopefuls strive to stand out among their fellow party candidates; however, many in the running remain tacit about specific policies on issues ranging from immigration to gun control and healthcare.
“Many of these candidates … do not feel like getting involved in an extensive policy discussion will influence whether they win Iowa and New Hampshire,” says Robert Blendon, ScD, professor of health policy and political analysis at the Harvard School of Public Health and Harvard Kennedy School of Government in Cambridge, Mass. “They see it as a distraction, because the people voting are not asking them.”
For physicians and others passionate about healthcare, “it’s very frustrating,” Dr. Blendon says. “People who are on the Republican side want a replacement [for the Affordable Care Act], but they are not driven—I have seen the surveys—to want to really know the details of that replacement.”
GOP candidates share many common ideas about the U.S. health system. Most say they want to allow people under age 26 to remain on their parents’ health plans and believe people with preexisting conditions should have access to coverage, generally through the creation of state-based, high-risk insurance pools. They believe expanded health savings accounts will give patients more skin in the game, and, across the board, they have vowed to “repeal and replace Obamacare.”
Listen to more of our interview with Robert Blendon, ScD
However, “with more than 10 candidates, there is going to be variation,” Dr. Blendon adds.
For instance, former Florida Governor Jeb Bush has proposed the Conservative Plan for 21st Century Health, which aims to “lower costs,” “promote innovation,” and “return power to states.”
Neurosurgeon Ben Carson originally suggested he would “abolish” Medicare and instead provide seniors with a $2,000-a-year federal subsidy to purchase private insurance. He has backtracked that idea and, in December 2015, issued a report highlighting the pillars of his health plan, which include creating “health empowerment accounts” and raising the Medicare age to 70.
New Jersey Governor Chris Christie’s plan suggests a priority for veterans, including the formation of a federal Secretary of Veterans Affairs, while Carly Fiorina says that “every healthcare provider “ought to publish its costs, its prices, its outcomes” so patients know what they are buying.
“As the field on the Republican side narrows, I think we will start to see more pressure on them to flesh those principles out a little bit more,” says Joshua Lenchus, DO, RPh, FACP, SFHM, a hospitalist at the University of Miami (Fla.) Jackson Memorial Hospital and a member of SHM’s Public Policy Committee.
Some GOP candidates, like Kentucky Senator and ophthalmologist Rand Paul, have proposed reforming medical malpractice. Some wish to make insurance portable from one job to the next, like former Arkansas Governor Mike Huckabee, or across state lines, as Ohio Governor John Kasich has proposed.
Some of these ideas, says hospitalist and SHM Public Policy Committee member Bradley Flansbaum, DO, MPH, MHM, “have been adequately dismembered, and they’re not going to carry weight.
“Buying insurance across state lines, fixing malpractice—that is not going to fix the healthcare system,” says Dr. Flansbaum, clinical professor of medicine at NYU School of Medicine in New York City.
Overall, a Republican-sponsored healthcare system will not guarantee the same level of comprehensive benefits patients have now under the ACA, Dr. Blendon says, and, in general, subsidies and tax credits will be less generous than they are today, in turn reducing federal expenditures.
Most Republican candidates are in favor of some version of free market healthcare, but Dr. Flansbaum points out that “there are so many imperfections in the market, everything from people having asymmetric information—a physician knows a lot more than a patient does—to opaque pricing,” he says. “It’s not exchanging goods like we are used to.”
Republicans are generally committed to “less federal government, less expenditures, more choices, and less expensive benefits,” in healthcare, but Dr. Blendon says the system “would not go back to 2009.”
For hospitalists interested in election-year or other healthcare policy issues, Dr. Flansbaum suggests getting involved in the SHM committee, visiting the advocacy section of the SHM website, and reaching out to local representatives and others who write and vote on laws.
“How do you affect change?” he asks. “It’s not sitting in the breakfast lounge at the hospital bellyaching to your colleagues.” TH
Editor's note: update Jan. 4, 2016.
Kelly April Tyrrell is a freelance writer in Madison, Wis.
As the long 2016 presidential election season draws on, Republican hopefuls strive to stand out among their fellow party candidates; however, many in the running remain tacit about specific policies on issues ranging from immigration to gun control and healthcare.
“Many of these candidates … do not feel like getting involved in an extensive policy discussion will influence whether they win Iowa and New Hampshire,” says Robert Blendon, ScD, professor of health policy and political analysis at the Harvard School of Public Health and Harvard Kennedy School of Government in Cambridge, Mass. “They see it as a distraction, because the people voting are not asking them.”
For physicians and others passionate about healthcare, “it’s very frustrating,” Dr. Blendon says. “People who are on the Republican side want a replacement [for the Affordable Care Act], but they are not driven—I have seen the surveys—to want to really know the details of that replacement.”
GOP candidates share many common ideas about the U.S. health system. Most say they want to allow people under age 26 to remain on their parents’ health plans and believe people with preexisting conditions should have access to coverage, generally through the creation of state-based, high-risk insurance pools. They believe expanded health savings accounts will give patients more skin in the game, and, across the board, they have vowed to “repeal and replace Obamacare.”
Listen to more of our interview with Robert Blendon, ScD
However, “with more than 10 candidates, there is going to be variation,” Dr. Blendon adds.
For instance, former Florida Governor Jeb Bush has proposed the Conservative Plan for 21st Century Health, which aims to “lower costs,” “promote innovation,” and “return power to states.”
Neurosurgeon Ben Carson originally suggested he would “abolish” Medicare and instead provide seniors with a $2,000-a-year federal subsidy to purchase private insurance. He has backtracked that idea and, in December 2015, issued a report highlighting the pillars of his health plan, which include creating “health empowerment accounts” and raising the Medicare age to 70.
New Jersey Governor Chris Christie’s plan suggests a priority for veterans, including the formation of a federal Secretary of Veterans Affairs, while Carly Fiorina says that “every healthcare provider “ought to publish its costs, its prices, its outcomes” so patients know what they are buying.
“As the field on the Republican side narrows, I think we will start to see more pressure on them to flesh those principles out a little bit more,” says Joshua Lenchus, DO, RPh, FACP, SFHM, a hospitalist at the University of Miami (Fla.) Jackson Memorial Hospital and a member of SHM’s Public Policy Committee.
Some GOP candidates, like Kentucky Senator and ophthalmologist Rand Paul, have proposed reforming medical malpractice. Some wish to make insurance portable from one job to the next, like former Arkansas Governor Mike Huckabee, or across state lines, as Ohio Governor John Kasich has proposed.
Some of these ideas, says hospitalist and SHM Public Policy Committee member Bradley Flansbaum, DO, MPH, MHM, “have been adequately dismembered, and they’re not going to carry weight.
“Buying insurance across state lines, fixing malpractice—that is not going to fix the healthcare system,” says Dr. Flansbaum, clinical professor of medicine at NYU School of Medicine in New York City.
Overall, a Republican-sponsored healthcare system will not guarantee the same level of comprehensive benefits patients have now under the ACA, Dr. Blendon says, and, in general, subsidies and tax credits will be less generous than they are today, in turn reducing federal expenditures.
Most Republican candidates are in favor of some version of free market healthcare, but Dr. Flansbaum points out that “there are so many imperfections in the market, everything from people having asymmetric information—a physician knows a lot more than a patient does—to opaque pricing,” he says. “It’s not exchanging goods like we are used to.”
Republicans are generally committed to “less federal government, less expenditures, more choices, and less expensive benefits,” in healthcare, but Dr. Blendon says the system “would not go back to 2009.”
For hospitalists interested in election-year or other healthcare policy issues, Dr. Flansbaum suggests getting involved in the SHM committee, visiting the advocacy section of the SHM website, and reaching out to local representatives and others who write and vote on laws.
“How do you affect change?” he asks. “It’s not sitting in the breakfast lounge at the hospital bellyaching to your colleagues.” TH
Editor's note: update Jan. 4, 2016.
Kelly April Tyrrell is a freelance writer in Madison, Wis.
Some Readmission Risk Factors Not Captured by Medicare
Clinical question: Are there patient characteristics not currently measured by the Medicare readmission program that account for differences in hospital readmission rates?
Background: The Medicare Hospital Readmissions Reduction Program (HRRP) financially penalizes hospitals with higher than expected 30-day readmission rates. During 2014, more than 2,000 U.S. hospitals were fined $480 million for high readmission rates. HRRP accounts for differences in patient age, gender, discharge diagnosis, and diagnoses identified in Medicare claims over the previous 12 months; however, the impact of other factors is uncertain.
Study design: Survey data from the Health and Retirement Study, with linked Medicare claims.
Setting: Community-dwelling U.S. adults, older than 50 years.
Synopsis: Investigators analyzed more than 33,000 admissions from 2000 to 2012. They found 22 patient characteristics not included in the HRRP calculation that were statistically significantly predictive of hospital-wide, 30-day readmission and were more likely to be present among patients cared for in hospitals in the highest quintile of readmission rates. These characteristics reduced by 48% the differences in readmission rate between the highest- and lowest-performing quintiles. Examples include patient ethnicity, education level, personal as well as household income level, presence of prescription drug plan, Medicaid enrollment, cognitive status, and numerous others.
Bottom line: Patient characteristics account for much of the difference in readmission rates between high- and low-performing hospitals, suggesting that HRRP penalties reflect who hospitals treat as much as how well they treat them.
Citation: Barnett ML, Hsu J, McWilliams JM. Patient characteristics and differences in hospital readmission rates. JAMA Intern Med. 2015;175(11):1803-1812.
Clinical question: Are there patient characteristics not currently measured by the Medicare readmission program that account for differences in hospital readmission rates?
Background: The Medicare Hospital Readmissions Reduction Program (HRRP) financially penalizes hospitals with higher than expected 30-day readmission rates. During 2014, more than 2,000 U.S. hospitals were fined $480 million for high readmission rates. HRRP accounts for differences in patient age, gender, discharge diagnosis, and diagnoses identified in Medicare claims over the previous 12 months; however, the impact of other factors is uncertain.
Study design: Survey data from the Health and Retirement Study, with linked Medicare claims.
Setting: Community-dwelling U.S. adults, older than 50 years.
Synopsis: Investigators analyzed more than 33,000 admissions from 2000 to 2012. They found 22 patient characteristics not included in the HRRP calculation that were statistically significantly predictive of hospital-wide, 30-day readmission and were more likely to be present among patients cared for in hospitals in the highest quintile of readmission rates. These characteristics reduced by 48% the differences in readmission rate between the highest- and lowest-performing quintiles. Examples include patient ethnicity, education level, personal as well as household income level, presence of prescription drug plan, Medicaid enrollment, cognitive status, and numerous others.
Bottom line: Patient characteristics account for much of the difference in readmission rates between high- and low-performing hospitals, suggesting that HRRP penalties reflect who hospitals treat as much as how well they treat them.
Citation: Barnett ML, Hsu J, McWilliams JM. Patient characteristics and differences in hospital readmission rates. JAMA Intern Med. 2015;175(11):1803-1812.
Clinical question: Are there patient characteristics not currently measured by the Medicare readmission program that account for differences in hospital readmission rates?
Background: The Medicare Hospital Readmissions Reduction Program (HRRP) financially penalizes hospitals with higher than expected 30-day readmission rates. During 2014, more than 2,000 U.S. hospitals were fined $480 million for high readmission rates. HRRP accounts for differences in patient age, gender, discharge diagnosis, and diagnoses identified in Medicare claims over the previous 12 months; however, the impact of other factors is uncertain.
Study design: Survey data from the Health and Retirement Study, with linked Medicare claims.
Setting: Community-dwelling U.S. adults, older than 50 years.
Synopsis: Investigators analyzed more than 33,000 admissions from 2000 to 2012. They found 22 patient characteristics not included in the HRRP calculation that were statistically significantly predictive of hospital-wide, 30-day readmission and were more likely to be present among patients cared for in hospitals in the highest quintile of readmission rates. These characteristics reduced by 48% the differences in readmission rate between the highest- and lowest-performing quintiles. Examples include patient ethnicity, education level, personal as well as household income level, presence of prescription drug plan, Medicaid enrollment, cognitive status, and numerous others.
Bottom line: Patient characteristics account for much of the difference in readmission rates between high- and low-performing hospitals, suggesting that HRRP penalties reflect who hospitals treat as much as how well they treat them.
Citation: Barnett ML, Hsu J, McWilliams JM. Patient characteristics and differences in hospital readmission rates. JAMA Intern Med. 2015;175(11):1803-1812.
Methylphenidate Linked to Sleep and Appetite Loss
LONDON - Researchers voiced concern on Nov. 25 about poor quality studies on the popular ADHD treatment methylphenidate, saying evidence of some benefits, but also of sleep problems and appetite loss, suggests the drug should be prescribed with caution.
Methylphenidate (brand names Ritalin, Concerta, Medikinet and Equasym) has been used to treat attention deficit hyperactivity disorder (ADHD) for more than 50 years.
The Cochrane Review researchers, who conducted a full assessment of studies on the benefits and harms of methylphenidate, said evidence on its use in children was poor.
"Our expectations of this treatment are probably greater than they should be," said Morris Zwi, a London-based consultant child and adolescent psychiatrist, who worked on the review.
"Whilst our review shows some evidence of benefit, we should bear in mind that this finding was based on very low-quality evidence. What we still need are large, well-conducted trials to clarify the risks versus the benefits."
Cochrane Reviews are conducted by international panels of independent researchers and considered as studies of the best available science on a topic.
Jonathan Green, a professor of child and adolescent psychiatry at Britain's Manchester University who was asked to comment on the Cochrane Review, said it would be "wrong to draw the conclusion... that methylphenidate is ineffective.
"In fact, clinical level evidence strongly supports the effectiveness of methylphenidate for many children with ADHD."
The Cochrane Review included data from 185 randomized controlled trials involving more than 12,000 children or adolescents. The studies were conducted mainly in the United States, Canada and Europe, and each one compared methylphenidate with either a placebo or no intervention.
In their review, the Cochrane researchers found that methylphenidate led to modest improvements in ADHD symptoms, general behavior, and quality of life, but that side-effects included a higher risk of sleep problems and loss of appetite.
The researchers added, however, that their confidence in the evidence was low since many of the trials were not conducted with sufficient rigor and results reporting was not complete.
"Clinicians prescribing methylphenidate must take account of the poor quality of the evidence, monitor treatment carefully, and weigh up the benefits and adverse effects," they said.
The analysis was published online Nov. 25 in the Cochrane Library.
LONDON - Researchers voiced concern on Nov. 25 about poor quality studies on the popular ADHD treatment methylphenidate, saying evidence of some benefits, but also of sleep problems and appetite loss, suggests the drug should be prescribed with caution.
Methylphenidate (brand names Ritalin, Concerta, Medikinet and Equasym) has been used to treat attention deficit hyperactivity disorder (ADHD) for more than 50 years.
The Cochrane Review researchers, who conducted a full assessment of studies on the benefits and harms of methylphenidate, said evidence on its use in children was poor.
"Our expectations of this treatment are probably greater than they should be," said Morris Zwi, a London-based consultant child and adolescent psychiatrist, who worked on the review.
"Whilst our review shows some evidence of benefit, we should bear in mind that this finding was based on very low-quality evidence. What we still need are large, well-conducted trials to clarify the risks versus the benefits."
Cochrane Reviews are conducted by international panels of independent researchers and considered as studies of the best available science on a topic.
Jonathan Green, a professor of child and adolescent psychiatry at Britain's Manchester University who was asked to comment on the Cochrane Review, said it would be "wrong to draw the conclusion... that methylphenidate is ineffective.
"In fact, clinical level evidence strongly supports the effectiveness of methylphenidate for many children with ADHD."
The Cochrane Review included data from 185 randomized controlled trials involving more than 12,000 children or adolescents. The studies were conducted mainly in the United States, Canada and Europe, and each one compared methylphenidate with either a placebo or no intervention.
In their review, the Cochrane researchers found that methylphenidate led to modest improvements in ADHD symptoms, general behavior, and quality of life, but that side-effects included a higher risk of sleep problems and loss of appetite.
The researchers added, however, that their confidence in the evidence was low since many of the trials were not conducted with sufficient rigor and results reporting was not complete.
"Clinicians prescribing methylphenidate must take account of the poor quality of the evidence, monitor treatment carefully, and weigh up the benefits and adverse effects," they said.
The analysis was published online Nov. 25 in the Cochrane Library.
LONDON - Researchers voiced concern on Nov. 25 about poor quality studies on the popular ADHD treatment methylphenidate, saying evidence of some benefits, but also of sleep problems and appetite loss, suggests the drug should be prescribed with caution.
Methylphenidate (brand names Ritalin, Concerta, Medikinet and Equasym) has been used to treat attention deficit hyperactivity disorder (ADHD) for more than 50 years.
The Cochrane Review researchers, who conducted a full assessment of studies on the benefits and harms of methylphenidate, said evidence on its use in children was poor.
"Our expectations of this treatment are probably greater than they should be," said Morris Zwi, a London-based consultant child and adolescent psychiatrist, who worked on the review.
"Whilst our review shows some evidence of benefit, we should bear in mind that this finding was based on very low-quality evidence. What we still need are large, well-conducted trials to clarify the risks versus the benefits."
Cochrane Reviews are conducted by international panels of independent researchers and considered as studies of the best available science on a topic.
Jonathan Green, a professor of child and adolescent psychiatry at Britain's Manchester University who was asked to comment on the Cochrane Review, said it would be "wrong to draw the conclusion... that methylphenidate is ineffective.
"In fact, clinical level evidence strongly supports the effectiveness of methylphenidate for many children with ADHD."
The Cochrane Review included data from 185 randomized controlled trials involving more than 12,000 children or adolescents. The studies were conducted mainly in the United States, Canada and Europe, and each one compared methylphenidate with either a placebo or no intervention.
In their review, the Cochrane researchers found that methylphenidate led to modest improvements in ADHD symptoms, general behavior, and quality of life, but that side-effects included a higher risk of sleep problems and loss of appetite.
The researchers added, however, that their confidence in the evidence was low since many of the trials were not conducted with sufficient rigor and results reporting was not complete.
"Clinicians prescribing methylphenidate must take account of the poor quality of the evidence, monitor treatment carefully, and weigh up the benefits and adverse effects," they said.
The analysis was published online Nov. 25 in the Cochrane Library.
Leadership Academy ‘Hits Nail on the Head’
The Leadership Academy, presented by SHM, was held in October in Austin, Texas. Three courses were offered: Leadership Foundations and two Advanced Leadership courses, Influential Management and Mastering Teamwork. These sessions are designed to offer training in leadership skills specifically for those working in the field of hospital medicine, as well as to provide career development and extensive networking among colleagues. I had the opportunity to attend the Mastering Teamwork course this year as one of a handful of pediatric hospitalists.
A large majority of attendees at the conference were hospitalists in internal medicine, but many other areas were represented as well, including pediatrics, family medicine, pulmonary/critical care, palliative care, and hospital administration. Although I was in the minority as a pediatric hospitalist, I found that all the information discussed was applicable to my own practice setting.
The Mastering Teamwork session began with a presentation given by Mark Williams, MD, FACP, MHM, and Amit Prachand, MEng, on secrets and misconceptions of teamwork. They discussed ways to improve organizational health by developing trust within the team, addressing and nurturing healthy conflict, obtaining commitment through clarity and buy-in, encouraging accountability, and focusing on team results. They also shared practical ideas for making meetings more valuable, with suggestions for preparation, the meeting itself, and follow-up.
Day two of Mastering Teamwork consisted of lectures and discussion on meta-leadership (defined as “overarching leadership that strategically links the work of different agencies”) within and throughout one’s sphere of influence. Leonard Marcus, PhD, a national leader in the fields of healthcare negotiation, conflict resolution, and emergency preparedness, led this session.
A new course offered to all levels of the Leadership Academy this year, on physician burnout, was led by Kay Cannon, MBA, MCC, a nationally recognized executive coach. This session, which certainly hit close to home for many attendees, was very well attended and well received. Causes include poor job fit and work demands exceeding resources. Signs of burnout were discussed, including fatigue, anxiety, depression, health problems, and breakdown. Burnout can have significant effects in the work place, from early retirements to poor morale to poor patient care. Cannon presented ways to improve burnout, with the idea of achieving a better balance between demands and resources.
Cannon also presented in the Mastering Teamwork course. Her topic, “Investing in Yourself,” consisted of a discussion about career paths and planning. Course members were encouraged to engage in self-assessment and a situational assessment of their positions and organizations. Attendees began to delineate personal and career goals and to develop action plans based on these goals.
To close the course, Jeffrey Wiese, MD, MHM, spoke on advanced communications. This broad session offered practical advice in multiple areas. Specific topics included building teams through mission and purpose, encouraging loyalty, and motivating performance and happiness, while touching on burnout and feedback as well. He also discussed leading a team through change, dealing with politics within an organization, and making decisions.
“Dr. Wiese was amazing; his first day hit the nail on the head in forming and keeping a team. He was blunt and to the point, and it was so helpful,” said Kayce Morton, DO, who attended the Mastering Teamwork session. “Dr. Marcus accentuated leadership at its best through his stories. Kay Cannon was great at discussing topics that affect our leadership every day—it was like a therapy session. This was a very stimulating conference.”
The Leadership Academy, and, specifically, the Mastering Teamwork course, was very valuable. The lessons learned were highly practical, regardless of one’s area of practice and level of leadership. Each of the speakers was engaging and well received. TH
Dr. Galloway is a pediatric hospitalist at Sanford Children’s Hospital in Sioux Falls, S.D., assistant professor of pediatrics at the University of South Dakota Sanford School of Medicine, and vice chief of the division of hospital pediatrics at USD SSOM and Sanford Children’s Hospital.
The Leadership Academy, presented by SHM, was held in October in Austin, Texas. Three courses were offered: Leadership Foundations and two Advanced Leadership courses, Influential Management and Mastering Teamwork. These sessions are designed to offer training in leadership skills specifically for those working in the field of hospital medicine, as well as to provide career development and extensive networking among colleagues. I had the opportunity to attend the Mastering Teamwork course this year as one of a handful of pediatric hospitalists.
A large majority of attendees at the conference were hospitalists in internal medicine, but many other areas were represented as well, including pediatrics, family medicine, pulmonary/critical care, palliative care, and hospital administration. Although I was in the minority as a pediatric hospitalist, I found that all the information discussed was applicable to my own practice setting.
The Mastering Teamwork session began with a presentation given by Mark Williams, MD, FACP, MHM, and Amit Prachand, MEng, on secrets and misconceptions of teamwork. They discussed ways to improve organizational health by developing trust within the team, addressing and nurturing healthy conflict, obtaining commitment through clarity and buy-in, encouraging accountability, and focusing on team results. They also shared practical ideas for making meetings more valuable, with suggestions for preparation, the meeting itself, and follow-up.
Day two of Mastering Teamwork consisted of lectures and discussion on meta-leadership (defined as “overarching leadership that strategically links the work of different agencies”) within and throughout one’s sphere of influence. Leonard Marcus, PhD, a national leader in the fields of healthcare negotiation, conflict resolution, and emergency preparedness, led this session.
A new course offered to all levels of the Leadership Academy this year, on physician burnout, was led by Kay Cannon, MBA, MCC, a nationally recognized executive coach. This session, which certainly hit close to home for many attendees, was very well attended and well received. Causes include poor job fit and work demands exceeding resources. Signs of burnout were discussed, including fatigue, anxiety, depression, health problems, and breakdown. Burnout can have significant effects in the work place, from early retirements to poor morale to poor patient care. Cannon presented ways to improve burnout, with the idea of achieving a better balance between demands and resources.
Cannon also presented in the Mastering Teamwork course. Her topic, “Investing in Yourself,” consisted of a discussion about career paths and planning. Course members were encouraged to engage in self-assessment and a situational assessment of their positions and organizations. Attendees began to delineate personal and career goals and to develop action plans based on these goals.
To close the course, Jeffrey Wiese, MD, MHM, spoke on advanced communications. This broad session offered practical advice in multiple areas. Specific topics included building teams through mission and purpose, encouraging loyalty, and motivating performance and happiness, while touching on burnout and feedback as well. He also discussed leading a team through change, dealing with politics within an organization, and making decisions.
“Dr. Wiese was amazing; his first day hit the nail on the head in forming and keeping a team. He was blunt and to the point, and it was so helpful,” said Kayce Morton, DO, who attended the Mastering Teamwork session. “Dr. Marcus accentuated leadership at its best through his stories. Kay Cannon was great at discussing topics that affect our leadership every day—it was like a therapy session. This was a very stimulating conference.”
The Leadership Academy, and, specifically, the Mastering Teamwork course, was very valuable. The lessons learned were highly practical, regardless of one’s area of practice and level of leadership. Each of the speakers was engaging and well received. TH
Dr. Galloway is a pediatric hospitalist at Sanford Children’s Hospital in Sioux Falls, S.D., assistant professor of pediatrics at the University of South Dakota Sanford School of Medicine, and vice chief of the division of hospital pediatrics at USD SSOM and Sanford Children’s Hospital.
The Leadership Academy, presented by SHM, was held in October in Austin, Texas. Three courses were offered: Leadership Foundations and two Advanced Leadership courses, Influential Management and Mastering Teamwork. These sessions are designed to offer training in leadership skills specifically for those working in the field of hospital medicine, as well as to provide career development and extensive networking among colleagues. I had the opportunity to attend the Mastering Teamwork course this year as one of a handful of pediatric hospitalists.
A large majority of attendees at the conference were hospitalists in internal medicine, but many other areas were represented as well, including pediatrics, family medicine, pulmonary/critical care, palliative care, and hospital administration. Although I was in the minority as a pediatric hospitalist, I found that all the information discussed was applicable to my own practice setting.
The Mastering Teamwork session began with a presentation given by Mark Williams, MD, FACP, MHM, and Amit Prachand, MEng, on secrets and misconceptions of teamwork. They discussed ways to improve organizational health by developing trust within the team, addressing and nurturing healthy conflict, obtaining commitment through clarity and buy-in, encouraging accountability, and focusing on team results. They also shared practical ideas for making meetings more valuable, with suggestions for preparation, the meeting itself, and follow-up.
Day two of Mastering Teamwork consisted of lectures and discussion on meta-leadership (defined as “overarching leadership that strategically links the work of different agencies”) within and throughout one’s sphere of influence. Leonard Marcus, PhD, a national leader in the fields of healthcare negotiation, conflict resolution, and emergency preparedness, led this session.
A new course offered to all levels of the Leadership Academy this year, on physician burnout, was led by Kay Cannon, MBA, MCC, a nationally recognized executive coach. This session, which certainly hit close to home for many attendees, was very well attended and well received. Causes include poor job fit and work demands exceeding resources. Signs of burnout were discussed, including fatigue, anxiety, depression, health problems, and breakdown. Burnout can have significant effects in the work place, from early retirements to poor morale to poor patient care. Cannon presented ways to improve burnout, with the idea of achieving a better balance between demands and resources.
Cannon also presented in the Mastering Teamwork course. Her topic, “Investing in Yourself,” consisted of a discussion about career paths and planning. Course members were encouraged to engage in self-assessment and a situational assessment of their positions and organizations. Attendees began to delineate personal and career goals and to develop action plans based on these goals.
To close the course, Jeffrey Wiese, MD, MHM, spoke on advanced communications. This broad session offered practical advice in multiple areas. Specific topics included building teams through mission and purpose, encouraging loyalty, and motivating performance and happiness, while touching on burnout and feedback as well. He also discussed leading a team through change, dealing with politics within an organization, and making decisions.
“Dr. Wiese was amazing; his first day hit the nail on the head in forming and keeping a team. He was blunt and to the point, and it was so helpful,” said Kayce Morton, DO, who attended the Mastering Teamwork session. “Dr. Marcus accentuated leadership at its best through his stories. Kay Cannon was great at discussing topics that affect our leadership every day—it was like a therapy session. This was a very stimulating conference.”
The Leadership Academy, and, specifically, the Mastering Teamwork course, was very valuable. The lessons learned were highly practical, regardless of one’s area of practice and level of leadership. Each of the speakers was engaging and well received. TH
Dr. Galloway is a pediatric hospitalist at Sanford Children’s Hospital in Sioux Falls, S.D., assistant professor of pediatrics at the University of South Dakota Sanford School of Medicine, and vice chief of the division of hospital pediatrics at USD SSOM and Sanford Children’s Hospital.
Team Hospitalist Advisory Board Accepting Applications for 2016-2018 Terms
The Hospitalist, the official news magazine of the Society of Hospital Medicine, is always on the lookout for creative individuals dedicated to the field of hospital medicine to assist with editorial ideas and occasional writing.
Team Hospitalist is a voluntary, editorial advisory board made up of physicians, physician assistants, nurse practitioners, and administrators working in hospitalist groups all across the United States. Now in its eighth year, the 12-member group meets monthly to discuss hot topics in hospital medicine. Members are featured in the magazine and publish news articles at our website. Two-year terms will be seated during the SHM annual meeting this March in San Diego.
If interested in joining the team, send a cover letter of interest and CV to publication editor Jason Carris. Deadline to apply is Jan. 19, 2016.
The Hospitalist, the official news magazine of the Society of Hospital Medicine, is always on the lookout for creative individuals dedicated to the field of hospital medicine to assist with editorial ideas and occasional writing.
Team Hospitalist is a voluntary, editorial advisory board made up of physicians, physician assistants, nurse practitioners, and administrators working in hospitalist groups all across the United States. Now in its eighth year, the 12-member group meets monthly to discuss hot topics in hospital medicine. Members are featured in the magazine and publish news articles at our website. Two-year terms will be seated during the SHM annual meeting this March in San Diego.
If interested in joining the team, send a cover letter of interest and CV to publication editor Jason Carris. Deadline to apply is Jan. 19, 2016.
The Hospitalist, the official news magazine of the Society of Hospital Medicine, is always on the lookout for creative individuals dedicated to the field of hospital medicine to assist with editorial ideas and occasional writing.
Team Hospitalist is a voluntary, editorial advisory board made up of physicians, physician assistants, nurse practitioners, and administrators working in hospitalist groups all across the United States. Now in its eighth year, the 12-member group meets monthly to discuss hot topics in hospital medicine. Members are featured in the magazine and publish news articles at our website. Two-year terms will be seated during the SHM annual meeting this March in San Diego.
If interested in joining the team, send a cover letter of interest and CV to publication editor Jason Carris. Deadline to apply is Jan. 19, 2016.
Stent Thrombosis Risk Linked to Bioresorbable Scaffold
NEW YORK - Restenosis rates are similar one year after implantation of an everolimus-eluting bioresorbable vascular scaffold or an everolimus-eluting metallic stent, but the scaffold has a higher risk of device thrombosis within 30 days, a new meta-analysis shows.
The meta-analysis suggests that the two interventions have a "similar requirement of repeat revascularization out to 1-year follow-up, despite inferior angiographic performance," first author Dr. Salvatore Cassese said by email.
This higher risk of stent thrombosis, twice as high with the bioresorbable device compared with the metallic stent after one year, "is somewhat surprising," said Dr. Cassese, of the Technical University of Munich's German Heart Center Munich. "The higher risk of scaffold thrombosis in relatively simple clinical (lesion) settings represents the new important finding showed by this meta-analysis."
A number of recently completed randomized trials showed comparable mid-term outcomes with the two devices, but data from routine clinical practice suggests a "somewhat higher rate of adverse events" with the bioresorbable scaffold, he said.
Most randomized trials comparing the two types of devices were small and not adequately powered to assess clinical endpoints, the authors noted. For their meta-analysis, they identified six trials involving 3,738 patients (mainly men, median age 62.3 years) that met their inclusion criteria (randomized design, an analysis by intention to treat, and a follow-up of at least six months).
The meta-analysis included 2,337 patients who received a bioresorbable scaffold and 1,401 who received a metallic stent. Median follow-up was 12 months.
Both groups had a 3% rate of target lesion revascularization, the primary efficacy outcome, the researchers noted in a report online November 16 in The Lancet.
The risk of the primary safety outcome, definite or probable stent/scaffold thrombosis, was significantly higher for those treated with a bioresorbable scaffold compared with those who received a metallic stent (1.3% versus 0.5%; odds ratio, 1.99), with the highest risk within 30 days after implantation.
In-device late lumen loss was also significantly greater in lesions treated with the bioresorbable device compared with the metallic stent.
Risk of myocardial infarction appeared to be higher in patients with the bioresorbable scaffolds than in those with metallic stents, but the difference was not statistically significant (5.2% versus 3.5%, p=0.06). The groups had similar rates of target lesion failure and risk of death.
The authors noted that their finding of at least similar efficacy of the bioresorbable scaffold versus the existing best-in-class drug-eluting stent at 12 months was achieved in a highly selected population that included mainly stable patients with single de-novo non-complex target lesions and excluded patients who had a higher risk for device failure.
Two large-scale randomized trials are under way that are expected to shed more light on the devices' relative efficacy in higher-risk populations.
Although the study's findings "should heighten concerns about the current generation of bioresorbable vascular scaffold technology, they should by no means be interpreted to mean that bioresorbable scaffolds are not worth pursuing," noted an editorial that accompanied the new meta-analysis. "Just as with first-generation drug-eluting stents, a complete understanding of the limitations of such technology is necessary before further advancements can be made."
"Little information appears available regarding the incidence of symptoms of angina in the comparison groups," Dr. Richard Chazal, who was not involved in the study, said in an email.
"This is important, as the principal utility of stents in stable patients is the relief of such symptoms," noted Dr. Chazal, president-elect of the American College of Cardiology and medical director of the Lee Memorial Health Systems' Heart and Vascular Institute in Fort Myers, Fla.
"Disappearing" bioresorbable scaffolds are viewed as a possible solution to potential problems of leaving metallic stents permanently inside a coronary vessel. These problems include impairing the function of the wall of the artery and limiting future options for treating the artery, especially with a bypass operation, explained Dr. Chazal.
Emergence of their anticipated benefit over metallic stents is expected several years after implantation, when elution of the anti-restenotic drug has stopped and the scaffold has dissolved.
"Longer-term follow-up will be needed to clarify whether these newer devices provide hoped-for advantages over metallic stents, or whether the early issues with thrombosis/clotting and vessel narrowing eventually results in more clinical problems," Dr. Chazal said.
The study had no funding source. Two of the 10 coauthors reported receiving fees from stent manufacturers or holding patents related to drug-eluting stent technologies, "outside the submitted work." A third coauthor is a member of the advisory board of Abbott, which includes a division that makes an everolimus-eluting bioresorbable vascular scaffold.
NEW YORK - Restenosis rates are similar one year after implantation of an everolimus-eluting bioresorbable vascular scaffold or an everolimus-eluting metallic stent, but the scaffold has a higher risk of device thrombosis within 30 days, a new meta-analysis shows.
The meta-analysis suggests that the two interventions have a "similar requirement of repeat revascularization out to 1-year follow-up, despite inferior angiographic performance," first author Dr. Salvatore Cassese said by email.
This higher risk of stent thrombosis, twice as high with the bioresorbable device compared with the metallic stent after one year, "is somewhat surprising," said Dr. Cassese, of the Technical University of Munich's German Heart Center Munich. "The higher risk of scaffold thrombosis in relatively simple clinical (lesion) settings represents the new important finding showed by this meta-analysis."
A number of recently completed randomized trials showed comparable mid-term outcomes with the two devices, but data from routine clinical practice suggests a "somewhat higher rate of adverse events" with the bioresorbable scaffold, he said.
Most randomized trials comparing the two types of devices were small and not adequately powered to assess clinical endpoints, the authors noted. For their meta-analysis, they identified six trials involving 3,738 patients (mainly men, median age 62.3 years) that met their inclusion criteria (randomized design, an analysis by intention to treat, and a follow-up of at least six months).
The meta-analysis included 2,337 patients who received a bioresorbable scaffold and 1,401 who received a metallic stent. Median follow-up was 12 months.
Both groups had a 3% rate of target lesion revascularization, the primary efficacy outcome, the researchers noted in a report online November 16 in The Lancet.
The risk of the primary safety outcome, definite or probable stent/scaffold thrombosis, was significantly higher for those treated with a bioresorbable scaffold compared with those who received a metallic stent (1.3% versus 0.5%; odds ratio, 1.99), with the highest risk within 30 days after implantation.
In-device late lumen loss was also significantly greater in lesions treated with the bioresorbable device compared with the metallic stent.
Risk of myocardial infarction appeared to be higher in patients with the bioresorbable scaffolds than in those with metallic stents, but the difference was not statistically significant (5.2% versus 3.5%, p=0.06). The groups had similar rates of target lesion failure and risk of death.
The authors noted that their finding of at least similar efficacy of the bioresorbable scaffold versus the existing best-in-class drug-eluting stent at 12 months was achieved in a highly selected population that included mainly stable patients with single de-novo non-complex target lesions and excluded patients who had a higher risk for device failure.
Two large-scale randomized trials are under way that are expected to shed more light on the devices' relative efficacy in higher-risk populations.
Although the study's findings "should heighten concerns about the current generation of bioresorbable vascular scaffold technology, they should by no means be interpreted to mean that bioresorbable scaffolds are not worth pursuing," noted an editorial that accompanied the new meta-analysis. "Just as with first-generation drug-eluting stents, a complete understanding of the limitations of such technology is necessary before further advancements can be made."
"Little information appears available regarding the incidence of symptoms of angina in the comparison groups," Dr. Richard Chazal, who was not involved in the study, said in an email.
"This is important, as the principal utility of stents in stable patients is the relief of such symptoms," noted Dr. Chazal, president-elect of the American College of Cardiology and medical director of the Lee Memorial Health Systems' Heart and Vascular Institute in Fort Myers, Fla.
"Disappearing" bioresorbable scaffolds are viewed as a possible solution to potential problems of leaving metallic stents permanently inside a coronary vessel. These problems include impairing the function of the wall of the artery and limiting future options for treating the artery, especially with a bypass operation, explained Dr. Chazal.
Emergence of their anticipated benefit over metallic stents is expected several years after implantation, when elution of the anti-restenotic drug has stopped and the scaffold has dissolved.
"Longer-term follow-up will be needed to clarify whether these newer devices provide hoped-for advantages over metallic stents, or whether the early issues with thrombosis/clotting and vessel narrowing eventually results in more clinical problems," Dr. Chazal said.
The study had no funding source. Two of the 10 coauthors reported receiving fees from stent manufacturers or holding patents related to drug-eluting stent technologies, "outside the submitted work." A third coauthor is a member of the advisory board of Abbott, which includes a division that makes an everolimus-eluting bioresorbable vascular scaffold.
NEW YORK - Restenosis rates are similar one year after implantation of an everolimus-eluting bioresorbable vascular scaffold or an everolimus-eluting metallic stent, but the scaffold has a higher risk of device thrombosis within 30 days, a new meta-analysis shows.
The meta-analysis suggests that the two interventions have a "similar requirement of repeat revascularization out to 1-year follow-up, despite inferior angiographic performance," first author Dr. Salvatore Cassese said by email.
This higher risk of stent thrombosis, twice as high with the bioresorbable device compared with the metallic stent after one year, "is somewhat surprising," said Dr. Cassese, of the Technical University of Munich's German Heart Center Munich. "The higher risk of scaffold thrombosis in relatively simple clinical (lesion) settings represents the new important finding showed by this meta-analysis."
A number of recently completed randomized trials showed comparable mid-term outcomes with the two devices, but data from routine clinical practice suggests a "somewhat higher rate of adverse events" with the bioresorbable scaffold, he said.
Most randomized trials comparing the two types of devices were small and not adequately powered to assess clinical endpoints, the authors noted. For their meta-analysis, they identified six trials involving 3,738 patients (mainly men, median age 62.3 years) that met their inclusion criteria (randomized design, an analysis by intention to treat, and a follow-up of at least six months).
The meta-analysis included 2,337 patients who received a bioresorbable scaffold and 1,401 who received a metallic stent. Median follow-up was 12 months.
Both groups had a 3% rate of target lesion revascularization, the primary efficacy outcome, the researchers noted in a report online November 16 in The Lancet.
The risk of the primary safety outcome, definite or probable stent/scaffold thrombosis, was significantly higher for those treated with a bioresorbable scaffold compared with those who received a metallic stent (1.3% versus 0.5%; odds ratio, 1.99), with the highest risk within 30 days after implantation.
In-device late lumen loss was also significantly greater in lesions treated with the bioresorbable device compared with the metallic stent.
Risk of myocardial infarction appeared to be higher in patients with the bioresorbable scaffolds than in those with metallic stents, but the difference was not statistically significant (5.2% versus 3.5%, p=0.06). The groups had similar rates of target lesion failure and risk of death.
The authors noted that their finding of at least similar efficacy of the bioresorbable scaffold versus the existing best-in-class drug-eluting stent at 12 months was achieved in a highly selected population that included mainly stable patients with single de-novo non-complex target lesions and excluded patients who had a higher risk for device failure.
Two large-scale randomized trials are under way that are expected to shed more light on the devices' relative efficacy in higher-risk populations.
Although the study's findings "should heighten concerns about the current generation of bioresorbable vascular scaffold technology, they should by no means be interpreted to mean that bioresorbable scaffolds are not worth pursuing," noted an editorial that accompanied the new meta-analysis. "Just as with first-generation drug-eluting stents, a complete understanding of the limitations of such technology is necessary before further advancements can be made."
"Little information appears available regarding the incidence of symptoms of angina in the comparison groups," Dr. Richard Chazal, who was not involved in the study, said in an email.
"This is important, as the principal utility of stents in stable patients is the relief of such symptoms," noted Dr. Chazal, president-elect of the American College of Cardiology and medical director of the Lee Memorial Health Systems' Heart and Vascular Institute in Fort Myers, Fla.
"Disappearing" bioresorbable scaffolds are viewed as a possible solution to potential problems of leaving metallic stents permanently inside a coronary vessel. These problems include impairing the function of the wall of the artery and limiting future options for treating the artery, especially with a bypass operation, explained Dr. Chazal.
Emergence of their anticipated benefit over metallic stents is expected several years after implantation, when elution of the anti-restenotic drug has stopped and the scaffold has dissolved.
"Longer-term follow-up will be needed to clarify whether these newer devices provide hoped-for advantages over metallic stents, or whether the early issues with thrombosis/clotting and vessel narrowing eventually results in more clinical problems," Dr. Chazal said.
The study had no funding source. Two of the 10 coauthors reported receiving fees from stent manufacturers or holding patents related to drug-eluting stent technologies, "outside the submitted work." A third coauthor is a member of the advisory board of Abbott, which includes a division that makes an everolimus-eluting bioresorbable vascular scaffold.
Listen Now: Highlights of the December 2015 issue of The Hospitalist
Highlights from the December 2015 issue of The Hospitalist include a look at ways hospitals can better care for unassigned or uninsured patients, how electronic health record implementation has contributed to physician burnout, and our key clinical question examines strategies for secondary stroke prevention.
Highlights from the December 2015 issue of The Hospitalist include a look at ways hospitals can better care for unassigned or uninsured patients, how electronic health record implementation has contributed to physician burnout, and our key clinical question examines strategies for secondary stroke prevention.
Highlights from the December 2015 issue of The Hospitalist include a look at ways hospitals can better care for unassigned or uninsured patients, how electronic health record implementation has contributed to physician burnout, and our key clinical question examines strategies for secondary stroke prevention.
IVUS Stent Implantation Could Reduce Cardiac Events
NEW YORK - Intravascular ultrasound-guided (IVUS) stent implantation can lead to fewer adverse cardiac events compared with angiography-guided implantation, according to a new trial.
"Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at one year," Dr. Myeong-Ki Hong of Severance Cardiovascular Hospital and Yonsei University College of Medicine in Seoul, Korea, and colleagues report.
"These differences were primarily due to lower risk of target lesion revascularization," they note in an article online November 10 in JAMA. They presented their findings simultaneously at the American Heart Association Scientific Sessions in Orlando, Fla.
Dr. Hong and colleagues conducted a trial involving 1,400 patients with long coronary lesions between 2010 and 2014 at 20 centers in Korea. They randomized 700 patients to IVUS-guided stent implantation and 700 to angiography-guided stent implantation. They had one-year follow-up results on 94.5%.
Patient mean age was 64 and 69% were men. The mean stented target length was 39.3 mm.
The composite endpoint of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction (MI), or ischemia-driven target lesion revascularization, occurred in 19 (2.9%) patients who underwent IVUS implantation and 39 (5.8%) patients who underwent angiography-guided implantation (hazard ratio, 0.48; p=0.007).
Cardiac death and target-related MI were not significantly different between the two groups. However, ischemia-driven target lesion revascularization occurred in 17 (2.5%) IVUS
patients and 33 (5%) angiography patients (HR 0.51, p=0.02).
Clinicians performed post-stent balloon dilation more frequently in IVUS patients than in angiography patients (76% vs. 57%, p<0.001), and the mean final balloon size was larger in IVUS patients.
Patients who met IVUS criteria for stent optimization (363, 54%) had significantly greater mean post-intervention minimal lumen area at the stented segment compared with patients who did not meet IVUS criteria.
"The clinical benefit of IVUS-guided (drug-eluting stent) implantation may be attributed to the larger minimal lumen diameter followed by the more frequent adjunct postdilation with a large-sized balloon in the IVUS-guided group," the researchers write.
"To our knowledge, the current study is the first demonstration of the clinical benefit of IVUS guidance in second generation (drug-eluting stent) implantation in an adequately powered randomized clinical trial," they note.
However, even though recent guidelines recommend IVUS-guided implantation for some patients, evidence for improved outcomes based on adequately powered trials remains inadequate, they caution.
Dr. Hong did not respond to a request for comments. Abbott Vascular funded this research. The authors reported no conflicts of interest.
NEW YORK - Intravascular ultrasound-guided (IVUS) stent implantation can lead to fewer adverse cardiac events compared with angiography-guided implantation, according to a new trial.
"Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at one year," Dr. Myeong-Ki Hong of Severance Cardiovascular Hospital and Yonsei University College of Medicine in Seoul, Korea, and colleagues report.
"These differences were primarily due to lower risk of target lesion revascularization," they note in an article online November 10 in JAMA. They presented their findings simultaneously at the American Heart Association Scientific Sessions in Orlando, Fla.
Dr. Hong and colleagues conducted a trial involving 1,400 patients with long coronary lesions between 2010 and 2014 at 20 centers in Korea. They randomized 700 patients to IVUS-guided stent implantation and 700 to angiography-guided stent implantation. They had one-year follow-up results on 94.5%.
Patient mean age was 64 and 69% were men. The mean stented target length was 39.3 mm.
The composite endpoint of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction (MI), or ischemia-driven target lesion revascularization, occurred in 19 (2.9%) patients who underwent IVUS implantation and 39 (5.8%) patients who underwent angiography-guided implantation (hazard ratio, 0.48; p=0.007).
Cardiac death and target-related MI were not significantly different between the two groups. However, ischemia-driven target lesion revascularization occurred in 17 (2.5%) IVUS
patients and 33 (5%) angiography patients (HR 0.51, p=0.02).
Clinicians performed post-stent balloon dilation more frequently in IVUS patients than in angiography patients (76% vs. 57%, p<0.001), and the mean final balloon size was larger in IVUS patients.
Patients who met IVUS criteria for stent optimization (363, 54%) had significantly greater mean post-intervention minimal lumen area at the stented segment compared with patients who did not meet IVUS criteria.
"The clinical benefit of IVUS-guided (drug-eluting stent) implantation may be attributed to the larger minimal lumen diameter followed by the more frequent adjunct postdilation with a large-sized balloon in the IVUS-guided group," the researchers write.
"To our knowledge, the current study is the first demonstration of the clinical benefit of IVUS guidance in second generation (drug-eluting stent) implantation in an adequately powered randomized clinical trial," they note.
However, even though recent guidelines recommend IVUS-guided implantation for some patients, evidence for improved outcomes based on adequately powered trials remains inadequate, they caution.
Dr. Hong did not respond to a request for comments. Abbott Vascular funded this research. The authors reported no conflicts of interest.
NEW YORK - Intravascular ultrasound-guided (IVUS) stent implantation can lead to fewer adverse cardiac events compared with angiography-guided implantation, according to a new trial.
"Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at one year," Dr. Myeong-Ki Hong of Severance Cardiovascular Hospital and Yonsei University College of Medicine in Seoul, Korea, and colleagues report.
"These differences were primarily due to lower risk of target lesion revascularization," they note in an article online November 10 in JAMA. They presented their findings simultaneously at the American Heart Association Scientific Sessions in Orlando, Fla.
Dr. Hong and colleagues conducted a trial involving 1,400 patients with long coronary lesions between 2010 and 2014 at 20 centers in Korea. They randomized 700 patients to IVUS-guided stent implantation and 700 to angiography-guided stent implantation. They had one-year follow-up results on 94.5%.
Patient mean age was 64 and 69% were men. The mean stented target length was 39.3 mm.
The composite endpoint of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction (MI), or ischemia-driven target lesion revascularization, occurred in 19 (2.9%) patients who underwent IVUS implantation and 39 (5.8%) patients who underwent angiography-guided implantation (hazard ratio, 0.48; p=0.007).
Cardiac death and target-related MI were not significantly different between the two groups. However, ischemia-driven target lesion revascularization occurred in 17 (2.5%) IVUS
patients and 33 (5%) angiography patients (HR 0.51, p=0.02).
Clinicians performed post-stent balloon dilation more frequently in IVUS patients than in angiography patients (76% vs. 57%, p<0.001), and the mean final balloon size was larger in IVUS patients.
Patients who met IVUS criteria for stent optimization (363, 54%) had significantly greater mean post-intervention minimal lumen area at the stented segment compared with patients who did not meet IVUS criteria.
"The clinical benefit of IVUS-guided (drug-eluting stent) implantation may be attributed to the larger minimal lumen diameter followed by the more frequent adjunct postdilation with a large-sized balloon in the IVUS-guided group," the researchers write.
"To our knowledge, the current study is the first demonstration of the clinical benefit of IVUS guidance in second generation (drug-eluting stent) implantation in an adequately powered randomized clinical trial," they note.
However, even though recent guidelines recommend IVUS-guided implantation for some patients, evidence for improved outcomes based on adequately powered trials remains inadequate, they caution.
Dr. Hong did not respond to a request for comments. Abbott Vascular funded this research. The authors reported no conflicts of interest.