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Outpatient Malpractice Payments Outnumbered Inpatient
More malpractice payments were made in 2009 for adverse events that happened in the outpatient setting than in the inpatient setting, according to a report in the June 15 issue of JAMA.
The outcomes of adverse events among outpatients "were not trivial," with death and major injury accounting for nearly two-thirds of those claims, said Dr. Tara F. Bishop of the department of public health at Weill Cornell Medical College, New York, and her associates.
The findings may come as a surprise, given that most initiatives addressing patient safety have centered on inpatient care. "For example, in the past 5 years, the number of studies funded by the Agency for Healthcare Research and Quality on inpatient safety has been almost 10-fold that of outpatient studies," the investigators noted (JAMA 2011;305:2427-31).
"Our findings provide empirical support for suggestions that patient safety initiatives should focus on the outpatient setting, not just on inpatient care," they said.
The researchers assessed trends in malpractice payments using data from the National Practitioner Data Bank, "a repository of all malpractice payments paid on behalf of practitioners in the United States." They performed a retrospective analysis of payments involving only MDs and DOs, including residents, and compared payments for adverse events that occurred in inpatient settings with those that occurred in outpatient settings between 2005 and 2009, the first and last dates for which complete data were available.
The researchers noted that their results are underestimates of actual malpractice payments, because the NPDB doesn’t track payments made on behalf of corporate entities.
Adverse events were classified into six categories: diagnostic, surgical, obstetric, treatment/medication, anesthesia, or other. The outcomes of those adverse events were classified as involving death, lifelong care, major injury, minor injury, or emotional injury.
In 2009, 10,739 payments were made on malpractice claims against physicians. In all, 4,910 of those (48%) were for adverse events that occurred in an inpatient setting, 4,448 (43%) were for events that occurred in an outpatient setting, and 966 (9%) were for events that occurred in both settings.
Thus, more than half (52%) of the adverse events "occurred in the outpatient setting, at least in part," the investigators noted.
The average payment amount for outpatient malpractice claims was approximately $300,000, and that amount did not change over time. "Almost $1.3 billion in malpractice claims was paid for outpatient events in 2009," the investigators noted.
Major injury was the most common patient outcome in both settings, accounting for 38% of inpatient and 36% of outpatient claim payments. Death was the next most common patient outcome, accounting for 36% of the inpatient and 31% of the outpatient claim payments.
For outpatients, the most common types of adverse events were diagnostic (46%), treatment (30%), and surgical (14%). In contrast, the most common type of adverse events for inpatients was surgical (34%), followed by diagnostic (21%) and treatment (20%). That indicates that "more attention should be paid to adverse events related to diagnostic errors" in outpatient practice, Dr. Bishop and her colleagues said.
"Events related to diagnosis may be particularly important in the outpatient setting, where follow-up is more difficult than in the hospital and where patients often present with symptoms and signs that may be subtle or not adequately noted amid the many short-term, long-term, and preventive care activities often undertaken in a single outpatient visit," they added.
Moreover, "the importance of adverse events related to diagnosis may be particularly relevant as pay-for-performance and public reporting programs increasingly demand attention from clinicians," Dr. Bishop and her associates said. "These programs do not reward diagnostic acuity or punish diagnostic error and may divert clinicians’ time and attention from the critical area of diagnosis."
The number of malpractice claims declined significantly over time in both inpatient and outpatient settings, but the rate of the decrease was lower for outpatient claims.
Dr. Bishop was supported in part as a Nanette Laitman Clinical Scholar in Public Health at Weill Cornell Medical College. An associate was supported in part by a grant from the Agency for Healthcare Research and Quality.
When doctors are asked to list the specialties that carry the highest malpractice risk, invariably they first cite obstetrics/gynecology, anesthesia, or surgery. This study shows that general internal medicine should be added to that list.
"This unrecognized risk, and the associated absence of risk management programs in ambulatory care settings across the country, is a cause for concern," said Dr. Gianna Zuccotti and Dr. Luke Sato.
"The study is a wake-up call for physicians who practice primarily in ambulatory settings and for physicians and administrators with the ability to set policy for these areas," they said.
Gianna Zuccotti, M.D., M.P.H., and Luke Sato, M.D., are at the risk Management Foundation of Harvard Medical Institutions, Boston. Dr. Zuccotti is also with Partners HealthCare Systems and is a contributing editor at JAMA. Dr. Sato also is at Brigham and Women’s Hospital. These remarks were taken from their editorial accompanying Dr. Bishop’s report (JAMA 2011;305:2464-5).
When doctors are asked to list the specialties that carry the highest malpractice risk, invariably they first cite obstetrics/gynecology, anesthesia, or surgery. This study shows that general internal medicine should be added to that list.
"This unrecognized risk, and the associated absence of risk management programs in ambulatory care settings across the country, is a cause for concern," said Dr. Gianna Zuccotti and Dr. Luke Sato.
"The study is a wake-up call for physicians who practice primarily in ambulatory settings and for physicians and administrators with the ability to set policy for these areas," they said.
Gianna Zuccotti, M.D., M.P.H., and Luke Sato, M.D., are at the risk Management Foundation of Harvard Medical Institutions, Boston. Dr. Zuccotti is also with Partners HealthCare Systems and is a contributing editor at JAMA. Dr. Sato also is at Brigham and Women’s Hospital. These remarks were taken from their editorial accompanying Dr. Bishop’s report (JAMA 2011;305:2464-5).
When doctors are asked to list the specialties that carry the highest malpractice risk, invariably they first cite obstetrics/gynecology, anesthesia, or surgery. This study shows that general internal medicine should be added to that list.
"This unrecognized risk, and the associated absence of risk management programs in ambulatory care settings across the country, is a cause for concern," said Dr. Gianna Zuccotti and Dr. Luke Sato.
"The study is a wake-up call for physicians who practice primarily in ambulatory settings and for physicians and administrators with the ability to set policy for these areas," they said.
Gianna Zuccotti, M.D., M.P.H., and Luke Sato, M.D., are at the risk Management Foundation of Harvard Medical Institutions, Boston. Dr. Zuccotti is also with Partners HealthCare Systems and is a contributing editor at JAMA. Dr. Sato also is at Brigham and Women’s Hospital. These remarks were taken from their editorial accompanying Dr. Bishop’s report (JAMA 2011;305:2464-5).
More malpractice payments were made in 2009 for adverse events that happened in the outpatient setting than in the inpatient setting, according to a report in the June 15 issue of JAMA.
The outcomes of adverse events among outpatients "were not trivial," with death and major injury accounting for nearly two-thirds of those claims, said Dr. Tara F. Bishop of the department of public health at Weill Cornell Medical College, New York, and her associates.
The findings may come as a surprise, given that most initiatives addressing patient safety have centered on inpatient care. "For example, in the past 5 years, the number of studies funded by the Agency for Healthcare Research and Quality on inpatient safety has been almost 10-fold that of outpatient studies," the investigators noted (JAMA 2011;305:2427-31).
"Our findings provide empirical support for suggestions that patient safety initiatives should focus on the outpatient setting, not just on inpatient care," they said.
The researchers assessed trends in malpractice payments using data from the National Practitioner Data Bank, "a repository of all malpractice payments paid on behalf of practitioners in the United States." They performed a retrospective analysis of payments involving only MDs and DOs, including residents, and compared payments for adverse events that occurred in inpatient settings with those that occurred in outpatient settings between 2005 and 2009, the first and last dates for which complete data were available.
The researchers noted that their results are underestimates of actual malpractice payments, because the NPDB doesn’t track payments made on behalf of corporate entities.
Adverse events were classified into six categories: diagnostic, surgical, obstetric, treatment/medication, anesthesia, or other. The outcomes of those adverse events were classified as involving death, lifelong care, major injury, minor injury, or emotional injury.
In 2009, 10,739 payments were made on malpractice claims against physicians. In all, 4,910 of those (48%) were for adverse events that occurred in an inpatient setting, 4,448 (43%) were for events that occurred in an outpatient setting, and 966 (9%) were for events that occurred in both settings.
Thus, more than half (52%) of the adverse events "occurred in the outpatient setting, at least in part," the investigators noted.
The average payment amount for outpatient malpractice claims was approximately $300,000, and that amount did not change over time. "Almost $1.3 billion in malpractice claims was paid for outpatient events in 2009," the investigators noted.
Major injury was the most common patient outcome in both settings, accounting for 38% of inpatient and 36% of outpatient claim payments. Death was the next most common patient outcome, accounting for 36% of the inpatient and 31% of the outpatient claim payments.
For outpatients, the most common types of adverse events were diagnostic (46%), treatment (30%), and surgical (14%). In contrast, the most common type of adverse events for inpatients was surgical (34%), followed by diagnostic (21%) and treatment (20%). That indicates that "more attention should be paid to adverse events related to diagnostic errors" in outpatient practice, Dr. Bishop and her colleagues said.
"Events related to diagnosis may be particularly important in the outpatient setting, where follow-up is more difficult than in the hospital and where patients often present with symptoms and signs that may be subtle or not adequately noted amid the many short-term, long-term, and preventive care activities often undertaken in a single outpatient visit," they added.
Moreover, "the importance of adverse events related to diagnosis may be particularly relevant as pay-for-performance and public reporting programs increasingly demand attention from clinicians," Dr. Bishop and her associates said. "These programs do not reward diagnostic acuity or punish diagnostic error and may divert clinicians’ time and attention from the critical area of diagnosis."
The number of malpractice claims declined significantly over time in both inpatient and outpatient settings, but the rate of the decrease was lower for outpatient claims.
Dr. Bishop was supported in part as a Nanette Laitman Clinical Scholar in Public Health at Weill Cornell Medical College. An associate was supported in part by a grant from the Agency for Healthcare Research and Quality.
More malpractice payments were made in 2009 for adverse events that happened in the outpatient setting than in the inpatient setting, according to a report in the June 15 issue of JAMA.
The outcomes of adverse events among outpatients "were not trivial," with death and major injury accounting for nearly two-thirds of those claims, said Dr. Tara F. Bishop of the department of public health at Weill Cornell Medical College, New York, and her associates.
The findings may come as a surprise, given that most initiatives addressing patient safety have centered on inpatient care. "For example, in the past 5 years, the number of studies funded by the Agency for Healthcare Research and Quality on inpatient safety has been almost 10-fold that of outpatient studies," the investigators noted (JAMA 2011;305:2427-31).
"Our findings provide empirical support for suggestions that patient safety initiatives should focus on the outpatient setting, not just on inpatient care," they said.
The researchers assessed trends in malpractice payments using data from the National Practitioner Data Bank, "a repository of all malpractice payments paid on behalf of practitioners in the United States." They performed a retrospective analysis of payments involving only MDs and DOs, including residents, and compared payments for adverse events that occurred in inpatient settings with those that occurred in outpatient settings between 2005 and 2009, the first and last dates for which complete data were available.
The researchers noted that their results are underestimates of actual malpractice payments, because the NPDB doesn’t track payments made on behalf of corporate entities.
Adverse events were classified into six categories: diagnostic, surgical, obstetric, treatment/medication, anesthesia, or other. The outcomes of those adverse events were classified as involving death, lifelong care, major injury, minor injury, or emotional injury.
In 2009, 10,739 payments were made on malpractice claims against physicians. In all, 4,910 of those (48%) were for adverse events that occurred in an inpatient setting, 4,448 (43%) were for events that occurred in an outpatient setting, and 966 (9%) were for events that occurred in both settings.
Thus, more than half (52%) of the adverse events "occurred in the outpatient setting, at least in part," the investigators noted.
The average payment amount for outpatient malpractice claims was approximately $300,000, and that amount did not change over time. "Almost $1.3 billion in malpractice claims was paid for outpatient events in 2009," the investigators noted.
Major injury was the most common patient outcome in both settings, accounting for 38% of inpatient and 36% of outpatient claim payments. Death was the next most common patient outcome, accounting for 36% of the inpatient and 31% of the outpatient claim payments.
For outpatients, the most common types of adverse events were diagnostic (46%), treatment (30%), and surgical (14%). In contrast, the most common type of adverse events for inpatients was surgical (34%), followed by diagnostic (21%) and treatment (20%). That indicates that "more attention should be paid to adverse events related to diagnostic errors" in outpatient practice, Dr. Bishop and her colleagues said.
"Events related to diagnosis may be particularly important in the outpatient setting, where follow-up is more difficult than in the hospital and where patients often present with symptoms and signs that may be subtle or not adequately noted amid the many short-term, long-term, and preventive care activities often undertaken in a single outpatient visit," they added.
Moreover, "the importance of adverse events related to diagnosis may be particularly relevant as pay-for-performance and public reporting programs increasingly demand attention from clinicians," Dr. Bishop and her associates said. "These programs do not reward diagnostic acuity or punish diagnostic error and may divert clinicians’ time and attention from the critical area of diagnosis."
The number of malpractice claims declined significantly over time in both inpatient and outpatient settings, but the rate of the decrease was lower for outpatient claims.
Dr. Bishop was supported in part as a Nanette Laitman Clinical Scholar in Public Health at Weill Cornell Medical College. An associate was supported in part by a grant from the Agency for Healthcare Research and Quality.
FROM JAMA
Outpatient Malpractice Payments Outnumbered Inpatient
More malpractice payments were made in 2009 for adverse events that happened in the outpatient setting than in the inpatient setting, according to a report in the June 15 issue of JAMA.
The outcomes of adverse events among outpatients "were not trivial," with death and major injury accounting for nearly two-thirds of those claims, said Dr. Tara F. Bishop of the department of public health at Weill Cornell Medical College, New York, and her associates.
The findings may come as a surprise, given that most initiatives addressing patient safety have centered on inpatient care. "For example, in the past 5 years, the number of studies funded by the Agency for Healthcare Research and Quality on inpatient safety has been almost 10-fold that of outpatient studies," the investigators noted (JAMA 2011;305:2427-31).
"Our findings provide empirical support for suggestions that patient safety initiatives should focus on the outpatient setting, not just on inpatient care," they said.
The researchers assessed trends in malpractice payments using data from the National Practitioner Data Bank, "a repository of all malpractice payments paid on behalf of practitioners in the United States." They performed a retrospective analysis of payments involving only MDs and DOs, including residents, and compared payments for adverse events that occurred in inpatient settings with those that occurred in outpatient settings between 2005 and 2009, the first and last dates for which complete data were available.
The researchers noted that their results are underestimates of actual malpractice payments, because the NPDB doesn’t track payments made on behalf of corporate entities.
Adverse events were classified into six categories: diagnostic, surgical, obstetric, treatment/medication, anesthesia, or other. The outcomes of those adverse events were classified as involving death, lifelong care, major injury, minor injury, or emotional injury.
In 2009, 10,739 payments were made on malpractice claims against physicians. In all, 4,910 of those (48%) were for adverse events that occurred in an inpatient setting, 4,448 (43%) were for events that occurred in an outpatient setting, and 966 (9%) were for events that occurred in both settings.
Thus, more than half (52%) of the adverse events "occurred in the outpatient setting, at least in part," the investigators noted.
The average payment amount for outpatient malpractice claims was approximately $300,000, and that amount did not change over time. "Almost $1.3 billion in malpractice claims was paid for outpatient events in 2009," the investigators noted.
Major injury was the most common patient outcome in both settings, accounting for 38% of inpatient and 36% of outpatient claim payments. Death was the next most common patient outcome, accounting for 36% of the inpatient and 31% of the outpatient claim payments.
For outpatients, the most common types of adverse events were diagnostic (46%), treatment (30%), and surgical (14%). In contrast, the most common type of adverse events for inpatients was surgical (34%), followed by diagnostic (21%) and treatment (20%). That indicates that "more attention should be paid to adverse events related to diagnostic errors" in outpatient practice, Dr. Bishop and her colleagues said.
"Events related to diagnosis may be particularly important in the outpatient setting, where follow-up is more difficult than in the hospital and where patients often present with symptoms and signs that may be subtle or not adequately noted amid the many short-term, long-term, and preventive care activities often undertaken in a single outpatient visit," they added.
Moreover, "the importance of adverse events related to diagnosis may be particularly relevant as pay-for-performance and public reporting programs increasingly demand attention from clinicians," Dr. Bishop and her associates said. "These programs do not reward diagnostic acuity or punish diagnostic error and may divert clinicians’ time and attention from the critical area of diagnosis."
The number of malpractice claims declined significantly over time in both inpatient and outpatient settings, but the rate of the decrease was lower for outpatient claims.
Dr. Bishop was supported in part as a Nanette Laitman Clinical Scholar in Public Health at Weill Cornell Medical College. An associate was supported in part by a grant from the Agency for Healthcare Research and Quality.
When doctors are asked to list the specialties that carry the highest malpractice risk, invariably they first cite obstetrics/gynecology, anesthesia, or surgery. This study shows that general internal medicine should be added to that list.
"This unrecognized risk, and the associated absence of risk management programs in ambulatory care settings across the country, is a cause for concern," said Dr. Gianna Zuccotti and Dr. Luke Sato.
"The study is a wake-up call for physicians who practice primarily in ambulatory settings and for physicians and administrators with the ability to set policy for these areas," they said.
Gianna Zuccotti, M.D., M.P.H., and Luke Sato, M.D., are at the risk Management Foundation of Harvard Medical Institutions, Boston. Dr. Zuccotti is also with Partners HealthCare Systems and is a contributing editor at JAMA. Dr. Sato also is at Brigham and Women’s Hospital. These remarks were taken from their editorial accompanying Dr. Bishop’s report (JAMA 2011;305:2464-5).
When doctors are asked to list the specialties that carry the highest malpractice risk, invariably they first cite obstetrics/gynecology, anesthesia, or surgery. This study shows that general internal medicine should be added to that list.
"This unrecognized risk, and the associated absence of risk management programs in ambulatory care settings across the country, is a cause for concern," said Dr. Gianna Zuccotti and Dr. Luke Sato.
"The study is a wake-up call for physicians who practice primarily in ambulatory settings and for physicians and administrators with the ability to set policy for these areas," they said.
Gianna Zuccotti, M.D., M.P.H., and Luke Sato, M.D., are at the risk Management Foundation of Harvard Medical Institutions, Boston. Dr. Zuccotti is also with Partners HealthCare Systems and is a contributing editor at JAMA. Dr. Sato also is at Brigham and Women’s Hospital. These remarks were taken from their editorial accompanying Dr. Bishop’s report (JAMA 2011;305:2464-5).
When doctors are asked to list the specialties that carry the highest malpractice risk, invariably they first cite obstetrics/gynecology, anesthesia, or surgery. This study shows that general internal medicine should be added to that list.
"This unrecognized risk, and the associated absence of risk management programs in ambulatory care settings across the country, is a cause for concern," said Dr. Gianna Zuccotti and Dr. Luke Sato.
"The study is a wake-up call for physicians who practice primarily in ambulatory settings and for physicians and administrators with the ability to set policy for these areas," they said.
Gianna Zuccotti, M.D., M.P.H., and Luke Sato, M.D., are at the risk Management Foundation of Harvard Medical Institutions, Boston. Dr. Zuccotti is also with Partners HealthCare Systems and is a contributing editor at JAMA. Dr. Sato also is at Brigham and Women’s Hospital. These remarks were taken from their editorial accompanying Dr. Bishop’s report (JAMA 2011;305:2464-5).
More malpractice payments were made in 2009 for adverse events that happened in the outpatient setting than in the inpatient setting, according to a report in the June 15 issue of JAMA.
The outcomes of adverse events among outpatients "were not trivial," with death and major injury accounting for nearly two-thirds of those claims, said Dr. Tara F. Bishop of the department of public health at Weill Cornell Medical College, New York, and her associates.
The findings may come as a surprise, given that most initiatives addressing patient safety have centered on inpatient care. "For example, in the past 5 years, the number of studies funded by the Agency for Healthcare Research and Quality on inpatient safety has been almost 10-fold that of outpatient studies," the investigators noted (JAMA 2011;305:2427-31).
"Our findings provide empirical support for suggestions that patient safety initiatives should focus on the outpatient setting, not just on inpatient care," they said.
The researchers assessed trends in malpractice payments using data from the National Practitioner Data Bank, "a repository of all malpractice payments paid on behalf of practitioners in the United States." They performed a retrospective analysis of payments involving only MDs and DOs, including residents, and compared payments for adverse events that occurred in inpatient settings with those that occurred in outpatient settings between 2005 and 2009, the first and last dates for which complete data were available.
The researchers noted that their results are underestimates of actual malpractice payments, because the NPDB doesn’t track payments made on behalf of corporate entities.
Adverse events were classified into six categories: diagnostic, surgical, obstetric, treatment/medication, anesthesia, or other. The outcomes of those adverse events were classified as involving death, lifelong care, major injury, minor injury, or emotional injury.
In 2009, 10,739 payments were made on malpractice claims against physicians. In all, 4,910 of those (48%) were for adverse events that occurred in an inpatient setting, 4,448 (43%) were for events that occurred in an outpatient setting, and 966 (9%) were for events that occurred in both settings.
Thus, more than half (52%) of the adverse events "occurred in the outpatient setting, at least in part," the investigators noted.
The average payment amount for outpatient malpractice claims was approximately $300,000, and that amount did not change over time. "Almost $1.3 billion in malpractice claims was paid for outpatient events in 2009," the investigators noted.
Major injury was the most common patient outcome in both settings, accounting for 38% of inpatient and 36% of outpatient claim payments. Death was the next most common patient outcome, accounting for 36% of the inpatient and 31% of the outpatient claim payments.
For outpatients, the most common types of adverse events were diagnostic (46%), treatment (30%), and surgical (14%). In contrast, the most common type of adverse events for inpatients was surgical (34%), followed by diagnostic (21%) and treatment (20%). That indicates that "more attention should be paid to adverse events related to diagnostic errors" in outpatient practice, Dr. Bishop and her colleagues said.
"Events related to diagnosis may be particularly important in the outpatient setting, where follow-up is more difficult than in the hospital and where patients often present with symptoms and signs that may be subtle or not adequately noted amid the many short-term, long-term, and preventive care activities often undertaken in a single outpatient visit," they added.
Moreover, "the importance of adverse events related to diagnosis may be particularly relevant as pay-for-performance and public reporting programs increasingly demand attention from clinicians," Dr. Bishop and her associates said. "These programs do not reward diagnostic acuity or punish diagnostic error and may divert clinicians’ time and attention from the critical area of diagnosis."
The number of malpractice claims declined significantly over time in both inpatient and outpatient settings, but the rate of the decrease was lower for outpatient claims.
Dr. Bishop was supported in part as a Nanette Laitman Clinical Scholar in Public Health at Weill Cornell Medical College. An associate was supported in part by a grant from the Agency for Healthcare Research and Quality.
More malpractice payments were made in 2009 for adverse events that happened in the outpatient setting than in the inpatient setting, according to a report in the June 15 issue of JAMA.
The outcomes of adverse events among outpatients "were not trivial," with death and major injury accounting for nearly two-thirds of those claims, said Dr. Tara F. Bishop of the department of public health at Weill Cornell Medical College, New York, and her associates.
The findings may come as a surprise, given that most initiatives addressing patient safety have centered on inpatient care. "For example, in the past 5 years, the number of studies funded by the Agency for Healthcare Research and Quality on inpatient safety has been almost 10-fold that of outpatient studies," the investigators noted (JAMA 2011;305:2427-31).
"Our findings provide empirical support for suggestions that patient safety initiatives should focus on the outpatient setting, not just on inpatient care," they said.
The researchers assessed trends in malpractice payments using data from the National Practitioner Data Bank, "a repository of all malpractice payments paid on behalf of practitioners in the United States." They performed a retrospective analysis of payments involving only MDs and DOs, including residents, and compared payments for adverse events that occurred in inpatient settings with those that occurred in outpatient settings between 2005 and 2009, the first and last dates for which complete data were available.
The researchers noted that their results are underestimates of actual malpractice payments, because the NPDB doesn’t track payments made on behalf of corporate entities.
Adverse events were classified into six categories: diagnostic, surgical, obstetric, treatment/medication, anesthesia, or other. The outcomes of those adverse events were classified as involving death, lifelong care, major injury, minor injury, or emotional injury.
In 2009, 10,739 payments were made on malpractice claims against physicians. In all, 4,910 of those (48%) were for adverse events that occurred in an inpatient setting, 4,448 (43%) were for events that occurred in an outpatient setting, and 966 (9%) were for events that occurred in both settings.
Thus, more than half (52%) of the adverse events "occurred in the outpatient setting, at least in part," the investigators noted.
The average payment amount for outpatient malpractice claims was approximately $300,000, and that amount did not change over time. "Almost $1.3 billion in malpractice claims was paid for outpatient events in 2009," the investigators noted.
Major injury was the most common patient outcome in both settings, accounting for 38% of inpatient and 36% of outpatient claim payments. Death was the next most common patient outcome, accounting for 36% of the inpatient and 31% of the outpatient claim payments.
For outpatients, the most common types of adverse events were diagnostic (46%), treatment (30%), and surgical (14%). In contrast, the most common type of adverse events for inpatients was surgical (34%), followed by diagnostic (21%) and treatment (20%). That indicates that "more attention should be paid to adverse events related to diagnostic errors" in outpatient practice, Dr. Bishop and her colleagues said.
"Events related to diagnosis may be particularly important in the outpatient setting, where follow-up is more difficult than in the hospital and where patients often present with symptoms and signs that may be subtle or not adequately noted amid the many short-term, long-term, and preventive care activities often undertaken in a single outpatient visit," they added.
Moreover, "the importance of adverse events related to diagnosis may be particularly relevant as pay-for-performance and public reporting programs increasingly demand attention from clinicians," Dr. Bishop and her associates said. "These programs do not reward diagnostic acuity or punish diagnostic error and may divert clinicians’ time and attention from the critical area of diagnosis."
The number of malpractice claims declined significantly over time in both inpatient and outpatient settings, but the rate of the decrease was lower for outpatient claims.
Dr. Bishop was supported in part as a Nanette Laitman Clinical Scholar in Public Health at Weill Cornell Medical College. An associate was supported in part by a grant from the Agency for Healthcare Research and Quality.
FROM JAMA
Major Finding: In all, 52% of the adverse events for which medical malpractice payments were made in 2009 occurred at least in part in the outpatient setting.
Data Source: A retrospective trend analysis and comparison of more than 10,000 malpractice payments for adverse events that occurred in outpatient and inpatient settings in 2005-2009.
Disclosures: Dr. Bishop was supported in part as a Nanette Laitman Clinical Scholar in Public Health at Weill Cornell Medical College. An associate was supported in part by a grant from the Agency for Healthcare Research and Quality. Dr Zuccotti reported partial funding by CRICO-RMF, the medical malpractice insurer of Harvard University’s hospitals.
Panel Calls for More Cautious, Conservative Prescribing Approach
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician's favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient's hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or 'experts' with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from 'newer and more [are] better' to 'fewer and more time-tested [are] best,' " Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician's favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient's hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or 'experts' with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from 'newer and more [are] better' to 'fewer and more time-tested [are] best,' " Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician's favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient's hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or 'experts' with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from 'newer and more [are] better' to 'fewer and more time-tested [are] best,' " Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
EXPERT ANALYSIS FROM ARCHIVES OF INTERNAL MEDICINE
Panel Calls for More Cautious, Conservative Prescribing Approach
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician’s favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient’s hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or ‘experts’ with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from ‘newer and more [are] better’ to ‘fewer and more time-tested [are] best,’’’ Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician’s favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient’s hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or ‘experts’ with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from ‘newer and more [are] better’ to ‘fewer and more time-tested [are] best,’’’ Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician’s favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient’s hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or ‘experts’ with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from ‘newer and more [are] better’ to ‘fewer and more time-tested [are] best,’’’ Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
EXPERT ANALYSIS FROM ARCHIVES OF INTERNAL MEDICINE
Panel Calls for More Cautious, Conservative Prescribing Approach
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician’s favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient’s hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or ‘experts’ with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from ‘newer and more [are] better’ to ‘fewer and more time-tested [are] best,’’’ Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician’s favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient’s hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or ‘experts’ with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from ‘newer and more [are] better’ to ‘fewer and more time-tested [are] best,’’’ Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician’s favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient’s hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or ‘experts’ with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from ‘newer and more [are] better’ to ‘fewer and more time-tested [are] best,’’’ Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
EXPERT ANALYSIS FROM ARCHIVES OF INTERNAL MEDICINE
Statin Cuts Recurrent Stroke Risk Similarly in Diabetic, Nondiabetic Patients
Statin therapy appears to reduce the risk of recurrent stroke among patients with diabetes or the metabolic syndrome to the same degree that it does in patients who have neither disorder, according to a planned post hoc analysis of data collected in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels clinical trial.
However, since patients with diabetes start off with a much higher risk of recurrent stroke, their risk remains higher than that of nondiabetic patients even after statin therapy, Dr. Alfred Callahan of Vanderbilt University, Nashville, Tenn., and his associates reported online June 13 in Archives of Neurology.
Until now, no information has been available on the effect of statin treatment on secondary stroke prevention in patients with type 2 diabetes or the metabolic syndrome, the investigators noted.
The primary conclusion of the SPARCL clinical trial was that atorvastatin (Lipitor) reduced stroke risk in general. For this secondary analysis, Dr. Callahan and his colleagues assessed stroke risk in 794 adults who had type 2 diabetes, 642 who had the metabolic syndrome, and a reference group of 3,295 who had neither disorder.
The study subjects were ambulatory men and women with no known coronary heart disease who had had ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) 1-6 months before undergoing randomization in the SPARCL trial. They were treated at 205 medical centers in Africa, Australia, Europe, the Middle East, North America, and South America. The mean age was 63 years, and subjects were assessed every 6 months for a mean of 5 years.
Treatment with atorvastatin decreased LDL cholesterol levels to a similar degree across the three study groups, and lowered triglycerides by 11% in the group with diabetes, 20% in the group with metabolic syndrome, and 9% in the reference group.
Despite these treatment benefits, subjects with diabetes remained at increased risk of recurrent stroke (hazard ratio, 1.62), of major cardiovascular events (HR, 1.66), and of revascularization procedures (HR, 2.39), compared with the reference group. Subjects with metabolic syndrome were at increased risk of revascularization procedures (HR, 1.78) but not of other adverse cardiovascular outcomes.
At the conclusion of the study, the rate of recurrent stroke was 18% in patients with diabetes, 11% in those with metabolic syndrome, and 11% in the reference group.
"There was no evidence of a difference in treatment effect" among the three study groups, Dr. Callahan and his associates said (Arch. Neurol. 2011 June 13 [doi:10.1001/archneurol.2011.146]).
"These results should be viewed as exploratory" because the SPARCL trial was not powered to test for subgroup effects, they noted.
However, the findings agree with those of the Cholesterol Treatment Trialists’ collaboration, which also found that the effect of statins on stroke risk was similar between diabetic and nondiabetic patients, the researchers added.
Pfizer sponsored the study. Dr. Callahan reported receiving support from Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb. His associates reported ties to numerous pharmaceutical and device companies.
Statin therapy appears to reduce the risk of recurrent stroke among patients with diabetes or the metabolic syndrome to the same degree that it does in patients who have neither disorder, according to a planned post hoc analysis of data collected in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels clinical trial.
However, since patients with diabetes start off with a much higher risk of recurrent stroke, their risk remains higher than that of nondiabetic patients even after statin therapy, Dr. Alfred Callahan of Vanderbilt University, Nashville, Tenn., and his associates reported online June 13 in Archives of Neurology.
Until now, no information has been available on the effect of statin treatment on secondary stroke prevention in patients with type 2 diabetes or the metabolic syndrome, the investigators noted.
The primary conclusion of the SPARCL clinical trial was that atorvastatin (Lipitor) reduced stroke risk in general. For this secondary analysis, Dr. Callahan and his colleagues assessed stroke risk in 794 adults who had type 2 diabetes, 642 who had the metabolic syndrome, and a reference group of 3,295 who had neither disorder.
The study subjects were ambulatory men and women with no known coronary heart disease who had had ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) 1-6 months before undergoing randomization in the SPARCL trial. They were treated at 205 medical centers in Africa, Australia, Europe, the Middle East, North America, and South America. The mean age was 63 years, and subjects were assessed every 6 months for a mean of 5 years.
Treatment with atorvastatin decreased LDL cholesterol levels to a similar degree across the three study groups, and lowered triglycerides by 11% in the group with diabetes, 20% in the group with metabolic syndrome, and 9% in the reference group.
Despite these treatment benefits, subjects with diabetes remained at increased risk of recurrent stroke (hazard ratio, 1.62), of major cardiovascular events (HR, 1.66), and of revascularization procedures (HR, 2.39), compared with the reference group. Subjects with metabolic syndrome were at increased risk of revascularization procedures (HR, 1.78) but not of other adverse cardiovascular outcomes.
At the conclusion of the study, the rate of recurrent stroke was 18% in patients with diabetes, 11% in those with metabolic syndrome, and 11% in the reference group.
"There was no evidence of a difference in treatment effect" among the three study groups, Dr. Callahan and his associates said (Arch. Neurol. 2011 June 13 [doi:10.1001/archneurol.2011.146]).
"These results should be viewed as exploratory" because the SPARCL trial was not powered to test for subgroup effects, they noted.
However, the findings agree with those of the Cholesterol Treatment Trialists’ collaboration, which also found that the effect of statins on stroke risk was similar between diabetic and nondiabetic patients, the researchers added.
Pfizer sponsored the study. Dr. Callahan reported receiving support from Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb. His associates reported ties to numerous pharmaceutical and device companies.
Statin therapy appears to reduce the risk of recurrent stroke among patients with diabetes or the metabolic syndrome to the same degree that it does in patients who have neither disorder, according to a planned post hoc analysis of data collected in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels clinical trial.
However, since patients with diabetes start off with a much higher risk of recurrent stroke, their risk remains higher than that of nondiabetic patients even after statin therapy, Dr. Alfred Callahan of Vanderbilt University, Nashville, Tenn., and his associates reported online June 13 in Archives of Neurology.
Until now, no information has been available on the effect of statin treatment on secondary stroke prevention in patients with type 2 diabetes or the metabolic syndrome, the investigators noted.
The primary conclusion of the SPARCL clinical trial was that atorvastatin (Lipitor) reduced stroke risk in general. For this secondary analysis, Dr. Callahan and his colleagues assessed stroke risk in 794 adults who had type 2 diabetes, 642 who had the metabolic syndrome, and a reference group of 3,295 who had neither disorder.
The study subjects were ambulatory men and women with no known coronary heart disease who had had ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) 1-6 months before undergoing randomization in the SPARCL trial. They were treated at 205 medical centers in Africa, Australia, Europe, the Middle East, North America, and South America. The mean age was 63 years, and subjects were assessed every 6 months for a mean of 5 years.
Treatment with atorvastatin decreased LDL cholesterol levels to a similar degree across the three study groups, and lowered triglycerides by 11% in the group with diabetes, 20% in the group with metabolic syndrome, and 9% in the reference group.
Despite these treatment benefits, subjects with diabetes remained at increased risk of recurrent stroke (hazard ratio, 1.62), of major cardiovascular events (HR, 1.66), and of revascularization procedures (HR, 2.39), compared with the reference group. Subjects with metabolic syndrome were at increased risk of revascularization procedures (HR, 1.78) but not of other adverse cardiovascular outcomes.
At the conclusion of the study, the rate of recurrent stroke was 18% in patients with diabetes, 11% in those with metabolic syndrome, and 11% in the reference group.
"There was no evidence of a difference in treatment effect" among the three study groups, Dr. Callahan and his associates said (Arch. Neurol. 2011 June 13 [doi:10.1001/archneurol.2011.146]).
"These results should be viewed as exploratory" because the SPARCL trial was not powered to test for subgroup effects, they noted.
However, the findings agree with those of the Cholesterol Treatment Trialists’ collaboration, which also found that the effect of statins on stroke risk was similar between diabetic and nondiabetic patients, the researchers added.
Pfizer sponsored the study. Dr. Callahan reported receiving support from Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb. His associates reported ties to numerous pharmaceutical and device companies.
FROM ARCHIVES OF NEUROLOGY
Major Finding: The rate of recurrent stroke was 18% in patients with type 2 diabetes, 11% in patients with metabolic syndrome, and 11% in patients who had neither disorder.
Data Source: A planned secondary analysis of data from the international Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial involving 4,731 patients with recent stroke or transient ischemic attack who were followed for a mean of 5 years.
Disclosures: Pfizer sponsored the study. Dr. Callahan reported receiving support from Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb. His associates reported ties to numerous pharmaceutical and device companies.
Panel Calls for More Cautious, Conservative Prescribing Approach
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician’s favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient’s hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or ‘experts’ with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from ‘newer and more [are] better’ to ‘fewer and more time-tested [are] best,’’’ Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician’s favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient’s hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or ‘experts’ with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from ‘newer and more [are] better’ to ‘fewer and more time-tested [are] best,’’’ Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
Medical professionals need to "take a more sober, balanced, and cautious approach to prescribing," according to a panel of a physicians, pharmacists, and educators who devised a list of 24 recommendations aimed at helping providers – especially young providers – achieve that goal.
Plenty of evidence suggests that "medications are commonly used inappropriately, overused, and associated with significant harm," the panelists wrote in a review article published online June 13 in the Archives of Internal Medicine.
"We urge clinicians to take a more cautious approach to prescribing and administering chemicals whose effects are imperfectly understood," said Dr. Gordon D. Schiff of the Center for Patient Safety Research and Practice, Boston, and his associates.
The six authors of the paper based their recommendations on evidence and "lessons from recent studies demonstrating problems with widely prescribed medications."
The principles are aimed at younger physicians and trainees "who lack historical knowledge of past drug harms and withdrawals from the market," and they are intended to counterbalance messages from pharmaceutical companies and pressure from patients.
Their recommendations include the following:
• Seek nondrug alternatives before prescribing. "Clinicians should broaden their repertoire to become more skilled and effective at counseling and prescribing exercise, physical therapy, diet changes, smoking cessation, orthotics, or surgery when appropriate.
"Substantial literature supports initiating nonpharmacologic measures as initial or preferred therapy for a range of conditions commonly treated with drugs, such as hypertension, diabetes, insomnia, back pain, arthritis, and headache," Dr. Schiff and his colleagues wrote (Arch. Intern. Med. 2011 June 13 [doi:10.1001/archinternmed.2011.256]).
• Consider potentially treatable, underlying causes of a medical problem rather than just treating the symptoms with a drug. For example, before prescribing a drug for erectile dysfunction, consider whether impotence might be a sign of marital discord, a pituitary problem, a sign of diabetes, or a drug-induced condition.
• Emphasize prevention. For example, "smoking cessation efforts save many more lives than [do] costly chemotherapies for smoking-related cancers."
• Use the "test of time" whenever possible. "Especially when dealing with undiagnosed symptoms or potentially self-limiting conditions, use restraint rather than reflex prescribing to avoid giving drugs that can confuse the clinical picture and compound uncertainties. Reassurance and close follow-up can often be as effective and acceptable to the patient as writing a prescription," they noted.
• Use only a few drugs, and learn to use them well. "By learning in depth how to use a more limited subset of medications and mastering dosing, adverse effects, interactions, and even what the tablets look like, clinicians will be in a better position to prevent errors and anticipate problems."
• Avoid frequent switching to new drugs without clear, compelling, evidence-based reasons. "Examples of irrational and often counterproductive medication changes include switching inpatient antibiotics frequently, switching new patients to a physician’s favorite medications even though the patient is stable [on other medications], or changing a regimen that has not had sufficient time to work."
• Start treatment with one drug at a time. "Temper the urge to start treatment with medications for a new patient’s hypertension, urinary tract infection, dyspepsia, headaches, and toenail infection – all on the first visit. When she develops a rash, or even reports dramatic improvement, you will not know which drug was responsible."
• Keep a high index of suspicion for adverse drug effects. "No matter how unusual or unlikely a symptom a patient reports, for any problem that develops while a patient is taking a medication, always consider that it might be drug related."
• Educate patients about possible adverse effects to ensure that they are recognized as early as possible.
• Learn about new drugs and new indications from trustworthy, unbiased sources. "Avoid education from pharmaceutical representatives or ‘experts’ with conflicts of interest; instead turn to independent drug bulletins," such as the Medical Letter, Prescrire, or Worst Pills, Best Pills, they noted.
• Do not rush to use newly marketed drugs. Long-term and rarer adverse effects cannot have been identified because too few patients have been exposed and not enough time has elapsed. Moreover, real-world patients are much more complex than are subjects in clinical trials, so the effect of new drugs on their preexisting conditions and complicated drug regimens is not yet known.
• Be certain that the drug improves actual patient-centered clinical outcomes rather than just treating or masking a surrogate marker. "There is a growing body of literature demonstrating situations where surrogate improvements do not translate into clinical benefits," such as longer survival or improved quality of life.
• Do not hastily or uncritically succumb to patient requests for drugs, especially drugs that they have heard advertised.
• Do not automatically raise drug doses or add new drugs to a regimen for a "refractory" disorder without strongly considering that the problem stems from nonadherence.
Taken together, these and 10 other principles "represent a shift in prescribing paradigm from ‘newer and more [are] better’ to ‘fewer and more time-tested [are] best,’’’ Dr. Schiff and his colleagues concluded.
"While clinicians must always weigh the benefits of conservative prescribing against the risks of withholding potentially needed medications, at the very least we should seek to shift the burden of proof toward demanding a higher standard of evidence of benefit before exposing patients to the risks of drugs," they said.
This work was supported in part by the FLIP (Formulary Leveraged Improved Prescribing) project and a grant from the Agency for Healthcare Research and Quality. Dr. Schiff’s associate, Bruce L. Lambert, Ph.D., reported ties to Abbott Laboratories, Transcept Pharmaceuticals, Pharm I.R., Novartis, and Ortho McNeil.
EXPERT ANALYSIS FROM ARCHIVES OF INTERNAL MEDICINE
Statin Cuts Recurrent Stroke Risk Similarly in Diabetic, Nondiabetic Patients
Statin therapy appears to reduce the risk of recurrent stroke among patients with diabetes or the metabolic syndrome to the same degree that it does in patients who have neither disorder, according to a planned post hoc analysis of data collected in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels clinical trial.
However, since patients with diabetes start off with a much higher risk of recurrent stroke, their risk remains higher than that of nondiabetic patients even after statin therapy, Dr. Alfred Callahan of Vanderbilt University, Nashville, Tenn., and his associates reported online June 13 in Archives of Neurology.
Until now, no information has been available on the effect of statin treatment on secondary stroke prevention in patients with type 2 diabetes or the metabolic syndrome, the investigators noted.
The primary conclusion of the SPARCL clinical trial was that atorvastatin (Lipitor) reduced stroke risk in general. For this secondary analysis, Dr. Callahan and his colleagues assessed stroke risk in 794 adults who had type 2 diabetes, 642 who had the metabolic syndrome, and a reference group of 3,295 who had neither disorder.
The study subjects were ambulatory men and women with no known coronary heart disease who had had ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) 1-6 months before undergoing randomization in the SPARCL trial. They were treated at 205 medical centers in Africa, Australia, Europe, the Middle East, North America, and South America. The mean age was 63 years, and subjects were assessed every 6 months for a mean of 5 years.
Treatment with atorvastatin decreased LDL cholesterol levels to a similar degree across the three study groups, and lowered triglycerides by 11% in the group with diabetes, 20% in the group with metabolic syndrome, and 9% in the reference group.
Despite these treatment benefits, subjects with diabetes remained at increased risk of recurrent stroke (hazard ratio, 1.62), of major cardiovascular events (HR, 1.66), and of revascularization procedures (HR, 2.39), compared with the reference group. Subjects with metabolic syndrome were at increased risk of revascularization procedures (HR, 1.78) but not of other adverse cardiovascular outcomes.
At the conclusion of the study, the rate of recurrent stroke was 18% in patients with diabetes, 11% in those with metabolic syndrome, and 11% in the reference group.
"There was no evidence of a difference in treatment effect" among the three study groups, Dr. Callahan and his associates said (Arch. Neurol. 2011 June 13 [doi:10.1001/archneurol.2011.146]).
"These results should be viewed as exploratory" because the SPARCL trial was not powered to test for subgroup effects, they noted.
However, the findings agree with those of the Cholesterol Treatment Trialists’ collaboration, which also found that the effect of statins on stroke risk was similar between diabetic and nondiabetic patients, the researchers added.
Pfizer sponsored the study. Dr. Callahan reported receiving support from Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb. His associates reported ties to numerous pharmaceutical and device companies.
Statin therapy appears to reduce the risk of recurrent stroke among patients with diabetes or the metabolic syndrome to the same degree that it does in patients who have neither disorder, according to a planned post hoc analysis of data collected in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels clinical trial.
However, since patients with diabetes start off with a much higher risk of recurrent stroke, their risk remains higher than that of nondiabetic patients even after statin therapy, Dr. Alfred Callahan of Vanderbilt University, Nashville, Tenn., and his associates reported online June 13 in Archives of Neurology.
Until now, no information has been available on the effect of statin treatment on secondary stroke prevention in patients with type 2 diabetes or the metabolic syndrome, the investigators noted.
The primary conclusion of the SPARCL clinical trial was that atorvastatin (Lipitor) reduced stroke risk in general. For this secondary analysis, Dr. Callahan and his colleagues assessed stroke risk in 794 adults who had type 2 diabetes, 642 who had the metabolic syndrome, and a reference group of 3,295 who had neither disorder.
The study subjects were ambulatory men and women with no known coronary heart disease who had had ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) 1-6 months before undergoing randomization in the SPARCL trial. They were treated at 205 medical centers in Africa, Australia, Europe, the Middle East, North America, and South America. The mean age was 63 years, and subjects were assessed every 6 months for a mean of 5 years.
Treatment with atorvastatin decreased LDL cholesterol levels to a similar degree across the three study groups, and lowered triglycerides by 11% in the group with diabetes, 20% in the group with metabolic syndrome, and 9% in the reference group.
Despite these treatment benefits, subjects with diabetes remained at increased risk of recurrent stroke (hazard ratio, 1.62), of major cardiovascular events (HR, 1.66), and of revascularization procedures (HR, 2.39), compared with the reference group. Subjects with metabolic syndrome were at increased risk of revascularization procedures (HR, 1.78) but not of other adverse cardiovascular outcomes.
At the conclusion of the study, the rate of recurrent stroke was 18% in patients with diabetes, 11% in those with metabolic syndrome, and 11% in the reference group.
"There was no evidence of a difference in treatment effect" among the three study groups, Dr. Callahan and his associates said (Arch. Neurol. 2011 June 13 [doi:10.1001/archneurol.2011.146]).
"These results should be viewed as exploratory" because the SPARCL trial was not powered to test for subgroup effects, they noted.
However, the findings agree with those of the Cholesterol Treatment Trialists’ collaboration, which also found that the effect of statins on stroke risk was similar between diabetic and nondiabetic patients, the researchers added.
Pfizer sponsored the study. Dr. Callahan reported receiving support from Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb. His associates reported ties to numerous pharmaceutical and device companies.
Statin therapy appears to reduce the risk of recurrent stroke among patients with diabetes or the metabolic syndrome to the same degree that it does in patients who have neither disorder, according to a planned post hoc analysis of data collected in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels clinical trial.
However, since patients with diabetes start off with a much higher risk of recurrent stroke, their risk remains higher than that of nondiabetic patients even after statin therapy, Dr. Alfred Callahan of Vanderbilt University, Nashville, Tenn., and his associates reported online June 13 in Archives of Neurology.
Until now, no information has been available on the effect of statin treatment on secondary stroke prevention in patients with type 2 diabetes or the metabolic syndrome, the investigators noted.
The primary conclusion of the SPARCL clinical trial was that atorvastatin (Lipitor) reduced stroke risk in general. For this secondary analysis, Dr. Callahan and his colleagues assessed stroke risk in 794 adults who had type 2 diabetes, 642 who had the metabolic syndrome, and a reference group of 3,295 who had neither disorder.
The study subjects were ambulatory men and women with no known coronary heart disease who had had ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) 1-6 months before undergoing randomization in the SPARCL trial. They were treated at 205 medical centers in Africa, Australia, Europe, the Middle East, North America, and South America. The mean age was 63 years, and subjects were assessed every 6 months for a mean of 5 years.
Treatment with atorvastatin decreased LDL cholesterol levels to a similar degree across the three study groups, and lowered triglycerides by 11% in the group with diabetes, 20% in the group with metabolic syndrome, and 9% in the reference group.
Despite these treatment benefits, subjects with diabetes remained at increased risk of recurrent stroke (hazard ratio, 1.62), of major cardiovascular events (HR, 1.66), and of revascularization procedures (HR, 2.39), compared with the reference group. Subjects with metabolic syndrome were at increased risk of revascularization procedures (HR, 1.78) but not of other adverse cardiovascular outcomes.
At the conclusion of the study, the rate of recurrent stroke was 18% in patients with diabetes, 11% in those with metabolic syndrome, and 11% in the reference group.
"There was no evidence of a difference in treatment effect" among the three study groups, Dr. Callahan and his associates said (Arch. Neurol. 2011 June 13 [doi:10.1001/archneurol.2011.146]).
"These results should be viewed as exploratory" because the SPARCL trial was not powered to test for subgroup effects, they noted.
However, the findings agree with those of the Cholesterol Treatment Trialists’ collaboration, which also found that the effect of statins on stroke risk was similar between diabetic and nondiabetic patients, the researchers added.
Pfizer sponsored the study. Dr. Callahan reported receiving support from Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb. His associates reported ties to numerous pharmaceutical and device companies.
FROM ARCHIVES OF NEUROLOGY
Major Finding: The rate of recurrent stroke was 18% in patients with type 2 diabetes, 11% in patients with metabolic syndrome, and 11% in patients who had neither disorder.
Data Source: A planned secondary analysis of data from the international Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial involving 4,731 patients with recent stroke or transient ischemic attack who were followed for a mean of 5 years.
Disclosures: Pfizer sponsored the study. Dr. Callahan reported receiving support from Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb. His associates reported ties to numerous pharmaceutical and device companies.
Immediate IUD Insertion Shows Advantages Over Delayed Insertion
IUD insertion immediately after first-trimester induced or spontaneous abortion rather than at a later visit decreases the likelihood of unintended pregnancy 6 months later, without raising the risk of complications such as IUD expulsion, pelvic infection, or uterine perforation, according to a report in the June 9 issue of the New England Journal of Medicine.
"Mathematical modeling suggests that a switch from delayed IUD insertion to immediate insertion could prevent more than 70,000 unintended pregnancies annually in the United States. However, the availability of immediate IUD insertion is restricted by federal funding for contraceptive use ... because the provision of contraceptive services on the day of an abortion in the same facility is prohibited.
"Such policies that require health care providers to separate contraception provision from abortion provision reduce the likelihood that women will obtain the contraception needed to prevent unintended pregnancy," said Dr. Paula H. Bednarek of Oregon Health and Science University, Portland, and her associates.
The investigators compared outcomes between immediate and delayed IUD insertion following first-trimester uterine aspiration in a study of 575 women who were treated at four academic medical centers across the United States. All the women requested an IUD, and selected either a levonorgestrel-releasing IUD (Mirena) or a copper device (ParaGard T380A) before undergoing uterine aspiration for induced or spontaneous abortion at 5-12 weeks’ gestation.
Before the procedure commenced, the study subjects were randomly assigned to either immediate IUD insertion (258 women) within 15 minutes after completion of the procedure, or delayed insertion (317 women) at a separate visit 2-6 weeks later. Women were excluded from the study "in cases of failure to confirm completion of the aspiration, hemorrhage, perforation, or any other condition that, in the opinion of the surgeon, precluded safe IUD insertion," the researchers noted.
All the study subjects maintained daily diaries of bleeding; cramping or pain; and medication use from the day of the aspiration until 1 month after IUD insertion. They were followed at 1, 3, and 6 months after the procedure with review of the diary; completion of a questionnaire; physical examination; ultrasound verification of the location of the IUD; and assessment for infection, pain, bleeding, pregnancy, and other medical concerns.
IUDs were inserted in 100% of the immediate-insertion group, compared with only 71% of the delayed-insertion group. This was because 29% of the women in the delayed-insertion group never returned for their scheduled insertion visit.
"Our results confirm previously published data showing that 25%-68% of women who make an appointment for an IUD placement after an abortion do not return," Dr. Bednarek and her colleagues said.
After 6 months, the rate of IUD use was significantly higher in the immediate-insertion group (92%) than in the delayed-insertion group (77%). Women in the delayed-insertion group who never received an IUD frequently reported that they were instead using much-less-effective forms of contraception such as condoms (32%), or no method at all (25%).
During follow-up, no pregnancies occurred in the immediate-insertion group, while five pregnancies occurred in the delayed-insertion group. All five occurred in women who were not using IUDs. "Although this difference was not statistically significant, our study was not powered for this outcome and involved only 6 months of follow-up. A greater cumulative effect would be expected over a longer period," they noted (N. Engl. J. Med. 2011;364:2208-17).
Rates of IUD expulsions were low in both groups and not significantly different between the two groups, with a 5% rate in the immediate-insertion group and a 2.7% rate in the delayed-insertion group. Thus, immediate IUD insertion carried a slightly higher but statistically noninferior rate of expulsion than delayed IUD insertion.
Rates of other adverse events also were no different between the two groups. Rates of incomplete abortion requiring a repeat uterine aspiration were 0.8% with immediate insertion and 0.9% with delayed insertion. Rates of pelvic infection were 1.9% and 1.6%, respectively, and there were no cases of uterine perforation.
Pelvic infections were uncommon, even among women with a history of pelvic inflammatory disease and women who tested positive for chlamydia at the time of the procedure. "These findings support the expansion of access to IUDs after first-trimester uterine aspiration, including elimination of an additional visit to test for sexually transmitted infection when no infection is clinically evident.
"In addition, these data add to the growing body of evidence supporting the safety and effectiveness of IUD use among a wider range of women who previously may not have been considered good candidates for an IUD," Dr. Bednarek and her associates said.
This study was limited in that there was substantial loss to follow-up in both groups of patients, with 27% of women in the immediate-insertion group and 25% of those in the delayed-insertion group dropping out of the study. "Ongoing contact with women who have undergone an abortion is difficult," as many of them "have to travel a great distance to obtain an abortion and many wish to maintain their privacy," the researchers said.
This study was supported by grants from the Susan Thompson Buffett Foundation. Duramed Pharmaceuticals (now Teva Pharmaceuticals) donated the copper IUDs for this study. Dr. Bednarek reported ties to Bayer HealthCare Pharmaceuticals (maker of Mirena IUDs), Schering Plough (now merged with Merck), and Medicines 360 (a not-for-profit pharmaceutical company); her associates reported ties to Merck, Medicines 360, Duramed, Teva Women’s Health Research, and others.
IUD insertion immediately after first-trimester induced or spontaneous abortion rather than at a later visit decreases the likelihood of unintended pregnancy 6 months later, without raising the risk of complications such as IUD expulsion, pelvic infection, or uterine perforation, according to a report in the June 9 issue of the New England Journal of Medicine.
"Mathematical modeling suggests that a switch from delayed IUD insertion to immediate insertion could prevent more than 70,000 unintended pregnancies annually in the United States. However, the availability of immediate IUD insertion is restricted by federal funding for contraceptive use ... because the provision of contraceptive services on the day of an abortion in the same facility is prohibited.
"Such policies that require health care providers to separate contraception provision from abortion provision reduce the likelihood that women will obtain the contraception needed to prevent unintended pregnancy," said Dr. Paula H. Bednarek of Oregon Health and Science University, Portland, and her associates.
The investigators compared outcomes between immediate and delayed IUD insertion following first-trimester uterine aspiration in a study of 575 women who were treated at four academic medical centers across the United States. All the women requested an IUD, and selected either a levonorgestrel-releasing IUD (Mirena) or a copper device (ParaGard T380A) before undergoing uterine aspiration for induced or spontaneous abortion at 5-12 weeks’ gestation.
Before the procedure commenced, the study subjects were randomly assigned to either immediate IUD insertion (258 women) within 15 minutes after completion of the procedure, or delayed insertion (317 women) at a separate visit 2-6 weeks later. Women were excluded from the study "in cases of failure to confirm completion of the aspiration, hemorrhage, perforation, or any other condition that, in the opinion of the surgeon, precluded safe IUD insertion," the researchers noted.
All the study subjects maintained daily diaries of bleeding; cramping or pain; and medication use from the day of the aspiration until 1 month after IUD insertion. They were followed at 1, 3, and 6 months after the procedure with review of the diary; completion of a questionnaire; physical examination; ultrasound verification of the location of the IUD; and assessment for infection, pain, bleeding, pregnancy, and other medical concerns.
IUDs were inserted in 100% of the immediate-insertion group, compared with only 71% of the delayed-insertion group. This was because 29% of the women in the delayed-insertion group never returned for their scheduled insertion visit.
"Our results confirm previously published data showing that 25%-68% of women who make an appointment for an IUD placement after an abortion do not return," Dr. Bednarek and her colleagues said.
After 6 months, the rate of IUD use was significantly higher in the immediate-insertion group (92%) than in the delayed-insertion group (77%). Women in the delayed-insertion group who never received an IUD frequently reported that they were instead using much-less-effective forms of contraception such as condoms (32%), or no method at all (25%).
During follow-up, no pregnancies occurred in the immediate-insertion group, while five pregnancies occurred in the delayed-insertion group. All five occurred in women who were not using IUDs. "Although this difference was not statistically significant, our study was not powered for this outcome and involved only 6 months of follow-up. A greater cumulative effect would be expected over a longer period," they noted (N. Engl. J. Med. 2011;364:2208-17).
Rates of IUD expulsions were low in both groups and not significantly different between the two groups, with a 5% rate in the immediate-insertion group and a 2.7% rate in the delayed-insertion group. Thus, immediate IUD insertion carried a slightly higher but statistically noninferior rate of expulsion than delayed IUD insertion.
Rates of other adverse events also were no different between the two groups. Rates of incomplete abortion requiring a repeat uterine aspiration were 0.8% with immediate insertion and 0.9% with delayed insertion. Rates of pelvic infection were 1.9% and 1.6%, respectively, and there were no cases of uterine perforation.
Pelvic infections were uncommon, even among women with a history of pelvic inflammatory disease and women who tested positive for chlamydia at the time of the procedure. "These findings support the expansion of access to IUDs after first-trimester uterine aspiration, including elimination of an additional visit to test for sexually transmitted infection when no infection is clinically evident.
"In addition, these data add to the growing body of evidence supporting the safety and effectiveness of IUD use among a wider range of women who previously may not have been considered good candidates for an IUD," Dr. Bednarek and her associates said.
This study was limited in that there was substantial loss to follow-up in both groups of patients, with 27% of women in the immediate-insertion group and 25% of those in the delayed-insertion group dropping out of the study. "Ongoing contact with women who have undergone an abortion is difficult," as many of them "have to travel a great distance to obtain an abortion and many wish to maintain their privacy," the researchers said.
This study was supported by grants from the Susan Thompson Buffett Foundation. Duramed Pharmaceuticals (now Teva Pharmaceuticals) donated the copper IUDs for this study. Dr. Bednarek reported ties to Bayer HealthCare Pharmaceuticals (maker of Mirena IUDs), Schering Plough (now merged with Merck), and Medicines 360 (a not-for-profit pharmaceutical company); her associates reported ties to Merck, Medicines 360, Duramed, Teva Women’s Health Research, and others.
IUD insertion immediately after first-trimester induced or spontaneous abortion rather than at a later visit decreases the likelihood of unintended pregnancy 6 months later, without raising the risk of complications such as IUD expulsion, pelvic infection, or uterine perforation, according to a report in the June 9 issue of the New England Journal of Medicine.
"Mathematical modeling suggests that a switch from delayed IUD insertion to immediate insertion could prevent more than 70,000 unintended pregnancies annually in the United States. However, the availability of immediate IUD insertion is restricted by federal funding for contraceptive use ... because the provision of contraceptive services on the day of an abortion in the same facility is prohibited.
"Such policies that require health care providers to separate contraception provision from abortion provision reduce the likelihood that women will obtain the contraception needed to prevent unintended pregnancy," said Dr. Paula H. Bednarek of Oregon Health and Science University, Portland, and her associates.
The investigators compared outcomes between immediate and delayed IUD insertion following first-trimester uterine aspiration in a study of 575 women who were treated at four academic medical centers across the United States. All the women requested an IUD, and selected either a levonorgestrel-releasing IUD (Mirena) or a copper device (ParaGard T380A) before undergoing uterine aspiration for induced or spontaneous abortion at 5-12 weeks’ gestation.
Before the procedure commenced, the study subjects were randomly assigned to either immediate IUD insertion (258 women) within 15 minutes after completion of the procedure, or delayed insertion (317 women) at a separate visit 2-6 weeks later. Women were excluded from the study "in cases of failure to confirm completion of the aspiration, hemorrhage, perforation, or any other condition that, in the opinion of the surgeon, precluded safe IUD insertion," the researchers noted.
All the study subjects maintained daily diaries of bleeding; cramping or pain; and medication use from the day of the aspiration until 1 month after IUD insertion. They were followed at 1, 3, and 6 months after the procedure with review of the diary; completion of a questionnaire; physical examination; ultrasound verification of the location of the IUD; and assessment for infection, pain, bleeding, pregnancy, and other medical concerns.
IUDs were inserted in 100% of the immediate-insertion group, compared with only 71% of the delayed-insertion group. This was because 29% of the women in the delayed-insertion group never returned for their scheduled insertion visit.
"Our results confirm previously published data showing that 25%-68% of women who make an appointment for an IUD placement after an abortion do not return," Dr. Bednarek and her colleagues said.
After 6 months, the rate of IUD use was significantly higher in the immediate-insertion group (92%) than in the delayed-insertion group (77%). Women in the delayed-insertion group who never received an IUD frequently reported that they were instead using much-less-effective forms of contraception such as condoms (32%), or no method at all (25%).
During follow-up, no pregnancies occurred in the immediate-insertion group, while five pregnancies occurred in the delayed-insertion group. All five occurred in women who were not using IUDs. "Although this difference was not statistically significant, our study was not powered for this outcome and involved only 6 months of follow-up. A greater cumulative effect would be expected over a longer period," they noted (N. Engl. J. Med. 2011;364:2208-17).
Rates of IUD expulsions were low in both groups and not significantly different between the two groups, with a 5% rate in the immediate-insertion group and a 2.7% rate in the delayed-insertion group. Thus, immediate IUD insertion carried a slightly higher but statistically noninferior rate of expulsion than delayed IUD insertion.
Rates of other adverse events also were no different between the two groups. Rates of incomplete abortion requiring a repeat uterine aspiration were 0.8% with immediate insertion and 0.9% with delayed insertion. Rates of pelvic infection were 1.9% and 1.6%, respectively, and there were no cases of uterine perforation.
Pelvic infections were uncommon, even among women with a history of pelvic inflammatory disease and women who tested positive for chlamydia at the time of the procedure. "These findings support the expansion of access to IUDs after first-trimester uterine aspiration, including elimination of an additional visit to test for sexually transmitted infection when no infection is clinically evident.
"In addition, these data add to the growing body of evidence supporting the safety and effectiveness of IUD use among a wider range of women who previously may not have been considered good candidates for an IUD," Dr. Bednarek and her associates said.
This study was limited in that there was substantial loss to follow-up in both groups of patients, with 27% of women in the immediate-insertion group and 25% of those in the delayed-insertion group dropping out of the study. "Ongoing contact with women who have undergone an abortion is difficult," as many of them "have to travel a great distance to obtain an abortion and many wish to maintain their privacy," the researchers said.
This study was supported by grants from the Susan Thompson Buffett Foundation. Duramed Pharmaceuticals (now Teva Pharmaceuticals) donated the copper IUDs for this study. Dr. Bednarek reported ties to Bayer HealthCare Pharmaceuticals (maker of Mirena IUDs), Schering Plough (now merged with Merck), and Medicines 360 (a not-for-profit pharmaceutical company); her associates reported ties to Merck, Medicines 360, Duramed, Teva Women’s Health Research, and others.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major Finding: After 6 months, the rate of IUD use was significantly higher in the immediate-insertion group (92%) than in the delayed-insertion group (77%). Women in the delayed-insertion group who never received an IUD frequently reported that they were instead using much-less-effective forms of contraception such as condoms (32%), or no method at all (25%).
Data Source: A randomized trial comparing immediate vs. delayed IUD insertion among 575 women at 5-12 weeks’ gestation who were treated at four U.S. academic medical centers.
Disclosures: This study was supported by grants from the Susan Thompson Buffett Foundation. Duramed Pharmaceuticals (now Teva Pharmaceuticals) donated the copper IUDs for this study. Dr. Bednarek reported ties to Bayer HealthCare Pharmaceuticals (maker of Mirena IUDs), Schering Plough (now merged with Merck), and Medicines 360 (a not-for-profit pharmaceutical company); her associates reported ties to Merck, Medicines 360, Duramed, Teva Women’s Health Research, and others.
Thirteen Steps Advised to Prevent Delirium in Hospitalized Patients
Delirium is common but underrecognized in hospitalized patients, "a neglected condition relative to its frequency and serious consequences," and approximately one-third of cases are preventable, according to a report in the June 7 Annals of Internal Medicine.
The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has released a new clinical guideline for preventing delirium, which lists 13 recommendations that "could probably be easily accommodated in current care without incurring high costs." On the contrary, preventing delirium in hospitalized patients is expected to markedly cut health care costs, as well as to improve quality-adjusted life-year gains, compared with usual care, said Rachel O’Mahony, Ph.D., of the National Clinical Guideline Centre at the Royal College of Physicians, London, and her associates.
A multidisciplinary group of experts, including physicians, psychiatrists, specialist nurses, a home care manager, and patient representatives, reviewed the literature to find which prevention strategies were effective to compile the guidelines.
No single intervention was identified that significantly reduced hospital stay, placement in long-term care facilities, mortality, or duration or severity of delirium. Instead, multicomponent interventions provided the strongest evidence of improving these factors.
The recommendations include:
- Avoid changes in patient surroundings to prevent confusion and disorientation. This includes avoiding unnecessary room changes as well as changes in the personnel who provide care.
"Several moves within an acute care hospital are now common ... [from] emergency department to assessment unit to acute care ward and sometimes to post-acute care ward.
"Moving could make it difficult for a sick person on the brink of a delirium episode to maintain his or her orientation and contact with reality," Dr. O’Mahony and her colleagues said (Ann. Intern. Med. 2011;154:746-51).
- Provide appropriate lighting, clear signage, an easily visible 24-hour clock (to distinguish day from night in rooms without windows), and a calendar to help patients stay oriented to time and place.
- Reorient patients by explaining where they are and what your role is.
- Provide cognitively stimulating activities, such as encouraging patients to reminisce and facilitating visits from family and friends.
- Address dehydration and constipation, with intravenous fluids, if necessary, and manage fluid balance in patients with relevant comorbidities such as heart failure or kidney disease.
- Assess for hypoxia and optimize oxygen saturation.
- Actively assess for infection and treat it; employ infection-control procedures; and avoid unnecessary catheterization.
The presence of a bladder catheter is a known risk factor for delirium, the researchers noted.
- Address immobility by encouraging patients to walk as soon as possible, providing appropriate walking aids and ensuring they are available at all times, and encouraging range-of-motion exercises.
- Assess for pain, attending to nonverbal signs of pain, and manage it.
Although some clinicians are leery of inducing confusion by providing painkillers, pain itself is an independent risk factor for delirium, the investigators said.
- Review both the type and the number of medications.
- Address poor nutrition, and make sure that dentures fit properly in patients who have them.
- Address sensory impairment and resolve any reversible causes such as impacted ear wax or need for visual or hearing aids. Ensure such aids are in good working order.
- Promote good sleep patterns by avoiding procedures and minimizing ambient noise during sleeping hours.
"Some of these components are provided to some patients some of the time, but prevention of delirium requires that we do all of these things all the time to all of the patients who are at risk," Dr. O’Mahony and her associates said.
"It makes sense" to target these interventions to patients at highest risk of developing delirium. There are four such easy-to-identify groups, each with a greater than fivefold increase in risk for delirium: patients aged 65 [years] and older, patients with preexisting cognitive impairment, patients with severe illness, and patients with hip fracture, they noted.
"This enhanced approach goes beyond well-trained and prepared staff. It requires a health care system ... that supports comprehensive and reliable delivery of specific tasks," they researchers added.
The guideline was supported by the National Clinical Guideline Centre at the Royal College of Physicians; the U.K. Cochrane Centre and KSG-Trans; and the Bradford Institute for Health Research. None of the authors reported having any relevant conflicts of interest.
The full version of the guideline, including details about the methods used in its development, is available online. A synopsis is available at Annals of Internal Medicine.
Clinical guidelines should bring order to the dizzying array of diagnostic and therapeutic options facing physicians, but too often, the thousands of such guidelines published by "hundreds of groups in dozens of countries" instead can make the "chaos" even worse, according to Dr. Christine Laine, Dr. Darren B. Taichman, and Dr. Cynthia Mulrow.
The American College of Physicians has always presented summaries of the high-quality guidelines compiled by themselves and by the U.S. Preventive Services Task Force, and the organization now seeks "to publish thoughtful synopses of guidelines initially released in other venues but whose topics are highly relevant to the practice of internal medicine and its subspecialties.
"As the first example of this new venture," the ACP presents a synopsis of the NICE guideline for preventing delirium, because the methods for developing it came so close to meeting the Institute of Medicine’s "rigorous definition of trustworthy."
"We urge readers to gain familiarity with the IOM standards and consider them as they use guidelines to navigate the maze of available clinical choices," the editors noted.
Christine Laine, M.D., is editor in chief of the Annals of Internal Medicine, senior vice president of the American College of Physicians, and an internist at Jefferson Medical College, all in Philadelphia. Darren B. Taichman, M.D., Ph.D., is executive deputy editor of the Annals and director of the medical ICU at the University of Pennsylvania Medical Center, Philadelphia. Cynthia Mulrow, M.D., is senior deputy editor of the Annals. These remarks were taken from their editorial accompanying the NICE guideline (Ann. Intern. Med. 2011;154:774-5). No potential conflicts of interest were disclosed.
Clinical guidelines should bring order to the dizzying array of diagnostic and therapeutic options facing physicians, but too often, the thousands of such guidelines published by "hundreds of groups in dozens of countries" instead can make the "chaos" even worse, according to Dr. Christine Laine, Dr. Darren B. Taichman, and Dr. Cynthia Mulrow.
The American College of Physicians has always presented summaries of the high-quality guidelines compiled by themselves and by the U.S. Preventive Services Task Force, and the organization now seeks "to publish thoughtful synopses of guidelines initially released in other venues but whose topics are highly relevant to the practice of internal medicine and its subspecialties.
"As the first example of this new venture," the ACP presents a synopsis of the NICE guideline for preventing delirium, because the methods for developing it came so close to meeting the Institute of Medicine’s "rigorous definition of trustworthy."
"We urge readers to gain familiarity with the IOM standards and consider them as they use guidelines to navigate the maze of available clinical choices," the editors noted.
Christine Laine, M.D., is editor in chief of the Annals of Internal Medicine, senior vice president of the American College of Physicians, and an internist at Jefferson Medical College, all in Philadelphia. Darren B. Taichman, M.D., Ph.D., is executive deputy editor of the Annals and director of the medical ICU at the University of Pennsylvania Medical Center, Philadelphia. Cynthia Mulrow, M.D., is senior deputy editor of the Annals. These remarks were taken from their editorial accompanying the NICE guideline (Ann. Intern. Med. 2011;154:774-5). No potential conflicts of interest were disclosed.
Clinical guidelines should bring order to the dizzying array of diagnostic and therapeutic options facing physicians, but too often, the thousands of such guidelines published by "hundreds of groups in dozens of countries" instead can make the "chaos" even worse, according to Dr. Christine Laine, Dr. Darren B. Taichman, and Dr. Cynthia Mulrow.
The American College of Physicians has always presented summaries of the high-quality guidelines compiled by themselves and by the U.S. Preventive Services Task Force, and the organization now seeks "to publish thoughtful synopses of guidelines initially released in other venues but whose topics are highly relevant to the practice of internal medicine and its subspecialties.
"As the first example of this new venture," the ACP presents a synopsis of the NICE guideline for preventing delirium, because the methods for developing it came so close to meeting the Institute of Medicine’s "rigorous definition of trustworthy."
"We urge readers to gain familiarity with the IOM standards and consider them as they use guidelines to navigate the maze of available clinical choices," the editors noted.
Christine Laine, M.D., is editor in chief of the Annals of Internal Medicine, senior vice president of the American College of Physicians, and an internist at Jefferson Medical College, all in Philadelphia. Darren B. Taichman, M.D., Ph.D., is executive deputy editor of the Annals and director of the medical ICU at the University of Pennsylvania Medical Center, Philadelphia. Cynthia Mulrow, M.D., is senior deputy editor of the Annals. These remarks were taken from their editorial accompanying the NICE guideline (Ann. Intern. Med. 2011;154:774-5). No potential conflicts of interest were disclosed.
Delirium is common but underrecognized in hospitalized patients, "a neglected condition relative to its frequency and serious consequences," and approximately one-third of cases are preventable, according to a report in the June 7 Annals of Internal Medicine.
The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has released a new clinical guideline for preventing delirium, which lists 13 recommendations that "could probably be easily accommodated in current care without incurring high costs." On the contrary, preventing delirium in hospitalized patients is expected to markedly cut health care costs, as well as to improve quality-adjusted life-year gains, compared with usual care, said Rachel O’Mahony, Ph.D., of the National Clinical Guideline Centre at the Royal College of Physicians, London, and her associates.
A multidisciplinary group of experts, including physicians, psychiatrists, specialist nurses, a home care manager, and patient representatives, reviewed the literature to find which prevention strategies were effective to compile the guidelines.
No single intervention was identified that significantly reduced hospital stay, placement in long-term care facilities, mortality, or duration or severity of delirium. Instead, multicomponent interventions provided the strongest evidence of improving these factors.
The recommendations include:
- Avoid changes in patient surroundings to prevent confusion and disorientation. This includes avoiding unnecessary room changes as well as changes in the personnel who provide care.
"Several moves within an acute care hospital are now common ... [from] emergency department to assessment unit to acute care ward and sometimes to post-acute care ward.
"Moving could make it difficult for a sick person on the brink of a delirium episode to maintain his or her orientation and contact with reality," Dr. O’Mahony and her colleagues said (Ann. Intern. Med. 2011;154:746-51).
- Provide appropriate lighting, clear signage, an easily visible 24-hour clock (to distinguish day from night in rooms without windows), and a calendar to help patients stay oriented to time and place.
- Reorient patients by explaining where they are and what your role is.
- Provide cognitively stimulating activities, such as encouraging patients to reminisce and facilitating visits from family and friends.
- Address dehydration and constipation, with intravenous fluids, if necessary, and manage fluid balance in patients with relevant comorbidities such as heart failure or kidney disease.
- Assess for hypoxia and optimize oxygen saturation.
- Actively assess for infection and treat it; employ infection-control procedures; and avoid unnecessary catheterization.
The presence of a bladder catheter is a known risk factor for delirium, the researchers noted.
- Address immobility by encouraging patients to walk as soon as possible, providing appropriate walking aids and ensuring they are available at all times, and encouraging range-of-motion exercises.
- Assess for pain, attending to nonverbal signs of pain, and manage it.
Although some clinicians are leery of inducing confusion by providing painkillers, pain itself is an independent risk factor for delirium, the investigators said.
- Review both the type and the number of medications.
- Address poor nutrition, and make sure that dentures fit properly in patients who have them.
- Address sensory impairment and resolve any reversible causes such as impacted ear wax or need for visual or hearing aids. Ensure such aids are in good working order.
- Promote good sleep patterns by avoiding procedures and minimizing ambient noise during sleeping hours.
"Some of these components are provided to some patients some of the time, but prevention of delirium requires that we do all of these things all the time to all of the patients who are at risk," Dr. O’Mahony and her associates said.
"It makes sense" to target these interventions to patients at highest risk of developing delirium. There are four such easy-to-identify groups, each with a greater than fivefold increase in risk for delirium: patients aged 65 [years] and older, patients with preexisting cognitive impairment, patients with severe illness, and patients with hip fracture, they noted.
"This enhanced approach goes beyond well-trained and prepared staff. It requires a health care system ... that supports comprehensive and reliable delivery of specific tasks," they researchers added.
The guideline was supported by the National Clinical Guideline Centre at the Royal College of Physicians; the U.K. Cochrane Centre and KSG-Trans; and the Bradford Institute for Health Research. None of the authors reported having any relevant conflicts of interest.
The full version of the guideline, including details about the methods used in its development, is available online. A synopsis is available at Annals of Internal Medicine.
Delirium is common but underrecognized in hospitalized patients, "a neglected condition relative to its frequency and serious consequences," and approximately one-third of cases are preventable, according to a report in the June 7 Annals of Internal Medicine.
The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has released a new clinical guideline for preventing delirium, which lists 13 recommendations that "could probably be easily accommodated in current care without incurring high costs." On the contrary, preventing delirium in hospitalized patients is expected to markedly cut health care costs, as well as to improve quality-adjusted life-year gains, compared with usual care, said Rachel O’Mahony, Ph.D., of the National Clinical Guideline Centre at the Royal College of Physicians, London, and her associates.
A multidisciplinary group of experts, including physicians, psychiatrists, specialist nurses, a home care manager, and patient representatives, reviewed the literature to find which prevention strategies were effective to compile the guidelines.
No single intervention was identified that significantly reduced hospital stay, placement in long-term care facilities, mortality, or duration or severity of delirium. Instead, multicomponent interventions provided the strongest evidence of improving these factors.
The recommendations include:
- Avoid changes in patient surroundings to prevent confusion and disorientation. This includes avoiding unnecessary room changes as well as changes in the personnel who provide care.
"Several moves within an acute care hospital are now common ... [from] emergency department to assessment unit to acute care ward and sometimes to post-acute care ward.
"Moving could make it difficult for a sick person on the brink of a delirium episode to maintain his or her orientation and contact with reality," Dr. O’Mahony and her colleagues said (Ann. Intern. Med. 2011;154:746-51).
- Provide appropriate lighting, clear signage, an easily visible 24-hour clock (to distinguish day from night in rooms without windows), and a calendar to help patients stay oriented to time and place.
- Reorient patients by explaining where they are and what your role is.
- Provide cognitively stimulating activities, such as encouraging patients to reminisce and facilitating visits from family and friends.
- Address dehydration and constipation, with intravenous fluids, if necessary, and manage fluid balance in patients with relevant comorbidities such as heart failure or kidney disease.
- Assess for hypoxia and optimize oxygen saturation.
- Actively assess for infection and treat it; employ infection-control procedures; and avoid unnecessary catheterization.
The presence of a bladder catheter is a known risk factor for delirium, the researchers noted.
- Address immobility by encouraging patients to walk as soon as possible, providing appropriate walking aids and ensuring they are available at all times, and encouraging range-of-motion exercises.
- Assess for pain, attending to nonverbal signs of pain, and manage it.
Although some clinicians are leery of inducing confusion by providing painkillers, pain itself is an independent risk factor for delirium, the investigators said.
- Review both the type and the number of medications.
- Address poor nutrition, and make sure that dentures fit properly in patients who have them.
- Address sensory impairment and resolve any reversible causes such as impacted ear wax or need for visual or hearing aids. Ensure such aids are in good working order.
- Promote good sleep patterns by avoiding procedures and minimizing ambient noise during sleeping hours.
"Some of these components are provided to some patients some of the time, but prevention of delirium requires that we do all of these things all the time to all of the patients who are at risk," Dr. O’Mahony and her associates said.
"It makes sense" to target these interventions to patients at highest risk of developing delirium. There are four such easy-to-identify groups, each with a greater than fivefold increase in risk for delirium: patients aged 65 [years] and older, patients with preexisting cognitive impairment, patients with severe illness, and patients with hip fracture, they noted.
"This enhanced approach goes beyond well-trained and prepared staff. It requires a health care system ... that supports comprehensive and reliable delivery of specific tasks," they researchers added.
The guideline was supported by the National Clinical Guideline Centre at the Royal College of Physicians; the U.K. Cochrane Centre and KSG-Trans; and the Bradford Institute for Health Research. None of the authors reported having any relevant conflicts of interest.
The full version of the guideline, including details about the methods used in its development, is available online. A synopsis is available at Annals of Internal Medicine.
FROM THE ANNALS OF INTERNAL MEDICINE
Major Finding: Delirium is underrecognized and underdiagnosed in hospitalized patients and approximately one-third of cases could be prevented.
Data Source: A review of the literature and compilation of the most effective strategies for preventing delirium in hospitalized patients.
Disclosures: The guideline was supported by the National Clinical Guideline Centre at the Royal College of Physicians; the U. K. Cochrane Centre and KSG-Trans; and the Bradford Institute for Health Research. None of the authors reported having any relevant conflicts of interest.