Mary Ann Moon

Women who have migraine with aura in their middle years are more likely than others to show cerebellar “infarct-like lesions” on brain MRI in late life, according to a report in JAMA.

This link between migraine with aura and presumed occult stroke is independent of cardiovascular risk factors and CV disease history at either time period, said Ann I. Scher, Ph.D., of the Uniformed Services University, Bethesda, Md., and her associates.

These findings from a prospective longitudinal study are consistent with those of the recent cross-sectional CAMERA (Cerebral Abnormalities in Migraine, an Epidemiological Risk Analysis) study (JAMA 2004;291:427-34), “the only other study that measured infarcts on MRI, which also found the migraine-associated infarcts to be preferentially located in the cerebellum,” the investigators noted.

As such, they confirm the previous findings and point to the need for additional research with sequential MRIs “to better establish the temporality and dose-response relationship between migraine with aura and brain infarcts,” they added.

Several researchers cautioned, however, that without knowledge of the source or type of lesions that were seen and without any known clinical symptoms or consequences of the lesions, it is too early to say whether migraine has harmful effects on the brain.

Dr. Scher and her colleagues studied this issue using data from the Reykjavik Study, a population-based prospective assessment of cardiovascular disease in Iceland, which began in 1967. They examined data on a subset of 4,689 subjects who were middle-aged (average age, 51 years) at enrollment, when migraine data were collected, and were elderly (average age, 76 years) in 2002-2006 when brain MRI was performed.

There were 2,693 women and 1,996 men in this study. A total of 12% (6% of the men and 17% of the women) had migraine at midlife, including approximately 5% who had migraine without aura and approximately 8% who had migraine with aura.

“Infarct-like lesions” were significantly more prevalent in women who reported migraine with aura in midlife (31%) than in women who did not have migraine (25%), but no difference was found in prevalence among men.

Similarly, infarcts in the cerebellum, but not in cortical or subcortical locations, were more prevalent in women who reported migraine with aura in midlife (23%) than in women without headache (15%), but there was no difference in prevalence among men.

“However, we cannot rule out a possible increased risk for men [who have] migraine with aura, due to the relatively small number of [such] men in our sample,” the investigators noted (JAMA 2009;301:2563-70).

In an editorial comment accompanying this report, Dr. Tobias Kurth and Dr. Christophe Tzourio of the University Pierre et Marie Curie, Paris, said these findings should be interpreted with caution (JAMA 2009;301:2594-5).

“In the absence of the source and the nature of 'infarct-like lesions' and the absence of clinical symptoms or consequences, it is premature to conclude that migraine has hazardous effects on the brain,” they said.

“New studies examining the association of migraine with structural brain changes and brain function should improve understanding of the associations, and perhaps further unveil migraine-specific mechanisms,” Dr. Kurth and Dr. Tzourio said.

Dr. Scher has served on advisory boards of Endo Pharmaceuticals and OrthoMcNeil Neurologics.

Dr. Kurth reported receiving funding from McNeil Consumer & Specialty Pharmaceuticals, Merck, and Wyeth Consumer Healthcare; serving as a consultant to i3 Drug Safety and World Health Information Science Consultants; and receiving honoraria from Genzyme, Merck, and Pfizer.

Dr. Tzourio reported receiving fees from Sanofi-Synthelabo and Merck Sharpe & Dohme.

The study was funded by the National Institutes of Health and several individual NIH institutes, as well as Hjartavernd (the Icelandic Heart Association), the Althingi (the Icelandic Parliament), and the Migraine Research Foundation.

Women who have migraine with aura in their middle years are more likely than others to show cerebellar “infarct-like lesions” on brain MRI in late life, according to a report in JAMA.

This link between migraine with aura and presumed occult stroke is independent of cardiovascular risk factors and CV disease history at either time period, said Ann I. Scher, Ph.D., of the Uniformed Services University, Bethesda, Md., and her associates.

These findings from a prospective longitudinal study are consistent with those of the recent cross-sectional CAMERA (Cerebral Abnormalities in Migraine, an Epidemiological Risk Analysis) study (JAMA 2004;291:427-34), “the only other study that measured infarcts on MRI, which also found the migraine-associated infarcts to be preferentially located in the cerebellum,” the investigators noted.

As such, they confirm the previous findings and point to the need for additional research with sequential MRIs “to better establish the temporality and dose-response relationship between migraine with aura and brain infarcts,” they added.

Several researchers cautioned, however, that without knowledge of the source or type of lesions that were seen and without any known clinical symptoms or consequences of the lesions, it is too early to say whether migraine has harmful effects on the brain.

Dr. Scher and her colleagues studied this issue using data from the Reykjavik Study, a population-based prospective assessment of cardiovascular disease in Iceland, which began in 1967. They examined data on a subset of 4,689 subjects who were middle-aged (average age, 51 years) at enrollment, when migraine data were collected, and were elderly (average age, 76 years) in 2002-2006 when brain MRI was performed.

There were 2,693 women and 1,996 men in this study. A total of 12% (6% of the men and 17% of the women) had migraine at midlife, including approximately 5% who had migraine without aura and approximately 8% who had migraine with aura.

“Infarct-like lesions” were significantly more prevalent in women who reported migraine with aura in midlife (31%) than in women who did not have migraine (25%), but no difference was found in prevalence among men.

Similarly, infarcts in the cerebellum, but not in cortical or subcortical locations, were more prevalent in women who reported migraine with aura in midlife (23%) than in women without headache (15%), but there was no difference in prevalence among men.

“However, we cannot rule out a possible increased risk for men [who have] migraine with aura, due to the relatively small number of [such] men in our sample,” the investigators noted (JAMA 2009;301:2563-70).

In an editorial comment accompanying this report, Dr. Tobias Kurth and Dr. Christophe Tzourio of the University Pierre et Marie Curie, Paris, said these findings should be interpreted with caution (JAMA 2009;301:2594-5).

“In the absence of the source and the nature of 'infarct-like lesions' and the absence of clinical symptoms or consequences, it is premature to conclude that migraine has hazardous effects on the brain,” they said.

“New studies examining the association of migraine with structural brain changes and brain function should improve understanding of the associations, and perhaps further unveil migraine-specific mechanisms,” Dr. Kurth and Dr. Tzourio said.

Dr. Scher has served on advisory boards of Endo Pharmaceuticals and OrthoMcNeil Neurologics.

Dr. Kurth reported receiving funding from McNeil Consumer & Specialty Pharmaceuticals, Merck, and Wyeth Consumer Healthcare; serving as a consultant to i3 Drug Safety and World Health Information Science Consultants; and receiving honoraria from Genzyme, Merck, and Pfizer.

Dr. Tzourio reported receiving fees from Sanofi-Synthelabo and Merck Sharpe & Dohme.

The study was funded by the National Institutes of Health and several individual NIH institutes, as well as Hjartavernd (the Icelandic Heart Association), the Althingi (the Icelandic Parliament), and the Migraine Research Foundation.

Women who have migraine with aura in their middle years are more likely than others to show cerebellar “infarct-like lesions” on brain MRI in late life, according to a report in JAMA.

This link between migraine with aura and presumed occult stroke is independent of cardiovascular risk factors and CV disease history at either time period, said Ann I. Scher, Ph.D., of the Uniformed Services University, Bethesda, Md., and her associates.

These findings from a prospective longitudinal study are consistent with those of the recent cross-sectional CAMERA (Cerebral Abnormalities in Migraine, an Epidemiological Risk Analysis) study (JAMA 2004;291:427-34), “the only other study that measured infarcts on MRI, which also found the migraine-associated infarcts to be preferentially located in the cerebellum,” the investigators noted.

As such, they confirm the previous findings and point to the need for additional research with sequential MRIs “to better establish the temporality and dose-response relationship between migraine with aura and brain infarcts,” they added.

Several researchers cautioned, however, that without knowledge of the source or type of lesions that were seen and without any known clinical symptoms or consequences of the lesions, it is too early to say whether migraine has harmful effects on the brain.

Dr. Scher and her colleagues studied this issue using data from the Reykjavik Study, a population-based prospective assessment of cardiovascular disease in Iceland, which began in 1967. They examined data on a subset of 4,689 subjects who were middle-aged (average age, 51 years) at enrollment, when migraine data were collected, and were elderly (average age, 76 years) in 2002-2006 when brain MRI was performed.

There were 2,693 women and 1,996 men in this study. A total of 12% (6% of the men and 17% of the women) had migraine at midlife, including approximately 5% who had migraine without aura and approximately 8% who had migraine with aura.

“Infarct-like lesions” were significantly more prevalent in women who reported migraine with aura in midlife (31%) than in women who did not have migraine (25%), but no difference was found in prevalence among men.

Similarly, infarcts in the cerebellum, but not in cortical or subcortical locations, were more prevalent in women who reported migraine with aura in midlife (23%) than in women without headache (15%), but there was no difference in prevalence among men.

“However, we cannot rule out a possible increased risk for men [who have] migraine with aura, due to the relatively small number of [such] men in our sample,” the investigators noted (JAMA 2009;301:2563-70).

In an editorial comment accompanying this report, Dr. Tobias Kurth and Dr. Christophe Tzourio of the University Pierre et Marie Curie, Paris, said these findings should be interpreted with caution (JAMA 2009;301:2594-5).

“In the absence of the source and the nature of 'infarct-like lesions' and the absence of clinical symptoms or consequences, it is premature to conclude that migraine has hazardous effects on the brain,” they said.

“New studies examining the association of migraine with structural brain changes and brain function should improve understanding of the associations, and perhaps further unveil migraine-specific mechanisms,” Dr. Kurth and Dr. Tzourio said.

Dr. Scher has served on advisory boards of Endo Pharmaceuticals and OrthoMcNeil Neurologics.

Dr. Kurth reported receiving funding from McNeil Consumer & Specialty Pharmaceuticals, Merck, and Wyeth Consumer Healthcare; serving as a consultant to i3 Drug Safety and World Health Information Science Consultants; and receiving honoraria from Genzyme, Merck, and Pfizer.

Dr. Tzourio reported receiving fees from Sanofi-Synthelabo and Merck Sharpe & Dohme.

The study was funded by the National Institutes of Health and several individual NIH institutes, as well as Hjartavernd (the Icelandic Heart Association), the Althingi (the Icelandic Parliament), and the Migraine Research Foundation.

Implementing the Institute of Medicine's four main recommendations for taming excessive resident work hours would cost an estimated $1.6 billion each year just to substitute other providers to perform the residents' work, according to a report.

Alternatively, hiring enough additional residents to take up the slack—rather than distributing this work among nurses, physician assistants, attending physicians, and others—would cost an estimated $1.7 billion annually, according to Dr. Teryl K. Nuckols of the University of California, Los Angeles, and her associates.

The four key IOM recommendations are that residents work no more than 80 hours per week, be ensured of an uninterrupted 5-hour nap during extended (21-hour) shifts, work no more than 16 hours at a time without such a nap, and have a generally reduced workload.

For each major teaching hospital, costs would be an estimated $3.2 million every year for substitute providers or $990,000-$3.5 million every year for additional residents. This is more expensive than implementing other patient safety systems, including computerized physician order entry ($3.3 million to $11.8 million over a period of 10 years) and medication bar-coding systems ($2.2 million over a period of 5 years).

Even after monetary outlays of this magnitude, “it remains unknown whether implementing the IOM's recommendations would reduce preventable adverse events” because research has not yet demonstrated such an effect. A single randomized trial suggested that shorter work shifts could reduce residents' errors in the ICU by 25%, but such errors rarely cause patient injury, and the results could differ in other clinical settings, the researchers wrote.

Moreover, the additional patient-care handoffs necessitated by these changes could increase preventable adverse events, Dr. Nuckols and her colleagues wrote in their IOM-supported report.

They arrived at these conclusions after constructing a probability model based on estimated labor costs at 1,206 hospitals accredited by the Accreditation Council for Graduate Medical Education and estimated costs at major teaching hosptials. The model simulated hypothetical changes in preventable adverse events when residents' workweek, duration and frequency of extended shifts, and time on inpatient rotations vary.

The investigators found that if the recommended changes prove to be very effective at reducing medical errors, they would be cost-effective for society at large but very expensive for hospitals.

“Possible strategies that teaching hospitals could use to manage the additional costs include reducing residents' salaries, increasing the workload of faculty physicians without increasing compensation, increasing charges to patients, allowing profitability to decrease, reducing clinical services, allowing quality of care to decline, improving efficiency, and securing subsidies—or not implementing the recommendations,” Dr. Nuckols and her associates wrote.

To date, surveys of residents have found widespread nonadherence to the recommendations, which were implemented by ACGME in 2003 but are not enforced.

In an editorial, Dr. Melvin S. Blanchard and Dr. Kenneth S. Polonsky of Washington University, St. Louis, and Dr. David Meltzer of the University of Chicago urged that the IOM recommendations not be implemented yet.

“Such a major policy change should be based not only on the recommendations of an expert committee but also on careful studies and evidence that improvements in both patient and educational outcomes will result. To date, the necessary research has not been done and the evidence of benefit is lacking,” they noted.

Dr. Blanchard reported receiving grant support from Pfizer Inc. No other potential conflicts of interest were reported.

Implementing the Institute of Medicine's four main recommendations for taming excessive resident work hours would cost an estimated $1.6 billion each year just to substitute other providers to perform the residents' work, according to a report.

Alternatively, hiring enough additional residents to take up the slack—rather than distributing this work among nurses, physician assistants, attending physicians, and others—would cost an estimated $1.7 billion annually, according to Dr. Teryl K. Nuckols of the University of California, Los Angeles, and her associates.

The four key IOM recommendations are that residents work no more than 80 hours per week, be ensured of an uninterrupted 5-hour nap during extended (21-hour) shifts, work no more than 16 hours at a time without such a nap, and have a generally reduced workload.

For each major teaching hospital, costs would be an estimated $3.2 million every year for substitute providers or $990,000-$3.5 million every year for additional residents. This is more expensive than implementing other patient safety systems, including computerized physician order entry ($3.3 million to $11.8 million over a period of 10 years) and medication bar-coding systems ($2.2 million over a period of 5 years).

Even after monetary outlays of this magnitude, “it remains unknown whether implementing the IOM's recommendations would reduce preventable adverse events” because research has not yet demonstrated such an effect. A single randomized trial suggested that shorter work shifts could reduce residents' errors in the ICU by 25%, but such errors rarely cause patient injury, and the results could differ in other clinical settings, the researchers wrote.

Moreover, the additional patient-care handoffs necessitated by these changes could increase preventable adverse events, Dr. Nuckols and her colleagues wrote in their IOM-supported report.

They arrived at these conclusions after constructing a probability model based on estimated labor costs at 1,206 hospitals accredited by the Accreditation Council for Graduate Medical Education and estimated costs at major teaching hosptials. The model simulated hypothetical changes in preventable adverse events when residents' workweek, duration and frequency of extended shifts, and time on inpatient rotations vary.

The investigators found that if the recommended changes prove to be very effective at reducing medical errors, they would be cost-effective for society at large but very expensive for hospitals.

“Possible strategies that teaching hospitals could use to manage the additional costs include reducing residents' salaries, increasing the workload of faculty physicians without increasing compensation, increasing charges to patients, allowing profitability to decrease, reducing clinical services, allowing quality of care to decline, improving efficiency, and securing subsidies—or not implementing the recommendations,” Dr. Nuckols and her associates wrote.

To date, surveys of residents have found widespread nonadherence to the recommendations, which were implemented by ACGME in 2003 but are not enforced.

In an editorial, Dr. Melvin S. Blanchard and Dr. Kenneth S. Polonsky of Washington University, St. Louis, and Dr. David Meltzer of the University of Chicago urged that the IOM recommendations not be implemented yet.

“Such a major policy change should be based not only on the recommendations of an expert committee but also on careful studies and evidence that improvements in both patient and educational outcomes will result. To date, the necessary research has not been done and the evidence of benefit is lacking,” they noted.

Dr. Blanchard reported receiving grant support from Pfizer Inc. No other potential conflicts of interest were reported.

Implementing the Institute of Medicine's four main recommendations for taming excessive resident work hours would cost an estimated $1.6 billion each year just to substitute other providers to perform the residents' work, according to a report.

Alternatively, hiring enough additional residents to take up the slack—rather than distributing this work among nurses, physician assistants, attending physicians, and others—would cost an estimated $1.7 billion annually, according to Dr. Teryl K. Nuckols of the University of California, Los Angeles, and her associates.

The four key IOM recommendations are that residents work no more than 80 hours per week, be ensured of an uninterrupted 5-hour nap during extended (21-hour) shifts, work no more than 16 hours at a time without such a nap, and have a generally reduced workload.

For each major teaching hospital, costs would be an estimated $3.2 million every year for substitute providers or $990,000-$3.5 million every year for additional residents. This is more expensive than implementing other patient safety systems, including computerized physician order entry ($3.3 million to $11.8 million over a period of 10 years) and medication bar-coding systems ($2.2 million over a period of 5 years).

Even after monetary outlays of this magnitude, “it remains unknown whether implementing the IOM's recommendations would reduce preventable adverse events” because research has not yet demonstrated such an effect. A single randomized trial suggested that shorter work shifts could reduce residents' errors in the ICU by 25%, but such errors rarely cause patient injury, and the results could differ in other clinical settings, the researchers wrote.

Moreover, the additional patient-care handoffs necessitated by these changes could increase preventable adverse events, Dr. Nuckols and her colleagues wrote in their IOM-supported report.

They arrived at these conclusions after constructing a probability model based on estimated labor costs at 1,206 hospitals accredited by the Accreditation Council for Graduate Medical Education and estimated costs at major teaching hosptials. The model simulated hypothetical changes in preventable adverse events when residents' workweek, duration and frequency of extended shifts, and time on inpatient rotations vary.

The investigators found that if the recommended changes prove to be very effective at reducing medical errors, they would be cost-effective for society at large but very expensive for hospitals.

“Possible strategies that teaching hospitals could use to manage the additional costs include reducing residents' salaries, increasing the workload of faculty physicians without increasing compensation, increasing charges to patients, allowing profitability to decrease, reducing clinical services, allowing quality of care to decline, improving efficiency, and securing subsidies—or not implementing the recommendations,” Dr. Nuckols and her associates wrote.

To date, surveys of residents have found widespread nonadherence to the recommendations, which were implemented by ACGME in 2003 but are not enforced.

In an editorial, Dr. Melvin S. Blanchard and Dr. Kenneth S. Polonsky of Washington University, St. Louis, and Dr. David Meltzer of the University of Chicago urged that the IOM recommendations not be implemented yet.

“Such a major policy change should be based not only on the recommendations of an expert committee but also on careful studies and evidence that improvements in both patient and educational outcomes will result. To date, the necessary research has not been done and the evidence of benefit is lacking,” they noted.

Dr. Blanchard reported receiving grant support from Pfizer Inc. No other potential conflicts of interest were reported.

Optimized antidepressant therapy and pain self-management produced substantial and sustained improvements in patients with comorbid depression and chronic pain.

The program, which was assessed in a study of 250 patients, was implemented in two primary care clinic systems by a nurse care-manager supervised by a physician, reported Dr. Kurt Kroenke of the divisions of internal medicine and geriatrics, Indiana University, Indianapolis, and his associates (JAMA 2009;301:2099-110).

They conducted the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study to determine whether pharmacologic and behavioral treatments would prove synergistic in treating the comorbid conditions.

A total of 123 adults were randomly assigned to receive the study intervention: 3 months of optimized antidepressant therapy, followed by an additional 3 months of pain self-management instruction, followed by 6 months of relapse prevention. The antidepressants that were selected for the trial were venlafaxine (Effexor), fluoxetine, sertraline (Zoloft), citalopram (Celexa), bupropion, mirtazapine (Remeron), and nortriptyline (Aventyl). The authors noted that the trial “was not designed to test any particular antidepressant.” The remaining 127 subjects served as a control group, receiving usual care.

The pain self-management program included at least five in-person and eight telephone contacts during which patients learned about “chronic pain triggers and flare-ups; coping with fear and other negative emotions; and strategies for physical activity, muscle relaxation, deep breathing, distraction, sleep hygiene, and working with clinicians and employers” to manage their disability.

Compared with usual care, the intervention produced “substantial” (at least 50%) reduction in depression severity within 1 month, which was sustained throughout 1 year of follow-up.

The intervention also produced a 30% or greater reduction in pain, which was evident within 1 month of starting the program and was sustained for 1 year. The authors noted several limitations of the study: Generalizability was limited because the subjects were drawn from urban underserved and Veterans Affairs clinics, a lack of blinding, and discordance between patient self-report and electronic health record data.

The study was funded by the National Institute of Mental Health. Dr. Kroenke reported receiving research funding and/or honoraria from Eli Lilly (Aventyl, Prozac), Pfizer (Zoloft), Wyeth (Effexor), and Astra-Zeneca and Forest Laboratories (Celexa). Dr. Blair reported receiving one-time consultant fees from Wyeth, Abbott, and Cephalon. None of the other authors reported any financial disclosures.

Optimized antidepressant therapy and pain self-management produced substantial and sustained improvements in patients with comorbid depression and chronic pain.

The program, which was assessed in a study of 250 patients, was implemented in two primary care clinic systems by a nurse care-manager supervised by a physician, reported Dr. Kurt Kroenke of the divisions of internal medicine and geriatrics, Indiana University, Indianapolis, and his associates (JAMA 2009;301:2099-110).

They conducted the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study to determine whether pharmacologic and behavioral treatments would prove synergistic in treating the comorbid conditions.

A total of 123 adults were randomly assigned to receive the study intervention: 3 months of optimized antidepressant therapy, followed by an additional 3 months of pain self-management instruction, followed by 6 months of relapse prevention. The antidepressants that were selected for the trial were venlafaxine (Effexor), fluoxetine, sertraline (Zoloft), citalopram (Celexa), bupropion, mirtazapine (Remeron), and nortriptyline (Aventyl). The authors noted that the trial “was not designed to test any particular antidepressant.” The remaining 127 subjects served as a control group, receiving usual care.

The pain self-management program included at least five in-person and eight telephone contacts during which patients learned about “chronic pain triggers and flare-ups; coping with fear and other negative emotions; and strategies for physical activity, muscle relaxation, deep breathing, distraction, sleep hygiene, and working with clinicians and employers” to manage their disability.

Compared with usual care, the intervention produced “substantial” (at least 50%) reduction in depression severity within 1 month, which was sustained throughout 1 year of follow-up.

The intervention also produced a 30% or greater reduction in pain, which was evident within 1 month of starting the program and was sustained for 1 year. The authors noted several limitations of the study: Generalizability was limited because the subjects were drawn from urban underserved and Veterans Affairs clinics, a lack of blinding, and discordance between patient self-report and electronic health record data.

The study was funded by the National Institute of Mental Health. Dr. Kroenke reported receiving research funding and/or honoraria from Eli Lilly (Aventyl, Prozac), Pfizer (Zoloft), Wyeth (Effexor), and Astra-Zeneca and Forest Laboratories (Celexa). Dr. Blair reported receiving one-time consultant fees from Wyeth, Abbott, and Cephalon. None of the other authors reported any financial disclosures.

Optimized antidepressant therapy and pain self-management produced substantial and sustained improvements in patients with comorbid depression and chronic pain.

The program, which was assessed in a study of 250 patients, was implemented in two primary care clinic systems by a nurse care-manager supervised by a physician, reported Dr. Kurt Kroenke of the divisions of internal medicine and geriatrics, Indiana University, Indianapolis, and his associates (JAMA 2009;301:2099-110).

They conducted the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study to determine whether pharmacologic and behavioral treatments would prove synergistic in treating the comorbid conditions.

A total of 123 adults were randomly assigned to receive the study intervention: 3 months of optimized antidepressant therapy, followed by an additional 3 months of pain self-management instruction, followed by 6 months of relapse prevention. The antidepressants that were selected for the trial were venlafaxine (Effexor), fluoxetine, sertraline (Zoloft), citalopram (Celexa), bupropion, mirtazapine (Remeron), and nortriptyline (Aventyl). The authors noted that the trial “was not designed to test any particular antidepressant.” The remaining 127 subjects served as a control group, receiving usual care.

The pain self-management program included at least five in-person and eight telephone contacts during which patients learned about “chronic pain triggers and flare-ups; coping with fear and other negative emotions; and strategies for physical activity, muscle relaxation, deep breathing, distraction, sleep hygiene, and working with clinicians and employers” to manage their disability.

Compared with usual care, the intervention produced “substantial” (at least 50%) reduction in depression severity within 1 month, which was sustained throughout 1 year of follow-up.

The intervention also produced a 30% or greater reduction in pain, which was evident within 1 month of starting the program and was sustained for 1 year. The authors noted several limitations of the study: Generalizability was limited because the subjects were drawn from urban underserved and Veterans Affairs clinics, a lack of blinding, and discordance between patient self-report and electronic health record data.

The study was funded by the National Institute of Mental Health. Dr. Kroenke reported receiving research funding and/or honoraria from Eli Lilly (Aventyl, Prozac), Pfizer (Zoloft), Wyeth (Effexor), and Astra-Zeneca and Forest Laboratories (Celexa). Dr. Blair reported receiving one-time consultant fees from Wyeth, Abbott, and Cephalon. None of the other authors reported any financial disclosures.

Implementing the Institute of Medicine's four main recommendations for taming excessive resident work hours would cost an estimated $1.6 billion each year just to substitute other providers to perform the residents' work, according to a new report.

Alternatively, hiring enough additional residents to take up the slack—rather than distributing this work among nurses, physician assistants, attending physicians, and others—would cost an estimated $1.7 billion annually, according to Dr. Teryl K. Nuckols of the University of California, Los Angeles, and her associates.

The four key IOM recommendations are that residents work no more than 80 hours per week, be ensured of an uninterrupted 5-hour nap during extended (21-hour) shifts, work no more than 16 hours at a time without such a nap, and have a generally reduced workload.

For each major teaching hospital, costs would be an estimated $3.2 million every year for substitute providers or $990,000–$3.5 million every year for additional residents.

This is more expensive than implementing other patient safety systems, including computerized physician order entry ($3.3 million to $11.8 million over a period of 10 years) and medication bar-coding systems ($2.2 million over a period of 5 years).

Even after monetary outlays of this magnitude, "it remains unknown whether implementing the IOM's recommendations would reduce preventable adverse events" because research has not yet demonstrated such an effect. A single randomized trial suggested that shorter work shifts could reduce residents' errors in the ICU by 25%, but such errors rarely cause patient injury, and the results could differ in other clinical settings, the researchers wrote (N. Engl. J. Med. 2009;360;2202-15).

Moreover, the additional patient care handoffs necessitated by these changes could increase preventable adverse events, Dr. Nuckols and her colleagues wrote in their IOM-supported report.

They arrived at these conclusions after constructing a probability model based on estimated labor costs at 1,206 hospitals accredited by the Accreditation Council for Graduate Medical Education and estimated costs at major teaching hosptials. The model simulated hypothetical changes in preventable adverse events when residents' workweek, duration and frequency of extended shifts, and time on inpatient rotations vary.

The investigators found that if the recommended changes prove to be very effective at reducing medical errors, they would be cost effective for society at large but very expensive for hospitals.

"Possible strategies that teaching hospitals could use to manage the additional costs include reducing residents' salaries, increasing the workload of faculty physicians without increasing compensation, increasing charges to patients, allowing profitability to decrease, reducing clinical services, allowing quality of care to decline, improving efficiency, and securing subsidies—or not implementing the recommendations," Dr. Nuckols and her associates wrote.

To date, surveys of residents have found widespread nonadherence to the recommendations, which were implemented by ACGME in 2003 but are not enforced.

In an editorial comment accompanying this report, Dr. Melvin S. Blanchard and Dr. Kenneth S. Polonsky of Washington University, St. Louis, and Dr. David Meltzer of the University of Chicago urged that the IOM recommendations not be implemented at this time.

"Such a major policy change should be based not only on the recommendations of an expert committee but also on careful studies and evidence that improvements in both patient and educational outcomes will result. To date, the necessary research has not been done and the evidence of benefit is lacking," they noted (N. Engl. J. Med. 2009;360:2242-4).

Dr. Blanchard reported receiving grant support from Pfizer. No other potential conflicts of interest were reported.

Implementing the Institute of Medicine's four main recommendations for taming excessive resident work hours would cost an estimated $1.6 billion each year just to substitute other providers to perform the residents' work, according to a new report.

Alternatively, hiring enough additional residents to take up the slack—rather than distributing this work among nurses, physician assistants, attending physicians, and others—would cost an estimated $1.7 billion annually, according to Dr. Teryl K. Nuckols of the University of California, Los Angeles, and her associates.

The four key IOM recommendations are that residents work no more than 80 hours per week, be ensured of an uninterrupted 5-hour nap during extended (21-hour) shifts, work no more than 16 hours at a time without such a nap, and have a generally reduced workload.

For each major teaching hospital, costs would be an estimated $3.2 million every year for substitute providers or $990,000–$3.5 million every year for additional residents.

This is more expensive than implementing other patient safety systems, including computerized physician order entry ($3.3 million to $11.8 million over a period of 10 years) and medication bar-coding systems ($2.2 million over a period of 5 years).

Even after monetary outlays of this magnitude, "it remains unknown whether implementing the IOM's recommendations would reduce preventable adverse events" because research has not yet demonstrated such an effect. A single randomized trial suggested that shorter work shifts could reduce residents' errors in the ICU by 25%, but such errors rarely cause patient injury, and the results could differ in other clinical settings, the researchers wrote (N. Engl. J. Med. 2009;360;2202-15).

Moreover, the additional patient care handoffs necessitated by these changes could increase preventable adverse events, Dr. Nuckols and her colleagues wrote in their IOM-supported report.

They arrived at these conclusions after constructing a probability model based on estimated labor costs at 1,206 hospitals accredited by the Accreditation Council for Graduate Medical Education and estimated costs at major teaching hosptials. The model simulated hypothetical changes in preventable adverse events when residents' workweek, duration and frequency of extended shifts, and time on inpatient rotations vary.

The investigators found that if the recommended changes prove to be very effective at reducing medical errors, they would be cost effective for society at large but very expensive for hospitals.

"Possible strategies that teaching hospitals could use to manage the additional costs include reducing residents' salaries, increasing the workload of faculty physicians without increasing compensation, increasing charges to patients, allowing profitability to decrease, reducing clinical services, allowing quality of care to decline, improving efficiency, and securing subsidies—or not implementing the recommendations," Dr. Nuckols and her associates wrote.

To date, surveys of residents have found widespread nonadherence to the recommendations, which were implemented by ACGME in 2003 but are not enforced.

In an editorial comment accompanying this report, Dr. Melvin S. Blanchard and Dr. Kenneth S. Polonsky of Washington University, St. Louis, and Dr. David Meltzer of the University of Chicago urged that the IOM recommendations not be implemented at this time.

"Such a major policy change should be based not only on the recommendations of an expert committee but also on careful studies and evidence that improvements in both patient and educational outcomes will result. To date, the necessary research has not been done and the evidence of benefit is lacking," they noted (N. Engl. J. Med. 2009;360:2242-4).

Dr. Blanchard reported receiving grant support from Pfizer. No other potential conflicts of interest were reported.

Implementing the Institute of Medicine's four main recommendations for taming excessive resident work hours would cost an estimated $1.6 billion each year just to substitute other providers to perform the residents' work, according to a new report.

Alternatively, hiring enough additional residents to take up the slack—rather than distributing this work among nurses, physician assistants, attending physicians, and others—would cost an estimated $1.7 billion annually, according to Dr. Teryl K. Nuckols of the University of California, Los Angeles, and her associates.

The four key IOM recommendations are that residents work no more than 80 hours per week, be ensured of an uninterrupted 5-hour nap during extended (21-hour) shifts, work no more than 16 hours at a time without such a nap, and have a generally reduced workload.

For each major teaching hospital, costs would be an estimated $3.2 million every year for substitute providers or $990,000–$3.5 million every year for additional residents.

This is more expensive than implementing other patient safety systems, including computerized physician order entry ($3.3 million to $11.8 million over a period of 10 years) and medication bar-coding systems ($2.2 million over a period of 5 years).

Even after monetary outlays of this magnitude, "it remains unknown whether implementing the IOM's recommendations would reduce preventable adverse events" because research has not yet demonstrated such an effect. A single randomized trial suggested that shorter work shifts could reduce residents' errors in the ICU by 25%, but such errors rarely cause patient injury, and the results could differ in other clinical settings, the researchers wrote (N. Engl. J. Med. 2009;360;2202-15).

Moreover, the additional patient care handoffs necessitated by these changes could increase preventable adverse events, Dr. Nuckols and her colleagues wrote in their IOM-supported report.

They arrived at these conclusions after constructing a probability model based on estimated labor costs at 1,206 hospitals accredited by the Accreditation Council for Graduate Medical Education and estimated costs at major teaching hosptials. The model simulated hypothetical changes in preventable adverse events when residents' workweek, duration and frequency of extended shifts, and time on inpatient rotations vary.

The investigators found that if the recommended changes prove to be very effective at reducing medical errors, they would be cost effective for society at large but very expensive for hospitals.

"Possible strategies that teaching hospitals could use to manage the additional costs include reducing residents' salaries, increasing the workload of faculty physicians without increasing compensation, increasing charges to patients, allowing profitability to decrease, reducing clinical services, allowing quality of care to decline, improving efficiency, and securing subsidies—or not implementing the recommendations," Dr. Nuckols and her associates wrote.

To date, surveys of residents have found widespread nonadherence to the recommendations, which were implemented by ACGME in 2003 but are not enforced.

In an editorial comment accompanying this report, Dr. Melvin S. Blanchard and Dr. Kenneth S. Polonsky of Washington University, St. Louis, and Dr. David Meltzer of the University of Chicago urged that the IOM recommendations not be implemented at this time.

"Such a major policy change should be based not only on the recommendations of an expert committee but also on careful studies and evidence that improvements in both patient and educational outcomes will result. To date, the necessary research has not been done and the evidence of benefit is lacking," they noted (N. Engl. J. Med. 2009;360:2242-4).

Dr. Blanchard reported receiving grant support from Pfizer. No other potential conflicts of interest were reported.

Retail clinics tend to be located in "advantaged" neighborhoods rather than in the medically underserved areas that they are purported to serve, according to researchers.

In a study that matched the geographic locations of 930 retail clinics across the country with census data on the populations living in those locations, 123 clinics (13%) were found to be situated in underserved areas, according to Dr. Craig Evan Pollack and Dr. Katrina Armstrong of the University of Pennsylvania, Philadelphia.

Proponents of retail clinics contend that these venues can increase access to care, particularly for the uninsured, and can serve as an entry point into the health care system. "A recent report … states that the placement of the clinics is determined in part by 'physician shortages and higher uninsured populations,'" the researchers noted.

But their analysis showed that these clinics are much more likely to be located in census tracts characterized by high incomes and low levels of poverty; high percentages of white residents and low percentages of black and Hispanic residents; and higher rates of home ownership and fewer rental units.

This disparity is not due to the "advantaged" location of the chain stores that house these clinics. Nearly one-third of such chain stores are located in medically underserved areas, but these are not the locations where the retail clinics are placed. Moreover, counties in which there were retail clinics had the same number of per capita hospital beds (approximately 2.3 per 1,000 residents) and the same number of general practitioners (2.8 per 10,000 residents) as did counties in which there were no retail clinics.

And despite the known shortage of physicians in rural areas, 96% of the counties in which retail clinics are located are classified as metropolitan, the researchers said (Arch. Intern. Med. 2009;169:945-9).

"If retail clinics are determined to be a valuable and effective source of care, rethinking the distribution of these clinics may be an important avenue for improving their potential societal benefit," they noted.

The investigators cautioned that their study was limited by its area-level assessment, which could not examine the clients who attend retail clinics nor measure other aspects of accessibility.

The Robert Wood Johnson Foundation provided the funding for this study.

In an invited commentary, Dr. Mark D. Smith of the California Healthcare Foundation, Oakland, and his colleague, Margaret A. Laws, noted that retail clinic operators generally do not portray their services as comprehensive care, nor do they claim to focus on underserved populations (Arch. Intern. Med. 2009;169:951-3).

"The major operators have positioned their offerings as meeting mainstream customer needs for convenient, timely access to basic care for a subset of needs rather than as an alternative to comprehensive primary care," they wrote, noting that "most consumers do not have access to basic, acute care after hours and on weekends." Consumers, therefore, have turned to retail clinics to meet these needs.

'Rethinking the distribution of these clinics may be an important avenue for improving their … societal benefit.' DR. ARMSTRONG

Retail clinics tend to be located in "advantaged" neighborhoods rather than in the medically underserved areas that they are purported to serve, according to researchers.

In a study that matched the geographic locations of 930 retail clinics across the country with census data on the populations living in those locations, 123 clinics (13%) were found to be situated in underserved areas, according to Dr. Craig Evan Pollack and Dr. Katrina Armstrong of the University of Pennsylvania, Philadelphia.

Proponents of retail clinics contend that these venues can increase access to care, particularly for the uninsured, and can serve as an entry point into the health care system. "A recent report … states that the placement of the clinics is determined in part by 'physician shortages and higher uninsured populations,'" the researchers noted.

But their analysis showed that these clinics are much more likely to be located in census tracts characterized by high incomes and low levels of poverty; high percentages of white residents and low percentages of black and Hispanic residents; and higher rates of home ownership and fewer rental units.

This disparity is not due to the "advantaged" location of the chain stores that house these clinics. Nearly one-third of such chain stores are located in medically underserved areas, but these are not the locations where the retail clinics are placed. Moreover, counties in which there were retail clinics had the same number of per capita hospital beds (approximately 2.3 per 1,000 residents) and the same number of general practitioners (2.8 per 10,000 residents) as did counties in which there were no retail clinics.

And despite the known shortage of physicians in rural areas, 96% of the counties in which retail clinics are located are classified as metropolitan, the researchers said (Arch. Intern. Med. 2009;169:945-9).

"If retail clinics are determined to be a valuable and effective source of care, rethinking the distribution of these clinics may be an important avenue for improving their potential societal benefit," they noted.

The investigators cautioned that their study was limited by its area-level assessment, which could not examine the clients who attend retail clinics nor measure other aspects of accessibility.

The Robert Wood Johnson Foundation provided the funding for this study.

In an invited commentary, Dr. Mark D. Smith of the California Healthcare Foundation, Oakland, and his colleague, Margaret A. Laws, noted that retail clinic operators generally do not portray their services as comprehensive care, nor do they claim to focus on underserved populations (Arch. Intern. Med. 2009;169:951-3).

"The major operators have positioned their offerings as meeting mainstream customer needs for convenient, timely access to basic care for a subset of needs rather than as an alternative to comprehensive primary care," they wrote, noting that "most consumers do not have access to basic, acute care after hours and on weekends." Consumers, therefore, have turned to retail clinics to meet these needs.

'Rethinking the distribution of these clinics may be an important avenue for improving their … societal benefit.' DR. ARMSTRONG

Retail clinics tend to be located in "advantaged" neighborhoods rather than in the medically underserved areas that they are purported to serve, according to researchers.

In a study that matched the geographic locations of 930 retail clinics across the country with census data on the populations living in those locations, 123 clinics (13%) were found to be situated in underserved areas, according to Dr. Craig Evan Pollack and Dr. Katrina Armstrong of the University of Pennsylvania, Philadelphia.

Proponents of retail clinics contend that these venues can increase access to care, particularly for the uninsured, and can serve as an entry point into the health care system. "A recent report … states that the placement of the clinics is determined in part by 'physician shortages and higher uninsured populations,'" the researchers noted.

But their analysis showed that these clinics are much more likely to be located in census tracts characterized by high incomes and low levels of poverty; high percentages of white residents and low percentages of black and Hispanic residents; and higher rates of home ownership and fewer rental units.

This disparity is not due to the "advantaged" location of the chain stores that house these clinics. Nearly one-third of such chain stores are located in medically underserved areas, but these are not the locations where the retail clinics are placed. Moreover, counties in which there were retail clinics had the same number of per capita hospital beds (approximately 2.3 per 1,000 residents) and the same number of general practitioners (2.8 per 10,000 residents) as did counties in which there were no retail clinics.

And despite the known shortage of physicians in rural areas, 96% of the counties in which retail clinics are located are classified as metropolitan, the researchers said (Arch. Intern. Med. 2009;169:945-9).

"If retail clinics are determined to be a valuable and effective source of care, rethinking the distribution of these clinics may be an important avenue for improving their potential societal benefit," they noted.

The investigators cautioned that their study was limited by its area-level assessment, which could not examine the clients who attend retail clinics nor measure other aspects of accessibility.

The Robert Wood Johnson Foundation provided the funding for this study.

In an invited commentary, Dr. Mark D. Smith of the California Healthcare Foundation, Oakland, and his colleague, Margaret A. Laws, noted that retail clinic operators generally do not portray their services as comprehensive care, nor do they claim to focus on underserved populations (Arch. Intern. Med. 2009;169:951-3).

"The major operators have positioned their offerings as meeting mainstream customer needs for convenient, timely access to basic care for a subset of needs rather than as an alternative to comprehensive primary care," they wrote, noting that "most consumers do not have access to basic, acute care after hours and on weekends." Consumers, therefore, have turned to retail clinics to meet these needs.

'Rethinking the distribution of these clinics may be an important avenue for improving their … societal benefit.' DR. ARMSTRONG

People with psoriasis are at higher risk than others for a full range of atherosclerotic diseases, not just cardiovascular but also cerebrovascular and peripheral vascular diseases, according to a new report.

The magnitude of risk appears to be similar to that of other well-established cardiovascular risk factors such as dyslipidemia, smoking, hypertension, and diabetes, said Dr. Srjdan Prodanovich of the departments of dermatology and cutaneous surgery at the University of Miami and associates. In recent years, psoriasis has been linked to myocardial infarction. Dr. Prodanovich and colleagues investigated whether the inflammatory skin disease could be associated with other manifestations of atherosclerosis as well.

They assessed the prevalences of ischemic heart disease, cerebral vascular disease, and peripheral arterial disease in 3,236 patients with psoriasis and 2,500 nonpsoriatic control patients treated at the Miami VA Medical Center between 1985 and 2006.

After controlling for subject age, sex, and history of hypertension, diabetes, dyslipidemia, and smoking status, the researchers found that patients with psoriasis were approximately twice as likely as controls to have any of these types of vascular disease.

This finding “has tremendous and far-reaching clinical implications, as all of these vascular conditions represent a major financial cost to the health care system as well as a major cause of disability and death,” they noted (Arch. Dermatol. 2009; 145:700-3).

Psoriasis was also found to be an independent risk factor for death. Mortality was nearly 20% among patients with psoriasis, compared with 10% among patients in the control group.

Because this was an observational study, it could not be determined whether psoriasis and its attendant inflammation caused the atherosclerosis. Also unknown is whether aggressive treatment of either cardiovascular risk factors or psoriasis will improve patients' total atherosclerotic burden.

For the present, “we recommend that health care providers who are caring for patients with psoriasis be vigilant with respect to traditional [cardiovascular] risk factor screening.

“Many of these patients are cared for solely by dermatologists. It would be prudent for dermatologists to be familiar with suggested screening for cardiovascular risk factors and recommendations for aspirin use. If not, it is imperative that they work in collaboration with a primary care provider or another internal medicine specialist,” Dr. Prodanovich and associates said.

“Clinicians caring for patients with this skin disorder should use a lower threshold when considering testing for peripheral arterial disease, carotid disease, or coronary artery disease in those with typical or atypical symptoms,” they added.

The investigators reported no financial conflicts of interest.

People with psoriasis are at higher risk than others for a full range of atherosclerotic diseases, not just cardiovascular but also cerebrovascular and peripheral vascular diseases, according to a new report.

The magnitude of risk appears to be similar to that of other well-established cardiovascular risk factors such as dyslipidemia, smoking, hypertension, and diabetes, said Dr. Srjdan Prodanovich of the departments of dermatology and cutaneous surgery at the University of Miami and associates. In recent years, psoriasis has been linked to myocardial infarction. Dr. Prodanovich and colleagues investigated whether the inflammatory skin disease could be associated with other manifestations of atherosclerosis as well.

They assessed the prevalences of ischemic heart disease, cerebral vascular disease, and peripheral arterial disease in 3,236 patients with psoriasis and 2,500 nonpsoriatic control patients treated at the Miami VA Medical Center between 1985 and 2006.

After controlling for subject age, sex, and history of hypertension, diabetes, dyslipidemia, and smoking status, the researchers found that patients with psoriasis were approximately twice as likely as controls to have any of these types of vascular disease.

This finding “has tremendous and far-reaching clinical implications, as all of these vascular conditions represent a major financial cost to the health care system as well as a major cause of disability and death,” they noted (Arch. Dermatol. 2009; 145:700-3).

Psoriasis was also found to be an independent risk factor for death. Mortality was nearly 20% among patients with psoriasis, compared with 10% among patients in the control group.

Because this was an observational study, it could not be determined whether psoriasis and its attendant inflammation caused the atherosclerosis. Also unknown is whether aggressive treatment of either cardiovascular risk factors or psoriasis will improve patients' total atherosclerotic burden.

For the present, “we recommend that health care providers who are caring for patients with psoriasis be vigilant with respect to traditional [cardiovascular] risk factor screening.

“Many of these patients are cared for solely by dermatologists. It would be prudent for dermatologists to be familiar with suggested screening for cardiovascular risk factors and recommendations for aspirin use. If not, it is imperative that they work in collaboration with a primary care provider or another internal medicine specialist,” Dr. Prodanovich and associates said.

“Clinicians caring for patients with this skin disorder should use a lower threshold when considering testing for peripheral arterial disease, carotid disease, or coronary artery disease in those with typical or atypical symptoms,” they added.

The investigators reported no financial conflicts of interest.

People with psoriasis are at higher risk than others for a full range of atherosclerotic diseases, not just cardiovascular but also cerebrovascular and peripheral vascular diseases, according to a new report.

The magnitude of risk appears to be similar to that of other well-established cardiovascular risk factors such as dyslipidemia, smoking, hypertension, and diabetes, said Dr. Srjdan Prodanovich of the departments of dermatology and cutaneous surgery at the University of Miami and associates. In recent years, psoriasis has been linked to myocardial infarction. Dr. Prodanovich and colleagues investigated whether the inflammatory skin disease could be associated with other manifestations of atherosclerosis as well.

They assessed the prevalences of ischemic heart disease, cerebral vascular disease, and peripheral arterial disease in 3,236 patients with psoriasis and 2,500 nonpsoriatic control patients treated at the Miami VA Medical Center between 1985 and 2006.

After controlling for subject age, sex, and history of hypertension, diabetes, dyslipidemia, and smoking status, the researchers found that patients with psoriasis were approximately twice as likely as controls to have any of these types of vascular disease.

This finding “has tremendous and far-reaching clinical implications, as all of these vascular conditions represent a major financial cost to the health care system as well as a major cause of disability and death,” they noted (Arch. Dermatol. 2009; 145:700-3).

Psoriasis was also found to be an independent risk factor for death. Mortality was nearly 20% among patients with psoriasis, compared with 10% among patients in the control group.

Because this was an observational study, it could not be determined whether psoriasis and its attendant inflammation caused the atherosclerosis. Also unknown is whether aggressive treatment of either cardiovascular risk factors or psoriasis will improve patients' total atherosclerotic burden.

For the present, “we recommend that health care providers who are caring for patients with psoriasis be vigilant with respect to traditional [cardiovascular] risk factor screening.

“Many of these patients are cared for solely by dermatologists. It would be prudent for dermatologists to be familiar with suggested screening for cardiovascular risk factors and recommendations for aspirin use. If not, it is imperative that they work in collaboration with a primary care provider or another internal medicine specialist,” Dr. Prodanovich and associates said.

“Clinicians caring for patients with this skin disorder should use a lower threshold when considering testing for peripheral arterial disease, carotid disease, or coronary artery disease in those with typical or atypical symptoms,” they added.

The investigators reported no financial conflicts of interest.

Retail clinics tend to be located in “advantaged” neighborhoods rather than in the medically underserved areas that they are purported to serve, according to researchers.

In a study that matched the geographic locations of 930 retail clinics across the country with census data on the populations living in those locations, 123 clinics (13%) were found to be situated in underserved areas, according to Dr. Craig Evan Pollack and Dr. Katrina Armstrong of the University of Pennsylvania, Philadelphia.

Proponents of retail clinics contend that these venues can increase access to care, particularly for the uninsured, and can serve as an entry point into the health care system for those who do not have a primary care provider.

“A recent report … states that the placement of the clinics is determined in part by 'physician shortages and higher uninsured populations,'” Dr. Pollack and Dr. Armstrong noted.

But their analysis showed that these clinics are much more likely to be located in census tracts characterized by high incomes and low levels of poverty; high percentages of white residents and low percentages of black and Hispanic residents; and higher rates of home ownership and fewer rental units.

This disparity is not due to the “advantaged” location of the chain stores that house these clinics. Nearly one-third of such chain stores are located in medically underserved areas, but these are not the locations where the retail clinics are placed.

Moreover, counties in which there were retail clinics had the same number of per capita hospital beds (approximately 2.3 per 1,000 residents) and the same number of general practitioners (2.8 per 10,000 residents) as did counties in which there were no retail clinics.

And despite the known shortage of physicians in rural areas, 96% of the counties in which retail clinics are located are classified as metropolitan, the researchers said (Arch. Intern. Med. 2009;169:945–9).

“If retail clinics are determined to be a valuable and effective source of care, rethinking the distribution of these clinics may be an important avenue for improving their potential societal benefit,” they noted.

The investigators cautioned that their study was limited by its area-level assessment, which could not examine the individual clients who attend retail clinics nor measure other aspects of accessibility such as hours of operation or available public transportation.

The funding for this study was provided by the Robert Wood Johnson Foundation.

In an invited commentary, Dr. Mark D. Smith of the California Healthcare Foundation in Oakland, and his colleague, Margaret A. Laws, noted that retail clinic operators generally do not portray their services as comprehensive primary care, nor do they claim to focus on underserved populations (Arch. Intern. Med. 2009;169:951–3).

“The major operators have positioned their offerings as meeting mainstream customer needs for convenient, timely access to basic care for a subset of needs rather than as an alternative to comprehensive primary care,” they wrote, noting that “most consumers do not have access to basic, acute care after hours and on weekends through their regular providers.” Consumers, therefore, have turned to retail clinics to meet these needs.

'Rethinking the distribution of these clinics may be an important avenue for improving their … societal benefit.' DR. ARMSTRONG

Retail clinics tend to be located in “advantaged” neighborhoods rather than in the medically underserved areas that they are purported to serve, according to researchers.

In a study that matched the geographic locations of 930 retail clinics across the country with census data on the populations living in those locations, 123 clinics (13%) were found to be situated in underserved areas, according to Dr. Craig Evan Pollack and Dr. Katrina Armstrong of the University of Pennsylvania, Philadelphia.

Proponents of retail clinics contend that these venues can increase access to care, particularly for the uninsured, and can serve as an entry point into the health care system for those who do not have a primary care provider.

“A recent report … states that the placement of the clinics is determined in part by 'physician shortages and higher uninsured populations,'” Dr. Pollack and Dr. Armstrong noted.

But their analysis showed that these clinics are much more likely to be located in census tracts characterized by high incomes and low levels of poverty; high percentages of white residents and low percentages of black and Hispanic residents; and higher rates of home ownership and fewer rental units.

This disparity is not due to the “advantaged” location of the chain stores that house these clinics. Nearly one-third of such chain stores are located in medically underserved areas, but these are not the locations where the retail clinics are placed.

Moreover, counties in which there were retail clinics had the same number of per capita hospital beds (approximately 2.3 per 1,000 residents) and the same number of general practitioners (2.8 per 10,000 residents) as did counties in which there were no retail clinics.

And despite the known shortage of physicians in rural areas, 96% of the counties in which retail clinics are located are classified as metropolitan, the researchers said (Arch. Intern. Med. 2009;169:945–9).

“If retail clinics are determined to be a valuable and effective source of care, rethinking the distribution of these clinics may be an important avenue for improving their potential societal benefit,” they noted.

The investigators cautioned that their study was limited by its area-level assessment, which could not examine the individual clients who attend retail clinics nor measure other aspects of accessibility such as hours of operation or available public transportation.

The funding for this study was provided by the Robert Wood Johnson Foundation.

In an invited commentary, Dr. Mark D. Smith of the California Healthcare Foundation in Oakland, and his colleague, Margaret A. Laws, noted that retail clinic operators generally do not portray their services as comprehensive primary care, nor do they claim to focus on underserved populations (Arch. Intern. Med. 2009;169:951–3).

“The major operators have positioned their offerings as meeting mainstream customer needs for convenient, timely access to basic care for a subset of needs rather than as an alternative to comprehensive primary care,” they wrote, noting that “most consumers do not have access to basic, acute care after hours and on weekends through their regular providers.” Consumers, therefore, have turned to retail clinics to meet these needs.

'Rethinking the distribution of these clinics may be an important avenue for improving their … societal benefit.' DR. ARMSTRONG

Retail clinics tend to be located in “advantaged” neighborhoods rather than in the medically underserved areas that they are purported to serve, according to researchers.

In a study that matched the geographic locations of 930 retail clinics across the country with census data on the populations living in those locations, 123 clinics (13%) were found to be situated in underserved areas, according to Dr. Craig Evan Pollack and Dr. Katrina Armstrong of the University of Pennsylvania, Philadelphia.

Proponents of retail clinics contend that these venues can increase access to care, particularly for the uninsured, and can serve as an entry point into the health care system for those who do not have a primary care provider.

“A recent report … states that the placement of the clinics is determined in part by 'physician shortages and higher uninsured populations,'” Dr. Pollack and Dr. Armstrong noted.

But their analysis showed that these clinics are much more likely to be located in census tracts characterized by high incomes and low levels of poverty; high percentages of white residents and low percentages of black and Hispanic residents; and higher rates of home ownership and fewer rental units.

This disparity is not due to the “advantaged” location of the chain stores that house these clinics. Nearly one-third of such chain stores are located in medically underserved areas, but these are not the locations where the retail clinics are placed.

Moreover, counties in which there were retail clinics had the same number of per capita hospital beds (approximately 2.3 per 1,000 residents) and the same number of general practitioners (2.8 per 10,000 residents) as did counties in which there were no retail clinics.

And despite the known shortage of physicians in rural areas, 96% of the counties in which retail clinics are located are classified as metropolitan, the researchers said (Arch. Intern. Med. 2009;169:945–9).

“If retail clinics are determined to be a valuable and effective source of care, rethinking the distribution of these clinics may be an important avenue for improving their potential societal benefit,” they noted.

The investigators cautioned that their study was limited by its area-level assessment, which could not examine the individual clients who attend retail clinics nor measure other aspects of accessibility such as hours of operation or available public transportation.

The funding for this study was provided by the Robert Wood Johnson Foundation.

In an invited commentary, Dr. Mark D. Smith of the California Healthcare Foundation in Oakland, and his colleague, Margaret A. Laws, noted that retail clinic operators generally do not portray their services as comprehensive primary care, nor do they claim to focus on underserved populations (Arch. Intern. Med. 2009;169:951–3).

“The major operators have positioned their offerings as meeting mainstream customer needs for convenient, timely access to basic care for a subset of needs rather than as an alternative to comprehensive primary care,” they wrote, noting that “most consumers do not have access to basic, acute care after hours and on weekends through their regular providers.” Consumers, therefore, have turned to retail clinics to meet these needs.

'Rethinking the distribution of these clinics may be an important avenue for improving their … societal benefit.' DR. ARMSTRONG

An estimated 35% of Americans aged 40 and older have objective evidence of vestibular dysfunction, according to a recent report.

If further research bears out this finding from this study, it means that approximately 69 million adults in the United States are affected, said Dr. Yuri Agrawal and his associates in the department of otolaryngology-head and neck surgery at Johns Hopkins University School of Medicine, Baltimore.

The investigators assessed the epidemiology of vestibular dysfunction, because little has been published about the issue, even though both the incidence and prevalence of fall-induced injuries has risen significantly over the past 25 years. They used data from two 2-year cycles of data from the National Health and Nutrition Examination Survey between 2001 and 2004 to estimate the prevalence of the disorder.

A total of 5,086 NHANES subjects underwent balance testing using a modified Romberg Test of Standing Balance on Firm and Compliant Support Surfaces, which assessed their ability to stand unassisted under four test conditions. One of the conditions—standing on a foam-padded surface that obscured proprioceptive input while closing their eyes to eliminate visual input—exclusively measured vestibular function.

The overall prevalence of the disorder was 35.4%, which corresponds to 69 million Americans aged 40 and older. This prevalence increased markedly with age (from 18.5% for those in their 40s to 85% in those aged 80 and older). The prevalence did not differ significantly between men and women (34% vs. 35%).

“We found that participants with vestibular dysfunction had a significantly increased odds of hearing loss, compared with participants without vestibular dysfunction,” Dr. Agrawal and his associates said (Arch. Intern. Med. 2009;169:938–44).

This shared susceptibility “likely reflects the common anatomic location of the vestibular and hearing organs, as well as a common blood supply, making both systems potentially vulnerable to the same degenerative, ischemic, traumatic, or toxic insults,” they noted.

Similarly, there was a significant association between vestibular dysfunction and a history of dizziness and falling.

A total of 536 study subjects reported dizziness and were found to have vestibular dysfunction. These participants were 12 times more likely to report having fallen as were subjects who had no dizziness and no vestibular dysfunction.

There were many subjects who reported no dizziness but were found to have vestibular dysfunction upon testing, however. These subjects also were at significantly increased risk for falling, with an odds ratio of 6.3, the researchers said.

The prevalence of vestibular dysfunction did not differ among non-Hispanic whites (34.7%), non-Hispanic blacks (35.5%), and Mexican-Americans (34.3%). It was significantly higher, however, in study participants categorized as “other” races or ethnicities (42.4%). “Perhaps genetic factors play a role, and indeed, several genes have been implicated in the pathophysiologic mechanism of one particular vestibulopathy, Meniere disease,” the researchers wrote.

Alternatively, subjects who had higher levels of education showed a markedly lower prevalence of vestibular dysfunction than those with less education, ranging from 51% in those with less than a high school education to 29% in those with greater than a high school eductation. This striking protective effect that has been noted in previous studies. “Incomplete adjustment for risk factors such as hypertension and diabetes may explain these socioeconomic and ethnic disparities,” Dr. Agrawal and his colleagues said.

Given this high prevalence in the general population, “screening for vestibular dysfunction … could be a life-saving and cost-effective practice,” particularly in high-risk groups such as the very old, people with hearing impairment, ethnic and racial minorities, and people with less than a high-school education. Those who are identified as having the disorder may benefit from vestibular physical therapy to improve balance control and prevent falls, they added.

An estimated 35% of Americans aged 40 and older have objective evidence of vestibular dysfunction, according to a recent report.

If further research bears out this finding from this study, it means that approximately 69 million adults in the United States are affected, said Dr. Yuri Agrawal and his associates in the department of otolaryngology-head and neck surgery at Johns Hopkins University School of Medicine, Baltimore.

The investigators assessed the epidemiology of vestibular dysfunction, because little has been published about the issue, even though both the incidence and prevalence of fall-induced injuries has risen significantly over the past 25 years. They used data from two 2-year cycles of data from the National Health and Nutrition Examination Survey between 2001 and 2004 to estimate the prevalence of the disorder.

A total of 5,086 NHANES subjects underwent balance testing using a modified Romberg Test of Standing Balance on Firm and Compliant Support Surfaces, which assessed their ability to stand unassisted under four test conditions. One of the conditions—standing on a foam-padded surface that obscured proprioceptive input while closing their eyes to eliminate visual input—exclusively measured vestibular function.

The overall prevalence of the disorder was 35.4%, which corresponds to 69 million Americans aged 40 and older. This prevalence increased markedly with age (from 18.5% for those in their 40s to 85% in those aged 80 and older). The prevalence did not differ significantly between men and women (34% vs. 35%).

“We found that participants with vestibular dysfunction had a significantly increased odds of hearing loss, compared with participants without vestibular dysfunction,” Dr. Agrawal and his associates said (Arch. Intern. Med. 2009;169:938–44).

This shared susceptibility “likely reflects the common anatomic location of the vestibular and hearing organs, as well as a common blood supply, making both systems potentially vulnerable to the same degenerative, ischemic, traumatic, or toxic insults,” they noted.

Similarly, there was a significant association between vestibular dysfunction and a history of dizziness and falling.

A total of 536 study subjects reported dizziness and were found to have vestibular dysfunction. These participants were 12 times more likely to report having fallen as were subjects who had no dizziness and no vestibular dysfunction.

There were many subjects who reported no dizziness but were found to have vestibular dysfunction upon testing, however. These subjects also were at significantly increased risk for falling, with an odds ratio of 6.3, the researchers said.

The prevalence of vestibular dysfunction did not differ among non-Hispanic whites (34.7%), non-Hispanic blacks (35.5%), and Mexican-Americans (34.3%). It was significantly higher, however, in study participants categorized as “other” races or ethnicities (42.4%). “Perhaps genetic factors play a role, and indeed, several genes have been implicated in the pathophysiologic mechanism of one particular vestibulopathy, Meniere disease,” the researchers wrote.

Alternatively, subjects who had higher levels of education showed a markedly lower prevalence of vestibular dysfunction than those with less education, ranging from 51% in those with less than a high school education to 29% in those with greater than a high school eductation. This striking protective effect that has been noted in previous studies. “Incomplete adjustment for risk factors such as hypertension and diabetes may explain these socioeconomic and ethnic disparities,” Dr. Agrawal and his colleagues said.

Given this high prevalence in the general population, “screening for vestibular dysfunction … could be a life-saving and cost-effective practice,” particularly in high-risk groups such as the very old, people with hearing impairment, ethnic and racial minorities, and people with less than a high-school education. Those who are identified as having the disorder may benefit from vestibular physical therapy to improve balance control and prevent falls, they added.

An estimated 35% of Americans aged 40 and older have objective evidence of vestibular dysfunction, according to a recent report.

If further research bears out this finding from this study, it means that approximately 69 million adults in the United States are affected, said Dr. Yuri Agrawal and his associates in the department of otolaryngology-head and neck surgery at Johns Hopkins University School of Medicine, Baltimore.

The investigators assessed the epidemiology of vestibular dysfunction, because little has been published about the issue, even though both the incidence and prevalence of fall-induced injuries has risen significantly over the past 25 years. They used data from two 2-year cycles of data from the National Health and Nutrition Examination Survey between 2001 and 2004 to estimate the prevalence of the disorder.

A total of 5,086 NHANES subjects underwent balance testing using a modified Romberg Test of Standing Balance on Firm and Compliant Support Surfaces, which assessed their ability to stand unassisted under four test conditions. One of the conditions—standing on a foam-padded surface that obscured proprioceptive input while closing their eyes to eliminate visual input—exclusively measured vestibular function.

The overall prevalence of the disorder was 35.4%, which corresponds to 69 million Americans aged 40 and older. This prevalence increased markedly with age (from 18.5% for those in their 40s to 85% in those aged 80 and older). The prevalence did not differ significantly between men and women (34% vs. 35%).

“We found that participants with vestibular dysfunction had a significantly increased odds of hearing loss, compared with participants without vestibular dysfunction,” Dr. Agrawal and his associates said (Arch. Intern. Med. 2009;169:938–44).

This shared susceptibility “likely reflects the common anatomic location of the vestibular and hearing organs, as well as a common blood supply, making both systems potentially vulnerable to the same degenerative, ischemic, traumatic, or toxic insults,” they noted.

Similarly, there was a significant association between vestibular dysfunction and a history of dizziness and falling.

A total of 536 study subjects reported dizziness and were found to have vestibular dysfunction. These participants were 12 times more likely to report having fallen as were subjects who had no dizziness and no vestibular dysfunction.

There were many subjects who reported no dizziness but were found to have vestibular dysfunction upon testing, however. These subjects also were at significantly increased risk for falling, with an odds ratio of 6.3, the researchers said.

The prevalence of vestibular dysfunction did not differ among non-Hispanic whites (34.7%), non-Hispanic blacks (35.5%), and Mexican-Americans (34.3%). It was significantly higher, however, in study participants categorized as “other” races or ethnicities (42.4%). “Perhaps genetic factors play a role, and indeed, several genes have been implicated in the pathophysiologic mechanism of one particular vestibulopathy, Meniere disease,” the researchers wrote.

Alternatively, subjects who had higher levels of education showed a markedly lower prevalence of vestibular dysfunction than those with less education, ranging from 51% in those with less than a high school education to 29% in those with greater than a high school eductation. This striking protective effect that has been noted in previous studies. “Incomplete adjustment for risk factors such as hypertension and diabetes may explain these socioeconomic and ethnic disparities,” Dr. Agrawal and his colleagues said.

Given this high prevalence in the general population, “screening for vestibular dysfunction … could be a life-saving and cost-effective practice,” particularly in high-risk groups such as the very old, people with hearing impairment, ethnic and racial minorities, and people with less than a high-school education. Those who are identified as having the disorder may benefit from vestibular physical therapy to improve balance control and prevent falls, they added.

A program of optimized antidepressant therapy and pain self-management in patients with comorbid depression and chronic pain produced substantial and sustained reductions in disability and depression and pain severity.

The program, which was assessed in a study of 250 patients, was implemented in two primary care clinic systems by a nurse care-manager supervised by a physician, reported Dr. Kurt Kroenke of the divisions of internal medicine and geriatrics, Indiana University, Indianapolis, and his associates (JAMA 2009;301:2099–110).

They conducted the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study to determine whether two types of treatment—pharmacologic and behavioral—would prove synergistic in treating the comorbid conditions. The subjects were men and women (mean age, 55 years) who had moderately severe or worse depression and moderately severe or worse chronic pain in the back, hip, or knee that had persisted for at least 3 months despite conventional analgesic therapy.

A total of 123 subjects were randomly assigned to receive the study intervention: 3 months of optimized antidepressant therapy, followed by an additional 3 months of pain self-management instruction, followed by 6 months of relapse prevention. The antidepressants that were selected for the trial were venlafaxine (Effexor), fluoxetine, sertraline (Zoloft), citalopram (Celexa), bupropion, mirtazapine (Remeron), and nortriptyline (Aventyl).

The authors noted that the trial “was not designed to test any particular antidepressant but instead analyzed optimal mediation management, which is both effective and tolerated in an individual patient.” The remaining 127 subjects served as a control group, receiving usual care.

The pain self-management program included at least five in-person and eight telephone contacts during which patients learned about “chronic pain triggers and flare-ups; coping with fear and other negative emotions; and strategies for physical activity, muscle relaxation, deep breathing, distraction, sleep hygiene, and working with clinicians and employers” to manage their disability, the authors wrote.

Compared with usual care, the intervention produced “substantial” (at least 50%) reduction in depression severity within 1 month, which was sustained throughout 1 year of follow-up. The intervention group also was much more likely to experience depression response (37% of subjects) or remission (18%) than was the control group (16% and 5%, respectively).

The intervention also produced a 30% or greater reduction in pain, which was evident within 1 month of starting the program and was sustained for 1 year. Subjects in the intervention group had significantly better scores on measures of pain severity and pain interfering with everyday activities.

“Of the 58 intervention participants whose pain was better at 12 months, 8 were a little better, 21 were somewhat or moderately better, and 29 were a lot or completely better. In contrast, only 16 usual care participants reported improved pain at 12 months, of whom 3 were a little better, 6 were somewhat or moderately better, and 7 were a lot or completely better,” Dr. Kroenke and his colleagues reported.

Patients in the intervention group also showed more improvement in secondary measures such as anxiety, functional impairments, and quality of life, the investigators said.

The authors noted several limitations of the study: Generalizability was limited because the subjects were drawn from urban underserved and Veterans Affairs clinics, a lack of blinding, and discordance between patient self-report and electronic health record data.

The study was funded by the National Institute of Mental Health. Dr. Kroenke reported receiving research funding and/or honoraria from Eli Lilly (Aventyl, Prozac), Pfizer (Zoloft), Wyeth (Effexor), and Astra-Zeneca and Forest Laboratories (Celexa). Dr. Blair reported receiving one-time consultant fees from Wyeth, Abbott, and Cephalon. None of the other authors reported any financial disclosures.

A program of optimized antidepressant therapy and pain self-management in patients with comorbid depression and chronic pain produced substantial and sustained reductions in disability and depression and pain severity.

The program, which was assessed in a study of 250 patients, was implemented in two primary care clinic systems by a nurse care-manager supervised by a physician, reported Dr. Kurt Kroenke of the divisions of internal medicine and geriatrics, Indiana University, Indianapolis, and his associates (JAMA 2009;301:2099–110).

They conducted the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study to determine whether two types of treatment—pharmacologic and behavioral—would prove synergistic in treating the comorbid conditions. The subjects were men and women (mean age, 55 years) who had moderately severe or worse depression and moderately severe or worse chronic pain in the back, hip, or knee that had persisted for at least 3 months despite conventional analgesic therapy.

A total of 123 subjects were randomly assigned to receive the study intervention: 3 months of optimized antidepressant therapy, followed by an additional 3 months of pain self-management instruction, followed by 6 months of relapse prevention. The antidepressants that were selected for the trial were venlafaxine (Effexor), fluoxetine, sertraline (Zoloft), citalopram (Celexa), bupropion, mirtazapine (Remeron), and nortriptyline (Aventyl).

The authors noted that the trial “was not designed to test any particular antidepressant but instead analyzed optimal mediation management, which is both effective and tolerated in an individual patient.” The remaining 127 subjects served as a control group, receiving usual care.

The pain self-management program included at least five in-person and eight telephone contacts during which patients learned about “chronic pain triggers and flare-ups; coping with fear and other negative emotions; and strategies for physical activity, muscle relaxation, deep breathing, distraction, sleep hygiene, and working with clinicians and employers” to manage their disability, the authors wrote.

Compared with usual care, the intervention produced “substantial” (at least 50%) reduction in depression severity within 1 month, which was sustained throughout 1 year of follow-up. The intervention group also was much more likely to experience depression response (37% of subjects) or remission (18%) than was the control group (16% and 5%, respectively).

The intervention also produced a 30% or greater reduction in pain, which was evident within 1 month of starting the program and was sustained for 1 year. Subjects in the intervention group had significantly better scores on measures of pain severity and pain interfering with everyday activities.

“Of the 58 intervention participants whose pain was better at 12 months, 8 were a little better, 21 were somewhat or moderately better, and 29 were a lot or completely better. In contrast, only 16 usual care participants reported improved pain at 12 months, of whom 3 were a little better, 6 were somewhat or moderately better, and 7 were a lot or completely better,” Dr. Kroenke and his colleagues reported.

Patients in the intervention group also showed more improvement in secondary measures such as anxiety, functional impairments, and quality of life, the investigators said.

The authors noted several limitations of the study: Generalizability was limited because the subjects were drawn from urban underserved and Veterans Affairs clinics, a lack of blinding, and discordance between patient self-report and electronic health record data.

The study was funded by the National Institute of Mental Health. Dr. Kroenke reported receiving research funding and/or honoraria from Eli Lilly (Aventyl, Prozac), Pfizer (Zoloft), Wyeth (Effexor), and Astra-Zeneca and Forest Laboratories (Celexa). Dr. Blair reported receiving one-time consultant fees from Wyeth, Abbott, and Cephalon. None of the other authors reported any financial disclosures.

A program of optimized antidepressant therapy and pain self-management in patients with comorbid depression and chronic pain produced substantial and sustained reductions in disability and depression and pain severity.

The program, which was assessed in a study of 250 patients, was implemented in two primary care clinic systems by a nurse care-manager supervised by a physician, reported Dr. Kurt Kroenke of the divisions of internal medicine and geriatrics, Indiana University, Indianapolis, and his associates (JAMA 2009;301:2099–110).

They conducted the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study to determine whether two types of treatment—pharmacologic and behavioral—would prove synergistic in treating the comorbid conditions. The subjects were men and women (mean age, 55 years) who had moderately severe or worse depression and moderately severe or worse chronic pain in the back, hip, or knee that had persisted for at least 3 months despite conventional analgesic therapy.

A total of 123 subjects were randomly assigned to receive the study intervention: 3 months of optimized antidepressant therapy, followed by an additional 3 months of pain self-management instruction, followed by 6 months of relapse prevention. The antidepressants that were selected for the trial were venlafaxine (Effexor), fluoxetine, sertraline (Zoloft), citalopram (Celexa), bupropion, mirtazapine (Remeron), and nortriptyline (Aventyl).

The authors noted that the trial “was not designed to test any particular antidepressant but instead analyzed optimal mediation management, which is both effective and tolerated in an individual patient.” The remaining 127 subjects served as a control group, receiving usual care.

The pain self-management program included at least five in-person and eight telephone contacts during which patients learned about “chronic pain triggers and flare-ups; coping with fear and other negative emotions; and strategies for physical activity, muscle relaxation, deep breathing, distraction, sleep hygiene, and working with clinicians and employers” to manage their disability, the authors wrote.

Compared with usual care, the intervention produced “substantial” (at least 50%) reduction in depression severity within 1 month, which was sustained throughout 1 year of follow-up. The intervention group also was much more likely to experience depression response (37% of subjects) or remission (18%) than was the control group (16% and 5%, respectively).

The intervention also produced a 30% or greater reduction in pain, which was evident within 1 month of starting the program and was sustained for 1 year. Subjects in the intervention group had significantly better scores on measures of pain severity and pain interfering with everyday activities.

“Of the 58 intervention participants whose pain was better at 12 months, 8 were a little better, 21 were somewhat or moderately better, and 29 were a lot or completely better. In contrast, only 16 usual care participants reported improved pain at 12 months, of whom 3 were a little better, 6 were somewhat or moderately better, and 7 were a lot or completely better,” Dr. Kroenke and his colleagues reported.

Patients in the intervention group also showed more improvement in secondary measures such as anxiety, functional impairments, and quality of life, the investigators said.

The authors noted several limitations of the study: Generalizability was limited because the subjects were drawn from urban underserved and Veterans Affairs clinics, a lack of blinding, and discordance between patient self-report and electronic health record data.

The study was funded by the National Institute of Mental Health. Dr. Kroenke reported receiving research funding and/or honoraria from Eli Lilly (Aventyl, Prozac), Pfizer (Zoloft), Wyeth (Effexor), and Astra-Zeneca and Forest Laboratories (Celexa). Dr. Blair reported receiving one-time consultant fees from Wyeth, Abbott, and Cephalon. None of the other authors reported any financial disclosures.

Fenofibrate use is associated with a lower risk of amputation in patients with type 2 diabetes, particularly in those who have no known large-vessel disease.

This effect appears to be unrelated to fenofibrate's antihypertensive effects or lipid-lowering activity. The drug's ability to decrease amputation risk also occurs regardless of patients' level of glycemic control and background use of ACE inhibitors or angiotensin-receptor blockers, “strongly suggesting that [fenofibrate's] effects are additive to other measures,” wrote Dr. Kushwin Rajamani of the University of Sydney and his associates.

The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was designed to assess whether long-term lipid-lowering therapy with fenofibrate could reduce adverse macrovascular and microvascular outcomes. The FIELD researchers previously found that the drug reduces the need for laser therapy for diabetic retinopathy, “beyond what could be expected from a moderate observed reduction in blood pressure.”

In this portion of the study, which was funded in part by Laboratoires Fournier SA (now part of Solvay Pharmaceuticals), maker of fenofibrate, patients aged 50–75 years were randomly assigned to receive once-daily micronized fenofibrate (4,895 subjects) or matching placebo (4,900 subjects) and were followed at 4- to 6-month intervals for a median of 5 years.

A total of 115 patients had lower-limb amputations due to diabetes, including 47 patients who required more than 1 amputation. The amputation rate was significantly lower among patients taking fenofibrate than among those taking placebo (39% vs. 61%).

There were 190 lower-limb amputations in all. Significantly fewer amputations occurred in patients taking fenofibrate than in those on placebo (73 vs. 117).

Fenofibrate's beneficial effect emerged just after 1.5 years of treatment and increased over time. It was most striking among patients without known large-vessel disease who required minor amputations (below the ankle) thought to be related to microvascular disease.

In contrast, the reduction in amputation risk was nonsignificant among patients with known large-vessel disease who required major amputations (above the ankle) thought to be related to atherosclerosis of the major arteries.

“The number of patients needed to treat with fenofibrate over 5 years to prevent at least 1 amputation in 1 patient is 197, but is 25 for someone with previous foot ulcer and albuminuria,” the researchers wrote (Lancet 2009;373:1780–8).

The drug's protective effect against amputation was similar between patients who were taking ACE inhibitors and those who were not, as well as between patients who were taking angiotensin-receptor blockers and those who were not. The protective effect also did not differ between patients with good versus poor glycemic control, nor between patients with and without dyslipidemia.

Fenofibrate's mechanism of action in preventing amputations is not known. The drug is thought to improve endothelial-dependent vascular reactivity, reduce markers of endothelial dysfunction and inflammation, reduce viscosity, decrease angiogenesis, decrease tissue ischemia, inhibit oxidative stress, and exert neuroprotective effects, the investigators said. Fenofibrate is indicated by the Food and Drug Administration as adjunctive therapy to diet for the reduction of LDL cholesterol, total cholesterol, triglycerides, and apo B in adults with primary hypercholesterolemia or mixed dyslipidemia.

In an accompanying editorial, Dr. Sergio Fazio and Dr. MacRae F. Linton of Vanderbilt University, Nashville, said that fenofibrate's ability to improve wound healing may be key. This effect would set fibrates apart from the many agents that have so far been unable to reduce amputations in people with diabetes, they noted (Lancet 2009;373:1740–1).

Dr. Fazio and Dr. Linton have received honoraria for lectures from Merck, Schering-Plough, GlaxoSmithKline, Abbott, and Astra-Zeneca, as well as clinical trial support from Merck, Schering-Plough, ISIS, Genzyme, and AstraZeneca.

Fenofibrate use is associated with a lower risk of amputation in patients with type 2 diabetes, particularly in those who have no known large-vessel disease.

This effect appears to be unrelated to fenofibrate's antihypertensive effects or lipid-lowering activity. The drug's ability to decrease amputation risk also occurs regardless of patients' level of glycemic control and background use of ACE inhibitors or angiotensin-receptor blockers, “strongly suggesting that [fenofibrate's] effects are additive to other measures,” wrote Dr. Kushwin Rajamani of the University of Sydney and his associates.

The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was designed to assess whether long-term lipid-lowering therapy with fenofibrate could reduce adverse macrovascular and microvascular outcomes. The FIELD researchers previously found that the drug reduces the need for laser therapy for diabetic retinopathy, “beyond what could be expected from a moderate observed reduction in blood pressure.”

In this portion of the study, which was funded in part by Laboratoires Fournier SA (now part of Solvay Pharmaceuticals), maker of fenofibrate, patients aged 50–75 years were randomly assigned to receive once-daily micronized fenofibrate (4,895 subjects) or matching placebo (4,900 subjects) and were followed at 4- to 6-month intervals for a median of 5 years.

A total of 115 patients had lower-limb amputations due to diabetes, including 47 patients who required more than 1 amputation. The amputation rate was significantly lower among patients taking fenofibrate than among those taking placebo (39% vs. 61%).

There were 190 lower-limb amputations in all. Significantly fewer amputations occurred in patients taking fenofibrate than in those on placebo (73 vs. 117).

Fenofibrate's beneficial effect emerged just after 1.5 years of treatment and increased over time. It was most striking among patients without known large-vessel disease who required minor amputations (below the ankle) thought to be related to microvascular disease.

In contrast, the reduction in amputation risk was nonsignificant among patients with known large-vessel disease who required major amputations (above the ankle) thought to be related to atherosclerosis of the major arteries.

“The number of patients needed to treat with fenofibrate over 5 years to prevent at least 1 amputation in 1 patient is 197, but is 25 for someone with previous foot ulcer and albuminuria,” the researchers wrote (Lancet 2009;373:1780–8).

The drug's protective effect against amputation was similar between patients who were taking ACE inhibitors and those who were not, as well as between patients who were taking angiotensin-receptor blockers and those who were not. The protective effect also did not differ between patients with good versus poor glycemic control, nor between patients with and without dyslipidemia.

Fenofibrate's mechanism of action in preventing amputations is not known. The drug is thought to improve endothelial-dependent vascular reactivity, reduce markers of endothelial dysfunction and inflammation, reduce viscosity, decrease angiogenesis, decrease tissue ischemia, inhibit oxidative stress, and exert neuroprotective effects, the investigators said. Fenofibrate is indicated by the Food and Drug Administration as adjunctive therapy to diet for the reduction of LDL cholesterol, total cholesterol, triglycerides, and apo B in adults with primary hypercholesterolemia or mixed dyslipidemia.

In an accompanying editorial, Dr. Sergio Fazio and Dr. MacRae F. Linton of Vanderbilt University, Nashville, said that fenofibrate's ability to improve wound healing may be key. This effect would set fibrates apart from the many agents that have so far been unable to reduce amputations in people with diabetes, they noted (Lancet 2009;373:1740–1).

Dr. Fazio and Dr. Linton have received honoraria for lectures from Merck, Schering-Plough, GlaxoSmithKline, Abbott, and Astra-Zeneca, as well as clinical trial support from Merck, Schering-Plough, ISIS, Genzyme, and AstraZeneca.

Fenofibrate use is associated with a lower risk of amputation in patients with type 2 diabetes, particularly in those who have no known large-vessel disease.

This effect appears to be unrelated to fenofibrate's antihypertensive effects or lipid-lowering activity. The drug's ability to decrease amputation risk also occurs regardless of patients' level of glycemic control and background use of ACE inhibitors or angiotensin-receptor blockers, “strongly suggesting that [fenofibrate's] effects are additive to other measures,” wrote Dr. Kushwin Rajamani of the University of Sydney and his associates.

The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was designed to assess whether long-term lipid-lowering therapy with fenofibrate could reduce adverse macrovascular and microvascular outcomes. The FIELD researchers previously found that the drug reduces the need for laser therapy for diabetic retinopathy, “beyond what could be expected from a moderate observed reduction in blood pressure.”

In this portion of the study, which was funded in part by Laboratoires Fournier SA (now part of Solvay Pharmaceuticals), maker of fenofibrate, patients aged 50–75 years were randomly assigned to receive once-daily micronized fenofibrate (4,895 subjects) or matching placebo (4,900 subjects) and were followed at 4- to 6-month intervals for a median of 5 years.

A total of 115 patients had lower-limb amputations due to diabetes, including 47 patients who required more than 1 amputation. The amputation rate was significantly lower among patients taking fenofibrate than among those taking placebo (39% vs. 61%).

There were 190 lower-limb amputations in all. Significantly fewer amputations occurred in patients taking fenofibrate than in those on placebo (73 vs. 117).

Fenofibrate's beneficial effect emerged just after 1.5 years of treatment and increased over time. It was most striking among patients without known large-vessel disease who required minor amputations (below the ankle) thought to be related to microvascular disease.

In contrast, the reduction in amputation risk was nonsignificant among patients with known large-vessel disease who required major amputations (above the ankle) thought to be related to atherosclerosis of the major arteries.

“The number of patients needed to treat with fenofibrate over 5 years to prevent at least 1 amputation in 1 patient is 197, but is 25 for someone with previous foot ulcer and albuminuria,” the researchers wrote (Lancet 2009;373:1780–8).

The drug's protective effect against amputation was similar between patients who were taking ACE inhibitors and those who were not, as well as between patients who were taking angiotensin-receptor blockers and those who were not. The protective effect also did not differ between patients with good versus poor glycemic control, nor between patients with and without dyslipidemia.

Fenofibrate's mechanism of action in preventing amputations is not known. The drug is thought to improve endothelial-dependent vascular reactivity, reduce markers of endothelial dysfunction and inflammation, reduce viscosity, decrease angiogenesis, decrease tissue ischemia, inhibit oxidative stress, and exert neuroprotective effects, the investigators said. Fenofibrate is indicated by the Food and Drug Administration as adjunctive therapy to diet for the reduction of LDL cholesterol, total cholesterol, triglycerides, and apo B in adults with primary hypercholesterolemia or mixed dyslipidemia.

In an accompanying editorial, Dr. Sergio Fazio and Dr. MacRae F. Linton of Vanderbilt University, Nashville, said that fenofibrate's ability to improve wound healing may be key. This effect would set fibrates apart from the many agents that have so far been unable to reduce amputations in people with diabetes, they noted (Lancet 2009;373:1740–1).

Dr. Fazio and Dr. Linton have received honoraria for lectures from Merck, Schering-Plough, GlaxoSmithKline, Abbott, and Astra-Zeneca, as well as clinical trial support from Merck, Schering-Plough, ISIS, Genzyme, and AstraZeneca.