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Studies: Practice consolidation drives up costs

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Thu, 03/28/2019 - 15:37
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Studies: Practice consolidation drives up costs

The consolidation of physician practices, once considered a way to curb spending, seems to be costing the health care system more money, according to the findings of two studies published Oct. 21 in JAMA.

When researchers examined the prices paid by private preferred provider organizations (PPOs) for 10 types of common office visits, they found that the prices were higher in areas where there was less competition among physicians. The study examined the impact of competition across 10 specialties: internal medicine, family medicine, cardiology, dermatology, gastroenterology, neurology, general surgery, orthopedics, urology, and otolaryngology (JAMA 2014;312:1653-62).

Digital Vision / thinkstockphotos.com
PPOs reported that prices for common types of office visits were higher in less competitive areas, according to two new studies.

Looking at claims paid in 2010 across 1,058 U.S. counties, Laurence C. Baker, Ph.D., of Stanford (Calif.) University, and his colleagues found that in areas with the lowest amount of physician competition (measured as the 90th percentile on the Hirschman-Herfindahl Index of economic competition), an intermediate office visit with an established patient (CPT code 99213) was between $5.85 and $11.67 higher than in areas with the greatest amount of physician competition (10th percentile).

When measured across 10 types of office visits (CPT codes 99201-99205, 99211-99215), average office visit prices ranged from 8.3% to 16.1% higher in areas with less competition. A more conservative model estimated that average prices were 3.5% to 5.4% higher.

The higher prices may be justified if these larger practices are producing higher quality care, the researchers wrote, but more information is needed to determine the full implications.

The study was funded by the National Institute for Health Care Management. Three of the study authors reported receiving consulting fees from the National Institute for Health Care Management and one of the authors received consulting fees from Kaiser Permanente and the American Hospital Association.

A second study, also published Oct. 21 in JAMA, found that hospital ownership of physician practices was associated with higher spending than in physician-owned practices (JAMA 2014;312:1663-9).

James C. Robinson, Ph.D., of the University of California, Berkeley, and Kelly Miller of the Integrated Healthcare Association in Oakland, compared total spending on 4.5 million patients treated by integrated medical groups and independent practice associations in California between 2009 and 2012. All the patients included in the study were covered by commercial health maintenance organizations (HMOs).

Total spending was 10.3% higher in local hospital-owned physician organizations than in physician-owned organizations, after adjustment for patient severity, geographic costs, and other factors. Spending was 19.8% higher in practices owned by multihospital systems, compared with physician-owned organizations.

The largest organizations had spending that was 9.2% higher than the smallest organizations, according to the study.

Of the 158 organizations studied, 75% were physician-owned organizations, 12% were owned by local hospitals, and 13% were owned by multihospital systems.

“These findings are in contrast to the hope and expectation that organizational consolidation of physicians with hospital would result in greater coordination, and hence lower expenditures,” the researchers wrote. “Policy makers must strive to ensure that hospital acquisition of medical groups and physician practices does not lead to higher expenditures.”

The study was funded by the Robert Wood Johnson Foundation. The researchers reported that they had no financial disclosures.

[email protected]

On Twitter @maryellenny

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The consolidation of physician practices, once considered a way to curb spending, seems to be costing the health care system more money, according to the findings of two studies published Oct. 21 in JAMA.

When researchers examined the prices paid by private preferred provider organizations (PPOs) for 10 types of common office visits, they found that the prices were higher in areas where there was less competition among physicians. The study examined the impact of competition across 10 specialties: internal medicine, family medicine, cardiology, dermatology, gastroenterology, neurology, general surgery, orthopedics, urology, and otolaryngology (JAMA 2014;312:1653-62).

Digital Vision / thinkstockphotos.com
PPOs reported that prices for common types of office visits were higher in less competitive areas, according to two new studies.

Looking at claims paid in 2010 across 1,058 U.S. counties, Laurence C. Baker, Ph.D., of Stanford (Calif.) University, and his colleagues found that in areas with the lowest amount of physician competition (measured as the 90th percentile on the Hirschman-Herfindahl Index of economic competition), an intermediate office visit with an established patient (CPT code 99213) was between $5.85 and $11.67 higher than in areas with the greatest amount of physician competition (10th percentile).

When measured across 10 types of office visits (CPT codes 99201-99205, 99211-99215), average office visit prices ranged from 8.3% to 16.1% higher in areas with less competition. A more conservative model estimated that average prices were 3.5% to 5.4% higher.

The higher prices may be justified if these larger practices are producing higher quality care, the researchers wrote, but more information is needed to determine the full implications.

The study was funded by the National Institute for Health Care Management. Three of the study authors reported receiving consulting fees from the National Institute for Health Care Management and one of the authors received consulting fees from Kaiser Permanente and the American Hospital Association.

A second study, also published Oct. 21 in JAMA, found that hospital ownership of physician practices was associated with higher spending than in physician-owned practices (JAMA 2014;312:1663-9).

James C. Robinson, Ph.D., of the University of California, Berkeley, and Kelly Miller of the Integrated Healthcare Association in Oakland, compared total spending on 4.5 million patients treated by integrated medical groups and independent practice associations in California between 2009 and 2012. All the patients included in the study were covered by commercial health maintenance organizations (HMOs).

Total spending was 10.3% higher in local hospital-owned physician organizations than in physician-owned organizations, after adjustment for patient severity, geographic costs, and other factors. Spending was 19.8% higher in practices owned by multihospital systems, compared with physician-owned organizations.

The largest organizations had spending that was 9.2% higher than the smallest organizations, according to the study.

Of the 158 organizations studied, 75% were physician-owned organizations, 12% were owned by local hospitals, and 13% were owned by multihospital systems.

“These findings are in contrast to the hope and expectation that organizational consolidation of physicians with hospital would result in greater coordination, and hence lower expenditures,” the researchers wrote. “Policy makers must strive to ensure that hospital acquisition of medical groups and physician practices does not lead to higher expenditures.”

The study was funded by the Robert Wood Johnson Foundation. The researchers reported that they had no financial disclosures.

[email protected]

On Twitter @maryellenny

The consolidation of physician practices, once considered a way to curb spending, seems to be costing the health care system more money, according to the findings of two studies published Oct. 21 in JAMA.

When researchers examined the prices paid by private preferred provider organizations (PPOs) for 10 types of common office visits, they found that the prices were higher in areas where there was less competition among physicians. The study examined the impact of competition across 10 specialties: internal medicine, family medicine, cardiology, dermatology, gastroenterology, neurology, general surgery, orthopedics, urology, and otolaryngology (JAMA 2014;312:1653-62).

Digital Vision / thinkstockphotos.com
PPOs reported that prices for common types of office visits were higher in less competitive areas, according to two new studies.

Looking at claims paid in 2010 across 1,058 U.S. counties, Laurence C. Baker, Ph.D., of Stanford (Calif.) University, and his colleagues found that in areas with the lowest amount of physician competition (measured as the 90th percentile on the Hirschman-Herfindahl Index of economic competition), an intermediate office visit with an established patient (CPT code 99213) was between $5.85 and $11.67 higher than in areas with the greatest amount of physician competition (10th percentile).

When measured across 10 types of office visits (CPT codes 99201-99205, 99211-99215), average office visit prices ranged from 8.3% to 16.1% higher in areas with less competition. A more conservative model estimated that average prices were 3.5% to 5.4% higher.

The higher prices may be justified if these larger practices are producing higher quality care, the researchers wrote, but more information is needed to determine the full implications.

The study was funded by the National Institute for Health Care Management. Three of the study authors reported receiving consulting fees from the National Institute for Health Care Management and one of the authors received consulting fees from Kaiser Permanente and the American Hospital Association.

A second study, also published Oct. 21 in JAMA, found that hospital ownership of physician practices was associated with higher spending than in physician-owned practices (JAMA 2014;312:1663-9).

James C. Robinson, Ph.D., of the University of California, Berkeley, and Kelly Miller of the Integrated Healthcare Association in Oakland, compared total spending on 4.5 million patients treated by integrated medical groups and independent practice associations in California between 2009 and 2012. All the patients included in the study were covered by commercial health maintenance organizations (HMOs).

Total spending was 10.3% higher in local hospital-owned physician organizations than in physician-owned organizations, after adjustment for patient severity, geographic costs, and other factors. Spending was 19.8% higher in practices owned by multihospital systems, compared with physician-owned organizations.

The largest organizations had spending that was 9.2% higher than the smallest organizations, according to the study.

Of the 158 organizations studied, 75% were physician-owned organizations, 12% were owned by local hospitals, and 13% were owned by multihospital systems.

“These findings are in contrast to the hope and expectation that organizational consolidation of physicians with hospital would result in greater coordination, and hence lower expenditures,” the researchers wrote. “Policy makers must strive to ensure that hospital acquisition of medical groups and physician practices does not lead to higher expenditures.”

The study was funded by the Robert Wood Johnson Foundation. The researchers reported that they had no financial disclosures.

[email protected]

On Twitter @maryellenny

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Physician groups: Fix interoperability before advancing with meaningful use

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Physician groups: Fix interoperability before advancing with meaningful use

Physician groups are growing increasingly frustrated with the focus on meaningful use of electronic health records at the expense of creating an interoperable health information technology infrastructure and are calling on the Department of Health & Human Services to step up on interoperability.

In an Oct. 15 letter to HHS Secretary Sylvia Burwell, a number of groups cited the HHS Office of the National Coordinator for Health Information Technology’s finding that less than 14% of physicians are able to electronically transmit health information outside of their organization because of a lack of EHR interoperability and other issues.

Courtesy HHS
Sylvia Burwell

“These barriers to data exchange proliferated as a result of a variety of factors [including] strict MU [meaningful use] requirements and deadlines that do not provide sufficient time to focus on achieving interoperability. This dynamic is also in part due to the strict EHR certification requirements that have forced all stakeholders involved to focus on meeting MU measures as opposed to developing more innovative technological solutions that will enhance patient care and safety while growing the marketplace.”

Groups signing the letter include the American Academy of Family Physicians, American Medical Association, Medical Group Management Association, National Rural Health Association and a number of health care systems.

The letter also notes that in addition to interoperability, usability remains an issue that causes disruption in provider workflow and diverts resources away from patient care, noting that “vendors are limited from addressing these concerns as they focus on meeting increasingly complex certification requirements.”

Among its recommendations, the groups asked for HHS to recognize that the vendor community needs time to develop, test, and implement updates to meet new criteria and should be afforded that time “before continuing on with subsequent stages of the MU program. Testing and achievement of specific performance benchmarks should occur before providers are held accountable for any MU requirements.”

The letter comes as an advisory committee to the Office of the National Coordinator (ONC) is making a same-day recommendation that it delays or staggers meaningful use stage 3 to shift focus on achieving meaningful interoperability and addressing other infrastructure issues.

In its October 2014 report to Congress, the ONC acknowledged issues related to interoperability and other issues that are presenting a barrier for health IT to achieve potential.

“Despite progress in establishing standards and services to support health information exchange and interoperability, practice patterns have not changed to the point that health care providers share patient health information electronically across organizational, vendor, and geographic boundaries,” the report states. “Patient electronic health information needs to be available for appropriate use in solving major challenges, such as providing more effective care and informing and accelerating scientific research.”

To that end, ONC released during an Oct. 15 advisory committee meeting some top-level aspects of its 10-year framework on how it will improve interoperability, which is scheduled to be formalized in March 2015.

According to draft materials, the roadmap calls for health care providers to be able to send, receive, find, and use a basic set of essential health information. By 2020, more granular information should be accessible across systems, which would lead to improved quality and reduced costs. By 2024, the interoperability vision, with systems communicating in full, will lead to a learning health system and facilitate ubiquitous precision medicine.

Separately, AMA in an Oct. 14 letter to CMS and ONC criticized the meaningful use program and offered a series of recommendations to fix it before movement to stage 3 of the program. The group wants to see more flexibility in requirements physicians need to meet requirements, expanding hardship exemptions for all stages, improving quality reporting, and addressing physician EHR usability challenges.

“Many of the MU requirements were designed to increase patient choice and quality of care,” the AMA writes. “Unfortunately, many of these requirements, especially those in the latter phases of the MU program, are having the opposite effect. Oftentimes the requirements decrease the efficiency of patient visits.”

AMA also called on CMS and ONC to “study the total cost of compliance with MU to understand the impact this program is having on practice.”

[email protected]

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Physician groups are growing increasingly frustrated with the focus on meaningful use of electronic health records at the expense of creating an interoperable health information technology infrastructure and are calling on the Department of Health & Human Services to step up on interoperability.

In an Oct. 15 letter to HHS Secretary Sylvia Burwell, a number of groups cited the HHS Office of the National Coordinator for Health Information Technology’s finding that less than 14% of physicians are able to electronically transmit health information outside of their organization because of a lack of EHR interoperability and other issues.

Courtesy HHS
Sylvia Burwell

“These barriers to data exchange proliferated as a result of a variety of factors [including] strict MU [meaningful use] requirements and deadlines that do not provide sufficient time to focus on achieving interoperability. This dynamic is also in part due to the strict EHR certification requirements that have forced all stakeholders involved to focus on meeting MU measures as opposed to developing more innovative technological solutions that will enhance patient care and safety while growing the marketplace.”

Groups signing the letter include the American Academy of Family Physicians, American Medical Association, Medical Group Management Association, National Rural Health Association and a number of health care systems.

The letter also notes that in addition to interoperability, usability remains an issue that causes disruption in provider workflow and diverts resources away from patient care, noting that “vendors are limited from addressing these concerns as they focus on meeting increasingly complex certification requirements.”

Among its recommendations, the groups asked for HHS to recognize that the vendor community needs time to develop, test, and implement updates to meet new criteria and should be afforded that time “before continuing on with subsequent stages of the MU program. Testing and achievement of specific performance benchmarks should occur before providers are held accountable for any MU requirements.”

The letter comes as an advisory committee to the Office of the National Coordinator (ONC) is making a same-day recommendation that it delays or staggers meaningful use stage 3 to shift focus on achieving meaningful interoperability and addressing other infrastructure issues.

In its October 2014 report to Congress, the ONC acknowledged issues related to interoperability and other issues that are presenting a barrier for health IT to achieve potential.

“Despite progress in establishing standards and services to support health information exchange and interoperability, practice patterns have not changed to the point that health care providers share patient health information electronically across organizational, vendor, and geographic boundaries,” the report states. “Patient electronic health information needs to be available for appropriate use in solving major challenges, such as providing more effective care and informing and accelerating scientific research.”

To that end, ONC released during an Oct. 15 advisory committee meeting some top-level aspects of its 10-year framework on how it will improve interoperability, which is scheduled to be formalized in March 2015.

According to draft materials, the roadmap calls for health care providers to be able to send, receive, find, and use a basic set of essential health information. By 2020, more granular information should be accessible across systems, which would lead to improved quality and reduced costs. By 2024, the interoperability vision, with systems communicating in full, will lead to a learning health system and facilitate ubiquitous precision medicine.

Separately, AMA in an Oct. 14 letter to CMS and ONC criticized the meaningful use program and offered a series of recommendations to fix it before movement to stage 3 of the program. The group wants to see more flexibility in requirements physicians need to meet requirements, expanding hardship exemptions for all stages, improving quality reporting, and addressing physician EHR usability challenges.

“Many of the MU requirements were designed to increase patient choice and quality of care,” the AMA writes. “Unfortunately, many of these requirements, especially those in the latter phases of the MU program, are having the opposite effect. Oftentimes the requirements decrease the efficiency of patient visits.”

AMA also called on CMS and ONC to “study the total cost of compliance with MU to understand the impact this program is having on practice.”

[email protected]

Physician groups are growing increasingly frustrated with the focus on meaningful use of electronic health records at the expense of creating an interoperable health information technology infrastructure and are calling on the Department of Health & Human Services to step up on interoperability.

In an Oct. 15 letter to HHS Secretary Sylvia Burwell, a number of groups cited the HHS Office of the National Coordinator for Health Information Technology’s finding that less than 14% of physicians are able to electronically transmit health information outside of their organization because of a lack of EHR interoperability and other issues.

Courtesy HHS
Sylvia Burwell

“These barriers to data exchange proliferated as a result of a variety of factors [including] strict MU [meaningful use] requirements and deadlines that do not provide sufficient time to focus on achieving interoperability. This dynamic is also in part due to the strict EHR certification requirements that have forced all stakeholders involved to focus on meeting MU measures as opposed to developing more innovative technological solutions that will enhance patient care and safety while growing the marketplace.”

Groups signing the letter include the American Academy of Family Physicians, American Medical Association, Medical Group Management Association, National Rural Health Association and a number of health care systems.

The letter also notes that in addition to interoperability, usability remains an issue that causes disruption in provider workflow and diverts resources away from patient care, noting that “vendors are limited from addressing these concerns as they focus on meeting increasingly complex certification requirements.”

Among its recommendations, the groups asked for HHS to recognize that the vendor community needs time to develop, test, and implement updates to meet new criteria and should be afforded that time “before continuing on with subsequent stages of the MU program. Testing and achievement of specific performance benchmarks should occur before providers are held accountable for any MU requirements.”

The letter comes as an advisory committee to the Office of the National Coordinator (ONC) is making a same-day recommendation that it delays or staggers meaningful use stage 3 to shift focus on achieving meaningful interoperability and addressing other infrastructure issues.

In its October 2014 report to Congress, the ONC acknowledged issues related to interoperability and other issues that are presenting a barrier for health IT to achieve potential.

“Despite progress in establishing standards and services to support health information exchange and interoperability, practice patterns have not changed to the point that health care providers share patient health information electronically across organizational, vendor, and geographic boundaries,” the report states. “Patient electronic health information needs to be available for appropriate use in solving major challenges, such as providing more effective care and informing and accelerating scientific research.”

To that end, ONC released during an Oct. 15 advisory committee meeting some top-level aspects of its 10-year framework on how it will improve interoperability, which is scheduled to be formalized in March 2015.

According to draft materials, the roadmap calls for health care providers to be able to send, receive, find, and use a basic set of essential health information. By 2020, more granular information should be accessible across systems, which would lead to improved quality and reduced costs. By 2024, the interoperability vision, with systems communicating in full, will lead to a learning health system and facilitate ubiquitous precision medicine.

Separately, AMA in an Oct. 14 letter to CMS and ONC criticized the meaningful use program and offered a series of recommendations to fix it before movement to stage 3 of the program. The group wants to see more flexibility in requirements physicians need to meet requirements, expanding hardship exemptions for all stages, improving quality reporting, and addressing physician EHR usability challenges.

“Many of the MU requirements were designed to increase patient choice and quality of care,” the AMA writes. “Unfortunately, many of these requirements, especially those in the latter phases of the MU program, are having the opposite effect. Oftentimes the requirements decrease the efficiency of patient visits.”

AMA also called on CMS and ONC to “study the total cost of compliance with MU to understand the impact this program is having on practice.”

[email protected]

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Three-minute assessment detected most cases of delirium

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Three-minute assessment detected most cases of delirium

A shortened version of the Confusion Assessment Method took 3 minutes to administer and identified 95% of patients with delirium, compared with a reference standard that involved 1.5 hours of interviews and medical record reviews by a panel of experts, researchers reported online Oct. 20 in the Annals of Internal Medicine.

The 3-minute CAM (3D-CAM) also had a high estimated specificity (94%; 95% confidence interval, 90%-97%), although specificity was substantially lower (86%) in patients with dementia (95% CI, 67%-96%), probably because it can be difficult to distinguish delirium from dementia, said Dr. Edward Marcantonio of the Beth Israel Deaconess Medical Center in Boston and his associates. “Further research will focus on developing the optimal strategies for translating the 3D-CAM into routine care and determining whether improved detection of delirium can result in improved outcomes for vulnerable hospitalized older persons,” said the researchers (Ann. Intern. Med. 2014 Oct. 20 [doi:10.7326/M14-0865]).

© Wavebreakmedia Ltd / thinkstockphotos.com
The overall sensitivity of the 3-minute CAM was 95%, and the test was sensitive in detecting delirium in patients with and without dementia.

The original CAM has been widely used since the 1990s and is regarded as accurate, but challenging to administer. To create the 3-minute version of the CAM, the investigators used a data set of 4,598 structured delirium assessments from a prior multisite trial in which they had selected the 36 items that best captured the four diagnostic features of the CAM. Those features include acute change or fluctuating course, inattention, disorganized thinking, and altered level of consciousness, said the investigators. They further reduced the 36-item list to 20 by using logistic regression to identify the most useful items for each diagnostic feature, they said.

The researchers then tested the 3D-CAM in a prospective cohort of 201 medical patients with a median age of 84 years. In all, 88% of patients were white, and 21% had been diagnosed with dementia, the researchers reported. An expert panel determined that 42 (21%) of these patients had delirium, of which 88% had hypoactive or normal psychomotor features, said Dr. Marcantonio and his associates.

When compared with this reference standard, the overall sensitivity of the 3D-CAM was 95% (95% CI, 84%-99%), and the test was similarly sensitive in patients with and without dementia, the researchers reported. Among nine false positives, six patients had subsyndromal delirium as determined by the expert panel, the investigators added.

The 3D-CAM took a median of 3 minutes to administer (interquartile range, 2-5 minutes), said the researchers. Because some 95% confidence intervals were wide and the study was conducted at one urban teaching hospital on a single day, they recommended validating the results in settings such as surgical wards and postacute and palliative care facilities.

The National Institute on Aging funded the study. The investigators declared no financial conflicts.

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A shortened version of the Confusion Assessment Method took 3 minutes to administer and identified 95% of patients with delirium, compared with a reference standard that involved 1.5 hours of interviews and medical record reviews by a panel of experts, researchers reported online Oct. 20 in the Annals of Internal Medicine.

The 3-minute CAM (3D-CAM) also had a high estimated specificity (94%; 95% confidence interval, 90%-97%), although specificity was substantially lower (86%) in patients with dementia (95% CI, 67%-96%), probably because it can be difficult to distinguish delirium from dementia, said Dr. Edward Marcantonio of the Beth Israel Deaconess Medical Center in Boston and his associates. “Further research will focus on developing the optimal strategies for translating the 3D-CAM into routine care and determining whether improved detection of delirium can result in improved outcomes for vulnerable hospitalized older persons,” said the researchers (Ann. Intern. Med. 2014 Oct. 20 [doi:10.7326/M14-0865]).

© Wavebreakmedia Ltd / thinkstockphotos.com
The overall sensitivity of the 3-minute CAM was 95%, and the test was sensitive in detecting delirium in patients with and without dementia.

The original CAM has been widely used since the 1990s and is regarded as accurate, but challenging to administer. To create the 3-minute version of the CAM, the investigators used a data set of 4,598 structured delirium assessments from a prior multisite trial in which they had selected the 36 items that best captured the four diagnostic features of the CAM. Those features include acute change or fluctuating course, inattention, disorganized thinking, and altered level of consciousness, said the investigators. They further reduced the 36-item list to 20 by using logistic regression to identify the most useful items for each diagnostic feature, they said.

The researchers then tested the 3D-CAM in a prospective cohort of 201 medical patients with a median age of 84 years. In all, 88% of patients were white, and 21% had been diagnosed with dementia, the researchers reported. An expert panel determined that 42 (21%) of these patients had delirium, of which 88% had hypoactive or normal psychomotor features, said Dr. Marcantonio and his associates.

When compared with this reference standard, the overall sensitivity of the 3D-CAM was 95% (95% CI, 84%-99%), and the test was similarly sensitive in patients with and without dementia, the researchers reported. Among nine false positives, six patients had subsyndromal delirium as determined by the expert panel, the investigators added.

The 3D-CAM took a median of 3 minutes to administer (interquartile range, 2-5 minutes), said the researchers. Because some 95% confidence intervals were wide and the study was conducted at one urban teaching hospital on a single day, they recommended validating the results in settings such as surgical wards and postacute and palliative care facilities.

The National Institute on Aging funded the study. The investigators declared no financial conflicts.

A shortened version of the Confusion Assessment Method took 3 minutes to administer and identified 95% of patients with delirium, compared with a reference standard that involved 1.5 hours of interviews and medical record reviews by a panel of experts, researchers reported online Oct. 20 in the Annals of Internal Medicine.

The 3-minute CAM (3D-CAM) also had a high estimated specificity (94%; 95% confidence interval, 90%-97%), although specificity was substantially lower (86%) in patients with dementia (95% CI, 67%-96%), probably because it can be difficult to distinguish delirium from dementia, said Dr. Edward Marcantonio of the Beth Israel Deaconess Medical Center in Boston and his associates. “Further research will focus on developing the optimal strategies for translating the 3D-CAM into routine care and determining whether improved detection of delirium can result in improved outcomes for vulnerable hospitalized older persons,” said the researchers (Ann. Intern. Med. 2014 Oct. 20 [doi:10.7326/M14-0865]).

© Wavebreakmedia Ltd / thinkstockphotos.com
The overall sensitivity of the 3-minute CAM was 95%, and the test was sensitive in detecting delirium in patients with and without dementia.

The original CAM has been widely used since the 1990s and is regarded as accurate, but challenging to administer. To create the 3-minute version of the CAM, the investigators used a data set of 4,598 structured delirium assessments from a prior multisite trial in which they had selected the 36 items that best captured the four diagnostic features of the CAM. Those features include acute change or fluctuating course, inattention, disorganized thinking, and altered level of consciousness, said the investigators. They further reduced the 36-item list to 20 by using logistic regression to identify the most useful items for each diagnostic feature, they said.

The researchers then tested the 3D-CAM in a prospective cohort of 201 medical patients with a median age of 84 years. In all, 88% of patients were white, and 21% had been diagnosed with dementia, the researchers reported. An expert panel determined that 42 (21%) of these patients had delirium, of which 88% had hypoactive or normal psychomotor features, said Dr. Marcantonio and his associates.

When compared with this reference standard, the overall sensitivity of the 3D-CAM was 95% (95% CI, 84%-99%), and the test was similarly sensitive in patients with and without dementia, the researchers reported. Among nine false positives, six patients had subsyndromal delirium as determined by the expert panel, the investigators added.

The 3D-CAM took a median of 3 minutes to administer (interquartile range, 2-5 minutes), said the researchers. Because some 95% confidence intervals were wide and the study was conducted at one urban teaching hospital on a single day, they recommended validating the results in settings such as surgical wards and postacute and palliative care facilities.

The National Institute on Aging funded the study. The investigators declared no financial conflicts.

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Key clinical point: A 3-minute version of the Confusion Assessment Method (3D-CAM) detected delirium in elderly patients.

Major finding: Median time to administer the assessment was 3 minutes, estimated sensitivity was 95%, and overall specificity was 94%.

Data source: Single-center, cross-sectional study of 201 patients at an academic medical center.

Disclosures: The National Institute on Aging funded the study. The authors declared no financial conflicts.

The Joys of a Life in Surgery

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The Joys of a Life in Surgery

I have been privileged to spend over one half of my 70 years on this planet as a surgeon. Even considering the innumerable highly stressful moments and the occasional failures in patient care that continue to haunt me, I cannot conceive of a more satisfying and enjoyable vocation. It saddens me to know that a significant percentage of those in our profession have not been able to gain a similar level of fulfillment from their lives in surgery as I have.

There is no doubt that a pall of negativity has descended upon the medical profession in recent years. The factors that have caused it are real – declining compensation in face of an increased workload, less autonomy in practice with a steadily increasing number of physicians and surgeons being employees rather than independent practitioners, an oppressive regulatory environment necessitating a seemingly endless amount of paperwork, and finally the uncertainty of what our profession will look like once health care reform settles into its final form.

These issues – along with the always-present stresses that accompany caring for sick patients and the challenge of balancing a too-busy professional life with a meaningful personal existence – have led to a shocking number of our colleagues experiencing the symptoms of burnout; emotional exhaustion, depersonalization, and a sense of low personal accomplishment.

It would be inappropriate for me to in any way minimize the effect that burnout is having on medical professionals. It is now a greater threat to surgeon wellness than any other dynamic, including alcoholism and drug abuse. I will deal with it in some detail in a future editorial. But here I would like to consider some of the unique and positive features that, in my opinion, still make surgery the most noble of professions and a career that we can highly recommend to our children and grandchildren. I sincerely hope that emphasizing the more upbeat and constructive aspects of our profession, most of which are obvious but are unfortunately obscured by the cloud of negativity, will provide at least a small beacon of light for those having difficulty seeing their way forward.

I feel compelled to admit to some important disclaimers. While I do not consider myself a Pollyanna, ever since reading a Dutch study (Giltay et al., Arch. Gen. Psychiatry 2004;61:1126-35) that showed an impressive difference in longevity between optimists and pessimists, I have solidly placed myself in the optimist camp. Additionally, I have spent my entire surgical career within the ivy-covered walls of academe. Finally, I fully realize that what brings joy to one person may not do so to another.

My basic assertion is that, while many aspects of our profession have changed, the basic core – the opportunity to make positive changes in the lives of others – remains solidly intact. As a surgical academician, this was not limited to just patients, but extended to medical students, surgical residents, and surgical faculty. I suspect in the private setting there are also numerous opportunities to mentor young colleagues and lend support to surgeons who are experiencing burnout or other issues that compromise the quality of their lives and their effectiveness as surgeons.

The most satisfying aspect of my practice was the nonmonetary rewards I received from grateful patients. The patient-doctor relationship that surgeons enjoy with their patients is particularly special. We alone among medical professionals have the opportunity to suddenly and dramatically alter the course of patients’ pain, suffering, and prognosis. We alone invade the sacred spaces of their bodies. Although what we do is based on science and anatomy, to many patients, it is almost in the realm of the supernatural. I have always thought that the designing and construction of a complex building is a more challenging feat than removing a diseased gallbladder, but patients don’t see it that way. If we are willing to simply maintain meaningful and kind communication with them, they freely and liberally express their gratitude for even minimal surgical achievements. When a life-threatening situation has been suddenly erased by a surgical operation, many consider it in the domain of the heroic.

Especially amazing to me is the generosity of patients and their families even when complications or death compromise the outcome. Occasionally, gratitude comes in the guise of a gift. The most memorable for me was an envelope labeled “Pennies from Heaven” that contained $2.83 designated for bile duct cancer research given to me by the grandchildren of a woman with that dread disease on whom I had operated. The sum may have been insufficient to have any scientific impact but was more than enough to brighten my day after I observed this lovely woman enduring a long, difficult, and eventually unsuccessful postoperative course (“Pennies from Heaven,” ACS Surgery News, December 2011, p. 18).

 

 

Aside from the privilege of caring for patients, the most rewarding element of my professional life has been the opportunity to mentor others. Nearly all of us who have had success in our profession have had one or more valuable mentors. Performing this function for others is not only appropriate, but, in a sense, represents a giving back for what others have done for us. An effective mentor provides a nurturing environment in which the mentee can reach his/her full potential. Whether you are helping a resident or junior associate better adjust to life as a surgeon or find their best career path, assisting them in achieving their goals is nearly as satisfying as successfully seeing a patient through a challenging operation and complicated postoperative course.

As difficult as life in surgery can often be, focusing on the unique positives – the appreciative patient cured of a life-threatening tumor, the skilled and accomplished senior resident who you helped train, the young associate who seeks your wisdom on difficult cases and becomes a better surgeon because of it – rather than the negative background of uncertainty and loss of control may help to confirm that what you are doing is worthwhile and most likely making the world a  better place.  

Dr. Rikkers is the editor in chief of ACS Surgery News. 

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I have been privileged to spend over one half of my 70 years on this planet as a surgeon. Even considering the innumerable highly stressful moments and the occasional failures in patient care that continue to haunt me, I cannot conceive of a more satisfying and enjoyable vocation. It saddens me to know that a significant percentage of those in our profession have not been able to gain a similar level of fulfillment from their lives in surgery as I have.

There is no doubt that a pall of negativity has descended upon the medical profession in recent years. The factors that have caused it are real – declining compensation in face of an increased workload, less autonomy in practice with a steadily increasing number of physicians and surgeons being employees rather than independent practitioners, an oppressive regulatory environment necessitating a seemingly endless amount of paperwork, and finally the uncertainty of what our profession will look like once health care reform settles into its final form.

These issues – along with the always-present stresses that accompany caring for sick patients and the challenge of balancing a too-busy professional life with a meaningful personal existence – have led to a shocking number of our colleagues experiencing the symptoms of burnout; emotional exhaustion, depersonalization, and a sense of low personal accomplishment.

It would be inappropriate for me to in any way minimize the effect that burnout is having on medical professionals. It is now a greater threat to surgeon wellness than any other dynamic, including alcoholism and drug abuse. I will deal with it in some detail in a future editorial. But here I would like to consider some of the unique and positive features that, in my opinion, still make surgery the most noble of professions and a career that we can highly recommend to our children and grandchildren. I sincerely hope that emphasizing the more upbeat and constructive aspects of our profession, most of which are obvious but are unfortunately obscured by the cloud of negativity, will provide at least a small beacon of light for those having difficulty seeing their way forward.

I feel compelled to admit to some important disclaimers. While I do not consider myself a Pollyanna, ever since reading a Dutch study (Giltay et al., Arch. Gen. Psychiatry 2004;61:1126-35) that showed an impressive difference in longevity between optimists and pessimists, I have solidly placed myself in the optimist camp. Additionally, I have spent my entire surgical career within the ivy-covered walls of academe. Finally, I fully realize that what brings joy to one person may not do so to another.

My basic assertion is that, while many aspects of our profession have changed, the basic core – the opportunity to make positive changes in the lives of others – remains solidly intact. As a surgical academician, this was not limited to just patients, but extended to medical students, surgical residents, and surgical faculty. I suspect in the private setting there are also numerous opportunities to mentor young colleagues and lend support to surgeons who are experiencing burnout or other issues that compromise the quality of their lives and their effectiveness as surgeons.

The most satisfying aspect of my practice was the nonmonetary rewards I received from grateful patients. The patient-doctor relationship that surgeons enjoy with their patients is particularly special. We alone among medical professionals have the opportunity to suddenly and dramatically alter the course of patients’ pain, suffering, and prognosis. We alone invade the sacred spaces of their bodies. Although what we do is based on science and anatomy, to many patients, it is almost in the realm of the supernatural. I have always thought that the designing and construction of a complex building is a more challenging feat than removing a diseased gallbladder, but patients don’t see it that way. If we are willing to simply maintain meaningful and kind communication with them, they freely and liberally express their gratitude for even minimal surgical achievements. When a life-threatening situation has been suddenly erased by a surgical operation, many consider it in the domain of the heroic.

Especially amazing to me is the generosity of patients and their families even when complications or death compromise the outcome. Occasionally, gratitude comes in the guise of a gift. The most memorable for me was an envelope labeled “Pennies from Heaven” that contained $2.83 designated for bile duct cancer research given to me by the grandchildren of a woman with that dread disease on whom I had operated. The sum may have been insufficient to have any scientific impact but was more than enough to brighten my day after I observed this lovely woman enduring a long, difficult, and eventually unsuccessful postoperative course (“Pennies from Heaven,” ACS Surgery News, December 2011, p. 18).

 

 

Aside from the privilege of caring for patients, the most rewarding element of my professional life has been the opportunity to mentor others. Nearly all of us who have had success in our profession have had one or more valuable mentors. Performing this function for others is not only appropriate, but, in a sense, represents a giving back for what others have done for us. An effective mentor provides a nurturing environment in which the mentee can reach his/her full potential. Whether you are helping a resident or junior associate better adjust to life as a surgeon or find their best career path, assisting them in achieving their goals is nearly as satisfying as successfully seeing a patient through a challenging operation and complicated postoperative course.

As difficult as life in surgery can often be, focusing on the unique positives – the appreciative patient cured of a life-threatening tumor, the skilled and accomplished senior resident who you helped train, the young associate who seeks your wisdom on difficult cases and becomes a better surgeon because of it – rather than the negative background of uncertainty and loss of control may help to confirm that what you are doing is worthwhile and most likely making the world a  better place.  

Dr. Rikkers is the editor in chief of ACS Surgery News. 

I have been privileged to spend over one half of my 70 years on this planet as a surgeon. Even considering the innumerable highly stressful moments and the occasional failures in patient care that continue to haunt me, I cannot conceive of a more satisfying and enjoyable vocation. It saddens me to know that a significant percentage of those in our profession have not been able to gain a similar level of fulfillment from their lives in surgery as I have.

There is no doubt that a pall of negativity has descended upon the medical profession in recent years. The factors that have caused it are real – declining compensation in face of an increased workload, less autonomy in practice with a steadily increasing number of physicians and surgeons being employees rather than independent practitioners, an oppressive regulatory environment necessitating a seemingly endless amount of paperwork, and finally the uncertainty of what our profession will look like once health care reform settles into its final form.

These issues – along with the always-present stresses that accompany caring for sick patients and the challenge of balancing a too-busy professional life with a meaningful personal existence – have led to a shocking number of our colleagues experiencing the symptoms of burnout; emotional exhaustion, depersonalization, and a sense of low personal accomplishment.

It would be inappropriate for me to in any way minimize the effect that burnout is having on medical professionals. It is now a greater threat to surgeon wellness than any other dynamic, including alcoholism and drug abuse. I will deal with it in some detail in a future editorial. But here I would like to consider some of the unique and positive features that, in my opinion, still make surgery the most noble of professions and a career that we can highly recommend to our children and grandchildren. I sincerely hope that emphasizing the more upbeat and constructive aspects of our profession, most of which are obvious but are unfortunately obscured by the cloud of negativity, will provide at least a small beacon of light for those having difficulty seeing their way forward.

I feel compelled to admit to some important disclaimers. While I do not consider myself a Pollyanna, ever since reading a Dutch study (Giltay et al., Arch. Gen. Psychiatry 2004;61:1126-35) that showed an impressive difference in longevity between optimists and pessimists, I have solidly placed myself in the optimist camp. Additionally, I have spent my entire surgical career within the ivy-covered walls of academe. Finally, I fully realize that what brings joy to one person may not do so to another.

My basic assertion is that, while many aspects of our profession have changed, the basic core – the opportunity to make positive changes in the lives of others – remains solidly intact. As a surgical academician, this was not limited to just patients, but extended to medical students, surgical residents, and surgical faculty. I suspect in the private setting there are also numerous opportunities to mentor young colleagues and lend support to surgeons who are experiencing burnout or other issues that compromise the quality of their lives and their effectiveness as surgeons.

The most satisfying aspect of my practice was the nonmonetary rewards I received from grateful patients. The patient-doctor relationship that surgeons enjoy with their patients is particularly special. We alone among medical professionals have the opportunity to suddenly and dramatically alter the course of patients’ pain, suffering, and prognosis. We alone invade the sacred spaces of their bodies. Although what we do is based on science and anatomy, to many patients, it is almost in the realm of the supernatural. I have always thought that the designing and construction of a complex building is a more challenging feat than removing a diseased gallbladder, but patients don’t see it that way. If we are willing to simply maintain meaningful and kind communication with them, they freely and liberally express their gratitude for even minimal surgical achievements. When a life-threatening situation has been suddenly erased by a surgical operation, many consider it in the domain of the heroic.

Especially amazing to me is the generosity of patients and their families even when complications or death compromise the outcome. Occasionally, gratitude comes in the guise of a gift. The most memorable for me was an envelope labeled “Pennies from Heaven” that contained $2.83 designated for bile duct cancer research given to me by the grandchildren of a woman with that dread disease on whom I had operated. The sum may have been insufficient to have any scientific impact but was more than enough to brighten my day after I observed this lovely woman enduring a long, difficult, and eventually unsuccessful postoperative course (“Pennies from Heaven,” ACS Surgery News, December 2011, p. 18).

 

 

Aside from the privilege of caring for patients, the most rewarding element of my professional life has been the opportunity to mentor others. Nearly all of us who have had success in our profession have had one or more valuable mentors. Performing this function for others is not only appropriate, but, in a sense, represents a giving back for what others have done for us. An effective mentor provides a nurturing environment in which the mentee can reach his/her full potential. Whether you are helping a resident or junior associate better adjust to life as a surgeon or find their best career path, assisting them in achieving their goals is nearly as satisfying as successfully seeing a patient through a challenging operation and complicated postoperative course.

As difficult as life in surgery can often be, focusing on the unique positives – the appreciative patient cured of a life-threatening tumor, the skilled and accomplished senior resident who you helped train, the young associate who seeks your wisdom on difficult cases and becomes a better surgeon because of it – rather than the negative background of uncertainty and loss of control may help to confirm that what you are doing is worthwhile and most likely making the world a  better place.  

Dr. Rikkers is the editor in chief of ACS Surgery News. 

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VIDEO: Winning health apps link patients, researchers

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SANTA CLARA, CALIF. – The federal Patient-Centered Outcomes Research Institute picked three apps for $150,000 in award funding to help patients and researchers connect and collaborate.

The Institute’s Dr. Karen Odom Walker moderated a Hospital Innovation Roundtable session at the Health 2.0 fall conference. In a video interview at the meeting, she described the work of the Patient-Centered Outcomes Research Institute (PCORI), which was part of the Affordable Care Act and is based in Washington, D.C.

So far, PCORI has awarded more than $500 million to 300 projects for patient-centered research, and it plans to distribute another $3.5 billion by 2019, she said.

The winners of PCORI’s 2014 Matchmaking App Challenge, announced at the conference, developed ready-to-use Web-based or smartphone apps to link patients, caregivers, clinicians, and researchers in various ways.

First-place winner PatientPowered.us of San Francisco received $100,000 for its mobile network connecting patients with researchers and healthcare professionals to share ideas for solving their medical conditions, such as Crohn’s disease, sleep apnea, migraines, or others, and to connect patients with clinical trials.

Second-place winner WellSpringboard, from the University of Michigan, Ann Arbor, received $35,000 for its software platform to enable crowdfunding of patient-focused research. CareHubs of Beaverton, Ore. received $15,000 in third-place prize money for a platform for patient engagement in health systems.

Dr. Walker’s spouse works for MedImmune. She reported having no other financial disclosures.

[email protected]


On Twitter @sherryboschert

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SANTA CLARA, CALIF. – The federal Patient-Centered Outcomes Research Institute picked three apps for $150,000 in award funding to help patients and researchers connect and collaborate.

The Institute’s Dr. Karen Odom Walker moderated a Hospital Innovation Roundtable session at the Health 2.0 fall conference. In a video interview at the meeting, she described the work of the Patient-Centered Outcomes Research Institute (PCORI), which was part of the Affordable Care Act and is based in Washington, D.C.

So far, PCORI has awarded more than $500 million to 300 projects for patient-centered research, and it plans to distribute another $3.5 billion by 2019, she said.

The winners of PCORI’s 2014 Matchmaking App Challenge, announced at the conference, developed ready-to-use Web-based or smartphone apps to link patients, caregivers, clinicians, and researchers in various ways.

First-place winner PatientPowered.us of San Francisco received $100,000 for its mobile network connecting patients with researchers and healthcare professionals to share ideas for solving their medical conditions, such as Crohn’s disease, sleep apnea, migraines, or others, and to connect patients with clinical trials.

Second-place winner WellSpringboard, from the University of Michigan, Ann Arbor, received $35,000 for its software platform to enable crowdfunding of patient-focused research. CareHubs of Beaverton, Ore. received $15,000 in third-place prize money for a platform for patient engagement in health systems.

Dr. Walker’s spouse works for MedImmune. She reported having no other financial disclosures.

[email protected]


On Twitter @sherryboschert

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

SANTA CLARA, CALIF. – The federal Patient-Centered Outcomes Research Institute picked three apps for $150,000 in award funding to help patients and researchers connect and collaborate.

The Institute’s Dr. Karen Odom Walker moderated a Hospital Innovation Roundtable session at the Health 2.0 fall conference. In a video interview at the meeting, she described the work of the Patient-Centered Outcomes Research Institute (PCORI), which was part of the Affordable Care Act and is based in Washington, D.C.

So far, PCORI has awarded more than $500 million to 300 projects for patient-centered research, and it plans to distribute another $3.5 billion by 2019, she said.

The winners of PCORI’s 2014 Matchmaking App Challenge, announced at the conference, developed ready-to-use Web-based or smartphone apps to link patients, caregivers, clinicians, and researchers in various ways.

First-place winner PatientPowered.us of San Francisco received $100,000 for its mobile network connecting patients with researchers and healthcare professionals to share ideas for solving their medical conditions, such as Crohn’s disease, sleep apnea, migraines, or others, and to connect patients with clinical trials.

Second-place winner WellSpringboard, from the University of Michigan, Ann Arbor, received $35,000 for its software platform to enable crowdfunding of patient-focused research. CareHubs of Beaverton, Ore. received $15,000 in third-place prize money for a platform for patient engagement in health systems.

Dr. Walker’s spouse works for MedImmune. She reported having no other financial disclosures.

[email protected]


On Twitter @sherryboschert

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Court: Fla. malpractice reform doesn’t violate HIPAA

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A federal appeals court has upheld a Florida tort reform law that enables physician defendants to have equal access to plaintiffs’ health information, ruling that the state law does not violate federal patient privacy protections.

The 11th U.S. Circuit Court of Appeals decision means Florida doctors can be better prepared for malpractice lawsuits and better able to defend themselves, said Jeff Scott, director of legal and governmental affairs for the Florida Medical Association. Before the reform, plaintiffs’ attorneys could obtain information from a patient’s treating physicians, but defense attorneys could not access the same doctors until the deposition period – and only with the patient’s attorney present.

“The impact (of the ruling) is: It’s going to level the playing field in medical malpractice cases by giving defendant physicians the same access to crucial expert witnesses that the plaintiff has,” Mr. Scott said in an interview.

Jeff Scott

As part of the 2013 law, prospective plaintiffs must execute a written form that authorizes defendants to obtain documents and conduct ex parte interviews of the plaintiff’s medical providers. The form is a precondition to filing a medical negligence claim.

A patient who planned to sue a Florida family physician asked a federal district court to vacate the rule, arguing that the law violated his privacy. The U.S. District Court for the Northern District of Florida concluded the law would result in disclosure of the patient’s HIPAA-protected health information without his consent. That court ruled HIPAA preempted the state law.

The appeals court overturned. In its opinion, the three-judge panel said the Florida law is fully compliant with HIPAA and should stand.

“Had the drafters of the HIPAA regulations wished to preclude a state legislature from conditioning a public benefit – such as filing a lawsuit – on signing a HIPAA authorization, they could have easily done so, just as they generally prohibited doctors from conditioning medical treatment on signing a HIPAA authorization,” the appellate judges said in their decision.

“Further, an individual’s decision to sign an authorization prior to bringing a medical negligence claim in state court is not an involuntary one,” the appeals court noted. “If an individual does not wish to execute such an authorization, he does not have to. He is, however, precluded from using the Florida courts to obtain relief through a medical negligence lawsuit against a health care provider.”

Florida is not the first state to adopt the ex parte communications lawsuit rule. Both Texas and Tennessee have enacted similar statutes. In 2009, the Texas Supreme Court upheld the state’s rule, and in 2013, the Tennessee Supreme Court followed suit.

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A federal appeals court has upheld a Florida tort reform law that enables physician defendants to have equal access to plaintiffs’ health information, ruling that the state law does not violate federal patient privacy protections.

The 11th U.S. Circuit Court of Appeals decision means Florida doctors can be better prepared for malpractice lawsuits and better able to defend themselves, said Jeff Scott, director of legal and governmental affairs for the Florida Medical Association. Before the reform, plaintiffs’ attorneys could obtain information from a patient’s treating physicians, but defense attorneys could not access the same doctors until the deposition period – and only with the patient’s attorney present.

“The impact (of the ruling) is: It’s going to level the playing field in medical malpractice cases by giving defendant physicians the same access to crucial expert witnesses that the plaintiff has,” Mr. Scott said in an interview.

Jeff Scott

As part of the 2013 law, prospective plaintiffs must execute a written form that authorizes defendants to obtain documents and conduct ex parte interviews of the plaintiff’s medical providers. The form is a precondition to filing a medical negligence claim.

A patient who planned to sue a Florida family physician asked a federal district court to vacate the rule, arguing that the law violated his privacy. The U.S. District Court for the Northern District of Florida concluded the law would result in disclosure of the patient’s HIPAA-protected health information without his consent. That court ruled HIPAA preempted the state law.

The appeals court overturned. In its opinion, the three-judge panel said the Florida law is fully compliant with HIPAA and should stand.

“Had the drafters of the HIPAA regulations wished to preclude a state legislature from conditioning a public benefit – such as filing a lawsuit – on signing a HIPAA authorization, they could have easily done so, just as they generally prohibited doctors from conditioning medical treatment on signing a HIPAA authorization,” the appellate judges said in their decision.

“Further, an individual’s decision to sign an authorization prior to bringing a medical negligence claim in state court is not an involuntary one,” the appeals court noted. “If an individual does not wish to execute such an authorization, he does not have to. He is, however, precluded from using the Florida courts to obtain relief through a medical negligence lawsuit against a health care provider.”

Florida is not the first state to adopt the ex parte communications lawsuit rule. Both Texas and Tennessee have enacted similar statutes. In 2009, the Texas Supreme Court upheld the state’s rule, and in 2013, the Tennessee Supreme Court followed suit.

[email protected]


On Twitter @legal_med

A federal appeals court has upheld a Florida tort reform law that enables physician defendants to have equal access to plaintiffs’ health information, ruling that the state law does not violate federal patient privacy protections.

The 11th U.S. Circuit Court of Appeals decision means Florida doctors can be better prepared for malpractice lawsuits and better able to defend themselves, said Jeff Scott, director of legal and governmental affairs for the Florida Medical Association. Before the reform, plaintiffs’ attorneys could obtain information from a patient’s treating physicians, but defense attorneys could not access the same doctors until the deposition period – and only with the patient’s attorney present.

“The impact (of the ruling) is: It’s going to level the playing field in medical malpractice cases by giving defendant physicians the same access to crucial expert witnesses that the plaintiff has,” Mr. Scott said in an interview.

Jeff Scott

As part of the 2013 law, prospective plaintiffs must execute a written form that authorizes defendants to obtain documents and conduct ex parte interviews of the plaintiff’s medical providers. The form is a precondition to filing a medical negligence claim.

A patient who planned to sue a Florida family physician asked a federal district court to vacate the rule, arguing that the law violated his privacy. The U.S. District Court for the Northern District of Florida concluded the law would result in disclosure of the patient’s HIPAA-protected health information without his consent. That court ruled HIPAA preempted the state law.

The appeals court overturned. In its opinion, the three-judge panel said the Florida law is fully compliant with HIPAA and should stand.

“Had the drafters of the HIPAA regulations wished to preclude a state legislature from conditioning a public benefit – such as filing a lawsuit – on signing a HIPAA authorization, they could have easily done so, just as they generally prohibited doctors from conditioning medical treatment on signing a HIPAA authorization,” the appellate judges said in their decision.

“Further, an individual’s decision to sign an authorization prior to bringing a medical negligence claim in state court is not an involuntary one,” the appeals court noted. “If an individual does not wish to execute such an authorization, he does not have to. He is, however, precluded from using the Florida courts to obtain relief through a medical negligence lawsuit against a health care provider.”

Florida is not the first state to adopt the ex parte communications lawsuit rule. Both Texas and Tennessee have enacted similar statutes. In 2009, the Texas Supreme Court upheld the state’s rule, and in 2013, the Tennessee Supreme Court followed suit.

[email protected]


On Twitter @legal_med

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Should ductal carcinoma in situ be treated?

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Remarks given during a session of the ASCO Breast Cancer Symposium titled Ductal Carcinoma in Situ Debate: Treatment vs. Observation

Dr. Kuerer comments: There has been a marked increase ductal carcinoma in situ (DCIS) in what is being called overdiagnosis, and this is leading to concerns of overtreatment, which has been in the news now for several years. We have more than 60,000 cases of DCIS diagnosed per year in the United States. We’re trying to prevent invasive breast cancer and distant metastases. The problem is identifying which patients will go on to develop invasive disease. That’s really unknown.

At M.D. Anderson, looking at 10-year follow-up of 2,449 patients, the rate of developing distant metastases was 0.1%. The problem with this is that no prominent variables were associated with the development of invasive metastatic disease. Overall, we are doing a good job at preventing death from breast cancer when we treat DCIS, with less than 1% of patients dying of breast cancer (Ann. Surg. Onc. 2011;18:2873-8).

Dr. Henry M. Kuerer

Dr. Shelley E. Hwang and her group very elegantly started exploring preoperative systemic therapy as a way to get a clue about which patients might be safely observed alone (that is, a core biopsy diagnosis of DCIS and then just follow-up without surgery or other treatments). At M.D. Anderson, we studied whether or not we could eradicate DCIS in patients with human epidermal growth factor receptor 2 (HER2) overexpression by treatment with trastuzumab prior to surgery, under the hypothesis that if we could eradicate the DCIS, we might eventually use this drug potentially to prevent HER2-positive invasive breast cancers. We saw very dramatic responses in their immune response with antibody-dependent cellular cytotoxicity mediated by natural killer cells, which is exciting, but there were no histopathologic changes. The most important finding was that 42% of our patients who we thought only had DCIS actually had occult invasive breast cancer (Cancer 2011;117:39-47). This is concerning because without surgery, we may be missing or leaving untreated invasive breast cancers in some patients.

 

 

So, we have an underestimation of invasive breast cancer at DCIS diagnosis. A very elegant meta-analysis of 7,350 patients reported that even if we take patients with non–high-grade, very-small DCIS, we’re still looking at an upgrade to invasive cancer of about 20% (Radiology 2011;260:119-28). The best and most recent studies of MRI and DCIS again found a diagnostic upgrade of about 27%. There were no MRI features correlating with invasive breast cancer, and this resulted in a 31% increase in procedures and more biopsies with the use of MRI.

So where are we? In active surveillance of 14 patients with DCIS at the University of California, San Francisco, 8 went on to surgery at a median follow-up of 28 months, and 5 of the 8 (62%) had invasive breast cancer (The Breast 2011;20:529-33).

What’s the cost to the health care system of surveillance if we biopsy only the DCIS and follow it without surgery or other adjuvant therapies? The psychological cost to our patients? What is the natural history of DCIS if left in place? What will be the result of microcalcifications? How are we going to follow this? What are the criteria that we will use for repeat biopsy? This really is not known.

Which are the patients that we’re going to select for observation alone? There are trials in Europe that have begun or will begin to address the safety of just observing DCIS without surgery and other therapies.

The United Kingdom Low-Risk DCIS Trial is randomizing patients with low and intermediate grade DCIS of any size to biopsy alone without surgical intervention (active monitoring) or standard therapy. Another trial, a joint Dutch Breast Cancer Research Group and European Organization for the Research and Treatment of Cancer trial is randomizing women with low-risk, low-grade DCIS to active surveillance or standard treatment. If we look at M.D. Anderson’s data and our National Cancer Database, only about 10%-15% of patients would be eligible for the latter study. I don’t think with these numbers we’d have a great impact, but it is a start.

I submit that the best U.S. patients to study will be patients with a diagnosis of atypical ductal hyperplasia (generally the smallest lesions and perhaps the earliest form of DCIS) because we have about 100,000 cases each year.

What’s the patient’s perspective? What about the need for continued repeat biopsies, and how this will affect their overall quality of life? Do patients in the United States really want to observe the DCIS in an era when our patients are requesting more and more mastectomy with reconstruction and contralateral mastectomy at diagnosis of DCIS? I seriously doubt that our patients in the United States would agree to be randomized in DCIS trials to no treatment at all. I really don’t know.

Dr. Kuerer is a professor of surgery at the University of Texas M.D. Anderson Cancer Center, Houston. He reported financial associations with Gerson Lehrman Group and McGraw-Hill Publishing.

 

 

Dr. Hwang comments: Today, about 1/1,300 screening mammograms result in a diagnosis of DCIS. There are two important considerations when we talk about active surveillance or doing less aggressive treatment. First, what is the rate at which progression to invasive cancer can occur, either with or without treatment? Second, what is the fate of these DCIS lesions? These are issues for which we currently don’t have good answers.

We’re treating all disease detected at an early stage, and for the sake of argument, I’ll include DCIS, as if it likely will cause harm if we did absolutely nothing when, in fact, there could be many cancers that progress so slowly and have such a low propensity for developing metastatic disease that they would not likely cause any symptoms or harm during a patient’s lifetime.

Dr. Shelley E. Hwang

In autopsy series, the disease reservoir of unrecognized DCIS is about 9% and the disease reservoir of invasive cancer is about 1%. It’s not that different from prostate cancer, although at a much lower rate. These data show that there certainly are women who die with DCIS rather than of it.

We really don’t have a very solid understanding of the natural history of DCIS. If we do nothing, but maybe surgically biopsy it, what happens to these patients in the long term? In a meta-analysis, the world’s literature included only 151 cases of women who had surgical biopsy of DCIS that initially was misdiagnosed as a benign lesion and therefore didn’t undergo any further therapy, some with up to 31 years of follow-up. The long-term risk of invasive cancer in this cohort is only 22% (Breast Cancer Res. Treat. 2006;97:135-44). The annual risk of breast cancer in women with atypia is 1% per year, so this ends up looking very similar to the risk of progression that you see for atypical ductal hyperplasia or lobular carcinoma in situ.

The most common treatment for DCIS in the United States is lumpectomy with radiation. A meta-analysis by the European Breast Cancer Trialists’ Group found a 50% proportional reduction in local recurrence risk in women treated with lumpectomy and radiation vs. lumpectomy alone. The absolute magnitude of reduction was dependent on baseline recurrence risk. That’s a really important concept, because if your baseline risk is only 5%, then the 50% proportional reduction only translates into a 2.5% reduction in risk in 10 years.

The prospective, randomized Radiation Therapy Oncologists Group 9804 study randomized low-risk women with DCIS, unlike prior randomized trials that included broad eligibility criteria for DCIS. In 5 years of follow-up, the ipsilateral recurrence risk (which includes both invasive cancer and DCIS) was 3.2% in the lumpectomy-only group vs. 0.4% in the lumpectomy and radiation therapy group. The difference is highly statistically significant, however, given the small absolute difference between groups, the clinical significance certainly can be argued. There was no significant difference between groups in contralateral new primary lesions (Radiat. Oncol. 2012;84:S5).

 

 

We just presented a study this year looking at DCIS and competing causes of mortality in different age groups with different types of treatment. Among women with DCIS over 70 years of age, there was a significant difference in overall survival but none of the treatments conferred any benefit in disease-specific survival.

Active surveillance alone may be reasonable to consider in some patients. We can learn a lot from our colleagues who treat prostate cancer. They’re at least 10 years ahead of us in thinking about reducing the harms that have been introduced by screening for prostate cancer. When you look at breast cancer–specific and other-cause mortality in the setting of DCIS, the mortality curves look very similar to those with early-stage prostate cancer. Women with DCIS, regardless of what they are treated with, die of other causes and very rarely die of breast cancer.

When we compare such different options as mastectomy to active surveillance only, it’s really hard for a patient to feel that both of those approaches can offer them the same outcomes. But when you look at the actual data and evidence, the differences in recurrence or progression to invasive cancer don’t translate easily into a large difference in breast cancer mortality provided that patients are diagnosed at stage I or II, with more than a 90% survival from breast cancer.

We have an opportunity to take a big step back and redefine our goals of DCIS “treatment” from “curing” DCIS to trying to reduce breast cancer-specific mortality. This will help us reduce the harms that can result from screening and will reserve our aggressive treatments for those most likely to benefit from them.

Dr. Hwang is a professor of surgery at Duke University, Durham, N.C. She serves as a consultant for Genomic Health.

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Remarks given during a session of the ASCO Breast Cancer Symposium titled Ductal Carcinoma in Situ Debate: Treatment vs. Observation

Dr. Kuerer comments: There has been a marked increase ductal carcinoma in situ (DCIS) in what is being called overdiagnosis, and this is leading to concerns of overtreatment, which has been in the news now for several years. We have more than 60,000 cases of DCIS diagnosed per year in the United States. We’re trying to prevent invasive breast cancer and distant metastases. The problem is identifying which patients will go on to develop invasive disease. That’s really unknown.

At M.D. Anderson, looking at 10-year follow-up of 2,449 patients, the rate of developing distant metastases was 0.1%. The problem with this is that no prominent variables were associated with the development of invasive metastatic disease. Overall, we are doing a good job at preventing death from breast cancer when we treat DCIS, with less than 1% of patients dying of breast cancer (Ann. Surg. Onc. 2011;18:2873-8).

Dr. Henry M. Kuerer

Dr. Shelley E. Hwang and her group very elegantly started exploring preoperative systemic therapy as a way to get a clue about which patients might be safely observed alone (that is, a core biopsy diagnosis of DCIS and then just follow-up without surgery or other treatments). At M.D. Anderson, we studied whether or not we could eradicate DCIS in patients with human epidermal growth factor receptor 2 (HER2) overexpression by treatment with trastuzumab prior to surgery, under the hypothesis that if we could eradicate the DCIS, we might eventually use this drug potentially to prevent HER2-positive invasive breast cancers. We saw very dramatic responses in their immune response with antibody-dependent cellular cytotoxicity mediated by natural killer cells, which is exciting, but there were no histopathologic changes. The most important finding was that 42% of our patients who we thought only had DCIS actually had occult invasive breast cancer (Cancer 2011;117:39-47). This is concerning because without surgery, we may be missing or leaving untreated invasive breast cancers in some patients.

 

 

So, we have an underestimation of invasive breast cancer at DCIS diagnosis. A very elegant meta-analysis of 7,350 patients reported that even if we take patients with non–high-grade, very-small DCIS, we’re still looking at an upgrade to invasive cancer of about 20% (Radiology 2011;260:119-28). The best and most recent studies of MRI and DCIS again found a diagnostic upgrade of about 27%. There were no MRI features correlating with invasive breast cancer, and this resulted in a 31% increase in procedures and more biopsies with the use of MRI.

So where are we? In active surveillance of 14 patients with DCIS at the University of California, San Francisco, 8 went on to surgery at a median follow-up of 28 months, and 5 of the 8 (62%) had invasive breast cancer (The Breast 2011;20:529-33).

What’s the cost to the health care system of surveillance if we biopsy only the DCIS and follow it without surgery or other adjuvant therapies? The psychological cost to our patients? What is the natural history of DCIS if left in place? What will be the result of microcalcifications? How are we going to follow this? What are the criteria that we will use for repeat biopsy? This really is not known.

Which are the patients that we’re going to select for observation alone? There are trials in Europe that have begun or will begin to address the safety of just observing DCIS without surgery and other therapies.

The United Kingdom Low-Risk DCIS Trial is randomizing patients with low and intermediate grade DCIS of any size to biopsy alone without surgical intervention (active monitoring) or standard therapy. Another trial, a joint Dutch Breast Cancer Research Group and European Organization for the Research and Treatment of Cancer trial is randomizing women with low-risk, low-grade DCIS to active surveillance or standard treatment. If we look at M.D. Anderson’s data and our National Cancer Database, only about 10%-15% of patients would be eligible for the latter study. I don’t think with these numbers we’d have a great impact, but it is a start.

I submit that the best U.S. patients to study will be patients with a diagnosis of atypical ductal hyperplasia (generally the smallest lesions and perhaps the earliest form of DCIS) because we have about 100,000 cases each year.

What’s the patient’s perspective? What about the need for continued repeat biopsies, and how this will affect their overall quality of life? Do patients in the United States really want to observe the DCIS in an era when our patients are requesting more and more mastectomy with reconstruction and contralateral mastectomy at diagnosis of DCIS? I seriously doubt that our patients in the United States would agree to be randomized in DCIS trials to no treatment at all. I really don’t know.

Dr. Kuerer is a professor of surgery at the University of Texas M.D. Anderson Cancer Center, Houston. He reported financial associations with Gerson Lehrman Group and McGraw-Hill Publishing.

 

 

Dr. Hwang comments: Today, about 1/1,300 screening mammograms result in a diagnosis of DCIS. There are two important considerations when we talk about active surveillance or doing less aggressive treatment. First, what is the rate at which progression to invasive cancer can occur, either with or without treatment? Second, what is the fate of these DCIS lesions? These are issues for which we currently don’t have good answers.

We’re treating all disease detected at an early stage, and for the sake of argument, I’ll include DCIS, as if it likely will cause harm if we did absolutely nothing when, in fact, there could be many cancers that progress so slowly and have such a low propensity for developing metastatic disease that they would not likely cause any symptoms or harm during a patient’s lifetime.

Dr. Shelley E. Hwang

In autopsy series, the disease reservoir of unrecognized DCIS is about 9% and the disease reservoir of invasive cancer is about 1%. It’s not that different from prostate cancer, although at a much lower rate. These data show that there certainly are women who die with DCIS rather than of it.

We really don’t have a very solid understanding of the natural history of DCIS. If we do nothing, but maybe surgically biopsy it, what happens to these patients in the long term? In a meta-analysis, the world’s literature included only 151 cases of women who had surgical biopsy of DCIS that initially was misdiagnosed as a benign lesion and therefore didn’t undergo any further therapy, some with up to 31 years of follow-up. The long-term risk of invasive cancer in this cohort is only 22% (Breast Cancer Res. Treat. 2006;97:135-44). The annual risk of breast cancer in women with atypia is 1% per year, so this ends up looking very similar to the risk of progression that you see for atypical ductal hyperplasia or lobular carcinoma in situ.

The most common treatment for DCIS in the United States is lumpectomy with radiation. A meta-analysis by the European Breast Cancer Trialists’ Group found a 50% proportional reduction in local recurrence risk in women treated with lumpectomy and radiation vs. lumpectomy alone. The absolute magnitude of reduction was dependent on baseline recurrence risk. That’s a really important concept, because if your baseline risk is only 5%, then the 50% proportional reduction only translates into a 2.5% reduction in risk in 10 years.

The prospective, randomized Radiation Therapy Oncologists Group 9804 study randomized low-risk women with DCIS, unlike prior randomized trials that included broad eligibility criteria for DCIS. In 5 years of follow-up, the ipsilateral recurrence risk (which includes both invasive cancer and DCIS) was 3.2% in the lumpectomy-only group vs. 0.4% in the lumpectomy and radiation therapy group. The difference is highly statistically significant, however, given the small absolute difference between groups, the clinical significance certainly can be argued. There was no significant difference between groups in contralateral new primary lesions (Radiat. Oncol. 2012;84:S5).

 

 

We just presented a study this year looking at DCIS and competing causes of mortality in different age groups with different types of treatment. Among women with DCIS over 70 years of age, there was a significant difference in overall survival but none of the treatments conferred any benefit in disease-specific survival.

Active surveillance alone may be reasonable to consider in some patients. We can learn a lot from our colleagues who treat prostate cancer. They’re at least 10 years ahead of us in thinking about reducing the harms that have been introduced by screening for prostate cancer. When you look at breast cancer–specific and other-cause mortality in the setting of DCIS, the mortality curves look very similar to those with early-stage prostate cancer. Women with DCIS, regardless of what they are treated with, die of other causes and very rarely die of breast cancer.

When we compare such different options as mastectomy to active surveillance only, it’s really hard for a patient to feel that both of those approaches can offer them the same outcomes. But when you look at the actual data and evidence, the differences in recurrence or progression to invasive cancer don’t translate easily into a large difference in breast cancer mortality provided that patients are diagnosed at stage I or II, with more than a 90% survival from breast cancer.

We have an opportunity to take a big step back and redefine our goals of DCIS “treatment” from “curing” DCIS to trying to reduce breast cancer-specific mortality. This will help us reduce the harms that can result from screening and will reserve our aggressive treatments for those most likely to benefit from them.

Dr. Hwang is a professor of surgery at Duke University, Durham, N.C. She serves as a consultant for Genomic Health.

Remarks given during a session of the ASCO Breast Cancer Symposium titled Ductal Carcinoma in Situ Debate: Treatment vs. Observation

Dr. Kuerer comments: There has been a marked increase ductal carcinoma in situ (DCIS) in what is being called overdiagnosis, and this is leading to concerns of overtreatment, which has been in the news now for several years. We have more than 60,000 cases of DCIS diagnosed per year in the United States. We’re trying to prevent invasive breast cancer and distant metastases. The problem is identifying which patients will go on to develop invasive disease. That’s really unknown.

At M.D. Anderson, looking at 10-year follow-up of 2,449 patients, the rate of developing distant metastases was 0.1%. The problem with this is that no prominent variables were associated with the development of invasive metastatic disease. Overall, we are doing a good job at preventing death from breast cancer when we treat DCIS, with less than 1% of patients dying of breast cancer (Ann. Surg. Onc. 2011;18:2873-8).

Dr. Henry M. Kuerer

Dr. Shelley E. Hwang and her group very elegantly started exploring preoperative systemic therapy as a way to get a clue about which patients might be safely observed alone (that is, a core biopsy diagnosis of DCIS and then just follow-up without surgery or other treatments). At M.D. Anderson, we studied whether or not we could eradicate DCIS in patients with human epidermal growth factor receptor 2 (HER2) overexpression by treatment with trastuzumab prior to surgery, under the hypothesis that if we could eradicate the DCIS, we might eventually use this drug potentially to prevent HER2-positive invasive breast cancers. We saw very dramatic responses in their immune response with antibody-dependent cellular cytotoxicity mediated by natural killer cells, which is exciting, but there were no histopathologic changes. The most important finding was that 42% of our patients who we thought only had DCIS actually had occult invasive breast cancer (Cancer 2011;117:39-47). This is concerning because without surgery, we may be missing or leaving untreated invasive breast cancers in some patients.

 

 

So, we have an underestimation of invasive breast cancer at DCIS diagnosis. A very elegant meta-analysis of 7,350 patients reported that even if we take patients with non–high-grade, very-small DCIS, we’re still looking at an upgrade to invasive cancer of about 20% (Radiology 2011;260:119-28). The best and most recent studies of MRI and DCIS again found a diagnostic upgrade of about 27%. There were no MRI features correlating with invasive breast cancer, and this resulted in a 31% increase in procedures and more biopsies with the use of MRI.

So where are we? In active surveillance of 14 patients with DCIS at the University of California, San Francisco, 8 went on to surgery at a median follow-up of 28 months, and 5 of the 8 (62%) had invasive breast cancer (The Breast 2011;20:529-33).

What’s the cost to the health care system of surveillance if we biopsy only the DCIS and follow it without surgery or other adjuvant therapies? The psychological cost to our patients? What is the natural history of DCIS if left in place? What will be the result of microcalcifications? How are we going to follow this? What are the criteria that we will use for repeat biopsy? This really is not known.

Which are the patients that we’re going to select for observation alone? There are trials in Europe that have begun or will begin to address the safety of just observing DCIS without surgery and other therapies.

The United Kingdom Low-Risk DCIS Trial is randomizing patients with low and intermediate grade DCIS of any size to biopsy alone without surgical intervention (active monitoring) or standard therapy. Another trial, a joint Dutch Breast Cancer Research Group and European Organization for the Research and Treatment of Cancer trial is randomizing women with low-risk, low-grade DCIS to active surveillance or standard treatment. If we look at M.D. Anderson’s data and our National Cancer Database, only about 10%-15% of patients would be eligible for the latter study. I don’t think with these numbers we’d have a great impact, but it is a start.

I submit that the best U.S. patients to study will be patients with a diagnosis of atypical ductal hyperplasia (generally the smallest lesions and perhaps the earliest form of DCIS) because we have about 100,000 cases each year.

What’s the patient’s perspective? What about the need for continued repeat biopsies, and how this will affect their overall quality of life? Do patients in the United States really want to observe the DCIS in an era when our patients are requesting more and more mastectomy with reconstruction and contralateral mastectomy at diagnosis of DCIS? I seriously doubt that our patients in the United States would agree to be randomized in DCIS trials to no treatment at all. I really don’t know.

Dr. Kuerer is a professor of surgery at the University of Texas M.D. Anderson Cancer Center, Houston. He reported financial associations with Gerson Lehrman Group and McGraw-Hill Publishing.

 

 

Dr. Hwang comments: Today, about 1/1,300 screening mammograms result in a diagnosis of DCIS. There are two important considerations when we talk about active surveillance or doing less aggressive treatment. First, what is the rate at which progression to invasive cancer can occur, either with or without treatment? Second, what is the fate of these DCIS lesions? These are issues for which we currently don’t have good answers.

We’re treating all disease detected at an early stage, and for the sake of argument, I’ll include DCIS, as if it likely will cause harm if we did absolutely nothing when, in fact, there could be many cancers that progress so slowly and have such a low propensity for developing metastatic disease that they would not likely cause any symptoms or harm during a patient’s lifetime.

Dr. Shelley E. Hwang

In autopsy series, the disease reservoir of unrecognized DCIS is about 9% and the disease reservoir of invasive cancer is about 1%. It’s not that different from prostate cancer, although at a much lower rate. These data show that there certainly are women who die with DCIS rather than of it.

We really don’t have a very solid understanding of the natural history of DCIS. If we do nothing, but maybe surgically biopsy it, what happens to these patients in the long term? In a meta-analysis, the world’s literature included only 151 cases of women who had surgical biopsy of DCIS that initially was misdiagnosed as a benign lesion and therefore didn’t undergo any further therapy, some with up to 31 years of follow-up. The long-term risk of invasive cancer in this cohort is only 22% (Breast Cancer Res. Treat. 2006;97:135-44). The annual risk of breast cancer in women with atypia is 1% per year, so this ends up looking very similar to the risk of progression that you see for atypical ductal hyperplasia or lobular carcinoma in situ.

The most common treatment for DCIS in the United States is lumpectomy with radiation. A meta-analysis by the European Breast Cancer Trialists’ Group found a 50% proportional reduction in local recurrence risk in women treated with lumpectomy and radiation vs. lumpectomy alone. The absolute magnitude of reduction was dependent on baseline recurrence risk. That’s a really important concept, because if your baseline risk is only 5%, then the 50% proportional reduction only translates into a 2.5% reduction in risk in 10 years.

The prospective, randomized Radiation Therapy Oncologists Group 9804 study randomized low-risk women with DCIS, unlike prior randomized trials that included broad eligibility criteria for DCIS. In 5 years of follow-up, the ipsilateral recurrence risk (which includes both invasive cancer and DCIS) was 3.2% in the lumpectomy-only group vs. 0.4% in the lumpectomy and radiation therapy group. The difference is highly statistically significant, however, given the small absolute difference between groups, the clinical significance certainly can be argued. There was no significant difference between groups in contralateral new primary lesions (Radiat. Oncol. 2012;84:S5).

 

 

We just presented a study this year looking at DCIS and competing causes of mortality in different age groups with different types of treatment. Among women with DCIS over 70 years of age, there was a significant difference in overall survival but none of the treatments conferred any benefit in disease-specific survival.

Active surveillance alone may be reasonable to consider in some patients. We can learn a lot from our colleagues who treat prostate cancer. They’re at least 10 years ahead of us in thinking about reducing the harms that have been introduced by screening for prostate cancer. When you look at breast cancer–specific and other-cause mortality in the setting of DCIS, the mortality curves look very similar to those with early-stage prostate cancer. Women with DCIS, regardless of what they are treated with, die of other causes and very rarely die of breast cancer.

When we compare such different options as mastectomy to active surveillance only, it’s really hard for a patient to feel that both of those approaches can offer them the same outcomes. But when you look at the actual data and evidence, the differences in recurrence or progression to invasive cancer don’t translate easily into a large difference in breast cancer mortality provided that patients are diagnosed at stage I or II, with more than a 90% survival from breast cancer.

We have an opportunity to take a big step back and redefine our goals of DCIS “treatment” from “curing” DCIS to trying to reduce breast cancer-specific mortality. This will help us reduce the harms that can result from screening and will reserve our aggressive treatments for those most likely to benefit from them.

Dr. Hwang is a professor of surgery at Duke University, Durham, N.C. She serves as a consultant for Genomic Health.

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ACS offers information on its Ebola virus transmission resource page

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The American College of Surgeons has posted a recommended surgical protocol for possible or confirmed Ebola cases on the Ebola virus transmission resource page. The protocol was developed by Dr. Sherry M. Wren, F.A.C.S., and Dr. Adam L. Kushner, M.P.H., F.A.C.S.

“Elective surgical procedures should not be performed in cases of suspected or confirmed Ebola. In cases where an emergency operation must be performed this protocol should be implemented to minimize risk to hospital personnel. The choice of operative approach (open or [minimally invasive surgery]) should take into consideration minimizing potential hazards to all members of the OR team,” according to the protocol.

©NIAID/Creative Commons License
The ACS has updated its webpage to include information on treating Ebola patients.

The document continues, “Although protocols for personal protective equipment (PPE) are in place to protect health care workers, there is no guideline for operating room personnel and surgical providers who might need to perform an operation on a patient with confirmed or suspected Ebola infection, therefore we have adapted relevant Centers for Disease Control recommendations and apply them specifically to the OR environment.”

Dr. David B. Hoyt, F.A.C.S., executive director of ACS, explains that, “the College, like other societies and various governmental entities, wants to do its part to share resources that may be helpful to the medical community and patients in the face of an emerging presence of Ebola, including this surgical protocol. It is important to emphasize, though, that what we learn about transmission, treatment, and protection will continue to evolve. Ultimately, I think all of us who are disseminating this and various other resources recognize that evidence-based guidelines will ultimately emerge. Until then we must be proactive in sharing even early recommendations from credible sources.”

Dr. David B. Hoyt

The resource page provides news, health care organization links, and other helpful information about Ebola. In addition, some guidance on surgical protocols is listed, including an overview of patient transport or transfer to the OR, a surgical checklist, protective equipment and draping, and special instrument requirements. A brief directive on how to handle cases of possible exposure of medical staff also is provided.

The ACS resource page will be updated as new information becomes available.

[email protected]

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The American College of Surgeons has posted a recommended surgical protocol for possible or confirmed Ebola cases on the Ebola virus transmission resource page. The protocol was developed by Dr. Sherry M. Wren, F.A.C.S., and Dr. Adam L. Kushner, M.P.H., F.A.C.S.

“Elective surgical procedures should not be performed in cases of suspected or confirmed Ebola. In cases where an emergency operation must be performed this protocol should be implemented to minimize risk to hospital personnel. The choice of operative approach (open or [minimally invasive surgery]) should take into consideration minimizing potential hazards to all members of the OR team,” according to the protocol.

©NIAID/Creative Commons License
The ACS has updated its webpage to include information on treating Ebola patients.

The document continues, “Although protocols for personal protective equipment (PPE) are in place to protect health care workers, there is no guideline for operating room personnel and surgical providers who might need to perform an operation on a patient with confirmed or suspected Ebola infection, therefore we have adapted relevant Centers for Disease Control recommendations and apply them specifically to the OR environment.”

Dr. David B. Hoyt, F.A.C.S., executive director of ACS, explains that, “the College, like other societies and various governmental entities, wants to do its part to share resources that may be helpful to the medical community and patients in the face of an emerging presence of Ebola, including this surgical protocol. It is important to emphasize, though, that what we learn about transmission, treatment, and protection will continue to evolve. Ultimately, I think all of us who are disseminating this and various other resources recognize that evidence-based guidelines will ultimately emerge. Until then we must be proactive in sharing even early recommendations from credible sources.”

Dr. David B. Hoyt

The resource page provides news, health care organization links, and other helpful information about Ebola. In addition, some guidance on surgical protocols is listed, including an overview of patient transport or transfer to the OR, a surgical checklist, protective equipment and draping, and special instrument requirements. A brief directive on how to handle cases of possible exposure of medical staff also is provided.

The ACS resource page will be updated as new information becomes available.

[email protected]

The American College of Surgeons has posted a recommended surgical protocol for possible or confirmed Ebola cases on the Ebola virus transmission resource page. The protocol was developed by Dr. Sherry M. Wren, F.A.C.S., and Dr. Adam L. Kushner, M.P.H., F.A.C.S.

“Elective surgical procedures should not be performed in cases of suspected or confirmed Ebola. In cases where an emergency operation must be performed this protocol should be implemented to minimize risk to hospital personnel. The choice of operative approach (open or [minimally invasive surgery]) should take into consideration minimizing potential hazards to all members of the OR team,” according to the protocol.

©NIAID/Creative Commons License
The ACS has updated its webpage to include information on treating Ebola patients.

The document continues, “Although protocols for personal protective equipment (PPE) are in place to protect health care workers, there is no guideline for operating room personnel and surgical providers who might need to perform an operation on a patient with confirmed or suspected Ebola infection, therefore we have adapted relevant Centers for Disease Control recommendations and apply them specifically to the OR environment.”

Dr. David B. Hoyt, F.A.C.S., executive director of ACS, explains that, “the College, like other societies and various governmental entities, wants to do its part to share resources that may be helpful to the medical community and patients in the face of an emerging presence of Ebola, including this surgical protocol. It is important to emphasize, though, that what we learn about transmission, treatment, and protection will continue to evolve. Ultimately, I think all of us who are disseminating this and various other resources recognize that evidence-based guidelines will ultimately emerge. Until then we must be proactive in sharing even early recommendations from credible sources.”

Dr. David B. Hoyt

The resource page provides news, health care organization links, and other helpful information about Ebola. In addition, some guidance on surgical protocols is listed, including an overview of patient transport or transfer to the OR, a surgical checklist, protective equipment and draping, and special instrument requirements. A brief directive on how to handle cases of possible exposure of medical staff also is provided.

The ACS resource page will be updated as new information becomes available.

[email protected]

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RA patients’ readmission rates after joint replacement are rising

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RA patients’ readmission rates after joint replacement are rising

Rheumatoid arthritis patients who have undergone a hip or knee replacement are more likely to be readmitted to a hospital than are patients with osteoarthritis, according to findings from a large prospective registry study.

The analysis revealed an increasing trend in the incidence of 90-day readmissions in the rheumatoid arthritis (RA) patients by year, at 5.8%, 8.9%, and 10.6% for 2009, 2010, and 2011, respectively, Dr. Jasvinder Singh of the Birmingham (Ala.) VA Medical Center and his colleagues reported (Arthritis Care Res. 2014 Oct. 9 [doi:10.1002/acr.22497]).

For osteoarthritis (OA) patients, the 90-day readmission rates were similar by year at 6.7%, 6.7%, and 6.8%, respectively. After accounting for differences, including the risk by year, the adjusted risk for 90-day readmission in RA patients was 0.89 (95% confidence interval, 0.46-1.71) in 2009, 1.34 (95% CI, 0.69-2.61) in 2010, and 1.74 (95% CI, 1.16-2.60) in 2011, compared with OA patients.

Readmission after an elective hip or knee replacement is a problem of significant public health proportions, the study authors noted. A 90-day readmission rate of 6.8% translates to more than 70,000 admissions annually in the United States, they said.

The investigators analyzed 34,311 joint replacement procedures during the 3-year period – 33,815 performed in OA patients and 496 in patients with RA.

Overall, 42 RA patients were readmitted over the 3-year period, and the two most common reasons for readmission were joint prosthesis infection (10.2%) and septicemia (10.2%). For the 2,277 OA patients who were readmitted, the most common reasons were joint prosthesis infection (5.7%) and other postoperative infections.

The finding of an increasing 90-day readmission over a 3-year period in RA patients was a particular concern. “We considered several patient, procedure, surgeon, and hospital variables as important covariates and adjusted for those that were significant (age, gender, American Society of Anesthesiologists category, and iron deficiency anemia) in our multivariable-adjusted model, indicating that the increasing readmission rate in RA patients is not explained by these variables,” they wrote.

The effects of medications and pre- and postoperative rehabilitation programs could have played a role in readmission rates in RA patients, but the authors did not have the information to analyze the impact of these factors.

No conflicts of interest were declared.

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Rheumatoid arthritis patients who have undergone a hip or knee replacement are more likely to be readmitted to a hospital than are patients with osteoarthritis, according to findings from a large prospective registry study.

The analysis revealed an increasing trend in the incidence of 90-day readmissions in the rheumatoid arthritis (RA) patients by year, at 5.8%, 8.9%, and 10.6% for 2009, 2010, and 2011, respectively, Dr. Jasvinder Singh of the Birmingham (Ala.) VA Medical Center and his colleagues reported (Arthritis Care Res. 2014 Oct. 9 [doi:10.1002/acr.22497]).

For osteoarthritis (OA) patients, the 90-day readmission rates were similar by year at 6.7%, 6.7%, and 6.8%, respectively. After accounting for differences, including the risk by year, the adjusted risk for 90-day readmission in RA patients was 0.89 (95% confidence interval, 0.46-1.71) in 2009, 1.34 (95% CI, 0.69-2.61) in 2010, and 1.74 (95% CI, 1.16-2.60) in 2011, compared with OA patients.

Readmission after an elective hip or knee replacement is a problem of significant public health proportions, the study authors noted. A 90-day readmission rate of 6.8% translates to more than 70,000 admissions annually in the United States, they said.

The investigators analyzed 34,311 joint replacement procedures during the 3-year period – 33,815 performed in OA patients and 496 in patients with RA.

Overall, 42 RA patients were readmitted over the 3-year period, and the two most common reasons for readmission were joint prosthesis infection (10.2%) and septicemia (10.2%). For the 2,277 OA patients who were readmitted, the most common reasons were joint prosthesis infection (5.7%) and other postoperative infections.

The finding of an increasing 90-day readmission over a 3-year period in RA patients was a particular concern. “We considered several patient, procedure, surgeon, and hospital variables as important covariates and adjusted for those that were significant (age, gender, American Society of Anesthesiologists category, and iron deficiency anemia) in our multivariable-adjusted model, indicating that the increasing readmission rate in RA patients is not explained by these variables,” they wrote.

The effects of medications and pre- and postoperative rehabilitation programs could have played a role in readmission rates in RA patients, but the authors did not have the information to analyze the impact of these factors.

No conflicts of interest were declared.

Rheumatoid arthritis patients who have undergone a hip or knee replacement are more likely to be readmitted to a hospital than are patients with osteoarthritis, according to findings from a large prospective registry study.

The analysis revealed an increasing trend in the incidence of 90-day readmissions in the rheumatoid arthritis (RA) patients by year, at 5.8%, 8.9%, and 10.6% for 2009, 2010, and 2011, respectively, Dr. Jasvinder Singh of the Birmingham (Ala.) VA Medical Center and his colleagues reported (Arthritis Care Res. 2014 Oct. 9 [doi:10.1002/acr.22497]).

For osteoarthritis (OA) patients, the 90-day readmission rates were similar by year at 6.7%, 6.7%, and 6.8%, respectively. After accounting for differences, including the risk by year, the adjusted risk for 90-day readmission in RA patients was 0.89 (95% confidence interval, 0.46-1.71) in 2009, 1.34 (95% CI, 0.69-2.61) in 2010, and 1.74 (95% CI, 1.16-2.60) in 2011, compared with OA patients.

Readmission after an elective hip or knee replacement is a problem of significant public health proportions, the study authors noted. A 90-day readmission rate of 6.8% translates to more than 70,000 admissions annually in the United States, they said.

The investigators analyzed 34,311 joint replacement procedures during the 3-year period – 33,815 performed in OA patients and 496 in patients with RA.

Overall, 42 RA patients were readmitted over the 3-year period, and the two most common reasons for readmission were joint prosthesis infection (10.2%) and septicemia (10.2%). For the 2,277 OA patients who were readmitted, the most common reasons were joint prosthesis infection (5.7%) and other postoperative infections.

The finding of an increasing 90-day readmission over a 3-year period in RA patients was a particular concern. “We considered several patient, procedure, surgeon, and hospital variables as important covariates and adjusted for those that were significant (age, gender, American Society of Anesthesiologists category, and iron deficiency anemia) in our multivariable-adjusted model, indicating that the increasing readmission rate in RA patients is not explained by these variables,” they wrote.

The effects of medications and pre- and postoperative rehabilitation programs could have played a role in readmission rates in RA patients, but the authors did not have the information to analyze the impact of these factors.

No conflicts of interest were declared.

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RA patients’ readmission rates after joint replacement are rising
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Key clinical point: The 90-day risk of readmission after hip or knee replacement surgery is higher in patients with RA, compared with patients with OA.

Major finding: Readmissions for RA patients climbed significantly each year studied, compared with OA patients.

Data source: A prospective analysis of data from a total joint replacement registry of adults with OA and RA.

Disclosures: No conflicts of interest were declared.

Bioprosthetic aortic valves may be a reasonable choice in younger patients

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Bioprosthetic aortic valves may be a reasonable choice in younger patients

No differences were seen in the 15-year stroke or survival rates in more than 4,000 propensity-matched patients in the age range of 50-69 years who received either a mechanical or a bioprosthetic aortic valve replacement, according to the results of a retrospective cohort analysis.

However, valves differed in two other major complications, according to a report published in the Oct. 1 issue of JAMA. Mechanical valve patients had a significantly higher 15-year cumulative incidence of bleeding compared with the bioprosthetic valve group, but had a significantly lower 15-year cumulative incidence of reoperation, according to Yuting P. Chiang and colleagues at the Icahn School of Medicine at Mount Sinai and Mount Sinai Medical Center, New York.

This study calls into question current practice guidelines, which recommend either a bioprosthetic or mechanical prosthetic aortic valve in patients aged 60-70 years, and a mechanical valve in patients younger than 60 years in the absence of a contraindication to warfarin (Coumadin), according to the researchers.

From an original population of more than 10,000 patients aged 50-69 with valve replacement, 4,253 remained after researchers applied exclusionary criteria such as prior valve repair and coronary artery bypass grafting. Of these, 1,466 (34.5%) received a bioprosthetic aortic valve replacement, and 2,787 received a mechanical valve.

Median follow-up was 10.6 and 10.9 years, respectively. Propensity scoring matching produced 1,001 patient pairs. After propensity matching, age and all baseline comorbidities were balanced between the two groups.

Overall, there were no differences in 30-day mortality in the matched groups (3% in both), nor in any other short-term outcome (JAMA 2014;312:1323-29).

In terms of long-term survival, there were no differences seen in the matched cohort, with an actuarial 15-year survival of 60.6% for the prosthetic valve group, and 62.1% for the mechanical valve group (P = .74).

Similarly, there was no significant difference in the cumulative 15-year stroke rate (7.7% for the bioprosthetic group, 8.6% for the mechanical group, P = .84). The 30-day mortality rate after stroke was 18.7%.

There was a significantly higher rate of aortic valve reoperation in the bioprosthetic group (cumulative 15-year incidence of 12.1%) compared with the mechanical group (cumulative incidence of 6.9%, P = .001). The 30-day mortality rate after aortic valve reoperation was 9.0%.

In contrast, cumulative major bleeding over 15 years was significantly higher in the mechanical group (13.0%), than in the bioprosthetic group (6.6%, P = .001). Thirty-day mortality after a major bleeding event was 13.2%.

In discussing the differences between this study and the randomized clinical trials that contributed to the class IIa recommendations on age-based valve choice, the researchers pointed out that two of the studies “enrolled patients nearly 4 decades ago and evaluated prostheses since superseded by more durable and less thrombogenic models.”

The analysis “supports the view that either prosthesis is a reasonable choice in patients aged 60 to 69 years and suggests that this recommendation could reasonably be extended to patients aged 50 to 59 years,” they concluded.

Potential problems inherent in a database analysis and the tendency for deaths at a younger age to be missing from the Social Security Death Master File were limitations of the study. Younger patients were more likely to receive a mechanical valve.

Mr. Chiang reported a research stipend from the Icahn School of Medicine, which receives royalty payments from Edwards Lifesciences and Medtronic related to two mitral valve and 1 tricuspid valve ring that Dr. David H. Adams, a coauthor, helped develop. Dr. Adams is coprincipal investigator for the CoreValve United States pivotal trial, supported by Medtronic.

[email protected]

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No differences were seen in the 15-year stroke or survival rates in more than 4,000 propensity-matched patients in the age range of 50-69 years who received either a mechanical or a bioprosthetic aortic valve replacement, according to the results of a retrospective cohort analysis.

However, valves differed in two other major complications, according to a report published in the Oct. 1 issue of JAMA. Mechanical valve patients had a significantly higher 15-year cumulative incidence of bleeding compared with the bioprosthetic valve group, but had a significantly lower 15-year cumulative incidence of reoperation, according to Yuting P. Chiang and colleagues at the Icahn School of Medicine at Mount Sinai and Mount Sinai Medical Center, New York.

This study calls into question current practice guidelines, which recommend either a bioprosthetic or mechanical prosthetic aortic valve in patients aged 60-70 years, and a mechanical valve in patients younger than 60 years in the absence of a contraindication to warfarin (Coumadin), according to the researchers.

From an original population of more than 10,000 patients aged 50-69 with valve replacement, 4,253 remained after researchers applied exclusionary criteria such as prior valve repair and coronary artery bypass grafting. Of these, 1,466 (34.5%) received a bioprosthetic aortic valve replacement, and 2,787 received a mechanical valve.

Median follow-up was 10.6 and 10.9 years, respectively. Propensity scoring matching produced 1,001 patient pairs. After propensity matching, age and all baseline comorbidities were balanced between the two groups.

Overall, there were no differences in 30-day mortality in the matched groups (3% in both), nor in any other short-term outcome (JAMA 2014;312:1323-29).

In terms of long-term survival, there were no differences seen in the matched cohort, with an actuarial 15-year survival of 60.6% for the prosthetic valve group, and 62.1% for the mechanical valve group (P = .74).

Similarly, there was no significant difference in the cumulative 15-year stroke rate (7.7% for the bioprosthetic group, 8.6% for the mechanical group, P = .84). The 30-day mortality rate after stroke was 18.7%.

There was a significantly higher rate of aortic valve reoperation in the bioprosthetic group (cumulative 15-year incidence of 12.1%) compared with the mechanical group (cumulative incidence of 6.9%, P = .001). The 30-day mortality rate after aortic valve reoperation was 9.0%.

In contrast, cumulative major bleeding over 15 years was significantly higher in the mechanical group (13.0%), than in the bioprosthetic group (6.6%, P = .001). Thirty-day mortality after a major bleeding event was 13.2%.

In discussing the differences between this study and the randomized clinical trials that contributed to the class IIa recommendations on age-based valve choice, the researchers pointed out that two of the studies “enrolled patients nearly 4 decades ago and evaluated prostheses since superseded by more durable and less thrombogenic models.”

The analysis “supports the view that either prosthesis is a reasonable choice in patients aged 60 to 69 years and suggests that this recommendation could reasonably be extended to patients aged 50 to 59 years,” they concluded.

Potential problems inherent in a database analysis and the tendency for deaths at a younger age to be missing from the Social Security Death Master File were limitations of the study. Younger patients were more likely to receive a mechanical valve.

Mr. Chiang reported a research stipend from the Icahn School of Medicine, which receives royalty payments from Edwards Lifesciences and Medtronic related to two mitral valve and 1 tricuspid valve ring that Dr. David H. Adams, a coauthor, helped develop. Dr. Adams is coprincipal investigator for the CoreValve United States pivotal trial, supported by Medtronic.

[email protected]

No differences were seen in the 15-year stroke or survival rates in more than 4,000 propensity-matched patients in the age range of 50-69 years who received either a mechanical or a bioprosthetic aortic valve replacement, according to the results of a retrospective cohort analysis.

However, valves differed in two other major complications, according to a report published in the Oct. 1 issue of JAMA. Mechanical valve patients had a significantly higher 15-year cumulative incidence of bleeding compared with the bioprosthetic valve group, but had a significantly lower 15-year cumulative incidence of reoperation, according to Yuting P. Chiang and colleagues at the Icahn School of Medicine at Mount Sinai and Mount Sinai Medical Center, New York.

This study calls into question current practice guidelines, which recommend either a bioprosthetic or mechanical prosthetic aortic valve in patients aged 60-70 years, and a mechanical valve in patients younger than 60 years in the absence of a contraindication to warfarin (Coumadin), according to the researchers.

From an original population of more than 10,000 patients aged 50-69 with valve replacement, 4,253 remained after researchers applied exclusionary criteria such as prior valve repair and coronary artery bypass grafting. Of these, 1,466 (34.5%) received a bioprosthetic aortic valve replacement, and 2,787 received a mechanical valve.

Median follow-up was 10.6 and 10.9 years, respectively. Propensity scoring matching produced 1,001 patient pairs. After propensity matching, age and all baseline comorbidities were balanced between the two groups.

Overall, there were no differences in 30-day mortality in the matched groups (3% in both), nor in any other short-term outcome (JAMA 2014;312:1323-29).

In terms of long-term survival, there were no differences seen in the matched cohort, with an actuarial 15-year survival of 60.6% for the prosthetic valve group, and 62.1% for the mechanical valve group (P = .74).

Similarly, there was no significant difference in the cumulative 15-year stroke rate (7.7% for the bioprosthetic group, 8.6% for the mechanical group, P = .84). The 30-day mortality rate after stroke was 18.7%.

There was a significantly higher rate of aortic valve reoperation in the bioprosthetic group (cumulative 15-year incidence of 12.1%) compared with the mechanical group (cumulative incidence of 6.9%, P = .001). The 30-day mortality rate after aortic valve reoperation was 9.0%.

In contrast, cumulative major bleeding over 15 years was significantly higher in the mechanical group (13.0%), than in the bioprosthetic group (6.6%, P = .001). Thirty-day mortality after a major bleeding event was 13.2%.

In discussing the differences between this study and the randomized clinical trials that contributed to the class IIa recommendations on age-based valve choice, the researchers pointed out that two of the studies “enrolled patients nearly 4 decades ago and evaluated prostheses since superseded by more durable and less thrombogenic models.”

The analysis “supports the view that either prosthesis is a reasonable choice in patients aged 60 to 69 years and suggests that this recommendation could reasonably be extended to patients aged 50 to 59 years,” they concluded.

Potential problems inherent in a database analysis and the tendency for deaths at a younger age to be missing from the Social Security Death Master File were limitations of the study. Younger patients were more likely to receive a mechanical valve.

Mr. Chiang reported a research stipend from the Icahn School of Medicine, which receives royalty payments from Edwards Lifesciences and Medtronic related to two mitral valve and 1 tricuspid valve ring that Dr. David H. Adams, a coauthor, helped develop. Dr. Adams is coprincipal investigator for the CoreValve United States pivotal trial, supported by Medtronic.

[email protected]

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Bioprosthetic aortic valves may be a reasonable choice in younger patients
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Key clinical point: Bioprosthetic and mechanical aortic valves were equivalent in stroke and survival rates across propensity-matched patients aged 50-69 years.

Major finding: Actuarial 15-year survival was 60.6% for bioprosthetic valves and 62.1% for mechanical valves.

Data source: A retrospective cohort analysis of 1,001 propensity-matched patient pairs who had a mechanical or bioprosthetic aortic valve replacement in New York State from 1997 through 2004.

Disclosures: Mr. Chiang reported a research stipend from the Icahn School of Medicine, which receives royalty payments from Edwards Lifesciences and Medtronic related to two mitral valve and 1 tricuspid valve ring that Dr. David H. Adams, a coauthor, helped develop. Dr. Adams is coprincipal investigator for the CoreValve United States pivotal trial, supported by Medtronic.