ACS Surgery News

SAN DIEGO – Delivery of a gene therapy viral vector designed to express only the gene for human growth factor to the nucleus basalis of Meynert in patients with mild to moderate Alzheimer’s disease appears to be safe and feasible, results from a first-in-human trial demonstrated.

"There are significant deficiencies with the therapies that exist for treating the memory and cognitive impairments of Alzheimer’s disease," Raymond T. Bartus, Ph.D., said at the Clinical Trials Conference on Alzheimer’s Disease.

Currently available cholinesterase inhibitors "are nonselective and suffer from serious dose-limiting side effects," said Dr. Bartus, president of San Diego–based RTBioconsultants. "Their mechanism of action for cholinergic enhancement is suboptimal, and they do not repair neurons, protect against death, or truly restore lost neuronal function. While they work to some extent, they are modest in their level of efficacy and do not improve symptoms in all patients. Moreover, they do nothing to affect the disease progression."

Nerve growth factor neurotrophic therapy, he continued, "should overcome all of these deficiencies and therefore provide a more effective therapy, applying a variation of the cholinergic approach that has shown proof of concept." Decades of research in animal models suggest that nerve growth factor "has remarkable antiapoptotic (i.e., antideath) and reparative properties for certain neurons in the degenerative brain," Dr. Bartus said. "There are at least two major obstacles to apply this technology to Alzheimer’s disease. The first is, Alzheimer’s is an extremely complicated disease, so determining where to target the treatment is especially important. Targeting the cholinergic neurons is compelling because their degeneration is known to contribute significantly to the memory loss."

The second key challenge, he said, is the need for constant exposure to cholinergic neurons that comprise the nucleus basalis of Meynert (NBM) while avoiding exposure to untargeted neuronal populations. This has proven very difficult in past efforts extending back 20 years. In the past decade, gene therapy combined with stereotactic surgery has emerged as a practical enabling technology to accomplish this. On this basis, Dr. Bartus and his associates at Ceregene (where he served as chief scientific officer for more than 10 years) developed a viral gene therapy vector bioengineered to express only the gene for human nerve growth factor (AAV2-NGF, or CERE-110).

"You can think of it as an off-the-shelf biopharmaceutical that when injected into the human brain will induce the target neurons to produce or express and secrete only nerve growth factor and therefore provide support to NBM cholinergic neurons," he explained. "Preclinical studies have demonstrated an orderly dose-response relationship with NGF restricted to targeted basal forebrain cholinergic neurons, and no side effects or toxicity, even after testing very high doses in animals. That was quite surprising and certainly welcome."

Dr. Bartus presented phase I clinical data from 10 patients aged 50-79 years with mild to moderate Alzheimer’s disease who received one of three ascending doses of AAV2-NGF via bilateral stereotactic injection into the nucleus basalis of Meynert: dose A (1.2 x 10¹⁰ viral genomes), dose B (5.8 x 10¹⁰ viral genomes; five times more than dose A), and dose C (1.2 x 10¹¹ viral genomes; two times more than dose B). Patients were followed at 24 months for safety and feasibility and preliminary efficacy as measured by 18-fluorodeoxyglucose PET scans at baseline, 6, 12, and 24 months; autopsy tissue; and validated neuropsychological tests that included the Alzheimer’s Disease Assessment Scale–Cognitive (ADAS-Cog). Computer graphic software was used to provide a 3-D model of the nucleus basalis of Meynert in an effort to "determine where to distribute CERE-110 in the NBM and how much should be given to achieve optimal NGF exposure."

Dr. Bartus reported that AAV2-NGF was safe and well tolerated through 24 months. Adverse events and serious adverse events "were uneventful," he said. "What you see is a profile that reflects either incidental or unrelated events, or those related to a surgical procedure (e.g., temporary headache)."

PET imaging showed no evidence of accelerated decline, and brain autopsy tissue from three patients who died of unrelated causes confirmed long-term, therapeutically active, gene-mediated NGF expression accurately targeted to the nucleus basalis of Meynert.

The researchers observed some deterioration over time based on the ADAS-Cog and other neuropsychological measures. "There is no clinical evidence that cognitive decline is accelerated, but we can’t speak to whether or not we actually improved rate of decline," Dr. Bartus said.

These findings formed the basis of a phase II trial currently underway that is funded by the National Institutes of Health under the auspices of the Alzheimer’s Disease Collaborative Study. Outcomes from that 24-month trial are expected in 2015.

The phase 1 study was funded by Ceregene, which was acquired in October 2013 by Sangamo BioSciences.

Dr. Bartus disclosed that he is a consultant for Sangamo BioSciences.

[email protected]

SAN DIEGO – Delivery of a gene therapy viral vector designed to express only the gene for human growth factor to the nucleus basalis of Meynert in patients with mild to moderate Alzheimer’s disease appears to be safe and feasible, results from a first-in-human trial demonstrated.

"There are significant deficiencies with the therapies that exist for treating the memory and cognitive impairments of Alzheimer’s disease," Raymond T. Bartus, Ph.D., said at the Clinical Trials Conference on Alzheimer’s Disease.

Currently available cholinesterase inhibitors "are nonselective and suffer from serious dose-limiting side effects," said Dr. Bartus, president of San Diego–based RTBioconsultants. "Their mechanism of action for cholinergic enhancement is suboptimal, and they do not repair neurons, protect against death, or truly restore lost neuronal function. While they work to some extent, they are modest in their level of efficacy and do not improve symptoms in all patients. Moreover, they do nothing to affect the disease progression."

Nerve growth factor neurotrophic therapy, he continued, "should overcome all of these deficiencies and therefore provide a more effective therapy, applying a variation of the cholinergic approach that has shown proof of concept." Decades of research in animal models suggest that nerve growth factor "has remarkable antiapoptotic (i.e., antideath) and reparative properties for certain neurons in the degenerative brain," Dr. Bartus said. "There are at least two major obstacles to apply this technology to Alzheimer’s disease. The first is, Alzheimer’s is an extremely complicated disease, so determining where to target the treatment is especially important. Targeting the cholinergic neurons is compelling because their degeneration is known to contribute significantly to the memory loss."

The second key challenge, he said, is the need for constant exposure to cholinergic neurons that comprise the nucleus basalis of Meynert (NBM) while avoiding exposure to untargeted neuronal populations. This has proven very difficult in past efforts extending back 20 years. In the past decade, gene therapy combined with stereotactic surgery has emerged as a practical enabling technology to accomplish this. On this basis, Dr. Bartus and his associates at Ceregene (where he served as chief scientific officer for more than 10 years) developed a viral gene therapy vector bioengineered to express only the gene for human nerve growth factor (AAV2-NGF, or CERE-110).

"You can think of it as an off-the-shelf biopharmaceutical that when injected into the human brain will induce the target neurons to produce or express and secrete only nerve growth factor and therefore provide support to NBM cholinergic neurons," he explained. "Preclinical studies have demonstrated an orderly dose-response relationship with NGF restricted to targeted basal forebrain cholinergic neurons, and no side effects or toxicity, even after testing very high doses in animals. That was quite surprising and certainly welcome."

Dr. Bartus presented phase I clinical data from 10 patients aged 50-79 years with mild to moderate Alzheimer’s disease who received one of three ascending doses of AAV2-NGF via bilateral stereotactic injection into the nucleus basalis of Meynert: dose A (1.2 x 10¹⁰ viral genomes), dose B (5.8 x 10¹⁰ viral genomes; five times more than dose A), and dose C (1.2 x 10¹¹ viral genomes; two times more than dose B). Patients were followed at 24 months for safety and feasibility and preliminary efficacy as measured by 18-fluorodeoxyglucose PET scans at baseline, 6, 12, and 24 months; autopsy tissue; and validated neuropsychological tests that included the Alzheimer’s Disease Assessment Scale–Cognitive (ADAS-Cog). Computer graphic software was used to provide a 3-D model of the nucleus basalis of Meynert in an effort to "determine where to distribute CERE-110 in the NBM and how much should be given to achieve optimal NGF exposure."

Dr. Bartus reported that AAV2-NGF was safe and well tolerated through 24 months. Adverse events and serious adverse events "were uneventful," he said. "What you see is a profile that reflects either incidental or unrelated events, or those related to a surgical procedure (e.g., temporary headache)."

PET imaging showed no evidence of accelerated decline, and brain autopsy tissue from three patients who died of unrelated causes confirmed long-term, therapeutically active, gene-mediated NGF expression accurately targeted to the nucleus basalis of Meynert.

The researchers observed some deterioration over time based on the ADAS-Cog and other neuropsychological measures. "There is no clinical evidence that cognitive decline is accelerated, but we can’t speak to whether or not we actually improved rate of decline," Dr. Bartus said.

These findings formed the basis of a phase II trial currently underway that is funded by the National Institutes of Health under the auspices of the Alzheimer’s Disease Collaborative Study. Outcomes from that 24-month trial are expected in 2015.

The phase 1 study was funded by Ceregene, which was acquired in October 2013 by Sangamo BioSciences.

Dr. Bartus disclosed that he is a consultant for Sangamo BioSciences.

[email protected]

SAN DIEGO – Delivery of a gene therapy viral vector designed to express only the gene for human growth factor to the nucleus basalis of Meynert in patients with mild to moderate Alzheimer’s disease appears to be safe and feasible, results from a first-in-human trial demonstrated.

"There are significant deficiencies with the therapies that exist for treating the memory and cognitive impairments of Alzheimer’s disease," Raymond T. Bartus, Ph.D., said at the Clinical Trials Conference on Alzheimer’s Disease.

Currently available cholinesterase inhibitors "are nonselective and suffer from serious dose-limiting side effects," said Dr. Bartus, president of San Diego–based RTBioconsultants. "Their mechanism of action for cholinergic enhancement is suboptimal, and they do not repair neurons, protect against death, or truly restore lost neuronal function. While they work to some extent, they are modest in their level of efficacy and do not improve symptoms in all patients. Moreover, they do nothing to affect the disease progression."

Nerve growth factor neurotrophic therapy, he continued, "should overcome all of these deficiencies and therefore provide a more effective therapy, applying a variation of the cholinergic approach that has shown proof of concept." Decades of research in animal models suggest that nerve growth factor "has remarkable antiapoptotic (i.e., antideath) and reparative properties for certain neurons in the degenerative brain," Dr. Bartus said. "There are at least two major obstacles to apply this technology to Alzheimer’s disease. The first is, Alzheimer’s is an extremely complicated disease, so determining where to target the treatment is especially important. Targeting the cholinergic neurons is compelling because their degeneration is known to contribute significantly to the memory loss."

The second key challenge, he said, is the need for constant exposure to cholinergic neurons that comprise the nucleus basalis of Meynert (NBM) while avoiding exposure to untargeted neuronal populations. This has proven very difficult in past efforts extending back 20 years. In the past decade, gene therapy combined with stereotactic surgery has emerged as a practical enabling technology to accomplish this. On this basis, Dr. Bartus and his associates at Ceregene (where he served as chief scientific officer for more than 10 years) developed a viral gene therapy vector bioengineered to express only the gene for human nerve growth factor (AAV2-NGF, or CERE-110).

"You can think of it as an off-the-shelf biopharmaceutical that when injected into the human brain will induce the target neurons to produce or express and secrete only nerve growth factor and therefore provide support to NBM cholinergic neurons," he explained. "Preclinical studies have demonstrated an orderly dose-response relationship with NGF restricted to targeted basal forebrain cholinergic neurons, and no side effects or toxicity, even after testing very high doses in animals. That was quite surprising and certainly welcome."

Dr. Bartus presented phase I clinical data from 10 patients aged 50-79 years with mild to moderate Alzheimer’s disease who received one of three ascending doses of AAV2-NGF via bilateral stereotactic injection into the nucleus basalis of Meynert: dose A (1.2 x 10¹⁰ viral genomes), dose B (5.8 x 10¹⁰ viral genomes; five times more than dose A), and dose C (1.2 x 10¹¹ viral genomes; two times more than dose B). Patients were followed at 24 months for safety and feasibility and preliminary efficacy as measured by 18-fluorodeoxyglucose PET scans at baseline, 6, 12, and 24 months; autopsy tissue; and validated neuropsychological tests that included the Alzheimer’s Disease Assessment Scale–Cognitive (ADAS-Cog). Computer graphic software was used to provide a 3-D model of the nucleus basalis of Meynert in an effort to "determine where to distribute CERE-110 in the NBM and how much should be given to achieve optimal NGF exposure."

Dr. Bartus reported that AAV2-NGF was safe and well tolerated through 24 months. Adverse events and serious adverse events "were uneventful," he said. "What you see is a profile that reflects either incidental or unrelated events, or those related to a surgical procedure (e.g., temporary headache)."

PET imaging showed no evidence of accelerated decline, and brain autopsy tissue from three patients who died of unrelated causes confirmed long-term, therapeutically active, gene-mediated NGF expression accurately targeted to the nucleus basalis of Meynert.

The researchers observed some deterioration over time based on the ADAS-Cog and other neuropsychological measures. "There is no clinical evidence that cognitive decline is accelerated, but we can’t speak to whether or not we actually improved rate of decline," Dr. Bartus said.

These findings formed the basis of a phase II trial currently underway that is funded by the National Institutes of Health under the auspices of the Alzheimer’s Disease Collaborative Study. Outcomes from that 24-month trial are expected in 2015.

The phase 1 study was funded by Ceregene, which was acquired in October 2013 by Sangamo BioSciences.

Dr. Bartus disclosed that he is a consultant for Sangamo BioSciences.

[email protected]

SAN FRANCISCO – Preoperative light transmission aggregometry assessments of platelet aggregation may help identify which patients on dual antiplatelet therapy are at greater risk of sustained bleeding from noncardiac surgery, a prospective study of 147 consecutive patients suggests.

The light transmission aggregometry (LTA) assessments of blood drawn immediately before noncardiac surgery were significantly lower in the 32% of patients with sustained bleeding than in the other patients.

All patients were on dual antiplatelet therapy, 95% of them on maintenance therapy with aspirin plus clopidogrel. The timing of the surgery was at the discretion of the surgeons. Treating physicians were blinded to LTA results. The average preoperative washout period for dual antiplatelet therapy was 1.5 days (range, 0-6 days).

The findings of the ongoing study might help define a "bleeding cutoff" measure by LTA to better individualize the timing of surgery, Dr. Wolfgang Toller and his associates suggested in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

In general, approximately 5% of patients in their first year of dual antiplatelet therapy undergo noncardiac surgery, which creates a conundrum for management. Discontinuing dual antiplatelet therapy before noncardiac surgery has been associated with a 20% risk of major adverse cardiac events, but there’s a 20%-40% risk of moderate to severe bleeding if dual antiplatelet therapy is continued during noncardiac surgery, said Dr. Toller of the Medical University of Graz, Austria.

The 147 patients in the study underwent vascular surgery (76%), orthopedic surgery (10%), abdominal surgery (7%), or other surgical procedures (7%). All had been on P2Y12 receptor inhibitors within 7 days before surgery.

Investigators used the Chronolog 700 Lumi-Aggregometer to assess platelet aggregation in preoperative blood, using 5 mcm of adenosine diphosphate as the specific inductor for platelet aggregation.

Overall, they found an average 40% maximum change in light transmission from baseline after adding the adenosine diphosphate to blood samples. In patients with increased bleeding, however, the mean maximum change in light transmission was approximately 30% (suggesting less platelet aggregation), compared with a more than 40% change in patients who bled less from the surgery.

The study used a composite definition of increased bleeding that included TIMI (Thrombolysis in Myocardial Infarction) criteria for major or minor bleeding, any postoperative bleeding requiring reoperation, any platelet transfusion, or at least two packed red blood cells more than the average surgery-specific transfusion requirements at the surgical site.

Dr. Toller reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Preoperative light transmission aggregometry assessments of platelet aggregation may help identify which patients on dual antiplatelet therapy are at greater risk of sustained bleeding from noncardiac surgery, a prospective study of 147 consecutive patients suggests.

The light transmission aggregometry (LTA) assessments of blood drawn immediately before noncardiac surgery were significantly lower in the 32% of patients with sustained bleeding than in the other patients.

All patients were on dual antiplatelet therapy, 95% of them on maintenance therapy with aspirin plus clopidogrel. The timing of the surgery was at the discretion of the surgeons. Treating physicians were blinded to LTA results. The average preoperative washout period for dual antiplatelet therapy was 1.5 days (range, 0-6 days).

The findings of the ongoing study might help define a "bleeding cutoff" measure by LTA to better individualize the timing of surgery, Dr. Wolfgang Toller and his associates suggested in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

In general, approximately 5% of patients in their first year of dual antiplatelet therapy undergo noncardiac surgery, which creates a conundrum for management. Discontinuing dual antiplatelet therapy before noncardiac surgery has been associated with a 20% risk of major adverse cardiac events, but there’s a 20%-40% risk of moderate to severe bleeding if dual antiplatelet therapy is continued during noncardiac surgery, said Dr. Toller of the Medical University of Graz, Austria.

The 147 patients in the study underwent vascular surgery (76%), orthopedic surgery (10%), abdominal surgery (7%), or other surgical procedures (7%). All had been on P2Y12 receptor inhibitors within 7 days before surgery.

Investigators used the Chronolog 700 Lumi-Aggregometer to assess platelet aggregation in preoperative blood, using 5 mcm of adenosine diphosphate as the specific inductor for platelet aggregation.

Overall, they found an average 40% maximum change in light transmission from baseline after adding the adenosine diphosphate to blood samples. In patients with increased bleeding, however, the mean maximum change in light transmission was approximately 30% (suggesting less platelet aggregation), compared with a more than 40% change in patients who bled less from the surgery.

The study used a composite definition of increased bleeding that included TIMI (Thrombolysis in Myocardial Infarction) criteria for major or minor bleeding, any postoperative bleeding requiring reoperation, any platelet transfusion, or at least two packed red blood cells more than the average surgery-specific transfusion requirements at the surgical site.

Dr. Toller reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Preoperative light transmission aggregometry assessments of platelet aggregation may help identify which patients on dual antiplatelet therapy are at greater risk of sustained bleeding from noncardiac surgery, a prospective study of 147 consecutive patients suggests.

The light transmission aggregometry (LTA) assessments of blood drawn immediately before noncardiac surgery were significantly lower in the 32% of patients with sustained bleeding than in the other patients.

All patients were on dual antiplatelet therapy, 95% of them on maintenance therapy with aspirin plus clopidogrel. The timing of the surgery was at the discretion of the surgeons. Treating physicians were blinded to LTA results. The average preoperative washout period for dual antiplatelet therapy was 1.5 days (range, 0-6 days).

The findings of the ongoing study might help define a "bleeding cutoff" measure by LTA to better individualize the timing of surgery, Dr. Wolfgang Toller and his associates suggested in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

In general, approximately 5% of patients in their first year of dual antiplatelet therapy undergo noncardiac surgery, which creates a conundrum for management. Discontinuing dual antiplatelet therapy before noncardiac surgery has been associated with a 20% risk of major adverse cardiac events, but there’s a 20%-40% risk of moderate to severe bleeding if dual antiplatelet therapy is continued during noncardiac surgery, said Dr. Toller of the Medical University of Graz, Austria.

The 147 patients in the study underwent vascular surgery (76%), orthopedic surgery (10%), abdominal surgery (7%), or other surgical procedures (7%). All had been on P2Y12 receptor inhibitors within 7 days before surgery.

Investigators used the Chronolog 700 Lumi-Aggregometer to assess platelet aggregation in preoperative blood, using 5 mcm of adenosine diphosphate as the specific inductor for platelet aggregation.

Overall, they found an average 40% maximum change in light transmission from baseline after adding the adenosine diphosphate to blood samples. In patients with increased bleeding, however, the mean maximum change in light transmission was approximately 30% (suggesting less platelet aggregation), compared with a more than 40% change in patients who bled less from the surgery.

The study used a composite definition of increased bleeding that included TIMI (Thrombolysis in Myocardial Infarction) criteria for major or minor bleeding, any postoperative bleeding requiring reoperation, any platelet transfusion, or at least two packed red blood cells more than the average surgery-specific transfusion requirements at the surgical site.

Dr. Toller reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

LAS VEGAS – A prediction model of seven combined risk factors provides a validated, individualized way to determine a patient’s risk for developing de novo stress urinary incontinence following pelvic prolapse surgery, a novel study showed.

"In women without stress urinary incontinence symptoms, prolapse surgery may cause de novo SUI in 16%-51% of patients," Dr. J. Eric Jelovsek said at the annual meeting of the American Urogynecologic Society.

"Recent studies have demonstrated effective prevention strategies, including prophylactic incontinence surgery such as concomitant midurethral sling or Burch urethropexy, and provided refined estimates of the average patient’s risk. While these studies have advanced our knowledge of the overall prevalence of de novo SUI, the risk prediction for a specific patient varies based on individual characteristics. A prediction model that more accurately predicts an individual’s risk may further help customize the shared decision-making process that occurs between a patient and her physician when planning for a concomitant continence operation," Dr. Jelovsek said.

In order to develop and validate a model to predict an individual’s risk of de novo SUI within 12 months of prolapse surgery, Dr. Jelovsek and his associates with the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Pelvic Floor Disorders Network used data from the OPUS (Outcomes Following Vaginal Prolapse Repair and Midurethral Sling) trial.

To externally validate the model, they also used data from the CARE (Colpopexy and Urinary Reduction Efforts) trial. The investigators identified 12 original preoperative patient and test characteristics commonly used to predict the risk of de novo SUI following surgery from the available data sets. They were increased age, white race, higher vaginal parity, higher body mass index (BMI), current smoker, current diagnosis of diabetes, strenuous physical activity, baseline urgency urinary incontinence symptoms, higher preoperative Pelvic Organ Prolapse Quantification (POP-Q) stage, higher POP-Q point Aa measure, positive preoperative prolapse reduction stress test, and performance of a concomitant retropubic midurethral sling.

"We hypothesized that all risk factors except for the performance of a concomitant [retropubic midurethral sling] would increase the risk of de novo SUI," said Dr. Jelovsek, who is director of the Cleveland Clinic Multidisciplinary Simulation Center. The outcome of the prediction model was defined as development of de novo SUI as determined by the response of "somewhat," "moderately," or "quite a bit" on the Pelvic Floor Distress Inventory (PFDI) questions 20-22, as these responses have been shown to be highly relevant outcomes to patients.

Of the 465 women in the OPUS trial, 457 had SUI data available 12 months after surgery. Of the 12 original risk factors hypothesized to predict de novo SUI, 7 final risk factors were identified that when combined together accurately predicted de novo SUI. They were decreased age, higher vaginal parity, higher BMI, current diagnosis of diabetes, baseline urgency urinary incontinence symptoms, positive preoperative prolapse reduction stress test, and performance of a concomitant retropubic midurethral sling.

"Contrary to our original hypothesis, as age increased, a participant’s risk of experiencing de novo SUI decreased when combined with other factors," Dr. Jelovsek said. The researchers created a calculator using the variables from the model for making predictions in a clinical setting.

He went on to report that the prediction model had useful discrimination between women who ultimately did or did not experience de novo SUI, with a concordance index of 0.73. The accuracy of the model on the entire CARE data set was also significantly better than that of random chance (a concordance index of 0.62) as well as that of using the preoperative prolapse reduction stress test alone (a concordance index of 0.54).

"Our model demonstrates good predictive accuracy, with a concordance index of 0.72 in women undergoing transvaginal prolapse surgery," Dr. Jelovsek said. "This compares favorably to the National Cancer Institute Gail Model for Breast Cancer (a concordance index of 0.59), and the Framingham Cardiovascular Risk Model (a concordance index of 0.72)."

He acknowledged certain limitations of the study, including the fact that although the model was better than random chance in predicting the probability of SUI after abdominal sacral colpopexy and Burch urethropexy in the CARE population, the accuracy was lower. "This may have been because women in the OPUS data set underwent sling with vaginal surgery for prolapse, while those in CARE underwent a Burch procedure and abdominal surgery," he explained.

"It is also possible that abdominal sacral colpopexy places a different amount of risk of de novo stress urinary incontinence on individuals than does vaginal surgery for pelvic organ prolapse. Despite this, a concordance index of 0.62 suggests that the model is also a valuable adjunct for shared decision-making between the clinician and patients prior to abdominal sacral colpopexy with Burch urethropexy surgery."

He said that future studies should include populations of women undergoing minimally invasive colpopexy.

Dr. Jelovsek said he had no relevant financial disclosures.

[email protected]

LAS VEGAS – A prediction model of seven combined risk factors provides a validated, individualized way to determine a patient’s risk for developing de novo stress urinary incontinence following pelvic prolapse surgery, a novel study showed.

"In women without stress urinary incontinence symptoms, prolapse surgery may cause de novo SUI in 16%-51% of patients," Dr. J. Eric Jelovsek said at the annual meeting of the American Urogynecologic Society.

"Recent studies have demonstrated effective prevention strategies, including prophylactic incontinence surgery such as concomitant midurethral sling or Burch urethropexy, and provided refined estimates of the average patient’s risk. While these studies have advanced our knowledge of the overall prevalence of de novo SUI, the risk prediction for a specific patient varies based on individual characteristics. A prediction model that more accurately predicts an individual’s risk may further help customize the shared decision-making process that occurs between a patient and her physician when planning for a concomitant continence operation," Dr. Jelovsek said.

In order to develop and validate a model to predict an individual’s risk of de novo SUI within 12 months of prolapse surgery, Dr. Jelovsek and his associates with the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Pelvic Floor Disorders Network used data from the OPUS (Outcomes Following Vaginal Prolapse Repair and Midurethral Sling) trial.

To externally validate the model, they also used data from the CARE (Colpopexy and Urinary Reduction Efforts) trial. The investigators identified 12 original preoperative patient and test characteristics commonly used to predict the risk of de novo SUI following surgery from the available data sets. They were increased age, white race, higher vaginal parity, higher body mass index (BMI), current smoker, current diagnosis of diabetes, strenuous physical activity, baseline urgency urinary incontinence symptoms, higher preoperative Pelvic Organ Prolapse Quantification (POP-Q) stage, higher POP-Q point Aa measure, positive preoperative prolapse reduction stress test, and performance of a concomitant retropubic midurethral sling.

"We hypothesized that all risk factors except for the performance of a concomitant [retropubic midurethral sling] would increase the risk of de novo SUI," said Dr. Jelovsek, who is director of the Cleveland Clinic Multidisciplinary Simulation Center. The outcome of the prediction model was defined as development of de novo SUI as determined by the response of "somewhat," "moderately," or "quite a bit" on the Pelvic Floor Distress Inventory (PFDI) questions 20-22, as these responses have been shown to be highly relevant outcomes to patients.

Of the 465 women in the OPUS trial, 457 had SUI data available 12 months after surgery. Of the 12 original risk factors hypothesized to predict de novo SUI, 7 final risk factors were identified that when combined together accurately predicted de novo SUI. They were decreased age, higher vaginal parity, higher BMI, current diagnosis of diabetes, baseline urgency urinary incontinence symptoms, positive preoperative prolapse reduction stress test, and performance of a concomitant retropubic midurethral sling.

"Contrary to our original hypothesis, as age increased, a participant’s risk of experiencing de novo SUI decreased when combined with other factors," Dr. Jelovsek said. The researchers created a calculator using the variables from the model for making predictions in a clinical setting.

He went on to report that the prediction model had useful discrimination between women who ultimately did or did not experience de novo SUI, with a concordance index of 0.73. The accuracy of the model on the entire CARE data set was also significantly better than that of random chance (a concordance index of 0.62) as well as that of using the preoperative prolapse reduction stress test alone (a concordance index of 0.54).

"Our model demonstrates good predictive accuracy, with a concordance index of 0.72 in women undergoing transvaginal prolapse surgery," Dr. Jelovsek said. "This compares favorably to the National Cancer Institute Gail Model for Breast Cancer (a concordance index of 0.59), and the Framingham Cardiovascular Risk Model (a concordance index of 0.72)."

He acknowledged certain limitations of the study, including the fact that although the model was better than random chance in predicting the probability of SUI after abdominal sacral colpopexy and Burch urethropexy in the CARE population, the accuracy was lower. "This may have been because women in the OPUS data set underwent sling with vaginal surgery for prolapse, while those in CARE underwent a Burch procedure and abdominal surgery," he explained.

"It is also possible that abdominal sacral colpopexy places a different amount of risk of de novo stress urinary incontinence on individuals than does vaginal surgery for pelvic organ prolapse. Despite this, a concordance index of 0.62 suggests that the model is also a valuable adjunct for shared decision-making between the clinician and patients prior to abdominal sacral colpopexy with Burch urethropexy surgery."

He said that future studies should include populations of women undergoing minimally invasive colpopexy.

Dr. Jelovsek said he had no relevant financial disclosures.

[email protected]

LAS VEGAS – A prediction model of seven combined risk factors provides a validated, individualized way to determine a patient’s risk for developing de novo stress urinary incontinence following pelvic prolapse surgery, a novel study showed.

"In women without stress urinary incontinence symptoms, prolapse surgery may cause de novo SUI in 16%-51% of patients," Dr. J. Eric Jelovsek said at the annual meeting of the American Urogynecologic Society.

"Recent studies have demonstrated effective prevention strategies, including prophylactic incontinence surgery such as concomitant midurethral sling or Burch urethropexy, and provided refined estimates of the average patient’s risk. While these studies have advanced our knowledge of the overall prevalence of de novo SUI, the risk prediction for a specific patient varies based on individual characteristics. A prediction model that more accurately predicts an individual’s risk may further help customize the shared decision-making process that occurs between a patient and her physician when planning for a concomitant continence operation," Dr. Jelovsek said.

In order to develop and validate a model to predict an individual’s risk of de novo SUI within 12 months of prolapse surgery, Dr. Jelovsek and his associates with the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Pelvic Floor Disorders Network used data from the OPUS (Outcomes Following Vaginal Prolapse Repair and Midurethral Sling) trial.

To externally validate the model, they also used data from the CARE (Colpopexy and Urinary Reduction Efforts) trial. The investigators identified 12 original preoperative patient and test characteristics commonly used to predict the risk of de novo SUI following surgery from the available data sets. They were increased age, white race, higher vaginal parity, higher body mass index (BMI), current smoker, current diagnosis of diabetes, strenuous physical activity, baseline urgency urinary incontinence symptoms, higher preoperative Pelvic Organ Prolapse Quantification (POP-Q) stage, higher POP-Q point Aa measure, positive preoperative prolapse reduction stress test, and performance of a concomitant retropubic midurethral sling.

"We hypothesized that all risk factors except for the performance of a concomitant [retropubic midurethral sling] would increase the risk of de novo SUI," said Dr. Jelovsek, who is director of the Cleveland Clinic Multidisciplinary Simulation Center. The outcome of the prediction model was defined as development of de novo SUI as determined by the response of "somewhat," "moderately," or "quite a bit" on the Pelvic Floor Distress Inventory (PFDI) questions 20-22, as these responses have been shown to be highly relevant outcomes to patients.

Of the 465 women in the OPUS trial, 457 had SUI data available 12 months after surgery. Of the 12 original risk factors hypothesized to predict de novo SUI, 7 final risk factors were identified that when combined together accurately predicted de novo SUI. They were decreased age, higher vaginal parity, higher BMI, current diagnosis of diabetes, baseline urgency urinary incontinence symptoms, positive preoperative prolapse reduction stress test, and performance of a concomitant retropubic midurethral sling.

"Contrary to our original hypothesis, as age increased, a participant’s risk of experiencing de novo SUI decreased when combined with other factors," Dr. Jelovsek said. The researchers created a calculator using the variables from the model for making predictions in a clinical setting.

He went on to report that the prediction model had useful discrimination between women who ultimately did or did not experience de novo SUI, with a concordance index of 0.73. The accuracy of the model on the entire CARE data set was also significantly better than that of random chance (a concordance index of 0.62) as well as that of using the preoperative prolapse reduction stress test alone (a concordance index of 0.54).

"Our model demonstrates good predictive accuracy, with a concordance index of 0.72 in women undergoing transvaginal prolapse surgery," Dr. Jelovsek said. "This compares favorably to the National Cancer Institute Gail Model for Breast Cancer (a concordance index of 0.59), and the Framingham Cardiovascular Risk Model (a concordance index of 0.72)."

He acknowledged certain limitations of the study, including the fact that although the model was better than random chance in predicting the probability of SUI after abdominal sacral colpopexy and Burch urethropexy in the CARE population, the accuracy was lower. "This may have been because women in the OPUS data set underwent sling with vaginal surgery for prolapse, while those in CARE underwent a Burch procedure and abdominal surgery," he explained.

"It is also possible that abdominal sacral colpopexy places a different amount of risk of de novo stress urinary incontinence on individuals than does vaginal surgery for pelvic organ prolapse. Despite this, a concordance index of 0.62 suggests that the model is also a valuable adjunct for shared decision-making between the clinician and patients prior to abdominal sacral colpopexy with Burch urethropexy surgery."

He said that future studies should include populations of women undergoing minimally invasive colpopexy.

Dr. Jelovsek said he had no relevant financial disclosures.

[email protected]

SYDNEY, AUSTRALIA – Video-assisted thoracoscopic partial pleurectomy significantly improved quality of life and control of pleural effusion compared with talc pleurodesis in patients with malignant mesothelioma in a randomized, controlled, multicenter trial.

However, pleurectomy did not increase overall survival in the study, based on data presented in a plenary session at a world conference on lung cancer.

"The problem we now have is, we’ve got a negative result and a positive result because of the primary endpoint, so detractors could say there’s a negative endpoint so there’s no role for surgery," lead researcher Dr. Robert Rintoul said in an interview at the meeting, which was sponsored by the International Association for the Study of Lung Cancer.

Courtesy Dr. Robert Rintoul

The MesoVATS trial is an open-label, parallel-group, multicenter trial that included 175 patients with malignant pleural mesothelioma and pleural effusion. Patients were randomized to either partial pleurectomy (n = 87) or talc pleurodesis with slurry or poudrage (n = 88).

At 1 year, survival rates were 57% in patients who received talc pleurodesis and 52% in those randomized to pleurectomy (hazard ratio, 1.03; 95% confidence interval, 0.76-1.42; P = .83).

In the secondary outcome measures, however, pleural effusion was controlled at 1 month in 37% of patients in the talc group and in 59% of patients in the pleurectomy group (P = .008). At 6 months, pleural effusion was controlled in 57% of talc and 76% of pleurectomy patients (P = .04). Control of pleural effusion did not significantly differ at 9 and 12 months.

The EQ-5D quality-of-life measure was significantly improved with pleurectomy versus talc at 6 months (mean difference, 0.08 [95% CI, 0.003-0.16; P = .042]). Quality of life at 12 months also was significantly better with pleurectomy, but this finding became nonsignificant after adjustment for bias due to missing data.

Median hospital stay was significantly longer in the pleurectomy group (8 vs. 6 days; P < .001), and complications such as prolonged air leak were seen in 26% of those in the surgery arm and 8% of the talc arm (P = .009). The groups did not differ significantly in the incidence of serious adverse events.

Previous, nonrandomized research had suggested that pleurectomy may be associated with increased survival and better control of pleural effusion.

While the study failed to find a significant effect of surgery on the primary endpoint of survival at 12 months, the improvements in quality of life were particularly relevant for patients with malignant mesothelioma, said Dr. Rintoul, consultant respiratory physician at Papworth Hospital, Cambridge, England. "Quality of life in those last 12-13 months of life is very important, and [surgery] is something that is fairly well tolerated and doesn’t require a lot longer hospital stay."

Although the surgical procedure was more expensive than talc pleurodesis, Dr. Rintoul said it was worth giving patients the choice.

No relevant conflicts of interest were declared.

SYDNEY, AUSTRALIA – Video-assisted thoracoscopic partial pleurectomy significantly improved quality of life and control of pleural effusion compared with talc pleurodesis in patients with malignant mesothelioma in a randomized, controlled, multicenter trial.

However, pleurectomy did not increase overall survival in the study, based on data presented in a plenary session at a world conference on lung cancer.

"The problem we now have is, we’ve got a negative result and a positive result because of the primary endpoint, so detractors could say there’s a negative endpoint so there’s no role for surgery," lead researcher Dr. Robert Rintoul said in an interview at the meeting, which was sponsored by the International Association for the Study of Lung Cancer.

Courtesy Dr. Robert Rintoul

The MesoVATS trial is an open-label, parallel-group, multicenter trial that included 175 patients with malignant pleural mesothelioma and pleural effusion. Patients were randomized to either partial pleurectomy (n = 87) or talc pleurodesis with slurry or poudrage (n = 88).

At 1 year, survival rates were 57% in patients who received talc pleurodesis and 52% in those randomized to pleurectomy (hazard ratio, 1.03; 95% confidence interval, 0.76-1.42; P = .83).

In the secondary outcome measures, however, pleural effusion was controlled at 1 month in 37% of patients in the talc group and in 59% of patients in the pleurectomy group (P = .008). At 6 months, pleural effusion was controlled in 57% of talc and 76% of pleurectomy patients (P = .04). Control of pleural effusion did not significantly differ at 9 and 12 months.

The EQ-5D quality-of-life measure was significantly improved with pleurectomy versus talc at 6 months (mean difference, 0.08 [95% CI, 0.003-0.16; P = .042]). Quality of life at 12 months also was significantly better with pleurectomy, but this finding became nonsignificant after adjustment for bias due to missing data.

Median hospital stay was significantly longer in the pleurectomy group (8 vs. 6 days; P < .001), and complications such as prolonged air leak were seen in 26% of those in the surgery arm and 8% of the talc arm (P = .009). The groups did not differ significantly in the incidence of serious adverse events.

Previous, nonrandomized research had suggested that pleurectomy may be associated with increased survival and better control of pleural effusion.

While the study failed to find a significant effect of surgery on the primary endpoint of survival at 12 months, the improvements in quality of life were particularly relevant for patients with malignant mesothelioma, said Dr. Rintoul, consultant respiratory physician at Papworth Hospital, Cambridge, England. "Quality of life in those last 12-13 months of life is very important, and [surgery] is something that is fairly well tolerated and doesn’t require a lot longer hospital stay."

Although the surgical procedure was more expensive than talc pleurodesis, Dr. Rintoul said it was worth giving patients the choice.

No relevant conflicts of interest were declared.

SYDNEY, AUSTRALIA – Video-assisted thoracoscopic partial pleurectomy significantly improved quality of life and control of pleural effusion compared with talc pleurodesis in patients with malignant mesothelioma in a randomized, controlled, multicenter trial.

However, pleurectomy did not increase overall survival in the study, based on data presented in a plenary session at a world conference on lung cancer.

"The problem we now have is, we’ve got a negative result and a positive result because of the primary endpoint, so detractors could say there’s a negative endpoint so there’s no role for surgery," lead researcher Dr. Robert Rintoul said in an interview at the meeting, which was sponsored by the International Association for the Study of Lung Cancer.

Courtesy Dr. Robert Rintoul

The MesoVATS trial is an open-label, parallel-group, multicenter trial that included 175 patients with malignant pleural mesothelioma and pleural effusion. Patients were randomized to either partial pleurectomy (n = 87) or talc pleurodesis with slurry or poudrage (n = 88).

At 1 year, survival rates were 57% in patients who received talc pleurodesis and 52% in those randomized to pleurectomy (hazard ratio, 1.03; 95% confidence interval, 0.76-1.42; P = .83).

In the secondary outcome measures, however, pleural effusion was controlled at 1 month in 37% of patients in the talc group and in 59% of patients in the pleurectomy group (P = .008). At 6 months, pleural effusion was controlled in 57% of talc and 76% of pleurectomy patients (P = .04). Control of pleural effusion did not significantly differ at 9 and 12 months.

The EQ-5D quality-of-life measure was significantly improved with pleurectomy versus talc at 6 months (mean difference, 0.08 [95% CI, 0.003-0.16; P = .042]). Quality of life at 12 months also was significantly better with pleurectomy, but this finding became nonsignificant after adjustment for bias due to missing data.

Median hospital stay was significantly longer in the pleurectomy group (8 vs. 6 days; P < .001), and complications such as prolonged air leak were seen in 26% of those in the surgery arm and 8% of the talc arm (P = .009). The groups did not differ significantly in the incidence of serious adverse events.

Previous, nonrandomized research had suggested that pleurectomy may be associated with increased survival and better control of pleural effusion.

While the study failed to find a significant effect of surgery on the primary endpoint of survival at 12 months, the improvements in quality of life were particularly relevant for patients with malignant mesothelioma, said Dr. Rintoul, consultant respiratory physician at Papworth Hospital, Cambridge, England. "Quality of life in those last 12-13 months of life is very important, and [surgery] is something that is fairly well tolerated and doesn’t require a lot longer hospital stay."

Although the surgical procedure was more expensive than talc pleurodesis, Dr. Rintoul said it was worth giving patients the choice.

No relevant conflicts of interest were declared.

During my mostly enjoyable 14 years as editor of a mainstream surgical publication, one of my less enjoyable but necessary functions was to detect and police author misconduct. Most instances of wrongdoing involved duplicate or redundant publication or the awarding of authorship when it was not deserved. I considered these infractions to be misdemeanors. The more serious sins of plagiarism and fabrication or falsification of data were considerably less common or at least infrequently detected. Based on my experience, one might conclude that most scientific findings are reported accurately and with integrity. In other words, we should be able to believe what we read. Unfortunately this may not be the case.

Compared to prior years, the past decade has seen a 10-fold increase in the number of articles retracted from the scientific literature. Although retractions account for well less than 1% of published articles, it is disturbing that fraudulent research and publishing rather than inadvertent errors underlie up to two-thirds of cases. Of note is that there appears to be a direct correlation between a journal\'s impact factor and the number of articles that are retracted from it. This may be due to a closer scrutiny by the scientific community of what initially were thought to be seminal contributions. Thus the limited number of retracted articles may, and probably does, represent the tip of an iceberg.

Deliberate fraud is an important issue in academic publishing, but an even greater problem is the abundance of poorly designed studies and the misuse of data. A significant fraction of the information available to us for clinical decision-making are underpowered studies with type I or II statistical errors, biased analyses, articles with data that cannot be reproduced by others, inappropriately done meta-analyses based on heterogeneous rather than homogeneous trials, and inaccurate conclusions based on erroneous manipulation of data.

In his analysis of the scientific literature in 2005, John Ioannidis, M.D., Ph.D. (PLoS 2:696-701) postulated that the majority of published articles were inaccurate. Flawed studies were more likely to result when sample sizes were small, the effect between tested variables was small, the number of tested relationships was large (at a P < .05, 5% will be statistically significant by chance), and conflicts of interest were present. Unsound studies were more likely to occur when they took place within popular and highly competitive scientific fields where the timing of publication was of the essence in order to claim primacy.

Compounding this cascade of misleading information is the reluctance of journals to publish negative studies, thereby giving greater weight to positive studies testing the same hypotheses.

These revelations regarding our research enterprise are not widely appreciated. In fact, in surveys of the public who are responsible for funding much of it with their tax dollars, biomedical research occupies an exalted position in comparison to most other endeavors. Why in recent times has it become tainted and what can be done to reverse the present trend? First, and probably most importantly, scientific research has become a highly competitive game. The battle for available research faculty positions in our universities is more intense than ever with room for only one of every six Ph.D. graduates. Once an appointment is attained, promotion and tenure are dependent on obtaining federal funding from an increasingly shrinking pool of money and publishing in high impact journals, many of which have rejection rates in excess of 90%. It is not surprising that minor or even major massaging of data to reach the magic 0.05 P value is probably not uncommon. Surveys of scientists regarding misconduct indicate that up to 20% have either participated in questionable practices themselves or know of colleagues who have.

The onus is not only on the researcher. Journal peer reviewers and editors are exerting much of their effort in looking for the rare seminal paper that would be attractive to their readers. Less attention is paid to the details of scientific rigor. Negative studies and those that are only confirmatory of previously published investigations are generally not given high enough grades to reach the threshold for publication.

Science has and continues to contribute much to the quality of human life. Most research scientists in the academic world operate with integrity and make a sincere effort to uncover truth in their fields. Marginally done and underpowered studies are the culprits leading to misinformation much more often than are issues of scientific honesty.

So what is to be done to right a somewhat listing research enterprise? From the researcher’s perspective, more attention to study design and rigid adherence to it to avoid bias is essential. Pre-study statistical consultation, especially regarding power calculation, is also a key to obtaining reliable results and conclusions. The editorial boards and editors of journals need to be more accepting of negative and confirmatory analyses than they have been in the past. The recent stance of most reputable journals to require registration of all clinical trials and to provide the data from those trials, positive or negative, to one of several web based repositories for review by others is a step in the right direction. It is the responsibility of our academic institutions to detect and police poor research design and implementation in addition to outright academic misconduct and, when necessary, to change the culture within their research establishments. Finally, it behooves us as readers and consumers of new information to realize that science marches forward in only small incremental steps. Important new findings need to be confirmed before they are adopted. The adage of never being the first to accept the new or the last to abandon the old still conveys a great deal of wisdom.

Dr. Rikkers is Editor in Chief of Surgery News.

During my mostly enjoyable 14 years as editor of a mainstream surgical publication, one of my less enjoyable but necessary functions was to detect and police author misconduct. Most instances of wrongdoing involved duplicate or redundant publication or the awarding of authorship when it was not deserved. I considered these infractions to be misdemeanors. The more serious sins of plagiarism and fabrication or falsification of data were considerably less common or at least infrequently detected. Based on my experience, one might conclude that most scientific findings are reported accurately and with integrity. In other words, we should be able to believe what we read. Unfortunately this may not be the case.

Compared to prior years, the past decade has seen a 10-fold increase in the number of articles retracted from the scientific literature. Although retractions account for well less than 1% of published articles, it is disturbing that fraudulent research and publishing rather than inadvertent errors underlie up to two-thirds of cases. Of note is that there appears to be a direct correlation between a journal\'s impact factor and the number of articles that are retracted from it. This may be due to a closer scrutiny by the scientific community of what initially were thought to be seminal contributions. Thus the limited number of retracted articles may, and probably does, represent the tip of an iceberg.

Deliberate fraud is an important issue in academic publishing, but an even greater problem is the abundance of poorly designed studies and the misuse of data. A significant fraction of the information available to us for clinical decision-making are underpowered studies with type I or II statistical errors, biased analyses, articles with data that cannot be reproduced by others, inappropriately done meta-analyses based on heterogeneous rather than homogeneous trials, and inaccurate conclusions based on erroneous manipulation of data.

In his analysis of the scientific literature in 2005, John Ioannidis, M.D., Ph.D. (PLoS 2:696-701) postulated that the majority of published articles were inaccurate. Flawed studies were more likely to result when sample sizes were small, the effect between tested variables was small, the number of tested relationships was large (at a P < .05, 5% will be statistically significant by chance), and conflicts of interest were present. Unsound studies were more likely to occur when they took place within popular and highly competitive scientific fields where the timing of publication was of the essence in order to claim primacy.

Compounding this cascade of misleading information is the reluctance of journals to publish negative studies, thereby giving greater weight to positive studies testing the same hypotheses.

These revelations regarding our research enterprise are not widely appreciated. In fact, in surveys of the public who are responsible for funding much of it with their tax dollars, biomedical research occupies an exalted position in comparison to most other endeavors. Why in recent times has it become tainted and what can be done to reverse the present trend? First, and probably most importantly, scientific research has become a highly competitive game. The battle for available research faculty positions in our universities is more intense than ever with room for only one of every six Ph.D. graduates. Once an appointment is attained, promotion and tenure are dependent on obtaining federal funding from an increasingly shrinking pool of money and publishing in high impact journals, many of which have rejection rates in excess of 90%. It is not surprising that minor or even major massaging of data to reach the magic 0.05 P value is probably not uncommon. Surveys of scientists regarding misconduct indicate that up to 20% have either participated in questionable practices themselves or know of colleagues who have.

The onus is not only on the researcher. Journal peer reviewers and editors are exerting much of their effort in looking for the rare seminal paper that would be attractive to their readers. Less attention is paid to the details of scientific rigor. Negative studies and those that are only confirmatory of previously published investigations are generally not given high enough grades to reach the threshold for publication.

Science has and continues to contribute much to the quality of human life. Most research scientists in the academic world operate with integrity and make a sincere effort to uncover truth in their fields. Marginally done and underpowered studies are the culprits leading to misinformation much more often than are issues of scientific honesty.

So what is to be done to right a somewhat listing research enterprise? From the researcher’s perspective, more attention to study design and rigid adherence to it to avoid bias is essential. Pre-study statistical consultation, especially regarding power calculation, is also a key to obtaining reliable results and conclusions. The editorial boards and editors of journals need to be more accepting of negative and confirmatory analyses than they have been in the past. The recent stance of most reputable journals to require registration of all clinical trials and to provide the data from those trials, positive or negative, to one of several web based repositories for review by others is a step in the right direction. It is the responsibility of our academic institutions to detect and police poor research design and implementation in addition to outright academic misconduct and, when necessary, to change the culture within their research establishments. Finally, it behooves us as readers and consumers of new information to realize that science marches forward in only small incremental steps. Important new findings need to be confirmed before they are adopted. The adage of never being the first to accept the new or the last to abandon the old still conveys a great deal of wisdom.

Dr. Rikkers is Editor in Chief of Surgery News.

During my mostly enjoyable 14 years as editor of a mainstream surgical publication, one of my less enjoyable but necessary functions was to detect and police author misconduct. Most instances of wrongdoing involved duplicate or redundant publication or the awarding of authorship when it was not deserved. I considered these infractions to be misdemeanors. The more serious sins of plagiarism and fabrication or falsification of data were considerably less common or at least infrequently detected. Based on my experience, one might conclude that most scientific findings are reported accurately and with integrity. In other words, we should be able to believe what we read. Unfortunately this may not be the case.

Compared to prior years, the past decade has seen a 10-fold increase in the number of articles retracted from the scientific literature. Although retractions account for well less than 1% of published articles, it is disturbing that fraudulent research and publishing rather than inadvertent errors underlie up to two-thirds of cases. Of note is that there appears to be a direct correlation between a journal\'s impact factor and the number of articles that are retracted from it. This may be due to a closer scrutiny by the scientific community of what initially were thought to be seminal contributions. Thus the limited number of retracted articles may, and probably does, represent the tip of an iceberg.

Deliberate fraud is an important issue in academic publishing, but an even greater problem is the abundance of poorly designed studies and the misuse of data. A significant fraction of the information available to us for clinical decision-making are underpowered studies with type I or II statistical errors, biased analyses, articles with data that cannot be reproduced by others, inappropriately done meta-analyses based on heterogeneous rather than homogeneous trials, and inaccurate conclusions based on erroneous manipulation of data.

In his analysis of the scientific literature in 2005, John Ioannidis, M.D., Ph.D. (PLoS 2:696-701) postulated that the majority of published articles were inaccurate. Flawed studies were more likely to result when sample sizes were small, the effect between tested variables was small, the number of tested relationships was large (at a P < .05, 5% will be statistically significant by chance), and conflicts of interest were present. Unsound studies were more likely to occur when they took place within popular and highly competitive scientific fields where the timing of publication was of the essence in order to claim primacy.

Compounding this cascade of misleading information is the reluctance of journals to publish negative studies, thereby giving greater weight to positive studies testing the same hypotheses.

These revelations regarding our research enterprise are not widely appreciated. In fact, in surveys of the public who are responsible for funding much of it with their tax dollars, biomedical research occupies an exalted position in comparison to most other endeavors. Why in recent times has it become tainted and what can be done to reverse the present trend? First, and probably most importantly, scientific research has become a highly competitive game. The battle for available research faculty positions in our universities is more intense than ever with room for only one of every six Ph.D. graduates. Once an appointment is attained, promotion and tenure are dependent on obtaining federal funding from an increasingly shrinking pool of money and publishing in high impact journals, many of which have rejection rates in excess of 90%. It is not surprising that minor or even major massaging of data to reach the magic 0.05 P value is probably not uncommon. Surveys of scientists regarding misconduct indicate that up to 20% have either participated in questionable practices themselves or know of colleagues who have.

The onus is not only on the researcher. Journal peer reviewers and editors are exerting much of their effort in looking for the rare seminal paper that would be attractive to their readers. Less attention is paid to the details of scientific rigor. Negative studies and those that are only confirmatory of previously published investigations are generally not given high enough grades to reach the threshold for publication.

Science has and continues to contribute much to the quality of human life. Most research scientists in the academic world operate with integrity and make a sincere effort to uncover truth in their fields. Marginally done and underpowered studies are the culprits leading to misinformation much more often than are issues of scientific honesty.

So what is to be done to right a somewhat listing research enterprise? From the researcher’s perspective, more attention to study design and rigid adherence to it to avoid bias is essential. Pre-study statistical consultation, especially regarding power calculation, is also a key to obtaining reliable results and conclusions. The editorial boards and editors of journals need to be more accepting of negative and confirmatory analyses than they have been in the past. The recent stance of most reputable journals to require registration of all clinical trials and to provide the data from those trials, positive or negative, to one of several web based repositories for review by others is a step in the right direction. It is the responsibility of our academic institutions to detect and police poor research design and implementation in addition to outright academic misconduct and, when necessary, to change the culture within their research establishments. Finally, it behooves us as readers and consumers of new information to realize that science marches forward in only small incremental steps. Important new findings need to be confirmed before they are adopted. The adage of never being the first to accept the new or the last to abandon the old still conveys a great deal of wisdom.

Dr. Rikkers is Editor in Chief of Surgery News.

Campaign pushes doctors to be the best

"YES"

Of all the tools at a physician’s disposal, the pen – and now the mouse – is among the most powerful. In a system that rewards physicians for doing more, it is no surprise that more is done. More tests and more procedures – often leading to more waste and more potential harm to patients.

In the Choosing Wisely campaign, I see professionalism at its highest level, as the campaign calls on physicians to be the very best doctors they can be for their patients. Nearly 60 societies have joined; by early next year, they will have issued more than 300 recommendations of tests and procedures they say are overused or unnecessary, based on the latest research and evidence. While we strive to embody professional values, clearly there are many areas in which we are doing things that do not benefit our patients.

Can Choosing Wisely improve quality of care? It already is. Systems are beginning to embed conversations on overuse—the aspiration of the campaign—into their cultures through electronic health records (EHR) and other constructs. For example, Cedars-Sinai Medical Center has incorporated 120 Choosing Wisely recommendations into its EHR system. When a physician orders tests, procedures, or medications that may be unwarranted or pose unnecessary risks, the system alerts the physician and provides information on the relevant Choosing Wisely recommendation.

Inspired by the campaign, Kaiser Permanente conducted an institutional review and has launched projects to reduce overuse of imaging in five areas: for uncomplicated headaches; of carotids for syncope without neurologic symptoms; for low back pain; for adnexal cysts; and for pulmonary embolism with low probability. In those areas, it is performing chart reviews to determine how widespread overuse really is. In the case of imaging for uncomplicated headaches, Kaiser Permanente found that 25% of employed physicians’ orders were unnecessary.

These are just two examples, and we are hearing many more as additional organizations join the effort and the ABIM Foundation’s 22 grantees advance projects in their communities.

There are some critics that say the campaign should address liability or tort reform. Those criticisms are misdirected—that’s not what Choosing Wisely is about. It is about conversations between physicians and patients aimed at getting the best care possible.

Choosing Wisely will help improve quality of care because it allows us – physicians and patients together – to find common ground by identifying areas in which we can avoid harm and helping change the mindset "more is better."

Reducing waste and improving care is complicated, but I am optimistic we are headed in the right direction. Physician leadership exemplified by Choosing Wisely has created spaces for us to have productive conversations about how we can work together to provide better care to all.

Dr. Richard Baron is the president and CEO of the ABIM Foundation, which spearheads the "Choosing Wisely" campaign.

Campaign lacks standard for ‘unnecessary’

"NO"

The Choosing Wisely campaign has the noble intent of trying to improve the quality of medical care in this country by decreasing the amount of unnecessary testing being performed. Many Choosing Wisely recommendations appear reasonable, yet many other recommendations may decrease the quality of medical care while increasing legal liability.

Perhaps the biggest flaw in the Choosing Wisely initiative is a lack of uniform metrics. It is easy to assert that a test is unnecessary, but what criteria are used to reliably and prospectively define what is necessary? Cost basis? Sensitivity? Negative predictive value? Failing to have a standard definition for "unnecessary" medical care invites hindsight bias into the determination of a test’s utility. Similarly, it is disingenuous to assert that Choosing Wisely will enhance the quality of medical care without first defining and vetting specific quality benchmarks. How can we improve quality when we haven’t even defined quality?

While some Choosing Wisely recommendations have a clear benefit (antibiotics just won’t cure children’s coughs), clinicians who follow other Choosing Wisely recommendations will inevitably miss more heart attacks, more pulmonary emboli, and more treatable cancers. Of course, the number of diagnostic misses will amount to only a small percentage of patients who would have otherwise received the unnecessary testing, but with more than 1 billion yearly outpatient medical visits in this country, that small percentage may total tens of thousands of patients with potential adverse outcomes caused by following Choosing Wisely recommendations.

According to the Institute of Medicine, up to 98,000 patients die from avoidable medical errors each year. Missed diagnoses account not only for a substantial portion of those avoidable deaths but are also the most common cause of malpractice litigation in the United States. Rest assured that when a physician withholds testing to decrease government expenditures, few state medical boards, fewer juries, and no patients will deem it "quality" medical care when a diagnosis is missed. We won’t convince the public that a preventable death from an undiagnosed pulmonary embolism resulted from adherence to a "quality" initiative. When bad outcomes occur, patients won’t thank us for being stewards of medical resources.

Fortunately, an increase in the overall quality of medical care should decrease legal liability, right? Perhaps not. Rather than inspiring confidence that use of its recommendations will save costs, improve quality, and decrease harm, Choosing Wisely acknowledges the opposite by trying to impose added liability for using its recommendations on the very people whose decision making it seeks to change. "The use of this report is at your own risk ... the ABIM Foundation ... [is] not liable for any loss, injury, or other damage related to your use of this report."

The Choosing Wisely site has many thoughtful recommendations, but don’t be misled: Many Choosing Wisely guidelines are more concerned with cost reduction than they are with quality improvement, regardless of the definition of "quality" we choose to use.

Dr. William Sullivan is an emergency physician, a past president of the Illinois College of Emergency Physicians, and has a private law practice in Frankfort, Ill.

Campaign pushes doctors to be the best

"YES"

Of all the tools at a physician’s disposal, the pen – and now the mouse – is among the most powerful. In a system that rewards physicians for doing more, it is no surprise that more is done. More tests and more procedures – often leading to more waste and more potential harm to patients.

In the Choosing Wisely campaign, I see professionalism at its highest level, as the campaign calls on physicians to be the very best doctors they can be for their patients. Nearly 60 societies have joined; by early next year, they will have issued more than 300 recommendations of tests and procedures they say are overused or unnecessary, based on the latest research and evidence. While we strive to embody professional values, clearly there are many areas in which we are doing things that do not benefit our patients.

Can Choosing Wisely improve quality of care? It already is. Systems are beginning to embed conversations on overuse—the aspiration of the campaign—into their cultures through electronic health records (EHR) and other constructs. For example, Cedars-Sinai Medical Center has incorporated 120 Choosing Wisely recommendations into its EHR system. When a physician orders tests, procedures, or medications that may be unwarranted or pose unnecessary risks, the system alerts the physician and provides information on the relevant Choosing Wisely recommendation.

Inspired by the campaign, Kaiser Permanente conducted an institutional review and has launched projects to reduce overuse of imaging in five areas: for uncomplicated headaches; of carotids for syncope without neurologic symptoms; for low back pain; for adnexal cysts; and for pulmonary embolism with low probability. In those areas, it is performing chart reviews to determine how widespread overuse really is. In the case of imaging for uncomplicated headaches, Kaiser Permanente found that 25% of employed physicians’ orders were unnecessary.

These are just two examples, and we are hearing many more as additional organizations join the effort and the ABIM Foundation’s 22 grantees advance projects in their communities.

There are some critics that say the campaign should address liability or tort reform. Those criticisms are misdirected—that’s not what Choosing Wisely is about. It is about conversations between physicians and patients aimed at getting the best care possible.

Choosing Wisely will help improve quality of care because it allows us – physicians and patients together – to find common ground by identifying areas in which we can avoid harm and helping change the mindset "more is better."

Reducing waste and improving care is complicated, but I am optimistic we are headed in the right direction. Physician leadership exemplified by Choosing Wisely has created spaces for us to have productive conversations about how we can work together to provide better care to all.

Dr. Richard Baron is the president and CEO of the ABIM Foundation, which spearheads the "Choosing Wisely" campaign.

Campaign lacks standard for ‘unnecessary’

"NO"

The Choosing Wisely campaign has the noble intent of trying to improve the quality of medical care in this country by decreasing the amount of unnecessary testing being performed. Many Choosing Wisely recommendations appear reasonable, yet many other recommendations may decrease the quality of medical care while increasing legal liability.

Perhaps the biggest flaw in the Choosing Wisely initiative is a lack of uniform metrics. It is easy to assert that a test is unnecessary, but what criteria are used to reliably and prospectively define what is necessary? Cost basis? Sensitivity? Negative predictive value? Failing to have a standard definition for "unnecessary" medical care invites hindsight bias into the determination of a test’s utility. Similarly, it is disingenuous to assert that Choosing Wisely will enhance the quality of medical care without first defining and vetting specific quality benchmarks. How can we improve quality when we haven’t even defined quality?

While some Choosing Wisely recommendations have a clear benefit (antibiotics just won’t cure children’s coughs), clinicians who follow other Choosing Wisely recommendations will inevitably miss more heart attacks, more pulmonary emboli, and more treatable cancers. Of course, the number of diagnostic misses will amount to only a small percentage of patients who would have otherwise received the unnecessary testing, but with more than 1 billion yearly outpatient medical visits in this country, that small percentage may total tens of thousands of patients with potential adverse outcomes caused by following Choosing Wisely recommendations.

According to the Institute of Medicine, up to 98,000 patients die from avoidable medical errors each year. Missed diagnoses account not only for a substantial portion of those avoidable deaths but are also the most common cause of malpractice litigation in the United States. Rest assured that when a physician withholds testing to decrease government expenditures, few state medical boards, fewer juries, and no patients will deem it "quality" medical care when a diagnosis is missed. We won’t convince the public that a preventable death from an undiagnosed pulmonary embolism resulted from adherence to a "quality" initiative. When bad outcomes occur, patients won’t thank us for being stewards of medical resources.

Fortunately, an increase in the overall quality of medical care should decrease legal liability, right? Perhaps not. Rather than inspiring confidence that use of its recommendations will save costs, improve quality, and decrease harm, Choosing Wisely acknowledges the opposite by trying to impose added liability for using its recommendations on the very people whose decision making it seeks to change. "The use of this report is at your own risk ... the ABIM Foundation ... [is] not liable for any loss, injury, or other damage related to your use of this report."

The Choosing Wisely site has many thoughtful recommendations, but don’t be misled: Many Choosing Wisely guidelines are more concerned with cost reduction than they are with quality improvement, regardless of the definition of "quality" we choose to use.

Dr. William Sullivan is an emergency physician, a past president of the Illinois College of Emergency Physicians, and has a private law practice in Frankfort, Ill.

Campaign pushes doctors to be the best

"YES"

Of all the tools at a physician’s disposal, the pen – and now the mouse – is among the most powerful. In a system that rewards physicians for doing more, it is no surprise that more is done. More tests and more procedures – often leading to more waste and more potential harm to patients.

In the Choosing Wisely campaign, I see professionalism at its highest level, as the campaign calls on physicians to be the very best doctors they can be for their patients. Nearly 60 societies have joined; by early next year, they will have issued more than 300 recommendations of tests and procedures they say are overused or unnecessary, based on the latest research and evidence. While we strive to embody professional values, clearly there are many areas in which we are doing things that do not benefit our patients.

Can Choosing Wisely improve quality of care? It already is. Systems are beginning to embed conversations on overuse—the aspiration of the campaign—into their cultures through electronic health records (EHR) and other constructs. For example, Cedars-Sinai Medical Center has incorporated 120 Choosing Wisely recommendations into its EHR system. When a physician orders tests, procedures, or medications that may be unwarranted or pose unnecessary risks, the system alerts the physician and provides information on the relevant Choosing Wisely recommendation.

Inspired by the campaign, Kaiser Permanente conducted an institutional review and has launched projects to reduce overuse of imaging in five areas: for uncomplicated headaches; of carotids for syncope without neurologic symptoms; for low back pain; for adnexal cysts; and for pulmonary embolism with low probability. In those areas, it is performing chart reviews to determine how widespread overuse really is. In the case of imaging for uncomplicated headaches, Kaiser Permanente found that 25% of employed physicians’ orders were unnecessary.

These are just two examples, and we are hearing many more as additional organizations join the effort and the ABIM Foundation’s 22 grantees advance projects in their communities.

There are some critics that say the campaign should address liability or tort reform. Those criticisms are misdirected—that’s not what Choosing Wisely is about. It is about conversations between physicians and patients aimed at getting the best care possible.

Choosing Wisely will help improve quality of care because it allows us – physicians and patients together – to find common ground by identifying areas in which we can avoid harm and helping change the mindset "more is better."

Reducing waste and improving care is complicated, but I am optimistic we are headed in the right direction. Physician leadership exemplified by Choosing Wisely has created spaces for us to have productive conversations about how we can work together to provide better care to all.

Dr. Richard Baron is the president and CEO of the ABIM Foundation, which spearheads the "Choosing Wisely" campaign.

Campaign lacks standard for ‘unnecessary’

"NO"

The Choosing Wisely campaign has the noble intent of trying to improve the quality of medical care in this country by decreasing the amount of unnecessary testing being performed. Many Choosing Wisely recommendations appear reasonable, yet many other recommendations may decrease the quality of medical care while increasing legal liability.

Perhaps the biggest flaw in the Choosing Wisely initiative is a lack of uniform metrics. It is easy to assert that a test is unnecessary, but what criteria are used to reliably and prospectively define what is necessary? Cost basis? Sensitivity? Negative predictive value? Failing to have a standard definition for "unnecessary" medical care invites hindsight bias into the determination of a test’s utility. Similarly, it is disingenuous to assert that Choosing Wisely will enhance the quality of medical care without first defining and vetting specific quality benchmarks. How can we improve quality when we haven’t even defined quality?

While some Choosing Wisely recommendations have a clear benefit (antibiotics just won’t cure children’s coughs), clinicians who follow other Choosing Wisely recommendations will inevitably miss more heart attacks, more pulmonary emboli, and more treatable cancers. Of course, the number of diagnostic misses will amount to only a small percentage of patients who would have otherwise received the unnecessary testing, but with more than 1 billion yearly outpatient medical visits in this country, that small percentage may total tens of thousands of patients with potential adverse outcomes caused by following Choosing Wisely recommendations.

According to the Institute of Medicine, up to 98,000 patients die from avoidable medical errors each year. Missed diagnoses account not only for a substantial portion of those avoidable deaths but are also the most common cause of malpractice litigation in the United States. Rest assured that when a physician withholds testing to decrease government expenditures, few state medical boards, fewer juries, and no patients will deem it "quality" medical care when a diagnosis is missed. We won’t convince the public that a preventable death from an undiagnosed pulmonary embolism resulted from adherence to a "quality" initiative. When bad outcomes occur, patients won’t thank us for being stewards of medical resources.

Fortunately, an increase in the overall quality of medical care should decrease legal liability, right? Perhaps not. Rather than inspiring confidence that use of its recommendations will save costs, improve quality, and decrease harm, Choosing Wisely acknowledges the opposite by trying to impose added liability for using its recommendations on the very people whose decision making it seeks to change. "The use of this report is at your own risk ... the ABIM Foundation ... [is] not liable for any loss, injury, or other damage related to your use of this report."

The Choosing Wisely site has many thoughtful recommendations, but don’t be misled: Many Choosing Wisely guidelines are more concerned with cost reduction than they are with quality improvement, regardless of the definition of "quality" we choose to use.

Dr. William Sullivan is an emergency physician, a past president of the Illinois College of Emergency Physicians, and has a private law practice in Frankfort, Ill.

WASHINGTON – Once again, Congress will likely scramble at year’s end to make a last-minute decision on the Medicare Sustainable Growth Rate formula, Rep. Michael Burgess (R-Texas) said at a forum on physician payment.

Although the House Energy and Commerce committee passed an SGR replacement bill in July, the Senate Finance committee is slated to make final changes its proposal by early December, said Rep. Burgess, an ob.gyn.

Rep. Burgess is the lead sponsor of the Energy and Commerce Committee bill, the Medicare Patient Access and Quality Improvement Act of 2013. If enacted, that legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

Alicia Ault/IMNG Medical Media

The December timeline in the Senate "is going to push us pretty close to the deadline, and that’s once again a very uncomfortable place to be," he said, adding that the House is scheduled to recess on Dec. 13.

Even if the Finance Committee approves its proposal, which was developed with the House Ways and Means Committee, the legislation would have to be reconciled with the Energy and Commerce bill. One key difference: The Finance/Ways and Means proposal would freeze physician payments for 10 years, which physician groups oppose.

Any final bill would then have to be approved by both the full House and full Senate – all of which would have to be accomplished before year’s end, since the SGR calls for a 25% cut in Medicare fees on Jan. 1. The tight timeframe raises the specter of a temporary deal – or a patch – to avoid the cut.

"A patch would look a lot like the opposite of success to me," Rep. Burgess said. He added that "as long as we are moving in the right direction, I won’t say no to a patch."

He said that he would not approve of such a deal if it was struck solely because Congress had not worked hard enough to achieve a meaningful SGR replacement.

Rep. Burgess noted that the cost of repeal – estimated at $150 billion to $200 billion over 10 years – is about the same as is already being spent each year just to avoid the statutory cuts.

Congressional leaders have yet to discuss how to pay for an SGR fix, he said, because they want to first develop a policy on which legislators, doctors, and the Centers for Medicare and Medicaid Services can agree. He acknowledged that finding a funding mechanism would be painful but should not derail SGR replacement efforts.

Figuring out how to reform physician payment going forward remains a thorny issue, according to congressional staff members at the forum.

Legislators understand from their constituents that many physicians aren’t ready to move away from fee-for-service medicine, so they have been wrestling with how to create incentives to embrace alternative payment systems and quality measures.

Staff members urged physicians to unify around the proposals in front of Congress now. "It’s awfully important for the physician community to say ‘we actually like this, we think this works, we think we should do this,’ " said Dan Todd, who works on the Senate Finance Committee’s Republican staff.

Getting the final bill right is critically important as well, said Amy Hall, who works on the House Ways and Means Committee’s Democratic staff. "We don’t want to be back here in 5 years repealing the SGR repeal bill."

[email protected]

On Twitter @aliciaault

WASHINGTON – Once again, Congress will likely scramble at year’s end to make a last-minute decision on the Medicare Sustainable Growth Rate formula, Rep. Michael Burgess (R-Texas) said at a forum on physician payment.

Although the House Energy and Commerce committee passed an SGR replacement bill in July, the Senate Finance committee is slated to make final changes its proposal by early December, said Rep. Burgess, an ob.gyn.

Rep. Burgess is the lead sponsor of the Energy and Commerce Committee bill, the Medicare Patient Access and Quality Improvement Act of 2013. If enacted, that legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

Alicia Ault/IMNG Medical Media

The December timeline in the Senate "is going to push us pretty close to the deadline, and that’s once again a very uncomfortable place to be," he said, adding that the House is scheduled to recess on Dec. 13.

Even if the Finance Committee approves its proposal, which was developed with the House Ways and Means Committee, the legislation would have to be reconciled with the Energy and Commerce bill. One key difference: The Finance/Ways and Means proposal would freeze physician payments for 10 years, which physician groups oppose.

Any final bill would then have to be approved by both the full House and full Senate – all of which would have to be accomplished before year’s end, since the SGR calls for a 25% cut in Medicare fees on Jan. 1. The tight timeframe raises the specter of a temporary deal – or a patch – to avoid the cut.

"A patch would look a lot like the opposite of success to me," Rep. Burgess said. He added that "as long as we are moving in the right direction, I won’t say no to a patch."

He said that he would not approve of such a deal if it was struck solely because Congress had not worked hard enough to achieve a meaningful SGR replacement.

Rep. Burgess noted that the cost of repeal – estimated at $150 billion to $200 billion over 10 years – is about the same as is already being spent each year just to avoid the statutory cuts.

Congressional leaders have yet to discuss how to pay for an SGR fix, he said, because they want to first develop a policy on which legislators, doctors, and the Centers for Medicare and Medicaid Services can agree. He acknowledged that finding a funding mechanism would be painful but should not derail SGR replacement efforts.

Figuring out how to reform physician payment going forward remains a thorny issue, according to congressional staff members at the forum.

Legislators understand from their constituents that many physicians aren’t ready to move away from fee-for-service medicine, so they have been wrestling with how to create incentives to embrace alternative payment systems and quality measures.

Staff members urged physicians to unify around the proposals in front of Congress now. "It’s awfully important for the physician community to say ‘we actually like this, we think this works, we think we should do this,’ " said Dan Todd, who works on the Senate Finance Committee’s Republican staff.

Getting the final bill right is critically important as well, said Amy Hall, who works on the House Ways and Means Committee’s Democratic staff. "We don’t want to be back here in 5 years repealing the SGR repeal bill."

[email protected]

On Twitter @aliciaault

WASHINGTON – Once again, Congress will likely scramble at year’s end to make a last-minute decision on the Medicare Sustainable Growth Rate formula, Rep. Michael Burgess (R-Texas) said at a forum on physician payment.

Although the House Energy and Commerce committee passed an SGR replacement bill in July, the Senate Finance committee is slated to make final changes its proposal by early December, said Rep. Burgess, an ob.gyn.

Rep. Burgess is the lead sponsor of the Energy and Commerce Committee bill, the Medicare Patient Access and Quality Improvement Act of 2013. If enacted, that legislation would replace the SGR with a 0.5% payment increase for physicians from 2014 through 2018. It would continue to support fee-for-service medicine, but also encourage the formation of new delivery models and reward reporting of quality data.

Alicia Ault/IMNG Medical Media

The December timeline in the Senate "is going to push us pretty close to the deadline, and that’s once again a very uncomfortable place to be," he said, adding that the House is scheduled to recess on Dec. 13.

Even if the Finance Committee approves its proposal, which was developed with the House Ways and Means Committee, the legislation would have to be reconciled with the Energy and Commerce bill. One key difference: The Finance/Ways and Means proposal would freeze physician payments for 10 years, which physician groups oppose.

Any final bill would then have to be approved by both the full House and full Senate – all of which would have to be accomplished before year’s end, since the SGR calls for a 25% cut in Medicare fees on Jan. 1. The tight timeframe raises the specter of a temporary deal – or a patch – to avoid the cut.

"A patch would look a lot like the opposite of success to me," Rep. Burgess said. He added that "as long as we are moving in the right direction, I won’t say no to a patch."

He said that he would not approve of such a deal if it was struck solely because Congress had not worked hard enough to achieve a meaningful SGR replacement.

Rep. Burgess noted that the cost of repeal – estimated at $150 billion to $200 billion over 10 years – is about the same as is already being spent each year just to avoid the statutory cuts.

Congressional leaders have yet to discuss how to pay for an SGR fix, he said, because they want to first develop a policy on which legislators, doctors, and the Centers for Medicare and Medicaid Services can agree. He acknowledged that finding a funding mechanism would be painful but should not derail SGR replacement efforts.

Figuring out how to reform physician payment going forward remains a thorny issue, according to congressional staff members at the forum.

Legislators understand from their constituents that many physicians aren’t ready to move away from fee-for-service medicine, so they have been wrestling with how to create incentives to embrace alternative payment systems and quality measures.

Staff members urged physicians to unify around the proposals in front of Congress now. "It’s awfully important for the physician community to say ‘we actually like this, we think this works, we think we should do this,’ " said Dan Todd, who works on the Senate Finance Committee’s Republican staff.

Getting the final bill right is critically important as well, said Amy Hall, who works on the House Ways and Means Committee’s Democratic staff. "We don’t want to be back here in 5 years repealing the SGR repeal bill."

[email protected]

On Twitter @aliciaault

NATIONAL HARBOR, MD. – Money issues, notably the Medicare Sustainable Growth Rate formula and ICD-10, dominated deliberations at the American Medical Association Interim House of Delegates meeting.

"The AMA has heard the nation’s physicians, and we’re pulling out the stops to get Congress to act and take a fiscally responsible course that will stop the annual cycle of draconian Medicare cuts and short-term patches," Dr. Ardis Dee Hoven, AMA president, said in a statement after the delegates voted on Nov. 18.

Alicia Ault/IMNG Medical Media

There was some dissent over what the AMA should ask for in terms of a replacement for the Sustainable Growth Rate (SGR) formula, but most resolutions relating to alternative approaches were struck down, with one exception: a request that the organization continue to push for annual increases in physician fees going forward.

The AMA previously had indicated its opposition to a provision in the proposal by the Senate Finance Committee and the House Ways and Means Committee to freeze payments for 10 years.

"This year, we have the opportunity to speak with a voice that will actually resonate across the country," said Dr. Richard E. Thorp,president of the California Medical Association. He noted that the House of Delegates had "spent a significant amount of time trying to develop a unified message," which it now had done. "The SGR needs to be put to bed, buried, pour concrete in it. We’ve got to get an end to this thing," said Dr. Thorp.

Dr. Corey Howard, chair of the Florida delegation, agreed. "This is absolutely the right time, with the right message, and it needs to be done now."

AMA delegates also reiterated their concerns about the implementation of the latest iteration of the International Classification of Diseases – ICD-10 – calling for a delay. The coding system is set to launch on Oct. 1, 2014.

"If you like the implementation of the ACA on Oct. 1, 2013, you’re going to love the implementation of ICD-10 on Oct. 1, 2014," said Dr. Gary Bryant, a delegate from the American College of Rheumatology.

The ACR sought a permanent delay to ICD-10 implementation at the House of Delegates annual meeting in June. The House instead approved a resolution calling for the AMA to seek legislation to delay the implementation by 2 years.

The AMA has estimated that it will cost from $83,290 to $2.7 million per practice, depending on size, to implement ICD-10.

The House of Delegates also expressed concern about an Affordable Care Act provision that allows insurers to deny payment for medical care if the patient does not pay his or her health insurance premiums. Under the law, patients can take up to 90 days to pay premiums on policies bought through the health insurance exchanges, yet still get covered services. If the patient skips out on premiums all together, insurers do not have to pay for care that has been provided.

The California delegation offered a resolution to require insurers to pay for services rendered if a patient had eligibility and authorized coverage. The resolution also called on the AMA to oppose efforts to mandate physician participation in exchange plans.

The House voted to support most of the resolution, but in a modification, asked the AMA to advocate that health plans be required to notify physicians that a patient is in the grace period, and which month the patient is in. If physicians are not notified, it would result in a binding eligibility determination for the insurer.

Finally, the delegates called on the Centers for Disease Control and Prevention to collect more detailed data on prescription drug abuse.

"The AMA will urge the CDC to take the lead in promoting a standard approach for documenting and assessing unintentional poisonings and deaths involving controlled substances for pain relief," Dr. Patrice Harris, an AMA board member, said in a statement. "If we are to effectively fight this public health epidemic, we must have a system of data collection and analysis that provides more detailed information on the contributing factors."

[email protected]

On Twitter @aliciaault

NATIONAL HARBOR, MD. – Money issues, notably the Medicare Sustainable Growth Rate formula and ICD-10, dominated deliberations at the American Medical Association Interim House of Delegates meeting.

"The AMA has heard the nation’s physicians, and we’re pulling out the stops to get Congress to act and take a fiscally responsible course that will stop the annual cycle of draconian Medicare cuts and short-term patches," Dr. Ardis Dee Hoven, AMA president, said in a statement after the delegates voted on Nov. 18.

Alicia Ault/IMNG Medical Media

There was some dissent over what the AMA should ask for in terms of a replacement for the Sustainable Growth Rate (SGR) formula, but most resolutions relating to alternative approaches were struck down, with one exception: a request that the organization continue to push for annual increases in physician fees going forward.

The AMA previously had indicated its opposition to a provision in the proposal by the Senate Finance Committee and the House Ways and Means Committee to freeze payments for 10 years.

"This year, we have the opportunity to speak with a voice that will actually resonate across the country," said Dr. Richard E. Thorp,president of the California Medical Association. He noted that the House of Delegates had "spent a significant amount of time trying to develop a unified message," which it now had done. "The SGR needs to be put to bed, buried, pour concrete in it. We’ve got to get an end to this thing," said Dr. Thorp.

Dr. Corey Howard, chair of the Florida delegation, agreed. "This is absolutely the right time, with the right message, and it needs to be done now."

AMA delegates also reiterated their concerns about the implementation of the latest iteration of the International Classification of Diseases – ICD-10 – calling for a delay. The coding system is set to launch on Oct. 1, 2014.

"If you like the implementation of the ACA on Oct. 1, 2013, you’re going to love the implementation of ICD-10 on Oct. 1, 2014," said Dr. Gary Bryant, a delegate from the American College of Rheumatology.

The ACR sought a permanent delay to ICD-10 implementation at the House of Delegates annual meeting in June. The House instead approved a resolution calling for the AMA to seek legislation to delay the implementation by 2 years.

The AMA has estimated that it will cost from $83,290 to $2.7 million per practice, depending on size, to implement ICD-10.

The House of Delegates also expressed concern about an Affordable Care Act provision that allows insurers to deny payment for medical care if the patient does not pay his or her health insurance premiums. Under the law, patients can take up to 90 days to pay premiums on policies bought through the health insurance exchanges, yet still get covered services. If the patient skips out on premiums all together, insurers do not have to pay for care that has been provided.

The California delegation offered a resolution to require insurers to pay for services rendered if a patient had eligibility and authorized coverage. The resolution also called on the AMA to oppose efforts to mandate physician participation in exchange plans.

The House voted to support most of the resolution, but in a modification, asked the AMA to advocate that health plans be required to notify physicians that a patient is in the grace period, and which month the patient is in. If physicians are not notified, it would result in a binding eligibility determination for the insurer.

Finally, the delegates called on the Centers for Disease Control and Prevention to collect more detailed data on prescription drug abuse.

"The AMA will urge the CDC to take the lead in promoting a standard approach for documenting and assessing unintentional poisonings and deaths involving controlled substances for pain relief," Dr. Patrice Harris, an AMA board member, said in a statement. "If we are to effectively fight this public health epidemic, we must have a system of data collection and analysis that provides more detailed information on the contributing factors."

[email protected]

On Twitter @aliciaault

NATIONAL HARBOR, MD. – Money issues, notably the Medicare Sustainable Growth Rate formula and ICD-10, dominated deliberations at the American Medical Association Interim House of Delegates meeting.

"The AMA has heard the nation’s physicians, and we’re pulling out the stops to get Congress to act and take a fiscally responsible course that will stop the annual cycle of draconian Medicare cuts and short-term patches," Dr. Ardis Dee Hoven, AMA president, said in a statement after the delegates voted on Nov. 18.

Alicia Ault/IMNG Medical Media

There was some dissent over what the AMA should ask for in terms of a replacement for the Sustainable Growth Rate (SGR) formula, but most resolutions relating to alternative approaches were struck down, with one exception: a request that the organization continue to push for annual increases in physician fees going forward.

The AMA previously had indicated its opposition to a provision in the proposal by the Senate Finance Committee and the House Ways and Means Committee to freeze payments for 10 years.

"This year, we have the opportunity to speak with a voice that will actually resonate across the country," said Dr. Richard E. Thorp,president of the California Medical Association. He noted that the House of Delegates had "spent a significant amount of time trying to develop a unified message," which it now had done. "The SGR needs to be put to bed, buried, pour concrete in it. We’ve got to get an end to this thing," said Dr. Thorp.

Dr. Corey Howard, chair of the Florida delegation, agreed. "This is absolutely the right time, with the right message, and it needs to be done now."

AMA delegates also reiterated their concerns about the implementation of the latest iteration of the International Classification of Diseases – ICD-10 – calling for a delay. The coding system is set to launch on Oct. 1, 2014.

"If you like the implementation of the ACA on Oct. 1, 2013, you’re going to love the implementation of ICD-10 on Oct. 1, 2014," said Dr. Gary Bryant, a delegate from the American College of Rheumatology.

The ACR sought a permanent delay to ICD-10 implementation at the House of Delegates annual meeting in June. The House instead approved a resolution calling for the AMA to seek legislation to delay the implementation by 2 years.

The AMA has estimated that it will cost from $83,290 to $2.7 million per practice, depending on size, to implement ICD-10.

The House of Delegates also expressed concern about an Affordable Care Act provision that allows insurers to deny payment for medical care if the patient does not pay his or her health insurance premiums. Under the law, patients can take up to 90 days to pay premiums on policies bought through the health insurance exchanges, yet still get covered services. If the patient skips out on premiums all together, insurers do not have to pay for care that has been provided.

The California delegation offered a resolution to require insurers to pay for services rendered if a patient had eligibility and authorized coverage. The resolution also called on the AMA to oppose efforts to mandate physician participation in exchange plans.

The House voted to support most of the resolution, but in a modification, asked the AMA to advocate that health plans be required to notify physicians that a patient is in the grace period, and which month the patient is in. If physicians are not notified, it would result in a binding eligibility determination for the insurer.

Finally, the delegates called on the Centers for Disease Control and Prevention to collect more detailed data on prescription drug abuse.

"The AMA will urge the CDC to take the lead in promoting a standard approach for documenting and assessing unintentional poisonings and deaths involving controlled substances for pain relief," Dr. Patrice Harris, an AMA board member, said in a statement. "If we are to effectively fight this public health epidemic, we must have a system of data collection and analysis that provides more detailed information on the contributing factors."

[email protected]

On Twitter @aliciaault

CHICAGO – The Affordable Care Act may still be stumbling into place, but it’s here to stay, bringing with it changes especially acute for private physicians.

That’s the consensus of a panel of experts who presented their perspective on the impact of "Obamacare" at this year’s annual meeting of the American College of Chest Physicians.

"Younger physicians are more supportive of the ACA than older physicians," said to Dr. Akram Khan of Oregon Health & Science University, Portland, referencing a survey that found 80% of physicians between 25 and 39 years were optimistic about the future of health care in America. "Older physicians have adapted to the fee-for-service system we currently are in, and so are more ambivalent about the effects of the ACA than [the younger generation] than younger physicians who have not adapted to the system yet."

Private practitioners pay more

Regardless of the number of years in practice, Dr. Edward J. Diamond told the audience that even though he had tried to "dig my head in the sand and tried not to think about this, but unfortunately we are compelled to address it."

The president of large, multisite pulmonary practice in suburban Chicago, Dr. Diamond listed some of the pressing concerns he said should be on the minds of all private physicians, who are almost always employers as well.

The first concern he noted was abiding by the ACA mandate that employee premiums do not exceed 9.5% of the employee’s gross income, and that employer-sponsored plans share at least 60% of the total cost.

Because the cost of private insurance is tied to that of public exchange enrollment and are therefore fluid, Dr. Diamond said this equates with "an enormous administrative burden. We as employers are now going to have to monitor the marketplace of health plans because we’re going to have to compare what we’re offering our employees to what they can get in an insurance exchange."

Further complicating coverage, he said, would be the need to tier coverage to accommodate the variances in office and medical staff salaries vis-à-vis the ACA’s definition of affordability.

Drag on system "real"

Dr. Mark Levine, chief medical officer for the Denver office of the Centers for Medicare and Medicaid Services, said that despite the multitudinous problems with the official ACA website, healthcare.gov, "It really does make comparisons of health plans much easier." He added that only "qualified health plans are listed, which means that they are of known benefit structure and quality."

Regarding the ACA’s direct effect on patient care, Dr. Diamond said that while practices that can accommodate a larger patient load will benefit, quality likely will suffer in practices that are already operating at capacity.

"You’ll be seeing patients that are more complex because they were uninsured in the past and have multiple medical problems," he said, adding that this will take more time and will be reimbursed at lower rates than was done previously.

Dr. Levine concurred, "There will be a drag on the system at first" because of the surge in patients with complex medical needs left untreated by their previously uninsured status.

"Perhaps everybody else needs to chip in to account for that and for the kind of cost shifting we have seen and these phantom pricing mechanisms that have been so common in American health care," said Dr. Levine. "The lack of coverage to a needy population is only going to exacerbate the systemic concerns."

Regardless of burdens shouldered, plenty of Americans will remain needy, according to Dr. Jonathan Pak, also of the Oregon Health & Science University.

"The goal is to get everyone insured, but we will be nowhere close to that 10 years into the future," he said, citing data released by the Congressional Budget Office earlier this year, indicating that in the year 2022, 31 million will remain uninsured. "Make no mistake, this is not a universal health care plan."

Impact on critical care

The ACA might actually benefit the bottom lines of hospitalists and intensivists, said Dr. Diamond. "In the critical care arena, you’re going to have an improved payer mix, you’re going to have the same number of patients, and you have a business model [in which] you don’t have clerical staff," he said.

Dr. Pak had a different view. Already shrinking numbers of critical care resources such as beds and critical care staff likely will be further stressed under the ACA, forcing up per-bed costs and exacerbating shortages of intensivists. "I think, despite many improvements, it won’t be very long before we have to face structural health reform all over again."

Still, Dr. Pak said there are some reasons to feel hopeful. "The ACA will relieve the suffering of millions and will potentially reduce the number of people who end up in the ICU because of better primary care," he said, among other benefits such as the ACA’s increased funding for critical care research.

"Think aggressively"

"It’s serious. You’ve got to cut costs," said Dr. Diamond, who said it was a good time to be a nurse practitioner or a physician assistant, as they are more in demand than are high-salary specialists.

Having appropriate software to improve efficiencies is also essential to the new world of ACA, said Dr. Diamond. "What is coming is clinical integration," he said, referring to ACA mandates on collecting patient and financial data. "You’re also going to be measured on a daily basis on clinical protocols, so you need to be thinking about this very aggressively. How will you have the IT to support what you’ve got to do?"

Included in this overhaul, said Dr. Diamond, must be an attitude change toward working with other providers, including local hospitals and pharmacies, in order to decrease the variation of practice and adhere to evidence-based medicine protocols and national guidelines.

Dr. Levine defended the ACA saying that the current system is "unsustainable" and that for the first time, portions of the ACA such as value-based purchasing, "which holds groups of people responsible" would help the CMS implement its 5-year plan for Americans to have "Better care, better health, and lower costs."

"The past is past," said Dr. Diamond. "You have to embrace change."

[email protected]

CHICAGO – The Affordable Care Act may still be stumbling into place, but it’s here to stay, bringing with it changes especially acute for private physicians.

That’s the consensus of a panel of experts who presented their perspective on the impact of "Obamacare" at this year’s annual meeting of the American College of Chest Physicians.

"Younger physicians are more supportive of the ACA than older physicians," said to Dr. Akram Khan of Oregon Health & Science University, Portland, referencing a survey that found 80% of physicians between 25 and 39 years were optimistic about the future of health care in America. "Older physicians have adapted to the fee-for-service system we currently are in, and so are more ambivalent about the effects of the ACA than [the younger generation] than younger physicians who have not adapted to the system yet."

Private practitioners pay more

Regardless of the number of years in practice, Dr. Edward J. Diamond told the audience that even though he had tried to "dig my head in the sand and tried not to think about this, but unfortunately we are compelled to address it."

The president of large, multisite pulmonary practice in suburban Chicago, Dr. Diamond listed some of the pressing concerns he said should be on the minds of all private physicians, who are almost always employers as well.

The first concern he noted was abiding by the ACA mandate that employee premiums do not exceed 9.5% of the employee’s gross income, and that employer-sponsored plans share at least 60% of the total cost.

Because the cost of private insurance is tied to that of public exchange enrollment and are therefore fluid, Dr. Diamond said this equates with "an enormous administrative burden. We as employers are now going to have to monitor the marketplace of health plans because we’re going to have to compare what we’re offering our employees to what they can get in an insurance exchange."

Further complicating coverage, he said, would be the need to tier coverage to accommodate the variances in office and medical staff salaries vis-à-vis the ACA’s definition of affordability.

Drag on system "real"

Dr. Mark Levine, chief medical officer for the Denver office of the Centers for Medicare and Medicaid Services, said that despite the multitudinous problems with the official ACA website, healthcare.gov, "It really does make comparisons of health plans much easier." He added that only "qualified health plans are listed, which means that they are of known benefit structure and quality."

Regarding the ACA’s direct effect on patient care, Dr. Diamond said that while practices that can accommodate a larger patient load will benefit, quality likely will suffer in practices that are already operating at capacity.

"You’ll be seeing patients that are more complex because they were uninsured in the past and have multiple medical problems," he said, adding that this will take more time and will be reimbursed at lower rates than was done previously.

Dr. Levine concurred, "There will be a drag on the system at first" because of the surge in patients with complex medical needs left untreated by their previously uninsured status.

"Perhaps everybody else needs to chip in to account for that and for the kind of cost shifting we have seen and these phantom pricing mechanisms that have been so common in American health care," said Dr. Levine. "The lack of coverage to a needy population is only going to exacerbate the systemic concerns."

Regardless of burdens shouldered, plenty of Americans will remain needy, according to Dr. Jonathan Pak, also of the Oregon Health & Science University.

"The goal is to get everyone insured, but we will be nowhere close to that 10 years into the future," he said, citing data released by the Congressional Budget Office earlier this year, indicating that in the year 2022, 31 million will remain uninsured. "Make no mistake, this is not a universal health care plan."

Impact on critical care

The ACA might actually benefit the bottom lines of hospitalists and intensivists, said Dr. Diamond. "In the critical care arena, you’re going to have an improved payer mix, you’re going to have the same number of patients, and you have a business model [in which] you don’t have clerical staff," he said.

Dr. Pak had a different view. Already shrinking numbers of critical care resources such as beds and critical care staff likely will be further stressed under the ACA, forcing up per-bed costs and exacerbating shortages of intensivists. "I think, despite many improvements, it won’t be very long before we have to face structural health reform all over again."

Still, Dr. Pak said there are some reasons to feel hopeful. "The ACA will relieve the suffering of millions and will potentially reduce the number of people who end up in the ICU because of better primary care," he said, among other benefits such as the ACA’s increased funding for critical care research.

"Think aggressively"

"It’s serious. You’ve got to cut costs," said Dr. Diamond, who said it was a good time to be a nurse practitioner or a physician assistant, as they are more in demand than are high-salary specialists.

Having appropriate software to improve efficiencies is also essential to the new world of ACA, said Dr. Diamond. "What is coming is clinical integration," he said, referring to ACA mandates on collecting patient and financial data. "You’re also going to be measured on a daily basis on clinical protocols, so you need to be thinking about this very aggressively. How will you have the IT to support what you’ve got to do?"

Included in this overhaul, said Dr. Diamond, must be an attitude change toward working with other providers, including local hospitals and pharmacies, in order to decrease the variation of practice and adhere to evidence-based medicine protocols and national guidelines.

Dr. Levine defended the ACA saying that the current system is "unsustainable" and that for the first time, portions of the ACA such as value-based purchasing, "which holds groups of people responsible" would help the CMS implement its 5-year plan for Americans to have "Better care, better health, and lower costs."

"The past is past," said Dr. Diamond. "You have to embrace change."

[email protected]

CHICAGO – The Affordable Care Act may still be stumbling into place, but it’s here to stay, bringing with it changes especially acute for private physicians.

That’s the consensus of a panel of experts who presented their perspective on the impact of "Obamacare" at this year’s annual meeting of the American College of Chest Physicians.

"Younger physicians are more supportive of the ACA than older physicians," said to Dr. Akram Khan of Oregon Health & Science University, Portland, referencing a survey that found 80% of physicians between 25 and 39 years were optimistic about the future of health care in America. "Older physicians have adapted to the fee-for-service system we currently are in, and so are more ambivalent about the effects of the ACA than [the younger generation] than younger physicians who have not adapted to the system yet."

Private practitioners pay more

Regardless of the number of years in practice, Dr. Edward J. Diamond told the audience that even though he had tried to "dig my head in the sand and tried not to think about this, but unfortunately we are compelled to address it."

The president of large, multisite pulmonary practice in suburban Chicago, Dr. Diamond listed some of the pressing concerns he said should be on the minds of all private physicians, who are almost always employers as well.

The first concern he noted was abiding by the ACA mandate that employee premiums do not exceed 9.5% of the employee’s gross income, and that employer-sponsored plans share at least 60% of the total cost.

Because the cost of private insurance is tied to that of public exchange enrollment and are therefore fluid, Dr. Diamond said this equates with "an enormous administrative burden. We as employers are now going to have to monitor the marketplace of health plans because we’re going to have to compare what we’re offering our employees to what they can get in an insurance exchange."

Further complicating coverage, he said, would be the need to tier coverage to accommodate the variances in office and medical staff salaries vis-à-vis the ACA’s definition of affordability.

Drag on system "real"

Dr. Mark Levine, chief medical officer for the Denver office of the Centers for Medicare and Medicaid Services, said that despite the multitudinous problems with the official ACA website, healthcare.gov, "It really does make comparisons of health plans much easier." He added that only "qualified health plans are listed, which means that they are of known benefit structure and quality."

Regarding the ACA’s direct effect on patient care, Dr. Diamond said that while practices that can accommodate a larger patient load will benefit, quality likely will suffer in practices that are already operating at capacity.

"You’ll be seeing patients that are more complex because they were uninsured in the past and have multiple medical problems," he said, adding that this will take more time and will be reimbursed at lower rates than was done previously.

Dr. Levine concurred, "There will be a drag on the system at first" because of the surge in patients with complex medical needs left untreated by their previously uninsured status.

"Perhaps everybody else needs to chip in to account for that and for the kind of cost shifting we have seen and these phantom pricing mechanisms that have been so common in American health care," said Dr. Levine. "The lack of coverage to a needy population is only going to exacerbate the systemic concerns."

Regardless of burdens shouldered, plenty of Americans will remain needy, according to Dr. Jonathan Pak, also of the Oregon Health & Science University.

"The goal is to get everyone insured, but we will be nowhere close to that 10 years into the future," he said, citing data released by the Congressional Budget Office earlier this year, indicating that in the year 2022, 31 million will remain uninsured. "Make no mistake, this is not a universal health care plan."

Impact on critical care

The ACA might actually benefit the bottom lines of hospitalists and intensivists, said Dr. Diamond. "In the critical care arena, you’re going to have an improved payer mix, you’re going to have the same number of patients, and you have a business model [in which] you don’t have clerical staff," he said.

Dr. Pak had a different view. Already shrinking numbers of critical care resources such as beds and critical care staff likely will be further stressed under the ACA, forcing up per-bed costs and exacerbating shortages of intensivists. "I think, despite many improvements, it won’t be very long before we have to face structural health reform all over again."

Still, Dr. Pak said there are some reasons to feel hopeful. "The ACA will relieve the suffering of millions and will potentially reduce the number of people who end up in the ICU because of better primary care," he said, among other benefits such as the ACA’s increased funding for critical care research.

"Think aggressively"

"It’s serious. You’ve got to cut costs," said Dr. Diamond, who said it was a good time to be a nurse practitioner or a physician assistant, as they are more in demand than are high-salary specialists.

Having appropriate software to improve efficiencies is also essential to the new world of ACA, said Dr. Diamond. "What is coming is clinical integration," he said, referring to ACA mandates on collecting patient and financial data. "You’re also going to be measured on a daily basis on clinical protocols, so you need to be thinking about this very aggressively. How will you have the IT to support what you’ve got to do?"

Included in this overhaul, said Dr. Diamond, must be an attitude change toward working with other providers, including local hospitals and pharmacies, in order to decrease the variation of practice and adhere to evidence-based medicine protocols and national guidelines.

Dr. Levine defended the ACA saying that the current system is "unsustainable" and that for the first time, portions of the ACA such as value-based purchasing, "which holds groups of people responsible" would help the CMS implement its 5-year plan for Americans to have "Better care, better health, and lower costs."

"The past is past," said Dr. Diamond. "You have to embrace change."

[email protected]

CHICAGO – Probably the last thing on the minds of office-based physicians is whether they are running afoul of antitrust regulations.

However, according to Dr. Edward J. Diamond, a pulmonary specialist, a faculty member of the American College of Chest Physicians, and president of Suburban Lung Associates – a large network of pulmonary care offices near Chicago – physicians can add that to their list of concerns about the Affordable Care Act.

The danger zone, according to Dr. Diamond, is what’s known as "clinical integration": pooling patient and protocol data for the purpose of meeting the ACA’s data-driven call on providers to improve care and lower costs. This can be achieved for less when physicians in private practice band together, but it’s not as simple as a handshake, said Dr. Diamond.

The U.S. Department of Justice specifically defines clinical integration as a "network implementing an active and ongoing program to evaluate and modify practice patterns ... and create a high degree of interdependence and cooperation among the physicians to control costs and ensure quality..."

"You have to really adhere to this definition to avoid antitrust issues," said Dr. Diamond, who made his remarks at the annual meeting of the American College of Chest Physicians.

"The Statements of Antitrust Enforcement Policy in Health Care, issued jointly by the Federal Trade Commission and Department of Justice in 1996, carve out certain safety zones for physician network joint ventures," said Christopher Gordon, a specialist in health care antitrust law at Squire Sanders LLP in Washington.

Mr. Gordon said that the DOJ and the FTC "will typically not challenge an exclusive physician network joint venture where the participants share substantial financial risk and constitute 20% or less of the physicians in each specialty practicing in the relevant geographic market. Where the network is nonexclusive, that number rises to 30% or less."

If they are too large, or if they don’t keep to these predetermined percentages of competing physicians by specialty, groups of competing health care providers cooperating to make their ACA mandates could be in danger.

"Networks that fall outside these safety zones – either because they include a higher percentage of physicians or do not involve financial risk sharing – do not necessarily raise antitrust concerns, but instead will have their conduct reviewed under what is known as the "rule of reason" to determine whether, on balance, the conduct is anticompetitive or not," said Mr. Gordon.

"You have to be very careful you don’t end up accused of illegal collective bargaining," said Dr. Diamond. "There is a disconnect between what the Department of Justice and what the ACA are asking."

If not a disconnect, at least a proscribed field of play.

According to Mr. Gordon, providers have latitude in how they cooperate when it comes to developing clinical protocols and best practices, so long as that cooperation does not include pricing agreements among multiple, independent clinics. "Such conduct would arguably constitute a per se violation of the antitrust laws regardless of how small or big the clinics are," he said.

Although the justice department and the FTC are primarily focused on conduct that impacts commercial health insurance markets, fee schedules and reimbursements that are part of any Medicare Advantage plan are considered part of the marketplace, because these plans are offered by private insurers contracting with the federal government, Mr. Gordon said. Medicare proper, meanwhile, is unaffected by antitrust concerns because "its pricing is set by the government, so there is little or no risk that provider misconduct could impact those prices," he noted.

Whatever happens, said Dr. Diamond, to survive in the era of the ACA, providers who will thrive with clinical integration are those who can develop areas of expertise such as excellent electronic health record systems, which make them attractive partners to other clinics and health care facilities. "Be a friendly competitor," he said, Above all else, he added: "Embrace change."

Dr. Diamond reported having no disclosures.

[email protected]

CHICAGO – Probably the last thing on the minds of office-based physicians is whether they are running afoul of antitrust regulations.

However, according to Dr. Edward J. Diamond, a pulmonary specialist, a faculty member of the American College of Chest Physicians, and president of Suburban Lung Associates – a large network of pulmonary care offices near Chicago – physicians can add that to their list of concerns about the Affordable Care Act.

The danger zone, according to Dr. Diamond, is what’s known as "clinical integration": pooling patient and protocol data for the purpose of meeting the ACA’s data-driven call on providers to improve care and lower costs. This can be achieved for less when physicians in private practice band together, but it’s not as simple as a handshake, said Dr. Diamond.

The U.S. Department of Justice specifically defines clinical integration as a "network implementing an active and ongoing program to evaluate and modify practice patterns ... and create a high degree of interdependence and cooperation among the physicians to control costs and ensure quality..."

"You have to really adhere to this definition to avoid antitrust issues," said Dr. Diamond, who made his remarks at the annual meeting of the American College of Chest Physicians.

"The Statements of Antitrust Enforcement Policy in Health Care, issued jointly by the Federal Trade Commission and Department of Justice in 1996, carve out certain safety zones for physician network joint ventures," said Christopher Gordon, a specialist in health care antitrust law at Squire Sanders LLP in Washington.

Mr. Gordon said that the DOJ and the FTC "will typically not challenge an exclusive physician network joint venture where the participants share substantial financial risk and constitute 20% or less of the physicians in each specialty practicing in the relevant geographic market. Where the network is nonexclusive, that number rises to 30% or less."

If they are too large, or if they don’t keep to these predetermined percentages of competing physicians by specialty, groups of competing health care providers cooperating to make their ACA mandates could be in danger.

"Networks that fall outside these safety zones – either because they include a higher percentage of physicians or do not involve financial risk sharing – do not necessarily raise antitrust concerns, but instead will have their conduct reviewed under what is known as the "rule of reason" to determine whether, on balance, the conduct is anticompetitive or not," said Mr. Gordon.

"You have to be very careful you don’t end up accused of illegal collective bargaining," said Dr. Diamond. "There is a disconnect between what the Department of Justice and what the ACA are asking."

If not a disconnect, at least a proscribed field of play.

According to Mr. Gordon, providers have latitude in how they cooperate when it comes to developing clinical protocols and best practices, so long as that cooperation does not include pricing agreements among multiple, independent clinics. "Such conduct would arguably constitute a per se violation of the antitrust laws regardless of how small or big the clinics are," he said.

Although the justice department and the FTC are primarily focused on conduct that impacts commercial health insurance markets, fee schedules and reimbursements that are part of any Medicare Advantage plan are considered part of the marketplace, because these plans are offered by private insurers contracting with the federal government, Mr. Gordon said. Medicare proper, meanwhile, is unaffected by antitrust concerns because "its pricing is set by the government, so there is little or no risk that provider misconduct could impact those prices," he noted.

Whatever happens, said Dr. Diamond, to survive in the era of the ACA, providers who will thrive with clinical integration are those who can develop areas of expertise such as excellent electronic health record systems, which make them attractive partners to other clinics and health care facilities. "Be a friendly competitor," he said, Above all else, he added: "Embrace change."

Dr. Diamond reported having no disclosures.

[email protected]

CHICAGO – Probably the last thing on the minds of office-based physicians is whether they are running afoul of antitrust regulations.

However, according to Dr. Edward J. Diamond, a pulmonary specialist, a faculty member of the American College of Chest Physicians, and president of Suburban Lung Associates – a large network of pulmonary care offices near Chicago – physicians can add that to their list of concerns about the Affordable Care Act.

The danger zone, according to Dr. Diamond, is what’s known as "clinical integration": pooling patient and protocol data for the purpose of meeting the ACA’s data-driven call on providers to improve care and lower costs. This can be achieved for less when physicians in private practice band together, but it’s not as simple as a handshake, said Dr. Diamond.

The U.S. Department of Justice specifically defines clinical integration as a "network implementing an active and ongoing program to evaluate and modify practice patterns ... and create a high degree of interdependence and cooperation among the physicians to control costs and ensure quality..."

"You have to really adhere to this definition to avoid antitrust issues," said Dr. Diamond, who made his remarks at the annual meeting of the American College of Chest Physicians.

"The Statements of Antitrust Enforcement Policy in Health Care, issued jointly by the Federal Trade Commission and Department of Justice in 1996, carve out certain safety zones for physician network joint ventures," said Christopher Gordon, a specialist in health care antitrust law at Squire Sanders LLP in Washington.

Mr. Gordon said that the DOJ and the FTC "will typically not challenge an exclusive physician network joint venture where the participants share substantial financial risk and constitute 20% or less of the physicians in each specialty practicing in the relevant geographic market. Where the network is nonexclusive, that number rises to 30% or less."

If they are too large, or if they don’t keep to these predetermined percentages of competing physicians by specialty, groups of competing health care providers cooperating to make their ACA mandates could be in danger.

"Networks that fall outside these safety zones – either because they include a higher percentage of physicians or do not involve financial risk sharing – do not necessarily raise antitrust concerns, but instead will have their conduct reviewed under what is known as the "rule of reason" to determine whether, on balance, the conduct is anticompetitive or not," said Mr. Gordon.

"You have to be very careful you don’t end up accused of illegal collective bargaining," said Dr. Diamond. "There is a disconnect between what the Department of Justice and what the ACA are asking."

If not a disconnect, at least a proscribed field of play.

According to Mr. Gordon, providers have latitude in how they cooperate when it comes to developing clinical protocols and best practices, so long as that cooperation does not include pricing agreements among multiple, independent clinics. "Such conduct would arguably constitute a per se violation of the antitrust laws regardless of how small or big the clinics are," he said.

Although the justice department and the FTC are primarily focused on conduct that impacts commercial health insurance markets, fee schedules and reimbursements that are part of any Medicare Advantage plan are considered part of the marketplace, because these plans are offered by private insurers contracting with the federal government, Mr. Gordon said. Medicare proper, meanwhile, is unaffected by antitrust concerns because "its pricing is set by the government, so there is little or no risk that provider misconduct could impact those prices," he noted.

Whatever happens, said Dr. Diamond, to survive in the era of the ACA, providers who will thrive with clinical integration are those who can develop areas of expertise such as excellent electronic health record systems, which make them attractive partners to other clinics and health care facilities. "Be a friendly competitor," he said, Above all else, he added: "Embrace change."

Dr. Diamond reported having no disclosures.

[email protected]