What's the Dose?

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What's the Dose?

Physicians struggle every day to pick the right drug dosage for the treatment and prevention of disease. For the acute illnesses, efficacy is evident within hours or days. For the prevention of chronic disease, however, the outcome is uncertain at best. Therefore, we rely on randomized clinical trials to provide evidence that a specific drug and dosage are safe and effective.

Unfortunately, because of the limited average follow-up of 3-5 years, randomized clinical trials (RCTs) do not provide efficacy and safety information for lifetime therapy that is often advocated for the prevention of chronic disease.

For both the patient and physician, the side effects become the deciding factor. The physician usually chooses the smallest dose in order to avoid toxicity and presumably to achieve some benefit. The patient takes the drug irregularly at best.

As an example, consider the appropriate dosage for statin therapy for the prevention of atherosclerotic cardiovascular disease. Although numerous RCTs have defined the effective dose of a number of statins, recent trends in therapeutics have advocated that rather than using the dose that was used in RCTs, clinicians should increase the dose in order to reach a specific LDL cholesterol blood level.

Choosing the dosage of a drug in an RCT is a less-than-perfect exercise. Here’s how it usually goes:

Phase I trials – often based on pharmacokinetic data derived from animal studies – examine the physiological characteristics of the drug in healthy human volunteers in order to determine an effective and safe dosage prior to a phase II trial.

Phase II trials are larger; they usually examine the effect of several different dosages on a target population, and are focused not on physiological effects but on clinical outcomes and safety, in order to choose the best dosage for a phase III study. Because of their small size, these phase II studies are underpowered and prone to providing misleading dose choices.

Nevertheless, one or two doses are chosen to be used in the definitive phase III RCT, which includes enough patients to provide proof of benefit and safety of the drug based solely on its effect on mortality and morbidity.

Information is often collected in regard to the physiological effects of the drug on, for example, LDL cholesterol (in the case of statins) or heart rate (in the case of beta-blocking drugs). The proof of benefit, however, is determined by clinical outcomes, not on the physiological or "surrogate" measurements.

In the process of designing an RCT, we often make presumptions about mechanisms and will identify certain parameters that theoretically provide insight into the presumed benefit. However, many of the drugs we use have physiological effects that extend beyond the specific therapeutic target. We often remain ignorant about the mechanism by which drugs express their benefit long after their proof of benefit is demonstrated.

Statins, for instance, have a variety of pleiotropic effects. One of the most interesting is their ability to modulate inflammation, a process that is thought to be central to the progression of atherosclerotic disease. Although we presume that their effect is on LDL cholesterol, that presumption may be incorrect. Similarly, beta-blockers have well-known effects on heart rate and blood pressure, but their effect on modulating the up-regulated sympathetic nervous system in heart failure has presumed importance well beyond their effect on heart rate and blood pressure.

It is tempting to make presumptions about the effect of a drug intervention on the basis of surrogate measures like heart rate or LDL cholesterol effects, but their mechanisms of action on mortality and morbidity of disease may be unrelated to that measure.

RCTs have come a long way from relying on "surrogate" end points as the basis for making therapeutic decisions. More than 20 years ago, the CAST (Cardiac Arrhythmia Suppression Trial) was the watershed RCT that excluded the surrogate as a measure of therapeutic efficacy (J. Am. Coll. Cardiol. 1991;18:14-9). At a time when ventricular premature contraction (VPC) suppression was the "mantra" to prevent sudden death, CAST examined the pharmacologic suppression of VPCs in post–MI patients and found that, as the drugs decreased ventricular ectopy, mortality increased.

The use of the seemingly appropriate and obvious "surrogate" of LDL cholesterol lowering as a measure of therapeutic efficacy may be just as illusory. As enticing as surrogates are, the contemporary drive to lower LDL cholesterol may be as misdirected as the target to decrease the frequency of VPCs to prevent sudden death.

Like many things in life and science, things may not be what they seem.

Dr. Goldstein, the medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

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Physicians struggle every day to pick the right drug dosage for the treatment and prevention of disease. For the acute illnesses, efficacy is evident within hours or days. For the prevention of chronic disease, however, the outcome is uncertain at best. Therefore, we rely on randomized clinical trials to provide evidence that a specific drug and dosage are safe and effective.

Unfortunately, because of the limited average follow-up of 3-5 years, randomized clinical trials (RCTs) do not provide efficacy and safety information for lifetime therapy that is often advocated for the prevention of chronic disease.

For both the patient and physician, the side effects become the deciding factor. The physician usually chooses the smallest dose in order to avoid toxicity and presumably to achieve some benefit. The patient takes the drug irregularly at best.

As an example, consider the appropriate dosage for statin therapy for the prevention of atherosclerotic cardiovascular disease. Although numerous RCTs have defined the effective dose of a number of statins, recent trends in therapeutics have advocated that rather than using the dose that was used in RCTs, clinicians should increase the dose in order to reach a specific LDL cholesterol blood level.

Choosing the dosage of a drug in an RCT is a less-than-perfect exercise. Here’s how it usually goes:

Phase I trials – often based on pharmacokinetic data derived from animal studies – examine the physiological characteristics of the drug in healthy human volunteers in order to determine an effective and safe dosage prior to a phase II trial.

Phase II trials are larger; they usually examine the effect of several different dosages on a target population, and are focused not on physiological effects but on clinical outcomes and safety, in order to choose the best dosage for a phase III study. Because of their small size, these phase II studies are underpowered and prone to providing misleading dose choices.

Nevertheless, one or two doses are chosen to be used in the definitive phase III RCT, which includes enough patients to provide proof of benefit and safety of the drug based solely on its effect on mortality and morbidity.

Information is often collected in regard to the physiological effects of the drug on, for example, LDL cholesterol (in the case of statins) or heart rate (in the case of beta-blocking drugs). The proof of benefit, however, is determined by clinical outcomes, not on the physiological or "surrogate" measurements.

In the process of designing an RCT, we often make presumptions about mechanisms and will identify certain parameters that theoretically provide insight into the presumed benefit. However, many of the drugs we use have physiological effects that extend beyond the specific therapeutic target. We often remain ignorant about the mechanism by which drugs express their benefit long after their proof of benefit is demonstrated.

Statins, for instance, have a variety of pleiotropic effects. One of the most interesting is their ability to modulate inflammation, a process that is thought to be central to the progression of atherosclerotic disease. Although we presume that their effect is on LDL cholesterol, that presumption may be incorrect. Similarly, beta-blockers have well-known effects on heart rate and blood pressure, but their effect on modulating the up-regulated sympathetic nervous system in heart failure has presumed importance well beyond their effect on heart rate and blood pressure.

It is tempting to make presumptions about the effect of a drug intervention on the basis of surrogate measures like heart rate or LDL cholesterol effects, but their mechanisms of action on mortality and morbidity of disease may be unrelated to that measure.

RCTs have come a long way from relying on "surrogate" end points as the basis for making therapeutic decisions. More than 20 years ago, the CAST (Cardiac Arrhythmia Suppression Trial) was the watershed RCT that excluded the surrogate as a measure of therapeutic efficacy (J. Am. Coll. Cardiol. 1991;18:14-9). At a time when ventricular premature contraction (VPC) suppression was the "mantra" to prevent sudden death, CAST examined the pharmacologic suppression of VPCs in post–MI patients and found that, as the drugs decreased ventricular ectopy, mortality increased.

The use of the seemingly appropriate and obvious "surrogate" of LDL cholesterol lowering as a measure of therapeutic efficacy may be just as illusory. As enticing as surrogates are, the contemporary drive to lower LDL cholesterol may be as misdirected as the target to decrease the frequency of VPCs to prevent sudden death.

Like many things in life and science, things may not be what they seem.

Dr. Goldstein, the medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Physicians struggle every day to pick the right drug dosage for the treatment and prevention of disease. For the acute illnesses, efficacy is evident within hours or days. For the prevention of chronic disease, however, the outcome is uncertain at best. Therefore, we rely on randomized clinical trials to provide evidence that a specific drug and dosage are safe and effective.

Unfortunately, because of the limited average follow-up of 3-5 years, randomized clinical trials (RCTs) do not provide efficacy and safety information for lifetime therapy that is often advocated for the prevention of chronic disease.

For both the patient and physician, the side effects become the deciding factor. The physician usually chooses the smallest dose in order to avoid toxicity and presumably to achieve some benefit. The patient takes the drug irregularly at best.

As an example, consider the appropriate dosage for statin therapy for the prevention of atherosclerotic cardiovascular disease. Although numerous RCTs have defined the effective dose of a number of statins, recent trends in therapeutics have advocated that rather than using the dose that was used in RCTs, clinicians should increase the dose in order to reach a specific LDL cholesterol blood level.

Choosing the dosage of a drug in an RCT is a less-than-perfect exercise. Here’s how it usually goes:

Phase I trials – often based on pharmacokinetic data derived from animal studies – examine the physiological characteristics of the drug in healthy human volunteers in order to determine an effective and safe dosage prior to a phase II trial.

Phase II trials are larger; they usually examine the effect of several different dosages on a target population, and are focused not on physiological effects but on clinical outcomes and safety, in order to choose the best dosage for a phase III study. Because of their small size, these phase II studies are underpowered and prone to providing misleading dose choices.

Nevertheless, one or two doses are chosen to be used in the definitive phase III RCT, which includes enough patients to provide proof of benefit and safety of the drug based solely on its effect on mortality and morbidity.

Information is often collected in regard to the physiological effects of the drug on, for example, LDL cholesterol (in the case of statins) or heart rate (in the case of beta-blocking drugs). The proof of benefit, however, is determined by clinical outcomes, not on the physiological or "surrogate" measurements.

In the process of designing an RCT, we often make presumptions about mechanisms and will identify certain parameters that theoretically provide insight into the presumed benefit. However, many of the drugs we use have physiological effects that extend beyond the specific therapeutic target. We often remain ignorant about the mechanism by which drugs express their benefit long after their proof of benefit is demonstrated.

Statins, for instance, have a variety of pleiotropic effects. One of the most interesting is their ability to modulate inflammation, a process that is thought to be central to the progression of atherosclerotic disease. Although we presume that their effect is on LDL cholesterol, that presumption may be incorrect. Similarly, beta-blockers have well-known effects on heart rate and blood pressure, but their effect on modulating the up-regulated sympathetic nervous system in heart failure has presumed importance well beyond their effect on heart rate and blood pressure.

It is tempting to make presumptions about the effect of a drug intervention on the basis of surrogate measures like heart rate or LDL cholesterol effects, but their mechanisms of action on mortality and morbidity of disease may be unrelated to that measure.

RCTs have come a long way from relying on "surrogate" end points as the basis for making therapeutic decisions. More than 20 years ago, the CAST (Cardiac Arrhythmia Suppression Trial) was the watershed RCT that excluded the surrogate as a measure of therapeutic efficacy (J. Am. Coll. Cardiol. 1991;18:14-9). At a time when ventricular premature contraction (VPC) suppression was the "mantra" to prevent sudden death, CAST examined the pharmacologic suppression of VPCs in post–MI patients and found that, as the drugs decreased ventricular ectopy, mortality increased.

The use of the seemingly appropriate and obvious "surrogate" of LDL cholesterol lowering as a measure of therapeutic efficacy may be just as illusory. As enticing as surrogates are, the contemporary drive to lower LDL cholesterol may be as misdirected as the target to decrease the frequency of VPCs to prevent sudden death.

Like many things in life and science, things may not be what they seem.

Dr. Goldstein, the medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

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Early Data Find No Adalimumab Teratogenicity

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BALTIMORE – Exposure to adalimumab was not associated with any specific pattern of minor or major birth defects in women with rheumatoid arthritis taking the biologic drug during pregnancy, according to preliminary data from an ongoing prospective cohort study.

Between November 2004 and January 2012, 312 pregnant women in the United States and Canada – 69 women with RA exposed to adalimumab, 80 women with RA who had not taken adalimumab, and 163 healthy controls – were enrolled before 20 weeks’ gestation. Their mean age was 32-33 years, and about two-thirds were white.

Dr. Christina Chambers

Major birth defects among the live births were identified in 5% of the babies born to women exposed to adalimumab, compared with about 4% among disease-matched controls who did not take adalimumab, and about 7% among healthy controls, Christina Chambers, Ph.D., of the University of California, San Diego, reported at the annual meeting of the Teratology Society.

The rate of minor structural abnormalities was similar in the three groups, at about 22%-24%, and there was no pattern of major or minor structural defects noted among the adalimumab-exposed group. (The three major malformations in the adalimumab-exposed group were one ventricular septal defect, one unilateral cryptorchidism, and one case of microcephaly.)

There were no stillbirths. The rate of spontaneous abortions was not significantly different between the three groups, nor were the rates of preterm delivery or birth weights, said Dr. Chambers, director of the California Teratogen Information Service and Clinical Research Program.

Through 1-year of follow-up, there were no malignancies among the infants and the rates of serious infections in the three groups were similar (about 3% in the two RA groups and 2% in the healthy comparison group).

The teratogenic effects of adalimumab, a tumor necrosis factor blocker, are being evaluated in the pregnancy registry, which is part of the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project.

Adalimumab, marketed as Humira by Abbott Laboratories, was first approved in the United States in 2002 as a treatment for people with moderately to severely active RA, and has since been approved for other autoimmune diseases, including psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and psoriasis.

The registry study is comparing outcomes in women with RA who are treated with adalimumab during pregnancy, in women with RA not treated with adalimumab during pregnancy, and in women who do not have an autoimmune disease and have not been exposed to adalimumab or any known teratogenic drug during pregnancy. The study includes medical record reviews, examination of infants for major and minor structural abnormalities, and follow-up for 1 year post partum. It is expected to continue through 2017; the pregnant women are recruited from OTIS member services and from rheumatologists, and other clinicians who care for these patients.

Although little to no placental transfer of adalimumab is expected during early pregnancy, limited information on the safety of adalimumab during pregnancy has been published, Dr. Chambers said.

Abbott Laboratories is among the sponsors of the OTIS Autoimmune Diseases in Pregnancy Project, which is also evaluating safety of medications in women with ankylosing spondylitis, psoriasis and psoriatic arthritis, and Crohn’s disease. Dr. Chambers and her coauthors have received or receive grant funding for research on medications for autoimmune diseases from Abbott and other manufacturers: Amgen, Bristol Myers Squibb, Roche Genentech, Sanofi, Teva, Par, Sandoz, and Apotex.

Information for women and clinicians interested in enrolling in the OTIS Autoimmune Diseases in Pregnancy Project is available at www.otispregnancy.org/autoimmune-studies-s13049.

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BALTIMORE – Exposure to adalimumab was not associated with any specific pattern of minor or major birth defects in women with rheumatoid arthritis taking the biologic drug during pregnancy, according to preliminary data from an ongoing prospective cohort study.

Between November 2004 and January 2012, 312 pregnant women in the United States and Canada – 69 women with RA exposed to adalimumab, 80 women with RA who had not taken adalimumab, and 163 healthy controls – were enrolled before 20 weeks’ gestation. Their mean age was 32-33 years, and about two-thirds were white.

Dr. Christina Chambers

Major birth defects among the live births were identified in 5% of the babies born to women exposed to adalimumab, compared with about 4% among disease-matched controls who did not take adalimumab, and about 7% among healthy controls, Christina Chambers, Ph.D., of the University of California, San Diego, reported at the annual meeting of the Teratology Society.

The rate of minor structural abnormalities was similar in the three groups, at about 22%-24%, and there was no pattern of major or minor structural defects noted among the adalimumab-exposed group. (The three major malformations in the adalimumab-exposed group were one ventricular septal defect, one unilateral cryptorchidism, and one case of microcephaly.)

There were no stillbirths. The rate of spontaneous abortions was not significantly different between the three groups, nor were the rates of preterm delivery or birth weights, said Dr. Chambers, director of the California Teratogen Information Service and Clinical Research Program.

Through 1-year of follow-up, there were no malignancies among the infants and the rates of serious infections in the three groups were similar (about 3% in the two RA groups and 2% in the healthy comparison group).

The teratogenic effects of adalimumab, a tumor necrosis factor blocker, are being evaluated in the pregnancy registry, which is part of the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project.

Adalimumab, marketed as Humira by Abbott Laboratories, was first approved in the United States in 2002 as a treatment for people with moderately to severely active RA, and has since been approved for other autoimmune diseases, including psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and psoriasis.

The registry study is comparing outcomes in women with RA who are treated with adalimumab during pregnancy, in women with RA not treated with adalimumab during pregnancy, and in women who do not have an autoimmune disease and have not been exposed to adalimumab or any known teratogenic drug during pregnancy. The study includes medical record reviews, examination of infants for major and minor structural abnormalities, and follow-up for 1 year post partum. It is expected to continue through 2017; the pregnant women are recruited from OTIS member services and from rheumatologists, and other clinicians who care for these patients.

Although little to no placental transfer of adalimumab is expected during early pregnancy, limited information on the safety of adalimumab during pregnancy has been published, Dr. Chambers said.

Abbott Laboratories is among the sponsors of the OTIS Autoimmune Diseases in Pregnancy Project, which is also evaluating safety of medications in women with ankylosing spondylitis, psoriasis and psoriatic arthritis, and Crohn’s disease. Dr. Chambers and her coauthors have received or receive grant funding for research on medications for autoimmune diseases from Abbott and other manufacturers: Amgen, Bristol Myers Squibb, Roche Genentech, Sanofi, Teva, Par, Sandoz, and Apotex.

Information for women and clinicians interested in enrolling in the OTIS Autoimmune Diseases in Pregnancy Project is available at www.otispregnancy.org/autoimmune-studies-s13049.

BALTIMORE – Exposure to adalimumab was not associated with any specific pattern of minor or major birth defects in women with rheumatoid arthritis taking the biologic drug during pregnancy, according to preliminary data from an ongoing prospective cohort study.

Between November 2004 and January 2012, 312 pregnant women in the United States and Canada – 69 women with RA exposed to adalimumab, 80 women with RA who had not taken adalimumab, and 163 healthy controls – were enrolled before 20 weeks’ gestation. Their mean age was 32-33 years, and about two-thirds were white.

Dr. Christina Chambers

Major birth defects among the live births were identified in 5% of the babies born to women exposed to adalimumab, compared with about 4% among disease-matched controls who did not take adalimumab, and about 7% among healthy controls, Christina Chambers, Ph.D., of the University of California, San Diego, reported at the annual meeting of the Teratology Society.

The rate of minor structural abnormalities was similar in the three groups, at about 22%-24%, and there was no pattern of major or minor structural defects noted among the adalimumab-exposed group. (The three major malformations in the adalimumab-exposed group were one ventricular septal defect, one unilateral cryptorchidism, and one case of microcephaly.)

There were no stillbirths. The rate of spontaneous abortions was not significantly different between the three groups, nor were the rates of preterm delivery or birth weights, said Dr. Chambers, director of the California Teratogen Information Service and Clinical Research Program.

Through 1-year of follow-up, there were no malignancies among the infants and the rates of serious infections in the three groups were similar (about 3% in the two RA groups and 2% in the healthy comparison group).

The teratogenic effects of adalimumab, a tumor necrosis factor blocker, are being evaluated in the pregnancy registry, which is part of the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project.

Adalimumab, marketed as Humira by Abbott Laboratories, was first approved in the United States in 2002 as a treatment for people with moderately to severely active RA, and has since been approved for other autoimmune diseases, including psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and psoriasis.

The registry study is comparing outcomes in women with RA who are treated with adalimumab during pregnancy, in women with RA not treated with adalimumab during pregnancy, and in women who do not have an autoimmune disease and have not been exposed to adalimumab or any known teratogenic drug during pregnancy. The study includes medical record reviews, examination of infants for major and minor structural abnormalities, and follow-up for 1 year post partum. It is expected to continue through 2017; the pregnant women are recruited from OTIS member services and from rheumatologists, and other clinicians who care for these patients.

Although little to no placental transfer of adalimumab is expected during early pregnancy, limited information on the safety of adalimumab during pregnancy has been published, Dr. Chambers said.

Abbott Laboratories is among the sponsors of the OTIS Autoimmune Diseases in Pregnancy Project, which is also evaluating safety of medications in women with ankylosing spondylitis, psoriasis and psoriatic arthritis, and Crohn’s disease. Dr. Chambers and her coauthors have received or receive grant funding for research on medications for autoimmune diseases from Abbott and other manufacturers: Amgen, Bristol Myers Squibb, Roche Genentech, Sanofi, Teva, Par, Sandoz, and Apotex.

Information for women and clinicians interested in enrolling in the OTIS Autoimmune Diseases in Pregnancy Project is available at www.otispregnancy.org/autoimmune-studies-s13049.

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Treating Kids' Sleep Apnea Can Improve Brain Function

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BOSTON – Neuronal abnormalities in the brains of children with obstructive sleep apnea are reversible with treatment, a prospective study has shown.

The findings are the first to show that the altered brain metabolites of the frontal cortex – the neuronal network responsible for attention and executive function – normalize with treatment of pediatric obstructive sleep apnea, Dr. Ann C. Halbower reported at the annual meeting of the Associated Professional Sleep Societies.

Previous studies have demonstrated an association between obstructive sleep apnea (OSA) and deficits in attention, cognition, and executive function, "but ours is the first to look at the effect of [OSA] treatment on the neuronal brain injury and to show a relationship between treatment and improvements in attention and verbal memory in these patients," said Dr. Halbower of the Children’s Hospital Colorado Sleep Center and the University of Colorado at Denver.

The study included 28 children aged 8-11 years; 17 had moderate or severe OSA and 11 were healthy controls matched by age, sex, race, and socioeconomic status. At study baseline, all participants underwent neuropsychological testing, and 22 of the children (15 with OSA and 7 healthy controls) also underwent magnetic resonance spectroscopy imaging. Six months post treatment, 11 of the OSA patients underwent repeat brain imaging and neuropsychological testing, Dr. Halbower said. Treatment for OSA consisted of adenotonsillectomy followed by monitored continuous positive airway pressure (CPAP) for children whose apnea-hypopnea index (AHI) score was higher than 3, or nasal treatments for those with an AHI score of 2-3, she explained.

Among the OSA patients, the mean AHI score at baseline was 13.6, compared with 0.3 for the healthy controls – a discrepancy mirrored by differences observed in both the brain imaging and the function tests. Specifically, Dr. Halbower reported, "the N-acetyl aspartate to choline (NAA/Cho) ratios in the left hippocampus and left frontal cortex were significantly decreased in [OSA] patients, compared with healthy controls, and the [OSA] patients had significant decreases in the executive function of working memory, attention, and verbal memory."

After treatment, "the neuronal metabolites of the right and left frontal cortex normalized, and the hippocampal metabolites improved with a medium effect size," Dr. Halbower said. The follow-up neuropsychological testing showed significant improvements in verbal memory and attention, "which correlated with the normalization of the [NAA/Cho] ratios in the frontal lobes," she said. A further analysis of the data linked improvement on the AHI with a more complete reversal of the hippocampal abnormalities in children with mild OSA, she said, noting, however, that this finding "is very preliminary."

Based on the study results, "we speculate that early diagnosis and treatment of obstructive sleep apnea in children could have profound effects on the trajectory of their development," Dr. Halbower said. In particular, she suggested, earlier treatment may lead to a "more brisk improvement" in the hippocampus, which is the "relay station" for executive function, learning, and memory.

Dr. Halbower said she had no relevant financial disclosures.

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BOSTON – Neuronal abnormalities in the brains of children with obstructive sleep apnea are reversible with treatment, a prospective study has shown.

The findings are the first to show that the altered brain metabolites of the frontal cortex – the neuronal network responsible for attention and executive function – normalize with treatment of pediatric obstructive sleep apnea, Dr. Ann C. Halbower reported at the annual meeting of the Associated Professional Sleep Societies.

Previous studies have demonstrated an association between obstructive sleep apnea (OSA) and deficits in attention, cognition, and executive function, "but ours is the first to look at the effect of [OSA] treatment on the neuronal brain injury and to show a relationship between treatment and improvements in attention and verbal memory in these patients," said Dr. Halbower of the Children’s Hospital Colorado Sleep Center and the University of Colorado at Denver.

The study included 28 children aged 8-11 years; 17 had moderate or severe OSA and 11 were healthy controls matched by age, sex, race, and socioeconomic status. At study baseline, all participants underwent neuropsychological testing, and 22 of the children (15 with OSA and 7 healthy controls) also underwent magnetic resonance spectroscopy imaging. Six months post treatment, 11 of the OSA patients underwent repeat brain imaging and neuropsychological testing, Dr. Halbower said. Treatment for OSA consisted of adenotonsillectomy followed by monitored continuous positive airway pressure (CPAP) for children whose apnea-hypopnea index (AHI) score was higher than 3, or nasal treatments for those with an AHI score of 2-3, she explained.

Among the OSA patients, the mean AHI score at baseline was 13.6, compared with 0.3 for the healthy controls – a discrepancy mirrored by differences observed in both the brain imaging and the function tests. Specifically, Dr. Halbower reported, "the N-acetyl aspartate to choline (NAA/Cho) ratios in the left hippocampus and left frontal cortex were significantly decreased in [OSA] patients, compared with healthy controls, and the [OSA] patients had significant decreases in the executive function of working memory, attention, and verbal memory."

After treatment, "the neuronal metabolites of the right and left frontal cortex normalized, and the hippocampal metabolites improved with a medium effect size," Dr. Halbower said. The follow-up neuropsychological testing showed significant improvements in verbal memory and attention, "which correlated with the normalization of the [NAA/Cho] ratios in the frontal lobes," she said. A further analysis of the data linked improvement on the AHI with a more complete reversal of the hippocampal abnormalities in children with mild OSA, she said, noting, however, that this finding "is very preliminary."

Based on the study results, "we speculate that early diagnosis and treatment of obstructive sleep apnea in children could have profound effects on the trajectory of their development," Dr. Halbower said. In particular, she suggested, earlier treatment may lead to a "more brisk improvement" in the hippocampus, which is the "relay station" for executive function, learning, and memory.

Dr. Halbower said she had no relevant financial disclosures.

BOSTON – Neuronal abnormalities in the brains of children with obstructive sleep apnea are reversible with treatment, a prospective study has shown.

The findings are the first to show that the altered brain metabolites of the frontal cortex – the neuronal network responsible for attention and executive function – normalize with treatment of pediatric obstructive sleep apnea, Dr. Ann C. Halbower reported at the annual meeting of the Associated Professional Sleep Societies.

Previous studies have demonstrated an association between obstructive sleep apnea (OSA) and deficits in attention, cognition, and executive function, "but ours is the first to look at the effect of [OSA] treatment on the neuronal brain injury and to show a relationship between treatment and improvements in attention and verbal memory in these patients," said Dr. Halbower of the Children’s Hospital Colorado Sleep Center and the University of Colorado at Denver.

The study included 28 children aged 8-11 years; 17 had moderate or severe OSA and 11 were healthy controls matched by age, sex, race, and socioeconomic status. At study baseline, all participants underwent neuropsychological testing, and 22 of the children (15 with OSA and 7 healthy controls) also underwent magnetic resonance spectroscopy imaging. Six months post treatment, 11 of the OSA patients underwent repeat brain imaging and neuropsychological testing, Dr. Halbower said. Treatment for OSA consisted of adenotonsillectomy followed by monitored continuous positive airway pressure (CPAP) for children whose apnea-hypopnea index (AHI) score was higher than 3, or nasal treatments for those with an AHI score of 2-3, she explained.

Among the OSA patients, the mean AHI score at baseline was 13.6, compared with 0.3 for the healthy controls – a discrepancy mirrored by differences observed in both the brain imaging and the function tests. Specifically, Dr. Halbower reported, "the N-acetyl aspartate to choline (NAA/Cho) ratios in the left hippocampus and left frontal cortex were significantly decreased in [OSA] patients, compared with healthy controls, and the [OSA] patients had significant decreases in the executive function of working memory, attention, and verbal memory."

After treatment, "the neuronal metabolites of the right and left frontal cortex normalized, and the hippocampal metabolites improved with a medium effect size," Dr. Halbower said. The follow-up neuropsychological testing showed significant improvements in verbal memory and attention, "which correlated with the normalization of the [NAA/Cho] ratios in the frontal lobes," she said. A further analysis of the data linked improvement on the AHI with a more complete reversal of the hippocampal abnormalities in children with mild OSA, she said, noting, however, that this finding "is very preliminary."

Based on the study results, "we speculate that early diagnosis and treatment of obstructive sleep apnea in children could have profound effects on the trajectory of their development," Dr. Halbower said. In particular, she suggested, earlier treatment may lead to a "more brisk improvement" in the hippocampus, which is the "relay station" for executive function, learning, and memory.

Dr. Halbower said she had no relevant financial disclosures.

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obstructive sleep apnea, children, adenotonsillectomy, CPAP, neuronal brain injury
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obstructive sleep apnea, children, adenotonsillectomy, CPAP, neuronal brain injury
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AT THE ANNUAL MEETING OF THE ASSOCIATED PROFESSIONAL SLEEP SOCIETIES

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Major Finding: Ratios of N-acetyl aspartate to choline in the frontal cortex of children with obstructive sleep apnea normalized after treatment, correlating to improvements in verbal memory and attention.

Data Source: The prospective study compared the pre- and posttreatment neuroimaging and neuropsychological test results of children with OSA to those of matched controls.

Disclosures: Dr. Halbower said she had no relevant financial disclosures.

Outcomes Data Used to Assess Residents' Surgical Skills

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SAN FRANCISCO – Resident involvement in surgical procedures does not clinically affect surgical outcomes, according to a retrospective study of more than 60,000 cases from the National Surgical Quality Improvement Program database.

"There is a small – although questionable as clinically relevant – overall increase in mild and surgical complications. This is mostly caused by superficial wound infections when residents participate in surgical procedures," said Dr. P. Ravi Kiran, staff surgeon and head of the research section in the department of colorectal surgery at the Cleveland Clinic.

Using data from the National Surgical Quality Improvement Program database from 2005 to 2007, Dr. Kiran and his colleagues compared outcomes for patients who underwent surgery with and without resident participation.

The database, which includes data from pre-, intra-, and postoperative phases, uses clearly defined parameters and specialist nurse reviewers. It also includes resident participation and a morbidity probability, which offers an opportunity to use preoperative factors to stratify risk within subgroups, Dr. Kiran said at the annual meeting of the American Surgical Association.

Resident cases were matched with nonresident cases on the basis of age, sex, specialty, surgical procedure, morbidity probability, and important comorbidities and risk factors. Primary outcomes included 30-day mortality and postoperative complications (mild vs. severe, and surgical vs. medical). Secondary outcomes included the duration of surgery and length of hospital stay.

Mild complications included superficial surgical site infections (SSIs), peripheral nerve injury, urinary tract infection, deep venous thrombosis, and thrombophlebitis. Severe complications included deep (organ) SSI, wound disruption, bleeding requiring transfusion, failure of graft or prosthesis, reoperation, pneumonia, pulmonary embolism, acute renal failure, stroke, myocardial infarction, and sepsis.

Surgical complications included superficial SSI, deep (organ) SSI, wound disruption, bleeding requiring transfusion, failure of graft or prosthesis, peripheral nerve injury, and reoperation. Medical complications included pneumonia, pulmonary embolism, acute renal failure, stroke, myocardial infarction, sepsis, urinary tract infection, deep vein thrombosis, and thrombophlebitis.

For cases with resident vs. nonresident participation, the surgical complication rates were 7% and 6.2%, respectively – a significant difference – and mild complications rates were 4.4% and 3.5%, respectively. In addition, the mean operative time was significantly greater for cases involving residents – 122 vs. 97 minutes. The length of postoperative hospital stay was not significantly longer in the resident group.

The researchers identified 40,474 patients in the resident group and 20,237 patients in the nonresident group. The two groups were similar in terms of median age (50 years), sex (67% female), mean morbidity probability (0.09), American Society of Anesthesiologists classification, and presence of diabetes (6.4%) and hypertension (35%).

The groups were also similar in terms of presence of chronic obstructive pulmonary disease (0.27%), congestive heart failure or myocardial infarction in the past 6 months (0%), dialysis (0.044%), and preoperative sepsis (0.035%). Surgeons’ speciality areas were likewise similar for the two groups (general, 93%; vascular, 6%; and other, 1.36%).

Postgraduate year (PGY) 1-2 residents participated in 31% of operations, PGY 3-5 residents participated in 56%, and residents in PGY 6 or higher participated in 13% of cases.

The 10 most common surgical procedures were laparoscopic appendectomy, laparoscopic gastric bypass, laparoscopic cholecystectomy with and without operative cholangiogram, open appendectomy (nonruptured), thromboendarterectomy, colectomy (partial with anastomosis), laparoscopic colectomy (partial with anastomosis), ventral hernia repair, and placement of gastric band. These procedures were similar in terms of the percentages of resident and nonresident participation.

"We found that there was no difference in the [overall] 30-day mortality between the groups – 0.18% in the resident group and 0.20% in the no-resident group," said Dr. Kiran. However, any 30-day complications were 7.5% in the resident group and 6.7% in the nonresident group, a significant difference.

"When we further looked at the surgical complications, we noted that the cause of the difference in surgical complications between the two groups was the higher rate of SSIs in the resident group, when compared with the no-resident group ... the other surgical complications were similar," he said. The SSI rate was 3.0% for the resident group, compared with 2.2% for the nonresident group.

Interestingly, the researchers also found that overall 30-day complication rates increased with PGY – the rates were 6% for PGY 1-2, 8% for PGY 3-5, and 9% for PGY of 6 or more.

When they examined specific outcomes and complications between different PGY groups and matched cases without the involvement of residents, they found a similar pattern for the overall cohort.

"The reason for the difference in 30-day complications in the groups was because of differences in complications that were classified as mild, and primarily because the superficial surgical site infections were higher in the PGY 1-2 years, with an increased operative time," they said. The same was true for PGY 3-5 and PGY 6 and greater.

 

 

Also, as PGY increased, so did operative time – in both resident and nonresident groups. "This suggests that the reason for the increasing complications with increasing PGY years may have been related to increasing complexity of surgery," said Dr. Kiran.

"One overarching issue seems to be how we might achieve high-quality patient care and delivery of the clinical outcomes in the context of training," said Dr. Clifford Ko, a discussant.

However, he also acknowledged that teaching residents takes time. Dr. Ko, a colorectal surgeon and the director of the Center for Surgical Outcomes and Quality at the University of California, Los Angeles, questioned whether the longer operating time associated with resident involvement should be reduced.

"Although we would not perhaps be able to minimize time differences, I think that we have already achieved some mark of control by the gradation of responsibility over time, as residents continue with their training," Dr. Kiran said.

Although the surgical and mild complication rates were slightly greater, it’s unclear whether these differences are clinically relevant.

"The reasons for [these differences] are likely multifactorial and may be related to prolonged operative time. Considering that more complex cases may be performed in teaching hospitals and require resident participation, ‘resident’ could be a surrogate of severity of disease and intensity of operation – factors that may not be clearly discernible in a retrospective study – and this may explain the differences seen.

"Also, quality measures currently underway to reduce surgical site infections across the board may further minimize any of these differences that may exist," Dr. Kiran concluded.

The authors reported that they had no relevant disclosures.

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SAN FRANCISCO – Resident involvement in surgical procedures does not clinically affect surgical outcomes, according to a retrospective study of more than 60,000 cases from the National Surgical Quality Improvement Program database.

"There is a small – although questionable as clinically relevant – overall increase in mild and surgical complications. This is mostly caused by superficial wound infections when residents participate in surgical procedures," said Dr. P. Ravi Kiran, staff surgeon and head of the research section in the department of colorectal surgery at the Cleveland Clinic.

Using data from the National Surgical Quality Improvement Program database from 2005 to 2007, Dr. Kiran and his colleagues compared outcomes for patients who underwent surgery with and without resident participation.

The database, which includes data from pre-, intra-, and postoperative phases, uses clearly defined parameters and specialist nurse reviewers. It also includes resident participation and a morbidity probability, which offers an opportunity to use preoperative factors to stratify risk within subgroups, Dr. Kiran said at the annual meeting of the American Surgical Association.

Resident cases were matched with nonresident cases on the basis of age, sex, specialty, surgical procedure, morbidity probability, and important comorbidities and risk factors. Primary outcomes included 30-day mortality and postoperative complications (mild vs. severe, and surgical vs. medical). Secondary outcomes included the duration of surgery and length of hospital stay.

Mild complications included superficial surgical site infections (SSIs), peripheral nerve injury, urinary tract infection, deep venous thrombosis, and thrombophlebitis. Severe complications included deep (organ) SSI, wound disruption, bleeding requiring transfusion, failure of graft or prosthesis, reoperation, pneumonia, pulmonary embolism, acute renal failure, stroke, myocardial infarction, and sepsis.

Surgical complications included superficial SSI, deep (organ) SSI, wound disruption, bleeding requiring transfusion, failure of graft or prosthesis, peripheral nerve injury, and reoperation. Medical complications included pneumonia, pulmonary embolism, acute renal failure, stroke, myocardial infarction, sepsis, urinary tract infection, deep vein thrombosis, and thrombophlebitis.

For cases with resident vs. nonresident participation, the surgical complication rates were 7% and 6.2%, respectively – a significant difference – and mild complications rates were 4.4% and 3.5%, respectively. In addition, the mean operative time was significantly greater for cases involving residents – 122 vs. 97 minutes. The length of postoperative hospital stay was not significantly longer in the resident group.

The researchers identified 40,474 patients in the resident group and 20,237 patients in the nonresident group. The two groups were similar in terms of median age (50 years), sex (67% female), mean morbidity probability (0.09), American Society of Anesthesiologists classification, and presence of diabetes (6.4%) and hypertension (35%).

The groups were also similar in terms of presence of chronic obstructive pulmonary disease (0.27%), congestive heart failure or myocardial infarction in the past 6 months (0%), dialysis (0.044%), and preoperative sepsis (0.035%). Surgeons’ speciality areas were likewise similar for the two groups (general, 93%; vascular, 6%; and other, 1.36%).

Postgraduate year (PGY) 1-2 residents participated in 31% of operations, PGY 3-5 residents participated in 56%, and residents in PGY 6 or higher participated in 13% of cases.

The 10 most common surgical procedures were laparoscopic appendectomy, laparoscopic gastric bypass, laparoscopic cholecystectomy with and without operative cholangiogram, open appendectomy (nonruptured), thromboendarterectomy, colectomy (partial with anastomosis), laparoscopic colectomy (partial with anastomosis), ventral hernia repair, and placement of gastric band. These procedures were similar in terms of the percentages of resident and nonresident participation.

"We found that there was no difference in the [overall] 30-day mortality between the groups – 0.18% in the resident group and 0.20% in the no-resident group," said Dr. Kiran. However, any 30-day complications were 7.5% in the resident group and 6.7% in the nonresident group, a significant difference.

"When we further looked at the surgical complications, we noted that the cause of the difference in surgical complications between the two groups was the higher rate of SSIs in the resident group, when compared with the no-resident group ... the other surgical complications were similar," he said. The SSI rate was 3.0% for the resident group, compared with 2.2% for the nonresident group.

Interestingly, the researchers also found that overall 30-day complication rates increased with PGY – the rates were 6% for PGY 1-2, 8% for PGY 3-5, and 9% for PGY of 6 or more.

When they examined specific outcomes and complications between different PGY groups and matched cases without the involvement of residents, they found a similar pattern for the overall cohort.

"The reason for the difference in 30-day complications in the groups was because of differences in complications that were classified as mild, and primarily because the superficial surgical site infections were higher in the PGY 1-2 years, with an increased operative time," they said. The same was true for PGY 3-5 and PGY 6 and greater.

 

 

Also, as PGY increased, so did operative time – in both resident and nonresident groups. "This suggests that the reason for the increasing complications with increasing PGY years may have been related to increasing complexity of surgery," said Dr. Kiran.

"One overarching issue seems to be how we might achieve high-quality patient care and delivery of the clinical outcomes in the context of training," said Dr. Clifford Ko, a discussant.

However, he also acknowledged that teaching residents takes time. Dr. Ko, a colorectal surgeon and the director of the Center for Surgical Outcomes and Quality at the University of California, Los Angeles, questioned whether the longer operating time associated with resident involvement should be reduced.

"Although we would not perhaps be able to minimize time differences, I think that we have already achieved some mark of control by the gradation of responsibility over time, as residents continue with their training," Dr. Kiran said.

Although the surgical and mild complication rates were slightly greater, it’s unclear whether these differences are clinically relevant.

"The reasons for [these differences] are likely multifactorial and may be related to prolonged operative time. Considering that more complex cases may be performed in teaching hospitals and require resident participation, ‘resident’ could be a surrogate of severity of disease and intensity of operation – factors that may not be clearly discernible in a retrospective study – and this may explain the differences seen.

"Also, quality measures currently underway to reduce surgical site infections across the board may further minimize any of these differences that may exist," Dr. Kiran concluded.

The authors reported that they had no relevant disclosures.

SAN FRANCISCO – Resident involvement in surgical procedures does not clinically affect surgical outcomes, according to a retrospective study of more than 60,000 cases from the National Surgical Quality Improvement Program database.

"There is a small – although questionable as clinically relevant – overall increase in mild and surgical complications. This is mostly caused by superficial wound infections when residents participate in surgical procedures," said Dr. P. Ravi Kiran, staff surgeon and head of the research section in the department of colorectal surgery at the Cleveland Clinic.

Using data from the National Surgical Quality Improvement Program database from 2005 to 2007, Dr. Kiran and his colleagues compared outcomes for patients who underwent surgery with and without resident participation.

The database, which includes data from pre-, intra-, and postoperative phases, uses clearly defined parameters and specialist nurse reviewers. It also includes resident participation and a morbidity probability, which offers an opportunity to use preoperative factors to stratify risk within subgroups, Dr. Kiran said at the annual meeting of the American Surgical Association.

Resident cases were matched with nonresident cases on the basis of age, sex, specialty, surgical procedure, morbidity probability, and important comorbidities and risk factors. Primary outcomes included 30-day mortality and postoperative complications (mild vs. severe, and surgical vs. medical). Secondary outcomes included the duration of surgery and length of hospital stay.

Mild complications included superficial surgical site infections (SSIs), peripheral nerve injury, urinary tract infection, deep venous thrombosis, and thrombophlebitis. Severe complications included deep (organ) SSI, wound disruption, bleeding requiring transfusion, failure of graft or prosthesis, reoperation, pneumonia, pulmonary embolism, acute renal failure, stroke, myocardial infarction, and sepsis.

Surgical complications included superficial SSI, deep (organ) SSI, wound disruption, bleeding requiring transfusion, failure of graft or prosthesis, peripheral nerve injury, and reoperation. Medical complications included pneumonia, pulmonary embolism, acute renal failure, stroke, myocardial infarction, sepsis, urinary tract infection, deep vein thrombosis, and thrombophlebitis.

For cases with resident vs. nonresident participation, the surgical complication rates were 7% and 6.2%, respectively – a significant difference – and mild complications rates were 4.4% and 3.5%, respectively. In addition, the mean operative time was significantly greater for cases involving residents – 122 vs. 97 minutes. The length of postoperative hospital stay was not significantly longer in the resident group.

The researchers identified 40,474 patients in the resident group and 20,237 patients in the nonresident group. The two groups were similar in terms of median age (50 years), sex (67% female), mean morbidity probability (0.09), American Society of Anesthesiologists classification, and presence of diabetes (6.4%) and hypertension (35%).

The groups were also similar in terms of presence of chronic obstructive pulmonary disease (0.27%), congestive heart failure or myocardial infarction in the past 6 months (0%), dialysis (0.044%), and preoperative sepsis (0.035%). Surgeons’ speciality areas were likewise similar for the two groups (general, 93%; vascular, 6%; and other, 1.36%).

Postgraduate year (PGY) 1-2 residents participated in 31% of operations, PGY 3-5 residents participated in 56%, and residents in PGY 6 or higher participated in 13% of cases.

The 10 most common surgical procedures were laparoscopic appendectomy, laparoscopic gastric bypass, laparoscopic cholecystectomy with and without operative cholangiogram, open appendectomy (nonruptured), thromboendarterectomy, colectomy (partial with anastomosis), laparoscopic colectomy (partial with anastomosis), ventral hernia repair, and placement of gastric band. These procedures were similar in terms of the percentages of resident and nonresident participation.

"We found that there was no difference in the [overall] 30-day mortality between the groups – 0.18% in the resident group and 0.20% in the no-resident group," said Dr. Kiran. However, any 30-day complications were 7.5% in the resident group and 6.7% in the nonresident group, a significant difference.

"When we further looked at the surgical complications, we noted that the cause of the difference in surgical complications between the two groups was the higher rate of SSIs in the resident group, when compared with the no-resident group ... the other surgical complications were similar," he said. The SSI rate was 3.0% for the resident group, compared with 2.2% for the nonresident group.

Interestingly, the researchers also found that overall 30-day complication rates increased with PGY – the rates were 6% for PGY 1-2, 8% for PGY 3-5, and 9% for PGY of 6 or more.

When they examined specific outcomes and complications between different PGY groups and matched cases without the involvement of residents, they found a similar pattern for the overall cohort.

"The reason for the difference in 30-day complications in the groups was because of differences in complications that were classified as mild, and primarily because the superficial surgical site infections were higher in the PGY 1-2 years, with an increased operative time," they said. The same was true for PGY 3-5 and PGY 6 and greater.

 

 

Also, as PGY increased, so did operative time – in both resident and nonresident groups. "This suggests that the reason for the increasing complications with increasing PGY years may have been related to increasing complexity of surgery," said Dr. Kiran.

"One overarching issue seems to be how we might achieve high-quality patient care and delivery of the clinical outcomes in the context of training," said Dr. Clifford Ko, a discussant.

However, he also acknowledged that teaching residents takes time. Dr. Ko, a colorectal surgeon and the director of the Center for Surgical Outcomes and Quality at the University of California, Los Angeles, questioned whether the longer operating time associated with resident involvement should be reduced.

"Although we would not perhaps be able to minimize time differences, I think that we have already achieved some mark of control by the gradation of responsibility over time, as residents continue with their training," Dr. Kiran said.

Although the surgical and mild complication rates were slightly greater, it’s unclear whether these differences are clinically relevant.

"The reasons for [these differences] are likely multifactorial and may be related to prolonged operative time. Considering that more complex cases may be performed in teaching hospitals and require resident participation, ‘resident’ could be a surrogate of severity of disease and intensity of operation – factors that may not be clearly discernible in a retrospective study – and this may explain the differences seen.

"Also, quality measures currently underway to reduce surgical site infections across the board may further minimize any of these differences that may exist," Dr. Kiran concluded.

The authors reported that they had no relevant disclosures.

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Outcomes Data Used to Assess Residents' Surgical Skills
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Major Finding: There was no difference in the overall 30-day mortality between the surgery patient groups with (0.18%) and without (0.20%) resident involvement.

Data Source: Data from the National Surgical Quality Improvement Program database from 2005 to 2007 were used to compare outcomes for patients who underwent surgery with and without resident participation.

Disclosures: The authors reported that they had no relevant disclosures.

TSRA Optimistic at the Annual Meeting

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This year’s 92nd Annual Meeting of The American Association for Thoracic Surgery (AATS) reemphasized a bright horizon for thoracic surgery trainees. The consensus amongst trainees is that there is a markedly improved job market and that the professions commitment toward innovation, cutting edge technology, and excellence has rejuvenated spirits.

The AATS annual meeting highlighted this drive toward technologic innovation with minimally invasive cardiac and thoracic surgery, transcatheter aortic valve, endovascular thoracic aortic stenting, and mechanical circulatory support for heart and lung being emphasized.

The Thoracic Surgery Resident’s Association (TSRA), which represents thoracic surgery residents across the nation, presented Dr. Hiroo Takayama from Columbia University with the 2012 Dwight C. McGoon Award. The McGoon award recognizes a distinguished young faculty member in cardiothoracic surgery with an outstanding commitment to resident education and mentorship.

The outgoing leadership of the TSRA, Dr. Jason Williams (President) from Duke University, Dr. Stephen McKellar (Vice President) from Mayo Clinic in Rochester, Minn., and Dr. Tom Nguyen from Columbia University are to be commended for their hard work and enthusiasm in promoting trainee issues, stimulating trainee recruitment, and interest in thoracic surgery.

At this year’s AATS meeting, the TSRA organized and hosted the first annual Spouse Support Network Mixer. Approximately 25-30 residents and spouses attended the successful event, and the Thoracic Surgery Directors Association has agreed to support future resident and spouse events.

The TSRA/AATS Residents’ Luncheon featured a keynote address by Dr. John Calhoon, Professor and Chairman of the Department of Cardiothoracic Surgery at the University of Texas Health Sciences Center in San Antonio. Dr. Calhoon commented on the importance of being prepared for the written and oral board exams.

In addition, Dr. Calhoon focused his talk on the complex nuances and need to create a balance of professional and personal development as trainees transition into their practice as cardiothoracic surgeons.

Over 3,200 copies of the TSRA Review of Cardiothoracic Surgery have been distributed internationally.

This useful book is a vademicum of cardiothoracic surgery knowledge.

The next educational project that the TSRA will undertake is a Primer of Cardiothoracic Surgery. The primer project, headed by Dr. Sam Youssef, will be a complementary book to augment the TSDA Boot Camp intended to ease the transition into thoracic residency.

There has been unprecedented interest in thoracic surgery resident leadership with 32 applicants for vacant positions on the TSRA Executive Committee.

The TSRA is committed to integrating newer training pathway residents. An ongoing dialogue of the role of faculty, traditional residents, and integrated residents as I-6 programs progress will be emphasized as general surgery residents and medical students are introduced to the field of cardiothoracic surgery.

Dr. Bryan A. Whitson is a resident editor of Thoracic Surgery News and a Cardiovascular and Thoracic Surgery Fellow at the University of Minnesota.

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This year’s 92nd Annual Meeting of The American Association for Thoracic Surgery (AATS) reemphasized a bright horizon for thoracic surgery trainees. The consensus amongst trainees is that there is a markedly improved job market and that the professions commitment toward innovation, cutting edge technology, and excellence has rejuvenated spirits.

The AATS annual meeting highlighted this drive toward technologic innovation with minimally invasive cardiac and thoracic surgery, transcatheter aortic valve, endovascular thoracic aortic stenting, and mechanical circulatory support for heart and lung being emphasized.

The Thoracic Surgery Resident’s Association (TSRA), which represents thoracic surgery residents across the nation, presented Dr. Hiroo Takayama from Columbia University with the 2012 Dwight C. McGoon Award. The McGoon award recognizes a distinguished young faculty member in cardiothoracic surgery with an outstanding commitment to resident education and mentorship.

The outgoing leadership of the TSRA, Dr. Jason Williams (President) from Duke University, Dr. Stephen McKellar (Vice President) from Mayo Clinic in Rochester, Minn., and Dr. Tom Nguyen from Columbia University are to be commended for their hard work and enthusiasm in promoting trainee issues, stimulating trainee recruitment, and interest in thoracic surgery.

At this year’s AATS meeting, the TSRA organized and hosted the first annual Spouse Support Network Mixer. Approximately 25-30 residents and spouses attended the successful event, and the Thoracic Surgery Directors Association has agreed to support future resident and spouse events.

The TSRA/AATS Residents’ Luncheon featured a keynote address by Dr. John Calhoon, Professor and Chairman of the Department of Cardiothoracic Surgery at the University of Texas Health Sciences Center in San Antonio. Dr. Calhoon commented on the importance of being prepared for the written and oral board exams.

In addition, Dr. Calhoon focused his talk on the complex nuances and need to create a balance of professional and personal development as trainees transition into their practice as cardiothoracic surgeons.

Over 3,200 copies of the TSRA Review of Cardiothoracic Surgery have been distributed internationally.

This useful book is a vademicum of cardiothoracic surgery knowledge.

The next educational project that the TSRA will undertake is a Primer of Cardiothoracic Surgery. The primer project, headed by Dr. Sam Youssef, will be a complementary book to augment the TSDA Boot Camp intended to ease the transition into thoracic residency.

There has been unprecedented interest in thoracic surgery resident leadership with 32 applicants for vacant positions on the TSRA Executive Committee.

The TSRA is committed to integrating newer training pathway residents. An ongoing dialogue of the role of faculty, traditional residents, and integrated residents as I-6 programs progress will be emphasized as general surgery residents and medical students are introduced to the field of cardiothoracic surgery.

Dr. Bryan A. Whitson is a resident editor of Thoracic Surgery News and a Cardiovascular and Thoracic Surgery Fellow at the University of Minnesota.

This year’s 92nd Annual Meeting of The American Association for Thoracic Surgery (AATS) reemphasized a bright horizon for thoracic surgery trainees. The consensus amongst trainees is that there is a markedly improved job market and that the professions commitment toward innovation, cutting edge technology, and excellence has rejuvenated spirits.

The AATS annual meeting highlighted this drive toward technologic innovation with minimally invasive cardiac and thoracic surgery, transcatheter aortic valve, endovascular thoracic aortic stenting, and mechanical circulatory support for heart and lung being emphasized.

The Thoracic Surgery Resident’s Association (TSRA), which represents thoracic surgery residents across the nation, presented Dr. Hiroo Takayama from Columbia University with the 2012 Dwight C. McGoon Award. The McGoon award recognizes a distinguished young faculty member in cardiothoracic surgery with an outstanding commitment to resident education and mentorship.

The outgoing leadership of the TSRA, Dr. Jason Williams (President) from Duke University, Dr. Stephen McKellar (Vice President) from Mayo Clinic in Rochester, Minn., and Dr. Tom Nguyen from Columbia University are to be commended for their hard work and enthusiasm in promoting trainee issues, stimulating trainee recruitment, and interest in thoracic surgery.

At this year’s AATS meeting, the TSRA organized and hosted the first annual Spouse Support Network Mixer. Approximately 25-30 residents and spouses attended the successful event, and the Thoracic Surgery Directors Association has agreed to support future resident and spouse events.

The TSRA/AATS Residents’ Luncheon featured a keynote address by Dr. John Calhoon, Professor and Chairman of the Department of Cardiothoracic Surgery at the University of Texas Health Sciences Center in San Antonio. Dr. Calhoon commented on the importance of being prepared for the written and oral board exams.

In addition, Dr. Calhoon focused his talk on the complex nuances and need to create a balance of professional and personal development as trainees transition into their practice as cardiothoracic surgeons.

Over 3,200 copies of the TSRA Review of Cardiothoracic Surgery have been distributed internationally.

This useful book is a vademicum of cardiothoracic surgery knowledge.

The next educational project that the TSRA will undertake is a Primer of Cardiothoracic Surgery. The primer project, headed by Dr. Sam Youssef, will be a complementary book to augment the TSDA Boot Camp intended to ease the transition into thoracic residency.

There has been unprecedented interest in thoracic surgery resident leadership with 32 applicants for vacant positions on the TSRA Executive Committee.

The TSRA is committed to integrating newer training pathway residents. An ongoing dialogue of the role of faculty, traditional residents, and integrated residents as I-6 programs progress will be emphasized as general surgery residents and medical students are introduced to the field of cardiothoracic surgery.

Dr. Bryan A. Whitson is a resident editor of Thoracic Surgery News and a Cardiovascular and Thoracic Surgery Fellow at the University of Minnesota.

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Report Finds Some Hospitalists Engage in Various Levels of Unprofessionalism

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New research published in the Journal of Hospital Medicine found two-thirds of hospitalists at three Chicago academic health centers engaged in some level of unprofessional behavior.

The report, "Participation in Unprofessional Behaviors Among Hospitalists: A Multicenter Study," found 67.1% of the 77 respondents had medical or personal conversations in patient corridors, 62.3% had ordered a routine test as "urgent" to speed up results, and 40.3% poked fun at other physicians to colleagues. More troubling, the report showed that 6.5% of respondents had engaged in falsifying patient records and that 2.6% had performed medical or surgical procedures on a patient beyond their self-perceived level of skill. Both behaviors were defined as egregious.

Some media reports have played up the findings of unprofessionalism, but study authors note that the findings are more nuanced than that. "I would emphasize that participation in egregious behaviors was low especially related to trainees, which is a plus," says co-author Vineet Arora, MD, FHM, MAPP, associate professor of medicine and associate director of internal-medicine residency at the University of Chicago's Pritzker School of Medicine. "However, certain job characteristics change the likelihood of unprofessional behavior—that is probably the most interesting finding."

Dr. Arora says that the report's findings helped craft a video intervention that has been used at all three academic centers. The video, funded by the American Board of Internal Medicine (ABIM), is just a first step in stressing to hospitalists behaviors that are considered professional, she adds.

One of the surprises of the data, she says, is that hospitalists with lower amounts of clinical work on their plate were more likely to report making fun of other physicians or patients.

"We often think that too much clinical work leads to burnout and depersonalization, but this shows the opposite," she says. "It may be that those hospitalists who do a lot of clinical work value their relationships and understand the importance of setting a professional tone for their work."

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New research published in the Journal of Hospital Medicine found two-thirds of hospitalists at three Chicago academic health centers engaged in some level of unprofessional behavior.

The report, "Participation in Unprofessional Behaviors Among Hospitalists: A Multicenter Study," found 67.1% of the 77 respondents had medical or personal conversations in patient corridors, 62.3% had ordered a routine test as "urgent" to speed up results, and 40.3% poked fun at other physicians to colleagues. More troubling, the report showed that 6.5% of respondents had engaged in falsifying patient records and that 2.6% had performed medical or surgical procedures on a patient beyond their self-perceived level of skill. Both behaviors were defined as egregious.

Some media reports have played up the findings of unprofessionalism, but study authors note that the findings are more nuanced than that. "I would emphasize that participation in egregious behaviors was low especially related to trainees, which is a plus," says co-author Vineet Arora, MD, FHM, MAPP, associate professor of medicine and associate director of internal-medicine residency at the University of Chicago's Pritzker School of Medicine. "However, certain job characteristics change the likelihood of unprofessional behavior—that is probably the most interesting finding."

Dr. Arora says that the report's findings helped craft a video intervention that has been used at all three academic centers. The video, funded by the American Board of Internal Medicine (ABIM), is just a first step in stressing to hospitalists behaviors that are considered professional, she adds.

One of the surprises of the data, she says, is that hospitalists with lower amounts of clinical work on their plate were more likely to report making fun of other physicians or patients.

"We often think that too much clinical work leads to burnout and depersonalization, but this shows the opposite," she says. "It may be that those hospitalists who do a lot of clinical work value their relationships and understand the importance of setting a professional tone for their work."

New research published in the Journal of Hospital Medicine found two-thirds of hospitalists at three Chicago academic health centers engaged in some level of unprofessional behavior.

The report, "Participation in Unprofessional Behaviors Among Hospitalists: A Multicenter Study," found 67.1% of the 77 respondents had medical or personal conversations in patient corridors, 62.3% had ordered a routine test as "urgent" to speed up results, and 40.3% poked fun at other physicians to colleagues. More troubling, the report showed that 6.5% of respondents had engaged in falsifying patient records and that 2.6% had performed medical or surgical procedures on a patient beyond their self-perceived level of skill. Both behaviors were defined as egregious.

Some media reports have played up the findings of unprofessionalism, but study authors note that the findings are more nuanced than that. "I would emphasize that participation in egregious behaviors was low especially related to trainees, which is a plus," says co-author Vineet Arora, MD, FHM, MAPP, associate professor of medicine and associate director of internal-medicine residency at the University of Chicago's Pritzker School of Medicine. "However, certain job characteristics change the likelihood of unprofessional behavior—that is probably the most interesting finding."

Dr. Arora says that the report's findings helped craft a video intervention that has been used at all three academic centers. The video, funded by the American Board of Internal Medicine (ABIM), is just a first step in stressing to hospitalists behaviors that are considered professional, she adds.

One of the surprises of the data, she says, is that hospitalists with lower amounts of clinical work on their plate were more likely to report making fun of other physicians or patients.

"We often think that too much clinical work leads to burnout and depersonalization, but this shows the opposite," she says. "It may be that those hospitalists who do a lot of clinical work value their relationships and understand the importance of setting a professional tone for their work."

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Hospitalist Honored for Humanitarian Work in Pakistan

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Syed Irfan Ali, MD, a hospitalist at MaineGeneral Medical Center's Thayer Campus in Waterville, recently was honored with the Humanitarian of the Year Award from the Nasreen and Alam Sher Foundation (NASF) for volunteering his medical skills in his native Pakistan.

In November 2011, during a visit to his family, Dr. Ali spent two weekends offering free medical services at Aisha Bibi Memorial Hospital, run by NASF in a village near Karachi. Dr. Ali's uncle heads a pharmacy company in Pakistan and arranged for free medications to be distributed. Approximately 2,100 patients turned up with complaints, such as malaria, typhoid, tuberculosis, lung disease, ear problems, peptic ulcer disease, skin conditions, and gynecologic infections. "Many of these people had never been to a hospital before," Dr. Ali says.

One case that stands out for Dr. Ali was that of a 7-year-old boy who had 15 fractures from a congenital bone condition known to respond to bisphosphonate treatment. Dr. Ali was able to refer the boy to a major hospital in Karachi, where he received the treatment.

"I was trained in family medicine, where you treat people of all ages," says Dr. Ali, who came to the United States in 2004 after completing medical school. "My friends in America, who are working doctors, and I feel we owe a debt to our native country and the people who live there." He started collecting funds for flood relief in 2010 but wanted to do more.

"Now that I've had such an experience, I'd like to go back, and also mobilize my medical friends to get involved," he says.

Chelsea, Maine-based NASF supports health, education, humanities, and peace in South Asian countries. Later this month, Dr. Ali will move to a residency program in anesthesiology at Brigham and Women's Hospital in Boston, but he hopes to return to Pakistan, perhaps at the end of this year.

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Syed Irfan Ali, MD, a hospitalist at MaineGeneral Medical Center's Thayer Campus in Waterville, recently was honored with the Humanitarian of the Year Award from the Nasreen and Alam Sher Foundation (NASF) for volunteering his medical skills in his native Pakistan.

In November 2011, during a visit to his family, Dr. Ali spent two weekends offering free medical services at Aisha Bibi Memorial Hospital, run by NASF in a village near Karachi. Dr. Ali's uncle heads a pharmacy company in Pakistan and arranged for free medications to be distributed. Approximately 2,100 patients turned up with complaints, such as malaria, typhoid, tuberculosis, lung disease, ear problems, peptic ulcer disease, skin conditions, and gynecologic infections. "Many of these people had never been to a hospital before," Dr. Ali says.

One case that stands out for Dr. Ali was that of a 7-year-old boy who had 15 fractures from a congenital bone condition known to respond to bisphosphonate treatment. Dr. Ali was able to refer the boy to a major hospital in Karachi, where he received the treatment.

"I was trained in family medicine, where you treat people of all ages," says Dr. Ali, who came to the United States in 2004 after completing medical school. "My friends in America, who are working doctors, and I feel we owe a debt to our native country and the people who live there." He started collecting funds for flood relief in 2010 but wanted to do more.

"Now that I've had such an experience, I'd like to go back, and also mobilize my medical friends to get involved," he says.

Chelsea, Maine-based NASF supports health, education, humanities, and peace in South Asian countries. Later this month, Dr. Ali will move to a residency program in anesthesiology at Brigham and Women's Hospital in Boston, but he hopes to return to Pakistan, perhaps at the end of this year.

Syed Irfan Ali, MD, a hospitalist at MaineGeneral Medical Center's Thayer Campus in Waterville, recently was honored with the Humanitarian of the Year Award from the Nasreen and Alam Sher Foundation (NASF) for volunteering his medical skills in his native Pakistan.

In November 2011, during a visit to his family, Dr. Ali spent two weekends offering free medical services at Aisha Bibi Memorial Hospital, run by NASF in a village near Karachi. Dr. Ali's uncle heads a pharmacy company in Pakistan and arranged for free medications to be distributed. Approximately 2,100 patients turned up with complaints, such as malaria, typhoid, tuberculosis, lung disease, ear problems, peptic ulcer disease, skin conditions, and gynecologic infections. "Many of these people had never been to a hospital before," Dr. Ali says.

One case that stands out for Dr. Ali was that of a 7-year-old boy who had 15 fractures from a congenital bone condition known to respond to bisphosphonate treatment. Dr. Ali was able to refer the boy to a major hospital in Karachi, where he received the treatment.

"I was trained in family medicine, where you treat people of all ages," says Dr. Ali, who came to the United States in 2004 after completing medical school. "My friends in America, who are working doctors, and I feel we owe a debt to our native country and the people who live there." He started collecting funds for flood relief in 2010 but wanted to do more.

"Now that I've had such an experience, I'd like to go back, and also mobilize my medical friends to get involved," he says.

Chelsea, Maine-based NASF supports health, education, humanities, and peace in South Asian countries. Later this month, Dr. Ali will move to a residency program in anesthesiology at Brigham and Women's Hospital in Boston, but he hopes to return to Pakistan, perhaps at the end of this year.

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Supreme Court Ruling Just the Beginning for Health Reform

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Days after the landmark Supreme Court ruling declaring the Affordable Care Act to be constitutional, some uncertainties remain. While most of the law was upheld, the Court did strike down the provision withholding Medicaid funding from states who opt out of the expansion. It's unclear, yet, how many states will choose to opt out.

Meanwhile, many physician groups have voiced support for the Court's ruling. However, they continue to call for eliminating the law's Independent Payment Advisory board, implementing malpractice reform, and finding a permanent replacement to Medicare's Sustainable Growth Rate formula.

Check out our video for more details.

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Days after the landmark Supreme Court ruling declaring the Affordable Care Act to be constitutional, some uncertainties remain. While most of the law was upheld, the Court did strike down the provision withholding Medicaid funding from states who opt out of the expansion. It's unclear, yet, how many states will choose to opt out.

Meanwhile, many physician groups have voiced support for the Court's ruling. However, they continue to call for eliminating the law's Independent Payment Advisory board, implementing malpractice reform, and finding a permanent replacement to Medicare's Sustainable Growth Rate formula.

Check out our video for more details.

Days after the landmark Supreme Court ruling declaring the Affordable Care Act to be constitutional, some uncertainties remain. While most of the law was upheld, the Court did strike down the provision withholding Medicaid funding from states who opt out of the expansion. It's unclear, yet, how many states will choose to opt out.

Meanwhile, many physician groups have voiced support for the Court's ruling. However, they continue to call for eliminating the law's Independent Payment Advisory board, implementing malpractice reform, and finding a permanent replacement to Medicare's Sustainable Growth Rate formula.

Check out our video for more details.

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Anticoagulation in Portal Vein Thrombosis Safe, Effective

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More than half of a group of cirrhosis patients with portal vein thrombosis achieved recanalization with anticoagulation treatment maintained for at least 12 months.

"Moreover, when complete recanalization is achieved, therapy with anticoagulants should be maintained throughout life in order to prevent recurrent thrombosis," wrote Dr. María Gabriela Delgado and Dr. Susana Seijo along with their colleagues in the July issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2012.01.012).

In the largest study to date to evaluate the safety and efficacy of anticoagulation for portal vein thrombosis in cirrhosis (for which there are no guidelines, according to the authors), the investigators looked at 55 patients with portal vein thrombosis and cirrhosis from four centers in Spain between June 2003 and September 2010.

All patients received anticoagulation according to the protocol of each hospital after the initiation of prophylaxis of variceal bleeding. For 31 patients, anticoagulation was indicated because of acute or subacute thrombosis, and in the remaining 24 patients, anticoagulation was started because of thrombosis progression.

Anticoagulant agents included low-molecular-weight heparin and vitamin K antagonists, wrote Dr. Delgado and Dr. Seijo, both of the University of Barcelona.

Over a mean 19 months of follow-up, half (n = 28) of the patients remained on anticoagulation until either the end of the study or liver transplant. The remaining 27 patients stopped treatment after a median of 6.3 months (range, 1-24 months).

A total of 33 patients achieved either complete or partial recanalization of the portal vein during the study period; 22 patients did not have a response.

There were three complete recanalizations that occurred within 1 month of anticoagulation initiation, and two patients achieved complete recanalization at month 12.

"Early initiation of anticoagulation therapy after the identification of thrombosis in an imaging study, especially in the first 2 weeks, was the only factor significantly associated with recanalization," wrote the authors.

A total of 17 patients had 30 clinical events during anticoagulation treatment. In 13 patients, these events were "liver related," according to the authors: six variceal bleeding episodes, eight new or worsening ascites cases, five hepatic encephalopathy cases, two spontaneous bacterial peritonitis cases, and two hepatocellular carcinoma cases (several patients had multiple events).

"Liver events were more frequent in patients not achieving recanalization (8/22) than in those achieving partial/complete recanalization (5/33)," added the investigators, though the difference between these groups did not reach significance (P = 0.1).

Non-liver-related events included five bleeding episodes, which the authors attributed to anticoagulation; one acute cholecystitis case; and one duodenal ulcer.

Overall, among the 11 total bleeding events (6 of which were liver related), the authors reported that all took place during the first year after starting anticoagulation, and five events occurred in the first 3 months of treatment.

Furthermore, the only significant predictor of bleeding was a platelet count below 50 × 109/L (P = .018).

Six patients died, none of whom were receiving anticoagulation at the time of death.

Despite its retrospective design and the fact that no comparison group was available, this study shows that "recanalization can be achieved very early after starting anticoagulation treatment; however, those patients who do not present early recanalization may finally achieve it when long-term anticoagulation therapy is maintained," wrote the authors.

More importantly, anticoagulation is "relatively safe" in this population, they added, except in cases of severely depressed platelet counts.

The authors disclosed no conflicts of interest related to this study, and indicated that the research was supported by public grants.

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More than half of a group of cirrhosis patients with portal vein thrombosis achieved recanalization with anticoagulation treatment maintained for at least 12 months.

"Moreover, when complete recanalization is achieved, therapy with anticoagulants should be maintained throughout life in order to prevent recurrent thrombosis," wrote Dr. María Gabriela Delgado and Dr. Susana Seijo along with their colleagues in the July issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2012.01.012).

In the largest study to date to evaluate the safety and efficacy of anticoagulation for portal vein thrombosis in cirrhosis (for which there are no guidelines, according to the authors), the investigators looked at 55 patients with portal vein thrombosis and cirrhosis from four centers in Spain between June 2003 and September 2010.

All patients received anticoagulation according to the protocol of each hospital after the initiation of prophylaxis of variceal bleeding. For 31 patients, anticoagulation was indicated because of acute or subacute thrombosis, and in the remaining 24 patients, anticoagulation was started because of thrombosis progression.

Anticoagulant agents included low-molecular-weight heparin and vitamin K antagonists, wrote Dr. Delgado and Dr. Seijo, both of the University of Barcelona.

Over a mean 19 months of follow-up, half (n = 28) of the patients remained on anticoagulation until either the end of the study or liver transplant. The remaining 27 patients stopped treatment after a median of 6.3 months (range, 1-24 months).

A total of 33 patients achieved either complete or partial recanalization of the portal vein during the study period; 22 patients did not have a response.

There were three complete recanalizations that occurred within 1 month of anticoagulation initiation, and two patients achieved complete recanalization at month 12.

"Early initiation of anticoagulation therapy after the identification of thrombosis in an imaging study, especially in the first 2 weeks, was the only factor significantly associated with recanalization," wrote the authors.

A total of 17 patients had 30 clinical events during anticoagulation treatment. In 13 patients, these events were "liver related," according to the authors: six variceal bleeding episodes, eight new or worsening ascites cases, five hepatic encephalopathy cases, two spontaneous bacterial peritonitis cases, and two hepatocellular carcinoma cases (several patients had multiple events).

"Liver events were more frequent in patients not achieving recanalization (8/22) than in those achieving partial/complete recanalization (5/33)," added the investigators, though the difference between these groups did not reach significance (P = 0.1).

Non-liver-related events included five bleeding episodes, which the authors attributed to anticoagulation; one acute cholecystitis case; and one duodenal ulcer.

Overall, among the 11 total bleeding events (6 of which were liver related), the authors reported that all took place during the first year after starting anticoagulation, and five events occurred in the first 3 months of treatment.

Furthermore, the only significant predictor of bleeding was a platelet count below 50 × 109/L (P = .018).

Six patients died, none of whom were receiving anticoagulation at the time of death.

Despite its retrospective design and the fact that no comparison group was available, this study shows that "recanalization can be achieved very early after starting anticoagulation treatment; however, those patients who do not present early recanalization may finally achieve it when long-term anticoagulation therapy is maintained," wrote the authors.

More importantly, anticoagulation is "relatively safe" in this population, they added, except in cases of severely depressed platelet counts.

The authors disclosed no conflicts of interest related to this study, and indicated that the research was supported by public grants.

More than half of a group of cirrhosis patients with portal vein thrombosis achieved recanalization with anticoagulation treatment maintained for at least 12 months.

"Moreover, when complete recanalization is achieved, therapy with anticoagulants should be maintained throughout life in order to prevent recurrent thrombosis," wrote Dr. María Gabriela Delgado and Dr. Susana Seijo along with their colleagues in the July issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2012.01.012).

In the largest study to date to evaluate the safety and efficacy of anticoagulation for portal vein thrombosis in cirrhosis (for which there are no guidelines, according to the authors), the investigators looked at 55 patients with portal vein thrombosis and cirrhosis from four centers in Spain between June 2003 and September 2010.

All patients received anticoagulation according to the protocol of each hospital after the initiation of prophylaxis of variceal bleeding. For 31 patients, anticoagulation was indicated because of acute or subacute thrombosis, and in the remaining 24 patients, anticoagulation was started because of thrombosis progression.

Anticoagulant agents included low-molecular-weight heparin and vitamin K antagonists, wrote Dr. Delgado and Dr. Seijo, both of the University of Barcelona.

Over a mean 19 months of follow-up, half (n = 28) of the patients remained on anticoagulation until either the end of the study or liver transplant. The remaining 27 patients stopped treatment after a median of 6.3 months (range, 1-24 months).

A total of 33 patients achieved either complete or partial recanalization of the portal vein during the study period; 22 patients did not have a response.

There were three complete recanalizations that occurred within 1 month of anticoagulation initiation, and two patients achieved complete recanalization at month 12.

"Early initiation of anticoagulation therapy after the identification of thrombosis in an imaging study, especially in the first 2 weeks, was the only factor significantly associated with recanalization," wrote the authors.

A total of 17 patients had 30 clinical events during anticoagulation treatment. In 13 patients, these events were "liver related," according to the authors: six variceal bleeding episodes, eight new or worsening ascites cases, five hepatic encephalopathy cases, two spontaneous bacterial peritonitis cases, and two hepatocellular carcinoma cases (several patients had multiple events).

"Liver events were more frequent in patients not achieving recanalization (8/22) than in those achieving partial/complete recanalization (5/33)," added the investigators, though the difference between these groups did not reach significance (P = 0.1).

Non-liver-related events included five bleeding episodes, which the authors attributed to anticoagulation; one acute cholecystitis case; and one duodenal ulcer.

Overall, among the 11 total bleeding events (6 of which were liver related), the authors reported that all took place during the first year after starting anticoagulation, and five events occurred in the first 3 months of treatment.

Furthermore, the only significant predictor of bleeding was a platelet count below 50 × 109/L (P = .018).

Six patients died, none of whom were receiving anticoagulation at the time of death.

Despite its retrospective design and the fact that no comparison group was available, this study shows that "recanalization can be achieved very early after starting anticoagulation treatment; however, those patients who do not present early recanalization may finally achieve it when long-term anticoagulation therapy is maintained," wrote the authors.

More importantly, anticoagulation is "relatively safe" in this population, they added, except in cases of severely depressed platelet counts.

The authors disclosed no conflicts of interest related to this study, and indicated that the research was supported by public grants.

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Hospitalists Should Prepare for the Patient-Centered Medical Home

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In 2009, five of the primary-care health centers in Wisconsin-based Dean Health System began to transform into an increasingly popular—but, to many, still somewhat fuzzy—feature of the new healthcare landscape: the “patient-centered medical home.”

The goals are noble: Orient and guide the patient through the healthcare system. Don’t repeat tests already performed. Keep costs down. Prevent illnesses that are, in fact, preventable. And reward doctors for doing so rather than encouraging visit after visit and test after test.

The hospitalists in the Dean system were brought late into the patient-centered medical home, or PCMH, project, but are now more involved:

  • They participate in discussions about impending hospitalizations for patients to determine whether hospitalization is really needed;
  • They make every effort to assign the same doctor to a patient each time the patient is hospitalized; and
  • They also are part of admissions and discharges that are smoother due to efforts to keep information flowing and keep patients in formed.

There have been hiccups, though. Dean hasn’t tracked readmission rates, so it isn’t known whether they’ve improved. And satisfaction ratings from patients haven’t improved—in part, says Kevin Eichhorn, MD, chief of the hospitalist division at Dean, because patients don’t fully appreciate the changes that have been made, although there is an effort to tell them.

I believe the hospitalist will be right at the center of the model, along with the PCPs. In my opinion, the PCMH model will expand the hospitalist’s role outside the four walls of the hospital.


—Ken Simone, DO, SFHM, principal, Hospitalist and Practice Solutions

“But we’ve also only been doing this routinely for about a year,” Dr. Eichhorn says. “My hope is that, as we get better at it, we will see some improvement in terms of patient satisfaction with their hospitalization and improvement in other quality metrics as well.”

If hospitalists already working in a PCMH model are struggling with the changes, imagine the question marks for hospitalists who aren’t familiar with the concept yet (see “The Patient-Centered Medical Home: A Primer,” below). Joseph Ming Wah Li, MD, SFHM, immediate past president of SHM, says most hospitalists are not.

“I think it’s fair to say that most hospitalists lack awareness and insight into what the patient-centered medical home will mean for patients and for hospitalists,” he says.

But it’s a concept HM as a whole should bone up on quickly. As attention to reducing healthcare costs intensifies and the PCMH model becomes more commonplace, hospitalists’ roles within such practices will increase.

Some say hospitalists will be hired by primary-care practices that previously did not employ hospitalists. They might provide extra help during transitions by following patients as they are discharged to skilled rehab units or nursing homes. They also might provide preoperative histories for elective surgeries.

“I believe the hospitalist will be right at the center of the model, along with the PCPs [primary-care physicians],” says Ken Simone, DO, SFHM, a national hospitalist practice management consultant and principal at Maine-based Hospitalist and Practice Solutions. “In my opinion, the PCMH model will expand the hospitalist’s role outside the four walls of the hospital.”

Time to Prepare

Dr. Simone and others say that now is the time for hospitalists to begin exploring the PCMH model and its implications in their locales. HM groups should:

Familiarize themselves with the PCMH concept.

Although the model continues to evolve, the main components can be found in a 2007 joint statement by the American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, and American Osteopathic Association.1 They include the principles of a personal physician with whom the patient has an ongoing relationship; coordinated care across all elements of the healthcare system; better quality and safety; enhanced access to doctors and their teams; and a payment system that factors in the role of physicians and nonphysicians alike, as well as the role of technology and rewards for good outcomes.

 

 

“In a patient-centered medical home, there is a strong emphasis on coordination of care and communication between all members of a patient’s healthcare team,” says Jeffrey Cain, MD, president-elect of the American Academy of Family Physicians (AAFP). “Patients receive the highest-quality, patient-centered care when the primary-care physician takes the lead in coordinating care. This means keeping patients, specialists, hospitalists, and other health providers informed of all test results, treatment plans, expectations, progress, and outcomes.”

Find out about the PCMH activity in their own communities.

Dr. Cain said that the degree of PCMH adoption depends on where you work.

“It is spotty throughout the United States,” he notes. “There are areas of tremendous growth and areas that are waiting to have that happen.”

Dr. Simone, a Team Hospitalist member, says the degree to which hospitalists are familiar with PCMH depends on the level of adoption in the area.

“I have found greater hospitalist awareness in communities that have integrated healthcare delivery systems,” he says. “This makes sense, because these are the communities that are aggressively pursing the patient-centered home.”

Forge relationships with primary-care providers.

Dr. Simone encourages hospitalist groups to make marketing visits to local PCP offices. During these visits, hospitalists should discuss the services they provide, their staffing model, admission and communication protocols—and, “most importantly, ask what the hospitalist practice can do to meet the needs of both the patient and the referring providers.”

Dr. Li says it’s always been important to have open lines of communication with your PCPs—but now more than ever.

“If you don’t have this already, you’re already behind in the ballgame,” he says. “But it’s never too late. It’s critically important to have those communication systems in place so that patients get the best care possible.”

Talk to hospital administrators about clinical and financial links with PCMH practices.

The time to do this, Dr. Simone says, is when a local PCMH is being created, or at contract renewal time, if a PCMH is already exists.

“Hospitalists will obviously need to have a voice within the organization and some autonomy for them to commit to such an integrated relationship,” Dr. Simone says.

Prepare for the demands of sicker patients.

If better primary care means fewer hospitalizations, the patients who are admitted will be sicker, posing more challenges to hospitalists.

“Make sure each individual provider has the skill set and schedule that allows them to take care of these patients,” Dr. Li says.

Embrace the possibilities this model offers.

In the PCMH model, the coordination between the hospitalist and the PCP can only help a hospitalist at the time of discharge.

“It will be easier to get their patients into a primary-care office,” says Dr. Cain of AAFP.

David Meyers, MD, director of the Center for Primary Care, Prevention and Clinical Partnerships at the federal Agency for Healthcare Research and Quality (AHRQ), which provides tools and information that support primary care’s redesign and the PCMH, says the model essentially adds a member to the hospitalist’s team.

“If done well, it gives the hospitalist a partner in the community with whom to establish joint accountability,” Dr. Meyers explains. “In addition to establishing accountability, the PCMH helps ensure information flows both into and out of the hospital.”

A Growth Spurt

As of March 1, the nonprofit National Committee on Quality Assurance had recognized 3,979 practices across the country as “patient-centered medical homes.” And that doesn’t include practices that function according to PCMH principles but are not officially recognized.

 

 

The Mayo Clinic recently began a three-year pilot PCMH project in Wisconsin, in conjunction with Group Health Cooperative of Eau Claire.

Crucially, insurance companies are coming on board. In January, Indianapolis-based benefits company WellPoint announced a new payment system designed to promote better primary care, with increases to regular fees, payments for “non-visit” services, and shared savings payments based on quality outcomes and reduced medical costs.

Blue Cross and Blue Shield has reported success with PCMH models.

Meanwhile, the Centers for Medicare & Medicaid Services (CMS) is testing a PCMH model to see whether it generates higher quality of care and cost savings. So is the Department of Veterans Affairs.

If done well, [PCMH] gives the hospitalist a partner in the community with whom to establish joint accountability. In addition to establishing accountability, the PCMH helps ensure information flows both into and out of the hospital.


—David Meyers, MD, director, Center for Primary Care, Prevention and Clinical Partnerships, Agency for Healthcare Research and Quality, Washington, D.C.

Primary-care doctors, hospitalists and government officials say the concept is likely here to stay. “We’re in a period of change,” Dr. Meyers says. “I don’t know where we’re going to be in five years from now, but forces are aligning such that this may really work.”

And hospitalists are vital to the success of any PCMH.

“The patient-centered medical home,” he says, “to be effective on what it can do, has to be integrated into a patient-centered medical neighborhood—the partnership between primary care or ambulatory care and inpatient care, and specifically the hospitalists and those folks working in nursing homes and skilled nursing facilities.”

Gordon Chen, MD, a cardiologist and senior vice president of medical affairs at Chen Medical in Miami, where a number of PCMH concepts have been in place for 10 years, says that he works both with hospitalists employed by Chen Medical and some not employed by Chen Medical. And he notices the difference.

“It can be a little bit more difficult to reach and to coordinate and collaborate with other physicians, but we can do it,” he says.

A tighter connection allows information to flow better between the PCPs and the hospitalists, he points out.

“One of the most frustrating things as a physician is to find out that your patient had a prolonged hospitalization and they come to see you in the clinic and you don’t have any information,” Dr. Chen says. “You look at this new medication list and you’re trying to put the pieces together. When a doctor doesn’t have all the information, and is guessing … it leads to poor decisions being made.”

Back at Dean Health System in Wisconsin, Dr. Eichhorn is confident that the concepts behind the patient-centered medical home can only be good for patients. Still, the project there—as at many other places—is a work in progress.

“Emphasizing wellness and preventative health certainly conveys significant benefits,” he says. “The challenge is defining what is a patient-centered medical home. It sounds like every group is struggling what that means and how to define it and then how to track your outcomes. And then does the patient have a sense of that? Are they appreciating something different in what’s happening to their healthcare?”

Thomas R. Collins is a freelance writer in South Florida.

Reference

  1. Patient-Centered Primary Care Collaborative. Joint Principles on the Patient-Centered Medical Home. Available at: http://www.pcpcc.net/content/joint-principles-patient-centered-medical-home. Accessed May 31, 2012.
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In 2009, five of the primary-care health centers in Wisconsin-based Dean Health System began to transform into an increasingly popular—but, to many, still somewhat fuzzy—feature of the new healthcare landscape: the “patient-centered medical home.”

The goals are noble: Orient and guide the patient through the healthcare system. Don’t repeat tests already performed. Keep costs down. Prevent illnesses that are, in fact, preventable. And reward doctors for doing so rather than encouraging visit after visit and test after test.

The hospitalists in the Dean system were brought late into the patient-centered medical home, or PCMH, project, but are now more involved:

  • They participate in discussions about impending hospitalizations for patients to determine whether hospitalization is really needed;
  • They make every effort to assign the same doctor to a patient each time the patient is hospitalized; and
  • They also are part of admissions and discharges that are smoother due to efforts to keep information flowing and keep patients in formed.

There have been hiccups, though. Dean hasn’t tracked readmission rates, so it isn’t known whether they’ve improved. And satisfaction ratings from patients haven’t improved—in part, says Kevin Eichhorn, MD, chief of the hospitalist division at Dean, because patients don’t fully appreciate the changes that have been made, although there is an effort to tell them.

I believe the hospitalist will be right at the center of the model, along with the PCPs. In my opinion, the PCMH model will expand the hospitalist’s role outside the four walls of the hospital.


—Ken Simone, DO, SFHM, principal, Hospitalist and Practice Solutions

“But we’ve also only been doing this routinely for about a year,” Dr. Eichhorn says. “My hope is that, as we get better at it, we will see some improvement in terms of patient satisfaction with their hospitalization and improvement in other quality metrics as well.”

If hospitalists already working in a PCMH model are struggling with the changes, imagine the question marks for hospitalists who aren’t familiar with the concept yet (see “The Patient-Centered Medical Home: A Primer,” below). Joseph Ming Wah Li, MD, SFHM, immediate past president of SHM, says most hospitalists are not.

“I think it’s fair to say that most hospitalists lack awareness and insight into what the patient-centered medical home will mean for patients and for hospitalists,” he says.

But it’s a concept HM as a whole should bone up on quickly. As attention to reducing healthcare costs intensifies and the PCMH model becomes more commonplace, hospitalists’ roles within such practices will increase.

Some say hospitalists will be hired by primary-care practices that previously did not employ hospitalists. They might provide extra help during transitions by following patients as they are discharged to skilled rehab units or nursing homes. They also might provide preoperative histories for elective surgeries.

“I believe the hospitalist will be right at the center of the model, along with the PCPs [primary-care physicians],” says Ken Simone, DO, SFHM, a national hospitalist practice management consultant and principal at Maine-based Hospitalist and Practice Solutions. “In my opinion, the PCMH model will expand the hospitalist’s role outside the four walls of the hospital.”

Time to Prepare

Dr. Simone and others say that now is the time for hospitalists to begin exploring the PCMH model and its implications in their locales. HM groups should:

Familiarize themselves with the PCMH concept.

Although the model continues to evolve, the main components can be found in a 2007 joint statement by the American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, and American Osteopathic Association.1 They include the principles of a personal physician with whom the patient has an ongoing relationship; coordinated care across all elements of the healthcare system; better quality and safety; enhanced access to doctors and their teams; and a payment system that factors in the role of physicians and nonphysicians alike, as well as the role of technology and rewards for good outcomes.

 

 

“In a patient-centered medical home, there is a strong emphasis on coordination of care and communication between all members of a patient’s healthcare team,” says Jeffrey Cain, MD, president-elect of the American Academy of Family Physicians (AAFP). “Patients receive the highest-quality, patient-centered care when the primary-care physician takes the lead in coordinating care. This means keeping patients, specialists, hospitalists, and other health providers informed of all test results, treatment plans, expectations, progress, and outcomes.”

Find out about the PCMH activity in their own communities.

Dr. Cain said that the degree of PCMH adoption depends on where you work.

“It is spotty throughout the United States,” he notes. “There are areas of tremendous growth and areas that are waiting to have that happen.”

Dr. Simone, a Team Hospitalist member, says the degree to which hospitalists are familiar with PCMH depends on the level of adoption in the area.

“I have found greater hospitalist awareness in communities that have integrated healthcare delivery systems,” he says. “This makes sense, because these are the communities that are aggressively pursing the patient-centered home.”

Forge relationships with primary-care providers.

Dr. Simone encourages hospitalist groups to make marketing visits to local PCP offices. During these visits, hospitalists should discuss the services they provide, their staffing model, admission and communication protocols—and, “most importantly, ask what the hospitalist practice can do to meet the needs of both the patient and the referring providers.”

Dr. Li says it’s always been important to have open lines of communication with your PCPs—but now more than ever.

“If you don’t have this already, you’re already behind in the ballgame,” he says. “But it’s never too late. It’s critically important to have those communication systems in place so that patients get the best care possible.”

Talk to hospital administrators about clinical and financial links with PCMH practices.

The time to do this, Dr. Simone says, is when a local PCMH is being created, or at contract renewal time, if a PCMH is already exists.

“Hospitalists will obviously need to have a voice within the organization and some autonomy for them to commit to such an integrated relationship,” Dr. Simone says.

Prepare for the demands of sicker patients.

If better primary care means fewer hospitalizations, the patients who are admitted will be sicker, posing more challenges to hospitalists.

“Make sure each individual provider has the skill set and schedule that allows them to take care of these patients,” Dr. Li says.

Embrace the possibilities this model offers.

In the PCMH model, the coordination between the hospitalist and the PCP can only help a hospitalist at the time of discharge.

“It will be easier to get their patients into a primary-care office,” says Dr. Cain of AAFP.

David Meyers, MD, director of the Center for Primary Care, Prevention and Clinical Partnerships at the federal Agency for Healthcare Research and Quality (AHRQ), which provides tools and information that support primary care’s redesign and the PCMH, says the model essentially adds a member to the hospitalist’s team.

“If done well, it gives the hospitalist a partner in the community with whom to establish joint accountability,” Dr. Meyers explains. “In addition to establishing accountability, the PCMH helps ensure information flows both into and out of the hospital.”

A Growth Spurt

As of March 1, the nonprofit National Committee on Quality Assurance had recognized 3,979 practices across the country as “patient-centered medical homes.” And that doesn’t include practices that function according to PCMH principles but are not officially recognized.

 

 

The Mayo Clinic recently began a three-year pilot PCMH project in Wisconsin, in conjunction with Group Health Cooperative of Eau Claire.

Crucially, insurance companies are coming on board. In January, Indianapolis-based benefits company WellPoint announced a new payment system designed to promote better primary care, with increases to regular fees, payments for “non-visit” services, and shared savings payments based on quality outcomes and reduced medical costs.

Blue Cross and Blue Shield has reported success with PCMH models.

Meanwhile, the Centers for Medicare & Medicaid Services (CMS) is testing a PCMH model to see whether it generates higher quality of care and cost savings. So is the Department of Veterans Affairs.

If done well, [PCMH] gives the hospitalist a partner in the community with whom to establish joint accountability. In addition to establishing accountability, the PCMH helps ensure information flows both into and out of the hospital.


—David Meyers, MD, director, Center for Primary Care, Prevention and Clinical Partnerships, Agency for Healthcare Research and Quality, Washington, D.C.

Primary-care doctors, hospitalists and government officials say the concept is likely here to stay. “We’re in a period of change,” Dr. Meyers says. “I don’t know where we’re going to be in five years from now, but forces are aligning such that this may really work.”

And hospitalists are vital to the success of any PCMH.

“The patient-centered medical home,” he says, “to be effective on what it can do, has to be integrated into a patient-centered medical neighborhood—the partnership between primary care or ambulatory care and inpatient care, and specifically the hospitalists and those folks working in nursing homes and skilled nursing facilities.”

Gordon Chen, MD, a cardiologist and senior vice president of medical affairs at Chen Medical in Miami, where a number of PCMH concepts have been in place for 10 years, says that he works both with hospitalists employed by Chen Medical and some not employed by Chen Medical. And he notices the difference.

“It can be a little bit more difficult to reach and to coordinate and collaborate with other physicians, but we can do it,” he says.

A tighter connection allows information to flow better between the PCPs and the hospitalists, he points out.

“One of the most frustrating things as a physician is to find out that your patient had a prolonged hospitalization and they come to see you in the clinic and you don’t have any information,” Dr. Chen says. “You look at this new medication list and you’re trying to put the pieces together. When a doctor doesn’t have all the information, and is guessing … it leads to poor decisions being made.”

Back at Dean Health System in Wisconsin, Dr. Eichhorn is confident that the concepts behind the patient-centered medical home can only be good for patients. Still, the project there—as at many other places—is a work in progress.

“Emphasizing wellness and preventative health certainly conveys significant benefits,” he says. “The challenge is defining what is a patient-centered medical home. It sounds like every group is struggling what that means and how to define it and then how to track your outcomes. And then does the patient have a sense of that? Are they appreciating something different in what’s happening to their healthcare?”

Thomas R. Collins is a freelance writer in South Florida.

Reference

  1. Patient-Centered Primary Care Collaborative. Joint Principles on the Patient-Centered Medical Home. Available at: http://www.pcpcc.net/content/joint-principles-patient-centered-medical-home. Accessed May 31, 2012.

In 2009, five of the primary-care health centers in Wisconsin-based Dean Health System began to transform into an increasingly popular—but, to many, still somewhat fuzzy—feature of the new healthcare landscape: the “patient-centered medical home.”

The goals are noble: Orient and guide the patient through the healthcare system. Don’t repeat tests already performed. Keep costs down. Prevent illnesses that are, in fact, preventable. And reward doctors for doing so rather than encouraging visit after visit and test after test.

The hospitalists in the Dean system were brought late into the patient-centered medical home, or PCMH, project, but are now more involved:

  • They participate in discussions about impending hospitalizations for patients to determine whether hospitalization is really needed;
  • They make every effort to assign the same doctor to a patient each time the patient is hospitalized; and
  • They also are part of admissions and discharges that are smoother due to efforts to keep information flowing and keep patients in formed.

There have been hiccups, though. Dean hasn’t tracked readmission rates, so it isn’t known whether they’ve improved. And satisfaction ratings from patients haven’t improved—in part, says Kevin Eichhorn, MD, chief of the hospitalist division at Dean, because patients don’t fully appreciate the changes that have been made, although there is an effort to tell them.

I believe the hospitalist will be right at the center of the model, along with the PCPs. In my opinion, the PCMH model will expand the hospitalist’s role outside the four walls of the hospital.


—Ken Simone, DO, SFHM, principal, Hospitalist and Practice Solutions

“But we’ve also only been doing this routinely for about a year,” Dr. Eichhorn says. “My hope is that, as we get better at it, we will see some improvement in terms of patient satisfaction with their hospitalization and improvement in other quality metrics as well.”

If hospitalists already working in a PCMH model are struggling with the changes, imagine the question marks for hospitalists who aren’t familiar with the concept yet (see “The Patient-Centered Medical Home: A Primer,” below). Joseph Ming Wah Li, MD, SFHM, immediate past president of SHM, says most hospitalists are not.

“I think it’s fair to say that most hospitalists lack awareness and insight into what the patient-centered medical home will mean for patients and for hospitalists,” he says.

But it’s a concept HM as a whole should bone up on quickly. As attention to reducing healthcare costs intensifies and the PCMH model becomes more commonplace, hospitalists’ roles within such practices will increase.

Some say hospitalists will be hired by primary-care practices that previously did not employ hospitalists. They might provide extra help during transitions by following patients as they are discharged to skilled rehab units or nursing homes. They also might provide preoperative histories for elective surgeries.

“I believe the hospitalist will be right at the center of the model, along with the PCPs [primary-care physicians],” says Ken Simone, DO, SFHM, a national hospitalist practice management consultant and principal at Maine-based Hospitalist and Practice Solutions. “In my opinion, the PCMH model will expand the hospitalist’s role outside the four walls of the hospital.”

Time to Prepare

Dr. Simone and others say that now is the time for hospitalists to begin exploring the PCMH model and its implications in their locales. HM groups should:

Familiarize themselves with the PCMH concept.

Although the model continues to evolve, the main components can be found in a 2007 joint statement by the American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, and American Osteopathic Association.1 They include the principles of a personal physician with whom the patient has an ongoing relationship; coordinated care across all elements of the healthcare system; better quality and safety; enhanced access to doctors and their teams; and a payment system that factors in the role of physicians and nonphysicians alike, as well as the role of technology and rewards for good outcomes.

 

 

“In a patient-centered medical home, there is a strong emphasis on coordination of care and communication between all members of a patient’s healthcare team,” says Jeffrey Cain, MD, president-elect of the American Academy of Family Physicians (AAFP). “Patients receive the highest-quality, patient-centered care when the primary-care physician takes the lead in coordinating care. This means keeping patients, specialists, hospitalists, and other health providers informed of all test results, treatment plans, expectations, progress, and outcomes.”

Find out about the PCMH activity in their own communities.

Dr. Cain said that the degree of PCMH adoption depends on where you work.

“It is spotty throughout the United States,” he notes. “There are areas of tremendous growth and areas that are waiting to have that happen.”

Dr. Simone, a Team Hospitalist member, says the degree to which hospitalists are familiar with PCMH depends on the level of adoption in the area.

“I have found greater hospitalist awareness in communities that have integrated healthcare delivery systems,” he says. “This makes sense, because these are the communities that are aggressively pursing the patient-centered home.”

Forge relationships with primary-care providers.

Dr. Simone encourages hospitalist groups to make marketing visits to local PCP offices. During these visits, hospitalists should discuss the services they provide, their staffing model, admission and communication protocols—and, “most importantly, ask what the hospitalist practice can do to meet the needs of both the patient and the referring providers.”

Dr. Li says it’s always been important to have open lines of communication with your PCPs—but now more than ever.

“If you don’t have this already, you’re already behind in the ballgame,” he says. “But it’s never too late. It’s critically important to have those communication systems in place so that patients get the best care possible.”

Talk to hospital administrators about clinical and financial links with PCMH practices.

The time to do this, Dr. Simone says, is when a local PCMH is being created, or at contract renewal time, if a PCMH is already exists.

“Hospitalists will obviously need to have a voice within the organization and some autonomy for them to commit to such an integrated relationship,” Dr. Simone says.

Prepare for the demands of sicker patients.

If better primary care means fewer hospitalizations, the patients who are admitted will be sicker, posing more challenges to hospitalists.

“Make sure each individual provider has the skill set and schedule that allows them to take care of these patients,” Dr. Li says.

Embrace the possibilities this model offers.

In the PCMH model, the coordination between the hospitalist and the PCP can only help a hospitalist at the time of discharge.

“It will be easier to get their patients into a primary-care office,” says Dr. Cain of AAFP.

David Meyers, MD, director of the Center for Primary Care, Prevention and Clinical Partnerships at the federal Agency for Healthcare Research and Quality (AHRQ), which provides tools and information that support primary care’s redesign and the PCMH, says the model essentially adds a member to the hospitalist’s team.

“If done well, it gives the hospitalist a partner in the community with whom to establish joint accountability,” Dr. Meyers explains. “In addition to establishing accountability, the PCMH helps ensure information flows both into and out of the hospital.”

A Growth Spurt

As of March 1, the nonprofit National Committee on Quality Assurance had recognized 3,979 practices across the country as “patient-centered medical homes.” And that doesn’t include practices that function according to PCMH principles but are not officially recognized.

 

 

The Mayo Clinic recently began a three-year pilot PCMH project in Wisconsin, in conjunction with Group Health Cooperative of Eau Claire.

Crucially, insurance companies are coming on board. In January, Indianapolis-based benefits company WellPoint announced a new payment system designed to promote better primary care, with increases to regular fees, payments for “non-visit” services, and shared savings payments based on quality outcomes and reduced medical costs.

Blue Cross and Blue Shield has reported success with PCMH models.

Meanwhile, the Centers for Medicare & Medicaid Services (CMS) is testing a PCMH model to see whether it generates higher quality of care and cost savings. So is the Department of Veterans Affairs.

If done well, [PCMH] gives the hospitalist a partner in the community with whom to establish joint accountability. In addition to establishing accountability, the PCMH helps ensure information flows both into and out of the hospital.


—David Meyers, MD, director, Center for Primary Care, Prevention and Clinical Partnerships, Agency for Healthcare Research and Quality, Washington, D.C.

Primary-care doctors, hospitalists and government officials say the concept is likely here to stay. “We’re in a period of change,” Dr. Meyers says. “I don’t know where we’re going to be in five years from now, but forces are aligning such that this may really work.”

And hospitalists are vital to the success of any PCMH.

“The patient-centered medical home,” he says, “to be effective on what it can do, has to be integrated into a patient-centered medical neighborhood—the partnership between primary care or ambulatory care and inpatient care, and specifically the hospitalists and those folks working in nursing homes and skilled nursing facilities.”

Gordon Chen, MD, a cardiologist and senior vice president of medical affairs at Chen Medical in Miami, where a number of PCMH concepts have been in place for 10 years, says that he works both with hospitalists employed by Chen Medical and some not employed by Chen Medical. And he notices the difference.

“It can be a little bit more difficult to reach and to coordinate and collaborate with other physicians, but we can do it,” he says.

A tighter connection allows information to flow better between the PCPs and the hospitalists, he points out.

“One of the most frustrating things as a physician is to find out that your patient had a prolonged hospitalization and they come to see you in the clinic and you don’t have any information,” Dr. Chen says. “You look at this new medication list and you’re trying to put the pieces together. When a doctor doesn’t have all the information, and is guessing … it leads to poor decisions being made.”

Back at Dean Health System in Wisconsin, Dr. Eichhorn is confident that the concepts behind the patient-centered medical home can only be good for patients. Still, the project there—as at many other places—is a work in progress.

“Emphasizing wellness and preventative health certainly conveys significant benefits,” he says. “The challenge is defining what is a patient-centered medical home. It sounds like every group is struggling what that means and how to define it and then how to track your outcomes. And then does the patient have a sense of that? Are they appreciating something different in what’s happening to their healthcare?”

Thomas R. Collins is a freelance writer in South Florida.

Reference

  1. Patient-Centered Primary Care Collaborative. Joint Principles on the Patient-Centered Medical Home. Available at: http://www.pcpcc.net/content/joint-principles-patient-centered-medical-home. Accessed May 31, 2012.
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