Last month, the Food and Drug Administration cleared a test designed to quickly identify a dozen types of bacteria that can lead to bloodstream infections.

The Verigene GP Blood Culture Nucleic Acid Test, developed by molecular diagnostic firm Nanosphere Inc. of Northbrook, Ill., can identify Staphylococcus (including methicillin-resistant S. aureus, or MRSA), Streptococcus, Enterococcus (including vancomycin-resistant enterococci), and Listeria.

"The current standard of treatment is to provide broad-spectrum antibiotics, including some last-line therapies, such as vancomycin, in order to get coverage for everything," says Mike McGarrity, a Nanosphere executive. "With antibiotic stewardship programs in the majority of hospitals, there is an understanding of the overuse of these last-line therapies and the development of resistance."

Currently, blood cultures can take two to four days to identify certain types of bacteria and determine whether any present are resistant to certain therapies. Once a blood culture is positive, the Nanosphere test can identify bacteria and antimicrobial resistance genes in roughly two and half hours. In a pitch that McGarrity believes will resonate with HM groups, he positions the product as a cost-saver that can reduce length of stay (LOS) for hospitalized patients, as physicians don’t have to wait two days for test results. Quicker identification can also lead to lower mortality rates, he says.

McGarrity, who says Nanosphere will submit an application to the FDA this year for a similar rapid-results test for Clostridium difficile and a broad enteric panel, adds that the test is $75 per use. With LOS reduction and cost savings for targeted de-escalated therapies, he says, there is clear value in the test.

"This gets the attention of stakeholders," he says.

Last month, the Food and Drug Administration cleared a test designed to quickly identify a dozen types of bacteria that can lead to bloodstream infections.

The Verigene GP Blood Culture Nucleic Acid Test, developed by molecular diagnostic firm Nanosphere Inc. of Northbrook, Ill., can identify Staphylococcus (including methicillin-resistant S. aureus, or MRSA), Streptococcus, Enterococcus (including vancomycin-resistant enterococci), and Listeria.

"The current standard of treatment is to provide broad-spectrum antibiotics, including some last-line therapies, such as vancomycin, in order to get coverage for everything," says Mike McGarrity, a Nanosphere executive. "With antibiotic stewardship programs in the majority of hospitals, there is an understanding of the overuse of these last-line therapies and the development of resistance."

Currently, blood cultures can take two to four days to identify certain types of bacteria and determine whether any present are resistant to certain therapies. Once a blood culture is positive, the Nanosphere test can identify bacteria and antimicrobial resistance genes in roughly two and half hours. In a pitch that McGarrity believes will resonate with HM groups, he positions the product as a cost-saver that can reduce length of stay (LOS) for hospitalized patients, as physicians don’t have to wait two days for test results. Quicker identification can also lead to lower mortality rates, he says.

McGarrity, who says Nanosphere will submit an application to the FDA this year for a similar rapid-results test for Clostridium difficile and a broad enteric panel, adds that the test is $75 per use. With LOS reduction and cost savings for targeted de-escalated therapies, he says, there is clear value in the test.

"This gets the attention of stakeholders," he says.

Last month, the Food and Drug Administration cleared a test designed to quickly identify a dozen types of bacteria that can lead to bloodstream infections.

The Verigene GP Blood Culture Nucleic Acid Test, developed by molecular diagnostic firm Nanosphere Inc. of Northbrook, Ill., can identify Staphylococcus (including methicillin-resistant S. aureus, or MRSA), Streptococcus, Enterococcus (including vancomycin-resistant enterococci), and Listeria.

"The current standard of treatment is to provide broad-spectrum antibiotics, including some last-line therapies, such as vancomycin, in order to get coverage for everything," says Mike McGarrity, a Nanosphere executive. "With antibiotic stewardship programs in the majority of hospitals, there is an understanding of the overuse of these last-line therapies and the development of resistance."

Currently, blood cultures can take two to four days to identify certain types of bacteria and determine whether any present are resistant to certain therapies. Once a blood culture is positive, the Nanosphere test can identify bacteria and antimicrobial resistance genes in roughly two and half hours. In a pitch that McGarrity believes will resonate with HM groups, he positions the product as a cost-saver that can reduce length of stay (LOS) for hospitalized patients, as physicians don’t have to wait two days for test results. Quicker identification can also lead to lower mortality rates, he says.

McGarrity, who says Nanosphere will submit an application to the FDA this year for a similar rapid-results test for Clostridium difficile and a broad enteric panel, adds that the test is $75 per use. With LOS reduction and cost savings for targeted de-escalated therapies, he says, there is clear value in the test.

"This gets the attention of stakeholders," he says.

Clinical question: Do oral fluoroquinolones increase the risk of retinal detachment?

Background: Fluoroquinolones are increasingly used in both inpatient and outpatient settings, given their broad antimicrobial coverage. However, adverse effects, including those related to connective tissue and the eye, are increasingly reported. Whether that also includes retinal detachment is not yet known.

Study design: Nested case control study.

Setting: Canadian province.

Synopsis: Using data from administrative databases to identify patients who visited ophthalmologists in British Columbia between 2000 and 2007, the investigators identified 4,384 cases of retinal detachment, and matched those cases to controls at a rate of 10:1. Current, recent, and past fluoroquinolone usage was the exposure of interest.

Patients actively taking a fluoroquinolone had a higher risk of retinal detachment compared with those not taking the drug (adjusted RR of 4.5, 95% CI of 3.56-5.70). Prior or recent use of a fluoroquinolone did not increase the rate of retinal detachment. The patients were more likely to be male, myopic, diabetic, and have a prior history of cataract surgery. Ciprofloxacin was the drug most frequently involved, but this is not adjusted by frequency of prescription. Despite this association, the actual outcome is quite rare (approximately 1,440 cases per year in the U.S.).

This study has the benefit of a large amount of data and captures prescription data well. It relied on coding to identify the cases and might have missed or inappropriately categorized some cases. Despite these caveats, this study adds to the concerning adverse events due to the increasing use of fluoroquinolone therapy, and hospitalists should use appropriate clinical judgment when prescribing and educating patients about the risks and benefits.

Bottom line: Fluoroquinolone use might increase the rate of retinal detachment in patients, but the absolute risk of the event is low.

Citation: Etminan M, Forooghian F, Brophy JM, Bird ST, Maberley D. Oral fluoroquinolones and the risk of retinal detachment. JAMA. 2012;307:1414-1419.

Clinical question: Do oral fluoroquinolones increase the risk of retinal detachment?

Background: Fluoroquinolones are increasingly used in both inpatient and outpatient settings, given their broad antimicrobial coverage. However, adverse effects, including those related to connective tissue and the eye, are increasingly reported. Whether that also includes retinal detachment is not yet known.

Study design: Nested case control study.

Setting: Canadian province.

Synopsis: Using data from administrative databases to identify patients who visited ophthalmologists in British Columbia between 2000 and 2007, the investigators identified 4,384 cases of retinal detachment, and matched those cases to controls at a rate of 10:1. Current, recent, and past fluoroquinolone usage was the exposure of interest.

Patients actively taking a fluoroquinolone had a higher risk of retinal detachment compared with those not taking the drug (adjusted RR of 4.5, 95% CI of 3.56-5.70). Prior or recent use of a fluoroquinolone did not increase the rate of retinal detachment. The patients were more likely to be male, myopic, diabetic, and have a prior history of cataract surgery. Ciprofloxacin was the drug most frequently involved, but this is not adjusted by frequency of prescription. Despite this association, the actual outcome is quite rare (approximately 1,440 cases per year in the U.S.).

This study has the benefit of a large amount of data and captures prescription data well. It relied on coding to identify the cases and might have missed or inappropriately categorized some cases. Despite these caveats, this study adds to the concerning adverse events due to the increasing use of fluoroquinolone therapy, and hospitalists should use appropriate clinical judgment when prescribing and educating patients about the risks and benefits.

Bottom line: Fluoroquinolone use might increase the rate of retinal detachment in patients, but the absolute risk of the event is low.

Citation: Etminan M, Forooghian F, Brophy JM, Bird ST, Maberley D. Oral fluoroquinolones and the risk of retinal detachment. JAMA. 2012;307:1414-1419.

Clinical question: Do oral fluoroquinolones increase the risk of retinal detachment?

Background: Fluoroquinolones are increasingly used in both inpatient and outpatient settings, given their broad antimicrobial coverage. However, adverse effects, including those related to connective tissue and the eye, are increasingly reported. Whether that also includes retinal detachment is not yet known.

Study design: Nested case control study.

Setting: Canadian province.

Synopsis: Using data from administrative databases to identify patients who visited ophthalmologists in British Columbia between 2000 and 2007, the investigators identified 4,384 cases of retinal detachment, and matched those cases to controls at a rate of 10:1. Current, recent, and past fluoroquinolone usage was the exposure of interest.

Patients actively taking a fluoroquinolone had a higher risk of retinal detachment compared with those not taking the drug (adjusted RR of 4.5, 95% CI of 3.56-5.70). Prior or recent use of a fluoroquinolone did not increase the rate of retinal detachment. The patients were more likely to be male, myopic, diabetic, and have a prior history of cataract surgery. Ciprofloxacin was the drug most frequently involved, but this is not adjusted by frequency of prescription. Despite this association, the actual outcome is quite rare (approximately 1,440 cases per year in the U.S.).

This study has the benefit of a large amount of data and captures prescription data well. It relied on coding to identify the cases and might have missed or inappropriately categorized some cases. Despite these caveats, this study adds to the concerning adverse events due to the increasing use of fluoroquinolone therapy, and hospitalists should use appropriate clinical judgment when prescribing and educating patients about the risks and benefits.

Bottom line: Fluoroquinolone use might increase the rate of retinal detachment in patients, but the absolute risk of the event is low.

Citation: Etminan M, Forooghian F, Brophy JM, Bird ST, Maberley D. Oral fluoroquinolones and the risk of retinal detachment. JAMA. 2012;307:1414-1419.

PARIS—Results of a large study suggest that 8 in 10 hemophilia patients feel

their disorder has had a negative impact on their career.

In fact, 1 in 5

patients said they have lost a job because of their condition. However, only 8% said they were unable to find employment because of it.

These findings were presented at the World Federation of Hemophilia 2012 World Congress. The data are part of the HERO study, which

evaluated the psychosocial aspects of living with hemophilia. The study

was sponsored by Novo Nordisk.

“Treatment of hemophilia has advanced greatly over the past decades, but psychosocial issues can still be a challenge for people with hemophilia . . . ,” said Alfonso Iorio, MD, PhD, a member of the HERO International Advisory Board and a professor at McMaster University in Canada.

With this in mind, HERO researchers examined hemophilia’s effects on relationships, sexual health, and quality of life. The investigators also assessed treatment and management of the disorder, patients’ knowledge and education levels, and how hemophilia has impacted their professional life.

For the career analysis, researchers interviewed 605 patients with hemophilia. Forty percent of patients said their hemophilia played a major role in their choice of profession or job training, but 21% of patients said their disorder had no impact on their job choice.

Thirty percent of patients said their current treatment allows them to work in most situations. But 21% of patients said they have to restrict their hours due to their hemophilia, and 17% said they must work flexible hours.

Twenty-four percent of patients said they have voluntarily left a job because of their hemophilia, and 22% thought they lost a job because of their disorder.

Twenty-two percent of patients believed they were not hired for a job because of their hemophilia, and 14% felt they had not received a promotion because of it. But 10% of patients said their disorder actually helped them land a job.

These results were presented at the World Federation of Hemophilia 2012 World Congress on Monday as poster 199. Other results from the HERO study will also be presented at the meeting, which is taking place July 8-12.

“The insights from the HERO study will provide much-needed evidence to support advocating for better comprehensive hemophilia care,” Dr Iorio said.

PARIS—Results of a large study suggest that 8 in 10 hemophilia patients feel

their disorder has had a negative impact on their career.

In fact, 1 in 5

patients said they have lost a job because of their condition. However, only 8% said they were unable to find employment because of it.

These findings were presented at the World Federation of Hemophilia 2012 World Congress. The data are part of the HERO study, which

evaluated the psychosocial aspects of living with hemophilia. The study

was sponsored by Novo Nordisk.

“Treatment of hemophilia has advanced greatly over the past decades, but psychosocial issues can still be a challenge for people with hemophilia . . . ,” said Alfonso Iorio, MD, PhD, a member of the HERO International Advisory Board and a professor at McMaster University in Canada.

With this in mind, HERO researchers examined hemophilia’s effects on relationships, sexual health, and quality of life. The investigators also assessed treatment and management of the disorder, patients’ knowledge and education levels, and how hemophilia has impacted their professional life.

For the career analysis, researchers interviewed 605 patients with hemophilia. Forty percent of patients said their hemophilia played a major role in their choice of profession or job training, but 21% of patients said their disorder had no impact on their job choice.

Thirty percent of patients said their current treatment allows them to work in most situations. But 21% of patients said they have to restrict their hours due to their hemophilia, and 17% said they must work flexible hours.

Twenty-four percent of patients said they have voluntarily left a job because of their hemophilia, and 22% thought they lost a job because of their disorder.

Twenty-two percent of patients believed they were not hired for a job because of their hemophilia, and 14% felt they had not received a promotion because of it. But 10% of patients said their disorder actually helped them land a job.

These results were presented at the World Federation of Hemophilia 2012 World Congress on Monday as poster 199. Other results from the HERO study will also be presented at the meeting, which is taking place July 8-12.

“The insights from the HERO study will provide much-needed evidence to support advocating for better comprehensive hemophilia care,” Dr Iorio said.

PARIS—Results of a large study suggest that 8 in 10 hemophilia patients feel

their disorder has had a negative impact on their career.

In fact, 1 in 5

patients said they have lost a job because of their condition. However, only 8% said they were unable to find employment because of it.

These findings were presented at the World Federation of Hemophilia 2012 World Congress. The data are part of the HERO study, which

evaluated the psychosocial aspects of living with hemophilia. The study

was sponsored by Novo Nordisk.

“Treatment of hemophilia has advanced greatly over the past decades, but psychosocial issues can still be a challenge for people with hemophilia . . . ,” said Alfonso Iorio, MD, PhD, a member of the HERO International Advisory Board and a professor at McMaster University in Canada.

With this in mind, HERO researchers examined hemophilia’s effects on relationships, sexual health, and quality of life. The investigators also assessed treatment and management of the disorder, patients’ knowledge and education levels, and how hemophilia has impacted their professional life.

For the career analysis, researchers interviewed 605 patients with hemophilia. Forty percent of patients said their hemophilia played a major role in their choice of profession or job training, but 21% of patients said their disorder had no impact on their job choice.

Thirty percent of patients said their current treatment allows them to work in most situations. But 21% of patients said they have to restrict their hours due to their hemophilia, and 17% said they must work flexible hours.

Twenty-four percent of patients said they have voluntarily left a job because of their hemophilia, and 22% thought they lost a job because of their disorder.

Twenty-two percent of patients believed they were not hired for a job because of their hemophilia, and 14% felt they had not received a promotion because of it. But 10% of patients said their disorder actually helped them land a job.

These results were presented at the World Federation of Hemophilia 2012 World Congress on Monday as poster 199. Other results from the HERO study will also be presented at the meeting, which is taking place July 8-12.

“The insights from the HERO study will provide much-needed evidence to support advocating for better comprehensive hemophilia care,” Dr Iorio said.

Picture this likely scenario: You’re a hospitalist in a remote setting, and a patient with stroke symptoms is rushed in by ambulance. Numbness has overcome one side of his body. Dizziness disrupts his balance, his speech becomes slurred, and his vision is blurred. Treatment must be started swiftly to halt irreversible brain damage. The nearest neurologist is located hours away, but thanks to advanced video technology, you’re able to instantly consult face to face with that specialist to help ensure optimal recovery for the patient.

Such applications of telemedicine are becoming more mainstream and affordable, facilitating discussions and decisions between healthcare providers while improving patient access to specialty care in emergencies and other situations.

Remote hospitalist services include videoconferencing for patient monitoring and assessment of various clinical services, says Jona

than D. Linkous, CEO of the American Telemedicine Association in Washington, D.C. About 60 specialities and subspecialties—from mental health to wound care—rely on telemedicine.

Advantages and Challenges

Remote patient monitoring in ICUs is on the upswing, filling gaps in the shortage of physicians specializing in critical care. Some unit administrators have established off-site command centers for these specialists to follow multiple facilities with the assistance of video technology and to intervene at urgent times.¹

In a neonatal ICU, this type of live-feed technology allows for a face-to-face interaction with a pediatric pulmonologist, for example, when a premature infant is exhibiting symptoms of respiratory distress in the middle of the night, says David Cattell-Gordon, MSW, director of the Office of Telemedicine at the University of Virginia in Charlottesville.

Similarly, in rural areas where women don’t have immediate access to high-risk obstetricians, telemedicine makes it possible to consult with maternal-fetal medicine specialists from a distance, boosting the chances for pregnant mothers with complex conditions to carry healthy babies to term, says Cattell-Gordon. “Our approach has been to bring telemedicine to hospitals and clinics in communities where that resource [specialists] otherwise is unavailable,” he adds.

Compared with telephone conversations, the advantages of video consultations are multifold: They display a patient’s facial expressions, gestures, and other body language, which might assist with the diagnosis and prescribed treatment, says Kerry Weiner, MD, chief clinical officer for IPC: The Hospitalist Company in North Hollywood, Calif., which has a presence in about 900 facilities in 25 states.

When the strength of that assessment depends on visual inspection, the technology can be particularly helpful. “The weak part of it is when you need to touch” to guide that assessment, Dr. Weiner says. That’s when the technology isn’t as useful. Still, he adds, “We use teleconferencing all over the place in a Skype-like manner, only more sophisticated. It’s more encrypted.”

Interacting within a secure network is crucial to protect privacy, says Peter Kragel, MD, clinical director of the Telemedicine Center at East Carolina University’s Brody School of Medicine in Greenville, N.C. As with any form of communication that transmits identifiable patient information, healthcare providers must comply with HIPAA guidelines when employing videoconferencing services similar to Skype.

“Because of concerns about compliance with encryption and confidentiality regulations, we do not use [videoconferencing] here,” Dr. Kragel says.

Additionally, “telemedicine isn’t always appropriate for patient care,” Linkous says. “All of this depends on the circumstances and needs of the patient. Obviously, surgery requires a direct physician-patient interaction, except for robotic surgery.” For hospitals that don’t have any neurology coverage, telemedicine robots can assist with outside consults for time-sensitive stroke care.

 

Videoconferencing isn’t necessary for all telemedicine encounters, Linkous says. Teledermatology and retinal screening use “store and forward” communication of images, which allows for the electronic transmission of images and documents in non-emergent situations in which immediate video isn’t necessary.

“As a society, we’ve become more comfortable with the technology,” says Matthew Harbison, MD, medical director of Sound Physicians hospitalist services at Memorial Hermann-Texas Medical Center in Houston. “And as the technology continues to develop, ultimately there will be [more of] a role, but how large that will be is difficult to predict.” He adds that “the advantages are obviously in low-staffed places or staffing-challenged sites.”

Moving Ahead

As experts continue to iron out the kinks and as communities obtain greater access to broadband signals, telemedicine equipment is moving to advanced high-definition platforms. Meanwhile, the expense has come down considerably since its inception in the mid-1990s. A high-definition setup that once cost upward of $130,000 is now available for less than $10,000, Cattell-Gordon says.

The digital transmission also can assist in patient follow-up after discharge from the hospital and in monitoring various chronic diseases from home. It’s an effective tool for medical staff meetings and training purposes as well.

IPC's hospitalists have been using the technology to communicate with each other, brainstorming across regions of the country. “Because we’re a national company,” Dr. Weiner says, “this has changed the game in terms of being able to collaborate.”

Susan Kreimer is a freelance medical writer based in New York.

Reference

1. Thomas EJ, Lucke JF, Wueste L, Weavind L, Patel B. Association of telemedicine for remote monitoring of intensive care patients with mortality, complications, and length of stay. JAMA. 2009;302:2671-2678.

 

 

 

Picture this likely scenario: You’re a hospitalist in a remote setting, and a patient with stroke symptoms is rushed in by ambulance. Numbness has overcome one side of his body. Dizziness disrupts his balance, his speech becomes slurred, and his vision is blurred. Treatment must be started swiftly to halt irreversible brain damage. The nearest neurologist is located hours away, but thanks to advanced video technology, you’re able to instantly consult face to face with that specialist to help ensure optimal recovery for the patient.

Such applications of telemedicine are becoming more mainstream and affordable, facilitating discussions and decisions between healthcare providers while improving patient access to specialty care in emergencies and other situations.

Remote hospitalist services include videoconferencing for patient monitoring and assessment of various clinical services, says Jona

than D. Linkous, CEO of the American Telemedicine Association in Washington, D.C. About 60 specialities and subspecialties—from mental health to wound care—rely on telemedicine.

Advantages and Challenges

Remote patient monitoring in ICUs is on the upswing, filling gaps in the shortage of physicians specializing in critical care. Some unit administrators have established off-site command centers for these specialists to follow multiple facilities with the assistance of video technology and to intervene at urgent times.¹

In a neonatal ICU, this type of live-feed technology allows for a face-to-face interaction with a pediatric pulmonologist, for example, when a premature infant is exhibiting symptoms of respiratory distress in the middle of the night, says David Cattell-Gordon, MSW, director of the Office of Telemedicine at the University of Virginia in Charlottesville.

Similarly, in rural areas where women don’t have immediate access to high-risk obstetricians, telemedicine makes it possible to consult with maternal-fetal medicine specialists from a distance, boosting the chances for pregnant mothers with complex conditions to carry healthy babies to term, says Cattell-Gordon. “Our approach has been to bring telemedicine to hospitals and clinics in communities where that resource [specialists] otherwise is unavailable,” he adds.

Compared with telephone conversations, the advantages of video consultations are multifold: They display a patient’s facial expressions, gestures, and other body language, which might assist with the diagnosis and prescribed treatment, says Kerry Weiner, MD, chief clinical officer for IPC: The Hospitalist Company in North Hollywood, Calif., which has a presence in about 900 facilities in 25 states.

When the strength of that assessment depends on visual inspection, the technology can be particularly helpful. “The weak part of it is when you need to touch” to guide that assessment, Dr. Weiner says. That’s when the technology isn’t as useful. Still, he adds, “We use teleconferencing all over the place in a Skype-like manner, only more sophisticated. It’s more encrypted.”

Interacting within a secure network is crucial to protect privacy, says Peter Kragel, MD, clinical director of the Telemedicine Center at East Carolina University’s Brody School of Medicine in Greenville, N.C. As with any form of communication that transmits identifiable patient information, healthcare providers must comply with HIPAA guidelines when employing videoconferencing services similar to Skype.

“Because of concerns about compliance with encryption and confidentiality regulations, we do not use [videoconferencing] here,” Dr. Kragel says.

Additionally, “telemedicine isn’t always appropriate for patient care,” Linkous says. “All of this depends on the circumstances and needs of the patient. Obviously, surgery requires a direct physician-patient interaction, except for robotic surgery.” For hospitals that don’t have any neurology coverage, telemedicine robots can assist with outside consults for time-sensitive stroke care.

 

Videoconferencing isn’t necessary for all telemedicine encounters, Linkous says. Teledermatology and retinal screening use “store and forward” communication of images, which allows for the electronic transmission of images and documents in non-emergent situations in which immediate video isn’t necessary.

“As a society, we’ve become more comfortable with the technology,” says Matthew Harbison, MD, medical director of Sound Physicians hospitalist services at Memorial Hermann-Texas Medical Center in Houston. “And as the technology continues to develop, ultimately there will be [more of] a role, but how large that will be is difficult to predict.” He adds that “the advantages are obviously in low-staffed places or staffing-challenged sites.”

Moving Ahead

As experts continue to iron out the kinks and as communities obtain greater access to broadband signals, telemedicine equipment is moving to advanced high-definition platforms. Meanwhile, the expense has come down considerably since its inception in the mid-1990s. A high-definition setup that once cost upward of $130,000 is now available for less than $10,000, Cattell-Gordon says.

The digital transmission also can assist in patient follow-up after discharge from the hospital and in monitoring various chronic diseases from home. It’s an effective tool for medical staff meetings and training purposes as well.

IPC's hospitalists have been using the technology to communicate with each other, brainstorming across regions of the country. “Because we’re a national company,” Dr. Weiner says, “this has changed the game in terms of being able to collaborate.”

Susan Kreimer is a freelance medical writer based in New York.

Reference

1. Thomas EJ, Lucke JF, Wueste L, Weavind L, Patel B. Association of telemedicine for remote monitoring of intensive care patients with mortality, complications, and length of stay. JAMA. 2009;302:2671-2678.

 

 

 

Picture this likely scenario: You’re a hospitalist in a remote setting, and a patient with stroke symptoms is rushed in by ambulance. Numbness has overcome one side of his body. Dizziness disrupts his balance, his speech becomes slurred, and his vision is blurred. Treatment must be started swiftly to halt irreversible brain damage. The nearest neurologist is located hours away, but thanks to advanced video technology, you’re able to instantly consult face to face with that specialist to help ensure optimal recovery for the patient.

Such applications of telemedicine are becoming more mainstream and affordable, facilitating discussions and decisions between healthcare providers while improving patient access to specialty care in emergencies and other situations.

Remote hospitalist services include videoconferencing for patient monitoring and assessment of various clinical services, says Jona

than D. Linkous, CEO of the American Telemedicine Association in Washington, D.C. About 60 specialities and subspecialties—from mental health to wound care—rely on telemedicine.

Advantages and Challenges

Remote patient monitoring in ICUs is on the upswing, filling gaps in the shortage of physicians specializing in critical care. Some unit administrators have established off-site command centers for these specialists to follow multiple facilities with the assistance of video technology and to intervene at urgent times.¹

In a neonatal ICU, this type of live-feed technology allows for a face-to-face interaction with a pediatric pulmonologist, for example, when a premature infant is exhibiting symptoms of respiratory distress in the middle of the night, says David Cattell-Gordon, MSW, director of the Office of Telemedicine at the University of Virginia in Charlottesville.

Similarly, in rural areas where women don’t have immediate access to high-risk obstetricians, telemedicine makes it possible to consult with maternal-fetal medicine specialists from a distance, boosting the chances for pregnant mothers with complex conditions to carry healthy babies to term, says Cattell-Gordon. “Our approach has been to bring telemedicine to hospitals and clinics in communities where that resource [specialists] otherwise is unavailable,” he adds.

Compared with telephone conversations, the advantages of video consultations are multifold: They display a patient’s facial expressions, gestures, and other body language, which might assist with the diagnosis and prescribed treatment, says Kerry Weiner, MD, chief clinical officer for IPC: The Hospitalist Company in North Hollywood, Calif., which has a presence in about 900 facilities in 25 states.

When the strength of that assessment depends on visual inspection, the technology can be particularly helpful. “The weak part of it is when you need to touch” to guide that assessment, Dr. Weiner says. That’s when the technology isn’t as useful. Still, he adds, “We use teleconferencing all over the place in a Skype-like manner, only more sophisticated. It’s more encrypted.”

Interacting within a secure network is crucial to protect privacy, says Peter Kragel, MD, clinical director of the Telemedicine Center at East Carolina University’s Brody School of Medicine in Greenville, N.C. As with any form of communication that transmits identifiable patient information, healthcare providers must comply with HIPAA guidelines when employing videoconferencing services similar to Skype.

“Because of concerns about compliance with encryption and confidentiality regulations, we do not use [videoconferencing] here,” Dr. Kragel says.

Additionally, “telemedicine isn’t always appropriate for patient care,” Linkous says. “All of this depends on the circumstances and needs of the patient. Obviously, surgery requires a direct physician-patient interaction, except for robotic surgery.” For hospitals that don’t have any neurology coverage, telemedicine robots can assist with outside consults for time-sensitive stroke care.

 

Videoconferencing isn’t necessary for all telemedicine encounters, Linkous says. Teledermatology and retinal screening use “store and forward” communication of images, which allows for the electronic transmission of images and documents in non-emergent situations in which immediate video isn’t necessary.

“As a society, we’ve become more comfortable with the technology,” says Matthew Harbison, MD, medical director of Sound Physicians hospitalist services at Memorial Hermann-Texas Medical Center in Houston. “And as the technology continues to develop, ultimately there will be [more of] a role, but how large that will be is difficult to predict.” He adds that “the advantages are obviously in low-staffed places or staffing-challenged sites.”

Moving Ahead

As experts continue to iron out the kinks and as communities obtain greater access to broadband signals, telemedicine equipment is moving to advanced high-definition platforms. Meanwhile, the expense has come down considerably since its inception in the mid-1990s. A high-definition setup that once cost upward of $130,000 is now available for less than $10,000, Cattell-Gordon says.

The digital transmission also can assist in patient follow-up after discharge from the hospital and in monitoring various chronic diseases from home. It’s an effective tool for medical staff meetings and training purposes as well.

IPC's hospitalists have been using the technology to communicate with each other, brainstorming across regions of the country. “Because we’re a national company,” Dr. Weiner says, “this has changed the game in terms of being able to collaborate.”

Susan Kreimer is a freelance medical writer based in New York.

Reference

1. Thomas EJ, Lucke JF, Wueste L, Weavind L, Patel B. Association of telemedicine for remote monitoring of intensive care patients with mortality, complications, and length of stay. JAMA. 2009;302:2671-2678.

 

 

 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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."

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."