Heidi Splete

In the wake of a cholera outbreak in Haiti in 2010, Partners in Health, the Boston-based nonprofit advocacy and global health organization, developed an ambitious pilot program to vaccinate against cholera, with Dr. Max Raymond in charge of the implementation. Dr. Raymond was born in Haiti and earned his medical degree there in 2004, at the Université Notre Dame d’Haiti, Port-au-Prince.

He first became involved with PIH (and its sister organization in Haiti, Zanmi Lasante) shortly after completing his medical studies, when he was invited to manage a program to combat sexually transmitted infections, tuberculosis, and HIV/AIDS in a commune of the Artibonite Valley.

Courtesy Dr. Max Raymond

"I accepted this position because I knew about the high quality work that PIH/ZL was doing in another region of the country, particularly its social justice-based mission to provide a preferential option for the poor in health care," he said.

How did you become involved in the cholera vaccination project in Haiti, and what were the goals of the project?

In the summer of 2011, I returned to Haiti after earning a master’s degree in public health at the Institute of Tropical Medicine of Antwerp, Belgium, on a Joint Japan/World Bank scholarship, when one of my mentors, Dr. Louise Ivers, PIH’s senior health and policy adviser, asked me to be the cholera vaccine project coordinator. The pilot project launched in one of the rural sections of Saint-Marc, which was where the first cases were reported during the outbreak in October 2010.

In addition to immunologically protecting this high-risk population, a secondary goal was to demonstrate the feasibility of the vaccine campaign because some experts believed it could not be executed successfully because of logistical constraints, costs, and social unrest. Oral cholera vaccines also were in short supply.

If successful, we wanted to use the results of this pilot program to advocate for more investment in cholera vaccine and a possible nationwide scale-up as one of the integral responses to the current epidemic, and upcoming endemicity.

Describe the cholera vaccination efforts overall.

The project was executed concomitantly by two organizations: By PIH/ZL in the rural setting of Saint-Marc and by the nongovernmental organization GHESKIO (Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections) in an urban setting in the capital, Port-au-Prince.

The cholera vaccine consists of two oral doses administered 2-6 weeks apart. Children younger than 1 year and pregnant women were excluded. Before the immunization, we conducted a census in the target area to preregister those who were eligible and to give them a vaccine card with a barcode that would give them access to their doses. We sent a team of 50 enumerators to the field and each recorded demographic data and eligibility status of the people living in the households via electronic data collection using Samsung Galaxy tablets. This census gave us the chance to explain the vaccine’s benefits, while educating the population about hygiene and sanitation, regardless of whether they were eligible to receive the vaccine.

We were not able to implement the campaign exactly as planned, because of a concurrent national vaccination campaign, which targeted newborns through children aged 9 years and also included the polio vaccine (polio and cholera vaccines must be administered 2 weeks apart because of possible interactions).

To avoid interfering with the national campaign, we split our campaign into two phases: the phase I vaccination was for individuals aged 10 years and older, and phase II included children aged 9 years and younger. The campaign lasted more than 1 month, with some breaks between the phases and the doses.

We had 40 teams (each team had two vaccinators and one registrar with the tablet) who were sent to various posts within the targeted area to vaccinate the eligible people. The community health workers and a sound truck service raised awareness before, during, and after each dose and each phase. First, the teams started at fixed vaccinations posts to capture as many people as possible. When fewer people showed up at the fixed posts, the teams started mobile posts to connect with the people who are farther away. Finally, when the number of the vaccinees was low at the mobile posts, we gave a list of the people left to be vaccinated to the teams and they started going door-to-door to do active case finding.

What were some of the challenges of administering the vaccines in a setting with limited medical resources?

The delay from the national polio vaccination campaign made our campaign last longer than we expected. Logistically, this resulted in greater challenges to keep the vaccines in cold chain and to reach some remote areas before the rainy season. Despite these challenges, we had a motivated, committed, and vigilant staff that worked hard to monitor the cold chain, and continually conducted regular thermometer readings and inspections of the cold container, cold boxes, and vaccine carriers (thermoses). Many of our teams did not hesitate to take canoes or donkeys or even to cross flooded rivers to reach vaccine recipients when our trucks could not reach those areas.

We experienced some issues with the technology used for data collection, though we did anticipate some problems. We had a team in United States and another in Haiti who were able to work together to respond quickly and effectively and resolve hardware, software, and Internet connection problems. The teams worked late nights to address those issues and to produce data reports, which allowed us to strategize our activities more effectively and efficiently. We also had a team on standby in our Saint-Marc office that could help locate the unique ID of a vaccine recipient in case the registrar in the field was unable to find the record on their tablet.

Another hurdle involved a group of farmers who we could not find during the daily vaccination periods because they were working late on their land. We sent some teams on later shifts, starting in the field in the afternoon and staying late into the evening in order to catch those recipients.

What are the plans for the vaccination program going forward?

We finished the vaccination campaign on June 19, 2012. We vaccinated more than 40,000 people. The next step is to evaluate the feasibility and the effectiveness of the project by assessing the operational activities, community acceptance, and cost effectiveness. We also are planning a case-control study. The vaccine already has been proven to be safe and effective.

What have you found most rewarding about your work on this program?

For me, the most rewarding part of this program was that we were able to deliver vaccine to this vulnerable population and protect them from this deadly disease. Ideally, this will help them maintain good health, so that they can continue to work and be productive to help their families survive. Seeing not only this population’s poor life conditions but also their acceptance of the vaccine inspired me and gave me more strength to continue the advocacy and the fight for a national scale-up vaccine campaign.

Think globally. Practice locally.

U.S.-trained internists who have practiced abroad will receive a $100 stipend for contributing to this column. For details, visit the World Wide Med column at www.internalmedicinenews.com or send an e-mail to [email protected].

In the wake of a cholera outbreak in Haiti in 2010, Partners in Health, the Boston-based nonprofit advocacy and global health organization, developed an ambitious pilot program to vaccinate against cholera, with Dr. Max Raymond in charge of the implementation. Dr. Raymond was born in Haiti and earned his medical degree there in 2004, at the Université Notre Dame d’Haiti, Port-au-Prince.

He first became involved with PIH (and its sister organization in Haiti, Zanmi Lasante) shortly after completing his medical studies, when he was invited to manage a program to combat sexually transmitted infections, tuberculosis, and HIV/AIDS in a commune of the Artibonite Valley.

Courtesy Dr. Max Raymond

"I accepted this position because I knew about the high quality work that PIH/ZL was doing in another region of the country, particularly its social justice-based mission to provide a preferential option for the poor in health care," he said.

How did you become involved in the cholera vaccination project in Haiti, and what were the goals of the project?

In the summer of 2011, I returned to Haiti after earning a master’s degree in public health at the Institute of Tropical Medicine of Antwerp, Belgium, on a Joint Japan/World Bank scholarship, when one of my mentors, Dr. Louise Ivers, PIH’s senior health and policy adviser, asked me to be the cholera vaccine project coordinator. The pilot project launched in one of the rural sections of Saint-Marc, which was where the first cases were reported during the outbreak in October 2010.

In addition to immunologically protecting this high-risk population, a secondary goal was to demonstrate the feasibility of the vaccine campaign because some experts believed it could not be executed successfully because of logistical constraints, costs, and social unrest. Oral cholera vaccines also were in short supply.

If successful, we wanted to use the results of this pilot program to advocate for more investment in cholera vaccine and a possible nationwide scale-up as one of the integral responses to the current epidemic, and upcoming endemicity.

Describe the cholera vaccination efforts overall.

The project was executed concomitantly by two organizations: By PIH/ZL in the rural setting of Saint-Marc and by the nongovernmental organization GHESKIO (Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections) in an urban setting in the capital, Port-au-Prince.

The cholera vaccine consists of two oral doses administered 2-6 weeks apart. Children younger than 1 year and pregnant women were excluded. Before the immunization, we conducted a census in the target area to preregister those who were eligible and to give them a vaccine card with a barcode that would give them access to their doses. We sent a team of 50 enumerators to the field and each recorded demographic data and eligibility status of the people living in the households via electronic data collection using Samsung Galaxy tablets. This census gave us the chance to explain the vaccine’s benefits, while educating the population about hygiene and sanitation, regardless of whether they were eligible to receive the vaccine.

We were not able to implement the campaign exactly as planned, because of a concurrent national vaccination campaign, which targeted newborns through children aged 9 years and also included the polio vaccine (polio and cholera vaccines must be administered 2 weeks apart because of possible interactions).

To avoid interfering with the national campaign, we split our campaign into two phases: the phase I vaccination was for individuals aged 10 years and older, and phase II included children aged 9 years and younger. The campaign lasted more than 1 month, with some breaks between the phases and the doses.

We had 40 teams (each team had two vaccinators and one registrar with the tablet) who were sent to various posts within the targeted area to vaccinate the eligible people. The community health workers and a sound truck service raised awareness before, during, and after each dose and each phase. First, the teams started at fixed vaccinations posts to capture as many people as possible. When fewer people showed up at the fixed posts, the teams started mobile posts to connect with the people who are farther away. Finally, when the number of the vaccinees was low at the mobile posts, we gave a list of the people left to be vaccinated to the teams and they started going door-to-door to do active case finding.

What were some of the challenges of administering the vaccines in a setting with limited medical resources?

The delay from the national polio vaccination campaign made our campaign last longer than we expected. Logistically, this resulted in greater challenges to keep the vaccines in cold chain and to reach some remote areas before the rainy season. Despite these challenges, we had a motivated, committed, and vigilant staff that worked hard to monitor the cold chain, and continually conducted regular thermometer readings and inspections of the cold container, cold boxes, and vaccine carriers (thermoses). Many of our teams did not hesitate to take canoes or donkeys or even to cross flooded rivers to reach vaccine recipients when our trucks could not reach those areas.

We experienced some issues with the technology used for data collection, though we did anticipate some problems. We had a team in United States and another in Haiti who were able to work together to respond quickly and effectively and resolve hardware, software, and Internet connection problems. The teams worked late nights to address those issues and to produce data reports, which allowed us to strategize our activities more effectively and efficiently. We also had a team on standby in our Saint-Marc office that could help locate the unique ID of a vaccine recipient in case the registrar in the field was unable to find the record on their tablet.

Another hurdle involved a group of farmers who we could not find during the daily vaccination periods because they were working late on their land. We sent some teams on later shifts, starting in the field in the afternoon and staying late into the evening in order to catch those recipients.

What are the plans for the vaccination program going forward?

We finished the vaccination campaign on June 19, 2012. We vaccinated more than 40,000 people. The next step is to evaluate the feasibility and the effectiveness of the project by assessing the operational activities, community acceptance, and cost effectiveness. We also are planning a case-control study. The vaccine already has been proven to be safe and effective.

What have you found most rewarding about your work on this program?

For me, the most rewarding part of this program was that we were able to deliver vaccine to this vulnerable population and protect them from this deadly disease. Ideally, this will help them maintain good health, so that they can continue to work and be productive to help their families survive. Seeing not only this population’s poor life conditions but also their acceptance of the vaccine inspired me and gave me more strength to continue the advocacy and the fight for a national scale-up vaccine campaign.

Think globally. Practice locally.

U.S.-trained internists who have practiced abroad will receive a $100 stipend for contributing to this column. For details, visit the World Wide Med column at www.internalmedicinenews.com or send an e-mail to [email protected].

In the wake of a cholera outbreak in Haiti in 2010, Partners in Health, the Boston-based nonprofit advocacy and global health organization, developed an ambitious pilot program to vaccinate against cholera, with Dr. Max Raymond in charge of the implementation. Dr. Raymond was born in Haiti and earned his medical degree there in 2004, at the Université Notre Dame d’Haiti, Port-au-Prince.

He first became involved with PIH (and its sister organization in Haiti, Zanmi Lasante) shortly after completing his medical studies, when he was invited to manage a program to combat sexually transmitted infections, tuberculosis, and HIV/AIDS in a commune of the Artibonite Valley.

Courtesy Dr. Max Raymond

"I accepted this position because I knew about the high quality work that PIH/ZL was doing in another region of the country, particularly its social justice-based mission to provide a preferential option for the poor in health care," he said.

How did you become involved in the cholera vaccination project in Haiti, and what were the goals of the project?

In the summer of 2011, I returned to Haiti after earning a master’s degree in public health at the Institute of Tropical Medicine of Antwerp, Belgium, on a Joint Japan/World Bank scholarship, when one of my mentors, Dr. Louise Ivers, PIH’s senior health and policy adviser, asked me to be the cholera vaccine project coordinator. The pilot project launched in one of the rural sections of Saint-Marc, which was where the first cases were reported during the outbreak in October 2010.

In addition to immunologically protecting this high-risk population, a secondary goal was to demonstrate the feasibility of the vaccine campaign because some experts believed it could not be executed successfully because of logistical constraints, costs, and social unrest. Oral cholera vaccines also were in short supply.

If successful, we wanted to use the results of this pilot program to advocate for more investment in cholera vaccine and a possible nationwide scale-up as one of the integral responses to the current epidemic, and upcoming endemicity.

Describe the cholera vaccination efforts overall.

The project was executed concomitantly by two organizations: By PIH/ZL in the rural setting of Saint-Marc and by the nongovernmental organization GHESKIO (Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections) in an urban setting in the capital, Port-au-Prince.

The cholera vaccine consists of two oral doses administered 2-6 weeks apart. Children younger than 1 year and pregnant women were excluded. Before the immunization, we conducted a census in the target area to preregister those who were eligible and to give them a vaccine card with a barcode that would give them access to their doses. We sent a team of 50 enumerators to the field and each recorded demographic data and eligibility status of the people living in the households via electronic data collection using Samsung Galaxy tablets. This census gave us the chance to explain the vaccine’s benefits, while educating the population about hygiene and sanitation, regardless of whether they were eligible to receive the vaccine.

We were not able to implement the campaign exactly as planned, because of a concurrent national vaccination campaign, which targeted newborns through children aged 9 years and also included the polio vaccine (polio and cholera vaccines must be administered 2 weeks apart because of possible interactions).

To avoid interfering with the national campaign, we split our campaign into two phases: the phase I vaccination was for individuals aged 10 years and older, and phase II included children aged 9 years and younger. The campaign lasted more than 1 month, with some breaks between the phases and the doses.

We had 40 teams (each team had two vaccinators and one registrar with the tablet) who were sent to various posts within the targeted area to vaccinate the eligible people. The community health workers and a sound truck service raised awareness before, during, and after each dose and each phase. First, the teams started at fixed vaccinations posts to capture as many people as possible. When fewer people showed up at the fixed posts, the teams started mobile posts to connect with the people who are farther away. Finally, when the number of the vaccinees was low at the mobile posts, we gave a list of the people left to be vaccinated to the teams and they started going door-to-door to do active case finding.

What were some of the challenges of administering the vaccines in a setting with limited medical resources?

The delay from the national polio vaccination campaign made our campaign last longer than we expected. Logistically, this resulted in greater challenges to keep the vaccines in cold chain and to reach some remote areas before the rainy season. Despite these challenges, we had a motivated, committed, and vigilant staff that worked hard to monitor the cold chain, and continually conducted regular thermometer readings and inspections of the cold container, cold boxes, and vaccine carriers (thermoses). Many of our teams did not hesitate to take canoes or donkeys or even to cross flooded rivers to reach vaccine recipients when our trucks could not reach those areas.

We experienced some issues with the technology used for data collection, though we did anticipate some problems. We had a team in United States and another in Haiti who were able to work together to respond quickly and effectively and resolve hardware, software, and Internet connection problems. The teams worked late nights to address those issues and to produce data reports, which allowed us to strategize our activities more effectively and efficiently. We also had a team on standby in our Saint-Marc office that could help locate the unique ID of a vaccine recipient in case the registrar in the field was unable to find the record on their tablet.

Another hurdle involved a group of farmers who we could not find during the daily vaccination periods because they were working late on their land. We sent some teams on later shifts, starting in the field in the afternoon and staying late into the evening in order to catch those recipients.

What are the plans for the vaccination program going forward?

We finished the vaccination campaign on June 19, 2012. We vaccinated more than 40,000 people. The next step is to evaluate the feasibility and the effectiveness of the project by assessing the operational activities, community acceptance, and cost effectiveness. We also are planning a case-control study. The vaccine already has been proven to be safe and effective.

What have you found most rewarding about your work on this program?

For me, the most rewarding part of this program was that we were able to deliver vaccine to this vulnerable population and protect them from this deadly disease. Ideally, this will help them maintain good health, so that they can continue to work and be productive to help their families survive. Seeing not only this population’s poor life conditions but also their acceptance of the vaccine inspired me and gave me more strength to continue the advocacy and the fight for a national scale-up vaccine campaign.

Think globally. Practice locally.

U.S.-trained internists who have practiced abroad will receive a $100 stipend for contributing to this column. For details, visit the World Wide Med column at www.internalmedicinenews.com or send an e-mail to [email protected].

A new multisociety sedation curriculum for gastrointestinal endoscopy spells out the essential elements of procedural sedation and should be useful to fellows and established practitioners alike. The complete curriculum was published in the July 2012 issue of Gastroenterology.

"It came to the attention of many practitioners, educators, and researchers that we needed to develop a standardized, competency-based curriculum for procedural sedation," Dr. John J. Vargo, committee chair and editor of the curriculum and one of the team of contributing experts, said in an interview. Such a curriculum would house all facets of procedural sedation, including patient assessment, pharmacology of relevant agents, and patient recovery parameters, in one core document, he explained.

"Ideally, we will be giving our fellows and their mentors a competency-based training platform for procedural sedation," he said.

The curriculum also provides practicing clinicians with an opportunity to review the information and identify areas in their procedural sedation practices that might need updating, noted Dr. Vargo. "Medicine is now a journey of continuous education and training, and this is a document that could serve established practitioners in that vein," he said.

"Sedation is a necessary core component for safe and effective performance of GI endoscopic procedures," said Dr. David R. Lichtenstein of Boston University, who was not involved in writing the curriculum.

In an interview, Dr. Lichtenstein noted that "Sedation is intended primarily to reduce our patients’ anxiety and discomfort, resulting in improved tolerability and satisfaction for the procedure."

However, use of sedation has both pros and cons, he said. "Sedation delays patient recovery and discharge, increases the risk of cardiopulmonary complications, and adds to the overall cost of the endoscopic procedure."

The curriculum, known as the Multisociety Sedation Curriculum for Gastrointestinal Endoscopy (MSCGE), is a joint effort of the American Association for the Study of Liver Diseases, the American College of Gastroenterology, the AGA Institute, and the American Society for Gastrointestinal Endoscopy. The Society for Gastroenterology Nurses and Associates also was involved in developing the curriculum, which was published simultaneously in Gastroenterology, the American Journal of Gastroenterology, Gastrointestinal Endoscopy, and Hepatology, and on the website of the Society of Gastroenterology Nurses and Associates (Gastroenterology 2012;143:e18-e41).

The sponsoring societies divided the curriculum into 11 sections: sedation pharmacology; informed consent for endoscopic sedation; periprocedure assessment for endoscopic procedures, levels of sedation; training in the administration of specific agents for moderate sedation; training in airway/rescue techniques and management of complications; anesthesiologist assistance for endoscopic procedures; intraprocedure monitoring; post-procedure assessment training; endoscopy in pregnant and lactating women; and an assessment of competency in endoscopic sedation.

The curriculum "serves as the societies’ vision of best practices in procedural sedation based on evidence-based publications and expert opinion," said Dr. Lichtenstein. "For the practicing gastroenterologist, the MSCGE can serve to validate an existing knowledge base and skill set while providing a curriculum to update deficiencies that may exist. For those individuals in training, the document serves as a reference [for] both the trainee and mentor, ensuring that the goals of training and assessment of competency have been achieved," he said.

Although some patients can undergo endoscopic procedures without sedation, most of these procedures in the United States do involve sedation and anesthesia, Dr. Lichtenstein said.

The curriculum attempts to address some of the challenges in endoscopic sedation. "The most difficult challenge facing our profession resides in the tailoring of the level of sedation to the individual patient and procedure, and selecting the most appropriate provider to deliver the sedation in an environment focused on optimizing patient safety [and] satisfaction, while maintaining fiscal responsibility," he said.

Despite these challenges, "the use of sedation during endoscopy and in particular the use of anesthesiologists and nurse anesthetists during routine ‘low risk’ gastrointestinal endoscopy continues to increase throughout the world," Dr. Lichtenstein noted. "Use of anesthesia services offers the opportunity for deeper sedation or general anesthesia requiring increased physiological monitoring and additional skills for airway management when compared with the lighter ‘moderate sedation’ typically provided by nurses under the direct supervision of the endoscopist," he said.

What does the future hold for endoscopic sedation? A key question is whether anesthesia services should be offered only to patients with absolute need, based on high- risk profiles, Dr. Lichtenstein said. Some examples of high-risk patients include those predicted to have a suboptimal response to sedation because of underlying substance abuse or those with a high-risk airway, he noted.

"We must demonstrate added value for our patients to justify the utilization of anesthesia services for our low-risk patients," he said. Questions to address in clinical practice include the following, he added: Are patients more satisfied? Are patients more likely to return for surveillance exam? Can patients recover faster and return to their preprocedure level of activity earlier? Can we increase efficiency in our endoscopy units? Is gastroenterologist-directed propofol administration off the table permanently or can we reintroduce this practice with appropriate training as outlined in prior societal guidelines?

"Additional research will address these and other future questions as we advance our knowledge within the sedation field," Dr. Lichtenstein said.

The curriculum will be subject to periodic review, Dr. Vargo said. "If this document remains static, we have not done a service to our patients or to those that we train," he said. As the techniques of sedation evolve, the curriculum will change to reflect the appropriate techniques and necessary competencies, he said.

As for implementation, "One of the ways to assess how this document is being used is through the training committees of the sponsoring societies," he noted. "This will give us a great opportunity to see where the needs are.

"One of the important aspects of this curriculum was that we tried to bring all the stakeholders in procedural sedation and gastrointestinal endoscopy together," Dr. Vargo said. The involvement of the Society for Gastroenterology Nurses was especially valuable, he noted. "When you are administering sedation to a patient, it is a physician and nurse team, and that really resonates in this document."

Neither Dr. Vargo nor Dr. Lichtenstein had any financial conflicts to disclose.

A new multisociety sedation curriculum for gastrointestinal endoscopy spells out the essential elements of procedural sedation and should be useful to fellows and established practitioners alike. The complete curriculum was published in the July 2012 issue of Gastroenterology.

"It came to the attention of many practitioners, educators, and researchers that we needed to develop a standardized, competency-based curriculum for procedural sedation," Dr. John J. Vargo, committee chair and editor of the curriculum and one of the team of contributing experts, said in an interview. Such a curriculum would house all facets of procedural sedation, including patient assessment, pharmacology of relevant agents, and patient recovery parameters, in one core document, he explained.

"Ideally, we will be giving our fellows and their mentors a competency-based training platform for procedural sedation," he said.

The curriculum also provides practicing clinicians with an opportunity to review the information and identify areas in their procedural sedation practices that might need updating, noted Dr. Vargo. "Medicine is now a journey of continuous education and training, and this is a document that could serve established practitioners in that vein," he said.

"Sedation is a necessary core component for safe and effective performance of GI endoscopic procedures," said Dr. David R. Lichtenstein of Boston University, who was not involved in writing the curriculum.

In an interview, Dr. Lichtenstein noted that "Sedation is intended primarily to reduce our patients’ anxiety and discomfort, resulting in improved tolerability and satisfaction for the procedure."

However, use of sedation has both pros and cons, he said. "Sedation delays patient recovery and discharge, increases the risk of cardiopulmonary complications, and adds to the overall cost of the endoscopic procedure."

The curriculum, known as the Multisociety Sedation Curriculum for Gastrointestinal Endoscopy (MSCGE), is a joint effort of the American Association for the Study of Liver Diseases, the American College of Gastroenterology, the AGA Institute, and the American Society for Gastrointestinal Endoscopy. The Society for Gastroenterology Nurses and Associates also was involved in developing the curriculum, which was published simultaneously in Gastroenterology, the American Journal of Gastroenterology, Gastrointestinal Endoscopy, and Hepatology, and on the website of the Society of Gastroenterology Nurses and Associates (Gastroenterology 2012;143:e18-e41).

The sponsoring societies divided the curriculum into 11 sections: sedation pharmacology; informed consent for endoscopic sedation; periprocedure assessment for endoscopic procedures, levels of sedation; training in the administration of specific agents for moderate sedation; training in airway/rescue techniques and management of complications; anesthesiologist assistance for endoscopic procedures; intraprocedure monitoring; post-procedure assessment training; endoscopy in pregnant and lactating women; and an assessment of competency in endoscopic sedation.

The curriculum "serves as the societies’ vision of best practices in procedural sedation based on evidence-based publications and expert opinion," said Dr. Lichtenstein. "For the practicing gastroenterologist, the MSCGE can serve to validate an existing knowledge base and skill set while providing a curriculum to update deficiencies that may exist. For those individuals in training, the document serves as a reference [for] both the trainee and mentor, ensuring that the goals of training and assessment of competency have been achieved," he said.

Although some patients can undergo endoscopic procedures without sedation, most of these procedures in the United States do involve sedation and anesthesia, Dr. Lichtenstein said.

The curriculum attempts to address some of the challenges in endoscopic sedation. "The most difficult challenge facing our profession resides in the tailoring of the level of sedation to the individual patient and procedure, and selecting the most appropriate provider to deliver the sedation in an environment focused on optimizing patient safety [and] satisfaction, while maintaining fiscal responsibility," he said.

Despite these challenges, "the use of sedation during endoscopy and in particular the use of anesthesiologists and nurse anesthetists during routine ‘low risk’ gastrointestinal endoscopy continues to increase throughout the world," Dr. Lichtenstein noted. "Use of anesthesia services offers the opportunity for deeper sedation or general anesthesia requiring increased physiological monitoring and additional skills for airway management when compared with the lighter ‘moderate sedation’ typically provided by nurses under the direct supervision of the endoscopist," he said.

What does the future hold for endoscopic sedation? A key question is whether anesthesia services should be offered only to patients with absolute need, based on high- risk profiles, Dr. Lichtenstein said. Some examples of high-risk patients include those predicted to have a suboptimal response to sedation because of underlying substance abuse or those with a high-risk airway, he noted.

"We must demonstrate added value for our patients to justify the utilization of anesthesia services for our low-risk patients," he said. Questions to address in clinical practice include the following, he added: Are patients more satisfied? Are patients more likely to return for surveillance exam? Can patients recover faster and return to their preprocedure level of activity earlier? Can we increase efficiency in our endoscopy units? Is gastroenterologist-directed propofol administration off the table permanently or can we reintroduce this practice with appropriate training as outlined in prior societal guidelines?

"Additional research will address these and other future questions as we advance our knowledge within the sedation field," Dr. Lichtenstein said.

The curriculum will be subject to periodic review, Dr. Vargo said. "If this document remains static, we have not done a service to our patients or to those that we train," he said. As the techniques of sedation evolve, the curriculum will change to reflect the appropriate techniques and necessary competencies, he said.

As for implementation, "One of the ways to assess how this document is being used is through the training committees of the sponsoring societies," he noted. "This will give us a great opportunity to see where the needs are.

"One of the important aspects of this curriculum was that we tried to bring all the stakeholders in procedural sedation and gastrointestinal endoscopy together," Dr. Vargo said. The involvement of the Society for Gastroenterology Nurses was especially valuable, he noted. "When you are administering sedation to a patient, it is a physician and nurse team, and that really resonates in this document."

Neither Dr. Vargo nor Dr. Lichtenstein had any financial conflicts to disclose.

A new multisociety sedation curriculum for gastrointestinal endoscopy spells out the essential elements of procedural sedation and should be useful to fellows and established practitioners alike. The complete curriculum was published in the July 2012 issue of Gastroenterology.

"It came to the attention of many practitioners, educators, and researchers that we needed to develop a standardized, competency-based curriculum for procedural sedation," Dr. John J. Vargo, committee chair and editor of the curriculum and one of the team of contributing experts, said in an interview. Such a curriculum would house all facets of procedural sedation, including patient assessment, pharmacology of relevant agents, and patient recovery parameters, in one core document, he explained.

"Ideally, we will be giving our fellows and their mentors a competency-based training platform for procedural sedation," he said.

The curriculum also provides practicing clinicians with an opportunity to review the information and identify areas in their procedural sedation practices that might need updating, noted Dr. Vargo. "Medicine is now a journey of continuous education and training, and this is a document that could serve established practitioners in that vein," he said.

"Sedation is a necessary core component for safe and effective performance of GI endoscopic procedures," said Dr. David R. Lichtenstein of Boston University, who was not involved in writing the curriculum.

In an interview, Dr. Lichtenstein noted that "Sedation is intended primarily to reduce our patients’ anxiety and discomfort, resulting in improved tolerability and satisfaction for the procedure."

However, use of sedation has both pros and cons, he said. "Sedation delays patient recovery and discharge, increases the risk of cardiopulmonary complications, and adds to the overall cost of the endoscopic procedure."

The curriculum, known as the Multisociety Sedation Curriculum for Gastrointestinal Endoscopy (MSCGE), is a joint effort of the American Association for the Study of Liver Diseases, the American College of Gastroenterology, the AGA Institute, and the American Society for Gastrointestinal Endoscopy. The Society for Gastroenterology Nurses and Associates also was involved in developing the curriculum, which was published simultaneously in Gastroenterology, the American Journal of Gastroenterology, Gastrointestinal Endoscopy, and Hepatology, and on the website of the Society of Gastroenterology Nurses and Associates (Gastroenterology 2012;143:e18-e41).

The sponsoring societies divided the curriculum into 11 sections: sedation pharmacology; informed consent for endoscopic sedation; periprocedure assessment for endoscopic procedures, levels of sedation; training in the administration of specific agents for moderate sedation; training in airway/rescue techniques and management of complications; anesthesiologist assistance for endoscopic procedures; intraprocedure monitoring; post-procedure assessment training; endoscopy in pregnant and lactating women; and an assessment of competency in endoscopic sedation.

The curriculum "serves as the societies’ vision of best practices in procedural sedation based on evidence-based publications and expert opinion," said Dr. Lichtenstein. "For the practicing gastroenterologist, the MSCGE can serve to validate an existing knowledge base and skill set while providing a curriculum to update deficiencies that may exist. For those individuals in training, the document serves as a reference [for] both the trainee and mentor, ensuring that the goals of training and assessment of competency have been achieved," he said.

Although some patients can undergo endoscopic procedures without sedation, most of these procedures in the United States do involve sedation and anesthesia, Dr. Lichtenstein said.

The curriculum attempts to address some of the challenges in endoscopic sedation. "The most difficult challenge facing our profession resides in the tailoring of the level of sedation to the individual patient and procedure, and selecting the most appropriate provider to deliver the sedation in an environment focused on optimizing patient safety [and] satisfaction, while maintaining fiscal responsibility," he said.

Despite these challenges, "the use of sedation during endoscopy and in particular the use of anesthesiologists and nurse anesthetists during routine ‘low risk’ gastrointestinal endoscopy continues to increase throughout the world," Dr. Lichtenstein noted. "Use of anesthesia services offers the opportunity for deeper sedation or general anesthesia requiring increased physiological monitoring and additional skills for airway management when compared with the lighter ‘moderate sedation’ typically provided by nurses under the direct supervision of the endoscopist," he said.

What does the future hold for endoscopic sedation? A key question is whether anesthesia services should be offered only to patients with absolute need, based on high- risk profiles, Dr. Lichtenstein said. Some examples of high-risk patients include those predicted to have a suboptimal response to sedation because of underlying substance abuse or those with a high-risk airway, he noted.

"We must demonstrate added value for our patients to justify the utilization of anesthesia services for our low-risk patients," he said. Questions to address in clinical practice include the following, he added: Are patients more satisfied? Are patients more likely to return for surveillance exam? Can patients recover faster and return to their preprocedure level of activity earlier? Can we increase efficiency in our endoscopy units? Is gastroenterologist-directed propofol administration off the table permanently or can we reintroduce this practice with appropriate training as outlined in prior societal guidelines?

"Additional research will address these and other future questions as we advance our knowledge within the sedation field," Dr. Lichtenstein said.

The curriculum will be subject to periodic review, Dr. Vargo said. "If this document remains static, we have not done a service to our patients or to those that we train," he said. As the techniques of sedation evolve, the curriculum will change to reflect the appropriate techniques and necessary competencies, he said.

As for implementation, "One of the ways to assess how this document is being used is through the training committees of the sponsoring societies," he noted. "This will give us a great opportunity to see where the needs are.

"One of the important aspects of this curriculum was that we tried to bring all the stakeholders in procedural sedation and gastrointestinal endoscopy together," Dr. Vargo said. The involvement of the Society for Gastroenterology Nurses was especially valuable, he noted. "When you are administering sedation to a patient, it is a physician and nurse team, and that really resonates in this document."

Neither Dr. Vargo nor Dr. Lichtenstein had any financial conflicts to disclose.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

More than half of American teens have been asked to send a "sext," based on data from 948 high school students. The findings were published online July 2 in the Archives of Pediatrics and Adolescent Medicine.

Sexting, the sending of explicit electronic messages, may predict real-life sexual behavior in teenagers, the study investigators wrote.  Although teen sexting has received much media attention, data on the public health implications of this behavior are limited, the researchers said.

Photo credit: Arkady Chubykin/Fotolia.com

To determine the prevalence of teen sexting and how it relates to dating and sexual activity, Jeff R. Temple, Ph.D., of the University of Texas, Galveston, and his colleagues surveyed high school students from seven public high schools in Texas (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:  10.1001/archpediatrics.2012.835]).

Overall, 28% of the teens reported sending a naked picture of themselves via text or e-mail (a "sext"), and 31% reported asking someone to send them a sext. Approximately 28% of both genders reported sending a sext, but significantly more girls than boys reported having been asked for a sext (69% vs. 42%) and significantly more boys than girls reported having asked someone for a sext (46% vs. 21%).

"Among girls, there was a significant association between all sexting behaviors and all dating, sex, and risky sex behaviors," the researchers said. Of the girls who reported sending a sext, 77% also reported having sex, compared with 42% of girls who did not report sending a sext. In addition, 96% of girls who said that they weren’t bothered by being asked for a sext reported having had sex, compared with 45%-71% of girls who said they were at least somewhat bothered by being asked for a sext.

Among boys, 82% of those who reported sending a sext also reported having sex, compared with 45% of boys who did not report sending a sext. In addition, 76% of boys who reported being asked for a sext also reported having sex, compared with 38% of boys who had not been asked for a sext.

Overall, "teens who engaged in sexting behaviors were more likely to have begun dating and to have had sex than those who did not sext," Dr. Temple and his associates wrote.

Despite the associations between sexting and sexual activity, however, "we found that teens are genuinely bothered by being asked to send a naked picture," the researchers said. Fewer than 10% of girls and 50% of boys were "not at all bothered" by a request for a sext, they said, but future research should be more clear about whether "bothered" means "annoyed" or "embarrassed," they said.

The students surveyed were 14-19 years of age and were in 10th or 11th grade. Approximately 56% were girls, 27% were black, 30% were white, 32% were Hispanic, 3% were Asian, and 8% were of mixed/other race. The study was conducted during school hours, and students received $10 gift cards for participating.

The study was limited by the use of self-reports and by the lack of data on whether risky sex behaviors occurred before or after sexting, but the study is the first to show a link between sexting and sexual behavior in a diverse, school-based sample of teens. "These findings reinforce calls by the American Academy of Pediatrics to discuss teen sexting with patients and patients’ parents," they noted.

In an accompanying editorial, Dr. Megan A. Moreno and Jennifer M. Whitehill, Ph.D., wrote that "sexting appears to be a media expression of adolescent sexual intent or behavior, rather than a distinct phenomenon limited to the digital world" (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:10.1001/archpediatrics.2012.1320]).

The current study findings suggest that clinicians "may consider sexual disclosures in a social media setting as an expression of adolescents’ offline sexual intentions or behaviors," said Dr. Moreno of the department of pediatrics at the University of Wisconsin, Madison, and Dr. Whitehill of the department of pediatrics at the University of Washington, Seattle.

Social media present unique challenges to those concerned with teen health because of the large amounts of time, largely unsupervised, that teens spend using social media. The social media, however, also can be an entry for clinicians and parents to talk to teens about sexual health and a tool for education and prevention efforts, they added.

Dr. Temple and his associates did not report any financial conflicts. Neither Dr. Moreno nor Dr. Whitehill had any financial conflicts to disclose.

More than half of American teens have been asked to send a "sext," based on data from 948 high school students. The findings were published online July 2 in the Archives of Pediatrics and Adolescent Medicine.

Sexting, the sending of explicit electronic messages, may predict real-life sexual behavior in teenagers, the study investigators wrote.  Although teen sexting has received much media attention, data on the public health implications of this behavior are limited, the researchers said.

Photo credit: Arkady Chubykin/Fotolia.com

To determine the prevalence of teen sexting and how it relates to dating and sexual activity, Jeff R. Temple, Ph.D., of the University of Texas, Galveston, and his colleagues surveyed high school students from seven public high schools in Texas (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:  10.1001/archpediatrics.2012.835]).

Overall, 28% of the teens reported sending a naked picture of themselves via text or e-mail (a "sext"), and 31% reported asking someone to send them a sext. Approximately 28% of both genders reported sending a sext, but significantly more girls than boys reported having been asked for a sext (69% vs. 42%) and significantly more boys than girls reported having asked someone for a sext (46% vs. 21%).

"Among girls, there was a significant association between all sexting behaviors and all dating, sex, and risky sex behaviors," the researchers said. Of the girls who reported sending a sext, 77% also reported having sex, compared with 42% of girls who did not report sending a sext. In addition, 96% of girls who said that they weren’t bothered by being asked for a sext reported having had sex, compared with 45%-71% of girls who said they were at least somewhat bothered by being asked for a sext.

Among boys, 82% of those who reported sending a sext also reported having sex, compared with 45% of boys who did not report sending a sext. In addition, 76% of boys who reported being asked for a sext also reported having sex, compared with 38% of boys who had not been asked for a sext.

Overall, "teens who engaged in sexting behaviors were more likely to have begun dating and to have had sex than those who did not sext," Dr. Temple and his associates wrote.

Despite the associations between sexting and sexual activity, however, "we found that teens are genuinely bothered by being asked to send a naked picture," the researchers said. Fewer than 10% of girls and 50% of boys were "not at all bothered" by a request for a sext, they said, but future research should be more clear about whether "bothered" means "annoyed" or "embarrassed," they said.

The students surveyed were 14-19 years of age and were in 10th or 11th grade. Approximately 56% were girls, 27% were black, 30% were white, 32% were Hispanic, 3% were Asian, and 8% were of mixed/other race. The study was conducted during school hours, and students received $10 gift cards for participating.

The study was limited by the use of self-reports and by the lack of data on whether risky sex behaviors occurred before or after sexting, but the study is the first to show a link between sexting and sexual behavior in a diverse, school-based sample of teens. "These findings reinforce calls by the American Academy of Pediatrics to discuss teen sexting with patients and patients’ parents," they noted.

In an accompanying editorial, Dr. Megan A. Moreno and Jennifer M. Whitehill, Ph.D., wrote that "sexting appears to be a media expression of adolescent sexual intent or behavior, rather than a distinct phenomenon limited to the digital world" (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:10.1001/archpediatrics.2012.1320]).

The current study findings suggest that clinicians "may consider sexual disclosures in a social media setting as an expression of adolescents’ offline sexual intentions or behaviors," said Dr. Moreno of the department of pediatrics at the University of Wisconsin, Madison, and Dr. Whitehill of the department of pediatrics at the University of Washington, Seattle.

Social media present unique challenges to those concerned with teen health because of the large amounts of time, largely unsupervised, that teens spend using social media. The social media, however, also can be an entry for clinicians and parents to talk to teens about sexual health and a tool for education and prevention efforts, they added.

Dr. Temple and his associates did not report any financial conflicts. Neither Dr. Moreno nor Dr. Whitehill had any financial conflicts to disclose.

More than half of American teens have been asked to send a "sext," based on data from 948 high school students. The findings were published online July 2 in the Archives of Pediatrics and Adolescent Medicine.

Sexting, the sending of explicit electronic messages, may predict real-life sexual behavior in teenagers, the study investigators wrote.  Although teen sexting has received much media attention, data on the public health implications of this behavior are limited, the researchers said.

Photo credit: Arkady Chubykin/Fotolia.com

To determine the prevalence of teen sexting and how it relates to dating and sexual activity, Jeff R. Temple, Ph.D., of the University of Texas, Galveston, and his colleagues surveyed high school students from seven public high schools in Texas (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:  10.1001/archpediatrics.2012.835]).

Overall, 28% of the teens reported sending a naked picture of themselves via text or e-mail (a "sext"), and 31% reported asking someone to send them a sext. Approximately 28% of both genders reported sending a sext, but significantly more girls than boys reported having been asked for a sext (69% vs. 42%) and significantly more boys than girls reported having asked someone for a sext (46% vs. 21%).

"Among girls, there was a significant association between all sexting behaviors and all dating, sex, and risky sex behaviors," the researchers said. Of the girls who reported sending a sext, 77% also reported having sex, compared with 42% of girls who did not report sending a sext. In addition, 96% of girls who said that they weren’t bothered by being asked for a sext reported having had sex, compared with 45%-71% of girls who said they were at least somewhat bothered by being asked for a sext.

Among boys, 82% of those who reported sending a sext also reported having sex, compared with 45% of boys who did not report sending a sext. In addition, 76% of boys who reported being asked for a sext also reported having sex, compared with 38% of boys who had not been asked for a sext.

Overall, "teens who engaged in sexting behaviors were more likely to have begun dating and to have had sex than those who did not sext," Dr. Temple and his associates wrote.

Despite the associations between sexting and sexual activity, however, "we found that teens are genuinely bothered by being asked to send a naked picture," the researchers said. Fewer than 10% of girls and 50% of boys were "not at all bothered" by a request for a sext, they said, but future research should be more clear about whether "bothered" means "annoyed" or "embarrassed," they said.

The students surveyed were 14-19 years of age and were in 10th or 11th grade. Approximately 56% were girls, 27% were black, 30% were white, 32% were Hispanic, 3% were Asian, and 8% were of mixed/other race. The study was conducted during school hours, and students received $10 gift cards for participating.

The study was limited by the use of self-reports and by the lack of data on whether risky sex behaviors occurred before or after sexting, but the study is the first to show a link between sexting and sexual behavior in a diverse, school-based sample of teens. "These findings reinforce calls by the American Academy of Pediatrics to discuss teen sexting with patients and patients’ parents," they noted.

In an accompanying editorial, Dr. Megan A. Moreno and Jennifer M. Whitehill, Ph.D., wrote that "sexting appears to be a media expression of adolescent sexual intent or behavior, rather than a distinct phenomenon limited to the digital world" (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:10.1001/archpediatrics.2012.1320]).

The current study findings suggest that clinicians "may consider sexual disclosures in a social media setting as an expression of adolescents’ offline sexual intentions or behaviors," said Dr. Moreno of the department of pediatrics at the University of Wisconsin, Madison, and Dr. Whitehill of the department of pediatrics at the University of Washington, Seattle.

Social media present unique challenges to those concerned with teen health because of the large amounts of time, largely unsupervised, that teens spend using social media. The social media, however, also can be an entry for clinicians and parents to talk to teens about sexual health and a tool for education and prevention efforts, they added.

Dr. Temple and his associates did not report any financial conflicts. Neither Dr. Moreno nor Dr. Whitehill had any financial conflicts to disclose.

A recently developed tool could help doctors stay ahead of the game in preventing delirium in intensive care patients.

Dutch researchers say their delirium prediction model, known as PRE-DELIRIC, was significantly more successful than doctors and nurses at predicting delirium in hospitalized adults.

Preventive measures for delirium can limit its incidence, severity, and duration. While several assessment tools exist for other segments of hospitalized patients, "no evidence-based prediction model for general intensive care patients is available," Mark van den Boogaard, Ph.D., of Radboud University Nijmegen (Netherlands) Medical Centre and his colleagues said (BMJ 2012;344:e420 [doi: 10.1136/bmj.e420]).

General preventive measures in all ICU patients are time consuming, and may expose many patients to unnecessary risks such as adverse events related to drug prophylaxis, the researchers explained.

For PRE-DELIRIC (Prediction of Delirium in ICU Patients), Dr. van den Boogaard and his colleagues defined 10 risk factors that can be easily assessed within 24 hours of admission to the ICU: age, APACHE II (Acute Physiology and Chronic Health Evaluation II) score, admission category, coma, infection, metabolic acidosis, morphine use, sedative use, urea concentration, and urgent admission.

"The use of the PRE-DELERIC model to identify and consequently preventively treat high-risk patients could offer an important contribution to intensive care practice and ensure efficient use of research resources to study only high-risk patients," the researchers said.

Clinically, the model may improve the use of nondrug measures to prevent delirium in high-risk patients, the researchers added. Such measures include improvement of orientation, cognitive stimulation, early mobilization, and listening to music, they said.

In noncritical patients, nondrug preventive measures have been shown to reduce delirium incidence and duration, and haloperidol treatment has lessened severity, duration, and associated length of stay. But for ICU patients, data are hard to come by. PRE-DELIRIC could inform the choice to use prophylactic haloperidol in these patients, the authors said. Existing research (Lancet 2009;373:1874-82) does show that "early mobilisation of mechanically ventilated patients in intensive care, besides other significant effects, resulted in a reduced duration of delirium," Dr. van den Boogaard and his coauthors wrote.

After testing their model for temporal validation, the researchers conducted an external validation study of data from intensive care patients admitted to four Dutch hospitals between Jan. 1 and Sept. 1, 2009. The pooled data included information from 3,056 patients aged 18 years and older, yielding an area under the receiver operating characteristics curve (AUROC) of 0.85. The patients were divided into four risk groups: low, moderate, high, and very high. The sensitivity and specificity were, respectively, 81% and 75% for the group with low-risk group; 62% and 89% for the moderate-risk group; 46% and 95% for the high-risk group; and 30% and 98% for the group with very high risk.

The researchers compared the predictions of patient delirium made by their model to predictions made by doctors and nurses in the hospital, using a convenience sample of 124 patients.

The AUROC for the PRE-DELIRIC model (0.87) was significantly higher than that of the doctors and nurses (0.59).

No significant differences appeared in the predictions of intensive care nurses compared with student intensive care nurses or among intensivists, fellow-intensivists, and residents, the researchers said.

The PRE-DELIRIC model is being used in daily practice in the hospital where the model was developed, the researchers said. "Intensive care patients with a high risk of delirium (at least a 50% PRE-DELIRIC score), and patients with dementia or alcohol misuse, receive preventive measures. The optimal cut-off point of the PRE-DELIRIC model and the most effective delirium preventive interventions for intensive care patients need to be studied in the near future."

The findings were limited by the static nature of the model, which does not account for changes in health status that might affect the odds of developing delirium, the researchers noted.

The researchers reported having no financial conflicts of interest.

A recently developed tool could help doctors stay ahead of the game in preventing delirium in intensive care patients.

Dutch researchers say their delirium prediction model, known as PRE-DELIRIC, was significantly more successful than doctors and nurses at predicting delirium in hospitalized adults.

Preventive measures for delirium can limit its incidence, severity, and duration. While several assessment tools exist for other segments of hospitalized patients, "no evidence-based prediction model for general intensive care patients is available," Mark van den Boogaard, Ph.D., of Radboud University Nijmegen (Netherlands) Medical Centre and his colleagues said (BMJ 2012;344:e420 [doi: 10.1136/bmj.e420]).

General preventive measures in all ICU patients are time consuming, and may expose many patients to unnecessary risks such as adverse events related to drug prophylaxis, the researchers explained.

For PRE-DELIRIC (Prediction of Delirium in ICU Patients), Dr. van den Boogaard and his colleagues defined 10 risk factors that can be easily assessed within 24 hours of admission to the ICU: age, APACHE II (Acute Physiology and Chronic Health Evaluation II) score, admission category, coma, infection, metabolic acidosis, morphine use, sedative use, urea concentration, and urgent admission.

"The use of the PRE-DELERIC model to identify and consequently preventively treat high-risk patients could offer an important contribution to intensive care practice and ensure efficient use of research resources to study only high-risk patients," the researchers said.

Clinically, the model may improve the use of nondrug measures to prevent delirium in high-risk patients, the researchers added. Such measures include improvement of orientation, cognitive stimulation, early mobilization, and listening to music, they said.

In noncritical patients, nondrug preventive measures have been shown to reduce delirium incidence and duration, and haloperidol treatment has lessened severity, duration, and associated length of stay. But for ICU patients, data are hard to come by. PRE-DELIRIC could inform the choice to use prophylactic haloperidol in these patients, the authors said. Existing research (Lancet 2009;373:1874-82) does show that "early mobilisation of mechanically ventilated patients in intensive care, besides other significant effects, resulted in a reduced duration of delirium," Dr. van den Boogaard and his coauthors wrote.

After testing their model for temporal validation, the researchers conducted an external validation study of data from intensive care patients admitted to four Dutch hospitals between Jan. 1 and Sept. 1, 2009. The pooled data included information from 3,056 patients aged 18 years and older, yielding an area under the receiver operating characteristics curve (AUROC) of 0.85. The patients were divided into four risk groups: low, moderate, high, and very high. The sensitivity and specificity were, respectively, 81% and 75% for the group with low-risk group; 62% and 89% for the moderate-risk group; 46% and 95% for the high-risk group; and 30% and 98% for the group with very high risk.

The researchers compared the predictions of patient delirium made by their model to predictions made by doctors and nurses in the hospital, using a convenience sample of 124 patients.

The AUROC for the PRE-DELIRIC model (0.87) was significantly higher than that of the doctors and nurses (0.59).

No significant differences appeared in the predictions of intensive care nurses compared with student intensive care nurses or among intensivists, fellow-intensivists, and residents, the researchers said.

The PRE-DELIRIC model is being used in daily practice in the hospital where the model was developed, the researchers said. "Intensive care patients with a high risk of delirium (at least a 50% PRE-DELIRIC score), and patients with dementia or alcohol misuse, receive preventive measures. The optimal cut-off point of the PRE-DELIRIC model and the most effective delirium preventive interventions for intensive care patients need to be studied in the near future."

The findings were limited by the static nature of the model, which does not account for changes in health status that might affect the odds of developing delirium, the researchers noted.

The researchers reported having no financial conflicts of interest.

A recently developed tool could help doctors stay ahead of the game in preventing delirium in intensive care patients.

Dutch researchers say their delirium prediction model, known as PRE-DELIRIC, was significantly more successful than doctors and nurses at predicting delirium in hospitalized adults.

Preventive measures for delirium can limit its incidence, severity, and duration. While several assessment tools exist for other segments of hospitalized patients, "no evidence-based prediction model for general intensive care patients is available," Mark van den Boogaard, Ph.D., of Radboud University Nijmegen (Netherlands) Medical Centre and his colleagues said (BMJ 2012;344:e420 [doi: 10.1136/bmj.e420]).

General preventive measures in all ICU patients are time consuming, and may expose many patients to unnecessary risks such as adverse events related to drug prophylaxis, the researchers explained.

For PRE-DELIRIC (Prediction of Delirium in ICU Patients), Dr. van den Boogaard and his colleagues defined 10 risk factors that can be easily assessed within 24 hours of admission to the ICU: age, APACHE II (Acute Physiology and Chronic Health Evaluation II) score, admission category, coma, infection, metabolic acidosis, morphine use, sedative use, urea concentration, and urgent admission.

"The use of the PRE-DELERIC model to identify and consequently preventively treat high-risk patients could offer an important contribution to intensive care practice and ensure efficient use of research resources to study only high-risk patients," the researchers said.

Clinically, the model may improve the use of nondrug measures to prevent delirium in high-risk patients, the researchers added. Such measures include improvement of orientation, cognitive stimulation, early mobilization, and listening to music, they said.

In noncritical patients, nondrug preventive measures have been shown to reduce delirium incidence and duration, and haloperidol treatment has lessened severity, duration, and associated length of stay. But for ICU patients, data are hard to come by. PRE-DELIRIC could inform the choice to use prophylactic haloperidol in these patients, the authors said. Existing research (Lancet 2009;373:1874-82) does show that "early mobilisation of mechanically ventilated patients in intensive care, besides other significant effects, resulted in a reduced duration of delirium," Dr. van den Boogaard and his coauthors wrote.

After testing their model for temporal validation, the researchers conducted an external validation study of data from intensive care patients admitted to four Dutch hospitals between Jan. 1 and Sept. 1, 2009. The pooled data included information from 3,056 patients aged 18 years and older, yielding an area under the receiver operating characteristics curve (AUROC) of 0.85. The patients were divided into four risk groups: low, moderate, high, and very high. The sensitivity and specificity were, respectively, 81% and 75% for the group with low-risk group; 62% and 89% for the moderate-risk group; 46% and 95% for the high-risk group; and 30% and 98% for the group with very high risk.

The researchers compared the predictions of patient delirium made by their model to predictions made by doctors and nurses in the hospital, using a convenience sample of 124 patients.

The AUROC for the PRE-DELIRIC model (0.87) was significantly higher than that of the doctors and nurses (0.59).

No significant differences appeared in the predictions of intensive care nurses compared with student intensive care nurses or among intensivists, fellow-intensivists, and residents, the researchers said.

The PRE-DELIRIC model is being used in daily practice in the hospital where the model was developed, the researchers said. "Intensive care patients with a high risk of delirium (at least a 50% PRE-DELIRIC score), and patients with dementia or alcohol misuse, receive preventive measures. The optimal cut-off point of the PRE-DELIRIC model and the most effective delirium preventive interventions for intensive care patients need to be studied in the near future."

The findings were limited by the static nature of the model, which does not account for changes in health status that might affect the odds of developing delirium, the researchers noted.

The researchers reported having no financial conflicts of interest.

Operating room time, body mass index, and the surgeon performing the procedure were the top three factors affecting readmission rates, transfusion rates, and surgical site infections after colorectal surgery in a single-center prospective study of more than 3,000 patients.

Many previous studies have addressed risk factors and surgical outcomes, but "little is known about the relative contribution of various risk factors to specific outcomes," said Elena Manilich, Ph.D., of the Cleveland Clinic. She presented the findings at the annual meeting of the American Society of Colon and Rectal Surgeons.

She and her colleagues analyzed outcomes from 3,552 patients who underwent colorectal surgery. Their average age at the time of surgery was 51 years, and approximately half were women. Cancer was the most common indication for surgery (16%).

Overall, the length of surgery was significantly associated with increased complication rates, Dr. Manilich said. In particular, the adjusted odds ratios for procedures lasting more than 200 minutes vs. those lasting less than 200 minutes were 2.79 for transfusion, 2.11 for surgical site infection and abscess, and 2.09 for wound infection.

Surgeons who performed fewer than 20 procedures were significant predictors of surgical site infections, abscesses, reoperation, and anastomotic leaks in their patients, Dr. Manilich said.

Increased patient body mass index was independently associated with wound infection, surgical site infection, and portal and deep vein thrombosis, she added.

In addition, a patient age older than 75 years was independently associated with transfusion and reoperation.

The outcomes that were most influenced by complications were hospital readmission, transfusion, surgical site infection, wound infections, and abscesses. Complications were defined as outcomes that occurred prior to hospital discharge or within 30 days of the initial surgery.

The findings were limited by the use of data from a single hospital and by the inability to adjust for patient histories (such as prior abdominal procedures) that might have affected the outcomes, Dr. Manilich said. But the study is unique in its use of a logistic regression analysis to identify which variables predict which outcomes, she added.

"An understanding of these results may be useful to colorectal surgeons who are making an effort to understand and improve their surgical outcomes," she said.

Dr. Manilich had no financial conflicts to disclose.

Operating room time, body mass index, and the surgeon performing the procedure were the top three factors affecting readmission rates, transfusion rates, and surgical site infections after colorectal surgery in a single-center prospective study of more than 3,000 patients.

Many previous studies have addressed risk factors and surgical outcomes, but "little is known about the relative contribution of various risk factors to specific outcomes," said Elena Manilich, Ph.D., of the Cleveland Clinic. She presented the findings at the annual meeting of the American Society of Colon and Rectal Surgeons.

She and her colleagues analyzed outcomes from 3,552 patients who underwent colorectal surgery. Their average age at the time of surgery was 51 years, and approximately half were women. Cancer was the most common indication for surgery (16%).

Overall, the length of surgery was significantly associated with increased complication rates, Dr. Manilich said. In particular, the adjusted odds ratios for procedures lasting more than 200 minutes vs. those lasting less than 200 minutes were 2.79 for transfusion, 2.11 for surgical site infection and abscess, and 2.09 for wound infection.

Surgeons who performed fewer than 20 procedures were significant predictors of surgical site infections, abscesses, reoperation, and anastomotic leaks in their patients, Dr. Manilich said.

Increased patient body mass index was independently associated with wound infection, surgical site infection, and portal and deep vein thrombosis, she added.

In addition, a patient age older than 75 years was independently associated with transfusion and reoperation.

The outcomes that were most influenced by complications were hospital readmission, transfusion, surgical site infection, wound infections, and abscesses. Complications were defined as outcomes that occurred prior to hospital discharge or within 30 days of the initial surgery.

The findings were limited by the use of data from a single hospital and by the inability to adjust for patient histories (such as prior abdominal procedures) that might have affected the outcomes, Dr. Manilich said. But the study is unique in its use of a logistic regression analysis to identify which variables predict which outcomes, she added.

"An understanding of these results may be useful to colorectal surgeons who are making an effort to understand and improve their surgical outcomes," she said.

Dr. Manilich had no financial conflicts to disclose.

Operating room time, body mass index, and the surgeon performing the procedure were the top three factors affecting readmission rates, transfusion rates, and surgical site infections after colorectal surgery in a single-center prospective study of more than 3,000 patients.

Many previous studies have addressed risk factors and surgical outcomes, but "little is known about the relative contribution of various risk factors to specific outcomes," said Elena Manilich, Ph.D., of the Cleveland Clinic. She presented the findings at the annual meeting of the American Society of Colon and Rectal Surgeons.

She and her colleagues analyzed outcomes from 3,552 patients who underwent colorectal surgery. Their average age at the time of surgery was 51 years, and approximately half were women. Cancer was the most common indication for surgery (16%).

Overall, the length of surgery was significantly associated with increased complication rates, Dr. Manilich said. In particular, the adjusted odds ratios for procedures lasting more than 200 minutes vs. those lasting less than 200 minutes were 2.79 for transfusion, 2.11 for surgical site infection and abscess, and 2.09 for wound infection.

Surgeons who performed fewer than 20 procedures were significant predictors of surgical site infections, abscesses, reoperation, and anastomotic leaks in their patients, Dr. Manilich said.

Increased patient body mass index was independently associated with wound infection, surgical site infection, and portal and deep vein thrombosis, she added.

In addition, a patient age older than 75 years was independently associated with transfusion and reoperation.

The outcomes that were most influenced by complications were hospital readmission, transfusion, surgical site infection, wound infections, and abscesses. Complications were defined as outcomes that occurred prior to hospital discharge or within 30 days of the initial surgery.

The findings were limited by the use of data from a single hospital and by the inability to adjust for patient histories (such as prior abdominal procedures) that might have affected the outcomes, Dr. Manilich said. But the study is unique in its use of a logistic regression analysis to identify which variables predict which outcomes, she added.

"An understanding of these results may be useful to colorectal surgeons who are making an effort to understand and improve their surgical outcomes," she said.

Dr. Manilich had no financial conflicts to disclose.

Thrombolysis with intravenous tissue plasminogen activator for the treatment of acute ischemic stroke does not increase the risk of brain hemorrhage in patients who are also taking warfarin, based on data from an observational study of more than 23,000 patients.

The patients in the study had an international normalized ratio (INR) of 1.7 or lower, which is the same population of warfarin-treated patients for whom intravenous tissue plasminogen activator (TPA) is recommended in the current American Heart Association/American Stroke Association guidelines.

Symptomatic intracranial hemorrhage (sICH) is an adverse event associated with intravenous TPA that may occur more often in patients receiving warfarin, according to Dr. Ying Xian, who was lead investigator on the study, published June 26 in JAMA. But "the true absolute risk of sICH in this population remains a matter of significant debate," and previous studies of bleeding risk associated with warfarin have been small, with inconsistent results, wrote Dr. Xian of the Duke Clinical Research Institute in Durham, N.C. and his colleagues.

The investigators reviewed data from 23,437 adults in the American Heart Association’s Get With the Guidelines - Stroke Registry. The study participants were treated with intravenous TPA at 1,203 registry hospitals between April 2009 and June 2011 (JAMA 2012;307:2600-8).

A total of 1,802 (8%) of the patients were receiving warfarin at the time of treatment with TPA. A total of 1,107 patients (5%) developed sICH after TPA.

Although the unadjusted rate of hemorrhage was significantly higher in warfarin-treated patients, compared with non-warfarin patients (6% vs. 5%, P less than .001), there was no significant difference in hemorrhage rates after risk adjustment (adjusted odds ratio, 1.01). The results were similar regardless of whether or not the patients’ scores on the National Institutes of Health Stroke Scale (NIHSS) were excluded from the risk adjustment, the researchers noted.

Similarly, there was no significant difference in the rates of life-threatening or serious systemic hemorrhage between the warfarin and non-warfarin groups (0.9% for both) and no significant differences between the two groups in TPA complications (11% vs. 8%, respectively) or in-hospital mortality (11% vs. 8%, respectively).

"We found the potential for substantial undertreatment, because up to 50% of warfarin-treated patients who might have been eligible for reperfusion therapy did not receive intravenous TPA," the researchers wrote.

The results also indicated that there was no significant relationship between warfarin use and sICH in a subgroup analysis of patients with INRs between 1.5 and 1.7 or in an exploratory analysis of patients with INRs of 2.0 or lower.

The higher unadjusted incidence of sICH in warfarin patients may be a result of the differences in risk profiles between the warfarin and non-warfarin patients, because those receiving warfarin were significantly older and had higher NIHSS scores, the researchers noted.

The study was limited by several factors, including its retrospective design and a lack of NIHSS information for all patients. More research is needed to explore the effectiveness of intravenous TPA for patients with INRs outside of the range recommended by the guidelines, they added.

The study was supported in part by the American Heart Association – Pharmaceutical Roundtable and from David and Stevie Spina. Dr. Xian had no financial conflicts to disclose. Several coauthors disclosed financial relationships with multiple companies, including Boehringer Ingelheim, Merck, Bristol-Myers Squibb, and Sanofi-aventis, which have supported the Get With the Guidelines – Stroke Program in the past, and Janssen Pharmaceutical Companies of Johnson & Johnson, which currently supports it. Boehringer Ingelheim markets TPA in the United States as Activase.

Thrombolysis with intravenous tissue plasminogen activator for the treatment of acute ischemic stroke does not increase the risk of brain hemorrhage in patients who are also taking warfarin, based on data from an observational study of more than 23,000 patients.

The patients in the study had an international normalized ratio (INR) of 1.7 or lower, which is the same population of warfarin-treated patients for whom intravenous tissue plasminogen activator (TPA) is recommended in the current American Heart Association/American Stroke Association guidelines.

Symptomatic intracranial hemorrhage (sICH) is an adverse event associated with intravenous TPA that may occur more often in patients receiving warfarin, according to Dr. Ying Xian, who was lead investigator on the study, published June 26 in JAMA. But "the true absolute risk of sICH in this population remains a matter of significant debate," and previous studies of bleeding risk associated with warfarin have been small, with inconsistent results, wrote Dr. Xian of the Duke Clinical Research Institute in Durham, N.C. and his colleagues.

The investigators reviewed data from 23,437 adults in the American Heart Association’s Get With the Guidelines - Stroke Registry. The study participants were treated with intravenous TPA at 1,203 registry hospitals between April 2009 and June 2011 (JAMA 2012;307:2600-8).

A total of 1,802 (8%) of the patients were receiving warfarin at the time of treatment with TPA. A total of 1,107 patients (5%) developed sICH after TPA.

Although the unadjusted rate of hemorrhage was significantly higher in warfarin-treated patients, compared with non-warfarin patients (6% vs. 5%, P less than .001), there was no significant difference in hemorrhage rates after risk adjustment (adjusted odds ratio, 1.01). The results were similar regardless of whether or not the patients’ scores on the National Institutes of Health Stroke Scale (NIHSS) were excluded from the risk adjustment, the researchers noted.

Similarly, there was no significant difference in the rates of life-threatening or serious systemic hemorrhage between the warfarin and non-warfarin groups (0.9% for both) and no significant differences between the two groups in TPA complications (11% vs. 8%, respectively) or in-hospital mortality (11% vs. 8%, respectively).

"We found the potential for substantial undertreatment, because up to 50% of warfarin-treated patients who might have been eligible for reperfusion therapy did not receive intravenous TPA," the researchers wrote.

The results also indicated that there was no significant relationship between warfarin use and sICH in a subgroup analysis of patients with INRs between 1.5 and 1.7 or in an exploratory analysis of patients with INRs of 2.0 or lower.

The higher unadjusted incidence of sICH in warfarin patients may be a result of the differences in risk profiles between the warfarin and non-warfarin patients, because those receiving warfarin were significantly older and had higher NIHSS scores, the researchers noted.

The study was limited by several factors, including its retrospective design and a lack of NIHSS information for all patients. More research is needed to explore the effectiveness of intravenous TPA for patients with INRs outside of the range recommended by the guidelines, they added.

The study was supported in part by the American Heart Association – Pharmaceutical Roundtable and from David and Stevie Spina. Dr. Xian had no financial conflicts to disclose. Several coauthors disclosed financial relationships with multiple companies, including Boehringer Ingelheim, Merck, Bristol-Myers Squibb, and Sanofi-aventis, which have supported the Get With the Guidelines – Stroke Program in the past, and Janssen Pharmaceutical Companies of Johnson & Johnson, which currently supports it. Boehringer Ingelheim markets TPA in the United States as Activase.

Thrombolysis with intravenous tissue plasminogen activator for the treatment of acute ischemic stroke does not increase the risk of brain hemorrhage in patients who are also taking warfarin, based on data from an observational study of more than 23,000 patients.

The patients in the study had an international normalized ratio (INR) of 1.7 or lower, which is the same population of warfarin-treated patients for whom intravenous tissue plasminogen activator (TPA) is recommended in the current American Heart Association/American Stroke Association guidelines.

Symptomatic intracranial hemorrhage (sICH) is an adverse event associated with intravenous TPA that may occur more often in patients receiving warfarin, according to Dr. Ying Xian, who was lead investigator on the study, published June 26 in JAMA. But "the true absolute risk of sICH in this population remains a matter of significant debate," and previous studies of bleeding risk associated with warfarin have been small, with inconsistent results, wrote Dr. Xian of the Duke Clinical Research Institute in Durham, N.C. and his colleagues.

The investigators reviewed data from 23,437 adults in the American Heart Association’s Get With the Guidelines - Stroke Registry. The study participants were treated with intravenous TPA at 1,203 registry hospitals between April 2009 and June 2011 (JAMA 2012;307:2600-8).

A total of 1,802 (8%) of the patients were receiving warfarin at the time of treatment with TPA. A total of 1,107 patients (5%) developed sICH after TPA.

Although the unadjusted rate of hemorrhage was significantly higher in warfarin-treated patients, compared with non-warfarin patients (6% vs. 5%, P less than .001), there was no significant difference in hemorrhage rates after risk adjustment (adjusted odds ratio, 1.01). The results were similar regardless of whether or not the patients’ scores on the National Institutes of Health Stroke Scale (NIHSS) were excluded from the risk adjustment, the researchers noted.

Similarly, there was no significant difference in the rates of life-threatening or serious systemic hemorrhage between the warfarin and non-warfarin groups (0.9% for both) and no significant differences between the two groups in TPA complications (11% vs. 8%, respectively) or in-hospital mortality (11% vs. 8%, respectively).

"We found the potential for substantial undertreatment, because up to 50% of warfarin-treated patients who might have been eligible for reperfusion therapy did not receive intravenous TPA," the researchers wrote.

The results also indicated that there was no significant relationship between warfarin use and sICH in a subgroup analysis of patients with INRs between 1.5 and 1.7 or in an exploratory analysis of patients with INRs of 2.0 or lower.

The higher unadjusted incidence of sICH in warfarin patients may be a result of the differences in risk profiles between the warfarin and non-warfarin patients, because those receiving warfarin were significantly older and had higher NIHSS scores, the researchers noted.

The study was limited by several factors, including its retrospective design and a lack of NIHSS information for all patients. More research is needed to explore the effectiveness of intravenous TPA for patients with INRs outside of the range recommended by the guidelines, they added.

The study was supported in part by the American Heart Association – Pharmaceutical Roundtable and from David and Stevie Spina. Dr. Xian had no financial conflicts to disclose. Several coauthors disclosed financial relationships with multiple companies, including Boehringer Ingelheim, Merck, Bristol-Myers Squibb, and Sanofi-aventis, which have supported the Get With the Guidelines – Stroke Program in the past, and Janssen Pharmaceutical Companies of Johnson & Johnson, which currently supports it. Boehringer Ingelheim markets TPA in the United States as Activase.

A new test for the early detection of dengue fever will be available for distribution on July 2, according to a written statement from the Centers for Disease Control and Prevention.

The new molecular test identifies the dengue virus itself rather than detecting antibodies, and it uses the same equipment and supplies that most public health laboratories already use to diagnose influenza, according to the CDC.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

The test, called the CDC DENV-1-4 Real Time PCR Assay, is designed for use during the first 7 days after dengue symptoms appear, which may be too early for antibody detection.

The ability to diagnose early will give clinicians and public health officials a more complete picture of dengue fever, which is now a reportable disease in the United States, said Jorge L. Muñoz-Jordán, Ph.D., chief of molecular diagnostics and research at the Dengue branch of the CDC, said in the statement.

"The availability of state-of-the-art dengue diagnostics will improve patient management and the public health response to dengue," he said.

Dengue fever is transmitted by Aedes mosquitoes and is a major cause of illness in Puerto Rico and the U.S. Virgin Islands, as well as some parts of the United States in which the mosquitoes are found. U.S. travelers returning home from Latin America, the Caribbean, and Asia are also at risk, the CDC stated.

Symptoms of dengue fever include a high fever; rash or bleeding of the nose and gums; headache, joint, muscle, or bone pain; severe pain behind the eyes; and easy bruising.

The test has been approved by the Food and Drug Administration, and it will be available to labs in the United States and internationally, according to the statement. For more details, visit the CDC website.

A new test for the early detection of dengue fever will be available for distribution on July 2, according to a written statement from the Centers for Disease Control and Prevention.

The new molecular test identifies the dengue virus itself rather than detecting antibodies, and it uses the same equipment and supplies that most public health laboratories already use to diagnose influenza, according to the CDC.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

The test, called the CDC DENV-1-4 Real Time PCR Assay, is designed for use during the first 7 days after dengue symptoms appear, which may be too early for antibody detection.

The ability to diagnose early will give clinicians and public health officials a more complete picture of dengue fever, which is now a reportable disease in the United States, said Jorge L. Muñoz-Jordán, Ph.D., chief of molecular diagnostics and research at the Dengue branch of the CDC, said in the statement.

"The availability of state-of-the-art dengue diagnostics will improve patient management and the public health response to dengue," he said.

Dengue fever is transmitted by Aedes mosquitoes and is a major cause of illness in Puerto Rico and the U.S. Virgin Islands, as well as some parts of the United States in which the mosquitoes are found. U.S. travelers returning home from Latin America, the Caribbean, and Asia are also at risk, the CDC stated.

Symptoms of dengue fever include a high fever; rash or bleeding of the nose and gums; headache, joint, muscle, or bone pain; severe pain behind the eyes; and easy bruising.

The test has been approved by the Food and Drug Administration, and it will be available to labs in the United States and internationally, according to the statement. For more details, visit the CDC website.

A new test for the early detection of dengue fever will be available for distribution on July 2, according to a written statement from the Centers for Disease Control and Prevention.

The new molecular test identifies the dengue virus itself rather than detecting antibodies, and it uses the same equipment and supplies that most public health laboratories already use to diagnose influenza, according to the CDC.

Courtesy Wikimedia Commons/Muhammad Mahdi Karim/Creative Commons License

The test, called the CDC DENV-1-4 Real Time PCR Assay, is designed for use during the first 7 days after dengue symptoms appear, which may be too early for antibody detection.

The ability to diagnose early will give clinicians and public health officials a more complete picture of dengue fever, which is now a reportable disease in the United States, said Jorge L. Muñoz-Jordán, Ph.D., chief of molecular diagnostics and research at the Dengue branch of the CDC, said in the statement.

"The availability of state-of-the-art dengue diagnostics will improve patient management and the public health response to dengue," he said.

Dengue fever is transmitted by Aedes mosquitoes and is a major cause of illness in Puerto Rico and the U.S. Virgin Islands, as well as some parts of the United States in which the mosquitoes are found. U.S. travelers returning home from Latin America, the Caribbean, and Asia are also at risk, the CDC stated.

Symptoms of dengue fever include a high fever; rash or bleeding of the nose and gums; headache, joint, muscle, or bone pain; severe pain behind the eyes; and easy bruising.

The test has been approved by the Food and Drug Administration, and it will be available to labs in the United States and internationally, according to the statement. For more details, visit the CDC website.

A noninvasive DNA screening test effectively detected chromosome abnormalities in fetuses of women with singleton pregnancies, based on data from approximately 3,000 women published online in June in the American Journal of Obstetrics and Gynecology.

Data from previous case-control studies have shown that the Digital Analysis of Selected Regions (DANSR) assay can identify chromosome abnormalities by evaluating specific fragments of maternal cell-free DNA (cfDNA), said Dr. Mary E. Norton of Stanford (Calif.) University and her colleagues.

In this multicenter, prospective cohort study, the researchers included pregnant women aged 18-50 years with singleton pregnancies who were planning to undergo invasive prenatal diagnostic testing for any reason. Women with multiples, those with known chromosome abnormalities, or those who had already undergone an invasive prenatal test in the current pregnancy were excluded. The final analysis included samples from 3,228 women with a mean maternal age of 34 years and a mean gestational age of 17 weeks (Am. J. Obstet. Gynecol. 2012 [doi:10.1016/j.ajog.2012.05.021]).

The sensitivity of the test was 100% for trisomy 21 malformations. A total of 81 cases of trisomy 21 were identified and all were classified as high risk, with one false positive out of 2,888 normal cases, for a false positive rate of 0.3% (specificity 99.97%). Similarly, the sensitivity was 97% for trisomy 18. A total of 38 cases of trisomy 18 were identified, and 37 were classified as high-risk, with 2 false positives for a false positive rate of 0.07% (specificity 99.93%).

The positive predictive values for trisomy 21 and trisomy 18 were 98.8% and 94.9%, respectively. The negative predictive values for trisomy 21 and trisomy 18 were 100% and 99.96%, respectively.

Another 73 cases of other chromosomal abnormalities were identified, but they did not affect the analysis of risk for trisomy 18 or 21, Dr. Norton and her associates noted.

The test involved collecting 20 mL of blood from each patient before she underwent any invasive diagnostic testing procedure. DNA samples were classified as high risk or low risk based on a predefined cutoff value of 1% based on previous analyses. Results from the DANSR assay were compared with results from invasive tests as a reference.

"With the methods reported here, the higher throughput and lower cost make this technique potentially scalable for population screening," Dr. Norton and her associates wrote. However, even the high detection rates achieved in the study do not compare with those obtained with invasive diagnoses and may not provide much in the way of additional information for women who then have invasive tests, they noted.

"Further experience in larger populations of average-risk women is needed to clarify the role and utility of cfDNA in clinical practice," they said.

Dr. Norton said she had no relevant financial disclosures. The study was funded by Ariosa Diagnostics, which makes the test used in the study. Several of her coauthors are employees, consultants, or board members of Ariosa Diagnostics.

A noninvasive DNA screening test effectively detected chromosome abnormalities in fetuses of women with singleton pregnancies, based on data from approximately 3,000 women published online in June in the American Journal of Obstetrics and Gynecology.

Data from previous case-control studies have shown that the Digital Analysis of Selected Regions (DANSR) assay can identify chromosome abnormalities by evaluating specific fragments of maternal cell-free DNA (cfDNA), said Dr. Mary E. Norton of Stanford (Calif.) University and her colleagues.

In this multicenter, prospective cohort study, the researchers included pregnant women aged 18-50 years with singleton pregnancies who were planning to undergo invasive prenatal diagnostic testing for any reason. Women with multiples, those with known chromosome abnormalities, or those who had already undergone an invasive prenatal test in the current pregnancy were excluded. The final analysis included samples from 3,228 women with a mean maternal age of 34 years and a mean gestational age of 17 weeks (Am. J. Obstet. Gynecol. 2012 [doi:10.1016/j.ajog.2012.05.021]).

The sensitivity of the test was 100% for trisomy 21 malformations. A total of 81 cases of trisomy 21 were identified and all were classified as high risk, with one false positive out of 2,888 normal cases, for a false positive rate of 0.3% (specificity 99.97%). Similarly, the sensitivity was 97% for trisomy 18. A total of 38 cases of trisomy 18 were identified, and 37 were classified as high-risk, with 2 false positives for a false positive rate of 0.07% (specificity 99.93%).

The positive predictive values for trisomy 21 and trisomy 18 were 98.8% and 94.9%, respectively. The negative predictive values for trisomy 21 and trisomy 18 were 100% and 99.96%, respectively.

Another 73 cases of other chromosomal abnormalities were identified, but they did not affect the analysis of risk for trisomy 18 or 21, Dr. Norton and her associates noted.

The test involved collecting 20 mL of blood from each patient before she underwent any invasive diagnostic testing procedure. DNA samples were classified as high risk or low risk based on a predefined cutoff value of 1% based on previous analyses. Results from the DANSR assay were compared with results from invasive tests as a reference.

"With the methods reported here, the higher throughput and lower cost make this technique potentially scalable for population screening," Dr. Norton and her associates wrote. However, even the high detection rates achieved in the study do not compare with those obtained with invasive diagnoses and may not provide much in the way of additional information for women who then have invasive tests, they noted.

"Further experience in larger populations of average-risk women is needed to clarify the role and utility of cfDNA in clinical practice," they said.

Dr. Norton said she had no relevant financial disclosures. The study was funded by Ariosa Diagnostics, which makes the test used in the study. Several of her coauthors are employees, consultants, or board members of Ariosa Diagnostics.

A noninvasive DNA screening test effectively detected chromosome abnormalities in fetuses of women with singleton pregnancies, based on data from approximately 3,000 women published online in June in the American Journal of Obstetrics and Gynecology.

Data from previous case-control studies have shown that the Digital Analysis of Selected Regions (DANSR) assay can identify chromosome abnormalities by evaluating specific fragments of maternal cell-free DNA (cfDNA), said Dr. Mary E. Norton of Stanford (Calif.) University and her colleagues.

In this multicenter, prospective cohort study, the researchers included pregnant women aged 18-50 years with singleton pregnancies who were planning to undergo invasive prenatal diagnostic testing for any reason. Women with multiples, those with known chromosome abnormalities, or those who had already undergone an invasive prenatal test in the current pregnancy were excluded. The final analysis included samples from 3,228 women with a mean maternal age of 34 years and a mean gestational age of 17 weeks (Am. J. Obstet. Gynecol. 2012 [doi:10.1016/j.ajog.2012.05.021]).

The sensitivity of the test was 100% for trisomy 21 malformations. A total of 81 cases of trisomy 21 were identified and all were classified as high risk, with one false positive out of 2,888 normal cases, for a false positive rate of 0.3% (specificity 99.97%). Similarly, the sensitivity was 97% for trisomy 18. A total of 38 cases of trisomy 18 were identified, and 37 were classified as high-risk, with 2 false positives for a false positive rate of 0.07% (specificity 99.93%).

The positive predictive values for trisomy 21 and trisomy 18 were 98.8% and 94.9%, respectively. The negative predictive values for trisomy 21 and trisomy 18 were 100% and 99.96%, respectively.

Another 73 cases of other chromosomal abnormalities were identified, but they did not affect the analysis of risk for trisomy 18 or 21, Dr. Norton and her associates noted.

The test involved collecting 20 mL of blood from each patient before she underwent any invasive diagnostic testing procedure. DNA samples were classified as high risk or low risk based on a predefined cutoff value of 1% based on previous analyses. Results from the DANSR assay were compared with results from invasive tests as a reference.

"With the methods reported here, the higher throughput and lower cost make this technique potentially scalable for population screening," Dr. Norton and her associates wrote. However, even the high detection rates achieved in the study do not compare with those obtained with invasive diagnoses and may not provide much in the way of additional information for women who then have invasive tests, they noted.

"Further experience in larger populations of average-risk women is needed to clarify the role and utility of cfDNA in clinical practice," they said.

Dr. Norton said she had no relevant financial disclosures. The study was funded by Ariosa Diagnostics, which makes the test used in the study. Several of her coauthors are employees, consultants, or board members of Ariosa Diagnostics.

Approximately one in eight Alzheimer’s disease patients who develop delirium while hospitalized will suffer at least one adverse outcome, based on data from 771 adults. The findings were published in Annals of Internal Medicine on June 18.

Previous studies have shown that delirium can increase the rate of cognitive decline in AD patients, but the impact of hospitalization and delirium has not been well studied, said Dr. Tamara G. Fong of the Aging Brain Center, Boston, and her colleagues. Adults with Alzheimer’s disease (AD) are three times more likely to be hospitalized than are those without AD, the researchers noted.

To assess the adverse outcomes of death, institutionalization, and cognitive decline associated with hospitalization and delirium, Dr. Fong and her colleagues followed 771 community-dwelling adults aged 65 years and older with a clinical diagnosis of AD. The mean follow-up was 2 years, and outcomes were assessed at 1 year after an initial hospitalization. A total of 367 individuals (48%) were hospitalized, and 194 of these patients (25%) developed delirium while hospitalized (Ann. Intern. Med. 2012;156:848-56).

At least one adverse outcome occurred in 32% of nonhospitalized patients, 55% of hospitalized patients without delirium, and 79% of hospitalized patients with delirium.

In the hospitalized patients, 6% of deaths, 15% of institutionalizations, and 21% of cases of cognitive decline were associated with delirium, the researchers said.

Death occurred in 15% of hospitalized patients with delirium, compared with 9% of hospitalized patients without delirium and 2% of nonhospitalized patients.

The hospitalized patients with delirium had an increased risk for death, institutionalization, and cognitive decline, compared with the other groups, with adjusted risk ratios of 5.4, 9.3, and 1.6, respectively. Hospitalized patients with no delirium had a slightly smaller increase in the risk of death (adjusted risk ratio 4.7) and institutionalization (adjusted risk ratio 6.9).

The mean age of the patients was 77 years, 57% were women, and 95% were white.

The results were limited by several factors, including the observational nature of the study and the incomplete data on the cognitive outcome and functional status of some patients, the researchers wrote. But the findings show "the important and incremental associations of hospitalization and delirium with 1-year outcomes," they said.

Additional research is needed to determine whether preventing hospitalization and delirium in AD patients can reduce their risk for death, institutionalization, and cognitive decline, they noted.

Dr. Fong had no financial conflicts to disclose. The study was funded by the National Institute on Aging and the Massachusetts Alzheimer’s Disease Research Center.

Approximately one in eight Alzheimer’s disease patients who develop delirium while hospitalized will suffer at least one adverse outcome, based on data from 771 adults. The findings were published in Annals of Internal Medicine on June 18.

Previous studies have shown that delirium can increase the rate of cognitive decline in AD patients, but the impact of hospitalization and delirium has not been well studied, said Dr. Tamara G. Fong of the Aging Brain Center, Boston, and her colleagues. Adults with Alzheimer’s disease (AD) are three times more likely to be hospitalized than are those without AD, the researchers noted.

To assess the adverse outcomes of death, institutionalization, and cognitive decline associated with hospitalization and delirium, Dr. Fong and her colleagues followed 771 community-dwelling adults aged 65 years and older with a clinical diagnosis of AD. The mean follow-up was 2 years, and outcomes were assessed at 1 year after an initial hospitalization. A total of 367 individuals (48%) were hospitalized, and 194 of these patients (25%) developed delirium while hospitalized (Ann. Intern. Med. 2012;156:848-56).

At least one adverse outcome occurred in 32% of nonhospitalized patients, 55% of hospitalized patients without delirium, and 79% of hospitalized patients with delirium.

In the hospitalized patients, 6% of deaths, 15% of institutionalizations, and 21% of cases of cognitive decline were associated with delirium, the researchers said.

Death occurred in 15% of hospitalized patients with delirium, compared with 9% of hospitalized patients without delirium and 2% of nonhospitalized patients.

The hospitalized patients with delirium had an increased risk for death, institutionalization, and cognitive decline, compared with the other groups, with adjusted risk ratios of 5.4, 9.3, and 1.6, respectively. Hospitalized patients with no delirium had a slightly smaller increase in the risk of death (adjusted risk ratio 4.7) and institutionalization (adjusted risk ratio 6.9).

The mean age of the patients was 77 years, 57% were women, and 95% were white.

The results were limited by several factors, including the observational nature of the study and the incomplete data on the cognitive outcome and functional status of some patients, the researchers wrote. But the findings show "the important and incremental associations of hospitalization and delirium with 1-year outcomes," they said.

Additional research is needed to determine whether preventing hospitalization and delirium in AD patients can reduce their risk for death, institutionalization, and cognitive decline, they noted.

Dr. Fong had no financial conflicts to disclose. The study was funded by the National Institute on Aging and the Massachusetts Alzheimer’s Disease Research Center.

Approximately one in eight Alzheimer’s disease patients who develop delirium while hospitalized will suffer at least one adverse outcome, based on data from 771 adults. The findings were published in Annals of Internal Medicine on June 18.

Previous studies have shown that delirium can increase the rate of cognitive decline in AD patients, but the impact of hospitalization and delirium has not been well studied, said Dr. Tamara G. Fong of the Aging Brain Center, Boston, and her colleagues. Adults with Alzheimer’s disease (AD) are three times more likely to be hospitalized than are those without AD, the researchers noted.

To assess the adverse outcomes of death, institutionalization, and cognitive decline associated with hospitalization and delirium, Dr. Fong and her colleagues followed 771 community-dwelling adults aged 65 years and older with a clinical diagnosis of AD. The mean follow-up was 2 years, and outcomes were assessed at 1 year after an initial hospitalization. A total of 367 individuals (48%) were hospitalized, and 194 of these patients (25%) developed delirium while hospitalized (Ann. Intern. Med. 2012;156:848-56).

At least one adverse outcome occurred in 32% of nonhospitalized patients, 55% of hospitalized patients without delirium, and 79% of hospitalized patients with delirium.

In the hospitalized patients, 6% of deaths, 15% of institutionalizations, and 21% of cases of cognitive decline were associated with delirium, the researchers said.

Death occurred in 15% of hospitalized patients with delirium, compared with 9% of hospitalized patients without delirium and 2% of nonhospitalized patients.

The hospitalized patients with delirium had an increased risk for death, institutionalization, and cognitive decline, compared with the other groups, with adjusted risk ratios of 5.4, 9.3, and 1.6, respectively. Hospitalized patients with no delirium had a slightly smaller increase in the risk of death (adjusted risk ratio 4.7) and institutionalization (adjusted risk ratio 6.9).

The mean age of the patients was 77 years, 57% were women, and 95% were white.

The results were limited by several factors, including the observational nature of the study and the incomplete data on the cognitive outcome and functional status of some patients, the researchers wrote. But the findings show "the important and incremental associations of hospitalization and delirium with 1-year outcomes," they said.

Additional research is needed to determine whether preventing hospitalization and delirium in AD patients can reduce their risk for death, institutionalization, and cognitive decline, they noted.

Dr. Fong had no financial conflicts to disclose. The study was funded by the National Institute on Aging and the Massachusetts Alzheimer’s Disease Research Center.