Whitney McKnight

ORLANDO – Independent investigators eager to author studies that have notable impact on the field of inflammatory bowel disease have plenty of important paths to pursue, according to Dr. Jean-Frederic Colombel, a professor of gastroenterology at Mt. Sinai Hospital in New York.

“Over the next 3-5 years, we will have a lot of new drugs, which is nice, but we don’t yet know how to use them, or which ones to use,” Dr. Colombel said during a presentation on the future of the field at this year’s meeting of the annual Advances in Inflammatory Bowel Disease, sponsored by the Crohn’s and Colitis Foundation of America.

Whitney McKnight/Frontline Medical Media

A host of biologics including vedolizumab, recently indicated by the U.S. Food and Drug Administration for ulcerative colitis and Crohn’s disease, and ustekinumab, currently in phase III studies for Crohn’s disease, are set to revolutionize treatment at a time when the field is already undergoing great change, according to Dr. Colombel. The result, he says, is that despite “formidable” challenges in recruitment and funding, “huge opportunities” exist for investigators willing to collaborate and be creative.

Studies that elucidate the natural history of Crohn’s disease and colitis offer insight into the efficacy of various treatment strategies, help determine whether to target symptoms or biomarkers, and answer whether combination therapies are safe and effective in certain patients, among others, are what Dr. Colombel says he hopes will help improve the field as the drug pipeline continues to grow.

He stipulated a caveat, however, “I strongly believe we need some new study designs.” Although he noted that trials needn’t be complicated, they should be long enough to collect sorely needed prospective data. “These can only be done in investigator-initiated trials because of the time frames,” Dr. Colombel urged the audience of young investigators and their colleagues.

A fieldwide shift in thinking about ulcerative colitis and Crohn’s disease as chronic, progressive diseases, rather than intermittent afflictions has already helped generate new study endpoints such as the Lémann Score, an index of progressive bowel damage that allows researchers to better track the history of IBD in patients, and thus provide a window of opportunity for interventions, said Dr. Colombel.

To wit, the CURE study, conducted by the French IBD society GITAID, is a 5-year, prospective study of patients whose early Crohn’s disease is treated with the biologic adalimumab. The Lémann Score is used to screen patients at the end of each successive year, in order to adjust their treatment to reach the final endpoint of deep remission by year 5 when several indicators are measured, including bowel image, level of disability, and whether there was the need for surgery. Dr. Colombel said the novel design of the study, which has already recruited 60 patients, with successive endpoints to evaluate new drugs and strategies over longer periods of time shows it is “feasible” to collect longitudinal data.

The field also has a responsibility to conduct randomly assigned controlled trials to demonstrate the comparative effectiveness, safety, immunogenicity, and cost benefits of the rapidly emerging spate of biosimilars, particularly since there is not global agreement about their use, according to Dr. Colombel. Their approval for IBD in Europe is “highly disputable ... I think this could be a very nice topic for an investigator-initiated trial, in Canada and the U.S.”

Head-to-head trials that are well designed will help answer “very important questions” about which treatment strategies, including the use of biosimilars, have the best outcomes, but doing so requires fortitude, according to Dr. Colombel. “The Dutch have the guts to conduct the LIRIC trial,” he said. In it, patients with Crohn’s disease in the terminal ileum, who have failed steroids or immune therapy, will be assigned randomly to either laparoscopic ileocolic resection or infliximab, the first available biosimilar. Sixty participants have enrolled to date, he said.

These types of studies could also help delineate how best to employ combination therapies. “What I propose for this kind of study is an intensive therapy combining biologics very early in patients with bad prognoses, and looking at the long-term outcome using bowel image,” Dr. Colombel said. These data, and others indicating the most appropriate length of treatment in patients with varying states of disease, are Dr. Colombel’s personal “top choice” for investigation.

The excitement that personalized medicine has engendered across the specialities has so far not resulted in specific, validated treatments for IBD patients. However, the question of how to use personal characteristics, serologic and genetic markers to create predictive models for which patients will need either step-up or top-down therapies, accounting for their individual risk of complication, is what he said is among the most “important [question] we need to answer because the choice of early therapy will depend on this predictor,” according to Dr. Colombel.

The question of which treatment targets are best remains unclear but is important to decipher, according to Dr. Colombel, who said simple studies comparing outcomes when patients are treated to symptoms vs. treated to biomarker measurements are needed. Whether to treat to certain medication trough levels vs. symptom relief is also a pressing need, as well as is the importance of mucosal healing vs. symptoms. “This is important because there is discordance between endoscopy and histology,” said Dr. Colombel. “Persistent histologic inflammation is frequently associated with bad outcomes.”

However, endoscopic scoring itself is another area Dr. Colombel said is worth investigating, especially when it comes to validating endpoints such as those in the Crohn’s Disease Index of Severity (CDEIS), and Simple Endoscopic Score for Crohn’s Disease (SES-CD), which will help determine remission cut offs. Also, using endoscopic scores in comparison with live video and imaging still need standardized approaches. “When you see how it is done in the U.S., it is generally very poor,” Dr. Colombel said.

The biggest obstacles of all when it comes to independent investigation in the United States, according to Frenchman Dr. Colombel, is heavy regulation and cost. “In France, [conducting trials] was considered part of my job. I was not compensated. It is different here.”

Despite that, he said successful studies are a matter of desire. “You have to have dedicated people who want to run these studies and who can meet often and drive the process, and be ready to recruit patients.”

Dr. Colombel has numerous financial ties to the pharmaceutical industry, including AB Science, Amgen, Baxter, Bristol-Meyers Squibb, Merck, Nutrition Science Partners, Teva, and Vertex, among several others.

[email protected]

On Twitter @whitneymcknight

ORLANDO – Independent investigators eager to author studies that have notable impact on the field of inflammatory bowel disease have plenty of important paths to pursue, according to Dr. Jean-Frederic Colombel, a professor of gastroenterology at Mt. Sinai Hospital in New York.

“Over the next 3-5 years, we will have a lot of new drugs, which is nice, but we don’t yet know how to use them, or which ones to use,” Dr. Colombel said during a presentation on the future of the field at this year’s meeting of the annual Advances in Inflammatory Bowel Disease, sponsored by the Crohn’s and Colitis Foundation of America.

Whitney McKnight/Frontline Medical Media

A host of biologics including vedolizumab, recently indicated by the U.S. Food and Drug Administration for ulcerative colitis and Crohn’s disease, and ustekinumab, currently in phase III studies for Crohn’s disease, are set to revolutionize treatment at a time when the field is already undergoing great change, according to Dr. Colombel. The result, he says, is that despite “formidable” challenges in recruitment and funding, “huge opportunities” exist for investigators willing to collaborate and be creative.

Studies that elucidate the natural history of Crohn’s disease and colitis offer insight into the efficacy of various treatment strategies, help determine whether to target symptoms or biomarkers, and answer whether combination therapies are safe and effective in certain patients, among others, are what Dr. Colombel says he hopes will help improve the field as the drug pipeline continues to grow.

He stipulated a caveat, however, “I strongly believe we need some new study designs.” Although he noted that trials needn’t be complicated, they should be long enough to collect sorely needed prospective data. “These can only be done in investigator-initiated trials because of the time frames,” Dr. Colombel urged the audience of young investigators and their colleagues.

A fieldwide shift in thinking about ulcerative colitis and Crohn’s disease as chronic, progressive diseases, rather than intermittent afflictions has already helped generate new study endpoints such as the Lémann Score, an index of progressive bowel damage that allows researchers to better track the history of IBD in patients, and thus provide a window of opportunity for interventions, said Dr. Colombel.

To wit, the CURE study, conducted by the French IBD society GITAID, is a 5-year, prospective study of patients whose early Crohn’s disease is treated with the biologic adalimumab. The Lémann Score is used to screen patients at the end of each successive year, in order to adjust their treatment to reach the final endpoint of deep remission by year 5 when several indicators are measured, including bowel image, level of disability, and whether there was the need for surgery. Dr. Colombel said the novel design of the study, which has already recruited 60 patients, with successive endpoints to evaluate new drugs and strategies over longer periods of time shows it is “feasible” to collect longitudinal data.

The field also has a responsibility to conduct randomly assigned controlled trials to demonstrate the comparative effectiveness, safety, immunogenicity, and cost benefits of the rapidly emerging spate of biosimilars, particularly since there is not global agreement about their use, according to Dr. Colombel. Their approval for IBD in Europe is “highly disputable ... I think this could be a very nice topic for an investigator-initiated trial, in Canada and the U.S.”

Head-to-head trials that are well designed will help answer “very important questions” about which treatment strategies, including the use of biosimilars, have the best outcomes, but doing so requires fortitude, according to Dr. Colombel. “The Dutch have the guts to conduct the LIRIC trial,” he said. In it, patients with Crohn’s disease in the terminal ileum, who have failed steroids or immune therapy, will be assigned randomly to either laparoscopic ileocolic resection or infliximab, the first available biosimilar. Sixty participants have enrolled to date, he said.

These types of studies could also help delineate how best to employ combination therapies. “What I propose for this kind of study is an intensive therapy combining biologics very early in patients with bad prognoses, and looking at the long-term outcome using bowel image,” Dr. Colombel said. These data, and others indicating the most appropriate length of treatment in patients with varying states of disease, are Dr. Colombel’s personal “top choice” for investigation.

The excitement that personalized medicine has engendered across the specialities has so far not resulted in specific, validated treatments for IBD patients. However, the question of how to use personal characteristics, serologic and genetic markers to create predictive models for which patients will need either step-up or top-down therapies, accounting for their individual risk of complication, is what he said is among the most “important [question] we need to answer because the choice of early therapy will depend on this predictor,” according to Dr. Colombel.

The question of which treatment targets are best remains unclear but is important to decipher, according to Dr. Colombel, who said simple studies comparing outcomes when patients are treated to symptoms vs. treated to biomarker measurements are needed. Whether to treat to certain medication trough levels vs. symptom relief is also a pressing need, as well as is the importance of mucosal healing vs. symptoms. “This is important because there is discordance between endoscopy and histology,” said Dr. Colombel. “Persistent histologic inflammation is frequently associated with bad outcomes.”

However, endoscopic scoring itself is another area Dr. Colombel said is worth investigating, especially when it comes to validating endpoints such as those in the Crohn’s Disease Index of Severity (CDEIS), and Simple Endoscopic Score for Crohn’s Disease (SES-CD), which will help determine remission cut offs. Also, using endoscopic scores in comparison with live video and imaging still need standardized approaches. “When you see how it is done in the U.S., it is generally very poor,” Dr. Colombel said.

The biggest obstacles of all when it comes to independent investigation in the United States, according to Frenchman Dr. Colombel, is heavy regulation and cost. “In France, [conducting trials] was considered part of my job. I was not compensated. It is different here.”

Despite that, he said successful studies are a matter of desire. “You have to have dedicated people who want to run these studies and who can meet often and drive the process, and be ready to recruit patients.”

Dr. Colombel has numerous financial ties to the pharmaceutical industry, including AB Science, Amgen, Baxter, Bristol-Meyers Squibb, Merck, Nutrition Science Partners, Teva, and Vertex, among several others.

[email protected]

On Twitter @whitneymcknight

ORLANDO – Independent investigators eager to author studies that have notable impact on the field of inflammatory bowel disease have plenty of important paths to pursue, according to Dr. Jean-Frederic Colombel, a professor of gastroenterology at Mt. Sinai Hospital in New York.

“Over the next 3-5 years, we will have a lot of new drugs, which is nice, but we don’t yet know how to use them, or which ones to use,” Dr. Colombel said during a presentation on the future of the field at this year’s meeting of the annual Advances in Inflammatory Bowel Disease, sponsored by the Crohn’s and Colitis Foundation of America.

Whitney McKnight/Frontline Medical Media

A host of biologics including vedolizumab, recently indicated by the U.S. Food and Drug Administration for ulcerative colitis and Crohn’s disease, and ustekinumab, currently in phase III studies for Crohn’s disease, are set to revolutionize treatment at a time when the field is already undergoing great change, according to Dr. Colombel. The result, he says, is that despite “formidable” challenges in recruitment and funding, “huge opportunities” exist for investigators willing to collaborate and be creative.

Studies that elucidate the natural history of Crohn’s disease and colitis offer insight into the efficacy of various treatment strategies, help determine whether to target symptoms or biomarkers, and answer whether combination therapies are safe and effective in certain patients, among others, are what Dr. Colombel says he hopes will help improve the field as the drug pipeline continues to grow.

He stipulated a caveat, however, “I strongly believe we need some new study designs.” Although he noted that trials needn’t be complicated, they should be long enough to collect sorely needed prospective data. “These can only be done in investigator-initiated trials because of the time frames,” Dr. Colombel urged the audience of young investigators and their colleagues.

A fieldwide shift in thinking about ulcerative colitis and Crohn’s disease as chronic, progressive diseases, rather than intermittent afflictions has already helped generate new study endpoints such as the Lémann Score, an index of progressive bowel damage that allows researchers to better track the history of IBD in patients, and thus provide a window of opportunity for interventions, said Dr. Colombel.

To wit, the CURE study, conducted by the French IBD society GITAID, is a 5-year, prospective study of patients whose early Crohn’s disease is treated with the biologic adalimumab. The Lémann Score is used to screen patients at the end of each successive year, in order to adjust their treatment to reach the final endpoint of deep remission by year 5 when several indicators are measured, including bowel image, level of disability, and whether there was the need for surgery. Dr. Colombel said the novel design of the study, which has already recruited 60 patients, with successive endpoints to evaluate new drugs and strategies over longer periods of time shows it is “feasible” to collect longitudinal data.

The field also has a responsibility to conduct randomly assigned controlled trials to demonstrate the comparative effectiveness, safety, immunogenicity, and cost benefits of the rapidly emerging spate of biosimilars, particularly since there is not global agreement about their use, according to Dr. Colombel. Their approval for IBD in Europe is “highly disputable ... I think this could be a very nice topic for an investigator-initiated trial, in Canada and the U.S.”

Head-to-head trials that are well designed will help answer “very important questions” about which treatment strategies, including the use of biosimilars, have the best outcomes, but doing so requires fortitude, according to Dr. Colombel. “The Dutch have the guts to conduct the LIRIC trial,” he said. In it, patients with Crohn’s disease in the terminal ileum, who have failed steroids or immune therapy, will be assigned randomly to either laparoscopic ileocolic resection or infliximab, the first available biosimilar. Sixty participants have enrolled to date, he said.

These types of studies could also help delineate how best to employ combination therapies. “What I propose for this kind of study is an intensive therapy combining biologics very early in patients with bad prognoses, and looking at the long-term outcome using bowel image,” Dr. Colombel said. These data, and others indicating the most appropriate length of treatment in patients with varying states of disease, are Dr. Colombel’s personal “top choice” for investigation.

The excitement that personalized medicine has engendered across the specialities has so far not resulted in specific, validated treatments for IBD patients. However, the question of how to use personal characteristics, serologic and genetic markers to create predictive models for which patients will need either step-up or top-down therapies, accounting for their individual risk of complication, is what he said is among the most “important [question] we need to answer because the choice of early therapy will depend on this predictor,” according to Dr. Colombel.

The question of which treatment targets are best remains unclear but is important to decipher, according to Dr. Colombel, who said simple studies comparing outcomes when patients are treated to symptoms vs. treated to biomarker measurements are needed. Whether to treat to certain medication trough levels vs. symptom relief is also a pressing need, as well as is the importance of mucosal healing vs. symptoms. “This is important because there is discordance between endoscopy and histology,” said Dr. Colombel. “Persistent histologic inflammation is frequently associated with bad outcomes.”

However, endoscopic scoring itself is another area Dr. Colombel said is worth investigating, especially when it comes to validating endpoints such as those in the Crohn’s Disease Index of Severity (CDEIS), and Simple Endoscopic Score for Crohn’s Disease (SES-CD), which will help determine remission cut offs. Also, using endoscopic scores in comparison with live video and imaging still need standardized approaches. “When you see how it is done in the U.S., it is generally very poor,” Dr. Colombel said.

The biggest obstacles of all when it comes to independent investigation in the United States, according to Frenchman Dr. Colombel, is heavy regulation and cost. “In France, [conducting trials] was considered part of my job. I was not compensated. It is different here.”

Despite that, he said successful studies are a matter of desire. “You have to have dedicated people who want to run these studies and who can meet often and drive the process, and be ready to recruit patients.”

Dr. Colombel has numerous financial ties to the pharmaceutical industry, including AB Science, Amgen, Baxter, Bristol-Meyers Squibb, Merck, Nutrition Science Partners, Teva, and Vertex, among several others.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Patients given propofol-based sedation in the intensive care unit were more likely to have daily dose optimization, stay at their target Richmond Agitation Sedation Scale rate, and be intubated for fewer days, compared with patients given benzodiazepine-based regimens, a retrospective study has shown. Being on propofol at the time of extubation, however, was associated with a significantly higher risk of being reintubated.

In 2013, the American College of Critical Care Medicine updated its guidelines for sedation in the ICU. The changes reflected what Dr. Steven J. Campbell, a presenter at this year’s annual meeting of the American College of Chest Physicians, said was the new paradigm in ICU sedation – namely, to use the least amount of sedation in patients and for the shortest amount of time possible. “We’ve also seen a shift away from benzodiazepines in recent years, and that when patients are given them, they stay in ICUs longer and have longer ventilation times,” Dr. Campbell said. The updated guidelines also suggest not relying on benzodiazepines as a first-line sedative.

To investigate how the updated sedation protocols have impacted the multiple ICUs at Ohio State University’s tertiary medical center, where Dr. Campbell is a third-year medical resident, and to assess the relationship of the changes with reintubation risk, Dr. Campbell and his colleagues retrospectively analyzed data on 988 intubated patients and 6,359 ventilator days recorded at the medical center during a 10-month period in 2013, after the new protocols were in place.

Considering either single sedation drips or combined sedation drips in the 988 unique intubations, about 69% of patients received at least 1 day of propofol, and roughly a third were given at least 1 day of a narcotic.

For 373 patients, the most commonly used drip was propofol only. Propofol combined with a narcotic was used in 141 patients, whereas the a combination of the two with a benzodiazepine was used in 140 patients.

A quarter of all intubated patients received at least 1 day of a continuous benzodiazepine drip, although only 7% of these received this sedation regimen as a first-line agent. Data were not presented on what previous benzodiazepine sedation rates were at the center before the protocol change.

The number of ventilator days for the propofol-only group was between 5.6 days plus or minus another 5.8 days, nearly half of the total propofol/narcotic/benzodiazepine ventilator days which came to 10.5 days give or take another 8 days.

“It intuitively makes sense that the more drips the patients were on, the more they would be on a ventilator,” Dr. Campbell said.

However, for patients given benzodiazepines only, the number of ventilator days was 4.3, plus or minus 4.2 days. Dr. Campbell theorized this was attributable to there being a number of patients withdrawing from alcohol and so needing to rely on an infusion of the benzodiazepine to help them through the process.

Propofol-based regimens were associated with improved dose optimization compliance if patients were eligible (P less than .0001).

Patients given narcotic drips were more likely to meet their targeted RASS levels of –1 to +1, compared with either benzodiazepines or propofol, although propofol patient RASS targets were higher than those of the benzodiazepine group (43% for narcotics, 22% for benzodiazepines, and 37% for propofol, P less than .0001).

The study also found a relationship between failed extubation rates and sedative use. There were 953 patients extubated in all. Seven percent of the extubated patients who had received continuous sedation on the day of extubation had to be reintubated within 48 hours. A significant risk of reintubation was found for patients who’d been given propofol alone since nearly half of that cohort were among those reintubated (P = .01).

Although Dr. Campbell and his colleagues wrote in their study that this could have been due to either lower levels of sedation to begin with, and so being more likely to have earlier extubation, or that the respiratory physiology of this group was altered by the propofol.

“The most important take-away here was that being on any sedative within 24 hours of extubation meant you had a high rate of failing that extubation,” Dr. Campbell said.

The investigators were not able to determine precisely when the sedation was terminated in each patient, only that it had occurred within a 24-hour period prior to extubation.

Dr. Campbell also noted that since dexmedetomidine was not widely used at the site ICUs as an alternative sedative, a future inquiry into the reasons why not would be worthwhile. “I suspect it’s because it’s still one of the newer agents,” he said.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Patients given propofol-based sedation in the intensive care unit were more likely to have daily dose optimization, stay at their target Richmond Agitation Sedation Scale rate, and be intubated for fewer days, compared with patients given benzodiazepine-based regimens, a retrospective study has shown. Being on propofol at the time of extubation, however, was associated with a significantly higher risk of being reintubated.

In 2013, the American College of Critical Care Medicine updated its guidelines for sedation in the ICU. The changes reflected what Dr. Steven J. Campbell, a presenter at this year’s annual meeting of the American College of Chest Physicians, said was the new paradigm in ICU sedation – namely, to use the least amount of sedation in patients and for the shortest amount of time possible. “We’ve also seen a shift away from benzodiazepines in recent years, and that when patients are given them, they stay in ICUs longer and have longer ventilation times,” Dr. Campbell said. The updated guidelines also suggest not relying on benzodiazepines as a first-line sedative.

To investigate how the updated sedation protocols have impacted the multiple ICUs at Ohio State University’s tertiary medical center, where Dr. Campbell is a third-year medical resident, and to assess the relationship of the changes with reintubation risk, Dr. Campbell and his colleagues retrospectively analyzed data on 988 intubated patients and 6,359 ventilator days recorded at the medical center during a 10-month period in 2013, after the new protocols were in place.

Considering either single sedation drips or combined sedation drips in the 988 unique intubations, about 69% of patients received at least 1 day of propofol, and roughly a third were given at least 1 day of a narcotic.

For 373 patients, the most commonly used drip was propofol only. Propofol combined with a narcotic was used in 141 patients, whereas the a combination of the two with a benzodiazepine was used in 140 patients.

A quarter of all intubated patients received at least 1 day of a continuous benzodiazepine drip, although only 7% of these received this sedation regimen as a first-line agent. Data were not presented on what previous benzodiazepine sedation rates were at the center before the protocol change.

The number of ventilator days for the propofol-only group was between 5.6 days plus or minus another 5.8 days, nearly half of the total propofol/narcotic/benzodiazepine ventilator days which came to 10.5 days give or take another 8 days.

“It intuitively makes sense that the more drips the patients were on, the more they would be on a ventilator,” Dr. Campbell said.

However, for patients given benzodiazepines only, the number of ventilator days was 4.3, plus or minus 4.2 days. Dr. Campbell theorized this was attributable to there being a number of patients withdrawing from alcohol and so needing to rely on an infusion of the benzodiazepine to help them through the process.

Propofol-based regimens were associated with improved dose optimization compliance if patients were eligible (P less than .0001).

Patients given narcotic drips were more likely to meet their targeted RASS levels of –1 to +1, compared with either benzodiazepines or propofol, although propofol patient RASS targets were higher than those of the benzodiazepine group (43% for narcotics, 22% for benzodiazepines, and 37% for propofol, P less than .0001).

The study also found a relationship between failed extubation rates and sedative use. There were 953 patients extubated in all. Seven percent of the extubated patients who had received continuous sedation on the day of extubation had to be reintubated within 48 hours. A significant risk of reintubation was found for patients who’d been given propofol alone since nearly half of that cohort were among those reintubated (P = .01).

Although Dr. Campbell and his colleagues wrote in their study that this could have been due to either lower levels of sedation to begin with, and so being more likely to have earlier extubation, or that the respiratory physiology of this group was altered by the propofol.

“The most important take-away here was that being on any sedative within 24 hours of extubation meant you had a high rate of failing that extubation,” Dr. Campbell said.

The investigators were not able to determine precisely when the sedation was terminated in each patient, only that it had occurred within a 24-hour period prior to extubation.

Dr. Campbell also noted that since dexmedetomidine was not widely used at the site ICUs as an alternative sedative, a future inquiry into the reasons why not would be worthwhile. “I suspect it’s because it’s still one of the newer agents,” he said.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Patients given propofol-based sedation in the intensive care unit were more likely to have daily dose optimization, stay at their target Richmond Agitation Sedation Scale rate, and be intubated for fewer days, compared with patients given benzodiazepine-based regimens, a retrospective study has shown. Being on propofol at the time of extubation, however, was associated with a significantly higher risk of being reintubated.

In 2013, the American College of Critical Care Medicine updated its guidelines for sedation in the ICU. The changes reflected what Dr. Steven J. Campbell, a presenter at this year’s annual meeting of the American College of Chest Physicians, said was the new paradigm in ICU sedation – namely, to use the least amount of sedation in patients and for the shortest amount of time possible. “We’ve also seen a shift away from benzodiazepines in recent years, and that when patients are given them, they stay in ICUs longer and have longer ventilation times,” Dr. Campbell said. The updated guidelines also suggest not relying on benzodiazepines as a first-line sedative.

To investigate how the updated sedation protocols have impacted the multiple ICUs at Ohio State University’s tertiary medical center, where Dr. Campbell is a third-year medical resident, and to assess the relationship of the changes with reintubation risk, Dr. Campbell and his colleagues retrospectively analyzed data on 988 intubated patients and 6,359 ventilator days recorded at the medical center during a 10-month period in 2013, after the new protocols were in place.

Considering either single sedation drips or combined sedation drips in the 988 unique intubations, about 69% of patients received at least 1 day of propofol, and roughly a third were given at least 1 day of a narcotic.

For 373 patients, the most commonly used drip was propofol only. Propofol combined with a narcotic was used in 141 patients, whereas the a combination of the two with a benzodiazepine was used in 140 patients.

A quarter of all intubated patients received at least 1 day of a continuous benzodiazepine drip, although only 7% of these received this sedation regimen as a first-line agent. Data were not presented on what previous benzodiazepine sedation rates were at the center before the protocol change.

The number of ventilator days for the propofol-only group was between 5.6 days plus or minus another 5.8 days, nearly half of the total propofol/narcotic/benzodiazepine ventilator days which came to 10.5 days give or take another 8 days.

“It intuitively makes sense that the more drips the patients were on, the more they would be on a ventilator,” Dr. Campbell said.

However, for patients given benzodiazepines only, the number of ventilator days was 4.3, plus or minus 4.2 days. Dr. Campbell theorized this was attributable to there being a number of patients withdrawing from alcohol and so needing to rely on an infusion of the benzodiazepine to help them through the process.

Propofol-based regimens were associated with improved dose optimization compliance if patients were eligible (P less than .0001).

Patients given narcotic drips were more likely to meet their targeted RASS levels of –1 to +1, compared with either benzodiazepines or propofol, although propofol patient RASS targets were higher than those of the benzodiazepine group (43% for narcotics, 22% for benzodiazepines, and 37% for propofol, P less than .0001).

The study also found a relationship between failed extubation rates and sedative use. There were 953 patients extubated in all. Seven percent of the extubated patients who had received continuous sedation on the day of extubation had to be reintubated within 48 hours. A significant risk of reintubation was found for patients who’d been given propofol alone since nearly half of that cohort were among those reintubated (P = .01).

Although Dr. Campbell and his colleagues wrote in their study that this could have been due to either lower levels of sedation to begin with, and so being more likely to have earlier extubation, or that the respiratory physiology of this group was altered by the propofol.

“The most important take-away here was that being on any sedative within 24 hours of extubation meant you had a high rate of failing that extubation,” Dr. Campbell said.

The investigators were not able to determine precisely when the sedation was terminated in each patient, only that it had occurred within a 24-hour period prior to extubation.

Dr. Campbell also noted that since dexmedetomidine was not widely used at the site ICUs as an alternative sedative, a future inquiry into the reasons why not would be worthwhile. “I suspect it’s because it’s still one of the newer agents,” he said.

[email protected]

On Twitter @whitneymcknight

NEW YORK – Patients taking daily opioid medication for pain had double the risk of depression over time at dosages of 50 mg or more per day, a new study has shown.

“We already know that depressed patients, over time, take more opioids. But we’ve been questioning whether this high-dose opioid use is really one of the reasons pain patients have higher rates of depression,” Jeffrey Scherrer, Ph.D., said at the annual meeting of the North American Primary Care Research Group.

A previous analysis of Veterans Affairs data conducted by Dr. Scherrer and colleagues demonstrated a risk of new-onset depression over time as opioid exposure increased. However, the retrospective study did not include repeated measures of individual pain severity (J. Gen. Intern. Med. 2014;29:491-9).

Whitney McKnight/Frontline Medical News

So Dr. Scherrer of the department of family and community medicine at Saint Louis University, and his colleagues prospectively studied 355 primary care patients – primarily white, middle-aged women – being treated for chronic low back pain at nine clinics across Texas. Patient levels of depression, pain, anxiety, health-related quality of life, and levels of stress and social support were self-reported at baseline, and at 1 year and 2 years of follow-up.

Information on opioid type and dose, and on comorbid conditions, was collected from patient records and used to assess any association between changes in opioid dosage (0, 1-50 mg, and greater than 50 mg daily) and probability of depression over time, as well as the change in depression levels and the odds of increased opioid dosage.

The adjusted odds ratio of depression over time was 2.65 (1.17-5.98) when opioid dosages increased from 0 to less than 50 mg per day. Although the risk of increased depression with an increase from 1 mg up to 50 mg of opioid per day was marginal (odds ratio, 1.08), the unadjusted odds of developing depression more than doubled (OR, 2.13) when opioid dosage surpassed 50 mg daily. The final adjusted analysis placed the odds ratio of developing depression at 1.65.

But what if patients are depressed because they are in pain or are more susceptible to pain because they are depressed?

“The depression being caused by the pain may be the baseline situation, but the worsening of depression is not due to the pain, it is due to the opioid.” Dr. Scherrer said. “We know that because we have repeated measures of pain, and while the pain remains about the same, the depression keeps going up at each time point. We have an epidemic of new-onset depression being driven by the opioid use, not by the pain.”

Why would a person’s level of pain remain flat despite escalated opioid dosing? Dr. Scherrer said that a previous but unreported history of depression may be making the person more sensitive to pain, and therefore less sensitive to the analgesic effects of the opioids – thus creating a cycle in which they use higher doses of pain medications for longer periods of time.

“If you have a history of depression, you ought to keep your opioids below 50 mg a day,” Dr. Scherrer counseled. “Otherwise, you’re going to jack up your risk of depression.”

The study was supported by the Residency Research Network of Texas Investigators.

[email protected]

On Twitter @whitneymcknight

NEW YORK – Patients taking daily opioid medication for pain had double the risk of depression over time at dosages of 50 mg or more per day, a new study has shown.

“We already know that depressed patients, over time, take more opioids. But we’ve been questioning whether this high-dose opioid use is really one of the reasons pain patients have higher rates of depression,” Jeffrey Scherrer, Ph.D., said at the annual meeting of the North American Primary Care Research Group.

A previous analysis of Veterans Affairs data conducted by Dr. Scherrer and colleagues demonstrated a risk of new-onset depression over time as opioid exposure increased. However, the retrospective study did not include repeated measures of individual pain severity (J. Gen. Intern. Med. 2014;29:491-9).

Whitney McKnight/Frontline Medical News

So Dr. Scherrer of the department of family and community medicine at Saint Louis University, and his colleagues prospectively studied 355 primary care patients – primarily white, middle-aged women – being treated for chronic low back pain at nine clinics across Texas. Patient levels of depression, pain, anxiety, health-related quality of life, and levels of stress and social support were self-reported at baseline, and at 1 year and 2 years of follow-up.

Information on opioid type and dose, and on comorbid conditions, was collected from patient records and used to assess any association between changes in opioid dosage (0, 1-50 mg, and greater than 50 mg daily) and probability of depression over time, as well as the change in depression levels and the odds of increased opioid dosage.

The adjusted odds ratio of depression over time was 2.65 (1.17-5.98) when opioid dosages increased from 0 to less than 50 mg per day. Although the risk of increased depression with an increase from 1 mg up to 50 mg of opioid per day was marginal (odds ratio, 1.08), the unadjusted odds of developing depression more than doubled (OR, 2.13) when opioid dosage surpassed 50 mg daily. The final adjusted analysis placed the odds ratio of developing depression at 1.65.

But what if patients are depressed because they are in pain or are more susceptible to pain because they are depressed?

“The depression being caused by the pain may be the baseline situation, but the worsening of depression is not due to the pain, it is due to the opioid.” Dr. Scherrer said. “We know that because we have repeated measures of pain, and while the pain remains about the same, the depression keeps going up at each time point. We have an epidemic of new-onset depression being driven by the opioid use, not by the pain.”

Why would a person’s level of pain remain flat despite escalated opioid dosing? Dr. Scherrer said that a previous but unreported history of depression may be making the person more sensitive to pain, and therefore less sensitive to the analgesic effects of the opioids – thus creating a cycle in which they use higher doses of pain medications for longer periods of time.

“If you have a history of depression, you ought to keep your opioids below 50 mg a day,” Dr. Scherrer counseled. “Otherwise, you’re going to jack up your risk of depression.”

The study was supported by the Residency Research Network of Texas Investigators.

[email protected]

On Twitter @whitneymcknight

NEW YORK – Patients taking daily opioid medication for pain had double the risk of depression over time at dosages of 50 mg or more per day, a new study has shown.

“We already know that depressed patients, over time, take more opioids. But we’ve been questioning whether this high-dose opioid use is really one of the reasons pain patients have higher rates of depression,” Jeffrey Scherrer, Ph.D., said at the annual meeting of the North American Primary Care Research Group.

A previous analysis of Veterans Affairs data conducted by Dr. Scherrer and colleagues demonstrated a risk of new-onset depression over time as opioid exposure increased. However, the retrospective study did not include repeated measures of individual pain severity (J. Gen. Intern. Med. 2014;29:491-9).

Whitney McKnight/Frontline Medical News

So Dr. Scherrer of the department of family and community medicine at Saint Louis University, and his colleagues prospectively studied 355 primary care patients – primarily white, middle-aged women – being treated for chronic low back pain at nine clinics across Texas. Patient levels of depression, pain, anxiety, health-related quality of life, and levels of stress and social support were self-reported at baseline, and at 1 year and 2 years of follow-up.

Information on opioid type and dose, and on comorbid conditions, was collected from patient records and used to assess any association between changes in opioid dosage (0, 1-50 mg, and greater than 50 mg daily) and probability of depression over time, as well as the change in depression levels and the odds of increased opioid dosage.

The adjusted odds ratio of depression over time was 2.65 (1.17-5.98) when opioid dosages increased from 0 to less than 50 mg per day. Although the risk of increased depression with an increase from 1 mg up to 50 mg of opioid per day was marginal (odds ratio, 1.08), the unadjusted odds of developing depression more than doubled (OR, 2.13) when opioid dosage surpassed 50 mg daily. The final adjusted analysis placed the odds ratio of developing depression at 1.65.

But what if patients are depressed because they are in pain or are more susceptible to pain because they are depressed?

“The depression being caused by the pain may be the baseline situation, but the worsening of depression is not due to the pain, it is due to the opioid.” Dr. Scherrer said. “We know that because we have repeated measures of pain, and while the pain remains about the same, the depression keeps going up at each time point. We have an epidemic of new-onset depression being driven by the opioid use, not by the pain.”

Why would a person’s level of pain remain flat despite escalated opioid dosing? Dr. Scherrer said that a previous but unreported history of depression may be making the person more sensitive to pain, and therefore less sensitive to the analgesic effects of the opioids – thus creating a cycle in which they use higher doses of pain medications for longer periods of time.

“If you have a history of depression, you ought to keep your opioids below 50 mg a day,” Dr. Scherrer counseled. “Otherwise, you’re going to jack up your risk of depression.”

The study was supported by the Residency Research Network of Texas Investigators.

[email protected]

On Twitter @whitneymcknight

ORLANDO – Despite recent, significant shifts in health care coverage thanks to the Affordable Care Act, many specialists are unaware of how patients pay for pricey prescriptions such as biologics.

One reason is that clinicians just haven’t been paying enough attention, according to Dr. Kim L. Isaacs, codirector of the multidiscipline treatment and research center for inflammatory bowel disease at the University of North Carolina.

“It gets complicated because we’re taking care of patients, so it’s hard to think about the financial end of things as well, and it lands on the patient’s lap,” Dr. Isaacs said in an interview after her presentation, “Navigating the Affordable Care Act,” at a conference on inflammatory bowel diseases sponsored by the Crohn’s and Colitis Foundation of America.

But not knowing how and if chronically ill patients can afford to pay for their medications can impact their compliance, and even their disease states.

Dr. Isaacs compared the histories of two patients. The first one purchased through the ACA’s health insurance marketplace provision, and regardless of her preexisting condition, she was able to receive and afford treatment for her Crohn’s disease for the first time in a decade. The second patient purchased ACA-sanctioned insurance but it still wasn’t enough to cover the costs of her care.

“She told me she had thought the Silver Plan would work for her, but that she still couldn’t afford her medications, and I was thinking, ‘What’s a Silver Plan?’ ” Dr. Isaacs said. “I didn’t have a clue.”

The discrepancy between the patients’ plans prompted Dr. Isaacs to investigate whether what she was prescribing was practical under her patients’ various levels of coverage. She discovered that under the ACA, the individual mandate requiring all Americans to purchase some form of health insurance means many have turned to a variety of state- and federally-sponsored health insurance marketplaces that offer coverage plans ranging from Bronze to Platinum.

“If you ask [most specialists] what the Gold Plan is, most of them won’t have heard of it, they don’t know,” she said.

Whitney McKnight

But she said that physicians need to be aware of whether the drugs they are prescribing are on the formulary used by their patients’ respective plans since the different insurance providers that back the various plans often don’t cover the same medications.

In addition, the so-called “donut hole,” the annually adjusted gap in prescription drug coverage for Medicare patients, is not scheduled to close until 2020. While the gap exists, Medicare patients have a set amount of annual drug coverage after which the patient shares a substantial portion of the cost until the following year when the process begins again.

“For our IBD patients, this is very important because for some of our more expensive drugs, there may be a period of time [annually] when the drugs are not covered,” Dr. Isaacs said.

The same could be true for other specialties such as oncology, rheumatology, and neurology, where disease states require high-cost specialty drugs; however, some patient advocacy groups will assist patients in paying for their treatment, she said.

Patients who purchase their health plans through the government-sponsored insurance marketplaces are usually eligible for subsidies, depending on their income and where they fall in relation to the federally set poverty level, said Dr. Isaacs.

Another important, basic point, she added, is that providers need to ensure that they are on their patients’ chosen plans. “If you’re not, then you need to be sure there is someone else who is on the plan who can take care of your patient.”

Dr. Isaacs reported she has affiliations with AbbVie, Janssen, Millennium, Takeda, UCB, and others.

[email protected]

On Twitter @whitneymcknight

ORLANDO – Despite recent, significant shifts in health care coverage thanks to the Affordable Care Act, many specialists are unaware of how patients pay for pricey prescriptions such as biologics.

One reason is that clinicians just haven’t been paying enough attention, according to Dr. Kim L. Isaacs, codirector of the multidiscipline treatment and research center for inflammatory bowel disease at the University of North Carolina.

“It gets complicated because we’re taking care of patients, so it’s hard to think about the financial end of things as well, and it lands on the patient’s lap,” Dr. Isaacs said in an interview after her presentation, “Navigating the Affordable Care Act,” at a conference on inflammatory bowel diseases sponsored by the Crohn’s and Colitis Foundation of America.

But not knowing how and if chronically ill patients can afford to pay for their medications can impact their compliance, and even their disease states.

Dr. Isaacs compared the histories of two patients. The first one purchased through the ACA’s health insurance marketplace provision, and regardless of her preexisting condition, she was able to receive and afford treatment for her Crohn’s disease for the first time in a decade. The second patient purchased ACA-sanctioned insurance but it still wasn’t enough to cover the costs of her care.

“She told me she had thought the Silver Plan would work for her, but that she still couldn’t afford her medications, and I was thinking, ‘What’s a Silver Plan?’ ” Dr. Isaacs said. “I didn’t have a clue.”

The discrepancy between the patients’ plans prompted Dr. Isaacs to investigate whether what she was prescribing was practical under her patients’ various levels of coverage. She discovered that under the ACA, the individual mandate requiring all Americans to purchase some form of health insurance means many have turned to a variety of state- and federally-sponsored health insurance marketplaces that offer coverage plans ranging from Bronze to Platinum.

“If you ask [most specialists] what the Gold Plan is, most of them won’t have heard of it, they don’t know,” she said.

Whitney McKnight

But she said that physicians need to be aware of whether the drugs they are prescribing are on the formulary used by their patients’ respective plans since the different insurance providers that back the various plans often don’t cover the same medications.

In addition, the so-called “donut hole,” the annually adjusted gap in prescription drug coverage for Medicare patients, is not scheduled to close until 2020. While the gap exists, Medicare patients have a set amount of annual drug coverage after which the patient shares a substantial portion of the cost until the following year when the process begins again.

“For our IBD patients, this is very important because for some of our more expensive drugs, there may be a period of time [annually] when the drugs are not covered,” Dr. Isaacs said.

The same could be true for other specialties such as oncology, rheumatology, and neurology, where disease states require high-cost specialty drugs; however, some patient advocacy groups will assist patients in paying for their treatment, she said.

Patients who purchase their health plans through the government-sponsored insurance marketplaces are usually eligible for subsidies, depending on their income and where they fall in relation to the federally set poverty level, said Dr. Isaacs.

Another important, basic point, she added, is that providers need to ensure that they are on their patients’ chosen plans. “If you’re not, then you need to be sure there is someone else who is on the plan who can take care of your patient.”

Dr. Isaacs reported she has affiliations with AbbVie, Janssen, Millennium, Takeda, UCB, and others.

[email protected]

On Twitter @whitneymcknight

ORLANDO – Despite recent, significant shifts in health care coverage thanks to the Affordable Care Act, many specialists are unaware of how patients pay for pricey prescriptions such as biologics.

One reason is that clinicians just haven’t been paying enough attention, according to Dr. Kim L. Isaacs, codirector of the multidiscipline treatment and research center for inflammatory bowel disease at the University of North Carolina.

“It gets complicated because we’re taking care of patients, so it’s hard to think about the financial end of things as well, and it lands on the patient’s lap,” Dr. Isaacs said in an interview after her presentation, “Navigating the Affordable Care Act,” at a conference on inflammatory bowel diseases sponsored by the Crohn’s and Colitis Foundation of America.

But not knowing how and if chronically ill patients can afford to pay for their medications can impact their compliance, and even their disease states.

Dr. Isaacs compared the histories of two patients. The first one purchased through the ACA’s health insurance marketplace provision, and regardless of her preexisting condition, she was able to receive and afford treatment for her Crohn’s disease for the first time in a decade. The second patient purchased ACA-sanctioned insurance but it still wasn’t enough to cover the costs of her care.

“She told me she had thought the Silver Plan would work for her, but that she still couldn’t afford her medications, and I was thinking, ‘What’s a Silver Plan?’ ” Dr. Isaacs said. “I didn’t have a clue.”

The discrepancy between the patients’ plans prompted Dr. Isaacs to investigate whether what she was prescribing was practical under her patients’ various levels of coverage. She discovered that under the ACA, the individual mandate requiring all Americans to purchase some form of health insurance means many have turned to a variety of state- and federally-sponsored health insurance marketplaces that offer coverage plans ranging from Bronze to Platinum.

“If you ask [most specialists] what the Gold Plan is, most of them won’t have heard of it, they don’t know,” she said.

Whitney McKnight

But she said that physicians need to be aware of whether the drugs they are prescribing are on the formulary used by their patients’ respective plans since the different insurance providers that back the various plans often don’t cover the same medications.

In addition, the so-called “donut hole,” the annually adjusted gap in prescription drug coverage for Medicare patients, is not scheduled to close until 2020. While the gap exists, Medicare patients have a set amount of annual drug coverage after which the patient shares a substantial portion of the cost until the following year when the process begins again.

“For our IBD patients, this is very important because for some of our more expensive drugs, there may be a period of time [annually] when the drugs are not covered,” Dr. Isaacs said.

The same could be true for other specialties such as oncology, rheumatology, and neurology, where disease states require high-cost specialty drugs; however, some patient advocacy groups will assist patients in paying for their treatment, she said.

Patients who purchase their health plans through the government-sponsored insurance marketplaces are usually eligible for subsidies, depending on their income and where they fall in relation to the federally set poverty level, said Dr. Isaacs.

Another important, basic point, she added, is that providers need to ensure that they are on their patients’ chosen plans. “If you’re not, then you need to be sure there is someone else who is on the plan who can take care of your patient.”

Dr. Isaacs reported she has affiliations with AbbVie, Janssen, Millennium, Takeda, UCB, and others.

[email protected]

On Twitter @whitneymcknight

NEW YORK– Family physicians are more comfortable with letting patients choose to die, and helping them do so comfortably, according to Dr. Richard Young, a speaker at this year’s annual meeting of the North American Primary Care Research Group.

“We’re more comfortable with death,” he said, comparing physicians accustomed to focusing on one part of the body rather than the whole. That can lead to unnecessary pain and agony for the patient and family, who would be better served being made comfortable, rather than having to endure the heroics of a specialist who “can’t let go,” noted Dr. Young, director of research at the John S. Peters Health System in Fort Worth, Tex.

This video interview is the third in a four-part series on the role family medicine plays in delivering humane, cost-effective health care.

[email protected]

On Twitter @whitneymcknight

NEW YORK– Family physicians are more comfortable with letting patients choose to die, and helping them do so comfortably, according to Dr. Richard Young, a speaker at this year’s annual meeting of the North American Primary Care Research Group.

“We’re more comfortable with death,” he said, comparing physicians accustomed to focusing on one part of the body rather than the whole. That can lead to unnecessary pain and agony for the patient and family, who would be better served being made comfortable, rather than having to endure the heroics of a specialist who “can’t let go,” noted Dr. Young, director of research at the John S. Peters Health System in Fort Worth, Tex.

This video interview is the third in a four-part series on the role family medicine plays in delivering humane, cost-effective health care.

[email protected]

On Twitter @whitneymcknight

NEW YORK– Family physicians are more comfortable with letting patients choose to die, and helping them do so comfortably, according to Dr. Richard Young, a speaker at this year’s annual meeting of the North American Primary Care Research Group.

“We’re more comfortable with death,” he said, comparing physicians accustomed to focusing on one part of the body rather than the whole. That can lead to unnecessary pain and agony for the patient and family, who would be better served being made comfortable, rather than having to endure the heroics of a specialist who “can’t let go,” noted Dr. Young, director of research at the John S. Peters Health System in Fort Worth, Tex.

This video interview is the third in a four-part series on the role family medicine plays in delivering humane, cost-effective health care.

[email protected]

On Twitter @whitneymcknight

NEW YORK – Family physicians are comfortable with uncertainty and view many tests as wastes of money.

These and other characteristics typical of family physicians are what Dr. Richard A. Young calls the foundation of the nation’s most practical and cost-effective care, despite what he calls “bigotry” toward the field from more specialized medicine and from those who created the current system of payment.

“The reason we add value to the world is because we don’t treat everybody the same,” said Dr. Young, the director of research and residency at the John Peter Smith Health System in Fort Worth, Tex.

In this video interview, the fourth and final in a series, Dr. Young makes the case for how, despite systematic overreliance on specialty care, evidence shows it is the primary care physician who is best suited to meet the majority of patients’ needs.

[email protected]

On Twitter @whitneymcknight

NEW YORK – Family physicians are comfortable with uncertainty and view many tests as wastes of money.

These and other characteristics typical of family physicians are what Dr. Richard A. Young calls the foundation of the nation’s most practical and cost-effective care, despite what he calls “bigotry” toward the field from more specialized medicine and from those who created the current system of payment.

“The reason we add value to the world is because we don’t treat everybody the same,” said Dr. Young, the director of research and residency at the John Peter Smith Health System in Fort Worth, Tex.

In this video interview, the fourth and final in a series, Dr. Young makes the case for how, despite systematic overreliance on specialty care, evidence shows it is the primary care physician who is best suited to meet the majority of patients’ needs.

[email protected]

On Twitter @whitneymcknight

NEW YORK – Family physicians are comfortable with uncertainty and view many tests as wastes of money.

These and other characteristics typical of family physicians are what Dr. Richard A. Young calls the foundation of the nation’s most practical and cost-effective care, despite what he calls “bigotry” toward the field from more specialized medicine and from those who created the current system of payment.

“The reason we add value to the world is because we don’t treat everybody the same,” said Dr. Young, the director of research and residency at the John Peter Smith Health System in Fort Worth, Tex.

In this video interview, the fourth and final in a series, Dr. Young makes the case for how, despite systematic overreliance on specialty care, evidence shows it is the primary care physician who is best suited to meet the majority of patients’ needs.

[email protected]

On Twitter @whitneymcknight

Nearly a fifth of American high school seniors have used e-cigarettes recently, although tobacco smoking in this population is at an all-time low, according to the annual Monitoring the Future survey released Dec. 16.

“About 4% of 12th graders use e-cigarettes alone. They’ve never smoked a regular cigarette in their life,” Richard A. Miech, Ph.D., of the University of Michigan, Ann Arbor, one of the lead researchers on the study, said during a press conference held by the National Institute on Drug Abuse. This was the first year that data on e-cigarette use in teens were collected for the Monitoring the Future survey of drug, tobacco, and alcohol use in adolescents in 8th, 10th, and 12th grade. The survey has been conducted every year since 1975 by the University of Michigan and funded by NIDA.

Just over 17% of 12th graders reported past-month use of e-cigarettes. For 10th graders, the number was 16%, and for 8th graders it was nearly 9%. Daily cigarette smoking has decreased by half in the past 5 years across all age groups surveyed, with the largest decline being from just over 6% to about 3% in 10th graders.

Whether the decline in tobacco smoking correlates directly with the rise in e-cigarettes is unknown, NIDA director Dr. Nora Volkow said during the teleconference.

©verbaska_studio/thinkstockphotos.com

Particularly troubling, according to Dr. Miech, is that the 4% of 12th graders who reported using e-cigarettes exclusively tended to be college bound, a cohort he said typically does not use tobacco.

What actual harm e-cigarettes pose to youth, and whether they lead to other drug use are still open questions, according to Dr. Volkow.

“We can’t do a randomized, controlled trial of teens and give them e-cigarettes to see if they progress to harder drugs,” Dr. Miech said. “The best we can do is follow them as they age.”

Marijuana use among teens is steady and prevalent across all three age groups, according to the survey. More than a third of 12th graders (35%) reported past-year use of marijuana; nearly 6% reported daily use. “This constitutes one of the highest rates seen in any student population world wide,” said Dr. Volkow.

Similar to last year’s rates, 7% of eighth graders, 17% of 10th graders, and just over 21% of 12th graders reported smoking marijuana in the previous month.

The steady rates of marijuana use came as a welcome surprise, said Dr. Volkow, considering recent changes to marijuana laws at the state level and the way those changes might impact perception of marijuana use. In fact, there was a change across the entire study population in the perceived danger posed by marijuana, down from 27% 5 years ago to 16% this year.

In states with medical marijuana laws, 40% of 12th graders who reported using marijuana in the past year said they had used edible marijuana products, compared with 26% of seniors who lived in states without such legislation.

Whether digested versus smoked cannabinoids pose greater health risks to teens “is relatively new for us,” Dr. Volkow said, noting that there are little data on how quickly cannabinoids consumed orally may enter the bloodstream. “When you smoke a drug, it gets into the brain very rapidly, and that is associated with stronger rewarding affects and more addictiveness, but it also is associated with better control of how much you ingest.”

“It’s pretty obvious when people are smoking a joint – the feedback is quick,” said Dr. Lloyd D. Johnston, lead investigator for Monitoring the Future, also of the University of Michigan. Ingested marijuana is different and variable, he noted, both in the amount of marijuana consumed and in the time it takes for the drug to take effect. “I think it’s considerably more dangerous.”Understanding the bioavailability and the pharmacokinetics of edible marijuana is a pressing research concern at NIDA, Dr. Volkow said.

Nonmedical use of prescription drugs is down overall among survey respondents. Nonmedical use of Vicodin declined from 9.7% 5 years ago to 4.5% this year. For oxycontin, nonmedical use declined from 4.8% to 3.3%.

Alcohol use, particularly binge drinking in 12th graders, also is losing popularity. At its peak in 1998, 31.5% of 12th graders reported binge drinking; less than 20% did so in 2014. A decline in the use of synthetic marijuana (also known as K2/Spice) was also noted, down from nearly 8% in 12th graders to just under 6%. Heroin, crack cocaine, and methamphetamine use remained low and relatively unchanged from last year.

“Over all, this is good news,” said Dr. Volkow.

Monitoring the Future is unusual in that the data, gathered from nearly 42,000 U.S. students at 377 public and private schools across the country, are reported in the same year they are gathered.

[email protected]

On Twitter @whitneymcknight

Nearly a fifth of American high school seniors have used e-cigarettes recently, although tobacco smoking in this population is at an all-time low, according to the annual Monitoring the Future survey released Dec. 16.

“About 4% of 12th graders use e-cigarettes alone. They’ve never smoked a regular cigarette in their life,” Richard A. Miech, Ph.D., of the University of Michigan, Ann Arbor, one of the lead researchers on the study, said during a press conference held by the National Institute on Drug Abuse. This was the first year that data on e-cigarette use in teens were collected for the Monitoring the Future survey of drug, tobacco, and alcohol use in adolescents in 8th, 10th, and 12th grade. The survey has been conducted every year since 1975 by the University of Michigan and funded by NIDA.

Just over 17% of 12th graders reported past-month use of e-cigarettes. For 10th graders, the number was 16%, and for 8th graders it was nearly 9%. Daily cigarette smoking has decreased by half in the past 5 years across all age groups surveyed, with the largest decline being from just over 6% to about 3% in 10th graders.

Whether the decline in tobacco smoking correlates directly with the rise in e-cigarettes is unknown, NIDA director Dr. Nora Volkow said during the teleconference.

©verbaska_studio/thinkstockphotos.com

Particularly troubling, according to Dr. Miech, is that the 4% of 12th graders who reported using e-cigarettes exclusively tended to be college bound, a cohort he said typically does not use tobacco.

What actual harm e-cigarettes pose to youth, and whether they lead to other drug use are still open questions, according to Dr. Volkow.

“We can’t do a randomized, controlled trial of teens and give them e-cigarettes to see if they progress to harder drugs,” Dr. Miech said. “The best we can do is follow them as they age.”

Marijuana use among teens is steady and prevalent across all three age groups, according to the survey. More than a third of 12th graders (35%) reported past-year use of marijuana; nearly 6% reported daily use. “This constitutes one of the highest rates seen in any student population world wide,” said Dr. Volkow.

Similar to last year’s rates, 7% of eighth graders, 17% of 10th graders, and just over 21% of 12th graders reported smoking marijuana in the previous month.

The steady rates of marijuana use came as a welcome surprise, said Dr. Volkow, considering recent changes to marijuana laws at the state level and the way those changes might impact perception of marijuana use. In fact, there was a change across the entire study population in the perceived danger posed by marijuana, down from 27% 5 years ago to 16% this year.

In states with medical marijuana laws, 40% of 12th graders who reported using marijuana in the past year said they had used edible marijuana products, compared with 26% of seniors who lived in states without such legislation.

Whether digested versus smoked cannabinoids pose greater health risks to teens “is relatively new for us,” Dr. Volkow said, noting that there are little data on how quickly cannabinoids consumed orally may enter the bloodstream. “When you smoke a drug, it gets into the brain very rapidly, and that is associated with stronger rewarding affects and more addictiveness, but it also is associated with better control of how much you ingest.”

“It’s pretty obvious when people are smoking a joint – the feedback is quick,” said Dr. Lloyd D. Johnston, lead investigator for Monitoring the Future, also of the University of Michigan. Ingested marijuana is different and variable, he noted, both in the amount of marijuana consumed and in the time it takes for the drug to take effect. “I think it’s considerably more dangerous.”Understanding the bioavailability and the pharmacokinetics of edible marijuana is a pressing research concern at NIDA, Dr. Volkow said.

Nonmedical use of prescription drugs is down overall among survey respondents. Nonmedical use of Vicodin declined from 9.7% 5 years ago to 4.5% this year. For oxycontin, nonmedical use declined from 4.8% to 3.3%.

Alcohol use, particularly binge drinking in 12th graders, also is losing popularity. At its peak in 1998, 31.5% of 12th graders reported binge drinking; less than 20% did so in 2014. A decline in the use of synthetic marijuana (also known as K2/Spice) was also noted, down from nearly 8% in 12th graders to just under 6%. Heroin, crack cocaine, and methamphetamine use remained low and relatively unchanged from last year.

“Over all, this is good news,” said Dr. Volkow.

Monitoring the Future is unusual in that the data, gathered from nearly 42,000 U.S. students at 377 public and private schools across the country, are reported in the same year they are gathered.

[email protected]

On Twitter @whitneymcknight

Nearly a fifth of American high school seniors have used e-cigarettes recently, although tobacco smoking in this population is at an all-time low, according to the annual Monitoring the Future survey released Dec. 16.

“About 4% of 12th graders use e-cigarettes alone. They’ve never smoked a regular cigarette in their life,” Richard A. Miech, Ph.D., of the University of Michigan, Ann Arbor, one of the lead researchers on the study, said during a press conference held by the National Institute on Drug Abuse. This was the first year that data on e-cigarette use in teens were collected for the Monitoring the Future survey of drug, tobacco, and alcohol use in adolescents in 8th, 10th, and 12th grade. The survey has been conducted every year since 1975 by the University of Michigan and funded by NIDA.

Just over 17% of 12th graders reported past-month use of e-cigarettes. For 10th graders, the number was 16%, and for 8th graders it was nearly 9%. Daily cigarette smoking has decreased by half in the past 5 years across all age groups surveyed, with the largest decline being from just over 6% to about 3% in 10th graders.

Whether the decline in tobacco smoking correlates directly with the rise in e-cigarettes is unknown, NIDA director Dr. Nora Volkow said during the teleconference.

©verbaska_studio/thinkstockphotos.com

Particularly troubling, according to Dr. Miech, is that the 4% of 12th graders who reported using e-cigarettes exclusively tended to be college bound, a cohort he said typically does not use tobacco.

What actual harm e-cigarettes pose to youth, and whether they lead to other drug use are still open questions, according to Dr. Volkow.

“We can’t do a randomized, controlled trial of teens and give them e-cigarettes to see if they progress to harder drugs,” Dr. Miech said. “The best we can do is follow them as they age.”

Marijuana use among teens is steady and prevalent across all three age groups, according to the survey. More than a third of 12th graders (35%) reported past-year use of marijuana; nearly 6% reported daily use. “This constitutes one of the highest rates seen in any student population world wide,” said Dr. Volkow.

Similar to last year’s rates, 7% of eighth graders, 17% of 10th graders, and just over 21% of 12th graders reported smoking marijuana in the previous month.

The steady rates of marijuana use came as a welcome surprise, said Dr. Volkow, considering recent changes to marijuana laws at the state level and the way those changes might impact perception of marijuana use. In fact, there was a change across the entire study population in the perceived danger posed by marijuana, down from 27% 5 years ago to 16% this year.

In states with medical marijuana laws, 40% of 12th graders who reported using marijuana in the past year said they had used edible marijuana products, compared with 26% of seniors who lived in states without such legislation.

Whether digested versus smoked cannabinoids pose greater health risks to teens “is relatively new for us,” Dr. Volkow said, noting that there are little data on how quickly cannabinoids consumed orally may enter the bloodstream. “When you smoke a drug, it gets into the brain very rapidly, and that is associated with stronger rewarding affects and more addictiveness, but it also is associated with better control of how much you ingest.”

“It’s pretty obvious when people are smoking a joint – the feedback is quick,” said Dr. Lloyd D. Johnston, lead investigator for Monitoring the Future, also of the University of Michigan. Ingested marijuana is different and variable, he noted, both in the amount of marijuana consumed and in the time it takes for the drug to take effect. “I think it’s considerably more dangerous.”Understanding the bioavailability and the pharmacokinetics of edible marijuana is a pressing research concern at NIDA, Dr. Volkow said.

Nonmedical use of prescription drugs is down overall among survey respondents. Nonmedical use of Vicodin declined from 9.7% 5 years ago to 4.5% this year. For oxycontin, nonmedical use declined from 4.8% to 3.3%.

Alcohol use, particularly binge drinking in 12th graders, also is losing popularity. At its peak in 1998, 31.5% of 12th graders reported binge drinking; less than 20% did so in 2014. A decline in the use of synthetic marijuana (also known as K2/Spice) was also noted, down from nearly 8% in 12th graders to just under 6%. Heroin, crack cocaine, and methamphetamine use remained low and relatively unchanged from last year.

“Over all, this is good news,” said Dr. Volkow.

Monitoring the Future is unusual in that the data, gathered from nearly 42,000 U.S. students at 377 public and private schools across the country, are reported in the same year they are gathered.

[email protected]

On Twitter @whitneymcknight

ORLANDO – Ulcerative colitis sufferers with higher vedolizumab trough scores at 6 weeks in the GEMINI-1 study were found to have higher rates of mucosal healing, a post hoc, population pharmacokinetics analysis has shown.

The findings’ significance, however, is still a matter of debate, according to Maria Rosario, Ph.D., a director at Takeda Pharmaceuticals, and the data’s presenter at this year’s annual Advances in Inflammatory Bowel Disease meeting sponsored by the Crohn’s and Colitis Foundation of America.

“We have established a relationship between higher endoscopic scores and faster clearance, but we need to be careful how we interpret the data,” she concluded in her presentation, citing a lack of an established causal relationship between the two.

Results from the GEMINI-1 study lead to the Food and Drug Administration’s 2013 indication of vedolizumab, a disease-modifying monoclonal antibody, for the treatment of refractory ulcerative colitis (UC) and Crohn’s disease.

In the phase III study, two cohorts of UC patients were either double-blinded to vedolizumab 300 mg or placebo; or, to open-label vedolizumab 300 mg at weeks 0 and 2 during induction.

At week 6, responders to the medication in each cohort were re-randomized to either placebo or the study drug every 4 or 8 weeks during maintenance, up to week 52. Induction placebo patients and week 6 nonresponders continued their respective regimens.

For the post hoc analysis, serum levels of the drug in both cohorts were determined at weeks 6 and 46 according to each person’s Mayo Clinic endoscopic subscore at weeks 6 and 52. Trough concentration levels were divided into quartiles at weeks 6 and 46, as were the associated rates of mucosal healing at weeks 6 and 52. Dr. Rosario and her colleagues then used population pharmacokinetic modeling to estimate individual clearance values.

Patients who had higher levels of drug serum concentrations at week 6 were also found to have more mucosal healing. In the 55 patients who had an endoscopic subscore of 0, median trough concentrations were 34.5 mcg/mL; 30.4 mcg/mL in the 223 patients with subscores of 1; 24.0 mcg/mL in the 224 patients with a subscore of 2; and 19.6 mcg/mL in the 188 patients who had a subscore of 3.

Dr. Rosario also noted that in median week 6, trough concentrations in patients with the highest subscores lagged behind the overall week 6 median GEMINI-1 results, which were 25.6 mcg/mL.

Because this study did not measure fecal levels of the drug, these preliminary findings should encourage further investigation, said Dr. Rosario, who said the role of disease severity would be key to more precise interpretation of the data. Dr. Rosario is a director at Takeda Pharmaceuticals, manufacturer of Entyvio, the brand name for vedolizumab.

[email protected]

On Twitter @whitneymcknight

ORLANDO – Ulcerative colitis sufferers with higher vedolizumab trough scores at 6 weeks in the GEMINI-1 study were found to have higher rates of mucosal healing, a post hoc, population pharmacokinetics analysis has shown.

The findings’ significance, however, is still a matter of debate, according to Maria Rosario, Ph.D., a director at Takeda Pharmaceuticals, and the data’s presenter at this year’s annual Advances in Inflammatory Bowel Disease meeting sponsored by the Crohn’s and Colitis Foundation of America.

“We have established a relationship between higher endoscopic scores and faster clearance, but we need to be careful how we interpret the data,” she concluded in her presentation, citing a lack of an established causal relationship between the two.

Results from the GEMINI-1 study lead to the Food and Drug Administration’s 2013 indication of vedolizumab, a disease-modifying monoclonal antibody, for the treatment of refractory ulcerative colitis (UC) and Crohn’s disease.

In the phase III study, two cohorts of UC patients were either double-blinded to vedolizumab 300 mg or placebo; or, to open-label vedolizumab 300 mg at weeks 0 and 2 during induction.

At week 6, responders to the medication in each cohort were re-randomized to either placebo or the study drug every 4 or 8 weeks during maintenance, up to week 52. Induction placebo patients and week 6 nonresponders continued their respective regimens.

For the post hoc analysis, serum levels of the drug in both cohorts were determined at weeks 6 and 46 according to each person’s Mayo Clinic endoscopic subscore at weeks 6 and 52. Trough concentration levels were divided into quartiles at weeks 6 and 46, as were the associated rates of mucosal healing at weeks 6 and 52. Dr. Rosario and her colleagues then used population pharmacokinetic modeling to estimate individual clearance values.

Patients who had higher levels of drug serum concentrations at week 6 were also found to have more mucosal healing. In the 55 patients who had an endoscopic subscore of 0, median trough concentrations were 34.5 mcg/mL; 30.4 mcg/mL in the 223 patients with subscores of 1; 24.0 mcg/mL in the 224 patients with a subscore of 2; and 19.6 mcg/mL in the 188 patients who had a subscore of 3.

Dr. Rosario also noted that in median week 6, trough concentrations in patients with the highest subscores lagged behind the overall week 6 median GEMINI-1 results, which were 25.6 mcg/mL.

Because this study did not measure fecal levels of the drug, these preliminary findings should encourage further investigation, said Dr. Rosario, who said the role of disease severity would be key to more precise interpretation of the data. Dr. Rosario is a director at Takeda Pharmaceuticals, manufacturer of Entyvio, the brand name for vedolizumab.

[email protected]

On Twitter @whitneymcknight

ORLANDO – Ulcerative colitis sufferers with higher vedolizumab trough scores at 6 weeks in the GEMINI-1 study were found to have higher rates of mucosal healing, a post hoc, population pharmacokinetics analysis has shown.

The findings’ significance, however, is still a matter of debate, according to Maria Rosario, Ph.D., a director at Takeda Pharmaceuticals, and the data’s presenter at this year’s annual Advances in Inflammatory Bowel Disease meeting sponsored by the Crohn’s and Colitis Foundation of America.

“We have established a relationship between higher endoscopic scores and faster clearance, but we need to be careful how we interpret the data,” she concluded in her presentation, citing a lack of an established causal relationship between the two.

Results from the GEMINI-1 study lead to the Food and Drug Administration’s 2013 indication of vedolizumab, a disease-modifying monoclonal antibody, for the treatment of refractory ulcerative colitis (UC) and Crohn’s disease.

In the phase III study, two cohorts of UC patients were either double-blinded to vedolizumab 300 mg or placebo; or, to open-label vedolizumab 300 mg at weeks 0 and 2 during induction.

At week 6, responders to the medication in each cohort were re-randomized to either placebo or the study drug every 4 or 8 weeks during maintenance, up to week 52. Induction placebo patients and week 6 nonresponders continued their respective regimens.

For the post hoc analysis, serum levels of the drug in both cohorts were determined at weeks 6 and 46 according to each person’s Mayo Clinic endoscopic subscore at weeks 6 and 52. Trough concentration levels were divided into quartiles at weeks 6 and 46, as were the associated rates of mucosal healing at weeks 6 and 52. Dr. Rosario and her colleagues then used population pharmacokinetic modeling to estimate individual clearance values.

Patients who had higher levels of drug serum concentrations at week 6 were also found to have more mucosal healing. In the 55 patients who had an endoscopic subscore of 0, median trough concentrations were 34.5 mcg/mL; 30.4 mcg/mL in the 223 patients with subscores of 1; 24.0 mcg/mL in the 224 patients with a subscore of 2; and 19.6 mcg/mL in the 188 patients who had a subscore of 3.

Dr. Rosario also noted that in median week 6, trough concentrations in patients with the highest subscores lagged behind the overall week 6 median GEMINI-1 results, which were 25.6 mcg/mL.

Because this study did not measure fecal levels of the drug, these preliminary findings should encourage further investigation, said Dr. Rosario, who said the role of disease severity would be key to more precise interpretation of the data. Dr. Rosario is a director at Takeda Pharmaceuticals, manufacturer of Entyvio, the brand name for vedolizumab.

[email protected]

On Twitter @whitneymcknight

NEW YORK – Graduates of a clinical program designed to train family practice physicians in a rural setting were significantly more likely to practice in rural areas than their peers who trained in a medical school located in more populous areas, according to a poster presented at this year’s North American Primary Care Research Group annual meeting.

Over a ten-year period, nearly half of all graduates of the Michigan State University College of Human Medicine’s Rural Physician Program, a clinical track specifically designed to expose students to life and practice in a rural setting, chose to practice in a rural setting, nearly four times more than graduates of the university’s main campus medical school.

Whitney McKnight/Frontline Medical News

“When the program started, there was a lot of skepticism as to whether it would be successful,” Dr. Julie Phillips, a family physician and assistant dean for student career development at the University’s East Lansing campus, said in an interview. An author of the retrospective analysis, Dr. Phillips said the program enrolls an average of 12 students annually, a quarter of whom stay in the region to set up practice.

The program was created in 1974 to address a shortage of family physicians in Michigan’s Upper Peninsula, and enrolls students who express an interest in rural practice. Once a student’s clinical training is complete, including a residency that typically occurs in Marquette, the Upper Peninsula’s most populous city with just under 22,000 residents, but a retrospective cohort analysis showed that 42.2 percent of participants enrolled from 1996 to 2006 chose to either return or stay in a more rural setting to set up their practice.

“It looks like [the program] has been a success,” Dr. Phillips said.

She also said relative to other medical schools, the program graduates tended to remain in the state and set up family care practices post-graduation, but that the rural residency program was “significantly better” at attracting physicians than the college’s traditional medical school program. She did not know what proportion of the program graduates who chose rural settings had actually grown up in the areas where they practiced, but said it was a predictor she and her colleagues were considering in a secondary analysis.

“Historically, we have attracted students who did grow up in the Upper Peninsula, but many students who become interested in rural practice actually don’t grow up in rural communities,” Dr. Phillips said.

During the time period studied, 55 percent of rural training track graduates chose to set up a primary care practice, roughly 15 percent more than the ratio of students graduated by the college’s main medical facility (P = .015). More than half of rural track graduates also chose to practice in Michigan, compared with 40 percent of the medical school graduates from the main campus (P = .006). A quarter of the rural program’s graduates stayed to practice in the Upper Peninsula, compared with the one percent of physicians graduated from the main campus (P less than .001) who chose to settle in the Upper Peninsula. Overall, 42.2 percent of rural program graduates set up practice in any rural area during the time period studied, compared with 13 percent of graduates from the main medical school (P less than .001)

Dr. Phillips and her colleagues considered a community rural if it met Code 4 specifications from the U.S. Department of Agriculture’s Rural Continuum – typically populations of 20,000 or less. The results of the program are impressive, Dr. Dana E. King, professor and chair of family medicine at the University of West Virginia, said in an interview.

Being able to attract people to places that are somehow geographically undesirable, either because they are isolated, have harsh winters, or aren’t near a city, is difficult.” The key to success is appealing to the physician’s spouse, said Dr. King. “What if you’re married to a Ph.D. in something, or another physician? There is a challenge to provide enough opportunities for both the physician and spouse. The fact that [Michigan State University’s rural practice program] has had these kind of results is a testament to the fact that it pays attention to the needs of the physician’s family and to the entire community.”

Dr. King, who is the secretary and treasurer of the North American Primary Care Research Group, is not affiliated with the study.

Dr. Phillips said that the program curriculum does address the specific challenges -- and rewards -- of living and practicing in a rural community, but that the program’s rural location itself was the most instructive. “The students are already there. They’re in medical school in a rural setting. They don’t need to go somewhere else to learn about a rural life after they learn medicine.”

On Twitter @whitneymcknight

[email protected]

NEW YORK – Graduates of a clinical program designed to train family practice physicians in a rural setting were significantly more likely to practice in rural areas than their peers who trained in a medical school located in more populous areas, according to a poster presented at this year’s North American Primary Care Research Group annual meeting.

Over a ten-year period, nearly half of all graduates of the Michigan State University College of Human Medicine’s Rural Physician Program, a clinical track specifically designed to expose students to life and practice in a rural setting, chose to practice in a rural setting, nearly four times more than graduates of the university’s main campus medical school.

Whitney McKnight/Frontline Medical News

“When the program started, there was a lot of skepticism as to whether it would be successful,” Dr. Julie Phillips, a family physician and assistant dean for student career development at the University’s East Lansing campus, said in an interview. An author of the retrospective analysis, Dr. Phillips said the program enrolls an average of 12 students annually, a quarter of whom stay in the region to set up practice.

The program was created in 1974 to address a shortage of family physicians in Michigan’s Upper Peninsula, and enrolls students who express an interest in rural practice. Once a student’s clinical training is complete, including a residency that typically occurs in Marquette, the Upper Peninsula’s most populous city with just under 22,000 residents, but a retrospective cohort analysis showed that 42.2 percent of participants enrolled from 1996 to 2006 chose to either return or stay in a more rural setting to set up their practice.

“It looks like [the program] has been a success,” Dr. Phillips said.

She also said relative to other medical schools, the program graduates tended to remain in the state and set up family care practices post-graduation, but that the rural residency program was “significantly better” at attracting physicians than the college’s traditional medical school program. She did not know what proportion of the program graduates who chose rural settings had actually grown up in the areas where they practiced, but said it was a predictor she and her colleagues were considering in a secondary analysis.

“Historically, we have attracted students who did grow up in the Upper Peninsula, but many students who become interested in rural practice actually don’t grow up in rural communities,” Dr. Phillips said.

During the time period studied, 55 percent of rural training track graduates chose to set up a primary care practice, roughly 15 percent more than the ratio of students graduated by the college’s main medical facility (P = .015). More than half of rural track graduates also chose to practice in Michigan, compared with 40 percent of the medical school graduates from the main campus (P = .006). A quarter of the rural program’s graduates stayed to practice in the Upper Peninsula, compared with the one percent of physicians graduated from the main campus (P less than .001) who chose to settle in the Upper Peninsula. Overall, 42.2 percent of rural program graduates set up practice in any rural area during the time period studied, compared with 13 percent of graduates from the main medical school (P less than .001)

Dr. Phillips and her colleagues considered a community rural if it met Code 4 specifications from the U.S. Department of Agriculture’s Rural Continuum – typically populations of 20,000 or less. The results of the program are impressive, Dr. Dana E. King, professor and chair of family medicine at the University of West Virginia, said in an interview.

Being able to attract people to places that are somehow geographically undesirable, either because they are isolated, have harsh winters, or aren’t near a city, is difficult.” The key to success is appealing to the physician’s spouse, said Dr. King. “What if you’re married to a Ph.D. in something, or another physician? There is a challenge to provide enough opportunities for both the physician and spouse. The fact that [Michigan State University’s rural practice program] has had these kind of results is a testament to the fact that it pays attention to the needs of the physician’s family and to the entire community.”

Dr. King, who is the secretary and treasurer of the North American Primary Care Research Group, is not affiliated with the study.

Dr. Phillips said that the program curriculum does address the specific challenges -- and rewards -- of living and practicing in a rural community, but that the program’s rural location itself was the most instructive. “The students are already there. They’re in medical school in a rural setting. They don’t need to go somewhere else to learn about a rural life after they learn medicine.”

On Twitter @whitneymcknight

[email protected]

NEW YORK – Graduates of a clinical program designed to train family practice physicians in a rural setting were significantly more likely to practice in rural areas than their peers who trained in a medical school located in more populous areas, according to a poster presented at this year’s North American Primary Care Research Group annual meeting.

Over a ten-year period, nearly half of all graduates of the Michigan State University College of Human Medicine’s Rural Physician Program, a clinical track specifically designed to expose students to life and practice in a rural setting, chose to practice in a rural setting, nearly four times more than graduates of the university’s main campus medical school.

Whitney McKnight/Frontline Medical News

“When the program started, there was a lot of skepticism as to whether it would be successful,” Dr. Julie Phillips, a family physician and assistant dean for student career development at the University’s East Lansing campus, said in an interview. An author of the retrospective analysis, Dr. Phillips said the program enrolls an average of 12 students annually, a quarter of whom stay in the region to set up practice.

The program was created in 1974 to address a shortage of family physicians in Michigan’s Upper Peninsula, and enrolls students who express an interest in rural practice. Once a student’s clinical training is complete, including a residency that typically occurs in Marquette, the Upper Peninsula’s most populous city with just under 22,000 residents, but a retrospective cohort analysis showed that 42.2 percent of participants enrolled from 1996 to 2006 chose to either return or stay in a more rural setting to set up their practice.

“It looks like [the program] has been a success,” Dr. Phillips said.

She also said relative to other medical schools, the program graduates tended to remain in the state and set up family care practices post-graduation, but that the rural residency program was “significantly better” at attracting physicians than the college’s traditional medical school program. She did not know what proportion of the program graduates who chose rural settings had actually grown up in the areas where they practiced, but said it was a predictor she and her colleagues were considering in a secondary analysis.

“Historically, we have attracted students who did grow up in the Upper Peninsula, but many students who become interested in rural practice actually don’t grow up in rural communities,” Dr. Phillips said.

During the time period studied, 55 percent of rural training track graduates chose to set up a primary care practice, roughly 15 percent more than the ratio of students graduated by the college’s main medical facility (P = .015). More than half of rural track graduates also chose to practice in Michigan, compared with 40 percent of the medical school graduates from the main campus (P = .006). A quarter of the rural program’s graduates stayed to practice in the Upper Peninsula, compared with the one percent of physicians graduated from the main campus (P less than .001) who chose to settle in the Upper Peninsula. Overall, 42.2 percent of rural program graduates set up practice in any rural area during the time period studied, compared with 13 percent of graduates from the main medical school (P less than .001)

Dr. Phillips and her colleagues considered a community rural if it met Code 4 specifications from the U.S. Department of Agriculture’s Rural Continuum – typically populations of 20,000 or less. The results of the program are impressive, Dr. Dana E. King, professor and chair of family medicine at the University of West Virginia, said in an interview.

Being able to attract people to places that are somehow geographically undesirable, either because they are isolated, have harsh winters, or aren’t near a city, is difficult.” The key to success is appealing to the physician’s spouse, said Dr. King. “What if you’re married to a Ph.D. in something, or another physician? There is a challenge to provide enough opportunities for both the physician and spouse. The fact that [Michigan State University’s rural practice program] has had these kind of results is a testament to the fact that it pays attention to the needs of the physician’s family and to the entire community.”

Dr. King, who is the secretary and treasurer of the North American Primary Care Research Group, is not affiliated with the study.

Dr. Phillips said that the program curriculum does address the specific challenges -- and rewards -- of living and practicing in a rural community, but that the program’s rural location itself was the most instructive. “The students are already there. They’re in medical school in a rural setting. They don’t need to go somewhere else to learn about a rural life after they learn medicine.”

On Twitter @whitneymcknight

[email protected]

BETHESDA, MD.– The National Children’s Study, congressionally mandated in 2000 to better understand phenotypical influences on American-born children, has been scrapped.

The longitudinal cohort study intended to observe 100,000 children from birth to at least age 21 years has provided infeasible, according to Dr. Francis S. Collins, director of the National Institutes of Health, explaining his decision to end it. “This study failed to achieve its goals,” based in large part to its cumbersome management by multiple committees, adherence to outdated biological science and technologies, and excessive costs during an era of austerity at the NIH, Dr. Collins said.

In an internal memo issued by the Advisory Committee to the Director of the NIH, posted on the NIH website along with Dr. Collins’s statement, the NCS was faulted for its “overly complex” sampling design and an overall design that was “incomplete even after years of effort.” The internal report also declared that despite the NCS’s intended launch date of 2015, there was no discernible manual of standard protocols.

Pending the ACD report, which was based on a similar review of the NCS earlier this year by the National Academies of Science, Dr. Collins previously had suspended the study in June.

The NCS’s roots go back to a 1990s White House Task force that concluded the United States sorely lacked data linking environmental exposure, development, and health outcomes in children. Congress then passed the Children’s Health Act of 2000 authorizing the National Institute of Child Health and Human Development to conduct a study to address that need. Since funding for the mandate began in 2007, nearly $1.3 billion have been allocated to the NCS, despite what the ACD concluded was the study’s lack of any discernible impact.

The ACD report also found that because the scientific landscape has changed dramatically since the NCS was passed into law, other nimbler and more accurate pathways to data collection could be tapped in lieu of the study, such as partnering with health insurers whose interest in research has ascended in the last decades or collaborating with multicenter networks already employing newly devised sophisticated phenotyping technologies to investigate similar concerns.

Dr. Collins said he agreed with the ACD’s overall conclusion that the need for conclusive data linking childhood health outcomes with environmental and developmental influences, but that these aims could be achieved by considering “alternative approaches ... in consultation with the broader scientific community.”

Dr. Collins said that data from the NCS’s pilot Vanguard Study, which tested potential study methodologies, will be archived and available upon request to investigators interested in conducting secondary analyses. According to the ACD report, the Vanguard project yielded 112 papers, primarily on study design, but with some preliminary results related to environmental exposure in childhood. David Murray, Ph.D., NIH associate director for prevention, will head the study’s closure. Meanwhile, Dr. Collins said that he will lead the NIH in talks with Congress and the Obama Administration to fully discontinue the NCS.

[email protected]

On Twitter @whitneymcknight

BETHESDA, MD.– The National Children’s Study, congressionally mandated in 2000 to better understand phenotypical influences on American-born children, has been scrapped.

The longitudinal cohort study intended to observe 100,000 children from birth to at least age 21 years has provided infeasible, according to Dr. Francis S. Collins, director of the National Institutes of Health, explaining his decision to end it. “This study failed to achieve its goals,” based in large part to its cumbersome management by multiple committees, adherence to outdated biological science and technologies, and excessive costs during an era of austerity at the NIH, Dr. Collins said.

In an internal memo issued by the Advisory Committee to the Director of the NIH, posted on the NIH website along with Dr. Collins’s statement, the NCS was faulted for its “overly complex” sampling design and an overall design that was “incomplete even after years of effort.” The internal report also declared that despite the NCS’s intended launch date of 2015, there was no discernible manual of standard protocols.

Pending the ACD report, which was based on a similar review of the NCS earlier this year by the National Academies of Science, Dr. Collins previously had suspended the study in June.

The NCS’s roots go back to a 1990s White House Task force that concluded the United States sorely lacked data linking environmental exposure, development, and health outcomes in children. Congress then passed the Children’s Health Act of 2000 authorizing the National Institute of Child Health and Human Development to conduct a study to address that need. Since funding for the mandate began in 2007, nearly $1.3 billion have been allocated to the NCS, despite what the ACD concluded was the study’s lack of any discernible impact.

The ACD report also found that because the scientific landscape has changed dramatically since the NCS was passed into law, other nimbler and more accurate pathways to data collection could be tapped in lieu of the study, such as partnering with health insurers whose interest in research has ascended in the last decades or collaborating with multicenter networks already employing newly devised sophisticated phenotyping technologies to investigate similar concerns.

Dr. Collins said he agreed with the ACD’s overall conclusion that the need for conclusive data linking childhood health outcomes with environmental and developmental influences, but that these aims could be achieved by considering “alternative approaches ... in consultation with the broader scientific community.”

Dr. Collins said that data from the NCS’s pilot Vanguard Study, which tested potential study methodologies, will be archived and available upon request to investigators interested in conducting secondary analyses. According to the ACD report, the Vanguard project yielded 112 papers, primarily on study design, but with some preliminary results related to environmental exposure in childhood. David Murray, Ph.D., NIH associate director for prevention, will head the study’s closure. Meanwhile, Dr. Collins said that he will lead the NIH in talks with Congress and the Obama Administration to fully discontinue the NCS.

[email protected]

On Twitter @whitneymcknight

BETHESDA, MD.– The National Children’s Study, congressionally mandated in 2000 to better understand phenotypical influences on American-born children, has been scrapped.

The longitudinal cohort study intended to observe 100,000 children from birth to at least age 21 years has provided infeasible, according to Dr. Francis S. Collins, director of the National Institutes of Health, explaining his decision to end it. “This study failed to achieve its goals,” based in large part to its cumbersome management by multiple committees, adherence to outdated biological science and technologies, and excessive costs during an era of austerity at the NIH, Dr. Collins said.

In an internal memo issued by the Advisory Committee to the Director of the NIH, posted on the NIH website along with Dr. Collins’s statement, the NCS was faulted for its “overly complex” sampling design and an overall design that was “incomplete even after years of effort.” The internal report also declared that despite the NCS’s intended launch date of 2015, there was no discernible manual of standard protocols.

Pending the ACD report, which was based on a similar review of the NCS earlier this year by the National Academies of Science, Dr. Collins previously had suspended the study in June.

The NCS’s roots go back to a 1990s White House Task force that concluded the United States sorely lacked data linking environmental exposure, development, and health outcomes in children. Congress then passed the Children’s Health Act of 2000 authorizing the National Institute of Child Health and Human Development to conduct a study to address that need. Since funding for the mandate began in 2007, nearly $1.3 billion have been allocated to the NCS, despite what the ACD concluded was the study’s lack of any discernible impact.

The ACD report also found that because the scientific landscape has changed dramatically since the NCS was passed into law, other nimbler and more accurate pathways to data collection could be tapped in lieu of the study, such as partnering with health insurers whose interest in research has ascended in the last decades or collaborating with multicenter networks already employing newly devised sophisticated phenotyping technologies to investigate similar concerns.

Dr. Collins said he agreed with the ACD’s overall conclusion that the need for conclusive data linking childhood health outcomes with environmental and developmental influences, but that these aims could be achieved by considering “alternative approaches ... in consultation with the broader scientific community.”

Dr. Collins said that data from the NCS’s pilot Vanguard Study, which tested potential study methodologies, will be archived and available upon request to investigators interested in conducting secondary analyses. According to the ACD report, the Vanguard project yielded 112 papers, primarily on study design, but with some preliminary results related to environmental exposure in childhood. David Murray, Ph.D., NIH associate director for prevention, will head the study’s closure. Meanwhile, Dr. Collins said that he will lead the NIH in talks with Congress and the Obama Administration to fully discontinue the NCS.

[email protected]

On Twitter @whitneymcknight