Faster clearance of vedolizumab associated with less mucosal healing in UC

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Faster clearance of vedolizumab associated with less mucosal healing in UC

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.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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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.

wmcknight@frontlinemedcom.com

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.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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Key clinical point: Patients with higher endoscopic subscores may be clearing vedolizumab faster than are those who show more mucosal healing.

Major finding: At 6 weeks, patients with higher trough concentrations of vedolizumab had lower endoscopic subscores.

Data source: Post hoc analysis of 693 ulcerative colitis patients from phase III, randomized GEMINI-1 study of vedolizumab’s efficacy in UC.

Disclosures: Dr. Rosario is a director at Takeda Pharmaceuticals, manufacturer of Entyvio, the brand name for vedolizumab.

Rural residency program trains, keeps more family physicians

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Rural residency program trains, keeps more family physicians

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
Dr. Julie Philips

“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

wmcknight@frontlinemedcom.com

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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
Dr. Julie Philips

“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

wmcknight@frontlinemedcom.com

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
Dr. Julie Philips

“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

wmcknight@frontlinemedcom.com

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Key clinical point: Clinical training programs designed specifically around rural communities can increase the number of physicians who choose to practice permanently in these settings.

Major finding: Graduates of a rural physician training program were significantly more likely to practice in rural areas, compared with graduates from non-rural physician programs (P less than .001).

Data source: Retrospective cohort study analysis of rural physician training program graduates and non-rural physician training from a single academic center between 1996 and 2006.

Disclosures: Dr. Phillips did not have any relevant disclosures.

NIH scraps unwieldy National Children’s Study

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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.

Dr. Francis S. Collins

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.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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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.

Dr. Francis S. Collins

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.

wmcknight@frontlinemedcom.com

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.

Dr. Francis S. Collins

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.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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VIDEO: ‘Meaningless use’? Quality measures pit physicians against patients

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VIDEO: ‘Meaningless use’? Quality measures pit physicians against patients

NEW YORK – Because quality measures intended to create patient-centered care are impractical, elitist, and ungrounded in the realities of most patients’ lives, physicians are forced to choose between being a failure, a bully, or both.

That’s according to Dr. Richard Young, director of research at the John S. Peters Health System in Fort Worth, Tex., and a speaker at the annual meeting of the North American Primary Care Research Group.

“The grand irony is that patient-centered care ... becomes a carrot-and-stick measurement system that incentivizes [doctors] to get what [they] want patients to do, not what the patients want,” Dr. Young said.

In a video interview, he also explains how borrowing “exception reporting” as practiced in the United Kingdom’s National Health Service would make the United States’ own quality measurement system more practical. Dr. Young also explains how physicians’ fear of missing quality measurement marks may lead them to avoid taking on the sickest and neediest of patients.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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NEW YORK – Because quality measures intended to create patient-centered care are impractical, elitist, and ungrounded in the realities of most patients’ lives, physicians are forced to choose between being a failure, a bully, or both.

That’s according to Dr. Richard Young, director of research at the John S. Peters Health System in Fort Worth, Tex., and a speaker at the annual meeting of the North American Primary Care Research Group.

“The grand irony is that patient-centered care ... becomes a carrot-and-stick measurement system that incentivizes [doctors] to get what [they] want patients to do, not what the patients want,” Dr. Young said.

In a video interview, he also explains how borrowing “exception reporting” as practiced in the United Kingdom’s National Health Service would make the United States’ own quality measurement system more practical. Dr. Young also explains how physicians’ fear of missing quality measurement marks may lead them to avoid taking on the sickest and neediest of patients.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

NEW YORK – Because quality measures intended to create patient-centered care are impractical, elitist, and ungrounded in the realities of most patients’ lives, physicians are forced to choose between being a failure, a bully, or both.

That’s according to Dr. Richard Young, director of research at the John S. Peters Health System in Fort Worth, Tex., and a speaker at the annual meeting of the North American Primary Care Research Group.

“The grand irony is that patient-centered care ... becomes a carrot-and-stick measurement system that incentivizes [doctors] to get what [they] want patients to do, not what the patients want,” Dr. Young said.

In a video interview, he also explains how borrowing “exception reporting” as practiced in the United Kingdom’s National Health Service would make the United States’ own quality measurement system more practical. Dr. Young also explains how physicians’ fear of missing quality measurement marks may lead them to avoid taking on the sickest and neediest of patients.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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Study: FPs with maternity care skills still needed in rural United States

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Study: FPs with maternity care skills still needed in rural United States

NEW YORK - In rural hospitals, family physicians are very likely to deliver babies, even if the facility has at least one obstetrician with admitting privileges, according to survey results of 457 chief executives of rural American hospitals.

The survey also showed that, in southwestern and western states like Texas and Montana, nearly all maternity care–skilled FPs were likely to perform any necessary C-sections, although, across the country, only 63% of FPs are able to deliver cesarean births, Dr. Richard Young said at the annual meeting of the North American Primary Care Research Group.

Just over two-thirds of the respondents said they had dedicated maternity facilities where, on average, 271 babies are born annually, with just over a quarter being delivered by C-section. The hospital executives reported an average ratio of 1.6 obstetricians to every 2.8 maternity-skilled family practitioners, according to Dr. Young, director of research and associate director of the family medicine residency program at John Peters Smith Hospital in Ft. Worth, Tex., which is affiliated with the University of Texas.

Going by the numbers, the average numbers of vaginal and caesarean births a rural hospital required a family doctor to have performed to receive hospital admitting privileges were 40 and 35, respectively.

Whitney McKnight/Frontline Medical News
"Family doctors continue to provide the majority of maternity care in rural U.S. hospitals," Dr. Richard Young said.

Because so many respondents either answered the question loosely or not at all, short of having been fellowship trained, “basically, if you claimed you could do this, then ol’ doc Pritchard would watch you do it, and if he said you were good, then you were good,” he concluded.

Practicing midwives in these hospitals were essentially nonexistent.

The findings point to a need for family practice residency programs to include and, in some cases, expand their maternity medicine offerings. “Rural America needs us,” Dr. Young said.

Other data support his imperative. The American Congress of Obstetricians and Gynecologists reports that nearly half of all 3,107 U.S. counties, many of them in rural areas, lack even one ob.gyn. Meanwhile, a 2013 study published in the Journal of Women’s Health and conducted in part by ACOG indicated that, even by modest measures, in 2020 the demand for maternity care specialists would increase 6%, much of it in states with large rural populations, such as Texas, Nevada, and Idaho, yet the number of ob.gyns. entering the field has remained relatively flat since 1980.

In Dr. Young’s survey, the number of acute-care beds corresponded to the maternity-care workload of the family care physicians. Overall, family physicians who offered maternity care tended to figure most prominently in hospitals with 100 beds or fewer, while facilities with 150 beds or more had double the number of OBs as maternity-skilled FPs; however, even then, two-thirds of the FPs still performed their own C-sections.

The study’s accuracy was limited because not all states were represented in the data, and Dr. Young was unsure if he had been able to reach all rural hospital facilities in each state (his initial mailing was to approximately 1,000 facilities). Of the states where hospital executives did respond, three-quarters of the hospitals were critical-access facilities, 60% were nonprofit centers, and just over a quarter were government run. The rest were either for-profit facilities or other types of centers.

Despite what he said were cultural differences from state to state, Dr. Young said that “family doctors continue to provide the majority of maternity care in rural U.S. hospitals.”

The implications of this, he said, were that, even though it was evident from the low threshold for admitting privileges across the facilities surveyed, family medicine residency programs “know what they need to teach … and we’ve got to keep training these doctors how to do obstetrics, including C-sections, because the OBs aren’t going to go to [rural areas] and do it.”

wmcknight@frontlinemedcom.com 


On Twitter @whitneymcknight

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NEW YORK - In rural hospitals, family physicians are very likely to deliver babies, even if the facility has at least one obstetrician with admitting privileges, according to survey results of 457 chief executives of rural American hospitals.

The survey also showed that, in southwestern and western states like Texas and Montana, nearly all maternity care–skilled FPs were likely to perform any necessary C-sections, although, across the country, only 63% of FPs are able to deliver cesarean births, Dr. Richard Young said at the annual meeting of the North American Primary Care Research Group.

Just over two-thirds of the respondents said they had dedicated maternity facilities where, on average, 271 babies are born annually, with just over a quarter being delivered by C-section. The hospital executives reported an average ratio of 1.6 obstetricians to every 2.8 maternity-skilled family practitioners, according to Dr. Young, director of research and associate director of the family medicine residency program at John Peters Smith Hospital in Ft. Worth, Tex., which is affiliated with the University of Texas.

Going by the numbers, the average numbers of vaginal and caesarean births a rural hospital required a family doctor to have performed to receive hospital admitting privileges were 40 and 35, respectively.

Whitney McKnight/Frontline Medical News
"Family doctors continue to provide the majority of maternity care in rural U.S. hospitals," Dr. Richard Young said.

Because so many respondents either answered the question loosely or not at all, short of having been fellowship trained, “basically, if you claimed you could do this, then ol’ doc Pritchard would watch you do it, and if he said you were good, then you were good,” he concluded.

Practicing midwives in these hospitals were essentially nonexistent.

The findings point to a need for family practice residency programs to include and, in some cases, expand their maternity medicine offerings. “Rural America needs us,” Dr. Young said.

Other data support his imperative. The American Congress of Obstetricians and Gynecologists reports that nearly half of all 3,107 U.S. counties, many of them in rural areas, lack even one ob.gyn. Meanwhile, a 2013 study published in the Journal of Women’s Health and conducted in part by ACOG indicated that, even by modest measures, in 2020 the demand for maternity care specialists would increase 6%, much of it in states with large rural populations, such as Texas, Nevada, and Idaho, yet the number of ob.gyns. entering the field has remained relatively flat since 1980.

In Dr. Young’s survey, the number of acute-care beds corresponded to the maternity-care workload of the family care physicians. Overall, family physicians who offered maternity care tended to figure most prominently in hospitals with 100 beds or fewer, while facilities with 150 beds or more had double the number of OBs as maternity-skilled FPs; however, even then, two-thirds of the FPs still performed their own C-sections.

The study’s accuracy was limited because not all states were represented in the data, and Dr. Young was unsure if he had been able to reach all rural hospital facilities in each state (his initial mailing was to approximately 1,000 facilities). Of the states where hospital executives did respond, three-quarters of the hospitals were critical-access facilities, 60% were nonprofit centers, and just over a quarter were government run. The rest were either for-profit facilities or other types of centers.

Despite what he said were cultural differences from state to state, Dr. Young said that “family doctors continue to provide the majority of maternity care in rural U.S. hospitals.”

The implications of this, he said, were that, even though it was evident from the low threshold for admitting privileges across the facilities surveyed, family medicine residency programs “know what they need to teach … and we’ve got to keep training these doctors how to do obstetrics, including C-sections, because the OBs aren’t going to go to [rural areas] and do it.”

wmcknight@frontlinemedcom.com 


On Twitter @whitneymcknight

NEW YORK - In rural hospitals, family physicians are very likely to deliver babies, even if the facility has at least one obstetrician with admitting privileges, according to survey results of 457 chief executives of rural American hospitals.

The survey also showed that, in southwestern and western states like Texas and Montana, nearly all maternity care–skilled FPs were likely to perform any necessary C-sections, although, across the country, only 63% of FPs are able to deliver cesarean births, Dr. Richard Young said at the annual meeting of the North American Primary Care Research Group.

Just over two-thirds of the respondents said they had dedicated maternity facilities where, on average, 271 babies are born annually, with just over a quarter being delivered by C-section. The hospital executives reported an average ratio of 1.6 obstetricians to every 2.8 maternity-skilled family practitioners, according to Dr. Young, director of research and associate director of the family medicine residency program at John Peters Smith Hospital in Ft. Worth, Tex., which is affiliated with the University of Texas.

Going by the numbers, the average numbers of vaginal and caesarean births a rural hospital required a family doctor to have performed to receive hospital admitting privileges were 40 and 35, respectively.

Whitney McKnight/Frontline Medical News
"Family doctors continue to provide the majority of maternity care in rural U.S. hospitals," Dr. Richard Young said.

Because so many respondents either answered the question loosely or not at all, short of having been fellowship trained, “basically, if you claimed you could do this, then ol’ doc Pritchard would watch you do it, and if he said you were good, then you were good,” he concluded.

Practicing midwives in these hospitals were essentially nonexistent.

The findings point to a need for family practice residency programs to include and, in some cases, expand their maternity medicine offerings. “Rural America needs us,” Dr. Young said.

Other data support his imperative. The American Congress of Obstetricians and Gynecologists reports that nearly half of all 3,107 U.S. counties, many of them in rural areas, lack even one ob.gyn. Meanwhile, a 2013 study published in the Journal of Women’s Health and conducted in part by ACOG indicated that, even by modest measures, in 2020 the demand for maternity care specialists would increase 6%, much of it in states with large rural populations, such as Texas, Nevada, and Idaho, yet the number of ob.gyns. entering the field has remained relatively flat since 1980.

In Dr. Young’s survey, the number of acute-care beds corresponded to the maternity-care workload of the family care physicians. Overall, family physicians who offered maternity care tended to figure most prominently in hospitals with 100 beds or fewer, while facilities with 150 beds or more had double the number of OBs as maternity-skilled FPs; however, even then, two-thirds of the FPs still performed their own C-sections.

The study’s accuracy was limited because not all states were represented in the data, and Dr. Young was unsure if he had been able to reach all rural hospital facilities in each state (his initial mailing was to approximately 1,000 facilities). Of the states where hospital executives did respond, three-quarters of the hospitals were critical-access facilities, 60% were nonprofit centers, and just over a quarter were government run. The rest were either for-profit facilities or other types of centers.

Despite what he said were cultural differences from state to state, Dr. Young said that “family doctors continue to provide the majority of maternity care in rural U.S. hospitals.”

The implications of this, he said, were that, even though it was evident from the low threshold for admitting privileges across the facilities surveyed, family medicine residency programs “know what they need to teach … and we’ve got to keep training these doctors how to do obstetrics, including C-sections, because the OBs aren’t going to go to [rural areas] and do it.”

wmcknight@frontlinemedcom.com 


On Twitter @whitneymcknight

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Key clinical point: Family physician residency programs must provide extensive maternity care training.

Major finding: Family physicians are twice as likely, on average, to deliver babies in the rural United States, compared with OBs; two-thirds of these FPs perform C-sections.

Data source: Survey of 457 rural American hospital CEOs.

Disclosures: Neither Dr. Young nor his associate, Dr. Kelsey Walker, had any relevant disclosures. The study was made possible by a grant from the Texas Academy of Family Physicians.

Immunosuppression not tied to subsequent cancer in IBD with cancer history

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Immunosuppression not tied to subsequent cancer in IBD with cancer history

ORLANDO – Immunosuppressive therapies were not associated with subsequent cancers in patients with inflammatory bowel disease who also had a history of cancer, a retrospective analysis showed.

In a review of 185 patient records from three sites chosen according to whether the person had both a history of cancer and a confirmed diagnosis of inflammatory bowel disease (IBD), patients had at least one follow-up visit after their respective cancer diagnosis.

There were three study arms: 65 patients who’d been treated for their IBD with anti–TNF-alpha immunosuppression, 46 patients who’d received antimetabolite immunosuppressive treatment, and 74 controls who’d not been exposed to immunosuppression. The primary outcome was the development of incident cancer, whether new or recurrent, as calculated from the date of the initial cancer diagnosis to the date of the recurrent or new malignancy or to the date of the patient’s last clinical visit.

Dr. Jordan Axelrad

Nearly a third of all patients developed incident cancer during the follow-up period, but there were not any statistically significant differences in incident rates between groups, Dr. Jordan Axelrad reported at a conference on inflammatory bowel diseases, sponsored by the Crohn’s & Colitis Foundation of America.

Just over 14% of all patients developed a new cancer, 12% developed a recurrent cancer, and slightly less than 3% developed both a new and recurrent cancer.

“There were qualitatively more skin cancers in the anti–TNF[-alpha] group, and more GI cancers in the control group,” said Dr. Axelrad of Mt. Sinai Hospital in New York.

Solid cancers occurred primarily in the control and antimetabolite groups, 46.4% and 46.2%, respectively. Hematologic cancers were least common, with none in the control group and one each in the study arms.

In addition, Dr. Axelrad said that at 5 years post follow-up, there was no significant difference in cancer-free survival rates between the three groups (P = .086).

Because the study was limited by a lack of data on any dose-related effects or periods of cancer remission, as well as the population size, Dr. Axelrad said he hoped a consortium effort by the New York Crohn’s and Colitis Organization, which includes Mt. Sinai, would help collect sufficient data to make future, higher-powered studies possible.

Dr. Axelrad said he had no relevant financial disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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ORLANDO – Immunosuppressive therapies were not associated with subsequent cancers in patients with inflammatory bowel disease who also had a history of cancer, a retrospective analysis showed.

In a review of 185 patient records from three sites chosen according to whether the person had both a history of cancer and a confirmed diagnosis of inflammatory bowel disease (IBD), patients had at least one follow-up visit after their respective cancer diagnosis.

There were three study arms: 65 patients who’d been treated for their IBD with anti–TNF-alpha immunosuppression, 46 patients who’d received antimetabolite immunosuppressive treatment, and 74 controls who’d not been exposed to immunosuppression. The primary outcome was the development of incident cancer, whether new or recurrent, as calculated from the date of the initial cancer diagnosis to the date of the recurrent or new malignancy or to the date of the patient’s last clinical visit.

Dr. Jordan Axelrad

Nearly a third of all patients developed incident cancer during the follow-up period, but there were not any statistically significant differences in incident rates between groups, Dr. Jordan Axelrad reported at a conference on inflammatory bowel diseases, sponsored by the Crohn’s & Colitis Foundation of America.

Just over 14% of all patients developed a new cancer, 12% developed a recurrent cancer, and slightly less than 3% developed both a new and recurrent cancer.

“There were qualitatively more skin cancers in the anti–TNF[-alpha] group, and more GI cancers in the control group,” said Dr. Axelrad of Mt. Sinai Hospital in New York.

Solid cancers occurred primarily in the control and antimetabolite groups, 46.4% and 46.2%, respectively. Hematologic cancers were least common, with none in the control group and one each in the study arms.

In addition, Dr. Axelrad said that at 5 years post follow-up, there was no significant difference in cancer-free survival rates between the three groups (P = .086).

Because the study was limited by a lack of data on any dose-related effects or periods of cancer remission, as well as the population size, Dr. Axelrad said he hoped a consortium effort by the New York Crohn’s and Colitis Organization, which includes Mt. Sinai, would help collect sufficient data to make future, higher-powered studies possible.

Dr. Axelrad said he had no relevant financial disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

ORLANDO – Immunosuppressive therapies were not associated with subsequent cancers in patients with inflammatory bowel disease who also had a history of cancer, a retrospective analysis showed.

In a review of 185 patient records from three sites chosen according to whether the person had both a history of cancer and a confirmed diagnosis of inflammatory bowel disease (IBD), patients had at least one follow-up visit after their respective cancer diagnosis.

There were three study arms: 65 patients who’d been treated for their IBD with anti–TNF-alpha immunosuppression, 46 patients who’d received antimetabolite immunosuppressive treatment, and 74 controls who’d not been exposed to immunosuppression. The primary outcome was the development of incident cancer, whether new or recurrent, as calculated from the date of the initial cancer diagnosis to the date of the recurrent or new malignancy or to the date of the patient’s last clinical visit.

Dr. Jordan Axelrad

Nearly a third of all patients developed incident cancer during the follow-up period, but there were not any statistically significant differences in incident rates between groups, Dr. Jordan Axelrad reported at a conference on inflammatory bowel diseases, sponsored by the Crohn’s & Colitis Foundation of America.

Just over 14% of all patients developed a new cancer, 12% developed a recurrent cancer, and slightly less than 3% developed both a new and recurrent cancer.

“There were qualitatively more skin cancers in the anti–TNF[-alpha] group, and more GI cancers in the control group,” said Dr. Axelrad of Mt. Sinai Hospital in New York.

Solid cancers occurred primarily in the control and antimetabolite groups, 46.4% and 46.2%, respectively. Hematologic cancers were least common, with none in the control group and one each in the study arms.

In addition, Dr. Axelrad said that at 5 years post follow-up, there was no significant difference in cancer-free survival rates between the three groups (P = .086).

Because the study was limited by a lack of data on any dose-related effects or periods of cancer remission, as well as the population size, Dr. Axelrad said he hoped a consortium effort by the New York Crohn’s and Colitis Organization, which includes Mt. Sinai, would help collect sufficient data to make future, higher-powered studies possible.

Dr. Axelrad said he had no relevant financial disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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Key clinical point: Immunosuppressive therapy in IBD patients is not related to cancer in patients with a history of cancer.

Major finding: There were no statistical differences between IBD patients exposed to various forms of immunosuppression and controls.

Data source: A multisite retrospective analysis of 185 records from patients with IBD and cancer and at least one follow-up postcancer diagnosis.

Disclosures: Dr. Axelrad said he had no relevant financial disclosures.

Lose the weight or lose the money: Online weight-loss contracts gain favor

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Lose the weight or lose the money: Online weight-loss contracts gain favor

NEW YORK – The more you stand to lose, the deeper your commitment to losing, particularly when it’s your wallet and not your word that’s at stake.

People who contractually committed online to lose a certain amount of weight or else fork over a predetermined amount of cash to a friend, a favorite charity, or even a hated charity were, on average, successful at losing 5.2% of their body weight, according to preliminary data presented at the annual meeting of the North American Primary Care Research Group.

Dr. Lenard Lesser

In a retrospective analysis of 5,024 self-selected participants in an online contractual weight loss site, 70% of whom were women whose average age was 39 years, the ones who pledged to let their money go to an “anticharity” if they didn’t meet their weight loss goals lost nearly 8% of their body weight. Those who pledged to give to a favorite charity lost just under 7%, and those who promised to pay a friend if they didn’t succeed lost 6.3% of their body weight. Those whose commitment did not involve any cash lost 3.4% of their body weight.

“If you are for gun control, your anticharity would be the National Rifle Association,” Dr. Lenard Lesser, a family physician and researcher at the Palo Alto (Calif.) Medical Foundation and Research Institute, said in an interview. “So, if you don’t lose the weight you said you’d lose, then the money you committed would go to the NRA.”

There was no statistical difference in weight loss between those who committed to either a charity or an anticharity, but according to Dr. Lesser, the data, set to be published in the near future, indicated that there was a statistical difference between the amount of weight lost when money was committed compared with when no money was committed. “People are averse to losing money wherever it goes,” he said.

The average duration of the weight loss commitments in the online weight loss commitment study were between 10 and 16 weeks, but it is unclear whether the weight loss was permanent, and whether the contracts could serve as a viable weight loss intervention in the primary care setting, according to Dr. Lesser. “We don’t know what happens to these people long term. We need to explore how these contracts can be integrated into a more comprehensive system.”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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NEW YORK – The more you stand to lose, the deeper your commitment to losing, particularly when it’s your wallet and not your word that’s at stake.

People who contractually committed online to lose a certain amount of weight or else fork over a predetermined amount of cash to a friend, a favorite charity, or even a hated charity were, on average, successful at losing 5.2% of their body weight, according to preliminary data presented at the annual meeting of the North American Primary Care Research Group.

Dr. Lenard Lesser

In a retrospective analysis of 5,024 self-selected participants in an online contractual weight loss site, 70% of whom were women whose average age was 39 years, the ones who pledged to let their money go to an “anticharity” if they didn’t meet their weight loss goals lost nearly 8% of their body weight. Those who pledged to give to a favorite charity lost just under 7%, and those who promised to pay a friend if they didn’t succeed lost 6.3% of their body weight. Those whose commitment did not involve any cash lost 3.4% of their body weight.

“If you are for gun control, your anticharity would be the National Rifle Association,” Dr. Lenard Lesser, a family physician and researcher at the Palo Alto (Calif.) Medical Foundation and Research Institute, said in an interview. “So, if you don’t lose the weight you said you’d lose, then the money you committed would go to the NRA.”

There was no statistical difference in weight loss between those who committed to either a charity or an anticharity, but according to Dr. Lesser, the data, set to be published in the near future, indicated that there was a statistical difference between the amount of weight lost when money was committed compared with when no money was committed. “People are averse to losing money wherever it goes,” he said.

The average duration of the weight loss commitments in the online weight loss commitment study were between 10 and 16 weeks, but it is unclear whether the weight loss was permanent, and whether the contracts could serve as a viable weight loss intervention in the primary care setting, according to Dr. Lesser. “We don’t know what happens to these people long term. We need to explore how these contracts can be integrated into a more comprehensive system.”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

NEW YORK – The more you stand to lose, the deeper your commitment to losing, particularly when it’s your wallet and not your word that’s at stake.

People who contractually committed online to lose a certain amount of weight or else fork over a predetermined amount of cash to a friend, a favorite charity, or even a hated charity were, on average, successful at losing 5.2% of their body weight, according to preliminary data presented at the annual meeting of the North American Primary Care Research Group.

Dr. Lenard Lesser

In a retrospective analysis of 5,024 self-selected participants in an online contractual weight loss site, 70% of whom were women whose average age was 39 years, the ones who pledged to let their money go to an “anticharity” if they didn’t meet their weight loss goals lost nearly 8% of their body weight. Those who pledged to give to a favorite charity lost just under 7%, and those who promised to pay a friend if they didn’t succeed lost 6.3% of their body weight. Those whose commitment did not involve any cash lost 3.4% of their body weight.

“If you are for gun control, your anticharity would be the National Rifle Association,” Dr. Lenard Lesser, a family physician and researcher at the Palo Alto (Calif.) Medical Foundation and Research Institute, said in an interview. “So, if you don’t lose the weight you said you’d lose, then the money you committed would go to the NRA.”

There was no statistical difference in weight loss between those who committed to either a charity or an anticharity, but according to Dr. Lesser, the data, set to be published in the near future, indicated that there was a statistical difference between the amount of weight lost when money was committed compared with when no money was committed. “People are averse to losing money wherever it goes,” he said.

The average duration of the weight loss commitments in the online weight loss commitment study were between 10 and 16 weeks, but it is unclear whether the weight loss was permanent, and whether the contracts could serve as a viable weight loss intervention in the primary care setting, according to Dr. Lesser. “We don’t know what happens to these people long term. We need to explore how these contracts can be integrated into a more comprehensive system.”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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Key clinical point: Online weight-loss commitment contracts can be effective interventions for patients.

Major finding: People who contractually committed to losing weight lost an average of 5.2% of their body weight; when loss of money was at stake, the body weight losses were highest.

Data source: A retrospective secondary analysis of online commitment contracts from 5,024 self-selected individuals.

Disclosures: Dr. Lesser said he did not have any relevant disclosures.

Less confident nurses more likely to elevate triage level in calls to primary care clinics

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Less confident nurses more likely to elevate triage level in calls to primary care clinics

NEW YORK – Nurses who lacked confidence as telephone triage advisers were more likely than more confident nurses to elevate the triage level of patients calling general practice clinics for same-day service, according to a British report.

The findings have implications for busy general practice physicians who are considering such programs to help ease their daily patient load.

Although there is “broad public support” in Britain for nurse practitioners and general nursing staff taking on many of the tasks usually associated with general practitioners, the manner in which these nurses handle patients varies greatly, according to Anna Varley, a social worker and researcher at the University of East Anglia, Norwich, England, who spoke at the annual meeting of the North American Primary Care Research Group.

Ms. Anna Varley

“Previous research is still equivocal as to explaining exactly why it is that different health professionals make different decisions about the same calls,” Ms. Varley said to a capacity crowd.

However, data from a randomized, controlled study of telephone triage services indicated that a nurse’s self-reported level of preparedness, was key to how – and if – she advised that callers receive follow-up care.

“Therefore, standardized telephone triage training is necessary, but it may not be sufficient,” Ms. Varley said.

The data were part of the larger, clustered, randomized controlled ESTEEM trial conducted across four regions in the United Kingdom between March 2011 and March 2013 to examine the outcomes and cost-effectiveness of telephone triage services. In the study, patients seeking same-day consultations were randomly assigned with intention to treat and by protocol, to either general practice–led phone triage care; nurse practitioner–led, computer-supported phone triage care; or usual practice. Allocation was not blinded to patients, clinicians, or researchers, but practice assignment was concealed from the study’s statistician. In all, 20,990 patient calls were managed by 42 general care clinics, with 77% of all patient-clinician interactions reaching the primary outcome of additional follow-up within 28 days of the initial call. The results of the larger trial were published recently in the Lancet (2014 Nov. 22 [doi:10.1016/S0140-6736(14)61058-8]). For the subanalysis, Ms. Varley and her coinvestigators evaluated the 7,012 patient calls randomly routed to triage intervention from 45 nurses across 15 general practices in the four regions. All of the nursing staff were women, and all had been trained in the use of the clinical decision support software. All nurses were surveyed to discover their levels of training, experience, and facility with triage software. Thirty-five of the original 45 nurses returned valid profiles.

Of these, eight were nurse practitioners, an important distinction given that in the United Kingdom, this denotes more years of formal medical training than other nursing professionals, the authority to diagnose, and typically, the authority to prescribe medication.

The remaining 27 nurses were what are known in Britain as “practice nurses.” This group is not authorized to prescribe, and generally has less authority in other matters as well.

The range of the two groups of nurses’ years of experience was 2.5-40 years, although 89% of all nurse participants had 10 or more years of practical experience; 69% had 20 or more years of experience.

Across both groups, nearly half had prior experience manning triage phone lines, although only 2 of the 35 women had ever used the clinical support software.

At the time of each call, the nurses were asked to rate how prepared they felt for the particulars of the call. These data were included when evaluating how often each nurse recommended a caller for follow-up. Although most calls (86%) were recommended to some form of follow-up, nurse practitioners were less likely than practice nurses to recommend follow-up care (odds ratio, 0.19; confidence interval, 0.07-0.49). Across both groups, nurses who reported less confidence in their ability to manage the call were found more likely to recommend patients for follow-up (OR, 3.17; CI, 1.18-5.55). Additionally, less seasoned nurses, defined as those with 10 or less years of practical experience, had significantly longer mean call durations (OR, 2.58; CI, 0.76-4.40).

As reported in the larger ESTEEM trial, nurse-led triage resulted in an overall 48% increase in patient contacts over a 28-day period, compared with usual care. General practice physician–led triage resulted in a 33% increase over usual care during the same period. Despite the increase in patient contacts, the costs of care were found to remain essentially the same (about 75 British pounds sterling). Eight deaths were reported overall, including two triaged by the nurses, but none of the deaths were associated with the trial itself.

 

 

The overall implications of the study are positive, so long as there is already an established trust between the patient and the general practice clinic, according to Dr. Garey Mazowita, a family practice physician in Vancouver, B.C., who is participating in a telephone screening program for general practitioners in his home province.

“At the heart of the medical home model we are moving toward is the continuity of the relationship between the family care doctor and the patient, and the knowledge that if you do something over the phone that averts an office visit, you’ve still got the security of the relationship [to rely on],” Dr. Mazowita, who is also the president of the College of Family Physicians of Canada, said in an interview. “We think it’s fundamentally safer than if no relationship exists.”

Ms. Varley agreed that how general practice clinics, and in particular, the physicians, related to patients overall was important, but said that for the purpose of nurse-led call screening, it was important to note that while all triage call screening was shown in the study to be comparably safe, “the individual characteristics of nurses independently influenced how telephone triage was implemented.”

Neither Ms. Varley nor Dr. Mazowita had any relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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NEW YORK – Nurses who lacked confidence as telephone triage advisers were more likely than more confident nurses to elevate the triage level of patients calling general practice clinics for same-day service, according to a British report.

The findings have implications for busy general practice physicians who are considering such programs to help ease their daily patient load.

Although there is “broad public support” in Britain for nurse practitioners and general nursing staff taking on many of the tasks usually associated with general practitioners, the manner in which these nurses handle patients varies greatly, according to Anna Varley, a social worker and researcher at the University of East Anglia, Norwich, England, who spoke at the annual meeting of the North American Primary Care Research Group.

Ms. Anna Varley

“Previous research is still equivocal as to explaining exactly why it is that different health professionals make different decisions about the same calls,” Ms. Varley said to a capacity crowd.

However, data from a randomized, controlled study of telephone triage services indicated that a nurse’s self-reported level of preparedness, was key to how – and if – she advised that callers receive follow-up care.

“Therefore, standardized telephone triage training is necessary, but it may not be sufficient,” Ms. Varley said.

The data were part of the larger, clustered, randomized controlled ESTEEM trial conducted across four regions in the United Kingdom between March 2011 and March 2013 to examine the outcomes and cost-effectiveness of telephone triage services. In the study, patients seeking same-day consultations were randomly assigned with intention to treat and by protocol, to either general practice–led phone triage care; nurse practitioner–led, computer-supported phone triage care; or usual practice. Allocation was not blinded to patients, clinicians, or researchers, but practice assignment was concealed from the study’s statistician. In all, 20,990 patient calls were managed by 42 general care clinics, with 77% of all patient-clinician interactions reaching the primary outcome of additional follow-up within 28 days of the initial call. The results of the larger trial were published recently in the Lancet (2014 Nov. 22 [doi:10.1016/S0140-6736(14)61058-8]). For the subanalysis, Ms. Varley and her coinvestigators evaluated the 7,012 patient calls randomly routed to triage intervention from 45 nurses across 15 general practices in the four regions. All of the nursing staff were women, and all had been trained in the use of the clinical decision support software. All nurses were surveyed to discover their levels of training, experience, and facility with triage software. Thirty-five of the original 45 nurses returned valid profiles.

Of these, eight were nurse practitioners, an important distinction given that in the United Kingdom, this denotes more years of formal medical training than other nursing professionals, the authority to diagnose, and typically, the authority to prescribe medication.

The remaining 27 nurses were what are known in Britain as “practice nurses.” This group is not authorized to prescribe, and generally has less authority in other matters as well.

The range of the two groups of nurses’ years of experience was 2.5-40 years, although 89% of all nurse participants had 10 or more years of practical experience; 69% had 20 or more years of experience.

Across both groups, nearly half had prior experience manning triage phone lines, although only 2 of the 35 women had ever used the clinical support software.

At the time of each call, the nurses were asked to rate how prepared they felt for the particulars of the call. These data were included when evaluating how often each nurse recommended a caller for follow-up. Although most calls (86%) were recommended to some form of follow-up, nurse practitioners were less likely than practice nurses to recommend follow-up care (odds ratio, 0.19; confidence interval, 0.07-0.49). Across both groups, nurses who reported less confidence in their ability to manage the call were found more likely to recommend patients for follow-up (OR, 3.17; CI, 1.18-5.55). Additionally, less seasoned nurses, defined as those with 10 or less years of practical experience, had significantly longer mean call durations (OR, 2.58; CI, 0.76-4.40).

As reported in the larger ESTEEM trial, nurse-led triage resulted in an overall 48% increase in patient contacts over a 28-day period, compared with usual care. General practice physician–led triage resulted in a 33% increase over usual care during the same period. Despite the increase in patient contacts, the costs of care were found to remain essentially the same (about 75 British pounds sterling). Eight deaths were reported overall, including two triaged by the nurses, but none of the deaths were associated with the trial itself.

 

 

The overall implications of the study are positive, so long as there is already an established trust between the patient and the general practice clinic, according to Dr. Garey Mazowita, a family practice physician in Vancouver, B.C., who is participating in a telephone screening program for general practitioners in his home province.

“At the heart of the medical home model we are moving toward is the continuity of the relationship between the family care doctor and the patient, and the knowledge that if you do something over the phone that averts an office visit, you’ve still got the security of the relationship [to rely on],” Dr. Mazowita, who is also the president of the College of Family Physicians of Canada, said in an interview. “We think it’s fundamentally safer than if no relationship exists.”

Ms. Varley agreed that how general practice clinics, and in particular, the physicians, related to patients overall was important, but said that for the purpose of nurse-led call screening, it was important to note that while all triage call screening was shown in the study to be comparably safe, “the individual characteristics of nurses independently influenced how telephone triage was implemented.”

Neither Ms. Varley nor Dr. Mazowita had any relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

NEW YORK – Nurses who lacked confidence as telephone triage advisers were more likely than more confident nurses to elevate the triage level of patients calling general practice clinics for same-day service, according to a British report.

The findings have implications for busy general practice physicians who are considering such programs to help ease their daily patient load.

Although there is “broad public support” in Britain for nurse practitioners and general nursing staff taking on many of the tasks usually associated with general practitioners, the manner in which these nurses handle patients varies greatly, according to Anna Varley, a social worker and researcher at the University of East Anglia, Norwich, England, who spoke at the annual meeting of the North American Primary Care Research Group.

Ms. Anna Varley

“Previous research is still equivocal as to explaining exactly why it is that different health professionals make different decisions about the same calls,” Ms. Varley said to a capacity crowd.

However, data from a randomized, controlled study of telephone triage services indicated that a nurse’s self-reported level of preparedness, was key to how – and if – she advised that callers receive follow-up care.

“Therefore, standardized telephone triage training is necessary, but it may not be sufficient,” Ms. Varley said.

The data were part of the larger, clustered, randomized controlled ESTEEM trial conducted across four regions in the United Kingdom between March 2011 and March 2013 to examine the outcomes and cost-effectiveness of telephone triage services. In the study, patients seeking same-day consultations were randomly assigned with intention to treat and by protocol, to either general practice–led phone triage care; nurse practitioner–led, computer-supported phone triage care; or usual practice. Allocation was not blinded to patients, clinicians, or researchers, but practice assignment was concealed from the study’s statistician. In all, 20,990 patient calls were managed by 42 general care clinics, with 77% of all patient-clinician interactions reaching the primary outcome of additional follow-up within 28 days of the initial call. The results of the larger trial were published recently in the Lancet (2014 Nov. 22 [doi:10.1016/S0140-6736(14)61058-8]). For the subanalysis, Ms. Varley and her coinvestigators evaluated the 7,012 patient calls randomly routed to triage intervention from 45 nurses across 15 general practices in the four regions. All of the nursing staff were women, and all had been trained in the use of the clinical decision support software. All nurses were surveyed to discover their levels of training, experience, and facility with triage software. Thirty-five of the original 45 nurses returned valid profiles.

Of these, eight were nurse practitioners, an important distinction given that in the United Kingdom, this denotes more years of formal medical training than other nursing professionals, the authority to diagnose, and typically, the authority to prescribe medication.

The remaining 27 nurses were what are known in Britain as “practice nurses.” This group is not authorized to prescribe, and generally has less authority in other matters as well.

The range of the two groups of nurses’ years of experience was 2.5-40 years, although 89% of all nurse participants had 10 or more years of practical experience; 69% had 20 or more years of experience.

Across both groups, nearly half had prior experience manning triage phone lines, although only 2 of the 35 women had ever used the clinical support software.

At the time of each call, the nurses were asked to rate how prepared they felt for the particulars of the call. These data were included when evaluating how often each nurse recommended a caller for follow-up. Although most calls (86%) were recommended to some form of follow-up, nurse practitioners were less likely than practice nurses to recommend follow-up care (odds ratio, 0.19; confidence interval, 0.07-0.49). Across both groups, nurses who reported less confidence in their ability to manage the call were found more likely to recommend patients for follow-up (OR, 3.17; CI, 1.18-5.55). Additionally, less seasoned nurses, defined as those with 10 or less years of practical experience, had significantly longer mean call durations (OR, 2.58; CI, 0.76-4.40).

As reported in the larger ESTEEM trial, nurse-led triage resulted in an overall 48% increase in patient contacts over a 28-day period, compared with usual care. General practice physician–led triage resulted in a 33% increase over usual care during the same period. Despite the increase in patient contacts, the costs of care were found to remain essentially the same (about 75 British pounds sterling). Eight deaths were reported overall, including two triaged by the nurses, but none of the deaths were associated with the trial itself.

 

 

The overall implications of the study are positive, so long as there is already an established trust between the patient and the general practice clinic, according to Dr. Garey Mazowita, a family practice physician in Vancouver, B.C., who is participating in a telephone screening program for general practitioners in his home province.

“At the heart of the medical home model we are moving toward is the continuity of the relationship between the family care doctor and the patient, and the knowledge that if you do something over the phone that averts an office visit, you’ve still got the security of the relationship [to rely on],” Dr. Mazowita, who is also the president of the College of Family Physicians of Canada, said in an interview. “We think it’s fundamentally safer than if no relationship exists.”

Ms. Varley agreed that how general practice clinics, and in particular, the physicians, related to patients overall was important, but said that for the purpose of nurse-led call screening, it was important to note that while all triage call screening was shown in the study to be comparably safe, “the individual characteristics of nurses independently influenced how telephone triage was implemented.”

Neither Ms. Varley nor Dr. Mazowita had any relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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Less confident nurses more likely to elevate triage level in calls to primary care clinics
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Key clinical point: Telephone triage training may not be enough to help nursing staff adequately manage callers seeking same-day consultations from general practice physicians.

Major finding: Nurses with more advanced medical training and higher levels of self-reported confidence about triage calls were less likely to recommend follow-up, compared with nurses with fewer years of formal education and less confidence in their skills (OR, 0.19, 3.17 respectively).

Data source: Telephone triage data from a randomized, controlled trial of 7,012 patient calls managed by 45 nurses across 15 general practice clinics in the United Kingdom.

Disclosures: Neither Ms. Varley nor Dr. Mazowita had any relevant disclosures.

New use for old DXA scanners?

BMI is still the best screening tool
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NATIONAL HARBOR, MD. – If you’re one of the many physicians with an X-ray absorptiometry machine collecting dust in the nether regions of your clinic, recent findings from a small pilot study might interest you.

Dr. Steven R. Goldstein said he found that roughly 20% of postmenopausal women whose body mass index (BMI) measurement indicated they had a normal weight actually had body fat measurements greater than the 75th percentile when their body fat was assessed using a X-ray absorptiometry (DXA) scanner.

Dr. Steven R. Goldstein

Similarly, about a fifth of postmenopausal women in the study whose BMI indicated they were in the overweight range actually had DXA scanner readings indicating their percentage of body fat placed them below the 25th percentile.

“When you have 20% in each group, that’s not a tiny number,” Dr. Goldstein said in an interview at this year’s annual meeting of the North American Menopause Society. “BMI or weight alone does not always predict metabolic health.”

BMI, a measurement first created for use by insurance actuaries by Belgian mathematician Adolphe Quetelet in the mid-1800s, has come under scrutiny across the specialties in recent years, particularly since 1998 when the Centers for Disease Control and Prevention aligned with the World Health Organization determined that the criteria for being overweight was a BMI of 25 kg/m2 instead of 27.8 kg/m2.

“This instantly rendered 29 million previously healthy Americans as now being overweight,” Dr. Goldstein, a professor of obstetrics and gynecology at New York (N.Y.) University Langone Medical Center, told the audience.

Additionally, as one audience member noted during the question and answer period of the presentation, many members of nonAnglo populations, such as those from Mexico and Central America, are strong, healthy endomorphs, even though their BMIs would indicate otherwise.

“Most people don’t think about the fact that BMI is 170 years old and that with it, a 25-year-old man who weighs 150 pounds and is 5 foot 8 inches, has the same BMI as a 60-year-old woman who also weighs 150 pounds,” Dr. Goldstein said in an interview. “And yet, it’s used almost as another vital sign.”

Instead, Dr. Goldstein said that data from DXA scanners could be used by insurance companies to make more accurate decisions about obesity-related medical procedures, such as bariatric surgery. Studies have shown that some adults considered normal weight have cardiovascular abnormalities, and some considered obese are metabolically healthy (Arch. Intern. Med. 2008;168:1617-24).

“Using BMI, some people are being denied bariatric surgery when they need it, but there may be other people who are having the surgery who don’t actually need it,” Dr. Goldstein said.

The scanners also have met with some darker times, especially as reimbursements for the technology primarily used to determine bone mineral density in an aging population have fluctuated over the years, leaving many physicians with thousands of dollars in equipment they no longer use for fear they will not be paid for their time.

DXA scanners use two different energy levels that are absorbed differently by bone and lean and fat tissues, then uses the differences between them to determine the amount of lean and fat tissue across the entire body.

Dr. Goldstein and his colleagues analyzed DXA data taken from 50 postmenopausal women who visited his clinic for a routine bone mass DXA scan. The scanner software was used to calculate the women’s body fat percentile according to age and sex. Women who were between the 25th and 75th percentile were considered to have “normal” body fat, whereas below the 25th percentile or above the 75th percentile was considered abnormally lean or heavy, respectively. The measurements then were compared with the women’s BMI measurements.

Just over 18% of the cohort had normal BMI readings but placed above the 75th percentile for body fat when measured by the scanner. Conversely, 22% of women in the lowest percentile for body fat per their DXA scan also had normal BMI weight. Twenty-three percent of women considered overweight according to their BMI fell into the normal range for DXA body fat results. All of the women in the study considered obese by BMI were in the 100th percentile using the DXA scanner.

“DXA determination of body fat percentile seems like a reasonable and probable surrogate for metabolic health that is more accurate than BMI,” Dr. Goldstein said.

“We have the equipment, it’s just a matter of updating the software,” he said.

Dr. Goldstein said he had no relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

References

Body

Body mass index is the best screening tool we have to identify and stage the disease of obesity. Like other diseases, there are additional prognostic factors that influence disease severity. Additional information regarding fat composition can indicate more risk in addition to BMI. For example, more visceral or abdominal fat could imply greater cardiac risk particularly in Asian populations. BMI is the fifth vital sign, and any BMI >30 warrants discussion regarding treatment. Additional studies like DXA scans can elaborate additional risk that can be mitigated through safe and effective treatments for obesity like bariatric surgery.

John Morton, M.D., is chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. He was asked to comment on this study.

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Body

Body mass index is the best screening tool we have to identify and stage the disease of obesity. Like other diseases, there are additional prognostic factors that influence disease severity. Additional information regarding fat composition can indicate more risk in addition to BMI. For example, more visceral or abdominal fat could imply greater cardiac risk particularly in Asian populations. BMI is the fifth vital sign, and any BMI >30 warrants discussion regarding treatment. Additional studies like DXA scans can elaborate additional risk that can be mitigated through safe and effective treatments for obesity like bariatric surgery.

John Morton, M.D., is chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. He was asked to comment on this study.

Body

Body mass index is the best screening tool we have to identify and stage the disease of obesity. Like other diseases, there are additional prognostic factors that influence disease severity. Additional information regarding fat composition can indicate more risk in addition to BMI. For example, more visceral or abdominal fat could imply greater cardiac risk particularly in Asian populations. BMI is the fifth vital sign, and any BMI >30 warrants discussion regarding treatment. Additional studies like DXA scans can elaborate additional risk that can be mitigated through safe and effective treatments for obesity like bariatric surgery.

John Morton, M.D., is chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. He was asked to comment on this study.

Title
BMI is still the best screening tool
BMI is still the best screening tool

NATIONAL HARBOR, MD. – If you’re one of the many physicians with an X-ray absorptiometry machine collecting dust in the nether regions of your clinic, recent findings from a small pilot study might interest you.

Dr. Steven R. Goldstein said he found that roughly 20% of postmenopausal women whose body mass index (BMI) measurement indicated they had a normal weight actually had body fat measurements greater than the 75th percentile when their body fat was assessed using a X-ray absorptiometry (DXA) scanner.

Dr. Steven R. Goldstein

Similarly, about a fifth of postmenopausal women in the study whose BMI indicated they were in the overweight range actually had DXA scanner readings indicating their percentage of body fat placed them below the 25th percentile.

“When you have 20% in each group, that’s not a tiny number,” Dr. Goldstein said in an interview at this year’s annual meeting of the North American Menopause Society. “BMI or weight alone does not always predict metabolic health.”

BMI, a measurement first created for use by insurance actuaries by Belgian mathematician Adolphe Quetelet in the mid-1800s, has come under scrutiny across the specialties in recent years, particularly since 1998 when the Centers for Disease Control and Prevention aligned with the World Health Organization determined that the criteria for being overweight was a BMI of 25 kg/m2 instead of 27.8 kg/m2.

“This instantly rendered 29 million previously healthy Americans as now being overweight,” Dr. Goldstein, a professor of obstetrics and gynecology at New York (N.Y.) University Langone Medical Center, told the audience.

Additionally, as one audience member noted during the question and answer period of the presentation, many members of nonAnglo populations, such as those from Mexico and Central America, are strong, healthy endomorphs, even though their BMIs would indicate otherwise.

“Most people don’t think about the fact that BMI is 170 years old and that with it, a 25-year-old man who weighs 150 pounds and is 5 foot 8 inches, has the same BMI as a 60-year-old woman who also weighs 150 pounds,” Dr. Goldstein said in an interview. “And yet, it’s used almost as another vital sign.”

Instead, Dr. Goldstein said that data from DXA scanners could be used by insurance companies to make more accurate decisions about obesity-related medical procedures, such as bariatric surgery. Studies have shown that some adults considered normal weight have cardiovascular abnormalities, and some considered obese are metabolically healthy (Arch. Intern. Med. 2008;168:1617-24).

“Using BMI, some people are being denied bariatric surgery when they need it, but there may be other people who are having the surgery who don’t actually need it,” Dr. Goldstein said.

The scanners also have met with some darker times, especially as reimbursements for the technology primarily used to determine bone mineral density in an aging population have fluctuated over the years, leaving many physicians with thousands of dollars in equipment they no longer use for fear they will not be paid for their time.

DXA scanners use two different energy levels that are absorbed differently by bone and lean and fat tissues, then uses the differences between them to determine the amount of lean and fat tissue across the entire body.

Dr. Goldstein and his colleagues analyzed DXA data taken from 50 postmenopausal women who visited his clinic for a routine bone mass DXA scan. The scanner software was used to calculate the women’s body fat percentile according to age and sex. Women who were between the 25th and 75th percentile were considered to have “normal” body fat, whereas below the 25th percentile or above the 75th percentile was considered abnormally lean or heavy, respectively. The measurements then were compared with the women’s BMI measurements.

Just over 18% of the cohort had normal BMI readings but placed above the 75th percentile for body fat when measured by the scanner. Conversely, 22% of women in the lowest percentile for body fat per their DXA scan also had normal BMI weight. Twenty-three percent of women considered overweight according to their BMI fell into the normal range for DXA body fat results. All of the women in the study considered obese by BMI were in the 100th percentile using the DXA scanner.

“DXA determination of body fat percentile seems like a reasonable and probable surrogate for metabolic health that is more accurate than BMI,” Dr. Goldstein said.

“We have the equipment, it’s just a matter of updating the software,” he said.

Dr. Goldstein said he had no relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

NATIONAL HARBOR, MD. – If you’re one of the many physicians with an X-ray absorptiometry machine collecting dust in the nether regions of your clinic, recent findings from a small pilot study might interest you.

Dr. Steven R. Goldstein said he found that roughly 20% of postmenopausal women whose body mass index (BMI) measurement indicated they had a normal weight actually had body fat measurements greater than the 75th percentile when their body fat was assessed using a X-ray absorptiometry (DXA) scanner.

Dr. Steven R. Goldstein

Similarly, about a fifth of postmenopausal women in the study whose BMI indicated they were in the overweight range actually had DXA scanner readings indicating their percentage of body fat placed them below the 25th percentile.

“When you have 20% in each group, that’s not a tiny number,” Dr. Goldstein said in an interview at this year’s annual meeting of the North American Menopause Society. “BMI or weight alone does not always predict metabolic health.”

BMI, a measurement first created for use by insurance actuaries by Belgian mathematician Adolphe Quetelet in the mid-1800s, has come under scrutiny across the specialties in recent years, particularly since 1998 when the Centers for Disease Control and Prevention aligned with the World Health Organization determined that the criteria for being overweight was a BMI of 25 kg/m2 instead of 27.8 kg/m2.

“This instantly rendered 29 million previously healthy Americans as now being overweight,” Dr. Goldstein, a professor of obstetrics and gynecology at New York (N.Y.) University Langone Medical Center, told the audience.

Additionally, as one audience member noted during the question and answer period of the presentation, many members of nonAnglo populations, such as those from Mexico and Central America, are strong, healthy endomorphs, even though their BMIs would indicate otherwise.

“Most people don’t think about the fact that BMI is 170 years old and that with it, a 25-year-old man who weighs 150 pounds and is 5 foot 8 inches, has the same BMI as a 60-year-old woman who also weighs 150 pounds,” Dr. Goldstein said in an interview. “And yet, it’s used almost as another vital sign.”

Instead, Dr. Goldstein said that data from DXA scanners could be used by insurance companies to make more accurate decisions about obesity-related medical procedures, such as bariatric surgery. Studies have shown that some adults considered normal weight have cardiovascular abnormalities, and some considered obese are metabolically healthy (Arch. Intern. Med. 2008;168:1617-24).

“Using BMI, some people are being denied bariatric surgery when they need it, but there may be other people who are having the surgery who don’t actually need it,” Dr. Goldstein said.

The scanners also have met with some darker times, especially as reimbursements for the technology primarily used to determine bone mineral density in an aging population have fluctuated over the years, leaving many physicians with thousands of dollars in equipment they no longer use for fear they will not be paid for their time.

DXA scanners use two different energy levels that are absorbed differently by bone and lean and fat tissues, then uses the differences between them to determine the amount of lean and fat tissue across the entire body.

Dr. Goldstein and his colleagues analyzed DXA data taken from 50 postmenopausal women who visited his clinic for a routine bone mass DXA scan. The scanner software was used to calculate the women’s body fat percentile according to age and sex. Women who were between the 25th and 75th percentile were considered to have “normal” body fat, whereas below the 25th percentile or above the 75th percentile was considered abnormally lean or heavy, respectively. The measurements then were compared with the women’s BMI measurements.

Just over 18% of the cohort had normal BMI readings but placed above the 75th percentile for body fat when measured by the scanner. Conversely, 22% of women in the lowest percentile for body fat per their DXA scan also had normal BMI weight. Twenty-three percent of women considered overweight according to their BMI fell into the normal range for DXA body fat results. All of the women in the study considered obese by BMI were in the 100th percentile using the DXA scanner.

“DXA determination of body fat percentile seems like a reasonable and probable surrogate for metabolic health that is more accurate than BMI,” Dr. Goldstein said.

“We have the equipment, it’s just a matter of updating the software,” he said.

Dr. Goldstein said he had no relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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Inside the Article

Vitals

Key clinical point: Dual energy X-ray absorptiometry (DXA) data may be better than BMI for assessing metabolic health in postmenopausal women, bariatric surgery candidates.

Major finding: Approximately 20% of postmenopausal women were possibly misdiagnosed as metabolically healthy when BMI was only measurement used.

Data source: Pilot study of 50 consecutive postmenopausal women given DXA scan at a single site.

Disclosures: Dr. Goldstein said he had no relevant disclosures.

Patient-centered medical homes bested others in chronic pain management

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Patient-centered medical homes bested others in chronic pain management

NEW YORK– Certified patient-centered medical homes were significantly more likely to adhere to pain management guidelines than were uncredentialed primary care practices, a retrospective study has shown.

Because patient-centered medical homes are predicated on safety and quality, coordination and integration, Dr. Nancy C. Elder, professor and director of research in the department of family and community medicine at the University of Cincinnati, said that they were already focused on primary care pain process guidelines for managing musculoskeletal pain established in 2011.

“A team, multidisciplinary approach to care, typical of a medical home, is generally associated with better pain outcomes,” Dr. Elder told a standing-room only crowd at the chronic pain research track of the annual meeting of the North American Primary Care Research Group.

Still, there are few data to support a direct correlation between patient-centered medical home (PCMH) protocols as defined by the National Committee for Quality Assurance and how chronic pain is managed.

To address that gap, Dr. Elder and her associates conducted a random review of 485 charts of chronic pain patients seen at least twice at one of 12 academic-affiliated primary care practices in a 12-month period. Three of the practices had achieved PCMH certification in 2010, five were certified in 2013 prior to the study, and four clinics had no medical home certification. There was one internal medicine residency, while the rest were a combination of either family and internal medicine or internal medicine and pediatrics practices. Between 6 to 15 charts were reviewed per provider, although per office the range was between 10 and 95 charts. Charts from experienced PCMH clinics numbered 128, while newer PCMH-certified-clinic charts numbered 242. There were 115 non–PCMH clinic chart reviews.

Patients across all three clinic groups ranged in age from 56 years to 61.6 years and were predominantly white women.

The non-PCMH offices, when compared with the certified clinics, were significantly less likely to document four of eight key data points to assess and manage chronic pain, including a patient’s pain severity (39% vs. 75%, P less than .001), functional disability (41% vs. 66%, P less than .001), psychosocial distress (38% vs. 54%, P = .01), or substance abuse (13% vs. 32%, P less than .001).

All clinics were inclined to address depression and employ nonpharmacologic approaches to pain, although opioids were prescribed chronically 57% of the time, regardless of PCMH certification status. All clinics were equally likely to ask patients to enter into an opioid-use contract, but noncertified practices were less likely to assess patients for the side effects of opioid use (56% vs. 68%, P = .02), perform a urine drug screen (27% vs. 48%), or review a state controlled-prescription report (38% vs. 50%, P = .005).

Although Dr. Elder concluded that the medical home model is conducive to better chronic pain management, the actual relationship between protocols and patient outcomes is still unknown. She also noted that, although there was not a statistically significant difference, practices that had been PCMH certified the longest did not perform as well as the practices with newer certification.

“That raised the question about whether some of the skills and benefits of becoming a PCMH wane with time,” she said.

Dr. Elder did not state any relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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NEW YORK– Certified patient-centered medical homes were significantly more likely to adhere to pain management guidelines than were uncredentialed primary care practices, a retrospective study has shown.

Because patient-centered medical homes are predicated on safety and quality, coordination and integration, Dr. Nancy C. Elder, professor and director of research in the department of family and community medicine at the University of Cincinnati, said that they were already focused on primary care pain process guidelines for managing musculoskeletal pain established in 2011.

“A team, multidisciplinary approach to care, typical of a medical home, is generally associated with better pain outcomes,” Dr. Elder told a standing-room only crowd at the chronic pain research track of the annual meeting of the North American Primary Care Research Group.

Still, there are few data to support a direct correlation between patient-centered medical home (PCMH) protocols as defined by the National Committee for Quality Assurance and how chronic pain is managed.

To address that gap, Dr. Elder and her associates conducted a random review of 485 charts of chronic pain patients seen at least twice at one of 12 academic-affiliated primary care practices in a 12-month period. Three of the practices had achieved PCMH certification in 2010, five were certified in 2013 prior to the study, and four clinics had no medical home certification. There was one internal medicine residency, while the rest were a combination of either family and internal medicine or internal medicine and pediatrics practices. Between 6 to 15 charts were reviewed per provider, although per office the range was between 10 and 95 charts. Charts from experienced PCMH clinics numbered 128, while newer PCMH-certified-clinic charts numbered 242. There were 115 non–PCMH clinic chart reviews.

Patients across all three clinic groups ranged in age from 56 years to 61.6 years and were predominantly white women.

The non-PCMH offices, when compared with the certified clinics, were significantly less likely to document four of eight key data points to assess and manage chronic pain, including a patient’s pain severity (39% vs. 75%, P less than .001), functional disability (41% vs. 66%, P less than .001), psychosocial distress (38% vs. 54%, P = .01), or substance abuse (13% vs. 32%, P less than .001).

All clinics were inclined to address depression and employ nonpharmacologic approaches to pain, although opioids were prescribed chronically 57% of the time, regardless of PCMH certification status. All clinics were equally likely to ask patients to enter into an opioid-use contract, but noncertified practices were less likely to assess patients for the side effects of opioid use (56% vs. 68%, P = .02), perform a urine drug screen (27% vs. 48%), or review a state controlled-prescription report (38% vs. 50%, P = .005).

Although Dr. Elder concluded that the medical home model is conducive to better chronic pain management, the actual relationship between protocols and patient outcomes is still unknown. She also noted that, although there was not a statistically significant difference, practices that had been PCMH certified the longest did not perform as well as the practices with newer certification.

“That raised the question about whether some of the skills and benefits of becoming a PCMH wane with time,” she said.

Dr. Elder did not state any relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

NEW YORK– Certified patient-centered medical homes were significantly more likely to adhere to pain management guidelines than were uncredentialed primary care practices, a retrospective study has shown.

Because patient-centered medical homes are predicated on safety and quality, coordination and integration, Dr. Nancy C. Elder, professor and director of research in the department of family and community medicine at the University of Cincinnati, said that they were already focused on primary care pain process guidelines for managing musculoskeletal pain established in 2011.

“A team, multidisciplinary approach to care, typical of a medical home, is generally associated with better pain outcomes,” Dr. Elder told a standing-room only crowd at the chronic pain research track of the annual meeting of the North American Primary Care Research Group.

Still, there are few data to support a direct correlation between patient-centered medical home (PCMH) protocols as defined by the National Committee for Quality Assurance and how chronic pain is managed.

To address that gap, Dr. Elder and her associates conducted a random review of 485 charts of chronic pain patients seen at least twice at one of 12 academic-affiliated primary care practices in a 12-month period. Three of the practices had achieved PCMH certification in 2010, five were certified in 2013 prior to the study, and four clinics had no medical home certification. There was one internal medicine residency, while the rest were a combination of either family and internal medicine or internal medicine and pediatrics practices. Between 6 to 15 charts were reviewed per provider, although per office the range was between 10 and 95 charts. Charts from experienced PCMH clinics numbered 128, while newer PCMH-certified-clinic charts numbered 242. There were 115 non–PCMH clinic chart reviews.

Patients across all three clinic groups ranged in age from 56 years to 61.6 years and were predominantly white women.

The non-PCMH offices, when compared with the certified clinics, were significantly less likely to document four of eight key data points to assess and manage chronic pain, including a patient’s pain severity (39% vs. 75%, P less than .001), functional disability (41% vs. 66%, P less than .001), psychosocial distress (38% vs. 54%, P = .01), or substance abuse (13% vs. 32%, P less than .001).

All clinics were inclined to address depression and employ nonpharmacologic approaches to pain, although opioids were prescribed chronically 57% of the time, regardless of PCMH certification status. All clinics were equally likely to ask patients to enter into an opioid-use contract, but noncertified practices were less likely to assess patients for the side effects of opioid use (56% vs. 68%, P = .02), perform a urine drug screen (27% vs. 48%), or review a state controlled-prescription report (38% vs. 50%, P = .005).

Although Dr. Elder concluded that the medical home model is conducive to better chronic pain management, the actual relationship between protocols and patient outcomes is still unknown. She also noted that, although there was not a statistically significant difference, practices that had been PCMH certified the longest did not perform as well as the practices with newer certification.

“That raised the question about whether some of the skills and benefits of becoming a PCMH wane with time,” she said.

Dr. Elder did not state any relevant disclosures.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

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Patient-centered medical homes bested others in chronic pain management
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Key clinical point: A patient-centered medical home model may be better at treating patients according to primary care pain management guidelines.

Major finding: Patient-centered medical home certification was associated with significantly more evidence-based chronic pain management protocols.

Data source: Chart review of chronic pain patients seen at 12 academic-affiliated primary care practices over 12 months.

Disclosures: Dr. Elder did not state any relevant disclosures.