M. Alexander Otto began his reporting career early in 1999 covering the pharmaceutical industry for a national pharmacists' magazine and freelancing for the Washington Post and other newspapers. He then joined BNA, now part of Bloomberg News, covering health law and the protection of people and animals in medical research. Alex next worked for the McClatchy Company. Based on his work, Alex won a year-long Knight Science Journalism Fellowship to MIT in 2008-2009. He joined the company shortly thereafter. Alex has a newspaper journalism degree from Syracuse (N.Y.) University and a master's degree in medical science -- a physician assistant degree -- from George Washington University. Alex is based in Seattle.

ABS wants feedback on 10-year exam alternatives

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Many surgeons let out a collective cheer recently when the American Board of Surgery announced that, as of 2018, they will no longer have to take a high-stakes, pass-fail exam every 10 years to maintain certification.

The Board also announced, effective immediately, that it’s extending its continuing medical education (CME) reporting cycle from 3 to 5 years and reducing the number of required self-assessment CMEs – lectures and articles with a short quiz at the end – by a third. Surgeons now have to report 150 credits over 5 years, 50 from self-assessment CMEs. Under the old system, it was 90 credits over 3 years, 60 of which had to include self-assessment.

Dr. Emery Chen
Surgeons have been telling ABS that the 3-year cycle was too short and that it was difficult to find meaningful CMEs with self assessment. The Board plans additional steps to make maintenance of certification (MOC) less burdensome and more relevant. “This is very positive. People are very encouraged that the Board is listening and trying to be more responsive,” said David Hoyt, MD, FACS, executive director of the American College of Surgeons (ACS).

Alternative evaluation options

What’s on the minds of many, though, is what the alternatives to the 10-year exam will be. “That’s the $64,000 question,” said Emery Chen, MD, FACS, a general surgeon in private practice in Lancaster, Calif.

ABS is considering models that have worked well for other medical boards and hopes to roll out the alternative pathways at its winter meeting in January 2018, according to ABS Executive Director Frank Lewis, MD, FACS.

Dr. Frank Lewis
At this point, it looks like surgeons will be able to take more frequent and convenient shorter tests that are better focused on their particular branch of general surgery, with opportunities to brush up on weak spots and take the tests again if needed. There are several options for how the new system could be structured.

“I think it will probably be less stressful. People worry about the high-stakes exam. They don’t know what’s going to be on it, and they worry that failing could result in losing their staff privileges. We don’t think that’s particularly useful. The purpose is not to either pass or fail you but for you to learn the material,” Dr. Lewis said.

Meanwhile, surgeons who want to take the 10-year exam will still have the option.

Among the many options, surgeons could be given the two dozen journal articles deemed by experts to be the most cutting-edge for a given period, and quizzed on the material, with a chance to be re-quizzed as needed. There could be CME mini-courses or open-book exams on the areas most relevant to a surgeon’s practice and opportunities to relearn what might have been forgotten. Questions could be pushed out by smart phone to assess surgeons’ knowledge, with follow-up review material for incorrect answers and additional questions until the material is aced.

“Everything’s on the table,” said ABS at-large Board Member Tyler G. Hughes, MD, FACS, clinical faculty member at Kansas University, Salina.

A changing world

Like the country’s many other medical boards, ABS has been under pressure to make its MOC process less burdensome and more useful. A major problem is that general surgery isn’t very general anymore; it covers everything from transplants and bariatrics to trauma, endocrine, and vascular operations and more. Surgeons who have specialized have chafed at being examined every 10 years on areas that are no longer part of their practice and at questions about rare diseases such as multiple endocrine neoplasia I and II.

“They remember that one question that kind of stuck in their craw,” said Carol Scott-Conner, MD, FACS, emeritus professor and former head of surgery at the University of Iowa, Iowa City. At one point in her career, Dr. Scott-Conner helped write questions for the exam. “It wasn’t designed to be tricky, but, if you were not practicing in all these fields,” it was tough. “What you’re tested on should be relevant to your practice and help you get better at what you are doing. I think it’s a good change,” she said.

Dr. Carol Scott-Conner
Controversy a few years ago about how the American Board of Internal Medicine (ABIM) ran its MOC program and spent its money also turned up the heat on medical boards, and some physicians have turned to state legislatures to do away with certification altogether as a prerequisite for hospital privileges, among other things. ABIM and many other boards have already made changes to make MOC smoother.

ABS has taken note. “There are a whole variety of things targeted at ways of maintaining longitudinal learning and providing some demonstration of it. We haven’t settled on any one of those. In fact, we may have more than one. We aim to get a good deal of feedback and see what our diplomates feel would be most helpful for them. It’s going to require a lot more detail, but hopefully it’s going to be more effective and more useful.” Dr. Lewis said.
 

 

 

The group will be at national and regional medical meetings this summer and fall to ask surgeons, in person, what they want their MOC system to be. There might be surveys as well, and ABS plans to be at the ACS Clinical Congress in October to solicit input.

The Board is looking to help surgeons with multiple certificates, whether from ABS or other boards, as well. “If we can create a more flexible assessment program that helps them maintain all their certifications, that’s what we want to do. We are looking at options to make it easier for them,” said ABS Director of Communications and Public Affairs Christine Shiffer, who noted that ABS will still likely require a 12-month case log every 10 years, even if surgeons opt out of the 10-year exam.

Will the new system have a negative impact on patient outcomes? After all, even specialized surgeons take night call sometimes. “ABS is responsible to surgeons but also the American public. If we say somebody is certified, it has to mean something. People would argue that there’s no real evidence that the recertification process improves surgical competence. Time will tell,” Dr. Scott-Conner said.

Dr. Lewis said he doesn’t know if the changes will save any money on MOC but noted that, instead of one $1,600 fee every 10 years, there’ll be an option to spread payments out.

Dr. Hughes is on the editorial advisory board of this publication.

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Many surgeons let out a collective cheer recently when the American Board of Surgery announced that, as of 2018, they will no longer have to take a high-stakes, pass-fail exam every 10 years to maintain certification.

The Board also announced, effective immediately, that it’s extending its continuing medical education (CME) reporting cycle from 3 to 5 years and reducing the number of required self-assessment CMEs – lectures and articles with a short quiz at the end – by a third. Surgeons now have to report 150 credits over 5 years, 50 from self-assessment CMEs. Under the old system, it was 90 credits over 3 years, 60 of which had to include self-assessment.

Dr. Emery Chen
Surgeons have been telling ABS that the 3-year cycle was too short and that it was difficult to find meaningful CMEs with self assessment. The Board plans additional steps to make maintenance of certification (MOC) less burdensome and more relevant. “This is very positive. People are very encouraged that the Board is listening and trying to be more responsive,” said David Hoyt, MD, FACS, executive director of the American College of Surgeons (ACS).

Alternative evaluation options

What’s on the minds of many, though, is what the alternatives to the 10-year exam will be. “That’s the $64,000 question,” said Emery Chen, MD, FACS, a general surgeon in private practice in Lancaster, Calif.

ABS is considering models that have worked well for other medical boards and hopes to roll out the alternative pathways at its winter meeting in January 2018, according to ABS Executive Director Frank Lewis, MD, FACS.

Dr. Frank Lewis
At this point, it looks like surgeons will be able to take more frequent and convenient shorter tests that are better focused on their particular branch of general surgery, with opportunities to brush up on weak spots and take the tests again if needed. There are several options for how the new system could be structured.

“I think it will probably be less stressful. People worry about the high-stakes exam. They don’t know what’s going to be on it, and they worry that failing could result in losing their staff privileges. We don’t think that’s particularly useful. The purpose is not to either pass or fail you but for you to learn the material,” Dr. Lewis said.

Meanwhile, surgeons who want to take the 10-year exam will still have the option.

Among the many options, surgeons could be given the two dozen journal articles deemed by experts to be the most cutting-edge for a given period, and quizzed on the material, with a chance to be re-quizzed as needed. There could be CME mini-courses or open-book exams on the areas most relevant to a surgeon’s practice and opportunities to relearn what might have been forgotten. Questions could be pushed out by smart phone to assess surgeons’ knowledge, with follow-up review material for incorrect answers and additional questions until the material is aced.

“Everything’s on the table,” said ABS at-large Board Member Tyler G. Hughes, MD, FACS, clinical faculty member at Kansas University, Salina.

A changing world

Like the country’s many other medical boards, ABS has been under pressure to make its MOC process less burdensome and more useful. A major problem is that general surgery isn’t very general anymore; it covers everything from transplants and bariatrics to trauma, endocrine, and vascular operations and more. Surgeons who have specialized have chafed at being examined every 10 years on areas that are no longer part of their practice and at questions about rare diseases such as multiple endocrine neoplasia I and II.

“They remember that one question that kind of stuck in their craw,” said Carol Scott-Conner, MD, FACS, emeritus professor and former head of surgery at the University of Iowa, Iowa City. At one point in her career, Dr. Scott-Conner helped write questions for the exam. “It wasn’t designed to be tricky, but, if you were not practicing in all these fields,” it was tough. “What you’re tested on should be relevant to your practice and help you get better at what you are doing. I think it’s a good change,” she said.

Dr. Carol Scott-Conner
Controversy a few years ago about how the American Board of Internal Medicine (ABIM) ran its MOC program and spent its money also turned up the heat on medical boards, and some physicians have turned to state legislatures to do away with certification altogether as a prerequisite for hospital privileges, among other things. ABIM and many other boards have already made changes to make MOC smoother.

ABS has taken note. “There are a whole variety of things targeted at ways of maintaining longitudinal learning and providing some demonstration of it. We haven’t settled on any one of those. In fact, we may have more than one. We aim to get a good deal of feedback and see what our diplomates feel would be most helpful for them. It’s going to require a lot more detail, but hopefully it’s going to be more effective and more useful.” Dr. Lewis said.
 

 

 

The group will be at national and regional medical meetings this summer and fall to ask surgeons, in person, what they want their MOC system to be. There might be surveys as well, and ABS plans to be at the ACS Clinical Congress in October to solicit input.

The Board is looking to help surgeons with multiple certificates, whether from ABS or other boards, as well. “If we can create a more flexible assessment program that helps them maintain all their certifications, that’s what we want to do. We are looking at options to make it easier for them,” said ABS Director of Communications and Public Affairs Christine Shiffer, who noted that ABS will still likely require a 12-month case log every 10 years, even if surgeons opt out of the 10-year exam.

Will the new system have a negative impact on patient outcomes? After all, even specialized surgeons take night call sometimes. “ABS is responsible to surgeons but also the American public. If we say somebody is certified, it has to mean something. People would argue that there’s no real evidence that the recertification process improves surgical competence. Time will tell,” Dr. Scott-Conner said.

Dr. Lewis said he doesn’t know if the changes will save any money on MOC but noted that, instead of one $1,600 fee every 10 years, there’ll be an option to spread payments out.

Dr. Hughes is on the editorial advisory board of this publication.

 

Many surgeons let out a collective cheer recently when the American Board of Surgery announced that, as of 2018, they will no longer have to take a high-stakes, pass-fail exam every 10 years to maintain certification.

The Board also announced, effective immediately, that it’s extending its continuing medical education (CME) reporting cycle from 3 to 5 years and reducing the number of required self-assessment CMEs – lectures and articles with a short quiz at the end – by a third. Surgeons now have to report 150 credits over 5 years, 50 from self-assessment CMEs. Under the old system, it was 90 credits over 3 years, 60 of which had to include self-assessment.

Dr. Emery Chen
Surgeons have been telling ABS that the 3-year cycle was too short and that it was difficult to find meaningful CMEs with self assessment. The Board plans additional steps to make maintenance of certification (MOC) less burdensome and more relevant. “This is very positive. People are very encouraged that the Board is listening and trying to be more responsive,” said David Hoyt, MD, FACS, executive director of the American College of Surgeons (ACS).

Alternative evaluation options

What’s on the minds of many, though, is what the alternatives to the 10-year exam will be. “That’s the $64,000 question,” said Emery Chen, MD, FACS, a general surgeon in private practice in Lancaster, Calif.

ABS is considering models that have worked well for other medical boards and hopes to roll out the alternative pathways at its winter meeting in January 2018, according to ABS Executive Director Frank Lewis, MD, FACS.

Dr. Frank Lewis
At this point, it looks like surgeons will be able to take more frequent and convenient shorter tests that are better focused on their particular branch of general surgery, with opportunities to brush up on weak spots and take the tests again if needed. There are several options for how the new system could be structured.

“I think it will probably be less stressful. People worry about the high-stakes exam. They don’t know what’s going to be on it, and they worry that failing could result in losing their staff privileges. We don’t think that’s particularly useful. The purpose is not to either pass or fail you but for you to learn the material,” Dr. Lewis said.

Meanwhile, surgeons who want to take the 10-year exam will still have the option.

Among the many options, surgeons could be given the two dozen journal articles deemed by experts to be the most cutting-edge for a given period, and quizzed on the material, with a chance to be re-quizzed as needed. There could be CME mini-courses or open-book exams on the areas most relevant to a surgeon’s practice and opportunities to relearn what might have been forgotten. Questions could be pushed out by smart phone to assess surgeons’ knowledge, with follow-up review material for incorrect answers and additional questions until the material is aced.

“Everything’s on the table,” said ABS at-large Board Member Tyler G. Hughes, MD, FACS, clinical faculty member at Kansas University, Salina.

A changing world

Like the country’s many other medical boards, ABS has been under pressure to make its MOC process less burdensome and more useful. A major problem is that general surgery isn’t very general anymore; it covers everything from transplants and bariatrics to trauma, endocrine, and vascular operations and more. Surgeons who have specialized have chafed at being examined every 10 years on areas that are no longer part of their practice and at questions about rare diseases such as multiple endocrine neoplasia I and II.

“They remember that one question that kind of stuck in their craw,” said Carol Scott-Conner, MD, FACS, emeritus professor and former head of surgery at the University of Iowa, Iowa City. At one point in her career, Dr. Scott-Conner helped write questions for the exam. “It wasn’t designed to be tricky, but, if you were not practicing in all these fields,” it was tough. “What you’re tested on should be relevant to your practice and help you get better at what you are doing. I think it’s a good change,” she said.

Dr. Carol Scott-Conner
Controversy a few years ago about how the American Board of Internal Medicine (ABIM) ran its MOC program and spent its money also turned up the heat on medical boards, and some physicians have turned to state legislatures to do away with certification altogether as a prerequisite for hospital privileges, among other things. ABIM and many other boards have already made changes to make MOC smoother.

ABS has taken note. “There are a whole variety of things targeted at ways of maintaining longitudinal learning and providing some demonstration of it. We haven’t settled on any one of those. In fact, we may have more than one. We aim to get a good deal of feedback and see what our diplomates feel would be most helpful for them. It’s going to require a lot more detail, but hopefully it’s going to be more effective and more useful.” Dr. Lewis said.
 

 

 

The group will be at national and regional medical meetings this summer and fall to ask surgeons, in person, what they want their MOC system to be. There might be surveys as well, and ABS plans to be at the ACS Clinical Congress in October to solicit input.

The Board is looking to help surgeons with multiple certificates, whether from ABS or other boards, as well. “If we can create a more flexible assessment program that helps them maintain all their certifications, that’s what we want to do. We are looking at options to make it easier for them,” said ABS Director of Communications and Public Affairs Christine Shiffer, who noted that ABS will still likely require a 12-month case log every 10 years, even if surgeons opt out of the 10-year exam.

Will the new system have a negative impact on patient outcomes? After all, even specialized surgeons take night call sometimes. “ABS is responsible to surgeons but also the American public. If we say somebody is certified, it has to mean something. People would argue that there’s no real evidence that the recertification process improves surgical competence. Time will tell,” Dr. Scott-Conner said.

Dr. Lewis said he doesn’t know if the changes will save any money on MOC but noted that, instead of one $1,600 fee every 10 years, there’ll be an option to spread payments out.

Dr. Hughes is on the editorial advisory board of this publication.

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Temporary tissue expanders optimize radiotherapy after mastectomy

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– Radiation oncologists at the University of Texas MD Anderson Cancer Center, Houston, were able to complete 98% of their radiotherapy plans when women received temporary tissue expanders, instead of immediate reconstructions, at the time of skin-sparing mastectomy, in a series of 384 women, most with stage 2-3 breast cancer.

The expanders – saline-filled bags commonly used in plastic surgery to create new skin – were kept in place but deflated for radiotherapy, which allowed for optimal access to treatment fields; the final reconstruction, successful in 90% of women, came a median of 7 months following radiation.

Dr. Eric Strom, professor of radiation oncology, and Dr. Zeina Ayoub, a radiation oncology fellow, at University of Texas MD Anderson Cancer Center, Houston
M. Alexander Otto/Frontline Medical News
Dr. Eric Strom and Dr. Zeina Ayoub
MD Anderson started offering the approach after the realization that more than 50% of radiation plans were compromised when breasts were reconstructed beforehand, at the time of mastectomy (Int J Radiat Oncol Biol Phys. 2006 Sep 1;66[1]:76-82).

“The shape and volume of the reconstruction” – and the need to avoid damaging the new breast – “got in the way of putting radiation where we wanted it to be. We ended up having bad radiotherapy plans, patients not getting skin-sparing mastectomies, and high probabilities of radiation complications to the reconstruction,” said investigator Eric Strom, MD, professor of radiation oncology at MD Anderson.

Radiologists and plastic and oncologic surgeons collaborated to try tissue expanders instead. “We wanted the advantage of skin-sparing mastectomy without the disadvantages” of immediate reconstruction, Dr. Strom said at the American Society of Breast Surgeons annual meeting.

With the new approach, “radiotherapy is superior. We don’t have to compromise our plans. I can put radiation everywhere it needs to be, without frying the heart” and almost completely avoiding the lungs, he said.

The 5-year rates of locoregional control, disease-free survival, and overall survival were 99.2%, 86.1%, and 92.4%, respectively, which “is extraordinary” in patients with stage 2-3 breast cancer, and likely due at least in part to optimal radiotherapy, he said.

Tissue expanders also keep the skin envelope open so it’s able to receive a graft at final reconstruction; abdominal skin doesn’t have to brought up to recreate the breast.

“This approach lessens negative interactions between breast reconstruction and [radiotherapy] and offers patients what they most desire: a high probability of freedom from cancer and optimal final aesthetic outcome,” said Zeina Ayoub, MD, a radiation oncology fellow at Anderson who presented the findings.

The median age of the women was 44 years, and almost all were node positive. Radiation was delivered to the chest wall and regional lymphatics, including the internal mammary chain.

Fifty women (13.0%) required explantation after radiation but before reconstruction, most commonly because of cellulitis; even so, more than half went on to final reconstruction.

Abdominal autologous reconstruction was the most common type, followed by latissimus dorsi–based reconstruction, and exchange of the tissue expander with an implant.

Dr. Ayoub and Dr. Strom had no relevant disclosures.

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– Radiation oncologists at the University of Texas MD Anderson Cancer Center, Houston, were able to complete 98% of their radiotherapy plans when women received temporary tissue expanders, instead of immediate reconstructions, at the time of skin-sparing mastectomy, in a series of 384 women, most with stage 2-3 breast cancer.

The expanders – saline-filled bags commonly used in plastic surgery to create new skin – were kept in place but deflated for radiotherapy, which allowed for optimal access to treatment fields; the final reconstruction, successful in 90% of women, came a median of 7 months following radiation.

Dr. Eric Strom, professor of radiation oncology, and Dr. Zeina Ayoub, a radiation oncology fellow, at University of Texas MD Anderson Cancer Center, Houston
M. Alexander Otto/Frontline Medical News
Dr. Eric Strom and Dr. Zeina Ayoub
MD Anderson started offering the approach after the realization that more than 50% of radiation plans were compromised when breasts were reconstructed beforehand, at the time of mastectomy (Int J Radiat Oncol Biol Phys. 2006 Sep 1;66[1]:76-82).

“The shape and volume of the reconstruction” – and the need to avoid damaging the new breast – “got in the way of putting radiation where we wanted it to be. We ended up having bad radiotherapy plans, patients not getting skin-sparing mastectomies, and high probabilities of radiation complications to the reconstruction,” said investigator Eric Strom, MD, professor of radiation oncology at MD Anderson.

Radiologists and plastic and oncologic surgeons collaborated to try tissue expanders instead. “We wanted the advantage of skin-sparing mastectomy without the disadvantages” of immediate reconstruction, Dr. Strom said at the American Society of Breast Surgeons annual meeting.

With the new approach, “radiotherapy is superior. We don’t have to compromise our plans. I can put radiation everywhere it needs to be, without frying the heart” and almost completely avoiding the lungs, he said.

The 5-year rates of locoregional control, disease-free survival, and overall survival were 99.2%, 86.1%, and 92.4%, respectively, which “is extraordinary” in patients with stage 2-3 breast cancer, and likely due at least in part to optimal radiotherapy, he said.

Tissue expanders also keep the skin envelope open so it’s able to receive a graft at final reconstruction; abdominal skin doesn’t have to brought up to recreate the breast.

“This approach lessens negative interactions between breast reconstruction and [radiotherapy] and offers patients what they most desire: a high probability of freedom from cancer and optimal final aesthetic outcome,” said Zeina Ayoub, MD, a radiation oncology fellow at Anderson who presented the findings.

The median age of the women was 44 years, and almost all were node positive. Radiation was delivered to the chest wall and regional lymphatics, including the internal mammary chain.

Fifty women (13.0%) required explantation after radiation but before reconstruction, most commonly because of cellulitis; even so, more than half went on to final reconstruction.

Abdominal autologous reconstruction was the most common type, followed by latissimus dorsi–based reconstruction, and exchange of the tissue expander with an implant.

Dr. Ayoub and Dr. Strom had no relevant disclosures.

 

– Radiation oncologists at the University of Texas MD Anderson Cancer Center, Houston, were able to complete 98% of their radiotherapy plans when women received temporary tissue expanders, instead of immediate reconstructions, at the time of skin-sparing mastectomy, in a series of 384 women, most with stage 2-3 breast cancer.

The expanders – saline-filled bags commonly used in plastic surgery to create new skin – were kept in place but deflated for radiotherapy, which allowed for optimal access to treatment fields; the final reconstruction, successful in 90% of women, came a median of 7 months following radiation.

Dr. Eric Strom, professor of radiation oncology, and Dr. Zeina Ayoub, a radiation oncology fellow, at University of Texas MD Anderson Cancer Center, Houston
M. Alexander Otto/Frontline Medical News
Dr. Eric Strom and Dr. Zeina Ayoub
MD Anderson started offering the approach after the realization that more than 50% of radiation plans were compromised when breasts were reconstructed beforehand, at the time of mastectomy (Int J Radiat Oncol Biol Phys. 2006 Sep 1;66[1]:76-82).

“The shape and volume of the reconstruction” – and the need to avoid damaging the new breast – “got in the way of putting radiation where we wanted it to be. We ended up having bad radiotherapy plans, patients not getting skin-sparing mastectomies, and high probabilities of radiation complications to the reconstruction,” said investigator Eric Strom, MD, professor of radiation oncology at MD Anderson.

Radiologists and plastic and oncologic surgeons collaborated to try tissue expanders instead. “We wanted the advantage of skin-sparing mastectomy without the disadvantages” of immediate reconstruction, Dr. Strom said at the American Society of Breast Surgeons annual meeting.

With the new approach, “radiotherapy is superior. We don’t have to compromise our plans. I can put radiation everywhere it needs to be, without frying the heart” and almost completely avoiding the lungs, he said.

The 5-year rates of locoregional control, disease-free survival, and overall survival were 99.2%, 86.1%, and 92.4%, respectively, which “is extraordinary” in patients with stage 2-3 breast cancer, and likely due at least in part to optimal radiotherapy, he said.

Tissue expanders also keep the skin envelope open so it’s able to receive a graft at final reconstruction; abdominal skin doesn’t have to brought up to recreate the breast.

“This approach lessens negative interactions between breast reconstruction and [radiotherapy] and offers patients what they most desire: a high probability of freedom from cancer and optimal final aesthetic outcome,” said Zeina Ayoub, MD, a radiation oncology fellow at Anderson who presented the findings.

The median age of the women was 44 years, and almost all were node positive. Radiation was delivered to the chest wall and regional lymphatics, including the internal mammary chain.

Fifty women (13.0%) required explantation after radiation but before reconstruction, most commonly because of cellulitis; even so, more than half went on to final reconstruction.

Abdominal autologous reconstruction was the most common type, followed by latissimus dorsi–based reconstruction, and exchange of the tissue expander with an implant.

Dr. Ayoub and Dr. Strom had no relevant disclosures.

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Key clinical point: Radiation oncologists at the University of Texas MD Anderson Cancer Center, Houston, were able to complete 98% of their radiotherapy plans when women with stage 2-3 breast cancer received temporary tissue expanders, instead of immediate reconstructions, at the time skin-sparing mastectomy.

Major finding: The 5-year rates of locoregional control, disease-free survival, and overall survival were 99.2%, 86.1%, and 92.4%, respectively, likely due at least in part to optimal radiotherapy.

Data source: Review of 384 patients.

Disclosures: The investigators said they had no relevant disclosures.

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Prior resections increase anastomotic leak risk in Crohn’s

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– The risk of anastomotic leaks after bowel resection for Crohn’s disease is more than three times higher in patients who have had prior resections, according to a review of 206 patients at Lahey Hospital and Medical Center in Burlington, Mass.

There were 20 anastomotic leaks within 30 days of resection in those patients, giving an overall leakage rate of 10%. Among the 123 patients who were having their first resection, however, the rate was 5% (6/123). The risk jumped to 17% in the 83 who had prior resections (14/83) and 23% (7) among the 30 patients who had two or more prior resections, which is “substantially higher than we talk about in the clinic when we are counseling these people,” said lead investigator Forrest Johnston, MD, a colorectal surgery fellow at Lahey.

M. Alexander Otto/Frontline Medical News
Dr. Forrest Johnston
The number of prior resections correlated almost perfectly with an increasing risk of anastomotic leakage (r = 0.998). The odds ratio for leakage with prior resection, compared with initial resection, was 3.5 (95% confidence interval, 1.3-9.4; P less than .005).

The findings are important because prior resections have not, until now, been formally recognized as a risk factor for anastomotic leaks, and repeat resections are common in Crohn’s. “When you see patients for repeat intestinal resections, you have to look at them as a higher risk population in terms of your counseling and algorithms,” Dr. Johnston said at the American Society of Colon and Rectal Surgeons annual meeting. In addition, to mitigate the increased risk, Crohn’s patients who have repeat resections need additional attention to correct modifiable risk factors before surgery, such as steroid use and malnutrition. “Some of these patients are pushed through the clinic,” but “they deserve a bit more time.”

The heightened risk is also “another factor that might tip you one way or another” in choosing surgical options. “It’s certainly something to think about,” he said.

The new and prior resection patients in the study were well matched in terms of known risk factors for leakage, including age, sex, preoperative serum albumin, and use of immune suppressing medications. “The increased risk of leak is not explained by preoperative nutritional status or medication use,” Dr. Johnston said.

Estimated blood loss, OR time, types of procedures, hand-sewn versus stapled anastomoses, and other surgical variables were also similar.

The lack of significant differences between the groups raises the question of why repeat resections leak more. “That’s the million dollar question. My thought is that repeat resections indicate a greater severity of Crohn’s disease. I think there’s microvascular disease that’s affecting their tissue integrity, but we don’t appreciate it at the time of their anastomosis. If it was obvious at the time of surgery, patients wouldn’t be put together. They’d just get a stoma and be done with it,” Dr. Johnston said

About 80% of both first-time and repeat procedures were ileocolic resections secondary to obstruction, generally without bowel prep. Repeat procedures were performed a mean of 15 years after the first operation. Most initial resections were done laparoscopically, and a good portion of repeat procedures were open. Anorectal cases were excluded from the analysis.

Dr. Johnston said his team looked into the issue after noticing that repeat patients “seemed to leak a little bit more than we expected.”

The investigators had no conflicts of interest.

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– The risk of anastomotic leaks after bowel resection for Crohn’s disease is more than three times higher in patients who have had prior resections, according to a review of 206 patients at Lahey Hospital and Medical Center in Burlington, Mass.

There were 20 anastomotic leaks within 30 days of resection in those patients, giving an overall leakage rate of 10%. Among the 123 patients who were having their first resection, however, the rate was 5% (6/123). The risk jumped to 17% in the 83 who had prior resections (14/83) and 23% (7) among the 30 patients who had two or more prior resections, which is “substantially higher than we talk about in the clinic when we are counseling these people,” said lead investigator Forrest Johnston, MD, a colorectal surgery fellow at Lahey.

M. Alexander Otto/Frontline Medical News
Dr. Forrest Johnston
The number of prior resections correlated almost perfectly with an increasing risk of anastomotic leakage (r = 0.998). The odds ratio for leakage with prior resection, compared with initial resection, was 3.5 (95% confidence interval, 1.3-9.4; P less than .005).

The findings are important because prior resections have not, until now, been formally recognized as a risk factor for anastomotic leaks, and repeat resections are common in Crohn’s. “When you see patients for repeat intestinal resections, you have to look at them as a higher risk population in terms of your counseling and algorithms,” Dr. Johnston said at the American Society of Colon and Rectal Surgeons annual meeting. In addition, to mitigate the increased risk, Crohn’s patients who have repeat resections need additional attention to correct modifiable risk factors before surgery, such as steroid use and malnutrition. “Some of these patients are pushed through the clinic,” but “they deserve a bit more time.”

The heightened risk is also “another factor that might tip you one way or another” in choosing surgical options. “It’s certainly something to think about,” he said.

The new and prior resection patients in the study were well matched in terms of known risk factors for leakage, including age, sex, preoperative serum albumin, and use of immune suppressing medications. “The increased risk of leak is not explained by preoperative nutritional status or medication use,” Dr. Johnston said.

Estimated blood loss, OR time, types of procedures, hand-sewn versus stapled anastomoses, and other surgical variables were also similar.

The lack of significant differences between the groups raises the question of why repeat resections leak more. “That’s the million dollar question. My thought is that repeat resections indicate a greater severity of Crohn’s disease. I think there’s microvascular disease that’s affecting their tissue integrity, but we don’t appreciate it at the time of their anastomosis. If it was obvious at the time of surgery, patients wouldn’t be put together. They’d just get a stoma and be done with it,” Dr. Johnston said

About 80% of both first-time and repeat procedures were ileocolic resections secondary to obstruction, generally without bowel prep. Repeat procedures were performed a mean of 15 years after the first operation. Most initial resections were done laparoscopically, and a good portion of repeat procedures were open. Anorectal cases were excluded from the analysis.

Dr. Johnston said his team looked into the issue after noticing that repeat patients “seemed to leak a little bit more than we expected.”

The investigators had no conflicts of interest.

 

– The risk of anastomotic leaks after bowel resection for Crohn’s disease is more than three times higher in patients who have had prior resections, according to a review of 206 patients at Lahey Hospital and Medical Center in Burlington, Mass.

There were 20 anastomotic leaks within 30 days of resection in those patients, giving an overall leakage rate of 10%. Among the 123 patients who were having their first resection, however, the rate was 5% (6/123). The risk jumped to 17% in the 83 who had prior resections (14/83) and 23% (7) among the 30 patients who had two or more prior resections, which is “substantially higher than we talk about in the clinic when we are counseling these people,” said lead investigator Forrest Johnston, MD, a colorectal surgery fellow at Lahey.

M. Alexander Otto/Frontline Medical News
Dr. Forrest Johnston
The number of prior resections correlated almost perfectly with an increasing risk of anastomotic leakage (r = 0.998). The odds ratio for leakage with prior resection, compared with initial resection, was 3.5 (95% confidence interval, 1.3-9.4; P less than .005).

The findings are important because prior resections have not, until now, been formally recognized as a risk factor for anastomotic leaks, and repeat resections are common in Crohn’s. “When you see patients for repeat intestinal resections, you have to look at them as a higher risk population in terms of your counseling and algorithms,” Dr. Johnston said at the American Society of Colon and Rectal Surgeons annual meeting. In addition, to mitigate the increased risk, Crohn’s patients who have repeat resections need additional attention to correct modifiable risk factors before surgery, such as steroid use and malnutrition. “Some of these patients are pushed through the clinic,” but “they deserve a bit more time.”

The heightened risk is also “another factor that might tip you one way or another” in choosing surgical options. “It’s certainly something to think about,” he said.

The new and prior resection patients in the study were well matched in terms of known risk factors for leakage, including age, sex, preoperative serum albumin, and use of immune suppressing medications. “The increased risk of leak is not explained by preoperative nutritional status or medication use,” Dr. Johnston said.

Estimated blood loss, OR time, types of procedures, hand-sewn versus stapled anastomoses, and other surgical variables were also similar.

The lack of significant differences between the groups raises the question of why repeat resections leak more. “That’s the million dollar question. My thought is that repeat resections indicate a greater severity of Crohn’s disease. I think there’s microvascular disease that’s affecting their tissue integrity, but we don’t appreciate it at the time of their anastomosis. If it was obvious at the time of surgery, patients wouldn’t be put together. They’d just get a stoma and be done with it,” Dr. Johnston said

About 80% of both first-time and repeat procedures were ileocolic resections secondary to obstruction, generally without bowel prep. Repeat procedures were performed a mean of 15 years after the first operation. Most initial resections were done laparoscopically, and a good portion of repeat procedures were open. Anorectal cases were excluded from the analysis.

Dr. Johnston said his team looked into the issue after noticing that repeat patients “seemed to leak a little bit more than we expected.”

The investigators had no conflicts of interest.

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Key clinical point: To mitigate the increased risk of anastomotic leaks, Crohn’s patients who have repeat resections need additional attention to correct modifiable risk factors before surgery, such as steroid use and malnutrition.

Major finding: The number of prior resections correlated almost perfectly with an increasing risk of anastomotic leakage (r = 0.998); the odds ratio for leakage with prior resection, compared with initial resection, was 3.5 (95% confidence interval, 1.3-9.4; P less than .005).

Data source: A review of 206 Crohn’ patients.

Disclosures: The investigators had no conflicts of interest.

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No easy answers for parastomal hernia repair

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– At present, laparoscopic Sugarbaker repair is probably the best surgical option for parastomal hernias when stomas can’t be reversed, according to Mark Gudgeon, MS, FRCS, a consultant general surgeon at the Frimley Park Hospital in England.

Parastomal hernias are common in colorectal surgery; more than a quarter of ileostomy stomas and well over half of colostomy stomas herniate within 10 years of placement, leading to pain, leakage, appliance problems, and embarrassment for patients. There’s also the risk of bowel obstruction and strangulation. “It’s something that’s a challenge to all of us. It’s a very difficult problem,” Dr. Gudgeon said at the American Society of Colon and Rectal Surgeons annual meeting.

Sebastian Kaulitzki/Thinkstock
It’s unclear what surgical approach is best because reports are largely drawn from small observational studies with short follow-up, and there are no randomized trials pitting one option against another. Dr. Gudgeon favors the increasingly popular Sugarbaker mesh technique because of the relatively low risk of recurrence. “It’s probably the best we’ve got right now,” he said.

It can be difficult to decide whether or not to even offer patients a surgical fix because they often fail, and sometimes lead to fistulas and well-known mesh complications. Obese patients are “a no-go because they do not do well, and neither do smokers. Both are things patients have an opportunity to correct before we go ahead with surgery,” Dr. Gudgeon said.

On top of that, about 6% of repair patients die from complications. Patients “don’t believe that at first, but when you rub it in, a lot of them will change their minds” about surgery. “These patients don’t do well,” so avoid surgery when possible, he said. “Pain can be dealt with; leakage can be dealt with; cosmesis can be accepted,” especially with the help of stoma specialists who are experts in the art of appliance fit and support garments, Dr. Gudgeon said.

If the decision to operate is made, forget about suture repair, Dr. Gudgeon recommended. It should be “abandoned. I know it still goes on, but the evidence speaks for itself: [hernias] just come back again.”

Dr. Gudgeon suggested that it may be best to reverse the stoma, if possible, and repair the defect. Relocating the stoma “is always an attractive alternative,” and laparoscopic mesh keyhole repairs are straightforward. But the risk of recurrence is high, he said.

The Food and Drug Administration recently found that there’s not much difference between synthetic and biologic mesh, so Dr. Gudgeon said he usually opts for synthetics because they are less expensive.

He reported speakers’ fees from Intuitive, Medtronic, and Cook Medical.

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– At present, laparoscopic Sugarbaker repair is probably the best surgical option for parastomal hernias when stomas can’t be reversed, according to Mark Gudgeon, MS, FRCS, a consultant general surgeon at the Frimley Park Hospital in England.

Parastomal hernias are common in colorectal surgery; more than a quarter of ileostomy stomas and well over half of colostomy stomas herniate within 10 years of placement, leading to pain, leakage, appliance problems, and embarrassment for patients. There’s also the risk of bowel obstruction and strangulation. “It’s something that’s a challenge to all of us. It’s a very difficult problem,” Dr. Gudgeon said at the American Society of Colon and Rectal Surgeons annual meeting.

Sebastian Kaulitzki/Thinkstock
It’s unclear what surgical approach is best because reports are largely drawn from small observational studies with short follow-up, and there are no randomized trials pitting one option against another. Dr. Gudgeon favors the increasingly popular Sugarbaker mesh technique because of the relatively low risk of recurrence. “It’s probably the best we’ve got right now,” he said.

It can be difficult to decide whether or not to even offer patients a surgical fix because they often fail, and sometimes lead to fistulas and well-known mesh complications. Obese patients are “a no-go because they do not do well, and neither do smokers. Both are things patients have an opportunity to correct before we go ahead with surgery,” Dr. Gudgeon said.

On top of that, about 6% of repair patients die from complications. Patients “don’t believe that at first, but when you rub it in, a lot of them will change their minds” about surgery. “These patients don’t do well,” so avoid surgery when possible, he said. “Pain can be dealt with; leakage can be dealt with; cosmesis can be accepted,” especially with the help of stoma specialists who are experts in the art of appliance fit and support garments, Dr. Gudgeon said.

If the decision to operate is made, forget about suture repair, Dr. Gudgeon recommended. It should be “abandoned. I know it still goes on, but the evidence speaks for itself: [hernias] just come back again.”

Dr. Gudgeon suggested that it may be best to reverse the stoma, if possible, and repair the defect. Relocating the stoma “is always an attractive alternative,” and laparoscopic mesh keyhole repairs are straightforward. But the risk of recurrence is high, he said.

The Food and Drug Administration recently found that there’s not much difference between synthetic and biologic mesh, so Dr. Gudgeon said he usually opts for synthetics because they are less expensive.

He reported speakers’ fees from Intuitive, Medtronic, and Cook Medical.

 

– At present, laparoscopic Sugarbaker repair is probably the best surgical option for parastomal hernias when stomas can’t be reversed, according to Mark Gudgeon, MS, FRCS, a consultant general surgeon at the Frimley Park Hospital in England.

Parastomal hernias are common in colorectal surgery; more than a quarter of ileostomy stomas and well over half of colostomy stomas herniate within 10 years of placement, leading to pain, leakage, appliance problems, and embarrassment for patients. There’s also the risk of bowel obstruction and strangulation. “It’s something that’s a challenge to all of us. It’s a very difficult problem,” Dr. Gudgeon said at the American Society of Colon and Rectal Surgeons annual meeting.

Sebastian Kaulitzki/Thinkstock
It’s unclear what surgical approach is best because reports are largely drawn from small observational studies with short follow-up, and there are no randomized trials pitting one option against another. Dr. Gudgeon favors the increasingly popular Sugarbaker mesh technique because of the relatively low risk of recurrence. “It’s probably the best we’ve got right now,” he said.

It can be difficult to decide whether or not to even offer patients a surgical fix because they often fail, and sometimes lead to fistulas and well-known mesh complications. Obese patients are “a no-go because they do not do well, and neither do smokers. Both are things patients have an opportunity to correct before we go ahead with surgery,” Dr. Gudgeon said.

On top of that, about 6% of repair patients die from complications. Patients “don’t believe that at first, but when you rub it in, a lot of them will change their minds” about surgery. “These patients don’t do well,” so avoid surgery when possible, he said. “Pain can be dealt with; leakage can be dealt with; cosmesis can be accepted,” especially with the help of stoma specialists who are experts in the art of appliance fit and support garments, Dr. Gudgeon said.

If the decision to operate is made, forget about suture repair, Dr. Gudgeon recommended. It should be “abandoned. I know it still goes on, but the evidence speaks for itself: [hernias] just come back again.”

Dr. Gudgeon suggested that it may be best to reverse the stoma, if possible, and repair the defect. Relocating the stoma “is always an attractive alternative,” and laparoscopic mesh keyhole repairs are straightforward. But the risk of recurrence is high, he said.

The Food and Drug Administration recently found that there’s not much difference between synthetic and biologic mesh, so Dr. Gudgeon said he usually opts for synthetics because they are less expensive.

He reported speakers’ fees from Intuitive, Medtronic, and Cook Medical.

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Algorithm for identifying IPF has low PPV

Case validation is key
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Sat, 12/08/2018 - 14:15

 

ICD-9 codes were poor at picking out idiopathic pulmonary fibrosis patients from administrative databases for epidemiologic studies, but a new tool could improve diagnostic accuracy, according to Kaiser Permanente and University of California, San Francisco (UCSF), investigators.

“In the age of large administrative databases and electronic medical records, there is rich opportunity to conduct population-based studies” of disease behavior, outcomes, health care use, and other matters, but researchers first need to be able to accurately identify patients with idiopathic pulmonary fibrosis (IPF) in large data sets, said investigators led by Brett Ley, MD, an assistant professor of medicine at UCSF.

The research community has traditionally relied on claims for specific IPF diagnostic codes – ICD-9 code 516.3 or ICD-9-CM code 516.31 – to identify patients, but the approach had never been validated. To see how well it works, the investigators applied it to the nearly 5.4 million adults in the Kaiser Permanente Northern California system during 2000-2014. After patients with interstitial lung disease-associated codes entered on or after the day of the last IPF code were excluded, the algorithm identified 2,608 patients as having IPF (Ann Am Thorac Soc. 2017 Jun;14[6]:880-7).

Next, the investigators randomly selected 150 of those patients and examined their medical records, procedure codes, CTs, and other patient-level data to see how many of them really had IPF. The results weren’t good. The positive predictive value of the IPF code-based algorithm was only 42.2%, with a sensitivity 55.6%.

The widely used code-based IPF algorithm does “not generate accurate estimates of IPF incidence and prevalence. ... Over half of the patients identified as having IPF ... did not have IPF on case review. Alarmingly, whereas half of the misclassified cases had an alternative [interstitial lung disease] diagnosis, the other half had no clinical or radiologic evidence of ILD [interstitial lung disease] at all.” The algorithm also “likely misses a substantial proportion of patients who do have IPF,” Dr. Ley and his colleagues said.

“We can only speculate about the reasons. ... It seems likely to be due to a combination of misdiagnosis at the clinical level and miscoding at the administrative level,” they said.

To try to improve the situation, the team tweaked the algorithm to include only patients 50 years or older who had at least two 516.3 or 516.31 claims 1 month or more apart and a chest CT procedure code beforehand. They again excluded ILD-associated claims on or after the day of the last IPF code.

Although the sensitivity of the modified algorithm was lower than the original, it had a more robust positive predictive value of 70.4% in the derivation cohort and 61.8% in the validation cohort, both derived from the 150 patients used to validate the original algorithm.

“By making a few simple, empirically derived changes to the IPF algorithm,” it’s possible to “more reliably identif[y] patients” with IPF. “We believe the modified IPF algorithm will be useful for population-based studies of IPF ... that require high diagnostic certainty,” the investigators concluded.

The traditional algorithm found an incidence of 6.8 cases per 100,000 person-years, which was on the low end of previous reports, perhaps because of the relative health and youth of the 5.4 million patient pool. As in past studies, IPF incidence increased with older age and was highest in white patients and men.

“Whether the more specific codes provided by the ICD-10 system will allow for improved case classification of IPF requires further study,” the investigators noted.

The work was funded by the National Institutes of Health. Dr. Ley reported speaker’s fees from Genentech, and one of the authors was an employee of the company. The senior author Harold Collard, MD, an associate professor in UCSF’s Division of Pulmonary and Critical Care Medicine, reported personal fees from Takeda, ImmuneWorks, Parexel, Pharma Capital Partners, and others.
 

Body

 

This study glaringly displays potential problems with using ICD codes for research purposes and calls into question results from a handful of studies that yielded epidemiological estimates for idiopathic pulmonary fibrosis. We are reminded that practitioner-generated diagnostic codes of IPF recorded in the medical record are subject to inaccuracies, which can be illuminated by the “gold standard” – multidisciplinary adjudication.

Moving forward, particularly as longitudinal, nationwide IPF registries come online, patient-level case validation should be employed. As we move into the era of ICD-10, the study should serve as a call to improve IPF case ascertainment accuracy for any investigators choosing to use large data analytic strategies. Doing so will mute the background noise and allow us to better hear the signals of this complex disease.

Evans R. Fernandez Perez, MD, is a pulmonologist at National Jewish Health, Denver. He made his comments in an editorial, and reported speaker’s fees from Boehringer Ingelheim and Genentech (Ann Am Thorac Soc. 2017 Jun;14[6]:829-30).

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Body

 

This study glaringly displays potential problems with using ICD codes for research purposes and calls into question results from a handful of studies that yielded epidemiological estimates for idiopathic pulmonary fibrosis. We are reminded that practitioner-generated diagnostic codes of IPF recorded in the medical record are subject to inaccuracies, which can be illuminated by the “gold standard” – multidisciplinary adjudication.

Moving forward, particularly as longitudinal, nationwide IPF registries come online, patient-level case validation should be employed. As we move into the era of ICD-10, the study should serve as a call to improve IPF case ascertainment accuracy for any investigators choosing to use large data analytic strategies. Doing so will mute the background noise and allow us to better hear the signals of this complex disease.

Evans R. Fernandez Perez, MD, is a pulmonologist at National Jewish Health, Denver. He made his comments in an editorial, and reported speaker’s fees from Boehringer Ingelheim and Genentech (Ann Am Thorac Soc. 2017 Jun;14[6]:829-30).

Body

 

This study glaringly displays potential problems with using ICD codes for research purposes and calls into question results from a handful of studies that yielded epidemiological estimates for idiopathic pulmonary fibrosis. We are reminded that practitioner-generated diagnostic codes of IPF recorded in the medical record are subject to inaccuracies, which can be illuminated by the “gold standard” – multidisciplinary adjudication.

Moving forward, particularly as longitudinal, nationwide IPF registries come online, patient-level case validation should be employed. As we move into the era of ICD-10, the study should serve as a call to improve IPF case ascertainment accuracy for any investigators choosing to use large data analytic strategies. Doing so will mute the background noise and allow us to better hear the signals of this complex disease.

Evans R. Fernandez Perez, MD, is a pulmonologist at National Jewish Health, Denver. He made his comments in an editorial, and reported speaker’s fees from Boehringer Ingelheim and Genentech (Ann Am Thorac Soc. 2017 Jun;14[6]:829-30).

Title
Case validation is key
Case validation is key

 

ICD-9 codes were poor at picking out idiopathic pulmonary fibrosis patients from administrative databases for epidemiologic studies, but a new tool could improve diagnostic accuracy, according to Kaiser Permanente and University of California, San Francisco (UCSF), investigators.

“In the age of large administrative databases and electronic medical records, there is rich opportunity to conduct population-based studies” of disease behavior, outcomes, health care use, and other matters, but researchers first need to be able to accurately identify patients with idiopathic pulmonary fibrosis (IPF) in large data sets, said investigators led by Brett Ley, MD, an assistant professor of medicine at UCSF.

The research community has traditionally relied on claims for specific IPF diagnostic codes – ICD-9 code 516.3 or ICD-9-CM code 516.31 – to identify patients, but the approach had never been validated. To see how well it works, the investigators applied it to the nearly 5.4 million adults in the Kaiser Permanente Northern California system during 2000-2014. After patients with interstitial lung disease-associated codes entered on or after the day of the last IPF code were excluded, the algorithm identified 2,608 patients as having IPF (Ann Am Thorac Soc. 2017 Jun;14[6]:880-7).

Next, the investigators randomly selected 150 of those patients and examined their medical records, procedure codes, CTs, and other patient-level data to see how many of them really had IPF. The results weren’t good. The positive predictive value of the IPF code-based algorithm was only 42.2%, with a sensitivity 55.6%.

The widely used code-based IPF algorithm does “not generate accurate estimates of IPF incidence and prevalence. ... Over half of the patients identified as having IPF ... did not have IPF on case review. Alarmingly, whereas half of the misclassified cases had an alternative [interstitial lung disease] diagnosis, the other half had no clinical or radiologic evidence of ILD [interstitial lung disease] at all.” The algorithm also “likely misses a substantial proportion of patients who do have IPF,” Dr. Ley and his colleagues said.

“We can only speculate about the reasons. ... It seems likely to be due to a combination of misdiagnosis at the clinical level and miscoding at the administrative level,” they said.

To try to improve the situation, the team tweaked the algorithm to include only patients 50 years or older who had at least two 516.3 or 516.31 claims 1 month or more apart and a chest CT procedure code beforehand. They again excluded ILD-associated claims on or after the day of the last IPF code.

Although the sensitivity of the modified algorithm was lower than the original, it had a more robust positive predictive value of 70.4% in the derivation cohort and 61.8% in the validation cohort, both derived from the 150 patients used to validate the original algorithm.

“By making a few simple, empirically derived changes to the IPF algorithm,” it’s possible to “more reliably identif[y] patients” with IPF. “We believe the modified IPF algorithm will be useful for population-based studies of IPF ... that require high diagnostic certainty,” the investigators concluded.

The traditional algorithm found an incidence of 6.8 cases per 100,000 person-years, which was on the low end of previous reports, perhaps because of the relative health and youth of the 5.4 million patient pool. As in past studies, IPF incidence increased with older age and was highest in white patients and men.

“Whether the more specific codes provided by the ICD-10 system will allow for improved case classification of IPF requires further study,” the investigators noted.

The work was funded by the National Institutes of Health. Dr. Ley reported speaker’s fees from Genentech, and one of the authors was an employee of the company. The senior author Harold Collard, MD, an associate professor in UCSF’s Division of Pulmonary and Critical Care Medicine, reported personal fees from Takeda, ImmuneWorks, Parexel, Pharma Capital Partners, and others.
 

 

ICD-9 codes were poor at picking out idiopathic pulmonary fibrosis patients from administrative databases for epidemiologic studies, but a new tool could improve diagnostic accuracy, according to Kaiser Permanente and University of California, San Francisco (UCSF), investigators.

“In the age of large administrative databases and electronic medical records, there is rich opportunity to conduct population-based studies” of disease behavior, outcomes, health care use, and other matters, but researchers first need to be able to accurately identify patients with idiopathic pulmonary fibrosis (IPF) in large data sets, said investigators led by Brett Ley, MD, an assistant professor of medicine at UCSF.

The research community has traditionally relied on claims for specific IPF diagnostic codes – ICD-9 code 516.3 or ICD-9-CM code 516.31 – to identify patients, but the approach had never been validated. To see how well it works, the investigators applied it to the nearly 5.4 million adults in the Kaiser Permanente Northern California system during 2000-2014. After patients with interstitial lung disease-associated codes entered on or after the day of the last IPF code were excluded, the algorithm identified 2,608 patients as having IPF (Ann Am Thorac Soc. 2017 Jun;14[6]:880-7).

Next, the investigators randomly selected 150 of those patients and examined their medical records, procedure codes, CTs, and other patient-level data to see how many of them really had IPF. The results weren’t good. The positive predictive value of the IPF code-based algorithm was only 42.2%, with a sensitivity 55.6%.

The widely used code-based IPF algorithm does “not generate accurate estimates of IPF incidence and prevalence. ... Over half of the patients identified as having IPF ... did not have IPF on case review. Alarmingly, whereas half of the misclassified cases had an alternative [interstitial lung disease] diagnosis, the other half had no clinical or radiologic evidence of ILD [interstitial lung disease] at all.” The algorithm also “likely misses a substantial proportion of patients who do have IPF,” Dr. Ley and his colleagues said.

“We can only speculate about the reasons. ... It seems likely to be due to a combination of misdiagnosis at the clinical level and miscoding at the administrative level,” they said.

To try to improve the situation, the team tweaked the algorithm to include only patients 50 years or older who had at least two 516.3 or 516.31 claims 1 month or more apart and a chest CT procedure code beforehand. They again excluded ILD-associated claims on or after the day of the last IPF code.

Although the sensitivity of the modified algorithm was lower than the original, it had a more robust positive predictive value of 70.4% in the derivation cohort and 61.8% in the validation cohort, both derived from the 150 patients used to validate the original algorithm.

“By making a few simple, empirically derived changes to the IPF algorithm,” it’s possible to “more reliably identif[y] patients” with IPF. “We believe the modified IPF algorithm will be useful for population-based studies of IPF ... that require high diagnostic certainty,” the investigators concluded.

The traditional algorithm found an incidence of 6.8 cases per 100,000 person-years, which was on the low end of previous reports, perhaps because of the relative health and youth of the 5.4 million patient pool. As in past studies, IPF incidence increased with older age and was highest in white patients and men.

“Whether the more specific codes provided by the ICD-10 system will allow for improved case classification of IPF requires further study,” the investigators noted.

The work was funded by the National Institutes of Health. Dr. Ley reported speaker’s fees from Genentech, and one of the authors was an employee of the company. The senior author Harold Collard, MD, an associate professor in UCSF’s Division of Pulmonary and Critical Care Medicine, reported personal fees from Takeda, ImmuneWorks, Parexel, Pharma Capital Partners, and others.
 

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FROM THE ANNALS OF THE AMERICAN THORACIC SOCIETY

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Key clinical point: ICD-9 codes were poor at picking out idiopathic pulmonary fibrosis patients from administrative databases for epidemiologic studies, but a new tool could improve diagnostic accuracy.

Major finding: The positive predictive value of the traditional IPF code-based algorithm was only 42.2%, with a sensitivity of 55.6%.

Data source: A study including almost 5.4 million patients at Kaiser Permanente Northern California.

Disclosures: The work was funded by the National Institutes of Health. One of the investigators was a Genentech employee. Others reported speaker’s and personal fees from Genentech and other companies.

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Loop ileostomy tops colectomy for IBD rescue

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Diverting loop ileostomies save patients with inflammatory bowel disease (IBD) with severe colitis from rushed total abdominal colectomies, buying time for patient optimization before surgery, and perhaps even saving colons, according to a report from the University of California, Los Angeles.

Urgent colectomy is the standard of care, but it’s a big operation when patients aren’t doing well. Immunosuppression, malnutrition, and other problems lead to high rates of complications.

In 2013, UCLA physicians decided to try rescue diverting loop ileostomies (DLIs), a relatively quick, minimally invasive option to temporarily divert the fecal stream, instead. The idea is to give the colon a chance to heal and the patient another shot at medical management and recovery before definitive surgery. There’s even a chance of colon salvage.

The approach has been working well at UCLA. Investigators previously reported good results for their first eight patients. They presented updated results for the series – now up to 34 patients – at the annual meeting of the American Society of Colon and Rectal Surgeons.

So far, DLI allowed 91% of patients (31/34) to avoid urgent total colectomies. It’s “a safe alternative. Patients undergoing DLI have acceptably low complication rates and most are afforded time for medical and nutritional optimization prior to proceeding with their definitive surgical care,” said presenter Tara Russell, MD, a UCLA surgery resident.

“Currently, [almost every] patient presenting with acute colitis who we aren’t able to get to the point of discharge with medical optimization” is now offered rescue DLI at the university, and patients have been eager for a chance at avoiding total colectomy. The only patients who are not offered DLI are those with, for instance, fulminant toxic megacolon, Dr. Russell said.

The DLI approach failed in just 2 of the 18 ulcerative colitis patients and 1 of the 16 Crohn’s patients in the series. All three went on to emergent total colectomies 11-53 days after the procedure.

The majority of DLI patients tolerated oral intake by postop day 1, and the median time to resuming a regular diet was 2 days. Most people were discharged within a day or 2 of diversion, and a few took longer to achieve medical rescue. Almost 90% had an improvement in nutritional status, and over 80% went on to elective laparoscopic definitive procedures or colon salvage.

Two patients had postop wound infections, “but there were no other complications” with DLI, Dr. Russell said.

All DLIs were performed with a single-incision laparoscopic approach and took an average of about a half hour. Most of the diversions were in the right lower abdominal quadrant.

The mean age of the patients was 36 years, with a range of 16-81 years. Just over half were men. Of 21 patients who met systemic inflammatory response syndrome criteria at the time of operation, 13 (62%) resolved within 24 hours of DLI.
 

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Diverting loop ileostomies save patients with inflammatory bowel disease (IBD) with severe colitis from rushed total abdominal colectomies, buying time for patient optimization before surgery, and perhaps even saving colons, according to a report from the University of California, Los Angeles.

Urgent colectomy is the standard of care, but it’s a big operation when patients aren’t doing well. Immunosuppression, malnutrition, and other problems lead to high rates of complications.

In 2013, UCLA physicians decided to try rescue diverting loop ileostomies (DLIs), a relatively quick, minimally invasive option to temporarily divert the fecal stream, instead. The idea is to give the colon a chance to heal and the patient another shot at medical management and recovery before definitive surgery. There’s even a chance of colon salvage.

The approach has been working well at UCLA. Investigators previously reported good results for their first eight patients. They presented updated results for the series – now up to 34 patients – at the annual meeting of the American Society of Colon and Rectal Surgeons.

So far, DLI allowed 91% of patients (31/34) to avoid urgent total colectomies. It’s “a safe alternative. Patients undergoing DLI have acceptably low complication rates and most are afforded time for medical and nutritional optimization prior to proceeding with their definitive surgical care,” said presenter Tara Russell, MD, a UCLA surgery resident.

“Currently, [almost every] patient presenting with acute colitis who we aren’t able to get to the point of discharge with medical optimization” is now offered rescue DLI at the university, and patients have been eager for a chance at avoiding total colectomy. The only patients who are not offered DLI are those with, for instance, fulminant toxic megacolon, Dr. Russell said.

The DLI approach failed in just 2 of the 18 ulcerative colitis patients and 1 of the 16 Crohn’s patients in the series. All three went on to emergent total colectomies 11-53 days after the procedure.

The majority of DLI patients tolerated oral intake by postop day 1, and the median time to resuming a regular diet was 2 days. Most people were discharged within a day or 2 of diversion, and a few took longer to achieve medical rescue. Almost 90% had an improvement in nutritional status, and over 80% went on to elective laparoscopic definitive procedures or colon salvage.

Two patients had postop wound infections, “but there were no other complications” with DLI, Dr. Russell said.

All DLIs were performed with a single-incision laparoscopic approach and took an average of about a half hour. Most of the diversions were in the right lower abdominal quadrant.

The mean age of the patients was 36 years, with a range of 16-81 years. Just over half were men. Of 21 patients who met systemic inflammatory response syndrome criteria at the time of operation, 13 (62%) resolved within 24 hours of DLI.
 

 

Diverting loop ileostomies save patients with inflammatory bowel disease (IBD) with severe colitis from rushed total abdominal colectomies, buying time for patient optimization before surgery, and perhaps even saving colons, according to a report from the University of California, Los Angeles.

Urgent colectomy is the standard of care, but it’s a big operation when patients aren’t doing well. Immunosuppression, malnutrition, and other problems lead to high rates of complications.

In 2013, UCLA physicians decided to try rescue diverting loop ileostomies (DLIs), a relatively quick, minimally invasive option to temporarily divert the fecal stream, instead. The idea is to give the colon a chance to heal and the patient another shot at medical management and recovery before definitive surgery. There’s even a chance of colon salvage.

The approach has been working well at UCLA. Investigators previously reported good results for their first eight patients. They presented updated results for the series – now up to 34 patients – at the annual meeting of the American Society of Colon and Rectal Surgeons.

So far, DLI allowed 91% of patients (31/34) to avoid urgent total colectomies. It’s “a safe alternative. Patients undergoing DLI have acceptably low complication rates and most are afforded time for medical and nutritional optimization prior to proceeding with their definitive surgical care,” said presenter Tara Russell, MD, a UCLA surgery resident.

“Currently, [almost every] patient presenting with acute colitis who we aren’t able to get to the point of discharge with medical optimization” is now offered rescue DLI at the university, and patients have been eager for a chance at avoiding total colectomy. The only patients who are not offered DLI are those with, for instance, fulminant toxic megacolon, Dr. Russell said.

The DLI approach failed in just 2 of the 18 ulcerative colitis patients and 1 of the 16 Crohn’s patients in the series. All three went on to emergent total colectomies 11-53 days after the procedure.

The majority of DLI patients tolerated oral intake by postop day 1, and the median time to resuming a regular diet was 2 days. Most people were discharged within a day or 2 of diversion, and a few took longer to achieve medical rescue. Almost 90% had an improvement in nutritional status, and over 80% went on to elective laparoscopic definitive procedures or colon salvage.

Two patients had postop wound infections, “but there were no other complications” with DLI, Dr. Russell said.

All DLIs were performed with a single-incision laparoscopic approach and took an average of about a half hour. Most of the diversions were in the right lower abdominal quadrant.

The mean age of the patients was 36 years, with a range of 16-81 years. Just over half were men. Of 21 patients who met systemic inflammatory response syndrome criteria at the time of operation, 13 (62%) resolved within 24 hours of DLI.
 

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Key clinical point: Diverting loop ileostomy seems to be a better option than total colectomy for severe, acute inflammatory bowel disease colitis.

Major finding: DLI allowed 91% of patients (31/34) to avoid urgent total colectomies.

Data source: A report on 34 patients with severe, acute inflammatory bowel disease colitis.

Disclosures: The presenter had no disclosures.

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Statins might protect against rectal anastomotic leaks

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Wed, 01/02/2019 - 09:55

 

– Statins appeared to decrease the risk of sepsis after colorectal surgery and of anastomotic leak after rectal resection in a review of 7,285 elective colorectal surgery patients at 64 Michigan hospitals.

Overall, 2,515 patients (34.5%) were on statins preoperatively and received at least one dose while in the hospital post op. Their outcomes were compared with those of the 4,770 patients (65.5%) who were not on statins.

Dr. David Disbrow
The statin group had a reduced risk of sepsis (odds ratio, 0.712; 95% confidence interval, 0.535-0.948; P = .020), and, while statins were not associated with a reduction in anastomotic leaks overall, they were protective in subgroup analysis of patients who had rectal resections, which are especially prone to leakage (OR, 0.260; 95% CI, 0.112-0.605; P = .002).

Statin patients were older (mean, 68 vs. 59 years) with more comorbidities (mean, 2.4 vs. 1.1), including diabetes (34% vs.12%) and hypertension (78% vs. 41%). The majority of statin patients were American Society of Anesthesiologists class 3, and the majority of nonstatin patients were class 1 or 2. The investigators controlled for those and other confounders by multivariate logistic regression and propensity scoring.

“We believe that statin medications can reduce sepsis in the colorectal patient population and may improve anastomotic leak rates for rectal resections,” concluded investigators led by David Disbrow, MD, a colorectal surgery fellow at St. Joseph Mercy Hospital in Ann Arbor, Mich.

The immediate take-home from the study is to make sure that patients who should be on statins for hypercholesterolemia or other reasons are actually taking the drugs prior to colorectal surgery. It just might improve their surgical outcomes. “I think that would be a good way to start,” Dr. Disbrow said at the American Society of Colon and Rectal Surgeons annual meeting.

If statins truly do help reduce postop sepsis and rectal anastomotic leaks, he said, it’s probably because of their anti-inflammatory effects, which have been demonstrated in previous studies. New Zealand investigators, for instance, randomized 65 patients to 40 mg oral simvastatin for up to a week before elective colorectal resections or Hartmann’s procedure reversals and for 2 weeks afterwards; 67 patients were randomized to placebo. The simvastatin group had significantly lower postop plasma concentrations of IL-6, IL-8, and tumor necrosis factor–alpha (J Am Coll Surg. 2016 Aug;223[2]:308-20.e1).

Even so, there were no between-group differences in postoperative complications in that study, and, in general, the impact of statins on postop complications has been mixed in the literature. Some studies have shown benefits, others have suggested harm, and a few have shown nothing either way.

It’s the same situation with prior looks at anastomotic leaks. A Danish review of 2,766 patients who had colorectal anastomoses – 496 (19%) treated perioperatively with statins, some in high-dose – found no difference in leakage rates (OR, 1.31; 95% CI, 0.84-2.05; P = 0.23)(Dis Colon Rectum. 2013 Aug;56[8]:980-6). On the other hand, a more recent British review of 144 patients – 45 (39.4%) on preoperative statins – found that “although patients taking statins did not have a significantly reduced leak risk, compared to nonstatin users, high-risk patients taking statins had the same leak risk as non–high risk patients; therefore, it is plausible that statins normalize the risk of anastomotic leak in high-risk patients” (Gut. 2015;64:A162-3).

In the new Michigan study, there were no differences in surgical site infections or 30-day mortality between statin and nonstatin patients, but patients on statins were less likely to get pneumonia, which might help account for their lower sepsis risk, Dr. Disbrow said.

Data for the study came from the Michigan Surgical Quality Collaborative database.

Dr. Disbrow had no disclosures.
 

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– Statins appeared to decrease the risk of sepsis after colorectal surgery and of anastomotic leak after rectal resection in a review of 7,285 elective colorectal surgery patients at 64 Michigan hospitals.

Overall, 2,515 patients (34.5%) were on statins preoperatively and received at least one dose while in the hospital post op. Their outcomes were compared with those of the 4,770 patients (65.5%) who were not on statins.

Dr. David Disbrow
The statin group had a reduced risk of sepsis (odds ratio, 0.712; 95% confidence interval, 0.535-0.948; P = .020), and, while statins were not associated with a reduction in anastomotic leaks overall, they were protective in subgroup analysis of patients who had rectal resections, which are especially prone to leakage (OR, 0.260; 95% CI, 0.112-0.605; P = .002).

Statin patients were older (mean, 68 vs. 59 years) with more comorbidities (mean, 2.4 vs. 1.1), including diabetes (34% vs.12%) and hypertension (78% vs. 41%). The majority of statin patients were American Society of Anesthesiologists class 3, and the majority of nonstatin patients were class 1 or 2. The investigators controlled for those and other confounders by multivariate logistic regression and propensity scoring.

“We believe that statin medications can reduce sepsis in the colorectal patient population and may improve anastomotic leak rates for rectal resections,” concluded investigators led by David Disbrow, MD, a colorectal surgery fellow at St. Joseph Mercy Hospital in Ann Arbor, Mich.

The immediate take-home from the study is to make sure that patients who should be on statins for hypercholesterolemia or other reasons are actually taking the drugs prior to colorectal surgery. It just might improve their surgical outcomes. “I think that would be a good way to start,” Dr. Disbrow said at the American Society of Colon and Rectal Surgeons annual meeting.

If statins truly do help reduce postop sepsis and rectal anastomotic leaks, he said, it’s probably because of their anti-inflammatory effects, which have been demonstrated in previous studies. New Zealand investigators, for instance, randomized 65 patients to 40 mg oral simvastatin for up to a week before elective colorectal resections or Hartmann’s procedure reversals and for 2 weeks afterwards; 67 patients were randomized to placebo. The simvastatin group had significantly lower postop plasma concentrations of IL-6, IL-8, and tumor necrosis factor–alpha (J Am Coll Surg. 2016 Aug;223[2]:308-20.e1).

Even so, there were no between-group differences in postoperative complications in that study, and, in general, the impact of statins on postop complications has been mixed in the literature. Some studies have shown benefits, others have suggested harm, and a few have shown nothing either way.

It’s the same situation with prior looks at anastomotic leaks. A Danish review of 2,766 patients who had colorectal anastomoses – 496 (19%) treated perioperatively with statins, some in high-dose – found no difference in leakage rates (OR, 1.31; 95% CI, 0.84-2.05; P = 0.23)(Dis Colon Rectum. 2013 Aug;56[8]:980-6). On the other hand, a more recent British review of 144 patients – 45 (39.4%) on preoperative statins – found that “although patients taking statins did not have a significantly reduced leak risk, compared to nonstatin users, high-risk patients taking statins had the same leak risk as non–high risk patients; therefore, it is plausible that statins normalize the risk of anastomotic leak in high-risk patients” (Gut. 2015;64:A162-3).

In the new Michigan study, there were no differences in surgical site infections or 30-day mortality between statin and nonstatin patients, but patients on statins were less likely to get pneumonia, which might help account for their lower sepsis risk, Dr. Disbrow said.

Data for the study came from the Michigan Surgical Quality Collaborative database.

Dr. Disbrow had no disclosures.
 

 

– Statins appeared to decrease the risk of sepsis after colorectal surgery and of anastomotic leak after rectal resection in a review of 7,285 elective colorectal surgery patients at 64 Michigan hospitals.

Overall, 2,515 patients (34.5%) were on statins preoperatively and received at least one dose while in the hospital post op. Their outcomes were compared with those of the 4,770 patients (65.5%) who were not on statins.

Dr. David Disbrow
The statin group had a reduced risk of sepsis (odds ratio, 0.712; 95% confidence interval, 0.535-0.948; P = .020), and, while statins were not associated with a reduction in anastomotic leaks overall, they were protective in subgroup analysis of patients who had rectal resections, which are especially prone to leakage (OR, 0.260; 95% CI, 0.112-0.605; P = .002).

Statin patients were older (mean, 68 vs. 59 years) with more comorbidities (mean, 2.4 vs. 1.1), including diabetes (34% vs.12%) and hypertension (78% vs. 41%). The majority of statin patients were American Society of Anesthesiologists class 3, and the majority of nonstatin patients were class 1 or 2. The investigators controlled for those and other confounders by multivariate logistic regression and propensity scoring.

“We believe that statin medications can reduce sepsis in the colorectal patient population and may improve anastomotic leak rates for rectal resections,” concluded investigators led by David Disbrow, MD, a colorectal surgery fellow at St. Joseph Mercy Hospital in Ann Arbor, Mich.

The immediate take-home from the study is to make sure that patients who should be on statins for hypercholesterolemia or other reasons are actually taking the drugs prior to colorectal surgery. It just might improve their surgical outcomes. “I think that would be a good way to start,” Dr. Disbrow said at the American Society of Colon and Rectal Surgeons annual meeting.

If statins truly do help reduce postop sepsis and rectal anastomotic leaks, he said, it’s probably because of their anti-inflammatory effects, which have been demonstrated in previous studies. New Zealand investigators, for instance, randomized 65 patients to 40 mg oral simvastatin for up to a week before elective colorectal resections or Hartmann’s procedure reversals and for 2 weeks afterwards; 67 patients were randomized to placebo. The simvastatin group had significantly lower postop plasma concentrations of IL-6, IL-8, and tumor necrosis factor–alpha (J Am Coll Surg. 2016 Aug;223[2]:308-20.e1).

Even so, there were no between-group differences in postoperative complications in that study, and, in general, the impact of statins on postop complications has been mixed in the literature. Some studies have shown benefits, others have suggested harm, and a few have shown nothing either way.

It’s the same situation with prior looks at anastomotic leaks. A Danish review of 2,766 patients who had colorectal anastomoses – 496 (19%) treated perioperatively with statins, some in high-dose – found no difference in leakage rates (OR, 1.31; 95% CI, 0.84-2.05; P = 0.23)(Dis Colon Rectum. 2013 Aug;56[8]:980-6). On the other hand, a more recent British review of 144 patients – 45 (39.4%) on preoperative statins – found that “although patients taking statins did not have a significantly reduced leak risk, compared to nonstatin users, high-risk patients taking statins had the same leak risk as non–high risk patients; therefore, it is plausible that statins normalize the risk of anastomotic leak in high-risk patients” (Gut. 2015;64:A162-3).

In the new Michigan study, there were no differences in surgical site infections or 30-day mortality between statin and nonstatin patients, but patients on statins were less likely to get pneumonia, which might help account for their lower sepsis risk, Dr. Disbrow said.

Data for the study came from the Michigan Surgical Quality Collaborative database.

Dr. Disbrow had no disclosures.
 

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Key clinical point: Make sure that patients who should be on statins for hypercholesterolemia or other reasons are actually taking the drugs prior to colorectal surgery. It just might improve their surgical outcomes.

Major finding: The statin group had a reduced risk of sepsis (OR, 0.712; 95% CI, 0.535-0.948; P = .020), and, while statins were not associated with a reduction in anastomotic leaks overall, they were protective in subgroup analysis of patients who had rectal resections, which are especially prone to leakage (OR, 0.260; 95% CI, 0.112-0.605, P = .002).

Data source: A review of 7,285 elective colorectal surgery patients.

Disclosures: The lead investigator had no disclosures.

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Childhood vaccine trauma decreases adolescent HPV immunization uptake

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Thu, 03/28/2019 - 14:50

 

The more vaccines children get at any one office visit between the ages of 4 and 6 years, the more fearful they are of needles later on and the less likely they are to start human papillomavirus vaccine (HPV) as adolescents, according to an investigation of 120 children.

Shot-stacking between ages 4 and 6 years is not uncommon, especially if children might not be back in the office any time soon. Although it’s convenient and often better reimbursed to give all the recommended 4- to 6-year-old shots – MMR, DTaP, varicella, IPV, and maybe flu and hepatitis B vaccines – in one visit, the investigators found a hidden cost.

M. Alexander Otto/Frontline Medical News
Dr. Amy Baxter
For some children, the trauma of being pinned down for shot after shot leaves a lasting impression that makes them shy away from needles, and maybe even medical care, later on.

“We don’t need to change the vaccine schedule,” but we do have to be careful because 4- to 6-year-olds are especially vulnerable to phobias. “I think the best thing would be to give one vaccine at age 4, two at age 5, and two at age 6,” years, said lead investigator and pediatric emergency physician Amy Baxter, MD, a clinical associate professor at the Medical College of Georgia, Augusta.

“I’ve dealt with needle phobia in the ED. These kids come in and they are already freaked out about needles. If they get diagnosed with diabetes or leukemia, parents don’t think they are going to be able to handle it,” she said in an interview.

Expanded school vaccination programs might help by making it more convenient for parents to space out shots. The development of patch, microneedle, or effective sublingual or intranasal options also would help.

Dr. Baxter and her colleagues asked 120 children aged 10 to 12 years old to rate their fear of needles on a visual analogue scale (VAS), from 0 points meaning no fear to 100. The investigators matched the scores against the children’s immunization records (Vaccine. 2017 Jun 20. doi: 10.1016/j.vaccine.2017.06.029).

There was no significant relationship between needle fear and the total number of injections. However, fear did correlate with the number of shots children received in 1 day from ages 4 to 6 years old. Six children (50%) who had four same-day injections during that period scored in the upper quartile of anxiety as adolescents (VAS greater than 83), versus 22 (27%) who had three, and 2 (10%) who had two. None of the children who had just one shot per office visit as preschoolers were very worried about needles (P = .0387).

The investigators found that the likelihood of being in the upper quartile of fear as adolescents increased with each additional same-day injection between the ages of 4 and 6 years (odds ratio, 3.108; 95% confidence interval, 1.311-7.367; P = .01).

The team checked back with the children a few years later to see who had started HPV immunizations by age 14 years. Just 27% of children in the upper quartile of needle fear had done so, versus 48% in the least anxious quartile (VAS less than 32). The study wasn’t powered to detect a statistically significant difference in HPV vaccine uptake, but decreased uptake with higher needle fear came close (OR, 2.57; 95% CI, 0.864-7.621; P = .0889).

“It’s the stacking that causes fear. There was no difference in the uptake of vaccines when they were spread out, but more shots” at one time “causes more distress, so there was a difference in fear 5 years later,” Dr. Baxter said.

The investigators also assessed parental concerns about immunizations. “What was interesting was that whether the parents were in the upper or lower quartile of anxiety didn’t impact HPV initiation at all. The children’s anxiety 2 years earlier seemed much more relevant,” Dr. Baxter said.

In a literature review of 15 studies from 1958-2016 that included over 8,000 subjects, the investigators also found that needle fear tracked neatly with the sixfold increase in scheduled vaccines since the 1970s, with more than 60% of people now endorsing some degree of injection anxiety – more than ever before. “The curve of increasing needle fear correlated strongly with increasing vaccine number,” they found (Kendall’s tau b = 0.747; 95% CI, 0.513-0.982; P = .0003).

As two-thirds of the literature review sample were adults, “these results imply that fear acquired in childhood persists,” they concluded.

The majority of children in the study were white. Their mothers were a mean of 44 years, with a mean education level of 18 years. Demographic differences didn’t affect needle fear.

Dr. Baxter is a pediatric pain researcher and the inventor of Buzzy, a bumblebee shaped vibrator to distract children and relieve pain during shots. When asked if readers could trust her study findings given her interest in selling the device, she noted that, in a previous study, “Buzzy for 15 seconds did not work well for 4 to 6 year olds” getting multiple injections at one office visit. “Buzzy is not the solution for giving four shots at once.”

 

 

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The more vaccines children get at any one office visit between the ages of 4 and 6 years, the more fearful they are of needles later on and the less likely they are to start human papillomavirus vaccine (HPV) as adolescents, according to an investigation of 120 children.

Shot-stacking between ages 4 and 6 years is not uncommon, especially if children might not be back in the office any time soon. Although it’s convenient and often better reimbursed to give all the recommended 4- to 6-year-old shots – MMR, DTaP, varicella, IPV, and maybe flu and hepatitis B vaccines – in one visit, the investigators found a hidden cost.

M. Alexander Otto/Frontline Medical News
Dr. Amy Baxter
For some children, the trauma of being pinned down for shot after shot leaves a lasting impression that makes them shy away from needles, and maybe even medical care, later on.

“We don’t need to change the vaccine schedule,” but we do have to be careful because 4- to 6-year-olds are especially vulnerable to phobias. “I think the best thing would be to give one vaccine at age 4, two at age 5, and two at age 6,” years, said lead investigator and pediatric emergency physician Amy Baxter, MD, a clinical associate professor at the Medical College of Georgia, Augusta.

“I’ve dealt with needle phobia in the ED. These kids come in and they are already freaked out about needles. If they get diagnosed with diabetes or leukemia, parents don’t think they are going to be able to handle it,” she said in an interview.

Expanded school vaccination programs might help by making it more convenient for parents to space out shots. The development of patch, microneedle, or effective sublingual or intranasal options also would help.

Dr. Baxter and her colleagues asked 120 children aged 10 to 12 years old to rate their fear of needles on a visual analogue scale (VAS), from 0 points meaning no fear to 100. The investigators matched the scores against the children’s immunization records (Vaccine. 2017 Jun 20. doi: 10.1016/j.vaccine.2017.06.029).

There was no significant relationship between needle fear and the total number of injections. However, fear did correlate with the number of shots children received in 1 day from ages 4 to 6 years old. Six children (50%) who had four same-day injections during that period scored in the upper quartile of anxiety as adolescents (VAS greater than 83), versus 22 (27%) who had three, and 2 (10%) who had two. None of the children who had just one shot per office visit as preschoolers were very worried about needles (P = .0387).

The investigators found that the likelihood of being in the upper quartile of fear as adolescents increased with each additional same-day injection between the ages of 4 and 6 years (odds ratio, 3.108; 95% confidence interval, 1.311-7.367; P = .01).

The team checked back with the children a few years later to see who had started HPV immunizations by age 14 years. Just 27% of children in the upper quartile of needle fear had done so, versus 48% in the least anxious quartile (VAS less than 32). The study wasn’t powered to detect a statistically significant difference in HPV vaccine uptake, but decreased uptake with higher needle fear came close (OR, 2.57; 95% CI, 0.864-7.621; P = .0889).

“It’s the stacking that causes fear. There was no difference in the uptake of vaccines when they were spread out, but more shots” at one time “causes more distress, so there was a difference in fear 5 years later,” Dr. Baxter said.

The investigators also assessed parental concerns about immunizations. “What was interesting was that whether the parents were in the upper or lower quartile of anxiety didn’t impact HPV initiation at all. The children’s anxiety 2 years earlier seemed much more relevant,” Dr. Baxter said.

In a literature review of 15 studies from 1958-2016 that included over 8,000 subjects, the investigators also found that needle fear tracked neatly with the sixfold increase in scheduled vaccines since the 1970s, with more than 60% of people now endorsing some degree of injection anxiety – more than ever before. “The curve of increasing needle fear correlated strongly with increasing vaccine number,” they found (Kendall’s tau b = 0.747; 95% CI, 0.513-0.982; P = .0003).

As two-thirds of the literature review sample were adults, “these results imply that fear acquired in childhood persists,” they concluded.

The majority of children in the study were white. Their mothers were a mean of 44 years, with a mean education level of 18 years. Demographic differences didn’t affect needle fear.

Dr. Baxter is a pediatric pain researcher and the inventor of Buzzy, a bumblebee shaped vibrator to distract children and relieve pain during shots. When asked if readers could trust her study findings given her interest in selling the device, she noted that, in a previous study, “Buzzy for 15 seconds did not work well for 4 to 6 year olds” getting multiple injections at one office visit. “Buzzy is not the solution for giving four shots at once.”

 

 

 

The more vaccines children get at any one office visit between the ages of 4 and 6 years, the more fearful they are of needles later on and the less likely they are to start human papillomavirus vaccine (HPV) as adolescents, according to an investigation of 120 children.

Shot-stacking between ages 4 and 6 years is not uncommon, especially if children might not be back in the office any time soon. Although it’s convenient and often better reimbursed to give all the recommended 4- to 6-year-old shots – MMR, DTaP, varicella, IPV, and maybe flu and hepatitis B vaccines – in one visit, the investigators found a hidden cost.

M. Alexander Otto/Frontline Medical News
Dr. Amy Baxter
For some children, the trauma of being pinned down for shot after shot leaves a lasting impression that makes them shy away from needles, and maybe even medical care, later on.

“We don’t need to change the vaccine schedule,” but we do have to be careful because 4- to 6-year-olds are especially vulnerable to phobias. “I think the best thing would be to give one vaccine at age 4, two at age 5, and two at age 6,” years, said lead investigator and pediatric emergency physician Amy Baxter, MD, a clinical associate professor at the Medical College of Georgia, Augusta.

“I’ve dealt with needle phobia in the ED. These kids come in and they are already freaked out about needles. If they get diagnosed with diabetes or leukemia, parents don’t think they are going to be able to handle it,” she said in an interview.

Expanded school vaccination programs might help by making it more convenient for parents to space out shots. The development of patch, microneedle, or effective sublingual or intranasal options also would help.

Dr. Baxter and her colleagues asked 120 children aged 10 to 12 years old to rate their fear of needles on a visual analogue scale (VAS), from 0 points meaning no fear to 100. The investigators matched the scores against the children’s immunization records (Vaccine. 2017 Jun 20. doi: 10.1016/j.vaccine.2017.06.029).

There was no significant relationship between needle fear and the total number of injections. However, fear did correlate with the number of shots children received in 1 day from ages 4 to 6 years old. Six children (50%) who had four same-day injections during that period scored in the upper quartile of anxiety as adolescents (VAS greater than 83), versus 22 (27%) who had three, and 2 (10%) who had two. None of the children who had just one shot per office visit as preschoolers were very worried about needles (P = .0387).

The investigators found that the likelihood of being in the upper quartile of fear as adolescents increased with each additional same-day injection between the ages of 4 and 6 years (odds ratio, 3.108; 95% confidence interval, 1.311-7.367; P = .01).

The team checked back with the children a few years later to see who had started HPV immunizations by age 14 years. Just 27% of children in the upper quartile of needle fear had done so, versus 48% in the least anxious quartile (VAS less than 32). The study wasn’t powered to detect a statistically significant difference in HPV vaccine uptake, but decreased uptake with higher needle fear came close (OR, 2.57; 95% CI, 0.864-7.621; P = .0889).

“It’s the stacking that causes fear. There was no difference in the uptake of vaccines when they were spread out, but more shots” at one time “causes more distress, so there was a difference in fear 5 years later,” Dr. Baxter said.

The investigators also assessed parental concerns about immunizations. “What was interesting was that whether the parents were in the upper or lower quartile of anxiety didn’t impact HPV initiation at all. The children’s anxiety 2 years earlier seemed much more relevant,” Dr. Baxter said.

In a literature review of 15 studies from 1958-2016 that included over 8,000 subjects, the investigators also found that needle fear tracked neatly with the sixfold increase in scheduled vaccines since the 1970s, with more than 60% of people now endorsing some degree of injection anxiety – more than ever before. “The curve of increasing needle fear correlated strongly with increasing vaccine number,” they found (Kendall’s tau b = 0.747; 95% CI, 0.513-0.982; P = .0003).

As two-thirds of the literature review sample were adults, “these results imply that fear acquired in childhood persists,” they concluded.

The majority of children in the study were white. Their mothers were a mean of 44 years, with a mean education level of 18 years. Demographic differences didn’t affect needle fear.

Dr. Baxter is a pediatric pain researcher and the inventor of Buzzy, a bumblebee shaped vibrator to distract children and relieve pain during shots. When asked if readers could trust her study findings given her interest in selling the device, she noted that, in a previous study, “Buzzy for 15 seconds did not work well for 4 to 6 year olds” getting multiple injections at one office visit. “Buzzy is not the solution for giving four shots at once.”

 

 

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Key clinical point: If possible, it’s best to spread 4- to 6-year-old immunizations out over a few office visits.

Major finding: Six children (50%) who had four same-day injections during that period scored in the upper quartile of anxiety as adolescents (VAS greater than 83), versus 22 (27%) who had three, and 2 (10%) who had two same-day injections. Just 27% of children in the upper quartile of needle fear had started HPV immunization at age 14 years, versus 48% in the least anxious quartile.

Data source: Survey and follow-up of 120 children and their parents.

Disclosures: The lead investigator is a pediatric pain researcher and the inventor of Buzzy, a bumblebee shaped vibrator to distract children and relieve pain during shots. When asked if readers could trust her findings given her interest in selling the device, she noted that, in a previous study, “Buzzy for 15 seconds did not work well for 4-6 year olds” getting multiple injections in one office visit. “Buzzy is not the solution for giving four shots at once.”

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Colonoscopy patients prefer propofol over fentanyl/midazolam

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– As patient satisfaction becomes increasingly important for reimbursements, it might be a good idea to switch to propofol for colonoscopies.

The reason is because patients prefer propofol over standard-of-care fentanyl/midazolam as their anesthetic for outpatient colonoscopies, according to a randomized, blinded trial at a single center. Importantly, clinical assessment also showed that propofol outperformed fentanyl/midazolam in terms of hypoxia, pain, nausea, and procedural difficulties.

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The 300 patients randomized to propofol were more likely than were the 300 randomized to fentanyl/midazolam to rate the amount of anesthesia they received as being “just right” (98.7% versus. 91.3%), and they were more likely to state that they were “very satisfied” with their anesthesia during the procedure (86.3% versus 74%). Propofol patients were also more likely to recommend their anesthesia to others (98.7% versus 94%).

“Our study demonstrated the superiority of propofol over fentanyl/midazolam in an outpatient setting from both a patient satisfaction standpoint and from a provider prospective,” said lead investigator Anantha Padmanabhan, MD, a colorectal surgeon with Mount Carmel Health, Columbus, Ohio.

The short duration of action and quick turnaround time have led to an increase in the use of propofol for outpatient procedures. It’s been studied extensively for safety and efficacy, but patient preference has not been well documented. The investigators wanted to look into the issue because patient satisfaction has become an important metric for reimbursement, Dr. Padmanabhan said at the annual meeting of the American Society of Colon and Rectal Surgeons, where the study was presented.

Patients were randomly assigned to propofol or fentanyl/midazolam in the colonoscopy suite at the Taylor Station Surgical Center in Columbus. Anesthesia personnel administered the assigned anesthetic, and circulating nurses rated the difficulty of the procedure. Patients were surveyed after they came to, and again over the phone at least 24 hours after discharge.

Alex Otto/Frontline Medical News
Dr. Anantha Padmanabhan
Dr. Padmanabhan performed all the colonoscopies in the study. He could not be completely blinded to the anesthetic used, so did not participate in any data collection.

Fewer propofol patients reported pain greater than zero during the procedure (2% versus 6%); fewer remembered being awake (2% versus 17%); and fewer had complications (2.7% versus 11.7%); 21 patients in the fentanyl/midazolam group had intraoperative hypoxia, versus 1 in the propofol group. Eleven fentanyl/midazolam patients had postprocedure nausea and vomiting, versus one propofol patient.

Nurses rated 26% of fentanyl/midazolam procedures as “difficult,” compared to 4.7% in the propofol group. Mean induction time was 2.1 minutes with propofol and 3.2 minutes with fentanyl/midazolam; mean procedure time was about 13 minutes in both groups. The cecal intubation rate was 100% in both groups, and there were no perforations.

Propofol patients reacted less during the procedure; an audience member wondered if the loss of feedback was a problem for Dr. Padmanabhan.

“We use propofol in a very light sedation, and sometimes we do get feedback, but more importantly we feel the technique of colonoscopy is as much by feel as it is by vision. If you feel that the scope is not going in correctly, you should pull back then try the loop reduction maneuvers,” he said.

The most common indication for colonoscopy was a history of polyps, followed by general colon screening. Patients in both groups were a mean of 61 years old, and about evenly split between the sexes. Body mass index was a mean of 30 kg/m2 in both groups. There were no between-group differences in comorbidities; hypertension and diabetes were the most common.

There was no external funding for the work, and the investigators had no disclosures.

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– As patient satisfaction becomes increasingly important for reimbursements, it might be a good idea to switch to propofol for colonoscopies.

The reason is because patients prefer propofol over standard-of-care fentanyl/midazolam as their anesthetic for outpatient colonoscopies, according to a randomized, blinded trial at a single center. Importantly, clinical assessment also showed that propofol outperformed fentanyl/midazolam in terms of hypoxia, pain, nausea, and procedural difficulties.

Copyright Eraxion/Thinkstock
The 300 patients randomized to propofol were more likely than were the 300 randomized to fentanyl/midazolam to rate the amount of anesthesia they received as being “just right” (98.7% versus. 91.3%), and they were more likely to state that they were “very satisfied” with their anesthesia during the procedure (86.3% versus 74%). Propofol patients were also more likely to recommend their anesthesia to others (98.7% versus 94%).

“Our study demonstrated the superiority of propofol over fentanyl/midazolam in an outpatient setting from both a patient satisfaction standpoint and from a provider prospective,” said lead investigator Anantha Padmanabhan, MD, a colorectal surgeon with Mount Carmel Health, Columbus, Ohio.

The short duration of action and quick turnaround time have led to an increase in the use of propofol for outpatient procedures. It’s been studied extensively for safety and efficacy, but patient preference has not been well documented. The investigators wanted to look into the issue because patient satisfaction has become an important metric for reimbursement, Dr. Padmanabhan said at the annual meeting of the American Society of Colon and Rectal Surgeons, where the study was presented.

Patients were randomly assigned to propofol or fentanyl/midazolam in the colonoscopy suite at the Taylor Station Surgical Center in Columbus. Anesthesia personnel administered the assigned anesthetic, and circulating nurses rated the difficulty of the procedure. Patients were surveyed after they came to, and again over the phone at least 24 hours after discharge.

Alex Otto/Frontline Medical News
Dr. Anantha Padmanabhan
Dr. Padmanabhan performed all the colonoscopies in the study. He could not be completely blinded to the anesthetic used, so did not participate in any data collection.

Fewer propofol patients reported pain greater than zero during the procedure (2% versus 6%); fewer remembered being awake (2% versus 17%); and fewer had complications (2.7% versus 11.7%); 21 patients in the fentanyl/midazolam group had intraoperative hypoxia, versus 1 in the propofol group. Eleven fentanyl/midazolam patients had postprocedure nausea and vomiting, versus one propofol patient.

Nurses rated 26% of fentanyl/midazolam procedures as “difficult,” compared to 4.7% in the propofol group. Mean induction time was 2.1 minutes with propofol and 3.2 minutes with fentanyl/midazolam; mean procedure time was about 13 minutes in both groups. The cecal intubation rate was 100% in both groups, and there were no perforations.

Propofol patients reacted less during the procedure; an audience member wondered if the loss of feedback was a problem for Dr. Padmanabhan.

“We use propofol in a very light sedation, and sometimes we do get feedback, but more importantly we feel the technique of colonoscopy is as much by feel as it is by vision. If you feel that the scope is not going in correctly, you should pull back then try the loop reduction maneuvers,” he said.

The most common indication for colonoscopy was a history of polyps, followed by general colon screening. Patients in both groups were a mean of 61 years old, and about evenly split between the sexes. Body mass index was a mean of 30 kg/m2 in both groups. There were no between-group differences in comorbidities; hypertension and diabetes were the most common.

There was no external funding for the work, and the investigators had no disclosures.

 

– As patient satisfaction becomes increasingly important for reimbursements, it might be a good idea to switch to propofol for colonoscopies.

The reason is because patients prefer propofol over standard-of-care fentanyl/midazolam as their anesthetic for outpatient colonoscopies, according to a randomized, blinded trial at a single center. Importantly, clinical assessment also showed that propofol outperformed fentanyl/midazolam in terms of hypoxia, pain, nausea, and procedural difficulties.

Copyright Eraxion/Thinkstock
The 300 patients randomized to propofol were more likely than were the 300 randomized to fentanyl/midazolam to rate the amount of anesthesia they received as being “just right” (98.7% versus. 91.3%), and they were more likely to state that they were “very satisfied” with their anesthesia during the procedure (86.3% versus 74%). Propofol patients were also more likely to recommend their anesthesia to others (98.7% versus 94%).

“Our study demonstrated the superiority of propofol over fentanyl/midazolam in an outpatient setting from both a patient satisfaction standpoint and from a provider prospective,” said lead investigator Anantha Padmanabhan, MD, a colorectal surgeon with Mount Carmel Health, Columbus, Ohio.

The short duration of action and quick turnaround time have led to an increase in the use of propofol for outpatient procedures. It’s been studied extensively for safety and efficacy, but patient preference has not been well documented. The investigators wanted to look into the issue because patient satisfaction has become an important metric for reimbursement, Dr. Padmanabhan said at the annual meeting of the American Society of Colon and Rectal Surgeons, where the study was presented.

Patients were randomly assigned to propofol or fentanyl/midazolam in the colonoscopy suite at the Taylor Station Surgical Center in Columbus. Anesthesia personnel administered the assigned anesthetic, and circulating nurses rated the difficulty of the procedure. Patients were surveyed after they came to, and again over the phone at least 24 hours after discharge.

Alex Otto/Frontline Medical News
Dr. Anantha Padmanabhan
Dr. Padmanabhan performed all the colonoscopies in the study. He could not be completely blinded to the anesthetic used, so did not participate in any data collection.

Fewer propofol patients reported pain greater than zero during the procedure (2% versus 6%); fewer remembered being awake (2% versus 17%); and fewer had complications (2.7% versus 11.7%); 21 patients in the fentanyl/midazolam group had intraoperative hypoxia, versus 1 in the propofol group. Eleven fentanyl/midazolam patients had postprocedure nausea and vomiting, versus one propofol patient.

Nurses rated 26% of fentanyl/midazolam procedures as “difficult,” compared to 4.7% in the propofol group. Mean induction time was 2.1 minutes with propofol and 3.2 minutes with fentanyl/midazolam; mean procedure time was about 13 minutes in both groups. The cecal intubation rate was 100% in both groups, and there were no perforations.

Propofol patients reacted less during the procedure; an audience member wondered if the loss of feedback was a problem for Dr. Padmanabhan.

“We use propofol in a very light sedation, and sometimes we do get feedback, but more importantly we feel the technique of colonoscopy is as much by feel as it is by vision. If you feel that the scope is not going in correctly, you should pull back then try the loop reduction maneuvers,” he said.

The most common indication for colonoscopy was a history of polyps, followed by general colon screening. Patients in both groups were a mean of 61 years old, and about evenly split between the sexes. Body mass index was a mean of 30 kg/m2 in both groups. There were no between-group differences in comorbidities; hypertension and diabetes were the most common.

There was no external funding for the work, and the investigators had no disclosures.

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Key clinical point: As patient satisfaction becomes increasingly important for reimbursements, it might be best to switch to propofol for colonoscopies.

Major finding: The 300 patients randomized to propofol were more likely than were the 300 randomized to standard-of-care fentanyl/midazolam to state that they were “very satisfied” with their anesthesia during the procedure (86.3% versus 74%).

Data source: Randomized, blinded trial of 600 patients at a single center.

Disclosures: There was no external funding for the work, and the investigators had no disclosures.

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NSAIDs remain a concern in colorectal ERAS protocols

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Fri, 01/04/2019 - 13:38

 

Nonselective NSAIDs increase the risk of anastomotic leaks after colorectal surgery, according to a meta-analysis from the University of Sydney, Australia.

After combing results from six randomized, controlled trials and seven retrospective studies involving a total of 23,508 patients, investigators found that postop nonselective NSAIDs (odds ratio, 0.54; 95% CI, 0.43-0.67; P less than .00001), and especially diclofenac (OR, 0.39; 95% CI, 0.28-0.55; P less than .00001), were both associated with an increased risk of leakage.

There was an increased risk with all NSAIDs compared to patients who did not receive them after surgery, but the risk was statistically significant only for nonselective options like diclofenac on subgroup analysis. There was a trend for increased leakage with the nonselective agent ketorolac, as well, but it was not significant (OR, 0.71; 95% CI, 0.35-1.43; P = .34).

Dr. Christopher Young


“I’m not going to say we need to wait for more studies; there’s something here. We have to be aware there could be a high risk of leakage with nonsteroidals, and we have to be mindful of that with our ERAS [Enhanced Recovery after Surgery] protocols. I don’t think you should be using nonsteroidals unless you are using them in a trial” and collecting data, “because of the uncertainty,” lead investigator and colorectal surgeon Christopher Young, MD, a clinical associate professor of surgery at the University of Sydney, said at the American Society of Colon and Rectal Surgeons annual meeting.

NSAIDS are a routine part of colorectal ERAS protocols in some places to limit opioid use and hasten recovery and hospital discharge, but there’s been concern for some time that they might also increase the risk of anastomotic leakage. The new Australian findings fit in with previous investigations that raised concerns.

A 2016 review, for instance, found that among 856 patients undergoing an elective colon or rectal resection for cancer, the anastomotic leakage rate was significantly higher in the group that received nonsteroidal anti-inflammatory drugs compared to patients who did not (9.2% versus 5.3%). The higher rate was only seen in patients receiving diclofenac. “The use of diclofenac in colorectal surgery can no longer be recommended. Alternatives for postoperative analgesia need to be explored within an enhanced recovery program,” the investigators concluded (J Gastrointest Surg. 2016 Apr;20[4]:776-82. doi: 10.1007/s11605-015-3010-1).

A review of 13,082 bariatric and colorectal surgery patients in Washington State found that NSAIDs beginning within 24 hours after surgery were associated with a 70% increased risk of anastomotic leaks in nonelective colorectal surgery, with a leak rate of 12.3% in the NSAID group and 8.3% in the non-NSAID group (OR, 1.70; 95% CI, 1.11–2.68; P = .01). Although it was unclear which nonsteroidals patients received, intravenous ketorolac or ibuprofen were likely the most common (JAMA Surg. 2015 Mar 1;150[3]: 223–8).

It’s unknown why, exactly, NSAIDs impair healing and anastomotic strength, but it’s thought to be related to effects on prostaglandin synthesis, Dr. Young noted.

Dr. Young had no disclosures.


 

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Nonselective NSAIDs increase the risk of anastomotic leaks after colorectal surgery, according to a meta-analysis from the University of Sydney, Australia.

After combing results from six randomized, controlled trials and seven retrospective studies involving a total of 23,508 patients, investigators found that postop nonselective NSAIDs (odds ratio, 0.54; 95% CI, 0.43-0.67; P less than .00001), and especially diclofenac (OR, 0.39; 95% CI, 0.28-0.55; P less than .00001), were both associated with an increased risk of leakage.

There was an increased risk with all NSAIDs compared to patients who did not receive them after surgery, but the risk was statistically significant only for nonselective options like diclofenac on subgroup analysis. There was a trend for increased leakage with the nonselective agent ketorolac, as well, but it was not significant (OR, 0.71; 95% CI, 0.35-1.43; P = .34).

Dr. Christopher Young


“I’m not going to say we need to wait for more studies; there’s something here. We have to be aware there could be a high risk of leakage with nonsteroidals, and we have to be mindful of that with our ERAS [Enhanced Recovery after Surgery] protocols. I don’t think you should be using nonsteroidals unless you are using them in a trial” and collecting data, “because of the uncertainty,” lead investigator and colorectal surgeon Christopher Young, MD, a clinical associate professor of surgery at the University of Sydney, said at the American Society of Colon and Rectal Surgeons annual meeting.

NSAIDS are a routine part of colorectal ERAS protocols in some places to limit opioid use and hasten recovery and hospital discharge, but there’s been concern for some time that they might also increase the risk of anastomotic leakage. The new Australian findings fit in with previous investigations that raised concerns.

A 2016 review, for instance, found that among 856 patients undergoing an elective colon or rectal resection for cancer, the anastomotic leakage rate was significantly higher in the group that received nonsteroidal anti-inflammatory drugs compared to patients who did not (9.2% versus 5.3%). The higher rate was only seen in patients receiving diclofenac. “The use of diclofenac in colorectal surgery can no longer be recommended. Alternatives for postoperative analgesia need to be explored within an enhanced recovery program,” the investigators concluded (J Gastrointest Surg. 2016 Apr;20[4]:776-82. doi: 10.1007/s11605-015-3010-1).

A review of 13,082 bariatric and colorectal surgery patients in Washington State found that NSAIDs beginning within 24 hours after surgery were associated with a 70% increased risk of anastomotic leaks in nonelective colorectal surgery, with a leak rate of 12.3% in the NSAID group and 8.3% in the non-NSAID group (OR, 1.70; 95% CI, 1.11–2.68; P = .01). Although it was unclear which nonsteroidals patients received, intravenous ketorolac or ibuprofen were likely the most common (JAMA Surg. 2015 Mar 1;150[3]: 223–8).

It’s unknown why, exactly, NSAIDs impair healing and anastomotic strength, but it’s thought to be related to effects on prostaglandin synthesis, Dr. Young noted.

Dr. Young had no disclosures.


 

 

Nonselective NSAIDs increase the risk of anastomotic leaks after colorectal surgery, according to a meta-analysis from the University of Sydney, Australia.

After combing results from six randomized, controlled trials and seven retrospective studies involving a total of 23,508 patients, investigators found that postop nonselective NSAIDs (odds ratio, 0.54; 95% CI, 0.43-0.67; P less than .00001), and especially diclofenac (OR, 0.39; 95% CI, 0.28-0.55; P less than .00001), were both associated with an increased risk of leakage.

There was an increased risk with all NSAIDs compared to patients who did not receive them after surgery, but the risk was statistically significant only for nonselective options like diclofenac on subgroup analysis. There was a trend for increased leakage with the nonselective agent ketorolac, as well, but it was not significant (OR, 0.71; 95% CI, 0.35-1.43; P = .34).

Dr. Christopher Young


“I’m not going to say we need to wait for more studies; there’s something here. We have to be aware there could be a high risk of leakage with nonsteroidals, and we have to be mindful of that with our ERAS [Enhanced Recovery after Surgery] protocols. I don’t think you should be using nonsteroidals unless you are using them in a trial” and collecting data, “because of the uncertainty,” lead investigator and colorectal surgeon Christopher Young, MD, a clinical associate professor of surgery at the University of Sydney, said at the American Society of Colon and Rectal Surgeons annual meeting.

NSAIDS are a routine part of colorectal ERAS protocols in some places to limit opioid use and hasten recovery and hospital discharge, but there’s been concern for some time that they might also increase the risk of anastomotic leakage. The new Australian findings fit in with previous investigations that raised concerns.

A 2016 review, for instance, found that among 856 patients undergoing an elective colon or rectal resection for cancer, the anastomotic leakage rate was significantly higher in the group that received nonsteroidal anti-inflammatory drugs compared to patients who did not (9.2% versus 5.3%). The higher rate was only seen in patients receiving diclofenac. “The use of diclofenac in colorectal surgery can no longer be recommended. Alternatives for postoperative analgesia need to be explored within an enhanced recovery program,” the investigators concluded (J Gastrointest Surg. 2016 Apr;20[4]:776-82. doi: 10.1007/s11605-015-3010-1).

A review of 13,082 bariatric and colorectal surgery patients in Washington State found that NSAIDs beginning within 24 hours after surgery were associated with a 70% increased risk of anastomotic leaks in nonelective colorectal surgery, with a leak rate of 12.3% in the NSAID group and 8.3% in the non-NSAID group (OR, 1.70; 95% CI, 1.11–2.68; P = .01). Although it was unclear which nonsteroidals patients received, intravenous ketorolac or ibuprofen were likely the most common (JAMA Surg. 2015 Mar 1;150[3]: 223–8).

It’s unknown why, exactly, NSAIDs impair healing and anastomotic strength, but it’s thought to be related to effects on prostaglandin synthesis, Dr. Young noted.

Dr. Young had no disclosures.


 

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Key clinical point: Nonselective NSAIDS increase the risk of anastomotic leaks after colorectal surgery.

Major finding: Postop nonselective NSAIDs (OR, 0.54; 95% CI, 0.43-0.67; P less than .00001), and especially diclofenac (OR, 0.39; 95% CI, 0.28-0.55; P less than .00001), were both associated with an increased risk of leakage.

Data source: Meta-analysis involving 23,508 patients

Disclosures: The presenter had no disclosures.