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DoJ refuses to challenge Texas ACA ruling
The U.S. Department of Justice has signaled it will not oppose any aspect of the recent court ruling to invalidate the Affordable Care Act.
“The Department of Justice has determined that the district court’s judgment should be affirmed, according to a March 25 letter to the U.S. Court of Appeal for the Fifth Circuit in New Orleans. “Because the United States is not urging that any portion of the district court’s judgment be reversed, the government intends to file a brief on the appellees’ schedule.”
At the onset of the trial in the U.S. District Court for the Northern District of Texas, the DOJ had initially challenged portions of the ACA, including declaring guaranteed issue unconstitutional by arguing that it could not be enacted with no penalty for failure to obtain coverage.
However, the judge ruled in the Texas v. United States case that the tax bill passed by Congress in December 2017 effectively rendered the entire health law unconstitutional.
“We said before that the district court’s decision was misguided and wrong. So, too, is the government’s reversal to now support it,” Matt Eyles, president and CEO of America’s Health Insurance Plans said in a statement. “This harmful position puts coverage at risk for more than 100 million Americans that rely on it. We will continue to engage on this issue as it continues through the appeals process so we can support and strengthen affordable coverage for every American.”
The U.S. Department of Justice has signaled it will not oppose any aspect of the recent court ruling to invalidate the Affordable Care Act.
“The Department of Justice has determined that the district court’s judgment should be affirmed, according to a March 25 letter to the U.S. Court of Appeal for the Fifth Circuit in New Orleans. “Because the United States is not urging that any portion of the district court’s judgment be reversed, the government intends to file a brief on the appellees’ schedule.”
At the onset of the trial in the U.S. District Court for the Northern District of Texas, the DOJ had initially challenged portions of the ACA, including declaring guaranteed issue unconstitutional by arguing that it could not be enacted with no penalty for failure to obtain coverage.
However, the judge ruled in the Texas v. United States case that the tax bill passed by Congress in December 2017 effectively rendered the entire health law unconstitutional.
“We said before that the district court’s decision was misguided and wrong. So, too, is the government’s reversal to now support it,” Matt Eyles, president and CEO of America’s Health Insurance Plans said in a statement. “This harmful position puts coverage at risk for more than 100 million Americans that rely on it. We will continue to engage on this issue as it continues through the appeals process so we can support and strengthen affordable coverage for every American.”
The U.S. Department of Justice has signaled it will not oppose any aspect of the recent court ruling to invalidate the Affordable Care Act.
“The Department of Justice has determined that the district court’s judgment should be affirmed, according to a March 25 letter to the U.S. Court of Appeal for the Fifth Circuit in New Orleans. “Because the United States is not urging that any portion of the district court’s judgment be reversed, the government intends to file a brief on the appellees’ schedule.”
At the onset of the trial in the U.S. District Court for the Northern District of Texas, the DOJ had initially challenged portions of the ACA, including declaring guaranteed issue unconstitutional by arguing that it could not be enacted with no penalty for failure to obtain coverage.
However, the judge ruled in the Texas v. United States case that the tax bill passed by Congress in December 2017 effectively rendered the entire health law unconstitutional.
“We said before that the district court’s decision was misguided and wrong. So, too, is the government’s reversal to now support it,” Matt Eyles, president and CEO of America’s Health Insurance Plans said in a statement. “This harmful position puts coverage at risk for more than 100 million Americans that rely on it. We will continue to engage on this issue as it continues through the appeals process so we can support and strengthen affordable coverage for every American.”
Time to revisit fasting rules for surgery patients
LAS VEGAS – Anesthesiologist Michael W. Manning, MD, has a few unusual rules about preparing patients for surgery: Give them a carb-heavy beverage. Definitely provide caffeine to coffee addicts who haven’t had a cup for quite a while. And tell them – again and again – what to expect in terms of pain.
All of these strategies can boost recovery, Dr. Manning, assistant professor of anesthesiology at Duke University Medical Center, Durham, N.C., said in a pair of presentations at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Dr. Manning’s tips
Don’t starve patients before procedures: “We should prep for a surgery like a marathon,” Dr. Manning recommended. That means allowing patients to eat and drink instead of starving them via fasting out of fear that they’ll aspirate under anesthesia, he said.
He pointed to 2017 guidelines issued by the American Society of Anesthesiologists, indicating that patients may drink clear liquids for up to 2 hours before procedures that require general or regional anesthesia or procedural sedation and anesthesia. And patients may consume a light meal, such as toast and a clear liquid, or nonhuman milk, until 6 hours before a procedure. However, they should fast 8 hours after eating fried or fatty foods or meat (Anesthesiology 2017:376-93).
Extensive research supports carb-loading via liquid prior to surgery, said Dr. Manning, who cited a 2014 Cochrane Library review that examined 27 trials on preoperative consumption of carbs prior to various types of surgery. The review found no increase in complications in patients who consumed carbs, compared with placebo or fasting, and there was a slight decrease in length of stay (Cochrane Database Syst Rev. 2014 Aug 14;[8]).
In terms of benefits, research suggests that carb-loading improves patient comfort and gastric emptying, Dr. Manning said, and patients welcome it.
Educate patients about pain expectations
“We surgeons and anesthesiologists need to partner together and talk to patients and define what the pain expectations are,” Dr. Manning said.
At Duke, physicians worked together to set up a script that patients will hear four different times by medical personnel such as the surgeon, the anesthesiologist, and nursing staff, he said.
The script aims to educate patients about what to expect in terms of pain. For example, he says, before some surgeries, patients might be told: “You’re going to have shoulder pain that’s going to feel like you’ve been in the garage all day putting boxes on the shelf all the time,” or “Your belly is going to feel like you did 1,000 sit-ups.”
This eliminates the “fear and anxiety” that comes with not knowing what to expect regarding pain, he said.
Ask about coffee. Yes, coffee.
According to Dr. Manning, patients who regularly drink “a robust amount” of coffee may experience more postoperative pain following afternoon surgery because they’ve gone for an unusually long time without caffeine. Take a “coffee history,” he advised, and ask how much coffee the patient would have consumed by this time on a normal day. Then give patients caffeine as needed. (Coffee is considered a clear beverage under the American Society of Anesthesiologists guidelines.)
“It takes the edge off and helps reduce postoperative pain,” he said.
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Manning has no disclosures.
LAS VEGAS – Anesthesiologist Michael W. Manning, MD, has a few unusual rules about preparing patients for surgery: Give them a carb-heavy beverage. Definitely provide caffeine to coffee addicts who haven’t had a cup for quite a while. And tell them – again and again – what to expect in terms of pain.
All of these strategies can boost recovery, Dr. Manning, assistant professor of anesthesiology at Duke University Medical Center, Durham, N.C., said in a pair of presentations at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Dr. Manning’s tips
Don’t starve patients before procedures: “We should prep for a surgery like a marathon,” Dr. Manning recommended. That means allowing patients to eat and drink instead of starving them via fasting out of fear that they’ll aspirate under anesthesia, he said.
He pointed to 2017 guidelines issued by the American Society of Anesthesiologists, indicating that patients may drink clear liquids for up to 2 hours before procedures that require general or regional anesthesia or procedural sedation and anesthesia. And patients may consume a light meal, such as toast and a clear liquid, or nonhuman milk, until 6 hours before a procedure. However, they should fast 8 hours after eating fried or fatty foods or meat (Anesthesiology 2017:376-93).
Extensive research supports carb-loading via liquid prior to surgery, said Dr. Manning, who cited a 2014 Cochrane Library review that examined 27 trials on preoperative consumption of carbs prior to various types of surgery. The review found no increase in complications in patients who consumed carbs, compared with placebo or fasting, and there was a slight decrease in length of stay (Cochrane Database Syst Rev. 2014 Aug 14;[8]).
In terms of benefits, research suggests that carb-loading improves patient comfort and gastric emptying, Dr. Manning said, and patients welcome it.
Educate patients about pain expectations
“We surgeons and anesthesiologists need to partner together and talk to patients and define what the pain expectations are,” Dr. Manning said.
At Duke, physicians worked together to set up a script that patients will hear four different times by medical personnel such as the surgeon, the anesthesiologist, and nursing staff, he said.
The script aims to educate patients about what to expect in terms of pain. For example, he says, before some surgeries, patients might be told: “You’re going to have shoulder pain that’s going to feel like you’ve been in the garage all day putting boxes on the shelf all the time,” or “Your belly is going to feel like you did 1,000 sit-ups.”
This eliminates the “fear and anxiety” that comes with not knowing what to expect regarding pain, he said.
Ask about coffee. Yes, coffee.
According to Dr. Manning, patients who regularly drink “a robust amount” of coffee may experience more postoperative pain following afternoon surgery because they’ve gone for an unusually long time without caffeine. Take a “coffee history,” he advised, and ask how much coffee the patient would have consumed by this time on a normal day. Then give patients caffeine as needed. (Coffee is considered a clear beverage under the American Society of Anesthesiologists guidelines.)
“It takes the edge off and helps reduce postoperative pain,” he said.
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Manning has no disclosures.
LAS VEGAS – Anesthesiologist Michael W. Manning, MD, has a few unusual rules about preparing patients for surgery: Give them a carb-heavy beverage. Definitely provide caffeine to coffee addicts who haven’t had a cup for quite a while. And tell them – again and again – what to expect in terms of pain.
All of these strategies can boost recovery, Dr. Manning, assistant professor of anesthesiology at Duke University Medical Center, Durham, N.C., said in a pair of presentations at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
Dr. Manning’s tips
Don’t starve patients before procedures: “We should prep for a surgery like a marathon,” Dr. Manning recommended. That means allowing patients to eat and drink instead of starving them via fasting out of fear that they’ll aspirate under anesthesia, he said.
He pointed to 2017 guidelines issued by the American Society of Anesthesiologists, indicating that patients may drink clear liquids for up to 2 hours before procedures that require general or regional anesthesia or procedural sedation and anesthesia. And patients may consume a light meal, such as toast and a clear liquid, or nonhuman milk, until 6 hours before a procedure. However, they should fast 8 hours after eating fried or fatty foods or meat (Anesthesiology 2017:376-93).
Extensive research supports carb-loading via liquid prior to surgery, said Dr. Manning, who cited a 2014 Cochrane Library review that examined 27 trials on preoperative consumption of carbs prior to various types of surgery. The review found no increase in complications in patients who consumed carbs, compared with placebo or fasting, and there was a slight decrease in length of stay (Cochrane Database Syst Rev. 2014 Aug 14;[8]).
In terms of benefits, research suggests that carb-loading improves patient comfort and gastric emptying, Dr. Manning said, and patients welcome it.
Educate patients about pain expectations
“We surgeons and anesthesiologists need to partner together and talk to patients and define what the pain expectations are,” Dr. Manning said.
At Duke, physicians worked together to set up a script that patients will hear four different times by medical personnel such as the surgeon, the anesthesiologist, and nursing staff, he said.
The script aims to educate patients about what to expect in terms of pain. For example, he says, before some surgeries, patients might be told: “You’re going to have shoulder pain that’s going to feel like you’ve been in the garage all day putting boxes on the shelf all the time,” or “Your belly is going to feel like you did 1,000 sit-ups.”
This eliminates the “fear and anxiety” that comes with not knowing what to expect regarding pain, he said.
Ask about coffee. Yes, coffee.
According to Dr. Manning, patients who regularly drink “a robust amount” of coffee may experience more postoperative pain following afternoon surgery because they’ve gone for an unusually long time without caffeine. Take a “coffee history,” he advised, and ask how much coffee the patient would have consumed by this time on a normal day. Then give patients caffeine as needed. (Coffee is considered a clear beverage under the American Society of Anesthesiologists guidelines.)
“It takes the edge off and helps reduce postoperative pain,” he said.
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Manning has no disclosures.
REPORTING FROM MISS
Tweet this! Social media as career development
Social media can be more than a tool to connect with friends and family, said Vineet Chopra, MD, MBBS, FHM, Charlie Wray, DO, and Vineet Arora, MD, MAPP, MHM, at Monday’s “Tweet Your Way to the Top? Social Media as a Career Development Tool in Hospital Medicine” session.
Online outreach can play crucial roles in everything from continuing education and research to networking and career advancement, but most of the conversations in medicine are really focused in the Twittersphere, the three hospitalists said.
“Social media has allowed me to connect with leaders in hospital medicine and many other medical communities,” said Dr. Wray, an assistant professor of medicine at the University of California, San Francisco. “It has allowed me to share my work and success with the hospitalist community in addition to highlighting my trainees’ and colleagues’ successes. My engagement has created opportunities to get involved with projects that I could never have previously imagined. And it has extended my networking circle and made annual gatherings like the SHM Annual Conference even more beneficial and high yield for my career.”
For session copresenter Dr. Chopra, associate professor and chief of the division of hospital medicine at the University of Michigan, Ann Arbor, social media “helps develop your brand and your identity. It is a wonderful way for people to know what you do, who you are, what you stand for, and your views and opinions on various topics.”
On the career front, social media “can connect you to leaders in the community so that they know who you are and what you are accomplishing. So when time comes for you to move on, people within this community will know who you are and what you’re known for at a national level,” said Dr. Wray, who is also deputy digital media editor for the Journal of Hospital Medicine.
Sharing on social media – and Twitter in particular – for the medical profession is focused mainly on dissemination of information, engaging in communities, and networking beyond your institution. The three presenters shared tips of the trade during the session, such as how to boost exposure to a tweet by including hashtags, posting photos, and sharing links. To overcome time commitment barriers, tie your Twitter contributions to something you are doing already, said Dr. Arora, associate chief medical officer-clinical learning environment at the University of Chicago.
A presence on social media isn’t just a tool to boost your own profile, Dr. Wray said. It also helps you stay on top of medical news. “There is so much information and new data coming out nowadays, it can be hard to keep up,” he said. “A properly curated social media feed can help a busy clinician stay on top of what is really important. This is an invaluable skill for the modern hospitalist.”
But be careful how much you disclose on social media about yourself and, especially, other people. “A good rule of thumb is: Don’t put anything online that you wouldn’t want your mother to read,” Dr. Chopra said. “As well, sharing any personal or patient information without understanding your institution’s guidelines or obtaining explicit permission is a general no-no,” he said.
“Also, many employers look at social media profiles before they hire people. We certainly do so when we are looking at various individuals. We often call this a ‘Google biopsy.’ ”
Randy Dotinga contributed to this report.
Social media can be more than a tool to connect with friends and family, said Vineet Chopra, MD, MBBS, FHM, Charlie Wray, DO, and Vineet Arora, MD, MAPP, MHM, at Monday’s “Tweet Your Way to the Top? Social Media as a Career Development Tool in Hospital Medicine” session.
Online outreach can play crucial roles in everything from continuing education and research to networking and career advancement, but most of the conversations in medicine are really focused in the Twittersphere, the three hospitalists said.
“Social media has allowed me to connect with leaders in hospital medicine and many other medical communities,” said Dr. Wray, an assistant professor of medicine at the University of California, San Francisco. “It has allowed me to share my work and success with the hospitalist community in addition to highlighting my trainees’ and colleagues’ successes. My engagement has created opportunities to get involved with projects that I could never have previously imagined. And it has extended my networking circle and made annual gatherings like the SHM Annual Conference even more beneficial and high yield for my career.”
For session copresenter Dr. Chopra, associate professor and chief of the division of hospital medicine at the University of Michigan, Ann Arbor, social media “helps develop your brand and your identity. It is a wonderful way for people to know what you do, who you are, what you stand for, and your views and opinions on various topics.”
On the career front, social media “can connect you to leaders in the community so that they know who you are and what you are accomplishing. So when time comes for you to move on, people within this community will know who you are and what you’re known for at a national level,” said Dr. Wray, who is also deputy digital media editor for the Journal of Hospital Medicine.
Sharing on social media – and Twitter in particular – for the medical profession is focused mainly on dissemination of information, engaging in communities, and networking beyond your institution. The three presenters shared tips of the trade during the session, such as how to boost exposure to a tweet by including hashtags, posting photos, and sharing links. To overcome time commitment barriers, tie your Twitter contributions to something you are doing already, said Dr. Arora, associate chief medical officer-clinical learning environment at the University of Chicago.
A presence on social media isn’t just a tool to boost your own profile, Dr. Wray said. It also helps you stay on top of medical news. “There is so much information and new data coming out nowadays, it can be hard to keep up,” he said. “A properly curated social media feed can help a busy clinician stay on top of what is really important. This is an invaluable skill for the modern hospitalist.”
But be careful how much you disclose on social media about yourself and, especially, other people. “A good rule of thumb is: Don’t put anything online that you wouldn’t want your mother to read,” Dr. Chopra said. “As well, sharing any personal or patient information without understanding your institution’s guidelines or obtaining explicit permission is a general no-no,” he said.
“Also, many employers look at social media profiles before they hire people. We certainly do so when we are looking at various individuals. We often call this a ‘Google biopsy.’ ”
Randy Dotinga contributed to this report.
Social media can be more than a tool to connect with friends and family, said Vineet Chopra, MD, MBBS, FHM, Charlie Wray, DO, and Vineet Arora, MD, MAPP, MHM, at Monday’s “Tweet Your Way to the Top? Social Media as a Career Development Tool in Hospital Medicine” session.
Online outreach can play crucial roles in everything from continuing education and research to networking and career advancement, but most of the conversations in medicine are really focused in the Twittersphere, the three hospitalists said.
“Social media has allowed me to connect with leaders in hospital medicine and many other medical communities,” said Dr. Wray, an assistant professor of medicine at the University of California, San Francisco. “It has allowed me to share my work and success with the hospitalist community in addition to highlighting my trainees’ and colleagues’ successes. My engagement has created opportunities to get involved with projects that I could never have previously imagined. And it has extended my networking circle and made annual gatherings like the SHM Annual Conference even more beneficial and high yield for my career.”
For session copresenter Dr. Chopra, associate professor and chief of the division of hospital medicine at the University of Michigan, Ann Arbor, social media “helps develop your brand and your identity. It is a wonderful way for people to know what you do, who you are, what you stand for, and your views and opinions on various topics.”
On the career front, social media “can connect you to leaders in the community so that they know who you are and what you are accomplishing. So when time comes for you to move on, people within this community will know who you are and what you’re known for at a national level,” said Dr. Wray, who is also deputy digital media editor for the Journal of Hospital Medicine.
Sharing on social media – and Twitter in particular – for the medical profession is focused mainly on dissemination of information, engaging in communities, and networking beyond your institution. The three presenters shared tips of the trade during the session, such as how to boost exposure to a tweet by including hashtags, posting photos, and sharing links. To overcome time commitment barriers, tie your Twitter contributions to something you are doing already, said Dr. Arora, associate chief medical officer-clinical learning environment at the University of Chicago.
A presence on social media isn’t just a tool to boost your own profile, Dr. Wray said. It also helps you stay on top of medical news. “There is so much information and new data coming out nowadays, it can be hard to keep up,” he said. “A properly curated social media feed can help a busy clinician stay on top of what is really important. This is an invaluable skill for the modern hospitalist.”
But be careful how much you disclose on social media about yourself and, especially, other people. “A good rule of thumb is: Don’t put anything online that you wouldn’t want your mother to read,” Dr. Chopra said. “As well, sharing any personal or patient information without understanding your institution’s guidelines or obtaining explicit permission is a general no-no,” he said.
“Also, many employers look at social media profiles before they hire people. We certainly do so when we are looking at various individuals. We often call this a ‘Google biopsy.’ ”
Randy Dotinga contributed to this report.
Anti-mesh trend may be felt by surgeons doing hernia repairs
LAS VEGAS – Hernia surgeons are square in the path of a growing backlash against the use of mesh in surgery, a fellow surgeon says, and he’s warning colleagues to take heed of the trend.
“I tell you, it’s coming,” B. Todd Heniford, MD,, professor and chief of gastrointestinal and minimally invasive surgery at Carolinas Medical Center, Charlotte, N.C., declared in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
“This is no time to abandon surgical mesh in hernia procedures,” he argued. Instead, he said surgeons should engage in better communication with patients. Otherwise, “we are not helping ourselves as surgeons.”
In the United States, most of the controversy around the use of mesh in surgery has revolved around transvaginal procedures in women. As a 2017 historical review explained, “mesh used to augment transvaginal repair of [pelvic organ prolapse] was introduced in the United States in 2005 without clinical safety and efficacy data. In the subsequent years of use, both major and minor complications were increasingly reported, leading to several [Food and Drug Administration] notifications and warnings” (Int Urogynecol J. 2017 Apr;28[4]:527-35).
An FDA safety alert in 2011 and new requirements for postmarked surveillance orders convinced most manufacturers to stop marketing surgical mesh for transvaginal repair of pelvic organ prolapse. According to a 2018 report, an estimated 73,000 patients in the United States have filed product liability claims regarding complications from mesh used in transvaginal procedures (Female Pelvic Med Reconstr Surg. 2018 Jan/Feb;24[1]:21-25).
Outside the United States, Dr. Heniford said, concerns about surgical mesh have spawned a global outcry about its use in another kind of procedure – hernia surgery. “It is gaining speed in Europe, Australia and New Zealand,” he said.
Indeed, these are some recent headlines in Australian and British news outlets: “Concern grows over hernia mesh as more patients share post-surgery horror stories,” “Hernia mesh concerns grow among men as more patients report surgery complications,” “Pelvic and hernia mesh patients will confront politicians and bureaucrats in April over the medical device industry,” and “Mesh implants: Man speaks of procedure’s devastating impact.”
“When people read this, it influences them,” Dr. Heniford said. “And mesh companies are not helping us, let’s be frank about it,” he added, noting that manufacturers have launched recalls due to problems and complications.
Is the anti-mesh frenzy regarding hernias coming to the United States? “Absolutely,” said Dr. Heniford, noting that an online search will turn up many legal websites devoted to hernia mesh lawsuits. And, he said, hernia patients are already concerned because of commercials they’ve seen on TV. “One of the issues is that the lawyers in the United States have become real experts on mesh for pelvic slings,” he said. “They’ve just about run through that.” It’s not just lawyers who are taking advantage of the anti-mesh trend. “If you go online and you type in ‘no-mesh surgery,’ ” he said, “you’ll see loads of surgeons who are trying to take advantage of this.”
In reality, research supports the use of mesh in hernia procedures. A 2018 Cochrane Library review found that “overall, hernia repairs with and without mesh both proved effective in the treatment of hernias, although mesh repairs demonstrated fewer hernia recurrences, a shorter operation time and faster return to normal activities. Non-mesh repairs are still widely used, often due to the cost and poor availability of the mesh product itself” (Cochrane Database Syst Rev. 2018, Issue 9.)
Dr. Heniford suggested that surgeons can do much more to calm patients about the use of mesh. One strategy, he said, is to help them understand that they may face pain after their procedures that has nothing to do with surgical mesh.
“We do not counsel our patients enough about postoperative pain,” he said. “If you see someone who had real pain prior to the operation, you really have to counsel them about postoperation pain. Patients who present with pain are much more likely to have pain after surgery.”
He noted that surgical mesh isn’t appropriate for all patients.
Dr. Heniford left colleagues with this message: “If we use mesh, there’s no question we improve our outcomes long term. But we’ve got to be careful about how we place it and the patients we choose.”
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Heniford disclosed relationships with Allergan, Stryker, and W.L. Gore.
LAS VEGAS – Hernia surgeons are square in the path of a growing backlash against the use of mesh in surgery, a fellow surgeon says, and he’s warning colleagues to take heed of the trend.
“I tell you, it’s coming,” B. Todd Heniford, MD,, professor and chief of gastrointestinal and minimally invasive surgery at Carolinas Medical Center, Charlotte, N.C., declared in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
“This is no time to abandon surgical mesh in hernia procedures,” he argued. Instead, he said surgeons should engage in better communication with patients. Otherwise, “we are not helping ourselves as surgeons.”
In the United States, most of the controversy around the use of mesh in surgery has revolved around transvaginal procedures in women. As a 2017 historical review explained, “mesh used to augment transvaginal repair of [pelvic organ prolapse] was introduced in the United States in 2005 without clinical safety and efficacy data. In the subsequent years of use, both major and minor complications were increasingly reported, leading to several [Food and Drug Administration] notifications and warnings” (Int Urogynecol J. 2017 Apr;28[4]:527-35).
An FDA safety alert in 2011 and new requirements for postmarked surveillance orders convinced most manufacturers to stop marketing surgical mesh for transvaginal repair of pelvic organ prolapse. According to a 2018 report, an estimated 73,000 patients in the United States have filed product liability claims regarding complications from mesh used in transvaginal procedures (Female Pelvic Med Reconstr Surg. 2018 Jan/Feb;24[1]:21-25).
Outside the United States, Dr. Heniford said, concerns about surgical mesh have spawned a global outcry about its use in another kind of procedure – hernia surgery. “It is gaining speed in Europe, Australia and New Zealand,” he said.
Indeed, these are some recent headlines in Australian and British news outlets: “Concern grows over hernia mesh as more patients share post-surgery horror stories,” “Hernia mesh concerns grow among men as more patients report surgery complications,” “Pelvic and hernia mesh patients will confront politicians and bureaucrats in April over the medical device industry,” and “Mesh implants: Man speaks of procedure’s devastating impact.”
“When people read this, it influences them,” Dr. Heniford said. “And mesh companies are not helping us, let’s be frank about it,” he added, noting that manufacturers have launched recalls due to problems and complications.
Is the anti-mesh frenzy regarding hernias coming to the United States? “Absolutely,” said Dr. Heniford, noting that an online search will turn up many legal websites devoted to hernia mesh lawsuits. And, he said, hernia patients are already concerned because of commercials they’ve seen on TV. “One of the issues is that the lawyers in the United States have become real experts on mesh for pelvic slings,” he said. “They’ve just about run through that.” It’s not just lawyers who are taking advantage of the anti-mesh trend. “If you go online and you type in ‘no-mesh surgery,’ ” he said, “you’ll see loads of surgeons who are trying to take advantage of this.”
In reality, research supports the use of mesh in hernia procedures. A 2018 Cochrane Library review found that “overall, hernia repairs with and without mesh both proved effective in the treatment of hernias, although mesh repairs demonstrated fewer hernia recurrences, a shorter operation time and faster return to normal activities. Non-mesh repairs are still widely used, often due to the cost and poor availability of the mesh product itself” (Cochrane Database Syst Rev. 2018, Issue 9.)
Dr. Heniford suggested that surgeons can do much more to calm patients about the use of mesh. One strategy, he said, is to help them understand that they may face pain after their procedures that has nothing to do with surgical mesh.
“We do not counsel our patients enough about postoperative pain,” he said. “If you see someone who had real pain prior to the operation, you really have to counsel them about postoperation pain. Patients who present with pain are much more likely to have pain after surgery.”
He noted that surgical mesh isn’t appropriate for all patients.
Dr. Heniford left colleagues with this message: “If we use mesh, there’s no question we improve our outcomes long term. But we’ve got to be careful about how we place it and the patients we choose.”
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Heniford disclosed relationships with Allergan, Stryker, and W.L. Gore.
LAS VEGAS – Hernia surgeons are square in the path of a growing backlash against the use of mesh in surgery, a fellow surgeon says, and he’s warning colleagues to take heed of the trend.
“I tell you, it’s coming,” B. Todd Heniford, MD,, professor and chief of gastrointestinal and minimally invasive surgery at Carolinas Medical Center, Charlotte, N.C., declared in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
“This is no time to abandon surgical mesh in hernia procedures,” he argued. Instead, he said surgeons should engage in better communication with patients. Otherwise, “we are not helping ourselves as surgeons.”
In the United States, most of the controversy around the use of mesh in surgery has revolved around transvaginal procedures in women. As a 2017 historical review explained, “mesh used to augment transvaginal repair of [pelvic organ prolapse] was introduced in the United States in 2005 without clinical safety and efficacy data. In the subsequent years of use, both major and minor complications were increasingly reported, leading to several [Food and Drug Administration] notifications and warnings” (Int Urogynecol J. 2017 Apr;28[4]:527-35).
An FDA safety alert in 2011 and new requirements for postmarked surveillance orders convinced most manufacturers to stop marketing surgical mesh for transvaginal repair of pelvic organ prolapse. According to a 2018 report, an estimated 73,000 patients in the United States have filed product liability claims regarding complications from mesh used in transvaginal procedures (Female Pelvic Med Reconstr Surg. 2018 Jan/Feb;24[1]:21-25).
Outside the United States, Dr. Heniford said, concerns about surgical mesh have spawned a global outcry about its use in another kind of procedure – hernia surgery. “It is gaining speed in Europe, Australia and New Zealand,” he said.
Indeed, these are some recent headlines in Australian and British news outlets: “Concern grows over hernia mesh as more patients share post-surgery horror stories,” “Hernia mesh concerns grow among men as more patients report surgery complications,” “Pelvic and hernia mesh patients will confront politicians and bureaucrats in April over the medical device industry,” and “Mesh implants: Man speaks of procedure’s devastating impact.”
“When people read this, it influences them,” Dr. Heniford said. “And mesh companies are not helping us, let’s be frank about it,” he added, noting that manufacturers have launched recalls due to problems and complications.
Is the anti-mesh frenzy regarding hernias coming to the United States? “Absolutely,” said Dr. Heniford, noting that an online search will turn up many legal websites devoted to hernia mesh lawsuits. And, he said, hernia patients are already concerned because of commercials they’ve seen on TV. “One of the issues is that the lawyers in the United States have become real experts on mesh for pelvic slings,” he said. “They’ve just about run through that.” It’s not just lawyers who are taking advantage of the anti-mesh trend. “If you go online and you type in ‘no-mesh surgery,’ ” he said, “you’ll see loads of surgeons who are trying to take advantage of this.”
In reality, research supports the use of mesh in hernia procedures. A 2018 Cochrane Library review found that “overall, hernia repairs with and without mesh both proved effective in the treatment of hernias, although mesh repairs demonstrated fewer hernia recurrences, a shorter operation time and faster return to normal activities. Non-mesh repairs are still widely used, often due to the cost and poor availability of the mesh product itself” (Cochrane Database Syst Rev. 2018, Issue 9.)
Dr. Heniford suggested that surgeons can do much more to calm patients about the use of mesh. One strategy, he said, is to help them understand that they may face pain after their procedures that has nothing to do with surgical mesh.
“We do not counsel our patients enough about postoperative pain,” he said. “If you see someone who had real pain prior to the operation, you really have to counsel them about postoperation pain. Patients who present with pain are much more likely to have pain after surgery.”
He noted that surgical mesh isn’t appropriate for all patients.
Dr. Heniford left colleagues with this message: “If we use mesh, there’s no question we improve our outcomes long term. But we’ve got to be careful about how we place it and the patients we choose.”
Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Heniford disclosed relationships with Allergan, Stryker, and W.L. Gore.
REPORTING FROM MISS
Experts offer insight on embracing diversity in the profession
Physicians have had diverse patients as long as there have been physicians (and patients). But diversity among health professionals remains elusive.
Can we do better? Absolutely, says a team of experts who will offer perspective to colleagues in a Wednesday morning session titled, “Best Practices and Tips for Developing Diversity in a Hospitalist Group.”
“The goals of our session are to review best practices for recruiting and retaining a diverse health care workforce, discuss strategies for dealing with implicit and explicit bias, and identify ways in which we can achieve common goals when working across cultures,” said hospitalist Amira del Pino-Jones, MD, assistant professor of medicine at the University of Colorado at Denver, Aurora, and director of the CU Hospitalist Scholars Program.
“Those who are interested in achieving excellence in hospital medicine through prioritizing diversity and equity efforts within their divisions, departments, and groups should attend,” said Dr. del Pino-Jones, who will be one of the speakers at the session.
Why is diversity important in hospital medicine? “Studies have shown that diversity enhances learning and work environments, promotes innovation, broadens research agendas, and improves the quality of care we provide for patients,” Dr. del Pino-Jones said. “In short, it is central to achieving excellence in hospital medicine.”
The session will focus on diverse groups, which have been historically underrepresented or discriminated against in medicine, including racial and ethnic minorities, women, LGBTQ+ individuals, and those with disabilities.
All speakers at the session are physicians, and each has seen or experienced challenges in diversifying their groups and divisions. “We hope to share our experiences, what we have learned, and ways to approach each of these issues. We also are hoping to hear from others and come up with new ways to approach these issues as a collective,” Dr. del Pino-Jones said.
Women and members of minority groups often have small numbers in their hospital medicine workplaces, especially in higher-level positions, and have trouble developing the critical mass to make progress on the diversity front, she said. Even when leaders recognize the importance of a diverse workforce, she said, “there is often a disconnect between motivation for increasing diversity and the ability to develop tangible, evidence-based methods that can be used to increase diversity.”
The session will tackle more than diversity at the workplace. Speakers also will discuss the relationship between medical professionals and patients.
“We will focus on the importance of inclusion and belonging, both of which are essential for creating a positive climate for all individuals,” Dr. del Pino-Jones said. “We will also discuss ways in which to cultivate cultural intelligence and enhance cross-cultural interactions between patients and providers. And we’ll look at ways to reduce and/or mitigate implicit and explicit bias in medicine.”
Dr. del Pino-Jones has no relevant disclosures.
Best Practices and Tips
for Developing Diversity in a Hospitalist Group
Wednesday, 10 - 11:30 a.m.
Potomac 4-6
Physicians have had diverse patients as long as there have been physicians (and patients). But diversity among health professionals remains elusive.
Can we do better? Absolutely, says a team of experts who will offer perspective to colleagues in a Wednesday morning session titled, “Best Practices and Tips for Developing Diversity in a Hospitalist Group.”
“The goals of our session are to review best practices for recruiting and retaining a diverse health care workforce, discuss strategies for dealing with implicit and explicit bias, and identify ways in which we can achieve common goals when working across cultures,” said hospitalist Amira del Pino-Jones, MD, assistant professor of medicine at the University of Colorado at Denver, Aurora, and director of the CU Hospitalist Scholars Program.
“Those who are interested in achieving excellence in hospital medicine through prioritizing diversity and equity efforts within their divisions, departments, and groups should attend,” said Dr. del Pino-Jones, who will be one of the speakers at the session.
Why is diversity important in hospital medicine? “Studies have shown that diversity enhances learning and work environments, promotes innovation, broadens research agendas, and improves the quality of care we provide for patients,” Dr. del Pino-Jones said. “In short, it is central to achieving excellence in hospital medicine.”
The session will focus on diverse groups, which have been historically underrepresented or discriminated against in medicine, including racial and ethnic minorities, women, LGBTQ+ individuals, and those with disabilities.
All speakers at the session are physicians, and each has seen or experienced challenges in diversifying their groups and divisions. “We hope to share our experiences, what we have learned, and ways to approach each of these issues. We also are hoping to hear from others and come up with new ways to approach these issues as a collective,” Dr. del Pino-Jones said.
Women and members of minority groups often have small numbers in their hospital medicine workplaces, especially in higher-level positions, and have trouble developing the critical mass to make progress on the diversity front, she said. Even when leaders recognize the importance of a diverse workforce, she said, “there is often a disconnect between motivation for increasing diversity and the ability to develop tangible, evidence-based methods that can be used to increase diversity.”
The session will tackle more than diversity at the workplace. Speakers also will discuss the relationship between medical professionals and patients.
“We will focus on the importance of inclusion and belonging, both of which are essential for creating a positive climate for all individuals,” Dr. del Pino-Jones said. “We will also discuss ways in which to cultivate cultural intelligence and enhance cross-cultural interactions between patients and providers. And we’ll look at ways to reduce and/or mitigate implicit and explicit bias in medicine.”
Dr. del Pino-Jones has no relevant disclosures.
Best Practices and Tips
for Developing Diversity in a Hospitalist Group
Wednesday, 10 - 11:30 a.m.
Potomac 4-6
Physicians have had diverse patients as long as there have been physicians (and patients). But diversity among health professionals remains elusive.
Can we do better? Absolutely, says a team of experts who will offer perspective to colleagues in a Wednesday morning session titled, “Best Practices and Tips for Developing Diversity in a Hospitalist Group.”
“The goals of our session are to review best practices for recruiting and retaining a diverse health care workforce, discuss strategies for dealing with implicit and explicit bias, and identify ways in which we can achieve common goals when working across cultures,” said hospitalist Amira del Pino-Jones, MD, assistant professor of medicine at the University of Colorado at Denver, Aurora, and director of the CU Hospitalist Scholars Program.
“Those who are interested in achieving excellence in hospital medicine through prioritizing diversity and equity efforts within their divisions, departments, and groups should attend,” said Dr. del Pino-Jones, who will be one of the speakers at the session.
Why is diversity important in hospital medicine? “Studies have shown that diversity enhances learning and work environments, promotes innovation, broadens research agendas, and improves the quality of care we provide for patients,” Dr. del Pino-Jones said. “In short, it is central to achieving excellence in hospital medicine.”
The session will focus on diverse groups, which have been historically underrepresented or discriminated against in medicine, including racial and ethnic minorities, women, LGBTQ+ individuals, and those with disabilities.
All speakers at the session are physicians, and each has seen or experienced challenges in diversifying their groups and divisions. “We hope to share our experiences, what we have learned, and ways to approach each of these issues. We also are hoping to hear from others and come up with new ways to approach these issues as a collective,” Dr. del Pino-Jones said.
Women and members of minority groups often have small numbers in their hospital medicine workplaces, especially in higher-level positions, and have trouble developing the critical mass to make progress on the diversity front, she said. Even when leaders recognize the importance of a diverse workforce, she said, “there is often a disconnect between motivation for increasing diversity and the ability to develop tangible, evidence-based methods that can be used to increase diversity.”
The session will tackle more than diversity at the workplace. Speakers also will discuss the relationship between medical professionals and patients.
“We will focus on the importance of inclusion and belonging, both of which are essential for creating a positive climate for all individuals,” Dr. del Pino-Jones said. “We will also discuss ways in which to cultivate cultural intelligence and enhance cross-cultural interactions between patients and providers. And we’ll look at ways to reduce and/or mitigate implicit and explicit bias in medicine.”
Dr. del Pino-Jones has no relevant disclosures.
Best Practices and Tips
for Developing Diversity in a Hospitalist Group
Wednesday, 10 - 11:30 a.m.
Potomac 4-6
How has hospital medicine changed? (VIDEO)

HM19 attendees describe how hospital medicine has changed over the years.

HM19 attendees describe how hospital medicine has changed over the years.

HM19 attendees describe how hospital medicine has changed over the years.
SHM’s Research Shark Tank a resounding success
A few lucky hospitalists had the chance to compete for dedicated consultation time from experienced hospital medicine mentors during the SHM Annual Conference’s first Research Shark Tank.
During the Monday afternoon session, four hospitalist projects were each presented in a 5-minute “pitch” to three senior quality and research leaders in hospital medicine who served as the “sharks.” These pitches were followed by 7 minutes of moderated questions and feedback from the sharks and the audience. Sharks then “bid” on the projects, offering up to 2 hours of one-on-one consultation during the conference or as needed.
The four projects included a study of the use of off-site scribes listening in to patient/hospitalist interactions to eliminate the need for the doctor to be glued to the computer screen, which was presented by Thea Dalfino, MD, chief of hospital medicine at Albany (N.Y.) Memorial Hospital; a rethinking of medical education to emphasize the role of hospitalists as mentors to individual student “apprentices,” presented by Amulya Nagarur, MD, of the department of medicine at Massachusetts General Hospital, Boston, and Christiana Renner, MD, of University of Texas Southwestern Medical Center, Dallas; and a redesign of patient hospital gowns to optimize, comfort, morale, and functionality, presented by Cheryl Dellasega, PhD, professor of medicine and humanities at Penn State University, Hershey.
The winning project was presented by Meera Udayakumar, MD, medical director at the University of North Carolina REX Healthcare in Raleigh. She discussed “The Equalizer,” a computerized tool to optimize patient distribution among hospitalists in order to balance workflow in a practice.
In discussing the thinking behind this unique session, Luci Leykum, MD, SFHM, chief of the division of general and hospital medicine at the University of Texas, San Antonio, who served as one of the sharks, stated that: “We’ve always tried to do things to promote the pipeline of research in hospital medicine and to raise the visibility of research activities at the annual conference. In the past, we have done one-on-one ‘speed dating’ with mentors, but the research committee thought this format would be more interactive and that audience members could benefit from hearing the discussion.”
The other participating sharks were Andrew Auerbach, MD, MPH, MHM, professor of medicine at the University of California, San Francisco, and former editor of the Journal of Hospital Medicine, and Hardeep Singh, MD, MPH, chief of the health policy, quality, and informatics program at the Center for Innovations in Quality, Effectiveness, and Safety at the Michael E. DeBakey Veterans Affairs Medical Center in Houston.
The selection process for those looking to pitch was rigorous. Projects submitted to the research committee had to focus on research, quality improvement, or medical education and be very specific to the practice of hospital medicine. In addition, the ideas needed to be relatively well developed, ideally with some pilot data. Applicants also needed to address a significant problem in hospital medicine, showcase an innovative approach, and make the case for how their solution would have short- and long-term effects.
Dr. Leykum said she was looking to see whether the pitched projects have clearly articulated questions that are important and interesting and whether the proposed methods would sufficiently answer those questions. She also considered what the implications were if the work was done.
Audience members had a chance to ask questions and, if they were interested, to potentially partner with presenters or adopt similar ideas at their own institutions. Attendees were exposed to innovative ways of solving problems that are common and ideas that have a big impact on the way problems are approached in hospital medicine.
“I think it was a fun, fast, interactive session, and it was interesting to see,” said Dr. Leykum. “Those of us who were the sharks know each other and each other’s work, so that was a fun dynamic.”
A few lucky hospitalists had the chance to compete for dedicated consultation time from experienced hospital medicine mentors during the SHM Annual Conference’s first Research Shark Tank.
During the Monday afternoon session, four hospitalist projects were each presented in a 5-minute “pitch” to three senior quality and research leaders in hospital medicine who served as the “sharks.” These pitches were followed by 7 minutes of moderated questions and feedback from the sharks and the audience. Sharks then “bid” on the projects, offering up to 2 hours of one-on-one consultation during the conference or as needed.
The four projects included a study of the use of off-site scribes listening in to patient/hospitalist interactions to eliminate the need for the doctor to be glued to the computer screen, which was presented by Thea Dalfino, MD, chief of hospital medicine at Albany (N.Y.) Memorial Hospital; a rethinking of medical education to emphasize the role of hospitalists as mentors to individual student “apprentices,” presented by Amulya Nagarur, MD, of the department of medicine at Massachusetts General Hospital, Boston, and Christiana Renner, MD, of University of Texas Southwestern Medical Center, Dallas; and a redesign of patient hospital gowns to optimize, comfort, morale, and functionality, presented by Cheryl Dellasega, PhD, professor of medicine and humanities at Penn State University, Hershey.
The winning project was presented by Meera Udayakumar, MD, medical director at the University of North Carolina REX Healthcare in Raleigh. She discussed “The Equalizer,” a computerized tool to optimize patient distribution among hospitalists in order to balance workflow in a practice.
In discussing the thinking behind this unique session, Luci Leykum, MD, SFHM, chief of the division of general and hospital medicine at the University of Texas, San Antonio, who served as one of the sharks, stated that: “We’ve always tried to do things to promote the pipeline of research in hospital medicine and to raise the visibility of research activities at the annual conference. In the past, we have done one-on-one ‘speed dating’ with mentors, but the research committee thought this format would be more interactive and that audience members could benefit from hearing the discussion.”
The other participating sharks were Andrew Auerbach, MD, MPH, MHM, professor of medicine at the University of California, San Francisco, and former editor of the Journal of Hospital Medicine, and Hardeep Singh, MD, MPH, chief of the health policy, quality, and informatics program at the Center for Innovations in Quality, Effectiveness, and Safety at the Michael E. DeBakey Veterans Affairs Medical Center in Houston.
The selection process for those looking to pitch was rigorous. Projects submitted to the research committee had to focus on research, quality improvement, or medical education and be very specific to the practice of hospital medicine. In addition, the ideas needed to be relatively well developed, ideally with some pilot data. Applicants also needed to address a significant problem in hospital medicine, showcase an innovative approach, and make the case for how their solution would have short- and long-term effects.
Dr. Leykum said she was looking to see whether the pitched projects have clearly articulated questions that are important and interesting and whether the proposed methods would sufficiently answer those questions. She also considered what the implications were if the work was done.
Audience members had a chance to ask questions and, if they were interested, to potentially partner with presenters or adopt similar ideas at their own institutions. Attendees were exposed to innovative ways of solving problems that are common and ideas that have a big impact on the way problems are approached in hospital medicine.
“I think it was a fun, fast, interactive session, and it was interesting to see,” said Dr. Leykum. “Those of us who were the sharks know each other and each other’s work, so that was a fun dynamic.”
A few lucky hospitalists had the chance to compete for dedicated consultation time from experienced hospital medicine mentors during the SHM Annual Conference’s first Research Shark Tank.
During the Monday afternoon session, four hospitalist projects were each presented in a 5-minute “pitch” to three senior quality and research leaders in hospital medicine who served as the “sharks.” These pitches were followed by 7 minutes of moderated questions and feedback from the sharks and the audience. Sharks then “bid” on the projects, offering up to 2 hours of one-on-one consultation during the conference or as needed.
The four projects included a study of the use of off-site scribes listening in to patient/hospitalist interactions to eliminate the need for the doctor to be glued to the computer screen, which was presented by Thea Dalfino, MD, chief of hospital medicine at Albany (N.Y.) Memorial Hospital; a rethinking of medical education to emphasize the role of hospitalists as mentors to individual student “apprentices,” presented by Amulya Nagarur, MD, of the department of medicine at Massachusetts General Hospital, Boston, and Christiana Renner, MD, of University of Texas Southwestern Medical Center, Dallas; and a redesign of patient hospital gowns to optimize, comfort, morale, and functionality, presented by Cheryl Dellasega, PhD, professor of medicine and humanities at Penn State University, Hershey.
The winning project was presented by Meera Udayakumar, MD, medical director at the University of North Carolina REX Healthcare in Raleigh. She discussed “The Equalizer,” a computerized tool to optimize patient distribution among hospitalists in order to balance workflow in a practice.
In discussing the thinking behind this unique session, Luci Leykum, MD, SFHM, chief of the division of general and hospital medicine at the University of Texas, San Antonio, who served as one of the sharks, stated that: “We’ve always tried to do things to promote the pipeline of research in hospital medicine and to raise the visibility of research activities at the annual conference. In the past, we have done one-on-one ‘speed dating’ with mentors, but the research committee thought this format would be more interactive and that audience members could benefit from hearing the discussion.”
The other participating sharks were Andrew Auerbach, MD, MPH, MHM, professor of medicine at the University of California, San Francisco, and former editor of the Journal of Hospital Medicine, and Hardeep Singh, MD, MPH, chief of the health policy, quality, and informatics program at the Center for Innovations in Quality, Effectiveness, and Safety at the Michael E. DeBakey Veterans Affairs Medical Center in Houston.
The selection process for those looking to pitch was rigorous. Projects submitted to the research committee had to focus on research, quality improvement, or medical education and be very specific to the practice of hospital medicine. In addition, the ideas needed to be relatively well developed, ideally with some pilot data. Applicants also needed to address a significant problem in hospital medicine, showcase an innovative approach, and make the case for how their solution would have short- and long-term effects.
Dr. Leykum said she was looking to see whether the pitched projects have clearly articulated questions that are important and interesting and whether the proposed methods would sufficiently answer those questions. She also considered what the implications were if the work was done.
Audience members had a chance to ask questions and, if they were interested, to potentially partner with presenters or adopt similar ideas at their own institutions. Attendees were exposed to innovative ways of solving problems that are common and ideas that have a big impact on the way problems are approached in hospital medicine.
“I think it was a fun, fast, interactive session, and it was interesting to see,” said Dr. Leykum. “Those of us who were the sharks know each other and each other’s work, so that was a fun dynamic.”
Antibiotic Overprescribing
Proinflammatory microbiome tied to colorectal adenoma
MIAMI – The fecal presence of least two genes harbored by toxin-producing or proinflammatory bacteria conferred a nearly 200% rise in the odds of colorectal adenoma, investigators reported.
Moreover, the fecal presence of usp (uropathogenic-specific protein), a bacterial gene encoding a genotoxin that damages DNA, correlated with nearly 1,200% greater odds of colorectal adenoma (P =.08), said senior investigator María González-Pons, PhD, of the University of Puerto Rico Comprehensive Cancer Center in San Juan.
“We are continuing to enlarge this study. We need more power to assess statistical significance and look at associations for individual combinations of bacterial genes,” Dr. Pons said in an interview. “Our ultimate goal is to risk-stratify patients so that we know whom to target for [colorectal cancer] prevention.”
Dr. Pons and the study’s lead author, Noe Crespo-Hernandez, of the University of Puerto Rico, presented the findings with their associates in a poster at the the annual Gut Microbiota for Health World Summit.
Colorectal cancer is the most lethal cancer and the second-most common malignancy in Puerto Rico. Despite recommendations for screening colonoscopy, many patients are diagnosed in late-stage disease, when treatment options are limited. Intestinal inflammation is itself key to colorectal carcinogenesis and also promotes the enteric proliferation of gram-negative bacteria that produce potentially carcinogenic toxins. Thus, gut inflammation and the microbiome are of great interest to researchers who are working to develop reliable, minimally invasive tests that assess future colorectal cancer risk.
For their study presented at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility, Dr. Pons and her coinvestigators compared stool samples from 67 adults with colonoscopically confirmed colorectal adenomas and 39 controls with negative screening colonoscopies. Both groups were captured in the Puerto Rico Familial Colorectal Cancer Registry. The researchers used TaqMan SNP Genotyping to look for single-nucleotide polymorphisms (SNPs) from promoter regions of genes encoding interleukin-1 beta, IL-6, and IL-10, cytokines that regulate gut inflammation. They found nonsignificant associations between colorectal adenoma and two of the three SNPs: rs143627 (encoding IL-1B) and rs1800795 (IL-6).
The real-time polymerase chain reaction results were even more striking. Using SYBR Green, the researchers tested stool for six genotoxic or proinflammatory bacterial genes and identified five, each of which correlated with colorectal adenoma. Colorectal adenoma also was linked with the fecal presence of a nonpathogenic housekeeping gene that is a surrogate for a mucolytic bacterium abundant in the stool of colorectal cancer patients.
Odds ratios for these associations ranged from 1.17 (for cnf, or cytotoxic necrotizing factor) to 12.83 (for usp), the researchers reported. Dr. Pons commented that Hurricane Maria greatly delayed this study and thus the cohort was underpowered to test for statistical significance. Nonetheless, P values approached significance for the usp gene (OR, 12.83; 95% confidence interval, 0.73-226.8; P = .08) and the fecal presence of at least two genes in combination (OR, 2.84; 95% CI, 1.01-8.90; P = .05).
Next, Dr. Pons and her team will expand the study to assess links between colorectal adenoma and these pathogenic bacterial genes, individually and in various combinations. They also plan to compare genes in normal and adenomatous colon tissue and to use enteroid (small intestinal organoid) models to tease out the carcinogenic mechanisms of these bacterial toxins.
The National Institutes of Health provided funding. The researchers disclosed no competing interests.
MIAMI – The fecal presence of least two genes harbored by toxin-producing or proinflammatory bacteria conferred a nearly 200% rise in the odds of colorectal adenoma, investigators reported.
Moreover, the fecal presence of usp (uropathogenic-specific protein), a bacterial gene encoding a genotoxin that damages DNA, correlated with nearly 1,200% greater odds of colorectal adenoma (P =.08), said senior investigator María González-Pons, PhD, of the University of Puerto Rico Comprehensive Cancer Center in San Juan.
“We are continuing to enlarge this study. We need more power to assess statistical significance and look at associations for individual combinations of bacterial genes,” Dr. Pons said in an interview. “Our ultimate goal is to risk-stratify patients so that we know whom to target for [colorectal cancer] prevention.”
Dr. Pons and the study’s lead author, Noe Crespo-Hernandez, of the University of Puerto Rico, presented the findings with their associates in a poster at the the annual Gut Microbiota for Health World Summit.
Colorectal cancer is the most lethal cancer and the second-most common malignancy in Puerto Rico. Despite recommendations for screening colonoscopy, many patients are diagnosed in late-stage disease, when treatment options are limited. Intestinal inflammation is itself key to colorectal carcinogenesis and also promotes the enteric proliferation of gram-negative bacteria that produce potentially carcinogenic toxins. Thus, gut inflammation and the microbiome are of great interest to researchers who are working to develop reliable, minimally invasive tests that assess future colorectal cancer risk.
For their study presented at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility, Dr. Pons and her coinvestigators compared stool samples from 67 adults with colonoscopically confirmed colorectal adenomas and 39 controls with negative screening colonoscopies. Both groups were captured in the Puerto Rico Familial Colorectal Cancer Registry. The researchers used TaqMan SNP Genotyping to look for single-nucleotide polymorphisms (SNPs) from promoter regions of genes encoding interleukin-1 beta, IL-6, and IL-10, cytokines that regulate gut inflammation. They found nonsignificant associations between colorectal adenoma and two of the three SNPs: rs143627 (encoding IL-1B) and rs1800795 (IL-6).
The real-time polymerase chain reaction results were even more striking. Using SYBR Green, the researchers tested stool for six genotoxic or proinflammatory bacterial genes and identified five, each of which correlated with colorectal adenoma. Colorectal adenoma also was linked with the fecal presence of a nonpathogenic housekeeping gene that is a surrogate for a mucolytic bacterium abundant in the stool of colorectal cancer patients.
Odds ratios for these associations ranged from 1.17 (for cnf, or cytotoxic necrotizing factor) to 12.83 (for usp), the researchers reported. Dr. Pons commented that Hurricane Maria greatly delayed this study and thus the cohort was underpowered to test for statistical significance. Nonetheless, P values approached significance for the usp gene (OR, 12.83; 95% confidence interval, 0.73-226.8; P = .08) and the fecal presence of at least two genes in combination (OR, 2.84; 95% CI, 1.01-8.90; P = .05).
Next, Dr. Pons and her team will expand the study to assess links between colorectal adenoma and these pathogenic bacterial genes, individually and in various combinations. They also plan to compare genes in normal and adenomatous colon tissue and to use enteroid (small intestinal organoid) models to tease out the carcinogenic mechanisms of these bacterial toxins.
The National Institutes of Health provided funding. The researchers disclosed no competing interests.
MIAMI – The fecal presence of least two genes harbored by toxin-producing or proinflammatory bacteria conferred a nearly 200% rise in the odds of colorectal adenoma, investigators reported.
Moreover, the fecal presence of usp (uropathogenic-specific protein), a bacterial gene encoding a genotoxin that damages DNA, correlated with nearly 1,200% greater odds of colorectal adenoma (P =.08), said senior investigator María González-Pons, PhD, of the University of Puerto Rico Comprehensive Cancer Center in San Juan.
“We are continuing to enlarge this study. We need more power to assess statistical significance and look at associations for individual combinations of bacterial genes,” Dr. Pons said in an interview. “Our ultimate goal is to risk-stratify patients so that we know whom to target for [colorectal cancer] prevention.”
Dr. Pons and the study’s lead author, Noe Crespo-Hernandez, of the University of Puerto Rico, presented the findings with their associates in a poster at the the annual Gut Microbiota for Health World Summit.
Colorectal cancer is the most lethal cancer and the second-most common malignancy in Puerto Rico. Despite recommendations for screening colonoscopy, many patients are diagnosed in late-stage disease, when treatment options are limited. Intestinal inflammation is itself key to colorectal carcinogenesis and also promotes the enteric proliferation of gram-negative bacteria that produce potentially carcinogenic toxins. Thus, gut inflammation and the microbiome are of great interest to researchers who are working to develop reliable, minimally invasive tests that assess future colorectal cancer risk.
For their study presented at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility, Dr. Pons and her coinvestigators compared stool samples from 67 adults with colonoscopically confirmed colorectal adenomas and 39 controls with negative screening colonoscopies. Both groups were captured in the Puerto Rico Familial Colorectal Cancer Registry. The researchers used TaqMan SNP Genotyping to look for single-nucleotide polymorphisms (SNPs) from promoter regions of genes encoding interleukin-1 beta, IL-6, and IL-10, cytokines that regulate gut inflammation. They found nonsignificant associations between colorectal adenoma and two of the three SNPs: rs143627 (encoding IL-1B) and rs1800795 (IL-6).
The real-time polymerase chain reaction results were even more striking. Using SYBR Green, the researchers tested stool for six genotoxic or proinflammatory bacterial genes and identified five, each of which correlated with colorectal adenoma. Colorectal adenoma also was linked with the fecal presence of a nonpathogenic housekeeping gene that is a surrogate for a mucolytic bacterium abundant in the stool of colorectal cancer patients.
Odds ratios for these associations ranged from 1.17 (for cnf, or cytotoxic necrotizing factor) to 12.83 (for usp), the researchers reported. Dr. Pons commented that Hurricane Maria greatly delayed this study and thus the cohort was underpowered to test for statistical significance. Nonetheless, P values approached significance for the usp gene (OR, 12.83; 95% confidence interval, 0.73-226.8; P = .08) and the fecal presence of at least two genes in combination (OR, 2.84; 95% CI, 1.01-8.90; P = .05).
Next, Dr. Pons and her team will expand the study to assess links between colorectal adenoma and these pathogenic bacterial genes, individually and in various combinations. They also plan to compare genes in normal and adenomatous colon tissue and to use enteroid (small intestinal organoid) models to tease out the carcinogenic mechanisms of these bacterial toxins.
The National Institutes of Health provided funding. The researchers disclosed no competing interests.
REPORTING FROM GUT 2019
Plasma genotyping yields actionable mutation in advanced NSCLC
Taking a deep dive into plasma cell-free DNA in patients with advanced non–small cell lung cancer may reveal targetable mutations and cancer resistance mechanisms in tumors, even when tissue biopsy samples are not adequate for genotyping, investigators say,
Noninvasive tumor genotyping of plasma cell-free DNA (cfDNA) with ultra-deep next generation sequencing (NGS) in plasma samples from 127 patients identified known oncogenic drivers with a sensitivity of 75% and ruled out the presence of driver mutations with a specificity of 100% in patients with tissue samples indicating no mutations, reported Bob T. Li, MD, MPH, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York, and his colleagues.
“These results reveal the potential utility of NGS assays that use cfDNA as input for detecting actionable driver alterations and both de novo and emergent resistance mechanisms in the clinical setting,” they wrote. The report is in Annals of Oncology.
Although the researchers did not directly assess clinical utility, the results suggest that NGS-based analysis of cfDNA may help guide treatment selection, they added.
Ultra-deep NGS is a kind of obsessive-compulsive form of sequencing in which the same genomic region is read repeatedly – in this study, 50,000 times over – with filtering of somatic mutations attributable to clonal hematopoiesis. The technique allows for detection of rare genetic alterations that can be missed by other methods.
“More recent studies employing plasma cfDNA NGS have shown promise in detecting a broader variety of genetic alterations with similar sensitivity to that of digital PCR, with potential to change clinical practice,” Dr. Li and his colleagues wrote.
They conducted a systematic study of a novel cfDNA assay in patients whose cancers had oncogenic driver mutations, those who were driver negative on tissue-based NGS, and those whose tumors had unknown mutational status.
A total of 127 patients from three centers (MSKCC, the Dana-Farber Cancer Center in Boston, and the University of Texas MD Anderson Cancer Center in Houston) were available for assessment.
Ultra-deep NGS was performed on cfDNA and matched white blood cells using a hybrid capture panel covering 37 lung cancer-related genes sequenced to 50,000 times raw-target coverage filtering somatic mutations attributable to clonal hematopoiesis.
Plasma NGS was able to detect driver mutations with variant allele frequencies ranging from as low as 0.14% to as high as 52%.
In 21 of 22 patients, plasma digital drop polymerase chain reaction (ddPCR) results for EGFR or KRAS mutations were nearly identical to those of NGS, with high concordance for variant allele frequencies (r = .98).
In analyses blinded to tissue genotyping results in 91 patients, plasma NGS detected de novo known oncogenic driver alterations in 68 samples, for a sensitivity of 75%, and in 19 of 19 patients who were driver negative by tissue sequencing, plasma NGS also showed an absence of mutations, for a specificity of 100%.
Furthermore, plasma NGS identified four KRAS mutations in plasma from 17 patients for whom tissues samples were not adequate for genotyping, and the plasma-based technique was able to identify potential resistance mutations in samples from 23 patients with EGFR mutations whose tumors had required resistance to targeted therapy.
“The sensitivity of detection by NGS was comparable to that of established ddPCR methods. Its high concordance with tissue genotyping and the detection of drivers in settings where tissue biopsy had failed or was not feasible lend credence to the potential clinical use of plasma cfDNA NGS and the development of cfDNA-guided intervention studies,” the investigators wrote.
The study was supported by Illumina. Authors from MSKCC and MD Anderson were supported by National Institutes of Health grants. Dr. Li received consulting/advisory board fees from Genentech, Thermo-Fisher Scientific, and Guardant Health outside of the submitted work. Multiple coauthors reported similar relationships, and eight coauthors were current or former employees of Illumina.
SOURCE: Source: Li BT et al. Ann Oncol. doi: 10.1093/annonc/mdz046.
Taking a deep dive into plasma cell-free DNA in patients with advanced non–small cell lung cancer may reveal targetable mutations and cancer resistance mechanisms in tumors, even when tissue biopsy samples are not adequate for genotyping, investigators say,
Noninvasive tumor genotyping of plasma cell-free DNA (cfDNA) with ultra-deep next generation sequencing (NGS) in plasma samples from 127 patients identified known oncogenic drivers with a sensitivity of 75% and ruled out the presence of driver mutations with a specificity of 100% in patients with tissue samples indicating no mutations, reported Bob T. Li, MD, MPH, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York, and his colleagues.
“These results reveal the potential utility of NGS assays that use cfDNA as input for detecting actionable driver alterations and both de novo and emergent resistance mechanisms in the clinical setting,” they wrote. The report is in Annals of Oncology.
Although the researchers did not directly assess clinical utility, the results suggest that NGS-based analysis of cfDNA may help guide treatment selection, they added.
Ultra-deep NGS is a kind of obsessive-compulsive form of sequencing in which the same genomic region is read repeatedly – in this study, 50,000 times over – with filtering of somatic mutations attributable to clonal hematopoiesis. The technique allows for detection of rare genetic alterations that can be missed by other methods.
“More recent studies employing plasma cfDNA NGS have shown promise in detecting a broader variety of genetic alterations with similar sensitivity to that of digital PCR, with potential to change clinical practice,” Dr. Li and his colleagues wrote.
They conducted a systematic study of a novel cfDNA assay in patients whose cancers had oncogenic driver mutations, those who were driver negative on tissue-based NGS, and those whose tumors had unknown mutational status.
A total of 127 patients from three centers (MSKCC, the Dana-Farber Cancer Center in Boston, and the University of Texas MD Anderson Cancer Center in Houston) were available for assessment.
Ultra-deep NGS was performed on cfDNA and matched white blood cells using a hybrid capture panel covering 37 lung cancer-related genes sequenced to 50,000 times raw-target coverage filtering somatic mutations attributable to clonal hematopoiesis.
Plasma NGS was able to detect driver mutations with variant allele frequencies ranging from as low as 0.14% to as high as 52%.
In 21 of 22 patients, plasma digital drop polymerase chain reaction (ddPCR) results for EGFR or KRAS mutations were nearly identical to those of NGS, with high concordance for variant allele frequencies (r = .98).
In analyses blinded to tissue genotyping results in 91 patients, plasma NGS detected de novo known oncogenic driver alterations in 68 samples, for a sensitivity of 75%, and in 19 of 19 patients who were driver negative by tissue sequencing, plasma NGS also showed an absence of mutations, for a specificity of 100%.
Furthermore, plasma NGS identified four KRAS mutations in plasma from 17 patients for whom tissues samples were not adequate for genotyping, and the plasma-based technique was able to identify potential resistance mutations in samples from 23 patients with EGFR mutations whose tumors had required resistance to targeted therapy.
“The sensitivity of detection by NGS was comparable to that of established ddPCR methods. Its high concordance with tissue genotyping and the detection of drivers in settings where tissue biopsy had failed or was not feasible lend credence to the potential clinical use of plasma cfDNA NGS and the development of cfDNA-guided intervention studies,” the investigators wrote.
The study was supported by Illumina. Authors from MSKCC and MD Anderson were supported by National Institutes of Health grants. Dr. Li received consulting/advisory board fees from Genentech, Thermo-Fisher Scientific, and Guardant Health outside of the submitted work. Multiple coauthors reported similar relationships, and eight coauthors were current or former employees of Illumina.
SOURCE: Source: Li BT et al. Ann Oncol. doi: 10.1093/annonc/mdz046.
Taking a deep dive into plasma cell-free DNA in patients with advanced non–small cell lung cancer may reveal targetable mutations and cancer resistance mechanisms in tumors, even when tissue biopsy samples are not adequate for genotyping, investigators say,
Noninvasive tumor genotyping of plasma cell-free DNA (cfDNA) with ultra-deep next generation sequencing (NGS) in plasma samples from 127 patients identified known oncogenic drivers with a sensitivity of 75% and ruled out the presence of driver mutations with a specificity of 100% in patients with tissue samples indicating no mutations, reported Bob T. Li, MD, MPH, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York, and his colleagues.
“These results reveal the potential utility of NGS assays that use cfDNA as input for detecting actionable driver alterations and both de novo and emergent resistance mechanisms in the clinical setting,” they wrote. The report is in Annals of Oncology.
Although the researchers did not directly assess clinical utility, the results suggest that NGS-based analysis of cfDNA may help guide treatment selection, they added.
Ultra-deep NGS is a kind of obsessive-compulsive form of sequencing in which the same genomic region is read repeatedly – in this study, 50,000 times over – with filtering of somatic mutations attributable to clonal hematopoiesis. The technique allows for detection of rare genetic alterations that can be missed by other methods.
“More recent studies employing plasma cfDNA NGS have shown promise in detecting a broader variety of genetic alterations with similar sensitivity to that of digital PCR, with potential to change clinical practice,” Dr. Li and his colleagues wrote.
They conducted a systematic study of a novel cfDNA assay in patients whose cancers had oncogenic driver mutations, those who were driver negative on tissue-based NGS, and those whose tumors had unknown mutational status.
A total of 127 patients from three centers (MSKCC, the Dana-Farber Cancer Center in Boston, and the University of Texas MD Anderson Cancer Center in Houston) were available for assessment.
Ultra-deep NGS was performed on cfDNA and matched white blood cells using a hybrid capture panel covering 37 lung cancer-related genes sequenced to 50,000 times raw-target coverage filtering somatic mutations attributable to clonal hematopoiesis.
Plasma NGS was able to detect driver mutations with variant allele frequencies ranging from as low as 0.14% to as high as 52%.
In 21 of 22 patients, plasma digital drop polymerase chain reaction (ddPCR) results for EGFR or KRAS mutations were nearly identical to those of NGS, with high concordance for variant allele frequencies (r = .98).
In analyses blinded to tissue genotyping results in 91 patients, plasma NGS detected de novo known oncogenic driver alterations in 68 samples, for a sensitivity of 75%, and in 19 of 19 patients who were driver negative by tissue sequencing, plasma NGS also showed an absence of mutations, for a specificity of 100%.
Furthermore, plasma NGS identified four KRAS mutations in plasma from 17 patients for whom tissues samples were not adequate for genotyping, and the plasma-based technique was able to identify potential resistance mutations in samples from 23 patients with EGFR mutations whose tumors had required resistance to targeted therapy.
“The sensitivity of detection by NGS was comparable to that of established ddPCR methods. Its high concordance with tissue genotyping and the detection of drivers in settings where tissue biopsy had failed or was not feasible lend credence to the potential clinical use of plasma cfDNA NGS and the development of cfDNA-guided intervention studies,” the investigators wrote.
The study was supported by Illumina. Authors from MSKCC and MD Anderson were supported by National Institutes of Health grants. Dr. Li received consulting/advisory board fees from Genentech, Thermo-Fisher Scientific, and Guardant Health outside of the submitted work. Multiple coauthors reported similar relationships, and eight coauthors were current or former employees of Illumina.
SOURCE: Source: Li BT et al. Ann Oncol. doi: 10.1093/annonc/mdz046.
FROM ANNALS OF ONCOLOGY