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A.I. and U
There is a good chance that your car is equipped with a backup camera. It also may have sensors that alert you when there is another vehicle in one of your blind spots. These wonders of modern technology simply are vision enhancers much like an x-ray or an ultrasound. The sensors merely collect visual data, but the decision of what should be done with this additional information is up to you, just as you decide how to respond to your patient’s lab work and imaging studies.
If you have more disposable income than I do, you may have a vehicle that not only gathers information but also makes decisions based on what it senses by slowing down, applying the brakes, or adjusting the steering. My friends who own these semi-autonomous cars generally have given these control systems positive grades once they have experienced a few events in which the vehicle took over in what it considered a dangerous situation. However, even my friends who are fans of their semi-autonomous cars are uncomfortable about the widespread introduction of fully autonomous vehicles.
The practice of medicine is riding the crest of this same wave of artificial intelligence that promises, or some might say threatens, to remove humans from the driver’s seat (“A.I. Shows Promise Assisting Physicians,” by Cade Metz, The New York Times, Feb. 11, 2019). As reported in the New York Times, a team of physicians has created a system capable of making diagnoses based on a “neural network” that uses complex computer algorithms to learn by analyzing extremely large amounts of data. Once this system had been “taught” to identify certain medical conditions in EMRs, the team tasked the system with analyzing the records of nearly 600,000 patients at a women and children’s hospital in southern China. The investigators claim that the system was able to diagnose asthma with more than 90% accuracy, while physicians can diagnose with an accuracy of 80%-94%, and the system diagnosed gastrointestinal disease with 87% accuracy, well within the physicians’ accuracy range of 82%-90%.
Does this apparent success for A.I. mean that not only will you be vacating your place behind the wheel of your car, but also taking down your shingle and hanging up your stethoscope? Before you rush out and sign up for a federally-funded retraining program, you should remember that this study was done in China, where the privacy laws are somewhat skimpy and the data more voluminous by several scales of magnitude than here. Replicating their results and However, this report should serve as wake-up call to those of you who believe that making diagnoses is at the core of what makes you a physician. If sorting through pages of data to arrive at an explanation for your patients’ complaints is the intellectual challenge that keeps the practice of medicine fresh and exciting, you may want to start looking for other sources of mental stimulation.
A.I. isn’t going to replace the primary care physician. There still will need to be someone available at the initial point of contact who can do a physical exam, take, or at least review, the patient’s history, and then order the lab work and imaging studies that the A.I. system will use to make the diagnosis. In other words, the physician will be primarily responsible for data collection. You may feel that you are almost there already.
Will there be new roles for primary care physicians once A.I. systems are making the diagnoses? It is hard to imagine a fully autonomous health care system in which physicians completely disappear. But, now is the time to think seriously about how we are going to reinvent ourselves to adapt to the inevitable changes and continue as an (or could be "the") essential human element in an increasingly automated system.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
There is a good chance that your car is equipped with a backup camera. It also may have sensors that alert you when there is another vehicle in one of your blind spots. These wonders of modern technology simply are vision enhancers much like an x-ray or an ultrasound. The sensors merely collect visual data, but the decision of what should be done with this additional information is up to you, just as you decide how to respond to your patient’s lab work and imaging studies.
If you have more disposable income than I do, you may have a vehicle that not only gathers information but also makes decisions based on what it senses by slowing down, applying the brakes, or adjusting the steering. My friends who own these semi-autonomous cars generally have given these control systems positive grades once they have experienced a few events in which the vehicle took over in what it considered a dangerous situation. However, even my friends who are fans of their semi-autonomous cars are uncomfortable about the widespread introduction of fully autonomous vehicles.
The practice of medicine is riding the crest of this same wave of artificial intelligence that promises, or some might say threatens, to remove humans from the driver’s seat (“A.I. Shows Promise Assisting Physicians,” by Cade Metz, The New York Times, Feb. 11, 2019). As reported in the New York Times, a team of physicians has created a system capable of making diagnoses based on a “neural network” that uses complex computer algorithms to learn by analyzing extremely large amounts of data. Once this system had been “taught” to identify certain medical conditions in EMRs, the team tasked the system with analyzing the records of nearly 600,000 patients at a women and children’s hospital in southern China. The investigators claim that the system was able to diagnose asthma with more than 90% accuracy, while physicians can diagnose with an accuracy of 80%-94%, and the system diagnosed gastrointestinal disease with 87% accuracy, well within the physicians’ accuracy range of 82%-90%.
Does this apparent success for A.I. mean that not only will you be vacating your place behind the wheel of your car, but also taking down your shingle and hanging up your stethoscope? Before you rush out and sign up for a federally-funded retraining program, you should remember that this study was done in China, where the privacy laws are somewhat skimpy and the data more voluminous by several scales of magnitude than here. Replicating their results and However, this report should serve as wake-up call to those of you who believe that making diagnoses is at the core of what makes you a physician. If sorting through pages of data to arrive at an explanation for your patients’ complaints is the intellectual challenge that keeps the practice of medicine fresh and exciting, you may want to start looking for other sources of mental stimulation.
A.I. isn’t going to replace the primary care physician. There still will need to be someone available at the initial point of contact who can do a physical exam, take, or at least review, the patient’s history, and then order the lab work and imaging studies that the A.I. system will use to make the diagnosis. In other words, the physician will be primarily responsible for data collection. You may feel that you are almost there already.
Will there be new roles for primary care physicians once A.I. systems are making the diagnoses? It is hard to imagine a fully autonomous health care system in which physicians completely disappear. But, now is the time to think seriously about how we are going to reinvent ourselves to adapt to the inevitable changes and continue as an (or could be "the") essential human element in an increasingly automated system.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
There is a good chance that your car is equipped with a backup camera. It also may have sensors that alert you when there is another vehicle in one of your blind spots. These wonders of modern technology simply are vision enhancers much like an x-ray or an ultrasound. The sensors merely collect visual data, but the decision of what should be done with this additional information is up to you, just as you decide how to respond to your patient’s lab work and imaging studies.
If you have more disposable income than I do, you may have a vehicle that not only gathers information but also makes decisions based on what it senses by slowing down, applying the brakes, or adjusting the steering. My friends who own these semi-autonomous cars generally have given these control systems positive grades once they have experienced a few events in which the vehicle took over in what it considered a dangerous situation. However, even my friends who are fans of their semi-autonomous cars are uncomfortable about the widespread introduction of fully autonomous vehicles.
The practice of medicine is riding the crest of this same wave of artificial intelligence that promises, or some might say threatens, to remove humans from the driver’s seat (“A.I. Shows Promise Assisting Physicians,” by Cade Metz, The New York Times, Feb. 11, 2019). As reported in the New York Times, a team of physicians has created a system capable of making diagnoses based on a “neural network” that uses complex computer algorithms to learn by analyzing extremely large amounts of data. Once this system had been “taught” to identify certain medical conditions in EMRs, the team tasked the system with analyzing the records of nearly 600,000 patients at a women and children’s hospital in southern China. The investigators claim that the system was able to diagnose asthma with more than 90% accuracy, while physicians can diagnose with an accuracy of 80%-94%, and the system diagnosed gastrointestinal disease with 87% accuracy, well within the physicians’ accuracy range of 82%-90%.
Does this apparent success for A.I. mean that not only will you be vacating your place behind the wheel of your car, but also taking down your shingle and hanging up your stethoscope? Before you rush out and sign up for a federally-funded retraining program, you should remember that this study was done in China, where the privacy laws are somewhat skimpy and the data more voluminous by several scales of magnitude than here. Replicating their results and However, this report should serve as wake-up call to those of you who believe that making diagnoses is at the core of what makes you a physician. If sorting through pages of data to arrive at an explanation for your patients’ complaints is the intellectual challenge that keeps the practice of medicine fresh and exciting, you may want to start looking for other sources of mental stimulation.
A.I. isn’t going to replace the primary care physician. There still will need to be someone available at the initial point of contact who can do a physical exam, take, or at least review, the patient’s history, and then order the lab work and imaging studies that the A.I. system will use to make the diagnosis. In other words, the physician will be primarily responsible for data collection. You may feel that you are almost there already.
Will there be new roles for primary care physicians once A.I. systems are making the diagnoses? It is hard to imagine a fully autonomous health care system in which physicians completely disappear. But, now is the time to think seriously about how we are going to reinvent ourselves to adapt to the inevitable changes and continue as an (or could be "the") essential human element in an increasingly automated system.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
Pseudoscience redux
My most recent column discussed the problem of pseudoscience that pervades some corners of the Internet. Personally, I respond to pseudoscience primarily by trying to provide accurate and less-biased information. I recognize that not everyone approaches decision making by seeking more information. When dealing a diverse public, a medical professional needs to have other approaches in the armamentarium.1 When dealing with other physicians, I am less flexible. Either the profession of medicine believes in science or it doesn’t.
Since that column was published, there have been major developments. There are measles outbreaks in the states of Washington and New York, and more than 100 deaths from a measles epidemic in the Philippines. The World Health Organization has made vaccine hesitancy one of its ten threats to global health in 2019.
Facebook has indicated that it might demote the priority and frequency with which it recommends articles that promulgate anti-vax information and conspiracy theories.2 Facebook isn’t doing this because it has had an epiphany; it has come under pressure for its role in the spread of misinformation. Current legislation was written before the rise of social media, when Internet Service Providers were primarily conduits to transfer bits and bytes between computers. Those ISPs were not liable for the content of the transmitted Web pages. Facebook, by producing what it called a newsfeed and by making personalized suggestions for other websites to browse, doesn’t fit the passive model of an ISP.
For alleged violations of user’s privacy, Facebook might be subject to billion dollar fines, according to a Washington Post article.3 Still, for a company whose revenue is $4 billion per month and whose stock market value is $400 billion, paying a billion dollar fine for years of alleged misbehaviors that have enabled it to become a giant empire is, “in the scheme of things ... a speeding ticket” in the parlance of the penultimate scene of the movie The Social Network. The real financial risk is people deciding they can’t trust the platform and going elsewhere.
Authorities in the United Kingdom in February 2019 released a highly critical, 108-page report about fake news, which said, “Facebook should not be allowed to behave like ‘digital gangsters’ in the online world.”4 The U.K. report urges new regulations to deal with privacy breaches and with fake news. It endeavors to create a duty for social media companies to combat the spread of misinformation.
Then the Wall Street Journal reported that Pinterest has stopped returning results for searches related to vaccination.5 Pinterest realized that most of the shared images on its platform cautioned against vaccination, which contradicts the recommendations of medical experts. Unable to otherwise combat the flow of misinformation, the company apparently has decided to eliminate returning results, pro or con, for any search terms related to vaccines.
While lamenting the public’s inability to distinguish misinformation on the Internet, I’ve also been observing the factors that lead physicians astray. I expect physicians, as trained scientists and as professionals, to be able to assimilate new information and change their practices accordingly. Those who do research on the translation of technology find that, this doesn’t happen with any regularity.
The February 2019 issue of Hospital Pediatrics has four items on the topic of treating bronchiolitis, including two research articles, a brief report, and a commentary. That is obviously a relevant topic this time of year. The impression after reading those four items is that hospitalists don’t really know how to best treat the most common illness they encounter. And even when they “know” how to do it, many factors distort the science. Those factors are highlighted in the article on barriers to minimizing viral testing.6
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
References
1. “Discussing immunization with vaccine-hesitant parents requires caring, individualized approach,” by Jeff Craven, Pediatric News, Nov. 7, 2018; “How do you get anti-vaxxers to vaccinate their kids? Talk to them – for hours,” by Nadine Gartner, Washington Post, Feb. 19, 2019.
2. “Facebook will consider removing or demoting anti-vaccination recommendations amid backlash,” by Taylor Telford, Washington Post, Feb. 15, 2019.
3. “U.S. regulators have met to discuss imposing a record-setting fine against Facebook for privacy violations,” by Tony Romm and Elizabeth Dwoskin, Washington Post, Jan. 18, 2019; “Report: Facebook, FTC discussing ‘multibillion dollar’ fine,” by Associated Press.
4. “Disinformation and ‘fake news’: Final Report,” House of Commons, Feb. 18, 2019, p. 42, item 139.
5. “Pinterest blocks vaccination searches in move to control the conversation,” by Robert McMillan and Daniela Hernandez, The Wall Street Journal, Feb. 20, 2019.
6. “Barriers to minimizing respiratory viral testing in bronchiolitis: Physician perceptions on testing practices,” by MZ Huang et al. Hospital Pediatrics 2019 Feb. doi: 10.1542/hpeds.2018-0108.
My most recent column discussed the problem of pseudoscience that pervades some corners of the Internet. Personally, I respond to pseudoscience primarily by trying to provide accurate and less-biased information. I recognize that not everyone approaches decision making by seeking more information. When dealing a diverse public, a medical professional needs to have other approaches in the armamentarium.1 When dealing with other physicians, I am less flexible. Either the profession of medicine believes in science or it doesn’t.
Since that column was published, there have been major developments. There are measles outbreaks in the states of Washington and New York, and more than 100 deaths from a measles epidemic in the Philippines. The World Health Organization has made vaccine hesitancy one of its ten threats to global health in 2019.
Facebook has indicated that it might demote the priority and frequency with which it recommends articles that promulgate anti-vax information and conspiracy theories.2 Facebook isn’t doing this because it has had an epiphany; it has come under pressure for its role in the spread of misinformation. Current legislation was written before the rise of social media, when Internet Service Providers were primarily conduits to transfer bits and bytes between computers. Those ISPs were not liable for the content of the transmitted Web pages. Facebook, by producing what it called a newsfeed and by making personalized suggestions for other websites to browse, doesn’t fit the passive model of an ISP.
For alleged violations of user’s privacy, Facebook might be subject to billion dollar fines, according to a Washington Post article.3 Still, for a company whose revenue is $4 billion per month and whose stock market value is $400 billion, paying a billion dollar fine for years of alleged misbehaviors that have enabled it to become a giant empire is, “in the scheme of things ... a speeding ticket” in the parlance of the penultimate scene of the movie The Social Network. The real financial risk is people deciding they can’t trust the platform and going elsewhere.
Authorities in the United Kingdom in February 2019 released a highly critical, 108-page report about fake news, which said, “Facebook should not be allowed to behave like ‘digital gangsters’ in the online world.”4 The U.K. report urges new regulations to deal with privacy breaches and with fake news. It endeavors to create a duty for social media companies to combat the spread of misinformation.
Then the Wall Street Journal reported that Pinterest has stopped returning results for searches related to vaccination.5 Pinterest realized that most of the shared images on its platform cautioned against vaccination, which contradicts the recommendations of medical experts. Unable to otherwise combat the flow of misinformation, the company apparently has decided to eliminate returning results, pro or con, for any search terms related to vaccines.
While lamenting the public’s inability to distinguish misinformation on the Internet, I’ve also been observing the factors that lead physicians astray. I expect physicians, as trained scientists and as professionals, to be able to assimilate new information and change their practices accordingly. Those who do research on the translation of technology find that, this doesn’t happen with any regularity.
The February 2019 issue of Hospital Pediatrics has four items on the topic of treating bronchiolitis, including two research articles, a brief report, and a commentary. That is obviously a relevant topic this time of year. The impression after reading those four items is that hospitalists don’t really know how to best treat the most common illness they encounter. And even when they “know” how to do it, many factors distort the science. Those factors are highlighted in the article on barriers to minimizing viral testing.6
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
References
1. “Discussing immunization with vaccine-hesitant parents requires caring, individualized approach,” by Jeff Craven, Pediatric News, Nov. 7, 2018; “How do you get anti-vaxxers to vaccinate their kids? Talk to them – for hours,” by Nadine Gartner, Washington Post, Feb. 19, 2019.
2. “Facebook will consider removing or demoting anti-vaccination recommendations amid backlash,” by Taylor Telford, Washington Post, Feb. 15, 2019.
3. “U.S. regulators have met to discuss imposing a record-setting fine against Facebook for privacy violations,” by Tony Romm and Elizabeth Dwoskin, Washington Post, Jan. 18, 2019; “Report: Facebook, FTC discussing ‘multibillion dollar’ fine,” by Associated Press.
4. “Disinformation and ‘fake news’: Final Report,” House of Commons, Feb. 18, 2019, p. 42, item 139.
5. “Pinterest blocks vaccination searches in move to control the conversation,” by Robert McMillan and Daniela Hernandez, The Wall Street Journal, Feb. 20, 2019.
6. “Barriers to minimizing respiratory viral testing in bronchiolitis: Physician perceptions on testing practices,” by MZ Huang et al. Hospital Pediatrics 2019 Feb. doi: 10.1542/hpeds.2018-0108.
My most recent column discussed the problem of pseudoscience that pervades some corners of the Internet. Personally, I respond to pseudoscience primarily by trying to provide accurate and less-biased information. I recognize that not everyone approaches decision making by seeking more information. When dealing a diverse public, a medical professional needs to have other approaches in the armamentarium.1 When dealing with other physicians, I am less flexible. Either the profession of medicine believes in science or it doesn’t.
Since that column was published, there have been major developments. There are measles outbreaks in the states of Washington and New York, and more than 100 deaths from a measles epidemic in the Philippines. The World Health Organization has made vaccine hesitancy one of its ten threats to global health in 2019.
Facebook has indicated that it might demote the priority and frequency with which it recommends articles that promulgate anti-vax information and conspiracy theories.2 Facebook isn’t doing this because it has had an epiphany; it has come under pressure for its role in the spread of misinformation. Current legislation was written before the rise of social media, when Internet Service Providers were primarily conduits to transfer bits and bytes between computers. Those ISPs were not liable for the content of the transmitted Web pages. Facebook, by producing what it called a newsfeed and by making personalized suggestions for other websites to browse, doesn’t fit the passive model of an ISP.
For alleged violations of user’s privacy, Facebook might be subject to billion dollar fines, according to a Washington Post article.3 Still, for a company whose revenue is $4 billion per month and whose stock market value is $400 billion, paying a billion dollar fine for years of alleged misbehaviors that have enabled it to become a giant empire is, “in the scheme of things ... a speeding ticket” in the parlance of the penultimate scene of the movie The Social Network. The real financial risk is people deciding they can’t trust the platform and going elsewhere.
Authorities in the United Kingdom in February 2019 released a highly critical, 108-page report about fake news, which said, “Facebook should not be allowed to behave like ‘digital gangsters’ in the online world.”4 The U.K. report urges new regulations to deal with privacy breaches and with fake news. It endeavors to create a duty for social media companies to combat the spread of misinformation.
Then the Wall Street Journal reported that Pinterest has stopped returning results for searches related to vaccination.5 Pinterest realized that most of the shared images on its platform cautioned against vaccination, which contradicts the recommendations of medical experts. Unable to otherwise combat the flow of misinformation, the company apparently has decided to eliminate returning results, pro or con, for any search terms related to vaccines.
While lamenting the public’s inability to distinguish misinformation on the Internet, I’ve also been observing the factors that lead physicians astray. I expect physicians, as trained scientists and as professionals, to be able to assimilate new information and change their practices accordingly. Those who do research on the translation of technology find that, this doesn’t happen with any regularity.
The February 2019 issue of Hospital Pediatrics has four items on the topic of treating bronchiolitis, including two research articles, a brief report, and a commentary. That is obviously a relevant topic this time of year. The impression after reading those four items is that hospitalists don’t really know how to best treat the most common illness they encounter. And even when they “know” how to do it, many factors distort the science. Those factors are highlighted in the article on barriers to minimizing viral testing.6
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
References
1. “Discussing immunization with vaccine-hesitant parents requires caring, individualized approach,” by Jeff Craven, Pediatric News, Nov. 7, 2018; “How do you get anti-vaxxers to vaccinate their kids? Talk to them – for hours,” by Nadine Gartner, Washington Post, Feb. 19, 2019.
2. “Facebook will consider removing or demoting anti-vaccination recommendations amid backlash,” by Taylor Telford, Washington Post, Feb. 15, 2019.
3. “U.S. regulators have met to discuss imposing a record-setting fine against Facebook for privacy violations,” by Tony Romm and Elizabeth Dwoskin, Washington Post, Jan. 18, 2019; “Report: Facebook, FTC discussing ‘multibillion dollar’ fine,” by Associated Press.
4. “Disinformation and ‘fake news’: Final Report,” House of Commons, Feb. 18, 2019, p. 42, item 139.
5. “Pinterest blocks vaccination searches in move to control the conversation,” by Robert McMillan and Daniela Hernandez, The Wall Street Journal, Feb. 20, 2019.
6. “Barriers to minimizing respiratory viral testing in bronchiolitis: Physician perceptions on testing practices,” by MZ Huang et al. Hospital Pediatrics 2019 Feb. doi: 10.1542/hpeds.2018-0108.
Experts: Consider enteral therapy in CD, with caveats
LAS VEGAS – Temporarily switching to an enteral diet – without solid food – has the potential to reverse Crohn’s disease (CD), especially in children, a panel of experts told gastroenterologists here.
They acknowledged the controversial treatment requires strict adherence and can be impossible for some patients to tolerate. But it can be successful too, said gastroenterologist Lindsey G. Albenberg, DO, of Children’s Hospital of Philadelphia, where enteral nutrition therapy (ENT) is commonly used in patients with CD.
“Parents are obviously thrilled that there’s no exposure to immunosuppressive medications,” she said in a discussion about ENT at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Typically, we provide 80%-90% of calorie needs through a polymeric formula by mouth. If we see clinical response at 4-6 weeks or even earlier, then we will pursue a course of about 8-12 weeks.”
Research into the best role for ENT therapy in CD is limited. A 2018 Cochrane Library review found there’s “very low quality evidence” suggesting that ENT is better than steroids to induce remission in children. It also found there’s “very low quality evidence” that steroids are better than ENT in adults with CD (Cochrane Database Syst Rev. 2018 Apr 1. doi: 10.1002/14651858.CD000542.pub3).
According to clinician-scientist James D. Lewis, MD, MSCE, of the University of Pennsylvania, Philadelphia, ENT “has gotten a bad name in some ways because of a meta-analysis showing it was inferior to corticosteroids to induce remission.” In fact, he said, studies “didn’t look at mucosal healing and pooled together adults and children.”
In children, he said, the treatment seems to clearly be effective. The picture is less promising in adults. “Presumably that’s because those of you who are parents probably have more control over your young children than your own behavior,” he said, referring to management of food intake.
In adults, “there’s no reason to think it wouldn’t work,” he said. “But trying to convince adults to give up food is really challenging.”
Children who try ENT are often required to use a nasogastric feeding tube, an approach that adults tend to avoid. In kids, “it’s a question of knowing your patient,” said gastroenterologist David Suskind, MD, of Seattle Children’s Hospital. “If the patient says, ‘There’s no way you’ll put a nasal gastric tube in, and no way I will drink it [the ENT supplement],’ this may not be the best therapy. If they’re interested, we push forward. We get much better efficacy because the patients will do what we’re asking.”
Several panelists recommended that patients use polymeric formulations instead of elemental formulations because they’re more palatable. It can be a struggle, however, to stick with the treatment.
Kelly Issokson, MS, RD, CNSC, a dietitian with Cedars-Sinai Medical Center in Los Angeles, tried an ENT therapy for 30 days in order to understand what patients experience and said it was “very challenging.”
“When you sit down to a meal, you anticipate it, you start to salivate. With shakes, it was a lot more clinical,” she said. “The other thing I struggled with was texture and having it be so sweet. I’d freeze [the shakes] into ice cube trays and popsicles. That helped break the monotony. It changes the flavor and cuts the sweetness.”
Ms. Issokson urges her patients to stick with ENT for the entire period of therapy. “Studies show when patients introduce real foods the efficacy of inducing remission goes down. We recommend 100% calories and proteins coming from the formula,” she said. That means “no coffee, no broth, no tea, no nothing but the formula. Most of our patients are able to do that exclusively.”
Toward the end of therapy, around week 8 or 11, some patients tell her they crave food like soup. “I say OK, have a tiny bit,” she said, “but remember, this is only temporary. We’re almost at the end. Try to be 100% exclusive.”
Dr. Albenberg and Dr. Suskind report no disclosures. Ms. Issokson reports consulting fees (speaking and teaching) from AGA, Crohn’s & Colitis Foundation, Academy of Nutrition and Dietetics, and United Ostomy Association. Dr. Lewis reports many relationships – including consulting fees, ownership interest, and grant/research support – with Eli Lilly, Bristol‐Myers Squibb, Gilead, and others.
Correction, 2/22/19: An earlier version of this article misidentified the person in the first photo above.
LAS VEGAS – Temporarily switching to an enteral diet – without solid food – has the potential to reverse Crohn’s disease (CD), especially in children, a panel of experts told gastroenterologists here.
They acknowledged the controversial treatment requires strict adherence and can be impossible for some patients to tolerate. But it can be successful too, said gastroenterologist Lindsey G. Albenberg, DO, of Children’s Hospital of Philadelphia, where enteral nutrition therapy (ENT) is commonly used in patients with CD.
“Parents are obviously thrilled that there’s no exposure to immunosuppressive medications,” she said in a discussion about ENT at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Typically, we provide 80%-90% of calorie needs through a polymeric formula by mouth. If we see clinical response at 4-6 weeks or even earlier, then we will pursue a course of about 8-12 weeks.”
Research into the best role for ENT therapy in CD is limited. A 2018 Cochrane Library review found there’s “very low quality evidence” suggesting that ENT is better than steroids to induce remission in children. It also found there’s “very low quality evidence” that steroids are better than ENT in adults with CD (Cochrane Database Syst Rev. 2018 Apr 1. doi: 10.1002/14651858.CD000542.pub3).
According to clinician-scientist James D. Lewis, MD, MSCE, of the University of Pennsylvania, Philadelphia, ENT “has gotten a bad name in some ways because of a meta-analysis showing it was inferior to corticosteroids to induce remission.” In fact, he said, studies “didn’t look at mucosal healing and pooled together adults and children.”
In children, he said, the treatment seems to clearly be effective. The picture is less promising in adults. “Presumably that’s because those of you who are parents probably have more control over your young children than your own behavior,” he said, referring to management of food intake.
In adults, “there’s no reason to think it wouldn’t work,” he said. “But trying to convince adults to give up food is really challenging.”
Children who try ENT are often required to use a nasogastric feeding tube, an approach that adults tend to avoid. In kids, “it’s a question of knowing your patient,” said gastroenterologist David Suskind, MD, of Seattle Children’s Hospital. “If the patient says, ‘There’s no way you’ll put a nasal gastric tube in, and no way I will drink it [the ENT supplement],’ this may not be the best therapy. If they’re interested, we push forward. We get much better efficacy because the patients will do what we’re asking.”
Several panelists recommended that patients use polymeric formulations instead of elemental formulations because they’re more palatable. It can be a struggle, however, to stick with the treatment.
Kelly Issokson, MS, RD, CNSC, a dietitian with Cedars-Sinai Medical Center in Los Angeles, tried an ENT therapy for 30 days in order to understand what patients experience and said it was “very challenging.”
“When you sit down to a meal, you anticipate it, you start to salivate. With shakes, it was a lot more clinical,” she said. “The other thing I struggled with was texture and having it be so sweet. I’d freeze [the shakes] into ice cube trays and popsicles. That helped break the monotony. It changes the flavor and cuts the sweetness.”
Ms. Issokson urges her patients to stick with ENT for the entire period of therapy. “Studies show when patients introduce real foods the efficacy of inducing remission goes down. We recommend 100% calories and proteins coming from the formula,” she said. That means “no coffee, no broth, no tea, no nothing but the formula. Most of our patients are able to do that exclusively.”
Toward the end of therapy, around week 8 or 11, some patients tell her they crave food like soup. “I say OK, have a tiny bit,” she said, “but remember, this is only temporary. We’re almost at the end. Try to be 100% exclusive.”
Dr. Albenberg and Dr. Suskind report no disclosures. Ms. Issokson reports consulting fees (speaking and teaching) from AGA, Crohn’s & Colitis Foundation, Academy of Nutrition and Dietetics, and United Ostomy Association. Dr. Lewis reports many relationships – including consulting fees, ownership interest, and grant/research support – with Eli Lilly, Bristol‐Myers Squibb, Gilead, and others.
Correction, 2/22/19: An earlier version of this article misidentified the person in the first photo above.
LAS VEGAS – Temporarily switching to an enteral diet – without solid food – has the potential to reverse Crohn’s disease (CD), especially in children, a panel of experts told gastroenterologists here.
They acknowledged the controversial treatment requires strict adherence and can be impossible for some patients to tolerate. But it can be successful too, said gastroenterologist Lindsey G. Albenberg, DO, of Children’s Hospital of Philadelphia, where enteral nutrition therapy (ENT) is commonly used in patients with CD.
“Parents are obviously thrilled that there’s no exposure to immunosuppressive medications,” she said in a discussion about ENT at the Crohn’s & Colitis Congress - a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Typically, we provide 80%-90% of calorie needs through a polymeric formula by mouth. If we see clinical response at 4-6 weeks or even earlier, then we will pursue a course of about 8-12 weeks.”
Research into the best role for ENT therapy in CD is limited. A 2018 Cochrane Library review found there’s “very low quality evidence” suggesting that ENT is better than steroids to induce remission in children. It also found there’s “very low quality evidence” that steroids are better than ENT in adults with CD (Cochrane Database Syst Rev. 2018 Apr 1. doi: 10.1002/14651858.CD000542.pub3).
According to clinician-scientist James D. Lewis, MD, MSCE, of the University of Pennsylvania, Philadelphia, ENT “has gotten a bad name in some ways because of a meta-analysis showing it was inferior to corticosteroids to induce remission.” In fact, he said, studies “didn’t look at mucosal healing and pooled together adults and children.”
In children, he said, the treatment seems to clearly be effective. The picture is less promising in adults. “Presumably that’s because those of you who are parents probably have more control over your young children than your own behavior,” he said, referring to management of food intake.
In adults, “there’s no reason to think it wouldn’t work,” he said. “But trying to convince adults to give up food is really challenging.”
Children who try ENT are often required to use a nasogastric feeding tube, an approach that adults tend to avoid. In kids, “it’s a question of knowing your patient,” said gastroenterologist David Suskind, MD, of Seattle Children’s Hospital. “If the patient says, ‘There’s no way you’ll put a nasal gastric tube in, and no way I will drink it [the ENT supplement],’ this may not be the best therapy. If they’re interested, we push forward. We get much better efficacy because the patients will do what we’re asking.”
Several panelists recommended that patients use polymeric formulations instead of elemental formulations because they’re more palatable. It can be a struggle, however, to stick with the treatment.
Kelly Issokson, MS, RD, CNSC, a dietitian with Cedars-Sinai Medical Center in Los Angeles, tried an ENT therapy for 30 days in order to understand what patients experience and said it was “very challenging.”
“When you sit down to a meal, you anticipate it, you start to salivate. With shakes, it was a lot more clinical,” she said. “The other thing I struggled with was texture and having it be so sweet. I’d freeze [the shakes] into ice cube trays and popsicles. That helped break the monotony. It changes the flavor and cuts the sweetness.”
Ms. Issokson urges her patients to stick with ENT for the entire period of therapy. “Studies show when patients introduce real foods the efficacy of inducing remission goes down. We recommend 100% calories and proteins coming from the formula,” she said. That means “no coffee, no broth, no tea, no nothing but the formula. Most of our patients are able to do that exclusively.”
Toward the end of therapy, around week 8 or 11, some patients tell her they crave food like soup. “I say OK, have a tiny bit,” she said, “but remember, this is only temporary. We’re almost at the end. Try to be 100% exclusive.”
Dr. Albenberg and Dr. Suskind report no disclosures. Ms. Issokson reports consulting fees (speaking and teaching) from AGA, Crohn’s & Colitis Foundation, Academy of Nutrition and Dietetics, and United Ostomy Association. Dr. Lewis reports many relationships – including consulting fees, ownership interest, and grant/research support – with Eli Lilly, Bristol‐Myers Squibb, Gilead, and others.
Correction, 2/22/19: An earlier version of this article misidentified the person in the first photo above.
EXPERT ANALYSIS FROM THE CROHN’S & COLITIS CONGRESS
Lawsuit against ABIM draws $200,000 in donation support
More than $200,000 has been raised by doctors and their supporters nationwide through a GoFundMe campaign launched to pay for costs associated with the class-action lawsuit against the American Board of Internal Medicine over its maintenance of certification (MOC) program.
Chicago-based cardiologist Wes Fisher, MD, and fellow physicians with the Practicing Physicians of America (PPA), started the fundraising campaign in May 2018 with an initial $150,000 goal to pay for attorney and prelitigation costs, according to posts on Dr. Fisher’s blog. After reaching that goal in September 2018, four internists filed suit against ABIM over its MOC process in December 2018, alleging antitrust claims.
PPA has since raised the GoFundMe goal to $400,000 to help support the next phase of the litigation, according to the campaign page.
In an email to supporters, Dr. Fisher said donations will help “take down MOC and end the unproven and burdensome continuous certification requirements for all subspecialties nationwide.” Dr. Fisher declined to comment for this article.
Brian Dixon, MD, a pediatric psychiatrist and PPA board member based in Fort Worth, Tex., said the campaign page and its success speaks for itself.
“Physicians are hurting and want to restore physician autonomy,” Dr. Dixon said in an interview. “Most physicians are pretty fiscally thoughtful so their donations are a powerful statement that they want change to the MOC process.”
Richard J. Baron, MD, ABIM president declined to specifically address the GoFundMe campaign, but said in an interview that the board is proud of its credential and grateful to the many physicians that have helped inform changes ABIM has made to its programs.
“Valuable credentials with standards behind them gain market share because they are meaningful and say something important about the doctors who hold them,” Dr. Baron said in an interview. “There is evidence in peer-reviewed journals that doctors holding our credential are more likely to meet quality metrics throughout their careers [Ann Intern Med. 2018 Jul 17. doi: 10.7326/M16-2643], that they are more likely to order mammograms for women who need them [Womens Health Issues. 2018 Jan-Feb. doi: 10.1016/j.whi.2017.10.003], that they provide care of equivalent quality at lower total cost[JAMA. 2014 Dec 10. doi: 10.1001/jama.2014.12716], and that they actually earn higher salaries [Health Serv Res. 2013 Jun. doi: 10.1111/1475-6773.12011]. All doctors should be concerned if making evidence-based claims about our credential based on data published in peer-reviewed journals gives rise to litigation alleging fraud.”
The lawsuit against ABIM, filed Dec. 6, 2018, in Pennsylvania district court, claims that ABIM is charging inflated monopoly prices for maintaining certification, that the organization is forcing physicians to purchase MOC, and that ABIM is inducing employers and others to require ABIM certification. The four plaintiff-physicians are asking a judge to find ABIM in violation of federal antitrust law and to bar the board from continuing its MOC process. The suit is filed as a class action on behalf of all internists and subspecialists required by ABIM to purchase MOC to maintain their ABIM certifications.
On Jan. 23 of this year the legal challenge was amended to include racketeering and unjust enrichment claims. The suit alleges that in violation of the Racketeer Influenced and Corrupt Organization Act, ABIM has deceived the public, including hospitals and insurance companies, into believing that its MOC credential benefits physicians, patients, and the public and that it constitutes self-regulation by internists and subspecialists. The challenge also asserts that ABIM has charged inappropriate, unreasonable, and unlawful MOC-related fees that result in the board becoming unjustly enriched at the expense of plaintiffs and other class members. The plaintiffs seek damages and injunctive relief, plus lawsuit and attorney costs.
ABIM has not yet responded to the lawsuit. In an interview, Dr. Baron said that the board will “have an opportunity to respond fully and completely in court in March and to [share] our side of the story.”
The lawsuit’s GoFundMe campaign has garnered more than 750 donations with sums ranging from $15 to $7,400. The average contribution is $210, according to an update on the funding website by Dr. Fisher, who serves as treasurer for Practicing Physicians of America.
PPA, the group behind the lawsuit – although not a named plaintiff – started in 2017 and focuses on strengthening physician autonomy, improving patient safety, and decreasing physician burnout, according to its website.
“Our current focus is beating burnout and empowering physicians to reclaim the leadership mantle in medicine and health care,” Dr. Dixon said. “By sharing the PPA ‘Seal of Approval’, we are inspiring physicians of all backgrounds to speak up and be heard. Ultimately, PPA wants to be a stable ‘stage’ for every physician’s voice that supports patient safety and physician autonomy.”
The organization, which is free to join, does not yet have concrete membership numbers, according to PPA’s secretary, Niran Al-Agba, MD, a Silverdale, Wash.–based pediatrician. Dr. Al-Agba referred to PPA as a resistance movement that is still building its infrastructure and recruiting members.
“We’re a work in progress,” she said in an interview. “The more people that know about us, the more people will join us.”
A central focus of the organization is ending MOC, according to the PPA website. Dr. Al-Agba said the current MOC process for physicians is burdensome and does not better medical practice. Dr. Al-Agba said her own personal experience with MOC has been negative, particularly a test she took in 2012 as part of the American Board of Pediatrics’ Maintenance of Certification program.
At the time, Dr. Al-Agba was nursing her young baby and was denied a request to take the 6-hour test at a later date. She had to bring her pumping equipment with her to take the test and faced inconsideration and humiliation when she needed a private place to pump at the test facility, said Dr. Al-Agba, who ultimately passed the test.
Dr. Al-Agba who blogs about being a mother and a doctor, wrote an open letter to the American Board of Pediatrics about her experience in 2016. She called the experience “demoralizing.” In general, she believes MOC is more about memorization and regurgitation, rather than education for physicians.
“What I want to see is a system that makes sense,” she said. “I want to see my learning tied to benefiting patients, as opposed to [MOC] which is showing you can still pass tests in medicine about esoteric facts.”
As a direct care physician, Dr. Dixon does not contract with insurance companies so MOC has little impact on his practice, he said. However, within a few years, he stands to lose an assistant professorship because the university requires board certification to stay in the position.
“As a business award winner, I bring a unique perspective to mental health care, and it would be a shame to be blacklisted from teaching the next generation of physician entrepreneurs because of the MOC process,” he said. “MOC is redundant and unnecessary so my hope is that it completely disappears. In the event ABIM and [the American Board of Medical Specialties] aren’t interested in making the right choice and making MOC optional, I’d like for medical schools, hospitals, and insurance companies to voluntarily disregard this useless designation to evaluate physicians. Great physicians are automatically lifelong learners and we’re committed to our patients.”
ABIM has made a number of modifications to its MOC process in recent years in response to physician concerns. This includes an overhaul of the organization’s governance structure to include more than 200 practicing physicians and opening new avenues for physicians to engage in the creation of assessment content that more closely reflects what they see in practice, Dr. Baron said. In addition, ABIM now surveys all specialists to contribute to the exam blueprint review and the creation of the new Item Writing Task Force.
In a December 2018 blog post, ABIM leaders said the organization would vigorously defend itself against the legal challenge, and that the board’s focus will “remain on maintaining a standard of professional achievement that the public values, signaling that ABIM diplomates are well-trained and staying current in their fields to better serve their patients.”
More than $200,000 has been raised by doctors and their supporters nationwide through a GoFundMe campaign launched to pay for costs associated with the class-action lawsuit against the American Board of Internal Medicine over its maintenance of certification (MOC) program.
Chicago-based cardiologist Wes Fisher, MD, and fellow physicians with the Practicing Physicians of America (PPA), started the fundraising campaign in May 2018 with an initial $150,000 goal to pay for attorney and prelitigation costs, according to posts on Dr. Fisher’s blog. After reaching that goal in September 2018, four internists filed suit against ABIM over its MOC process in December 2018, alleging antitrust claims.
PPA has since raised the GoFundMe goal to $400,000 to help support the next phase of the litigation, according to the campaign page.
In an email to supporters, Dr. Fisher said donations will help “take down MOC and end the unproven and burdensome continuous certification requirements for all subspecialties nationwide.” Dr. Fisher declined to comment for this article.
Brian Dixon, MD, a pediatric psychiatrist and PPA board member based in Fort Worth, Tex., said the campaign page and its success speaks for itself.
“Physicians are hurting and want to restore physician autonomy,” Dr. Dixon said in an interview. “Most physicians are pretty fiscally thoughtful so their donations are a powerful statement that they want change to the MOC process.”
Richard J. Baron, MD, ABIM president declined to specifically address the GoFundMe campaign, but said in an interview that the board is proud of its credential and grateful to the many physicians that have helped inform changes ABIM has made to its programs.
“Valuable credentials with standards behind them gain market share because they are meaningful and say something important about the doctors who hold them,” Dr. Baron said in an interview. “There is evidence in peer-reviewed journals that doctors holding our credential are more likely to meet quality metrics throughout their careers [Ann Intern Med. 2018 Jul 17. doi: 10.7326/M16-2643], that they are more likely to order mammograms for women who need them [Womens Health Issues. 2018 Jan-Feb. doi: 10.1016/j.whi.2017.10.003], that they provide care of equivalent quality at lower total cost[JAMA. 2014 Dec 10. doi: 10.1001/jama.2014.12716], and that they actually earn higher salaries [Health Serv Res. 2013 Jun. doi: 10.1111/1475-6773.12011]. All doctors should be concerned if making evidence-based claims about our credential based on data published in peer-reviewed journals gives rise to litigation alleging fraud.”
The lawsuit against ABIM, filed Dec. 6, 2018, in Pennsylvania district court, claims that ABIM is charging inflated monopoly prices for maintaining certification, that the organization is forcing physicians to purchase MOC, and that ABIM is inducing employers and others to require ABIM certification. The four plaintiff-physicians are asking a judge to find ABIM in violation of federal antitrust law and to bar the board from continuing its MOC process. The suit is filed as a class action on behalf of all internists and subspecialists required by ABIM to purchase MOC to maintain their ABIM certifications.
On Jan. 23 of this year the legal challenge was amended to include racketeering and unjust enrichment claims. The suit alleges that in violation of the Racketeer Influenced and Corrupt Organization Act, ABIM has deceived the public, including hospitals and insurance companies, into believing that its MOC credential benefits physicians, patients, and the public and that it constitutes self-regulation by internists and subspecialists. The challenge also asserts that ABIM has charged inappropriate, unreasonable, and unlawful MOC-related fees that result in the board becoming unjustly enriched at the expense of plaintiffs and other class members. The plaintiffs seek damages and injunctive relief, plus lawsuit and attorney costs.
ABIM has not yet responded to the lawsuit. In an interview, Dr. Baron said that the board will “have an opportunity to respond fully and completely in court in March and to [share] our side of the story.”
The lawsuit’s GoFundMe campaign has garnered more than 750 donations with sums ranging from $15 to $7,400. The average contribution is $210, according to an update on the funding website by Dr. Fisher, who serves as treasurer for Practicing Physicians of America.
PPA, the group behind the lawsuit – although not a named plaintiff – started in 2017 and focuses on strengthening physician autonomy, improving patient safety, and decreasing physician burnout, according to its website.
“Our current focus is beating burnout and empowering physicians to reclaim the leadership mantle in medicine and health care,” Dr. Dixon said. “By sharing the PPA ‘Seal of Approval’, we are inspiring physicians of all backgrounds to speak up and be heard. Ultimately, PPA wants to be a stable ‘stage’ for every physician’s voice that supports patient safety and physician autonomy.”
The organization, which is free to join, does not yet have concrete membership numbers, according to PPA’s secretary, Niran Al-Agba, MD, a Silverdale, Wash.–based pediatrician. Dr. Al-Agba referred to PPA as a resistance movement that is still building its infrastructure and recruiting members.
“We’re a work in progress,” she said in an interview. “The more people that know about us, the more people will join us.”
A central focus of the organization is ending MOC, according to the PPA website. Dr. Al-Agba said the current MOC process for physicians is burdensome and does not better medical practice. Dr. Al-Agba said her own personal experience with MOC has been negative, particularly a test she took in 2012 as part of the American Board of Pediatrics’ Maintenance of Certification program.
At the time, Dr. Al-Agba was nursing her young baby and was denied a request to take the 6-hour test at a later date. She had to bring her pumping equipment with her to take the test and faced inconsideration and humiliation when she needed a private place to pump at the test facility, said Dr. Al-Agba, who ultimately passed the test.
Dr. Al-Agba who blogs about being a mother and a doctor, wrote an open letter to the American Board of Pediatrics about her experience in 2016. She called the experience “demoralizing.” In general, she believes MOC is more about memorization and regurgitation, rather than education for physicians.
“What I want to see is a system that makes sense,” she said. “I want to see my learning tied to benefiting patients, as opposed to [MOC] which is showing you can still pass tests in medicine about esoteric facts.”
As a direct care physician, Dr. Dixon does not contract with insurance companies so MOC has little impact on his practice, he said. However, within a few years, he stands to lose an assistant professorship because the university requires board certification to stay in the position.
“As a business award winner, I bring a unique perspective to mental health care, and it would be a shame to be blacklisted from teaching the next generation of physician entrepreneurs because of the MOC process,” he said. “MOC is redundant and unnecessary so my hope is that it completely disappears. In the event ABIM and [the American Board of Medical Specialties] aren’t interested in making the right choice and making MOC optional, I’d like for medical schools, hospitals, and insurance companies to voluntarily disregard this useless designation to evaluate physicians. Great physicians are automatically lifelong learners and we’re committed to our patients.”
ABIM has made a number of modifications to its MOC process in recent years in response to physician concerns. This includes an overhaul of the organization’s governance structure to include more than 200 practicing physicians and opening new avenues for physicians to engage in the creation of assessment content that more closely reflects what they see in practice, Dr. Baron said. In addition, ABIM now surveys all specialists to contribute to the exam blueprint review and the creation of the new Item Writing Task Force.
In a December 2018 blog post, ABIM leaders said the organization would vigorously defend itself against the legal challenge, and that the board’s focus will “remain on maintaining a standard of professional achievement that the public values, signaling that ABIM diplomates are well-trained and staying current in their fields to better serve their patients.”
More than $200,000 has been raised by doctors and their supporters nationwide through a GoFundMe campaign launched to pay for costs associated with the class-action lawsuit against the American Board of Internal Medicine over its maintenance of certification (MOC) program.
Chicago-based cardiologist Wes Fisher, MD, and fellow physicians with the Practicing Physicians of America (PPA), started the fundraising campaign in May 2018 with an initial $150,000 goal to pay for attorney and prelitigation costs, according to posts on Dr. Fisher’s blog. After reaching that goal in September 2018, four internists filed suit against ABIM over its MOC process in December 2018, alleging antitrust claims.
PPA has since raised the GoFundMe goal to $400,000 to help support the next phase of the litigation, according to the campaign page.
In an email to supporters, Dr. Fisher said donations will help “take down MOC and end the unproven and burdensome continuous certification requirements for all subspecialties nationwide.” Dr. Fisher declined to comment for this article.
Brian Dixon, MD, a pediatric psychiatrist and PPA board member based in Fort Worth, Tex., said the campaign page and its success speaks for itself.
“Physicians are hurting and want to restore physician autonomy,” Dr. Dixon said in an interview. “Most physicians are pretty fiscally thoughtful so their donations are a powerful statement that they want change to the MOC process.”
Richard J. Baron, MD, ABIM president declined to specifically address the GoFundMe campaign, but said in an interview that the board is proud of its credential and grateful to the many physicians that have helped inform changes ABIM has made to its programs.
“Valuable credentials with standards behind them gain market share because they are meaningful and say something important about the doctors who hold them,” Dr. Baron said in an interview. “There is evidence in peer-reviewed journals that doctors holding our credential are more likely to meet quality metrics throughout their careers [Ann Intern Med. 2018 Jul 17. doi: 10.7326/M16-2643], that they are more likely to order mammograms for women who need them [Womens Health Issues. 2018 Jan-Feb. doi: 10.1016/j.whi.2017.10.003], that they provide care of equivalent quality at lower total cost[JAMA. 2014 Dec 10. doi: 10.1001/jama.2014.12716], and that they actually earn higher salaries [Health Serv Res. 2013 Jun. doi: 10.1111/1475-6773.12011]. All doctors should be concerned if making evidence-based claims about our credential based on data published in peer-reviewed journals gives rise to litigation alleging fraud.”
The lawsuit against ABIM, filed Dec. 6, 2018, in Pennsylvania district court, claims that ABIM is charging inflated monopoly prices for maintaining certification, that the organization is forcing physicians to purchase MOC, and that ABIM is inducing employers and others to require ABIM certification. The four plaintiff-physicians are asking a judge to find ABIM in violation of federal antitrust law and to bar the board from continuing its MOC process. The suit is filed as a class action on behalf of all internists and subspecialists required by ABIM to purchase MOC to maintain their ABIM certifications.
On Jan. 23 of this year the legal challenge was amended to include racketeering and unjust enrichment claims. The suit alleges that in violation of the Racketeer Influenced and Corrupt Organization Act, ABIM has deceived the public, including hospitals and insurance companies, into believing that its MOC credential benefits physicians, patients, and the public and that it constitutes self-regulation by internists and subspecialists. The challenge also asserts that ABIM has charged inappropriate, unreasonable, and unlawful MOC-related fees that result in the board becoming unjustly enriched at the expense of plaintiffs and other class members. The plaintiffs seek damages and injunctive relief, plus lawsuit and attorney costs.
ABIM has not yet responded to the lawsuit. In an interview, Dr. Baron said that the board will “have an opportunity to respond fully and completely in court in March and to [share] our side of the story.”
The lawsuit’s GoFundMe campaign has garnered more than 750 donations with sums ranging from $15 to $7,400. The average contribution is $210, according to an update on the funding website by Dr. Fisher, who serves as treasurer for Practicing Physicians of America.
PPA, the group behind the lawsuit – although not a named plaintiff – started in 2017 and focuses on strengthening physician autonomy, improving patient safety, and decreasing physician burnout, according to its website.
“Our current focus is beating burnout and empowering physicians to reclaim the leadership mantle in medicine and health care,” Dr. Dixon said. “By sharing the PPA ‘Seal of Approval’, we are inspiring physicians of all backgrounds to speak up and be heard. Ultimately, PPA wants to be a stable ‘stage’ for every physician’s voice that supports patient safety and physician autonomy.”
The organization, which is free to join, does not yet have concrete membership numbers, according to PPA’s secretary, Niran Al-Agba, MD, a Silverdale, Wash.–based pediatrician. Dr. Al-Agba referred to PPA as a resistance movement that is still building its infrastructure and recruiting members.
“We’re a work in progress,” she said in an interview. “The more people that know about us, the more people will join us.”
A central focus of the organization is ending MOC, according to the PPA website. Dr. Al-Agba said the current MOC process for physicians is burdensome and does not better medical practice. Dr. Al-Agba said her own personal experience with MOC has been negative, particularly a test she took in 2012 as part of the American Board of Pediatrics’ Maintenance of Certification program.
At the time, Dr. Al-Agba was nursing her young baby and was denied a request to take the 6-hour test at a later date. She had to bring her pumping equipment with her to take the test and faced inconsideration and humiliation when she needed a private place to pump at the test facility, said Dr. Al-Agba, who ultimately passed the test.
Dr. Al-Agba who blogs about being a mother and a doctor, wrote an open letter to the American Board of Pediatrics about her experience in 2016. She called the experience “demoralizing.” In general, she believes MOC is more about memorization and regurgitation, rather than education for physicians.
“What I want to see is a system that makes sense,” she said. “I want to see my learning tied to benefiting patients, as opposed to [MOC] which is showing you can still pass tests in medicine about esoteric facts.”
As a direct care physician, Dr. Dixon does not contract with insurance companies so MOC has little impact on his practice, he said. However, within a few years, he stands to lose an assistant professorship because the university requires board certification to stay in the position.
“As a business award winner, I bring a unique perspective to mental health care, and it would be a shame to be blacklisted from teaching the next generation of physician entrepreneurs because of the MOC process,” he said. “MOC is redundant and unnecessary so my hope is that it completely disappears. In the event ABIM and [the American Board of Medical Specialties] aren’t interested in making the right choice and making MOC optional, I’d like for medical schools, hospitals, and insurance companies to voluntarily disregard this useless designation to evaluate physicians. Great physicians are automatically lifelong learners and we’re committed to our patients.”
ABIM has made a number of modifications to its MOC process in recent years in response to physician concerns. This includes an overhaul of the organization’s governance structure to include more than 200 practicing physicians and opening new avenues for physicians to engage in the creation of assessment content that more closely reflects what they see in practice, Dr. Baron said. In addition, ABIM now surveys all specialists to contribute to the exam blueprint review and the creation of the new Item Writing Task Force.
In a December 2018 blog post, ABIM leaders said the organization would vigorously defend itself against the legal challenge, and that the board’s focus will “remain on maintaining a standard of professional achievement that the public values, signaling that ABIM diplomates are well-trained and staying current in their fields to better serve their patients.”
Dupilumab conjunctivitis does not always require an ophthalmologist referral
WAIKOLOA, HAWAII – Since its approval in 2017, dupilumab (Dupixent) has proven to be a solid addition to the atopic dermatitis (AD) armamentarium.

About 80% to 85% of patients treated with the biologic will achieve a 50% reduction in their Eczema Area and Severity Index score, and some will go on to a 90% reduction, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.
But Dr. Silverberg has seen it in his own practice and said it can be hard to know whether or not to refer to ophthalmology. “We’re often left with this conundrum of ... ‘Is it a side effect of the medication, or is it just because they happen to have hay fever or keratoconjunctivitis or other ophthalmic comorbidities?’ And it’s not always easy to sort out.”
In an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation, he offered his advice on managing a patient who develops conjunctivitis during dupilumab treatment, including his treatment tips for when it is safe to handle in the dermatology clinic.
Dr. Silverberg, who was an investigator in the dupilumab phase 3 trials, said that, while dupilumab is the only systemic agent approved by the Food and Drug Administration for treating AD, and more are on the way for AD, there will always still be a role for traditional immunosuppressives. He explained why in the interview and why he favors methotrexate when old school options are in order.
This news organization and SDEF/Global Academy for Medical Education are owned by the same parent company.
WAIKOLOA, HAWAII – Since its approval in 2017, dupilumab (Dupixent) has proven to be a solid addition to the atopic dermatitis (AD) armamentarium.

About 80% to 85% of patients treated with the biologic will achieve a 50% reduction in their Eczema Area and Severity Index score, and some will go on to a 90% reduction, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.
But Dr. Silverberg has seen it in his own practice and said it can be hard to know whether or not to refer to ophthalmology. “We’re often left with this conundrum of ... ‘Is it a side effect of the medication, or is it just because they happen to have hay fever or keratoconjunctivitis or other ophthalmic comorbidities?’ And it’s not always easy to sort out.”
In an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation, he offered his advice on managing a patient who develops conjunctivitis during dupilumab treatment, including his treatment tips for when it is safe to handle in the dermatology clinic.
Dr. Silverberg, who was an investigator in the dupilumab phase 3 trials, said that, while dupilumab is the only systemic agent approved by the Food and Drug Administration for treating AD, and more are on the way for AD, there will always still be a role for traditional immunosuppressives. He explained why in the interview and why he favors methotrexate when old school options are in order.
This news organization and SDEF/Global Academy for Medical Education are owned by the same parent company.
WAIKOLOA, HAWAII – Since its approval in 2017, dupilumab (Dupixent) has proven to be a solid addition to the atopic dermatitis (AD) armamentarium.

About 80% to 85% of patients treated with the biologic will achieve a 50% reduction in their Eczema Area and Severity Index score, and some will go on to a 90% reduction, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.
But Dr. Silverberg has seen it in his own practice and said it can be hard to know whether or not to refer to ophthalmology. “We’re often left with this conundrum of ... ‘Is it a side effect of the medication, or is it just because they happen to have hay fever or keratoconjunctivitis or other ophthalmic comorbidities?’ And it’s not always easy to sort out.”
In an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation, he offered his advice on managing a patient who develops conjunctivitis during dupilumab treatment, including his treatment tips for when it is safe to handle in the dermatology clinic.
Dr. Silverberg, who was an investigator in the dupilumab phase 3 trials, said that, while dupilumab is the only systemic agent approved by the Food and Drug Administration for treating AD, and more are on the way for AD, there will always still be a role for traditional immunosuppressives. He explained why in the interview and why he favors methotrexate when old school options are in order.
This news organization and SDEF/Global Academy for Medical Education are owned by the same parent company.
EXPERT ANALYSIS FROM THE SDEF HAWAII DERMATOLOGY SEMINAR
FDA clears first-of-its-kind phone app for insulin management
The Food and Drug Administration has granted 501(k) clearance to a phone app for managing insulin in patients with type 2 diabetes.
The app will enhance Hygieia’s d-Nav Insulin Guidance Service, which uses Cloud-based technology and a small group of health care professionals to support physicians and help patients with diabetes achieve better glycemic control by providing personalized insulin adjustments. The system has been shown, in a 90-day clinical study, to reduce both costs and levels of glycosylated hemoglobin. Patients can use the app to enter glucose-event data and receive a recommended insulin dose.
“Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires a continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive, and less costly for everyone involved,” Eran Bashan, CEO of Hygieia, said in a press release.
This is the first insulin-mangement app that can titrate individualized doses for all insulin regimens and the first that can connect to any glucose meter that shares information with the cloud. It is available for both Android and iOS.
Find the full press release on the Hygieia website.
The Food and Drug Administration has granted 501(k) clearance to a phone app for managing insulin in patients with type 2 diabetes.
The app will enhance Hygieia’s d-Nav Insulin Guidance Service, which uses Cloud-based technology and a small group of health care professionals to support physicians and help patients with diabetes achieve better glycemic control by providing personalized insulin adjustments. The system has been shown, in a 90-day clinical study, to reduce both costs and levels of glycosylated hemoglobin. Patients can use the app to enter glucose-event data and receive a recommended insulin dose.
“Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires a continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive, and less costly for everyone involved,” Eran Bashan, CEO of Hygieia, said in a press release.
This is the first insulin-mangement app that can titrate individualized doses for all insulin regimens and the first that can connect to any glucose meter that shares information with the cloud. It is available for both Android and iOS.
Find the full press release on the Hygieia website.
The Food and Drug Administration has granted 501(k) clearance to a phone app for managing insulin in patients with type 2 diabetes.
The app will enhance Hygieia’s d-Nav Insulin Guidance Service, which uses Cloud-based technology and a small group of health care professionals to support physicians and help patients with diabetes achieve better glycemic control by providing personalized insulin adjustments. The system has been shown, in a 90-day clinical study, to reduce both costs and levels of glycosylated hemoglobin. Patients can use the app to enter glucose-event data and receive a recommended insulin dose.
“Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires a continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive, and less costly for everyone involved,” Eran Bashan, CEO of Hygieia, said in a press release.
This is the first insulin-mangement app that can titrate individualized doses for all insulin regimens and the first that can connect to any glucose meter that shares information with the cloud. It is available for both Android and iOS.
Find the full press release on the Hygieia website.
Haplo-HCT shows viability in DLBCL
For patients with diffuse large B-cell lymphoma (DLBCL) who need allogeneic hematopoietic cell transplantation (allo-HCT), a haploidentical family member could be a viable donor, according to a retrospective study of 1,438 patients.
When combined with nonmyeloablative/reduced intensity conditioning (NMC/RIC) and posttransplant cyclophosphamide (PTCy), patients treated with haploidentical HCT (haplo-HCT) had outcomes similar to those seen in patients with matched donors, reported Peter Dreger, MD, of the University of Heidelberg (Germany) and his colleagues.
“Using well-matched sibling donors (MSDs) or unrelated donors (MUDs), allo-HCT can result in sustained disease control in 30% to 45% of patients with DLBCL who have early disease recurrence after standard chemoimmunotherapy or have failed auto-HCT [autologous HCT],” the investigators wrote in Blood Advances. “However, the search for a well-matched unrelated donor could be time-consuming and unsuccessful in up to 50% of the patients in need.”
But the present findings suggest that haplo-HCT may one day improve these odds by providing a larger pool of potential donors.
The patients in the study were divided into four treatment groups: haplo-HCT (n = 132), MSD (n = 525), MUD with T-cell depletion (n = 403), and MUD without T-cell depletion (n = 378). For graft-versus-host disease (GVHD) prophylaxis, patients in the haplo-HCT group received PTCy, with or without a calcineurin inhibitor and mycophenolate mofetil, whereas all patients with matched donors received a calcineurin inhibitor. T-cell depletion was accomplished by in vivo antithymocyte globulin and alemtuzumab.
The primary end point was overall survival (OS). Secondary end points were progression-free survival (PFS), progression/relapse, and nonrelapse mortality (NRM).
After a median follow-up of 4.1 years, all groups had similar outcomes, without statistical differences in multivariable analysis.
In the haplo-HCT group, the 3-year OS rate was 46%, the NRM rate was 22%, the PFS rate was 38%, and the relapse/progression rate was 41%.
Of note, patients receiving haplo-HCT did have a lower cumulative incidence of chronic GVHD, at 15% after 1 year and 18% after 2 years. These rates were significantly lower than the other groups’ 1- and 2-year GVHD rates, which were as follows: MSD, 41% and 48%; MUD with T-cell depletion, 23% and 27%; and MUD without T-cell depletion, 48% and 57%.
The investigators noted that these disparities may actually be caused by the use of bone marrow grafts in the haplo-HCT group instead of peripheral blood grafts, which were used in most of the patients in the other groups.
Overall, the findings were encouraging, but the investigators cautioned that “additional studies are needed before haploidentical donors can be considered as equivalent to well-matched related or unrelated donors in patients with DLBCL.”
The study was funded by the Center for International Blood & Marrow Transplant Research (CIBMTR) and the European Society for Blood and Marrow Transplantation. CIBMTR is supported by grants from the U.S. government and the pharmaceutical industry. The authors reported having no competing financial interests.
SOURCE: Dreger P et al. Blood Adv. 2019 Feb 12;3(3):360-9.
For patients with diffuse large B-cell lymphoma (DLBCL) who need allogeneic hematopoietic cell transplantation (allo-HCT), a haploidentical family member could be a viable donor, according to a retrospective study of 1,438 patients.
When combined with nonmyeloablative/reduced intensity conditioning (NMC/RIC) and posttransplant cyclophosphamide (PTCy), patients treated with haploidentical HCT (haplo-HCT) had outcomes similar to those seen in patients with matched donors, reported Peter Dreger, MD, of the University of Heidelberg (Germany) and his colleagues.
“Using well-matched sibling donors (MSDs) or unrelated donors (MUDs), allo-HCT can result in sustained disease control in 30% to 45% of patients with DLBCL who have early disease recurrence after standard chemoimmunotherapy or have failed auto-HCT [autologous HCT],” the investigators wrote in Blood Advances. “However, the search for a well-matched unrelated donor could be time-consuming and unsuccessful in up to 50% of the patients in need.”
But the present findings suggest that haplo-HCT may one day improve these odds by providing a larger pool of potential donors.
The patients in the study were divided into four treatment groups: haplo-HCT (n = 132), MSD (n = 525), MUD with T-cell depletion (n = 403), and MUD without T-cell depletion (n = 378). For graft-versus-host disease (GVHD) prophylaxis, patients in the haplo-HCT group received PTCy, with or without a calcineurin inhibitor and mycophenolate mofetil, whereas all patients with matched donors received a calcineurin inhibitor. T-cell depletion was accomplished by in vivo antithymocyte globulin and alemtuzumab.
The primary end point was overall survival (OS). Secondary end points were progression-free survival (PFS), progression/relapse, and nonrelapse mortality (NRM).
After a median follow-up of 4.1 years, all groups had similar outcomes, without statistical differences in multivariable analysis.
In the haplo-HCT group, the 3-year OS rate was 46%, the NRM rate was 22%, the PFS rate was 38%, and the relapse/progression rate was 41%.
Of note, patients receiving haplo-HCT did have a lower cumulative incidence of chronic GVHD, at 15% after 1 year and 18% after 2 years. These rates were significantly lower than the other groups’ 1- and 2-year GVHD rates, which were as follows: MSD, 41% and 48%; MUD with T-cell depletion, 23% and 27%; and MUD without T-cell depletion, 48% and 57%.
The investigators noted that these disparities may actually be caused by the use of bone marrow grafts in the haplo-HCT group instead of peripheral blood grafts, which were used in most of the patients in the other groups.
Overall, the findings were encouraging, but the investigators cautioned that “additional studies are needed before haploidentical donors can be considered as equivalent to well-matched related or unrelated donors in patients with DLBCL.”
The study was funded by the Center for International Blood & Marrow Transplant Research (CIBMTR) and the European Society for Blood and Marrow Transplantation. CIBMTR is supported by grants from the U.S. government and the pharmaceutical industry. The authors reported having no competing financial interests.
SOURCE: Dreger P et al. Blood Adv. 2019 Feb 12;3(3):360-9.
For patients with diffuse large B-cell lymphoma (DLBCL) who need allogeneic hematopoietic cell transplantation (allo-HCT), a haploidentical family member could be a viable donor, according to a retrospective study of 1,438 patients.
When combined with nonmyeloablative/reduced intensity conditioning (NMC/RIC) and posttransplant cyclophosphamide (PTCy), patients treated with haploidentical HCT (haplo-HCT) had outcomes similar to those seen in patients with matched donors, reported Peter Dreger, MD, of the University of Heidelberg (Germany) and his colleagues.
“Using well-matched sibling donors (MSDs) or unrelated donors (MUDs), allo-HCT can result in sustained disease control in 30% to 45% of patients with DLBCL who have early disease recurrence after standard chemoimmunotherapy or have failed auto-HCT [autologous HCT],” the investigators wrote in Blood Advances. “However, the search for a well-matched unrelated donor could be time-consuming and unsuccessful in up to 50% of the patients in need.”
But the present findings suggest that haplo-HCT may one day improve these odds by providing a larger pool of potential donors.
The patients in the study were divided into four treatment groups: haplo-HCT (n = 132), MSD (n = 525), MUD with T-cell depletion (n = 403), and MUD without T-cell depletion (n = 378). For graft-versus-host disease (GVHD) prophylaxis, patients in the haplo-HCT group received PTCy, with or without a calcineurin inhibitor and mycophenolate mofetil, whereas all patients with matched donors received a calcineurin inhibitor. T-cell depletion was accomplished by in vivo antithymocyte globulin and alemtuzumab.
The primary end point was overall survival (OS). Secondary end points were progression-free survival (PFS), progression/relapse, and nonrelapse mortality (NRM).
After a median follow-up of 4.1 years, all groups had similar outcomes, without statistical differences in multivariable analysis.
In the haplo-HCT group, the 3-year OS rate was 46%, the NRM rate was 22%, the PFS rate was 38%, and the relapse/progression rate was 41%.
Of note, patients receiving haplo-HCT did have a lower cumulative incidence of chronic GVHD, at 15% after 1 year and 18% after 2 years. These rates were significantly lower than the other groups’ 1- and 2-year GVHD rates, which were as follows: MSD, 41% and 48%; MUD with T-cell depletion, 23% and 27%; and MUD without T-cell depletion, 48% and 57%.
The investigators noted that these disparities may actually be caused by the use of bone marrow grafts in the haplo-HCT group instead of peripheral blood grafts, which were used in most of the patients in the other groups.
Overall, the findings were encouraging, but the investigators cautioned that “additional studies are needed before haploidentical donors can be considered as equivalent to well-matched related or unrelated donors in patients with DLBCL.”
The study was funded by the Center for International Blood & Marrow Transplant Research (CIBMTR) and the European Society for Blood and Marrow Transplantation. CIBMTR is supported by grants from the U.S. government and the pharmaceutical industry. The authors reported having no competing financial interests.
SOURCE: Dreger P et al. Blood Adv. 2019 Feb 12;3(3):360-9.
FROM BLOOD ADVANCES
Stroke endovascular therapy: The more you do, the better you do
HONOLULU – The well-documented link between higher procedure volumes and better procedure efficacy also applies to endovascular thrombectomy for acute ischemic stroke.
Sunil A. Sheth, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The finding raises questions about how to best triage patients with an acute ischemic stroke, suggesting that, in at least some situations, patients might be better served being taken to a higher-volume center even if it’s not the closest, noted Dr. Sheth, The results also suggest that the findings in the trials proving the value of EST run primarily at large, tertiary care, referral centers might not be generalizable to all centers that start an endovascular program.
The study looked at data collected during 2006-2016 in Florida and during 2012-2016 in the NIS, and found that in both databases the rate of EST procedures performed showed steadily increasing use over time, with a sharp increase in the number of centers performing EST in 2015. Each of the two data sets also showed that better discharge outcomes occurred in patients treated at centers with the highest procedural volumes.
In the nationwide NIS data, for every 10 additional patients a center treated with EST annually, the incidence of a “good” hospital-discharge outcome (defined as either discharge home or to an acute rehabilitation hospital) rose by 30%, compared with lower-volume centers in a multivariate regression analysis, a statistically significant relationship, said Dr. Sheth, a neurologist at the University of Texas, Houston. This volume-outcome relationship held fairly constant through volumes up to about 50 EST cases annually. “The more the better,” he observed.
“The data suggest that EST outcomes are not always the same,” but right now most emergency medical service systems do not take EST case volume into account when deciding where to take an acute stroke patient, Dr. Sheth said in an interview. But he cautioned against an oversimplified focus on just EST case volume.
A link between volume and better outcomes “is easy to understand and not surprising. We see this relationship for a variety of procedures. The data suggest we need to consider procedure volumes. But volume is only part of makes for good outcomes; it’s not the only factor,” he stressed.
Dr. Sheth and his associates used data collected by the Florida Agency for Health Care Administration on 3,890 acute ischemic stroke patients treated with EST at 56 Florida hospitals and on 42,505 such patients in the NIS database treated at 2,260 U.S. hospitals. During the 11-year period for Florida data collection, the number of centers performing EST in the state rose steadily at an average rate of about four new centers per year. Although the number of EST procedures done also rose sharply, in general over time a higher percentage of patients underwent treatment at lower-volume centers. Similar patterns existed in the national data. The Florida data showed a statistically significant 10% improvement in good discharge outcomes for every 10 additional EST patients a center treated a year, consistent with the NIS data.
Concurrently with Dr. Sheth’s report, the results also appeared in an article published online (Stroke. 2019 Feb 6. doi: 10.1161/STROKEAHA.118.023967).
Dr. Sheth reported no disclosures.
SOURCE: Sheth SA et al. ISC 2019, Abstract 002.
The idea that when centers perform more of a procedure, such as endovascular thrombectomy for acute ischemic stroke, they more often do it better is intuitively plausible, which helps makes these findings believable. It’s also a relationship we’ve already seen for other types of endovascular therapies. What this study did not address were other factors beyond case volume also might also make important contributions to outcome, such as the speed of treatment delivery.
Volume thresholds for endovascular stroke programs will come eventually, but for the time being our focus should be on insuring wide access to endovascular treatment.
Bruce Ovbiagele, MD, a neurologist and chief of staff for the San Francisco Veteran Affairs Health Care System, made these comments in an interview. He reported no disclosures.
The idea that when centers perform more of a procedure, such as endovascular thrombectomy for acute ischemic stroke, they more often do it better is intuitively plausible, which helps makes these findings believable. It’s also a relationship we’ve already seen for other types of endovascular therapies. What this study did not address were other factors beyond case volume also might also make important contributions to outcome, such as the speed of treatment delivery.
Volume thresholds for endovascular stroke programs will come eventually, but for the time being our focus should be on insuring wide access to endovascular treatment.
Bruce Ovbiagele, MD, a neurologist and chief of staff for the San Francisco Veteran Affairs Health Care System, made these comments in an interview. He reported no disclosures.
The idea that when centers perform more of a procedure, such as endovascular thrombectomy for acute ischemic stroke, they more often do it better is intuitively plausible, which helps makes these findings believable. It’s also a relationship we’ve already seen for other types of endovascular therapies. What this study did not address were other factors beyond case volume also might also make important contributions to outcome, such as the speed of treatment delivery.
Volume thresholds for endovascular stroke programs will come eventually, but for the time being our focus should be on insuring wide access to endovascular treatment.
Bruce Ovbiagele, MD, a neurologist and chief of staff for the San Francisco Veteran Affairs Health Care System, made these comments in an interview. He reported no disclosures.
HONOLULU – The well-documented link between higher procedure volumes and better procedure efficacy also applies to endovascular thrombectomy for acute ischemic stroke.
Sunil A. Sheth, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The finding raises questions about how to best triage patients with an acute ischemic stroke, suggesting that, in at least some situations, patients might be better served being taken to a higher-volume center even if it’s not the closest, noted Dr. Sheth, The results also suggest that the findings in the trials proving the value of EST run primarily at large, tertiary care, referral centers might not be generalizable to all centers that start an endovascular program.
The study looked at data collected during 2006-2016 in Florida and during 2012-2016 in the NIS, and found that in both databases the rate of EST procedures performed showed steadily increasing use over time, with a sharp increase in the number of centers performing EST in 2015. Each of the two data sets also showed that better discharge outcomes occurred in patients treated at centers with the highest procedural volumes.
In the nationwide NIS data, for every 10 additional patients a center treated with EST annually, the incidence of a “good” hospital-discharge outcome (defined as either discharge home or to an acute rehabilitation hospital) rose by 30%, compared with lower-volume centers in a multivariate regression analysis, a statistically significant relationship, said Dr. Sheth, a neurologist at the University of Texas, Houston. This volume-outcome relationship held fairly constant through volumes up to about 50 EST cases annually. “The more the better,” he observed.
“The data suggest that EST outcomes are not always the same,” but right now most emergency medical service systems do not take EST case volume into account when deciding where to take an acute stroke patient, Dr. Sheth said in an interview. But he cautioned against an oversimplified focus on just EST case volume.
A link between volume and better outcomes “is easy to understand and not surprising. We see this relationship for a variety of procedures. The data suggest we need to consider procedure volumes. But volume is only part of makes for good outcomes; it’s not the only factor,” he stressed.
Dr. Sheth and his associates used data collected by the Florida Agency for Health Care Administration on 3,890 acute ischemic stroke patients treated with EST at 56 Florida hospitals and on 42,505 such patients in the NIS database treated at 2,260 U.S. hospitals. During the 11-year period for Florida data collection, the number of centers performing EST in the state rose steadily at an average rate of about four new centers per year. Although the number of EST procedures done also rose sharply, in general over time a higher percentage of patients underwent treatment at lower-volume centers. Similar patterns existed in the national data. The Florida data showed a statistically significant 10% improvement in good discharge outcomes for every 10 additional EST patients a center treated a year, consistent with the NIS data.
Concurrently with Dr. Sheth’s report, the results also appeared in an article published online (Stroke. 2019 Feb 6. doi: 10.1161/STROKEAHA.118.023967).
Dr. Sheth reported no disclosures.
SOURCE: Sheth SA et al. ISC 2019, Abstract 002.
HONOLULU – The well-documented link between higher procedure volumes and better procedure efficacy also applies to endovascular thrombectomy for acute ischemic stroke.
Sunil A. Sheth, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The finding raises questions about how to best triage patients with an acute ischemic stroke, suggesting that, in at least some situations, patients might be better served being taken to a higher-volume center even if it’s not the closest, noted Dr. Sheth, The results also suggest that the findings in the trials proving the value of EST run primarily at large, tertiary care, referral centers might not be generalizable to all centers that start an endovascular program.
The study looked at data collected during 2006-2016 in Florida and during 2012-2016 in the NIS, and found that in both databases the rate of EST procedures performed showed steadily increasing use over time, with a sharp increase in the number of centers performing EST in 2015. Each of the two data sets also showed that better discharge outcomes occurred in patients treated at centers with the highest procedural volumes.
In the nationwide NIS data, for every 10 additional patients a center treated with EST annually, the incidence of a “good” hospital-discharge outcome (defined as either discharge home or to an acute rehabilitation hospital) rose by 30%, compared with lower-volume centers in a multivariate regression analysis, a statistically significant relationship, said Dr. Sheth, a neurologist at the University of Texas, Houston. This volume-outcome relationship held fairly constant through volumes up to about 50 EST cases annually. “The more the better,” he observed.
“The data suggest that EST outcomes are not always the same,” but right now most emergency medical service systems do not take EST case volume into account when deciding where to take an acute stroke patient, Dr. Sheth said in an interview. But he cautioned against an oversimplified focus on just EST case volume.
A link between volume and better outcomes “is easy to understand and not surprising. We see this relationship for a variety of procedures. The data suggest we need to consider procedure volumes. But volume is only part of makes for good outcomes; it’s not the only factor,” he stressed.
Dr. Sheth and his associates used data collected by the Florida Agency for Health Care Administration on 3,890 acute ischemic stroke patients treated with EST at 56 Florida hospitals and on 42,505 such patients in the NIS database treated at 2,260 U.S. hospitals. During the 11-year period for Florida data collection, the number of centers performing EST in the state rose steadily at an average rate of about four new centers per year. Although the number of EST procedures done also rose sharply, in general over time a higher percentage of patients underwent treatment at lower-volume centers. Similar patterns existed in the national data. The Florida data showed a statistically significant 10% improvement in good discharge outcomes for every 10 additional EST patients a center treated a year, consistent with the NIS data.
Concurrently with Dr. Sheth’s report, the results also appeared in an article published online (Stroke. 2019 Feb 6. doi: 10.1161/STROKEAHA.118.023967).
Dr. Sheth reported no disclosures.
SOURCE: Sheth SA et al. ISC 2019, Abstract 002.
REPORTING FROM ISC 2019
HHS to target step therapy, Stark Law in 2019
WASHINGTON –
Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.
“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.
“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”
The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.
“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”
He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.
He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.
“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”
He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”
However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.
AGA is pleased about Secretary Azar’s commitment to ensuring Medicare beneficiaries will continue to have access to and coverage of medications that work for them. Patients should not be forced to switch to a therapy that they have already failed if they change insurance plans. Read more about AGA’s advocacy for similar federal legislation at http://ow.ly/2t3030nLbcB.
AGA, in conjunction with other physician specialty organizations, continues to advocate for changes in the Stark Law to allow physician practices to participate in advanced payment models in the Medicare program that will improve care coordination and patient outcomes.
WASHINGTON –
Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.
“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.
“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”
The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.
“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”
He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.
He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.
“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”
He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”
However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.
AGA is pleased about Secretary Azar’s commitment to ensuring Medicare beneficiaries will continue to have access to and coverage of medications that work for them. Patients should not be forced to switch to a therapy that they have already failed if they change insurance plans. Read more about AGA’s advocacy for similar federal legislation at http://ow.ly/2t3030nLbcB.
AGA, in conjunction with other physician specialty organizations, continues to advocate for changes in the Stark Law to allow physician practices to participate in advanced payment models in the Medicare program that will improve care coordination and patient outcomes.
WASHINGTON –
Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.
“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.
“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”
The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.
“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”
He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.
He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.
“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”
He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”
However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.
AGA is pleased about Secretary Azar’s commitment to ensuring Medicare beneficiaries will continue to have access to and coverage of medications that work for them. Patients should not be forced to switch to a therapy that they have already failed if they change insurance plans. Read more about AGA’s advocacy for similar federal legislation at http://ow.ly/2t3030nLbcB.
AGA, in conjunction with other physician specialty organizations, continues to advocate for changes in the Stark Law to allow physician practices to participate in advanced payment models in the Medicare program that will improve care coordination and patient outcomes.