ORLANDO – What doctors think they know to be true in medicine has changed dramatically in the past several decades and will be different again in the decades to come, leaving them with a dilemma, according to Kevin T. Powell, MD, PhD, a pediatric hospitalist in St. Louis. If half of what doctors teach or know in medicine today will ultimately end up not being true, how do they know what to believe or accept?

While there is not a single satisfactory answer to that question, researchers can select research that gets doctors closer to reliable findings and steer them away from the barrage of poor-quality research that emerges from the current publish-or-perish system, Dr. Powell told his colleagues at the annual meeting of the American Academy of Pediatrics.

During his talk, Dr. Powell discussed the challenges and flaws with medical research as it is currently conducted, citing Doug Altman’s writings on these problems as early as 1994.

“The poor quality of much medical research is widely acknowledged, yet disturbingly the leaders of the medical profession seem only minimally concerned about the problem and make no apparent effort to find a solution,” wrote Mr. Altman, an English medical statistician (BMJ. 1994;308:283).

“We need less research, better research, and research done for the right reasons,” Mr. Altman concluded. “Abandoning using the number of publications as a measure of ability would be a start.”

In an interview, Dr. Powell described an unfortunate consequence of the publish-or-perish pressure in academic medicine: A glut of short-term, small studies with little clinical utility that researchers can complete in 1 or 2 years rather than the large, multicenter studies that take several years – and produce higher-quality findings – but cannot be turned into as many publications.

“We’re generating a lot of medical research findings that end up being false,” he said. “It’s a random walk in terms of getting to the truth rather than having an accurate process of getting to truth through evidence-based medicine.”

But he was hopeful, not cynical, about the way forward. By persuading people that medical research has changed for the worse over time and can change into something better, Dr. Powell saw potential for future research resulting in the same sort of public health achievements that research produced in the past, such as big reductions in smoking or sudden infant death syndrome.

Dr. Powell concluded his talk with a riff on Martin Luther’s 95 Theses, the 9.5 Theses, for a reformation of evidence-based medicine that together address the various shortcomings he discussed.

1. Recognize academic promotion as a bias, just like drug money.

2. Don’t confound statistically significant and clinically significant.

3. Use only significant figures.

4. Use the phrase “we did not DETECT a difference” and include power calculations.

5. Use confidence intervals instead of P values.

6. Use number needed to harm and number needed to treat instead of relative risk.

7. Absence of proof is not proof of absence. When there is insufficient randomized, controlled trial evidence, have an independent party estimate an effect based on non-RCT articles.

8. Any article implying clinical practice should change must include a counterpoint and a benefit cost analysis. Consider both effectiveness and safety.

9. Use postmarketing peer review.

9.5. Beware of research based on surveys.

Dr. Powell reported no relevant financial disclosures.
 

ORLANDO – What doctors think they know to be true in medicine has changed dramatically in the past several decades and will be different again in the decades to come, leaving them with a dilemma, according to Kevin T. Powell, MD, PhD, a pediatric hospitalist in St. Louis. If half of what doctors teach or know in medicine today will ultimately end up not being true, how do they know what to believe or accept?

While there is not a single satisfactory answer to that question, researchers can select research that gets doctors closer to reliable findings and steer them away from the barrage of poor-quality research that emerges from the current publish-or-perish system, Dr. Powell told his colleagues at the annual meeting of the American Academy of Pediatrics.

During his talk, Dr. Powell discussed the challenges and flaws with medical research as it is currently conducted, citing Doug Altman’s writings on these problems as early as 1994.

“The poor quality of much medical research is widely acknowledged, yet disturbingly the leaders of the medical profession seem only minimally concerned about the problem and make no apparent effort to find a solution,” wrote Mr. Altman, an English medical statistician (BMJ. 1994;308:283).

“We need less research, better research, and research done for the right reasons,” Mr. Altman concluded. “Abandoning using the number of publications as a measure of ability would be a start.”

In an interview, Dr. Powell described an unfortunate consequence of the publish-or-perish pressure in academic medicine: A glut of short-term, small studies with little clinical utility that researchers can complete in 1 or 2 years rather than the large, multicenter studies that take several years – and produce higher-quality findings – but cannot be turned into as many publications.

“We’re generating a lot of medical research findings that end up being false,” he said. “It’s a random walk in terms of getting to the truth rather than having an accurate process of getting to truth through evidence-based medicine.”

But he was hopeful, not cynical, about the way forward. By persuading people that medical research has changed for the worse over time and can change into something better, Dr. Powell saw potential for future research resulting in the same sort of public health achievements that research produced in the past, such as big reductions in smoking or sudden infant death syndrome.

Dr. Powell concluded his talk with a riff on Martin Luther’s 95 Theses, the 9.5 Theses, for a reformation of evidence-based medicine that together address the various shortcomings he discussed.

1. Recognize academic promotion as a bias, just like drug money.

2. Don’t confound statistically significant and clinically significant.

3. Use only significant figures.

4. Use the phrase “we did not DETECT a difference” and include power calculations.

5. Use confidence intervals instead of P values.

6. Use number needed to harm and number needed to treat instead of relative risk.

7. Absence of proof is not proof of absence. When there is insufficient randomized, controlled trial evidence, have an independent party estimate an effect based on non-RCT articles.

8. Any article implying clinical practice should change must include a counterpoint and a benefit cost analysis. Consider both effectiveness and safety.

9. Use postmarketing peer review.

9.5. Beware of research based on surveys.

Dr. Powell reported no relevant financial disclosures.
 

ORLANDO – What doctors think they know to be true in medicine has changed dramatically in the past several decades and will be different again in the decades to come, leaving them with a dilemma, according to Kevin T. Powell, MD, PhD, a pediatric hospitalist in St. Louis. If half of what doctors teach or know in medicine today will ultimately end up not being true, how do they know what to believe or accept?

While there is not a single satisfactory answer to that question, researchers can select research that gets doctors closer to reliable findings and steer them away from the barrage of poor-quality research that emerges from the current publish-or-perish system, Dr. Powell told his colleagues at the annual meeting of the American Academy of Pediatrics.

During his talk, Dr. Powell discussed the challenges and flaws with medical research as it is currently conducted, citing Doug Altman’s writings on these problems as early as 1994.

“The poor quality of much medical research is widely acknowledged, yet disturbingly the leaders of the medical profession seem only minimally concerned about the problem and make no apparent effort to find a solution,” wrote Mr. Altman, an English medical statistician (BMJ. 1994;308:283).

“We need less research, better research, and research done for the right reasons,” Mr. Altman concluded. “Abandoning using the number of publications as a measure of ability would be a start.”

In an interview, Dr. Powell described an unfortunate consequence of the publish-or-perish pressure in academic medicine: A glut of short-term, small studies with little clinical utility that researchers can complete in 1 or 2 years rather than the large, multicenter studies that take several years – and produce higher-quality findings – but cannot be turned into as many publications.

“We’re generating a lot of medical research findings that end up being false,” he said. “It’s a random walk in terms of getting to the truth rather than having an accurate process of getting to truth through evidence-based medicine.”

But he was hopeful, not cynical, about the way forward. By persuading people that medical research has changed for the worse over time and can change into something better, Dr. Powell saw potential for future research resulting in the same sort of public health achievements that research produced in the past, such as big reductions in smoking or sudden infant death syndrome.

Dr. Powell concluded his talk with a riff on Martin Luther’s 95 Theses, the 9.5 Theses, for a reformation of evidence-based medicine that together address the various shortcomings he discussed.

1. Recognize academic promotion as a bias, just like drug money.

2. Don’t confound statistically significant and clinically significant.

3. Use only significant figures.

4. Use the phrase “we did not DETECT a difference” and include power calculations.

5. Use confidence intervals instead of P values.

6. Use number needed to harm and number needed to treat instead of relative risk.

7. Absence of proof is not proof of absence. When there is insufficient randomized, controlled trial evidence, have an independent party estimate an effect based on non-RCT articles.

8. Any article implying clinical practice should change must include a counterpoint and a benefit cost analysis. Consider both effectiveness and safety.

9. Use postmarketing peer review.

9.5. Beware of research based on surveys.

Dr. Powell reported no relevant financial disclosures.
 

Medicare just released its 2019 physician fee schedule, which is called the “final rule.” Of course, there is a new final rule every year, so it really isn’t very final. I know this is confusing to many of you, I was dazed for several days by this year’s proposed final rule.

Each year, the Centers for Medicare & Medicaid Services receives input from innumerable sources and formulates its payment for physicians. These responses are often in response to requests by CMS itself, which wants to make sure reimbursements are accurate. Generally, input comes from the American Medical Association’s RVS Update Committee (RUC), which values new and existing CPT codes, as well as Congress, the Health & Human Services Office of Inspector General, lobbyists, specialty society organizations, public advocacy groups, and anyone who can wrangle an appointment at or write a letter to CMS headquarters in Baltimore. This conflicted brew is hashed over, and published in late July as a proposed rule. Public comments are then solicited (all letters and emails are considered, dermatologists sent 1,500 responses to this one!) and a final rule is published in the fall. I have constructed a flowchart of this process.

This year’s proposed rule was particularly disturbing because of major changes in reimbursement proposed by CMS. As you may recall, officials proposed to collapse all the evaluation and management (E/M) codes into two levels and pay bonuses to certain specialists (but not dermatologists). This might have been agreeable, except Medicare reimbursements are a zero-sum game. If someone is paid more, someone else will be paid less. Of course, you could always let the increase come out of the general pool, but that would decrease the conversion factor, and some health care professionals (usually primary care) might not see an overall increase. So, the proposed rule was going to “pay” for this increase by way of eliminating the 25 modifier, the CPT modifier that allows you to be paid for the evaluation and management (E/M) service on the same day as a procedure. This has been averted, at least for two years.

The final rule also makes a real effort to eliminate some meaningless documentation. Effective Jan. 1, 2019, for established patients, practitioners can focus their notes on patient changes. With new and established patients, they need not personally reenter the chief complaint and history already recorded by staff or the patient, other than simply indicate that they reviewed and verified the information in the medical record. In addition, teaching physicians do not have to duplicate notations by residents. CMS also included practice expense for additional skin biopsies.

CMS is also going to pay for services using communication technology. These include:

• Brief communication technology-based service, e.g. virtual check-in (HCPCS code G2012). This is provided by a physician or other qualified health care professional who can report E/M services for an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion. It is important to note that CMS is allowing for this code to include audio-only, real-time telephone interactions, in addition to synchronous, two-way audio interactions that are enhanced with video or other kinds of data transmission.
• Remote evaluation of recorded video and/or images submitted by an established patient (HCPCS code G2010). This is remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment). The code can be reported effective Jan. 1, 2019, for established patients only.

You can use G2012 to decide if an office visit is needed. Similarly, the service of remote evaluation of recorded video and/or images submitted by an established patient would allow health care professionals to be paid separately for reviewing patient-transmitted photo or video information whether or not a visit is needed. The encounter must be synchronous (real-time), two-way audio interactions enhanced with video or other kinds of data transmission.

It appears that these would only be practical for established patients, and don’t forget, your Internet and text responses to patients’ messages are not secure, unless they are on a secure portal, although their messages to you are HIPAA compliant. However, the telephone, some Internet portals, and your electronic medical record portals are secure. It is intriguing to me that I might get paid for all those bad pictures patients send me, at least if it is not in a global period.

It also appears that Rural Health Clinics and Federally Qualified Health Centers will be able to bill for new and established patient visits via communication technology.

This is all great news to physicians. Kudos to dermatologists Jack Resneck Jr., MD, American Medical Association trustee; and George Hruza, MD, the American Academy of Dermatology president-elect; and Sabra Sullivan, MD, PhD, chair of the AAD’s Council on Government Affairs and Health Policy Government, who organized this lemonade-making effort. And once again, the AAD’s Washington office has shown its great value. This also aptly demonstrates why you write letters to CMS.

In 2021, levels 2-4 will be collapsed into one code (levels 5 will remain, but remember, very few dermatologists use level 5) and you will have to document only at level 2 code levels. Special add-on codes will be added for exceptionally difficult cases for primary care and all specialist physicians, including dermatology. What is not clear is how this new reimbursement schemata will be funded. CMS is still suspicious that there is overlapping work when procedures are performed on the same day as an E/M (evaluation and management code). We may end up fighting this battle all over again.

Currently CMS is conducting a survey, sent to 1,500 dermatologists, on follow-up visits. CMS has stated that they will evaluate the public comments received and consider whether to propose action at a future date. CMS plans to send a letter describing the requirements, once again, to health care professionals in nine affected states, who are required to report the global period encounter. If you are one of these practitioners, please do fill this out and contact Faith McNicholas at AAD ([email protected]) if you have questions. The decision to eliminate global periods (disastrous) will be based on this survey.

This is why you need to stay engaged, write letters, join the AMA, donate to SkinPAC, and attend the legislative fly in, the AAD’s legislative conference held every year in Washington. We are a small specialty. If we do not speak up and stay engaged, we will become the lemons for the next pitcher of lemonade.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

Medicare just released its 2019 physician fee schedule, which is called the “final rule.” Of course, there is a new final rule every year, so it really isn’t very final. I know this is confusing to many of you, I was dazed for several days by this year’s proposed final rule.

Each year, the Centers for Medicare & Medicaid Services receives input from innumerable sources and formulates its payment for physicians. These responses are often in response to requests by CMS itself, which wants to make sure reimbursements are accurate. Generally, input comes from the American Medical Association’s RVS Update Committee (RUC), which values new and existing CPT codes, as well as Congress, the Health & Human Services Office of Inspector General, lobbyists, specialty society organizations, public advocacy groups, and anyone who can wrangle an appointment at or write a letter to CMS headquarters in Baltimore. This conflicted brew is hashed over, and published in late July as a proposed rule. Public comments are then solicited (all letters and emails are considered, dermatologists sent 1,500 responses to this one!) and a final rule is published in the fall. I have constructed a flowchart of this process.

This year’s proposed rule was particularly disturbing because of major changes in reimbursement proposed by CMS. As you may recall, officials proposed to collapse all the evaluation and management (E/M) codes into two levels and pay bonuses to certain specialists (but not dermatologists). This might have been agreeable, except Medicare reimbursements are a zero-sum game. If someone is paid more, someone else will be paid less. Of course, you could always let the increase come out of the general pool, but that would decrease the conversion factor, and some health care professionals (usually primary care) might not see an overall increase. So, the proposed rule was going to “pay” for this increase by way of eliminating the 25 modifier, the CPT modifier that allows you to be paid for the evaluation and management (E/M) service on the same day as a procedure. This has been averted, at least for two years.

The final rule also makes a real effort to eliminate some meaningless documentation. Effective Jan. 1, 2019, for established patients, practitioners can focus their notes on patient changes. With new and established patients, they need not personally reenter the chief complaint and history already recorded by staff or the patient, other than simply indicate that they reviewed and verified the information in the medical record. In addition, teaching physicians do not have to duplicate notations by residents. CMS also included practice expense for additional skin biopsies.

CMS is also going to pay for services using communication technology. These include:

• Brief communication technology-based service, e.g. virtual check-in (HCPCS code G2012). This is provided by a physician or other qualified health care professional who can report E/M services for an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion. It is important to note that CMS is allowing for this code to include audio-only, real-time telephone interactions, in addition to synchronous, two-way audio interactions that are enhanced with video or other kinds of data transmission.
• Remote evaluation of recorded video and/or images submitted by an established patient (HCPCS code G2010). This is remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment). The code can be reported effective Jan. 1, 2019, for established patients only.

You can use G2012 to decide if an office visit is needed. Similarly, the service of remote evaluation of recorded video and/or images submitted by an established patient would allow health care professionals to be paid separately for reviewing patient-transmitted photo or video information whether or not a visit is needed. The encounter must be synchronous (real-time), two-way audio interactions enhanced with video or other kinds of data transmission.

It appears that these would only be practical for established patients, and don’t forget, your Internet and text responses to patients’ messages are not secure, unless they are on a secure portal, although their messages to you are HIPAA compliant. However, the telephone, some Internet portals, and your electronic medical record portals are secure. It is intriguing to me that I might get paid for all those bad pictures patients send me, at least if it is not in a global period.

It also appears that Rural Health Clinics and Federally Qualified Health Centers will be able to bill for new and established patient visits via communication technology.

This is all great news to physicians. Kudos to dermatologists Jack Resneck Jr., MD, American Medical Association trustee; and George Hruza, MD, the American Academy of Dermatology president-elect; and Sabra Sullivan, MD, PhD, chair of the AAD’s Council on Government Affairs and Health Policy Government, who organized this lemonade-making effort. And once again, the AAD’s Washington office has shown its great value. This also aptly demonstrates why you write letters to CMS.

In 2021, levels 2-4 will be collapsed into one code (levels 5 will remain, but remember, very few dermatologists use level 5) and you will have to document only at level 2 code levels. Special add-on codes will be added for exceptionally difficult cases for primary care and all specialist physicians, including dermatology. What is not clear is how this new reimbursement schemata will be funded. CMS is still suspicious that there is overlapping work when procedures are performed on the same day as an E/M (evaluation and management code). We may end up fighting this battle all over again.

Currently CMS is conducting a survey, sent to 1,500 dermatologists, on follow-up visits. CMS has stated that they will evaluate the public comments received and consider whether to propose action at a future date. CMS plans to send a letter describing the requirements, once again, to health care professionals in nine affected states, who are required to report the global period encounter. If you are one of these practitioners, please do fill this out and contact Faith McNicholas at AAD ([email protected]) if you have questions. The decision to eliminate global periods (disastrous) will be based on this survey.

This is why you need to stay engaged, write letters, join the AMA, donate to SkinPAC, and attend the legislative fly in, the AAD’s legislative conference held every year in Washington. We are a small specialty. If we do not speak up and stay engaged, we will become the lemons for the next pitcher of lemonade.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

Medicare just released its 2019 physician fee schedule, which is called the “final rule.” Of course, there is a new final rule every year, so it really isn’t very final. I know this is confusing to many of you, I was dazed for several days by this year’s proposed final rule.

Each year, the Centers for Medicare & Medicaid Services receives input from innumerable sources and formulates its payment for physicians. These responses are often in response to requests by CMS itself, which wants to make sure reimbursements are accurate. Generally, input comes from the American Medical Association’s RVS Update Committee (RUC), which values new and existing CPT codes, as well as Congress, the Health & Human Services Office of Inspector General, lobbyists, specialty society organizations, public advocacy groups, and anyone who can wrangle an appointment at or write a letter to CMS headquarters in Baltimore. This conflicted brew is hashed over, and published in late July as a proposed rule. Public comments are then solicited (all letters and emails are considered, dermatologists sent 1,500 responses to this one!) and a final rule is published in the fall. I have constructed a flowchart of this process.

This year’s proposed rule was particularly disturbing because of major changes in reimbursement proposed by CMS. As you may recall, officials proposed to collapse all the evaluation and management (E/M) codes into two levels and pay bonuses to certain specialists (but not dermatologists). This might have been agreeable, except Medicare reimbursements are a zero-sum game. If someone is paid more, someone else will be paid less. Of course, you could always let the increase come out of the general pool, but that would decrease the conversion factor, and some health care professionals (usually primary care) might not see an overall increase. So, the proposed rule was going to “pay” for this increase by way of eliminating the 25 modifier, the CPT modifier that allows you to be paid for the evaluation and management (E/M) service on the same day as a procedure. This has been averted, at least for two years.

The final rule also makes a real effort to eliminate some meaningless documentation. Effective Jan. 1, 2019, for established patients, practitioners can focus their notes on patient changes. With new and established patients, they need not personally reenter the chief complaint and history already recorded by staff or the patient, other than simply indicate that they reviewed and verified the information in the medical record. In addition, teaching physicians do not have to duplicate notations by residents. CMS also included practice expense for additional skin biopsies.

CMS is also going to pay for services using communication technology. These include:

• Brief communication technology-based service, e.g. virtual check-in (HCPCS code G2012). This is provided by a physician or other qualified health care professional who can report E/M services for an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion. It is important to note that CMS is allowing for this code to include audio-only, real-time telephone interactions, in addition to synchronous, two-way audio interactions that are enhanced with video or other kinds of data transmission.
• Remote evaluation of recorded video and/or images submitted by an established patient (HCPCS code G2010). This is remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment). The code can be reported effective Jan. 1, 2019, for established patients only.

You can use G2012 to decide if an office visit is needed. Similarly, the service of remote evaluation of recorded video and/or images submitted by an established patient would allow health care professionals to be paid separately for reviewing patient-transmitted photo or video information whether or not a visit is needed. The encounter must be synchronous (real-time), two-way audio interactions enhanced with video or other kinds of data transmission.

It appears that these would only be practical for established patients, and don’t forget, your Internet and text responses to patients’ messages are not secure, unless they are on a secure portal, although their messages to you are HIPAA compliant. However, the telephone, some Internet portals, and your electronic medical record portals are secure. It is intriguing to me that I might get paid for all those bad pictures patients send me, at least if it is not in a global period.

It also appears that Rural Health Clinics and Federally Qualified Health Centers will be able to bill for new and established patient visits via communication technology.

This is all great news to physicians. Kudos to dermatologists Jack Resneck Jr., MD, American Medical Association trustee; and George Hruza, MD, the American Academy of Dermatology president-elect; and Sabra Sullivan, MD, PhD, chair of the AAD’s Council on Government Affairs and Health Policy Government, who organized this lemonade-making effort. And once again, the AAD’s Washington office has shown its great value. This also aptly demonstrates why you write letters to CMS.

In 2021, levels 2-4 will be collapsed into one code (levels 5 will remain, but remember, very few dermatologists use level 5) and you will have to document only at level 2 code levels. Special add-on codes will be added for exceptionally difficult cases for primary care and all specialist physicians, including dermatology. What is not clear is how this new reimbursement schemata will be funded. CMS is still suspicious that there is overlapping work when procedures are performed on the same day as an E/M (evaluation and management code). We may end up fighting this battle all over again.

Currently CMS is conducting a survey, sent to 1,500 dermatologists, on follow-up visits. CMS has stated that they will evaluate the public comments received and consider whether to propose action at a future date. CMS plans to send a letter describing the requirements, once again, to health care professionals in nine affected states, who are required to report the global period encounter. If you are one of these practitioners, please do fill this out and contact Faith McNicholas at AAD ([email protected]) if you have questions. The decision to eliminate global periods (disastrous) will be based on this survey.

This is why you need to stay engaged, write letters, join the AMA, donate to SkinPAC, and attend the legislative fly in, the AAD’s legislative conference held every year in Washington. We are a small specialty. If we do not speak up and stay engaged, we will become the lemons for the next pitcher of lemonade.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

A newly released comprehensive second edition of the federal physical guidelines aims to transform the current sick system into a system that promotes health. Also today, hydroxychloroquine treatment of SLE is hobbled by fears of blindness, antiepileptic drugs are strongly linked to rare serious skin reactions, and the FDA aims to squash vaping and smoking among youth.

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A newly released comprehensive second edition of the federal physical guidelines aims to transform the current sick system into a system that promotes health. Also today, hydroxychloroquine treatment of SLE is hobbled by fears of blindness, antiepileptic drugs are strongly linked to rare serious skin reactions, and the FDA aims to squash vaping and smoking among youth.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify

A newly released comprehensive second edition of the federal physical guidelines aims to transform the current sick system into a system that promotes health. Also today, hydroxychloroquine treatment of SLE is hobbled by fears of blindness, antiepileptic drugs are strongly linked to rare serious skin reactions, and the FDA aims to squash vaping and smoking among youth.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify

According to 2017 data from the CDC’s National Center for Health Statistics, on average 115 Americans die every day from an opioid overdose—and it is happening more often at work. Between 2013 and 2016, the Bureau of Labor Statistics finds overdose deaths at work from nonmedical use of drugs and alcohol increased by at least 38% annually.

Naloxone can be one of the first-aid tools of today’s workplace. To help employers decide whether to supply naloxone at work, NIOSH has released a new fact sheet that outlines questions to consider. Using Naloxone to Reverse Opioid Overdose in the Workplace: Information for Employers and Workers gives an overview of opioids and naloxone, a checklist to determine whether a naloxone program is appropriate, and information about how to implement and maintain a program.

The fact sheet is available at www.cdc.gov/niosh/docs/2019-101/.  

According to 2017 data from the CDC’s National Center for Health Statistics, on average 115 Americans die every day from an opioid overdose—and it is happening more often at work. Between 2013 and 2016, the Bureau of Labor Statistics finds overdose deaths at work from nonmedical use of drugs and alcohol increased by at least 38% annually.

Naloxone can be one of the first-aid tools of today’s workplace. To help employers decide whether to supply naloxone at work, NIOSH has released a new fact sheet that outlines questions to consider. Using Naloxone to Reverse Opioid Overdose in the Workplace: Information for Employers and Workers gives an overview of opioids and naloxone, a checklist to determine whether a naloxone program is appropriate, and information about how to implement and maintain a program.

The fact sheet is available at www.cdc.gov/niosh/docs/2019-101/.  

According to 2017 data from the CDC’s National Center for Health Statistics, on average 115 Americans die every day from an opioid overdose—and it is happening more often at work. Between 2013 and 2016, the Bureau of Labor Statistics finds overdose deaths at work from nonmedical use of drugs and alcohol increased by at least 38% annually.

Naloxone can be one of the first-aid tools of today’s workplace. To help employers decide whether to supply naloxone at work, NIOSH has released a new fact sheet that outlines questions to consider. Using Naloxone to Reverse Opioid Overdose in the Workplace: Information for Employers and Workers gives an overview of opioids and naloxone, a checklist to determine whether a naloxone program is appropriate, and information about how to implement and maintain a program.

The fact sheet is available at www.cdc.gov/niosh/docs/2019-101/.  

and David Joseph Russell

Bortezomib may help overcome treatment resistance in patients with Waldenström’s macroglobulinemia (WM) and CXCR4 mutations, according to a new study.

Researchers assessed the impact of treatment with bortezomib and rituximab in patients with WM, based on their CXCR4 mutation status.

The team found no significant difference in progression-free survival or overall survival between patients with CXCR4 mutations and those with wild-type CXCR4.

Romanos Sklavenitis-Pistofidis, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, and his colleagues reported this discovery in Blood.

The researchers’ main analysis included 43 patients with WM, 17 (39.5%) of whom had a CXCR4 mutation.

All patients who carried a CXCR4 mutation also had MYD88 L265P. Ten patients had frameshift mutations, one patient had a nonsense mutation, and six patients had missense mutations.

The patients were treated with bortezomib and rituximab, either upfront (n=14) or in the relapsed/refractory (n=29) setting, as part of a phase 2 trial.

Bortezomib was given at 1.6 mg/m² on days 1, 8, and 15 every 28 days for six cycles, and rituximab was given at 375 mg/m² on days 1, 8, 15, and 22 during cycles one and four. Patients were taken off therapy after two cycles if they had progressive disease.

The median follow-up was 90.7 months.

The researchers found no significant difference between CXCR4-mutated and wild-type patients when it came to progression-free survival (P=0.994) or overall survival (P=0.407).

The researchers repeated their analysis after excluding six patients with missense mutations and accounting for different treatment settings and found that survival remained unchanged.

“We report, for the first time, that a bortezomib-based combination is impervious to the impact of CXCR4 mutations in a cohort of patients with WM,” the researchers wrote.

“Previously, we had shown this to be true in WM cell lines, whereby genetically engineering BCWM.1 and MWCL-1 to overexpress CXCR4 had no impact on bortezomib resistance.”

The researchers noted, however, that the mechanism at work here may be different than what is seen with bortezomib in other cancers.

“Different experiments have linked CXCR4 expression and bortezomib in a variety of ways in other hematological malignancies, including multiple myeloma,” the researchers wrote.

“However, despite the complicated association in those cancer types, in WM, there seems to be a consistently neutral effect of CXCR4 mutations on bortezomib resistance in both cell line and patient data.”

The researchers recommended that this theory be tested in a prospective trial of bortezomib-based therapy in WM patients with CXCR4 mutations.

Another thing to be determined, they said, is the role of rituximab in the survival results seen in the current analysis.

This study was supported by the National Institutes of Health, the Leukemia and Lymphoma Society, and the International Waldenström Macroglobulinemia Foundation. One of the authors reported consulting and research funding from Takeda, which markets bortezomib, and other companies.

and David Joseph Russell

Bortezomib may help overcome treatment resistance in patients with Waldenström’s macroglobulinemia (WM) and CXCR4 mutations, according to a new study.

Researchers assessed the impact of treatment with bortezomib and rituximab in patients with WM, based on their CXCR4 mutation status.

The team found no significant difference in progression-free survival or overall survival between patients with CXCR4 mutations and those with wild-type CXCR4.

Romanos Sklavenitis-Pistofidis, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, and his colleagues reported this discovery in Blood.

The researchers’ main analysis included 43 patients with WM, 17 (39.5%) of whom had a CXCR4 mutation.

All patients who carried a CXCR4 mutation also had MYD88 L265P. Ten patients had frameshift mutations, one patient had a nonsense mutation, and six patients had missense mutations.

The patients were treated with bortezomib and rituximab, either upfront (n=14) or in the relapsed/refractory (n=29) setting, as part of a phase 2 trial.

Bortezomib was given at 1.6 mg/m² on days 1, 8, and 15 every 28 days for six cycles, and rituximab was given at 375 mg/m² on days 1, 8, 15, and 22 during cycles one and four. Patients were taken off therapy after two cycles if they had progressive disease.

The median follow-up was 90.7 months.

The researchers found no significant difference between CXCR4-mutated and wild-type patients when it came to progression-free survival (P=0.994) or overall survival (P=0.407).

The researchers repeated their analysis after excluding six patients with missense mutations and accounting for different treatment settings and found that survival remained unchanged.

“We report, for the first time, that a bortezomib-based combination is impervious to the impact of CXCR4 mutations in a cohort of patients with WM,” the researchers wrote.

“Previously, we had shown this to be true in WM cell lines, whereby genetically engineering BCWM.1 and MWCL-1 to overexpress CXCR4 had no impact on bortezomib resistance.”

The researchers noted, however, that the mechanism at work here may be different than what is seen with bortezomib in other cancers.

“Different experiments have linked CXCR4 expression and bortezomib in a variety of ways in other hematological malignancies, including multiple myeloma,” the researchers wrote.

“However, despite the complicated association in those cancer types, in WM, there seems to be a consistently neutral effect of CXCR4 mutations on bortezomib resistance in both cell line and patient data.”

The researchers recommended that this theory be tested in a prospective trial of bortezomib-based therapy in WM patients with CXCR4 mutations.

Another thing to be determined, they said, is the role of rituximab in the survival results seen in the current analysis.

This study was supported by the National Institutes of Health, the Leukemia and Lymphoma Society, and the International Waldenström Macroglobulinemia Foundation. One of the authors reported consulting and research funding from Takeda, which markets bortezomib, and other companies.

and David Joseph Russell

Bortezomib may help overcome treatment resistance in patients with Waldenström’s macroglobulinemia (WM) and CXCR4 mutations, according to a new study.

Researchers assessed the impact of treatment with bortezomib and rituximab in patients with WM, based on their CXCR4 mutation status.

The team found no significant difference in progression-free survival or overall survival between patients with CXCR4 mutations and those with wild-type CXCR4.

Romanos Sklavenitis-Pistofidis, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, and his colleagues reported this discovery in Blood.

The researchers’ main analysis included 43 patients with WM, 17 (39.5%) of whom had a CXCR4 mutation.

All patients who carried a CXCR4 mutation also had MYD88 L265P. Ten patients had frameshift mutations, one patient had a nonsense mutation, and six patients had missense mutations.

The patients were treated with bortezomib and rituximab, either upfront (n=14) or in the relapsed/refractory (n=29) setting, as part of a phase 2 trial.

Bortezomib was given at 1.6 mg/m² on days 1, 8, and 15 every 28 days for six cycles, and rituximab was given at 375 mg/m² on days 1, 8, 15, and 22 during cycles one and four. Patients were taken off therapy after two cycles if they had progressive disease.

The median follow-up was 90.7 months.

The researchers found no significant difference between CXCR4-mutated and wild-type patients when it came to progression-free survival (P=0.994) or overall survival (P=0.407).

The researchers repeated their analysis after excluding six patients with missense mutations and accounting for different treatment settings and found that survival remained unchanged.

“We report, for the first time, that a bortezomib-based combination is impervious to the impact of CXCR4 mutations in a cohort of patients with WM,” the researchers wrote.

“Previously, we had shown this to be true in WM cell lines, whereby genetically engineering BCWM.1 and MWCL-1 to overexpress CXCR4 had no impact on bortezomib resistance.”

The researchers noted, however, that the mechanism at work here may be different than what is seen with bortezomib in other cancers.

“Different experiments have linked CXCR4 expression and bortezomib in a variety of ways in other hematological malignancies, including multiple myeloma,” the researchers wrote.

“However, despite the complicated association in those cancer types, in WM, there seems to be a consistently neutral effect of CXCR4 mutations on bortezomib resistance in both cell line and patient data.”

The researchers recommended that this theory be tested in a prospective trial of bortezomib-based therapy in WM patients with CXCR4 mutations.

Another thing to be determined, they said, is the role of rituximab in the survival results seen in the current analysis.

This study was supported by the National Institutes of Health, the Leukemia and Lymphoma Society, and the International Waldenström Macroglobulinemia Foundation. One of the authors reported consulting and research funding from Takeda, which markets bortezomib, and other companies.

The SVS Research and Education Committee encourages eligible members to apply for the prestigious Resident Research Award. The recipient will showcase his or her work at the 2019 Vascular Annual Meeting in June as well as receive a $5,000 award. This award is designed to provide special recognition of original scientific work that has yet to be published in manuscript form. It’s an excellent opportunity for surgical trainees in vascular research laboratories to be recognized and rewarded for their research efforts. The application deadline is Jan. 16, 2019, and the annual meeting will take place June 12 to 15 in National Harbor, Md., outside of Washington, D.C.

The SVS Research and Education Committee encourages eligible members to apply for the prestigious Resident Research Award. The recipient will showcase his or her work at the 2019 Vascular Annual Meeting in June as well as receive a $5,000 award. This award is designed to provide special recognition of original scientific work that has yet to be published in manuscript form. It’s an excellent opportunity for surgical trainees in vascular research laboratories to be recognized and rewarded for their research efforts. The application deadline is Jan. 16, 2019, and the annual meeting will take place June 12 to 15 in National Harbor, Md., outside of Washington, D.C.

The SVS Research and Education Committee encourages eligible members to apply for the prestigious Resident Research Award. The recipient will showcase his or her work at the 2019 Vascular Annual Meeting in June as well as receive a $5,000 award. This award is designed to provide special recognition of original scientific work that has yet to be published in manuscript form. It’s an excellent opportunity for surgical trainees in vascular research laboratories to be recognized and rewarded for their research efforts. The application deadline is Jan. 16, 2019, and the annual meeting will take place June 12 to 15 in National Harbor, Md., outside of Washington, D.C.

The abstract submission site for the 2019 Vascular Annual Meeting is now open. Submissions may be considered for the following programs: Scientific Session, Vascular and Endovascular Surgical Society (VESS), International Forum, International Fast Talk, Poster Competition and Interactive Poster. In addition to the International Forum and International Fast Talk, the international community has added two further opportunities to showcase research: The International Young Surgeon Competition and the International Poster Competition. This year the submission site is mobile friendly! Get more information on submission and policy guidelines here.

The abstract submission site for the 2019 Vascular Annual Meeting is now open. Submissions may be considered for the following programs: Scientific Session, Vascular and Endovascular Surgical Society (VESS), International Forum, International Fast Talk, Poster Competition and Interactive Poster. In addition to the International Forum and International Fast Talk, the international community has added two further opportunities to showcase research: The International Young Surgeon Competition and the International Poster Competition. This year the submission site is mobile friendly! Get more information on submission and policy guidelines here.

The abstract submission site for the 2019 Vascular Annual Meeting is now open. Submissions may be considered for the following programs: Scientific Session, Vascular and Endovascular Surgical Society (VESS), International Forum, International Fast Talk, Poster Competition and Interactive Poster. In addition to the International Forum and International Fast Talk, the international community has added two further opportunities to showcase research: The International Young Surgeon Competition and the International Poster Competition. This year the submission site is mobile friendly! Get more information on submission and policy guidelines here.

Peanut-allergic children and adolescents treated with a peanut-derived oral immunotherapy drug have shown significant improvements in response to a challenge dose of peanut protein, according to data presented at the annual meeting of the American College of Allergy, Asthma, and Immunology.

A phase 3 placebo-controlled study, published simultaneously Nov. 18 in the New England Journal of Medicine, randomized 551 individuals with peanut allergy to receive an escalating dose of AR101 – an investigational peanut-derived biologic oral immunotherapy drug – ranging from 0.5-300 mg daily, or placebo.

After 12 months, 67.2% of the 372 participants aged 4-17 years who received the immunotherapy drug were able to eat a dose of 600 mg or more of peanut protein with only mild symptoms, compared with 4% of the 124 participants aged 4-17 years in the placebo group.

The secondary endpoints were whether participants could tolerate either a 300 mg or 1,000 mg dose in the exit food challenge. For the 300 mg dose, 76.6% of the immunotherapy group and 8.1% of the placebo group were able to tolerate it, and for the 1,000 mg group, 50.3% of the immunotherapy group were able to tolerate it, compared with 2.4% of the placebo group.

During the exit food challenge, the severity of symptoms was significantly higher in the placebo group than in the treatment group. One-quarter of participants in the treatment group had at most moderate symptoms, compared with 59% in the placebo group. However, severe symptoms were experienced by 11% of the placebo group, compared with 5% of the treatment group.

One in 10 participants in the active group had to be treated with rescue epinephrine during the exit food challenge, compared with 53% of participants in the placebo group, and the number who required a second dose of rescue epinephrine was 1% and 15%, respectively.

“These data show that, in the context of a clinical trial, among participants 4-17 years of age, AR101 had immunomodulatory activity, raised the threshold dose of peanut exposure triggering the onset of clinically significant allergic symptoms (among participants having symptoms), during the double-blind, placebo-controlled exit food challenge, and attenuated the severity of those symptoms when they occurred,” wrote Brian P. Vickery, MD, of Emory University in Atlanta, and his coauthors.

The 55 participants aged 18-55 years were analyzed separately, and researchers found that for the 600 mg exit food test, the difference between the two groups did not reach statistical significance.

Apart from adverse events that occurred during the exit food challenge, the rate of adverse events was slightly higher in the treatment group compared to the placebo group (98.7% vs. 95.2%). The most common adverse events in the treatment arm were abdominal pain, vomiting, oral pruritis, and nausea. Overall, 6.5% of participants in the treatment arm withdrew because of gastrointestinal adverse events, compared with just 1.2% in the placebo group.

The study was funded by Aimmune Therapeutics. Three authors were employees of or investigators for Aimmune Therapeutics and one also had a patent pending for oral immunotherapy for peanut allergy. Most authors declared funding, grants, consultancies, or other support from the pharmaceutical industry, including from some from Aimmune.

SOURCE: Vickery BP et al. N Engl J Med. 18 Nov 2018. doi: 10.1056/NEJMoa1812856.

Peanut-allergic children and adolescents treated with a peanut-derived oral immunotherapy drug have shown significant improvements in response to a challenge dose of peanut protein, according to data presented at the annual meeting of the American College of Allergy, Asthma, and Immunology.

A phase 3 placebo-controlled study, published simultaneously Nov. 18 in the New England Journal of Medicine, randomized 551 individuals with peanut allergy to receive an escalating dose of AR101 – an investigational peanut-derived biologic oral immunotherapy drug – ranging from 0.5-300 mg daily, or placebo.

After 12 months, 67.2% of the 372 participants aged 4-17 years who received the immunotherapy drug were able to eat a dose of 600 mg or more of peanut protein with only mild symptoms, compared with 4% of the 124 participants aged 4-17 years in the placebo group.

The secondary endpoints were whether participants could tolerate either a 300 mg or 1,000 mg dose in the exit food challenge. For the 300 mg dose, 76.6% of the immunotherapy group and 8.1% of the placebo group were able to tolerate it, and for the 1,000 mg group, 50.3% of the immunotherapy group were able to tolerate it, compared with 2.4% of the placebo group.

During the exit food challenge, the severity of symptoms was significantly higher in the placebo group than in the treatment group. One-quarter of participants in the treatment group had at most moderate symptoms, compared with 59% in the placebo group. However, severe symptoms were experienced by 11% of the placebo group, compared with 5% of the treatment group.

One in 10 participants in the active group had to be treated with rescue epinephrine during the exit food challenge, compared with 53% of participants in the placebo group, and the number who required a second dose of rescue epinephrine was 1% and 15%, respectively.

“These data show that, in the context of a clinical trial, among participants 4-17 years of age, AR101 had immunomodulatory activity, raised the threshold dose of peanut exposure triggering the onset of clinically significant allergic symptoms (among participants having symptoms), during the double-blind, placebo-controlled exit food challenge, and attenuated the severity of those symptoms when they occurred,” wrote Brian P. Vickery, MD, of Emory University in Atlanta, and his coauthors.

The 55 participants aged 18-55 years were analyzed separately, and researchers found that for the 600 mg exit food test, the difference between the two groups did not reach statistical significance.

Apart from adverse events that occurred during the exit food challenge, the rate of adverse events was slightly higher in the treatment group compared to the placebo group (98.7% vs. 95.2%). The most common adverse events in the treatment arm were abdominal pain, vomiting, oral pruritis, and nausea. Overall, 6.5% of participants in the treatment arm withdrew because of gastrointestinal adverse events, compared with just 1.2% in the placebo group.

The study was funded by Aimmune Therapeutics. Three authors were employees of or investigators for Aimmune Therapeutics and one also had a patent pending for oral immunotherapy for peanut allergy. Most authors declared funding, grants, consultancies, or other support from the pharmaceutical industry, including from some from Aimmune.

SOURCE: Vickery BP et al. N Engl J Med. 18 Nov 2018. doi: 10.1056/NEJMoa1812856.

Peanut-allergic children and adolescents treated with a peanut-derived oral immunotherapy drug have shown significant improvements in response to a challenge dose of peanut protein, according to data presented at the annual meeting of the American College of Allergy, Asthma, and Immunology.

A phase 3 placebo-controlled study, published simultaneously Nov. 18 in the New England Journal of Medicine, randomized 551 individuals with peanut allergy to receive an escalating dose of AR101 – an investigational peanut-derived biologic oral immunotherapy drug – ranging from 0.5-300 mg daily, or placebo.

After 12 months, 67.2% of the 372 participants aged 4-17 years who received the immunotherapy drug were able to eat a dose of 600 mg or more of peanut protein with only mild symptoms, compared with 4% of the 124 participants aged 4-17 years in the placebo group.

The secondary endpoints were whether participants could tolerate either a 300 mg or 1,000 mg dose in the exit food challenge. For the 300 mg dose, 76.6% of the immunotherapy group and 8.1% of the placebo group were able to tolerate it, and for the 1,000 mg group, 50.3% of the immunotherapy group were able to tolerate it, compared with 2.4% of the placebo group.

During the exit food challenge, the severity of symptoms was significantly higher in the placebo group than in the treatment group. One-quarter of participants in the treatment group had at most moderate symptoms, compared with 59% in the placebo group. However, severe symptoms were experienced by 11% of the placebo group, compared with 5% of the treatment group.

One in 10 participants in the active group had to be treated with rescue epinephrine during the exit food challenge, compared with 53% of participants in the placebo group, and the number who required a second dose of rescue epinephrine was 1% and 15%, respectively.

“These data show that, in the context of a clinical trial, among participants 4-17 years of age, AR101 had immunomodulatory activity, raised the threshold dose of peanut exposure triggering the onset of clinically significant allergic symptoms (among participants having symptoms), during the double-blind, placebo-controlled exit food challenge, and attenuated the severity of those symptoms when they occurred,” wrote Brian P. Vickery, MD, of Emory University in Atlanta, and his coauthors.

The 55 participants aged 18-55 years were analyzed separately, and researchers found that for the 600 mg exit food test, the difference between the two groups did not reach statistical significance.

Apart from adverse events that occurred during the exit food challenge, the rate of adverse events was slightly higher in the treatment group compared to the placebo group (98.7% vs. 95.2%). The most common adverse events in the treatment arm were abdominal pain, vomiting, oral pruritis, and nausea. Overall, 6.5% of participants in the treatment arm withdrew because of gastrointestinal adverse events, compared with just 1.2% in the placebo group.

The study was funded by Aimmune Therapeutics. Three authors were employees of or investigators for Aimmune Therapeutics and one also had a patent pending for oral immunotherapy for peanut allergy. Most authors declared funding, grants, consultancies, or other support from the pharmaceutical industry, including from some from Aimmune.

SOURCE: Vickery BP et al. N Engl J Med. 18 Nov 2018. doi: 10.1056/NEJMoa1812856.

Persistent and nonepisodic foot pain in hyperuricemia is associated with ultrasound features of monosodium urate deposition within joints that is responsive to urate-lowering therapy, a case-control study shows.

The research suggests that symptomatic hyperuricemia occurring prior to episodic gout could represent an earlier or alternative disease presentation, reported Yousef Mohammed Alammari, of the department of rheumatology, Tallaght University Hospital, Dublin, and associates.

Furthermore, the researchers wrote in Annals of the Rheumatic Diseases, their findings serve as “potential rationale” for reclassification of the ACR/EULAR 2015 gout classification criteria.

The research team noted that the gout classification criteria from the two rheumatology organizations require a history of a “prior episode of swelling, pain, or tenderness of a peripheral joint/bursa before confirmation either through MSU crystal identification in synovial fluid or through achieving a score of greater than 8 using a predefined scoring system of radiological, laboratory, and clinical features.”

Yet, emerging evidence suggests that foot pain could be a preclinical and clinical phase of gout that might occur prior to a first episodic gout attack, the investigators noted.

The current study involved 16 hyperuricemia individuals with persistent, nonepisodic foot pain who did not fulfill ACR/EULAR 2015 gout classification criteria but received febuxostat 80 mg once daily for 3 months. Controls were 15 individuals with asymptomatic hyperuricemia.

Results showed that double contour sign erosion and tophus occurred in 44%, 37%, and 37% of the cases, respectively, whereas no ultrasound features of gout were seen in the controls.

No significant difference in baseline serum urate was observed between the cases (450 plus or minus 18 mg/dL) and controls (426 plus or minus 7; P = nonsignificant), but at 1- and 3-month time points, serum urate fell in the cases (200 plus or minus 18; P less than 0.001 and 223 plus or minus 28; P less than less than 0.001).

In the cases, baseline 24-hour pain visual analogue score (65 plus or minus 4.9) reduced at 1 month (41 plus or minus 6.6; P = 0.001) and 3 months (33 plus or minus 7.2; P less than 0.001) of urate lowering therapy, as did the 7-day pain visual analogue score (70 plus or minus 4.7) scores (44 plus or minus 7.1; P less than 0.001 at 1 month; 38 plus or minus 8; P less than 0.001 at 3 months).

The Manchester Foot Pain and Disability Index also decreased at 1 month (21 plus or minus 2.9; P = 0.019) and 3 months (17 plus or minus 2.8; P = 0.012).

When the investigators grouped the cases according to the presence (n = 7) or absence (n = 9) of double contour sign on baseline ultrasound, no differences were observed for baseline pain scores.

However, after treatment with ultrasound, 24-hour pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months.

In addition, the researchers found, the 7-day pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months. No significant differences were seen between double contour positive and double contour negative patients in the Manchester Foot Pain and Disability Index or serum urate at 1 or 3 months of ultrasound.

The investigators noted that their findings indicated that persistent, nonepisodic foot pain in hyperuricemia was both associated with ultrasound features of monosodium urate deposition and was responsive to urate lowering therapy.

“Symptomatic hyperuricemia occurring prior to episodic gout therefore represents an earlier or alternative disease presentation,” they wrote. “Changes to the ACR/ EULAR classification criteria to include nonepisodic foot pain in the presence of [ultrasound] features of gout may increase the sensitivity of disease classification at an early stage, leading to improved future treatment strategies and long-term outcomes.”

No disclosures were declared.

SOURCE: Alammari YM et al. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-214305.
 

Persistent and nonepisodic foot pain in hyperuricemia is associated with ultrasound features of monosodium urate deposition within joints that is responsive to urate-lowering therapy, a case-control study shows.

The research suggests that symptomatic hyperuricemia occurring prior to episodic gout could represent an earlier or alternative disease presentation, reported Yousef Mohammed Alammari, of the department of rheumatology, Tallaght University Hospital, Dublin, and associates.

Furthermore, the researchers wrote in Annals of the Rheumatic Diseases, their findings serve as “potential rationale” for reclassification of the ACR/EULAR 2015 gout classification criteria.

The research team noted that the gout classification criteria from the two rheumatology organizations require a history of a “prior episode of swelling, pain, or tenderness of a peripheral joint/bursa before confirmation either through MSU crystal identification in synovial fluid or through achieving a score of greater than 8 using a predefined scoring system of radiological, laboratory, and clinical features.”

Yet, emerging evidence suggests that foot pain could be a preclinical and clinical phase of gout that might occur prior to a first episodic gout attack, the investigators noted.

The current study involved 16 hyperuricemia individuals with persistent, nonepisodic foot pain who did not fulfill ACR/EULAR 2015 gout classification criteria but received febuxostat 80 mg once daily for 3 months. Controls were 15 individuals with asymptomatic hyperuricemia.

Results showed that double contour sign erosion and tophus occurred in 44%, 37%, and 37% of the cases, respectively, whereas no ultrasound features of gout were seen in the controls.

No significant difference in baseline serum urate was observed between the cases (450 plus or minus 18 mg/dL) and controls (426 plus or minus 7; P = nonsignificant), but at 1- and 3-month time points, serum urate fell in the cases (200 plus or minus 18; P less than 0.001 and 223 plus or minus 28; P less than less than 0.001).

In the cases, baseline 24-hour pain visual analogue score (65 plus or minus 4.9) reduced at 1 month (41 plus or minus 6.6; P = 0.001) and 3 months (33 plus or minus 7.2; P less than 0.001) of urate lowering therapy, as did the 7-day pain visual analogue score (70 plus or minus 4.7) scores (44 plus or minus 7.1; P less than 0.001 at 1 month; 38 plus or minus 8; P less than 0.001 at 3 months).

The Manchester Foot Pain and Disability Index also decreased at 1 month (21 plus or minus 2.9; P = 0.019) and 3 months (17 plus or minus 2.8; P = 0.012).

When the investigators grouped the cases according to the presence (n = 7) or absence (n = 9) of double contour sign on baseline ultrasound, no differences were observed for baseline pain scores.

However, after treatment with ultrasound, 24-hour pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months.

In addition, the researchers found, the 7-day pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months. No significant differences were seen between double contour positive and double contour negative patients in the Manchester Foot Pain and Disability Index or serum urate at 1 or 3 months of ultrasound.

The investigators noted that their findings indicated that persistent, nonepisodic foot pain in hyperuricemia was both associated with ultrasound features of monosodium urate deposition and was responsive to urate lowering therapy.

“Symptomatic hyperuricemia occurring prior to episodic gout therefore represents an earlier or alternative disease presentation,” they wrote. “Changes to the ACR/ EULAR classification criteria to include nonepisodic foot pain in the presence of [ultrasound] features of gout may increase the sensitivity of disease classification at an early stage, leading to improved future treatment strategies and long-term outcomes.”

No disclosures were declared.

SOURCE: Alammari YM et al. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-214305.
 

Persistent and nonepisodic foot pain in hyperuricemia is associated with ultrasound features of monosodium urate deposition within joints that is responsive to urate-lowering therapy, a case-control study shows.

The research suggests that symptomatic hyperuricemia occurring prior to episodic gout could represent an earlier or alternative disease presentation, reported Yousef Mohammed Alammari, of the department of rheumatology, Tallaght University Hospital, Dublin, and associates.

Furthermore, the researchers wrote in Annals of the Rheumatic Diseases, their findings serve as “potential rationale” for reclassification of the ACR/EULAR 2015 gout classification criteria.

The research team noted that the gout classification criteria from the two rheumatology organizations require a history of a “prior episode of swelling, pain, or tenderness of a peripheral joint/bursa before confirmation either through MSU crystal identification in synovial fluid or through achieving a score of greater than 8 using a predefined scoring system of radiological, laboratory, and clinical features.”

Yet, emerging evidence suggests that foot pain could be a preclinical and clinical phase of gout that might occur prior to a first episodic gout attack, the investigators noted.

The current study involved 16 hyperuricemia individuals with persistent, nonepisodic foot pain who did not fulfill ACR/EULAR 2015 gout classification criteria but received febuxostat 80 mg once daily for 3 months. Controls were 15 individuals with asymptomatic hyperuricemia.

Results showed that double contour sign erosion and tophus occurred in 44%, 37%, and 37% of the cases, respectively, whereas no ultrasound features of gout were seen in the controls.

No significant difference in baseline serum urate was observed between the cases (450 plus or minus 18 mg/dL) and controls (426 plus or minus 7; P = nonsignificant), but at 1- and 3-month time points, serum urate fell in the cases (200 plus or minus 18; P less than 0.001 and 223 plus or minus 28; P less than less than 0.001).

In the cases, baseline 24-hour pain visual analogue score (65 plus or minus 4.9) reduced at 1 month (41 plus or minus 6.6; P = 0.001) and 3 months (33 plus or minus 7.2; P less than 0.001) of urate lowering therapy, as did the 7-day pain visual analogue score (70 plus or minus 4.7) scores (44 plus or minus 7.1; P less than 0.001 at 1 month; 38 plus or minus 8; P less than 0.001 at 3 months).

The Manchester Foot Pain and Disability Index also decreased at 1 month (21 plus or minus 2.9; P = 0.019) and 3 months (17 plus or minus 2.8; P = 0.012).

When the investigators grouped the cases according to the presence (n = 7) or absence (n = 9) of double contour sign on baseline ultrasound, no differences were observed for baseline pain scores.

However, after treatment with ultrasound, 24-hour pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months.

In addition, the researchers found, the 7-day pain visual analogue scores were significantly lower in double contour positive patients at 1 month and 3 months. No significant differences were seen between double contour positive and double contour negative patients in the Manchester Foot Pain and Disability Index or serum urate at 1 or 3 months of ultrasound.

The investigators noted that their findings indicated that persistent, nonepisodic foot pain in hyperuricemia was both associated with ultrasound features of monosodium urate deposition and was responsive to urate lowering therapy.

“Symptomatic hyperuricemia occurring prior to episodic gout therefore represents an earlier or alternative disease presentation,” they wrote. “Changes to the ACR/ EULAR classification criteria to include nonepisodic foot pain in the presence of [ultrasound] features of gout may increase the sensitivity of disease classification at an early stage, leading to improved future treatment strategies and long-term outcomes.”

No disclosures were declared.

SOURCE: Alammari YM et al. Ann Rheum Dis. 2018. doi: 10.1136/annrheumdis-2018-214305.
 

LAS VEGAS – There hasn’t been a single corneal abrasion in 860 cases of gynecologic robotic surgery at the University of Texas, Austin, since surgeons and anesthesiologists there started sealing women’s eyes shut with a thick layer of ointment and Tegaderm, instead of the usual small squeeze of ointment and tape, according to Michael T. Breen, MD, a gynecologic surgeon at the university.

M. Alexander Otto/MDedge News

Slathered eyes and Tegaderm are now standard practice at the university. Before the switch was made, there were six corneal abrasions in 231 cases over 6 months. Two of those patients stayed longer in the hospital than they would have otherwise. The changes have eliminated the problem.

The impetus for the switch was a 42-year-old woman who had a robotic hysterectomy. The surgery went fine, but then Dr. Breen had to rush back to the recovery room. The woman was screaming in pain, not from her surgery, but from her left eye.

Corneal abrasions are a well-known risk of surgery because anesthesia decreases tear production and dries the eyes. Robotic gynecologic surgery increases the risk even more, because patients are under longer than with other approaches, and the steep Trendelenburg increases intraocular pressure and eye edema, especially with excess IV fluid.

And “believe it or not, having a pulse oximeter on the dominant hand [also] increases your risk of ocular injury,” Dr. Breen said. Sometimes, patients wake up, go to rub their eyes, and drag the device across their cornea, he said.

The screaming patient – who recovered without permanent damage – prompted Dr. Breen and his colleagues to turn to the literature for solutions. “One was a fully occlusive eye dressing, more than the tape we’ve all been accustomed to, with thick eye ointment application and Tegaderm applying positive pressure to the eye,” he said.

Dr. Michael Breen/University of Texas, Austin

Dr. Breen showed his audience a slide of the setup. “It looks a little unorthodox, but this is how every one of our robotic patients now have their eyes protected. Thick gel which is then covered with a positive pressure Tegaderm,” he said.

Another change was telling patients to keep their hands off their eyes for the first few postop hours, and placing the pulse ox on the nondominant hand. The team already had been decreasing IV fluids as part of their enhanced recovery after surgery protocol, and bringing patients out of steep Trendelenburg as soon as possible.

With the changes, “the rate of corneal abrasions decreased from 2.6% to 0% – and has stayed there,” Dr. Breen said.

There’ve been no allergic reactions to Tegaderm and no eyelid problems. “What we have seen with the simple taping is that, when it comes off, so does some of the eyelid, particularly with geriatric patients. We have not seen that with Tegaderm,” he said.

“Some people use goggles to protect the eyes, and we thought initially that the camera was hitting the face, so we used the Mayo stand to protect it from the camera,” but that didn’t turn out to be the problem, he said. “Goggles actually may make things worse.”

The project had no industry funding, and Dr. Breen had no relevant disclosures.

[email protected]
 

SOURCE: Breen MT et al. 2018 AAGL Global Congress, Abstract 16.

LAS VEGAS – There hasn’t been a single corneal abrasion in 860 cases of gynecologic robotic surgery at the University of Texas, Austin, since surgeons and anesthesiologists there started sealing women’s eyes shut with a thick layer of ointment and Tegaderm, instead of the usual small squeeze of ointment and tape, according to Michael T. Breen, MD, a gynecologic surgeon at the university.

M. Alexander Otto/MDedge News

Slathered eyes and Tegaderm are now standard practice at the university. Before the switch was made, there were six corneal abrasions in 231 cases over 6 months. Two of those patients stayed longer in the hospital than they would have otherwise. The changes have eliminated the problem.

The impetus for the switch was a 42-year-old woman who had a robotic hysterectomy. The surgery went fine, but then Dr. Breen had to rush back to the recovery room. The woman was screaming in pain, not from her surgery, but from her left eye.

Corneal abrasions are a well-known risk of surgery because anesthesia decreases tear production and dries the eyes. Robotic gynecologic surgery increases the risk even more, because patients are under longer than with other approaches, and the steep Trendelenburg increases intraocular pressure and eye edema, especially with excess IV fluid.

And “believe it or not, having a pulse oximeter on the dominant hand [also] increases your risk of ocular injury,” Dr. Breen said. Sometimes, patients wake up, go to rub their eyes, and drag the device across their cornea, he said.

The screaming patient – who recovered without permanent damage – prompted Dr. Breen and his colleagues to turn to the literature for solutions. “One was a fully occlusive eye dressing, more than the tape we’ve all been accustomed to, with thick eye ointment application and Tegaderm applying positive pressure to the eye,” he said.

Dr. Michael Breen/University of Texas, Austin

Dr. Breen showed his audience a slide of the setup. “It looks a little unorthodox, but this is how every one of our robotic patients now have their eyes protected. Thick gel which is then covered with a positive pressure Tegaderm,” he said.

Another change was telling patients to keep their hands off their eyes for the first few postop hours, and placing the pulse ox on the nondominant hand. The team already had been decreasing IV fluids as part of their enhanced recovery after surgery protocol, and bringing patients out of steep Trendelenburg as soon as possible.

With the changes, “the rate of corneal abrasions decreased from 2.6% to 0% – and has stayed there,” Dr. Breen said.

There’ve been no allergic reactions to Tegaderm and no eyelid problems. “What we have seen with the simple taping is that, when it comes off, so does some of the eyelid, particularly with geriatric patients. We have not seen that with Tegaderm,” he said.

“Some people use goggles to protect the eyes, and we thought initially that the camera was hitting the face, so we used the Mayo stand to protect it from the camera,” but that didn’t turn out to be the problem, he said. “Goggles actually may make things worse.”

The project had no industry funding, and Dr. Breen had no relevant disclosures.

[email protected]
 

SOURCE: Breen MT et al. 2018 AAGL Global Congress, Abstract 16.

LAS VEGAS – There hasn’t been a single corneal abrasion in 860 cases of gynecologic robotic surgery at the University of Texas, Austin, since surgeons and anesthesiologists there started sealing women’s eyes shut with a thick layer of ointment and Tegaderm, instead of the usual small squeeze of ointment and tape, according to Michael T. Breen, MD, a gynecologic surgeon at the university.

M. Alexander Otto/MDedge News

Slathered eyes and Tegaderm are now standard practice at the university. Before the switch was made, there were six corneal abrasions in 231 cases over 6 months. Two of those patients stayed longer in the hospital than they would have otherwise. The changes have eliminated the problem.

The impetus for the switch was a 42-year-old woman who had a robotic hysterectomy. The surgery went fine, but then Dr. Breen had to rush back to the recovery room. The woman was screaming in pain, not from her surgery, but from her left eye.

Corneal abrasions are a well-known risk of surgery because anesthesia decreases tear production and dries the eyes. Robotic gynecologic surgery increases the risk even more, because patients are under longer than with other approaches, and the steep Trendelenburg increases intraocular pressure and eye edema, especially with excess IV fluid.

And “believe it or not, having a pulse oximeter on the dominant hand [also] increases your risk of ocular injury,” Dr. Breen said. Sometimes, patients wake up, go to rub their eyes, and drag the device across their cornea, he said.

The screaming patient – who recovered without permanent damage – prompted Dr. Breen and his colleagues to turn to the literature for solutions. “One was a fully occlusive eye dressing, more than the tape we’ve all been accustomed to, with thick eye ointment application and Tegaderm applying positive pressure to the eye,” he said.

Dr. Michael Breen/University of Texas, Austin

Dr. Breen showed his audience a slide of the setup. “It looks a little unorthodox, but this is how every one of our robotic patients now have their eyes protected. Thick gel which is then covered with a positive pressure Tegaderm,” he said.

Another change was telling patients to keep their hands off their eyes for the first few postop hours, and placing the pulse ox on the nondominant hand. The team already had been decreasing IV fluids as part of their enhanced recovery after surgery protocol, and bringing patients out of steep Trendelenburg as soon as possible.

With the changes, “the rate of corneal abrasions decreased from 2.6% to 0% – and has stayed there,” Dr. Breen said.

There’ve been no allergic reactions to Tegaderm and no eyelid problems. “What we have seen with the simple taping is that, when it comes off, so does some of the eyelid, particularly with geriatric patients. We have not seen that with Tegaderm,” he said.

“Some people use goggles to protect the eyes, and we thought initially that the camera was hitting the face, so we used the Mayo stand to protect it from the camera,” but that didn’t turn out to be the problem, he said. “Goggles actually may make things worse.”

The project had no industry funding, and Dr. Breen had no relevant disclosures.

[email protected]
 

SOURCE: Breen MT et al. 2018 AAGL Global Congress, Abstract 16.