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A prescription for health literacy
As physicians, we have a responsibility to stay abreast of the medical literature to provide state of the art pediatric care. We have at our disposal reliable resources to stay current, from professional organizations that provide us with updated practice guidelines, to scientific publications with cutting-edge medical research and clinical databases that offer support for medical decision making.
The greater public, however, does not have the luxury of a guide to navigate the health information ocean. In addition to traditional news outlets, such as television and the printed press, the advent of the Internet and social media have placed unprecedented amounts of medical information at everyone’s fingertips.1 But not all health information is created equal, and even “Dr. Google” has admitted its symptoms search engine has not been very helpful.2
Many websites, despite authoritarian-sounding domain names, are not impartial providers of medical information. The power of the media to shape public perception is perhaps nowhere more poignantly felt than in the pediatric community, where the now thoroughly debunked study by Dr. Andrew Wakefield that linked the MMR vaccine to autism continues to have lingering effects on vaccination rates.3,4
I recently completed an internship in medical journalism with ABC News in New York City to better understand how the news media provides health and medical information to millions of Americans. Lay medical journalists have the complicated task of reviewing new research, weighing its newsworthiness, and distilling complex concepts down to easy-to-digest sound bites. Working with medical correspondents and the editorial team, I reviewed new scientific studies, dissected their impact, and pondered their potential for a catchy headline. I also wrote content for medical segments and participated in educational Twitter chats. What made the headlines wasn’t always what I thought should make the headlines, and translating the results of a randomized, controlled trial into a 60-second script for television felt near impossible. Dipping my toes into medical journalism gave me a new appreciation of my role as a physician educator – avoiding health information overload and promoting meaningful health literacy for my patients.
The 24/7 medical news cycle is here to stay. Our patients will continue to use various media platforms for medical information whether we like it or not. It is our responsibility as pediatricians to help families get the most relevant and current medical information. By directing them to trustworthy sources, such as the American Academy of Pediatrics at healthychildren.org or the National Library of Medicine at www.nlm.nih.gov/medlineplus, we can strengthen our therapeutic alliance while promoting health literacy.
References
1. Interact J Med Res. 2015 Jun 22;4(2):e12.
3. “A Discredited Vaccine Study’s Continuing Impact on Public Health,” by Clyde Haberman, Feb. 1, 2015.
4. Ann Pharmacother. 2011 Oct;45(10):1302-4.
Dr. Talbot is a third-year resident at Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.
As physicians, we have a responsibility to stay abreast of the medical literature to provide state of the art pediatric care. We have at our disposal reliable resources to stay current, from professional organizations that provide us with updated practice guidelines, to scientific publications with cutting-edge medical research and clinical databases that offer support for medical decision making.
The greater public, however, does not have the luxury of a guide to navigate the health information ocean. In addition to traditional news outlets, such as television and the printed press, the advent of the Internet and social media have placed unprecedented amounts of medical information at everyone’s fingertips.1 But not all health information is created equal, and even “Dr. Google” has admitted its symptoms search engine has not been very helpful.2
Many websites, despite authoritarian-sounding domain names, are not impartial providers of medical information. The power of the media to shape public perception is perhaps nowhere more poignantly felt than in the pediatric community, where the now thoroughly debunked study by Dr. Andrew Wakefield that linked the MMR vaccine to autism continues to have lingering effects on vaccination rates.3,4
I recently completed an internship in medical journalism with ABC News in New York City to better understand how the news media provides health and medical information to millions of Americans. Lay medical journalists have the complicated task of reviewing new research, weighing its newsworthiness, and distilling complex concepts down to easy-to-digest sound bites. Working with medical correspondents and the editorial team, I reviewed new scientific studies, dissected their impact, and pondered their potential for a catchy headline. I also wrote content for medical segments and participated in educational Twitter chats. What made the headlines wasn’t always what I thought should make the headlines, and translating the results of a randomized, controlled trial into a 60-second script for television felt near impossible. Dipping my toes into medical journalism gave me a new appreciation of my role as a physician educator – avoiding health information overload and promoting meaningful health literacy for my patients.
The 24/7 medical news cycle is here to stay. Our patients will continue to use various media platforms for medical information whether we like it or not. It is our responsibility as pediatricians to help families get the most relevant and current medical information. By directing them to trustworthy sources, such as the American Academy of Pediatrics at healthychildren.org or the National Library of Medicine at www.nlm.nih.gov/medlineplus, we can strengthen our therapeutic alliance while promoting health literacy.
References
1. Interact J Med Res. 2015 Jun 22;4(2):e12.
3. “A Discredited Vaccine Study’s Continuing Impact on Public Health,” by Clyde Haberman, Feb. 1, 2015.
4. Ann Pharmacother. 2011 Oct;45(10):1302-4.
Dr. Talbot is a third-year resident at Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.
As physicians, we have a responsibility to stay abreast of the medical literature to provide state of the art pediatric care. We have at our disposal reliable resources to stay current, from professional organizations that provide us with updated practice guidelines, to scientific publications with cutting-edge medical research and clinical databases that offer support for medical decision making.
The greater public, however, does not have the luxury of a guide to navigate the health information ocean. In addition to traditional news outlets, such as television and the printed press, the advent of the Internet and social media have placed unprecedented amounts of medical information at everyone’s fingertips.1 But not all health information is created equal, and even “Dr. Google” has admitted its symptoms search engine has not been very helpful.2
Many websites, despite authoritarian-sounding domain names, are not impartial providers of medical information. The power of the media to shape public perception is perhaps nowhere more poignantly felt than in the pediatric community, where the now thoroughly debunked study by Dr. Andrew Wakefield that linked the MMR vaccine to autism continues to have lingering effects on vaccination rates.3,4
I recently completed an internship in medical journalism with ABC News in New York City to better understand how the news media provides health and medical information to millions of Americans. Lay medical journalists have the complicated task of reviewing new research, weighing its newsworthiness, and distilling complex concepts down to easy-to-digest sound bites. Working with medical correspondents and the editorial team, I reviewed new scientific studies, dissected their impact, and pondered their potential for a catchy headline. I also wrote content for medical segments and participated in educational Twitter chats. What made the headlines wasn’t always what I thought should make the headlines, and translating the results of a randomized, controlled trial into a 60-second script for television felt near impossible. Dipping my toes into medical journalism gave me a new appreciation of my role as a physician educator – avoiding health information overload and promoting meaningful health literacy for my patients.
The 24/7 medical news cycle is here to stay. Our patients will continue to use various media platforms for medical information whether we like it or not. It is our responsibility as pediatricians to help families get the most relevant and current medical information. By directing them to trustworthy sources, such as the American Academy of Pediatrics at healthychildren.org or the National Library of Medicine at www.nlm.nih.gov/medlineplus, we can strengthen our therapeutic alliance while promoting health literacy.
References
1. Interact J Med Res. 2015 Jun 22;4(2):e12.
3. “A Discredited Vaccine Study’s Continuing Impact on Public Health,” by Clyde Haberman, Feb. 1, 2015.
4. Ann Pharmacother. 2011 Oct;45(10):1302-4.
Dr. Talbot is a third-year resident at Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.
Resolving patients’ complaints
For most physicians, the resolution of patients’ complaints ranks second only to firing an employee on the Least Favorite Tasks List. With so many potential problems, and so many ways patients can react to them, it seems impossible to construct any sort of template for consistent, mutually satisfactory resolutions.
But it can be done, and it’s not as complex as it appears, once you realize that the vast majority of complaints have the same basic root: The patient’s expectations have not been met. Sometimes it’s your fault, sometimes the patient’s, and often a bit of both. Either way, the result is the same: You have an unhappy patient, and you must deal with it.
In most cases, this is not a job you should delegate. Unless the complaint is trivial or purely administrative, you should address it yourself. It’s what you would want if you were the complainant, and it’s often too important to trust to a subordinate.
I have distilled this unpleasant duty down to a simple three-part strategy:
• Discover which expectations went unmet, and why.
• Agree on a solution.
• Learn from the experience, to prevent similar future complaints.
At this point, you may be asking, “Why should I care? Is the personal expenditure of my time and effort necessary to resolve complaints really worth it?” Absolutely, because the old cliché is true: A satisfied patient will refer 5 new patients, but a dissatisfied one will chase away 20 or more. Besides, if the complaint is significant, and you won’t resolve it, the patient is likely to find someone who will; and chances are you won’t like the choice, or the venue – or the eventual resolution.
Of course, the easiest way to deal with complaints is to prevent as many as possible in the first place. Try to nip unrealistic expectations in the bud. Take the time to explain all treatments and procedures, and their most likely outcomes, in a clear and honest manner. And since even the most astute patients will not absorb everything you tell them, make liberal use of written handouts and other visual aids.
And, of course, document everything you have explained. Documentation is like garlic: There is no such thing as too much of it.
But despite your best efforts, there will always be complaints, and handling them is a skill set worth honing. The most important skill in that set is the one most people – especially physicians – do poorly: listening to the complaint. Before you can resolve a problem you have to know what it is, and this is precisely the wrong time to make assumptions or jump to conclusions.
So listen to the entire complaint without interrupting, defending, or justifying. Angry patients don’t care why the problem occurred, and they are not interested in your side of the story. This is not about you, so listen and understand.
As you listen, the unmet expectations will become clear. When the patient is finished, I like to summarize the complaint in that context: “So if I understand you correctly, you expected “X” to happen, but “Y” happened instead.” If I’m wrong, I modify my summary until the patient agrees that I understand the problem.
Once you know the problem, you can talk about a solution. The patient usually has one in mind – additional treatment, a referral elsewhere, a fee adjustment, or sometimes simply an apology. Consider it.
If the patient’s solution is reasonable, by all means, agree to it; if it is unreasonable, try to offer a reasonable alternative. The temptation here is to think more about protecting yourself than making the patient happy, but that often leads to bigger problems. Don’t be defensive. Again, this is not about you.
I am often asked if refunding a fee is a reasonable option. Some patients (and lawyers) will interpret a refund as a tacit admission of guilt, so I generally try to avoid them. However, canceling a small fee for an angry patient can be an expedient solution, and in my opinion looks exactly like what it is: an honest effort to rectify the situation. But in general, additional materials or services, at reduced or waived fees, are a better alternative than refunding money.
Once you have arrived at a mutually satisfactory solution, again, document everything; but consider reserving a “private” chart area for such documentation (unless it is a bona fide clinical issue), so that it won’t go out to referrers and other third parties with copies of your clinical notes. Also, consider having the patient sign off on the documentation, acknowledging that the complaint has been resolved.
Finally, always try to learn something from the experience. Ask yourself how you might prevent a repetition of the complaint, what you did that you can avoid doing next time, and how you might prevent unrealistic expectations in a similar future situation.
Above all, never take complaints personally – even when they are personal. It’s always worth reminding yourself that no matter how hard you try, you can never please everyone.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at dermnews@frontlinemedcom.com.
For most physicians, the resolution of patients’ complaints ranks second only to firing an employee on the Least Favorite Tasks List. With so many potential problems, and so many ways patients can react to them, it seems impossible to construct any sort of template for consistent, mutually satisfactory resolutions.
But it can be done, and it’s not as complex as it appears, once you realize that the vast majority of complaints have the same basic root: The patient’s expectations have not been met. Sometimes it’s your fault, sometimes the patient’s, and often a bit of both. Either way, the result is the same: You have an unhappy patient, and you must deal with it.
In most cases, this is not a job you should delegate. Unless the complaint is trivial or purely administrative, you should address it yourself. It’s what you would want if you were the complainant, and it’s often too important to trust to a subordinate.
I have distilled this unpleasant duty down to a simple three-part strategy:
• Discover which expectations went unmet, and why.
• Agree on a solution.
• Learn from the experience, to prevent similar future complaints.
At this point, you may be asking, “Why should I care? Is the personal expenditure of my time and effort necessary to resolve complaints really worth it?” Absolutely, because the old cliché is true: A satisfied patient will refer 5 new patients, but a dissatisfied one will chase away 20 or more. Besides, if the complaint is significant, and you won’t resolve it, the patient is likely to find someone who will; and chances are you won’t like the choice, or the venue – or the eventual resolution.
Of course, the easiest way to deal with complaints is to prevent as many as possible in the first place. Try to nip unrealistic expectations in the bud. Take the time to explain all treatments and procedures, and their most likely outcomes, in a clear and honest manner. And since even the most astute patients will not absorb everything you tell them, make liberal use of written handouts and other visual aids.
And, of course, document everything you have explained. Documentation is like garlic: There is no such thing as too much of it.
But despite your best efforts, there will always be complaints, and handling them is a skill set worth honing. The most important skill in that set is the one most people – especially physicians – do poorly: listening to the complaint. Before you can resolve a problem you have to know what it is, and this is precisely the wrong time to make assumptions or jump to conclusions.
So listen to the entire complaint without interrupting, defending, or justifying. Angry patients don’t care why the problem occurred, and they are not interested in your side of the story. This is not about you, so listen and understand.
As you listen, the unmet expectations will become clear. When the patient is finished, I like to summarize the complaint in that context: “So if I understand you correctly, you expected “X” to happen, but “Y” happened instead.” If I’m wrong, I modify my summary until the patient agrees that I understand the problem.
Once you know the problem, you can talk about a solution. The patient usually has one in mind – additional treatment, a referral elsewhere, a fee adjustment, or sometimes simply an apology. Consider it.
If the patient’s solution is reasonable, by all means, agree to it; if it is unreasonable, try to offer a reasonable alternative. The temptation here is to think more about protecting yourself than making the patient happy, but that often leads to bigger problems. Don’t be defensive. Again, this is not about you.
I am often asked if refunding a fee is a reasonable option. Some patients (and lawyers) will interpret a refund as a tacit admission of guilt, so I generally try to avoid them. However, canceling a small fee for an angry patient can be an expedient solution, and in my opinion looks exactly like what it is: an honest effort to rectify the situation. But in general, additional materials or services, at reduced or waived fees, are a better alternative than refunding money.
Once you have arrived at a mutually satisfactory solution, again, document everything; but consider reserving a “private” chart area for such documentation (unless it is a bona fide clinical issue), so that it won’t go out to referrers and other third parties with copies of your clinical notes. Also, consider having the patient sign off on the documentation, acknowledging that the complaint has been resolved.
Finally, always try to learn something from the experience. Ask yourself how you might prevent a repetition of the complaint, what you did that you can avoid doing next time, and how you might prevent unrealistic expectations in a similar future situation.
Above all, never take complaints personally – even when they are personal. It’s always worth reminding yourself that no matter how hard you try, you can never please everyone.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at dermnews@frontlinemedcom.com.
For most physicians, the resolution of patients’ complaints ranks second only to firing an employee on the Least Favorite Tasks List. With so many potential problems, and so many ways patients can react to them, it seems impossible to construct any sort of template for consistent, mutually satisfactory resolutions.
But it can be done, and it’s not as complex as it appears, once you realize that the vast majority of complaints have the same basic root: The patient’s expectations have not been met. Sometimes it’s your fault, sometimes the patient’s, and often a bit of both. Either way, the result is the same: You have an unhappy patient, and you must deal with it.
In most cases, this is not a job you should delegate. Unless the complaint is trivial or purely administrative, you should address it yourself. It’s what you would want if you were the complainant, and it’s often too important to trust to a subordinate.
I have distilled this unpleasant duty down to a simple three-part strategy:
• Discover which expectations went unmet, and why.
• Agree on a solution.
• Learn from the experience, to prevent similar future complaints.
At this point, you may be asking, “Why should I care? Is the personal expenditure of my time and effort necessary to resolve complaints really worth it?” Absolutely, because the old cliché is true: A satisfied patient will refer 5 new patients, but a dissatisfied one will chase away 20 or more. Besides, if the complaint is significant, and you won’t resolve it, the patient is likely to find someone who will; and chances are you won’t like the choice, or the venue – or the eventual resolution.
Of course, the easiest way to deal with complaints is to prevent as many as possible in the first place. Try to nip unrealistic expectations in the bud. Take the time to explain all treatments and procedures, and their most likely outcomes, in a clear and honest manner. And since even the most astute patients will not absorb everything you tell them, make liberal use of written handouts and other visual aids.
And, of course, document everything you have explained. Documentation is like garlic: There is no such thing as too much of it.
But despite your best efforts, there will always be complaints, and handling them is a skill set worth honing. The most important skill in that set is the one most people – especially physicians – do poorly: listening to the complaint. Before you can resolve a problem you have to know what it is, and this is precisely the wrong time to make assumptions or jump to conclusions.
So listen to the entire complaint without interrupting, defending, or justifying. Angry patients don’t care why the problem occurred, and they are not interested in your side of the story. This is not about you, so listen and understand.
As you listen, the unmet expectations will become clear. When the patient is finished, I like to summarize the complaint in that context: “So if I understand you correctly, you expected “X” to happen, but “Y” happened instead.” If I’m wrong, I modify my summary until the patient agrees that I understand the problem.
Once you know the problem, you can talk about a solution. The patient usually has one in mind – additional treatment, a referral elsewhere, a fee adjustment, or sometimes simply an apology. Consider it.
If the patient’s solution is reasonable, by all means, agree to it; if it is unreasonable, try to offer a reasonable alternative. The temptation here is to think more about protecting yourself than making the patient happy, but that often leads to bigger problems. Don’t be defensive. Again, this is not about you.
I am often asked if refunding a fee is a reasonable option. Some patients (and lawyers) will interpret a refund as a tacit admission of guilt, so I generally try to avoid them. However, canceling a small fee for an angry patient can be an expedient solution, and in my opinion looks exactly like what it is: an honest effort to rectify the situation. But in general, additional materials or services, at reduced or waived fees, are a better alternative than refunding money.
Once you have arrived at a mutually satisfactory solution, again, document everything; but consider reserving a “private” chart area for such documentation (unless it is a bona fide clinical issue), so that it won’t go out to referrers and other third parties with copies of your clinical notes. Also, consider having the patient sign off on the documentation, acknowledging that the complaint has been resolved.
Finally, always try to learn something from the experience. Ask yourself how you might prevent a repetition of the complaint, what you did that you can avoid doing next time, and how you might prevent unrealistic expectations in a similar future situation.
Above all, never take complaints personally – even when they are personal. It’s always worth reminding yourself that no matter how hard you try, you can never please everyone.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at dermnews@frontlinemedcom.com.
A welcome addition
On behalf of the SVS Publications Committee I am delighted to announce the appointment of Malachi Sheahan, III, M.D., as Associate Medical Editor of Vascular Specialist. I am sure readers will realize this official newspaper of the Society for Vascular Surgery has grown substantially over the last few years. With the help of generous advertisers we now “publish” Vascular Specialist not only in print but in multiple formats. These include electronic versions on the Web, Facebook, and Twitter, as well as mobile versions for smartphones and tablets. The print version is now published monthly and most often as 20 pages.
Further, www.vascularspecialistonline.com includes many articles not found in the print edition. Articles can be searched based on subject and author and the print version can be seen in PDF version. The web version also allows readers to answer polls posed in the print edition. These are archived for review.
A recent survey of 250 members of the SVS confirmed that Vascular Specialist is now the most widely read vascular news publication. More importantly, it was considered by far the most authoritative.
This expansion requires a significant expenditure of time by the Associate Editors and the Medical Editor in particular. Accordingly, it is essential that the medical editorial staff be supplemented by an Associate Medical Editor. This will also allow the smooth transition when the Medical Editor’s appointment terminates.
Mal has already proven to be an excellent writer, and his commitment to the SVS, resident/fellow training, and his sense of humor make him an outstanding choice to assume this position. Mal completed his vascular surgery training at the Beth Israel Deaconess program in 2003. Shortly thereafter he joined the faculty at the Louisiana State University Health Sciences Center in New Orleans. He currently serves as the program director for both their integrated and independent vascular training programs. In 2014, he was named the Claude C. Craighead Jr. Professor and Chair of the Division of Vascular and Endovascular Surgery.
I have previously requested that all members consider themselves not only readers but also contributors. Once again I encourage you to send Mal and me opinion pieces or letters to the editor. We also welcome Tips and Tricks. These can be quite short and do not require any references. They are meant to highlight a technique that you have found to be helpful in performing an open or endovascular procedure. One or two photos often help the piece but they must be in .jpg format and at least 124kb. If you are so inclined we will also print your photo and affiliation alongside. However, we regret you cannot submit your high school photo or substitute one of Tom Cruise or Beyoncé! Don’t worry that you may not be a Pulitzer Prize journalist since we have professional writers who will tidy up your writing as necessary. We also welcome suggestions about news items that we may have missed or overlooked. These may be news items from the lay press or a manuscript you read in a journal other than the JVS. Again, our professional reporters will turn the item into a news article. You can also send us a comment and, if appropriate, we will print it as a sidebar to the article.
Further, we encourage news about your comings and goings which we can publish in the “From the community” section. Executive members of the various regional Societies can also utilize this section to bring us news about their Societies activities.
In order to keep the commentaries fresh, we do need to rotate the members of the editorial board. So, if you would like to be considered for such a position, please send us a short biography and your area of interest. This could be related to a disease process, treatment, or socioeconomic issues. Associate Editors will be required to read short news items about 12 times a year and to provide commentary when requested. Even if you are not selected we may occasionally turn to you to write a comment on a news item related to your stated interest.
The SVS wants Vascular Specialist to be YOUR newspaper. Please help us achieve that goal as we continue to make Vascular Specialist the most read and respected supplier of news and opinions about vascular surgery and vascular surgeons.
You can contact me at RSamson@veinsandarteries.com and Dr. Sheahan at msheah@lsuhsc.edu.
On behalf of the SVS Publications Committee I am delighted to announce the appointment of Malachi Sheahan, III, M.D., as Associate Medical Editor of Vascular Specialist. I am sure readers will realize this official newspaper of the Society for Vascular Surgery has grown substantially over the last few years. With the help of generous advertisers we now “publish” Vascular Specialist not only in print but in multiple formats. These include electronic versions on the Web, Facebook, and Twitter, as well as mobile versions for smartphones and tablets. The print version is now published monthly and most often as 20 pages.
Further, www.vascularspecialistonline.com includes many articles not found in the print edition. Articles can be searched based on subject and author and the print version can be seen in PDF version. The web version also allows readers to answer polls posed in the print edition. These are archived for review.
A recent survey of 250 members of the SVS confirmed that Vascular Specialist is now the most widely read vascular news publication. More importantly, it was considered by far the most authoritative.
This expansion requires a significant expenditure of time by the Associate Editors and the Medical Editor in particular. Accordingly, it is essential that the medical editorial staff be supplemented by an Associate Medical Editor. This will also allow the smooth transition when the Medical Editor’s appointment terminates.
Mal has already proven to be an excellent writer, and his commitment to the SVS, resident/fellow training, and his sense of humor make him an outstanding choice to assume this position. Mal completed his vascular surgery training at the Beth Israel Deaconess program in 2003. Shortly thereafter he joined the faculty at the Louisiana State University Health Sciences Center in New Orleans. He currently serves as the program director for both their integrated and independent vascular training programs. In 2014, he was named the Claude C. Craighead Jr. Professor and Chair of the Division of Vascular and Endovascular Surgery.
I have previously requested that all members consider themselves not only readers but also contributors. Once again I encourage you to send Mal and me opinion pieces or letters to the editor. We also welcome Tips and Tricks. These can be quite short and do not require any references. They are meant to highlight a technique that you have found to be helpful in performing an open or endovascular procedure. One or two photos often help the piece but they must be in .jpg format and at least 124kb. If you are so inclined we will also print your photo and affiliation alongside. However, we regret you cannot submit your high school photo or substitute one of Tom Cruise or Beyoncé! Don’t worry that you may not be a Pulitzer Prize journalist since we have professional writers who will tidy up your writing as necessary. We also welcome suggestions about news items that we may have missed or overlooked. These may be news items from the lay press or a manuscript you read in a journal other than the JVS. Again, our professional reporters will turn the item into a news article. You can also send us a comment and, if appropriate, we will print it as a sidebar to the article.
Further, we encourage news about your comings and goings which we can publish in the “From the community” section. Executive members of the various regional Societies can also utilize this section to bring us news about their Societies activities.
In order to keep the commentaries fresh, we do need to rotate the members of the editorial board. So, if you would like to be considered for such a position, please send us a short biography and your area of interest. This could be related to a disease process, treatment, or socioeconomic issues. Associate Editors will be required to read short news items about 12 times a year and to provide commentary when requested. Even if you are not selected we may occasionally turn to you to write a comment on a news item related to your stated interest.
The SVS wants Vascular Specialist to be YOUR newspaper. Please help us achieve that goal as we continue to make Vascular Specialist the most read and respected supplier of news and opinions about vascular surgery and vascular surgeons.
You can contact me at RSamson@veinsandarteries.com and Dr. Sheahan at msheah@lsuhsc.edu.
On behalf of the SVS Publications Committee I am delighted to announce the appointment of Malachi Sheahan, III, M.D., as Associate Medical Editor of Vascular Specialist. I am sure readers will realize this official newspaper of the Society for Vascular Surgery has grown substantially over the last few years. With the help of generous advertisers we now “publish” Vascular Specialist not only in print but in multiple formats. These include electronic versions on the Web, Facebook, and Twitter, as well as mobile versions for smartphones and tablets. The print version is now published monthly and most often as 20 pages.
Further, www.vascularspecialistonline.com includes many articles not found in the print edition. Articles can be searched based on subject and author and the print version can be seen in PDF version. The web version also allows readers to answer polls posed in the print edition. These are archived for review.
A recent survey of 250 members of the SVS confirmed that Vascular Specialist is now the most widely read vascular news publication. More importantly, it was considered by far the most authoritative.
This expansion requires a significant expenditure of time by the Associate Editors and the Medical Editor in particular. Accordingly, it is essential that the medical editorial staff be supplemented by an Associate Medical Editor. This will also allow the smooth transition when the Medical Editor’s appointment terminates.
Mal has already proven to be an excellent writer, and his commitment to the SVS, resident/fellow training, and his sense of humor make him an outstanding choice to assume this position. Mal completed his vascular surgery training at the Beth Israel Deaconess program in 2003. Shortly thereafter he joined the faculty at the Louisiana State University Health Sciences Center in New Orleans. He currently serves as the program director for both their integrated and independent vascular training programs. In 2014, he was named the Claude C. Craighead Jr. Professor and Chair of the Division of Vascular and Endovascular Surgery.
I have previously requested that all members consider themselves not only readers but also contributors. Once again I encourage you to send Mal and me opinion pieces or letters to the editor. We also welcome Tips and Tricks. These can be quite short and do not require any references. They are meant to highlight a technique that you have found to be helpful in performing an open or endovascular procedure. One or two photos often help the piece but they must be in .jpg format and at least 124kb. If you are so inclined we will also print your photo and affiliation alongside. However, we regret you cannot submit your high school photo or substitute one of Tom Cruise or Beyoncé! Don’t worry that you may not be a Pulitzer Prize journalist since we have professional writers who will tidy up your writing as necessary. We also welcome suggestions about news items that we may have missed or overlooked. These may be news items from the lay press or a manuscript you read in a journal other than the JVS. Again, our professional reporters will turn the item into a news article. You can also send us a comment and, if appropriate, we will print it as a sidebar to the article.
Further, we encourage news about your comings and goings which we can publish in the “From the community” section. Executive members of the various regional Societies can also utilize this section to bring us news about their Societies activities.
In order to keep the commentaries fresh, we do need to rotate the members of the editorial board. So, if you would like to be considered for such a position, please send us a short biography and your area of interest. This could be related to a disease process, treatment, or socioeconomic issues. Associate Editors will be required to read short news items about 12 times a year and to provide commentary when requested. Even if you are not selected we may occasionally turn to you to write a comment on a news item related to your stated interest.
The SVS wants Vascular Specialist to be YOUR newspaper. Please help us achieve that goal as we continue to make Vascular Specialist the most read and respected supplier of news and opinions about vascular surgery and vascular surgeons.
You can contact me at RSamson@veinsandarteries.com and Dr. Sheahan at msheah@lsuhsc.edu.
From the Washington Office: The operationalization of MACRA
On April 27, 2016, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule on the Medicare Access and CHIP Reauthorization Act (MACRA). Fellows will remember that the MACRA legislation, passed in April of 2015, permanently repealed the Sustainable Growth Rate (SGR) formula and thus, represents the greatest sea change in Medicare physician payment since the establishment of the RBRVS (Resource-Based Relative Value Scale) in 1992.
In broadest policy terms, the law continues to advance the CMS policy goal of basing payment on quality and value over volume. From a granular perspective, the law combines Medicare’s three current quality programs into one new system. CMS published this 982-page proposed rule after reviewing the comments submitted by ACS and other interested parties in response to its request for information last fall. As I write, staff of the Division of Advocacy and Health Policy are in the process of crafting the ACS response to the proposed rule. Comments were due on June 27, 2016. It is anticipated that CMS will publish the final rule later this year, likely in late October or early November. Accordingly, the following description of the implementation of MACRA is based on the current understanding from the proposed rule, and is likely to change in some respects with the final rule.
CMS has designated the payment program operationalizing the MACRA law as the Quality Payment Program (QPP). The QPP has two tracks, the Merit-based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs). For the first several years of the program, it is widely expected that the vast majority of physicians will participate in the QPP via the MIPS track. As such, I will direct the remainder of the text this month to the MIPS program.
MIPS: Merit-Based Incentive Payment System
The Merit-based Incentive Payment System, MIPS, consists of four components. They are: Quality, Resource Use, Advancing Care Information (ACI) and the Clinical Practice Improvement Activities (CPIA). Though the names have changed, Fellows are familiar with the substance of three of the components. For example, the Quality component replaces the Physician Quality Reporting System (PQRS); the Resource Use component replaces the Value-Based Modifier (VBM); and the Advancing Care Information component modifies and replaces the Electronic Health Record Meaningful Use (EHR-MU) program. The fourth component of MIPS is the new Clinical Practice Improvement Activities, which the legislation designates as intended to provide “credit for work to improve practice and facilitates future participation in alternative payment models.”
Composite Performance Score: MIPS participants will be assigned a Composite Performance Score based on their performance in all four components. For 2017, the first year for assessment under the QPP, 50 percent of the score will be based on performance in the Quality component, 10 percent will be based on the Resource Use component, 25 percent will be based on the Advancing Care Information component, and 15 percent will be based on the Clinical Practice Improvement Activities. In future years, there will be a gradual increase in the relative value of the Resource Use component with an equal and accompanying decrease in the value of the Quality component. As proposed, by the third assessment year (2019), the Quality and Resource Use components are expected to each account for 30 percent of the Composite Performance Score.
MIPS Quality Component: Though the Quality component of MIPS replaces the PQRS, CMS is proposing some changes that Fellows will welcome. As opposed to the previous PQRS requirement to report nine measures, the MIPS Quality component requires providers to report only six measures. One of these six must be an “Outcome” measure and another must be a “Cross-cutting” measure. While the reporting threshold for the percentage of patients on which reports will be required is proposed to increase substantially, ACS and other physician groups will be advocating that the required percentage published in the final rule be close to the 50 percent level found in current law.
Resources Use Component: There is also some good news relative to the Resource Use component in that there are NO reporting requirements. CMS will calculate this component from Medicare claims data and base its assessment of individual provider performance on the resource measures currently used for the Value-Based Modifier. Namely, those are the VBM Total per Capita Cost measure and the VBM Medicare Spending per Beneficiary measure. In addition, CMS will also be taking into account measures that specifically focus on episodes of care, something for which the College has previously advocated. Beginning in 2018, CMS plans to also take into consideration factors of patient condition and patient relation in order to address physician concerns about risk adjustment and attribution.
Advancing Care Information Component: This modifies and replaces the Electronic Health Record Meaningful Use program. The score for this component is derived in two parts, a Base score (50 percent) and a Performance score (up to an additional 50 percent). The threshold for achieving the Base score remains “all or nothing.” Only after meeting the requirements for the Base score is one eligible to receive additional Performance score credit based on the level of performance on a subset of the same measures required to achieve the Base score. Assessment in 2017 will be based on the EHR-MU requirements published in the 2015 Final Rule for the EHR-MU program.
Clinical Practice Improvement Component: The fourth component of MIPS is the Clinical Practice Improvement Activities component. As mentioned previously, this is a new requirement with no prior analogous program requirement. As such, it is very much in evolution. In the first year of MIPS assessment (2017), achieving full credit for the CPIA component should not pose much additional administrative burden as reporting will be by simple attestation. Physicians will chose from a list of 94 activities assigned two different weighted values. In order to receive full credit for the CPIA component, most providers will need to attest that they have participated in a minimum of three and a maximum of six of the 94 activities, depending on the weight of the activities selected, for 90 days.
As outlined above, the final rule on the Quality Payment Program is expected to be released in late October or early November. As proposed, assessment under the provisions of that final rule would begin in January of 2017. This leaves all providers with a very short time window in which to become familiar with the program that will impact their Medicare payment beginning in 2019.
Accordingly, in the next several editions of this column, I will provide more specific information about each of the four MIPS components, the scoring mechanism for MIPS assessment and the aforementioned alternate track to MIPS, the Alternative Payment Models. While it is easy to understand how many Fellows could initially find this change daunting and overwhelming, I am confident that with a minimal investment of time all can develop adequate working knowledge of the MIPS and APMs to participate successfully in the QPP.
Until next month...
Dr. Bailey is an ACS Fellow, a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington.
On April 27, 2016, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule on the Medicare Access and CHIP Reauthorization Act (MACRA). Fellows will remember that the MACRA legislation, passed in April of 2015, permanently repealed the Sustainable Growth Rate (SGR) formula and thus, represents the greatest sea change in Medicare physician payment since the establishment of the RBRVS (Resource-Based Relative Value Scale) in 1992.
In broadest policy terms, the law continues to advance the CMS policy goal of basing payment on quality and value over volume. From a granular perspective, the law combines Medicare’s three current quality programs into one new system. CMS published this 982-page proposed rule after reviewing the comments submitted by ACS and other interested parties in response to its request for information last fall. As I write, staff of the Division of Advocacy and Health Policy are in the process of crafting the ACS response to the proposed rule. Comments were due on June 27, 2016. It is anticipated that CMS will publish the final rule later this year, likely in late October or early November. Accordingly, the following description of the implementation of MACRA is based on the current understanding from the proposed rule, and is likely to change in some respects with the final rule.
CMS has designated the payment program operationalizing the MACRA law as the Quality Payment Program (QPP). The QPP has two tracks, the Merit-based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs). For the first several years of the program, it is widely expected that the vast majority of physicians will participate in the QPP via the MIPS track. As such, I will direct the remainder of the text this month to the MIPS program.
MIPS: Merit-Based Incentive Payment System
The Merit-based Incentive Payment System, MIPS, consists of four components. They are: Quality, Resource Use, Advancing Care Information (ACI) and the Clinical Practice Improvement Activities (CPIA). Though the names have changed, Fellows are familiar with the substance of three of the components. For example, the Quality component replaces the Physician Quality Reporting System (PQRS); the Resource Use component replaces the Value-Based Modifier (VBM); and the Advancing Care Information component modifies and replaces the Electronic Health Record Meaningful Use (EHR-MU) program. The fourth component of MIPS is the new Clinical Practice Improvement Activities, which the legislation designates as intended to provide “credit for work to improve practice and facilitates future participation in alternative payment models.”
Composite Performance Score: MIPS participants will be assigned a Composite Performance Score based on their performance in all four components. For 2017, the first year for assessment under the QPP, 50 percent of the score will be based on performance in the Quality component, 10 percent will be based on the Resource Use component, 25 percent will be based on the Advancing Care Information component, and 15 percent will be based on the Clinical Practice Improvement Activities. In future years, there will be a gradual increase in the relative value of the Resource Use component with an equal and accompanying decrease in the value of the Quality component. As proposed, by the third assessment year (2019), the Quality and Resource Use components are expected to each account for 30 percent of the Composite Performance Score.
MIPS Quality Component: Though the Quality component of MIPS replaces the PQRS, CMS is proposing some changes that Fellows will welcome. As opposed to the previous PQRS requirement to report nine measures, the MIPS Quality component requires providers to report only six measures. One of these six must be an “Outcome” measure and another must be a “Cross-cutting” measure. While the reporting threshold for the percentage of patients on which reports will be required is proposed to increase substantially, ACS and other physician groups will be advocating that the required percentage published in the final rule be close to the 50 percent level found in current law.
Resources Use Component: There is also some good news relative to the Resource Use component in that there are NO reporting requirements. CMS will calculate this component from Medicare claims data and base its assessment of individual provider performance on the resource measures currently used for the Value-Based Modifier. Namely, those are the VBM Total per Capita Cost measure and the VBM Medicare Spending per Beneficiary measure. In addition, CMS will also be taking into account measures that specifically focus on episodes of care, something for which the College has previously advocated. Beginning in 2018, CMS plans to also take into consideration factors of patient condition and patient relation in order to address physician concerns about risk adjustment and attribution.
Advancing Care Information Component: This modifies and replaces the Electronic Health Record Meaningful Use program. The score for this component is derived in two parts, a Base score (50 percent) and a Performance score (up to an additional 50 percent). The threshold for achieving the Base score remains “all or nothing.” Only after meeting the requirements for the Base score is one eligible to receive additional Performance score credit based on the level of performance on a subset of the same measures required to achieve the Base score. Assessment in 2017 will be based on the EHR-MU requirements published in the 2015 Final Rule for the EHR-MU program.
Clinical Practice Improvement Component: The fourth component of MIPS is the Clinical Practice Improvement Activities component. As mentioned previously, this is a new requirement with no prior analogous program requirement. As such, it is very much in evolution. In the first year of MIPS assessment (2017), achieving full credit for the CPIA component should not pose much additional administrative burden as reporting will be by simple attestation. Physicians will chose from a list of 94 activities assigned two different weighted values. In order to receive full credit for the CPIA component, most providers will need to attest that they have participated in a minimum of three and a maximum of six of the 94 activities, depending on the weight of the activities selected, for 90 days.
As outlined above, the final rule on the Quality Payment Program is expected to be released in late October or early November. As proposed, assessment under the provisions of that final rule would begin in January of 2017. This leaves all providers with a very short time window in which to become familiar with the program that will impact their Medicare payment beginning in 2019.
Accordingly, in the next several editions of this column, I will provide more specific information about each of the four MIPS components, the scoring mechanism for MIPS assessment and the aforementioned alternate track to MIPS, the Alternative Payment Models. While it is easy to understand how many Fellows could initially find this change daunting and overwhelming, I am confident that with a minimal investment of time all can develop adequate working knowledge of the MIPS and APMs to participate successfully in the QPP.
Until next month...
Dr. Bailey is an ACS Fellow, a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington.
On April 27, 2016, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule on the Medicare Access and CHIP Reauthorization Act (MACRA). Fellows will remember that the MACRA legislation, passed in April of 2015, permanently repealed the Sustainable Growth Rate (SGR) formula and thus, represents the greatest sea change in Medicare physician payment since the establishment of the RBRVS (Resource-Based Relative Value Scale) in 1992.
In broadest policy terms, the law continues to advance the CMS policy goal of basing payment on quality and value over volume. From a granular perspective, the law combines Medicare’s three current quality programs into one new system. CMS published this 982-page proposed rule after reviewing the comments submitted by ACS and other interested parties in response to its request for information last fall. As I write, staff of the Division of Advocacy and Health Policy are in the process of crafting the ACS response to the proposed rule. Comments were due on June 27, 2016. It is anticipated that CMS will publish the final rule later this year, likely in late October or early November. Accordingly, the following description of the implementation of MACRA is based on the current understanding from the proposed rule, and is likely to change in some respects with the final rule.
CMS has designated the payment program operationalizing the MACRA law as the Quality Payment Program (QPP). The QPP has two tracks, the Merit-based Incentive Payment System (MIPS) and advanced Alternative Payment Models (APMs). For the first several years of the program, it is widely expected that the vast majority of physicians will participate in the QPP via the MIPS track. As such, I will direct the remainder of the text this month to the MIPS program.
MIPS: Merit-Based Incentive Payment System
The Merit-based Incentive Payment System, MIPS, consists of four components. They are: Quality, Resource Use, Advancing Care Information (ACI) and the Clinical Practice Improvement Activities (CPIA). Though the names have changed, Fellows are familiar with the substance of three of the components. For example, the Quality component replaces the Physician Quality Reporting System (PQRS); the Resource Use component replaces the Value-Based Modifier (VBM); and the Advancing Care Information component modifies and replaces the Electronic Health Record Meaningful Use (EHR-MU) program. The fourth component of MIPS is the new Clinical Practice Improvement Activities, which the legislation designates as intended to provide “credit for work to improve practice and facilitates future participation in alternative payment models.”
Composite Performance Score: MIPS participants will be assigned a Composite Performance Score based on their performance in all four components. For 2017, the first year for assessment under the QPP, 50 percent of the score will be based on performance in the Quality component, 10 percent will be based on the Resource Use component, 25 percent will be based on the Advancing Care Information component, and 15 percent will be based on the Clinical Practice Improvement Activities. In future years, there will be a gradual increase in the relative value of the Resource Use component with an equal and accompanying decrease in the value of the Quality component. As proposed, by the third assessment year (2019), the Quality and Resource Use components are expected to each account for 30 percent of the Composite Performance Score.
MIPS Quality Component: Though the Quality component of MIPS replaces the PQRS, CMS is proposing some changes that Fellows will welcome. As opposed to the previous PQRS requirement to report nine measures, the MIPS Quality component requires providers to report only six measures. One of these six must be an “Outcome” measure and another must be a “Cross-cutting” measure. While the reporting threshold for the percentage of patients on which reports will be required is proposed to increase substantially, ACS and other physician groups will be advocating that the required percentage published in the final rule be close to the 50 percent level found in current law.
Resources Use Component: There is also some good news relative to the Resource Use component in that there are NO reporting requirements. CMS will calculate this component from Medicare claims data and base its assessment of individual provider performance on the resource measures currently used for the Value-Based Modifier. Namely, those are the VBM Total per Capita Cost measure and the VBM Medicare Spending per Beneficiary measure. In addition, CMS will also be taking into account measures that specifically focus on episodes of care, something for which the College has previously advocated. Beginning in 2018, CMS plans to also take into consideration factors of patient condition and patient relation in order to address physician concerns about risk adjustment and attribution.
Advancing Care Information Component: This modifies and replaces the Electronic Health Record Meaningful Use program. The score for this component is derived in two parts, a Base score (50 percent) and a Performance score (up to an additional 50 percent). The threshold for achieving the Base score remains “all or nothing.” Only after meeting the requirements for the Base score is one eligible to receive additional Performance score credit based on the level of performance on a subset of the same measures required to achieve the Base score. Assessment in 2017 will be based on the EHR-MU requirements published in the 2015 Final Rule for the EHR-MU program.
Clinical Practice Improvement Component: The fourth component of MIPS is the Clinical Practice Improvement Activities component. As mentioned previously, this is a new requirement with no prior analogous program requirement. As such, it is very much in evolution. In the first year of MIPS assessment (2017), achieving full credit for the CPIA component should not pose much additional administrative burden as reporting will be by simple attestation. Physicians will chose from a list of 94 activities assigned two different weighted values. In order to receive full credit for the CPIA component, most providers will need to attest that they have participated in a minimum of three and a maximum of six of the 94 activities, depending on the weight of the activities selected, for 90 days.
As outlined above, the final rule on the Quality Payment Program is expected to be released in late October or early November. As proposed, assessment under the provisions of that final rule would begin in January of 2017. This leaves all providers with a very short time window in which to become familiar with the program that will impact their Medicare payment beginning in 2019.
Accordingly, in the next several editions of this column, I will provide more specific information about each of the four MIPS components, the scoring mechanism for MIPS assessment and the aforementioned alternate track to MIPS, the Alternative Payment Models. While it is easy to understand how many Fellows could initially find this change daunting and overwhelming, I am confident that with a minimal investment of time all can develop adequate working knowledge of the MIPS and APMs to participate successfully in the QPP.
Until next month...
Dr. Bailey is an ACS Fellow, a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy, in the ACS offices in Washington.
Digital snake oil?
In what might have been a lecture from the early 19th century, CEO of the American Medical Association James Madara gave a fire and brimstone address railing against snake oil hucksters, at the AMA annual meeting. The quacks he attacked, however, are of a 21st century kind: those peddling digital health wares.
Dr. Madara claimed, “Appearing in disguise … are other digital so-called advancements that don’t have an appropriate evidence base, or that just don’t work that well – or that actually impede care, confuse patients, and waste our time. From ineffective electronic health records, to an explosion of direct-to-consumer digital health products, to apps of mixed quality. This is the digital snake oil of the early 21st century.”
Dr. Madara listed telemedicine as an example of “positive” digital products, then spent the bulk of the speech admonishing health app and EMR vendors. “American physicians have become the most expensive data entry workforce on the face of the planet,” he said to resounding applause from his audience of AMA delegates. In what was most likely a reference to Dr. Eric Topol’s work, he criticized, without naming, a book for touting a future where patients order their own labs and treat their own diseases, an ostentatious prediction that Dr. Madara pointed out sells books but fails to resonate with real medicine. There are digital tools that “impede care, confuse patients, and waste our time,” he added. So, is Dr. Madara right? Is all digital medicine just snake oil?
Dr. Madara used his time on the dais to defend doctors and patients. His voice trembled and brow furrowed as he spoke; no doubt many of us feel the same frustration with the practice of medicine today. And digital tools are as fine a scapegoat as any. His snake oil analogy, however, is misleading. While no physician loves his or her EMR, and all physicians wish they could spend more time caring and less time typing, EMRs, unlike snake oil, are not without benefit. From a population health and patient safety perspective, they are as efficacious as any quality evidence-based medicine. The fact that EMRs have increased drudgery and decreased patient time for physicians is an undesirable, but predictable side effect – one that we ought to mitigate as we take a more active role in designing future versions.
As for the innumerate apps, wearables, and websites that promise more health than they deliver, Dr. Madara pointed out: “Only in the fine print [do they] say ‘for entertainment purposes only.’ ” While this is true, these apps aren’t the real problem. There have always been and will always be alternative health products of dubious benefit that patients love. I’m quite sure randomized controlled trials don’t exist for apple cider vinegar cures, but it doesn’t seem to hurt their popularity, or us. Dr. Madara argued that we should be working to leverage, not eliminate, physicians. The real threat here is that we fail to appreciate and to meet our patients’ needs and wants.
We want to spend more time with our patients and believe that a deep doctor-patient relationship is a key factor in good medicine. But a profound connection with their doctor is not always what our modern patients want. The proliferation of $1.99 health apps is not the evidence here; rather, it is the proliferation of retail health clinics and virtual health. On-demand telephone and video appointments are exploding in popularity. This type of growth cannot be from slick sales pitches; rather, the growth stems from true patient demand.
We have throughout our history stayed close to our patients and adapted to their changing desires. In antiquity, we were spiritual; in the 18th and 19th centuries, we were personal (picture the family doctor arriving in horse and buggy to see the patient, pat the kids on the head, and do little more than listen). In the 20th century, we became scientific, accurate, and effective. Today, patients have added demands for us to be convenient, current, and affordable. For us to meet these changing requirements, we must add digital tools to our black bag. It is up to us to design and deploy them.
I disagree with Dr. Madara when he says that other industries have benefited from digital tools whereas medicine has not. Digital killed Borders and Blockbuster. Digital has saved radiology and rural medicine. Compelling and competing arguments are being made from many industries as to whether digital technology has either decreased or increased U.S. productivity. I am glad this speech has incited so much discussion in health care. We have a lot to talk about.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. Dr. Benabio is @Dermdoc on Twitter.
In what might have been a lecture from the early 19th century, CEO of the American Medical Association James Madara gave a fire and brimstone address railing against snake oil hucksters, at the AMA annual meeting. The quacks he attacked, however, are of a 21st century kind: those peddling digital health wares.
Dr. Madara claimed, “Appearing in disguise … are other digital so-called advancements that don’t have an appropriate evidence base, or that just don’t work that well – or that actually impede care, confuse patients, and waste our time. From ineffective electronic health records, to an explosion of direct-to-consumer digital health products, to apps of mixed quality. This is the digital snake oil of the early 21st century.”
Dr. Madara listed telemedicine as an example of “positive” digital products, then spent the bulk of the speech admonishing health app and EMR vendors. “American physicians have become the most expensive data entry workforce on the face of the planet,” he said to resounding applause from his audience of AMA delegates. In what was most likely a reference to Dr. Eric Topol’s work, he criticized, without naming, a book for touting a future where patients order their own labs and treat their own diseases, an ostentatious prediction that Dr. Madara pointed out sells books but fails to resonate with real medicine. There are digital tools that “impede care, confuse patients, and waste our time,” he added. So, is Dr. Madara right? Is all digital medicine just snake oil?
Dr. Madara used his time on the dais to defend doctors and patients. His voice trembled and brow furrowed as he spoke; no doubt many of us feel the same frustration with the practice of medicine today. And digital tools are as fine a scapegoat as any. His snake oil analogy, however, is misleading. While no physician loves his or her EMR, and all physicians wish they could spend more time caring and less time typing, EMRs, unlike snake oil, are not without benefit. From a population health and patient safety perspective, they are as efficacious as any quality evidence-based medicine. The fact that EMRs have increased drudgery and decreased patient time for physicians is an undesirable, but predictable side effect – one that we ought to mitigate as we take a more active role in designing future versions.
As for the innumerate apps, wearables, and websites that promise more health than they deliver, Dr. Madara pointed out: “Only in the fine print [do they] say ‘for entertainment purposes only.’ ” While this is true, these apps aren’t the real problem. There have always been and will always be alternative health products of dubious benefit that patients love. I’m quite sure randomized controlled trials don’t exist for apple cider vinegar cures, but it doesn’t seem to hurt their popularity, or us. Dr. Madara argued that we should be working to leverage, not eliminate, physicians. The real threat here is that we fail to appreciate and to meet our patients’ needs and wants.
We want to spend more time with our patients and believe that a deep doctor-patient relationship is a key factor in good medicine. But a profound connection with their doctor is not always what our modern patients want. The proliferation of $1.99 health apps is not the evidence here; rather, it is the proliferation of retail health clinics and virtual health. On-demand telephone and video appointments are exploding in popularity. This type of growth cannot be from slick sales pitches; rather, the growth stems from true patient demand.
We have throughout our history stayed close to our patients and adapted to their changing desires. In antiquity, we were spiritual; in the 18th and 19th centuries, we were personal (picture the family doctor arriving in horse and buggy to see the patient, pat the kids on the head, and do little more than listen). In the 20th century, we became scientific, accurate, and effective. Today, patients have added demands for us to be convenient, current, and affordable. For us to meet these changing requirements, we must add digital tools to our black bag. It is up to us to design and deploy them.
I disagree with Dr. Madara when he says that other industries have benefited from digital tools whereas medicine has not. Digital killed Borders and Blockbuster. Digital has saved radiology and rural medicine. Compelling and competing arguments are being made from many industries as to whether digital technology has either decreased or increased U.S. productivity. I am glad this speech has incited so much discussion in health care. We have a lot to talk about.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. Dr. Benabio is @Dermdoc on Twitter.
In what might have been a lecture from the early 19th century, CEO of the American Medical Association James Madara gave a fire and brimstone address railing against snake oil hucksters, at the AMA annual meeting. The quacks he attacked, however, are of a 21st century kind: those peddling digital health wares.
Dr. Madara claimed, “Appearing in disguise … are other digital so-called advancements that don’t have an appropriate evidence base, or that just don’t work that well – or that actually impede care, confuse patients, and waste our time. From ineffective electronic health records, to an explosion of direct-to-consumer digital health products, to apps of mixed quality. This is the digital snake oil of the early 21st century.”
Dr. Madara listed telemedicine as an example of “positive” digital products, then spent the bulk of the speech admonishing health app and EMR vendors. “American physicians have become the most expensive data entry workforce on the face of the planet,” he said to resounding applause from his audience of AMA delegates. In what was most likely a reference to Dr. Eric Topol’s work, he criticized, without naming, a book for touting a future where patients order their own labs and treat their own diseases, an ostentatious prediction that Dr. Madara pointed out sells books but fails to resonate with real medicine. There are digital tools that “impede care, confuse patients, and waste our time,” he added. So, is Dr. Madara right? Is all digital medicine just snake oil?
Dr. Madara used his time on the dais to defend doctors and patients. His voice trembled and brow furrowed as he spoke; no doubt many of us feel the same frustration with the practice of medicine today. And digital tools are as fine a scapegoat as any. His snake oil analogy, however, is misleading. While no physician loves his or her EMR, and all physicians wish they could spend more time caring and less time typing, EMRs, unlike snake oil, are not without benefit. From a population health and patient safety perspective, they are as efficacious as any quality evidence-based medicine. The fact that EMRs have increased drudgery and decreased patient time for physicians is an undesirable, but predictable side effect – one that we ought to mitigate as we take a more active role in designing future versions.
As for the innumerate apps, wearables, and websites that promise more health than they deliver, Dr. Madara pointed out: “Only in the fine print [do they] say ‘for entertainment purposes only.’ ” While this is true, these apps aren’t the real problem. There have always been and will always be alternative health products of dubious benefit that patients love. I’m quite sure randomized controlled trials don’t exist for apple cider vinegar cures, but it doesn’t seem to hurt their popularity, or us. Dr. Madara argued that we should be working to leverage, not eliminate, physicians. The real threat here is that we fail to appreciate and to meet our patients’ needs and wants.
We want to spend more time with our patients and believe that a deep doctor-patient relationship is a key factor in good medicine. But a profound connection with their doctor is not always what our modern patients want. The proliferation of $1.99 health apps is not the evidence here; rather, it is the proliferation of retail health clinics and virtual health. On-demand telephone and video appointments are exploding in popularity. This type of growth cannot be from slick sales pitches; rather, the growth stems from true patient demand.
We have throughout our history stayed close to our patients and adapted to their changing desires. In antiquity, we were spiritual; in the 18th and 19th centuries, we were personal (picture the family doctor arriving in horse and buggy to see the patient, pat the kids on the head, and do little more than listen). In the 20th century, we became scientific, accurate, and effective. Today, patients have added demands for us to be convenient, current, and affordable. For us to meet these changing requirements, we must add digital tools to our black bag. It is up to us to design and deploy them.
I disagree with Dr. Madara when he says that other industries have benefited from digital tools whereas medicine has not. Digital killed Borders and Blockbuster. Digital has saved radiology and rural medicine. Compelling and competing arguments are being made from many industries as to whether digital technology has either decreased or increased U.S. productivity. I am glad this speech has incited so much discussion in health care. We have a lot to talk about.
Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. Dr. Benabio is @Dermdoc on Twitter.
Prescription opioid analgesics: Is there a risk for birth defects?
Concerns have been raised about the widespread use of opioid analgesics in the general population, and specifically among pregnant women.
In women of reproductive age, U.S. claims data for the years 2008-2012 indicate that 39.4% of Medicaid-enrolled women and 27.7% of privately insured women had at least one opioid analgesic prescription claim.1 Among pregnant women, approximately 4.4% reported use of opioid analgesics any time in the month before and throughout gestation in a sample of 11,724 control mothers who participated in the National Birth Defects Prevention Study (NBDPS) 1998-2011.2
Previous studies of first-trimester exposure to opioid analgesics have shown inconsistent associations with selected major congenital anomalies. A 2011 analysis of 1,693 first-trimester codeine-exposed pregnancies enrolled in the Norwegian Mother and Child Cohort Study found no evidence of an increased risk of major birth defects overall (odds ratio, 0.8; 95% confidence interval, 0.5-1.1), compared with 65,316 unexposed pregnancies. However, this study had insufficient power to examine modest associations with most specific major birth defects.3
In contrast, two recent case-control studies have demonstrated significantly increased risks for early pregnancy opioid analgesic use and specific defects.
Broussard et al (2011) used data from the NBDPS 1997-2005 to test hypotheses related to specific defect associations previously reported in the literature, as well as to explore associations with additional defects. Therapeutic opioid use in early pregnancy was reported by 2.6% of 17,449 case mothers and 2.0% of 6,701 control mothers. The authors confirmed associations with some specific heart defects, (for example, conoventricular septal defects, atrioventricular septal defects, and hypoplastic left heart syndrome), and spina bifida, with ORs ranging from 2.0 to 2.7. In exploratory analysis, gastroschisis was also significantly associated with opioid analgesic exposure in early pregnancy (OR, 1.8; 95% CI, 1.1-2.9). Although additional analyses were performed stratified by specific opioid product (codeine, hydrocodone, oxycodone, meperidine), as might be expected, the most commonly used products (codeine and hydrocodone) were linked to a greater number of elevated ORs for specific defects.4
In the second case-control study, Yazdy et al (2013) used data collected in four cities in the United States and Canada and from two birth defect registries between 1998 and 2010 to examine periconceptional opioid use and risk for neural tube defects. The adjusted OR for spina bifida, comparing mothers of malformed infants with mothers of non-malformed infants, was 2.5 (95% CI, 1.3-5.0). To help rule out the possible contribution of recall bias, a sensitivity analysis was also conducted comparing mothers of malformed infants with mothers of infants with other malformations not implicated in the Broussard NBDPS study. The adjusted OR in this secondary analysis was somewhat attenuated but remained significantly elevated (adjusted OR, 2.2; 95% CI, 1.1-4.1).5
The usual limitations apply to these large case-control studies, including the potential for mothers to inaccurately recall the use of, and specific gestational timing of, exposure to these medications. However, the sensitivity analysis conducted in the Yazdy et al study suggests that this bias did not account for the association between opioid analgesics and spina bifida. Although a wide range of important potential confounders were considered in both studies, unmeasured confounding could be a contributing factor. For example, it would be useful to have a comparison group of pregnant women with similar indications but no treatment with opioid analgesics during embryogenesis.
From a clinical perspective, given the proportion of unplanned pregnancies and the high prevalence of opioid analgesic dispensing in the United States, the potential for pregnancy should be considered when these medications are prescribed for women in their reproductive years. In a recognized pregnancy, to date, the risks reported for early pregnancy exposure are generally modest for specific defects. The rarity of even the most common of these specific defects means that these elevated ORs translate to very low absolute risks for any individual pregnancy.
As with other medications with a similar profile, need for the medication should be considered at the time of prescribing, and if an opioid analgesic is needed, consider the lowest effective dose of the most effective medication given for the shortest period of time necessary.
References
1. MMWR Morb Mortal Wkly Rep. 2015; 64:37-41.
2. Birth Defects Res A Clin Mol Teratol. 2015 Aug;103(8):703-12.
3. Eur J Clin Pharmacol. 2011 Dec;67(12):1253-61.
4. Am J Obstet Gynecol. 2011 Apr;204(4):314.e1-11.
5. Obstet Gynecol. 2013 Oct;122(4):838-44.
Dr. Chambers is professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She receives no industry funding for the study of opioid analgesic medications in pregnancy. She does receive research funding for studies of other medications and vaccines in pregnancy from Amgen, AbbVie, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Pfizer, Roche-Genentech, Sanofi-Genzyme, Seqirus, Takeda, Teva, UCB. Email her at obnews@frontlinemedcom.com.
Concerns have been raised about the widespread use of opioid analgesics in the general population, and specifically among pregnant women.
In women of reproductive age, U.S. claims data for the years 2008-2012 indicate that 39.4% of Medicaid-enrolled women and 27.7% of privately insured women had at least one opioid analgesic prescription claim.1 Among pregnant women, approximately 4.4% reported use of opioid analgesics any time in the month before and throughout gestation in a sample of 11,724 control mothers who participated in the National Birth Defects Prevention Study (NBDPS) 1998-2011.2
Previous studies of first-trimester exposure to opioid analgesics have shown inconsistent associations with selected major congenital anomalies. A 2011 analysis of 1,693 first-trimester codeine-exposed pregnancies enrolled in the Norwegian Mother and Child Cohort Study found no evidence of an increased risk of major birth defects overall (odds ratio, 0.8; 95% confidence interval, 0.5-1.1), compared with 65,316 unexposed pregnancies. However, this study had insufficient power to examine modest associations with most specific major birth defects.3
In contrast, two recent case-control studies have demonstrated significantly increased risks for early pregnancy opioid analgesic use and specific defects.
Broussard et al (2011) used data from the NBDPS 1997-2005 to test hypotheses related to specific defect associations previously reported in the literature, as well as to explore associations with additional defects. Therapeutic opioid use in early pregnancy was reported by 2.6% of 17,449 case mothers and 2.0% of 6,701 control mothers. The authors confirmed associations with some specific heart defects, (for example, conoventricular septal defects, atrioventricular septal defects, and hypoplastic left heart syndrome), and spina bifida, with ORs ranging from 2.0 to 2.7. In exploratory analysis, gastroschisis was also significantly associated with opioid analgesic exposure in early pregnancy (OR, 1.8; 95% CI, 1.1-2.9). Although additional analyses were performed stratified by specific opioid product (codeine, hydrocodone, oxycodone, meperidine), as might be expected, the most commonly used products (codeine and hydrocodone) were linked to a greater number of elevated ORs for specific defects.4
In the second case-control study, Yazdy et al (2013) used data collected in four cities in the United States and Canada and from two birth defect registries between 1998 and 2010 to examine periconceptional opioid use and risk for neural tube defects. The adjusted OR for spina bifida, comparing mothers of malformed infants with mothers of non-malformed infants, was 2.5 (95% CI, 1.3-5.0). To help rule out the possible contribution of recall bias, a sensitivity analysis was also conducted comparing mothers of malformed infants with mothers of infants with other malformations not implicated in the Broussard NBDPS study. The adjusted OR in this secondary analysis was somewhat attenuated but remained significantly elevated (adjusted OR, 2.2; 95% CI, 1.1-4.1).5
The usual limitations apply to these large case-control studies, including the potential for mothers to inaccurately recall the use of, and specific gestational timing of, exposure to these medications. However, the sensitivity analysis conducted in the Yazdy et al study suggests that this bias did not account for the association between opioid analgesics and spina bifida. Although a wide range of important potential confounders were considered in both studies, unmeasured confounding could be a contributing factor. For example, it would be useful to have a comparison group of pregnant women with similar indications but no treatment with opioid analgesics during embryogenesis.
From a clinical perspective, given the proportion of unplanned pregnancies and the high prevalence of opioid analgesic dispensing in the United States, the potential for pregnancy should be considered when these medications are prescribed for women in their reproductive years. In a recognized pregnancy, to date, the risks reported for early pregnancy exposure are generally modest for specific defects. The rarity of even the most common of these specific defects means that these elevated ORs translate to very low absolute risks for any individual pregnancy.
As with other medications with a similar profile, need for the medication should be considered at the time of prescribing, and if an opioid analgesic is needed, consider the lowest effective dose of the most effective medication given for the shortest period of time necessary.
References
1. MMWR Morb Mortal Wkly Rep. 2015; 64:37-41.
2. Birth Defects Res A Clin Mol Teratol. 2015 Aug;103(8):703-12.
3. Eur J Clin Pharmacol. 2011 Dec;67(12):1253-61.
4. Am J Obstet Gynecol. 2011 Apr;204(4):314.e1-11.
5. Obstet Gynecol. 2013 Oct;122(4):838-44.
Dr. Chambers is professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She receives no industry funding for the study of opioid analgesic medications in pregnancy. She does receive research funding for studies of other medications and vaccines in pregnancy from Amgen, AbbVie, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Pfizer, Roche-Genentech, Sanofi-Genzyme, Seqirus, Takeda, Teva, UCB. Email her at obnews@frontlinemedcom.com.
Concerns have been raised about the widespread use of opioid analgesics in the general population, and specifically among pregnant women.
In women of reproductive age, U.S. claims data for the years 2008-2012 indicate that 39.4% of Medicaid-enrolled women and 27.7% of privately insured women had at least one opioid analgesic prescription claim.1 Among pregnant women, approximately 4.4% reported use of opioid analgesics any time in the month before and throughout gestation in a sample of 11,724 control mothers who participated in the National Birth Defects Prevention Study (NBDPS) 1998-2011.2
Previous studies of first-trimester exposure to opioid analgesics have shown inconsistent associations with selected major congenital anomalies. A 2011 analysis of 1,693 first-trimester codeine-exposed pregnancies enrolled in the Norwegian Mother and Child Cohort Study found no evidence of an increased risk of major birth defects overall (odds ratio, 0.8; 95% confidence interval, 0.5-1.1), compared with 65,316 unexposed pregnancies. However, this study had insufficient power to examine modest associations with most specific major birth defects.3
In contrast, two recent case-control studies have demonstrated significantly increased risks for early pregnancy opioid analgesic use and specific defects.
Broussard et al (2011) used data from the NBDPS 1997-2005 to test hypotheses related to specific defect associations previously reported in the literature, as well as to explore associations with additional defects. Therapeutic opioid use in early pregnancy was reported by 2.6% of 17,449 case mothers and 2.0% of 6,701 control mothers. The authors confirmed associations with some specific heart defects, (for example, conoventricular septal defects, atrioventricular septal defects, and hypoplastic left heart syndrome), and spina bifida, with ORs ranging from 2.0 to 2.7. In exploratory analysis, gastroschisis was also significantly associated with opioid analgesic exposure in early pregnancy (OR, 1.8; 95% CI, 1.1-2.9). Although additional analyses were performed stratified by specific opioid product (codeine, hydrocodone, oxycodone, meperidine), as might be expected, the most commonly used products (codeine and hydrocodone) were linked to a greater number of elevated ORs for specific defects.4
In the second case-control study, Yazdy et al (2013) used data collected in four cities in the United States and Canada and from two birth defect registries between 1998 and 2010 to examine periconceptional opioid use and risk for neural tube defects. The adjusted OR for spina bifida, comparing mothers of malformed infants with mothers of non-malformed infants, was 2.5 (95% CI, 1.3-5.0). To help rule out the possible contribution of recall bias, a sensitivity analysis was also conducted comparing mothers of malformed infants with mothers of infants with other malformations not implicated in the Broussard NBDPS study. The adjusted OR in this secondary analysis was somewhat attenuated but remained significantly elevated (adjusted OR, 2.2; 95% CI, 1.1-4.1).5
The usual limitations apply to these large case-control studies, including the potential for mothers to inaccurately recall the use of, and specific gestational timing of, exposure to these medications. However, the sensitivity analysis conducted in the Yazdy et al study suggests that this bias did not account for the association between opioid analgesics and spina bifida. Although a wide range of important potential confounders were considered in both studies, unmeasured confounding could be a contributing factor. For example, it would be useful to have a comparison group of pregnant women with similar indications but no treatment with opioid analgesics during embryogenesis.
From a clinical perspective, given the proportion of unplanned pregnancies and the high prevalence of opioid analgesic dispensing in the United States, the potential for pregnancy should be considered when these medications are prescribed for women in their reproductive years. In a recognized pregnancy, to date, the risks reported for early pregnancy exposure are generally modest for specific defects. The rarity of even the most common of these specific defects means that these elevated ORs translate to very low absolute risks for any individual pregnancy.
As with other medications with a similar profile, need for the medication should be considered at the time of prescribing, and if an opioid analgesic is needed, consider the lowest effective dose of the most effective medication given for the shortest period of time necessary.
References
1. MMWR Morb Mortal Wkly Rep. 2015; 64:37-41.
2. Birth Defects Res A Clin Mol Teratol. 2015 Aug;103(8):703-12.
3. Eur J Clin Pharmacol. 2011 Dec;67(12):1253-61.
4. Am J Obstet Gynecol. 2011 Apr;204(4):314.e1-11.
5. Obstet Gynecol. 2013 Oct;122(4):838-44.
Dr. Chambers is professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She receives no industry funding for the study of opioid analgesic medications in pregnancy. She does receive research funding for studies of other medications and vaccines in pregnancy from Amgen, AbbVie, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Pfizer, Roche-Genentech, Sanofi-Genzyme, Seqirus, Takeda, Teva, UCB. Email her at obnews@frontlinemedcom.com.
Preventing and managing vaginal cuff dehiscence
Vaginal cuff dehiscence, or separation of the vaginal incision, is a rare postoperative complication unique to hysterectomy. Morbidity related to evisceration of abdominal contents can be profound and prompt intervention is required.
A 10-year observational study of 11,000 patients described a 0.24% cumulative incidence after all modes of hysterectomy.1 Though data are varied, the mode of hysterectomy does have an impact on the risk of dehiscence.
Laparoscopic (0.64%-1.35%) and robotic (0.46%-1.5%) hysterectomy have a higher incidence than abdominal (0.15%-0.26%) and vaginal (0.08%-0.25%) approaches.2 The use of monopolar cautery for colpotomy and different closure techniques may account for these differences.
Cuff cellulitis, early sexual intercourse, cigarette smoking, poor nutrition, obesity, menopausal status, and corticosteroid use are all proposed risk factors that promote infection, pressure at the vaginal cuff, and poor wound healing. Although some are modifiable, the rarity of this complication has made establishing causality and promoting prevention challenging.
Prevention
• Preoperatively. Treating bacterial vaginosis, Trichomonas vaginalis, gonorrhea, and chlamydia can decrease the risk of cuff cellulitis and dehiscence.3
• Intraoperatively. Surgeons should ensure adequate vaginal margins (greater than 1 cm) with full-thickness cuff closures while avoiding excessive electrocautery.4 Retrospective data show that transvaginal cuff closure is associated with a decreased risk of dehiscence.5 However, given the lack of randomized data and the difficulty controlling for surgeon experience, gynecologists should use the approach that they are most comfortable with. Though the various laparoscopic cuff closure techniques have limited evidence regarding superiority, some experts propose using two-layer cuff closure and barbed sutures.6-8 Several retrospective studies have found an equivalent or a decreased incidence of cuff dehiscence with barbed sutures, compared with other methods (e.g., 0-Vicryl, Endo Stitch).9,10
• Postoperatively. Women should avoid intercourse and lifting more than 15 pounds for at least 6-8 weeks as the vaginal cuff gains tensile strength. Vaginal estrogen can promote healing in postmenopausal patients.11
Management
Patients with vaginal cuff dehiscence commonly present within the first several weeks to months after surgery with pelvic pain (60%-100%), vaginal bleeding (30%-60%), vaginal discharge (30%), or vaginal pressure/mass (30%).1,7 Posthysterectomy patients with these complaints warrant an urgent evaluation. The diagnosis is made during a pelvic exam.
Broad-spectrum antibiotics are necessary because all vaginal cuff separations or dehiscences expose the peritoneal cavity to vaginal flora. Nonsurgical management is reasonable for small separations – less than 25% of the cuff – if there is no evidence of evisceration.
However, surgically closing all recognized cuff dehiscences is reasonable, given the potential for further separation. A vaginal approach is preferred when possible. Women with vaginal cuff dehiscence, stable vital signs, and no evidence of bowel evisceration can be repaired vaginally without an abdominal survey.
In contrast, women with bowel evisceration have a surgical emergency because of the risk of peritonitis and bowel injury. If the eviscerated bowel is not reducible, it should be irrigated and wrapped in a warm moist towel or gauze in preparation for inspection and reduction in the operating room. If the bowel is reducible, the patient can be placed in Trendelenburg’s position. Her vagina should be packed to reduce the risk of re-evisceration as she moves toward operative cuff repair.
If the physician is concerned about bowel injury, inspection via laparoscopy or laparotomy would be reasonable. However, when bowel injury is not suspected, a vaginal technique for dehiscence repair has been described by Matthews et al.:12
1. Expose the cuff with a weighted speculum and Breisky-Navratil retractors.
2. Sharply debride the cuff edges back to viable tissue.
3. Dissect adherent bowel or omentum to allow for full-thickness closure.
4. Place full-thickness, interrupted delayed absorbable sutures to reapproximate the cuff edges.
Cuff dehiscence is a rare but potentially morbid complication of hysterectomy. Prevention, recognition, and appropriate management can avoid life-threatening sequelae.
References
1. Obstet Gynecol. 2011 Oct;118(4):794-801.
2. JSLS. 2012 Oct-Dec;16(4):530-6.
3. Am J Obstet Gynecol. 1990 Sep;163(3):1016-21; discussion 1021-3.
4. Obstet Gynecol. 2013 Mar;121(3):654-73.
5. Obstet Gynecol. 2012 Sep;120(3):516-23.
6. J Am Assoc Gynecol Laparosc. 2002 Nov;9(4):474-80.
7. Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):134-8.
8. Obstet Gynecol. 2009 Aug;114(2 Pt 1):231-5.
9. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23.
10. Int J Surg. 2015 Jul;19:27-30.
11. Maturitas. 2006 Feb 20;53(3):282-98.
12. Obstet Gynecol. 2014 Oct;124(4):705-8.
Dr. Pierce is a gynecologic oncology fellow in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology and professor in the division of gynecologic oncology at the university. They reported having no relevant financial disclosures.
Vaginal cuff dehiscence, or separation of the vaginal incision, is a rare postoperative complication unique to hysterectomy. Morbidity related to evisceration of abdominal contents can be profound and prompt intervention is required.
A 10-year observational study of 11,000 patients described a 0.24% cumulative incidence after all modes of hysterectomy.1 Though data are varied, the mode of hysterectomy does have an impact on the risk of dehiscence.
Laparoscopic (0.64%-1.35%) and robotic (0.46%-1.5%) hysterectomy have a higher incidence than abdominal (0.15%-0.26%) and vaginal (0.08%-0.25%) approaches.2 The use of monopolar cautery for colpotomy and different closure techniques may account for these differences.
Cuff cellulitis, early sexual intercourse, cigarette smoking, poor nutrition, obesity, menopausal status, and corticosteroid use are all proposed risk factors that promote infection, pressure at the vaginal cuff, and poor wound healing. Although some are modifiable, the rarity of this complication has made establishing causality and promoting prevention challenging.
Prevention
• Preoperatively. Treating bacterial vaginosis, Trichomonas vaginalis, gonorrhea, and chlamydia can decrease the risk of cuff cellulitis and dehiscence.3
• Intraoperatively. Surgeons should ensure adequate vaginal margins (greater than 1 cm) with full-thickness cuff closures while avoiding excessive electrocautery.4 Retrospective data show that transvaginal cuff closure is associated with a decreased risk of dehiscence.5 However, given the lack of randomized data and the difficulty controlling for surgeon experience, gynecologists should use the approach that they are most comfortable with. Though the various laparoscopic cuff closure techniques have limited evidence regarding superiority, some experts propose using two-layer cuff closure and barbed sutures.6-8 Several retrospective studies have found an equivalent or a decreased incidence of cuff dehiscence with barbed sutures, compared with other methods (e.g., 0-Vicryl, Endo Stitch).9,10
• Postoperatively. Women should avoid intercourse and lifting more than 15 pounds for at least 6-8 weeks as the vaginal cuff gains tensile strength. Vaginal estrogen can promote healing in postmenopausal patients.11
Management
Patients with vaginal cuff dehiscence commonly present within the first several weeks to months after surgery with pelvic pain (60%-100%), vaginal bleeding (30%-60%), vaginal discharge (30%), or vaginal pressure/mass (30%).1,7 Posthysterectomy patients with these complaints warrant an urgent evaluation. The diagnosis is made during a pelvic exam.
Broad-spectrum antibiotics are necessary because all vaginal cuff separations or dehiscences expose the peritoneal cavity to vaginal flora. Nonsurgical management is reasonable for small separations – less than 25% of the cuff – if there is no evidence of evisceration.
However, surgically closing all recognized cuff dehiscences is reasonable, given the potential for further separation. A vaginal approach is preferred when possible. Women with vaginal cuff dehiscence, stable vital signs, and no evidence of bowel evisceration can be repaired vaginally without an abdominal survey.
In contrast, women with bowel evisceration have a surgical emergency because of the risk of peritonitis and bowel injury. If the eviscerated bowel is not reducible, it should be irrigated and wrapped in a warm moist towel or gauze in preparation for inspection and reduction in the operating room. If the bowel is reducible, the patient can be placed in Trendelenburg’s position. Her vagina should be packed to reduce the risk of re-evisceration as she moves toward operative cuff repair.
If the physician is concerned about bowel injury, inspection via laparoscopy or laparotomy would be reasonable. However, when bowel injury is not suspected, a vaginal technique for dehiscence repair has been described by Matthews et al.:12
1. Expose the cuff with a weighted speculum and Breisky-Navratil retractors.
2. Sharply debride the cuff edges back to viable tissue.
3. Dissect adherent bowel or omentum to allow for full-thickness closure.
4. Place full-thickness, interrupted delayed absorbable sutures to reapproximate the cuff edges.
Cuff dehiscence is a rare but potentially morbid complication of hysterectomy. Prevention, recognition, and appropriate management can avoid life-threatening sequelae.
References
1. Obstet Gynecol. 2011 Oct;118(4):794-801.
2. JSLS. 2012 Oct-Dec;16(4):530-6.
3. Am J Obstet Gynecol. 1990 Sep;163(3):1016-21; discussion 1021-3.
4. Obstet Gynecol. 2013 Mar;121(3):654-73.
5. Obstet Gynecol. 2012 Sep;120(3):516-23.
6. J Am Assoc Gynecol Laparosc. 2002 Nov;9(4):474-80.
7. Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):134-8.
8. Obstet Gynecol. 2009 Aug;114(2 Pt 1):231-5.
9. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23.
10. Int J Surg. 2015 Jul;19:27-30.
11. Maturitas. 2006 Feb 20;53(3):282-98.
12. Obstet Gynecol. 2014 Oct;124(4):705-8.
Dr. Pierce is a gynecologic oncology fellow in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology and professor in the division of gynecologic oncology at the university. They reported having no relevant financial disclosures.
Vaginal cuff dehiscence, or separation of the vaginal incision, is a rare postoperative complication unique to hysterectomy. Morbidity related to evisceration of abdominal contents can be profound and prompt intervention is required.
A 10-year observational study of 11,000 patients described a 0.24% cumulative incidence after all modes of hysterectomy.1 Though data are varied, the mode of hysterectomy does have an impact on the risk of dehiscence.
Laparoscopic (0.64%-1.35%) and robotic (0.46%-1.5%) hysterectomy have a higher incidence than abdominal (0.15%-0.26%) and vaginal (0.08%-0.25%) approaches.2 The use of monopolar cautery for colpotomy and different closure techniques may account for these differences.
Cuff cellulitis, early sexual intercourse, cigarette smoking, poor nutrition, obesity, menopausal status, and corticosteroid use are all proposed risk factors that promote infection, pressure at the vaginal cuff, and poor wound healing. Although some are modifiable, the rarity of this complication has made establishing causality and promoting prevention challenging.
Prevention
• Preoperatively. Treating bacterial vaginosis, Trichomonas vaginalis, gonorrhea, and chlamydia can decrease the risk of cuff cellulitis and dehiscence.3
• Intraoperatively. Surgeons should ensure adequate vaginal margins (greater than 1 cm) with full-thickness cuff closures while avoiding excessive electrocautery.4 Retrospective data show that transvaginal cuff closure is associated with a decreased risk of dehiscence.5 However, given the lack of randomized data and the difficulty controlling for surgeon experience, gynecologists should use the approach that they are most comfortable with. Though the various laparoscopic cuff closure techniques have limited evidence regarding superiority, some experts propose using two-layer cuff closure and barbed sutures.6-8 Several retrospective studies have found an equivalent or a decreased incidence of cuff dehiscence with barbed sutures, compared with other methods (e.g., 0-Vicryl, Endo Stitch).9,10
• Postoperatively. Women should avoid intercourse and lifting more than 15 pounds for at least 6-8 weeks as the vaginal cuff gains tensile strength. Vaginal estrogen can promote healing in postmenopausal patients.11
Management
Patients with vaginal cuff dehiscence commonly present within the first several weeks to months after surgery with pelvic pain (60%-100%), vaginal bleeding (30%-60%), vaginal discharge (30%), or vaginal pressure/mass (30%).1,7 Posthysterectomy patients with these complaints warrant an urgent evaluation. The diagnosis is made during a pelvic exam.
Broad-spectrum antibiotics are necessary because all vaginal cuff separations or dehiscences expose the peritoneal cavity to vaginal flora. Nonsurgical management is reasonable for small separations – less than 25% of the cuff – if there is no evidence of evisceration.
However, surgically closing all recognized cuff dehiscences is reasonable, given the potential for further separation. A vaginal approach is preferred when possible. Women with vaginal cuff dehiscence, stable vital signs, and no evidence of bowel evisceration can be repaired vaginally without an abdominal survey.
In contrast, women with bowel evisceration have a surgical emergency because of the risk of peritonitis and bowel injury. If the eviscerated bowel is not reducible, it should be irrigated and wrapped in a warm moist towel or gauze in preparation for inspection and reduction in the operating room. If the bowel is reducible, the patient can be placed in Trendelenburg’s position. Her vagina should be packed to reduce the risk of re-evisceration as she moves toward operative cuff repair.
If the physician is concerned about bowel injury, inspection via laparoscopy or laparotomy would be reasonable. However, when bowel injury is not suspected, a vaginal technique for dehiscence repair has been described by Matthews et al.:12
1. Expose the cuff with a weighted speculum and Breisky-Navratil retractors.
2. Sharply debride the cuff edges back to viable tissue.
3. Dissect adherent bowel or omentum to allow for full-thickness closure.
4. Place full-thickness, interrupted delayed absorbable sutures to reapproximate the cuff edges.
Cuff dehiscence is a rare but potentially morbid complication of hysterectomy. Prevention, recognition, and appropriate management can avoid life-threatening sequelae.
References
1. Obstet Gynecol. 2011 Oct;118(4):794-801.
2. JSLS. 2012 Oct-Dec;16(4):530-6.
3. Am J Obstet Gynecol. 1990 Sep;163(3):1016-21; discussion 1021-3.
4. Obstet Gynecol. 2013 Mar;121(3):654-73.
5. Obstet Gynecol. 2012 Sep;120(3):516-23.
6. J Am Assoc Gynecol Laparosc. 2002 Nov;9(4):474-80.
7. Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):134-8.
8. Obstet Gynecol. 2009 Aug;114(2 Pt 1):231-5.
9. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23.
10. Int J Surg. 2015 Jul;19:27-30.
11. Maturitas. 2006 Feb 20;53(3):282-98.
12. Obstet Gynecol. 2014 Oct;124(4):705-8.
Dr. Pierce is a gynecologic oncology fellow in the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology and professor in the division of gynecologic oncology at the university. They reported having no relevant financial disclosures.
What is the VA? The Largest Educator of Health Care Professionals in the U.S.
This July, medical students, residents, and fellows in almost every medical and surgical specialty will join nurses at all levels of training, undergraduate and graduate pharmacists, dentists, and allied health students to train at a VA hospital. The VA Office of Academic Affiliations (OAA), which coordinates this massive educational effort, reported that in 2015, the last year for which data are available, 123,552 health care trainees were enrolled in VA programs.1 That’s in addition to the hundreds of health care professionals trained in the 4 branches of the armed services, including students at the Uniformed Services University of the Health Sciences and those receiving a health care education through the PHS. Federal institutions are easily the largest contributors to health care education in the nation and very likely in the world.
This mission to educate the U.S. health care workforce is not new. This year marks the 70th anniversary of the collaboration between the VA and academic affiliates across the country to ensure a highly qualified cadre of health care professionals care, not only for veterans, but also for the public. Hence, the OAA motto: To educate for VA and for the nation.
When allopathic and osteopathic medical schools are combined, there are partnerships between the VA and 90% of U.S. medical schools. More than 70% of all U.S. practicing physicians trained at a VA facility at some time.2 Currently, the VA has more than 40 different health care professional training programs under its auspices.
This educational mission is a core VA function that is enshrined in law as are VA’s other 3 core charges. According to the statute, the VA secretary shall “to the extent feasible without interfering with the medical care and treatment of veterans, develop and carry out a program of education and training of health personnel.” The primary clinical care, education, and research functions of the VA are inseparable, and none can be carried out without an adequate number of qualified staff.
Government reports and the media have identified the shortage of VA health care professionals as a major contributor to the wait times crisis of the past several years.3 Section 301 of the Veterans Access, Choice, and Accountability Act of 2014 actually requires the VA Office of Inspector General (OIG) to conduct assessments of the staffing shortages in the department. Reports from the OIG have identified 5 critical need occupations: medical officer, nurse, psychologist, physician assistant, and physical therapist.4
From my perspective as a medical officer, I am certain that the reason I went straight to the VA after my residency in psychiatry and have never left is my overwhelmingly positive experience as a medical student and resident. The VA had many of the best teachers in my training programs. The patients were—and still are nearly 20 years later—among the most respectful and appreciative of any I have treated.
Many VA patients considered us, even as trainees, their doctors and often asked us when we were residents whether they could “keep us,” although they knew that as former members of the military, most of us would rotate out of their lives. Yet they also knew that because of the strength of the training programs, a new young doctor would come to take care of them. Even now when the occasional angry patient says, “all you doctors care about is money,” I am proud to say that I could probably make more money in the private sector, but I choose to work at the VA.
Many of my fine colleagues in medicine, nursing, psychology, and allied health also remained at the VA after their training, inspired to provide public health to those who served and were underserved. Those who entered military medicine or the PHS had similar ideals borne of the role models who taught them in those federal institutions. One of the often unappreciated negative consequences of the VA scandal is that it may discouarge students in the health care professions from rotating through or seriously considering careers in the VA.
The VA and the military often do not receive the recognition they deserve as academic medical institutions. Some of the most renowned and accomplished faculty of prestigious medical universities also work at VA facilities. The ability to simultaneously teach gifted students, conduct cutting-edge research, and practice high-quality medicine all in a public health setting are what attracted me and many other idealistic health care professionals to the VA.
The VA, however, has taken active steps to restore its reputation as one of the best places to learn and work. Three outstanding initiatives deserve special attention. The first being a series of visits to medical schools that Carolyn M. Clancy, MD, made when she was the interim under secretary for health. Fortunately for me, she spoke at the academic affiliate of my VAMC (the University of New Mexico School of Medicine), where she talked about the excitement and rewards of VA clinical care and research.5
The VA Nursing Academic Partnerships (VANAP) is another initiative to promote VA as an educator and employer of health professionals. Comprised of 18 competitively selected nursing schools in the nation and the VA, VANAP’s objective is “increasing recruitment and retention of VA nurses as a result of enhanced roles in nursing education.” The New Mexico VA Health Care System, the hospital I practice at, had the honor of being awarded one of these partnerships, and I have been encouraged to see many student nurses choose the training track at the VA and express interest in employment.
According to a nurse at the Oregon Health & Science University VA partnership, “One thing I learned that I did not expect was about the wars the clients had served in. I gained a greater respect for our men and women in the service past and present…I have now an understanding of not only the physical, but also the mental and emotional effects war has on an individual.”6 It is important to realize that even if physicians and nurses in training do not ultimately enter the VA workforce, they still leave their educational experience with a more empathic understanding of the health care needs of veterans.
The salience of the third endeavor, however, has not been widely recognized. In March, Secretary Robert McDonald spoke at a meeting of the Association of American Medical Colleges Council of Deans. His speech traced the history of academic collaboration with the VA; acknowledged the bureaucratic, information technology, and other challenges faced by the VA and its academic affiliates; and reaffirmed the VA’s commitment to academic partnerships. He recognized the significant and lasting contributions the relationship with academic medical centers has had on the care of veterans and the community for decades. His remarks concluded with a vision of the potential the partnership has to transform health education and the delivery of care in the years to come. But perhaps the most hopeful remarks in the speech came not from Secretary McDonald but from the comments of medical students who had rotated at the San Diego VAMC, which he shared:
“The emphasis on teaching was fantastic, and far superior to most other rotations.”
“The vets were a wonderful patient population who really allowed us a great opportunity to learn.”
“The VA is the best place for medical students to work.”7
1. U.S. Veterans Health Administration Office of Academic Affiliations. 2015 statistics: health professions traineees. U.S. Department of Veterans Affairs website. http://www.va.gov/oaa/docs/OAA_Statistics.pdf. Accessed June 14, 2016.
2. Office of Academic Affiliations. 70th anniversary of academic affiliations. U.S. Department of Veterans Affairs website. http://www.va.gov/OAA/OAA_70th_Anniversary.asp. Update February 18, 2016. Accessed June 4, 2016.
3. Oppel RA, Goodnough A. Doctor shortage is cited in delays at V.A. hospitals. The New York Times. May 29, 2014.
4. Zonana HV, Wells JA, Getz MA, Buchanan J. Part I: The NGRI Registry: initial analyses of data collected on Connecticut insanity acquittees. Bull Am Acad Psychiatry Law. 1990;18(2):115-128.
5. Foster C. V.A. official visits HSC, as agency seeks to hire health care workers. UNM HSC Newsbeat. November 11, 2014.
6. VA Nursing Academic Partnerships. Oregon Health and Science University website. http://www.ohsu.edu/xd/education/schools/school-of-nursing/about/loader.cfm?csModule=security/getfile&pageid=2301310. Accessed June 14, 2016.
7. McDonald R. McDonald: Academic affiliations a source of strength for VA, medical schools. U.S. Department of Veterans Affairs website. http://www.blogs.va.gov/VAntage/18655/mcdonald-academic-affiliations-a-source-of-strength-for-the-va-medical-schools. Updated March 30, 2015. Accessed June 14, 2016.
This July, medical students, residents, and fellows in almost every medical and surgical specialty will join nurses at all levels of training, undergraduate and graduate pharmacists, dentists, and allied health students to train at a VA hospital. The VA Office of Academic Affiliations (OAA), which coordinates this massive educational effort, reported that in 2015, the last year for which data are available, 123,552 health care trainees were enrolled in VA programs.1 That’s in addition to the hundreds of health care professionals trained in the 4 branches of the armed services, including students at the Uniformed Services University of the Health Sciences and those receiving a health care education through the PHS. Federal institutions are easily the largest contributors to health care education in the nation and very likely in the world.
This mission to educate the U.S. health care workforce is not new. This year marks the 70th anniversary of the collaboration between the VA and academic affiliates across the country to ensure a highly qualified cadre of health care professionals care, not only for veterans, but also for the public. Hence, the OAA motto: To educate for VA and for the nation.
When allopathic and osteopathic medical schools are combined, there are partnerships between the VA and 90% of U.S. medical schools. More than 70% of all U.S. practicing physicians trained at a VA facility at some time.2 Currently, the VA has more than 40 different health care professional training programs under its auspices.
This educational mission is a core VA function that is enshrined in law as are VA’s other 3 core charges. According to the statute, the VA secretary shall “to the extent feasible without interfering with the medical care and treatment of veterans, develop and carry out a program of education and training of health personnel.” The primary clinical care, education, and research functions of the VA are inseparable, and none can be carried out without an adequate number of qualified staff.
Government reports and the media have identified the shortage of VA health care professionals as a major contributor to the wait times crisis of the past several years.3 Section 301 of the Veterans Access, Choice, and Accountability Act of 2014 actually requires the VA Office of Inspector General (OIG) to conduct assessments of the staffing shortages in the department. Reports from the OIG have identified 5 critical need occupations: medical officer, nurse, psychologist, physician assistant, and physical therapist.4
From my perspective as a medical officer, I am certain that the reason I went straight to the VA after my residency in psychiatry and have never left is my overwhelmingly positive experience as a medical student and resident. The VA had many of the best teachers in my training programs. The patients were—and still are nearly 20 years later—among the most respectful and appreciative of any I have treated.
Many VA patients considered us, even as trainees, their doctors and often asked us when we were residents whether they could “keep us,” although they knew that as former members of the military, most of us would rotate out of their lives. Yet they also knew that because of the strength of the training programs, a new young doctor would come to take care of them. Even now when the occasional angry patient says, “all you doctors care about is money,” I am proud to say that I could probably make more money in the private sector, but I choose to work at the VA.
Many of my fine colleagues in medicine, nursing, psychology, and allied health also remained at the VA after their training, inspired to provide public health to those who served and were underserved. Those who entered military medicine or the PHS had similar ideals borne of the role models who taught them in those federal institutions. One of the often unappreciated negative consequences of the VA scandal is that it may discouarge students in the health care professions from rotating through or seriously considering careers in the VA.
The VA and the military often do not receive the recognition they deserve as academic medical institutions. Some of the most renowned and accomplished faculty of prestigious medical universities also work at VA facilities. The ability to simultaneously teach gifted students, conduct cutting-edge research, and practice high-quality medicine all in a public health setting are what attracted me and many other idealistic health care professionals to the VA.
The VA, however, has taken active steps to restore its reputation as one of the best places to learn and work. Three outstanding initiatives deserve special attention. The first being a series of visits to medical schools that Carolyn M. Clancy, MD, made when she was the interim under secretary for health. Fortunately for me, she spoke at the academic affiliate of my VAMC (the University of New Mexico School of Medicine), where she talked about the excitement and rewards of VA clinical care and research.5
The VA Nursing Academic Partnerships (VANAP) is another initiative to promote VA as an educator and employer of health professionals. Comprised of 18 competitively selected nursing schools in the nation and the VA, VANAP’s objective is “increasing recruitment and retention of VA nurses as a result of enhanced roles in nursing education.” The New Mexico VA Health Care System, the hospital I practice at, had the honor of being awarded one of these partnerships, and I have been encouraged to see many student nurses choose the training track at the VA and express interest in employment.
According to a nurse at the Oregon Health & Science University VA partnership, “One thing I learned that I did not expect was about the wars the clients had served in. I gained a greater respect for our men and women in the service past and present…I have now an understanding of not only the physical, but also the mental and emotional effects war has on an individual.”6 It is important to realize that even if physicians and nurses in training do not ultimately enter the VA workforce, they still leave their educational experience with a more empathic understanding of the health care needs of veterans.
The salience of the third endeavor, however, has not been widely recognized. In March, Secretary Robert McDonald spoke at a meeting of the Association of American Medical Colleges Council of Deans. His speech traced the history of academic collaboration with the VA; acknowledged the bureaucratic, information technology, and other challenges faced by the VA and its academic affiliates; and reaffirmed the VA’s commitment to academic partnerships. He recognized the significant and lasting contributions the relationship with academic medical centers has had on the care of veterans and the community for decades. His remarks concluded with a vision of the potential the partnership has to transform health education and the delivery of care in the years to come. But perhaps the most hopeful remarks in the speech came not from Secretary McDonald but from the comments of medical students who had rotated at the San Diego VAMC, which he shared:
“The emphasis on teaching was fantastic, and far superior to most other rotations.”
“The vets were a wonderful patient population who really allowed us a great opportunity to learn.”
“The VA is the best place for medical students to work.”7
This July, medical students, residents, and fellows in almost every medical and surgical specialty will join nurses at all levels of training, undergraduate and graduate pharmacists, dentists, and allied health students to train at a VA hospital. The VA Office of Academic Affiliations (OAA), which coordinates this massive educational effort, reported that in 2015, the last year for which data are available, 123,552 health care trainees were enrolled in VA programs.1 That’s in addition to the hundreds of health care professionals trained in the 4 branches of the armed services, including students at the Uniformed Services University of the Health Sciences and those receiving a health care education through the PHS. Federal institutions are easily the largest contributors to health care education in the nation and very likely in the world.
This mission to educate the U.S. health care workforce is not new. This year marks the 70th anniversary of the collaboration between the VA and academic affiliates across the country to ensure a highly qualified cadre of health care professionals care, not only for veterans, but also for the public. Hence, the OAA motto: To educate for VA and for the nation.
When allopathic and osteopathic medical schools are combined, there are partnerships between the VA and 90% of U.S. medical schools. More than 70% of all U.S. practicing physicians trained at a VA facility at some time.2 Currently, the VA has more than 40 different health care professional training programs under its auspices.
This educational mission is a core VA function that is enshrined in law as are VA’s other 3 core charges. According to the statute, the VA secretary shall “to the extent feasible without interfering with the medical care and treatment of veterans, develop and carry out a program of education and training of health personnel.” The primary clinical care, education, and research functions of the VA are inseparable, and none can be carried out without an adequate number of qualified staff.
Government reports and the media have identified the shortage of VA health care professionals as a major contributor to the wait times crisis of the past several years.3 Section 301 of the Veterans Access, Choice, and Accountability Act of 2014 actually requires the VA Office of Inspector General (OIG) to conduct assessments of the staffing shortages in the department. Reports from the OIG have identified 5 critical need occupations: medical officer, nurse, psychologist, physician assistant, and physical therapist.4
From my perspective as a medical officer, I am certain that the reason I went straight to the VA after my residency in psychiatry and have never left is my overwhelmingly positive experience as a medical student and resident. The VA had many of the best teachers in my training programs. The patients were—and still are nearly 20 years later—among the most respectful and appreciative of any I have treated.
Many VA patients considered us, even as trainees, their doctors and often asked us when we were residents whether they could “keep us,” although they knew that as former members of the military, most of us would rotate out of their lives. Yet they also knew that because of the strength of the training programs, a new young doctor would come to take care of them. Even now when the occasional angry patient says, “all you doctors care about is money,” I am proud to say that I could probably make more money in the private sector, but I choose to work at the VA.
Many of my fine colleagues in medicine, nursing, psychology, and allied health also remained at the VA after their training, inspired to provide public health to those who served and were underserved. Those who entered military medicine or the PHS had similar ideals borne of the role models who taught them in those federal institutions. One of the often unappreciated negative consequences of the VA scandal is that it may discouarge students in the health care professions from rotating through or seriously considering careers in the VA.
The VA and the military often do not receive the recognition they deserve as academic medical institutions. Some of the most renowned and accomplished faculty of prestigious medical universities also work at VA facilities. The ability to simultaneously teach gifted students, conduct cutting-edge research, and practice high-quality medicine all in a public health setting are what attracted me and many other idealistic health care professionals to the VA.
The VA, however, has taken active steps to restore its reputation as one of the best places to learn and work. Three outstanding initiatives deserve special attention. The first being a series of visits to medical schools that Carolyn M. Clancy, MD, made when she was the interim under secretary for health. Fortunately for me, she spoke at the academic affiliate of my VAMC (the University of New Mexico School of Medicine), where she talked about the excitement and rewards of VA clinical care and research.5
The VA Nursing Academic Partnerships (VANAP) is another initiative to promote VA as an educator and employer of health professionals. Comprised of 18 competitively selected nursing schools in the nation and the VA, VANAP’s objective is “increasing recruitment and retention of VA nurses as a result of enhanced roles in nursing education.” The New Mexico VA Health Care System, the hospital I practice at, had the honor of being awarded one of these partnerships, and I have been encouraged to see many student nurses choose the training track at the VA and express interest in employment.
According to a nurse at the Oregon Health & Science University VA partnership, “One thing I learned that I did not expect was about the wars the clients had served in. I gained a greater respect for our men and women in the service past and present…I have now an understanding of not only the physical, but also the mental and emotional effects war has on an individual.”6 It is important to realize that even if physicians and nurses in training do not ultimately enter the VA workforce, they still leave their educational experience with a more empathic understanding of the health care needs of veterans.
The salience of the third endeavor, however, has not been widely recognized. In March, Secretary Robert McDonald spoke at a meeting of the Association of American Medical Colleges Council of Deans. His speech traced the history of academic collaboration with the VA; acknowledged the bureaucratic, information technology, and other challenges faced by the VA and its academic affiliates; and reaffirmed the VA’s commitment to academic partnerships. He recognized the significant and lasting contributions the relationship with academic medical centers has had on the care of veterans and the community for decades. His remarks concluded with a vision of the potential the partnership has to transform health education and the delivery of care in the years to come. But perhaps the most hopeful remarks in the speech came not from Secretary McDonald but from the comments of medical students who had rotated at the San Diego VAMC, which he shared:
“The emphasis on teaching was fantastic, and far superior to most other rotations.”
“The vets were a wonderful patient population who really allowed us a great opportunity to learn.”
“The VA is the best place for medical students to work.”7
1. U.S. Veterans Health Administration Office of Academic Affiliations. 2015 statistics: health professions traineees. U.S. Department of Veterans Affairs website. http://www.va.gov/oaa/docs/OAA_Statistics.pdf. Accessed June 14, 2016.
2. Office of Academic Affiliations. 70th anniversary of academic affiliations. U.S. Department of Veterans Affairs website. http://www.va.gov/OAA/OAA_70th_Anniversary.asp. Update February 18, 2016. Accessed June 4, 2016.
3. Oppel RA, Goodnough A. Doctor shortage is cited in delays at V.A. hospitals. The New York Times. May 29, 2014.
4. Zonana HV, Wells JA, Getz MA, Buchanan J. Part I: The NGRI Registry: initial analyses of data collected on Connecticut insanity acquittees. Bull Am Acad Psychiatry Law. 1990;18(2):115-128.
5. Foster C. V.A. official visits HSC, as agency seeks to hire health care workers. UNM HSC Newsbeat. November 11, 2014.
6. VA Nursing Academic Partnerships. Oregon Health and Science University website. http://www.ohsu.edu/xd/education/schools/school-of-nursing/about/loader.cfm?csModule=security/getfile&pageid=2301310. Accessed June 14, 2016.
7. McDonald R. McDonald: Academic affiliations a source of strength for VA, medical schools. U.S. Department of Veterans Affairs website. http://www.blogs.va.gov/VAntage/18655/mcdonald-academic-affiliations-a-source-of-strength-for-the-va-medical-schools. Updated March 30, 2015. Accessed June 14, 2016.
1. U.S. Veterans Health Administration Office of Academic Affiliations. 2015 statistics: health professions traineees. U.S. Department of Veterans Affairs website. http://www.va.gov/oaa/docs/OAA_Statistics.pdf. Accessed June 14, 2016.
2. Office of Academic Affiliations. 70th anniversary of academic affiliations. U.S. Department of Veterans Affairs website. http://www.va.gov/OAA/OAA_70th_Anniversary.asp. Update February 18, 2016. Accessed June 4, 2016.
3. Oppel RA, Goodnough A. Doctor shortage is cited in delays at V.A. hospitals. The New York Times. May 29, 2014.
4. Zonana HV, Wells JA, Getz MA, Buchanan J. Part I: The NGRI Registry: initial analyses of data collected on Connecticut insanity acquittees. Bull Am Acad Psychiatry Law. 1990;18(2):115-128.
5. Foster C. V.A. official visits HSC, as agency seeks to hire health care workers. UNM HSC Newsbeat. November 11, 2014.
6. VA Nursing Academic Partnerships. Oregon Health and Science University website. http://www.ohsu.edu/xd/education/schools/school-of-nursing/about/loader.cfm?csModule=security/getfile&pageid=2301310. Accessed June 14, 2016.
7. McDonald R. McDonald: Academic affiliations a source of strength for VA, medical schools. U.S. Department of Veterans Affairs website. http://www.blogs.va.gov/VAntage/18655/mcdonald-academic-affiliations-a-source-of-strength-for-the-va-medical-schools. Updated March 30, 2015. Accessed June 14, 2016.
Incident to billing
There is apparently confusion about incident to billing of Medicare when employing nurse practitioners and physician assistants. Letters have been published in Dermatology News and other venues that confuse what is straightforward (JAMA Dermatol. 2014;150[11]:1153-9). I will, in my usual blunt fashion, explain incident to billing in dermatology.
First, private insurers may have different standards, but for Medicare, the most succinct government explanation is the introduction of the Office of Inspector General’s audit of incident to billing in the office. More recently, the rules have changed just a little, requiring the incident to biller to bill under the original supervising physician’s billing number, instead of whichever doctor is in the house. When a licensed extender bills under the supervising physician’s NPI number, the extender gets paid at 100% of the Medicare rates. If billing independently, the extender earns only 85%, so it behooves the employing dermatologist to make sure they are billing incident to, whenever possible.
The following examples should cover 95% of dermatologic encounters.
Example No. 1
A new patient is seen by the extender and supervising physician and is diagnosed with a chronic condition such as acne, warts, rosacea, psoriasis, eczema, or benign moles. A care plan is arrived at by the supervising physician, and the treatment is initiated by the extender. This and all subsequent visits can be billed at 100% under the physician’s billing number as long as the problems remain the same and there is a supervising physician in the building. Note that the supervising physician does not have to see the patient on the subsequent visits for the extender to continue to bill incident to. The extender can also bill under the original physician’s number at 100% if there is another physician in the house; the extender doesn’t have to change who they bill under depending on who is available (unless that physician sees the patient). The extender can change medications and change treatments as long as the original problems remain the same.
If the patient develops a new problem – say a growth that may need biopsy – the supervising physician must see the patient in order to bill at 100%. If the patient is not seen by the supervising physician, the extender must bill under their own number and collect only 85%.
Example No. 2
Let’s say a new patient comes in with extensive actinic damage, and is seen by the supervising physician, multiple skin lesions are identified, then the extender freezes multiple actinic keratoses (AKs), and does multiple skin biopsies. These can all be billed under the supervising physician’s number and paid at 100%.
When the same patient returns 6 months later with new AKs and suspicious growths, and the supervising physician does not see the patient, or is not in the house, the extender freezes AKs and does skin biopsies per their best judgment. These procedures must be billed under the extender’s NPI number because they are new problems.
Thus, you can see that for the great majority of diseases that dermatologists treat, you should be collecting the full amount from Medicare, for use of your extenders.
Either physicians are giving away a lot of income (not correctly billing incident to) or there are a lot of unsupervised extenders identifying suspicious lesions and performing surgery without formal training and direct supervision.
What makes me anxious is when I see in the Medicare database that the percentage of skin biopsies billed independently by extenders has increased from 0% to 14% over 10 years (2004-2014). I believe these lesions are being selected for biopsy by the extenders, and the supervising physician never sees them, and these are being billed correctly. This supports my concern about dermatologists setting up extenders in satellite biopsy clinics.
I get even more anxious when I see text from video outreach efforts from the president of the dermatology physician assistants society , stating, “I have my own patient schedule, my own medical assistant, my own rooms, I see new patients, I do my own surgeries, and see my own return patients,” apparently having become a dermatologist by shadowing and working for one.
I believe this is magical thinking. Either the many years of medical school and residency dermatologists went through were unnecessary (possible, but unlikely) or the extenders are overextended. Patients may never know they have not seen a dermatologist after scheduling an appointment with a dermatology group. At least one study has shown that unsupervised extenders may take up to twice as many skin biopsies to make a malignant diagnosis. This suggests that patients are being operated on unnecessarily and costs are being added to the health care system.
In addition, the Medicare data show that the number of skin biopsies has risen 34% over the past 10 years, while the number of skin cancer procedures has increased only 14%. No, these skin biopsies are not being done by extenders working for primary care doctors. Primary care docs perform only 3% of skin biopsies.
Perhaps these extenders are supervised, and their dermatologist employers just don’t want the possibility of a Medicare audit. Let me see: Dermatologists, the most accurate of all coding specialties, are willing to give up 15% of their income because they are confused by these simple rules? What do you think?
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently 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.
There is apparently confusion about incident to billing of Medicare when employing nurse practitioners and physician assistants. Letters have been published in Dermatology News and other venues that confuse what is straightforward (JAMA Dermatol. 2014;150[11]:1153-9). I will, in my usual blunt fashion, explain incident to billing in dermatology.
First, private insurers may have different standards, but for Medicare, the most succinct government explanation is the introduction of the Office of Inspector General’s audit of incident to billing in the office. More recently, the rules have changed just a little, requiring the incident to biller to bill under the original supervising physician’s billing number, instead of whichever doctor is in the house. When a licensed extender bills under the supervising physician’s NPI number, the extender gets paid at 100% of the Medicare rates. If billing independently, the extender earns only 85%, so it behooves the employing dermatologist to make sure they are billing incident to, whenever possible.
The following examples should cover 95% of dermatologic encounters.
Example No. 1
A new patient is seen by the extender and supervising physician and is diagnosed with a chronic condition such as acne, warts, rosacea, psoriasis, eczema, or benign moles. A care plan is arrived at by the supervising physician, and the treatment is initiated by the extender. This and all subsequent visits can be billed at 100% under the physician’s billing number as long as the problems remain the same and there is a supervising physician in the building. Note that the supervising physician does not have to see the patient on the subsequent visits for the extender to continue to bill incident to. The extender can also bill under the original physician’s number at 100% if there is another physician in the house; the extender doesn’t have to change who they bill under depending on who is available (unless that physician sees the patient). The extender can change medications and change treatments as long as the original problems remain the same.
If the patient develops a new problem – say a growth that may need biopsy – the supervising physician must see the patient in order to bill at 100%. If the patient is not seen by the supervising physician, the extender must bill under their own number and collect only 85%.
Example No. 2
Let’s say a new patient comes in with extensive actinic damage, and is seen by the supervising physician, multiple skin lesions are identified, then the extender freezes multiple actinic keratoses (AKs), and does multiple skin biopsies. These can all be billed under the supervising physician’s number and paid at 100%.
When the same patient returns 6 months later with new AKs and suspicious growths, and the supervising physician does not see the patient, or is not in the house, the extender freezes AKs and does skin biopsies per their best judgment. These procedures must be billed under the extender’s NPI number because they are new problems.
Thus, you can see that for the great majority of diseases that dermatologists treat, you should be collecting the full amount from Medicare, for use of your extenders.
Either physicians are giving away a lot of income (not correctly billing incident to) or there are a lot of unsupervised extenders identifying suspicious lesions and performing surgery without formal training and direct supervision.
What makes me anxious is when I see in the Medicare database that the percentage of skin biopsies billed independently by extenders has increased from 0% to 14% over 10 years (2004-2014). I believe these lesions are being selected for biopsy by the extenders, and the supervising physician never sees them, and these are being billed correctly. This supports my concern about dermatologists setting up extenders in satellite biopsy clinics.
I get even more anxious when I see text from video outreach efforts from the president of the dermatology physician assistants society , stating, “I have my own patient schedule, my own medical assistant, my own rooms, I see new patients, I do my own surgeries, and see my own return patients,” apparently having become a dermatologist by shadowing and working for one.
I believe this is magical thinking. Either the many years of medical school and residency dermatologists went through were unnecessary (possible, but unlikely) or the extenders are overextended. Patients may never know they have not seen a dermatologist after scheduling an appointment with a dermatology group. At least one study has shown that unsupervised extenders may take up to twice as many skin biopsies to make a malignant diagnosis. This suggests that patients are being operated on unnecessarily and costs are being added to the health care system.
In addition, the Medicare data show that the number of skin biopsies has risen 34% over the past 10 years, while the number of skin cancer procedures has increased only 14%. No, these skin biopsies are not being done by extenders working for primary care doctors. Primary care docs perform only 3% of skin biopsies.
Perhaps these extenders are supervised, and their dermatologist employers just don’t want the possibility of a Medicare audit. Let me see: Dermatologists, the most accurate of all coding specialties, are willing to give up 15% of their income because they are confused by these simple rules? What do you think?
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently 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.
There is apparently confusion about incident to billing of Medicare when employing nurse practitioners and physician assistants. Letters have been published in Dermatology News and other venues that confuse what is straightforward (JAMA Dermatol. 2014;150[11]:1153-9). I will, in my usual blunt fashion, explain incident to billing in dermatology.
First, private insurers may have different standards, but for Medicare, the most succinct government explanation is the introduction of the Office of Inspector General’s audit of incident to billing in the office. More recently, the rules have changed just a little, requiring the incident to biller to bill under the original supervising physician’s billing number, instead of whichever doctor is in the house. When a licensed extender bills under the supervising physician’s NPI number, the extender gets paid at 100% of the Medicare rates. If billing independently, the extender earns only 85%, so it behooves the employing dermatologist to make sure they are billing incident to, whenever possible.
The following examples should cover 95% of dermatologic encounters.
Example No. 1
A new patient is seen by the extender and supervising physician and is diagnosed with a chronic condition such as acne, warts, rosacea, psoriasis, eczema, or benign moles. A care plan is arrived at by the supervising physician, and the treatment is initiated by the extender. This and all subsequent visits can be billed at 100% under the physician’s billing number as long as the problems remain the same and there is a supervising physician in the building. Note that the supervising physician does not have to see the patient on the subsequent visits for the extender to continue to bill incident to. The extender can also bill under the original physician’s number at 100% if there is another physician in the house; the extender doesn’t have to change who they bill under depending on who is available (unless that physician sees the patient). The extender can change medications and change treatments as long as the original problems remain the same.
If the patient develops a new problem – say a growth that may need biopsy – the supervising physician must see the patient in order to bill at 100%. If the patient is not seen by the supervising physician, the extender must bill under their own number and collect only 85%.
Example No. 2
Let’s say a new patient comes in with extensive actinic damage, and is seen by the supervising physician, multiple skin lesions are identified, then the extender freezes multiple actinic keratoses (AKs), and does multiple skin biopsies. These can all be billed under the supervising physician’s number and paid at 100%.
When the same patient returns 6 months later with new AKs and suspicious growths, and the supervising physician does not see the patient, or is not in the house, the extender freezes AKs and does skin biopsies per their best judgment. These procedures must be billed under the extender’s NPI number because they are new problems.
Thus, you can see that for the great majority of diseases that dermatologists treat, you should be collecting the full amount from Medicare, for use of your extenders.
Either physicians are giving away a lot of income (not correctly billing incident to) or there are a lot of unsupervised extenders identifying suspicious lesions and performing surgery without formal training and direct supervision.
What makes me anxious is when I see in the Medicare database that the percentage of skin biopsies billed independently by extenders has increased from 0% to 14% over 10 years (2004-2014). I believe these lesions are being selected for biopsy by the extenders, and the supervising physician never sees them, and these are being billed correctly. This supports my concern about dermatologists setting up extenders in satellite biopsy clinics.
I get even more anxious when I see text from video outreach efforts from the president of the dermatology physician assistants society , stating, “I have my own patient schedule, my own medical assistant, my own rooms, I see new patients, I do my own surgeries, and see my own return patients,” apparently having become a dermatologist by shadowing and working for one.
I believe this is magical thinking. Either the many years of medical school and residency dermatologists went through were unnecessary (possible, but unlikely) or the extenders are overextended. Patients may never know they have not seen a dermatologist after scheduling an appointment with a dermatology group. At least one study has shown that unsupervised extenders may take up to twice as many skin biopsies to make a malignant diagnosis. This suggests that patients are being operated on unnecessarily and costs are being added to the health care system.
In addition, the Medicare data show that the number of skin biopsies has risen 34% over the past 10 years, while the number of skin cancer procedures has increased only 14%. No, these skin biopsies are not being done by extenders working for primary care doctors. Primary care docs perform only 3% of skin biopsies.
Perhaps these extenders are supervised, and their dermatologist employers just don’t want the possibility of a Medicare audit. Let me see: Dermatologists, the most accurate of all coding specialties, are willing to give up 15% of their income because they are confused by these simple rules? What do you think?
Dr. Coldiron is a past president of the American Academy of Dermatology. He is currently 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.
Update on green tea
During the last 25 years, green tea, which is derived from Camellia sinensis (an evergreen member of the Theaceae family), has gained considerable attention because of its purported antioxidant and anticarcinogenic properties. Believed to have been used by human beings for 4,000 years,1 green tea is now one of the most heavily researched of the antioxidants, with numerous studies of its cutaneous effects appearing in the literature.2 Laden with plant polyphenols, orally administered or topically applied green tea has been shown to display significant antioxidant, chemopreventive, immunomodulatory, and anti-inflammatory activity, affecting the biochemical pathways important in cell proliferation.3-6 For this reason, and due to its global popularity as a beverage, green tea polyphenols are among the most frequently studied herbal agents used in medicine.
Polyphenols, many of which are potent antioxidants, are a large diverse family of thousands of chemical compounds present in plants. The four major polyphenolic catechins present in green tea include: ECG [(-)EpiCatechin-3-O-Gallate], GCG [(-)GalloCatechin-3-O-Gallate], EGC [(-)EpiGalloCatechin], and EGCG [(-)EpiGalloCatechin-3-O-Gallate], the most abundant and biologically active green tea constituent. In fact, EGCG is the component associated with the greatest anticarcinogenic and chemopreventive properties.6
A wide-ranging evidence-based review of the use of botanicals in dermatology, published in 2010, showed that the oral administration, in particular, as well as topical application of antioxidant plant extracts of green tea, among other botanicals, can protect skin against the harmful effects of UV exposure, including erythema, premature aging, and cancer.7
Green tea is thought to be challenging to formulate because of the inherent hydrophilicity of EGCG, which limits penetration into human skin.8,9 Nevertheless, green tea is thought to have great potential in traditional sunscreens to enhance photoprotection.10,11 The photoprotective activity of orally administered or topically applied green tea has been supported in various studies.12-15
The remainder of this column will focus on recent studies of topically applied green tea polyphenols in human beings as well as clinical uses of this agent.
Topical uses
Topical green tea appears to reduce skin inflammation and neutralize free radicals, which explains its popularity as an additive in rosacea and antiaging skin care products. The antiaging effects of green tea are difficult to measure because it functions as an antioxidant that prevents aging and does not have the capacity to increase collagen synthesis or ameliorate already existing wrinkles. However, there is relatively good evidence, in comparison to other antioxidants, suggesting that topically applied green tea can help protect skin from UV radiation.16
Investigators performed a thorough literature search of all in vitro, in vivo, and controlled clinical trials involving green tea formulations and their dermatologic applications, which was published in 2012. They evaluated 20 studies, with evidence suggesting that orally administered green tea displays a broad range of healthy activity, and supportive data for the use of topically applied green tea extract for treatment of various cutaneous conditions, including acne, rosacea, atopic dermatitis, androgenetic alopecia, hirsutism, candidiasis, keloids, leishmaniasis, and genital warts.17
Also, a green tea topical formulation, green tea sinecatechin Polyphenon E (Veregen) ointment, has recently been shown to exert antioxidant, antiviral, and antitumor activity, and has demonstrated efficacy in treating Condylomata acuminata (external anogenital warts).18 In addition, topically applying green tea catechins in the morning in combination with traditional sunscreens is believed to have the potential to protect the skin from UV-induced damage. Topical green tea may improve rosacea, prevent retinoid dermatitis, and play a role in managing pigmentation disorders. Few of the many over-the-counter products that contain green tea catechins have been tested in controlled clinical trials and the concentration of polyphenols in these products is too low to demonstrate efficacy. It is necessary to know the amount of green tea catechins in a formulation to judge its efficacy.
Acne
In 2009, in a 6-week study investigating the efficacy of 2% green tea lotion for the treatment of mild-to-moderate acne vulgaris in 20 patients, researchers reported statistically significant reductions in mean total lesion count and mean severity index (devised by the authors to correlate with total lesion count in increasing intensity, scaled from 1 to 3). They concluded that 2% green tea lotion is both an effective and cost effective approach for treating mild-to-moderate acne lesions.19
A 2012 study revealed that ethanol extracts of several herbs, including green tea, exhibited the potential for inhibiting acne when incorporated into a topical moisturizer, specifically acting against acne-causing bacteria without provoking irritation.20 Earlier that year, other investigators conducted in vitro and in vivo experiments to evaluate the effects against acne of polyphenon-60, which contains various green tea catechins (now referred to as sinecatechins in the United States.).21 In this clinical study, patients exhibited improvement in acne symptoms, including a reduction in the number of pustules and comedones.22
A study published in 2013, a single-blind, placebo-controlled, split-face comparative study in 22 individuals over 60 days, evaluated the efficacy of green tea, as well as green tea plus lotus, compared with placebo for controlling casual sebum secretions in healthy adults. Compared with placebo, consistent and statistically significant decreases in sebum secretions were observed in both treatment groups. The combination of green tea and lotus extracts also achieved statistically sounder results than green tea alone. The investigators concluded that a synergistic interaction between green tea and lotus extract constituents appears to hold promise for the treatment of skin conditions in which elevated sebum levels are involved.23
Anogenital warts
In 2006, the Food and Drug Administration approved for the first time a botanical drug formulation for the topical treatment of genital and perianal warts: sinecatechins, derived from green tea catechins and other C. sinensis constituents in a topical 15% ointment (Veregen).21, 24-28
Two years later, Tatti et al. conducted a randomized, double-blind, vehicle-controlled trial to evaluate the efficacy of topical sinecatechins in 502 male and female patients (aged 18 years and older) for the treatment of anogenital warts. For 16 weeks or until complete clearance, subjects applied sinecatechins ointment 15% or 10% or vehicle (placebo) three times daily. Complete clearance was achieved in 57.2% of patients treated with 15% ointment, 56.3% using 10% ointment, and 33.7% who used only the vehicle. Respective recurrence rates, after 12 weeks, were 6.5%, 8.3%, and 8.8%. The investigators concluded that topical sinecatechins in 15% and 10% concentrations represent effective and well-tolerated options for anogenital wart treatment.29
Similarly favorable results regarding polyphenon E 15% were reported in reference to three placebo-controlled clinical studies in 1,400 patients with genital warts from Europe, North and South America, and South Africa,30,31 and by Tatti et al. again in 2010 after randomized, double-blind, vehicle-controlled safety and efficacy trials in nearly 1,000 patients treated with polyphenon E 15% and 10% formulations.21
Two years later, investigators evaluated sinecatechins (Polyphenon E) 10% ointment in two double-blind, multinational studies in adults with external genital and perianal warts. Polyphenon E 10% was found to be significantly more effective than vehicle in completely or partially clearing all warts.32
Earlier that year, a review of the use of sinecatechins ointment for the treatment of external anogenital warts noted that while clearance rates are similar among sinecatechins and other indicated topical medications such as imiquimod and podophyllotoxin, recurrence rates are lower for patients treated with sinecatechins. The authors concluded that the use of sinecatechins for condylomata acuminata was safe and effective and its various molecular activities suggest broader applications to other viral and tumor lesions.33
In 2015, Gupta and Daigle reported that sinecatechins 10% ointment for the treatment of external genital warts was found in phase III trials to display greater efficacy and lower rates of recurrence in comparison to patient-applied treatments now available.28 Later that year, in a systematic PubMed and Embase review of clinical trials involving the use of polyphenol-based therapies, Tuong et al. identified cogent evidence suggesting the effectiveness of green tea polyphenols for the treatment of anogenital warts.34
Antiaging activity
Green tea has been shown to work in combination with red light to exert a rejuvenating effect on the skin, as Sommer and Zhu reported in 2009 that green tea filled cotton pads applied once daily for 20 minutes prior to treatment with light-emitting diodes (central wavelength 670 nm, dermal dose 4 J/cm2) reduced wrinkles in 1 month comparably to 10 months of light treatment alone.35
In 2013, Hong et al. studied the antiwrinkle effects of topically applied green tea extract with high antioxidant activity after tannase treatment. Study participants were randomly divided to receive either green tea extract or tannase-converted green tea extract on their crow’s feet for an 8-week period. The investigators found that tannase treatment elevated the antioxidant activity of green tea and imparted antiwrinkle effects.36
At around the same time, Gianeti conducted clinical studies in 24 volunteers to assess the effects of a cosmetic formulation containing 6% C. sinensis glycolic leaf extracts. Skin moisture was enhanced after 30 days of topical application as was the viscoelastic-to-elastic ratio compared with vehicle and control (a forearm area left untreated). Skin roughness was significantly diminished after 30 days. The investigators concluded that the topical cosmetic formulation with green tea yielded salient moisturizing and cutaneous microrelief benefits.37
Also in 2013, oral intake of green tea catechins in 16 healthy human subjects (with 14 completing the study) appeared to result in the integration of catechin metabolites into human skin linked to the negation of UV-induced 12-hydroxyeicosatetraenoic acid (12-HETE). The investigators speculated that this incorporation of catechins may render protection against sunburn inflammation and even cumulative UV-induced harm.38
After earlier showing the efficacy of green tea and lotus extracts in skin disorders involving excess sebum in a single-blinded, placebo-controlled, split-face comparative study,23 Mahmood and Akhtar conducted a 60-day placebo-controlled comparative split-face study in 33 healthy Asian men to evaluate the efficacy of two cosmetic formulations (green tea and lotus extract) for facial wrinkles. All of the formulations yielded improvements in skin roughness, scaliness, smoothness, and wrinkling, with the greatest reduction in wrinkling conferred by the combination formulation. The investigators concluded that the synergistic activity of green tea and lotus extracts exerted significant improvement along several skin parameters, suggesting the potential for these ingredients in antiaging products.38
In 2014, the synergistic effects of green tea and ginkgo biloba were explored in preclinical and clinical studies. In the clinical study, 48 participants applied the formulations on forearm skin and were evaluated before and after 3 hours and following 15- and 30-day use periods. Results showed a moisturizing effect and enhancement in skin microrelief, as well as improvements in skin elasticity and barrier function.3
Conclusion
Green tea remains one of the most researched antioxidants as benefits from its use continue to emerge. Indeed, green tea polyphenols are in use for a growing number of indications, especially acne and anogenital warts, and there is reason for optimism that topically applied green tea will gain momentum as an increasingly selected therapeutic option. More clinical studies are necessary to further establish the potential role of green tea for a wider range of cutaneous indications. Green tea holds particular promise in relation to photoprotection against UV-induced skin cancer and skin aging.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin typing systems and related products
References:
1. Cancer Lett. 1997 Mar 19;114(1-2):315-7.
2. J Am Acad Dermatol. 2005 Jun;52(6):1049-59.
3. Arch Dermatol. 2000 Aug;136(8):989-94.
4. Photochem Photobiol. 1995 Nov;62(5):855-61.
5. Oxid Med Cell Longev. 2012:2012:560682.
6. J Dtsch Dermatol Ges. 2015 Aug;13(8):768-75.
7. Am J Clin Dermatol. 2010;11(4):247-67.
8. Dermatol Ther. 2007 Sep-Oct;20(5):322-9.
9. J Clin Aesthet Dermatol. 2010 Feb;3(2):22-41.
10. Photodermatol Photoimmunol Photomed. 2007 Feb;23(1):48-56.
11. Skin Res Technol. 2009 Aug;15(3):338-45.
12. Exp Dermatol. 2009 Jan;18(1):69-77.
13. Exp Dermatol. 2009 Jun;18(6):522-6.
14. Arch Biochem Biophys. 2011 Apr 15;508(2):152-8.
15. Cancer Prev Res (Phila). 2010 Feb;3(2):179-89.
16. Complement Ther Clin Pract. 2014 Feb;20(1):11-5.
17. Skinmed. 2012 Nov-Dec;10(6):352-5.
18. J Eur Acad Dermatol Venereol. 2011 Mar;25(3):345-53.
19. J Drugs Dermatol. 2009 Apr;8(4):358-64.
20. Pak J Pharm Sci. 2012 Oct;25(4):867-70.
21. Br J Dermatol. 2010 Jan;162(1):176-84.
22. Arch Dermatol Res. 2012 Oct;304(8):655-63.
23. Hippokratia. 2013 Jan;17(1):64-7.
24. Food Chem Toxicol. 2008 Aug;46(8):2606-10.
25. Nat Biotechnol. 2008 Oct;26(10):1077-83.
26. Skin Therapy Lett. 2012 Apr;17(4):5-7.
27. J Clin Aesthet Dermatol. 2012 Jan;5(1):19-26.
28. Skin Therapy Lett. 2015 Jan-Feb;20(1):6-8.
29. Obstet Gynecol. 2008 Jun;111(6):1371-9.
30. Hautarzt. 2008 Jan;59(1):31-5.
31. J Eur Acad Dermatol Venereol. 2007 Nov;21(10):1404-12.
32. Am J Clin Dermatol. 2012 Aug 1:13(4):275-81.
33. Expert Opin Biol Ther. 2012 Jun;12(6):783-93.
34. J Dermatolog Treat. 2015;26(4):381-8.
35. Photomed Laser Surg. 2009 Dec;27(6):969-71.
36. J Cosmet Dermatol. 2013 Jun;12(2):137-43.
37. Dermatol Ther. 2013 May-Jun;26(3):267-71.
During the last 25 years, green tea, which is derived from Camellia sinensis (an evergreen member of the Theaceae family), has gained considerable attention because of its purported antioxidant and anticarcinogenic properties. Believed to have been used by human beings for 4,000 years,1 green tea is now one of the most heavily researched of the antioxidants, with numerous studies of its cutaneous effects appearing in the literature.2 Laden with plant polyphenols, orally administered or topically applied green tea has been shown to display significant antioxidant, chemopreventive, immunomodulatory, and anti-inflammatory activity, affecting the biochemical pathways important in cell proliferation.3-6 For this reason, and due to its global popularity as a beverage, green tea polyphenols are among the most frequently studied herbal agents used in medicine.
Polyphenols, many of which are potent antioxidants, are a large diverse family of thousands of chemical compounds present in plants. The four major polyphenolic catechins present in green tea include: ECG [(-)EpiCatechin-3-O-Gallate], GCG [(-)GalloCatechin-3-O-Gallate], EGC [(-)EpiGalloCatechin], and EGCG [(-)EpiGalloCatechin-3-O-Gallate], the most abundant and biologically active green tea constituent. In fact, EGCG is the component associated with the greatest anticarcinogenic and chemopreventive properties.6
A wide-ranging evidence-based review of the use of botanicals in dermatology, published in 2010, showed that the oral administration, in particular, as well as topical application of antioxidant plant extracts of green tea, among other botanicals, can protect skin against the harmful effects of UV exposure, including erythema, premature aging, and cancer.7
Green tea is thought to be challenging to formulate because of the inherent hydrophilicity of EGCG, which limits penetration into human skin.8,9 Nevertheless, green tea is thought to have great potential in traditional sunscreens to enhance photoprotection.10,11 The photoprotective activity of orally administered or topically applied green tea has been supported in various studies.12-15
The remainder of this column will focus on recent studies of topically applied green tea polyphenols in human beings as well as clinical uses of this agent.
Topical uses
Topical green tea appears to reduce skin inflammation and neutralize free radicals, which explains its popularity as an additive in rosacea and antiaging skin care products. The antiaging effects of green tea are difficult to measure because it functions as an antioxidant that prevents aging and does not have the capacity to increase collagen synthesis or ameliorate already existing wrinkles. However, there is relatively good evidence, in comparison to other antioxidants, suggesting that topically applied green tea can help protect skin from UV radiation.16
Investigators performed a thorough literature search of all in vitro, in vivo, and controlled clinical trials involving green tea formulations and their dermatologic applications, which was published in 2012. They evaluated 20 studies, with evidence suggesting that orally administered green tea displays a broad range of healthy activity, and supportive data for the use of topically applied green tea extract for treatment of various cutaneous conditions, including acne, rosacea, atopic dermatitis, androgenetic alopecia, hirsutism, candidiasis, keloids, leishmaniasis, and genital warts.17
Also, a green tea topical formulation, green tea sinecatechin Polyphenon E (Veregen) ointment, has recently been shown to exert antioxidant, antiviral, and antitumor activity, and has demonstrated efficacy in treating Condylomata acuminata (external anogenital warts).18 In addition, topically applying green tea catechins in the morning in combination with traditional sunscreens is believed to have the potential to protect the skin from UV-induced damage. Topical green tea may improve rosacea, prevent retinoid dermatitis, and play a role in managing pigmentation disorders. Few of the many over-the-counter products that contain green tea catechins have been tested in controlled clinical trials and the concentration of polyphenols in these products is too low to demonstrate efficacy. It is necessary to know the amount of green tea catechins in a formulation to judge its efficacy.
Acne
In 2009, in a 6-week study investigating the efficacy of 2% green tea lotion for the treatment of mild-to-moderate acne vulgaris in 20 patients, researchers reported statistically significant reductions in mean total lesion count and mean severity index (devised by the authors to correlate with total lesion count in increasing intensity, scaled from 1 to 3). They concluded that 2% green tea lotion is both an effective and cost effective approach for treating mild-to-moderate acne lesions.19
A 2012 study revealed that ethanol extracts of several herbs, including green tea, exhibited the potential for inhibiting acne when incorporated into a topical moisturizer, specifically acting against acne-causing bacteria without provoking irritation.20 Earlier that year, other investigators conducted in vitro and in vivo experiments to evaluate the effects against acne of polyphenon-60, which contains various green tea catechins (now referred to as sinecatechins in the United States.).21 In this clinical study, patients exhibited improvement in acne symptoms, including a reduction in the number of pustules and comedones.22
A study published in 2013, a single-blind, placebo-controlled, split-face comparative study in 22 individuals over 60 days, evaluated the efficacy of green tea, as well as green tea plus lotus, compared with placebo for controlling casual sebum secretions in healthy adults. Compared with placebo, consistent and statistically significant decreases in sebum secretions were observed in both treatment groups. The combination of green tea and lotus extracts also achieved statistically sounder results than green tea alone. The investigators concluded that a synergistic interaction between green tea and lotus extract constituents appears to hold promise for the treatment of skin conditions in which elevated sebum levels are involved.23
Anogenital warts
In 2006, the Food and Drug Administration approved for the first time a botanical drug formulation for the topical treatment of genital and perianal warts: sinecatechins, derived from green tea catechins and other C. sinensis constituents in a topical 15% ointment (Veregen).21, 24-28
Two years later, Tatti et al. conducted a randomized, double-blind, vehicle-controlled trial to evaluate the efficacy of topical sinecatechins in 502 male and female patients (aged 18 years and older) for the treatment of anogenital warts. For 16 weeks or until complete clearance, subjects applied sinecatechins ointment 15% or 10% or vehicle (placebo) three times daily. Complete clearance was achieved in 57.2% of patients treated with 15% ointment, 56.3% using 10% ointment, and 33.7% who used only the vehicle. Respective recurrence rates, after 12 weeks, were 6.5%, 8.3%, and 8.8%. The investigators concluded that topical sinecatechins in 15% and 10% concentrations represent effective and well-tolerated options for anogenital wart treatment.29
Similarly favorable results regarding polyphenon E 15% were reported in reference to three placebo-controlled clinical studies in 1,400 patients with genital warts from Europe, North and South America, and South Africa,30,31 and by Tatti et al. again in 2010 after randomized, double-blind, vehicle-controlled safety and efficacy trials in nearly 1,000 patients treated with polyphenon E 15% and 10% formulations.21
Two years later, investigators evaluated sinecatechins (Polyphenon E) 10% ointment in two double-blind, multinational studies in adults with external genital and perianal warts. Polyphenon E 10% was found to be significantly more effective than vehicle in completely or partially clearing all warts.32
Earlier that year, a review of the use of sinecatechins ointment for the treatment of external anogenital warts noted that while clearance rates are similar among sinecatechins and other indicated topical medications such as imiquimod and podophyllotoxin, recurrence rates are lower for patients treated with sinecatechins. The authors concluded that the use of sinecatechins for condylomata acuminata was safe and effective and its various molecular activities suggest broader applications to other viral and tumor lesions.33
In 2015, Gupta and Daigle reported that sinecatechins 10% ointment for the treatment of external genital warts was found in phase III trials to display greater efficacy and lower rates of recurrence in comparison to patient-applied treatments now available.28 Later that year, in a systematic PubMed and Embase review of clinical trials involving the use of polyphenol-based therapies, Tuong et al. identified cogent evidence suggesting the effectiveness of green tea polyphenols for the treatment of anogenital warts.34
Antiaging activity
Green tea has been shown to work in combination with red light to exert a rejuvenating effect on the skin, as Sommer and Zhu reported in 2009 that green tea filled cotton pads applied once daily for 20 minutes prior to treatment with light-emitting diodes (central wavelength 670 nm, dermal dose 4 J/cm2) reduced wrinkles in 1 month comparably to 10 months of light treatment alone.35
In 2013, Hong et al. studied the antiwrinkle effects of topically applied green tea extract with high antioxidant activity after tannase treatment. Study participants were randomly divided to receive either green tea extract or tannase-converted green tea extract on their crow’s feet for an 8-week period. The investigators found that tannase treatment elevated the antioxidant activity of green tea and imparted antiwrinkle effects.36
At around the same time, Gianeti conducted clinical studies in 24 volunteers to assess the effects of a cosmetic formulation containing 6% C. sinensis glycolic leaf extracts. Skin moisture was enhanced after 30 days of topical application as was the viscoelastic-to-elastic ratio compared with vehicle and control (a forearm area left untreated). Skin roughness was significantly diminished after 30 days. The investigators concluded that the topical cosmetic formulation with green tea yielded salient moisturizing and cutaneous microrelief benefits.37
Also in 2013, oral intake of green tea catechins in 16 healthy human subjects (with 14 completing the study) appeared to result in the integration of catechin metabolites into human skin linked to the negation of UV-induced 12-hydroxyeicosatetraenoic acid (12-HETE). The investigators speculated that this incorporation of catechins may render protection against sunburn inflammation and even cumulative UV-induced harm.38
After earlier showing the efficacy of green tea and lotus extracts in skin disorders involving excess sebum in a single-blinded, placebo-controlled, split-face comparative study,23 Mahmood and Akhtar conducted a 60-day placebo-controlled comparative split-face study in 33 healthy Asian men to evaluate the efficacy of two cosmetic formulations (green tea and lotus extract) for facial wrinkles. All of the formulations yielded improvements in skin roughness, scaliness, smoothness, and wrinkling, with the greatest reduction in wrinkling conferred by the combination formulation. The investigators concluded that the synergistic activity of green tea and lotus extracts exerted significant improvement along several skin parameters, suggesting the potential for these ingredients in antiaging products.38
In 2014, the synergistic effects of green tea and ginkgo biloba were explored in preclinical and clinical studies. In the clinical study, 48 participants applied the formulations on forearm skin and were evaluated before and after 3 hours and following 15- and 30-day use periods. Results showed a moisturizing effect and enhancement in skin microrelief, as well as improvements in skin elasticity and barrier function.3
Conclusion
Green tea remains one of the most researched antioxidants as benefits from its use continue to emerge. Indeed, green tea polyphenols are in use for a growing number of indications, especially acne and anogenital warts, and there is reason for optimism that topically applied green tea will gain momentum as an increasingly selected therapeutic option. More clinical studies are necessary to further establish the potential role of green tea for a wider range of cutaneous indications. Green tea holds particular promise in relation to photoprotection against UV-induced skin cancer and skin aging.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin typing systems and related products
References:
1. Cancer Lett. 1997 Mar 19;114(1-2):315-7.
2. J Am Acad Dermatol. 2005 Jun;52(6):1049-59.
3. Arch Dermatol. 2000 Aug;136(8):989-94.
4. Photochem Photobiol. 1995 Nov;62(5):855-61.
5. Oxid Med Cell Longev. 2012:2012:560682.
6. J Dtsch Dermatol Ges. 2015 Aug;13(8):768-75.
7. Am J Clin Dermatol. 2010;11(4):247-67.
8. Dermatol Ther. 2007 Sep-Oct;20(5):322-9.
9. J Clin Aesthet Dermatol. 2010 Feb;3(2):22-41.
10. Photodermatol Photoimmunol Photomed. 2007 Feb;23(1):48-56.
11. Skin Res Technol. 2009 Aug;15(3):338-45.
12. Exp Dermatol. 2009 Jan;18(1):69-77.
13. Exp Dermatol. 2009 Jun;18(6):522-6.
14. Arch Biochem Biophys. 2011 Apr 15;508(2):152-8.
15. Cancer Prev Res (Phila). 2010 Feb;3(2):179-89.
16. Complement Ther Clin Pract. 2014 Feb;20(1):11-5.
17. Skinmed. 2012 Nov-Dec;10(6):352-5.
18. J Eur Acad Dermatol Venereol. 2011 Mar;25(3):345-53.
19. J Drugs Dermatol. 2009 Apr;8(4):358-64.
20. Pak J Pharm Sci. 2012 Oct;25(4):867-70.
21. Br J Dermatol. 2010 Jan;162(1):176-84.
22. Arch Dermatol Res. 2012 Oct;304(8):655-63.
23. Hippokratia. 2013 Jan;17(1):64-7.
24. Food Chem Toxicol. 2008 Aug;46(8):2606-10.
25. Nat Biotechnol. 2008 Oct;26(10):1077-83.
26. Skin Therapy Lett. 2012 Apr;17(4):5-7.
27. J Clin Aesthet Dermatol. 2012 Jan;5(1):19-26.
28. Skin Therapy Lett. 2015 Jan-Feb;20(1):6-8.
29. Obstet Gynecol. 2008 Jun;111(6):1371-9.
30. Hautarzt. 2008 Jan;59(1):31-5.
31. J Eur Acad Dermatol Venereol. 2007 Nov;21(10):1404-12.
32. Am J Clin Dermatol. 2012 Aug 1:13(4):275-81.
33. Expert Opin Biol Ther. 2012 Jun;12(6):783-93.
34. J Dermatolog Treat. 2015;26(4):381-8.
35. Photomed Laser Surg. 2009 Dec;27(6):969-71.
36. J Cosmet Dermatol. 2013 Jun;12(2):137-43.
37. Dermatol Ther. 2013 May-Jun;26(3):267-71.
During the last 25 years, green tea, which is derived from Camellia sinensis (an evergreen member of the Theaceae family), has gained considerable attention because of its purported antioxidant and anticarcinogenic properties. Believed to have been used by human beings for 4,000 years,1 green tea is now one of the most heavily researched of the antioxidants, with numerous studies of its cutaneous effects appearing in the literature.2 Laden with plant polyphenols, orally administered or topically applied green tea has been shown to display significant antioxidant, chemopreventive, immunomodulatory, and anti-inflammatory activity, affecting the biochemical pathways important in cell proliferation.3-6 For this reason, and due to its global popularity as a beverage, green tea polyphenols are among the most frequently studied herbal agents used in medicine.
Polyphenols, many of which are potent antioxidants, are a large diverse family of thousands of chemical compounds present in plants. The four major polyphenolic catechins present in green tea include: ECG [(-)EpiCatechin-3-O-Gallate], GCG [(-)GalloCatechin-3-O-Gallate], EGC [(-)EpiGalloCatechin], and EGCG [(-)EpiGalloCatechin-3-O-Gallate], the most abundant and biologically active green tea constituent. In fact, EGCG is the component associated with the greatest anticarcinogenic and chemopreventive properties.6
A wide-ranging evidence-based review of the use of botanicals in dermatology, published in 2010, showed that the oral administration, in particular, as well as topical application of antioxidant plant extracts of green tea, among other botanicals, can protect skin against the harmful effects of UV exposure, including erythema, premature aging, and cancer.7
Green tea is thought to be challenging to formulate because of the inherent hydrophilicity of EGCG, which limits penetration into human skin.8,9 Nevertheless, green tea is thought to have great potential in traditional sunscreens to enhance photoprotection.10,11 The photoprotective activity of orally administered or topically applied green tea has been supported in various studies.12-15
The remainder of this column will focus on recent studies of topically applied green tea polyphenols in human beings as well as clinical uses of this agent.
Topical uses
Topical green tea appears to reduce skin inflammation and neutralize free radicals, which explains its popularity as an additive in rosacea and antiaging skin care products. The antiaging effects of green tea are difficult to measure because it functions as an antioxidant that prevents aging and does not have the capacity to increase collagen synthesis or ameliorate already existing wrinkles. However, there is relatively good evidence, in comparison to other antioxidants, suggesting that topically applied green tea can help protect skin from UV radiation.16
Investigators performed a thorough literature search of all in vitro, in vivo, and controlled clinical trials involving green tea formulations and their dermatologic applications, which was published in 2012. They evaluated 20 studies, with evidence suggesting that orally administered green tea displays a broad range of healthy activity, and supportive data for the use of topically applied green tea extract for treatment of various cutaneous conditions, including acne, rosacea, atopic dermatitis, androgenetic alopecia, hirsutism, candidiasis, keloids, leishmaniasis, and genital warts.17
Also, a green tea topical formulation, green tea sinecatechin Polyphenon E (Veregen) ointment, has recently been shown to exert antioxidant, antiviral, and antitumor activity, and has demonstrated efficacy in treating Condylomata acuminata (external anogenital warts).18 In addition, topically applying green tea catechins in the morning in combination with traditional sunscreens is believed to have the potential to protect the skin from UV-induced damage. Topical green tea may improve rosacea, prevent retinoid dermatitis, and play a role in managing pigmentation disorders. Few of the many over-the-counter products that contain green tea catechins have been tested in controlled clinical trials and the concentration of polyphenols in these products is too low to demonstrate efficacy. It is necessary to know the amount of green tea catechins in a formulation to judge its efficacy.
Acne
In 2009, in a 6-week study investigating the efficacy of 2% green tea lotion for the treatment of mild-to-moderate acne vulgaris in 20 patients, researchers reported statistically significant reductions in mean total lesion count and mean severity index (devised by the authors to correlate with total lesion count in increasing intensity, scaled from 1 to 3). They concluded that 2% green tea lotion is both an effective and cost effective approach for treating mild-to-moderate acne lesions.19
A 2012 study revealed that ethanol extracts of several herbs, including green tea, exhibited the potential for inhibiting acne when incorporated into a topical moisturizer, specifically acting against acne-causing bacteria without provoking irritation.20 Earlier that year, other investigators conducted in vitro and in vivo experiments to evaluate the effects against acne of polyphenon-60, which contains various green tea catechins (now referred to as sinecatechins in the United States.).21 In this clinical study, patients exhibited improvement in acne symptoms, including a reduction in the number of pustules and comedones.22
A study published in 2013, a single-blind, placebo-controlled, split-face comparative study in 22 individuals over 60 days, evaluated the efficacy of green tea, as well as green tea plus lotus, compared with placebo for controlling casual sebum secretions in healthy adults. Compared with placebo, consistent and statistically significant decreases in sebum secretions were observed in both treatment groups. The combination of green tea and lotus extracts also achieved statistically sounder results than green tea alone. The investigators concluded that a synergistic interaction between green tea and lotus extract constituents appears to hold promise for the treatment of skin conditions in which elevated sebum levels are involved.23
Anogenital warts
In 2006, the Food and Drug Administration approved for the first time a botanical drug formulation for the topical treatment of genital and perianal warts: sinecatechins, derived from green tea catechins and other C. sinensis constituents in a topical 15% ointment (Veregen).21, 24-28
Two years later, Tatti et al. conducted a randomized, double-blind, vehicle-controlled trial to evaluate the efficacy of topical sinecatechins in 502 male and female patients (aged 18 years and older) for the treatment of anogenital warts. For 16 weeks or until complete clearance, subjects applied sinecatechins ointment 15% or 10% or vehicle (placebo) three times daily. Complete clearance was achieved in 57.2% of patients treated with 15% ointment, 56.3% using 10% ointment, and 33.7% who used only the vehicle. Respective recurrence rates, after 12 weeks, were 6.5%, 8.3%, and 8.8%. The investigators concluded that topical sinecatechins in 15% and 10% concentrations represent effective and well-tolerated options for anogenital wart treatment.29
Similarly favorable results regarding polyphenon E 15% were reported in reference to three placebo-controlled clinical studies in 1,400 patients with genital warts from Europe, North and South America, and South Africa,30,31 and by Tatti et al. again in 2010 after randomized, double-blind, vehicle-controlled safety and efficacy trials in nearly 1,000 patients treated with polyphenon E 15% and 10% formulations.21
Two years later, investigators evaluated sinecatechins (Polyphenon E) 10% ointment in two double-blind, multinational studies in adults with external genital and perianal warts. Polyphenon E 10% was found to be significantly more effective than vehicle in completely or partially clearing all warts.32
Earlier that year, a review of the use of sinecatechins ointment for the treatment of external anogenital warts noted that while clearance rates are similar among sinecatechins and other indicated topical medications such as imiquimod and podophyllotoxin, recurrence rates are lower for patients treated with sinecatechins. The authors concluded that the use of sinecatechins for condylomata acuminata was safe and effective and its various molecular activities suggest broader applications to other viral and tumor lesions.33
In 2015, Gupta and Daigle reported that sinecatechins 10% ointment for the treatment of external genital warts was found in phase III trials to display greater efficacy and lower rates of recurrence in comparison to patient-applied treatments now available.28 Later that year, in a systematic PubMed and Embase review of clinical trials involving the use of polyphenol-based therapies, Tuong et al. identified cogent evidence suggesting the effectiveness of green tea polyphenols for the treatment of anogenital warts.34
Antiaging activity
Green tea has been shown to work in combination with red light to exert a rejuvenating effect on the skin, as Sommer and Zhu reported in 2009 that green tea filled cotton pads applied once daily for 20 minutes prior to treatment with light-emitting diodes (central wavelength 670 nm, dermal dose 4 J/cm2) reduced wrinkles in 1 month comparably to 10 months of light treatment alone.35
In 2013, Hong et al. studied the antiwrinkle effects of topically applied green tea extract with high antioxidant activity after tannase treatment. Study participants were randomly divided to receive either green tea extract or tannase-converted green tea extract on their crow’s feet for an 8-week period. The investigators found that tannase treatment elevated the antioxidant activity of green tea and imparted antiwrinkle effects.36
At around the same time, Gianeti conducted clinical studies in 24 volunteers to assess the effects of a cosmetic formulation containing 6% C. sinensis glycolic leaf extracts. Skin moisture was enhanced after 30 days of topical application as was the viscoelastic-to-elastic ratio compared with vehicle and control (a forearm area left untreated). Skin roughness was significantly diminished after 30 days. The investigators concluded that the topical cosmetic formulation with green tea yielded salient moisturizing and cutaneous microrelief benefits.37
Also in 2013, oral intake of green tea catechins in 16 healthy human subjects (with 14 completing the study) appeared to result in the integration of catechin metabolites into human skin linked to the negation of UV-induced 12-hydroxyeicosatetraenoic acid (12-HETE). The investigators speculated that this incorporation of catechins may render protection against sunburn inflammation and even cumulative UV-induced harm.38
After earlier showing the efficacy of green tea and lotus extracts in skin disorders involving excess sebum in a single-blinded, placebo-controlled, split-face comparative study,23 Mahmood and Akhtar conducted a 60-day placebo-controlled comparative split-face study in 33 healthy Asian men to evaluate the efficacy of two cosmetic formulations (green tea and lotus extract) for facial wrinkles. All of the formulations yielded improvements in skin roughness, scaliness, smoothness, and wrinkling, with the greatest reduction in wrinkling conferred by the combination formulation. The investigators concluded that the synergistic activity of green tea and lotus extracts exerted significant improvement along several skin parameters, suggesting the potential for these ingredients in antiaging products.38
In 2014, the synergistic effects of green tea and ginkgo biloba were explored in preclinical and clinical studies. In the clinical study, 48 participants applied the formulations on forearm skin and were evaluated before and after 3 hours and following 15- and 30-day use periods. Results showed a moisturizing effect and enhancement in skin microrelief, as well as improvements in skin elasticity and barrier function.3
Conclusion
Green tea remains one of the most researched antioxidants as benefits from its use continue to emerge. Indeed, green tea polyphenols are in use for a growing number of indications, especially acne and anogenital warts, and there is reason for optimism that topically applied green tea will gain momentum as an increasingly selected therapeutic option. More clinical studies are necessary to further establish the potential role of green tea for a wider range of cutaneous indications. Green tea holds particular promise in relation to photoprotection against UV-induced skin cancer and skin aging.
Dr. Baumann is chief executive officer of the Baumann Cosmetic & Research Institute in the Design District in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote the textbook “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and a book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Her latest book, “Cosmeceuticals and Cosmetic Ingredients,” was published in November 2014. Dr. Baumann has received funding for clinical grants from Allergan, Aveeno, Avon Products, Evolus, Galderma, GlaxoSmithKline, Kythera Biopharmaceuticals, Mary Kay, Medicis Pharmaceuticals, Neutrogena, Philosophy, Topix Pharmaceuticals, and Unilever. She also developed and owns the Baumann Skin Type Solution skin typing systems and related products
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• Green tea is one of the most researched antioxidants, particularly its constituent polyphenolic catechins (notably epigallocatechin gallate, or EGCG).
• It is thought to be difficult to formulate in topical products because of the intrinsic hydrophilicity of EGCG.
• Topical application is thought to reduce inflammation and neutralize free radicals, but does not increase collagen production or reduce already existing wrinkles.
• It has been shown to be effective topically for treating acne, anogenital warts, and aging skin.
