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Migraineurs Bear Stigma That Influences Health Outcomes
Stigma in Media and Society
Although neurologists and the general public acknowledge the symptoms and disability associated with a disease, they generally discount or fail to recognize its associated stigma, said Dr. Shapiro. Internalized stigma is a person’s sense that he or she is kept at a social distance, and enacted stigma refers to instances of discrimination on the basis of a person’s condition. Consequences of stigma include psychologic distress, low self-esteem, poor social outcomes, and poor health outcomes.
In a 2006 analysis, Caspermeyer et al examined 1,203 newspaper articles about neurologic conditions. They found that, after articles about epilepsy, articles about migraine contained the highest frequency of stigmatizing language (29%). Although migraine was among the most prevalent diseases in the analysis, it was among the least covered topics in newspaper articles.
To determine whether migraine is associated with stigma, Young and colleagues administered the Stigma Scale for Chronic Illness, a questionnaire, to patients with episodic migraine, chronic migraine, or epilepsy. The investigators observed that patients with chronic migraine and patients with epilepsy faced a similar amount of stigma. They further observed that stigma correlated most strongly with inability to work and was greater for chronic migraine than for epilepsy or episodic migraine.
Level of Stigma by Disease
Following these studies, Dr. Shapiro and colleagues investigated externalized stigma, or the rejection of others because of their condition. They polled adult members of the Amazon Mechanical Turk community, a group of approximately 500,000 people who voluntarily respond to surveys for modest monetary compensation. Compared with the US population, the Amazon Mechanical Turk community includes more women, Caucasians, young people, liberals, educated people, secular people, and people with low incomes. The group better represents the US population, however, than general Internet or university convenience samples do.
The investigators presented each respondent with one of four vignettes about people with a disease that does not respond well to treatment and that sometimes results in missed work or family activities. The vignettes were identical except for the condition named. The four conditions were migraine, epilepsy, panic disorder, and asthma. After reviewing the vignette, each respondent completed a validated stigma-assessment instrument using a Likert scale for each item.
In all, 765 people completed the instrument. Respondents’ mean age was 28, and 60% of the sample was female. There was no difference in the level of stigma attributed to migraine, panic disorder, or epilepsy, but respondents attributed less stigma to asthma than to the other three conditions. Noting the similar level of stigma between migraine and epilepsy, Dr. Shapiro said, “Epilepsy historically has been associated with demonic possession. If ever there were a disease that you would assume would have social distance or stigma attached, it certainly would be epilepsy.”
Disease and Productivity Loss
In a second study, Dr. Shapiro and colleagues presented members of the Amazon Mechanical Turk community with one of five vignettes. The vignettes described the following cases:
- A woman with migraine on four days per month who missed no workdays per year
- A woman with migraine on four days per month who missed two workdays per year
- A woman with migraine on 20 days per month who missed 10 workdays per year
- A man with migraine on four days per month who missed two workdays per year
- A woman with seizures on four days per month who missed two workdays per year.
Respondents then completed a social distance scale that included questions about the respondent’s willingness to socialize with, trust, hire, or allow the person in the vignette to marry into his or her family.
The researchers found that the level of externalized stigma was the same for the woman with migraine who missed two workdays per year as it was for the woman with epilepsy who missed two workdays per year. Respondents believed that the person with epilepsy would care more about whether he or she was a burden on others, compared with the migraineur. Respondents also said that the person with epilepsy would try harder and would be less likely to malinger, compared with the migraineur.
The gender of the person in the vignette was not associated with the level of stigma, said Dr. Shapiro. On the other hand, men were much more likely to stigmatize a man or a woman with migraine than women were.
In addition, the researchers found that the woman with chronic migraine who missed 10 workdays per year was much more likely to be stigmatized than migraineurs who missed fewer workdays. People who missed more workdays were less likely to be seen as trying hard, less likely to be interviewed, more likely to be considered malingerers, and less likely to be considered trustworthy.
Fear of Pain and Social Distance
As part of the same study, respondents completed instruments that measured fear of pain and empathy, and also provided demographic information, including migraine status. Overall, fear of pain was similar between migraineurs and nonmigraineurs. Migraineurs feared migraine as much as they feared falling down a flight of stairs or having a car door slammed on the hand. Nonmigraineurs, however, considered migraine to be less severe than migraineurs did. Among nonmigraineurs, greater fear of pain was associated with greater social distance from migraineurs. But in the same group, greater fear of migraine was associated with less social distance from migraineurs.
Furthermore, Dr. Shapiro’s group noted that the more migraine is part of a person’s experience, the less social distance that person maintains from migraineurs. Similarly, they found that as empathy increased, the social distance to migraine decreased.
Other findings included that younger people were more likely to stigmatize migraine than older people, and that non-Caucasians were more likely to stigmatize migraine than Caucasians. The gender of the stigmatizer was a dominant influence on the amount of stigma.
Reasons for Migraine Stigma
Various hypotheses offer potential reasons for stigmatizing migraine. Approximately 75% of migraineurs are women, and migraine changes with hormonal fluctuations. Hence, sexism against women may be one cause of stigma.
Also, migraine has been considered a behavior problem or conversion disorder for decades, said Dr. Shapiro. One illustration of this point is that a monograph published in 1926 identified migraine as a neurosis. In 1894, Freud described migraine as the result of a failure to find release after sexual stimulation.
Migraine is associated with headache, and headache has various connotations. The type of headache with which most people are familiar is tension-type headache, thus the general public may be likely to minimize the severity or importance of migraine. The word “headache” also connotes “concern” or “annoyance,” which may contribute to a minimization of migraine’s severity.
Whatever its origin, the stigma associated with migraine often is overlooked, said Dr. Shapiro. Neurologists should consider the potential effects of stigma on health outcomes as they treat patients with headache, he concluded.
—Erik Greb
Suggested Reading
Caspermeyer JJ, Sylvester EJ, Drazkowski JF, et al. Evaluation of stigmatizing language and medical errors in neurology coverage by US newspapers. Mayo Clin Proc. 2006;81(3):300-306.
Evans RW, Evans RE. A survey of neurologists on the likeability of headaches and other neurological disorders. Headache. 2010;50(7):1126-1129.
Evans RW, Evans RE, Kell HJ. A survey of family doctors on the likeability of migraine and other common diseases and their prevalence of migraine. Cephalalgia. 2010;30(5):620-623.
Young WB, Park JE, Tian IX, Kempner J. The stigma of migraine. PLoS One. 2013;8(1):e54074.
Stigma in Media and Society
Although neurologists and the general public acknowledge the symptoms and disability associated with a disease, they generally discount or fail to recognize its associated stigma, said Dr. Shapiro. Internalized stigma is a person’s sense that he or she is kept at a social distance, and enacted stigma refers to instances of discrimination on the basis of a person’s condition. Consequences of stigma include psychologic distress, low self-esteem, poor social outcomes, and poor health outcomes.
In a 2006 analysis, Caspermeyer et al examined 1,203 newspaper articles about neurologic conditions. They found that, after articles about epilepsy, articles about migraine contained the highest frequency of stigmatizing language (29%). Although migraine was among the most prevalent diseases in the analysis, it was among the least covered topics in newspaper articles.
To determine whether migraine is associated with stigma, Young and colleagues administered the Stigma Scale for Chronic Illness, a questionnaire, to patients with episodic migraine, chronic migraine, or epilepsy. The investigators observed that patients with chronic migraine and patients with epilepsy faced a similar amount of stigma. They further observed that stigma correlated most strongly with inability to work and was greater for chronic migraine than for epilepsy or episodic migraine.
Level of Stigma by Disease
Following these studies, Dr. Shapiro and colleagues investigated externalized stigma, or the rejection of others because of their condition. They polled adult members of the Amazon Mechanical Turk community, a group of approximately 500,000 people who voluntarily respond to surveys for modest monetary compensation. Compared with the US population, the Amazon Mechanical Turk community includes more women, Caucasians, young people, liberals, educated people, secular people, and people with low incomes. The group better represents the US population, however, than general Internet or university convenience samples do.
The investigators presented each respondent with one of four vignettes about people with a disease that does not respond well to treatment and that sometimes results in missed work or family activities. The vignettes were identical except for the condition named. The four conditions were migraine, epilepsy, panic disorder, and asthma. After reviewing the vignette, each respondent completed a validated stigma-assessment instrument using a Likert scale for each item.
In all, 765 people completed the instrument. Respondents’ mean age was 28, and 60% of the sample was female. There was no difference in the level of stigma attributed to migraine, panic disorder, or epilepsy, but respondents attributed less stigma to asthma than to the other three conditions. Noting the similar level of stigma between migraine and epilepsy, Dr. Shapiro said, “Epilepsy historically has been associated with demonic possession. If ever there were a disease that you would assume would have social distance or stigma attached, it certainly would be epilepsy.”
Disease and Productivity Loss
In a second study, Dr. Shapiro and colleagues presented members of the Amazon Mechanical Turk community with one of five vignettes. The vignettes described the following cases:
- A woman with migraine on four days per month who missed no workdays per year
- A woman with migraine on four days per month who missed two workdays per year
- A woman with migraine on 20 days per month who missed 10 workdays per year
- A man with migraine on four days per month who missed two workdays per year
- A woman with seizures on four days per month who missed two workdays per year.
Respondents then completed a social distance scale that included questions about the respondent’s willingness to socialize with, trust, hire, or allow the person in the vignette to marry into his or her family.
The researchers found that the level of externalized stigma was the same for the woman with migraine who missed two workdays per year as it was for the woman with epilepsy who missed two workdays per year. Respondents believed that the person with epilepsy would care more about whether he or she was a burden on others, compared with the migraineur. Respondents also said that the person with epilepsy would try harder and would be less likely to malinger, compared with the migraineur.
The gender of the person in the vignette was not associated with the level of stigma, said Dr. Shapiro. On the other hand, men were much more likely to stigmatize a man or a woman with migraine than women were.
In addition, the researchers found that the woman with chronic migraine who missed 10 workdays per year was much more likely to be stigmatized than migraineurs who missed fewer workdays. People who missed more workdays were less likely to be seen as trying hard, less likely to be interviewed, more likely to be considered malingerers, and less likely to be considered trustworthy.
Fear of Pain and Social Distance
As part of the same study, respondents completed instruments that measured fear of pain and empathy, and also provided demographic information, including migraine status. Overall, fear of pain was similar between migraineurs and nonmigraineurs. Migraineurs feared migraine as much as they feared falling down a flight of stairs or having a car door slammed on the hand. Nonmigraineurs, however, considered migraine to be less severe than migraineurs did. Among nonmigraineurs, greater fear of pain was associated with greater social distance from migraineurs. But in the same group, greater fear of migraine was associated with less social distance from migraineurs.
Furthermore, Dr. Shapiro’s group noted that the more migraine is part of a person’s experience, the less social distance that person maintains from migraineurs. Similarly, they found that as empathy increased, the social distance to migraine decreased.
Other findings included that younger people were more likely to stigmatize migraine than older people, and that non-Caucasians were more likely to stigmatize migraine than Caucasians. The gender of the stigmatizer was a dominant influence on the amount of stigma.
Reasons for Migraine Stigma
Various hypotheses offer potential reasons for stigmatizing migraine. Approximately 75% of migraineurs are women, and migraine changes with hormonal fluctuations. Hence, sexism against women may be one cause of stigma.
Also, migraine has been considered a behavior problem or conversion disorder for decades, said Dr. Shapiro. One illustration of this point is that a monograph published in 1926 identified migraine as a neurosis. In 1894, Freud described migraine as the result of a failure to find release after sexual stimulation.
Migraine is associated with headache, and headache has various connotations. The type of headache with which most people are familiar is tension-type headache, thus the general public may be likely to minimize the severity or importance of migraine. The word “headache” also connotes “concern” or “annoyance,” which may contribute to a minimization of migraine’s severity.
Whatever its origin, the stigma associated with migraine often is overlooked, said Dr. Shapiro. Neurologists should consider the potential effects of stigma on health outcomes as they treat patients with headache, he concluded.
—Erik Greb
Suggested Reading
Caspermeyer JJ, Sylvester EJ, Drazkowski JF, et al. Evaluation of stigmatizing language and medical errors in neurology coverage by US newspapers. Mayo Clin Proc. 2006;81(3):300-306.
Evans RW, Evans RE. A survey of neurologists on the likeability of headaches and other neurological disorders. Headache. 2010;50(7):1126-1129.
Evans RW, Evans RE, Kell HJ. A survey of family doctors on the likeability of migraine and other common diseases and their prevalence of migraine. Cephalalgia. 2010;30(5):620-623.
Young WB, Park JE, Tian IX, Kempner J. The stigma of migraine. PLoS One. 2013;8(1):e54074.
Stigma in Media and Society
Although neurologists and the general public acknowledge the symptoms and disability associated with a disease, they generally discount or fail to recognize its associated stigma, said Dr. Shapiro. Internalized stigma is a person’s sense that he or she is kept at a social distance, and enacted stigma refers to instances of discrimination on the basis of a person’s condition. Consequences of stigma include psychologic distress, low self-esteem, poor social outcomes, and poor health outcomes.
In a 2006 analysis, Caspermeyer et al examined 1,203 newspaper articles about neurologic conditions. They found that, after articles about epilepsy, articles about migraine contained the highest frequency of stigmatizing language (29%). Although migraine was among the most prevalent diseases in the analysis, it was among the least covered topics in newspaper articles.
To determine whether migraine is associated with stigma, Young and colleagues administered the Stigma Scale for Chronic Illness, a questionnaire, to patients with episodic migraine, chronic migraine, or epilepsy. The investigators observed that patients with chronic migraine and patients with epilepsy faced a similar amount of stigma. They further observed that stigma correlated most strongly with inability to work and was greater for chronic migraine than for epilepsy or episodic migraine.
Level of Stigma by Disease
Following these studies, Dr. Shapiro and colleagues investigated externalized stigma, or the rejection of others because of their condition. They polled adult members of the Amazon Mechanical Turk community, a group of approximately 500,000 people who voluntarily respond to surveys for modest monetary compensation. Compared with the US population, the Amazon Mechanical Turk community includes more women, Caucasians, young people, liberals, educated people, secular people, and people with low incomes. The group better represents the US population, however, than general Internet or university convenience samples do.
The investigators presented each respondent with one of four vignettes about people with a disease that does not respond well to treatment and that sometimes results in missed work or family activities. The vignettes were identical except for the condition named. The four conditions were migraine, epilepsy, panic disorder, and asthma. After reviewing the vignette, each respondent completed a validated stigma-assessment instrument using a Likert scale for each item.
In all, 765 people completed the instrument. Respondents’ mean age was 28, and 60% of the sample was female. There was no difference in the level of stigma attributed to migraine, panic disorder, or epilepsy, but respondents attributed less stigma to asthma than to the other three conditions. Noting the similar level of stigma between migraine and epilepsy, Dr. Shapiro said, “Epilepsy historically has been associated with demonic possession. If ever there were a disease that you would assume would have social distance or stigma attached, it certainly would be epilepsy.”
Disease and Productivity Loss
In a second study, Dr. Shapiro and colleagues presented members of the Amazon Mechanical Turk community with one of five vignettes. The vignettes described the following cases:
- A woman with migraine on four days per month who missed no workdays per year
- A woman with migraine on four days per month who missed two workdays per year
- A woman with migraine on 20 days per month who missed 10 workdays per year
- A man with migraine on four days per month who missed two workdays per year
- A woman with seizures on four days per month who missed two workdays per year.
Respondents then completed a social distance scale that included questions about the respondent’s willingness to socialize with, trust, hire, or allow the person in the vignette to marry into his or her family.
The researchers found that the level of externalized stigma was the same for the woman with migraine who missed two workdays per year as it was for the woman with epilepsy who missed two workdays per year. Respondents believed that the person with epilepsy would care more about whether he or she was a burden on others, compared with the migraineur. Respondents also said that the person with epilepsy would try harder and would be less likely to malinger, compared with the migraineur.
The gender of the person in the vignette was not associated with the level of stigma, said Dr. Shapiro. On the other hand, men were much more likely to stigmatize a man or a woman with migraine than women were.
In addition, the researchers found that the woman with chronic migraine who missed 10 workdays per year was much more likely to be stigmatized than migraineurs who missed fewer workdays. People who missed more workdays were less likely to be seen as trying hard, less likely to be interviewed, more likely to be considered malingerers, and less likely to be considered trustworthy.
Fear of Pain and Social Distance
As part of the same study, respondents completed instruments that measured fear of pain and empathy, and also provided demographic information, including migraine status. Overall, fear of pain was similar between migraineurs and nonmigraineurs. Migraineurs feared migraine as much as they feared falling down a flight of stairs or having a car door slammed on the hand. Nonmigraineurs, however, considered migraine to be less severe than migraineurs did. Among nonmigraineurs, greater fear of pain was associated with greater social distance from migraineurs. But in the same group, greater fear of migraine was associated with less social distance from migraineurs.
Furthermore, Dr. Shapiro’s group noted that the more migraine is part of a person’s experience, the less social distance that person maintains from migraineurs. Similarly, they found that as empathy increased, the social distance to migraine decreased.
Other findings included that younger people were more likely to stigmatize migraine than older people, and that non-Caucasians were more likely to stigmatize migraine than Caucasians. The gender of the stigmatizer was a dominant influence on the amount of stigma.
Reasons for Migraine Stigma
Various hypotheses offer potential reasons for stigmatizing migraine. Approximately 75% of migraineurs are women, and migraine changes with hormonal fluctuations. Hence, sexism against women may be one cause of stigma.
Also, migraine has been considered a behavior problem or conversion disorder for decades, said Dr. Shapiro. One illustration of this point is that a monograph published in 1926 identified migraine as a neurosis. In 1894, Freud described migraine as the result of a failure to find release after sexual stimulation.
Migraine is associated with headache, and headache has various connotations. The type of headache with which most people are familiar is tension-type headache, thus the general public may be likely to minimize the severity or importance of migraine. The word “headache” also connotes “concern” or “annoyance,” which may contribute to a minimization of migraine’s severity.
Whatever its origin, the stigma associated with migraine often is overlooked, said Dr. Shapiro. Neurologists should consider the potential effects of stigma on health outcomes as they treat patients with headache, he concluded.
—Erik Greb
Suggested Reading
Caspermeyer JJ, Sylvester EJ, Drazkowski JF, et al. Evaluation of stigmatizing language and medical errors in neurology coverage by US newspapers. Mayo Clin Proc. 2006;81(3):300-306.
Evans RW, Evans RE. A survey of neurologists on the likeability of headaches and other neurological disorders. Headache. 2010;50(7):1126-1129.
Evans RW, Evans RE, Kell HJ. A survey of family doctors on the likeability of migraine and other common diseases and their prevalence of migraine. Cephalalgia. 2010;30(5):620-623.
Young WB, Park JE, Tian IX, Kempner J. The stigma of migraine. PLoS One. 2013;8(1):e54074.
Saturday - On Tap
It’s the final day of the Vascular Annual Meeting – and there is plenty on the agenda to keep you busy.
6:30 to 8:00 a.m. – Three Breakfast Sessions: “Beyond the Basics of Hemodialysis Access,” “The Treatment of Chronic Venous Leg Ulcers,” and “How to Write a Paper and Have it Accepted in the JVS or EJVES.”
8:00 to 10:00 a.m. – Plenary 7 and Plenary 8. With so many high-quality abstracts submitted, two plenary sessions are set for Saturday; Plenary 8 includes late-breaking abstracts and the Vascular Quality Initiative. SDCC, Room 6 A/B
9:00 a.m. to 1:00 p.m. – It’s your last chance to visit the Exhibit Hall to see what’s new and improved. Exhibit Hall B.
10:30 a.m. to 12:00 p.m. – Four concurrent sessions, on the modern VA vascular practice and three joint sessions with an alphabet soup of allied societies, on medical management of vascular disease (SVM), collaboration of vascular surgeons and nurses (SVN), and building and managing a vascular laboratory (SVU).
10:30 a.m. to 12:00 p.m. – Top 10 papers relevant to vascular surgery that were NOT published in the Journal of Vascular Surgery. SDCC, Room 6 A/B.
12:00 p.m. – SVS members, see the passing of the gavel and other business issues, as well as award presentations. SDCC, Room 6 D/E.
1:30 to 3:30 p.m. – Sometimes seeing makes more of an impact than listening. The “How I do it” Video Session will feature 11 video abstracts on a variety of topics. SDCC, Room 6C.
1:30 to 5:00 p.m. – RPVI exam preparation, in collaboration with the Society for Vascular Ultrasound. SDCC, Room 4.
1:30 to 5:15 p.m. – Aortic Summit, with the Society of Thoracic Surgeons. SDCC, Room 3.
3:30 to 4:30 p.m. – Poster Runoff: Championship Round. From 120 posters to just 10, with three winners selected by the audience. SDCC, Room 6C.
It’s the final day of the Vascular Annual Meeting – and there is plenty on the agenda to keep you busy.
6:30 to 8:00 a.m. – Three Breakfast Sessions: “Beyond the Basics of Hemodialysis Access,” “The Treatment of Chronic Venous Leg Ulcers,” and “How to Write a Paper and Have it Accepted in the JVS or EJVES.”
8:00 to 10:00 a.m. – Plenary 7 and Plenary 8. With so many high-quality abstracts submitted, two plenary sessions are set for Saturday; Plenary 8 includes late-breaking abstracts and the Vascular Quality Initiative. SDCC, Room 6 A/B
9:00 a.m. to 1:00 p.m. – It’s your last chance to visit the Exhibit Hall to see what’s new and improved. Exhibit Hall B.
10:30 a.m. to 12:00 p.m. – Four concurrent sessions, on the modern VA vascular practice and three joint sessions with an alphabet soup of allied societies, on medical management of vascular disease (SVM), collaboration of vascular surgeons and nurses (SVN), and building and managing a vascular laboratory (SVU).
10:30 a.m. to 12:00 p.m. – Top 10 papers relevant to vascular surgery that were NOT published in the Journal of Vascular Surgery. SDCC, Room 6 A/B.
12:00 p.m. – SVS members, see the passing of the gavel and other business issues, as well as award presentations. SDCC, Room 6 D/E.
1:30 to 3:30 p.m. – Sometimes seeing makes more of an impact than listening. The “How I do it” Video Session will feature 11 video abstracts on a variety of topics. SDCC, Room 6C.
1:30 to 5:00 p.m. – RPVI exam preparation, in collaboration with the Society for Vascular Ultrasound. SDCC, Room 4.
1:30 to 5:15 p.m. – Aortic Summit, with the Society of Thoracic Surgeons. SDCC, Room 3.
3:30 to 4:30 p.m. – Poster Runoff: Championship Round. From 120 posters to just 10, with three winners selected by the audience. SDCC, Room 6C.
It’s the final day of the Vascular Annual Meeting – and there is plenty on the agenda to keep you busy.
6:30 to 8:00 a.m. – Three Breakfast Sessions: “Beyond the Basics of Hemodialysis Access,” “The Treatment of Chronic Venous Leg Ulcers,” and “How to Write a Paper and Have it Accepted in the JVS or EJVES.”
8:00 to 10:00 a.m. – Plenary 7 and Plenary 8. With so many high-quality abstracts submitted, two plenary sessions are set for Saturday; Plenary 8 includes late-breaking abstracts and the Vascular Quality Initiative. SDCC, Room 6 A/B
9:00 a.m. to 1:00 p.m. – It’s your last chance to visit the Exhibit Hall to see what’s new and improved. Exhibit Hall B.
10:30 a.m. to 12:00 p.m. – Four concurrent sessions, on the modern VA vascular practice and three joint sessions with an alphabet soup of allied societies, on medical management of vascular disease (SVM), collaboration of vascular surgeons and nurses (SVN), and building and managing a vascular laboratory (SVU).
10:30 a.m. to 12:00 p.m. – Top 10 papers relevant to vascular surgery that were NOT published in the Journal of Vascular Surgery. SDCC, Room 6 A/B.
12:00 p.m. – SVS members, see the passing of the gavel and other business issues, as well as award presentations. SDCC, Room 6 D/E.
1:30 to 3:30 p.m. – Sometimes seeing makes more of an impact than listening. The “How I do it” Video Session will feature 11 video abstracts on a variety of topics. SDCC, Room 6C.
1:30 to 5:00 p.m. – RPVI exam preparation, in collaboration with the Society for Vascular Ultrasound. SDCC, Room 4.
1:30 to 5:15 p.m. – Aortic Summit, with the Society of Thoracic Surgeons. SDCC, Room 3.
3:30 to 4:30 p.m. – Poster Runoff: Championship Round. From 120 posters to just 10, with three winners selected by the audience. SDCC, Room 6C.
Reader inquires about coding for McCall culdoplasty
Reader inquires about coding for McCall culdoplasty
It is difficult to know what CPT code to use for billing when my practice’s physicians do a McCall culdoplasty during a vaginal or laparoscopic hysterectomy. They often do a McCall procedure when a rectocele is present. One provider said it is CPT 57283. But I read an article that said a McCall repairs an “enterocele” and code 58263 would be used if doing one during a vaginal hysterectomy. Do you have a recommendation?
Sonia Pap, CPC, COBGC
Linville/Boone, North Carolina
Melanie Witt responds
Preventing vaginal vault prolapse by supporting the vaginal cuff is an essential part of hysterectomy, whether abdominal or vaginal. The McCall culdoplasty procedure is performed to support the vaginal cuff at the time of a vaginal hysterectomy by attaching the uterosacral and cardinal ligaments to the peritoneal surface with suture material such that, when tied, it draws toward the midline, helping to close off the cul-de-sac. This procedure not only supports the vaginal cuff but also closes off the cul-de-sac, thus preventing the formation of an enterocele.
As such it would be considered integral to the normal vaginal hysterectomy procedure and is not separately billable. However, in some cases where the patient has stage 1 to stage 4 uterovaginal prolapse, adjunct vaginal apex support is necessary. If the patient has this documented prior to the surgery, she will likely need more than the included uterosacral-cardinal ligament attachment to the vaginal membrane. This is where a colpopexy comes into play, and traditionally, sacrospinous fixation has been performed to accomplish this. In recent years, the uterosacral ligaments have been used instead, which is why we now have 2 codes for vaginal approach colpopexy: 57283 (uterosacral) and 57282 (sacrospinous). Both of these procedures will eliminate an existing enterocele and therefore could potentially be billed with a vaginal hysterectomy unless a more comprehensive code exits that describes the total surgery.
If the purpose of the colpopexy is to repair an existing enterocele, you would not itemize, but rather would report a vaginal hysterectomy with enterocele repair code (58263, 58270, 58292, or 58294) for that complete surgery. The codes do not specify the type of enterocele repair performed and so by definition would include “any method” including a colpopexy. You will note that the colpopexy codes 57283 and 57282 are bundled into all vaginal hysterectomy codes, and although you can use a modifier -59 to bypass this edit, you must meet the criteria for doing so. But especially, 57283 and 57282 are permanently bundled with the vaginal hysterectomy codes that include enterocele repair. Since there already exists a code that describes a vaginal hysterectomy with enterocele repair, you cannot report the modifier -59 for a separate colpopexy if the reason for doing it was to repair an enterocele. You could, however, use it if the sole reason was to do an adjunct vaginal vault repair due to documented uterovaginal prolapse.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Reader inquires about coding for McCall culdoplasty
It is difficult to know what CPT code to use for billing when my practice’s physicians do a McCall culdoplasty during a vaginal or laparoscopic hysterectomy. They often do a McCall procedure when a rectocele is present. One provider said it is CPT 57283. But I read an article that said a McCall repairs an “enterocele” and code 58263 would be used if doing one during a vaginal hysterectomy. Do you have a recommendation?
Sonia Pap, CPC, COBGC
Linville/Boone, North Carolina
Melanie Witt responds
Preventing vaginal vault prolapse by supporting the vaginal cuff is an essential part of hysterectomy, whether abdominal or vaginal. The McCall culdoplasty procedure is performed to support the vaginal cuff at the time of a vaginal hysterectomy by attaching the uterosacral and cardinal ligaments to the peritoneal surface with suture material such that, when tied, it draws toward the midline, helping to close off the cul-de-sac. This procedure not only supports the vaginal cuff but also closes off the cul-de-sac, thus preventing the formation of an enterocele.
As such it would be considered integral to the normal vaginal hysterectomy procedure and is not separately billable. However, in some cases where the patient has stage 1 to stage 4 uterovaginal prolapse, adjunct vaginal apex support is necessary. If the patient has this documented prior to the surgery, she will likely need more than the included uterosacral-cardinal ligament attachment to the vaginal membrane. This is where a colpopexy comes into play, and traditionally, sacrospinous fixation has been performed to accomplish this. In recent years, the uterosacral ligaments have been used instead, which is why we now have 2 codes for vaginal approach colpopexy: 57283 (uterosacral) and 57282 (sacrospinous). Both of these procedures will eliminate an existing enterocele and therefore could potentially be billed with a vaginal hysterectomy unless a more comprehensive code exits that describes the total surgery.
If the purpose of the colpopexy is to repair an existing enterocele, you would not itemize, but rather would report a vaginal hysterectomy with enterocele repair code (58263, 58270, 58292, or 58294) for that complete surgery. The codes do not specify the type of enterocele repair performed and so by definition would include “any method” including a colpopexy. You will note that the colpopexy codes 57283 and 57282 are bundled into all vaginal hysterectomy codes, and although you can use a modifier -59 to bypass this edit, you must meet the criteria for doing so. But especially, 57283 and 57282 are permanently bundled with the vaginal hysterectomy codes that include enterocele repair. Since there already exists a code that describes a vaginal hysterectomy with enterocele repair, you cannot report the modifier -59 for a separate colpopexy if the reason for doing it was to repair an enterocele. You could, however, use it if the sole reason was to do an adjunct vaginal vault repair due to documented uterovaginal prolapse.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Reader inquires about coding for McCall culdoplasty
It is difficult to know what CPT code to use for billing when my practice’s physicians do a McCall culdoplasty during a vaginal or laparoscopic hysterectomy. They often do a McCall procedure when a rectocele is present. One provider said it is CPT 57283. But I read an article that said a McCall repairs an “enterocele” and code 58263 would be used if doing one during a vaginal hysterectomy. Do you have a recommendation?
Sonia Pap, CPC, COBGC
Linville/Boone, North Carolina
Melanie Witt responds
Preventing vaginal vault prolapse by supporting the vaginal cuff is an essential part of hysterectomy, whether abdominal or vaginal. The McCall culdoplasty procedure is performed to support the vaginal cuff at the time of a vaginal hysterectomy by attaching the uterosacral and cardinal ligaments to the peritoneal surface with suture material such that, when tied, it draws toward the midline, helping to close off the cul-de-sac. This procedure not only supports the vaginal cuff but also closes off the cul-de-sac, thus preventing the formation of an enterocele.
As such it would be considered integral to the normal vaginal hysterectomy procedure and is not separately billable. However, in some cases where the patient has stage 1 to stage 4 uterovaginal prolapse, adjunct vaginal apex support is necessary. If the patient has this documented prior to the surgery, she will likely need more than the included uterosacral-cardinal ligament attachment to the vaginal membrane. This is where a colpopexy comes into play, and traditionally, sacrospinous fixation has been performed to accomplish this. In recent years, the uterosacral ligaments have been used instead, which is why we now have 2 codes for vaginal approach colpopexy: 57283 (uterosacral) and 57282 (sacrospinous). Both of these procedures will eliminate an existing enterocele and therefore could potentially be billed with a vaginal hysterectomy unless a more comprehensive code exits that describes the total surgery.
If the purpose of the colpopexy is to repair an existing enterocele, you would not itemize, but rather would report a vaginal hysterectomy with enterocele repair code (58263, 58270, 58292, or 58294) for that complete surgery. The codes do not specify the type of enterocele repair performed and so by definition would include “any method” including a colpopexy. You will note that the colpopexy codes 57283 and 57282 are bundled into all vaginal hysterectomy codes, and although you can use a modifier -59 to bypass this edit, you must meet the criteria for doing so. But especially, 57283 and 57282 are permanently bundled with the vaginal hysterectomy codes that include enterocele repair. Since there already exists a code that describes a vaginal hysterectomy with enterocele repair, you cannot report the modifier -59 for a separate colpopexy if the reason for doing it was to repair an enterocele. You could, however, use it if the sole reason was to do an adjunct vaginal vault repair due to documented uterovaginal prolapse.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Refutes concept of overdiagnosis of breast cancer
“MORE THAN ONE-THIRD OF TUMORS FOUND ON BREAST CANCER SCREENING REPRESENT OVERDIAGNOSIS”
ANDREW M. KAUNITZ, MD (MARCH 2017)
Refutes concept of overdiagnosis of breast cancer
I read with interest and serious concern the commentary and conclusions of “overdiagnosed” breast cancer. Let us revisit a few time-honored principles. Are we throwing away the valued concept of the early diagnosis of node-negative breast cancer? Is it still true that 5-year and long-term survivals are markedly better for stage I and II disease as opposed to stage III and IV disease? Is it still true that treatments designed for cure are substantially less involved, more successful, and more likely to conserve the breast and require less chemotherapy in early stage disease? Is it still true that the majority of women diagnosed with breast cancer are in the lowest risk category, ie, no family history and negative for the BRCA gene? If so, then who can explain the statement that “an invasive breast cancer detected by any means is overdiagnosis”? Would this imply that screening and the biopsy required to make the diagnosis was time poorly spent, the breast cancer should not be treated, and/or we should simply wait for a lump to be found by the patient deep in a large breast most likely at that point representing advanced disease?
The last paragraph notes the current US Preventive Services Task Force (USPSTF) guidance: wait until 50 years of age to start biennial screening. If so, what do we say to women in their 40s who, through screening with mammography and/or ultrasound, were diagnosed with early node-negative invasive breast cancer? That all of that was unnecessary and would not have led to symptoms? Would extreme morbidity from advanced or recurrent disease and the horrors of treatment just to extend a few months of life qualify as a symptom to these investigators? Lax protocols are not for me, my colleagues, or patients that I know. One of the most common reasons for a lawsuit to be brought against a primary care or ObGyn provider is failure to diagnose breast cancer!
John T. Armstrong, MD
Napa, California
Dr. Kaunitz responds
I thank Dr. Armstrong for his interest in my commentary on screening mammography and overdiagnosis. As I indicated in my commentary, I continue to recommend screening mammography for my patients, encouraging average-risk women to begin biennial screens at age 50 (consistent with USPSTF guidance), when the likelihood that tumors found with mammograms representing overdiagnosis is lower. I also indicated that I recognize that some patients prefer to begin screening at a younger age and to be screened more frequently. Dr. Armstrong’s letter refers to the “horrors of treatment” of breast cancer. From my perspective, the most “horrible” treatment is that which is administered to a woman diagnosed with a tumor destined to not cause clinical problems during her lifetime (overdiagnosis). You also refer to a statement, “an invasive breast cancer detected by any means is overdiagnosis.” That statement does not appear in my commentary.
My commentary’s point is that overdiagnosis is common among tumors diagnosed by screening mammography, and likely explains why, in contrast with cervical cancer screening, screening mammography has failed to reduce the incidence of breast cancers presenting as advanced (metastatic) disease. Although this represents a confusing and disquieting reality for our patients, and for us their clinicians, I agree with Dr. Otis Brawley, Chief Medical and Scientific Officer of the American Cancer Society, that we must acknowledge to our patients that overdiagnosis is common, the benefits of screening have been overstated, and that some patients considered as “cured” from breast cancer have in fact been harmed by unneeded treatment.1
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Brawley OW. Accepting the existence of breast cancer overdiagnosis [published online ahead of print January 10, 2017]. Ann Intern Med. doi:10.7326/M16-2850.
“MORE THAN ONE-THIRD OF TUMORS FOUND ON BREAST CANCER SCREENING REPRESENT OVERDIAGNOSIS”
ANDREW M. KAUNITZ, MD (MARCH 2017)
Refutes concept of overdiagnosis of breast cancer
I read with interest and serious concern the commentary and conclusions of “overdiagnosed” breast cancer. Let us revisit a few time-honored principles. Are we throwing away the valued concept of the early diagnosis of node-negative breast cancer? Is it still true that 5-year and long-term survivals are markedly better for stage I and II disease as opposed to stage III and IV disease? Is it still true that treatments designed for cure are substantially less involved, more successful, and more likely to conserve the breast and require less chemotherapy in early stage disease? Is it still true that the majority of women diagnosed with breast cancer are in the lowest risk category, ie, no family history and negative for the BRCA gene? If so, then who can explain the statement that “an invasive breast cancer detected by any means is overdiagnosis”? Would this imply that screening and the biopsy required to make the diagnosis was time poorly spent, the breast cancer should not be treated, and/or we should simply wait for a lump to be found by the patient deep in a large breast most likely at that point representing advanced disease?
The last paragraph notes the current US Preventive Services Task Force (USPSTF) guidance: wait until 50 years of age to start biennial screening. If so, what do we say to women in their 40s who, through screening with mammography and/or ultrasound, were diagnosed with early node-negative invasive breast cancer? That all of that was unnecessary and would not have led to symptoms? Would extreme morbidity from advanced or recurrent disease and the horrors of treatment just to extend a few months of life qualify as a symptom to these investigators? Lax protocols are not for me, my colleagues, or patients that I know. One of the most common reasons for a lawsuit to be brought against a primary care or ObGyn provider is failure to diagnose breast cancer!
John T. Armstrong, MD
Napa, California
Dr. Kaunitz responds
I thank Dr. Armstrong for his interest in my commentary on screening mammography and overdiagnosis. As I indicated in my commentary, I continue to recommend screening mammography for my patients, encouraging average-risk women to begin biennial screens at age 50 (consistent with USPSTF guidance), when the likelihood that tumors found with mammograms representing overdiagnosis is lower. I also indicated that I recognize that some patients prefer to begin screening at a younger age and to be screened more frequently. Dr. Armstrong’s letter refers to the “horrors of treatment” of breast cancer. From my perspective, the most “horrible” treatment is that which is administered to a woman diagnosed with a tumor destined to not cause clinical problems during her lifetime (overdiagnosis). You also refer to a statement, “an invasive breast cancer detected by any means is overdiagnosis.” That statement does not appear in my commentary.
My commentary’s point is that overdiagnosis is common among tumors diagnosed by screening mammography, and likely explains why, in contrast with cervical cancer screening, screening mammography has failed to reduce the incidence of breast cancers presenting as advanced (metastatic) disease. Although this represents a confusing and disquieting reality for our patients, and for us their clinicians, I agree with Dr. Otis Brawley, Chief Medical and Scientific Officer of the American Cancer Society, that we must acknowledge to our patients that overdiagnosis is common, the benefits of screening have been overstated, and that some patients considered as “cured” from breast cancer have in fact been harmed by unneeded treatment.1
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
“MORE THAN ONE-THIRD OF TUMORS FOUND ON BREAST CANCER SCREENING REPRESENT OVERDIAGNOSIS”
ANDREW M. KAUNITZ, MD (MARCH 2017)
Refutes concept of overdiagnosis of breast cancer
I read with interest and serious concern the commentary and conclusions of “overdiagnosed” breast cancer. Let us revisit a few time-honored principles. Are we throwing away the valued concept of the early diagnosis of node-negative breast cancer? Is it still true that 5-year and long-term survivals are markedly better for stage I and II disease as opposed to stage III and IV disease? Is it still true that treatments designed for cure are substantially less involved, more successful, and more likely to conserve the breast and require less chemotherapy in early stage disease? Is it still true that the majority of women diagnosed with breast cancer are in the lowest risk category, ie, no family history and negative for the BRCA gene? If so, then who can explain the statement that “an invasive breast cancer detected by any means is overdiagnosis”? Would this imply that screening and the biopsy required to make the diagnosis was time poorly spent, the breast cancer should not be treated, and/or we should simply wait for a lump to be found by the patient deep in a large breast most likely at that point representing advanced disease?
The last paragraph notes the current US Preventive Services Task Force (USPSTF) guidance: wait until 50 years of age to start biennial screening. If so, what do we say to women in their 40s who, through screening with mammography and/or ultrasound, were diagnosed with early node-negative invasive breast cancer? That all of that was unnecessary and would not have led to symptoms? Would extreme morbidity from advanced or recurrent disease and the horrors of treatment just to extend a few months of life qualify as a symptom to these investigators? Lax protocols are not for me, my colleagues, or patients that I know. One of the most common reasons for a lawsuit to be brought against a primary care or ObGyn provider is failure to diagnose breast cancer!
John T. Armstrong, MD
Napa, California
Dr. Kaunitz responds
I thank Dr. Armstrong for his interest in my commentary on screening mammography and overdiagnosis. As I indicated in my commentary, I continue to recommend screening mammography for my patients, encouraging average-risk women to begin biennial screens at age 50 (consistent with USPSTF guidance), when the likelihood that tumors found with mammograms representing overdiagnosis is lower. I also indicated that I recognize that some patients prefer to begin screening at a younger age and to be screened more frequently. Dr. Armstrong’s letter refers to the “horrors of treatment” of breast cancer. From my perspective, the most “horrible” treatment is that which is administered to a woman diagnosed with a tumor destined to not cause clinical problems during her lifetime (overdiagnosis). You also refer to a statement, “an invasive breast cancer detected by any means is overdiagnosis.” That statement does not appear in my commentary.
My commentary’s point is that overdiagnosis is common among tumors diagnosed by screening mammography, and likely explains why, in contrast with cervical cancer screening, screening mammography has failed to reduce the incidence of breast cancers presenting as advanced (metastatic) disease. Although this represents a confusing and disquieting reality for our patients, and for us their clinicians, I agree with Dr. Otis Brawley, Chief Medical and Scientific Officer of the American Cancer Society, that we must acknowledge to our patients that overdiagnosis is common, the benefits of screening have been overstated, and that some patients considered as “cured” from breast cancer have in fact been harmed by unneeded treatment.1
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Brawley OW. Accepting the existence of breast cancer overdiagnosis [published online ahead of print January 10, 2017]. Ann Intern Med. doi:10.7326/M16-2850.
- Brawley OW. Accepting the existence of breast cancer overdiagnosis [published online ahead of print January 10, 2017]. Ann Intern Med. doi:10.7326/M16-2850.
Highlights from new guidelines, and a chance to weigh in
Though the Society for Vascular Surgery has long published clinical practice guidelines, its 2017 annual meeting marks the first seminar dedicated to guidelines in progress, allowing for more interaction, debate, and feedback across the vascular community before these guidelines become final.
At Friday afternoon’s update on SVS clinical practice guidelines, speakers will present on four that are in advanced development, including new global vascular guidelines.
All too often, Dr. Forbes said, the guideline process can seem opaque, or top-town or cumbersome in soliciting and incorporating feedback – problems that this kind of interactive seminar can help rectify. “We don’t want to be Moses with the tablet from the mountain, handing them down and asking everybody to follow them without question,” he said.
Keith D. Calligaro, MD, who practices in Philadelphia, starts the seminar off with highlights from new guidelines on hospital privileges across practice settings, an update of SVS guidelines from 2008. The new guidelines “describe specific procedure-related training requirements that would then lead to privileges in a hospital setting. This is especially relevant in some of the practice environments in the U.S.,” Dr. Forbes said.
R. Eugene Zierler, MD, of the University of Washington in Seattle, will present broad-reaching new advice on the follow-up of patients after vascular procedures. These guidelines cover patients who’ve undergone a wide variety of procedures, “all the way from carotid to abdominal aortic aneurysm repairs to venous surgery – and offers specific, evidence-based recommendations for how patients should be followed up, how often they should undergo imaging, bloodwork, and other follow-up modalities,” Dr. Forbes said.
And Elliot Chaikof, MD, of Beth Israel Deaconess Medical Center in Boston, will discuss new guidelines on the care of patients with abdominal aortic aneurysms that incorporates “what we know today about the different therapeutic options: from medical management to endovascular and open repair to different treatment strategies for men and women – all this based on advances from the last couple years,” Dr. Forbes said.
Finally, in separate talks, two presenters will describe different elements of a new global vascular guideline developed jointly by the SVS, the European Society for Vascular Surgery, and the World Federation of Vascular Societies.
Andrew W. Bradbury, MD, of the University of Birmingham in the U.K. and Michael S. Conte of the University of California San Francisco will speak on some issues the guidelines are tackling, all with an aim to reflect a more inclusive, worldwide picture of vascular practice.
“This is the first time we’re going to hear what these recommendations are,” Dr. Forbes said. One highlight is likely to be a new global classification system for peripheral arterial disease. “This is a new and novel concept in vascular disease, and that is similar to the classification systems used for cancer,” Dr. Forbes said.
Dr. Forbes said that he hopes that a seminar focused on guidelines in progress will become a regular feature of the annual meeting, and that this year’s seminar will help shape the society’s approach to future guidelines as well.
“Members may know of areas of vascular surgery where there’s a real need for guidelines, or some evidence-based recommendations that we don’t have, and we’d love them to come forward and propose those topics,” he said. “We need practitioners in academic centers and community practitioners alike, to represent the breath of the work being done out there.”
Friday, June 2
3:30 p.m. - 5:00 p.m., SDCC, Room 4
C9: Update on Society for Vascular Surgery Clinical Practice Guidelines
Though the Society for Vascular Surgery has long published clinical practice guidelines, its 2017 annual meeting marks the first seminar dedicated to guidelines in progress, allowing for more interaction, debate, and feedback across the vascular community before these guidelines become final.
At Friday afternoon’s update on SVS clinical practice guidelines, speakers will present on four that are in advanced development, including new global vascular guidelines.
All too often, Dr. Forbes said, the guideline process can seem opaque, or top-town or cumbersome in soliciting and incorporating feedback – problems that this kind of interactive seminar can help rectify. “We don’t want to be Moses with the tablet from the mountain, handing them down and asking everybody to follow them without question,” he said.
Keith D. Calligaro, MD, who practices in Philadelphia, starts the seminar off with highlights from new guidelines on hospital privileges across practice settings, an update of SVS guidelines from 2008. The new guidelines “describe specific procedure-related training requirements that would then lead to privileges in a hospital setting. This is especially relevant in some of the practice environments in the U.S.,” Dr. Forbes said.
R. Eugene Zierler, MD, of the University of Washington in Seattle, will present broad-reaching new advice on the follow-up of patients after vascular procedures. These guidelines cover patients who’ve undergone a wide variety of procedures, “all the way from carotid to abdominal aortic aneurysm repairs to venous surgery – and offers specific, evidence-based recommendations for how patients should be followed up, how often they should undergo imaging, bloodwork, and other follow-up modalities,” Dr. Forbes said.
And Elliot Chaikof, MD, of Beth Israel Deaconess Medical Center in Boston, will discuss new guidelines on the care of patients with abdominal aortic aneurysms that incorporates “what we know today about the different therapeutic options: from medical management to endovascular and open repair to different treatment strategies for men and women – all this based on advances from the last couple years,” Dr. Forbes said.
Finally, in separate talks, two presenters will describe different elements of a new global vascular guideline developed jointly by the SVS, the European Society for Vascular Surgery, and the World Federation of Vascular Societies.
Andrew W. Bradbury, MD, of the University of Birmingham in the U.K. and Michael S. Conte of the University of California San Francisco will speak on some issues the guidelines are tackling, all with an aim to reflect a more inclusive, worldwide picture of vascular practice.
“This is the first time we’re going to hear what these recommendations are,” Dr. Forbes said. One highlight is likely to be a new global classification system for peripheral arterial disease. “This is a new and novel concept in vascular disease, and that is similar to the classification systems used for cancer,” Dr. Forbes said.
Dr. Forbes said that he hopes that a seminar focused on guidelines in progress will become a regular feature of the annual meeting, and that this year’s seminar will help shape the society’s approach to future guidelines as well.
“Members may know of areas of vascular surgery where there’s a real need for guidelines, or some evidence-based recommendations that we don’t have, and we’d love them to come forward and propose those topics,” he said. “We need practitioners in academic centers and community practitioners alike, to represent the breath of the work being done out there.”
Friday, June 2
3:30 p.m. - 5:00 p.m., SDCC, Room 4
C9: Update on Society for Vascular Surgery Clinical Practice Guidelines
Though the Society for Vascular Surgery has long published clinical practice guidelines, its 2017 annual meeting marks the first seminar dedicated to guidelines in progress, allowing for more interaction, debate, and feedback across the vascular community before these guidelines become final.
At Friday afternoon’s update on SVS clinical practice guidelines, speakers will present on four that are in advanced development, including new global vascular guidelines.
All too often, Dr. Forbes said, the guideline process can seem opaque, or top-town or cumbersome in soliciting and incorporating feedback – problems that this kind of interactive seminar can help rectify. “We don’t want to be Moses with the tablet from the mountain, handing them down and asking everybody to follow them without question,” he said.
Keith D. Calligaro, MD, who practices in Philadelphia, starts the seminar off with highlights from new guidelines on hospital privileges across practice settings, an update of SVS guidelines from 2008. The new guidelines “describe specific procedure-related training requirements that would then lead to privileges in a hospital setting. This is especially relevant in some of the practice environments in the U.S.,” Dr. Forbes said.
R. Eugene Zierler, MD, of the University of Washington in Seattle, will present broad-reaching new advice on the follow-up of patients after vascular procedures. These guidelines cover patients who’ve undergone a wide variety of procedures, “all the way from carotid to abdominal aortic aneurysm repairs to venous surgery – and offers specific, evidence-based recommendations for how patients should be followed up, how often they should undergo imaging, bloodwork, and other follow-up modalities,” Dr. Forbes said.
And Elliot Chaikof, MD, of Beth Israel Deaconess Medical Center in Boston, will discuss new guidelines on the care of patients with abdominal aortic aneurysms that incorporates “what we know today about the different therapeutic options: from medical management to endovascular and open repair to different treatment strategies for men and women – all this based on advances from the last couple years,” Dr. Forbes said.
Finally, in separate talks, two presenters will describe different elements of a new global vascular guideline developed jointly by the SVS, the European Society for Vascular Surgery, and the World Federation of Vascular Societies.
Andrew W. Bradbury, MD, of the University of Birmingham in the U.K. and Michael S. Conte of the University of California San Francisco will speak on some issues the guidelines are tackling, all with an aim to reflect a more inclusive, worldwide picture of vascular practice.
“This is the first time we’re going to hear what these recommendations are,” Dr. Forbes said. One highlight is likely to be a new global classification system for peripheral arterial disease. “This is a new and novel concept in vascular disease, and that is similar to the classification systems used for cancer,” Dr. Forbes said.
Dr. Forbes said that he hopes that a seminar focused on guidelines in progress will become a regular feature of the annual meeting, and that this year’s seminar will help shape the society’s approach to future guidelines as well.
“Members may know of areas of vascular surgery where there’s a real need for guidelines, or some evidence-based recommendations that we don’t have, and we’d love them to come forward and propose those topics,” he said. “We need practitioners in academic centers and community practitioners alike, to represent the breath of the work being done out there.”
Friday, June 2
3:30 p.m. - 5:00 p.m., SDCC, Room 4
C9: Update on Society for Vascular Surgery Clinical Practice Guidelines
How to get published in JVS and EJVES: Editors disclose secrets of success
Over the past year, the Journal of Vascular Surgery and its two affiliated journals have undergone a number of important changes.
Editorial boards have been revamped, disadvantageous limits on the number of contributing authors and on references have been scrapped, and editors’ videos accompany every new issue. New short abstracts, take-home messages, and extended tables of contents allow even the most time-crunched clinicians to get up to speed.
Even the look of the journals has changed – with a red color scheme for JVS, a blue one for JVS-VL, the venous and lymphatic disorders journal, and a mixed red and blue one for the open-access publication dedicated to cases and techniques.
On Saturday morning, Dr. Gloviczki, the editor in chief of JVS, and senior editor Peter F. Lawrence helm a seminar that describes not only what they’ve been doing since taking over the journals’ leadership in July 2016, but how more SVS members can take part by producing quality papers or reviewing for the journals.
Dr. Gloviczki and Dr. Lawrence have also invited Dr. Philip Kolh if the University of Liege in Liege, Belgium, to co-lead the seminar. Dr. Kolh, who is editor in chief of the European Journal of Vascular and Endovascular Surgery, will advise on what the EJVES is looking for in its reviews and submissions.
“We believe it is important for JVS and EJVES to work together, to develop joint guidelines, to avoid repetition and redundancy, and double-publish papers that are important for both readerships,” Dr. Gloviczki said.
Dr. Gloviczki will start the seminar off by discussing the sweeping changes aimed at raising the quality of all three JVS journals and, he hopes, will also affect their impact factor, currently at 3.45 for JVS.
In addition to increasing the scrutiny of the peer review and the number of statistical reviews performed by master statisticians, the editors are looking for systematic reviews, meta-analyses, practice guidelines, and reporting standards – and will publish paper types not previously accepted, such as study protocols.
The journal will retain many initiatives of the previous editors, including the international debates, and will continue recruiting international authors and reviewers. Having the best reviewers, Dr. Gloviczki noted, “is an important parallel to having top-quality studies.”
Dr. Lawrence, of the University of California Los Angeles, will discuss what makes a clinical research paper successful. “We want papers that are highly cited – and the highly cited papers are prospective studies, whether randomized controlled trials or single-arm cohort studies,” Dr. Gloviczki said. “We also favor large retrospective reviews of prospectively collected national or international registries.”
Peter Henke, MD, of the University of Michigan in Ann Arbor, Mich., will talk about what the JVS editors and reviewers want in basic science papers – which Dr. Gloviczki called an important and sometimes overlooked counterpart to the clinical studies. “We believe that our profession must be in charge of basic research, that whoever owns basic research in our field owns the disease,” he said.
“To understand vascular disease you have to start at the basics of anatomy, pathophysiology, etiology, prevention, presentation and finally treatment,” he said, noting that vascular surgeons at many academic centers are conducting experimental studies and other basic research, efforts often supported by SVS grants.
Last year the JVS editors re-named the journal’s basic science section and called it “From Bench to Bedside” to try and capture the importance of preclinical vascular studies. “It’s a relatively small section of our journal but it’s important,” Dr. Gloviczki said. “And now we are really pushing to get commentaries that emphasize the potential clinical application of the basic science research.”
Richard L. Amdur, MD, of George Washington University in Washington, DC, will talk about what the JVS journal editors want to see in terms of statistics, while Marc L. Schermerhorn, MD, of Beth Israel Deaconess Medical Center in Boston and Martin Bjorck, MD, PhD, of Uppsala University, Uppsala, Sweden, will both discuss mining the large vascular registries from the United States and Europe for studies attractive to JVS or EJVES.
“There are so many papers where real-world experience is given to us by analyzing these registries,” Dr. Gloviczki said. Studies from the SVS Vascular Quality Initiatives database, the American College of Surgeons’ National Surgical Quality Improvement Program, the National Inpatient Sample, the Swedish Vascular registry, VADUNET and the International Consortium of Vascular Registries, “have changed the way we practice vascular surgery, and we publish multiple papers from these in every issue.”
Saturday, June 3
6:30 a.m. - 8:00 a.m.
Breakfast Session B9: How to Write a Paper and Have it Accepted in the JVS or EJVES
Over the past year, the Journal of Vascular Surgery and its two affiliated journals have undergone a number of important changes.
Editorial boards have been revamped, disadvantageous limits on the number of contributing authors and on references have been scrapped, and editors’ videos accompany every new issue. New short abstracts, take-home messages, and extended tables of contents allow even the most time-crunched clinicians to get up to speed.
Even the look of the journals has changed – with a red color scheme for JVS, a blue one for JVS-VL, the venous and lymphatic disorders journal, and a mixed red and blue one for the open-access publication dedicated to cases and techniques.
On Saturday morning, Dr. Gloviczki, the editor in chief of JVS, and senior editor Peter F. Lawrence helm a seminar that describes not only what they’ve been doing since taking over the journals’ leadership in July 2016, but how more SVS members can take part by producing quality papers or reviewing for the journals.
Dr. Gloviczki and Dr. Lawrence have also invited Dr. Philip Kolh if the University of Liege in Liege, Belgium, to co-lead the seminar. Dr. Kolh, who is editor in chief of the European Journal of Vascular and Endovascular Surgery, will advise on what the EJVES is looking for in its reviews and submissions.
“We believe it is important for JVS and EJVES to work together, to develop joint guidelines, to avoid repetition and redundancy, and double-publish papers that are important for both readerships,” Dr. Gloviczki said.
Dr. Gloviczki will start the seminar off by discussing the sweeping changes aimed at raising the quality of all three JVS journals and, he hopes, will also affect their impact factor, currently at 3.45 for JVS.
In addition to increasing the scrutiny of the peer review and the number of statistical reviews performed by master statisticians, the editors are looking for systematic reviews, meta-analyses, practice guidelines, and reporting standards – and will publish paper types not previously accepted, such as study protocols.
The journal will retain many initiatives of the previous editors, including the international debates, and will continue recruiting international authors and reviewers. Having the best reviewers, Dr. Gloviczki noted, “is an important parallel to having top-quality studies.”
Dr. Lawrence, of the University of California Los Angeles, will discuss what makes a clinical research paper successful. “We want papers that are highly cited – and the highly cited papers are prospective studies, whether randomized controlled trials or single-arm cohort studies,” Dr. Gloviczki said. “We also favor large retrospective reviews of prospectively collected national or international registries.”
Peter Henke, MD, of the University of Michigan in Ann Arbor, Mich., will talk about what the JVS editors and reviewers want in basic science papers – which Dr. Gloviczki called an important and sometimes overlooked counterpart to the clinical studies. “We believe that our profession must be in charge of basic research, that whoever owns basic research in our field owns the disease,” he said.
“To understand vascular disease you have to start at the basics of anatomy, pathophysiology, etiology, prevention, presentation and finally treatment,” he said, noting that vascular surgeons at many academic centers are conducting experimental studies and other basic research, efforts often supported by SVS grants.
Last year the JVS editors re-named the journal’s basic science section and called it “From Bench to Bedside” to try and capture the importance of preclinical vascular studies. “It’s a relatively small section of our journal but it’s important,” Dr. Gloviczki said. “And now we are really pushing to get commentaries that emphasize the potential clinical application of the basic science research.”
Richard L. Amdur, MD, of George Washington University in Washington, DC, will talk about what the JVS journal editors want to see in terms of statistics, while Marc L. Schermerhorn, MD, of Beth Israel Deaconess Medical Center in Boston and Martin Bjorck, MD, PhD, of Uppsala University, Uppsala, Sweden, will both discuss mining the large vascular registries from the United States and Europe for studies attractive to JVS or EJVES.
“There are so many papers where real-world experience is given to us by analyzing these registries,” Dr. Gloviczki said. Studies from the SVS Vascular Quality Initiatives database, the American College of Surgeons’ National Surgical Quality Improvement Program, the National Inpatient Sample, the Swedish Vascular registry, VADUNET and the International Consortium of Vascular Registries, “have changed the way we practice vascular surgery, and we publish multiple papers from these in every issue.”
Saturday, June 3
6:30 a.m. - 8:00 a.m.
Breakfast Session B9: How to Write a Paper and Have it Accepted in the JVS or EJVES
Over the past year, the Journal of Vascular Surgery and its two affiliated journals have undergone a number of important changes.
Editorial boards have been revamped, disadvantageous limits on the number of contributing authors and on references have been scrapped, and editors’ videos accompany every new issue. New short abstracts, take-home messages, and extended tables of contents allow even the most time-crunched clinicians to get up to speed.
Even the look of the journals has changed – with a red color scheme for JVS, a blue one for JVS-VL, the venous and lymphatic disorders journal, and a mixed red and blue one for the open-access publication dedicated to cases and techniques.
On Saturday morning, Dr. Gloviczki, the editor in chief of JVS, and senior editor Peter F. Lawrence helm a seminar that describes not only what they’ve been doing since taking over the journals’ leadership in July 2016, but how more SVS members can take part by producing quality papers or reviewing for the journals.
Dr. Gloviczki and Dr. Lawrence have also invited Dr. Philip Kolh if the University of Liege in Liege, Belgium, to co-lead the seminar. Dr. Kolh, who is editor in chief of the European Journal of Vascular and Endovascular Surgery, will advise on what the EJVES is looking for in its reviews and submissions.
“We believe it is important for JVS and EJVES to work together, to develop joint guidelines, to avoid repetition and redundancy, and double-publish papers that are important for both readerships,” Dr. Gloviczki said.
Dr. Gloviczki will start the seminar off by discussing the sweeping changes aimed at raising the quality of all three JVS journals and, he hopes, will also affect their impact factor, currently at 3.45 for JVS.
In addition to increasing the scrutiny of the peer review and the number of statistical reviews performed by master statisticians, the editors are looking for systematic reviews, meta-analyses, practice guidelines, and reporting standards – and will publish paper types not previously accepted, such as study protocols.
The journal will retain many initiatives of the previous editors, including the international debates, and will continue recruiting international authors and reviewers. Having the best reviewers, Dr. Gloviczki noted, “is an important parallel to having top-quality studies.”
Dr. Lawrence, of the University of California Los Angeles, will discuss what makes a clinical research paper successful. “We want papers that are highly cited – and the highly cited papers are prospective studies, whether randomized controlled trials or single-arm cohort studies,” Dr. Gloviczki said. “We also favor large retrospective reviews of prospectively collected national or international registries.”
Peter Henke, MD, of the University of Michigan in Ann Arbor, Mich., will talk about what the JVS editors and reviewers want in basic science papers – which Dr. Gloviczki called an important and sometimes overlooked counterpart to the clinical studies. “We believe that our profession must be in charge of basic research, that whoever owns basic research in our field owns the disease,” he said.
“To understand vascular disease you have to start at the basics of anatomy, pathophysiology, etiology, prevention, presentation and finally treatment,” he said, noting that vascular surgeons at many academic centers are conducting experimental studies and other basic research, efforts often supported by SVS grants.
Last year the JVS editors re-named the journal’s basic science section and called it “From Bench to Bedside” to try and capture the importance of preclinical vascular studies. “It’s a relatively small section of our journal but it’s important,” Dr. Gloviczki said. “And now we are really pushing to get commentaries that emphasize the potential clinical application of the basic science research.”
Richard L. Amdur, MD, of George Washington University in Washington, DC, will talk about what the JVS journal editors want to see in terms of statistics, while Marc L. Schermerhorn, MD, of Beth Israel Deaconess Medical Center in Boston and Martin Bjorck, MD, PhD, of Uppsala University, Uppsala, Sweden, will both discuss mining the large vascular registries from the United States and Europe for studies attractive to JVS or EJVES.
“There are so many papers where real-world experience is given to us by analyzing these registries,” Dr. Gloviczki said. Studies from the SVS Vascular Quality Initiatives database, the American College of Surgeons’ National Surgical Quality Improvement Program, the National Inpatient Sample, the Swedish Vascular registry, VADUNET and the International Consortium of Vascular Registries, “have changed the way we practice vascular surgery, and we publish multiple papers from these in every issue.”
Saturday, June 3
6:30 a.m. - 8:00 a.m.
Breakfast Session B9: How to Write a Paper and Have it Accepted in the JVS or EJVES
Biologics after methotrexate fails: Huge cost, minimal benefit
Prescribing rheumatoid arthritis patients a biologic agent rather than triple therapy, when they fail to respond adequately to methotrexate, costs more than half a million dollars per quality-adjusted life year gained over a lifetime but provides only a minimal health benefit beyond triple therapy, according to a report published online May 30 in Annals of Internal Medicine.
The evidence is clear that triple therapy using sulfasalazine, hydroxychloroquine, and methotrexate is at least as effective as methotrexate plus an anti–tumor necrosis factor biologic (etanercept, adalimumab, infliximab, golimumab, or certolizumab pegol). Nevertheless, few RA patients are transitioned to triple therapy before escalating to biologics. This occurred in only 2.5% of patients in one Veterans Affairs study, said Nick Bansback, PhD, of the University of British Columbia and St. Paul’s Hospital, Vancouver, and his associates.
Dr. Bansback and his colleagues performed a cost-effectiveness study of proceeding directly to etanercept when RA fails to respond to methotrexate, using data from the Rheumatoid Arthritis Comparison of Active Therapies (RACAT) trial. The RACAT study, a large international, randomized, double-blind trial, confirmed the clinical noninferiority of triple therapy versus etanercept plus methotrexate. In their analysis, Dr. Bansback and his associates calculated the costs and QALYs for both treatment strategies for 324 RACAT participants.
Switching directly to etanercept-methotrexate instead of triple therapy provided only a marginal advantage in QALYs, a difference of only 0.004 QALY over 24 weeks of treatment (0.358 with etanercept-methotrexate vs. 0.353 with triple therapy) and of only 0.016 QALY over 48 weeks of treatment (0.743 with etanercept-methotrexate vs. 0.726 with triple therapy). The associated costs were $11,295 for 24 weeks of etanercept-methotrexate, vs. $343 for 24 weeks of triple therapy, and $19,634 for 48 weeks of etanercept-methotrexate, vs. $3,680 for 48 weeks of triple therapy.
“The resultant ICER [incremental cost-effectiveness ratio] for first-line etanercept-methotrexate, vs. triple therapy, was $2.7 million per QALY gained over 24 weeks,” the investigators said (Ann Intern Med. 2017 May 29. doi: 10.7326/M16-0713).
When they extrapolated the data to determine the cost-effectiveness of the two treatment strategies over the course of the average patient’s lifetime, the model predicted an ICER of $521,520 per QALY gained for etanercept-methotrexate instead of triple therapy. These findings remained robust in numerous sensitivity and scenario analyses. For example, when the model assumed that radiographic and quality of life benefits of triple therapy were far lower than observed in the RACAT trial and far lower than what has been reported in the literature and that the tolerability of triple therapy was far worse than observed in the RACAT trial and reported in the literature, switching to etanercept-methotrexate instead of triple therapy still predicted an ICER of $350,000 per QALY per patient.
All of these ICERs far exceed the standard cost-effectiveness acceptability threshold ICER of $100,000 per QALY, Dr. Bansback and his associates noted.
This study demonstrates the substantial cost savings of prescribing triple therapy before a biologic. It shows that “for every patient who tries triple therapy before a biologic, payers will save an average of $78,000 over the patient’s lifetime, and most of the savings will accrue within the first 10 years,” the investigators wrote.
“Patients who receive triple therapy before a biologic will miss out on a benefit of approximately 0.15 QALY over their lifetime or a benefit of approximately 0.05 HAQ [Health Assessment Questionnaire] point at any point in time. To put these numbers in perspective, total hip arthroplasty in a patient with osteoarthritis who is approximately the same age as an average patient with RA provides an additional 6.9 QALYs. In terms of HAQ score, only differences greater than 0.2 points are considered minimally important to patients,” Dr. Bansback and his associates wrote.
Changing health care policy to require, rather than to just recommend, that triple therapy be prescribed before biologics would save millions of dollars in health care expenditures, they added.
This study was supported by the U.S. Department of Veterans Affairs Office of Research and Development, the Canadian Institutes for Health Research, the National Institutes of Health, and the American Recovery and Reinvestment Act. Dr. Bansback reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.
The findings of Bansback et al., consistent with those of several other researchers, indicate that patients who have RA and no contraindications to triple-conventional, disease-modifying antirheumatic drug therapy should use therapy instead of biologics as the next regimen if methotrexate alone fails to control symptoms and radiographic progression.
Elena Losina, PhD, and Jeffrey N. Katz, MD, are at Brigham and Women’s Hospital in Boston. They disclosed having no conflicts of interest. Dr. Losina and Dr. Katz made these remarks in an editorial accompanying Dr. Bansback’s report (Ann Intern Med. 2017 May 29. doi: 10.7326/M17-1176).
The findings of Bansback et al., consistent with those of several other researchers, indicate that patients who have RA and no contraindications to triple-conventional, disease-modifying antirheumatic drug therapy should use therapy instead of biologics as the next regimen if methotrexate alone fails to control symptoms and radiographic progression.
Elena Losina, PhD, and Jeffrey N. Katz, MD, are at Brigham and Women’s Hospital in Boston. They disclosed having no conflicts of interest. Dr. Losina and Dr. Katz made these remarks in an editorial accompanying Dr. Bansback’s report (Ann Intern Med. 2017 May 29. doi: 10.7326/M17-1176).
The findings of Bansback et al., consistent with those of several other researchers, indicate that patients who have RA and no contraindications to triple-conventional, disease-modifying antirheumatic drug therapy should use therapy instead of biologics as the next regimen if methotrexate alone fails to control symptoms and radiographic progression.
Elena Losina, PhD, and Jeffrey N. Katz, MD, are at Brigham and Women’s Hospital in Boston. They disclosed having no conflicts of interest. Dr. Losina and Dr. Katz made these remarks in an editorial accompanying Dr. Bansback’s report (Ann Intern Med. 2017 May 29. doi: 10.7326/M17-1176).
Prescribing rheumatoid arthritis patients a biologic agent rather than triple therapy, when they fail to respond adequately to methotrexate, costs more than half a million dollars per quality-adjusted life year gained over a lifetime but provides only a minimal health benefit beyond triple therapy, according to a report published online May 30 in Annals of Internal Medicine.
The evidence is clear that triple therapy using sulfasalazine, hydroxychloroquine, and methotrexate is at least as effective as methotrexate plus an anti–tumor necrosis factor biologic (etanercept, adalimumab, infliximab, golimumab, or certolizumab pegol). Nevertheless, few RA patients are transitioned to triple therapy before escalating to biologics. This occurred in only 2.5% of patients in one Veterans Affairs study, said Nick Bansback, PhD, of the University of British Columbia and St. Paul’s Hospital, Vancouver, and his associates.
Dr. Bansback and his colleagues performed a cost-effectiveness study of proceeding directly to etanercept when RA fails to respond to methotrexate, using data from the Rheumatoid Arthritis Comparison of Active Therapies (RACAT) trial. The RACAT study, a large international, randomized, double-blind trial, confirmed the clinical noninferiority of triple therapy versus etanercept plus methotrexate. In their analysis, Dr. Bansback and his associates calculated the costs and QALYs for both treatment strategies for 324 RACAT participants.
Switching directly to etanercept-methotrexate instead of triple therapy provided only a marginal advantage in QALYs, a difference of only 0.004 QALY over 24 weeks of treatment (0.358 with etanercept-methotrexate vs. 0.353 with triple therapy) and of only 0.016 QALY over 48 weeks of treatment (0.743 with etanercept-methotrexate vs. 0.726 with triple therapy). The associated costs were $11,295 for 24 weeks of etanercept-methotrexate, vs. $343 for 24 weeks of triple therapy, and $19,634 for 48 weeks of etanercept-methotrexate, vs. $3,680 for 48 weeks of triple therapy.
“The resultant ICER [incremental cost-effectiveness ratio] for first-line etanercept-methotrexate, vs. triple therapy, was $2.7 million per QALY gained over 24 weeks,” the investigators said (Ann Intern Med. 2017 May 29. doi: 10.7326/M16-0713).
When they extrapolated the data to determine the cost-effectiveness of the two treatment strategies over the course of the average patient’s lifetime, the model predicted an ICER of $521,520 per QALY gained for etanercept-methotrexate instead of triple therapy. These findings remained robust in numerous sensitivity and scenario analyses. For example, when the model assumed that radiographic and quality of life benefits of triple therapy were far lower than observed in the RACAT trial and far lower than what has been reported in the literature and that the tolerability of triple therapy was far worse than observed in the RACAT trial and reported in the literature, switching to etanercept-methotrexate instead of triple therapy still predicted an ICER of $350,000 per QALY per patient.
All of these ICERs far exceed the standard cost-effectiveness acceptability threshold ICER of $100,000 per QALY, Dr. Bansback and his associates noted.
This study demonstrates the substantial cost savings of prescribing triple therapy before a biologic. It shows that “for every patient who tries triple therapy before a biologic, payers will save an average of $78,000 over the patient’s lifetime, and most of the savings will accrue within the first 10 years,” the investigators wrote.
“Patients who receive triple therapy before a biologic will miss out on a benefit of approximately 0.15 QALY over their lifetime or a benefit of approximately 0.05 HAQ [Health Assessment Questionnaire] point at any point in time. To put these numbers in perspective, total hip arthroplasty in a patient with osteoarthritis who is approximately the same age as an average patient with RA provides an additional 6.9 QALYs. In terms of HAQ score, only differences greater than 0.2 points are considered minimally important to patients,” Dr. Bansback and his associates wrote.
Changing health care policy to require, rather than to just recommend, that triple therapy be prescribed before biologics would save millions of dollars in health care expenditures, they added.
This study was supported by the U.S. Department of Veterans Affairs Office of Research and Development, the Canadian Institutes for Health Research, the National Institutes of Health, and the American Recovery and Reinvestment Act. Dr. Bansback reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.
Prescribing rheumatoid arthritis patients a biologic agent rather than triple therapy, when they fail to respond adequately to methotrexate, costs more than half a million dollars per quality-adjusted life year gained over a lifetime but provides only a minimal health benefit beyond triple therapy, according to a report published online May 30 in Annals of Internal Medicine.
The evidence is clear that triple therapy using sulfasalazine, hydroxychloroquine, and methotrexate is at least as effective as methotrexate plus an anti–tumor necrosis factor biologic (etanercept, adalimumab, infliximab, golimumab, or certolizumab pegol). Nevertheless, few RA patients are transitioned to triple therapy before escalating to biologics. This occurred in only 2.5% of patients in one Veterans Affairs study, said Nick Bansback, PhD, of the University of British Columbia and St. Paul’s Hospital, Vancouver, and his associates.
Dr. Bansback and his colleagues performed a cost-effectiveness study of proceeding directly to etanercept when RA fails to respond to methotrexate, using data from the Rheumatoid Arthritis Comparison of Active Therapies (RACAT) trial. The RACAT study, a large international, randomized, double-blind trial, confirmed the clinical noninferiority of triple therapy versus etanercept plus methotrexate. In their analysis, Dr. Bansback and his associates calculated the costs and QALYs for both treatment strategies for 324 RACAT participants.
Switching directly to etanercept-methotrexate instead of triple therapy provided only a marginal advantage in QALYs, a difference of only 0.004 QALY over 24 weeks of treatment (0.358 with etanercept-methotrexate vs. 0.353 with triple therapy) and of only 0.016 QALY over 48 weeks of treatment (0.743 with etanercept-methotrexate vs. 0.726 with triple therapy). The associated costs were $11,295 for 24 weeks of etanercept-methotrexate, vs. $343 for 24 weeks of triple therapy, and $19,634 for 48 weeks of etanercept-methotrexate, vs. $3,680 for 48 weeks of triple therapy.
“The resultant ICER [incremental cost-effectiveness ratio] for first-line etanercept-methotrexate, vs. triple therapy, was $2.7 million per QALY gained over 24 weeks,” the investigators said (Ann Intern Med. 2017 May 29. doi: 10.7326/M16-0713).
When they extrapolated the data to determine the cost-effectiveness of the two treatment strategies over the course of the average patient’s lifetime, the model predicted an ICER of $521,520 per QALY gained for etanercept-methotrexate instead of triple therapy. These findings remained robust in numerous sensitivity and scenario analyses. For example, when the model assumed that radiographic and quality of life benefits of triple therapy were far lower than observed in the RACAT trial and far lower than what has been reported in the literature and that the tolerability of triple therapy was far worse than observed in the RACAT trial and reported in the literature, switching to etanercept-methotrexate instead of triple therapy still predicted an ICER of $350,000 per QALY per patient.
All of these ICERs far exceed the standard cost-effectiveness acceptability threshold ICER of $100,000 per QALY, Dr. Bansback and his associates noted.
This study demonstrates the substantial cost savings of prescribing triple therapy before a biologic. It shows that “for every patient who tries triple therapy before a biologic, payers will save an average of $78,000 over the patient’s lifetime, and most of the savings will accrue within the first 10 years,” the investigators wrote.
“Patients who receive triple therapy before a biologic will miss out on a benefit of approximately 0.15 QALY over their lifetime or a benefit of approximately 0.05 HAQ [Health Assessment Questionnaire] point at any point in time. To put these numbers in perspective, total hip arthroplasty in a patient with osteoarthritis who is approximately the same age as an average patient with RA provides an additional 6.9 QALYs. In terms of HAQ score, only differences greater than 0.2 points are considered minimally important to patients,” Dr. Bansback and his associates wrote.
Changing health care policy to require, rather than to just recommend, that triple therapy be prescribed before biologics would save millions of dollars in health care expenditures, they added.
This study was supported by the U.S. Department of Veterans Affairs Office of Research and Development, the Canadian Institutes for Health Research, the National Institutes of Health, and the American Recovery and Reinvestment Act. Dr. Bansback reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point:
Major finding: For every RA patient who tries triple therapy before a biologic, payers will save an average of $78,000 over the patient’s lifetime without sacrificing their health or quality of life.
Data source: A cost-effectiveness analysis using data from 324 participants in an international, randomized, double-blind trial.
Disclosures: This study was supported by the U.S. Department of Veterans Affairs Office of Research and Development, the Canadian Institutes for Health Research, the National Institutes of Health, and the American Recovery and Reinvestment Act. Dr. Bansback reported having no relevant financial disclosures. His associates reported ties to numerous industry sources.
Tafamidis Delays Progression of Rare Polyneuropathy
Tafamidis, an oral non-NSAID and highly specific stabilizer of the TTR protein, delays neurologic progression in early-stage transthyretin familial amyloid polyneuropathy (ATTR-FAP), according to research published online ahead of print April 10 in Amyloid.
ATTR-FAP is a progressive condition caused by mutations in the TTR gene that destabilize the TTR protein, thereby facilitating misfolding and aggregation. The neuropathy may be accompanied by cardiac, gastrointestinal, renal, or ocular symptoms, and death occurs at an average of 10 years after symptom onset.
A pivotal phase III trial compared tafamidis with placebo over 18 months in 128 patients with early-stage ATTR-FAP. Researchers observed a trend toward a smaller increase in Neuropathy Impairment Score for Lower Limbs (NIS-LL) with tafamidis, compared with placebo, but the result was not statistically significant. Baseline NIS-LL values were higher among controls than among actively treated patients, however, and many participants dropped out of the study for liver transplantation.
In a post hoc analysis, the investigators took these factors into account and reanalyzed change from baseline in NIS-LL in the trial. They also analyzed change in NIS-LL plus three small-fiber nerve tests (NIS-LL+Σ3) and NIS-LL plus seven nerve tests (NIS-LL+Σ7) without baseline measurements as covariates.
The analysis indicated a significant benefit of tafamidis, compared with placebo, at Months 12 and 18. The baseline-adjusted mean increase in NIS-LL from baseline to Month 12 was 1.5 points in the tafamidis group versus 4.5 points in the placebo group. By Month 18, the mean change from baseline was 2.9 points in the tafamidis group versus 5.6 points in the placebo group.
When the researchers applied sensitivity analysis based on multiple imputation for missing data by treatment group, the mean estimates of the increase in NIS-LL total score from baseline to Month 18 were significantly lower for tafamidis, compared with placebo. A more conservative model based on multiple imputation showed a benefit of tafamidis, but results did not reach statistical significance.
The researchers also found a statistically significant benefit of tafamidis, compared with placebo, on NIS-LL+Σ3 at Months 12 and 18. Significant differences favoring tafamidis also were observed on NIS-LL+Σ7 at Months 12 and 18. Four of the study’s five authors are employees of Pfizer, which owns tafamidis and sponsored the study.
—Erik Greb
Suggested Reading
Keohane D, Schwartz J, Gundapaneni B, et al. Tafamidis delays disease progression in patients with early stage transthyretin familial amyloid polyneuropathy: additional supportive analyses from the pivotal trial. Amyloid. 2017 Apr 10 [Epub ahead of print].
Tafamidis, an oral non-NSAID and highly specific stabilizer of the TTR protein, delays neurologic progression in early-stage transthyretin familial amyloid polyneuropathy (ATTR-FAP), according to research published online ahead of print April 10 in Amyloid.
ATTR-FAP is a progressive condition caused by mutations in the TTR gene that destabilize the TTR protein, thereby facilitating misfolding and aggregation. The neuropathy may be accompanied by cardiac, gastrointestinal, renal, or ocular symptoms, and death occurs at an average of 10 years after symptom onset.
A pivotal phase III trial compared tafamidis with placebo over 18 months in 128 patients with early-stage ATTR-FAP. Researchers observed a trend toward a smaller increase in Neuropathy Impairment Score for Lower Limbs (NIS-LL) with tafamidis, compared with placebo, but the result was not statistically significant. Baseline NIS-LL values were higher among controls than among actively treated patients, however, and many participants dropped out of the study for liver transplantation.
In a post hoc analysis, the investigators took these factors into account and reanalyzed change from baseline in NIS-LL in the trial. They also analyzed change in NIS-LL plus three small-fiber nerve tests (NIS-LL+Σ3) and NIS-LL plus seven nerve tests (NIS-LL+Σ7) without baseline measurements as covariates.
The analysis indicated a significant benefit of tafamidis, compared with placebo, at Months 12 and 18. The baseline-adjusted mean increase in NIS-LL from baseline to Month 12 was 1.5 points in the tafamidis group versus 4.5 points in the placebo group. By Month 18, the mean change from baseline was 2.9 points in the tafamidis group versus 5.6 points in the placebo group.
When the researchers applied sensitivity analysis based on multiple imputation for missing data by treatment group, the mean estimates of the increase in NIS-LL total score from baseline to Month 18 were significantly lower for tafamidis, compared with placebo. A more conservative model based on multiple imputation showed a benefit of tafamidis, but results did not reach statistical significance.
The researchers also found a statistically significant benefit of tafamidis, compared with placebo, on NIS-LL+Σ3 at Months 12 and 18. Significant differences favoring tafamidis also were observed on NIS-LL+Σ7 at Months 12 and 18. Four of the study’s five authors are employees of Pfizer, which owns tafamidis and sponsored the study.
—Erik Greb
Suggested Reading
Keohane D, Schwartz J, Gundapaneni B, et al. Tafamidis delays disease progression in patients with early stage transthyretin familial amyloid polyneuropathy: additional supportive analyses from the pivotal trial. Amyloid. 2017 Apr 10 [Epub ahead of print].
Tafamidis, an oral non-NSAID and highly specific stabilizer of the TTR protein, delays neurologic progression in early-stage transthyretin familial amyloid polyneuropathy (ATTR-FAP), according to research published online ahead of print April 10 in Amyloid.
ATTR-FAP is a progressive condition caused by mutations in the TTR gene that destabilize the TTR protein, thereby facilitating misfolding and aggregation. The neuropathy may be accompanied by cardiac, gastrointestinal, renal, or ocular symptoms, and death occurs at an average of 10 years after symptom onset.
A pivotal phase III trial compared tafamidis with placebo over 18 months in 128 patients with early-stage ATTR-FAP. Researchers observed a trend toward a smaller increase in Neuropathy Impairment Score for Lower Limbs (NIS-LL) with tafamidis, compared with placebo, but the result was not statistically significant. Baseline NIS-LL values were higher among controls than among actively treated patients, however, and many participants dropped out of the study for liver transplantation.
In a post hoc analysis, the investigators took these factors into account and reanalyzed change from baseline in NIS-LL in the trial. They also analyzed change in NIS-LL plus three small-fiber nerve tests (NIS-LL+Σ3) and NIS-LL plus seven nerve tests (NIS-LL+Σ7) without baseline measurements as covariates.
The analysis indicated a significant benefit of tafamidis, compared with placebo, at Months 12 and 18. The baseline-adjusted mean increase in NIS-LL from baseline to Month 12 was 1.5 points in the tafamidis group versus 4.5 points in the placebo group. By Month 18, the mean change from baseline was 2.9 points in the tafamidis group versus 5.6 points in the placebo group.
When the researchers applied sensitivity analysis based on multiple imputation for missing data by treatment group, the mean estimates of the increase in NIS-LL total score from baseline to Month 18 were significantly lower for tafamidis, compared with placebo. A more conservative model based on multiple imputation showed a benefit of tafamidis, but results did not reach statistical significance.
The researchers also found a statistically significant benefit of tafamidis, compared with placebo, on NIS-LL+Σ3 at Months 12 and 18. Significant differences favoring tafamidis also were observed on NIS-LL+Σ7 at Months 12 and 18. Four of the study’s five authors are employees of Pfizer, which owns tafamidis and sponsored the study.
—Erik Greb
Suggested Reading
Keohane D, Schwartz J, Gundapaneni B, et al. Tafamidis delays disease progression in patients with early stage transthyretin familial amyloid polyneuropathy: additional supportive analyses from the pivotal trial. Amyloid. 2017 Apr 10 [Epub ahead of print].
Friday - On Tap
What will happen Friday that people will be talking about Saturday? All of the below, and much more:
• 6:30 to 8:00 a.m. Breakfast Sessions: Pushing the boundaries in managing PAD, managing arterial infections and the aging of vascular surgeons. See Mobile App for room locations.
• 8:00 - 11:00 a.m.Plenary Sessions 4 through 6. Room 6 A/B. See Mobile App for abstracts and times.
• 11:00 a.m. Presidential address from Dr. Ronald M. Fairman. President-Elect Dr. R. Clement Darling, III, will introduce Dr. Fairman. Room 6 A/B.
• 3:30 to 5:00 p.m. Six Concurrent Sessions: the SVS/ESVS debate, joint sessions with the STS and AVF, an update on clinical practice guidelines and introduction of global vascular guidelines, and the Poster Competition. See Mobile App for details and room locations.
• 12:15 to 1:30 p.m. The Vascular Surgery Trainee Luncheon, Room 6C. Topics include how to find a job and “day in the life” stories from recent 5+2 and 0+5 graduates. Register at the Registration Counter.
• 5:00 to 6:30 p.m. Residency Fair. Exhibit Hall A.
What will happen Friday that people will be talking about Saturday? All of the below, and much more:
• 6:30 to 8:00 a.m. Breakfast Sessions: Pushing the boundaries in managing PAD, managing arterial infections and the aging of vascular surgeons. See Mobile App for room locations.
• 8:00 - 11:00 a.m.Plenary Sessions 4 through 6. Room 6 A/B. See Mobile App for abstracts and times.
• 11:00 a.m. Presidential address from Dr. Ronald M. Fairman. President-Elect Dr. R. Clement Darling, III, will introduce Dr. Fairman. Room 6 A/B.
• 3:30 to 5:00 p.m. Six Concurrent Sessions: the SVS/ESVS debate, joint sessions with the STS and AVF, an update on clinical practice guidelines and introduction of global vascular guidelines, and the Poster Competition. See Mobile App for details and room locations.
• 12:15 to 1:30 p.m. The Vascular Surgery Trainee Luncheon, Room 6C. Topics include how to find a job and “day in the life” stories from recent 5+2 and 0+5 graduates. Register at the Registration Counter.
• 5:00 to 6:30 p.m. Residency Fair. Exhibit Hall A.
What will happen Friday that people will be talking about Saturday? All of the below, and much more:
• 6:30 to 8:00 a.m. Breakfast Sessions: Pushing the boundaries in managing PAD, managing arterial infections and the aging of vascular surgeons. See Mobile App for room locations.
• 8:00 - 11:00 a.m.Plenary Sessions 4 through 6. Room 6 A/B. See Mobile App for abstracts and times.
• 11:00 a.m. Presidential address from Dr. Ronald M. Fairman. President-Elect Dr. R. Clement Darling, III, will introduce Dr. Fairman. Room 6 A/B.
• 3:30 to 5:00 p.m. Six Concurrent Sessions: the SVS/ESVS debate, joint sessions with the STS and AVF, an update on clinical practice guidelines and introduction of global vascular guidelines, and the Poster Competition. See Mobile App for details and room locations.
• 12:15 to 1:30 p.m. The Vascular Surgery Trainee Luncheon, Room 6C. Topics include how to find a job and “day in the life” stories from recent 5+2 and 0+5 graduates. Register at the Registration Counter.
• 5:00 to 6:30 p.m. Residency Fair. Exhibit Hall A.
Stop By, Say Hi! 6 Great Reasons to Visit the Membership Booth
While you’re in the neighborhood, why not stop by the SVS Membership Booth, located just outside the plenary doors?
Whether you are a member of SVS or not, we’d love to see you. Here are some reasons you’ll be glad you did:
Enter to win a $500 gift card if you update your SVS member profile or fill out a membership form.
Pick up a memento – SVS pens, notebooks, even saltwater taffy – of your visit (while supplies last).
Members are encouraged to update their personal information – emails, addresses, and even names can change. Don’t let yourself fall off the contact lists!
Inquire about membership options; learn about the benefits of belonging.
Get help with your mobile app.
Bonus: If you update your member details AND make a donation to the SVS Foundation (adjoining booth), you can enter the contest twice.
While you’re in the neighborhood, why not stop by the SVS Membership Booth, located just outside the plenary doors?
Whether you are a member of SVS or not, we’d love to see you. Here are some reasons you’ll be glad you did:
Enter to win a $500 gift card if you update your SVS member profile or fill out a membership form.
Pick up a memento – SVS pens, notebooks, even saltwater taffy – of your visit (while supplies last).
Members are encouraged to update their personal information – emails, addresses, and even names can change. Don’t let yourself fall off the contact lists!
Inquire about membership options; learn about the benefits of belonging.
Get help with your mobile app.
Bonus: If you update your member details AND make a donation to the SVS Foundation (adjoining booth), you can enter the contest twice.
While you’re in the neighborhood, why not stop by the SVS Membership Booth, located just outside the plenary doors?
Whether you are a member of SVS or not, we’d love to see you. Here are some reasons you’ll be glad you did:
Enter to win a $500 gift card if you update your SVS member profile or fill out a membership form.
Pick up a memento – SVS pens, notebooks, even saltwater taffy – of your visit (while supplies last).
Members are encouraged to update their personal information – emails, addresses, and even names can change. Don’t let yourself fall off the contact lists!
Inquire about membership options; learn about the benefits of belonging.
Get help with your mobile app.
Bonus: If you update your member details AND make a donation to the SVS Foundation (adjoining booth), you can enter the contest twice.