SAN FRANCISCO – Nearly 1 in 10 chronic migraine patients say they’ve delayed having children or had fewer children because of their headaches, according to a new analysis from the CaMEO study.

Bruce Jancin/MDedge News

“I think this is the most heartbreaking of the survey responses; we asked, ‘Have you delayed having children or had fewer children because of your headaches?’ and 2.6% of patients with episodic migraine and 9.6% with chronic migraine said yes,” Dawn C. Buse, PhD, said at the annual meeting of the American Headache Society.

CaMEO (the Chronic Migraine Epidemiology and Outcomes study) is a longitudinal, prospective, Internet-based survey whose aim is to flesh out the full impact of migraine. Dr. Buse presented an analysis of 13,064 migraineur participants, which focused on the impact of migraine on intimate relationships and parenting, an aspect of the disease burden that hasn’t been closely examined. All subjects completed the in-depth Family Burden Module, which is concerned with the emotional consequences of migraine.

The bottom line is that “migraine has significant negative impact on the most important relationships in our life: with our spouses, partners, and children,” declared Dr. Buse, a clinical psychologist at the Albert Einstein College of Medicine and director of behavioral medicine for the Montefiore Headache Center in New York.

The extent to which migraineurs perceived their headaches to be a problem increased stepwise with their number of headache days per month. For example, when the 8,127 CaMEO participants in a relationship with a live-in partner were asked to respond to the statement, “If I did not have headaches, I would be a better partner,” somewhat or complete agreement was endorsed by 38% of those with low-frequency episodic migraine at a rate of up to 4 headache days per month, 68% of those with 5-9 headache days per month, 73% of those with high-frequency episodic migraine with 10-14 headache days per month, and 78% of those with chronic migraine, defined as 15 or more headache days per month.

“Not surprising, certainly, but something to keep in mind as we care for our patients; that just because someone has episodic migraine they may have a range of expressions of how much those migraines have impacted their life,” Dr. Buse observed.

Another example: The proportion of subjects who reported delaying having children or having fewer kids because of their headaches was 1.6%, 5.5%, and 6.5% in low-, moderate-, and high-frequency episodic migraineurs, respectively, before topping out at 9.6% among those with chronic migraine.

Although she and her coinvestigators broke down the data by gender, there were no significant gender differences in the impact of migraine on significant relationships. The major differences were between patients with episodic as compared with chronic migraine.

Among the more than 3,500 CaMEO participants not currently in a relationship, 37% of those with chronic migraine and 15% of those with episodic migraine indicated that their headaches had contributed to relationship problems.

Of those in a relationship but not living together, 44% of individuals with chronic migraine reported that their headaches were preventing a closer relationship, such as moving in together or getting married, as did 16% of those with episodic migraine.

About 47%of respondents with chronic migraine reported that their headaches had caused at least one previous break-up, as did 18% of those with episodic migraine.

“Health care professionals should consider the overall burden of disease when managing migraine, particularly for those with chronic migraine,” Dr. Buse concluded. “Personalized comprehensive treatment plans may include both acute and preventive pharmacologic treatments as well as behavioral treatment for the proband, marital dyad, and family members as appropriate.”

She reported receiving research support and honoraria from Allergan, the study sponsor, as well as from Avenir, Eli Lilly, and Promius.

bjancin@mdedge.com

SOURCE: Buse DC et al. AHS 2018, Abstract OR06.

SAN FRANCISCO – Nearly 1 in 10 chronic migraine patients say they’ve delayed having children or had fewer children because of their headaches, according to a new analysis from the CaMEO study.

Bruce Jancin/MDedge News

“I think this is the most heartbreaking of the survey responses; we asked, ‘Have you delayed having children or had fewer children because of your headaches?’ and 2.6% of patients with episodic migraine and 9.6% with chronic migraine said yes,” Dawn C. Buse, PhD, said at the annual meeting of the American Headache Society.

CaMEO (the Chronic Migraine Epidemiology and Outcomes study) is a longitudinal, prospective, Internet-based survey whose aim is to flesh out the full impact of migraine. Dr. Buse presented an analysis of 13,064 migraineur participants, which focused on the impact of migraine on intimate relationships and parenting, an aspect of the disease burden that hasn’t been closely examined. All subjects completed the in-depth Family Burden Module, which is concerned with the emotional consequences of migraine.

The bottom line is that “migraine has significant negative impact on the most important relationships in our life: with our spouses, partners, and children,” declared Dr. Buse, a clinical psychologist at the Albert Einstein College of Medicine and director of behavioral medicine for the Montefiore Headache Center in New York.

The extent to which migraineurs perceived their headaches to be a problem increased stepwise with their number of headache days per month. For example, when the 8,127 CaMEO participants in a relationship with a live-in partner were asked to respond to the statement, “If I did not have headaches, I would be a better partner,” somewhat or complete agreement was endorsed by 38% of those with low-frequency episodic migraine at a rate of up to 4 headache days per month, 68% of those with 5-9 headache days per month, 73% of those with high-frequency episodic migraine with 10-14 headache days per month, and 78% of those with chronic migraine, defined as 15 or more headache days per month.

“Not surprising, certainly, but something to keep in mind as we care for our patients; that just because someone has episodic migraine they may have a range of expressions of how much those migraines have impacted their life,” Dr. Buse observed.

Another example: The proportion of subjects who reported delaying having children or having fewer kids because of their headaches was 1.6%, 5.5%, and 6.5% in low-, moderate-, and high-frequency episodic migraineurs, respectively, before topping out at 9.6% among those with chronic migraine.

Although she and her coinvestigators broke down the data by gender, there were no significant gender differences in the impact of migraine on significant relationships. The major differences were between patients with episodic as compared with chronic migraine.

Among the more than 3,500 CaMEO participants not currently in a relationship, 37% of those with chronic migraine and 15% of those with episodic migraine indicated that their headaches had contributed to relationship problems.

Of those in a relationship but not living together, 44% of individuals with chronic migraine reported that their headaches were preventing a closer relationship, such as moving in together or getting married, as did 16% of those with episodic migraine.

About 47%of respondents with chronic migraine reported that their headaches had caused at least one previous break-up, as did 18% of those with episodic migraine.

“Health care professionals should consider the overall burden of disease when managing migraine, particularly for those with chronic migraine,” Dr. Buse concluded. “Personalized comprehensive treatment plans may include both acute and preventive pharmacologic treatments as well as behavioral treatment for the proband, marital dyad, and family members as appropriate.”

She reported receiving research support and honoraria from Allergan, the study sponsor, as well as from Avenir, Eli Lilly, and Promius.

bjancin@mdedge.com

SOURCE: Buse DC et al. AHS 2018, Abstract OR06.

SAN FRANCISCO – Nearly 1 in 10 chronic migraine patients say they’ve delayed having children or had fewer children because of their headaches, according to a new analysis from the CaMEO study.

Bruce Jancin/MDedge News

“I think this is the most heartbreaking of the survey responses; we asked, ‘Have you delayed having children or had fewer children because of your headaches?’ and 2.6% of patients with episodic migraine and 9.6% with chronic migraine said yes,” Dawn C. Buse, PhD, said at the annual meeting of the American Headache Society.

CaMEO (the Chronic Migraine Epidemiology and Outcomes study) is a longitudinal, prospective, Internet-based survey whose aim is to flesh out the full impact of migraine. Dr. Buse presented an analysis of 13,064 migraineur participants, which focused on the impact of migraine on intimate relationships and parenting, an aspect of the disease burden that hasn’t been closely examined. All subjects completed the in-depth Family Burden Module, which is concerned with the emotional consequences of migraine.

The bottom line is that “migraine has significant negative impact on the most important relationships in our life: with our spouses, partners, and children,” declared Dr. Buse, a clinical psychologist at the Albert Einstein College of Medicine and director of behavioral medicine for the Montefiore Headache Center in New York.

The extent to which migraineurs perceived their headaches to be a problem increased stepwise with their number of headache days per month. For example, when the 8,127 CaMEO participants in a relationship with a live-in partner were asked to respond to the statement, “If I did not have headaches, I would be a better partner,” somewhat or complete agreement was endorsed by 38% of those with low-frequency episodic migraine at a rate of up to 4 headache days per month, 68% of those with 5-9 headache days per month, 73% of those with high-frequency episodic migraine with 10-14 headache days per month, and 78% of those with chronic migraine, defined as 15 or more headache days per month.

“Not surprising, certainly, but something to keep in mind as we care for our patients; that just because someone has episodic migraine they may have a range of expressions of how much those migraines have impacted their life,” Dr. Buse observed.

Another example: The proportion of subjects who reported delaying having children or having fewer kids because of their headaches was 1.6%, 5.5%, and 6.5% in low-, moderate-, and high-frequency episodic migraineurs, respectively, before topping out at 9.6% among those with chronic migraine.

Although she and her coinvestigators broke down the data by gender, there were no significant gender differences in the impact of migraine on significant relationships. The major differences were between patients with episodic as compared with chronic migraine.

Among the more than 3,500 CaMEO participants not currently in a relationship, 37% of those with chronic migraine and 15% of those with episodic migraine indicated that their headaches had contributed to relationship problems.

Of those in a relationship but not living together, 44% of individuals with chronic migraine reported that their headaches were preventing a closer relationship, such as moving in together or getting married, as did 16% of those with episodic migraine.

About 47%of respondents with chronic migraine reported that their headaches had caused at least one previous break-up, as did 18% of those with episodic migraine.

“Health care professionals should consider the overall burden of disease when managing migraine, particularly for those with chronic migraine,” Dr. Buse concluded. “Personalized comprehensive treatment plans may include both acute and preventive pharmacologic treatments as well as behavioral treatment for the proband, marital dyad, and family members as appropriate.”

She reported receiving research support and honoraria from Allergan, the study sponsor, as well as from Avenir, Eli Lilly, and Promius.

bjancin@mdedge.com

SOURCE: Buse DC et al. AHS 2018, Abstract OR06.

Anatomic localization (the hypothalamus as a key and early mediator in the pathophysiology of migraine), common mediating signaling molecules (such as serotonin and dopamine), and the discovery of a new central nervous system waste removal system, the glymphatic system, all point to a common pathophysiology manifesting in migraine and sleep problems, according to recent research. Patients consistently report poor sleep prior to migraine attacks and during them, identifying poor sleep as a migraine trigger. However, anecdotally, sleep is reported to serve a therapeutic role in terminating headache. Researchers reviewed studies of sleep and migraine from the last 2 decades, utilizing validated subjective and objective measures of sleep and to explore potential mechanisms underlying this complex relationship by incorporating recent advances in neuroscience. They specifically focused on:

• insomnia,
• obstructive sleep apnea,
• parasomnias,
• sleep-related movement disorders, and
• rapid eye movement (REM) sleep-related disorders and their relationship to migraine.

In addition, parts of brainstem‐cortical networks involved in sleep physiology are unintentionally being identified as important factors in the common migraine pathway.

Vgontzas A, Pavlović JM. Sleep disorders and migraine: Review of literature and potential pathophysiology mechanisms. [Published online ahead of print August 8, 2018]. Headache. doi:10.1111/head.13358.

Anatomic localization (the hypothalamus as a key and early mediator in the pathophysiology of migraine), common mediating signaling molecules (such as serotonin and dopamine), and the discovery of a new central nervous system waste removal system, the glymphatic system, all point to a common pathophysiology manifesting in migraine and sleep problems, according to recent research. Patients consistently report poor sleep prior to migraine attacks and during them, identifying poor sleep as a migraine trigger. However, anecdotally, sleep is reported to serve a therapeutic role in terminating headache. Researchers reviewed studies of sleep and migraine from the last 2 decades, utilizing validated subjective and objective measures of sleep and to explore potential mechanisms underlying this complex relationship by incorporating recent advances in neuroscience. They specifically focused on:

• insomnia,
• obstructive sleep apnea,
• parasomnias,
• sleep-related movement disorders, and
• rapid eye movement (REM) sleep-related disorders and their relationship to migraine.

In addition, parts of brainstem‐cortical networks involved in sleep physiology are unintentionally being identified as important factors in the common migraine pathway.

Vgontzas A, Pavlović JM. Sleep disorders and migraine: Review of literature and potential pathophysiology mechanisms. [Published online ahead of print August 8, 2018]. Headache. doi:10.1111/head.13358.

Anatomic localization (the hypothalamus as a key and early mediator in the pathophysiology of migraine), common mediating signaling molecules (such as serotonin and dopamine), and the discovery of a new central nervous system waste removal system, the glymphatic system, all point to a common pathophysiology manifesting in migraine and sleep problems, according to recent research. Patients consistently report poor sleep prior to migraine attacks and during them, identifying poor sleep as a migraine trigger. However, anecdotally, sleep is reported to serve a therapeutic role in terminating headache. Researchers reviewed studies of sleep and migraine from the last 2 decades, utilizing validated subjective and objective measures of sleep and to explore potential mechanisms underlying this complex relationship by incorporating recent advances in neuroscience. They specifically focused on:

• insomnia,
• obstructive sleep apnea,
• parasomnias,
• sleep-related movement disorders, and
• rapid eye movement (REM) sleep-related disorders and their relationship to migraine.

In addition, parts of brainstem‐cortical networks involved in sleep physiology are unintentionally being identified as important factors in the common migraine pathway.

Vgontzas A, Pavlović JM. Sleep disorders and migraine: Review of literature and potential pathophysiology mechanisms. [Published online ahead of print August 8, 2018]. Headache. doi:10.1111/head.13358.

The presence of a sleep disorder is associated with more frequent and severe migraine and portends a poorer headache prognosis, according to recent research that focuses on clinical assessment and treatment of sleep disorders. Interestingly, the disorders linked to migraine are quite varied, including insomnia, snoring and obstructive sleep apnea, restless legs, circadian rhythm disorders, and narcolepsy. Insomnia is by far the most common sleep disorder in headache patients.  New developments in treatment have produced abbreviated and cost‐effective therapies for insomnia and obstructive sleep apnea that may reach a larger population. Recommendations include:

• behavioral sleep regulation, shown in recent controlled trials to decrease migraine frequency,
• management for sleep apnea headache, and
• cognitive behavioral therapy (CBT) for insomnia abbreviated for the physician practice setting.

There is no empirical evidence that sleep evaluation should delay or supersede usual headache care. Rather, sleep management is complimentary to standard headache practice.

Rains JC. Sleep and migraine: Assessment and treatment of comorbid sleep disorders. [Published online ahead of print August 10, 2018]. Headache. doi:10.1111/head.13357.

The presence of a sleep disorder is associated with more frequent and severe migraine and portends a poorer headache prognosis, according to recent research that focuses on clinical assessment and treatment of sleep disorders. Interestingly, the disorders linked to migraine are quite varied, including insomnia, snoring and obstructive sleep apnea, restless legs, circadian rhythm disorders, and narcolepsy. Insomnia is by far the most common sleep disorder in headache patients.  New developments in treatment have produced abbreviated and cost‐effective therapies for insomnia and obstructive sleep apnea that may reach a larger population. Recommendations include:

• behavioral sleep regulation, shown in recent controlled trials to decrease migraine frequency,
• management for sleep apnea headache, and
• cognitive behavioral therapy (CBT) for insomnia abbreviated for the physician practice setting.

There is no empirical evidence that sleep evaluation should delay or supersede usual headache care. Rather, sleep management is complimentary to standard headache practice.

Rains JC. Sleep and migraine: Assessment and treatment of comorbid sleep disorders. [Published online ahead of print August 10, 2018]. Headache. doi:10.1111/head.13357.

The presence of a sleep disorder is associated with more frequent and severe migraine and portends a poorer headache prognosis, according to recent research that focuses on clinical assessment and treatment of sleep disorders. Interestingly, the disorders linked to migraine are quite varied, including insomnia, snoring and obstructive sleep apnea, restless legs, circadian rhythm disorders, and narcolepsy. Insomnia is by far the most common sleep disorder in headache patients.  New developments in treatment have produced abbreviated and cost‐effective therapies for insomnia and obstructive sleep apnea that may reach a larger population. Recommendations include:

• behavioral sleep regulation, shown in recent controlled trials to decrease migraine frequency,
• management for sleep apnea headache, and
• cognitive behavioral therapy (CBT) for insomnia abbreviated for the physician practice setting.

There is no empirical evidence that sleep evaluation should delay or supersede usual headache care. Rather, sleep management is complimentary to standard headache practice.

Rains JC. Sleep and migraine: Assessment and treatment of comorbid sleep disorders. [Published online ahead of print August 10, 2018]. Headache. doi:10.1111/head.13357.

The optimist says the glass is half-full. The pessimist says it is half-empty. An engineer says the glass is twice as large as needed to contain the specified amount of fluid. To some people, that mindset makes engineers negative people. We focus on weaknesses and inefficiencies. A chain is only as strong as its weakest link. There is no partial credit when building a bridge. 98% right is still wrong.

When I worked as an engineer, critiquing ideas was a daily activity. I am used to conflicting opinions. Industry trains people to be professional and act appropriately when disagreeing with a colleague. Tact is the art of making a point without making an enemy. Engineering has a strong culture of focusing on a problem rather than on personalities. Upper management made it clear that in any turf war, both sides will lose. Academia has a different culture. Turf wars in academia are so bitter because the stakes are so small.

Pediatrics has less confrontation and competitiveness than do other subspecialties. That makes the work environment more pleasant, as long as every other group in the hospital isn’t walking all over you. Pediatricians often view themselves as dedicated to doing what is right for the children, even to the point of martyrdom. Some early pediatric hospitalist programs got into economic trouble because they adopted tasks that benefited the children but that weren’t being performed by other physicians precisely because those tasks were neither valued nor compensated. Learning to say “No” is hard but necessary.

As a clinical ethics consultant, I was consulted when conflict had developed between providers and patients/parents or between different specialties. Ethics consults are rarely about what philosophers would call ethics. They are mostly about miscommunication, empowering voices to be heard and clarifying values. Practical skills in de-escalation and mediation are more important than either law or philosophy degrees.

There are downsides to avoiding confrontation. Truth suffers. Integrity is lost. Goals become corrupted. I will give two examples. One ED had a five-level triage system. Level 1 was reserved for life-threatening situations such as gunshot wounds and resuscitations. So I was surprised to see a “bili” baby triaged at Level 1. He was a good baby with normal vitals. Admission for phototherapy was reasonable, but the urgency of a bilirubin of 19 did not match that of a gunshot wound. A colleague warned me not to even consider challenging the practice. A powerful physician at that institution had made it policy years earlier.

I witnessed a similar dynamic many times at that institution. Residents are even better than 4-year-olds at noticing hypocritical behavior. Once they perceive that the dynamic is political power and not science, they adapt quickly. A couple days later, I asked a resident if he really thought an IV was necessary for a toddler we were admitting. He replied no, but if he hadn’t put an IV in, the hospital wouldn’t get paid for the admission. To him, that was the unspoken policy. The action didn’t even cause him moral distress. I worry about that much cynicism so early in a career. Cognitive dissonance starts small and slowly creeps its way into everything.

The art of managing conflict is particularly important in pediatric hospital medicine because of its heavy investment in reducing overdiagnosis and overtreatment. Many pediatric hospitalists are located at academic institutions and more subject to its turf wars than outpatient colleagues practicing in small groups. The recent conference for pediatric hospital medicine was held in Atlanta, a few blocks from the Center for Civil and Human Rights. That museum evokes powerful images of struggles around the world. My two takeaway lessons: Silence is a form of collaboration. Tyrannical suppression of dissent magnifies suffering.

In poorly managed academic institutions, it can be harmful to one’s career to ask questions, challenge assumptions, and seek truth. A recent report found that the Department of Veterans Affairs health system also has a culture that punishes whistle-blowers. Nationally, politics has become polarized. Splitting, once considered a dysfunctional behavior, has become normalized. So I understand the reluctance to speak up. One must choose one’s battles.

Given the personal and career risks, why confront inaccurate research, wasteful practices, and unjust policies? I believe that there is a balance and a choice each person must make. Canadian engineers wear an iron ring to remind themselves of their professional responsibilities. Doctors wear white coats. Personally, I share a memory with other engineers of my generation. In January 1986, NASA engineers could not convince their managers about a risk. The space shuttle Challenger exploded. I heard about it in the medical school’s cafeteria. So for me, disputation is part of the vocation.

 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

The optimist says the glass is half-full. The pessimist says it is half-empty. An engineer says the glass is twice as large as needed to contain the specified amount of fluid. To some people, that mindset makes engineers negative people. We focus on weaknesses and inefficiencies. A chain is only as strong as its weakest link. There is no partial credit when building a bridge. 98% right is still wrong.

When I worked as an engineer, critiquing ideas was a daily activity. I am used to conflicting opinions. Industry trains people to be professional and act appropriately when disagreeing with a colleague. Tact is the art of making a point without making an enemy. Engineering has a strong culture of focusing on a problem rather than on personalities. Upper management made it clear that in any turf war, both sides will lose. Academia has a different culture. Turf wars in academia are so bitter because the stakes are so small.

Pediatrics has less confrontation and competitiveness than do other subspecialties. That makes the work environment more pleasant, as long as every other group in the hospital isn’t walking all over you. Pediatricians often view themselves as dedicated to doing what is right for the children, even to the point of martyrdom. Some early pediatric hospitalist programs got into economic trouble because they adopted tasks that benefited the children but that weren’t being performed by other physicians precisely because those tasks were neither valued nor compensated. Learning to say “No” is hard but necessary.

As a clinical ethics consultant, I was consulted when conflict had developed between providers and patients/parents or between different specialties. Ethics consults are rarely about what philosophers would call ethics. They are mostly about miscommunication, empowering voices to be heard and clarifying values. Practical skills in de-escalation and mediation are more important than either law or philosophy degrees.

There are downsides to avoiding confrontation. Truth suffers. Integrity is lost. Goals become corrupted. I will give two examples. One ED had a five-level triage system. Level 1 was reserved for life-threatening situations such as gunshot wounds and resuscitations. So I was surprised to see a “bili” baby triaged at Level 1. He was a good baby with normal vitals. Admission for phototherapy was reasonable, but the urgency of a bilirubin of 19 did not match that of a gunshot wound. A colleague warned me not to even consider challenging the practice. A powerful physician at that institution had made it policy years earlier.

I witnessed a similar dynamic many times at that institution. Residents are even better than 4-year-olds at noticing hypocritical behavior. Once they perceive that the dynamic is political power and not science, they adapt quickly. A couple days later, I asked a resident if he really thought an IV was necessary for a toddler we were admitting. He replied no, but if he hadn’t put an IV in, the hospital wouldn’t get paid for the admission. To him, that was the unspoken policy. The action didn’t even cause him moral distress. I worry about that much cynicism so early in a career. Cognitive dissonance starts small and slowly creeps its way into everything.

The art of managing conflict is particularly important in pediatric hospital medicine because of its heavy investment in reducing overdiagnosis and overtreatment. Many pediatric hospitalists are located at academic institutions and more subject to its turf wars than outpatient colleagues practicing in small groups. The recent conference for pediatric hospital medicine was held in Atlanta, a few blocks from the Center for Civil and Human Rights. That museum evokes powerful images of struggles around the world. My two takeaway lessons: Silence is a form of collaboration. Tyrannical suppression of dissent magnifies suffering.

In poorly managed academic institutions, it can be harmful to one’s career to ask questions, challenge assumptions, and seek truth. A recent report found that the Department of Veterans Affairs health system also has a culture that punishes whistle-blowers. Nationally, politics has become polarized. Splitting, once considered a dysfunctional behavior, has become normalized. So I understand the reluctance to speak up. One must choose one’s battles.

Given the personal and career risks, why confront inaccurate research, wasteful practices, and unjust policies? I believe that there is a balance and a choice each person must make. Canadian engineers wear an iron ring to remind themselves of their professional responsibilities. Doctors wear white coats. Personally, I share a memory with other engineers of my generation. In January 1986, NASA engineers could not convince their managers about a risk. The space shuttle Challenger exploded. I heard about it in the medical school’s cafeteria. So for me, disputation is part of the vocation.

 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

The optimist says the glass is half-full. The pessimist says it is half-empty. An engineer says the glass is twice as large as needed to contain the specified amount of fluid. To some people, that mindset makes engineers negative people. We focus on weaknesses and inefficiencies. A chain is only as strong as its weakest link. There is no partial credit when building a bridge. 98% right is still wrong.

When I worked as an engineer, critiquing ideas was a daily activity. I am used to conflicting opinions. Industry trains people to be professional and act appropriately when disagreeing with a colleague. Tact is the art of making a point without making an enemy. Engineering has a strong culture of focusing on a problem rather than on personalities. Upper management made it clear that in any turf war, both sides will lose. Academia has a different culture. Turf wars in academia are so bitter because the stakes are so small.

Pediatrics has less confrontation and competitiveness than do other subspecialties. That makes the work environment more pleasant, as long as every other group in the hospital isn’t walking all over you. Pediatricians often view themselves as dedicated to doing what is right for the children, even to the point of martyrdom. Some early pediatric hospitalist programs got into economic trouble because they adopted tasks that benefited the children but that weren’t being performed by other physicians precisely because those tasks were neither valued nor compensated. Learning to say “No” is hard but necessary.

As a clinical ethics consultant, I was consulted when conflict had developed between providers and patients/parents or between different specialties. Ethics consults are rarely about what philosophers would call ethics. They are mostly about miscommunication, empowering voices to be heard and clarifying values. Practical skills in de-escalation and mediation are more important than either law or philosophy degrees.

There are downsides to avoiding confrontation. Truth suffers. Integrity is lost. Goals become corrupted. I will give two examples. One ED had a five-level triage system. Level 1 was reserved for life-threatening situations such as gunshot wounds and resuscitations. So I was surprised to see a “bili” baby triaged at Level 1. He was a good baby with normal vitals. Admission for phototherapy was reasonable, but the urgency of a bilirubin of 19 did not match that of a gunshot wound. A colleague warned me not to even consider challenging the practice. A powerful physician at that institution had made it policy years earlier.

I witnessed a similar dynamic many times at that institution. Residents are even better than 4-year-olds at noticing hypocritical behavior. Once they perceive that the dynamic is political power and not science, they adapt quickly. A couple days later, I asked a resident if he really thought an IV was necessary for a toddler we were admitting. He replied no, but if he hadn’t put an IV in, the hospital wouldn’t get paid for the admission. To him, that was the unspoken policy. The action didn’t even cause him moral distress. I worry about that much cynicism so early in a career. Cognitive dissonance starts small and slowly creeps its way into everything.

The art of managing conflict is particularly important in pediatric hospital medicine because of its heavy investment in reducing overdiagnosis and overtreatment. Many pediatric hospitalists are located at academic institutions and more subject to its turf wars than outpatient colleagues practicing in small groups. The recent conference for pediatric hospital medicine was held in Atlanta, a few blocks from the Center for Civil and Human Rights. That museum evokes powerful images of struggles around the world. My two takeaway lessons: Silence is a form of collaboration. Tyrannical suppression of dissent magnifies suffering.

In poorly managed academic institutions, it can be harmful to one’s career to ask questions, challenge assumptions, and seek truth. A recent report found that the Department of Veterans Affairs health system also has a culture that punishes whistle-blowers. Nationally, politics has become polarized. Splitting, once considered a dysfunctional behavior, has become normalized. So I understand the reluctance to speak up. One must choose one’s battles.

Given the personal and career risks, why confront inaccurate research, wasteful practices, and unjust policies? I believe that there is a balance and a choice each person must make. Canadian engineers wear an iron ring to remind themselves of their professional responsibilities. Doctors wear white coats. Personally, I share a memory with other engineers of my generation. In January 1986, NASA engineers could not convince their managers about a risk. The space shuttle Challenger exploded. I heard about it in the medical school’s cafeteria. So for me, disputation is part of the vocation.

 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

Defensive medicine exists. The question is how often it happens and how large a role it plays in making medical care in the United States so costly. When Dr. Tom Price was a congressman, he was quoted as saying that defensive medicine is responsible for more than 25% of every dollar this country spends on health care. (“A Fear of Lawsuits Really Does Seem to Result in Extra Medical Tests” Margot Sanger-Katz, New York Times, July 23, 2018). Neither I nor anyone else had any data to support or refute Dr. Price’s claim in 2010, but based on 50 years of practicing and observing medicine, I don’t find his claim completely unreasonable.

iStock

Defensive medicine has been going on for so many generations of physicians that most doctors practicing today don’t realize they are doing it. A physician may order a full battery of chemistries on a patient presenting with mild anemia when only a CBC is necessary because that’s the way he was trained.

However, the evidence to support my suspicion that defensive medicine is a significant financial drain on our economy has been difficult to tease out of the tangled web of confounders that is woven into our patchwork health care system. A recent study by two economists provides a glimpse into the role of defensive medicine in the cost of health care (“Defensive Medicine: Evidence from Military Immunity” Michael D. Frakes and Jonathan Gruber, National Bureau of Economic Research, July 2018). Using the unusual combination of circumstances in which military personnel and their dependents can or cannot sue depending on where they are receiving care, the investigators found that “liability immunity reduces inpatient spending by 5% with no measurable negative effect on patient outcomes.” While that may not be as high as Dr. Price or I think it may be, 5% of three trillion dollars is serious money.

The bigger problem is that defensive medicine is ugly, artless, and intellectually unsatisfying. While the patient may not view your diagnosis of his chronic debilitating or terminal illness as a work of art, there are such things as beautiful diagnoses. One may be beautiful in its simplicity and its ability to unify a variety of previously unexplained symptoms. Another diagnosis may be the intellectually stimulating result of a carefully thought out branching decision tree to solve a puzzling array of complaints using a minimum of costly studies.

Defensive medicine decisions are made primarily to avoid mistakes and omissions. Physicians often behave as though we believe our errors will always be fatal. That may be somewhat true for surgeons, but for the rest of us errors can be an important part of learning. The unfortunate outcome of an error, particularly one of omission, can usually be avoided by following the patient closely, remaining available ... and continuing to exude an aura of caring.

With close and thoughtful follow-up, you are going to discover pretty quickly when you have missed the target. Patients understand that we aren’t going to get the correct diagnosis or prescribe the best treatment on the first try every time. What patients don’t understand and what may prompt them to sue is feeling that they are being ignored.

While practicing defensive medicine isn’t usually listed as one of the cardinal symptoms of physician burnout, it probably deserves more attention. With some introspection and a bit of courage, recasting what you do in terms of its artistry and intellectual integrity could add a new and positive dimension to how you practice medicine. How many of your decisions are being made to avoid an error? Wouldn’t it be more fun to be making beautiful diagnoses you can be proud of?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Is My Child Overtired?: The Sleep Solution for Raising Happier, Healthier Children.” Email him at pdnews@mdedge.com.

Defensive medicine exists. The question is how often it happens and how large a role it plays in making medical care in the United States so costly. When Dr. Tom Price was a congressman, he was quoted as saying that defensive medicine is responsible for more than 25% of every dollar this country spends on health care. (“A Fear of Lawsuits Really Does Seem to Result in Extra Medical Tests” Margot Sanger-Katz, New York Times, July 23, 2018). Neither I nor anyone else had any data to support or refute Dr. Price’s claim in 2010, but based on 50 years of practicing and observing medicine, I don’t find his claim completely unreasonable.

iStock

Defensive medicine has been going on for so many generations of physicians that most doctors practicing today don’t realize they are doing it. A physician may order a full battery of chemistries on a patient presenting with mild anemia when only a CBC is necessary because that’s the way he was trained.

However, the evidence to support my suspicion that defensive medicine is a significant financial drain on our economy has been difficult to tease out of the tangled web of confounders that is woven into our patchwork health care system. A recent study by two economists provides a glimpse into the role of defensive medicine in the cost of health care (“Defensive Medicine: Evidence from Military Immunity” Michael D. Frakes and Jonathan Gruber, National Bureau of Economic Research, July 2018). Using the unusual combination of circumstances in which military personnel and their dependents can or cannot sue depending on where they are receiving care, the investigators found that “liability immunity reduces inpatient spending by 5% with no measurable negative effect on patient outcomes.” While that may not be as high as Dr. Price or I think it may be, 5% of three trillion dollars is serious money.

The bigger problem is that defensive medicine is ugly, artless, and intellectually unsatisfying. While the patient may not view your diagnosis of his chronic debilitating or terminal illness as a work of art, there are such things as beautiful diagnoses. One may be beautiful in its simplicity and its ability to unify a variety of previously unexplained symptoms. Another diagnosis may be the intellectually stimulating result of a carefully thought out branching decision tree to solve a puzzling array of complaints using a minimum of costly studies.

Defensive medicine decisions are made primarily to avoid mistakes and omissions. Physicians often behave as though we believe our errors will always be fatal. That may be somewhat true for surgeons, but for the rest of us errors can be an important part of learning. The unfortunate outcome of an error, particularly one of omission, can usually be avoided by following the patient closely, remaining available ... and continuing to exude an aura of caring.

With close and thoughtful follow-up, you are going to discover pretty quickly when you have missed the target. Patients understand that we aren’t going to get the correct diagnosis or prescribe the best treatment on the first try every time. What patients don’t understand and what may prompt them to sue is feeling that they are being ignored.

While practicing defensive medicine isn’t usually listed as one of the cardinal symptoms of physician burnout, it probably deserves more attention. With some introspection and a bit of courage, recasting what you do in terms of its artistry and intellectual integrity could add a new and positive dimension to how you practice medicine. How many of your decisions are being made to avoid an error? Wouldn’t it be more fun to be making beautiful diagnoses you can be proud of?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Is My Child Overtired?: The Sleep Solution for Raising Happier, Healthier Children.” Email him at pdnews@mdedge.com.

Defensive medicine exists. The question is how often it happens and how large a role it plays in making medical care in the United States so costly. When Dr. Tom Price was a congressman, he was quoted as saying that defensive medicine is responsible for more than 25% of every dollar this country spends on health care. (“A Fear of Lawsuits Really Does Seem to Result in Extra Medical Tests” Margot Sanger-Katz, New York Times, July 23, 2018). Neither I nor anyone else had any data to support or refute Dr. Price’s claim in 2010, but based on 50 years of practicing and observing medicine, I don’t find his claim completely unreasonable.

iStock

Defensive medicine has been going on for so many generations of physicians that most doctors practicing today don’t realize they are doing it. A physician may order a full battery of chemistries on a patient presenting with mild anemia when only a CBC is necessary because that’s the way he was trained.

However, the evidence to support my suspicion that defensive medicine is a significant financial drain on our economy has been difficult to tease out of the tangled web of confounders that is woven into our patchwork health care system. A recent study by two economists provides a glimpse into the role of defensive medicine in the cost of health care (“Defensive Medicine: Evidence from Military Immunity” Michael D. Frakes and Jonathan Gruber, National Bureau of Economic Research, July 2018). Using the unusual combination of circumstances in which military personnel and their dependents can or cannot sue depending on where they are receiving care, the investigators found that “liability immunity reduces inpatient spending by 5% with no measurable negative effect on patient outcomes.” While that may not be as high as Dr. Price or I think it may be, 5% of three trillion dollars is serious money.

The bigger problem is that defensive medicine is ugly, artless, and intellectually unsatisfying. While the patient may not view your diagnosis of his chronic debilitating or terminal illness as a work of art, there are such things as beautiful diagnoses. One may be beautiful in its simplicity and its ability to unify a variety of previously unexplained symptoms. Another diagnosis may be the intellectually stimulating result of a carefully thought out branching decision tree to solve a puzzling array of complaints using a minimum of costly studies.

Defensive medicine decisions are made primarily to avoid mistakes and omissions. Physicians often behave as though we believe our errors will always be fatal. That may be somewhat true for surgeons, but for the rest of us errors can be an important part of learning. The unfortunate outcome of an error, particularly one of omission, can usually be avoided by following the patient closely, remaining available ... and continuing to exude an aura of caring.

With close and thoughtful follow-up, you are going to discover pretty quickly when you have missed the target. Patients understand that we aren’t going to get the correct diagnosis or prescribe the best treatment on the first try every time. What patients don’t understand and what may prompt them to sue is feeling that they are being ignored.

While practicing defensive medicine isn’t usually listed as one of the cardinal symptoms of physician burnout, it probably deserves more attention. With some introspection and a bit of courage, recasting what you do in terms of its artistry and intellectual integrity could add a new and positive dimension to how you practice medicine. How many of your decisions are being made to avoid an error? Wouldn’t it be more fun to be making beautiful diagnoses you can be proud of?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Is My Child Overtired?: The Sleep Solution for Raising Happier, Healthier Children.” Email him at pdnews@mdedge.com.

An estimated 72,000 drug overdose deaths occurred in 2017 in the United States, making it the worst year on record, according to preliminary data released by the Centers for Disease Control and Prevention.

The record high was driven by a sharp increase in deaths attributed to synthetic opioids, such as fentanyl and tramadol, data published on the agency’s website show.

The provisional counts are based on death records sent to the CDC’s National Center for Health Statistics from state vital registration offices in all 50 states and the District of Columbia, reported lead author Farida B. Ahmad, MPH, of the division of vital statistics at the NCHS. Overall, the predicted number of drug overdose deaths has climbed steadily, from 54,207 in November 2015 to 66,012 in November 2016, and to 72,287 in November 2017, according to an interactive chart accessible on the website.

Deaths attributable to synthetic opioids have climbed faster than any other drug class, soaring from just 9,983 in 2015 to 20,310 in 2016, and to 29,418 in 2017.

The next-largest category, heroin-related deaths, increased from 13,407 in 2015 to 16,012 in 2016, but appeared to plateau at 15,959 in 2017. However, the CDC cautioned that flat or declining numbers could be attributable to incomplete data, true decreases in deaths, or some combination of the two. “True declines or plateaus in the numbers of drug overdose deaths across the U.S. cannot be ascertained until final data become available.”

Cocaine-related deaths were fewer in number but appear to have risen substantially to the point where the number of deaths now nearly rival that of heroin. The number of deaths was 7,106 in 2015, 10,868 in 2016, and 14,614 in 2017.

The count of drug overdose deaths varied by state. Nebraska had the sharpest increase in predicted deaths between January 2017 and January 2018, coming in at 33.3%, though the absolute numbers of cases were low (114 through January 2017 and 152 through January 2018). North Carolina also showed substantial increases (from 2,053 to 2,515 cases, 22.5%), as did New Jersey (2,219 to 2,687 cases, 21.1%), the CDC data showed.

Provisional data will be updated on a monthly basis as additional records are received, the CDC said.

An estimated 72,000 drug overdose deaths occurred in 2017 in the United States, making it the worst year on record, according to preliminary data released by the Centers for Disease Control and Prevention.

The record high was driven by a sharp increase in deaths attributed to synthetic opioids, such as fentanyl and tramadol, data published on the agency’s website show.

The provisional counts are based on death records sent to the CDC’s National Center for Health Statistics from state vital registration offices in all 50 states and the District of Columbia, reported lead author Farida B. Ahmad, MPH, of the division of vital statistics at the NCHS. Overall, the predicted number of drug overdose deaths has climbed steadily, from 54,207 in November 2015 to 66,012 in November 2016, and to 72,287 in November 2017, according to an interactive chart accessible on the website.

Deaths attributable to synthetic opioids have climbed faster than any other drug class, soaring from just 9,983 in 2015 to 20,310 in 2016, and to 29,418 in 2017.

The next-largest category, heroin-related deaths, increased from 13,407 in 2015 to 16,012 in 2016, but appeared to plateau at 15,959 in 2017. However, the CDC cautioned that flat or declining numbers could be attributable to incomplete data, true decreases in deaths, or some combination of the two. “True declines or plateaus in the numbers of drug overdose deaths across the U.S. cannot be ascertained until final data become available.”

Cocaine-related deaths were fewer in number but appear to have risen substantially to the point where the number of deaths now nearly rival that of heroin. The number of deaths was 7,106 in 2015, 10,868 in 2016, and 14,614 in 2017.

The count of drug overdose deaths varied by state. Nebraska had the sharpest increase in predicted deaths between January 2017 and January 2018, coming in at 33.3%, though the absolute numbers of cases were low (114 through January 2017 and 152 through January 2018). North Carolina also showed substantial increases (from 2,053 to 2,515 cases, 22.5%), as did New Jersey (2,219 to 2,687 cases, 21.1%), the CDC data showed.

Provisional data will be updated on a monthly basis as additional records are received, the CDC said.

An estimated 72,000 drug overdose deaths occurred in 2017 in the United States, making it the worst year on record, according to preliminary data released by the Centers for Disease Control and Prevention.

The record high was driven by a sharp increase in deaths attributed to synthetic opioids, such as fentanyl and tramadol, data published on the agency’s website show.

The provisional counts are based on death records sent to the CDC’s National Center for Health Statistics from state vital registration offices in all 50 states and the District of Columbia, reported lead author Farida B. Ahmad, MPH, of the division of vital statistics at the NCHS. Overall, the predicted number of drug overdose deaths has climbed steadily, from 54,207 in November 2015 to 66,012 in November 2016, and to 72,287 in November 2017, according to an interactive chart accessible on the website.

Deaths attributable to synthetic opioids have climbed faster than any other drug class, soaring from just 9,983 in 2015 to 20,310 in 2016, and to 29,418 in 2017.

The next-largest category, heroin-related deaths, increased from 13,407 in 2015 to 16,012 in 2016, but appeared to plateau at 15,959 in 2017. However, the CDC cautioned that flat or declining numbers could be attributable to incomplete data, true decreases in deaths, or some combination of the two. “True declines or plateaus in the numbers of drug overdose deaths across the U.S. cannot be ascertained until final data become available.”

Cocaine-related deaths were fewer in number but appear to have risen substantially to the point where the number of deaths now nearly rival that of heroin. The number of deaths was 7,106 in 2015, 10,868 in 2016, and 14,614 in 2017.

The count of drug overdose deaths varied by state. Nebraska had the sharpest increase in predicted deaths between January 2017 and January 2018, coming in at 33.3%, though the absolute numbers of cases were low (114 through January 2017 and 152 through January 2018). North Carolina also showed substantial increases (from 2,053 to 2,515 cases, 22.5%), as did New Jersey (2,219 to 2,687 cases, 21.1%), the CDC data showed.

Provisional data will be updated on a monthly basis as additional records are received, the CDC said.

The Food and Drug Administration has granted orphan drug designation to CPI-613 for the treatment of peripheral T-cell lymphoma (PTCL).

CPI-613 is a novel lipoic acid analogue that inhibits multiple enzyme targets within the tricarboxylic acid cycle.

Rafael Pharmaceuticals is developing CPI-613 as a treatment for hematologic malignancies and solid tumors.

CPI-613 is currently under investigation in combination with bendamustine in a phase 1 study of patients with relapsed or refractory T-cell lymphoma or classical Hodgkin lymphoma, according to the press release from the company.

Results from this trial were presented at the 2016 annual meeting of the American Society of Hematology.

CPI-613 was given at escalating doses starting at 2,000 mg/m² over 2 hours on days 1-4 as well as on days 8, 11, 15, and 18. Bendamustine was infused at 90 mg/m² on days 4 and 5 of each 4-week treatment cycle. The treatment cycles were repeated for up to six cycles. There was no intrapatient dose escalation.

The ASH presentation included safety data on eight patients. The most common grade 3 or higher toxicities – lymphopenia and neutropenia – occurred in four patients.

A patient dosed at 2,750 mg/m² had a dose-limiting toxicity of grade 3 acute kidney injury and grade 4 lactic acidosis. Because of this, the study protocol was amended to discontinue dose escalation at doses of 2,750 mg/m² or higher and to expand the 2,500 mg/m² cohort.

Six patients were evaluable for efficacy, and the overall response rate was 83% (5/6).

There were three complete responses in patients with PTCL not otherwise specified, a partial response in a patient with mycosis fungoides, and a partial response in a patient with angioimmunoblastic T-cell lymphoma.

One patient with T-cell acute lymphoblastic leukemia experienced progressive disease.

The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the United States.

The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.

The Food and Drug Administration has granted orphan drug designation to CPI-613 for the treatment of peripheral T-cell lymphoma (PTCL).

CPI-613 is a novel lipoic acid analogue that inhibits multiple enzyme targets within the tricarboxylic acid cycle.

Rafael Pharmaceuticals is developing CPI-613 as a treatment for hematologic malignancies and solid tumors.

CPI-613 is currently under investigation in combination with bendamustine in a phase 1 study of patients with relapsed or refractory T-cell lymphoma or classical Hodgkin lymphoma, according to the press release from the company.

Results from this trial were presented at the 2016 annual meeting of the American Society of Hematology.

CPI-613 was given at escalating doses starting at 2,000 mg/m² over 2 hours on days 1-4 as well as on days 8, 11, 15, and 18. Bendamustine was infused at 90 mg/m² on days 4 and 5 of each 4-week treatment cycle. The treatment cycles were repeated for up to six cycles. There was no intrapatient dose escalation.

The ASH presentation included safety data on eight patients. The most common grade 3 or higher toxicities – lymphopenia and neutropenia – occurred in four patients.

A patient dosed at 2,750 mg/m² had a dose-limiting toxicity of grade 3 acute kidney injury and grade 4 lactic acidosis. Because of this, the study protocol was amended to discontinue dose escalation at doses of 2,750 mg/m² or higher and to expand the 2,500 mg/m² cohort.

Six patients were evaluable for efficacy, and the overall response rate was 83% (5/6).

There were three complete responses in patients with PTCL not otherwise specified, a partial response in a patient with mycosis fungoides, and a partial response in a patient with angioimmunoblastic T-cell lymphoma.

One patient with T-cell acute lymphoblastic leukemia experienced progressive disease.

The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the United States.

The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.

The Food and Drug Administration has granted orphan drug designation to CPI-613 for the treatment of peripheral T-cell lymphoma (PTCL).

CPI-613 is a novel lipoic acid analogue that inhibits multiple enzyme targets within the tricarboxylic acid cycle.

Rafael Pharmaceuticals is developing CPI-613 as a treatment for hematologic malignancies and solid tumors.

CPI-613 is currently under investigation in combination with bendamustine in a phase 1 study of patients with relapsed or refractory T-cell lymphoma or classical Hodgkin lymphoma, according to the press release from the company.

Results from this trial were presented at the 2016 annual meeting of the American Society of Hematology.

CPI-613 was given at escalating doses starting at 2,000 mg/m² over 2 hours on days 1-4 as well as on days 8, 11, 15, and 18. Bendamustine was infused at 90 mg/m² on days 4 and 5 of each 4-week treatment cycle. The treatment cycles were repeated for up to six cycles. There was no intrapatient dose escalation.

The ASH presentation included safety data on eight patients. The most common grade 3 or higher toxicities – lymphopenia and neutropenia – occurred in four patients.

A patient dosed at 2,750 mg/m² had a dose-limiting toxicity of grade 3 acute kidney injury and grade 4 lactic acidosis. Because of this, the study protocol was amended to discontinue dose escalation at doses of 2,750 mg/m² or higher and to expand the 2,500 mg/m² cohort.

Six patients were evaluable for efficacy, and the overall response rate was 83% (5/6).

There were three complete responses in patients with PTCL not otherwise specified, a partial response in a patient with mycosis fungoides, and a partial response in a patient with angioimmunoblastic T-cell lymphoma.

One patient with T-cell acute lymphoblastic leukemia experienced progressive disease.

The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the United States.

The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.

ORLANDO – Improvements in cardiovascular and renal outcomes seen after nearly 10 years of improved glucose control among participants in the Veterans Affairs Diabetes Trial (VADT) who received intensive glucose-lowering therapy dissipated by year 15, according to final results from the VADT follow-up study (VADT-F).

Participants in the randomized, controlled VADT, which compared the effects of intensive versus standard glucose control in more than 1,700 patients with type 2 diabetes mellitus (T2DM), did not experience a significant improvement in the primary cardiovascular disease (CVD) outcome – a composite of myocardial infarction, stroke, cardiovascular death, new congestive heart failure, cardiovascular surgery or inoperable coronary artery disease, and ischemic amputation – after a median of 5.6 years of active treatment (hazard ratio, 0.88; P = .14). Nor did they experience significant improvement in secondary cardiovascular outcomes, including cardiovascular death and death from any cause (HRs, 1.32 and 1.07, respectively), or in a renal composite outcome (HR, 0.85), according to the findings published in 2009 (N Engl J Med. 2009 Jan 8;360[2]:129-39).

This was despite a rapid and statistically significant separation of hemoglobin A_1c (HbA_1c) levels between the treatment groups, Peter Reaven, MD, noted during a presentation of the final follow-up data at the annual scientific sessions of the American Diabetes Association.

Approximately 6 months after the start of the VADT, median HbA_1c levels decreased from more than 9% in both groups to 6.9% and 8.4% in intensive and standard treatment groups, respectively (a median separation of 1.5%), said Dr. Reaven, director of the diabetes research program at the Phoenix VA Health Care System and a professor of clinical medicine at the University of Arizona in Phoenix.

“This was maintained throughout the study period,” he said. “All other risk factors during this period of time were equal between the two treatment groups.”
 

10-year outcomes

However, 10-year interim data from VADT-F, published in the New England Journal of Medicine (2015 Jun 4;372[23]:2197-206), showed a delayed benefit in these outcomes among those in the intensive control group: The incidence of the primary CVD composite outcome was reduced by 17% (HR, 0.83; P = .04) in favor of the intensive therapy at that time, Dr. Reaven said.

The incidence of the renal composite outcome, which included estimated glomerular filtration rate less than 54 mL/min per 1.73m², sustained macroalbuminuria, and end-stage renal disease, was reduced by 32% (HR, 0.68; P = .008), said Nicholas Emanuele, MD, who presented the VADT-F renal and microvascular outcomes at the ADA meeting.

At that 10-year follow-up, HbA_1c levels in the intensive and standard treatment groups had nearly equalized (although they remained slightly better in the intensive treatment group), and eventually, the levels stabilized at about 8.2% in both groups through the end of the 15-year follow-up, the investigators said.

“So it was still lower by nearly 1.2 hemoglobin percent units, compared to baseline values nearly 15 years earlier, and despite ending the study in very good control, after we released these patients to the primary care providers for their diabetes care, there was a substantial rise in HbA_1c levels over time ... illustrating the difficulty of controlling HbA_1c values to this level in this advanced diabetes population,” Dr. Reaven said.
 

15-year outcomes

At the final 15-year follow up, with the HbA_1c levels similar in the groups, nearly all benefits seen at 10 years were lost. Event rates for the CVD primary composite outcome were 51.8 and 47.3 per 1,000 patient-years in the intensive care and standard care groups, respectively (HR, 0.91; P = .23), and event rates for the renal composite outcome were 88 and 85 per 1,000 patient-years (HR, 0.90; P = .55).

Similarly, no differences were seen at 15 years in the secondary VADT-F outcomes of any major diabetes outcome, (HR, 0.90; P = .16), cardiovascular death (HR, 0.94; P = .61), or death from any cause (HR 1.02; P = .81), and no differences were seen in the individual components of the composite outcomes, the investigators said.

The same was true for other outcomes, including hospitalizations and health-related quality of life, Dr. Reaven said.

Ocular events studied in the VADT-F included cataract extraction, laster photocoagulation, vitrectomy, and intravitreal injections, with the latter three constituting a retinal event composite for which there was a difference of “very borderline significance (HR, 0.84; P = .053),” said Dr. Emanuele of Hines (Ill.) VA Hospital and Loyola University of Chicago.

There was no difference between groups for cataract extraction. (HR, 1.16; P = .30) or in participants’ self reported vision at 15 years, he added.

Additional analyses showed that there were no treatment interactions for results based on baseline differences in diabetes duration, prior CV events, or risk scores.

In essence, there was no evidence of a legacy effect, Dr. Reaven said, noting that the findings are “relatively consistent” with those from other recent glucose-lowering trials, including ACCORDION and ADVANCE-ON, which also showed no legacy benefits of intensive glucose lowering.

Dr. Emanuele also concluded that no prolonged legacy effect was apparent for renal and other microvascular outcomes.

The lack of a legacy effect at 15 years, however, shouldn’t discount the benefits seen at the 10-year follow-up because there are other ways to look at “legacy,” Hertzel C. Gerstein, MD, said during an independent “clinical perspective” commentary on the VADT and VADT-F findings.

“Another way to define ‘legacy’ is what happens after the active clinical trial ends, and if you think of it that way, there is a legacy,” said Dr. Gerstein, a professor and Population Health Institute chair in diabetes research at McMaster University and Hamilton Health Sciences, Ontario, Canada.

That is, the intensive glycemic control led to significant improvements at 10-year follow-up. While he acknowledged “that’s just semantics,” he stressed that a number of important lessons have been learned from the VADT and VADT-F – not the least of which relate to mediation analyses that showed the benefit seen at 10 years can be explained, at least statistically, by the differences in HbA_1c levels achieved during those intervening 10 years of follow-up.

For example, the 10-year cardiovascular outcome hazard ratios changed from 0.83 with a P value of .04 to 0.86 with a P value of .12 (after controlling for time-varying HbA_1c levels) and to 0.94 with a P value of .53 (after controlling for time-varying cumulative mean HbA_1c), he said, noting that similar findings have been reported from prior trials.

The VADT was designed to evaluate whether an intensive glycemic control regimen could reduce the incidence of major cardiovascular events compared with standard care in patients with T2DM; secondary objectives included differences in additional cardiovascular, renal, and other outcomes.

Subjects, who were enrolled from 20 VA medical centers beginning in December 2000, were aged 41 years or older (mean of about 60 years) and had failed to respond to a maximum dose of at least one oral agent and/or daily insulin. Patients were excluded if they had HbA_1c less than 7.5%, had had a cardiovascular event in the previous 6 months, had advanced congestive heart failure, had severe angina, had a life expectancy of less than 7 years, had a body mass index over 40 kg/m², had serum creatinine less than 1.6 mg/dL, or had an alanine transaminase level greater than 3 times the upper limit of normal, according to Wyndy L. Wiitala, PhD, of the VA Center for Clinical Management Research in Ann Arbor, Michigan.

A total of 818 patients in the standard care group and 837 in the intensive treatment group completed the study with up to 7.5 years of total follow-up (median, 5.6 years). The groups were similar in age; both were mostly male, which is expected for a VA population; and the average HbA_1c level was 9.4% in both groups. Other clinical measures, including lipids, blood pressure, and estimated cardiovascular risk were also similar between the two groups.

“The VADT was designed so that the only planned difference between the treatment groups was the level of glycemic control,” Dr. Wiitala said.

All patients with a BMI of 27 kg/m² or greater were started on metformin plus rosiglitazone, and those with a BMI less than 27 kg/m² were started on glimepiride plus rosiglitazone. Those in the intensive therapy arm were started on maximal doses, and those in the standard therapy arm were started on half the maximal doses. Insulin was added for patients in the intensive-therapy group who did not achieve HbA_1c below 6%, as well as for those in the standard-therapy group with a level of less than 9%.

Any subsequent medication changes were determined according to protocol guidelines and local assessment, and investigators were allowed to use any approved drug at their discretion.

“The use of medications between the two groups was similar, with differences in dose and insulin intensity only,” Dr. Wiitala said, adding that all other aspects of treatment, including blood pressure control, lipid control, aspirin therapy, diet, and nutrition, were “nearly identical” in the two groups.



The VADT-F design

The negative findings from the VADT raised “a number of questions, which really provided the rationale for the VADT follow-up study,” Dr. Reaven said.

“Would the post-VADT follow-up reveal an emerging cardiovascular benefit? This was particularly relevant as there was an indication that the group differences were increasing toward the end of the study, and benefits in cardiovascular outcomes, as we know, take a fair amount of time,” he said, adding that since the glucose separation seen in the treatment groups was greater than that seen in other recent studies involving patients with advanced T2DM and remained that way for an extended period of time, the follow-up study provided an excellent opportunity to examine whether there was a legacy or other effects.

The VADT-F continued to follow the VADT patients after the intervention ended in 2008; at that time, patients returned to normal care with no further intervention by the research team, Dr. Wiitala said, noting that participants were followed using national data sources, annual mail surveys, and targeted chart reviews.

The 10-year interim analysis was reported in 2015, and the 15-year final analysis, which is currently under review, represents the longest follow-up of patients with advanced T2DM with high risk for cardiovascular disease, she said.

“These results suggest that there are modest long-term cardiovascular disease benefits of therapies directed toward bringing glucose control to near-normal range in high-risk type 2 diabetes and that substantial and continuous glucose separation may be required to maintain these improvements,” Dr. Reaven concluded, adding that “recent studies demonstrating cardiovascular benefit with diabetes agents that only achieve modest improvements in glycemic control highlight the importance of also considering nonglycemic approaches to reducing cardiovascular disease events and mortality in these patients.”

Similarly, Dr. Emanuele concluded that there is a delayed beneficial effect of intensive glycemic control on kidney outcomes but that the effect dissipates as glycemic separation wanes.

However, in his commentary at the meeting, Dr. Gerstein stressed that the findings add value; in addition to showing, via mediation analyses, that HbA_1c levels statistically explain the differences seen between the intensive and standard therapy arms at 10 years, the VADT and VADT-F findings also underscore the veracity of the ADA’s recommended target of HbA_1c less than 7%, albeit “with all sorts of caveats.”

“But one point to make is that clinical trials do not tell you how to treat the patient in front of you. [They] just tell you what works on average for the average patient. ... You have to take the information you get from randomized trials and put it into your brain as a doctor and treat the patient,” he said.

He and several colleagues further explained this concept in a recent editorial (Diabetes Care. 2018 Jun;41[6]:1121-4) penned in response to new guidance statements published by the American College of Physicians advocating for relaxation of HbA_1c control goals in patients with T2DM.

“The ACP proposal may encourage a step backward at a time when accumulating evidence from randomized, controlled trials calls for movement forward in the treatment of diabetes,” they wrote in the editorial entitled “A_1c targets should be personalized to maximize benefits while limiting risks.”

Findings from those trials, including the VADT and VADT-F, continue to increase diabetes insights and inform care, and while there is not yet a statin-like “prescribe-and-go” treatment for diabetes, the findings represent a step in the right direction, Dr Gerstein said.

“All you have to do is look at all the clinical trials that are happening. We’re going to get there. ... This is not the end of the end, this is the beginning of the next phase,” he said.

The VADT and VADT-F were funded by the VA Cooperative Studies Program, the ADA, and the National Institutes of Health/National Eye Institute. Medication and additional support were provided by Aventis, GlaxoSmithKline, and Novo Nordisk Pharmaceuticals, which provided funding and supplies, and by Abbott Laboratory, Amylin, Eli Lily, Kos, Roche, and the University of Chicago, which also provided supplies. Dr. Reaven is an advisory panel member for Sanofi and has received research support from AstraZeneca and Novo Nordisk. Dr. Gerstein has received grants or other research support, honoraria, and/or consulting fees from Abbott, AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Merck, Novo Nordisk, and Sanofi. Dr. Wiitala and Dr. Emanuele reported having no disclosures.

sworcester@mdedge.com

ORLANDO – Improvements in cardiovascular and renal outcomes seen after nearly 10 years of improved glucose control among participants in the Veterans Affairs Diabetes Trial (VADT) who received intensive glucose-lowering therapy dissipated by year 15, according to final results from the VADT follow-up study (VADT-F).

Participants in the randomized, controlled VADT, which compared the effects of intensive versus standard glucose control in more than 1,700 patients with type 2 diabetes mellitus (T2DM), did not experience a significant improvement in the primary cardiovascular disease (CVD) outcome – a composite of myocardial infarction, stroke, cardiovascular death, new congestive heart failure, cardiovascular surgery or inoperable coronary artery disease, and ischemic amputation – after a median of 5.6 years of active treatment (hazard ratio, 0.88; P = .14). Nor did they experience significant improvement in secondary cardiovascular outcomes, including cardiovascular death and death from any cause (HRs, 1.32 and 1.07, respectively), or in a renal composite outcome (HR, 0.85), according to the findings published in 2009 (N Engl J Med. 2009 Jan 8;360[2]:129-39).

This was despite a rapid and statistically significant separation of hemoglobin A_1c (HbA_1c) levels between the treatment groups, Peter Reaven, MD, noted during a presentation of the final follow-up data at the annual scientific sessions of the American Diabetes Association.

Approximately 6 months after the start of the VADT, median HbA_1c levels decreased from more than 9% in both groups to 6.9% and 8.4% in intensive and standard treatment groups, respectively (a median separation of 1.5%), said Dr. Reaven, director of the diabetes research program at the Phoenix VA Health Care System and a professor of clinical medicine at the University of Arizona in Phoenix.

“This was maintained throughout the study period,” he said. “All other risk factors during this period of time were equal between the two treatment groups.”
 

10-year outcomes

However, 10-year interim data from VADT-F, published in the New England Journal of Medicine (2015 Jun 4;372[23]:2197-206), showed a delayed benefit in these outcomes among those in the intensive control group: The incidence of the primary CVD composite outcome was reduced by 17% (HR, 0.83; P = .04) in favor of the intensive therapy at that time, Dr. Reaven said.

The incidence of the renal composite outcome, which included estimated glomerular filtration rate less than 54 mL/min per 1.73m², sustained macroalbuminuria, and end-stage renal disease, was reduced by 32% (HR, 0.68; P = .008), said Nicholas Emanuele, MD, who presented the VADT-F renal and microvascular outcomes at the ADA meeting.

At that 10-year follow-up, HbA_1c levels in the intensive and standard treatment groups had nearly equalized (although they remained slightly better in the intensive treatment group), and eventually, the levels stabilized at about 8.2% in both groups through the end of the 15-year follow-up, the investigators said.

“So it was still lower by nearly 1.2 hemoglobin percent units, compared to baseline values nearly 15 years earlier, and despite ending the study in very good control, after we released these patients to the primary care providers for their diabetes care, there was a substantial rise in HbA_1c levels over time ... illustrating the difficulty of controlling HbA_1c values to this level in this advanced diabetes population,” Dr. Reaven said.
 

15-year outcomes

At the final 15-year follow up, with the HbA_1c levels similar in the groups, nearly all benefits seen at 10 years were lost. Event rates for the CVD primary composite outcome were 51.8 and 47.3 per 1,000 patient-years in the intensive care and standard care groups, respectively (HR, 0.91; P = .23), and event rates for the renal composite outcome were 88 and 85 per 1,000 patient-years (HR, 0.90; P = .55).

Similarly, no differences were seen at 15 years in the secondary VADT-F outcomes of any major diabetes outcome, (HR, 0.90; P = .16), cardiovascular death (HR, 0.94; P = .61), or death from any cause (HR 1.02; P = .81), and no differences were seen in the individual components of the composite outcomes, the investigators said.

The same was true for other outcomes, including hospitalizations and health-related quality of life, Dr. Reaven said.

Ocular events studied in the VADT-F included cataract extraction, laster photocoagulation, vitrectomy, and intravitreal injections, with the latter three constituting a retinal event composite for which there was a difference of “very borderline significance (HR, 0.84; P = .053),” said Dr. Emanuele of Hines (Ill.) VA Hospital and Loyola University of Chicago.

There was no difference between groups for cataract extraction. (HR, 1.16; P = .30) or in participants’ self reported vision at 15 years, he added.

Additional analyses showed that there were no treatment interactions for results based on baseline differences in diabetes duration, prior CV events, or risk scores.

In essence, there was no evidence of a legacy effect, Dr. Reaven said, noting that the findings are “relatively consistent” with those from other recent glucose-lowering trials, including ACCORDION and ADVANCE-ON, which also showed no legacy benefits of intensive glucose lowering.

Dr. Emanuele also concluded that no prolonged legacy effect was apparent for renal and other microvascular outcomes.

The lack of a legacy effect at 15 years, however, shouldn’t discount the benefits seen at the 10-year follow-up because there are other ways to look at “legacy,” Hertzel C. Gerstein, MD, said during an independent “clinical perspective” commentary on the VADT and VADT-F findings.

“Another way to define ‘legacy’ is what happens after the active clinical trial ends, and if you think of it that way, there is a legacy,” said Dr. Gerstein, a professor and Population Health Institute chair in diabetes research at McMaster University and Hamilton Health Sciences, Ontario, Canada.

That is, the intensive glycemic control led to significant improvements at 10-year follow-up. While he acknowledged “that’s just semantics,” he stressed that a number of important lessons have been learned from the VADT and VADT-F – not the least of which relate to mediation analyses that showed the benefit seen at 10 years can be explained, at least statistically, by the differences in HbA_1c levels achieved during those intervening 10 years of follow-up.

For example, the 10-year cardiovascular outcome hazard ratios changed from 0.83 with a P value of .04 to 0.86 with a P value of .12 (after controlling for time-varying HbA_1c levels) and to 0.94 with a P value of .53 (after controlling for time-varying cumulative mean HbA_1c), he said, noting that similar findings have been reported from prior trials.

The VADT was designed to evaluate whether an intensive glycemic control regimen could reduce the incidence of major cardiovascular events compared with standard care in patients with T2DM; secondary objectives included differences in additional cardiovascular, renal, and other outcomes.

Subjects, who were enrolled from 20 VA medical centers beginning in December 2000, were aged 41 years or older (mean of about 60 years) and had failed to respond to a maximum dose of at least one oral agent and/or daily insulin. Patients were excluded if they had HbA_1c less than 7.5%, had had a cardiovascular event in the previous 6 months, had advanced congestive heart failure, had severe angina, had a life expectancy of less than 7 years, had a body mass index over 40 kg/m², had serum creatinine less than 1.6 mg/dL, or had an alanine transaminase level greater than 3 times the upper limit of normal, according to Wyndy L. Wiitala, PhD, of the VA Center for Clinical Management Research in Ann Arbor, Michigan.

A total of 818 patients in the standard care group and 837 in the intensive treatment group completed the study with up to 7.5 years of total follow-up (median, 5.6 years). The groups were similar in age; both were mostly male, which is expected for a VA population; and the average HbA_1c level was 9.4% in both groups. Other clinical measures, including lipids, blood pressure, and estimated cardiovascular risk were also similar between the two groups.

“The VADT was designed so that the only planned difference between the treatment groups was the level of glycemic control,” Dr. Wiitala said.

All patients with a BMI of 27 kg/m² or greater were started on metformin plus rosiglitazone, and those with a BMI less than 27 kg/m² were started on glimepiride plus rosiglitazone. Those in the intensive therapy arm were started on maximal doses, and those in the standard therapy arm were started on half the maximal doses. Insulin was added for patients in the intensive-therapy group who did not achieve HbA_1c below 6%, as well as for those in the standard-therapy group with a level of less than 9%.

Any subsequent medication changes were determined according to protocol guidelines and local assessment, and investigators were allowed to use any approved drug at their discretion.

“The use of medications between the two groups was similar, with differences in dose and insulin intensity only,” Dr. Wiitala said, adding that all other aspects of treatment, including blood pressure control, lipid control, aspirin therapy, diet, and nutrition, were “nearly identical” in the two groups.



The VADT-F design

The negative findings from the VADT raised “a number of questions, which really provided the rationale for the VADT follow-up study,” Dr. Reaven said.

“Would the post-VADT follow-up reveal an emerging cardiovascular benefit? This was particularly relevant as there was an indication that the group differences were increasing toward the end of the study, and benefits in cardiovascular outcomes, as we know, take a fair amount of time,” he said, adding that since the glucose separation seen in the treatment groups was greater than that seen in other recent studies involving patients with advanced T2DM and remained that way for an extended period of time, the follow-up study provided an excellent opportunity to examine whether there was a legacy or other effects.

The VADT-F continued to follow the VADT patients after the intervention ended in 2008; at that time, patients returned to normal care with no further intervention by the research team, Dr. Wiitala said, noting that participants were followed using national data sources, annual mail surveys, and targeted chart reviews.

The 10-year interim analysis was reported in 2015, and the 15-year final analysis, which is currently under review, represents the longest follow-up of patients with advanced T2DM with high risk for cardiovascular disease, she said.

“These results suggest that there are modest long-term cardiovascular disease benefits of therapies directed toward bringing glucose control to near-normal range in high-risk type 2 diabetes and that substantial and continuous glucose separation may be required to maintain these improvements,” Dr. Reaven concluded, adding that “recent studies demonstrating cardiovascular benefit with diabetes agents that only achieve modest improvements in glycemic control highlight the importance of also considering nonglycemic approaches to reducing cardiovascular disease events and mortality in these patients.”

Similarly, Dr. Emanuele concluded that there is a delayed beneficial effect of intensive glycemic control on kidney outcomes but that the effect dissipates as glycemic separation wanes.

However, in his commentary at the meeting, Dr. Gerstein stressed that the findings add value; in addition to showing, via mediation analyses, that HbA_1c levels statistically explain the differences seen between the intensive and standard therapy arms at 10 years, the VADT and VADT-F findings also underscore the veracity of the ADA’s recommended target of HbA_1c less than 7%, albeit “with all sorts of caveats.”

“But one point to make is that clinical trials do not tell you how to treat the patient in front of you. [They] just tell you what works on average for the average patient. ... You have to take the information you get from randomized trials and put it into your brain as a doctor and treat the patient,” he said.

He and several colleagues further explained this concept in a recent editorial (Diabetes Care. 2018 Jun;41[6]:1121-4) penned in response to new guidance statements published by the American College of Physicians advocating for relaxation of HbA_1c control goals in patients with T2DM.

“The ACP proposal may encourage a step backward at a time when accumulating evidence from randomized, controlled trials calls for movement forward in the treatment of diabetes,” they wrote in the editorial entitled “A_1c targets should be personalized to maximize benefits while limiting risks.”

Findings from those trials, including the VADT and VADT-F, continue to increase diabetes insights and inform care, and while there is not yet a statin-like “prescribe-and-go” treatment for diabetes, the findings represent a step in the right direction, Dr Gerstein said.

“All you have to do is look at all the clinical trials that are happening. We’re going to get there. ... This is not the end of the end, this is the beginning of the next phase,” he said.

The VADT and VADT-F were funded by the VA Cooperative Studies Program, the ADA, and the National Institutes of Health/National Eye Institute. Medication and additional support were provided by Aventis, GlaxoSmithKline, and Novo Nordisk Pharmaceuticals, which provided funding and supplies, and by Abbott Laboratory, Amylin, Eli Lily, Kos, Roche, and the University of Chicago, which also provided supplies. Dr. Reaven is an advisory panel member for Sanofi and has received research support from AstraZeneca and Novo Nordisk. Dr. Gerstein has received grants or other research support, honoraria, and/or consulting fees from Abbott, AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Merck, Novo Nordisk, and Sanofi. Dr. Wiitala and Dr. Emanuele reported having no disclosures.

sworcester@mdedge.com

ORLANDO – Improvements in cardiovascular and renal outcomes seen after nearly 10 years of improved glucose control among participants in the Veterans Affairs Diabetes Trial (VADT) who received intensive glucose-lowering therapy dissipated by year 15, according to final results from the VADT follow-up study (VADT-F).

Participants in the randomized, controlled VADT, which compared the effects of intensive versus standard glucose control in more than 1,700 patients with type 2 diabetes mellitus (T2DM), did not experience a significant improvement in the primary cardiovascular disease (CVD) outcome – a composite of myocardial infarction, stroke, cardiovascular death, new congestive heart failure, cardiovascular surgery or inoperable coronary artery disease, and ischemic amputation – after a median of 5.6 years of active treatment (hazard ratio, 0.88; P = .14). Nor did they experience significant improvement in secondary cardiovascular outcomes, including cardiovascular death and death from any cause (HRs, 1.32 and 1.07, respectively), or in a renal composite outcome (HR, 0.85), according to the findings published in 2009 (N Engl J Med. 2009 Jan 8;360[2]:129-39).

This was despite a rapid and statistically significant separation of hemoglobin A_1c (HbA_1c) levels between the treatment groups, Peter Reaven, MD, noted during a presentation of the final follow-up data at the annual scientific sessions of the American Diabetes Association.

Approximately 6 months after the start of the VADT, median HbA_1c levels decreased from more than 9% in both groups to 6.9% and 8.4% in intensive and standard treatment groups, respectively (a median separation of 1.5%), said Dr. Reaven, director of the diabetes research program at the Phoenix VA Health Care System and a professor of clinical medicine at the University of Arizona in Phoenix.

“This was maintained throughout the study period,” he said. “All other risk factors during this period of time were equal between the two treatment groups.”
 

10-year outcomes

However, 10-year interim data from VADT-F, published in the New England Journal of Medicine (2015 Jun 4;372[23]:2197-206), showed a delayed benefit in these outcomes among those in the intensive control group: The incidence of the primary CVD composite outcome was reduced by 17% (HR, 0.83; P = .04) in favor of the intensive therapy at that time, Dr. Reaven said.

The incidence of the renal composite outcome, which included estimated glomerular filtration rate less than 54 mL/min per 1.73m², sustained macroalbuminuria, and end-stage renal disease, was reduced by 32% (HR, 0.68; P = .008), said Nicholas Emanuele, MD, who presented the VADT-F renal and microvascular outcomes at the ADA meeting.

At that 10-year follow-up, HbA_1c levels in the intensive and standard treatment groups had nearly equalized (although they remained slightly better in the intensive treatment group), and eventually, the levels stabilized at about 8.2% in both groups through the end of the 15-year follow-up, the investigators said.

“So it was still lower by nearly 1.2 hemoglobin percent units, compared to baseline values nearly 15 years earlier, and despite ending the study in very good control, after we released these patients to the primary care providers for their diabetes care, there was a substantial rise in HbA_1c levels over time ... illustrating the difficulty of controlling HbA_1c values to this level in this advanced diabetes population,” Dr. Reaven said.
 

15-year outcomes

At the final 15-year follow up, with the HbA_1c levels similar in the groups, nearly all benefits seen at 10 years were lost. Event rates for the CVD primary composite outcome were 51.8 and 47.3 per 1,000 patient-years in the intensive care and standard care groups, respectively (HR, 0.91; P = .23), and event rates for the renal composite outcome were 88 and 85 per 1,000 patient-years (HR, 0.90; P = .55).

Similarly, no differences were seen at 15 years in the secondary VADT-F outcomes of any major diabetes outcome, (HR, 0.90; P = .16), cardiovascular death (HR, 0.94; P = .61), or death from any cause (HR 1.02; P = .81), and no differences were seen in the individual components of the composite outcomes, the investigators said.

The same was true for other outcomes, including hospitalizations and health-related quality of life, Dr. Reaven said.

Ocular events studied in the VADT-F included cataract extraction, laster photocoagulation, vitrectomy, and intravitreal injections, with the latter three constituting a retinal event composite for which there was a difference of “very borderline significance (HR, 0.84; P = .053),” said Dr. Emanuele of Hines (Ill.) VA Hospital and Loyola University of Chicago.

There was no difference between groups for cataract extraction. (HR, 1.16; P = .30) or in participants’ self reported vision at 15 years, he added.

Additional analyses showed that there were no treatment interactions for results based on baseline differences in diabetes duration, prior CV events, or risk scores.

In essence, there was no evidence of a legacy effect, Dr. Reaven said, noting that the findings are “relatively consistent” with those from other recent glucose-lowering trials, including ACCORDION and ADVANCE-ON, which also showed no legacy benefits of intensive glucose lowering.

Dr. Emanuele also concluded that no prolonged legacy effect was apparent for renal and other microvascular outcomes.

The lack of a legacy effect at 15 years, however, shouldn’t discount the benefits seen at the 10-year follow-up because there are other ways to look at “legacy,” Hertzel C. Gerstein, MD, said during an independent “clinical perspective” commentary on the VADT and VADT-F findings.

“Another way to define ‘legacy’ is what happens after the active clinical trial ends, and if you think of it that way, there is a legacy,” said Dr. Gerstein, a professor and Population Health Institute chair in diabetes research at McMaster University and Hamilton Health Sciences, Ontario, Canada.

That is, the intensive glycemic control led to significant improvements at 10-year follow-up. While he acknowledged “that’s just semantics,” he stressed that a number of important lessons have been learned from the VADT and VADT-F – not the least of which relate to mediation analyses that showed the benefit seen at 10 years can be explained, at least statistically, by the differences in HbA_1c levels achieved during those intervening 10 years of follow-up.

For example, the 10-year cardiovascular outcome hazard ratios changed from 0.83 with a P value of .04 to 0.86 with a P value of .12 (after controlling for time-varying HbA_1c levels) and to 0.94 with a P value of .53 (after controlling for time-varying cumulative mean HbA_1c), he said, noting that similar findings have been reported from prior trials.

The VADT was designed to evaluate whether an intensive glycemic control regimen could reduce the incidence of major cardiovascular events compared with standard care in patients with T2DM; secondary objectives included differences in additional cardiovascular, renal, and other outcomes.

Subjects, who were enrolled from 20 VA medical centers beginning in December 2000, were aged 41 years or older (mean of about 60 years) and had failed to respond to a maximum dose of at least one oral agent and/or daily insulin. Patients were excluded if they had HbA_1c less than 7.5%, had had a cardiovascular event in the previous 6 months, had advanced congestive heart failure, had severe angina, had a life expectancy of less than 7 years, had a body mass index over 40 kg/m², had serum creatinine less than 1.6 mg/dL, or had an alanine transaminase level greater than 3 times the upper limit of normal, according to Wyndy L. Wiitala, PhD, of the VA Center for Clinical Management Research in Ann Arbor, Michigan.

A total of 818 patients in the standard care group and 837 in the intensive treatment group completed the study with up to 7.5 years of total follow-up (median, 5.6 years). The groups were similar in age; both were mostly male, which is expected for a VA population; and the average HbA_1c level was 9.4% in both groups. Other clinical measures, including lipids, blood pressure, and estimated cardiovascular risk were also similar between the two groups.

“The VADT was designed so that the only planned difference between the treatment groups was the level of glycemic control,” Dr. Wiitala said.

All patients with a BMI of 27 kg/m² or greater were started on metformin plus rosiglitazone, and those with a BMI less than 27 kg/m² were started on glimepiride plus rosiglitazone. Those in the intensive therapy arm were started on maximal doses, and those in the standard therapy arm were started on half the maximal doses. Insulin was added for patients in the intensive-therapy group who did not achieve HbA_1c below 6%, as well as for those in the standard-therapy group with a level of less than 9%.

Any subsequent medication changes were determined according to protocol guidelines and local assessment, and investigators were allowed to use any approved drug at their discretion.

“The use of medications between the two groups was similar, with differences in dose and insulin intensity only,” Dr. Wiitala said, adding that all other aspects of treatment, including blood pressure control, lipid control, aspirin therapy, diet, and nutrition, were “nearly identical” in the two groups.



The VADT-F design

The negative findings from the VADT raised “a number of questions, which really provided the rationale for the VADT follow-up study,” Dr. Reaven said.

“Would the post-VADT follow-up reveal an emerging cardiovascular benefit? This was particularly relevant as there was an indication that the group differences were increasing toward the end of the study, and benefits in cardiovascular outcomes, as we know, take a fair amount of time,” he said, adding that since the glucose separation seen in the treatment groups was greater than that seen in other recent studies involving patients with advanced T2DM and remained that way for an extended period of time, the follow-up study provided an excellent opportunity to examine whether there was a legacy or other effects.

The VADT-F continued to follow the VADT patients after the intervention ended in 2008; at that time, patients returned to normal care with no further intervention by the research team, Dr. Wiitala said, noting that participants were followed using national data sources, annual mail surveys, and targeted chart reviews.

The 10-year interim analysis was reported in 2015, and the 15-year final analysis, which is currently under review, represents the longest follow-up of patients with advanced T2DM with high risk for cardiovascular disease, she said.

“These results suggest that there are modest long-term cardiovascular disease benefits of therapies directed toward bringing glucose control to near-normal range in high-risk type 2 diabetes and that substantial and continuous glucose separation may be required to maintain these improvements,” Dr. Reaven concluded, adding that “recent studies demonstrating cardiovascular benefit with diabetes agents that only achieve modest improvements in glycemic control highlight the importance of also considering nonglycemic approaches to reducing cardiovascular disease events and mortality in these patients.”

Similarly, Dr. Emanuele concluded that there is a delayed beneficial effect of intensive glycemic control on kidney outcomes but that the effect dissipates as glycemic separation wanes.

However, in his commentary at the meeting, Dr. Gerstein stressed that the findings add value; in addition to showing, via mediation analyses, that HbA_1c levels statistically explain the differences seen between the intensive and standard therapy arms at 10 years, the VADT and VADT-F findings also underscore the veracity of the ADA’s recommended target of HbA_1c less than 7%, albeit “with all sorts of caveats.”

“But one point to make is that clinical trials do not tell you how to treat the patient in front of you. [They] just tell you what works on average for the average patient. ... You have to take the information you get from randomized trials and put it into your brain as a doctor and treat the patient,” he said.

He and several colleagues further explained this concept in a recent editorial (Diabetes Care. 2018 Jun;41[6]:1121-4) penned in response to new guidance statements published by the American College of Physicians advocating for relaxation of HbA_1c control goals in patients with T2DM.

“The ACP proposal may encourage a step backward at a time when accumulating evidence from randomized, controlled trials calls for movement forward in the treatment of diabetes,” they wrote in the editorial entitled “A_1c targets should be personalized to maximize benefits while limiting risks.”

Findings from those trials, including the VADT and VADT-F, continue to increase diabetes insights and inform care, and while there is not yet a statin-like “prescribe-and-go” treatment for diabetes, the findings represent a step in the right direction, Dr Gerstein said.

“All you have to do is look at all the clinical trials that are happening. We’re going to get there. ... This is not the end of the end, this is the beginning of the next phase,” he said.

The VADT and VADT-F were funded by the VA Cooperative Studies Program, the ADA, and the National Institutes of Health/National Eye Institute. Medication and additional support were provided by Aventis, GlaxoSmithKline, and Novo Nordisk Pharmaceuticals, which provided funding and supplies, and by Abbott Laboratory, Amylin, Eli Lily, Kos, Roche, and the University of Chicago, which also provided supplies. Dr. Reaven is an advisory panel member for Sanofi and has received research support from AstraZeneca and Novo Nordisk. Dr. Gerstein has received grants or other research support, honoraria, and/or consulting fees from Abbott, AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Merck, Novo Nordisk, and Sanofi. Dr. Wiitala and Dr. Emanuele reported having no disclosures.

sworcester@mdedge.com

Patients with comorbid fibromyalgia and migraine report more depressive symptoms, higher headache intensity, and are more likely to have severe headache-related disability as compared to controls without fibromyalgia, according to a recent study. Cases of comorbid fibromyalgia and migraine were identified using a prospectively maintained headache database at Mayo Clinic Rochester. Depressive symptoms as assessed by Patient Health Questionnaire (PHQ)-9, intensity of headache, and migraine-related disability as assessed by Migraine Disability Assessment (MIDAS) were primary measures used to compare migraine patients with comorbid fibromyalgia vs those without. One hundred and fifty-seven cases and 471 controls were identified. Researchers found:

• Patients with comorbid fibromyalgia reported significantly higher PHQ-9 scores (OR 1.08) and headache intensity scores (odds ratio [OR] 1.149).
• There was no significant difference in migraine-related disability (OR 1.002).
• Patients with fibromyalgia were more likely to score in a higher category of depression severity (OR 1.467) and more likely to score in a higher category of migraine-related disability (OR 1.23).

Whealy M, Nanda S, Vincent A, Mandrekar J, Cutrer FM. Fibromyalgia in migraine: A retrospective cohort study. J Headache Pain. 2018;19(1):61. doi:10.1186/s10194-018-0892-9.

Patients with comorbid fibromyalgia and migraine report more depressive symptoms, higher headache intensity, and are more likely to have severe headache-related disability as compared to controls without fibromyalgia, according to a recent study. Cases of comorbid fibromyalgia and migraine were identified using a prospectively maintained headache database at Mayo Clinic Rochester. Depressive symptoms as assessed by Patient Health Questionnaire (PHQ)-9, intensity of headache, and migraine-related disability as assessed by Migraine Disability Assessment (MIDAS) were primary measures used to compare migraine patients with comorbid fibromyalgia vs those without. One hundred and fifty-seven cases and 471 controls were identified. Researchers found:

• Patients with comorbid fibromyalgia reported significantly higher PHQ-9 scores (OR 1.08) and headache intensity scores (odds ratio [OR] 1.149).
• There was no significant difference in migraine-related disability (OR 1.002).
• Patients with fibromyalgia were more likely to score in a higher category of depression severity (OR 1.467) and more likely to score in a higher category of migraine-related disability (OR 1.23).

Whealy M, Nanda S, Vincent A, Mandrekar J, Cutrer FM. Fibromyalgia in migraine: A retrospective cohort study. J Headache Pain. 2018;19(1):61. doi:10.1186/s10194-018-0892-9.

Patients with comorbid fibromyalgia and migraine report more depressive symptoms, higher headache intensity, and are more likely to have severe headache-related disability as compared to controls without fibromyalgia, according to a recent study. Cases of comorbid fibromyalgia and migraine were identified using a prospectively maintained headache database at Mayo Clinic Rochester. Depressive symptoms as assessed by Patient Health Questionnaire (PHQ)-9, intensity of headache, and migraine-related disability as assessed by Migraine Disability Assessment (MIDAS) were primary measures used to compare migraine patients with comorbid fibromyalgia vs those without. One hundred and fifty-seven cases and 471 controls were identified. Researchers found:

• Patients with comorbid fibromyalgia reported significantly higher PHQ-9 scores (OR 1.08) and headache intensity scores (odds ratio [OR] 1.149).
• There was no significant difference in migraine-related disability (OR 1.002).
• Patients with fibromyalgia were more likely to score in a higher category of depression severity (OR 1.467) and more likely to score in a higher category of migraine-related disability (OR 1.23).

Whealy M, Nanda S, Vincent A, Mandrekar J, Cutrer FM. Fibromyalgia in migraine: A retrospective cohort study. J Headache Pain. 2018;19(1):61. doi:10.1186/s10194-018-0892-9.

When sitting through interminable meetings, endless reports, and unfocused discussions, I often feel a building pressure in my head that, if it continues, will surely result in my brain exploding. I used to carry in my pocket an elastic compression bandage, intending to wrap it around my head as a signal to the offending speakers, but never had the heart to use it. Still, that bandage in my pocket was the backup resource that gave me solace, gave me patience.

Yet, my emergency bandage was nowhere to be found while I was reading the 2019 Medicare proposed rule, which unexpectedly triggered the threat of a brain explosion.

I was prepared for the usual proposed rule of about 1,500 pages of dense, bureaucratic “Engfish,” proposing a cut here, a tuck there, an occasional evisceration, and several correctable errors. This time, though, the proposed rule is wide open, disruptive, uninformed, and disappointing to almost all medical practitioners.

For dermatology, it starts out promisingly, by collapsing the evaluation and management (E/M) codes into two levels, instead of five. That should benefit us slightly, because our coding usually falls at about level three. Also, it would simplify record keeping by only requiring level two documentation and not making docs repeatedly reenter data. Well, OK so far.

Keep reading, though, and then the hammer falls: a proposed 50% reduction in reimbursement for any procedure performed on the same day as the E/M code. What?! Implementation of this change would result in an estimated 20% reduction in reimbursement for dermatologists who, as a courtesy to their patients, do procedures on the same day as an evaluation visit. And this proposed change would likely hurt ophthalmologists, otolaryngologists, and even primary care physicians who do same-day procedures.

There are new extended-care codes that only primary care docs could use, and some other extended care codes for specialists (dermatology is not mentioned) that pay about $5 extra. There is a bone thrown to telemedicine, since telemedicine coverage is supported, including “store and forward,” but not if the patient is seen in person within a week, “or at the soonest available appointment.” Very strange.

The current reimbursement system is a carefully honed, carefully balanced, work of reasonable rational thought by the current procedural terminology committee, the American Medical Association’s RVS Update Committee (RUC) and the Centers for Medicare & Medicaid Services. CMS officials sit at the table at all these meetings, frequently comment, and the agency has the power of final approval. No one loves the final product, particularly the participants, but there are procedures and rules, an appeals process, and the process allows for a rough form of justice administered by your medical peers. Who better to decide what is fair to pay anyone out of a fixed reimbursement pool?

Unfortunately, there seems to be no institutional memory in this year’s final rule. For example, since it came out, various branches of organized medicine have held urgent meetings at which it was pointed out that a 50% reduction in procedures on the same day as an evaluation and management code is inappropriate, since the overlapping work and practice expense already had been removed for such codes by the relative value update committee. This observation reportedly came as a surprise to the CMS attendees – a most disturbing admission.

There was also discouraging news about the global period survey. Dermatology reported only 3% of the global visits possible.

It turns out that CMS did not look for additional 99024 visits beyond the 10- or 90-day global period in the surveyed states and did not look at practices of fewer than 10 dermatologists, even if they did report. Think about it, how many dermatology groups do you know of 10 or more dermatologists in Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island? How often do you delay suture removal beyond 10 days? How many times do you see a patient back for a triamcinolone injection or reassurance at no charge more than 10 days after procedures? Talk about a flawed process destined to fail!

The loss of global periods will hurt much, much more than the 50% cut in procedures on the same day as an E/M code. The premalignant and benign destruction codes could be cut by 75% – and good luck in charging for suture removal after surgery. We are talking about another 20% reimbursement cut if implemented.

The American Academy of Dermatology and other dermatology societies are actively involved in responding to the CMS regarding the shortcomings of the proposed rule. Be prepared to be called upon to submit your comments to CMS soon. I am hopeful that much of these misguided proposals can be corrected, but it will take a concerted effort of numerous individual dermatologists, including you.

Finally, I advise you to read the final rule for yourself. And, unlike me, do not forget to keep your emergency wrap handy!

Comments will be taken at www.regulations.gov through Sept. 10, 2018.

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

When sitting through interminable meetings, endless reports, and unfocused discussions, I often feel a building pressure in my head that, if it continues, will surely result in my brain exploding. I used to carry in my pocket an elastic compression bandage, intending to wrap it around my head as a signal to the offending speakers, but never had the heart to use it. Still, that bandage in my pocket was the backup resource that gave me solace, gave me patience.

Yet, my emergency bandage was nowhere to be found while I was reading the 2019 Medicare proposed rule, which unexpectedly triggered the threat of a brain explosion.

I was prepared for the usual proposed rule of about 1,500 pages of dense, bureaucratic “Engfish,” proposing a cut here, a tuck there, an occasional evisceration, and several correctable errors. This time, though, the proposed rule is wide open, disruptive, uninformed, and disappointing to almost all medical practitioners.

For dermatology, it starts out promisingly, by collapsing the evaluation and management (E/M) codes into two levels, instead of five. That should benefit us slightly, because our coding usually falls at about level three. Also, it would simplify record keeping by only requiring level two documentation and not making docs repeatedly reenter data. Well, OK so far.

Keep reading, though, and then the hammer falls: a proposed 50% reduction in reimbursement for any procedure performed on the same day as the E/M code. What?! Implementation of this change would result in an estimated 20% reduction in reimbursement for dermatologists who, as a courtesy to their patients, do procedures on the same day as an evaluation visit. And this proposed change would likely hurt ophthalmologists, otolaryngologists, and even primary care physicians who do same-day procedures.

There are new extended-care codes that only primary care docs could use, and some other extended care codes for specialists (dermatology is not mentioned) that pay about $5 extra. There is a bone thrown to telemedicine, since telemedicine coverage is supported, including “store and forward,” but not if the patient is seen in person within a week, “or at the soonest available appointment.” Very strange.

The current reimbursement system is a carefully honed, carefully balanced, work of reasonable rational thought by the current procedural terminology committee, the American Medical Association’s RVS Update Committee (RUC) and the Centers for Medicare & Medicaid Services. CMS officials sit at the table at all these meetings, frequently comment, and the agency has the power of final approval. No one loves the final product, particularly the participants, but there are procedures and rules, an appeals process, and the process allows for a rough form of justice administered by your medical peers. Who better to decide what is fair to pay anyone out of a fixed reimbursement pool?

Unfortunately, there seems to be no institutional memory in this year’s final rule. For example, since it came out, various branches of organized medicine have held urgent meetings at which it was pointed out that a 50% reduction in procedures on the same day as an evaluation and management code is inappropriate, since the overlapping work and practice expense already had been removed for such codes by the relative value update committee. This observation reportedly came as a surprise to the CMS attendees – a most disturbing admission.

There was also discouraging news about the global period survey. Dermatology reported only 3% of the global visits possible.

It turns out that CMS did not look for additional 99024 visits beyond the 10- or 90-day global period in the surveyed states and did not look at practices of fewer than 10 dermatologists, even if they did report. Think about it, how many dermatology groups do you know of 10 or more dermatologists in Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island? How often do you delay suture removal beyond 10 days? How many times do you see a patient back for a triamcinolone injection or reassurance at no charge more than 10 days after procedures? Talk about a flawed process destined to fail!

The loss of global periods will hurt much, much more than the 50% cut in procedures on the same day as an E/M code. The premalignant and benign destruction codes could be cut by 75% – and good luck in charging for suture removal after surgery. We are talking about another 20% reimbursement cut if implemented.

The American Academy of Dermatology and other dermatology societies are actively involved in responding to the CMS regarding the shortcomings of the proposed rule. Be prepared to be called upon to submit your comments to CMS soon. I am hopeful that much of these misguided proposals can be corrected, but it will take a concerted effort of numerous individual dermatologists, including you.

Finally, I advise you to read the final rule for yourself. And, unlike me, do not forget to keep your emergency wrap handy!

Comments will be taken at www.regulations.gov through Sept. 10, 2018.

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

When sitting through interminable meetings, endless reports, and unfocused discussions, I often feel a building pressure in my head that, if it continues, will surely result in my brain exploding. I used to carry in my pocket an elastic compression bandage, intending to wrap it around my head as a signal to the offending speakers, but never had the heart to use it. Still, that bandage in my pocket was the backup resource that gave me solace, gave me patience.

Yet, my emergency bandage was nowhere to be found while I was reading the 2019 Medicare proposed rule, which unexpectedly triggered the threat of a brain explosion.

I was prepared for the usual proposed rule of about 1,500 pages of dense, bureaucratic “Engfish,” proposing a cut here, a tuck there, an occasional evisceration, and several correctable errors. This time, though, the proposed rule is wide open, disruptive, uninformed, and disappointing to almost all medical practitioners.

For dermatology, it starts out promisingly, by collapsing the evaluation and management (E/M) codes into two levels, instead of five. That should benefit us slightly, because our coding usually falls at about level three. Also, it would simplify record keeping by only requiring level two documentation and not making docs repeatedly reenter data. Well, OK so far.

Keep reading, though, and then the hammer falls: a proposed 50% reduction in reimbursement for any procedure performed on the same day as the E/M code. What?! Implementation of this change would result in an estimated 20% reduction in reimbursement for dermatologists who, as a courtesy to their patients, do procedures on the same day as an evaluation visit. And this proposed change would likely hurt ophthalmologists, otolaryngologists, and even primary care physicians who do same-day procedures.

There are new extended-care codes that only primary care docs could use, and some other extended care codes for specialists (dermatology is not mentioned) that pay about $5 extra. There is a bone thrown to telemedicine, since telemedicine coverage is supported, including “store and forward,” but not if the patient is seen in person within a week, “or at the soonest available appointment.” Very strange.

The current reimbursement system is a carefully honed, carefully balanced, work of reasonable rational thought by the current procedural terminology committee, the American Medical Association’s RVS Update Committee (RUC) and the Centers for Medicare & Medicaid Services. CMS officials sit at the table at all these meetings, frequently comment, and the agency has the power of final approval. No one loves the final product, particularly the participants, but there are procedures and rules, an appeals process, and the process allows for a rough form of justice administered by your medical peers. Who better to decide what is fair to pay anyone out of a fixed reimbursement pool?

Unfortunately, there seems to be no institutional memory in this year’s final rule. For example, since it came out, various branches of organized medicine have held urgent meetings at which it was pointed out that a 50% reduction in procedures on the same day as an evaluation and management code is inappropriate, since the overlapping work and practice expense already had been removed for such codes by the relative value update committee. This observation reportedly came as a surprise to the CMS attendees – a most disturbing admission.

There was also discouraging news about the global period survey. Dermatology reported only 3% of the global visits possible.

It turns out that CMS did not look for additional 99024 visits beyond the 10- or 90-day global period in the surveyed states and did not look at practices of fewer than 10 dermatologists, even if they did report. Think about it, how many dermatology groups do you know of 10 or more dermatologists in Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island? How often do you delay suture removal beyond 10 days? How many times do you see a patient back for a triamcinolone injection or reassurance at no charge more than 10 days after procedures? Talk about a flawed process destined to fail!

The loss of global periods will hurt much, much more than the 50% cut in procedures on the same day as an E/M code. The premalignant and benign destruction codes could be cut by 75% – and good luck in charging for suture removal after surgery. We are talking about another 20% reimbursement cut if implemented.

The American Academy of Dermatology and other dermatology societies are actively involved in responding to the CMS regarding the shortcomings of the proposed rule. Be prepared to be called upon to submit your comments to CMS soon. I am hopeful that much of these misguided proposals can be corrected, but it will take a concerted effort of numerous individual dermatologists, including you.

Finally, I advise you to read the final rule for yourself. And, unlike me, do not forget to keep your emergency wrap handy!

Comments will be taken at www.regulations.gov through Sept. 10, 2018.

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