The emotionally exhausted physician

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The emotionally exhausted physician

CASE ‘I’m stuck’

Dr. D, age 48, an internist practicing general medicine who is a married mother of 2 teenagers, presents with emotional exhaustion. Her medical history is unremarkable other than hyperlipidemia controlled by diet. She describes an episode of reactive depressive symptoms and anxiety when in college, which was related to the stress of final exams, finances, and the dissolution of a long-standing relationship. Regardless, she functioned well and graduated summa cum laude. She says her current feelings of being “stuck” have gradually increased during the past 3 to 4 years. Although she describes being mildly anxious and dysphoric, she also said she feels like her “wheels are spinning” and that she doesn’t even seem to care. Dr. D had been a high achiever, yet says she feels like she isn’t getting anywhere at work or at home.

[polldaddy:10064977]

The authors’ observations

As psychiatrists in the business of diagnosis and treatment, we immediately considered common diagnoses, such as major depressive disorder and persistent depressive disorder. However, despite our training in pathology, we believe patients should be considered well until proven sick. This paradigm shift is in line with the definition of mental health per the World Health Organization: “A state of well-being in which every individual realizes his or her own potential, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to her or his community.”1

In Dr. D’s case, there was not enough information yet to fully support any of the diagnoses. She did not exhibit enough depressive symptoms to support a diagnosis of a depressive disorder. She said that she didn’t feel like she was getting anywhere at work or home. Yet there was no objective information that suggested impairment in functioning, which would preclude a diagnosis of adjustment disorder. At this point, we would support the “V code” diagnosis of phase of life problem, or even what is rarely seen in a psychiatric evaluation: “no diagnosis.”

EVALUATION Is work the problem?

We diligently conduct a thorough review of systems with Dr. D and confirm there is not enough information to diagnose a depressive disorder, anxiety disorder, or other psychiatric disorder. Collateral history suggests her teenagers are well-adjusted and doing well in high school, and she is well-respected at work with reportedly excellent performance ratings. We identify strongly with her and her situation.

Dr. D admits she is an idealist and half-jokingly says she entered into medicine “to save the world.” Yet she laments the long hours and finding herself mired in paperwork. She is barely making it to her kids’ school events and says she can’t believe her first child will be graduating within a year. She has had some particularly challenging patients recently, and although she is still diligent about their care, she is shocked she doesn’t seem to care as much about “solving the medical puzzle.” This came to light for her when a longtime patient observed that Dr. D didn’t seem herself and asked, “Are you all right, Doc?”

Dr. D is professionally dressed and has excellent grooming and hygiene. She looks tired, yet has a full affect, a witty conversational style, and responds appropriately to humor.

[polldaddy:10064980]

The authors’ observations

It can be difficult to know what to do next when there isn’t an established “playbook” for a problem without a diagnosis. We realized Dr. D was describing burnout, a syndrome of depersonalization (detached and not caring, to the point of viewing people as objects), emotional exhaustion, and low personal accomplishment that leads to decreased effectiveness at work.2 DSM-5 does not include “burnout” as a diagnosis3; however, if symptoms evolve to the point where they affect occupational or social functioning, burnout can be similar to adjustment disorder. Treatment with an antidepressant medication is not appropriate. It is possible that CBT might be helpful for many patients, yet there is no evidence that Dr. D has any cognitive distortions. Although we already had some collateral information, it is never wrong to gather additional collateral. However, because burnout is common, we may not need additional information. We could reassure her and send her on her way, but we want to add therapeutic value. We advocated exploring issues in her life and work related to meaning.

Continue to: Physician burnout

 

 

Physician burnout

Burnout is an alarmingly common problem among physicians that affects approximately half of psychiatrists. In 2014, 54.4% of physicians, and slightly less than 50% of psychiatrists, had at least 1 symptom of burnout.4 This was up from the 45.5% of physicians and a little more than 40% of psychiatrists who reported burnout in 2011,4 which suggests that as medicine continues to change, doctors may increasingly feel the brunt of this change. The rate of burnout is highest in front-line specialties (family medicine, general internal medicine, and emergency medicine) and lowest in preventive medicine.5 Physician burnout leads to real-world occupational issues, such as medical errors, poor relationships with coworkers and patients, decreased patient satisfaction, and medical malpractice suits.6,7

Even though burnout is clearly a concern for our colleagues, don’t expect them to proactively line up outside our offices. In a survey of 7,197 surgeons, 86.6% of respondents answered it was not important that “I have regular meetings with a psychologist/psychiatrist to discuss stress.”8 At the same time, the idea of meeting with a psychologist/psychiatrist was rated more highly by surgeons who were burnt out and found to be a factor independently associated with burnout.8 Perhaps we have some work to do in marketing our services in a way that welcomes our colleagues.

Although physician burnout has been a focus of recent studies, burnout in general has been studied for decades in other working populations. There are 2 useful models describing burnout:

  • The job demand-control(-support) model suggests that individuals experience strain and subsequent ill effects when the demands of their job exceed the control they have,9 and social support from supervisors and colleagues can buffer the harmful effects of job strain.10
  • The effort-reward imbalance model suggests that high-effort, low-reward occupational conditions are particularly stressful.11

Both models are simple, intuitive, and suggest solutions.

When engaging your physician colleagues about their burnout, remember that physicians are people, too, and have the same difficulties that everyone else does in successfully practicing healthy behaviors. As physicians, we have significant demands on our time that make it difficult to control our ability to eat, sleep, and exercise. In general, the food available where we work is not nutritious,12 half of us are overweight or obese,13 and working more than 40 hours per week increases the likelihood we’ll have a higher body mass index.14 We don’t sleep well, either—we get less sleep than the general population,15 and more sleep equates to less burnout.16 Regarding exercise, doctors who cannot prioritize exercise tend to have more burnout.17

Continue to: When evaluating a physician colleague for symptoms of burnout...

 

 

When evaluating a physician colleague for symptoms of burnout, start by assessing the basics: eating, sleeping, and moving. In Dr. D’s case, this also included taking a quick inventory of what demands were on her proverbial plate. Taking inventory of these demands (ie, demand-control[-support] model) may lead to new insights about what she can control. Prioritization is important to determine where efforts go (ie, effort-reward imbalance model). This is where your skills as a psychiatrist can especially help, as you explore values and bring trade-offs to light.

EVALUATION Permission not to be perfect

As we interview Dr. D, we realize she has some obsessive-compulsive personality traits that are mostly self-serving. She places a high value on being thorough and having elegant clinical notes. Yet this value competes with her desire to be efficient and get home on time to see her kids’ school events. You point this out to her and see if she can come up with some solutions. You also discuss with Dr. D the tension everyone feels between valuing career and valuing family and friends. You normalize her situation, and give her permission to pick something about which she will allow herself not to be perfect.

[polldaddy:10064981]

The authors’ observations

Since perfectionism is a common trait among physicians,18 failure doesn’t seem to be compatible with their DNA. We encourage other physicians to be scientific about their own lives, just as they are in the profession they have chosen. Physicians can delude themselves into thinking they can have it all, not recognizing that every choice has its cost. For example, a physician who decides that it’s okay to publish one fewer research paper this year might have more time to enjoy spending time with his or her children. In our work with physicians, we strive to normalize their experiences, helping them reframe their perfectionistic viewpoint to recognize that everyone struggles with work-life balance issues. We validate that physicians have difficult choices to make in finding what works for them, and we challenge and support them in exploring these choices.

Choosing where to put one’s efforts is also contingent upon the expected rewards. Sometime before the daily grind of our careers in medicine started, we had strong visions of what such careers would mean to us. We visualized the ideal of helping people and making a difference. Then, at some point, many of us took this for granted and forgot about the intrinsic rewards of our work. In a 2014-2015 survey of U.S. physicians across all specialties, only 64.6% of respondents who were highly burned out said they found their work personally rewarding. This is a sharp contrast to the 97.5% of respondents who were not burned out who reported that they found their work personally rewarding.19

As psychiatrists, we can challenge our physician colleagues to dare to dream again. We can help them rediscover the rewarding aspects of their work (ie, per effort-reward imbalance model) that drew them into medicine in the first place. This may include exploring their future legacy. How do they want to be remembered at retirement? Such consideration is linked to mental simulation and meaning in their lives.20 We guide our colleagues to reframe their current situation to see the myriad of choices they have based upon their own specific value system. If family and friends are currently taking priority over work, it also helps to reframe that working allows us to make a good living so we can fully enjoy that time spent with family and friends.

Continue to: If we do our jobs well...

 

 

If we do our jobs well, the next part is easy. We have them set specific short- and long-term goals related to their situation. This is something we do every day in our practices. It may help to make sure we’re using SMART (Specific, Measurable, Achievable, Relevant, Time-Bound), a well-known mnemonic used for goals (Table 121), and brush up on our motivational interviewing skills (see Related Resources). It is especially important to make sure our colleagues have goals that are relevant—the “R” in the SMART mnemonic—to their situation.

SMART Goals

Finally, we do a better job of reaching our goals and engaging more at work and at home when we have good social support. For physicians, co-worker support has been found to be directly related to our well-being as well as buffering the negative effects of work demands.22 Furthermore, our colleagues are the most acceptable sources of support when we are faced with stressful situations.23 Thus, as psychiatrists, we can doubly help our physician patients by providing collegial support and doing our usual job of holding them accountable to their goals (Table 2).

Considerations in helping physicians combat burnout

OUTCOME Goal-setting, priorities, accountability

As we’re exploring goals with Dr. D, she makes a conscious decision to spend less time on documentation and start focusing on being present with her patients. She returns in 1 month to tell you time management is still a struggle, but her visit with you was instrumental in making her realize how important it was to get home on time for her kids’ activities. She says it greatly helped that you kept her accountable, yet also validated her struggles and gave her permission to design her life within the constraints of her situation and without the burden of having to be perfect at everything.

Bottom Line

We can best help our physician colleagues who are experiencing burnout by shifting our paradigm to a wellness model that focuses on helping them reach their potential and balance their professional and personal lives.

Related Resources

  • Balch CM, Shanafelt TD. Combating stress and burnout in surgical practice: a review. Thorac Surg Clin. 2011;21(3):417-430.
  • Miller WR, Rollnick S. Motivational interviewing: preparing people for change, 2nd ed. New York, NY: The Guilford Press; 2002.
  • Stanford Medicine WellMD. Stress & Burnout. https://wellmd.stanford.edu.
References

1. World Health Organization. Mental health: a state of well-being. http://www.who.int/features/factfiles/mental_health/en/. Updated August 2014. Accessed March 17, 2017.
2. Maslach C, Jackson S, Leiter M. Maslach burnout inventory manual, 3rd ed. Palo Alto, CA: Consulting Psychologists Press; 1996.
3. Diagnostic and statistical manual of mental disorders, 5th ed. Washington, DC: American Psychiatric Association; 2013.
4. Shanafelt TD, Hasan O, Dyrbye LN, et al. Changes in burnout and satisfaction with work-life balance in physicians and the general US working population between 2011 and 2014. Mayo Clin Proc. 2015;90(12):1600-1613.
5. Shanafelt TD, Boone S, Tan L, et al. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012;172(18):1377-1385.
6. Shanafelt TD, Sloan JA, Habermann TM. The well-being of physicians. Am J Med. 2003;114(6):513-519.
7. Balch CM, Shanafelt TD. Combating stress and burnout in surgical practice: a review. Adv Surg. 2010;44:29-47.
8. Shanafelt TD, Oreskovich MR, Dyrbye LN, et al. Avoiding burnout: the personal health habits and wellness practices of US Surgeons. Ann Surg. 2012;255(4):625-633.
9. Karasek RA Jr. Job demands, job decision latitude, and mental strain: implications for job redesign. Adm Sci Q. 1979;24(2):285-308.
10. Johnson JV. Collective control: strategies for survival in the workplace. Int J Health Serv. 1989;19(3):469-480.
11. Siegrist J. Adverse health effects of high-effort/low-reward conditions. J Occup Health Psychol. 1996;1(1):27-41.
12. Lesser LI, Cohen DA, Brook RH. Changing eating habits for the medical profession. JAMA. 2012;308(10):983-984.
13. Bleich SN, Bennett WL, Gudzune KA, et al. Impact of physician BMI on obesity care and beliefs. Obesity (Silver Spring). 2012;20(5):999-1005.
14. Stanford FC, Durkin MW, Blair SN, et al. Determining levels of physical activity in attending physicians, resident and fellow physicians, and medical students in the USA. Br J Sports Med. 2012;46(5):360-364.
15. Tucker P, Bejerot E, Kecklund G, et al. Stress Research Institute at Stockholm University. Stress Research Report-doctors’ work hours in Sweden: their impact on sleep, health, work-family balance, patient care and thoughts about work. https://www.stressforskning.su.se/polopoly_fs/1.233341.1429526778!/menu/standard/file/sfr325.pdf. Accessed March 17, 2017.
16. Wisetborisut A, Angkurawaranon C, Jiraporncharoen W, et al. Shift work and burnout among health care workers. Occup Med (Lond). 2014;64(4):279-286.
17. Eckleberry-Hunt J, Lick D, Boura J, et al. An exploratory study of resident burnout and wellness. Acad Med. 2009;84(2):269-277.
18. Peters M, King J. Perfectionism in doctors. BMJ. 2012;344:e1674. doi: https://doi.org/10.1136/bmj.e1674.
19. Jager AJ, Tutty MA, Kao AC. Association between physician burnout and identification with medicine as a calling. Mayo Clin Proc. 2017;92(3):415-422.
20. Waytz A, Hershfield HE, Tamir DI. Neural and behavioral evidence for the role of mental simulation in meaning in life. J Pers Soc Psychol. 2015;108(2):336-355.
21. SMART Criteria. https://en.wikipedia.org/wiki/SMART_criteria. Accessed March 17, 2017.
22. Hu YY, Fix ML, Hevelone ND, et al. Physicians’ needs in coping with emotional stressors: the case for peer support. Arch Surg. 2012;147(3):212-217.
23. Wallace JE, Lemaire J. On physician well being–you’ll get by with a little help from your friends. Soc Sci Med. 2007;64(12):2565-2577.

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Dr. Couser is Medical Director, Employee Assistance Program, Mayo Clinic Physician Health Center, and Assistant Professor of Medicine and Psychiatry, Mayo Clinic, Rochester, Minnesota. Dr. Melin is Medical Director, Emergency Psychiatry, and Assistant Professor of Psychiatry, Mayo Clinic, Rochester, Minnesota.

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The authors report no financial relationships with any company whose products are mentioned in this article, or with manufacturers of competing products.

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Dr. Couser is Medical Director, Employee Assistance Program, Mayo Clinic Physician Health Center, and Assistant Professor of Medicine and Psychiatry, Mayo Clinic, Rochester, Minnesota. Dr. Melin is Medical Director, Emergency Psychiatry, and Assistant Professor of Psychiatry, Mayo Clinic, Rochester, Minnesota.

Disclosures
The authors report no financial relationships with any company whose products are mentioned in this article, or with manufacturers of competing products.

Author and Disclosure Information

Dr. Couser is Medical Director, Employee Assistance Program, Mayo Clinic Physician Health Center, and Assistant Professor of Medicine and Psychiatry, Mayo Clinic, Rochester, Minnesota. Dr. Melin is Medical Director, Emergency Psychiatry, and Assistant Professor of Psychiatry, Mayo Clinic, Rochester, Minnesota.

Disclosures
The authors report no financial relationships with any company whose products are mentioned in this article, or with manufacturers of competing products.

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CASE ‘I’m stuck’

Dr. D, age 48, an internist practicing general medicine who is a married mother of 2 teenagers, presents with emotional exhaustion. Her medical history is unremarkable other than hyperlipidemia controlled by diet. She describes an episode of reactive depressive symptoms and anxiety when in college, which was related to the stress of final exams, finances, and the dissolution of a long-standing relationship. Regardless, she functioned well and graduated summa cum laude. She says her current feelings of being “stuck” have gradually increased during the past 3 to 4 years. Although she describes being mildly anxious and dysphoric, she also said she feels like her “wheels are spinning” and that she doesn’t even seem to care. Dr. D had been a high achiever, yet says she feels like she isn’t getting anywhere at work or at home.

[polldaddy:10064977]

The authors’ observations

As psychiatrists in the business of diagnosis and treatment, we immediately considered common diagnoses, such as major depressive disorder and persistent depressive disorder. However, despite our training in pathology, we believe patients should be considered well until proven sick. This paradigm shift is in line with the definition of mental health per the World Health Organization: “A state of well-being in which every individual realizes his or her own potential, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to her or his community.”1

In Dr. D’s case, there was not enough information yet to fully support any of the diagnoses. She did not exhibit enough depressive symptoms to support a diagnosis of a depressive disorder. She said that she didn’t feel like she was getting anywhere at work or home. Yet there was no objective information that suggested impairment in functioning, which would preclude a diagnosis of adjustment disorder. At this point, we would support the “V code” diagnosis of phase of life problem, or even what is rarely seen in a psychiatric evaluation: “no diagnosis.”

EVALUATION Is work the problem?

We diligently conduct a thorough review of systems with Dr. D and confirm there is not enough information to diagnose a depressive disorder, anxiety disorder, or other psychiatric disorder. Collateral history suggests her teenagers are well-adjusted and doing well in high school, and she is well-respected at work with reportedly excellent performance ratings. We identify strongly with her and her situation.

Dr. D admits she is an idealist and half-jokingly says she entered into medicine “to save the world.” Yet she laments the long hours and finding herself mired in paperwork. She is barely making it to her kids’ school events and says she can’t believe her first child will be graduating within a year. She has had some particularly challenging patients recently, and although she is still diligent about their care, she is shocked she doesn’t seem to care as much about “solving the medical puzzle.” This came to light for her when a longtime patient observed that Dr. D didn’t seem herself and asked, “Are you all right, Doc?”

Dr. D is professionally dressed and has excellent grooming and hygiene. She looks tired, yet has a full affect, a witty conversational style, and responds appropriately to humor.

[polldaddy:10064980]

The authors’ observations

It can be difficult to know what to do next when there isn’t an established “playbook” for a problem without a diagnosis. We realized Dr. D was describing burnout, a syndrome of depersonalization (detached and not caring, to the point of viewing people as objects), emotional exhaustion, and low personal accomplishment that leads to decreased effectiveness at work.2 DSM-5 does not include “burnout” as a diagnosis3; however, if symptoms evolve to the point where they affect occupational or social functioning, burnout can be similar to adjustment disorder. Treatment with an antidepressant medication is not appropriate. It is possible that CBT might be helpful for many patients, yet there is no evidence that Dr. D has any cognitive distortions. Although we already had some collateral information, it is never wrong to gather additional collateral. However, because burnout is common, we may not need additional information. We could reassure her and send her on her way, but we want to add therapeutic value. We advocated exploring issues in her life and work related to meaning.

Continue to: Physician burnout

 

 

Physician burnout

Burnout is an alarmingly common problem among physicians that affects approximately half of psychiatrists. In 2014, 54.4% of physicians, and slightly less than 50% of psychiatrists, had at least 1 symptom of burnout.4 This was up from the 45.5% of physicians and a little more than 40% of psychiatrists who reported burnout in 2011,4 which suggests that as medicine continues to change, doctors may increasingly feel the brunt of this change. The rate of burnout is highest in front-line specialties (family medicine, general internal medicine, and emergency medicine) and lowest in preventive medicine.5 Physician burnout leads to real-world occupational issues, such as medical errors, poor relationships with coworkers and patients, decreased patient satisfaction, and medical malpractice suits.6,7

Even though burnout is clearly a concern for our colleagues, don’t expect them to proactively line up outside our offices. In a survey of 7,197 surgeons, 86.6% of respondents answered it was not important that “I have regular meetings with a psychologist/psychiatrist to discuss stress.”8 At the same time, the idea of meeting with a psychologist/psychiatrist was rated more highly by surgeons who were burnt out and found to be a factor independently associated with burnout.8 Perhaps we have some work to do in marketing our services in a way that welcomes our colleagues.

Although physician burnout has been a focus of recent studies, burnout in general has been studied for decades in other working populations. There are 2 useful models describing burnout:

  • The job demand-control(-support) model suggests that individuals experience strain and subsequent ill effects when the demands of their job exceed the control they have,9 and social support from supervisors and colleagues can buffer the harmful effects of job strain.10
  • The effort-reward imbalance model suggests that high-effort, low-reward occupational conditions are particularly stressful.11

Both models are simple, intuitive, and suggest solutions.

When engaging your physician colleagues about their burnout, remember that physicians are people, too, and have the same difficulties that everyone else does in successfully practicing healthy behaviors. As physicians, we have significant demands on our time that make it difficult to control our ability to eat, sleep, and exercise. In general, the food available where we work is not nutritious,12 half of us are overweight or obese,13 and working more than 40 hours per week increases the likelihood we’ll have a higher body mass index.14 We don’t sleep well, either—we get less sleep than the general population,15 and more sleep equates to less burnout.16 Regarding exercise, doctors who cannot prioritize exercise tend to have more burnout.17

Continue to: When evaluating a physician colleague for symptoms of burnout...

 

 

When evaluating a physician colleague for symptoms of burnout, start by assessing the basics: eating, sleeping, and moving. In Dr. D’s case, this also included taking a quick inventory of what demands were on her proverbial plate. Taking inventory of these demands (ie, demand-control[-support] model) may lead to new insights about what she can control. Prioritization is important to determine where efforts go (ie, effort-reward imbalance model). This is where your skills as a psychiatrist can especially help, as you explore values and bring trade-offs to light.

EVALUATION Permission not to be perfect

As we interview Dr. D, we realize she has some obsessive-compulsive personality traits that are mostly self-serving. She places a high value on being thorough and having elegant clinical notes. Yet this value competes with her desire to be efficient and get home on time to see her kids’ school events. You point this out to her and see if she can come up with some solutions. You also discuss with Dr. D the tension everyone feels between valuing career and valuing family and friends. You normalize her situation, and give her permission to pick something about which she will allow herself not to be perfect.

[polldaddy:10064981]

The authors’ observations

Since perfectionism is a common trait among physicians,18 failure doesn’t seem to be compatible with their DNA. We encourage other physicians to be scientific about their own lives, just as they are in the profession they have chosen. Physicians can delude themselves into thinking they can have it all, not recognizing that every choice has its cost. For example, a physician who decides that it’s okay to publish one fewer research paper this year might have more time to enjoy spending time with his or her children. In our work with physicians, we strive to normalize their experiences, helping them reframe their perfectionistic viewpoint to recognize that everyone struggles with work-life balance issues. We validate that physicians have difficult choices to make in finding what works for them, and we challenge and support them in exploring these choices.

Choosing where to put one’s efforts is also contingent upon the expected rewards. Sometime before the daily grind of our careers in medicine started, we had strong visions of what such careers would mean to us. We visualized the ideal of helping people and making a difference. Then, at some point, many of us took this for granted and forgot about the intrinsic rewards of our work. In a 2014-2015 survey of U.S. physicians across all specialties, only 64.6% of respondents who were highly burned out said they found their work personally rewarding. This is a sharp contrast to the 97.5% of respondents who were not burned out who reported that they found their work personally rewarding.19

As psychiatrists, we can challenge our physician colleagues to dare to dream again. We can help them rediscover the rewarding aspects of their work (ie, per effort-reward imbalance model) that drew them into medicine in the first place. This may include exploring their future legacy. How do they want to be remembered at retirement? Such consideration is linked to mental simulation and meaning in their lives.20 We guide our colleagues to reframe their current situation to see the myriad of choices they have based upon their own specific value system. If family and friends are currently taking priority over work, it also helps to reframe that working allows us to make a good living so we can fully enjoy that time spent with family and friends.

Continue to: If we do our jobs well...

 

 

If we do our jobs well, the next part is easy. We have them set specific short- and long-term goals related to their situation. This is something we do every day in our practices. It may help to make sure we’re using SMART (Specific, Measurable, Achievable, Relevant, Time-Bound), a well-known mnemonic used for goals (Table 121), and brush up on our motivational interviewing skills (see Related Resources). It is especially important to make sure our colleagues have goals that are relevant—the “R” in the SMART mnemonic—to their situation.

SMART Goals

Finally, we do a better job of reaching our goals and engaging more at work and at home when we have good social support. For physicians, co-worker support has been found to be directly related to our well-being as well as buffering the negative effects of work demands.22 Furthermore, our colleagues are the most acceptable sources of support when we are faced with stressful situations.23 Thus, as psychiatrists, we can doubly help our physician patients by providing collegial support and doing our usual job of holding them accountable to their goals (Table 2).

Considerations in helping physicians combat burnout

OUTCOME Goal-setting, priorities, accountability

As we’re exploring goals with Dr. D, she makes a conscious decision to spend less time on documentation and start focusing on being present with her patients. She returns in 1 month to tell you time management is still a struggle, but her visit with you was instrumental in making her realize how important it was to get home on time for her kids’ activities. She says it greatly helped that you kept her accountable, yet also validated her struggles and gave her permission to design her life within the constraints of her situation and without the burden of having to be perfect at everything.

Bottom Line

We can best help our physician colleagues who are experiencing burnout by shifting our paradigm to a wellness model that focuses on helping them reach their potential and balance their professional and personal lives.

Related Resources

  • Balch CM, Shanafelt TD. Combating stress and burnout in surgical practice: a review. Thorac Surg Clin. 2011;21(3):417-430.
  • Miller WR, Rollnick S. Motivational interviewing: preparing people for change, 2nd ed. New York, NY: The Guilford Press; 2002.
  • Stanford Medicine WellMD. Stress & Burnout. https://wellmd.stanford.edu.

CASE ‘I’m stuck’

Dr. D, age 48, an internist practicing general medicine who is a married mother of 2 teenagers, presents with emotional exhaustion. Her medical history is unremarkable other than hyperlipidemia controlled by diet. She describes an episode of reactive depressive symptoms and anxiety when in college, which was related to the stress of final exams, finances, and the dissolution of a long-standing relationship. Regardless, she functioned well and graduated summa cum laude. She says her current feelings of being “stuck” have gradually increased during the past 3 to 4 years. Although she describes being mildly anxious and dysphoric, she also said she feels like her “wheels are spinning” and that she doesn’t even seem to care. Dr. D had been a high achiever, yet says she feels like she isn’t getting anywhere at work or at home.

[polldaddy:10064977]

The authors’ observations

As psychiatrists in the business of diagnosis and treatment, we immediately considered common diagnoses, such as major depressive disorder and persistent depressive disorder. However, despite our training in pathology, we believe patients should be considered well until proven sick. This paradigm shift is in line with the definition of mental health per the World Health Organization: “A state of well-being in which every individual realizes his or her own potential, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to her or his community.”1

In Dr. D’s case, there was not enough information yet to fully support any of the diagnoses. She did not exhibit enough depressive symptoms to support a diagnosis of a depressive disorder. She said that she didn’t feel like she was getting anywhere at work or home. Yet there was no objective information that suggested impairment in functioning, which would preclude a diagnosis of adjustment disorder. At this point, we would support the “V code” diagnosis of phase of life problem, or even what is rarely seen in a psychiatric evaluation: “no diagnosis.”

EVALUATION Is work the problem?

We diligently conduct a thorough review of systems with Dr. D and confirm there is not enough information to diagnose a depressive disorder, anxiety disorder, or other psychiatric disorder. Collateral history suggests her teenagers are well-adjusted and doing well in high school, and she is well-respected at work with reportedly excellent performance ratings. We identify strongly with her and her situation.

Dr. D admits she is an idealist and half-jokingly says she entered into medicine “to save the world.” Yet she laments the long hours and finding herself mired in paperwork. She is barely making it to her kids’ school events and says she can’t believe her first child will be graduating within a year. She has had some particularly challenging patients recently, and although she is still diligent about their care, she is shocked she doesn’t seem to care as much about “solving the medical puzzle.” This came to light for her when a longtime patient observed that Dr. D didn’t seem herself and asked, “Are you all right, Doc?”

Dr. D is professionally dressed and has excellent grooming and hygiene. She looks tired, yet has a full affect, a witty conversational style, and responds appropriately to humor.

[polldaddy:10064980]

The authors’ observations

It can be difficult to know what to do next when there isn’t an established “playbook” for a problem without a diagnosis. We realized Dr. D was describing burnout, a syndrome of depersonalization (detached and not caring, to the point of viewing people as objects), emotional exhaustion, and low personal accomplishment that leads to decreased effectiveness at work.2 DSM-5 does not include “burnout” as a diagnosis3; however, if symptoms evolve to the point where they affect occupational or social functioning, burnout can be similar to adjustment disorder. Treatment with an antidepressant medication is not appropriate. It is possible that CBT might be helpful for many patients, yet there is no evidence that Dr. D has any cognitive distortions. Although we already had some collateral information, it is never wrong to gather additional collateral. However, because burnout is common, we may not need additional information. We could reassure her and send her on her way, but we want to add therapeutic value. We advocated exploring issues in her life and work related to meaning.

Continue to: Physician burnout

 

 

Physician burnout

Burnout is an alarmingly common problem among physicians that affects approximately half of psychiatrists. In 2014, 54.4% of physicians, and slightly less than 50% of psychiatrists, had at least 1 symptom of burnout.4 This was up from the 45.5% of physicians and a little more than 40% of psychiatrists who reported burnout in 2011,4 which suggests that as medicine continues to change, doctors may increasingly feel the brunt of this change. The rate of burnout is highest in front-line specialties (family medicine, general internal medicine, and emergency medicine) and lowest in preventive medicine.5 Physician burnout leads to real-world occupational issues, such as medical errors, poor relationships with coworkers and patients, decreased patient satisfaction, and medical malpractice suits.6,7

Even though burnout is clearly a concern for our colleagues, don’t expect them to proactively line up outside our offices. In a survey of 7,197 surgeons, 86.6% of respondents answered it was not important that “I have regular meetings with a psychologist/psychiatrist to discuss stress.”8 At the same time, the idea of meeting with a psychologist/psychiatrist was rated more highly by surgeons who were burnt out and found to be a factor independently associated with burnout.8 Perhaps we have some work to do in marketing our services in a way that welcomes our colleagues.

Although physician burnout has been a focus of recent studies, burnout in general has been studied for decades in other working populations. There are 2 useful models describing burnout:

  • The job demand-control(-support) model suggests that individuals experience strain and subsequent ill effects when the demands of their job exceed the control they have,9 and social support from supervisors and colleagues can buffer the harmful effects of job strain.10
  • The effort-reward imbalance model suggests that high-effort, low-reward occupational conditions are particularly stressful.11

Both models are simple, intuitive, and suggest solutions.

When engaging your physician colleagues about their burnout, remember that physicians are people, too, and have the same difficulties that everyone else does in successfully practicing healthy behaviors. As physicians, we have significant demands on our time that make it difficult to control our ability to eat, sleep, and exercise. In general, the food available where we work is not nutritious,12 half of us are overweight or obese,13 and working more than 40 hours per week increases the likelihood we’ll have a higher body mass index.14 We don’t sleep well, either—we get less sleep than the general population,15 and more sleep equates to less burnout.16 Regarding exercise, doctors who cannot prioritize exercise tend to have more burnout.17

Continue to: When evaluating a physician colleague for symptoms of burnout...

 

 

When evaluating a physician colleague for symptoms of burnout, start by assessing the basics: eating, sleeping, and moving. In Dr. D’s case, this also included taking a quick inventory of what demands were on her proverbial plate. Taking inventory of these demands (ie, demand-control[-support] model) may lead to new insights about what she can control. Prioritization is important to determine where efforts go (ie, effort-reward imbalance model). This is where your skills as a psychiatrist can especially help, as you explore values and bring trade-offs to light.

EVALUATION Permission not to be perfect

As we interview Dr. D, we realize she has some obsessive-compulsive personality traits that are mostly self-serving. She places a high value on being thorough and having elegant clinical notes. Yet this value competes with her desire to be efficient and get home on time to see her kids’ school events. You point this out to her and see if she can come up with some solutions. You also discuss with Dr. D the tension everyone feels between valuing career and valuing family and friends. You normalize her situation, and give her permission to pick something about which she will allow herself not to be perfect.

[polldaddy:10064981]

The authors’ observations

Since perfectionism is a common trait among physicians,18 failure doesn’t seem to be compatible with their DNA. We encourage other physicians to be scientific about their own lives, just as they are in the profession they have chosen. Physicians can delude themselves into thinking they can have it all, not recognizing that every choice has its cost. For example, a physician who decides that it’s okay to publish one fewer research paper this year might have more time to enjoy spending time with his or her children. In our work with physicians, we strive to normalize their experiences, helping them reframe their perfectionistic viewpoint to recognize that everyone struggles with work-life balance issues. We validate that physicians have difficult choices to make in finding what works for them, and we challenge and support them in exploring these choices.

Choosing where to put one’s efforts is also contingent upon the expected rewards. Sometime before the daily grind of our careers in medicine started, we had strong visions of what such careers would mean to us. We visualized the ideal of helping people and making a difference. Then, at some point, many of us took this for granted and forgot about the intrinsic rewards of our work. In a 2014-2015 survey of U.S. physicians across all specialties, only 64.6% of respondents who were highly burned out said they found their work personally rewarding. This is a sharp contrast to the 97.5% of respondents who were not burned out who reported that they found their work personally rewarding.19

As psychiatrists, we can challenge our physician colleagues to dare to dream again. We can help them rediscover the rewarding aspects of their work (ie, per effort-reward imbalance model) that drew them into medicine in the first place. This may include exploring their future legacy. How do they want to be remembered at retirement? Such consideration is linked to mental simulation and meaning in their lives.20 We guide our colleagues to reframe their current situation to see the myriad of choices they have based upon their own specific value system. If family and friends are currently taking priority over work, it also helps to reframe that working allows us to make a good living so we can fully enjoy that time spent with family and friends.

Continue to: If we do our jobs well...

 

 

If we do our jobs well, the next part is easy. We have them set specific short- and long-term goals related to their situation. This is something we do every day in our practices. It may help to make sure we’re using SMART (Specific, Measurable, Achievable, Relevant, Time-Bound), a well-known mnemonic used for goals (Table 121), and brush up on our motivational interviewing skills (see Related Resources). It is especially important to make sure our colleagues have goals that are relevant—the “R” in the SMART mnemonic—to their situation.

SMART Goals

Finally, we do a better job of reaching our goals and engaging more at work and at home when we have good social support. For physicians, co-worker support has been found to be directly related to our well-being as well as buffering the negative effects of work demands.22 Furthermore, our colleagues are the most acceptable sources of support when we are faced with stressful situations.23 Thus, as psychiatrists, we can doubly help our physician patients by providing collegial support and doing our usual job of holding them accountable to their goals (Table 2).

Considerations in helping physicians combat burnout

OUTCOME Goal-setting, priorities, accountability

As we’re exploring goals with Dr. D, she makes a conscious decision to spend less time on documentation and start focusing on being present with her patients. She returns in 1 month to tell you time management is still a struggle, but her visit with you was instrumental in making her realize how important it was to get home on time for her kids’ activities. She says it greatly helped that you kept her accountable, yet also validated her struggles and gave her permission to design her life within the constraints of her situation and without the burden of having to be perfect at everything.

Bottom Line

We can best help our physician colleagues who are experiencing burnout by shifting our paradigm to a wellness model that focuses on helping them reach their potential and balance their professional and personal lives.

Related Resources

  • Balch CM, Shanafelt TD. Combating stress and burnout in surgical practice: a review. Thorac Surg Clin. 2011;21(3):417-430.
  • Miller WR, Rollnick S. Motivational interviewing: preparing people for change, 2nd ed. New York, NY: The Guilford Press; 2002.
  • Stanford Medicine WellMD. Stress & Burnout. https://wellmd.stanford.edu.
References

1. World Health Organization. Mental health: a state of well-being. http://www.who.int/features/factfiles/mental_health/en/. Updated August 2014. Accessed March 17, 2017.
2. Maslach C, Jackson S, Leiter M. Maslach burnout inventory manual, 3rd ed. Palo Alto, CA: Consulting Psychologists Press; 1996.
3. Diagnostic and statistical manual of mental disorders, 5th ed. Washington, DC: American Psychiatric Association; 2013.
4. Shanafelt TD, Hasan O, Dyrbye LN, et al. Changes in burnout and satisfaction with work-life balance in physicians and the general US working population between 2011 and 2014. Mayo Clin Proc. 2015;90(12):1600-1613.
5. Shanafelt TD, Boone S, Tan L, et al. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012;172(18):1377-1385.
6. Shanafelt TD, Sloan JA, Habermann TM. The well-being of physicians. Am J Med. 2003;114(6):513-519.
7. Balch CM, Shanafelt TD. Combating stress and burnout in surgical practice: a review. Adv Surg. 2010;44:29-47.
8. Shanafelt TD, Oreskovich MR, Dyrbye LN, et al. Avoiding burnout: the personal health habits and wellness practices of US Surgeons. Ann Surg. 2012;255(4):625-633.
9. Karasek RA Jr. Job demands, job decision latitude, and mental strain: implications for job redesign. Adm Sci Q. 1979;24(2):285-308.
10. Johnson JV. Collective control: strategies for survival in the workplace. Int J Health Serv. 1989;19(3):469-480.
11. Siegrist J. Adverse health effects of high-effort/low-reward conditions. J Occup Health Psychol. 1996;1(1):27-41.
12. Lesser LI, Cohen DA, Brook RH. Changing eating habits for the medical profession. JAMA. 2012;308(10):983-984.
13. Bleich SN, Bennett WL, Gudzune KA, et al. Impact of physician BMI on obesity care and beliefs. Obesity (Silver Spring). 2012;20(5):999-1005.
14. Stanford FC, Durkin MW, Blair SN, et al. Determining levels of physical activity in attending physicians, resident and fellow physicians, and medical students in the USA. Br J Sports Med. 2012;46(5):360-364.
15. Tucker P, Bejerot E, Kecklund G, et al. Stress Research Institute at Stockholm University. Stress Research Report-doctors’ work hours in Sweden: their impact on sleep, health, work-family balance, patient care and thoughts about work. https://www.stressforskning.su.se/polopoly_fs/1.233341.1429526778!/menu/standard/file/sfr325.pdf. Accessed March 17, 2017.
16. Wisetborisut A, Angkurawaranon C, Jiraporncharoen W, et al. Shift work and burnout among health care workers. Occup Med (Lond). 2014;64(4):279-286.
17. Eckleberry-Hunt J, Lick D, Boura J, et al. An exploratory study of resident burnout and wellness. Acad Med. 2009;84(2):269-277.
18. Peters M, King J. Perfectionism in doctors. BMJ. 2012;344:e1674. doi: https://doi.org/10.1136/bmj.e1674.
19. Jager AJ, Tutty MA, Kao AC. Association between physician burnout and identification with medicine as a calling. Mayo Clin Proc. 2017;92(3):415-422.
20. Waytz A, Hershfield HE, Tamir DI. Neural and behavioral evidence for the role of mental simulation in meaning in life. J Pers Soc Psychol. 2015;108(2):336-355.
21. SMART Criteria. https://en.wikipedia.org/wiki/SMART_criteria. Accessed March 17, 2017.
22. Hu YY, Fix ML, Hevelone ND, et al. Physicians’ needs in coping with emotional stressors: the case for peer support. Arch Surg. 2012;147(3):212-217.
23. Wallace JE, Lemaire J. On physician well being–you’ll get by with a little help from your friends. Soc Sci Med. 2007;64(12):2565-2577.

References

1. World Health Organization. Mental health: a state of well-being. http://www.who.int/features/factfiles/mental_health/en/. Updated August 2014. Accessed March 17, 2017.
2. Maslach C, Jackson S, Leiter M. Maslach burnout inventory manual, 3rd ed. Palo Alto, CA: Consulting Psychologists Press; 1996.
3. Diagnostic and statistical manual of mental disorders, 5th ed. Washington, DC: American Psychiatric Association; 2013.
4. Shanafelt TD, Hasan O, Dyrbye LN, et al. Changes in burnout and satisfaction with work-life balance in physicians and the general US working population between 2011 and 2014. Mayo Clin Proc. 2015;90(12):1600-1613.
5. Shanafelt TD, Boone S, Tan L, et al. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012;172(18):1377-1385.
6. Shanafelt TD, Sloan JA, Habermann TM. The well-being of physicians. Am J Med. 2003;114(6):513-519.
7. Balch CM, Shanafelt TD. Combating stress and burnout in surgical practice: a review. Adv Surg. 2010;44:29-47.
8. Shanafelt TD, Oreskovich MR, Dyrbye LN, et al. Avoiding burnout: the personal health habits and wellness practices of US Surgeons. Ann Surg. 2012;255(4):625-633.
9. Karasek RA Jr. Job demands, job decision latitude, and mental strain: implications for job redesign. Adm Sci Q. 1979;24(2):285-308.
10. Johnson JV. Collective control: strategies for survival in the workplace. Int J Health Serv. 1989;19(3):469-480.
11. Siegrist J. Adverse health effects of high-effort/low-reward conditions. J Occup Health Psychol. 1996;1(1):27-41.
12. Lesser LI, Cohen DA, Brook RH. Changing eating habits for the medical profession. JAMA. 2012;308(10):983-984.
13. Bleich SN, Bennett WL, Gudzune KA, et al. Impact of physician BMI on obesity care and beliefs. Obesity (Silver Spring). 2012;20(5):999-1005.
14. Stanford FC, Durkin MW, Blair SN, et al. Determining levels of physical activity in attending physicians, resident and fellow physicians, and medical students in the USA. Br J Sports Med. 2012;46(5):360-364.
15. Tucker P, Bejerot E, Kecklund G, et al. Stress Research Institute at Stockholm University. Stress Research Report-doctors’ work hours in Sweden: their impact on sleep, health, work-family balance, patient care and thoughts about work. https://www.stressforskning.su.se/polopoly_fs/1.233341.1429526778!/menu/standard/file/sfr325.pdf. Accessed March 17, 2017.
16. Wisetborisut A, Angkurawaranon C, Jiraporncharoen W, et al. Shift work and burnout among health care workers. Occup Med (Lond). 2014;64(4):279-286.
17. Eckleberry-Hunt J, Lick D, Boura J, et al. An exploratory study of resident burnout and wellness. Acad Med. 2009;84(2):269-277.
18. Peters M, King J. Perfectionism in doctors. BMJ. 2012;344:e1674. doi: https://doi.org/10.1136/bmj.e1674.
19. Jager AJ, Tutty MA, Kao AC. Association between physician burnout and identification with medicine as a calling. Mayo Clin Proc. 2017;92(3):415-422.
20. Waytz A, Hershfield HE, Tamir DI. Neural and behavioral evidence for the role of mental simulation in meaning in life. J Pers Soc Psychol. 2015;108(2):336-355.
21. SMART Criteria. https://en.wikipedia.org/wiki/SMART_criteria. Accessed March 17, 2017.
22. Hu YY, Fix ML, Hevelone ND, et al. Physicians’ needs in coping with emotional stressors: the case for peer support. Arch Surg. 2012;147(3):212-217.
23. Wallace JE, Lemaire J. On physician well being–you’ll get by with a little help from your friends. Soc Sci Med. 2007;64(12):2565-2577.

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Partial hold placed on trial of drug for AML, MDS

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Micrograph showing MDS

The US Food and Drug Administration (FDA) has placed a partial clinical hold on a phase 1b/2 study of OXi4503, a vascular disrupting agent.

In this trial (NCT02576301), researchers are evaluating OXi4503, alone and in combination with cytarabine, in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

The partial clinical hold applies to the 12.2 mg/m2 dose of OXi4503.

The FDA is allowing the continued treatment and enrollment of patients using a dose of 9.76 mg/m2.

The agency said additional data on patients receiving OXi4503 at 9.76 mg/m2 must be evaluated before dosing at 12.2 mg/m2 can be resumed.

The partial clinical hold is a result of 2 potential dose-limiting toxicities (DLTs) observed at the 12.2 mg/m2 dose level.

One DLT was hypotension, which occurred shortly after initial treatment with OXi4503. The other DLT was acute hypoxic respiratory failure, which occurred approximately 2 weeks after receiving OXi4503 and cytarabine.

Both events were deemed “possibly related” to OXi4503, and both patients recovered following treatment.

The study protocol generally defines a DLT as any grade 3 serious adverse event where a relationship to OXi4503 cannot be ruled out.

“Although it is disappointing that we are not currently continuing with the higher dose of OXi4503, we look forward to gathering more safety and efficacy data at the previous dose level, where we observed 2 complete remissions in the 4 patients that we treated,” said William D. Schwieterman, MD, chief executive officer of Mateon Therapeutics, Inc., the company developing OXi4503.

About OXi4503

According to Mateon Therapeutics, OXi4503 has a dual mechanism of action that disrupts the shape of tumor bone marrow endothelial cells through reversible binding to tubulin at the colchicine binding site, downregulating intercellular adhesion molecules.

This alters the endothelial cell shape, releasing quiescent adherent tumor cells from bone marrow endothelial cells and activating the cell cycle, which makes the tumor cells vulnerable to chemotherapy.

OXi4503 also kills tumor cells directly via myeloperoxidase activation of an orthoquinone cytotoxic mediator.

In preclinical research, OXi4503 demonstrated activity against AML, both when given alone and in combination with bevacizumab. These results were published in Blood in 2010.

Clinical trials

In a phase 1 trial (NCT01085656), researchers evaluated OXi4503 in patients with relapsed or refractory AML or MDS. The goals were to determine the safety profile, maximum tolerated dose, and biologic activity of OXi4503.

The researchers said OXi4503 demonstrated preliminary evidence of disease response in heavily pre-treated, refractory AML and advanced MDS.

The maximum tolerated dose of OXi4503 was not identified, but adverse events attributable to the drug included hypertension, bone pain, fever, anemia, thrombocytopenia, and coagulopathies.

Results from this study were presented at the 2013 ASH Annual Meeting.

In 2015, Mateon Therapeutics initiated the phase 1b/2 study of OXi4503 (NCT02576301) that is now on partial clinical hold.

The phase 1 portion of this study was designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent OXi4503 in patients with relapsed/refractory AML and MDS.

The phase 1 portion was also intended to determine the safety, pharmacokinetics, and pharmacodynamics of OXi4503 plus intermediate-dose cytarabine.

The goal of the phase 2 portion is to assess the preliminary efficacy of OXi4503 and cytarabine in patients with AML and MDS.

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Micrograph showing MDS

The US Food and Drug Administration (FDA) has placed a partial clinical hold on a phase 1b/2 study of OXi4503, a vascular disrupting agent.

In this trial (NCT02576301), researchers are evaluating OXi4503, alone and in combination with cytarabine, in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

The partial clinical hold applies to the 12.2 mg/m2 dose of OXi4503.

The FDA is allowing the continued treatment and enrollment of patients using a dose of 9.76 mg/m2.

The agency said additional data on patients receiving OXi4503 at 9.76 mg/m2 must be evaluated before dosing at 12.2 mg/m2 can be resumed.

The partial clinical hold is a result of 2 potential dose-limiting toxicities (DLTs) observed at the 12.2 mg/m2 dose level.

One DLT was hypotension, which occurred shortly after initial treatment with OXi4503. The other DLT was acute hypoxic respiratory failure, which occurred approximately 2 weeks after receiving OXi4503 and cytarabine.

Both events were deemed “possibly related” to OXi4503, and both patients recovered following treatment.

The study protocol generally defines a DLT as any grade 3 serious adverse event where a relationship to OXi4503 cannot be ruled out.

“Although it is disappointing that we are not currently continuing with the higher dose of OXi4503, we look forward to gathering more safety and efficacy data at the previous dose level, where we observed 2 complete remissions in the 4 patients that we treated,” said William D. Schwieterman, MD, chief executive officer of Mateon Therapeutics, Inc., the company developing OXi4503.

About OXi4503

According to Mateon Therapeutics, OXi4503 has a dual mechanism of action that disrupts the shape of tumor bone marrow endothelial cells through reversible binding to tubulin at the colchicine binding site, downregulating intercellular adhesion molecules.

This alters the endothelial cell shape, releasing quiescent adherent tumor cells from bone marrow endothelial cells and activating the cell cycle, which makes the tumor cells vulnerable to chemotherapy.

OXi4503 also kills tumor cells directly via myeloperoxidase activation of an orthoquinone cytotoxic mediator.

In preclinical research, OXi4503 demonstrated activity against AML, both when given alone and in combination with bevacizumab. These results were published in Blood in 2010.

Clinical trials

In a phase 1 trial (NCT01085656), researchers evaluated OXi4503 in patients with relapsed or refractory AML or MDS. The goals were to determine the safety profile, maximum tolerated dose, and biologic activity of OXi4503.

The researchers said OXi4503 demonstrated preliminary evidence of disease response in heavily pre-treated, refractory AML and advanced MDS.

The maximum tolerated dose of OXi4503 was not identified, but adverse events attributable to the drug included hypertension, bone pain, fever, anemia, thrombocytopenia, and coagulopathies.

Results from this study were presented at the 2013 ASH Annual Meeting.

In 2015, Mateon Therapeutics initiated the phase 1b/2 study of OXi4503 (NCT02576301) that is now on partial clinical hold.

The phase 1 portion of this study was designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent OXi4503 in patients with relapsed/refractory AML and MDS.

The phase 1 portion was also intended to determine the safety, pharmacokinetics, and pharmacodynamics of OXi4503 plus intermediate-dose cytarabine.

The goal of the phase 2 portion is to assess the preliminary efficacy of OXi4503 and cytarabine in patients with AML and MDS.

Micrograph showing MDS

The US Food and Drug Administration (FDA) has placed a partial clinical hold on a phase 1b/2 study of OXi4503, a vascular disrupting agent.

In this trial (NCT02576301), researchers are evaluating OXi4503, alone and in combination with cytarabine, in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

The partial clinical hold applies to the 12.2 mg/m2 dose of OXi4503.

The FDA is allowing the continued treatment and enrollment of patients using a dose of 9.76 mg/m2.

The agency said additional data on patients receiving OXi4503 at 9.76 mg/m2 must be evaluated before dosing at 12.2 mg/m2 can be resumed.

The partial clinical hold is a result of 2 potential dose-limiting toxicities (DLTs) observed at the 12.2 mg/m2 dose level.

One DLT was hypotension, which occurred shortly after initial treatment with OXi4503. The other DLT was acute hypoxic respiratory failure, which occurred approximately 2 weeks after receiving OXi4503 and cytarabine.

Both events were deemed “possibly related” to OXi4503, and both patients recovered following treatment.

The study protocol generally defines a DLT as any grade 3 serious adverse event where a relationship to OXi4503 cannot be ruled out.

“Although it is disappointing that we are not currently continuing with the higher dose of OXi4503, we look forward to gathering more safety and efficacy data at the previous dose level, where we observed 2 complete remissions in the 4 patients that we treated,” said William D. Schwieterman, MD, chief executive officer of Mateon Therapeutics, Inc., the company developing OXi4503.

About OXi4503

According to Mateon Therapeutics, OXi4503 has a dual mechanism of action that disrupts the shape of tumor bone marrow endothelial cells through reversible binding to tubulin at the colchicine binding site, downregulating intercellular adhesion molecules.

This alters the endothelial cell shape, releasing quiescent adherent tumor cells from bone marrow endothelial cells and activating the cell cycle, which makes the tumor cells vulnerable to chemotherapy.

OXi4503 also kills tumor cells directly via myeloperoxidase activation of an orthoquinone cytotoxic mediator.

In preclinical research, OXi4503 demonstrated activity against AML, both when given alone and in combination with bevacizumab. These results were published in Blood in 2010.

Clinical trials

In a phase 1 trial (NCT01085656), researchers evaluated OXi4503 in patients with relapsed or refractory AML or MDS. The goals were to determine the safety profile, maximum tolerated dose, and biologic activity of OXi4503.

The researchers said OXi4503 demonstrated preliminary evidence of disease response in heavily pre-treated, refractory AML and advanced MDS.

The maximum tolerated dose of OXi4503 was not identified, but adverse events attributable to the drug included hypertension, bone pain, fever, anemia, thrombocytopenia, and coagulopathies.

Results from this study were presented at the 2013 ASH Annual Meeting.

In 2015, Mateon Therapeutics initiated the phase 1b/2 study of OXi4503 (NCT02576301) that is now on partial clinical hold.

The phase 1 portion of this study was designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent OXi4503 in patients with relapsed/refractory AML and MDS.

The phase 1 portion was also intended to determine the safety, pharmacokinetics, and pharmacodynamics of OXi4503 plus intermediate-dose cytarabine.

The goal of the phase 2 portion is to assess the preliminary efficacy of OXi4503 and cytarabine in patients with AML and MDS.

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Open AAA and peripheral bypass surgery patients among the highest users of post-acute care

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The wide disparity among hospitals in their rates of postsurgery discharge to post-acute care (PAC) could be an area of focus for cost containment in Medicare spending, according to the findings of a study that used data from the National Inpatient Sample (NIS) and the Veterans Affairs health system (VA) regarding surgical patients.

peterspiro/Thinkstock

PAC, including skilled nursing facilities and inpatient rehabilitation, accounts for 73% of regional variation in Medicare spending, and studies on hospital variation in this area have typically focused on nonsurgical patients or been limited to Medicare data. However, a high degree of variation also appears to hold for surgical patients, according to the authors of this large database study of more than 4 million patients who had aortic aneurysm repair, peripheral vascular bypass, colorectal surgery, hepatectomy, pancreatectomy, or coronary bypass.

“We found that there is significant variation in use of PAC and rates of home discharge following complex cardiac, abdominal, and vascular surgery,” Courtney J. Balentine, MD, of the University of Alabama at Birmingham and his colleagues wrote in their report in the Journal of Surgical Research.

To explore hospital variation in post-surgery PAC, they evaluated 3,487,365 patients from the NIS (39% were aged 70 years or older, and 60% were men) and 60,666 from the VA (32% were aged 70 years or older, and 98% were men) who had surgery during 2008-2011.

Within the NIS, 631,199 patients (18%) were discharged to PAC facilities, and among the 60,666 veterans, 4744 (7.8%) were discharged to PAC facilities. In addition, hospital rates of discharge to PAC facilities varied from 1% to 36% for VA hospitals and from 1% to 59% for non-VA hospitals, according to the researchers. They found that some VA hospitals were four times more likely to discharge patients to PAC facilities than would be expected from their patients’ characteristics, while others were 90% more likely to send patients home than would be expected, according to Dr. Balentine and his colleagues.

Procedure-specific rates of discharge to PAC facilities from VA hospitals ranged from 2% following endovascular aneurysm repair to 10% after pancreatectomy and peripheral vascular bypass. Among the NIS hospitals, in contrast, rates of discharge to PAC facilities ranged from 6% following hepatectomy to as high as 44% following open aneurysm repair.

“These data could be used to characterize practices that promote more effective recovery from surgery and minimize the need for PAC,” the authors wrote. “Given that skilled nursing facilities and inpatient rehabilitation cost [$5,000]-$24,000 more than treatment at home, even minor reductions in the need for PAC facilities could result in substantial cost savings,” they stated.

“Our findings suggest that there is considerable room for improvement in the use of PAC after surgery and that we still have a long way to go in terms of using PAC to help patients recover and regain their independence,” the researchers concluded.

The authors reported that they had no conflicts of interest.

SOURCE: Balentine CJ et al. J Surg Res. 2018 Oct;230:61-70.

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The wide disparity among hospitals in their rates of postsurgery discharge to post-acute care (PAC) could be an area of focus for cost containment in Medicare spending, according to the findings of a study that used data from the National Inpatient Sample (NIS) and the Veterans Affairs health system (VA) regarding surgical patients.

peterspiro/Thinkstock

PAC, including skilled nursing facilities and inpatient rehabilitation, accounts for 73% of regional variation in Medicare spending, and studies on hospital variation in this area have typically focused on nonsurgical patients or been limited to Medicare data. However, a high degree of variation also appears to hold for surgical patients, according to the authors of this large database study of more than 4 million patients who had aortic aneurysm repair, peripheral vascular bypass, colorectal surgery, hepatectomy, pancreatectomy, or coronary bypass.

“We found that there is significant variation in use of PAC and rates of home discharge following complex cardiac, abdominal, and vascular surgery,” Courtney J. Balentine, MD, of the University of Alabama at Birmingham and his colleagues wrote in their report in the Journal of Surgical Research.

To explore hospital variation in post-surgery PAC, they evaluated 3,487,365 patients from the NIS (39% were aged 70 years or older, and 60% were men) and 60,666 from the VA (32% were aged 70 years or older, and 98% were men) who had surgery during 2008-2011.

Within the NIS, 631,199 patients (18%) were discharged to PAC facilities, and among the 60,666 veterans, 4744 (7.8%) were discharged to PAC facilities. In addition, hospital rates of discharge to PAC facilities varied from 1% to 36% for VA hospitals and from 1% to 59% for non-VA hospitals, according to the researchers. They found that some VA hospitals were four times more likely to discharge patients to PAC facilities than would be expected from their patients’ characteristics, while others were 90% more likely to send patients home than would be expected, according to Dr. Balentine and his colleagues.

Procedure-specific rates of discharge to PAC facilities from VA hospitals ranged from 2% following endovascular aneurysm repair to 10% after pancreatectomy and peripheral vascular bypass. Among the NIS hospitals, in contrast, rates of discharge to PAC facilities ranged from 6% following hepatectomy to as high as 44% following open aneurysm repair.

“These data could be used to characterize practices that promote more effective recovery from surgery and minimize the need for PAC,” the authors wrote. “Given that skilled nursing facilities and inpatient rehabilitation cost [$5,000]-$24,000 more than treatment at home, even minor reductions in the need for PAC facilities could result in substantial cost savings,” they stated.

“Our findings suggest that there is considerable room for improvement in the use of PAC after surgery and that we still have a long way to go in terms of using PAC to help patients recover and regain their independence,” the researchers concluded.

The authors reported that they had no conflicts of interest.

SOURCE: Balentine CJ et al. J Surg Res. 2018 Oct;230:61-70.

 

The wide disparity among hospitals in their rates of postsurgery discharge to post-acute care (PAC) could be an area of focus for cost containment in Medicare spending, according to the findings of a study that used data from the National Inpatient Sample (NIS) and the Veterans Affairs health system (VA) regarding surgical patients.

peterspiro/Thinkstock

PAC, including skilled nursing facilities and inpatient rehabilitation, accounts for 73% of regional variation in Medicare spending, and studies on hospital variation in this area have typically focused on nonsurgical patients or been limited to Medicare data. However, a high degree of variation also appears to hold for surgical patients, according to the authors of this large database study of more than 4 million patients who had aortic aneurysm repair, peripheral vascular bypass, colorectal surgery, hepatectomy, pancreatectomy, or coronary bypass.

“We found that there is significant variation in use of PAC and rates of home discharge following complex cardiac, abdominal, and vascular surgery,” Courtney J. Balentine, MD, of the University of Alabama at Birmingham and his colleagues wrote in their report in the Journal of Surgical Research.

To explore hospital variation in post-surgery PAC, they evaluated 3,487,365 patients from the NIS (39% were aged 70 years or older, and 60% were men) and 60,666 from the VA (32% were aged 70 years or older, and 98% were men) who had surgery during 2008-2011.

Within the NIS, 631,199 patients (18%) were discharged to PAC facilities, and among the 60,666 veterans, 4744 (7.8%) were discharged to PAC facilities. In addition, hospital rates of discharge to PAC facilities varied from 1% to 36% for VA hospitals and from 1% to 59% for non-VA hospitals, according to the researchers. They found that some VA hospitals were four times more likely to discharge patients to PAC facilities than would be expected from their patients’ characteristics, while others were 90% more likely to send patients home than would be expected, according to Dr. Balentine and his colleagues.

Procedure-specific rates of discharge to PAC facilities from VA hospitals ranged from 2% following endovascular aneurysm repair to 10% after pancreatectomy and peripheral vascular bypass. Among the NIS hospitals, in contrast, rates of discharge to PAC facilities ranged from 6% following hepatectomy to as high as 44% following open aneurysm repair.

“These data could be used to characterize practices that promote more effective recovery from surgery and minimize the need for PAC,” the authors wrote. “Given that skilled nursing facilities and inpatient rehabilitation cost [$5,000]-$24,000 more than treatment at home, even minor reductions in the need for PAC facilities could result in substantial cost savings,” they stated.

“Our findings suggest that there is considerable room for improvement in the use of PAC after surgery and that we still have a long way to go in terms of using PAC to help patients recover and regain their independence,” the researchers concluded.

The authors reported that they had no conflicts of interest.

SOURCE: Balentine CJ et al. J Surg Res. 2018 Oct;230:61-70.

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FROM THE JOURNAL OF SURGICAL RESEARCH

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Key clinical point: The wide disparity among hospitals in their rates of postsurgery discharge to post-acute care (PAC) could be an area of focus for cost containment in Medicare spending.

Major finding: Rates of discharge to PAC facilities varied from 1% to 36% for VA hospitals and from 1% to 59% for non-VA hospitals.

Study details: A database analysis of 3,487,365 National Inpatient Sample patients and 60,666 VA patients who had surgery during 2008-2011.

Disclosures: The authors reported that they had no conflicts of interest.

Source: Balentine CJ et al. J Surg Res. 2018 Oct;230:61-70.

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Migraine takes toll on intimate relationships

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– 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
Dr. Dawn C. Buse

“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.

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

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– 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
Dr. Dawn C. Buse

“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.

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

 

– 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
Dr. Dawn C. Buse

“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.

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

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REPORTING FROM THE AHS ANNUAL MEETING

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Key clinical point: Migraine is a major contributor to relationship problems.

Major finding: Nearly 10% of chronic migraineurs say they’ve delayed having children or had fewer of them because of their headaches.

Study details: This analysis included more than 13,000 participants in the CaMEO study, a prospective, longitudinal, Internet-based survey.

Disclosures: The presenter reported receiving research support and honoraria from Allergan, the study sponsor, as well as from Avenir, Eli Lilly, and Promius.

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

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Exploring Link Between Sleep Disorders and Migraine

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Exploring Link Between Sleep Disorders and Migraine
Headache; ePub 2018 Aug 8; Vgontzas, Pavlović

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.

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Headache; ePub 2018 Aug 8; Vgontzas, Pavlović
Headache; ePub 2018 Aug 8; Vgontzas, Pavlović

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.

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Sleep Disorders and Migraine: Assessment, Treatment

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Sleep Disorders and Migraine: Assessment, Treatment
Headache; ePub 2018 Aug 10; Rains

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.

 

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Headache; ePub 2018 Aug 10; Rains
Headache; ePub 2018 Aug 10; Rains

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.

 

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Promoting confrontation

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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.

Dr. Kevin T. Powell

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 [email protected].

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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.

Dr. Kevin T. Powell

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 [email protected].

 

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.

Dr. Kevin T. Powell

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 [email protected].

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A beautiful diagnosis

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Thu, 03/28/2019 - 14:34

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.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

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 [email protected].

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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.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

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 [email protected].

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.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

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 [email protected].

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CDC: 2017 worst year yet for drug overdoses

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Fri, 01/18/2019 - 17:53

 

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.

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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.

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CPI-613 receives orphan designation for PTCL

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Wed, 02/06/2019 - 13:27

 

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.

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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.

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