The ShrinkRap blog posted a link to an E. Fuller Torrey and D.J. Jaffe editorial in the National Review about how the government has dismantled mental health care for serious mental illnesses and some of the repercussions. Since I have been saying the exact same thing for the past 20 years, they will get no argument from me. Only in the theatre of the absurd that passes for press coverage of mental illness and psychiatry in this country can this subject be ignored and silenced for so long. It was obviously much more important to see an endless stream of articles trying to make the DSM-5 seem relevant for every man. The stunning part about the Newtown article is the commentary about what government officials responsible for policy have actually been saying about it.
The authors waste very little time examining the sequence of events in the Obama administration following the Newtown, Connecticut mass shooting. President Obama initially stated he would "make access to mental health care as easy as access to guns." and set up a Task Force under Vice President Biden to make recommendations. The authors argue that the agency that was consulted, the Substance Abuse and Mental Health Services Administration (SAMHSA) promotes a model of treating mental illness that has no proven efficacy, does not discuss serious mental illnesses in its planning document, ignores effective treatments for serious mental illnesses and actually goes so far as to fund programs that block the implementation of effective treatment programs. In an example of the obstruction of effective programming by SAMHSA funded programs following the Newtown mass shooting:
"But, alas, the situation is even worse. SAMHSA does not merely ignore effective treatments for individuals with severe mental illness. It also funds programs that attempt to undermine the implementation of such treatments at the state and county level. One such program is the Protection and Advocacy program, a $34 million SAMHSA program that was originally implemented to protect patients in mental hospitals from abuse. It was kidnapped by civil-liberties zealots and has been used to block the implementation of assisted outpatient treatment, funding efforts to undermine it in at least 13 states. For example in Connecticut, following the Newtown massacre of schoolchildren, the federally funded Connecticut Office of Protection and Advocacy for Persons with Disabilities testified before a state-legislature working group in opposition to the proposed implementation of a proposed law permitting court-ordered outpatient treatment for individuals with severe mental illness who have been proven dangerous. The law did not pass." (page 3, par 2.)
In other words, a SAMHSA funded program was opposed to a law in Connecticut that could potentially reduce violence from persons with severe mental illness.
SAMHSA administrators are quoted at times in the article. Any quote can be taken out of context but the characterizations of severe mental illness as "severe emotional distress", "a spiritual experience" and "a coping mechanism and not a disease" reflect a serious lack of knowledge about these disorders. The idea that "the covert mission of the mental health system ...is social control" is standard antipsychiatry philosophy from the 1960s. How is it that after the Decade of the Brain and the new Obama Brain Initiative we can have a lead federal agency that apparently knows nothing about the treatment of serious mental illnesses? How is it that apart from some fairly obscure testimony, no professional organizations have pointed this out? How is it in an era where governments at all levels seem to demand evidence based care, that a lead agency on mental health promotes treatment that has no evidence basis and ignores the treatment that is evidence based?
Having been a long time advocate for the prevention of violence by the treatment of severe mental illnesses my comments parallel those of the authors. Inpatient bed capacity in psychiatry has been decimated. They point out that there are only 5% of the public psychiatry beds available that there were 50 years ago. It is well known that people with mental illnesses are being incarcerated in record numbers and some of the nation's county jails have become the largest psychiatric institutions. Where are all of the civil liberties advocates trying to get the mentally ill out of jail?
Only a small portion of the beds available can be used for potentially violent or aggressive patients and that number gets much smaller if a violent act has actually been committed. Most of the bed capacity in this country is under the purview of some type of managed care organization and that reduces the likelihood of adequate assessment or treatment. The discharge plan in some cases is to just put the patient on a bus to another state.
Community psychiatry is a valuable unmentioned resource in this area. In most of the individual cases mentioned in this article, the lack of insight into mental illness or anosognosia is prominent. It is not reasonable to expect that a person with anosognosia will follow up with outpatient appointments or even continue to take a medication that treats their symptoms into remission. Active treatment in the community by a psychiatrists and a team who knows the patient and their family is the best way to proceed. All of this active treatment has been cost shifted out of insurance coverage and is subject to budget cuts at the county and state level.
Civil commitment laws and proceedings are probably the weakest link in treatment. Further cost shifting occurs and violent patients often end up aggregating in the counties with the most resources. Even while they are there, many courts hear (from a budgetary perspective) that they are committing too many people and the interpretation of the commitment law becomes more liberal until there is an incident that leads to the interpretation tightening up again. Bureaucrats involved often become libertarians and suggest that commitment can occur only if an actual violent incident has happened rather than the threat of violence.
Although Torrey and Jaffe are using the extreme situation of violence in the seriously mentally ill to make their point, the majority of the seriously mentally ill are not violent. They need the same resources. It has been thirty years of systematic discrimination against these people, their families and the doctors trying to treat them that has led to these problems. I pointed out earlier on this blog the problem I have with SAMHSA and the use of the term "behavioral health". The problems with SAMHSA and current federal policy are covered in this article and I encourage anyone with an interest to read it. If history is any indication, I don't expect anything serious to come of the criticism. I anticipate a lot of rhetorical blow back at Dr. Torrey. But as a psychiatrist who has worked in these environments for most of my career, his analysis of the problem is right on the mark.
George Dawson, MD, DFAPA
E. Fuller Torrey & D.J. Jaffe. After Newtown. National Review Online.
White House. Now Is The Time. The President's plan to protect our children and our communities by reducing gun violence. January 16, 2013.
Saturday, August 17, 2013
Straight Talk About the Government Dismantling Care for Serious Mental Illness
Tuesday, August 13, 2013
Lessons on Medical Pricing and Service from My Toyota Dealer
I really like my Toyota dealer. They advertise that they are one of the most successful dealerships in Minnesota and I have no reason to doubt that. Everytime I end up waiting in their customer service area there are anywhere from 30 - 50 people waiting with me. Everybody checks out at the same cashier. Everybody hears the conversation between the customer and the service manager and basically the fact that the customers seem uniformly satisfied and all of their problems have been addressed. As I sat there today looking at a long line of satisfied customers I thought of a comparison with medicine.
Let me start off discussing my parallel by saying that I have always been a proponent of medical pricing being one of the most significant problems in health care. The example that I frequently post is the difference between an MRI scan of the cervical spine in Japan ($150) to the cost of the same scan in the US ($1200). But in other posts I have compared the costs of formulary to non-formulary drugs and the steep discounts that frequently apply to services by physicians. Economist Ed Lotterman discusses the effects of price discrimination in health care at this link and the reason why health care companies do it. They make more money even though they end up charging much higher prices to the people who can afford it the least. There are many other subtle (if you don't think about it too long) ways of rationing medical services to provide a high volume low quality product that really does not address the problems that most people want. As an example, I was shocked in 1987 when I encountered for the very first time a physician who refused to answer any questions about a "second" problem. He was obviously annoyed when I asked him about a medical concern that was not identified as the reason for the appointment, even though I am certain he could have answered the question in two minutes. The people at my Toyota dealer frequently have two or three or even five problems and the service manager calmly explains what has been done or what the cost will be in the event of a major repair.
As I thought more about it, my name was eventually called and I walked over to pick up the car and review what had been done. I thought I might need a price list for a comparison, so I walked back out into the service area and talked to a service manager who looked like he was about my age. I asked him for a price list and thought about what kind of reaction that would get in a medical clinic - not just the price list but asking additional questions after the appointment with the doctor was officially over. He enthusiastically replied: "No problem at all sir. It is tricky to find on our web site. Let me show you how to get it there. And let me print it out for you. My usual printer doesn't do a good job, so let me send it to a better network printer." Within a minute it was in my hand. None of the gasping and eye rolling that you might expect in a medical clinic.
What is a fair comparison? I decided against emergency departments. Car repairs are generally not life or death, even though a lot of people with non-emergency problems end up staying in emergency departments for a long time. I decided that urgent care and primary care clinics were problems the best comparisons. The Toyota dealer has three levels of maintenance based on mileage or time:
The price list shows all of the specific tasks that this dealer does for car maintenance and the task list is longer as the price increases. I can't post any medical comparisons because the actual price that you will pay is unknown. If you are insured, your insurance company generally negotiates prices with a clinic that are generally much lower than you would pay if they billed you their usual retail price. Practically all physician billing would occur at the Green or Blue Service level. As I look at the Yellow service, it is strictly maintenance without the services of a diagnostician. How many times have you had to see a doctor in order to get lab tests or an x-ray? There are a list of things you can get from Toyota without seeing a mechanic.
What about affordability? Everybody in the service center today was driving a Toyota ranging from essentially new to at least 6 years old (the age of my car). Everyone with a fairly new car wants to keep the warranty current by doing the suggested maintenance. There will always be some outliers who never change their oil, but let's assume that people generally want to protect their investment for at least 6 years or 100,000 miles. What is the trade off in terms of investment at risk driving service fees? If we look at the current per capita health care expenditure in the US it stands at $8,233 per person per year. According to the Kaiser Family Foundation in 2012, the average cost of insurance for a family was $15,745 with the worker paying $4, 316. Worker only coverage averaged $5,615 per year with the annual cost to the worker of $951. The current cost of health care for a retired couple at age 65 with Medicare is estimated to be $220,000, not including nursing home care.
The 5 or 6 year cost of health insurance for a family costs the same amount as just about any brand new Toyota on the lot. There are a couple of potential questions about the value of the purchase. If we are considering non emergency and routine medical care, does the purchaser of health insurance get the same value as the purchaser of a new Toyota? Or is medical insurance purchased strictly to protect the family against bankruptcy associated with a medical catastrophe? And do your get the same level of service?
On the service level, I don't think that primary care or urgent care clinics can compare to my Toyota dealer. I just learned today that they are open until midnight and they see all of the walk ins who want to be seen at all times. Their pricing is completely transparent and affordable to everyone who pays the same amount for health insurance that they would pay to purchase a new Toyota every 6 years. That is basically any family purchasing health insurance. Technology is a frequent argument to justify the high cost of American medicine, but people purchasing hybrids are the beneficiaries of a $6 billion research project by Toyota that put them at the forefront of that technology and made it as cost effective as purchasing any other new car. Technological innovation like that in medicine rarely translates into a cost effective solution for patients that quickly.
Without government mandates and the threat of bankruptcy, I think health insurance would be a very difficult product to sell based solely on market factors and the actual service you get for the money. That is what health care companies like to call value. I guess the bright side is that we all don't have to purchase an insurance product that would allow us to get a new car. It is hard to imagine how bad that product and the service of that product would be.
George Dawson, MD, DFAPA
Disclosure: Not a stockholder in Toyota. My only interest in Toyota is in keeping my car running well.
References:
Ed Lotterman. Price discrimination: Free market at work. November 15, 2009.
Ed Lotterman. Trip to hospital illustrates complexities of health care pricing. December 23, 2012.
Let me start off discussing my parallel by saying that I have always been a proponent of medical pricing being one of the most significant problems in health care. The example that I frequently post is the difference between an MRI scan of the cervical spine in Japan ($150) to the cost of the same scan in the US ($1200). But in other posts I have compared the costs of formulary to non-formulary drugs and the steep discounts that frequently apply to services by physicians. Economist Ed Lotterman discusses the effects of price discrimination in health care at this link and the reason why health care companies do it. They make more money even though they end up charging much higher prices to the people who can afford it the least. There are many other subtle (if you don't think about it too long) ways of rationing medical services to provide a high volume low quality product that really does not address the problems that most people want. As an example, I was shocked in 1987 when I encountered for the very first time a physician who refused to answer any questions about a "second" problem. He was obviously annoyed when I asked him about a medical concern that was not identified as the reason for the appointment, even though I am certain he could have answered the question in two minutes. The people at my Toyota dealer frequently have two or three or even five problems and the service manager calmly explains what has been done or what the cost will be in the event of a major repair.
As I thought more about it, my name was eventually called and I walked over to pick up the car and review what had been done. I thought I might need a price list for a comparison, so I walked back out into the service area and talked to a service manager who looked like he was about my age. I asked him for a price list and thought about what kind of reaction that would get in a medical clinic - not just the price list but asking additional questions after the appointment with the doctor was officially over. He enthusiastically replied: "No problem at all sir. It is tricky to find on our web site. Let me show you how to get it there. And let me print it out for you. My usual printer doesn't do a good job, so let me send it to a better network printer." Within a minute it was in my hand. None of the gasping and eye rolling that you might expect in a medical clinic.
What is a fair comparison? I decided against emergency departments. Car repairs are generally not life or death, even though a lot of people with non-emergency problems end up staying in emergency departments for a long time. I decided that urgent care and primary care clinics were problems the best comparisons. The Toyota dealer has three levels of maintenance based on mileage or time:
Yellow Service
|
Every 4 months
|
$72.95
|
Green Service
|
Every 12 months
|
$219
|
Blue Service
|
Every 24 months
|
$379
|
Friday, August 9, 2013
Don Draper loses it - Can he be saved?
Don Draper, the main character in AMC's MadMen is without a doubt the most complicated character I have ever seen on television. I have often thought about whether or not I have seen him over the years. What would be the most likely way that he would come to the attention of a psychiatrist? I can remember several years ago he went in to see his primary care physician and was told that he had hypertension (150/100). The prescribed course of action was a combination of a barbiturate and reserpine. Being seen as a complication of that therapy might be one way. He also has demonstrated that he has a progressive problem with alcohol. Everyone on MadMen drinks at work, and it is typically hard liquor. At one level it seems to be part of the Madison Avenue culture, but Don has taken it many steps beyond that to overt intoxication and vomiting in the office. Even in the 1960s, this behavior could result in a period of detoxification and residential treatment. If he really was mixing alcohol with barbiturates that is a setup for an accidental overdose or a withdrawal seizure.
Another avenue to consultation might have to do with his philandering behavior. Over the course of the show he has had two wives and he has had extramarital affairs in both marriages. During his second marriage, he befriends a cardiothoracic surgeon in his building. He admires this man and he seems like the only real friendship that Draper has been interested in over the course of the series. That does not deter him from sleeping with the surgeon's wife. During his previous marriage, he had affairs with numerous women resulting in his wife finding out and on one occasion he was punched in the face by an irate husband. None of that has had much of an impact on his lifestyle that consists of drinking a lot at work and frequently using work as an excuse to neglect his wife and family and continue extramarital sex.
Whenever I think of philandering, I think of Frank Pittman's work that I read fresh out of residency training. In outpatient practice, anxious and depressed persons have two major sources of stress - their job and their significant relationship. It is fairly common to see significant others and spouses during the treatment of an individual. The usual requests are for a basic explanation of the diagnosis and treatment plan, but in more complicated circumstances an analysis of the spouses behavior. I think that Pittman may have seen Don Draper as a subtype of philanderer that he refers to as a "hostile philanderer" who is not empathic toward women. A more psychodynamic approach might suggest that Draper is narcissistic and that might be the driving force behind his lack of empathy. In either case, the therapy focused on this problem is complicated and requires skills that focus on neutrality and a focus on the goals of therapy rather than an endless description of the problem.
A more recent approach might employ a model of sexual addiction rather than looking at the problem as repetitive marital infidelity. One of the conceptualizations of the problem is that it can be a behavioral addiction like food and gambling and that it involves and activates the same neurobiological substrates that addictive drugs and alcohol do. Some authors have developed criteria sets for sexual addiction based on the characteristics of substance use disorders, but this disorder is not listed in the main DSM or the section on "Conditions for Further Study." Some people will come in for assessment based on someone telling them that they have a sex addiction or their participation in 12-step recovery groups with that focus. Experts in the field have produced reviews of psychotherapy and pharmacotherapy that might be useful for this problem, but at this point most psychiatrists would see this as an issue for psychotherapy and would have reservations about the medical treatment of a model that has not been widely accepted.
There is also a more biological approach to infidelity. Some people may present with requests for a medication that has decreased libido as a side effect or a medication that produces that result by its physiological effect.
In the season 6 finale, Don Draper is trying to seal an advertising deal with Hershey. The staff knows they are swimming up stream, because Hershey has outstanding brand recognition and packaging. Don has to sell them on a campaign that takes their advertising to a new level. He tells a poignant story about mowing the lawn as a kid and his father taking him to the store later so that he could buy a Hershey bar. That candy symbolizing the bond between a father and son and a bridge to those memories in the past. His associates in the room are beaming. They think he has hit it out of the park. A few minutes later, he tells everyone in the room that the story he has just told never happened. He says he was raised in a "whorehouse" and one of the prostitutes would ask him to go through the trousers of her clients, looking for extra money. He would get some of that change and buy a Hershey bar. When he ate it he was living vicariously like the kid in his original story.
Can Don Draper be saved? In a way he already has. He was at a clear disadvantage in terms of childhood trauma and adapted to that by becoming somebody who he was not and trying to consciously block out that previous existence. We get a glimpse of one of his strategies from an earlier scene. I think that from an artistic point of view the writers are saying that he cannot. He could no longer suppress the truth about himself at a critical juncture in his career. That is true not only with his clients and coworkers but also with his children. In the final scene of the season, he is standing with his children in front of the whorehouse where he was raised. His daughter looks at him for some kind of reaction.
From a psychiatric standpoint the answer is a qualified yes. Certainly any psychiatrist could come up with a plan that might address some of the areas highlighted above. It would take a comprehensive formulation of his problems. Framing the problem as simple anxiety or depression or some other DSM-5 diagnosis is an obvious mistake. In many practice settings that pressure is there. There is also the chance that he might walk into an AA meeting for any number of reasons and make some changes to get his life back on track. He might even get some advice from a friend or coworker about a particular aspect of his problems that he might decide to pursue and that could lead to some changes. The main drawback to advice from a peer is that he has no peers and no close friends. Human consciousness is complex and there are many roads to change.
George Dawson, MD, DFAPA
Frank Pittman. Private Lies - Infidelity and the Betrayal of Intimacy. WW Norton and Company, New York, 1989.
Shoptaw SJ. Sexual addiction in Ries R, Fiellin DA, Miller SC, Saitz R. Principles of Addiction Medicine. 4th ed. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins; 2009: pp 519-530.
Another avenue to consultation might have to do with his philandering behavior. Over the course of the show he has had two wives and he has had extramarital affairs in both marriages. During his second marriage, he befriends a cardiothoracic surgeon in his building. He admires this man and he seems like the only real friendship that Draper has been interested in over the course of the series. That does not deter him from sleeping with the surgeon's wife. During his previous marriage, he had affairs with numerous women resulting in his wife finding out and on one occasion he was punched in the face by an irate husband. None of that has had much of an impact on his lifestyle that consists of drinking a lot at work and frequently using work as an excuse to neglect his wife and family and continue extramarital sex.
Whenever I think of philandering, I think of Frank Pittman's work that I read fresh out of residency training. In outpatient practice, anxious and depressed persons have two major sources of stress - their job and their significant relationship. It is fairly common to see significant others and spouses during the treatment of an individual. The usual requests are for a basic explanation of the diagnosis and treatment plan, but in more complicated circumstances an analysis of the spouses behavior. I think that Pittman may have seen Don Draper as a subtype of philanderer that he refers to as a "hostile philanderer" who is not empathic toward women. A more psychodynamic approach might suggest that Draper is narcissistic and that might be the driving force behind his lack of empathy. In either case, the therapy focused on this problem is complicated and requires skills that focus on neutrality and a focus on the goals of therapy rather than an endless description of the problem.
A more recent approach might employ a model of sexual addiction rather than looking at the problem as repetitive marital infidelity. One of the conceptualizations of the problem is that it can be a behavioral addiction like food and gambling and that it involves and activates the same neurobiological substrates that addictive drugs and alcohol do. Some authors have developed criteria sets for sexual addiction based on the characteristics of substance use disorders, but this disorder is not listed in the main DSM or the section on "Conditions for Further Study." Some people will come in for assessment based on someone telling them that they have a sex addiction or their participation in 12-step recovery groups with that focus. Experts in the field have produced reviews of psychotherapy and pharmacotherapy that might be useful for this problem, but at this point most psychiatrists would see this as an issue for psychotherapy and would have reservations about the medical treatment of a model that has not been widely accepted.
There is also a more biological approach to infidelity. Some people may present with requests for a medication that has decreased libido as a side effect or a medication that produces that result by its physiological effect.
In the season 6 finale, Don Draper is trying to seal an advertising deal with Hershey. The staff knows they are swimming up stream, because Hershey has outstanding brand recognition and packaging. Don has to sell them on a campaign that takes their advertising to a new level. He tells a poignant story about mowing the lawn as a kid and his father taking him to the store later so that he could buy a Hershey bar. That candy symbolizing the bond between a father and son and a bridge to those memories in the past. His associates in the room are beaming. They think he has hit it out of the park. A few minutes later, he tells everyone in the room that the story he has just told never happened. He says he was raised in a "whorehouse" and one of the prostitutes would ask him to go through the trousers of her clients, looking for extra money. He would get some of that change and buy a Hershey bar. When he ate it he was living vicariously like the kid in his original story.
Can Don Draper be saved? In a way he already has. He was at a clear disadvantage in terms of childhood trauma and adapted to that by becoming somebody who he was not and trying to consciously block out that previous existence. We get a glimpse of one of his strategies from an earlier scene. I think that from an artistic point of view the writers are saying that he cannot. He could no longer suppress the truth about himself at a critical juncture in his career. That is true not only with his clients and coworkers but also with his children. In the final scene of the season, he is standing with his children in front of the whorehouse where he was raised. His daughter looks at him for some kind of reaction.
From a psychiatric standpoint the answer is a qualified yes. Certainly any psychiatrist could come up with a plan that might address some of the areas highlighted above. It would take a comprehensive formulation of his problems. Framing the problem as simple anxiety or depression or some other DSM-5 diagnosis is an obvious mistake. In many practice settings that pressure is there. There is also the chance that he might walk into an AA meeting for any number of reasons and make some changes to get his life back on track. He might even get some advice from a friend or coworker about a particular aspect of his problems that he might decide to pursue and that could lead to some changes. The main drawback to advice from a peer is that he has no peers and no close friends. Human consciousness is complex and there are many roads to change.
George Dawson, MD, DFAPA
Frank Pittman. Private Lies - Infidelity and the Betrayal of Intimacy. WW Norton and Company, New York, 1989.
Shoptaw SJ. Sexual addiction in Ries R, Fiellin DA, Miller SC, Saitz R. Principles of Addiction Medicine. 4th ed. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins; 2009: pp 519-530.
Monday, August 5, 2013
Asthma Endophenotypes? Their Implications for Psychiatry
Asthma is an annoying and sometimes fatal disease. I have first hand experience with it because I have had asthma for at least 40 years. Like many of my personal medical afflictions that I have posted about on this blog it was initially missed and not treated. According to recent studies, that is still a common experience. When I was a teenager, wheezing when mowing the lawn was apparently considered a normal reaction. When I developed a more systemic reaction right in a physician's office, my parents were taken into an adjacent room and advised that it was apparently all "in my head" and it was some sort of psychosomatic reaction. The psychosomatic reaction responded well to epinephrine injections and diphenhydramine. Even when I was in medical school the treatment of asthma was shaky. I was taking theophylline pills twice a day for several years and the patients I began treating for exacerbations of chronic obstructive pulmonary disease were all on aminophylline drips and corticosteroids. We all had to memorize those protocols and of course know the mechanism of action (now invalidated) that was based on Sutherland's Nobel Prize winning work on cyclic AMP. Today theophylline is considered a tertiary option for uncontrolled asthma rather than a first line treatment.
As a fourth year medical student, I presented a very well received seminar on "slow reacting substance of anaphylaxis" or SRS-A now known to be a mixture of leukotrienes. Eventually the treatment of asthma changed and glucocorticoid inhalers became the treatment of choice for a while. As any primary care physician or asthmatic patient knows - no two asthmatic patients are the same. As an example, peak flow meters are routinely used to measure asthmatic control. No matter how badly I am wheezing, I can always max out that peak flow meter. Asthma is a complex disease with varied presentations and the current treatment algorithms are complex with varied medications.
The diagnostic criteria of asthma seem relatively straightforward and are listed in the table below:
Medicine texts have traditionally used breakpoints in the above parameters to distinguish mild, moderate and severe asthma. Despite what seem to be clear diagnostic criteria a recent review (8) in the New England Journal of Medicine states: "Most patients with asthma have mild persistent disease which tends to be underdiagnosed, undertreated, and inadequately controlled." The reference cited in that review points out that only 1 in 7 patients achieved good control of their asthma.
There has been a sudden surge in research on asthma phenotypes, endotypes, and endophenotypes. Endophenotypes are subtypes of a particular phenotype that are thought to have a common pathophysiological mechanism or in the case of psychiatry a biochemical, neurophysiological, neuropsychological maker that allows for the subclassification. If you have attended any serious psychiatric genetics course in the past decade you have probably heard about endophenotypes. Gottesman and Gould published a widely cited paper in the American Journal of Psychiatry in 2003 discussed the concept and its application in psychiatry. There have been 132 references to papers on endophenotype in the Schizophrenia Bulletin alone, including a special theme issue.
A group of 5 asthma endotypes have been suggested by Corren (7). He uses the definition of endotype as "a subtype of a condition defined by a distinct pathophysiological mechanism." The classification was a consensus of experts looking at clinical characteristics, biomarkers, lung physiology, genetics, histopathology, and treatment response. The following 5 endotypes were identified.
George Dawson, MD, DFAPA
1: Barranco P, Pérez-Francés C, Quirce S, Gómez-Torrijos E, Cárdenas R, Sánchez-GarcÃa S, RodrÃguez-Fernández F, Campo P, Olaguibel JM, Delgado J; Severe Asthma Working Group of the SEAIC Asthma Committee. Consensus document on the diagnosis of severe uncontrolled asthma. J Investig Allergol Clin Immunol. 2012;22(7):460-75; quiz 2 p following 475. PubMed PMID: 23397668.
2: Simon T, Semsei AF, Ungvári I, Hadadi E, Virág V, Nagy A, Vangor MS, László V, Szalai C, Falus A. Asthma endophenotypes and polymorphisms in the histamine receptor HRH4 gene. Int Arch Allergy Immunol. 2012;159(2):109-20. doi: 10.1159/000335919. Epub 2012 May 30. PubMed PMID: 22653292.
As a fourth year medical student, I presented a very well received seminar on "slow reacting substance of anaphylaxis" or SRS-A now known to be a mixture of leukotrienes. Eventually the treatment of asthma changed and glucocorticoid inhalers became the treatment of choice for a while. As any primary care physician or asthmatic patient knows - no two asthmatic patients are the same. As an example, peak flow meters are routinely used to measure asthmatic control. No matter how badly I am wheezing, I can always max out that peak flow meter. Asthma is a complex disease with varied presentations and the current treatment algorithms are complex with varied medications.
The diagnostic criteria of asthma seem relatively straightforward and are listed in the table below:
Diagnosis of Asthma (see additional details in National Heart, Lung and Blood Institute reference) and reference 8 below:
|
1. Recurrent symptoms of airflow
obstruction or airway hyperresponsiveness (eg. wheezing, chest tightness, cough, shortness of breath.)
2. Objective assessment as
evidenced by:
A.
Airflow obstruction as least
partially reversible by inhaled short acting beta2 agonists as demonstrated by any of the
following:
-
Increase in FEV1 of ≥ 12% from
baseline
-
Increase in predicted FEV1 of ≥ 10%
from baseline
-
Increase in PEF (liters/minute) of ≥ 20% from baseline
B. Diurnal variation in PEF of more than 10%
C. No other causes of obstruction
|
FEV1 = forced expiratory volume in 1 second (liters)
PEF = peak expiratory flow
|
A group of 5 asthma endotypes have been suggested by Corren (7). He uses the definition of endotype as "a subtype of a condition defined by a distinct pathophysiological mechanism." The classification was a consensus of experts looking at clinical characteristics, biomarkers, lung physiology, genetics, histopathology, and treatment response. The following 5 endotypes were identified.
Asthma Endotypes
|
|
Allergic Asthma
|
Childhood onset, hypersensitivity to airborne allergens, Th2 mediated inflammatory process, eosinophilia of blood and airways, inhaled corticosteroids less effective, IgE antagonists are more effective.
|
Aspirin exacerbated respiratory disease (AERD)
|
Chronic rhinosinusitis with nasal polyps, severe bronchospasm if NSAIDs are ingested, marked blood and airway eosinophilia, increased expression of leukotriene C4 synthetase, response to cysteinyl leukotriene receptor antagonists and 5-lipoxyenase inhibitors
|
Allergic bronchopulmonary mycosis (ABPM)
|
Colonization of airways by Aspergillus fumigatus, increased fungal specific IgE and IgG, elevated blood eosinophil and total IgE levels, elevated airway eosinophils and neutrophils, requires oral corticosteroids and antifungals
|
Late Onset Asthma
|
Pulmonary function testing is more impaired than allergic asthma, marked eosinophilia in blood and airways, need oral corticosteroids. May be mediated by IL-5.
|
Cross country skiing induced asthma (CCSA)
|
Triggered by exposure to cold dry air and intense exercise, not usually due to allergies, inflammatory infiltrate consists of lymphocytes, macrophages, and neutrophils rather than eosinophils, airway remodeling with thickened basement membrane, not usually responsive to inhaled corticosteroids.
|
The tables on diagnosis and endophenotype are remarkable for their parallels with psychiatric diagnosis and research. The available endotypes do probably not capture all of the clinical scenarios of asthma because patient behavior is a significant factor. The endotype classification of asthma by experts is interesting in that it includes a treatment response dimension and this has been avoided in psychiatry at the diagnostic level.
Like mental illnesses, asthma is a complex polygenic disease with considerable clinical heterogeneity. Using endophenotype approaches very similar to the approaches that have been applied to the study of schizophrenia offers the hope that classification and treatments of subtypes will be more effective and the connection between the genetics of the illness, pathophysiological mechanisms, and subtype will become more apparent. Although the parallels with mental illness are clear, asthma researchers and clinicians treating asthma have the advantage in that they can proceed without the stigmatization that only accompanies psychiatric disorders and psychiatrists.
Like mental illnesses, asthma is a complex polygenic disease with considerable clinical heterogeneity. Using endophenotype approaches very similar to the approaches that have been applied to the study of schizophrenia offers the hope that classification and treatments of subtypes will be more effective and the connection between the genetics of the illness, pathophysiological mechanisms, and subtype will become more apparent. Although the parallels with mental illness are clear, asthma researchers and clinicians treating asthma have the advantage in that they can proceed without the stigmatization that only accompanies psychiatric disorders and psychiatrists.
George Dawson, MD, DFAPA
1: Barranco P, Pérez-Francés C, Quirce S, Gómez-Torrijos E, Cárdenas R, Sánchez-GarcÃa S, RodrÃguez-Fernández F, Campo P, Olaguibel JM, Delgado J; Severe Asthma Working Group of the SEAIC Asthma Committee. Consensus document on the diagnosis of severe uncontrolled asthma. J Investig Allergol Clin Immunol. 2012;22(7):460-75; quiz 2 p following 475. PubMed PMID: 23397668.
2: Simon T, Semsei AF, Ungvári I, Hadadi E, Virág V, Nagy A, Vangor MS, László V, Szalai C, Falus A. Asthma endophenotypes and polymorphisms in the histamine receptor HRH4 gene. Int Arch Allergy Immunol. 2012;159(2):109-20. doi: 10.1159/000335919. Epub 2012 May 30. PubMed PMID: 22653292.
3: Matteini AM, Fallin MD, Kammerer CM, Schupf N, Yashin AI, Christensen K,
Arbeev KG, Barr G, Mayeux R, Newman AB, Walston JD. Heritability estimates of
endophenotypes of long and health life: the Long Life Family Study. J Gerontol A
Biol Sci Med Sci. 2010 Dec;65(12):1375-9. doi: 10.1093/gerona/glq154. Epub 2010
Sep 2. PubMed PMID: 20813793; PubMed Central PMCID: PMC2990267.
4: Bisgaard H, Bønnelykke K. Long-term studies of the natural history of asthma
in childhood. J Allergy Clin Immunol. 2010 Aug;126(2):187-97; quiz 198-9. doi: 10.1016/j.jaci.2010.07.011. Review. PubMed PMID: 20688204.
5: Chan IH, Tang NL, Leung TF, Huang W, Lam YY, Li CY, Wong CK, Wong GW, Lam CW.
Study of gene-gene interactions for endophenotypic quantitative traits in Chinese
asthmatic children. Allergy. 2008 Aug;63(8):1031-9.
doi: 10.1111/j.1398-9995.2008.01639.x. PubMed PMID: 18691306.
doi: 10.1111/j.1398-9995.2008.01639.x. PubMed PMID: 18691306.
6: Thompson MD, Takasaki J, Capra V, Rovati GE, Siminovitch KA, Burnham WM, Hudson TJ, Bossé Y, Cole DE. G-protein-coupled receptors and asthma endophenotypes: the cysteinyl leukotriene system in perspective. Mol Diagn Ther. 2006;10(6):353-66. Review. PubMed PMID: 17154652.
7. Corren J. Asthma phenotypes and endotypes: an evolving paradigm for classification.
Discov Med. 2013 Apr;15(83):243-9. PubMed PMID: 23636141.
8. Bel EH. Clinical Practice. Mild asthma. N Engl J Med. 2013 Aug 8;369(6):549-57.
doi: 10.1056/NEJMcp1214826. PubMed PMID: 23924005
7. Corren J. Asthma phenotypes and endotypes: an evolving paradigm for classification.
Discov Med. 2013 Apr;15(83):243-9. PubMed PMID: 23636141.
8. Bel EH. Clinical Practice. Mild asthma. N Engl J Med. 2013 Aug 8;369(6):549-57.
doi: 10.1056/NEJMcp1214826. PubMed PMID: 23924005
Sunday, July 28, 2013
Pattern Matching in Psychiatric Diagnosis
I first heard about pattern matching and the importance it has in medical diagnosis over 30 years ago. A friend of mine who was in medical school at the time told me about one of his professors who was always interested in the Augenblick diagnosis or the diagnosis that could be arrived at in the blink of an eye. He gave me examples of several diagnoses that could be either made immediately or within minutes based on a set of features that would lead to immediate associations in the mind of the clinician without an extensive evaluation.
I had many encounters in my medical training with the same phenomenon. I can recall being on the Infectious Disease consult team and being asked to see a patient with ascites for the possible diagnosis and treatment of spontaneous bacterial peritonitis. The consultant with an expert in Streptococcal infections and after patiently listening to the resident's presentation he asked what we thought of the rash on the patient's leg. The patient had lower extremity edema with a slightly erythematous hue and a slight exudate in areas. What was the diagnosis? Without skipping a beat the consultant said this was streptococcal cellulitis and suggested sending a sample to the lab for confirmation. It was subsequently confirmed and treated. Why was the attending physician able to hone in on and diagnose this rash when it escaped the detection of two Medicine residents and two medical students? He was an Infectious Disease specialist and that may have biased him in that direction but is there something else?
One of the ways that physicians and probably all classes of diagnosticians arrive at Augenblick diagnoses or efficiently clump and sort through larger amounts of information faster is by pattern matching. Pattern matching is also the reason why clinical training is necessary to become an adequate diagnostician. That will not happen with rote learning alone. It is one thing to read about heart sounds and actually experience them and to have that skill refined by listening to hundreds and thousands of normal hearts and hearts with varying degrees of pathology. Rashes are classic examples and several studies have documented that the speed and accuracy with which dermatologists can make an accurate diagnosis of a rash is much higher than the average physician. In pattern matching a recognizable feature of the patient's illness triggers an immediate association with the physicians experiences from the past leading to a facilitated diagnosis.
Probably the best conceptualizations of pattern matching comes from the fields of philosophy and cognitive science. My favorite author is Andy Clarke and his book Microcognition. He addresses the issue of biologically relevant cognitive science and the model of parallel distributed processing. A simplified diagram drawn from this model is shown below:
In this case we have a very practical problem of a patient with known bipolar disorder and a question of whether or not they have had a stroke. In this case the respective clouds (there are many more) represent collection of features of medical diagnoses that may be relevant to the case. Unlike a textbook, these features represent a lot of varied information including actual events and nonverbal information like the clinicians past history of diagnosing strokes and caring for people who have had strokes. Each cloud here can contain hundreds or tens of thousands of these features. These features are unique aspects of the clinician conscious state and the only way to control for variability between clinicians is to assure that physicians in the same speciality have similar exposure to these experiences in their training. Even in the ideal situation where all specialists have an identical exposure to the same illness there will be variability based on different levels of ability and other capacities. An example would be a Medicine resident I worked with whose examination of the heart with a stethoscope predicted the echocardiogram results. It became kind of a joke on our team at the time that all he had to do was hold his stethoscope in the air in a patient's room and it was as good as an ultrasound.
The basic idea in pattern matching is that the clinician immediately recognizes one of the features they know and that allows for a rapid diagnosis or plan based on that feature. Looking how that works in the hypothetical case we can look at a few features in the map:
For the purpose of this discussion consider that our patient B is a 60 year old woman with a 35 year history of known bipolar disorder. She has known her psychiatrist for years. One day the husband calls with the concern that the patient seems to have developed a problem with communication. She seems to be talking in her usual voice but he can't comprehend what she is saying. She does not appear to be manic or depressed. The psychiatrist listens to the patient on the phone and concludes that she has a fluent aphasia and recommends that they take her to the emergency department as soon as possible. Ongoing care requires that the psychiatrist talk with the emergency department physician and hospitalist to make sure that acute stroke is high in their differential diagnosis and eventually go in to the hospital and examine the patient to confirm the diagnosis.
Practically all cases of psychiatric diagnosis require some measure of this pattern matching process with varying degrees of medical acuity. I would go so far to suggest that it is the most important aspect of the diagnosis. Keep in mind that the pattern matching also applies to the purely psychiatric part of the diagram. Despite all of the recent criticism and focus on the DSM 5 the elaboration of pattern matching leads us to several important conclusions:
1. Psychiatric diagnosis is a much more dynamic process than rote learning from a diagnostic manual. The average clinician should have many more features of diagnoses than are listed in any manual.
2. Psychiatric diagnosis requires medical training. There is no way that our psychiatrist in the example could have made the diagnosis of aphasia and remain involved in the diagnostic process to its conclusion without medical training and previous exposures to these scenarios.
3. The training implications of these scenarios are not often made explicit. Every medical student, resident and practicing physician needs to be exposed to a diverse population of patients with problems in their area of expertise in order to develop a pattern matching capability. They can also benefit by asking attending clinicians about how they made rapid diagnoses, but at that level of training the question is not obvious.
4. Removing physicians with these capabilities from the diagnostic loop reduces the capability of that loop. The best example I can continue to think of is the primary care process where the diagnosis and ongoing treatment of depression or anxiety depends on the results of a checklist that the patient completes in less than 5 minutes. This assumes that there is an entity out there called depression that is based purely on a verbal description and pattern matching is not required. It actually assumes that there is a population of people with this affliction. Despite all of the hype about how this is "measurement based care" - I don't think that a single person like that exists.
5. Pattern matching blurs the line between objective and subjective. There is often much confusion about this line. Are there "objective criteria" that can be written in a manual somewhere that captures even the basic essence of diagnosing a stroke in a patient with bipolar disorder? Is there an "objective" checklist out there somewhere that can capture the problem? Obviously not. For some reason people tend to equate "subjective" with "bad" or "unscientific". In the example given and any similar example, the subjective state with the most experience diagnosing strokes is probably the "best" diagnostician - subjective or not. An "objective" rating scale doesn't stand a chance.
So consider pattern matching to be an important but unspoken part of the diagnostic process. For obvious reasons it is more important than diagnostic criteria in a manual. The most obvious of these reasons is that you really cannot practice medicine without it.
George Dawson, MD, DFAPA
Clark A. Microcognition. London, A Bradford Book, 1991.
I had many encounters in my medical training with the same phenomenon. I can recall being on the Infectious Disease consult team and being asked to see a patient with ascites for the possible diagnosis and treatment of spontaneous bacterial peritonitis. The consultant with an expert in Streptococcal infections and after patiently listening to the resident's presentation he asked what we thought of the rash on the patient's leg. The patient had lower extremity edema with a slightly erythematous hue and a slight exudate in areas. What was the diagnosis? Without skipping a beat the consultant said this was streptococcal cellulitis and suggested sending a sample to the lab for confirmation. It was subsequently confirmed and treated. Why was the attending physician able to hone in on and diagnose this rash when it escaped the detection of two Medicine residents and two medical students? He was an Infectious Disease specialist and that may have biased him in that direction but is there something else?
One of the ways that physicians and probably all classes of diagnosticians arrive at Augenblick diagnoses or efficiently clump and sort through larger amounts of information faster is by pattern matching. Pattern matching is also the reason why clinical training is necessary to become an adequate diagnostician. That will not happen with rote learning alone. It is one thing to read about heart sounds and actually experience them and to have that skill refined by listening to hundreds and thousands of normal hearts and hearts with varying degrees of pathology. Rashes are classic examples and several studies have documented that the speed and accuracy with which dermatologists can make an accurate diagnosis of a rash is much higher than the average physician. In pattern matching a recognizable feature of the patient's illness triggers an immediate association with the physicians experiences from the past leading to a facilitated diagnosis.
Probably the best conceptualizations of pattern matching comes from the fields of philosophy and cognitive science. My favorite author is Andy Clarke and his book Microcognition. He addresses the issue of biologically relevant cognitive science and the model of parallel distributed processing. A simplified diagram drawn from this model is shown below:
In this case we have a very practical problem of a patient with known bipolar disorder and a question of whether or not they have had a stroke. In this case the respective clouds (there are many more) represent collection of features of medical diagnoses that may be relevant to the case. Unlike a textbook, these features represent a lot of varied information including actual events and nonverbal information like the clinicians past history of diagnosing strokes and caring for people who have had strokes. Each cloud here can contain hundreds or tens of thousands of these features. These features are unique aspects of the clinician conscious state and the only way to control for variability between clinicians is to assure that physicians in the same speciality have similar exposure to these experiences in their training. Even in the ideal situation where all specialists have an identical exposure to the same illness there will be variability based on different levels of ability and other capacities. An example would be a Medicine resident I worked with whose examination of the heart with a stethoscope predicted the echocardiogram results. It became kind of a joke on our team at the time that all he had to do was hold his stethoscope in the air in a patient's room and it was as good as an ultrasound.
The basic idea in pattern matching is that the clinician immediately recognizes one of the features they know and that allows for a rapid diagnosis or plan based on that feature. Looking how that works in the hypothetical case we can look at a few features in the map:
For the purpose of this discussion consider that our patient B is a 60 year old woman with a 35 year history of known bipolar disorder. She has known her psychiatrist for years. One day the husband calls with the concern that the patient seems to have developed a problem with communication. She seems to be talking in her usual voice but he can't comprehend what she is saying. She does not appear to be manic or depressed. The psychiatrist listens to the patient on the phone and concludes that she has a fluent aphasia and recommends that they take her to the emergency department as soon as possible. Ongoing care requires that the psychiatrist talk with the emergency department physician and hospitalist to make sure that acute stroke is high in their differential diagnosis and eventually go in to the hospital and examine the patient to confirm the diagnosis.
Practically all cases of psychiatric diagnosis require some measure of this pattern matching process with varying degrees of medical acuity. I would go so far to suggest that it is the most important aspect of the diagnosis. Keep in mind that the pattern matching also applies to the purely psychiatric part of the diagram. Despite all of the recent criticism and focus on the DSM 5 the elaboration of pattern matching leads us to several important conclusions:
1. Psychiatric diagnosis is a much more dynamic process than rote learning from a diagnostic manual. The average clinician should have many more features of diagnoses than are listed in any manual.
2. Psychiatric diagnosis requires medical training. There is no way that our psychiatrist in the example could have made the diagnosis of aphasia and remain involved in the diagnostic process to its conclusion without medical training and previous exposures to these scenarios.
3. The training implications of these scenarios are not often made explicit. Every medical student, resident and practicing physician needs to be exposed to a diverse population of patients with problems in their area of expertise in order to develop a pattern matching capability. They can also benefit by asking attending clinicians about how they made rapid diagnoses, but at that level of training the question is not obvious.
4. Removing physicians with these capabilities from the diagnostic loop reduces the capability of that loop. The best example I can continue to think of is the primary care process where the diagnosis and ongoing treatment of depression or anxiety depends on the results of a checklist that the patient completes in less than 5 minutes. This assumes that there is an entity out there called depression that is based purely on a verbal description and pattern matching is not required. It actually assumes that there is a population of people with this affliction. Despite all of the hype about how this is "measurement based care" - I don't think that a single person like that exists.
5. Pattern matching blurs the line between objective and subjective. There is often much confusion about this line. Are there "objective criteria" that can be written in a manual somewhere that captures even the basic essence of diagnosing a stroke in a patient with bipolar disorder? Is there an "objective" checklist out there somewhere that can capture the problem? Obviously not. For some reason people tend to equate "subjective" with "bad" or "unscientific". In the example given and any similar example, the subjective state with the most experience diagnosing strokes is probably the "best" diagnostician - subjective or not. An "objective" rating scale doesn't stand a chance.
So consider pattern matching to be an important but unspoken part of the diagnostic process. For obvious reasons it is more important than diagnostic criteria in a manual. The most obvious of these reasons is that you really cannot practice medicine without it.
George Dawson, MD, DFAPA
Clark A. Microcognition. London, A Bradford Book, 1991.
Sunday, July 21, 2013
Why A Checklist is Not A Psychiatric Diagnosis
I was inspired by a post by Massimo Pugliucci on his excellent philosophy blog Rationally Speaking, to start using concept mapping software to describe some of the things that psychiatrists do and rarely get credit for. There is the associated problem (as I have posted here many times) of checklists being seen as the equivalent of a psychiatric diagnosis. That has been carried to the extreme that some have said rating scales are actual "measurements" or validating markers of psychiatric diagnosis. Any cursory inspection of the combination of parallel and sequential processes that actually occur during an interview will demonstrate that is not remotely accurate.
Click on this link for the actual concept map. A click on the diagram will zoom it for viewing. Another click will zoom out. Navigate by mouse wheel or scroll bars. It should print out onto one standard sheet of paper in a landscape view.
I am interested in feedback from psychiatrists on what aspects they would modify. If you have suggestions about what should be modified post them in the comments section or send me an e-mail.
The concept map may also be useful for explaining some findings that are commonly held up as "problems" with the diagnosis such as low reliability. A common ( and purely hypothetical) example would be the 35 year old patient with a clear diagnosis of depression as a teenager, no history of remission of symptoms and multiple antidepressant trials who develops a polysubstance dependence (alcohol, cocaine, heroin) problem who is being seen in various states of withdrawal for the treatment of depression, insomnia and suicidal ideation. At this point does the patient have major depression, dysthymia, substance induced depression, or depression due to withdrawal symptoms? What would tell you more about this patient's problems - a psychiatric diagnosis or a PHQ-9 score? What would be more helpful in developing a treatment plan?
This answer to that question is the difference between medical quality and a term that is frequently substituted by governments and managed care companies. That term is "value". Governments and managed care companies apparently believe that giving someone an antidepressant medication for a PHQ-9 score is a better value than a psychiatric evaluation.
George Dawson, MD, DFAPA
Click on this link for the actual concept map. A click on the diagram will zoom it for viewing. Another click will zoom out. Navigate by mouse wheel or scroll bars. It should print out onto one standard sheet of paper in a landscape view.
I am interested in feedback from psychiatrists on what aspects they would modify. If you have suggestions about what should be modified post them in the comments section or send me an e-mail.
Concept Map |
The concept map may also be useful for explaining some findings that are commonly held up as "problems" with the diagnosis such as low reliability. A common ( and purely hypothetical) example would be the 35 year old patient with a clear diagnosis of depression as a teenager, no history of remission of symptoms and multiple antidepressant trials who develops a polysubstance dependence (alcohol, cocaine, heroin) problem who is being seen in various states of withdrawal for the treatment of depression, insomnia and suicidal ideation. At this point does the patient have major depression, dysthymia, substance induced depression, or depression due to withdrawal symptoms? What would tell you more about this patient's problems - a psychiatric diagnosis or a PHQ-9 score? What would be more helpful in developing a treatment plan?
This answer to that question is the difference between medical quality and a term that is frequently substituted by governments and managed care companies. That term is "value". Governments and managed care companies apparently believe that giving someone an antidepressant medication for a PHQ-9 score is a better value than a psychiatric evaluation.
George Dawson, MD, DFAPA
Saturday, July 20, 2013
Is the FDA objective enough to assess treatments in psychiatry - or is this just politics as usual?
The American Psychiatric Association (APA) feed posted a link to this FDA news release regarding a new biological test for Attention Deficit Hyperactivity disorder. The device is essentially a quantitative EEG (QEEG) machine. The QEEG heyday was back in the mid 1980s to 1990's. Devices were designed that could take the standard output of an EEG montage and look at the frequency bands and how that activity fluctuated topographically within the individual. There were two major manufacturers at the time and both of those technologies allowed for a comparison of the subjects QEEG with a standardized groups. The difference could be determined as a t or z score and that was plotted relative to the electrode placements. The final analysis would yield maps consisting of frequencies and mathematical operations on those frequencies.
There were several articles on this methodology including an impressive article in Science on the diagnostic capabilities of these instruments. One manufacturer provided an algorithm of clinical features and EEG features that purported to diagnose major psychiatric disorders. You could actually analyze the data both ways - with or without the clinical features. There was enthusiasm to the point that a new psychiatric subspecialty in electrophysiology was made to meet the requirements of psychiatrists who wanted to use QEEG technology.
In 1988, I was so impressed with the technology that I approached a potential employer and struck a bargain that I would take a salary cut if they would buy me the machine and the deal was struck. I was fortunate enough to be affiliated with a certified electrophysiology lab with an outstanding electrophysiologist and EEG technologists. This was critical in order to collect standardized data and select numerous 2 second epochs of EEG data for computerized analysis. The epochs had to be completely free of artifact in order to provide valid data for analysis and anywhere from 30 to 60 of these epochs needed to be selected per patient.
If you think about it for more than a few minutes, what is wrong with the idea that EEG frequencies should point to a specific psychiatric diagnosis? The short answer is a lack of specificity. There are literally hundreds of conditions that can lead to fast or slow frequencies including normal fluctuations of conscious states. During my QEEG work we had to collect EEG epochs for analysis in the "eyes closed but alert" state. Quantitative EEGs can demonstrate significant fluctuation in that state.
After several hundred QEEGs with and without the computerized algorithm, it was apparent that the diagnostic abilities of QEEG were low. There were literally a handful of analyses that seemed to match the clinical diagnosis and at that point we shut down the project. As far as I can tell from their web site, that company no longer sells a QEEG machine claiming to make psychiatric diagnoses.
I have not been able to locate the specific reference for this FDA approval. The FDA press release states:
"In support of the de novo petition, the manufacturer submitted data including a clinical study that evaluated 275 children and adolescents ranging from 6 to 17 years old with attention or behavioral concerns. Clinicians evaluated all 275 patients using the NEBA System and using standard diagnostic protocols, including the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision(DSM-IV-TR) criteria, behavioral questionnaires, behavioral and IQ testing, and physical exams to determine if the patient had ADHD. An independent group of ADHD experts reviewed these data and arrived at a consensus diagnosis regarding whether the research subject met clinical criteria for ADHD or another condition. The study results showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone."
From ClinicalTrials.gov that appears to be this registered clinical trial. No results are reported and there are no publications in peer reviewed journals that I can find. The concerns about this technology should be apparent from the history outlined in the above narrative and the same application suggested by the FDA. This is not a diagnostic procedure but one that is a supplement to the clinical evaluation for ADHD. It reminds me what Russell Barkley - noted ADHD expert and scholar said in a seminar I attended last fall. There are no gold standard tests for ADHD any more than there are for any other problems of executive function. He pointed out that hours of neuropsychological testing (he is a neuropsychologist) is no more accurate than standard ADHD checklists. Neuropsychological testing is important because of the high prevalence of learning disorders in ADHD.
My prediction at this point (pending an actual published research paper) is that this QEEG machine will not be that clinically useful and if it is a question of neuropsychological testing versus the QEEG, neuropsych testing should be the the option because it can detect and allow for treatment planning for any associated learning disorders and QEEG cannot. One of the risks here in an age where insurance companies deny diagnostic costs is that neuropsychological testing is denied and the QEEG substituted depending on cost. That would not allow for the recognition or treatment planning for a learning disorder.
The larger question is how competent the FDA is to make decisions on devices for psychiatric disorders? The FDA came out with a notice in 2011 that electroconvulsive therapy devices may need to be reclassified (Class II to Class III) resulting in the need for additional testing, clinical trials, and regulation. That occurred after two generations of psychiatrists were trained on the current devices and have clinically demonstrated that it is a safe, effective and in many cases life saving therapy. They completed their own study and meta-analyses and it is unclear to me what they concluded. I consider the FDA web site to essentially be unnavigable. Available information in the psychiatric literature suggests that they are still is the process of coming up with a formula for reclassification of ECT devices to a more restrictive category and that their analysis of the efficacy of ECT may have been seriously underestimated. The concern of the authors is that reclassification will restrict availability of ECT to patients who have clear indications for its use much in the same way that poor Medicare reimbursement restricts the availability in some hospitals now.
The even larger question is there some kind of systematic bias operating here? Both the ECT and QEEG decisions seem mismatched with the available science and clinical experience. The FDA has the appearance of transparency, but you can never find what you need in the thousands of web pages that are linked to the agency. In the ECT example, I could not find a clear statement, vote or conclusion about the ECT decision until I read the article by Weiner, at al. In the case of the QEEG device there is no publication of the study supporting its use. Independent review suggests that there have been no advances in the past 16 years.
George Dawson, MD, DFAPA
FDA Executive Summary. Meeting to Discuss the Classification of Electroconvulsive Therapy (ECT) Devices. January 27-28, 2011.
Weiner R, Lisanby SH, Husain MM, Morales OG, Maixner DF, Hall SE, Beeghly J,Greden JF; National Network of Depression Centers. Electroconvulsive therapy device classification: response to FDA advisory panel hearing and recommendations. J Clin Psychiatry. 2013 Jan;74(1):38-42. doi:10.4088/JCP.12cs08260. PubMed PMID: 23419224.
Sand T, Bjørk MH, Vaaler AE. Is EEG a useful test in adult psychiatry? Tidsskr Nor Laegeforen. 2013 Jun 11;133(11):1200-1204. English, Norwegian. PubMed PMID: 23759782.
Nuwer M. Assessment of digital EEG, quantitative EEG, and EEG brain mapping: report of the American Academy of Neurology and the American Clinical Neurophysiology Society. Neurology. 1997 Jul;49(1):277-92. Review. PubMed PMID: 9222209.
"E. On the basis of current clinical literature, opinions of most experts, and proposed rationales for their use,QEEG remains investigational for clinical use in postconcussion syndrome, mild or moderate head injury, learning disability, attention disorders, schizophrenia, depression, alcoholism, and drug abuse." (from Nuwer 1997)
There were several articles on this methodology including an impressive article in Science on the diagnostic capabilities of these instruments. One manufacturer provided an algorithm of clinical features and EEG features that purported to diagnose major psychiatric disorders. You could actually analyze the data both ways - with or without the clinical features. There was enthusiasm to the point that a new psychiatric subspecialty in electrophysiology was made to meet the requirements of psychiatrists who wanted to use QEEG technology.
In 1988, I was so impressed with the technology that I approached a potential employer and struck a bargain that I would take a salary cut if they would buy me the machine and the deal was struck. I was fortunate enough to be affiliated with a certified electrophysiology lab with an outstanding electrophysiologist and EEG technologists. This was critical in order to collect standardized data and select numerous 2 second epochs of EEG data for computerized analysis. The epochs had to be completely free of artifact in order to provide valid data for analysis and anywhere from 30 to 60 of these epochs needed to be selected per patient.
If you think about it for more than a few minutes, what is wrong with the idea that EEG frequencies should point to a specific psychiatric diagnosis? The short answer is a lack of specificity. There are literally hundreds of conditions that can lead to fast or slow frequencies including normal fluctuations of conscious states. During my QEEG work we had to collect EEG epochs for analysis in the "eyes closed but alert" state. Quantitative EEGs can demonstrate significant fluctuation in that state.
After several hundred QEEGs with and without the computerized algorithm, it was apparent that the diagnostic abilities of QEEG were low. There were literally a handful of analyses that seemed to match the clinical diagnosis and at that point we shut down the project. As far as I can tell from their web site, that company no longer sells a QEEG machine claiming to make psychiatric diagnoses.
I have not been able to locate the specific reference for this FDA approval. The FDA press release states:
"In support of the de novo petition, the manufacturer submitted data including a clinical study that evaluated 275 children and adolescents ranging from 6 to 17 years old with attention or behavioral concerns. Clinicians evaluated all 275 patients using the NEBA System and using standard diagnostic protocols, including the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision(DSM-IV-TR) criteria, behavioral questionnaires, behavioral and IQ testing, and physical exams to determine if the patient had ADHD. An independent group of ADHD experts reviewed these data and arrived at a consensus diagnosis regarding whether the research subject met clinical criteria for ADHD or another condition. The study results showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone."
From ClinicalTrials.gov that appears to be this registered clinical trial. No results are reported and there are no publications in peer reviewed journals that I can find. The concerns about this technology should be apparent from the history outlined in the above narrative and the same application suggested by the FDA. This is not a diagnostic procedure but one that is a supplement to the clinical evaluation for ADHD. It reminds me what Russell Barkley - noted ADHD expert and scholar said in a seminar I attended last fall. There are no gold standard tests for ADHD any more than there are for any other problems of executive function. He pointed out that hours of neuropsychological testing (he is a neuropsychologist) is no more accurate than standard ADHD checklists. Neuropsychological testing is important because of the high prevalence of learning disorders in ADHD.
My prediction at this point (pending an actual published research paper) is that this QEEG machine will not be that clinically useful and if it is a question of neuropsychological testing versus the QEEG, neuropsych testing should be the the option because it can detect and allow for treatment planning for any associated learning disorders and QEEG cannot. One of the risks here in an age where insurance companies deny diagnostic costs is that neuropsychological testing is denied and the QEEG substituted depending on cost. That would not allow for the recognition or treatment planning for a learning disorder.
The larger question is how competent the FDA is to make decisions on devices for psychiatric disorders? The FDA came out with a notice in 2011 that electroconvulsive therapy devices may need to be reclassified (Class II to Class III) resulting in the need for additional testing, clinical trials, and regulation. That occurred after two generations of psychiatrists were trained on the current devices and have clinically demonstrated that it is a safe, effective and in many cases life saving therapy. They completed their own study and meta-analyses and it is unclear to me what they concluded. I consider the FDA web site to essentially be unnavigable. Available information in the psychiatric literature suggests that they are still is the process of coming up with a formula for reclassification of ECT devices to a more restrictive category and that their analysis of the efficacy of ECT may have been seriously underestimated. The concern of the authors is that reclassification will restrict availability of ECT to patients who have clear indications for its use much in the same way that poor Medicare reimbursement restricts the availability in some hospitals now.
The even larger question is there some kind of systematic bias operating here? Both the ECT and QEEG decisions seem mismatched with the available science and clinical experience. The FDA has the appearance of transparency, but you can never find what you need in the thousands of web pages that are linked to the agency. In the ECT example, I could not find a clear statement, vote or conclusion about the ECT decision until I read the article by Weiner, at al. In the case of the QEEG device there is no publication of the study supporting its use. Independent review suggests that there have been no advances in the past 16 years.
George Dawson, MD, DFAPA
FDA Executive Summary. Meeting to Discuss the Classification of Electroconvulsive Therapy (ECT) Devices. January 27-28, 2011.
Weiner R, Lisanby SH, Husain MM, Morales OG, Maixner DF, Hall SE, Beeghly J,Greden JF; National Network of Depression Centers. Electroconvulsive therapy device classification: response to FDA advisory panel hearing and recommendations. J Clin Psychiatry. 2013 Jan;74(1):38-42. doi:10.4088/JCP.12cs08260. PubMed PMID: 23419224.
Sand T, Bjørk MH, Vaaler AE. Is EEG a useful test in adult psychiatry? Tidsskr Nor Laegeforen. 2013 Jun 11;133(11):1200-1204. English, Norwegian. PubMed PMID: 23759782.
Nuwer M. Assessment of digital EEG, quantitative EEG, and EEG brain mapping: report of the American Academy of Neurology and the American Clinical Neurophysiology Society. Neurology. 1997 Jul;49(1):277-92. Review. PubMed PMID: 9222209.
"E. On the basis of current clinical literature, opinions of most experts, and proposed rationales for their use,QEEG remains investigational for clinical use in postconcussion syndrome, mild or moderate head injury, learning disability, attention disorders, schizophrenia, depression, alcoholism, and drug abuse." (from Nuwer 1997)
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