Monday, January 19, 2015

How Should APA Guidelines Work?

The guidelines of the American Psychiatric Association (APA) are an interesting story in how guidelines are important if used correctly by professional organizations.  The whole idea behind a profession is that the practitioners in that area have special expertise and that the expertise is standardized to some degree.  Standardization is useful in the case of physicians to assure the safety of the practitioners and so that people have some idea of what to expect in terms of safe and effective care.  Over a decade ago the APA began producing guidelines for practice in various areas of the field.  I thought it was an exciting development.  The guidelines were initially sent along with the monthly copy of the Journal of the American Psychiatric Association.  All of the guidelines are available publicly on this web site, but hardly anyone knows about them.  I make this statement because one of the many red herrings that the critics of psychiatry use is that psychiatry has no standards of care.  They seem quite shocked to find that these guidelines exist and address their complaints directly.  

I was asked to critique one of the existing guidelines and suggest how these guidelines could be used more effectively.   In looking at the guidelines web site, it is apparent that some of the guidelines have not been updated in quite a while.  Publication dates range from 2000 - 2010.  Given the pace of clinical research 5 years might be somewhat acceptable, but 10 - 15 is probably not.  Another issue that the APA needs to grapple with is the diagnostic manual versus treatment approaches.  There is widespread confusion about whether or not the DSM-5 is a guidebook for treatment as opposed to a guidebook for diagnoses.  The APA actually two approaches to treatment guidance - the guidelines themselves and a text entitled Treatment of Psychiatric Disorders (TPD).  TPD is currently in its 4th edition and it has gone from a series of two volume detailed text to a more basic single volume text.  That text was published in 2007.  Some of the chapters in the previous editions provide some of the most detailed information on the pathophysiology and treatment of certain disorders that could be found anywhere.  At that level of analysis, the APA has gone from providing outstanding information on the pathophysiology and treatment of psychiatric disorders to a relative vacuum over the past 10 years.

For the purpose of a more detailed analysis I will consider the Practice Guidelines on Substance Use Disorders and the associated Quick Reference Guide and Guideline Watch - a 2007 update of the original 2006 guideline.  I looked at the Guideline Watch first because it should reflect the latest literature reviews and treatment guidelines.  The document reviews medication assisted treatment of tobacco and alcohol use disorders with varenicline, naltrexone and acamprosate.  The document was a good summary of the literature at the time but it needs a serious update.  Since then there have been more extensive studies of the genetics, combination therapies, re-analysis of existing studies and side effects of naltrexone, acamprosate, and varenicline including use in specific psychiatric populations.  In at least one case, the current literature supports a course of action that is exactly the opposite of what is recommended in this document.  That course of action is: " Given its high potency and partial agonist activity at central nicotinic acetylcholine receptors, varenicline should not be combined with alternate nicotine replacement therapies."  An inspection of the references for varenicline notes that additional research has been done in this area and should be discussed.      

The Quick Reference Guide contains extensive tables from the original guideline so I will go directly to that document.  At first glance it looks like a significant document more than 200 pages long.  But about 177 of the 276 pages of the document are relevant text.   The rest are references and polls of various expert groups on what they consider necessary for a guideline.  Looking at the Table of Contents, the first thing that is apparent is that only a subset of substance use disorders is being considered.  Although it is likely that nicotine, alcohol, marijuana, cocaine and opioids represent the majority of abused substances psychiatrists treating addiction see a broader array of compounds being abused.  The full gamut of abused compounds should probably be addressed in the guideline whether or not there is a consensus about treatment methods or not.  The safety of users and treatment setting considerations will still need to be considered as well as the need for further assessments.  A good example would be Hallucinogen Persisting Perceptual Disorder and what might be the best assessment and treatment.  If the guidelines are supposed to apply to clinical practice then patterns encountered in clinical practice need to be addressed.  If the APA does not address them - governments and managed care companies will, most frequently to the detriment of patients.

The guideline uses the following conventions for the treatment recommendations.  They are conventions frequently see in professional guidelines:

[I] Recommended with substantial clinical confidence.
[II] Recommended with moderate clinical confidence.
[III] May be recommended on the basis of individual circumstances.

The introductory section does not suggest who the guidelines are written for.   This is a critical aspect of the document.  There is an implication that it is for psychiatrists based on the statement about a comprehensive psychiatric evaluation but I think that needs to be more explicit.  It is not uncommon for managed care companies to send letters that deny care to psychiatrists.  The letter often contains a list of guidelines that an insurance company reviewer used to deny the care.  The APA needs to be explicit that these guidelines are intended for use by the psychiatrist who has personally assessed and is treating the patient and not by an insurance company employee or contractor who is sitting in an office reading through paperwork.  Somewhere along the line professional organizations seem to have lost track of the concept that only direct assessment and treatment of the patient was considered the correct way to do things.  Putting it in all guidelines is a critical first step.

The next thing I would change in terms of guidelines is breaking out the treatment setting recommendations into separate sections in table form.  For example the Hospitalization guidelines are copied into the Supplementary section of this post.  They are all very appropriate and I doubt that there are any reasonable clinicians that would have a problem with them.   The problem is that these services are rationed to the point that it is difficult for any reasonable clinician to implement them.  By that I mean that a psychiatrist cannot get a patient meeting these criteria into an inpatient detox or treatment setting based on these criteria.  As an example, consider the patient who says they are drinking 1 liter to 1.75 liters of vodka per day for 6 months.  They describe uncomplicated symptoms of alcohol withdrawal (shakes, sweats, hangover symptoms and drinking in the morning to suppress these symptoms).  I think the person in this vignette meets criteria 2 for hospitalization and detox at least.  A significant number of patients presenting to emergency departments with this pattern of findings are not hospitalized.  Many are sent out with a supply of benzodiazepines to detoxify themselves.  Many are sent to county detox facilities where there is no medical coverage or so-called social detoxification settings.  None of these non-hospitalization options are realistic approaches to the problem.  Giving a person with an alcohol use disorder a bottle of benzodiazepines for home detox ignores the uncontrolled use and cross addiction aspects of the primary disorder.  It is highly likely that person will ingest the benzodiazepines all at once or use them to treat the morning withdrawal symptoms of the disorder.  Social detoxification is an equally suboptimal approach.  It depends on probabilities.  It is more likely that the person transferred to that setting will leave due to the adverse environment and go back to drinking or undergo withdrawal and not experience delirium tremens or withdrawal seizures.  Over the past 30 years, the managed care industry has refused to consider admissions in practically all of these situations often whether there was psychiatric comorbidity or not resulting in the rationing of care at the initial assessment in the Emergency Department.  There must be an awareness that clinical guidelines don't operate in a vacuum.  Having a guideline in place that nobody can use is not the best approach to providing quality care.   Managed care companies can deny inpatient care on practically any of the 7 inpatient criteria simply by saying that they do not exist.    

On the treatment side there are inconsistencies noted in the recommendations and editing problems.  For example, there are 49 references to "12-step" and 2 references to 12 steps.  One of the first statement one encounters is:  "The efficacy of treatment is related to the amount of psychosocial treatment received. The 12-step programs, hypnosis, and inpatient therapy have not been proven effective."  That characterization of 12-step recovery is inconsistent with just about every other reference in the document.  Where it is suggested it is footnoted with a "I" designation or "substantial clinical confidence."

Rather than critique other sections based on data that was not available at the time that this guideline was posted, I thought I would end with a comment on the process and general philosophy of professional guidelines.  Right at the top of this guideline is a section entitled "Statement of Intent".  The crux of that argument is contained in the paragraph (p. 5):

 "The American Psychiatric Association (APA) Practice Guidelines are not intended to be construed
or to serve as a standard of medical care. Standards of medical care are determined on
the basis of all clinical data available for an individual patient and are subject to change as scientific
knowledge and technology advance and practice patterns evolve. These parameters of
practice should be considered guidelines only. Adherence to them will not ensure a successful
outcome for every individual, nor should they be interpreted as including all proper methods
of care or excluding other acceptable methods of care aimed at the same results........"

I don't really agree with that approach.  The concerns about saying that these are standards of care is a medico-legal one and I have rarely found that to be a sufficient basis to practice medicine.  An example would be litigation against a psychiatrist for not following the stated standards of care in a malpractice suit.  This may seem protective of psychiatrists for varying practice styles but it also has the more insidious effect of basically allowing any standard of care to apply.  A walk down the street to a different hospital results in an admission for medical detoxification when the first hospital discharges the patient with a prescription of lorazepam and a promise to follow up with their primary care MD.  The resulting business incentive practice creep results in a complete lack of detoxification and a lack of any standards of medical care.  The default standard is whatever businesses decide to pay for.  My observation is that results in an unacceptable level of medical care.  And further:

"The ultimate judgment regarding a particular clinical procedure or treatment plan must be made by the psychiatrist in light of the clinical data presented by the patient and the diagnostic and treatment
options available....." 

I agree with the statement but let's face it,  the judgment of the psychiatrist frequently has very little to do with the judgment of the psychiatrist or what options are ultimately considered in the working alliance with the patient.  Practically all inpatient and residential care these days is dictated by managed care companies and insurance companies irrespective of what a psychiatrist would recommend or a patient would accept.  These are standards of care that are forced on psychiatrists and patients rather than the prospective quality based standards.

Stepping back from that fact medical standards play a peripheral role to what businesses want and that unacceptable standard has been present to one degree to another for the past 30 years, I don't think a new approach in guidelines is too much to ask for.  I don't think it is too much to ask that APA guidelines be up to date, internally consistent, inclusive, actually apply as a standard of care as opposed to using business standards as the default, and be used to advocate for the best possible treatment settings for psychiatrists and their patients.  There are a number of specific methods that can be used and I will discuss them when the draft version of the latest  Practice Guidelines for the Psychiatric Evaluation of Adults comes out this year.

George Dawson, MD, DFAPA


Work Group On Substance Use Disorder.  Practice Guideline For TheTreatment of Patients WithSubstance Use Disorders,  Second Edition.  American Psychiatric Association.  This practice guideline was approved in December 2005 and published in August 2006.

Supplementary 1:   These are the hospitalization guidelines from the APA Substance Use Disorders Guideline.

"Hospitalization is appropriate for patients who 

1) have a substance overdose who cannot be safely treated in an outpatient or emergency department setting

2) are at risk for severe or medically complicated withdrawal syndromes (e.g., history of delirium tremens, documented history of very heavy alcohol use and high tolerance); 

3) have co-occurring general medical conditions that make ambulatory detoxification unsafe; 

4) have a documented history of not engaging in or benefiting from treatment in a less intensive setting (e.g., residential, outpatient); 

5) have a level of psychiatric comorbidity that would markedly impair their ability to participate in, adhere to, or benefit from treatment or have a co-occurring disorder that by itself would require hospital level care (e.g., depression with suicidal thoughts, acute psychosis); 

6) manifest substance use or other behaviors that constitute an acute danger to themselves or others; 


7) have not responded to or were unable to adhere to less intensive treatment efforts and have a substance use disorder(s) that endangers others or poses an ongoing threat to their physical and mental health [I]."      (p.  11).

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