simply absurd…

Posted on Tuesday 13 December 2011

Earlier, I wrote about the PROMIS Depression Questionnaire [how silly!…] put together as an NIMH initiative. And it is silly. The eight questions approximate synonyms, conflating severity with frequency. But there’s another questionnaire being considered by the DSM-5: the PHQ-9 [Patient Health Questionnaire, 9 item], the one used in the study discussed in the last post. Here it is:
The PHQ-9 is a creation of the MacArthur Foundation [MacArthur Initiative on Depression and Primary Care] called RESPECT-Depression [Re-Engineering Systems for Primary Care Treatment of Depression Project]:

    The mission of the MacArthur Initiative on Depression and Primary Care is to enhance the ability of primary care clinicians to recognize and manage depression… The goals that serve the Initiative’s mission are:
    1. To develop practice systems that facilitate recognition and care of depression;
    2. To develop educational programs and tools for primary care that enhance patient care;
    3. To evaluate the impact of these programs, tools and models; and
    4. To disseminate these ideas and materials to primary care clinicians, medical groups, specialty societies, health plans, and other organizations committed to high quality depression care.

The website covers the the program, the studies, it’s adoption by Health Plans, HMOs, etc. The gist of the argument is by now familiar – a Public Health argument about the under-treatment of depression.

In the lead-in to the DSM-5 Revision process, there was a conference concerning adding a dimensional component to the DSM-5:
Prepared by Michael B. First, M.D., DSM Consultant to the American Psychiatric Institute for Research and Education [APIRE], a subsidiary of the American Psychiatric Association.

A diagnosis-related research planning conference focusing on dimensional approaches in diagnostic classification was held at the Natcher Conference Center on the NIH campus in Bethesda, Maryland on July 27th and 28th, 2006. The conference was the seventh in a series of 12 conferences on "The Future of Psychiatric Diagnosis: Refining the Research Agenda" convened by the American Psychiatric Institute for Research and Education [APIRE] in collaboration with the WHO and NIH, with funding from NIH…

John Helzer, MD [Burlington, VT] opened the conference with a description of its rationale and goals These were:

  1. to review the advantages and drawbacks of offering a quantitative "dimensional" component in DSM-V and ICD-11;
  2. to discuss various alternative dimensional approaches; and
  3. to discuss a research agenda relevant to designing and testing dimensional alternatives.
He stressed that the six diagnostic areas scheduled for formal presentation – i.e., substance use disorders, mood disorders, psychotic disorders, anxiety disorders, childhood disorders, and personality disorders – were illustrative examples and that it was not the intention of the conference to confine discussion to these areas. Dr. Helzer noted that although DSM-III was a revolutionary paradigmatic shift, the diagnostic progress it fostered revealed the inadequacies of a strictly categorical diagnostic model. He then offered four recommendations for DSM-V:

  1. that the DSM-V criteria should include options for dimensional approaches;
  2. that the categorical approach of DSM should be retained given the ongoing need for diagnostic categories for clinical work and research;
  3. that the content of DSM-V dimensional components be determined by categorical definitions given the need to be able to relate the dimensional scales back to the categorical definitions; and
  4. that DSM-V should be structured to ensure maximum utility for future taxonomic needs…
And at this conference, the Mood Disorders Group ended with this:
The mood disorders breakout group proposed adding dimensionality to major depressive disorder by exploring the implications of adopting the PHQ-9, a nine-item self-report scale with a 0-27 range of scores. Used as a severity measure, suggested cutpoints include 5-9 for mild, 10-14 for moderate, 15-19 for moderately severe, and 20 or greater for severe, with "significantly improved" defined as a 5-point drop after 6 weeks, "responded to treatment" as a 50% drop in score, and "remission of depression" as a score of less than 5. Such an approach has clinical utility in that it can identify probable cases, it identifies cases at risk who need referral, it confirmed current treatment in 60% of cases, it informed a change of treatment in 40% of cases, and in >90% of visits, clinicians rated it as useful. It has research utility in that it sets benchmarks for improvement, recovery, and remission and permits clinical audits of practice. The scale still needs validation in different settings and with different types of patients [e.g., high risk patients with comorbid conditions].
I have a number of reactions to this conference and where it proposes to take the field of psychiatry, some already stated, some probably coming attractions, but for the moment, I want to stick to the PHQ-9. It’s certainly more rational than the PROMIS Questionnaire. At least it queries the breadth of Depressive symptoms. It seems to confuse frequency with severity like the PROMIS Questionnaire, but in looking at the way it’s scored, I think they’re "weeding out" common unhappiness. As such things go, it is what it is – a waiting room screening instrument for Depression. What the MacArthur Foundation, the Health Care Plans, or Primary Care Physicians do with the PHQ-9 is none of my business. But the American Psychiatric Association is considering including it in the DSM-5 as a dimensional component of the diagnosis of Major Depressive Disorder, and I have plenty to say about that. They said:
    Dr. Helzer noted that although DSM-III was a revolutionary paradigmatic shift, the diagnostic progress it fostered revealed the inadequacies of a strictly categorical diagnostic model.
They say things like that as if they are facts. In the case in point, Depression, the DSM-III was not a revolutionary paradigmatic shift, it was a cataclysmic error, reducing multiple clinical syndromes to a fictitious unitary category – inadequate to be sure, but not because of missing dimensions, rather because poor clinical science. Beyond that, since when did a severity index become a part of diagnosis? But I’ll stay with the topic I defined, the PHQ-9 itself.

In spite of their glowing remarks about the PHQ-9, it’s hard to imagine using it to follow a patient’s progress because of the way it’s constructed. It defines nine symptomatic areas and measures their severity by their frequency [in terms of number of days the symptom is present]. I know of nothing, including my own clinical experience, that suggests that depression improves by a symptom being present in more or less days. And if you look at any of the standard measures, that’s not at all how they work. The Hamilton Rating Scale for Depression, Clinician Rated measures severity differently for each symptom, and the parameters are quality of the experience rather than simply frequency. It’s the same for the Montgomery Åsberg Depression Rating Scale. Even the simplistic QIDS-SR, a self rating depression scale used in STAR*D, measures severity with specific questions:

    10. Concentration/Decision making:

      0 There is no change in my usual capacity to concentrate or make decisions.
      1 I occasionally feel indecisive or find that my attention wanders.
      2 Most of the time, I struggle to focus my attention or to make decisions.
      3 I cannot concentrate well enough to read or cannot make even minor decisions.
    11. View of myself:
      0 I see myself as equally worthwhile and deserving as other people.
      1 I am more self-blaming than usual.
      2 I largely believe that I cause problems for others.
      3 I think almost constantly about major and minor defects in myself.

So, for me, even considering the PHQ-9 for inclusion in the DSM-5 seems to further trivialize the entire DSM-5 enterprise. We already have a category [Major Depressive Disorder] that is not a diagnosis worthy  of the state of our knowledge, one that needs to be deconstructed into the more clinically relevant syndromes we already accept. Now they propose adding a waiting-room screening tool that is not designed for detecting or monitoring change. This only adds to a suspicion that these changes are being tailored to the needs of the pharmaceutical or managed care industries rather that having anything to do with the clinical science of psychiatry. It’s one of the reasons there’s so much uproar about the DSM-5 – because of suggestions like this that are simply absurd…
  1.  
    Bernard Carroll
    December 13, 2011 | 11:48 PM
     

    The provenance of the PHQ-9 could bear some scrutiny. It is a creation of Robert Spitzer, architect of DSM-III. So, it should surprise nobody that the 9 items in the PHQ-9 mirror the 9 symptoms in the DSM-III criteria for major depressive episode. It was embedded in a larger instrument (PRIME-MD) that Pfizer underwrote. Here is the boilerplate from the Macarthur Foundation (http://www.depression-primarycare.org/clinicians/toolkits/materials/forms/phq9/) :

    The PHQ-9 is adapted from PRIMEMDTODAY, developed by Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke, and colleagues, with an educational grant from Pfizer Inc. For research information, contact Dr Spitzer at rls8@columbia.edu. The names PRIME-MD® and PRIMEMDTODAY™ are trademarks of Pfizer Inc.

    PHQ9 Copyright © Pfizer Inc. All rights reserved. Reproduced with permission of Pfizer, Inc. PRIME-MD ® is a trademark of Pfizer Inc.

    These 9 items then were formatted into a Zung scale-like format that treats frequency of a symptom as equivalent to its severity (not!). It looks like the Macarthur Foundation and its money contributed no added value. One is reminded of the saying that a camel is a horse designed by a committee. It seems that DSM-5 bids fair to be a cavalcade of camels.

  2.  
    December 14, 2011 | 3:34 AM
     

    Boy, I sure missed that page! What are they trying to do? Buy Spitzer off? The Cavalcade of Camels would make a great book title for the DSM-5…

  3.  
    Talbot
    December 14, 2011 | 7:46 AM
     

    It’s trolling for patients, plain and simple. By asking how often a person has felt even slightly lousy over a relatively short time period, you allow people to be diagnose as depressed who might simply be responding to many of life’s ups and downs. A person whose company has just been bought and is waiting if they will have a job, someone in arbitration with the IRS, a million different things could cause someone to have those symptoms.

  4.  
    jamzo
    December 14, 2011 | 3:48 PM
     

    FYI

    “Despite the potential for pharmacogenomics to improve patient care, we have yet to see a pharmacotherapeutic paradigm shift in which information on a patient’s genetic makeup is used with other patient-specific factors to guide therapy decisions.””

    “Mrazek predicted that it won’t be too long before diagnostic and treatment guidelines for psychiatric disorders recommend pharmacogenomics testing as part of the initial workup, to protect patients from adverse effects and to decrease the time and cost in identifying the right medicines.”

    “In their JAMA article, Mrazek and coauthor Lerman, Professor of Psychology in the Department of Psychiatry at the University of Pennsylvania, urged that pragmatic clinical trials (PCTs) be considered, rather than just exclusive reliance on randomized controlled trials.

    “Once initial efficacy has been documented, a PCT could be part of the validation pathway for implementation of pharmacogenomic tests,” they wrote.”

    Psychiatric Pharmacogenomics

    By Arline Kaplan | December 12, 2011

    http://www.psychiatrictimes.com/display/article/10168/2004602

  5.  
    Ivan
    December 14, 2011 | 5:30 PM
     

    Uh, oh! Does he mean a pragmatic clinical trial like STAR*D? LOL.

    In pursuit of the grand obsession, NIMH has poured millions of dollars down the drain with pharmacogenetic add-on studies to crappy trials like STAR*D, where the quality of the clinical data is next to worthless.

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