The Corpus Callosum

Comparative Effectiveness Research (CER) has been controversial, as href="http://www.washingtonpost.com/wp-dyn/content/article/2009/03/16/AR2009031602913.html">noted
in the Washington Post. 
Admittedly, most of the controversy has been contrived. 
Fortunately, the process is moving forward; there is no meaningful
opposition at this point.

A good summary of the objections of this was posted by Hilzoy at href="http://www.washingtonmonthly.com/archives/individual/2009_05/018133.php">Political
Animal.  I’ll deal with the objections simply by posting the
link, as refuting them is not the point of this post.  Let it
suffice to say that there is no substance there.

The background of the push toward CER is provided by the Institute of
Medicine’s publication, href="http://www.nap.edu/catalog.php?record_id=12648">Initial National
Priorities for Comparative Effectiveness Research.  You can
read it online using the link above, or download the (uncorrected
proof) PDF version using the link.  (The book is 1.9MB, 207 pages,
and it does not download directly from the link; you have to go to the
page, fill out a form, then download it)

The U.S. Congress mandated this study in the American
Recovery and Reinvestment Act of 2009, which the President signed into
law 19 weeks ago. The legislation required the Institute of Medicine
(IOM) to convene a committee to establish a list of research questions
that would have the highest priority for study with comparative
effectiveness research (CER) funds that the law placed at the
discretion of the Secretary of Health and Human Services. Moreover, the
law required the committee to seek advice from stakeholders who might
benefit from the research: researchers, physicians, professional
organizations, and the general public. Basing its approach on methods
developed by the Agency for Healthcare Research and Quality, the
committee held a public meeting to get advice from professional and
consumer groups and from the general public and solicited nominations
for research questions through a web-based questionnaire. The committee
developed a process for deciding which conditions to place on its list
of the highest priority research questions, and, over a 10-day period,
winnowed several thousand nominations to a list of 100 high priority
topics.

Pretty impressive: 19 weeks to design the study, collect the data, and
write a coherent book about it.  Congress should just go home and
let these people take over. 

The overall priorities are reviewed in a free-access article at NEJM: href="http://content.nejm.org/cgi/content/full/NEJMp0904133">Prioritizing
Comparative-Effectiveness Research — IOM Recommendations, by John
K. Iglehart.  The priorities are summarized in a chart (click to
make big) :

style="display: inline;"> href="http://content.nejm.org/content/vol0/issue2009/images/large/NEJMp0904133f1.jpeg">i-948d2b866c76cbf51db6ad6abc82af73-NEJMp0904133f1.gif

Psychiatric Disorders are fifth from the left, a reasonably high
position.  Add the substance-abuse topics, and the total would be
the third in terms of the number of high-priority topics.  I was
curious to see what priorities they established for mental
health.  It turns out that their system of ranking priorities is
complex.  I won’t go into it here, other than to say it is
confusing at first.

There are four top priorities noted in mental health:

  1. Compare the effectiveness and costs of alternative detection and
    management strategies (e.g., pharmacologic treatment, social/family
    support, combined pharmacologic and social/family support) for dementia
    in community-dwelling individuals and their caregivers.
  2. Compare the effectiveness of pharmacologic and non-pharmacologic
    treatments in managing behavioral disorders in people with Alzheimer’s
    disease and other dementias in home and institutional settings.
  3. Compare the effectiveness of various primary care treatment
    strategies (e.g., symptom management, cognitive behavior therapy,
    biofeedback, social skills, educator/teacher training, parent training,
    pharmacologic treatment) for attention deficit hyperactivity disorder
    (ADHD) in children.
  4. Compare the effectiveness of wraparound home and community-based
    services and residential treatment in managing serious emotional
    disorders in children and adults.

These are the items that are in the top quartile of priority, that
include psychiatric disorders as part of their classification. 

Additional items, that are not in the top quartile, but which are
designated as pertaining primarily to psychiatric disorders, are as
follows:

  1. Compare the effectiveness of pharmacologic treatment and
    behavioral interventions in managing major depressive disorders in
    adolescents and adults in diverse treatment settings.
  2. Compare the effectiveness of atypical antipsychotic drug therapy
    and conventional pharmacologic treatment for Food and Drug
    Administration-approved indications and compendia-referenced off-label
    indications using large datasets.
  3. Compare the effectiveness of management strategies (e.g.,
    inpatient psychiatric hospitalization, extended observation, partial
    hospitalization, intensive outpatient care) for adolescents and adults
    following a suicide attempt.
  4. Compare the effectiveness of different treatment approaches
    (e.g., integrating mental health care and primary care, improving
    consumer self-care, a combination of integration and self-care) in
    avoiding early mortality and comorbidity among people with serious and
    persistent mental illness.
  5. Compare the effectiveness of different treatment strategies
    (e.g., psychotherapy, antidepressants, combination treatment with case
    management) for depression after myocardial infarction on medication
    adherence, cardiovascular events, hospitalization, and death.
  6. Compare the effectiveness of traditional training of primary care
    physicians in primary care mental health and co-location systems of
    primary care and mental health care on outcomes including depression,
    anxiety, physical symptoms, physical disability, prescription substance
    use, mental and physical function, satisfaction with the provider, and
    cost.

There are three things that stand out.  One is that most of the
priorities are rather broad.  Indeed, some are too broad to be
meaningful.  Another thing that I notice is that they include
treatment modalities spanning the biopsychosocial spectrum.  The
third thing I notice is the relative lack of attention to psychosis in
general, and to schizophrenia in particular.  There is no mention
of bipolar disorder. 

It is very strange that treatment of depression after myocardial
infarction would make the list, but earlier diagnosis of bipolar
disorder would not,  or early interventions for persons at risk
for schizophrenia.

There are some priorities that make sense.  Integration of mental
health care with primary care, and improvements in community-based care
are two things that have been lagging for decades, and seem likely to
be highly cost-effective.  The problem up until now has been that
reimbursement is based upon procedures and patient volumes.  Time
spent in the community, or coordinating with other providers, is either
not reimbursed, or is reimbursed poorly. 

Perhaps additional research in these areas would help change the
reimbursement scheme to something that provides the incentives that
would lead to more cost-effective treatment.  But anytime you
tamper with the reimbursement scheme, you run into two problems. 
For one, there is a lot of resistance.  Two, people immediately
try to figure out how to exploit the change.

I don’t mean to be highly critical of the IOM report.  It actually
is an impressive document, especially given the short time frame. 
Unfortunately, it simply wasn’t possible to do a properly thorough
job.  Perhaps the significance of their accomplishment is not so
much the list of priorities, but the methodology in collecting and
collating suggestions.  It probably would take several iterations
of a similar process, in order to refine the list to something that is
more realistic and more practical.