January 11th, 2011

Revised DHHS Guidelines, and Some Thoughts on Guidelines in General

blizzard of 78 bostonAs another major snow storm barrels in on us, you might have time over the next 24-48 hours to make some hot chocolate, throw some logs on the fire, and read the spanking-new 2011 Department of Health and Human Services (DHHS) HIV Treatment Guidelines, just posted here on the AIDSinfo web site.

(Disclosure: I’m on the Guidelines panel — opinions that follow are mine, and do not represent the panel.)

There are no major changes — befitting a relatively quiet era in HIV treatment — but here are a few highlights:

  • Frequency of CD4 determinations can be decreased in stable patients who are virologically suppressed, down to every 6-12 months.  This makes abundant sense for multiple reasons:  1) high variability with higher counts; 2) no proven strategy for managing decreases in CD4 with virologic suppression; 3) reduces potential anxiety for unanticipated results; 4) saves money.
  • Virologic failure criterion has been shifted to a confirmed viral load > 200 cop/mL; this is in response to the higher rates of lower level viremia using the newer assays.  I’ve written about this a couple of times — it takes some time learning not to panic for a viral load of “121” or even better, “49”, but it can be done.
  • Some minor tweaks on the “what to start” section.
  • Timing of ART initiation with TB updated to reflect results from SAPiT and CAMELIA studies.
  • A new format for adverse event tables.

Some other points worth mentioning:  1) The whole operation could not happen without the incredible coordination and support of  Alice Pau, PharmD, from the NIH; 2) the PDF is 166 pages long, a major test for even industrial-strength staplers; and 2) An HTML version is in the works.

And in case you haven’t had enough of Guidelines recently, here’s a somewhat critical review of the IDSA Guidelines — the ones I praised earlier in the week.  The complaint?  Not enough recommendations backed by “Level I” evidence, i.e., a randomized clinical trial.

Well, I for one remain a fan of these IDSA Guidelines, and for the following reason:  Patient care is frequently a chaotic, messy business, and the expectation that all clinical scenarios will be addressed by prospective randomized trials is invariably going to be disappointed.

So even though we would like to have an evidenced-based approach to every decision, it’s never going to happen.

Which means that getting a bunch of smart, experienced, and detail-obsessed clinicians together to decide what’s best is pretty darn valuable, if you ask me.

9 Responses to “Revised DHHS Guidelines, and Some Thoughts on Guidelines in General”

  1. Al Taege says:

    Thank you Paul for this effort. Why not consider naming the blog:
    “Pieces from Paul”
    HIV, ID and other topics.

  2. Phil Bolduc says:

    Hi Paul –
    I agree with your assessment of doing the best we can where level I evidence is (and may always be) lacking. As always I enjoyed the conference this year; it is my annual HIV “checkup”, and I appreciate all the hard work the faculty puts into it. As a family doc who must spread out my CME among other topics and cannot go to all the HIV meetings, I appreciate having a strong clinically-based conference right in my backyard. – Phil

  3. David Chakoian says:

    “Getting a bunch of smart, experienced, and detail-obsessed clinicians together to decide what’s best is pretty darn valuable, if you ask me.” Valuable, yes.

    Unfortunately, “guidelines” are no longer treated as “guidelines” by those who judge physician performance, nor by the courts. They are treated as iron-clad rules, as one-size-fits-all. And they are always behind medical science, by the nature of the process.

    “Decide what’s best”? Best for a population, based on current thought and knowledge? Or what is best for an individual you have not seen or treated? Guidelines for populations, or for treating individuals?

    And guidelines are put out by those with vested interests in a disease – a mixed bag, because zeal for a disease can cloud the larger picture of caring for the person’s health. They are based on studies paid for by drug companies that have the bottom line as their motive, done by researchers who generally want to present their findings in the most positive (“significant”) light possible. I cannot read guidelines put out by a professional society without feeling “caveat emptor.”

    I appreciate the intense effort and professionalism that goes into developing guidelines. But it would help if we had a broader understanding of their limitations, and if we had a culture of remembering that they are not laws, that they are advice on treating populations and not necessarily applicable to the individual, if my capacity to “decide what’s best” for my patient was granted some credence.

  4. RxEngineer says:

    I agree with the statement “Which means that getting a bunch of smart, experienced, and detail-obsessed clinicians together to decide what’s best is pretty darn valuable, if you ask me.” However, the problem is not that the guidelines (any of them) are not good. The problem is that they are frequently not viewed as GUIDLINES, but as prescriptive mandates by practitioners (and bureaucrats) who are too lazy (or to uninformed)or to busy to look at individual patients, think for themselves and then use the guidelines as a starting point rather than the end point for treatment of that specific patient.

  5. Ed Yourtee says:

    Physicians can look at guidelines and decide how appropriate they are for an individual patient. But large industries (like GE or CMS) would like to improve efficiency and reduce costs by “reducing unwanted variability”, as enshrined in the Six Sigma approach (and in clinical guidelines). Of course this approach is disastrous when applied to individual patients, who themselves bring extraordinary amounts of “unwanted variability” to the diagnostic and therapeutic endeavor.

  6. Bernardino Roca, Castellon, Spain says:

    My complaint? Not enough time to read so many guidelines.

  7. Just found your blog. Very interesting and helpful. Can you update us with what is new with HIV screening using saliva test specimens. Reliability and follow up advice? Test choice and availability? CLIA waiver?
    I just recently heard that the CDC is now recommending routine screening for HIV for all adolescents age 13 and over. Is that true? If so, are salivary screening tests the preferred modality or at least an acceptable modality?
    Thank you,
    Marc Tanenbaum

  8. Roberto Quiroz G says:

    Guidelines, guidelines….
    quien puede decidir el mejor tratamiento en base a una guia?? porque ahora cada 6 o 12 meses la cuenta de CD4…basado en intereses de los grandes laboratorios, para promover “nuevos medicamentos”…
    atte: Medico residente de Medicina Interna, Mexico.

  9. Sami Shafiq, PharmD says:

    Hi Dr. Sax, Thank you for recognizing my colleague, Alice Pau,PharmD

    Hoping to see you at OPMAN, in March in FL.

HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Contributing Editor

NEJM Journal Watch
Infectious Diseases

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