HIV and ID Observations

Are doctors’ neckties causing infections?  That’s the implication of this Wall Street Journal piece:

The list of things to avoid during flu season includes crowded buses, hospitals and handshakes. Consider adding this: your doctor’s necktie. … A 2004 analysis of neckties worn by 42 doctors and medical staffers at the New York Hospital Medical Center of Queens found that nearly half carried bacteria that could cause illnesses such as pneumonia and blood infections. That compared with 10% for ties worn by security guards at the hospital.

This is old news, of course (yet somehow it warranted front page coverage in the WSJ, go figure).  In fact, the British went so far as to ban neckties for doctors entirely in 2006, stating a tie is an “unnecessary piece of clothing.”   (No comments about ascots, however.)

One problem with the cited study in the WSJ is that it does not link the wearing of neckties to actual infections in patients — and I don’t think any study has.  Meaning this:  do the patients of the necktie-wearing docs get more infections than the patients of MDs who dress more casually?

If not, then it’s just another study of this ilk:  “We cultured ________ [fill in the blank of some seemingly innocuous item -- computer keyboard, reflex hammer, clock radio], and found evidence of staph and coliform bacteria in XX%.  These results suggest that [insert item] should be sterilized prior to patient care.”

My hunch:  neckties may carry bacteria — see this company’s antimicrobial neckties for vivid proof — but they are not themselves causing nosocomial infections.

But since I could be wrong on this one, should we get rid of neckties in the hospitals and clinics just in case?

Emphatically yes — to the tune of >600,000* years of life gained nationwide.  So says a nifty paper being presented at the annual IDSA meeting today by Mike April, under the direction of Rochelle Walensky.

(*Original abstract said 549,437, cited in the link; number at the actual presentation, though, was 609,656.)

Bottom line is that laws that limit HIV testing (such as requiring written consent, ahem) lead to later diagnoses, and hence shorter projected life span for those with HIV.  As always with such models, one could quibble with certain assumptions, but the results remain robust through a wide range of sensitivity analyses.

In fact, the only way that switching to an opt-out testing policy could fail to improve survival is if opt-out discouraged a large group of people from getting tested at all — for which there’s not the slightest bit of evidence whatsoever.

Are you listening Massachusetts?  I think you are .

Remember the HIV vaccine trial press release?  The one announcing the first-ever positive result?

Then the backlash, with people questioning how the analyses were done, and reported?

Now, less than a month later, we have the scientific presentation and the paper appear on the same day.

Read all about it here and here.

If you want the view from 10,000 feet (why is that the chosen altitude for that cliche?), here it is:

• The vaccine strategy combines two vaccine generally thought to be ineffective on their own — canarypox ALVAC-HIV and glycoprotein 120 AIDSVAX B/E — in a “prime and boost” approach
• Over 16,000 patients are enrolled in Thailand in a placebo-controlled trial
• The “modified intention-to-treat” analysis, which excludes those who are found to be HIV positive at entry, shows a modest but statistically significant protective effect, reducing the infection rate by about 30%
• There is a trend towards a protective effect in the intention-to-treat and per protocol analyses
• In those who were vaccinated and became infected, there was no effect on CD4 cell count or HIV RNA

Numerous questions remain, many of them summarized in this accompanying editorial:  Why did it work when the individual strategies didn’t?  How durable is the protection?  How do the strains causing infection relate to those in the vaccine?  Did the per-protocol analysis fail to show a significant protective effect solely because of a smaller sample size?  Would the vaccine work if tested on higher-risk populations?  What effect will this study have on the ongoing vaccine development effort, both in the lab and in trials?

Answers to some of these questions may be forthcoming.  Regardless, the surprising results of this study serve as a reminder of just how mysterious the immune system remains — despite some incredibly smart people working on it with lots of resources.

Because if you asked the vaccine cognoscenti to vote a little over a year ago on which strategy in clinical trials would end up with a positive result — the “prime and boost” one published today or the adenovirus vector approach –  the latter would have won in a landslide.

“Are you writing another funny blog post because there’s no baseball?” asks my son J.

As “funny” is very much in the eye of the beholder, that remains to be seen.  But here are a few things on my mind the last few days:

• No data supporting N95 over surgical masks for flu.  One huge logistical issue dodged — at least for now.  But Consumer Reports, that darling of objective reporting, seems to think they’re just great. Since “minimax” is the operative strategy for infection control, look for this controversy to go on for a bit.
• Speaking of flu, I’ve been hearing for weeks (from a certain someone) how chaotic this H1N1 vaccine situation will be in pediatric practices.  And here’s proof.
• LONG (wow) piece on E. coli O157:H7.  Not unreasonable, given the potential severity of the illness and the tortuous route hamburgers take en route to our kitchens.  (Yuck.)  Did I mention before that this is one of the few ID issues that my wife and I take a hard line on?  Make those burgers well-done, thank you.
• Hey, did you catch the 10AM agenda in tomorrow’s General Court of the Commonwealth of Massachusetts?  Can’t miss that.
• Finally, did a throat infection bring down the mighty Tyrannosaurus rex? Perhaps if the dinosaur doc sent a “hold” tube to the lab, they can make the diagnosis retrospectively.

Good luck Tigers/Twins fans!

So says this press release by the US Military HIV Research Program:

A Phase III clinical trial involving more than 16,000 adult volunteers in Thailand has demonstrated that an investigational HIV vaccine regimen was safe and modestly effective in preventing HIV infection. According to final results released by the trial sponsor, the U.S. Army Surgeon General, the prime boost combination of ALVAC^® HIV and AIDSVAX^® B/E lowered the rate of HIV infection by 31.2% compared with placebo … In the final analysis, 74 placebo recipients became infected with HIV compared to 51 in the vaccine regimen arm. The efficacy result is statistically significant. The vaccine regimen had no effect on the amount of virus in the blood of volunteers who became HIV-infected during the study.

This is great news, of course; we’ve become so used to hearing gloom and doom about HIV vaccine studies that one can’t help but be excited, despite the relatively low (but statistically significant) rate of protection.

Still, one suspects such a combination vaccine could be logistically difficult to manufacture and administer , especially since one arm of the strategy employs the live-canarypox virus ALVAC vector, and 5 injections were required.

Plus there is the issue of cross-clade protection — the vaccine was designed to protect against the most common strains circulating in Thailand (B and E).  While B is quite common in North America and Western Europe, is is far less so in Sub-Saharan Africa, where the HIV epidemic is the most severe.

Nonetheless, if you put this news along with the proven protective effects of male circumcision and HIV treatment — the latter I believe to be greatly underestimated by the medical and non-medical community — things are definitely looking up in the HIV prevention arena.

Further details on the study will be presented at the AIDS Vaccine Conference, October 19-22 in Paris — interestingly a return to the same city where HIV was discovered.

So says the Institute of Medicine’s recommendations for protection of health care workers:

Healthcare workers (including those in non-hospital settings) who are in close contact with individuals with nH1N1 influenza or influenza-like illnesses should use fit-tested N95 respirators … Employers should ensure that the use and fit testing of N95 respirators be conducted in accordance with OSHA regulations.

Every so often — well, more like constantly — my wife (the primary care pediatrician in full-time practice) reminds me what life is like seeing patients outside of a tertiary care, academic medical setting.

Her response to this recommendation to use N95 respirators for evaluation of all “influenza-like illness”?

Amazement, incredulity, bafflement, dismay.  Seeing as waiting rooms of pediatricians’ offices in the winter are filled with kids with cough, runny nose, and fever, I can certainly understand her response.  If these guidelines were followed literally, everyone in these offices would have to wear such a mask virtually all day — never mind the high cost and short supply of N95s, the logistics of fit-testing everyone, the effect on provider morale, etc.

In short, since following this recommendation is currently impossible, one possible response would be to refer all such patients to hospitals.  Bad for everyone.

Let’s hope when the CDC reviews these guidelines, they can provide some more practical (i.e., actually do-able) advice for people in practice.

Read all about it here:

As of August 17, 2009, written (signature) consent is no longer required for HIV testing in the VHA. Instead, patients will provide verbal informed consent prior to HIV testing. Furthermore, scripted pre-test and post-test counseling are no longer mandated.

Since the VA is the largest HIV provider in the nation — and has an exceptional electronic medical record/database — it will be fascinating to see how this policy influences new case detection, linkage to care, and whether there are any negative repurcussions.

Nice page of FAQs here.  And though you’re sick of hearing from me on this issue, I totally agree with this move.

One of the most important recent studies in HIV has just been “published” in (on?) PLoS ONE.  It’s ACTG 5164, led by Andrew Zolopa, which compared “early” versus “deferred” antiretroviral therapy in 282 patients presenting with acute opportunistic infections.

(Full disclosure: I am on the protocol study team — but am not an author on this paper.)

Take home message:  Starting antiretroviral therapy within 2 weeks of the OI diagnosis significantly reduced the risk of further AIDS complications or death, compared to the group that started 6-12 weeks later.  (For additional details of the study, here’s a nice summary in AIDS Clinical Care.)

When I discussed 5164 with some of my less clinically-inclined colleagues, they wonder why the study was even done — of course starting these severely immunocompromised patients on ART as soon as possible would be better than waiting.

But the clinicians, they were not so sure, and raised appropriate concerns about drug-drug interactions, pill burden, overlapping toxicities, reduced adherence, and — drum roll — the immune reconstitution inflammatory syndrome, or IRIS.

Some of us are terrified of IRIS, and I’m not quite sure why.  Yes, it can be difficult to manage (my sense is that we’re too reluctant to use steroids), and sometimes it’s very confusing exactly what is going on.  And of course there are occasional case reports of severe IRIS, some even leading to death — but always with such cases, I wonder whether the outcome would have been just as poor without ART, just with a different clinical manifestation.

So that’s why it’s particularly gratifying to see this finding in 5164:

IRIS was reported in 23 cases and confirmed in 20: 8 subjects in the immediate arm and 12 in the deferred arm.

Read more of this post »

From the New York Times last week:

Health officials in Los Angeles said Friday that 22 actors in adult sex movies had contracted HIV since 2004, when a previous outbreak led to efforts to protect pornography industry employees.

(snip)

Occupational health officials have long argued that failing to require that performers wear condoms during intercourse and other acts is a violation of safe-workplace regulations.

But Deborah Gold, a senior safety engineer with the California occupational health department, said violations in the pornography industry were so widespread that the state had a difficult time cracking down.

My first response on reading this was amazement that the number was so small – and, remarkably, that number turned out to be even smaller (1 case) when further details emerged in the LA Times:

Los Angeles County public health officials backtracked Tuesday on their statements last week that at least 16 unpublicized cases of HIV in adult film performers had been reported to them since 2004.

Despite their release of data to The Times describing the cases as “adult film performers,” the county’s top health official acknowledged that the agency does not know whether any of those people were actively working as porn performers at the time of their positive test.

(snip)

The county lacks sufficient information to delve deeply into the cases and still has received no formal report on the most recent case.

“The system we have and the laws we have do not facilitate the kind of contact tracing and verification that we’d like to see,” [LA County Health Officer] Fielding said. “AIDS has been treated separately from other STDs.”

Bottom line here:  Aside from this well-researched cluster of cases reported in 2004 in the MMWR, we likely only have a vague idea how many cases of HIV are in, or linked, to this “industry” — which in addition to these semi-regulated companies undoubtedly has a huge underground as well.

And until we get rid of this bit of HIV exceptionalism cited above by Dr Fielding, appropriate contact tracing and partner notification are going to be very difficult indeed.

A:  Depends who you’re asking.

The best guidance I ever received on how to write a good note came from my residency program director, who told us that a note needn’t be encyclopedic to be excellent; in fact, he urged us to get away from the “second-year medical student” style, which typically includes absolutely everything.

Instead, he urged us to write, as concisely as possible, notes that included the following:

1. What is going on with the patient
2. Why we think so
3. What we’re going to do about it

All this gets thrown on its head, however, when you get an email like this one:

Hello Dr. Sax,
Just a reminder that I will be meeting with you to discuss your billing audit results on Thursday 5:30 pm, right after your outpatient session is completed.
Judy

In this meeting, I predict Judy will tell me that the occasional visit I coded as “Level 5″ really should have been “Level 4″, or even “Level 3″ — since even though the case was incredibly complicated and involved reviewing years of treatment history, lab results, and prolonged communication with outside providers and the patient and his family members, I somehow neglected to include the requisite # of “Review of Systems” (10 required), with explicit mention of past, family, and social history, as well as a 9-system physical exam.  Oh, and the sentence:  “Time spent reviewing impression and plan with patient and family:  — minutes.”

Yes, abuses by MDs and hospitals on billing have been well documented.  Cases like this one are obviously serious, and cannot be condoned.  It could be argued that these periodic “compliance reviews” (my session this week with Judy) are merely the just rewards of a previously unpoliced system.

But does anyone think that the current rules we have in place — with these explicit guidelines for what constitutes a complex case based on who knows what (”Review of Systems?”  c’mon!) — is anything other than an invitation to game the system with fancy software, macros, templates, lots of copy-and-paste, and other such tricks?

And what happened to what should be the primary purpose of the note — which is to communicate the critical items of the medical encounter?

That’s the saddest part — it’s gone.