Editore"s Note
Tilting at Windmills

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February 14, 2008
By: Kevin Drum

CHECKLIST FOLLOWUP....Last night I blogged about Atul Gawande's New Yorker article from December about the lifesaving benefits of using a simple checklist to reduce line infections in hospitals. I didn't see this at the time, but a reader alerts me to an op-ed Gawande wrote a few weeks after the original article appeared:

The results [of using the checklist] were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.

Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.

....Scientific research regulations had previously exempted efforts to improve medical quality and public health — because they hadn't been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. And they're in danger of putting ethics bureaucracy in the way of actual ethical medical care. The agency should allow this research to continue unencumbered. If it won't, then Congress will have to.

Wouldn't it be great if Congress held hearings on this instead of preening for the cameras over Roger Clemens's alleged steroid use? Or is that too much to ask for?

Kevin Drum 11:54 AM Permalink | Trackbacks | Comments (39)

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Comments

This exactly why I left academia. Rules rule.

Posted by: Chuckchuck on February 14, 2008 at 12:10 PM | PERMALINK

This is why I left academia. Rules rule.

Posted by: chuckchuck on February 14, 2008 at 12:13 PM | PERMALINK

Just a note on these checklists:

They refer to results "Within three months". I would be more interested in results after a year. The first three months people is when people are likely to be more careful, knowing they are testing something new.

Posted by: DR on February 14, 2008 at 12:15 PM | PERMALINK

Good post, Kevin.

No wonder we all love Congress so.

Posted by: Gore/Edwards 08 on February 14, 2008 at 12:21 PM | PERMALINK

DR asks about results "after a year". To quote from the original New Yorker article, "The successes have been sustained for almost four years—all because of a stupid little checklist."

Posted by: Randy on February 14, 2008 at 12:32 PM | PERMALINK

I suspect Congress can hold hearings into both. One possibly segue, were Clemen's needles sterilized?

Posted by: jerry on February 14, 2008 at 12:40 PM | PERMALINK

The arguments against a national health care system always stress not letting the government make decisions about health--doctors should make those decisions. Well guess what? The government does decide, along with the insurance industry, Joint Commission, medicare/medicaid. Hospitals and doctors have to follow rules and regulations to be reimbursed for services. Add malpractice to that list.

Posted by: Ravinia on February 14, 2008 at 12:42 PM | PERMALINK

Um, we've had a couple of healthcare threads now, only one of which we were at all successful in hijacking into a discussion of airplanes.

We can haz airplane thread now?

Posted by: jerry on February 14, 2008 at 12:43 PM | PERMALINK

Ours is a culture conditioned by television. Glitz, glamor are the important issues of our time. Iraq gets less coverage than Britney.

Posted by: jen on February 14, 2008 at 12:49 PM | PERMALINK

Kevin,
Exactly, why not make checklist a mandatory at federal level will a bill or an ammendament to budget bill. Attach it to the budget bill, then it sure will get passed.
Thank you,
ksk

Posted by: ksk on February 14, 2008 at 12:50 PM | PERMALINK

Wouldn't it be great if Congress held hearings on this instead of preening for the cameras over Roger Clemens's alleged steroid use?

Yes. It certainly would. And while they are addressing healthcare, lets define staffing levels. If a nurse has more than two patients the care ceases to be intensive. And on a med-surge floor, nurses should never have more than five patients.

When those staffing levels are met, infection rates go down considerable.

And hey - Kevin - while we are addressing nosocomial infections in US healthcare facilities, are you going to get around to addressing the C-Diff epidemic?

Posted by: Blue Girl, Red State on February 14, 2008 at 12:54 PM | PERMALINK

DR said:
They refer to results "Within three months". I would be more interested in results after a year. The first three months people is when people are likely to be more careful, knowing they are testing something new.


As a Pilot I can attest that I use checklists every time they are called for (for three years now). And wen the FAA instituted checklists accident rates dropped. It's all about training.

Posted by: chuckchuck on February 14, 2008 at 12:56 PM | PERMALINK

The solution to the problem is simple - just have DHS declare the infection causing microbes "terrorists." At that point, we will be compelled by necessity to break however many rules and regulations necessary to defeat the terrorist threat and save American lives.

We can even grant Peter Pronovost and Johns Hopkins retroactive immunity!

Posted by: Chesire11 on February 14, 2008 at 12:57 PM | PERMALINK

Is this checklist available in an easy-to-printout form so I can have it handy in case I or anyone I know is hospitalized? If it can save money, time, or a life, I want it.

Posted by: jon on February 14, 2008 at 12:58 PM | PERMALINK

Blue Girl, Red State on February 14, 2008 at 12:54 PM:

..while we are addressing nosocomial infections in US healthcare facilities, are you going to get around to addressing the C-Diff epidemic?

Show-off.

:)

Posted by: grape_crush on February 14, 2008 at 12:58 PM | PERMALINK

I'm surprised no one has linked to Gawande's NYT op-ed piece in December.

The key paragraph: Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.

Posted by: marcel on February 14, 2008 at 1:02 PM | PERMALINK

Nevermind. I should learn to read. Any care at all would have save me from that blunder!

Posted by: marcel on February 14, 2008 at 1:03 PM | PERMALINK

KD: Or is that too much to ask for?

When the Senate is more interested in he Patriots "spygate" videotapes than the CIA waterboarding tapes? Dream on.

Welcome to Nero World. Now where did I put that damn fiddle?

Posted by: thersites on February 14, 2008 at 1:04 PM | PERMALINK

C'mon, grape! Gimme a break! A lab rat like me doesn't get a lot of posts that roll the ball right up the center of my alley!

Posted by: Blue Girl, Red State on February 14, 2008 at 1:05 PM | PERMALINK

It's about training, as chuckchuck said, but mostly it's about training to use checklists. Checklists are today accepted as the norm in cockpits, but not so in ICUs, where they are still widely considered insulting to doctors' intelligence. It's similar to what used to be the case with pilots, even when the evidence was pretty conclusive that piloting a modern aircraft -- like ICU care -- is too complicated for anyone to always remember everything, and missing anything can be a fatal mistake: it still took a new generation of pilots, trained in using checklists, to make checklists a standard.

The situation is further complicated by the division of authority in many ICUs, and the lack of standards for how ICUs are organized and run. Critical care medicine is in flux right now, and there are almost as many models for how to run an ICU as there are hospitals. There is currently no equivalent in ICUs to the captain of an aircraft. Once ICU management becomes more standardized -- which is happening, as a new cadre emerges of intensivists who are trained as such -- and lines of authority become more settled, it should be easier to make checklists a professional standard.

Governmental authority is a very blunt instrument to use in cases like this. IMHO, it should only be used in cases where a medical norm has been firmly established that is clearly contrary to the public interest, e.g., as was the case with working hours for residents. Critical care medicine is still too much in flux, with too many moving parts, for legislation not to run a significant risk of creating more problems than it solves -- if indeed it solves any.

Posted by: bleh on February 14, 2008 at 1:12 PM | PERMALINK

Wouldn't it be great if Congress held hearings on this instead of preening for the cameras over Roger Clemens's alleged steroid use? Or is that too much to ask for?

Can I safely assume that we only get one guess on this one?

Posted by: Brian on February 14, 2008 at 1:16 PM | PERMALINK

FWIW, Congress is also holding hearings on crooked megachurches. Somewhy, that's not all over cable TV news.

Posted by: Grumpy on February 14, 2008 at 1:16 PM | PERMALINK

"Checklists are today accepted as the norm in cockpits, but not so in ICUs, where they are still widely considered insulting to doctors' intelligence."

This is one of the underlying problems, doctors are actually a lot dumber than they, or most people, think they are. There's this whole mystique about the brilliance of doctors, probably driven by the difficulty of getting into med school. And as we all know, stupidity and arrogance make a nasty cocktail (sort of like a Jagerbomb, but not as fun)

Posted by: ramster on February 14, 2008 at 1:21 PM | PERMALINK

Find the 1000 most attractive, sympathy inducing victims killed in the last years by this comic book level of malpractice, make posters of the people, and parade them in front of Congress.

Posted by: ferd on February 14, 2008 at 1:21 PM | PERMALINK

bleh: Governmental authority is a very blunt instrument to use in cases like this.

Which is probably why people are objecting to the use of governmental authority to stop the use of this practice.

Posted by: alex on February 14, 2008 at 1:29 PM | PERMALINK

Oooh...I got another one. Let's talk about the nursing shortage. Anyone been in a hospital lately? Next time you are, check out the nurses station - there are a lot more Lavernes than Carlas, if you know what I mean. The workforce is aging, and retiring in droves. (I retired after 22 years and nine knee surgeries. I'm still a few birthdays away from 50.)

Knee and back injuries are very high among healthcare workers, and often end careers. The older one gets, the more likely one is to sustain a career-ending injury.

Staffing would help here - simply having a helper when you are moving the 250 pound patient from the bedside commode back to the bed would be a lot more effective than a Gait Belt.

Posted by: Blue Girl, Red State on February 14, 2008 at 1:38 PM | PERMALINK

The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations.

I suspect that the problem is not with the checklists, but with tracking the results . . .

Posted by: rea on February 14, 2008 at 1:40 PM | PERMALINK

alex, don't get me wrong. I'm certainly in favor of funding further studies and/or pilot programs to get more checklists into ICUs; they do save lives, after all, and remarkably efficiently at that. I'd simply be very wary of requiring their use legislatively, given the complexity of ICU care and the current very dynamic state of the field.

Posted by: bleh on February 14, 2008 at 1:43 PM | PERMALINK

I'd simply be very wary of requiring their use legislatively, given the complexity of ICU care and the current very dynamic state of the field.

With all due respect, I've heard this same thing, or a variation thereof, for over twenty years, and I have not seen things get better via internal locus of control, so I'm not inclined to buy it any longer.

And so long as we have profit-driven healthcare in this country, it will never get better via internal reform.

I am, quite simply, utterly disgusted and ready for radical reform. Emphasis on radical.

Posted by: Blue Girl, Red State on February 14, 2008 at 1:47 PM | PERMALINK

If there is any justice in the world, Pronovost will receive the Nobel Prize for medicine. Don't hold your breath, though.

Why isn't anyone here upset about the Government rules that are holding up the adoption of Pronovost's insights? These rules weren't created by Big Pharma; on the contrary, these were rules promoted by liberal activists to prevent abuses of patients by drug researchers. I think you can file this under "unintended consequences" or, perhaps, "the road to Hell is paved with good intentions." We can undoubtedly expect many more such delights once the goo-goos take over in 2009.

Posted by: DBL on February 14, 2008 at 1:58 PM | PERMALINK

And so long as we have profit-driven healthcare in this country, it will never get better via internal reform.

I am, quite simply, utterly disgusted and ready for radical reform. Emphasis on radical.

Any particular "radical" suggestions for reforming the practice of critical care medicine in the US? It's already very complicated, subject to a lot of comparatively powerful forces, and in the middle of substantial change.

Granted some aspects of the US healthcare system are in need of material reform -- I'm very much in favor of the US adopting single-payer funding (which I guess I wouldn't describe as "radical," given its near-ubiquity elsewhere) -- but I'm really leery of categorical condemnations, especially of the provider side.

Posted by: bleh on February 14, 2008 at 2:23 PM | PERMALINK

This case is not about checklists. The question is whether the activity is human subjects research. If it is, then an IRB should review it for safety and consent issues. The fact that the intervention was effective in hindsight is irrelevant. An IRB can waive the consent in this kind of case and the work can go forward just as it was originally intended.

Peer review of research is a good idea. Anyone really want to go back to the day when investigators made their own decisions about the safety and ethics of their protocols?

Posted by: jb on February 14, 2008 at 2:34 PM | PERMALINK

Kevin, I work for a BlueCross plan, and this is what one of our nurse quality reviewers posted in reply to your two items on this:

The 5 Million Lives campaign sponsored by the Institute for Healthcare Improvement (IHI) has set a goal to save 5 million incidents of medical harm over a 2 year period from Dec. 2006 to Dec 2008. One of the "planks" of this national initiative is to prevent central line infections as well as ventilator associated pneumonia, pressure ulcers, surgical site infections, etc. There are 11 "planks" in all.

The BCBS Association has given $5,000,000 as the major sponsor of this campaign with one of the goals being to enroll at least 4,000 hospitals nation-wide. BCBSNE is a partner organization within NE and has worked with the NE Hospital Association and CIMRO (the CMS QIO) to enroll over 50% of NE hospitals. We have 4 national mentor hospitals within our state.

Hospitals develop protocols and order sets "checklists" that establish standardized evidence-based methods to reduce the risk of harm to patients and prevent life threatening complications.

So, I think we are doing something significant here. And, it is going on nation-wide. :-)

Here is a web link to the 5 Million Lives campaign. There are lists of participating hospitals by state.

http://www.ihi.org/IHI/Programs/Campaign/

Posted by: Zoomie on February 14, 2008 at 2:34 PM | PERMALINK

bleh: Governmental authority is a very blunt instrument to use in cases like this.

In the absence of governmental authority or regulation, tort law should suffice. Oh yeah, I forgot, we reformed that too. Blunt intruments are a bitch.

Posted by: Gavin Stevens on February 14, 2008 at 3:44 PM | PERMALINK

Just to make sure it's clear, because some of you are missing the point badly:

The Federal regulator in charge of protecting patients killed the project.

Not the doctors, the medical profession, the university, the hospital--the patient protection regulator.

Posted by: SamChevre on February 14, 2008 at 4:57 PM | PERMALINK

I believe rea is correct. The agency didn't bar the use of checklists, but rather collecting and tracking the results of their use. Still, the point is valid. I've read -- though I can't verify it -- that the agency acted in response to a single complaint. But no confidential information was actually collected, and collections were done post-procedure so this hardly amounts to a failure to obtain informed consent.

As far as Roger Clemens goes, I'm sick of the whole thing. He was a great pitcher before steroids and HGH ever came on the scene, so you can hardly see he got there because of it. And what of the many players who used steroids and HGH and never got more than a cup of coffee in the bigs? And Congress also wants to look into the New England Patriots' videotaping scandal to determine why the NFL destroyed the tapes. Holy mother of God, is there no sanity left?

Posted by: AndrewBW on February 14, 2008 at 5:07 PM | PERMALINK

SamChevre said:

"Just to make sure it's clear, because some of you are missing the point badly:

The Federal regulator in charge of protecting patients killed the project.

Not the doctors, the medical profession, the university, the hospital--the patient protection regulator."

That's right. But it's so much easier to demonize doctors, isn't it? Accept it's not if you actually want to solve any of these problems.

Posted by: Jonathan Dworkin on February 14, 2008 at 5:48 PM | PERMALINK

My head is about to explode.

I was completely blown away by the New Yorker article last year, and now they're killing the program instead of expanding it on a stupid technicality?

The reason this program isn't catching on like it should be is that it is not a drug. Doctors are impressed by drugs. They are not impressed by annoying little procedures. Also, drugs have huge profit-seeking organization behind them. This program has Dr. Gawande.

Doctor's do not have to be stupid to need checklists. No one thinks pilots are stupid just because they routinely use such checklists. Software developers have similar sorts of procedures in place to catch stupid mistakes. A brilliant mind doesn't necessarily always remember every single step in a complex process.

What's funny, though, is the line insertion checklist is very simple. It mostly consists of nurses hectoring doctors to wash their hands. This is an amazing reflection of probably the greatest innovation in modern medicine--Florence Nightingale and her nurses forcing arrogant doctors to be a little less filthy.

Last year my sister almost died from a staph infection from a line insertion. This subject is very personal to me.

Posted by: Rob Mac on February 14, 2008 at 6:09 PM | PERMALINK

The program has not been killed by federal regulators. The project was suspended because it was not reviewed by the IRBs at the participating institutions.

Posted by: JB on February 15, 2008 at 12:03 AM | PERMALINK




 

 

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