Checklists Can Save Lives

Responding to Chris and Lars

Chris: I don't know.

Lars: Hopkins had a crisis a couple of years ago that resulted in the death of a patient in a clinical trial. Now, as one Hopkins individual half-joked to me, "we send our DINNER MENU to the IRB."

Yes, the hospitals are still using the checklist. But they just as easily could have previously adopted all of the items on the list on their own. None was controversial or costly. Yet hospitals did not do that. Most still don't. Why not? Take a look at another New Yorker piece Gawande did about handwashing. It's complicated.

The power of the study was the indisputable evidence in a top-tier journal that the simple act of making a checklist and having ICU staff use it worked almost unbelievably well--fewer deaths, 66 percent fewer infections, and sizable financial savings for hospital (and patients--and by extension for our national health budget).

Do all of the hospital ICUs where you live use such a checklist?

Thanks

I appreciate that answer, people don't seem to understand what you said that "once the determination was made by the agency, regulators had no alternative but to march through the mandated process." It is the determination, not the action, that needs scrutiny.

So answer me this then, why was the study submitted to the IRB at Hopkins if the researchers there did not consider IRB approval in Michigan necessary?

And to Checklist: keep in mind, nobody told anyone they could not continue using the checklists. No one is going without a checklist. They are in fact still using the checklists. They just have to stop transmitting the data.

Cui bono

What I want to know is: who complained about this and what were their motives for doing so? Regarding halting this data collection -- cui bono?

Response from Avery:

Lars: The meaning of "research" isn't obvious even to OHRP. The agency's public position, implied in its news release and explicitly stated to me, is that if an individual hospital puts a quality initiative (like the checklist) in place and collects data to compare the results before and after, that's NOT research.

As I wrote, it's still not completely clear to me how the project under discussion constituted research. It IS clear to me that once the determination was made by the agency, regulators had no alternative but to march through the mandated process. Accordingly, they asked for "corrective action," since individual or regional IRBs in Michigan did not review and approve the initiative as required for research involving human subjects.

If further evidence is needed that "research" is a term of art and not just a matter of common sense: OHRP is now revisiting its interpretation of research and could very well modify its regulatory definition.

Mike:

I honestly don't believe this had anything to do with egos. Pronovost pointed out to me that the whole quality-improvement movement is really very new--it's been less than 10 years since the IOM report kicked it off--and instituting a carefully constructed, multi-institutional protocol, collecting data, and rigorously analyzing them to see whether the change did improve quality is even newer. I'm not sure whether the agency had ever dealt with a case like this before (and wouldn't have had to if they hadn't gotten a complaint). I suspect that as such, it was almost inevitable that they would interpret research tightly rather than broadly. They wouldn't have wanted to leave the barn door half open at the start.

Checklist

I saw the article when it came out in the New Yorker and drafted my thoughts on my blog mikesviewpoint.com. I too was left shaking my head in disbelief. It is disappointing to see the rejection of a simple process that can make a huge difference. Too many egos.

Quick question.

Hm, so what precisely is "research" then?

Checklists

Thanks for this terrific column. I agree 100%.

I reviewed the letters sent to the research team at Johns Hopkins by OHRP on July 19 and November 6 for my blog on health care organizational ethics. I concluded that OHRP followed the letter of its regulations, while entirely ignoring the spirit of its mission. The two letters cite numerous details that indicate that research was being done. Luckily, it was.

The Johns Hopkins team was studying, in a rigorous manner, the impact of an effort to systemize good clinical care. The question was not whether an experimental intervention helped or hurt research subjects, but whether a disciplined managerial approach to doing what we know is the right thing to do produced measurable improvements. We need research of this kind to help us understand how we can best make use of our knowldge.

If Kristina C. Borror, Ph.D., Director of the Division of Compliance Oversight at OHRP, who wrote the letters to Johns Hopkins, reported to me, this is what I would have said:

“The purpose of our office is to protect people in the health care system. The checklists aren’t research. They are part of a managerially sophisticated effort to make ICUs accountable for doing what all ICUs agree should be done, in order to protect people in the health care system. It is great that Johns Hopkins is studying that care management process. Please show them how their application could be corrected so that we don’t erroneously subject the project to a misguided requirement for individual informed consent.”