Research regarding checklists to reduce hospital errors

[Martha]

Rich, and other medical providers: today's NYTimes had the linked article about how research on the effectiveness of checklists to reduce hospital errors was shut down due to ethical issues about the need for consent to the research. What do you think this will do to the use of such checklists?

A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.
The results 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.


http://www.nytimes.com/2007/12/30/opinion/30gawande.html?ref=opinion

 

[Meadbh]

Martha, thank you for referencing this article, which is very relevant to my own work. It's also bang on. I'm involved in several research studies in the area of quality improvement and patient safety. The research ethics boards are proving major barriers to doing this type of research. If one were to simply make the change and not study it, that would be management, and changes like that are made by managers every day, without asking anyone's consent. But if it is a "study", the expectations are higher. Basically, the paranoia all stems from the abuses in research on humans that led to the Nuremberg trials. Patients' rights must of course be protected. The problem is, protection of the rights of individual patients to the exclusion of all other interests is leading to inabilty to document, publish and establish credibility for improvement work in healthcare. And without that type of review, many healthcare professionals won't buy into such improvement strategies.

Randomized controlled trials have become the "idols" of healthcare research. It's relatively simple to set up such a study with informed consent from each patient when the change to be examined is whether the patient gets a medication or a placebo, under very carefuly controlled conditions. But it's becoming more and more clear that current research methodologies are inadequate to examine system improvement and change in the "real world". Dr. Don Berwick gave an excellent plenary speech on this at the recent annual forum of the Institute for Healthcare Improvement. Dr. Gawande was also a speaker at that meeting. It's clear that he is passionate about quality of care.

I would be very interested to hear what the forum members think on this issue.

 

[Martha]

Meadh, have you heard of possible ways to resolve the ethical issue? Or other ways to approach the research into system improvements?

EDIT: Though I understand the ethical issue, as a customer of healthcare services it feels unnecessarily picky.

 

[Meadbh]

Without a writen approval from an REB, it's impossible to publish the results of a study. Some research ethics boards will issue a waiver, saying "this is quality improvement and not really research". We are now seeing the emergence of specific journals that specify a focus on quality improvement reports, even if they are not "research studies". Unfortunately these journals do not rank highly among academics, and a lot of great quality improvement work gets presented but is never published. So it won't be available for reference decades from now. The same controversy applies when it comes to grant funding, although I must say the Canadian Institutes of Health Research finally seems to "get it". This is a controversial issue in the academic healthcare community right now and there are lots of articles being written and speeches given. I suspect there will be a lot of advocacy, lobbying and consensus conferences over the next five years before we reach some accommodation. Hopefully one that involves common sense.

 

[Moemg]

Very interesting topic and article and thank you Meadbh for a good explanation.

 

[Meadbh]

Thanks Moe, this is my area of expertise!

 

[Rich_by_the_Bay]

What Meadbh said.

There is also an irrational resistance to checklists in certain quarters of the medical establishment. It is finally melting away and has to do with cultural issues where reliance on a written checklist implied that you didn't know your stuff.

My PDA is filled with checklists. Standard order sets for specific situations are similar and I use them whenever I can, assuming I have verified them. Pilots use checklists and aviation is so safe it is a modern miracle. Nuclear power industry is a leading checklist and safety role model.

Medicine is getting there, but in some ways kicking and screaming. Another understandable but never proven concern is that many patients' situations call for deviation from specific protocols. Some physicians have said that they fear liabilitly consequences if they veer from the recommended course even when that is the right thing to do. In reality all you have to do is acknowledge the deviation and explain why you chose to do so. But still, some have concerns, valid or not.


But I have little doubt this is a growth area.

 

[Nords]

I would be very interested to hear what the forum members think on this issue.

I ain't volunteerin' for the control group who gets the doctors with unwashed hands! Heck, after Rich's posts about hand-washing I'm reluctant to even shake hands with them. Maybe I should just give 'em a shaka.

There is also an irrational resistance to checklists in certain quarters of the medical establishment. It is finally melting away and has to do with cultural issues where reliance on a written checklist implied that you didn't know your stuff.
My PDA is filled with checklists. Standard order sets for specific situations are similar and I use them whenever I can, assuming I have verified them. Pilots use checklists and aviation is so safe it is a modern miracle. Nuclear power industry is a leading checklist and safety role model.

Checklists are a blanket invitation for [-]anal-retentive[/-] extremely-detail-oriented people to run wild with documentation. This checklist system doesn't sound so awful, but the nuclear power industry is also a leading example of checklists gone bad. I don't think anyone enters the nuke industry for its reputation of creativity, initiative, and potential to execute on the fly.

The only good thing about checklists is their ability to produce a stellar safety record. But thousands of medical professionals will suffer in pursuit of that noble goal.

I've done over 100 reactor startups in my career. Each one was generally eight hours of preps and four hours of execution. The only one I really remember fondly was the "emergency reactor startup" checklist, which essentially consisted of "Is anything broken? Any holes in the dashboard? OK, latch 'em & snatch 'em and don't accidentally scram out!" We were only able to do that type of startup because we'd let ourselves get stuck near an active volcanic eruption, and we still got kibitzed for "putting ourselves" in that situation.

 

[Meadbh]

I ain't volunteerin' for the control group who gets the doctors with unwashed hands! Heck, after Rich's posts about hand-washing I'm reluctant to even shake hands with them. Maybe I should just give 'em a shaka.

In these types of studies the comparison would be something like: Hospital A staff use a checklist to make sure that all the correct procedures are used when you have your central IV catheter put in; their objective is that every patient has every item on the checklist. And if the surgeon doesn't wash his or her hands in the right solution for the requisite period of time, the nurse will jolly well tell him or her to stop right there (just as an autoworker might do when a quality problem is detected at Toyota). Hospital B staff know the right things to do, but no checklist is used. The intervention is not the handwashing, but the use of the checklist. What is being studied here is the management of human behaviour.

 

[Meadbh]

I ain't volunteerin' for the control group who gets the doctors with unwashed hands! Heck, after Rich's posts about hand-washing I'm reluctant to even shake hands with them. Maybe I should just give 'em a shaka.

In these types of studies the comparison would be something like: Hospital A staff use a checklist to make sure that all the correct procedures are used when you have your central IV catheter put in; their objective is that every patient has every item on the checklist. And if the surgeon doesn't wash his or her hands in the right solution for the requisite period of time, the nurse will jolly well tell him or her to stop right there (just as an autoworker might do when a quality problem is detected at Toyota). Hospital B staff know the right things to do, but no checklist is used. The intervention is not the handwashing, but the use of the checklist. What is being studied here is the management of human behaviour.

If I were a patient in Hospital A, I would have no problem with this. But if I were in Hospital B, I would spoil the study by requesting that they get out the checklist and use it, NOW.

 

[Meadbh]

Oops, double post, more or less.

 

[Buckeye]

What ever happened to the "fake" blood testing that was going on? I thought it was interesting that everyone was considered to have been informed in that it was announced the test was going on in the area and you had a chance of having the "fake" blood being used on you if you were treated by paramedics.