Monday, June 23, 2014

Do operating room checklists improve outcomes?

The other day Atul Gawande tweeted the following:



I am not against checklists. When I was a surgical chairman, I implemented and used one in both the operating room and the ICU. They do not add costs and may be helpful.

However, the randomized trial that Gawande referred to does not necessarily settle the issue about whether checklists really do reduce complications and deaths.

The paper, published online in Annals of Surgery [full text here], looked at 5,295 operations done in two Norwegian hospitals. The intervention was a 20-item checklist consisting of three critical steps–the sign in before anesthesia, the timeout before the operation began, and the sign out before the surgeon left the operating room. Using a stepped wedge cluster design, patients were randomized to control or the checklist.

Complications occurred in 19.9% of the control patients and 11.5% in those who got the checklist, a significant difference with p < 0.001.

A look at Table 2 finds that of 27 complications or groups of complications, 14 occurred in significantly fewer patients in the checklist group.

Of the significant 14, a few, such as cardiac or mechanical implant complications, could possibly have been prevented by the implementation of the checklist.

For most of the others, the relationship between the use of a checklist and a post-operative complication is tenuous. How could a checklist possibly prevent technical complications like bleeding requiring transfusion, surgical wound dehiscence, and unintended punctures or lacerations?

Here are a few more of the complications that occurred significantly less frequently in the checklist cohort—urinary tract infection, pneumonia, asthma, pleural effusion, dyspnea, and the nebulous categories of "complications after surgical and medical procedures" and "complications to surgery not classified."

What item on a checklist prevents asthma, UTI or any of those on that list?

Embolism, sepsis, and surgical site infection, three complications one would expect a checklist to impact because of reminders to give prophylactic antibiotics and anticoagulation, did not occur at significantly lower rates in the checklist group.

Even the cardiac complication category is open to question because none of the 5 subcategories (cardiac arrest, arrhythmia, congestive heart failure, acute myocardial infarction) differed significantly between the two groups. Only when the 5 were combined did statistical significance emerge.

In the 300-bed community hospital, checklist use was associated with a significantly lower mortality rate than non-use, 0.2% vs. 1.9% respectively (p = 0.02), but no mortality difference was seen in the 1100-bed tertiary care hospital.

The tertiary care institution enrolled 3,811 patients while the 300-bed hospital contributed 1,083. If more patients had been in the latter group, the difference may have disappeared due to the principle of regression to the mean.

Despite the heightened vigilance associated with an ongoing research project, compliance with checklist use was only 73.4%.

Before you go off on me, I will remind you that I do not oppose checklists. Most things we do in medicine are not based on Class 1 evidence.

Just don't tell me that checklists have been proven to reduce complication rates or save lives.

4 comments:

Allan Palmer said...

Completely agree with what you are saying and would also point out that unless you are doing incredibly high risk surgery a 20% (19.9%) complication rate in your control group to me says you should probably not be doing the surgery in the first place. Thats 1 in 5 complications.

In that environment then maybe there is an indirect checklist benefit in that ANY attention paid to the patient results in improvement.

Control groups in RCTs need to be representative of the real world. If I were reviewing this paper I would reject it for publication for that reason alone.

Like you I have no problem per se with checklists but am concerned that their risks as well as benefits are not the focus of attention. Extra time taken - both to do the checklist as well as disruption of everyones routine - is associated with increased cost and complications via prolonging anaesthesia. It may not seem like a big change but it is a change and has not been evaluated when we already know that prolonged surgery and anaesthesia is an independent risk factor with its own dose/response (duration/hazard) curve.

Vamsi Aribindi said...

I'm a big believer in checklists and systems improvement, but I too agree that in far too many cases enthusiasm for doing something outstrips rational thought and consideration, or the recognition that everything has a negative consequence.

In Dr. Gawande's book (titled, in the best traditions of scientific dispassion and objectivity, "The Checklist Manifesto"), he himself related that he stopped using the first checklist that was developed- it wasn't until after an extensive process with feedback and modification for local operating conditions that it became useful and "saved" one of his patients.

In comparison, I fear the checklist movement will end up imposing a non-useful tool upon surgeons and other doctors everywhere, making the problem worse not better (after all, now there's bad checklist documentation waiting for a malpractice lawyer to find it).

Respectfully,
Vamsi Aribindi

Skeptical Scalpel said...

Allan and Vamsi, thanks for the comments. I agree that the setting in Norway may not represent all operating rooms. I also agree that if your hospital uses a checklist, it should be monitored and changed if needed. The biggest mistake people make is having too many items on a checklist.

jack said...

Nice...

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