Thursday, January 15, 2009

Cookbook Surgery

Atul Gawande has published his "checklist paper" in the latest NEJM. Last year he wrote a profile in the New Yoker on the efforts of Peter Pronovost at Johns Hopkins who had implemented a strict protocol algorithm (or checklist) to be followed for the insertion of central venous catheters, which almost completely eradicated the incidence of catheter-associated infectious complications. So this paper has been eagerly anticipated.

The paper is a prospective collection of 30 day complication data from hospitals around the world for patients undergoing non-cardiac surgery. Half the patients were subjected to a 19-item Surgical Safety Checklist during the peri-operative period. The checklist includes such items as making sure the correct surgical site is marked, noting allergies, making sure peri-op antibiotics have been given appropriately, and confirming that sponge and instrument counts are correct before closing the incision.

The results are rather astounding. According to the study, death rates were reduced by almost 50% when patients were subjected to this magical checklist. Now that's an amazing achievement. So much so that even Dr. Pronovost is a little suspicious. Surgical teams participating in the study were not blinded to the the study and the patients had not been randomized to either arm. So it's hard to make definitive, standard-of-care conclusions. Closer inspection of the data demonstrates that the biggest improvements were seen in hospitals from third world countries. This makes sense because in the United States, we've already been marking surgical sites and calling pre-op "time-outs" for several years.

Certainly, there is something to be said for meticulous routines when it comes to surgery or other procedures. But do we need mandatory 19 item checklists? Why stop there? Why not make it a 40 item checklist? Why not make the attending surgeon write an essay on how to avoid complications before every case? Or how about having the surgeon and all assistants read the chapter corresponding to the proposed operation from the textbook out loud together (alternating paragraphs) prior to making the incision?

It's good to be organized and precise in surgery. Limited checklists are useful in this regard. We ought to mark our initials on the correct side of the hernia repair. Point taken. Nothing groundbreaking here. We don't want to be operating on the wrong leg or leaving sponges inside bellies. But it's rather a ridiculous leap to think that death rates can be halved just by following a series of irritating instructions on a laminated list.


Anonymous said...

Irritating like the checklist airline pilots use before they fly the aircraft? Seems like common sense.

Jeffrey Parks MD FACS said...

When I fix someone's inguinal hernia, we already mark the surgical site, check that antibiotics are given, make sure the consent is signed and count instruments/sponges at the end. That's 4 or 5 things right there. I'm having a difficult time thinking of 13 or 14 other things to check off that will reduce my death rate (0% for hernia surgery) to whatever half of zero is. So yes, a longer, more inclusive checklist starts to verge into the realm of "irritating".

Anonymous said...

You must be kidding?

Your post "Cookbook Surgery" is dangerous. The 19 item Surgical Safety Checklist could save lives.

Cookbooks exist for a reason-they assist the cook so that he or she makes no errors and there are no mistakes.

The 19 item Surgical Safety Checklist is a simple method that will save lives around the world, and you are criticizing it because you feel that, what? - it is too simple, too easy, too much of a bother to ensure that some of the most important steps have been taken to reduce risk in surgery.

Perhaps your hospital already follows all of these procedures, but do all the hospitals on Earth follow them? What if your ridicule of this simple step convinces people in the hospitals that do not follow the same procedures as your near perfect hospital to disregard the list?

What if your (borders on)egotistical tirade causes someone to die? Then-how would you feel?

I really think that you should write another post that encourages the use of this checklist in all hospitals.

You are a doctor, remember why you wanted to become one. It was to help people and reduce suffering and death in this world.

Please remember that there are other hospitals that are not like yours, and those hospitals need this checklist-your post could do the opposite of what you want for the world. Get some rest, and think it over.

Best intentions.

Joseph Sucher, MD FACS said...

"Ridiculous leap"? Really? Maybe its perturbed. Certainly its not the whole story. But it is not ridiculous. The way we practice medicine can be ridiculous.

Unfortunately we live in a less than optimal medical environment. Not everyone is a true professional. There are folks that are taking care of patients that shouldn't be allowed to touch my dog. So we continue to build and evolve our safety protocols focused on the systems of care in an attempt to reduce adverse events. That's what this article is really about. Let's not throw it out completely.

The checklist items are all valid, and in fact probably are all being performed by you and your staff already. Just not necessarily as a 'checklist'.

We need to continue to foster a culture of safety and quality of care. Where the checklist stops is dependant on you and me.

Quite frankly I believe its our education system that needs the most work. What is going on in our hospitals starts with the lack of appropriately trained doctors, nurses, and technicians. Stop treating professional schools like puppy mills where the intention is to simply birth volumes of workers, and start seriously cranking down on ensuring high level quality training. Support this front end, and we won't need to keep adding safety nets on the back end.

Thank you very much for your blog. I am hooked.

Anonymous said...

I just read your list of favorite music and books. I have to admit that they nearly match mine. But I still think what I wrote in my post, "You must be kidding?" is right.

Sorry, maybe I should not have used that opening line.

Best intentions.

Jeffrey Parks MD FACS said...

Let's dial down the drama just a bit, ok? Surgical safety is always paramount when I do an operation. But to use the results of this study as definitive proof that by simply implementing Dr Gawande's 19 point checklist will save thousands of lives is misguided. This was a non-randomized, non-blinded study. It's not hard science. Long, indepth checklists are only going to complicate health care. Will we need different checklists depending on the operation? Will there be separate checklists for doctors vs nurses vs anesthesia staff? Who will be in charge of determining each checklist? A subcommittee of the AMA? A national bureaucracy>

Common sense and moderation, as usual, ought to be our guiding principles. The article is useful in the sense that it highlights the potential benefits of a checklist; but let's not fall over ourselves thinking that we've found some sort of panacea....

Anonymous said...

You're off the mark on this one Buckeye. A lack of a surgical pause is obviously disadvantageous to outcomes, and a 200 point check list would be inefficient and unwieldy. The point of research is to try to parse out when we get into limited returns on a protocols like this.

Clearly this was a well run multicenter study. It wasn't blinded but how could you possibly blind a surgical protocol study? Virtually every clinical trial involving surgical procedure suffers from lack of blinding due to the fact that most surgeons know what it is they are or are not doing.

I seriously doubt Atul Gawande thinks his list will "magically reduce" complications by 50%; he is simply presenting his results. More research will undoubtedly follow.

Anonymous said...

on another note is atul gawande your nemesis?

verbose, popular, overly specialized in something you're probably pretty good at operating on anyway (endocrine surgery), at a major academic center in a better football town?

Jeffrey Parks MD FACS said...

Anon 1:21-
Bettah football town? Who are you, Wes Welkah, the greatest wide receivah evah??? No one denies that the Patriots got screwed ovah this year not makin the playoffs!!!!

Seriously, though. I like Atul Gawande. I've been reading his stuff for years.

Andrew_M_Garland said...

It's easy to get better outcomes in a non-blind trial.

(Then again, I wouldn't blindfold the surgeons. Maybe I would blindfold the patients. Never mind.)

Maybe there were a few statements like this in the operating room: "The patient just died, but it didn't have anything to do with the checklist, so I'm not writing this into the study".

Survival rates go way up.

Bongi said...

i'm struggeling to visualise this study.

"death rates were reduced by almost 50% when patients were subjected to this magical checklist"

so in a 30 day prospective trial on cvp insertion, you can decrease your mortality on cvp insertion with 50%?

mortality from cvp? do these people know how to insert a cvp?

sorry but i'm with buckeye on this. i think this is the result of forced studies and the data just has to be flawed. if you lose even one single patient due to cvp insertion, you are absolutely useless and checklist or not, you should be struck from the roll.

sorry, but this seems to be bogus.

Anonymous said...

Once again, you have an example "Buckeye Surgeon") of a physician more interested in preserving his professional prerogatives and dispelling any notion that what he does is rote or ungodlike than in saving the lives of his clients.

This is NOT the first time checklists have been shown to save lives. I remember a similar study in Duke Univ. Hospital ERs.

Drs. make a lot of mistakes. They kill a quarter of a million thru their mistakes and probably another million thru their accepted, though misbeggotten treatments. (Wow--that's a Holocaust every half decade). Organization-level decision-making is often better than individualized decision-making. This is just an example.

Anonymous said...

i think hospitals are trying to save too much money by scrimping on operating room nurses and technicians for advanced procedures like neuroradiology and cardiac surgery. these penny pinching measures are more likely to cause harm than absence of formal 19 item checklists.

Anonymous said...

I read an interesting article about a safety guy from Boeing who goes around helping airlines.

You are safer when the Co-pilot is flying because the Capt. doesn't hesitate to review his actions and comment/correct.

Korea Air was about to lose all its' partnerships with other airlines because they had so many problems. The consultant immediately began by forcing them to all speak English in the cockpit. That eliminated much of the hierarchial nature of interchanges and made it easier for the team to communicate without soft-pedaling emergency situations.

Josh said...

You have to admit that there is a point to what's being criticized here. Anybody (i.e. hospital administrators, OR nurse supervisors) can decide for any odd reason that something needs to be added to 'the magic checklist' even if it doesn't have anything to do with the procedure being performed and regardless of whether that bit of data would improve outcomes or efficiency.

I would highly recommend to anyone interested an article published in The Atlantic Monthly within the last year that talks about the differences between the American and British traffic systems in terms of how they treat and communicate with the driver and what this might imply about how much deadlier it is to drive here than there (it has relevance, I swear). Long story short: rote routines like these have their drawbacks too. People have the ability (nay, inclination) to tune things out and go through the motions, say what needs to be said to get an annoying checklist over with so they can start. I've seen it happen; you've seen it happen. [How many 'time-outs' have you heard unceremoniously glossed over?] I would be highly suspicious of the kind of drastic data being touted here.... On occasion, someone who doesn't take a personal interest in their responsibility as a physician will chop off the wrong testicle no matter what you do. I remain unconvinced these sort of things will save careless physicians from themselves.

Anonymous said...

Buckeye - thanks for your post on the Checklist. I was hoping you'd comment on it. I'm one of the surgical fellows in Atul's group. We absolutely realize the concerns that many surgeons will have in the US. I, like you, will be an attending one day and loathe the idea of being slowed down in the OR. And, whether the Checklist will reduce mortality by 50% in the US is certainly up for debate. However, one thing to consider is that all surgeons think they do these things all the time - give timely abx, know the patient's allergies, have blood ready when it needs to be, etc. However, even in the Seattle site, these things were missed a surprisingly high number of times. Your criticisms of the study design are fair. It was a pre/post study, not randomized and there was no blinding. There were ethical concerns about implementing the Checklist in some sites and not others because all steps are already accepted standards of care. Our group is entirely composed of surgeons and we're not trying to torture us or our colleagues. We're hoping that surgeons will see the possible benefit to their patients, and give it a whirl. In the UK, they're taking a different stance. The NHS is mandating it. That's not the way things move in this country, as you know. I'm sure the editors at NEJM will be publishing comments very similar to yours over the next couple of months, many of which are valid criticisms. Anyway, thanks for your comments. One interesting question is whether or not you would want the Checklist to be used on you or your family member during surgery. I think most of us would.

Anonymous said...

I know the real reason Surgeons resist the checklists, its cause Anesthesia started em 30 years ago, and WE don't even use em', you show me an Anesthesiologist following the "Official ASA Anesthesia Machine Checkout Checklist" and I'll show you an early case of Alzheimers, theres only 3 steps, Turn Machine "ON", Check O2 and Suction, DONE...Of course in residency, I made my own checklists, scribbled on waterproof tape applied to my right leg...
1: IV supplies
2: Resuscitation Drugs
3: NY Times Sunday Crossword
4: Menu from Pizza Takeout place

Really sucks if you forget somethin'

Anonymous said...

Is this the study that the feds shut down because they did not get informed consent from patients?

Anonymous said...

Paratrooper JJ - no. The feds attempted to halt a central line checklist study that was shown to reduce blood stream infections by 2/3. That study was led by Peter Pronovost at Hopkins. Due to the absurdity of forcing clinicians to obtain consent for the common sense things on that central line checklist (washing your hands, draping the patient), the decision was reversed. It would have had catastrophic consequences for health services research.

Dr J said...

There seem to be a lot of "courageous" anonymous posters on this topic. Good, bad, or indifferent, if you believe what you say, why not stand behind it? It might control some of the vitriol in the blogosphere.

Jeffrey Parks MD FACS said...

Anon 1/15/829pm-
Thanks for stopping by.

You forgot customized seat cushion for your comfort. (My wife is an anesthesiologist...I can crack on gaspassers right?)

Victor Lazaron said...

Whether the checklist will reduce mortality by 50% in the US is not at all up for debate. It won't. The results of the study show the benefits overwhelmingly coming from the less-developed world ORs. I do not believe there was ANY statistically significant mortality benefit from the checklist in the US (which makes some sense since it is largely duplicative of what we already do here.)

I am not against the checklist at all, in fact I use a somewhat longer "time-out" than I am mandated to in order to brief my whole team on the operative plan and any anticipated problems, needs for equipment, etc.

I think the pushback we see from the surgical community in the US regarding this study has to do with the breathless press coverage which spectacularly exaggerates it's results vis-a-vis current American surgical practice.

Sarah said...

One important feature from the checklist is the application of the pulse oximeter. As a US anesthesiologist, I cannot imagine that anyone would consider this something to put in a checklist.

Since this was an international study, I'll be interested in the data mining. My theory is that it will show that this alone was responsible for the lion's share of complication reduction. If so there's not likely to be a big change in US statistics with implementation of the checklist.

We are implementing it in our hospital today. It's not so onerous since we already do all the items on the list.

I don't have a problem with checklists, but I do find we tend to go a little crazy over regulating "evidence based procedures" before we get all the evidence. Great example: perioperative beta blockade. I predict the VTE prophylaxis is going to be the next "oops" issue.

jeff spillane said...

I'm a board certified 50 yo surgeon

I use the WHO's easy/fun, and the real intent is to get your operating room to the level of a highly functioning team.

Please look at the airline industry and CRM training.
Then, look at the career of "Sully"
who landed the plane in the Hudson.

.....go to the WHO safesurgery site and watch the videos.

It adds 60-90 seconds to the time of operation.....maybe its a PITA, but why not try it?

jeff spillane said...

We dropped the Pulse Ox requirement from our checklist.
We added DVT and bHCG
The WHO encourages modification.
I can send anyone our modifications if you want.

jeff spillane said...

oops...made a mistake!

Steve Harden said...

I am commercial airline captain (33 years) and have been working in ORs for the last 10 years helping OR teams implement pre-procedure checklists. So, I see the issue from both sides. Here's a short list of what I have learned about checklists that work in the OR. Effective OR checklists are:

1. Only as long as they need to be. Shorter is better.
2. Created only by the people who actually use them - never an administrator.
3. Revised over and over again to make them perfect - and only as long as they need to be.
4. Led by the surgeon.
5. Interactive - there are many SHORT speaking parts for other team members (and God help you if you are not ready or unprepared for your part).
6. Customized to each department or specialty.
7. Used with the "Do and Check" method - not the "Read and Do" method.
8. Shortened for Emergent conditions.

I'm happy to discuss any of these and more if any have questions.