FIRST trial prelim results

[thedrjojo]

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Simultaneously presented at the Academic Surgical Congress and released on NEJM (I've tried uploading it but got an error)

Our program hopes the acgme acts quickly and let's us continue relaxed hours next year, because restricted hour scheduling was a nightmare. What do you guys think of the results?

 

[OMFS21]

....

 

[Dr.LeoSpaceman]

I was at the ASC, and heard the presentation. General consensus was: Yeah, no kidding. Overall, it was striking how "managed" the presentation was. It was as political as it was scientific.

Personally, I think the trial was ambitious and impressive...but ultimately flawed. They got the answer they wanted to get, which is what everyone predicted when the design was announced two years ago. Did anyone really believe that having a few residents (potentially) working more would influence the total mortality and serious morbidity rate by 10%?

The presentation also glossed over the fact that I do believe that it is reasonable to question the ethics surrounding how it was approved. The answer to the criticisms was basically: "Some people have problems, but they're wrong. We have a bioethicist who says we are ok, and no surgery residents complained." First, of course no surgery residents complained. Second, it seems laughable that the IRB determined that the people participating in the trial were the Institutions, and not the residents or patients.

As for what the results will mean, I suspect we will see the rules relaxed. The ACGME rep that was there hinted as much. But as for what the trial means for surgical education, I think Birkmeyer's critique is interesting. Sure the trial could be interpreted to mean that flexible rules are ok. But it can also be interpreted to mean that the restrictive hours are ok too. I think Dr. Hoyt's comments were the most important. This is just a small piece of efforts to determine how surgeons should be trained, and it shouldn't be interpreted to mean that we can simply put people in the hospital for longer periods of time and expect they will be better surgeons. The amount of time is much less important than what is actually done with that time. If the flexible time is used in the OR, managing active patient issues or in educational activities that is great. If it's used to wait 3 hours while a chief/attending gets out of the OR so you can round in the evening it's likely less useful.

 

[vhawk]

I was at the ASC, and heard the presentation. General consensus was: Yeah, no kidding. Overall, it was striking how "managed" the presentation was. It was as political as it was scientific.

Personally, I think the trial was ambitious and impressive...but ultimately flawed. They got the answer they wanted to get, which is what everyone predicted when the design was announced two years ago. Did anyone really believe that having a few residents (potentially) working more would influence the total mortality and serious morbidity rate by 10%?

The presentation also glossed over the fact that I do believe that it is reasonable to question the ethics surrounding how it was approved. The answer to the criticisms was basically: "Some people have problems, but they're wrong. We have a bioethicist who says we are ok, and no surgery residents complained." First, of course no surgery residents complained. Second, it seems laughable that the IRB determined that the people participating in the trial were the Institutions, and not the residents or patients.

As for what the results will mean, I suspect we will see the rules relaxed. The ACGME rep that was there hinted as much. But as for what the trial means for surgical education, I think Birkmeyer's critique is interesting. Sure the trial could be interpreted to mean that flexible rules are ok. But it can also be interpreted to mean that the restrictive hours are ok too. I think Dr. Hoyt's comments were the most important. This is just a small piece of efforts to determine how surgeons should be trained, and it shouldn't be interpreted to mean that we can simply put people in the hospital for longer periods of time and expect they will be better surgeons. The amount of time is much less important than what is actually done with that time. If the flexible time is used in the OR, managing active patient issues or in educational activities that is great. If it's used to wait 3 hours while a chief/attending gets out of the OR so you can round in the evening it's likely less useful.

What would be your interpretation of the results that leads to "restrictive hours are ok too?" Because the justification for the increased restrictions on hours was that it was for the good of the patients and the good of the residents. Since neither of those seem to be true, it seems awfully galling to still proclaim it a victory for the restrictive hours group.

I do agree that the results of this study were never really in doubt, but if "overall mortality and serious morbidity" weren't the end points you wanted, what did you want? Those are the ones the general public cares about. If the changes arent enough to make a dent in either one of those, then why would we accept stringent policies forced upon us from the ACGME?

I guess I'm saying it seems you can really only be making this argument if you start from a baseline of "man I sure want to tell everyone what to do and pass a bunch of inflexible rules..." and then reason backwards from that. From any other standpoint this seems to be a clear loss for the restrictive hours proponents. That the results were obvious to all should be even more humiliating for people who made a bunch of feel-good rules without any actual science to back them up or really any ability to predict outcomes or understanding of how incentives work. Its probably cost millions of dollars implementing these changes in terms of shaking up programs and coming up with novel strategies, hiring APPs, etc. And could cost even more to go back, if programs choose. Who foots the bill for that massive wasteful expenditure on what was basically a forced experiment by the ACGME without ANY IRB approval or any plan to collect data or confirm a hypothesis or anything?

What SHOULD have happened is the ACGME should have designed the FIRST trial 10 years ago, and then been upfront about the results. But its likely that they were just as capable as all of us at guessing what those results would be, and instead chose to score political points.

 

[deleted547339]

What would be your interpretation of the results that leads to "restrictive hours are ok too?" Because the justification for the increased restrictions on hours was that it was for the good of the patients and the good of the residents. Since neither of those seem to be true, it seems awfully galling to still proclaim it a victory for the restrictive hours group.

I do agree that the results of this study were never really in doubt, but if "overall mortality and serious morbidity" weren't the end points you wanted, what did you want? Those are the ones the general public cares about. If the changes arent enough to make a dent in either one of those, then why would we accept stringent policies forced upon us from the ACGME?

I guess I'm saying it seems you can really only be making this argument if you start from a baseline of "man I sure want to tell everyone what to do and pass a bunch of inflexible rules..." and then reason backwards from that. From any other standpoint this seems to be a clear loss for the restrictive hours proponents. That the results were obvious to all should be even more humiliating for people who made a bunch of feel-good rules without any actual science to back them up or really any ability to predict outcomes or understanding of how incentives work. Its probably cost millions of dollars implementing these changes in terms of shaking up programs and coming up with novel strategies, hiring APPs, etc. And could cost even more to go back, if programs choose. Who foots the bill for that massive wasteful expenditure on what was basically a forced experiment by the ACGME without ANY IRB approval or any plan to collect data or confirm a hypothesis or anything?

What SHOULD have happened is the ACGME should have designed the FIRST trial 10 years ago, and then been upfront about the results. But its likely that they were just as capable as all of us at guessing what those results would be, and instead chose to score political points.

One could make the fairly simple argument that fewer hours (likely) leads to improved resident satisfaction. If patients are still receiving the same quality of care and if we are still producing competent physicians, shouldn't we ideally strive for some semblance of improved resident life? Any before some crucifies me as a lazy resident, I think we can all agree that 80 hours is far from easy. It's not up hill in the snow both ways without shoes, but it's still a ton of work.

 

[vhawk]

One could make the fairly simple argument that fewer hours (likely) leads to improved resident satisfaction. If patients are still receiving the same quality of care and if we are still producing competent physicians, shouldn't we ideally strive for some semblance of improved resident life? Any before some crucifies me as a lazy resident, I think we can all agree that 80 hours is far from easy. It's not up hill in the snow both ways without shoes, but it's still a ton of work.

I guess it depends a lot on the individual resident of course, but I dont really think that your "simple argument" is something I would just automatically agree to. To take the argument to its extreme, if we reduced resident work hours to 10 hrs a week, my satisfaction would have plummeted. There is probably a "too much" just as there is a "too little" and it isnt immediately obvious where 80 hrs/week falls on that curve. It seems on superficial first glance that it must fall on the "too much" side but I would argue thats a little myopic. And I bet you every surgeon in his first 2 years of practice would immediately see why its myopic.

 

[dynx]

I guess it depends a lot on the individual resident of course, but I dont really think that your "simple argument" is something I would just automatically agree to. To take the argument to its extreme, if we reduced resident work hours to 10 hrs a week, my satisfaction would have plummeted. There is probably a "too much" just as there is a "too little" and it isnt immediately obvious where 80 hrs/week falls on that curve. It seems on superficial first glance that it must fall on the "too much" side but I would argue thats a little myopic. And I bet you every surgeon in his first 2 years of practice would immediately see why its myopic.

Exactly. 80 seems like a lot and it is in an absolute sense. If the idea is to have good patient outcomes and a nice lifestyle while you're in your residence then have the attending do all the operating...mission accomplished.
If the goal is to maintain good outcomes AND train good surgeons well then there's something to be said for more time in the hospital. Is it 80? 90? 100? I don't know. I can tell you from experience 110 is too much but 80? Probably too little for our current training paradigm.
But, I'm done and not training residents. I took a lot of pride in teaching those that wanted to learn when I did and overall, those that dedicated more time were better. If my future free market competitors don't want to work >80 hours great, more business for me. Good luck, like sports bra chick, you're an adult, you make your own choices. But when you're alone at 2 AM with an aortic dissection you're gonna wish you had hung around that Tuesday 9 months ago.

 

[Alby]

My issue with this trial is two fold.

First, hours are still capped at 80 hours. Show me a surgery resident who has not broken 80 hours and recorded only 80 hours on a fairly regular basis because we want to be there and get more experience. I think there is self reporting bias in this trial.

Second, so many confounding variables that are impossible to control. The amount of safety measures implemented over the last 13 years is vast!!!! Safety checks galore were adopted since that time.

I think we need to focus more on effective education and teaching styles than numbers of hours.


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[SLUser11]

I think we need to focus more on effective education and teaching styles than numbers of hours.

What makes you think that work hours are separate from effective education and teaching styles?

The FIRST trial is imperfect, but it is definitely thoughtful, well-designed, and extremely innovative. The authors are not tyrants trying to ruin resident lives. They are dedicated lifelong educators trying to improve the quality of resident education.

Within the current surgical model, which certainly contains flaws, flexible work hours are essential to professionalism, autonomy, and patient ownership. Opponents of the most recent rules would argue that the policies impede their ability to effectively educate.

Still, I agree that residents in both arms of the study are not being truthful about their adherence to work hour rules. This is a whole separate philosophical discussion, as we are trying to foster professionalism, but are willing to ignore lying about work hours. It's a bit schizophrenic.

I am very worried about the future of surgical education. It's not because of any change in the residents themselves, or even their teachers. Instead, it's the new transparency of the process, with the public more aware of what we're doing. Along with this is increasing scrutiny of outcomes, and declining reimbursements that demand efficiency to get paid....which impacts how much we'll let the residents do, and how patient we'll be when they struggle. Increasing specialization has dramatically improved surgical quality, but is also a huge detriment to a well-rounded surgical education. It's all a very bittersweet evolution.

 

[thedrjojo]

My issue with this trial is two fold.

First, hours are still capped at 80 hours. Show me a surgery resident who has not broken 80 hours and recorded only 80 hours on a fairly regular basis because we want to be there and get more experience. I think there is self reporting bias in this trial.

Second, so many confounding variables that are impossible to control. The amount of safety measures implemented over the last 13 years is vast!!!! Safety checks galore were adopted since that time.

I think we need to focus more on effective education and teaching styles than numbers of hours.


Sent from my iPhone using SDN mobile

do you even know what the first trial compared? it was a prospective study comparing two groups of residents over the same time period, one with the old hour restrictions (80hrs, 1 in 7 off, q3 call) and one group with the new hour restrictions (interns no more than 16hrs, 8hrs in between, 10 hrs off after a 24hr shift, etc). So your second point makes no difference since both groups are operating within the same confounding, hence the randomization.

 

[Alby]

I realize this. All I was trying to say is that the study does not compare pre-hour restrictions to the 80 hour work week. This was not the intent of the study, and I realize that, however I've heard a lot of people try and extrapolate just that.

That's all I was trying to say, I guess I just did not articulate myself very well, I apologize.


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[SLUser11]

I realize this. All I was trying to say is that the study does not compare pre-hour restrictions to the 80 hour work week. This was not the intent of the study, and I realize that, however I've heard a lot of people try and extrapolate just that.

That's all I was trying to say, I guess I just did not articulate myself very well, I apologize.


Sent from my iPhone using SDN mobile

Don't apologize. This is an internet message board...we ignore intent, see what we want to see, then argue a bunch...that's what makes it fun.

I just happen to like the study. I agree that the number of variables is quite intimidating, and little is likely to be gained. However, if the APDS/ABS are able to get the newer 2011 rules scaled back (which I doubt), I believe it would be beneficial to resident education. However, I echo your sentiment that this is but one tiny piece of a huge puzzle.

I listen to many of the higher-uppers, and they seem to think it's too late to fix anything. In my opinion, surgery will be changing to a model similar to IM in the next 10 years (i.e. 4+2 or 4+3). The big question will be how to make those 4 years high yield, as a great deal of what makes residents ready for fellowship occurs in their chief year (autonomy, refinement of technical skills, troubleshooting, teaching of junior residents, etc).