Work Wife II says the interns need to sack up.

Dr. J. was alerted to this article at USA Today by Work Wife II, with additional analysis by the International Business Times. Feel free to read those articles for background. Dr. J. won’t quote them to analyze their analysis.

The studies they discuss are from The Journal of the American Medical Association: Internal Medicine (formerly Archives of Internal Medicine) which Dr. J. links to here and here for your benefit. They are summarized by Dr. J. as follows:

Now, the reason you are here, Dr. J.’s J-tastic™ analysis of the studies and the ramifications for your well being.

The first study, by Sen, et al, is a prospective cohort design, meaning they take identify a group of subjects and study them moving forward into the future. In this study interns from 2009 and 2010 were compared against interns from 2011, before and after the most recent work hour restrictions for interns were created.

Subjects filled out questionnaires at the beginning, 3, 6, 9 and 12 months answering questions about well being (work hours, sleep, mood, etc) AND if concern if they’ve committed a serious medical error in the interval time period.

The results found that the new work hour restrictions for interns had no impact on their quality of life. Their hours, sleep time and mood were unchanged. The big difference is that the percentage of interns who are concerned they made a serious medical error over the prior 12 months 19.1% to 22.3%, an increase of 2.1%, or one more reported serious error in the last 3 months per 50 interns, or 4 more serious errors per year per 50 interns (the size of a larger residency program).

In the second study, by Desai, et al, is more rigorous. It is an actual randomized-control trial. Forty-three interns were asked to take call for one month using an ‘old school’ every fourth night call, staying for six hours on their post-call day versus two different methods that incorporate the current 16 hour restrictions. One with ever fifth night call, the other using a night float system. Each intern spent one month in each system in a random order.

Endpoints included sleep duration, admission volume, access to educational opportunities (teaching conferences) number of handoffs and quality of life surveys. The results demonstrated that the interns received more sleep (natch) under the new system, but at a cost of an increased number of handoffs (130-200% more), poorer conference attendance, fewer admissions per intern and a perception among residents and nurses that poorer care is being delivered. Most interestingly job satisfaction was highest in the ‘old school’ model.

So, what are the take-aways. While neither study is the ‘perfect design’ the perfect design would be hard, but not impossible to do. The ideal study would be a multicenter randomized crossover design analyzing medical records for adverse outcomes. The first study above is limited by being a questionnaire relying on the honesty and self-awareness of residents to report medical errors. While Dr. J. believes that while the residents would be honest, they may still underreport due to minimizing ‘near misses’ as not serious, and not being aware of errors as a consequence of going off service, or the consequence becoming manifest after patient discharg. The second study’s limits are that the primary clinical outcome is ‘number of handoffs’ which, even though it is a powerful predictor of adverse outcomes is still only a ‘surrogate endpoint.’

Surrogate endpoints (reduction in blood pressure and cholesterol)  are used instead of hard endpoints (stroke, death) in studies because they occur more frequently and usually are a sufficently powerful predictors that the trade off of a less rigorous endpoint is offset by the ability to design a smaller and less costly study.

Surrogate endpoints must be taken with a grain of salt. In the pre-angioplasty era, premature ventricular contraction (PVC) frequency was a very powerful predictor of death in patients who were admitted to the hospital for a heart attack. Flecanide and encanide were new antiarrhythmic drugs that suppress ventricular arrhythmias including PVCs. The Cardiac Arrhythmia Suppression Trial was performed to see if suppressing PVCs would reduce risk of post-MI death. There were folks that believed that it was obvious that this would work, so a placebo group would be unethical. Fortunately cooler heads prevailed and there was a control arm. It turned out that the drugs actually killed more people than placebo, so while PVCs were a predictor of death post MI, suppressing them with a 1C agent actually harmful. As a consequence of that study, 1C agents (flecanide, etc…) are contraindicated in patients with ischemic heart disease. Flecanide is safe, however, for patients without ischemic heart disease to manage atrial fibrillation.

That being said, these studies tell us a couple of things. First, the current work hours are not only effect neutral, they are clearly having a negative impact on patient care above and beyond reducing manpower. Residents are making more serious medical errors that they’re aware of, and through a greater number of handoffs are increasing risk of harm to patients. They are learning less through admitting less patients and missing teaching conferences. Furthermore, they’re demoralized by being treated by children.

The thing that Dr. J. finds patently offensive is that the Institute of Medicine and the American College for Graduate Medication imposed these restrictions without studying them. The majority of teaching physicians knew that these work hour restrictions would have a negative impact on educating the next generation of doctors. Furthermore if this were a drug, or a medical device, there would have been a series of carefully designed clinical trials performed before approval. Dr. J. thinks that they’re sufficient to warrant larger scale studies, alternatively it would not be unreasonable  to change the rules back to at least the 2003 rules, if not earlier given this data.

These work hour restrictions were not well thought through and have been clearly ineffective if not harmful. It’s just a matter of time before some enterprising ambulance chaser files a class action lawsuit against the IoM, the ACGME, and perhaps teaching hospitals nationwide.

Dr. J.