FIRST Trial in Surgery Explained: Surgeons are NOT human!

The FIRST (Flexibility in Duty Hour Requirements for Surgical Trainees)¹ trial randomized American surgical residency programs to one of two arms – either to continue with their current standard restricted hours practice of 80 hours per week with time for breaks/rest and a limit to hours of work at any one time, or to have ‘flexible’ hours which involved removing current restrictions on hours worked at any one time and waiving the need for breaks etc., whilst somehow maintaining the same overall 80 hour per week averaged over four weeks. Data was collected via systems and surveys that are already undertaken in the USA to establish if there was any detriment to the patient or the surgeon.

It has often been considered by those outside and inside the profession that surgeons are not human (possibly subhuman or superhuman depending on your experience!) – and now we have it confirmed, as this trial, which included an intervention that impacted human subjects (I am making the assumption here that trainee surgeons are in fact human) – was somehow classified as ‘non-human subjects’ research, thus not subjecting it to a more in-depth review.

How did it get classified as ‘non-human subjects’ research?

A look at the supplementary information shows the box was ticked that claimed it was LIMITED to the use of existing or collected data. Whilst the study team did not collect primary data and other sources were used, it was not solely limited to that. An intervention was applied – an intervention which, whilst it was applied to residency programs, impacted and affected the lives of human subjects and was therefore not limited purely to the collection of data that already existed or was being collected. Calling the intervention a ‘policy change’ that randomised residency programs (not individuals) does not take away from the fact that this research involved an intervention that affected living human subjects. Has the correct box been ticked? Has there been fudging of information so as what is in fact human subjects’ research is somehow classified as not? All very convenient when you have a specific aim and agenda to fulfill with the backing of the American College of Surgeons, the American Board of Surgery and the Accreditation for Graduate Medical Education – I imagine any IRB (Institutional Review Board) would have difficulty contravening the weight of those establishments!

I also question how it is possible to maintain 80 hour week average over 4 weeks for both groups and yet have one group work normal duties plus waive all restrictions on their work hours? Sounds like magic to me – how to make 100 hours of work fit into 80! There is no mention of days off in lieu or how the study arm group limited their overall hours to 80 per week. And what is even more concerning is the statement that ‘monitoring to ensure strict adherence to study arm conditions was not undertaken’ or in other words, ‘we have no idea if the total hours worked in the study arm exceeded 80 or not and we don’t care if it did.’

Even the use of language in this paper is misleading – calling the study arm group the ‘flexible working hours’ group when really there is no flexibility – it is prolongation of hours. Flexible hours implies one can decide to start late or finish early – neither of which are options in this trial.

It is clear that from the inception of this trial that there was a predetermined agenda to find that long hours were not detrimental to patient care or quality of wellbeing for trainees. Using gross measures of outcome like patient mortality is also not an accurate marker as teams of nurses and doctors – not just one trainee – care for patients. More sensitive measures of outcome were not utilised.

It does report that there were subtle differences in wellbeing, with those in the ‘flexible’ hours group reporting negative effects on activities away from the hospital like time with friends and family, extra-curricular activities, research time and rest/health – again suggesting that the 80 hours limit was most likely exceeded or else they would have had the same amount of time outside work.

In addition, they report that the resident survey was conducted half way through the trial, not at the end of the trial, when a bigger discrepancy may have been noted. Surgeons are pretty resilient, they want to work hard and do well for their patients, often to the detriment of their own health and wellbeing, and are used to overriding bodily needs, often priding themselves on their levels of stamina, endurance and ability to go not just the extra mile, but perhaps the extra marathon. But if there are differences at 6 months, what would they be at one year? At 2, 5, 10 years, at 20 or 30 years?

If there are no detrimental effects to long hours of work then why are burn out rates amongst surgeons in the USA around 50%?

This perception of not being human plays out in many ways. We arrogantly believe we can work extremely long hours yet not get affected or have our work or our own health detrimentally affected. I used to be of that view too. Proponents of this trial will say that this is the case and that it has been confirmed or validated by trial, opening the door to abusively long hours of work once more. Yet other humans like airline pilots and lorry drivers are restricted in their hours of work because it has been shown that human error increases with fatigue. So is the answer that surgeons are indeed not human and not subject to the same laws of life as everyone else or is something else going on?

As trainee surgeons, we love what we do and we are happy to spend long hours in theatre or at work, to provide good quality care and to get the experience needed to be a competent surgeon. I get it. I’ve been there, done it, got the tee shirt. And nobody would have convinced me otherwise. I was a strong proponent of such a system. I have experienced both ends of the spectrum – working continuously 24/7 with only 48 hours off somewhere between every two to six weeks, with night after night of sleep deprivation culminating in a cotton wool head where I could hardly string two words together. I remember handing over to my colleagues on a Friday evening at 7pm, when I was going off for 48 hours, and hearing them fall asleep on the end of the line as they continued on duty. One even recounted how he fell asleep whilst assisting, standing up! And we think all of this has no effect on our performance or wellbeing? Come on!

If there are no detrimental effects to long hours of work then why are burn out rates amongst surgeons in the USA around 50%?

It’s not rocket science! Yes, multiple factors contribute to that, but we have basic human needs that, if we override for long enough, will come back to bite us in the bum.

On top of that there is all the research showing the detrimental effects of sleep deprivation and an association with a multitude of conditions like heart disease, diabetes, dementia and more. Our lifestyle is a major determinant of our health and wellbeing – and whilst we may not believe or notice these effects when we are young, they undoubtedly take their toll on the human body over time. This does not mean we cannot work hard, but we have to know how to do that in a way that is not detrimental and that is currently not mainstream knowledge and is certainly not part of surgical training.

I have also worked in a system where hours of work are restricted and I know the frustrations that can come from there being a lack of continuity of care by junior staff. I understand the surgical mindset that laments the days of yore – but those days, at least in the UK, are gone. It is not about returning to those days, but how do we improve our systems, structures and personal levels of wellbeing such that quality of patient care is maintained? I know from personal experience there is much we can do to help ourselves so that we can work hard, play healthy, and not get so detrimentally affected by the work we do. John D Birkmeyer reaches a similar conclusion in his editorial on this trial, that surgical leaders, rather than endeavouring to turn back the clock, should focus on developing safe healthcare systems that ‘do not depend on overworked physicians’.²

And so whilst I fully appreciate the need for continuity of care and high quality surgical training, I also am acutely aware of the need to not abuse trainees in the process or to have them exploited by programs and people who do not care for the wellbeing of the trainee and assume that just because they did it, everyone should do it.  

If we do not care for ourselves, we cannot provide a true quality of care to others – for we cannot give what we do not have. A trainee who is self-caring, alert, vital, vibrant, aware and fully present undoubtedly delivers a quality of care that is superior to one who is tired, exhausted, sleep deprived, falling asleep on duty, and who overrides their own bodily needs. The environment within which we work can be supportive and engendering of such qualities or it can be highly abusive and detrimental to the trainees’ own wellbeing – and trainees in pursuit of their dream job are all too often only too willing to subjugate their own needs for professional progress.

It is common sense that excessively long hours of work are detrimental to our own health and wellbeing and affect performance – it does not even need a trial to tell us this, as our own bodies will do the job if we listen to them honestly. So just for the record – surgeons are human, not superhuman, we have the same bodies made of the same stuff as everyone else, we get just as tired and detrimentally affected by persistently long hours of work devoid of self-care as other professions, we are perhaps just better at denying, ignoring and overriding the fact that we do. 

Unfortunately this trial belongs to the waste paper bin for it is nothing more than a biased, pre-determined, agenda-laden study, undertaken on false pretences of being a non-human subject study designed to permit the ongoing abuse and exploitation of trainee surgeons – who themselves are often so enwrapped in their desire to pursue a surgical career that they do not even recognise when they are being abused or when they are abusing their own bodies.

Having been there myself – I know it only too well.

In the words of Dr Marcia Angell, the former editor in chief of the New England Journal of Medicine, ironically where this study was published:

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”³

  

References:

1)    Bilmoria, K., Chung, JW., Hedges, L., et al. (2016). National Cluster Randomized Trial of Duty-Hour Flexibility in Surgical Training. NEJM Feb 2 http://www.nejm.org/doi/full/10.1056/NEJMoa1515724#t=article

2)    Birkmeyer, JD.,(2016) Surgical Resident Duty-Hour Rules – Weighing the New Evidence. NEJM Feb 2 http://www.nejm.org/doi/full/10.1056/NEJMe1516572

3)    Angell, Marcia (2009) Drug Companies and Doctors: A story of corruption. In the New York Review of Books.

http://www.nybooks.com/articles/2009/01/15/drug-companies-doctorsa-story-of-corruption/