It all seemed so bizarre. In 2014, with little fanfare, two large trials that imposed longer work hours and sleep deprivation on physician-trainees (interns and residents), ostensibly to combat the problem of excess hand-offs of patients among physicians. Both trials involved multiple academic medical centers, including some of the most prestigious in the US. Within a year, the American Medical Student Association (AMSA) and Public Citizen called for a federal investigation of the trials, calling them "highly unethical."
This unprecented conflict between prestigious academic medical institutions and the largest organization of medical students and a respected watchdog group suggests either the former have serious ethical problems, or the latter have gone a little crazy. The minimal media attention to the dispute did not explain what is going on. My suspicion is that these events open a window on how respected medical academics are now in the thrall of the
managerialist leaders of health care.
Background of the StudiesMy Personal Experience on the Medical Housestaff Let me start by disclosing the axe I am grinding. I was an internal medicine intern from 1978-79 in a program known to be very arduous. For much of the year, I worked up to 36 consecutive hours every fourth night, often without more than a few hours of sleep. My on call shifts were extremely busy, involving admission of usually 4-5 complex and acutely ill patients, handling exacerbations and emergencies affecting my own patients already in the hospital, and three other interns' patients for about 12-15 hours of the shift. The workload was augmented by a hefty amount of "scut," that is, tasks that either did not involve direct patient care, or could easily have been done by someone who was not a physician, e.g., paperwork and phone calls, other bureaucratic tasks, drawing blood, starting IVs, and even transporting patients. As the shift dragged on into the evening, I knew my mind was getting fuzzier and my coordination was getting clumsier.
The notion that working 36 hours straight was educational, was good for my patients, or was good for me seemed nonsensical. One reason I went into medical education was to improve the experience for future trainees.
Addressing Housestaff Sleep Deprivation I was hardly the only person who thought the work requirements imposed on medical housestaff were nonsensical. The first notable improvement was the advent of night float systems that allowed on-call housestaff to get at least some sleep. Eventually, in part after the infamous "Libby Zion case," (see NY Times retrospective
here,) teaching hospitals were required to limit work hours. In 2003, Accreditation Council for Graduate Medical Education
limited the total work week to 80 hours, required one day off a week, and required call schedules no more frequent than every third night. (Note that my old program fulfilled all but the first.) In 2011, the rules were
tightened further, limiting interns to shifts no longer than 16 hours.
Pushback Against Duty Hour Restrictions Yet soon after the pushback began. A
2014 MedPage today article that described the two studies noted,
The rule change elicited mixed reactions from residents and program directors of residency programs, who worried that increased hand-offs led to worse patient care and shorter hours reduced education opportunities.
I agree that the increasing number of hand-offs could be problematic, and discuss that below. On the other hand, the notion that sleep deprived housestaff could learn anything useful while in that condition seems bizarre. There is plenty of evidence about the adverse cognitive effects of sleep deprivation, including affects on learning. (See, for example, Durmer et al.)(1)
A brief discussion of one of the two trials, the iCOMPARE trial, put it this way:
Policy limiting duty hours in graduate medical education training programs has become a central point of debate amongst stakeholders. Evidence from human chronobiology and sleep science argues for shorter shifts, because fatigue leads to errors. Evidence from operations research argues for more continuity because patient handoffs also lead to errors, and may reduce the effectiveness of education necessary to produce independent clinicians for the nation’s future.
Poorly Conceived Study Question The two controversial trials were thus designed to answer the question of whether allowing increased consecutive duty hours would lead to better hand-offs and better outcomes. This question seems poorly conceived, and was not clearly justified.
The trials were apparently based on the idea that housestaff training programs can exist in only two possible states: allowing longer duty hours with fewer and better done hand-offs, or allowing shorter duty hours with more and badly done hand-offs. Therefore, the only choice seems to be to maintain the current system (tighter duty hour restrictions) or go back to the old system (more relaxed restrictions).
However, these are not the only possible alternatives. One can easily think of other choices.
Oddly, the spotty
materials about the iCOMPARE trial available online did not include any consideration of why the more restrictive duty hour regulations may have led to bad handoffs. Perhaps the current problem with hand-offs, while it may be real, may have not come about only due to a decrease in the consecutive hours housestaff were allowed to work. Perhaps it came about because the consecutive hours regulation was imposed on the closed systems of housestaff training programs in which the clinical and non-clinical responsibilities of the housestaff were fixed. So, cutting consecutive work hours without decreasing the number of patients that need to be managed, or the housestaff's total workload, including "scut," may have pushed individual residents to try to do more work in less time. This could have had various detrimental effects, including increased numbers of hand-offs occurring under too much time pressure.
That hypothesis suggests that measures other than allowing more consecutive work hours could address any unintended effects on hand-offs of the mandated consecutive work hour reduction. It seems plausible that shorter duty hours combined with measures to decrease total housestaff workload, starting with offloading "scut" work, could produce as good or better results than simply going back to the old system.
Nonetheless, the two trails were set up as if the only alternative to the current situation is to return to the old situation (longer work hours allowed). Thus it seems that the reasoning underlying the trials was based on a
false dilemma.
Summary of the Studies' MethodsThis apparently badly conceived study question led to trials whose design and implementation raised further concerns. Per the 2014 Medpage article:
The Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) will compare the current duty-hour regimen (16-hour maximum continuous work period for interns) to what the trial calls a 'more flexible regimen' that eliminates the 16-hour cap.
A total of 59 residency programs are enrolled, including academic and community-based programs.
The 12-month study, led by investigators from the University of Pennsylvania, Johns Hopkins University, and Brigham and Women's Hospital, states that its goal is 'to provide evidence to help policymakers evaluate whether the current duty-hour standards should be changed.'
Measured outcomes will include 'patient safety and trainee education,' with data from Medicare claims, exam scores, and participant surveys.
The study comes on the heels of a similar year-long, randomized trial for surgical interns (Flexibility In duty hour Requirements for Surgical Trainees, or FIRST), which began in July 2014 and is currently underway.
Also
The programs in iCOMPARE's intervention arm will adhere to three rules, which are consistent with the ACGME's July 2003 duty hour regulations:
An 80-hour weekly limit
1 day off in 7
In-house call no more frequent than every 3 nights, averaged over 4 weeks
The ProtestIn November, 2015, the complaints about the two trials were announced by AMSA and Public Citizen. The main issues were summarized in a
Huffington Post article by Dr Michael Carome of Public Citizen. First he stated that on its face, making house staff work long hours, as they are in the intervention group, is dangerous.
The iCOMPARE and FIRST trials have allowed first-year medical residents to work shifts lasting 28 consecutive hours or more -- nearly twice the current maximum number of hours allowed by the Accreditation Council for Graduate Medical Education (ACGME) for such residents. The ACGME's awareness of the known harms to both residents and patients caused by excessively long work hours led the organization in 2011 to tighten restrictions on resident physicians' work hours, including limiting shifts for first-year residents to a maximum of 16 hours.
Substantial evidence shows that sleep deprivation due to excessively long work shifts increases the risk of motor vehicle accidents, needle-stick injuries and exposure to blood-borne pathogens, , and depression in medical residents. It also exposes their patients to an increased risk of medical errors, sometimes leading to patient injuries and deaths
The last statement cited seven references. I should note here that I could not find in the current media reports, or in the spotty documentation of the ICompare trial avaiable online any engagement with the evidence that sleep deprivation is bad for trainee physicians (and everyone else).
The next important point is that the housestaff who were research subjects of the trial, and their patients who also were at least indirectly research subjects did not give their informed consent for participation in the trial.
Among the many disturbing aspects of the trials is the researchers' failure to seek the voluntary informed consent of either the resident doctors or their patients who are forced to be part of these experiments.
According to a recent media report, the University of Pennsylvania's IRB -- the designated lead IRB that reviewed and approved the iCOMPARE trial -- incorrectly found that the trial involves only 'minimal' risk and therefore waived the requirements for obtaining informed consent for all subjects.
For the FIRST trial, the administrator of the IRB at Northwestern University, the lead institution for that trial, shockingly determined that the trial was not even 'research with human subjects' and, therefore, that IRB review and approval were not required. As a result, there was no opportunity for the IRB to discuss the risks of the research and the need for obtaining the voluntary informed consent of both the general surgery residents and their patients. This determination represents a colossal failure of Northwestern University's human subjects protection system. This same failure presumably occurred at many of the other institutions that participated in the FIRST trial.
An
article in the business section of the Chicago Tribune added that Public Citizen claimed the failure to obtain informed consent was all the more serious because the house staff and patients were exposed to danger contingent on their trial participation.
It claimed the 'highly unethical' experiments, including the other led by the University of Pennsylvania and Johns Hopkins University, exposed doctors to an increased risk of making serious medical errors and suffering personal injury.
'Substantial evidence shows that sleep deprivation due to excessively long work shifts increases the risk of motor vehicle accidents, needle-stick injuries and exposure to blood-borne pathogens and depression in medical students,' according to the complaint. For patients, the long hours could lead to increased medical errors and death, the complaint said.
Furthermore, the trials apparently did not include mechanisms for house staff to refuse participation, or to stop participating. An
article in Medscape quoted Dr Karl Bilimoria, a professor of surgery at Northwestern who led the surgical trial,
Dr Bilimoria said that for first-year general surgery residents assigned extended hours at intervention-arm hospitals, the trial was no secret. 'They were told, because they had to monitor their hours,' he said. 'Residents knew which arm of the trial they were in.'
'This has been very public.'
Asked whether this process amounted to informed consent, he replied that if residents strongly disagreed with the prospect of longer hours, 'they could choose to work elsewhere.'
The news coverage of the controversy included several statements that the trials were particularly and severely unethical. For example, a
BMJ news article quoted
Charles Czeisler, professor of medicine and director of sleep medicine at Harvard Medical School [who] told the BMJ, 'I was shocked when I heard about this study assigning resident physicians to work marathon shifts.' Czeisler said that even as little as one week of sleep deprivation was knwon to cause serious harms.
In
Modern Healthcare,
Other ethics researchers found it difficult to understand how such a trial could be approved by an institutional review board.
'Because you're looking at deaths of patients as the major outcome, that makes it much more difficult ethically to support because patients may be harmed,' said Dr. Robert Klitzman, director of the master of bioethics program at Columbia University. 'If you find that twice as many patients died under anything but the current system, you could say they died unnecessarily.'
Apparent Violations of the Nuremberg Code [Photograph: Defendants in the dock at Nuremberg trials. Link
here.]
In fact, in my humble opinion, the two trials appeared to violate several major components of the
Nuremberg Code, the set of principles for ethical research that was developed after Nazi atrocities visited in the course of supposed medical experiments were revealed during the Nuremberg Trials. These principles include,
1. The voluntary consent of the human subject is absolutely essential.
This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment.
The two trials did not get true informed consent from the housestaff subjects. As trainees required to complete housestaff training to become surgeons or internists, informing housestaff that their program would be participating in the trial, and their only option if they did not want to participate would be to seek another program surely seems like any consent they provided was given under duress. Furthermore, it is not clear that they were ever informed of "all the inconveniences and hazards reasonably to be expected; and the effects upon" their "health or person[s]."
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methds or means of study, and not random and unncessary in nature.
Again, if the major rationale for doing the trials was to mitigate the postulated effects of increasing hand-offs, there are many other ways one could try to do this which do not involve increasing duty hours and sleep deprivation.
3. The experiment should be designed based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment.
Again, there is a considerable body of research that sleep deprivation is harmful to patient and humans in general. Thus, the science suggests that increasing sleep deprivation will have unfavorable results, and thus the performance of a trial of increasing sleep deprivation seems unjustified.
9. During the course of the experiment, the human subject should be at liberty to bring the experiment to an end, if he has reached the physical or mental state, where continuation of the experiment seemed to him to be impossible.
Again, the housestaff could not easily opt out of further participation. At best, to do so, as one of the investigators said, they would have to quit their training programs, which could jeopardize their careers and entail major financial costs.
The RebuttalThe main arguments of the trial proponents in response to the complaints seemed weak, and often appeared to be based on logical fallacies.
The ACGME and the IRBs Approved the Trials - Appeals to AuthorityIn the Chicago Tribune article:
But Northwestern said the council [ACGME] granted a waiver for the longer hours and helped fund the study.
'It was done with their approval,' Dr Karl Bilimoria, principal investigator for the trial ... said.
An article from the Milwaukee Journal Sentinel and
MedPage Today quoted Dr Thomas Nasca, CEO of the ACGME,
He said institutional review boards at all the participating hospital reviewed the trial protocols and determined the patients did not need to be informed.
These arguments amount to assertions that the trials must have been ethical because external authorities said they were. Thus they appear to be based on logical fallacies,
appeals to authority.
The Arguments and Evidence Supporting Duty Hour Restrictions are Weak - Burden of ProofIn an unfortunately misnamed
ModernHealthcare article (it refers to medical students rather than housestaff) , Dr Bilimoria was again quoted,
The key piece is that we just have never had prospective, randomized high-level evidence to inform our decisionmaking....
Similarly, in a
Medscape article Dr Nasca, the ACGME CEO,
calls resident scheduling rules a work in progress, especially because only very small, single-institution studies have examined the effect of long hours on residents and patients.
On the other hand, there are no big randomized trials to suggest that longer duty hours or increased sleep deprivation is advantageous. However, there are huge numbers of studies that show that sleep deprivation is bad for patients and people in non-medical settings, as well as medical trainees.
In any case, the supporters of the trials seem to be arguing that the burden of proof should be on those who want to limit duty hours, while it seems more reasonable that to justify a trial of increased sleep deprivation, the burden of proof was on those who proposed the trial. Thus, this appears to be a version of the
burden of proof logical fallacy.
Increased Hand-Offs are Bad, and the Only Alternative to Having Them is to Increase Duty Hours - False DilemmaIn trying to defend their work the advocates for these trials further corroborated my concerns above that the trials were conceived without any consideration that measures other than increasing duty hours (and consequent sleep deprivation) was the only possible alternative to the current situation. For example, in the Modern Healthcare article.
'There's always a trade-off,' [senior RAND natural scientist Dr Mark] Friedberg said, noting the increased number of patient hand-offs that occur with shorter hours. These hand-offs reduce consistency of care and open patients up to more mistakes and miscommunication among providers. 'It's not clear-cut. That's why you have to do the science,' he said.
However, he did not argue that increased hand-offs are so bad that a trial of increasing duty hours and sleep deprivation to achieve fewer hand-offs could be justified. He also did not consider whether there might be some way to mitigate the effect of increased hand-offs without causing sleep deprivation.
Similarly a
New Haven Register article quoted Dr Thomas Balcezak, chief medical officer for Yale-New Haven, saying
one issue is that there are 'more handoffs between caregivers' when residents work shorter hours. 'There’s always a risk that important information could fall through the cracks' because of 'a lack of consistency or continuity.'
Again, that seems to be at best a theory, but not evidence based argument. Besides, the article quoted Dr Carome of Public Citizen on just one of many other possible approaches to mitigate the effects of increased hand-offs,
hospitals could overcome that problem by hiring doctors to work overlapping shifts.
There is no evidence that the people who were so concerned about hand-offs thought of any alternative ways to mitigate any problems the duty hour restrictions could have created. This corroborates my concerns that the trials were fundamentally based on a logical fallacy,
the false dilemma.
Managerialism and Tunnel VisionSo why would medical educators at some of the most prestigious US teaching hospitals launch trials to see if increasing housestaff sleep deprivation might benefit them and their patients, mandate partcipation of housestaff and patients in these trials without obtaining informed consent or allowing these subjects to opt out of the trials, thus seemingly violating the Nuremberg Code, and then defend their actions with logical fallacies?
I do not think they have gone mad. I do suspect they are in the thrall of their managerialist hospital executives.
Recently we
discussed the rise of
managerialism in the leadership of health care organizations. Managerialism, which wraps up what we have called
generic management, the
manager's coup d'etat, and aspects of
mission-hostile management into a very troubling but coherent package, was first described for a medical audience in 2015 by Komesaroff in an article in the Medical Journal of Australia(2):
The particular system of beliefs and practices defining the roles and powers of managers in our present context is what is referred to as managerialism. This is defined by two basic tenets: (i) that all social organisations must conform to a single structure [defined by management theory and dogma]; and (ii) that the sole regulatory principle is the market. Both ideas have far-reaching implications. The claim that every organisation — whether it is a mining company, a hospital, a school, a professional association or a charity — must be structured according to a single model, conforming to a single set of legislative requirements, not so long ago would have seemed bizarre, but is now largely taken for granted. The principle of the market has become the solitary, or dominant, criterion for decision making, and other criteria, such as loyalty, trust, care and a commitment to critical reflection, have become displaced and devalued. Indeed, the latter are viewed as quaint anachronisms with less importance and meaning than formal procedures or standards that can be readily linked to key performance indicators, budget end points, efficiency markers and externally imposed targets.
Many of the prestigious teaching hospitals/ acacemic medical centers/ hospital systems participating in the two controversial trials may be led in the managerialist tradition. We have shown numerous examples of such leadership that may put short term revenue and the continuing enrichment of top managers ahead of all other concerns, including good patient care and the integrity of academics, has been frankly mission hostile, and jump on the latest management bandwagons as solutions all problems.
I postulate that housestaff directors at such institutions tremble at the idea of challenging such leaders. Yet to improve the handoff problem, teaching programs might have to do things that cost money. Spending money that does not lead to immediate increases in revenue, and boosts in management pay, could be an anathema to managerialists. Also, to improve the hand-off problem, programs might have to challenge management dogma, such as the worship of badly designed, time wasting electronic health records. So I suspect the leaders of the two studies consciously or unconsciously eschewed trial designs that could assess any educational alternative that might have made management uncomfortable. Thus boxed in, they wound up with an apparently indefensibly unethical research project.
I hope that the two studies create the degree of controversy they deserve, and that the federal government promptly starts investigating honestly and thoroughly. I further hope that this unseemly episode causes medical educators to rethink the cozy or at least conflict averse relationships they have with their managerialist leaders.
True health care reform would restore health care leadership that understands health care and medicine, upholds the health care mission, is accountable for its actions, and is transparent, ethical and honest.
ADDENDUM (5 December, 2015) - This post was republished on the
Naked Capitalism blog.
References1. Durmer JS, Dinges DF. Neurocognitive consequences of sleep deprivation. Sem Neurology 2005. 25. 117-129. Link
here.
2. Komesaroff PA, Kerridge IH, Isaacs D, Brooks PM. The scourge of managerialism and the Royal Australasian College of Physicians. Med J Aust 2015; 202: 519- 521. Link
here.
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