The Boston Globe’s 2015 coverage of the case of Tony Meng, a young man who unfortunately suffered paralysis following complex spinal surgery in the course of overlapping procedures by his surgeon, has reinvigorated the debate regarding the extent of necessary physician disclosure.1 Although it is unclear if simultaneous surgeries and potentially autonomous trainee involvement affected Mr. Meng’s outcome, occurrences such as these and the concerns they elicit erode the integrity of the physician-patient relationship. Furthermore, they result in public distrust of current practice paradigms, which are guided by medical professionalism. The question then arises of whether certain aspects of a surgeon’s practice—including the extent of trainee participation in patient care or surgeon fatigue—should be divulged in a mandatory fashion to patients as a part of the informed consent process to maintain patient autonomy and, ostensibly, facilitate greater patient safety.
There are multiple pitfalls, however, regarding the enhancement of the informed consent process, which will limit its utility in producing its desired outcomes. The first is lack of conclusive evidence that these factors—though they may seem distressing to a patient in the particularly vulnerable and anxiety-provoking moments prior to an operation—have a measurable impact on a patient’s postoperative outcomes. For instance, there is conflicting evidence regarding the actual effect of sleep deprivation on the ability of a seasoned surgeon to complete the technical elements of an operation, as well as whether there is an impact on outcomes. Extrapolating from the sleep-deprivation challenges discerned in other skilled practitioners, including those in locomotion or aviation, it stands to reason that sleep-deprived surgeons will be less mindful than well-rested ones.2,3 In fact, acute sleep deprivation has been linked to diminished cognitive performance, reaction time, and visual-perceptual ability, among other deficits.4
A substantial body of literature investigates physician skills in simulated settings or examining retrospective patient outcomes. Results vary, but several of these studies fail to demonstrate a deleterious effect on patient outcomes or diminished performance. For instance, Tomasko and colleagues observed in one study of sleep-deprived and control students that although there was greater “cognitive workload” in the sleep-limited students, they were able to complete technical tasks and demonstrate learned proficiency in new ones.5 Similar results have been seen at more advanced levels of the profession, including among staff surgeons, and experimentation with skills at the resident level.6,7 These results, however, are inconsistent with other studies, which indicate reduced performance, specifically in laparoscopic skills in sleep-limited residents as demonstrated by Eastridge and colleagues. This study contrasts with a similar study showing non-inferiority in laparoscopic ability.8,9 When examining patient outcomes, the results are, again, mixed. Although Rothschild and colleagues noted an increase in complications in elective cases following call (3.4 percent versus 6.2 percent), on examination of the data from all types of procedures and all surgeons, there was no significant difference in outcomes with or without a prior night of call.10 Several investigations of cardiac procedures have not detected an increase in morbidity of patients of post-call surgeons.11-13 One item which may be suggested by the variations in the data is that there are disparities in the operations that are affected by sleep deprivation, whereas others exist where necessary technical abilities are well-preserved despite operator fatigue; this may also vary depending on the surgeon. These considerations still need to be elucidated. Therefore, any attempt to standardize mandatory disclosures seems somewhat heavy-handed.
Some of the inconsistencies are affected by confounding factors, and comparisons between studies are limited by differing definitions of sleep-deprived. A surgeon may be classified as such if limited sleep opportunities between call and elective cases are available, or simply if he or she takes a call shift the preceding evening. However, countless other factors play into the surgeon’s performance, even if post-call status disclosure is mandated. An off-duty surgeon may not have slept well the previous night in his or her own bed; the corollary is that a post-call surgeon may have not been disturbed once during their shift. Additionally, other pressures, personal or professional, arguably may have an equivalent impact on performance.14 Further, given the group dynamics of a successful operation, would the state of all members of the operative team be expected to be disclosed in the informed consent? Mandating disclosure of one aspect of a provider’s mental state opens the gate to further unwarranted personal investigation. And without conclusive evidence to confirm consistently different outcomes, these actions pander to public fear, rather than improve patient safety.15
Resident involvement in operations
Another major point of contention is disclosure of the trainee’s role in invasive procedures. One study of 30 surgeons at an academic center determined that 83 percent did not discuss the role of residents during the informed consent process. However, it’s notable that these surgeons still espoused an educational propensity, with 77 percent permitting independent operating prior to their presence within the operating room.16 This practice is in conflict with a recent study of patients surveyed at a large military teaching hospital where only 18.2 percent agreed that they would consent to such an unsupervised scenario. In fact, in their survey, a realistic description of trainee involvement reduced patient assent to greater than 50 percent in most cases.17 These concerns are not well founded, though. Myriad investigations of outcomes in the American College of Surgeons National Surgical Quality Improvement Program suggest that resident involvement is safe and results in similar morbidity.18-20
Informed consent is, at its core, based on patient autonomy and empowerment of patients to make voluntary and educated health care decisions. Legally, we are compelled to disclose those factors that would pose material risk to the patient although, at present, no consistent evidence exists that obligatory disclosure of trainee responsibilities or previous call will result in improved outcomes or that avoidance of these factors mitigates risk. Ethically, it remains our duty as physicians to act professionally and provide quality care, which may require postponing an operation if we are unfit to provide appropriate supervision to surgical trainees. The responsibility to make an informed decision together with the patient cannot be aided or supplanted by mandates from governing bodies. Instead, the burden should remain on the physician to ensure excellent care with recognition of the finite nature of resources and the need for optimal education of trainees. However, surgeons should be supported in this process by health care systems, specifically by the development of policies that strive to reduce surgeon fatigue and provide a safe working environment.
- Abelson J, Saltzman, J, Kowalczyk L, Allen S. Clash in the name of care. Boston Globe. December 2015. Available at: apps.bostonglobe.com/spotlight/clash-in-the-name-of-care/story/. Accessed September 12, 2016.
- Roach GD, Dorrian J, Fletcher A, et al. Comparing the effects of fatigue and alcohol consumption on locomotive engineers’ performance in a rail simulator. J Hum Ergol. 2001;30(1-2):125-130.
- Morris TL, Miller JC. Electrooculographic and performance indices of fatigue during simulated flight. Biol Psychol. 1996;42(3):343-360.
- Anderson C, Dickinson DL. Bargaining and trust: The effects of 36-hours total sleep deprivation on socially interactive decisions. J Sleep Res. 2009;19(1):54-63.
- Tomasko JM, Pauli EM, Kunselman AR, Haluck RS. Sleep deprivation increases cognitive workload during simulated surgical tasks. Am J Surg. 2012;203(1):37-43.
- Uchal M, Tjugum J, Martinsen E, et al. The impact of sleep deprivation on product quality and procedure effectiveness in a laparoscopic physical simulator: A randomized controlled trial. Am J Surg. 2005;189(6):753-757.
- Jakubowicz DM, Price EM, Glassman HJ, et al. Effects of a twenty-four hour call period on resident performance during simulated endoscopic sinus surgery in an Accreditation Council for Graduate Medical Education-compliant training program. Laryngoscope. 2005;115(1):143-146.
- Eastridge BJ, Hamilton EC, O’Keefe GE, et al. Effect of sleep deprivation on the performance of simulated laparoscopic surgical skill. Am J Surg. 2003;186(2):169-174.
- Olasky J, Chellali A, Sankaranarayanan G, et al. Effect of sleep hours and fatigue on performance in laparoscopic surgery simulators. Surg Endosc. 2014;28(9):2564-2568.
- Rothschild JM, Keohane CA, Rogers S, et al. Risks of complications by attending physicians after performing nighttime procedures. JAMA. 2009;302(14):1565-1572.
- Chu MW, Stitt LW, Fox SA, et al. Prospective evaluation of consultant surgeon sleep deprivation and outcomes in more than 4,000 consecutive cardiac surgical procedures. Arch Surg. 2011; 146(9):1080-1085.
- Ellman PI, Law MG, Tache-Leon C, et al. Sleep deprivation does not affect operative results in cardiac surgery. Ann Thorac Surg. 2004;78(30):906-911.
- Asfour L, Asfour V, McCormack D, Attia R. In surgeons performing cardiothoracic surgery, is sleep deprivation significant in its impact on morbidity or mortality? Interact Cardiovasc Thorac Surg. 2014;19(3):479-487.
- Czeisler CA, Pellegrini CA, Sade RA. Should sleep-deprived surgeons be prohibited from operating without patients’ consent? Ann Thor Surg. 2013;95(2):757-766.
- Berg DB, Engel AM, Saba A, Hatton EK. Differences in public belief and reality in the care of operative patients in a teaching hospital. J Surg Educ. 2011;68(1):10-17.
- Knifed E, Taylor B, Bernstein M. What surgeons tell their patients about the intraoperative role of residents: A qualitative study. Am J Surg. 2008;196(5):788-794.
- Porta CR, Sebesta JA, Brown TA, Steele SR, Martin MJ. Training surgeons and informed consent process: Routine disclosure of trainee participation and its effect on patient willingness and consent rates. Arch Surg. 2012;147(1):57-62.
- Jordan SW, Mioton LM, Smetona J, et al. Resident involvement and plastic surgery outcomes: An analysis of 10,356 patients from the ACS National Surgical Quality Improvement Program database. Plast Reconstr Surg. 2013;131(4):763-773.
- Edelstein AI, Lovecchio FC, Saha S, Hsu WK, Kim JY. Impact of resident involvement on orthopaedic surgery outcomes: An analysis of 30,628 patients from the ACS National Surgical Quality Improvement Program Database. J Bone Joint Surg Am. 2014;96(15):e131.
- Saliba AN, Taher AT, Tamim H, et al. Impact of resident involvement in surgery (IRIS-NSQIP): Looking at the bigger picture based on the American College of Surgeons NSQIP Database. J Am Coll Surg. 2016;222(1):30-40.