SURGICAL ETHICS CHALLENGES James W. Jones, MD, PhD, MHA, Section Editor
Transgression confession: Ethics of medical error disclosure James W. Jones, MD, PhD, MHA, and Laurence B. McCullough, PhD, Houston, Tex Complications of medicine are like the sand traps in golf courses. They are regrettable, cannot be completely avoided even by the best, and the real skill lies in solving the problems they present. Dr Al Mighty told a resident to ignore a barely elevated temperature in a postoperative patient. “It is nothing worthy of your concern,” the Al Mighty said. But, the surgical resident remembered a break in operative sterile technique had occurred, about which she remained concerned. When an area felt mildly edematous, the wound was probed, and pus exuded. The patient asked how this had happened. The resident should respond: A. B. C. D. E.
Keep her mouth shut. Tell the patient that wound infections just happen. Tell the patient that a break in sterile technique was responsible. Refer the matter to the chief resident for advice. Tell the patient to ask the attending surgeon.
I have never seen a man or woman made worse by telling them the truth. eRichard Clarke Cabot
Full postoperative disclosure has become part of the informed consent process.1 In the middle of the last century, few patients would question their physicians about recommended therapy; complications were considered to have been unfortunate luck from the elements, not from their therapy. The ethical justification for postoperative disclosure is the same as that for informed consent: patients should be informed about their medical condition and the medically reasonable alternatives for its responsible clinical management. Clinically salient information about the patient’s condition includes its etiology, which can include errors of clinical judgment and management. In November 1999, the prestigious Institute of Medicine shocked the medical profession with an exposé on the
From The Center for Medical Ethics and Health Policy, Baylor College of Medicine. Author conflict of interest: none. Reprint requests: James W. Jones, MD, PhD, MHA, 31 La Costa Dr, Montgomery, TX 77356 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. J Vasc Surg 2013;58:1697-9 0741-5214/$36.00 Copyright Ó 2013 by the Society for Vascular Surgery. http://dx.doi.org/10.1016/j.jvs.2013.10.068
amount of medical error. Medical error leading to adverse events killed more people than highway accidents. The figures and conclusions were outrageous and must be wrong was the initial reaction of many. But, when academic institutions examined their own statistics, their laundry was dirtier than had been previously been appreciated. 2 Error is defined as a departure from the processes of patient care that are supported in deliberative (evidencebased, rigorous, transparent, and accountable) clinical judgment. These departures include failure to do what should have been done or doing what should not have been done. Errors can be categorized as errors of diagnosis, errors of technique, or errors of judgment. Most often, errors are of judgment, when in retrospect one wishes they had handled care differently. Errors will be made. One saying goes, “If you haven’t had a particular complication, you just haven’t done enough of that particular procedure.” It is important that errors be divided broadly into adverse events and negligence.3 Medicine is the most complex profession by far because of the volume of information and the inherent unpredictability of biological systems. Adverse events are clinically significant outcomes that are unexpected, such as untoward effects of drugs. Adverse events are quite different from negligence, which is a culpable departure from the accepted standard of care, such as prescribing the wrong dose of a drug.3 In a large study, only one-fourth of medical errors were caused by preventable negligence.4 For this discussion, error-caused injuries can be divided into minor or major categories. Major errors are those 1697
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1698 Jones and McCullough
resulting in permanent evident disabilities or those that pose a temporary threat to life. Minor injuries, such as the wound infection in this case, are correctable by alterations in subsequent therapy. Inasmuch as errors are clinically significant in that they require attention and alteration of the plan of care, there is a strict ethical obligation to disclose them to patients in a timely fashion. There has been recent interest in the ethics of error disclosure, especially among trainees.5 In surveys, physicians, residents, and medical students universally agreed that major events/errors, as well as minor events/errors, should be disclosed to patients.6 In practice, however, less than half of those surveyed had ever disclosed a minor error to a patient, and only 5% admitted disclosing the cause of a major error. Fear of malpractice litigation is a real deterrent to admitting error to patients. The possibility of a lawsuit or reduction of patient confidence is reduced by full disclosure in one online web study.7 Respondent’s trust would be augmented toward the disclosing physician. It should be noted that one-fourth of respondents to the online scenario still would have sued with full disclosure. Contrast that rate with a study of over 14,000 medical records that found only 3% of patients harmed by verifiable medical error sued.8 Medical tort law is one of the most convoluted and vexing aspects of United States common and statutory law. Malpractice lawsuits originate with patients or their families, and the overwhelming reason is a lack of physician communication skills.9 Patients suffering a complication need reassurance from the physician in charge. Most patients get satisfactory closure from the knowledge that a mistake was recognized, a plan will be implemented to deal with error effectively, and measures will be taken to prevent the error from being repeated among future patients. Next and a great obstacle to just selection of cases is the contingency fee system. The attorney is bettingd essentially buying the patient’s disabilitydthat the investment being made will result in a much larger monetary reward. The decision to take the case does not pair the disability and degree of malpractice; litigation is initiated by competent plaintiffs’ attorneys on the basis of win ability and amount of reward. When 113 medical tort attorneys were questioned about their criteria for taking a case, they responded that economic damages (clients with higher-paying jobs), physician unworthiness (marginal credentials), and potential for winning the case were their main considerations.10 Completing the circle of vexation (or worse, which is left to the reader) are medical experts who are willing to testify wrongly that the standard of care was breached. In a large multistate U.S. study, 46% of those awarded judgments did not experience malpractice as a cause, and 41% of those suing and compensated did not experience an adverse practice event.11 Not surprisingly, this flawed system rewards plaintiff attorneys and their costs with 88% of awards.12 Who has the responsibility to answer the Dr Al Mighty’s patient’s question? The question is an important
one that encompasses what percentage of the surgeonpatient relationship devolves to the resident. Clearly, the patient has agreed for the surgeon to provide care with or without the resident, but the resident was not responsible for the overall plan of care. This rested with Dr Al Mighty. Thus, the ethical responsibility for major communication is the attending surgeon’s. And, what should the disclosure be? Informed consent has become the touchstone for medical professionalism in the last several decades.13 It expanded from the preoperative encounter to inform patients about all important events in their care: operative and postoperative.14 The guiding consideration is the answer to this question: What are the clinically salient or significant aspects of the error and its subsequent management? These include the etiology of the error, the medically reasonable alternatives for its clinical management, the expected outcomes with clinical management, and the patient’s role in that management after discharge from the hospital. The disclosure should be done because although minor in nature, the care of the patient has been altereddeliminating option A. Wound infections don’t just happen; they happen because of bacterial contamination. The patient should be informed that although infrequent, it is possible that, when opening the protective barrier called the skin, bacteria occasionally cause a wound infection. This results from a breach in sterile technique, which is often not discoverable and therefore not preventable. The break in sterile technique was from a breached glove, which was promptly replaced. This may or may not be responsible for the adverse event; after all, gloves develop holes without infections, and infections develop without noticeable holes in surgeon’s gloves. If there is an area of surgery where surgeons universally are compulsive, it is sterile technique. Nonetheless, option B is ruled out as misleading and therefore inconsistent with the ethics of informed consent. Asking the chief resident for advice, option D, may be politically wise but is not the best answer. The full explanation should be referred to the attending surgeon, option E. While the resident is certainly qualified to explain inadvertent breach of sterile technique, option C, the professional responsibility to make this disclosure rests with Dr Al Mighty. REFERENCES 1. Jones JW, McCullough LB. The extent of informed consent. J Vasc Surg 2007;46:821-2. 2. Healey MA, Shackford SR, Osler TM, Rogers FB, Burns E. Complications in surgical patients. Arch Surg 2002;137:611-7; discussion: 617-8. 3. Sohn DH. Negligence, genuine error, and litigation. International journal of general medicine 2013;6:49-56. 4. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. 1991. Quality & safety in health care 2004;13:145-51; discussion: 151-2.
JOURNAL OF VASCULAR SURGERY Volume 58, Number 6
5. Martinez W, Lehmann LS. The “hidden curriculum” and residents’ attitudes about medical error disclosure: comparison of surgical and nonsurgical residents [published online ahead of print September 5, 2013]. J Am Coll Surg doi.org/10.1016/j.jamcollsurg.2013. 07.391. 6. Kaldjian LC, Jones EW, Wu BJ, Forman-Hoffman VL, Levi BH, Rosenthal GE. Disclosing medical errors to patients: attitudes and practices of physicians and trainees. J Gen Intern Med 2007;22: 988-96. 7. Helmchen LA, Richards MR, McDonald TB. How does routine disclosure of medical error affect patients’ propensity to sue and their assessment of provider quality? Evidence from survey data. Med Care 2010;48:955-61. 8. Studdert DM, Thomas EJ, Burstin HR, Zbar BI, Orav EJ, Brennan TA. Negligent care and malpractice claiming behavior in Utah and Colorado. Med Care 2000;38:250-60.
Jones and McCullough 1699
9. Jones JW, McCullough LB, Richman BW. A helping hand bitten: an ethical response to medical malpractice suits. J Vasc Surg 2006;43: 422-5. 10. Penchansky R, Macnee C. Initiation of medical malpractice suits: a conceptualization and test. Med Care 1994;32:813-31. 11. Brennan TA, Sox CM, Burstin HR. Relation between negligent adverse events and the outcomes of medical-malpractice litigation. N Engl J Med 1996;335:1963-7. 12. Ransom SB, Dombrowski MP, Shephard R, Leonardi M. The economic cost of the medical-legal tort system. Am J Obstet Gynecol 1996;174:1903-7; discussion: 1907-9. 13. McCullough L, Jones J, Brody B. Informed consent: autonomous decision making of the surgical patient. In: McCullough L, Jones J, Brody B, editors. Surgical Ethics. New York: Oxford University Press; 1998. 14. Jones JW, McCullough LB. Disclosure of intraoperative events. Surgery 2002;132:531-2.
Transgression confession: Ethics of medical error disclosure James W. Jones, MD, PhD, MHA, and Laurence B. McCullough, PhD, Houston, Tex Complications of medicine are like the sand traps in golf courses. They are regrettable, cannot be completely avoided even by the best, and the real skill lies in solving the problems they present. Dr Al Mighty told a resident to ignore a barely elevated temperature in a postoperative patient. “It is nothing worthy of your concern,” the Al Mighty said. But, the surgical resident remembered a break in operative sterile technique had occurred, about which she remained concerned. When an area felt mildly edematous, the wound was probed, and pus exuded. The patient asked how this had happened. The resident should respond: A. B. C. D. E.
Keep her mouth shut. Tell the patient that wound infections just happen. Tell the patient that a break in sterile technique was responsible. Refer the matter to the chief resident for advice. Tell the patient to ask the attending surgeon.
I have never seen a man or woman made worse by telling them the truth. eRichard Clarke Cabot
Full postoperative disclosure has become part of the informed consent process.1 In the middle of the last century, few patients would question their physicians about recommended therapy; complications were considered to have been unfortunate luck from the elements, not from their therapy. The ethical justification for postoperative disclosure is the same as that for informed consent: patients should be informed about their medical condition and the medically reasonable alternatives for its responsible clinical management. Clinically salient information about the patient’s condition includes its etiology, which can include errors of clinical judgment and management. In November 1999, the prestigious Institute of Medicine shocked the medical profession with an exposé on the
From The Center for Medical Ethics and Health Policy, Baylor College of Medicine. Author conflict of interest: none. Reprint requests: James W. Jones, MD, PhD, MHA, 31 La Costa Dr, Montgomery, TX 77356 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. J Vasc Surg 2013;58:1697-9 0741-5214/$36.00 Copyright Ó 2013 by the Society for Vascular Surgery. http://dx.doi.org/10.1016/j.jvs.2013.10.068
amount of medical error. Medical error leading to adverse events killed more people than highway accidents. The figures and conclusions were outrageous and must be wrong was the initial reaction of many. But, when academic institutions examined their own statistics, their laundry was dirtier than had been previously been appreciated. 2 Error is defined as a departure from the processes of patient care that are supported in deliberative (evidencebased, rigorous, transparent, and accountable) clinical judgment. These departures include failure to do what should have been done or doing what should not have been done. Errors can be categorized as errors of diagnosis, errors of technique, or errors of judgment. Most often, errors are of judgment, when in retrospect one wishes they had handled care differently. Errors will be made. One saying goes, “If you haven’t had a particular complication, you just haven’t done enough of that particular procedure.” It is important that errors be divided broadly into adverse events and negligence.3 Medicine is the most complex profession by far because of the volume of information and the inherent unpredictability of biological systems. Adverse events are clinically significant outcomes that are unexpected, such as untoward effects of drugs. Adverse events are quite different from negligence, which is a culpable departure from the accepted standard of care, such as prescribing the wrong dose of a drug.3 In a large study, only one-fourth of medical errors were caused by preventable negligence.4 For this discussion, error-caused injuries can be divided into minor or major categories. Major errors are those 1697
JOURNAL OF VASCULAR SURGERY December 2013
1698 Jones and McCullough
resulting in permanent evident disabilities or those that pose a temporary threat to life. Minor injuries, such as the wound infection in this case, are correctable by alterations in subsequent therapy. Inasmuch as errors are clinically significant in that they require attention and alteration of the plan of care, there is a strict ethical obligation to disclose them to patients in a timely fashion. There has been recent interest in the ethics of error disclosure, especially among trainees.5 In surveys, physicians, residents, and medical students universally agreed that major events/errors, as well as minor events/errors, should be disclosed to patients.6 In practice, however, less than half of those surveyed had ever disclosed a minor error to a patient, and only 5% admitted disclosing the cause of a major error. Fear of malpractice litigation is a real deterrent to admitting error to patients. The possibility of a lawsuit or reduction of patient confidence is reduced by full disclosure in one online web study.7 Respondent’s trust would be augmented toward the disclosing physician. It should be noted that one-fourth of respondents to the online scenario still would have sued with full disclosure. Contrast that rate with a study of over 14,000 medical records that found only 3% of patients harmed by verifiable medical error sued.8 Medical tort law is one of the most convoluted and vexing aspects of United States common and statutory law. Malpractice lawsuits originate with patients or their families, and the overwhelming reason is a lack of physician communication skills.9 Patients suffering a complication need reassurance from the physician in charge. Most patients get satisfactory closure from the knowledge that a mistake was recognized, a plan will be implemented to deal with error effectively, and measures will be taken to prevent the error from being repeated among future patients. Next and a great obstacle to just selection of cases is the contingency fee system. The attorney is bettingd essentially buying the patient’s disabilitydthat the investment being made will result in a much larger monetary reward. The decision to take the case does not pair the disability and degree of malpractice; litigation is initiated by competent plaintiffs’ attorneys on the basis of win ability and amount of reward. When 113 medical tort attorneys were questioned about their criteria for taking a case, they responded that economic damages (clients with higher-paying jobs), physician unworthiness (marginal credentials), and potential for winning the case were their main considerations.10 Completing the circle of vexation (or worse, which is left to the reader) are medical experts who are willing to testify wrongly that the standard of care was breached. In a large multistate U.S. study, 46% of those awarded judgments did not experience malpractice as a cause, and 41% of those suing and compensated did not experience an adverse practice event.11 Not surprisingly, this flawed system rewards plaintiff attorneys and their costs with 88% of awards.12 Who has the responsibility to answer the Dr Al Mighty’s patient’s question? The question is an important
one that encompasses what percentage of the surgeonpatient relationship devolves to the resident. Clearly, the patient has agreed for the surgeon to provide care with or without the resident, but the resident was not responsible for the overall plan of care. This rested with Dr Al Mighty. Thus, the ethical responsibility for major communication is the attending surgeon’s. And, what should the disclosure be? Informed consent has become the touchstone for medical professionalism in the last several decades.13 It expanded from the preoperative encounter to inform patients about all important events in their care: operative and postoperative.14 The guiding consideration is the answer to this question: What are the clinically salient or significant aspects of the error and its subsequent management? These include the etiology of the error, the medically reasonable alternatives for its clinical management, the expected outcomes with clinical management, and the patient’s role in that management after discharge from the hospital. The disclosure should be done because although minor in nature, the care of the patient has been altereddeliminating option A. Wound infections don’t just happen; they happen because of bacterial contamination. The patient should be informed that although infrequent, it is possible that, when opening the protective barrier called the skin, bacteria occasionally cause a wound infection. This results from a breach in sterile technique, which is often not discoverable and therefore not preventable. The break in sterile technique was from a breached glove, which was promptly replaced. This may or may not be responsible for the adverse event; after all, gloves develop holes without infections, and infections develop without noticeable holes in surgeon’s gloves. If there is an area of surgery where surgeons universally are compulsive, it is sterile technique. Nonetheless, option B is ruled out as misleading and therefore inconsistent with the ethics of informed consent. Asking the chief resident for advice, option D, may be politically wise but is not the best answer. The full explanation should be referred to the attending surgeon, option E. While the resident is certainly qualified to explain inadvertent breach of sterile technique, option C, the professional responsibility to make this disclosure rests with Dr Al Mighty. REFERENCES 1. Jones JW, McCullough LB. The extent of informed consent. J Vasc Surg 2007;46:821-2. 2. Healey MA, Shackford SR, Osler TM, Rogers FB, Burns E. Complications in surgical patients. Arch Surg 2002;137:611-7; discussion: 617-8. 3. Sohn DH. Negligence, genuine error, and litigation. International journal of general medicine 2013;6:49-56. 4. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. 1991. Quality & safety in health care 2004;13:145-51; discussion: 151-2.
JOURNAL OF VASCULAR SURGERY Volume 58, Number 6
5. Martinez W, Lehmann LS. The “hidden curriculum” and residents’ attitudes about medical error disclosure: comparison of surgical and nonsurgical residents [published online ahead of print September 5, 2013]. J Am Coll Surg doi.org/10.1016/j.jamcollsurg.2013. 07.391. 6. Kaldjian LC, Jones EW, Wu BJ, Forman-Hoffman VL, Levi BH, Rosenthal GE. Disclosing medical errors to patients: attitudes and practices of physicians and trainees. J Gen Intern Med 2007;22: 988-96. 7. Helmchen LA, Richards MR, McDonald TB. How does routine disclosure of medical error affect patients’ propensity to sue and their assessment of provider quality? Evidence from survey data. Med Care 2010;48:955-61. 8. Studdert DM, Thomas EJ, Burstin HR, Zbar BI, Orav EJ, Brennan TA. Negligent care and malpractice claiming behavior in Utah and Colorado. Med Care 2000;38:250-60.
Jones and McCullough 1699
9. Jones JW, McCullough LB, Richman BW. A helping hand bitten: an ethical response to medical malpractice suits. J Vasc Surg 2006;43: 422-5. 10. Penchansky R, Macnee C. Initiation of medical malpractice suits: a conceptualization and test. Med Care 1994;32:813-31. 11. Brennan TA, Sox CM, Burstin HR. Relation between negligent adverse events and the outcomes of medical-malpractice litigation. N Engl J Med 1996;335:1963-7. 12. Ransom SB, Dombrowski MP, Shephard R, Leonardi M. The economic cost of the medical-legal tort system. Am J Obstet Gynecol 1996;174:1903-7; discussion: 1907-9. 13. McCullough L, Jones J, Brody B. Informed consent: autonomous decision making of the surgical patient. In: McCullough L, Jones J, Brody B, editors. Surgical Ethics. New York: Oxford University Press; 1998. 14. Jones JW, McCullough LB. Disclosure of intraoperative events. Surgery 2002;132:531-2.
