- BWH Bulletin - For and about the People of Brigham and Women's Hospital
- BWH Bulletin - For and about the People of Brigham and Women's Hospital
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May 16, 2000
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In This Issue:
Medical Errors
BWH’s Center for Excellence in Nursing Practice
Lily Kravitz Nursing Studies Award
FY 2000 2nd Quarter Results:
AIDSWalk 2000
ASK YOURSELF
“Volunteers Meet the Challenge”
The New England Journal of Medicine
Sounding Board
THE INSTITUTE OF MEDICINE REPORT ON MEDICAL ERRORS — COULD IT DO HARM?
The recent Institute of Medicine (IOM) report on the quality of care, entitled "To Err Is Human," has awakened much of the health care system to the challenge of reducing the number of adverse events in hospitals.1 The Agency for Healthcare Research and Quality is supporting research on methods of preventing injuries, and private industry is insisting on accountability. Many hospitals and their medical staffs are developing task forces to address the prevention of errors. Insurers and hospital associations are launching similar initiatives. 2 Physicians and hospital leaders should welcome all these efforts; for too long we have been complacent about iatrogenic injury. Yet a careful reader must have some reservations about the IOM report. The report states that errors cause between 44,000 and 98,000 deaths every year in American hospitals. I was prompted by this statement to look up the definition of error. The American Heritage College Dictionary, third edition, defines an error as a deviation from that which is generally held to be acceptable. More telling are the synonyms given in the Merriam-Webster Thesaurus: blooper, blunder, boner, bungle, goof, lapse, miscue, misstep, mistake, and slip-up. The prevention of errors through analysis of human factors has a specific definition in the engineering literature, and the introduction of the science of error prevention in health care is an extremely important advance. 3 The combination of the strikingly large numbers of errors cited by the report and the connotations of the word "error" create an impression that is not warranted by the scientific work underlying the IOM report. Two studies of injuries due to medical care are the source of the headline-grabbing numbers in the IOM report: a 1984 study of New York hospitals that my colleagues and I reported in 1991 and a 1992 study of Colorado and Utah hospitals that my colleagues and I reported this year. 4,5 In both studies, we used an approach pioneered by the California Medical Association in 1976 6: physicians reviewed hospital medical records for evidence of adverse events caused by medical care, not by the disease process. We further classified a subgroup of adverse events as the result of negligent care, meaning that the care fell short of the expected standard. In both studies, two investigators subsequently reviewed the data and reclassified the events as preventable or not preventable. Preventability is difficult to determine because it is often influenced by decisions about expenditures. For example, if every patient were tested for drug allergies before being given a prescription for antibiotics, many drug reactions would be prevented. From this perspective, all allergic reactions to antibiotics, which are adverse events according to the studies' definitions, are preventable. But such preventive testing would not be cost effective, so we did not classify all drug reactions as preventable adverse events. In both studies, we agreed among ourselves about whether events should be classified as preventable or not preventable, but these decisions do not necessarily reflect the views of the average physician and certainly do not mean that all preventable adverse events were blunders. For instance, surgeons know that postoperative hemorrhage occurs in a certain number of cases, but with proper surgical technique, the rate decreases. Even with the best surgical technique and proper precautions, however, a hemorrhage can occur. We classified most postoperative hemorrhages resulting in the transfer of patients back to the operating room after simple procedures (such as hysterectomy or appendectomy) as preventable, even though in most cases there was no apparent blunder or slip-up by the surgeon. The IOM report refers to these cases as medical errors, which to some observers may seem inappropriate. Perhaps more to the point, neither study cited by the IOM as the source of data on the incidence of injuries due to medical care 2,4 involved judgments by the physicians reviewing medical records about whether the injuries were caused by errors. Indeed, there is no evidence that such judgments can be made reliably. All these points might be considered hairsplitting over definitions if it were not for four important aspects of the IOM report. First, the report and the accounts of it in the media give the impression that doctors and hospitals are doing very little about the problem of injuries caused by medical care. Yet the data that the report cites give a different impression. In the three studies cited, the rate of injury due to medical care was 4.6 percent in California in 1976, 3.7 percent in New York in 1984, and 2.9 percent in Colorado and Utah in 1992. 4,5,6 Moreover, if one extrapolates from our studies in New York and in Colorado and Utah in order to calculate the number of deaths nationwide due to substandard care, the total decreases from 92,000 deaths in 1984 (on the basis of the data in New York) to 25,000 in 1992 (on the basis of the data in Colorado and Utah). Although no statistician would be convinced by data extrapolated from three different settings, and although my colleagues and I have cautioned against drawing conclusions about the numbers of deaths in these studies, 7 the evidence suggests that safety has improved, not deteriorated. More serious efforts to prevent injuries from medical care are needed, as the IOM report suggests, but we should not assume that hospitals and physicians have become more complacent. Is there reason to believe that hospital care has become safer? The answer is yes, at least over particular periods for particular procedures. Consider, for example, surgical care. When Harvey Cushing began performing craniotomies for brain tumors at the Peter Bent Brigham Hospital in Boston in 1913, the mortality rate was 80 percent. Sedulous efforts to refine techniques brought the rate down to 13 percent in 20 years, and it is now less than 1 percent (Black P: personal communication). For many common procedures, mortality rates declined in the 1960s and 1970s. 8 For more sophisticated operations, such as cardiac surgery, the rates continue to decline. 9 These changes have occurred because surgeons have continuously sought to improve techniques, share information, and report the results of clinical studies. The reduction in mortality rates is due in large part to technological advances, but it is also due to simple attention to surgical practice. Surgical training has always emphasized a commitment to details, systematic thinking, and intolerance of failure -- the hallmarks of approaches to the prevention of errors. This is anything but the "cycle of inaction" that the IOM notes. An important part of the medical ethic is the improvement of care, which most physicians and hospitals take very seriously. I do not mean to imply that all hospitals perform at optimal levels or that we should not be scrutinizing the effects of new management techniques on the quality of care. Indeed, the profession should welcome a renewed emphasis on safety, but it is inaccurate to suggest that safety has been overlooked. Nor have regulators been ignoring the problem of iatrogenic injury. Since the 1991 report of our study of New York hospitals, the Joint Commission on Accreditation of Healthcare Organizations, which oversees the quality of hospital care, has quietly but thoroughly integrated the investigation and reporting of sentinel events (i.e., serious adverse events) into its inspection program. This program alone cannot prevent all injuries due to medical care, but it is a step in the right direction. A number of malpractice insurers have also incorporated prevention efforts into their risk-management programs. None of these efforts were mentioned in the media reports, and the IOM report itself dealt with them in a summary fashion. Second, the report calls for more systematic approaches to the prevention of injuries due to medical care -- for example, the use of computer systems to prevent such injuries. Brigham and Women's Hospital in Boston has been experimenting with a sophisticated computer system for patient care similar to the systems used by other leaders in computerized prevention systems, such as LDS Hospital in Salt Lake City and Wishard Memorial Hospital in Indianapolis. These systems can be used by motivated medical staff members to prevent adverse events. 10,11 However, the systems are expensive to build, maintain, and upgrade. No health insurers or employers purchasing health insurance have been willing to pay for the extra expense. With current fiscal constraints, it is difficult to find sufficient resources to fund such innovations in safety, even if an analysis of the return on the investment suggests that they are cost effective in the long run. Preventing adverse events will be a matter of creativity, commitment, and dollars. Nurses and doctors provide the creativity and commitment, but the dollars, especially for computerized prevention systems, are increasingly scarce. Employers, as purchasers of health care, are forming coalitions to promote the development of these systems, but there is little talk of increases in insurance premiums that would fund them. The costs of prevention systems must be addressed, perhaps through research funded by the federal government, as the IOM report suggests. It is professionally unethical and politically insensitive to suggest that we cannot afford to institute measures that increase the safety of patients. But it is shortsighted to overlook the fact that hospitals and medical groups will quietly decide whether they can afford to invest in new safety measures. Of course, there are easier and less costly steps that can be taken, such as making sure that prescriptions are legible, but employers in particular must know that safety will require investment. Third, the IOM calls for a 50 percent reduction in the incidence of errors. This will be difficult to accomplish for several reasons. As I noted above, no one has yet measured the incidence of errors in a general medical population. Without this important base-line information, it is impossible to document such a reduction, even if it is achievable. Moreover, the reliability of identifying errors is methodologically suspect, and some astute observers have recommended that reviews based on implicit judgments by physicians, such as the reviews we used in the New York and Utah-Colorado studies, be replaced by reviews based on the use of explicit criteria. 12 Unless the epidemiologic science of error detection improves greatly, the effort to prevent errors may deteriorate into a marketing ploy, especially after the relatively easy solutions, such as ensuring that prescriptions are legible, have been undertaken. Fourth, the publicity surrounding the IOM findings may lead to new reporting requirements. The IOM recommends confidential, voluntary reporting of injuries due to medical care, an approach similar to that used by the National Aeronautics and Space Administration and the Federal Aeronautics Administration for near misses in aviation, but also supports some degree of federally mandated public disclosure for reports of serious events, the criteria for which are quite vague. Why, some might ask, should the public not know about blunders made by doctors? The answer is that most injuries from medical care are not due to mistakes. More important, a system of self-reporting relies on careful and confidential investigation by peers. 10 Without confidentiality, I doubt that there will be substantial voluntary reporting. In addition, public disclosure would spawn lawsuits, which would in turn chill any interest in voluntary reporting. Unfortunately, the law is less and less sympathetic to so-called peer-review protection, with judges increasingly hostile to claims of confidentiality. 13 An interpretation of the IOM findings as 98,000 deaths due to blunders and a cycle of inaction could give impetus to legislation requiring greater public disclosure, which in turn would lead to more lawsuits. Therein lies the key problem overlooked by the IOM report. Any effort to prevent injury due to medical care is complicated by the dead weight of a litigation system that induces secrecy and silence. No matter how much we might insist that physicians have an ethical duty to report injuries resulting from medical care or to work on their prevention, 14 fear of malpractice litigation drags us back to the status quo. To address the problem of iatrogenic injuries seriously, we must reform the system of malpractice litigation. 7 If the only legislative result of the IOM report is federally mandated reporting, we will have failed, and once the publicity dies down, the rates of injury due to medical care will remain unchanged. No one can disagree with the main point of the IOM report: we should be working to make hospitals safer. We can do better. The report will help us do better by encouraging research on the prevention of medical errors, by sharpening regulatory oversight, and by raising awareness of the problem. But we have an opportunity to do much more, and medical leaders should take the next step by addressing liability reform as part of the overall solution to the problem of medical errors. Troyen A. Brennan, M.D., J.D., M.P.H. Brigham and Women's Hospital Boston, MA 02115 Address reprint requests to Dr. Brennan at Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, or at tabrennan@partners.org. References 1. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: building a safer health system. Washington, D.C.: National Academy Press, 2000. 2. Booth B. IOM report spurs momentum for patient safety movement. American Medical News. January 24, 2000:14-8. 3. Leape LL. Error in medicine. JAMA 1994;272:1851-7. 4. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients -- results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370-6. 5. Thomas EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care 2000;38:261-71. 6. California Medical Association, California Hospital Association. Report on the Medical Insurance Feasibility Study. San Francisco: California Medical Association, 1977. 7. Weiler PC, Hiatt HH, Newhouse JP, Johnson WG, Brennan TA, Leape LL. A measure of malpractice: medical injury, malpractice litigation, and patient compensation. Cambridge, Mass.: Harvard University Press, 1993. 8. Milamed DR, Hedley-Whyte J. Contributions of the surgical sciences to a reduction of the mortality rate in the United States for the period 1968 to 1988. Ann Surg 1994;219:94-102. 9. Ghali WA, Ash AS, Hall RE, Moskowitz MA. Statewide quality improvement initiatives and mortality after cardiac surgery. JAMA 1997;277:379-82. 10. Petersen LA, Orav EJ, Teich JM, O'Neil AC, Brennan TA. Using a computerized sign-out program to improve continuity of inpatient care and prevent adverse events. J Comm J Qual Improv 1998;24:77-87. 11. Bates DW, Cullen DJ, Laird NM, et al. Incidence of adverse drug events and potential adverse drug events: implications for prevention. JAMA 1995;274:29-34. 12. Ashton CM, Kuykendall DH, Johnson ML, Wray NP. An empirical assessment of the validity of explicit and implicit process-of-care criteria for quality assessment. Med Care 1999;37:798-808. 13. Brennan TA. Hospital peer review and clinical privileges actions: to report or not report. JAMA 1999;282:381-2. 14. Peterson LM, Brennan TA. Medical ethics and medical injuries: taking our duties seriously. J Clin Ethics 1990;1:207-11. Reprinted with permission of The New England Journal of Medicine (www.nejm.org) Copyright © 2000 Massachusetts Medical Society