Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. 1991.

BACKGROUND: As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. METHODS: We reviewed 30121 randomly selected records from 51 randomly selected acute care, non-psychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. RESULTS: Adverse events occurred in 3.7% of the hospitalizations (95% confidence interval 3.2 to 4.2), and 27.6% of the adverse events were due to negligence (95% confidence interval 22.5 to 32.6). Although 70.5% of the adverse events gave rise to disability lasting less than 6 months, 2.6% caused permanently disabling injuries and 13.6% led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test chi(2) = 21.04, p<0.0001). Using weighted totals we estimated that among the 2671863 patients discharged from New York hospitals in 1984 there were 98609 adverse events and 27179 adverse events involving negligence. Rates of adverse events rose with age (p<0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (p<0.01). There were significant differences in rates of adverse events among categories of clinical specialties (p<0.0001), but no differences in the percentage due to negligence. CONCLUSIONS: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.

The economic consequences of medical injuries. Implications for a no-fault insurance plan.

BACKGROUND: There has been little research into the actual economic consequences of medical injuries. This inhibits informed discussion of alternatives to malpractice litigation. For example, the cost of no-fault medical accident insurance has been thought to be prohibitive. METHOD: As part of a comprehensive analysis of medical injury and litigation, we interviewed a random sample of 794 individuals who had suffered medical adverse events in New York hospitals in 1984 and used their responses to calculate the cost of injuries. We then estimated the costs of a simulated no-fault insurance program that would operate as a second payer to direct insurance sources and would compensate for all financial losses attributed to medical injury. RESULTS: The estimated costs that would be paid by a simulated no-fault program were $161 million for medical care, $276 million for lost wages, and $441 million in lost household production, or a total of $878 million in 1989 dollars for the cohort of patients who were injured in 1984. CONCLUSION: Although our estimate does not include administrative costs, it nonetheless indicates that a no-fault program would not be notably costlier than the more than $1 billion New York physicians now spend annually on malpractice insurance.

Relation between malpractice claims and adverse events due to negligence. Results of the Harvard Medical Practice Study III.

BACKGROUND AND METHODS: By matching the medical records of a random sample of 31,429 patients hospitalized in New York State in 1984 with statewide data on medical-malpractice claims, we identified patients who had filed claims against physicians and hospitals. These results were then compared with our findings, based on a review of the same medical records, regarding the incidence of injuries to patients caused by medical management (adverse events). RESULTS: We identified 47 malpractice claims among 30,195 patients' records located on our initial visits to the hospitals, and 4 claims among 580 additional records located during follow-up visits. The overall rate of claims per discharge (weighted) was 0.13 percent (95 percent confidence interval, 0.076 to 0.18 percent). Of the 280 patients who had adverse events caused by medical negligence as defined by the study protocol, 8 filed malpractice claims (weighted rate, 1.53 percent; 95 percent confidence interval, 0 to 3.2 percent). By contrast, our estimate of the statewide ratio of adverse events caused by negligence (27,179) to malpractice claims (3570) is 7.6 to 1. This relative frequency overstates the chances that a negligent adverse event will produce a claim, however, because most of the events for which claims were made in the sample did not meet our definition of adverse events due to negligence. CONCLUSIONS: Medical-malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.

Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I.

BACKGROUND: As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. METHODS: We reviewed 30,121 randomly selected records from 51 randomly selected acute care, nonpsychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. RESULTS: Adverse events occurred in 3.7 percent of the hospitalizations (95 percent confidence interval, 3.2 to 4.2), and 27.6 percent of the adverse events were due to negligence (95 percent confidence interval, 22.5 to 32.6). Although 70.5 percent of the adverse events gave rise to disability lasting less than six months, 2.6 percent caused permanently disabling injuries and 13.6 percent led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test chi 2 = 21.04, P less than 0.0001). Using weighted totals, we estimated that among the 2,671,863 patients discharged from New York hospitals in 1984 there were 98,609 adverse events and 27,179 adverse events involving negligence. Rates of adverse events rose with age (P less than 0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (P less than 0.01). There were significant differences in rates of adverse events among categories of clinical specialties (P less than 0.0001), but no differences in the percentage due to negligence. CONCLUSIONS: There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.

Identification of adverse events occurring during hospitalization. A cross-sectional study of litigation, quality assurance, and medical records at two teaching hospitals.

STUDY OBJECTIVES: To estimate the efficacy of a medical record review for identifying adverse events and negligent case suffered by hospitalized patients. DESIGN: Cross-sectional study comparing an objective medical record review with information available from hospital quality assurance records as well as risk management and litigation records. SETTING: Two metropolitan teaching hospitals in the northeastern United States. MEASUREMENTS AND MAIN RESULTS: Using the litigation and risk management records as a criterion standard, we found that the medical record review had a sensitivity of 80% (93 of 116; 95% CI, 73% to 88%) for discovering adverse events and a sensitivity of 76% (51 of 67; 95% CI, 66% to 86%) for discovering negligent care. We estimated that record review of a random sample of hospitalizations across a geographic region would have even higher sensitivity (adverse-event sensitivity, 84%; negligence sensitivity, 80%). Moreover, we found that the adverse events we failed to discover led to less costly malpractice claims. A significant number of adverse events (20 of 172) among hospitalizations never gave rise to litigation or risk management investigation. Six of the twenty were due to negligent care. Quality assurance efforts at the level of the clinical departments in one hospital led to review of only 12 out of 82 risk management records. CONCLUSIONS: The overwhelming majority of adverse events and episodes of negligent care are discoverable with the methods we used to evaluate medical records. Quality assurance efforts using similar record review methods should be further evaluated.

Will disease prevention spare the medical commons?

Everywhere the disparity grows between what modern medicine can achieve, on the one hand, and what society can afford, on the other. In industrialized nations health resource allocation questions now focus primarily on diagnostic, therapeutic and rehabilitative medical programmes. With increases both in our capabilities in preventive medicine and in public awareness of those capabilities, soon that realm is likely to be demanding more resources from the health budget. These considerations and others make urgent the development of better methods for setting priorities for the allocation of health resources. A common thread in the consideration of competing programmes will be issues of trade-offs. Beneficial programmes that save more health resources than they consume are much to be desired, but resource saving should not be regarded as a necessary condition for giving high priority to a programme. Cost-effectiveness ratios provide one approach to measuring the ability of competing programmes to use health-care resources to produce health benefits. Application of cost-effectiveness principles suggests that prevention programmes merit a greater share of resources, even though such programmes generally consume more health resources than they save. For the process of priority-setting to be equitable and rational, more and better data will be required on programmatic costs and benefits. Furthermore, the process should be flexible, allowing priorities to differ from one geographic area to another, and from time to time within the same area. Finally, the process must be understood by a majority of the population, and perceived as fair.

The final epidemic. Prescriptions for prevention.

KIE: This is the author's keynote address to the Fourth Congress of the International Physicians for the Prevention of Nuclear War in June 1984. He describes activities aimed at stemming the nuclear arms race that were undertaken by medical and other professional groups during the four years since the first meeting of the U.S. Physicians for Social Responsibility. He also analyzes improvements in infant mortality that could have been obtained if resources devoted to the weapons buildup had been allocated instead to health care programs. Finally, he calls on physicians to take an active role in publicizing the medical realities of a nuclear war and the negative impact of the arms race on health care spending.^ieng

Tenth Daniel C. Baker, Jr, memorial lecture. The physician's contribution to national security.

Nuclear weapons make possible the ultimate epidemic. Since their use would lead to human and material damage orders of magnitude more extensive than anything ever known, and since the medical community would be impotent to respond in any meaningful way, all efforts must be directed to the prevention of nuclear war. By ensuring that the medical realities are known to decision-makers and the people of the world, the medical community can help focus attention on the critical need for an effective prescription for prevention and thereby can contribute in an important fashion to national security.

Preventing the last epidemic: II.

KIE: In a 1980 editorial, Hiatt urged physicians to regard nuclear war as an epidemic for which treatment is lacking and costs unacceptable, and so to direct their efforts at prevention. Here, he expands on that position, describing the disastrous medical consequences to be expected and recommending that the American Medical Association and other medical organizations publicize these medical realities to the leaders and peoples of the world.^ieng

Evaluation of medical practices. The case for technology assessment.

We believe that the systematic evaluation of medical practices, especially those that are risky or costly deserves more attention. Available methods are limited, and definitive assessments of innovative or controversial practices are infrequent. Nevertheless, some evaluations have successfully enhanced the use of effective practices and diminished the reliance on ineffective ones. Greater efforts at evaluation can improve the quality of patient care, avoid waste and promote the more rational use of health resources. The cost of assessing new practices should be viewed as an intrinsic part of the cost of medical care. Physicians and medical societies bear primary responsibility for recognizing the need for this evaluation, for enlisting other experts, participating in technology assessment and working to translate the results of evaluation into practice. The commitment of government agencies, insurance companies and teaching institutions is also essential to an effective program of evaluation.

Evaluation of medical practices.

Evaluation of the efficacy of a medical intervention requires valid measurements of both its benefits and risks as compared to those of alternative forms of management. The requisite measurements are more difficult to make than this simple description suggests, and the accumulation of information is further inhibited by certain characteristics of our pattern of health care. These features include, for example, discontinuous care by a variety of unrelated providers, inadequate records, the autonomy of physicians as decision-makers, financial disincentives, ambiguities in what we mean by "experimental" and "accepted" forms of therapy, and failure to see continuing evaluation as a necessary component of the cost of providing good medical care. Although no single change will solve all the problems of evaluation, several offer promise of improving our ability to choose from among medical interventions those most likely to be useful.