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      Incidence of Adverse Events and Negligence in Hospitalized Patients : Results of the Harvard Medical Practice Study I

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          Abstract

          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. 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. 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. There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.

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          Iatrogenic illness on a general medical service at a university hospital.

          We found that 36% of 815 consecutive patients on a general medical service of a university hospital had an iatrogenic illness. In 9% of all persons admitted, the incident was considered major in that it threatened life or produced considerable disability. In 2% of the 815 patients, the iatrogenic illness was believed to contribute to the death of the patient. Exposure to drugs was a particularly important factor in determining which patients had complications. Given the increasing number and complexity of diagnostic procedures and therapeutic agents, monitoring of untoward events is essential, and attention should be paid to educational efforts to reduce the risks of iatrogenic illness.
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            A study of medical injury and medical malpractice.

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              Reliability and validity of judgments concerning adverse events suffered by hospitalized patients.

              To evaluate a process for identifying adverse events through review of medical records, multiple reviews of 360 medical records from two teaching hospital were performed. The data from these multiple reviews provided information about the validity and reliability of our two-phase review process. In particular, it was found that the initial phase, involving review of the medical records by medical-record-room administrators using explicit criteria, was valid, with a sensitivity of 84% and negative predictive value of 92%. Results also showed that the second phase, involving judgments by physicians guided by an adverse event analysis form, was reliable (Spearman Brown Rm = 0.78, m = 2) and demonstrated construct validity when compared with a review by a set of senior physicians employing a different method of review (Kappa = 0.57). In addition, it was found that these cases classified as difficult to judge from causation were judged less reliable (Rm = 0.48, for difficult case, Rm = 0.65, for other cases, m = 1). These results indicate that a two-step review process of medical records can produce judgments about adverse events that are both reliable and valid.
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                Author and article information

                Journal
                New England Journal of Medicine
                N Engl J Med
                Massachusetts Medical Society
                0028-4793
                1533-4406
                February 07 1991
                February 07 1991
                : 324
                : 6
                : 370-376
                Article
                10.1056/NEJM199102073240604
                1987460
                d752f07e-1a26-419c-bca5-4cc02c5ca873
                © 1991
                History

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