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Biomedical subjects
Publications and source records attributed to A R Localio.
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OBJECTIVE: To compare and contrast a managed care program's analysis of differences in hospital mortality with results obtained by accepted statistical methods. DESIGN: A re-analysis of computerized discharge data using the same method used by a managed care program, and using conventional methods of categorical data analysis. One thousand computer simulations of a method for comparing hospitals by severity-adjusted mortality were done to determine the probability of falsely identifying hospitals as high-mortality outliers. SETTING: 22 acute care hospitals in central Pennsylvania. PATIENTS: All adult patients with pneumonia (n = 4587; diagnosis-related groups 089-090) less than 65 years of age who were discharged from the 22 hospitals in 1989, 1990, and 1991, excluding patients with the acquired immunodeficiency syndrome and transplant recipients. MEASUREMENTS: In-hospital mortality adjusted for age and severity of illness using MedisGroups admission severity group score. RESULTS: The hospital that had the highest mortality for adult pneumonia according to the managed care program's analysis did not, according to an appropriate analysis, differ significantly from other area hospitals (likelihood ratio test, P = 0.23). Random variation in this sample of patients with a low average mortality rate (3.5%) showed a 60% chance that 1 or more of the 22 hospitals would be falsely identified as a "high-mortality outlier" when simplistic statistical methods were used. CONCLUSION: Organizations seeking to compare the quality of hospitals and physicians through outcome data need to recognize that simplistic methods applicable to large samples fail when applied to the outcomes of typical patients, such as those admitted for pneumonia. Although these comparisons are much in demand, careful attention must be paid to their statistical methods to ensure validity and fairness.
OBJECTIVE: To test the hypothesis that lymphocyte and normoblast counts in neonatal blood can be used to identify the time that ischemia and hypoxemia produced cerebral palsy. METHODS: Blood lymphocyte and normoblast counts were analyzed at intervals after birth in 16 neonates for whom we knew the time when antenatal ischemic and hypoxemic brain damage began. These counts were compared with counts from normal newborns, infants with low Apgar scores and no cerebral palsy, and infants with cerebral palsy caused by developmental and other early gestational disorders. RESULTS: Lymphocyte counts increased to more than 10,000/mm3 and normoblast counts to 2000/mm3 or more within 2 hours after the brain-damaging ischemia and hypoxemia began. Lymphocyte counts returned to normal levels 24 hours after the damaging event took place, and normoblast counts in 24-36 hours. Normal neonates had a mean +/- one standard deviation lymphocyte count of 4430 +/- 1418/mm3 and a normoblast count of 560 +/- 771/mm3. CONCLUSION: Following the changing counts of lymphocytes and normoblasts in neonates' blood may accurately identify the time before birth when brain-damaging ischemia and hypoxemia began.
STUDY OBJECTIVE: To evaluate the impact of a week-long course of inhaled albuterol compared with ipratropium on expiratory peak flow, exercise performance, and dyspnea in patients with stable COPD. DESIGN AND INTERVENTIONS: A double-blind, two-period, crossover evaluation, wherein the subjects inhaled albuterol, two puffs four times a day (qid) for 7 days, or ipratropium, two puffs quid for 7 days, in random sequence. SETTING: Outpatients of the Pennsylvania State University Hospital, Lebanon VA Medical Center, and local private office practices. PARTICIPANTS: A sample of 15 subjects with stable COPD with FEV1 < 55% predicted. MEASUREMENTS AND RESULTS: Variables measured at baseline (no inhaled bronchodilator) and/or on day 7 of each arm included FEV1 (liters), 12-min walk test distance (meters), "rescue" puffs of metaproterenol needed each week, and dyspnea scoring after walking, on the Borg Category Scale (0 to 10 = maximal). There was no significant difference in distance walked in 12 min (mean of 751.0 +/- 55.5 [+/- SE]) vs 755.7 +/- 61.3 m) or perceived dyspnea (mean 2.7 +/- 0.4 vs 3.3 +/- 0.4) during albuterol or ipratropium use. Seven patients preferred ipratropium, seven preferred albuterol, and one had no preference. CONCLUSION: We conclude that the effects of 1 week of albuterol or ipratropium have similar effects on exercise performance and subjective dyspnea in patients with stable COPD.
BACKGROUND: The diagnosis of an acute malignant hyperthermia reaction by clinical criteria can be difficult because of the nonspecific nature and variable incidence of many of the clinical signs and laboratory findings. Development of a standardized means for estimating the qualitative likelihood of malignant hyperthermia in a given patient without the use of specialized diagnostic testing would be useful for patient management and would promote research into improved means for diagnosing this disease. METHODS: Using the Delphi method and an international panel of 11 experts on malignant hyperthermia, a multifactor malignant hyperthermia clinical grading scale comprising standardized clinical diagnostic criteria was developed for classification of existing records and for application to new patients. RESULTS: This scale ranks the qualitative likelihood that an adverse anesthetic event represents malignant hyperthermia (malignant hyperthermia event rank) and that, with further investigation of family history, an individual patient will be diagnosed as malignant hyperthermia susceptible (malignant hyperthermia susceptibility rank). The assigned rank represents a lower bound on the likelihood of malignant hyperthermia. The clinical grading scale requires the anesthesiologist to judge whether specific clinical signs are appropriate for the patient's medical condition, anesthetic technique, and surgical procedure. CONCLUSIONS: The malignant hyperthermia clinical grading scale is recommended for use as an aid to the objective definition of this disease. It use may improve malignant hyperthermia research by allowing comparisons among well-defined groups of patients. This clinical grading system provides a new and comprehensive clinical case definition for the malignant hyperthermia syndrome.
OBJECTIVE: To investigate whether an association exists between the probability of a cesarean delivery and the level of malpractice claims risk faced by hospitals and physicians. DESIGN: Survey of computerized discharge data linked with physician and hospital malpractice claims records based on stratified, random sample of hospitals. SETTING: Acute care hospitals in New York State in 1984. POPULATION: All deliveries (60 490) at 31 hospitals. RESULTS: After controlling for the clinical risk of a cesarean delivery, patient socioeconomic status, and physician and hospital characteristics, cesarean delivery was positively associated with physician malpractice premiums (odds ratio [OR], 3.00; 95% confidence interval [CI], 2.13 to 4.24 for the difference between upstate and New York City levels), with the number of physician claims opened per 100 physicians at the hospital level (OR, 1.15; 95% CI, 1.02 to 1.30 for a 1-SD change), and with the number of hospital claims opened per 1000 discharges (OR, 1.26; 95% CI, 1.10 to 1.43 for a 1-SD change). Measures of physician-perceived risk of suit also showed a significant association with cesarean delivery (OR, 1.96; 95% CI, 1.53 to 2.52, upstate vs New York City). Within hospitals, there was no significant association (OR, 1.15; P = .126) between the odds of cesarean delivery and the claims history (none vs one or more) of an individual physician. CONCLUSION: Results support previous speculations of a positive association between malpractice claims risk and the rate of cesarean delivery.
PURPOSE: To develop a scoring system for stratifying patients in intensive care units (ICUs) by risk of developing nosocomial pneumonia (NP) and to identify the time period associated with the highest risk. PATIENTS AND METHODS: Two hundred and three patients 18 years of age or older and residing in the ICU for 72 hours or more were followed until development of NP or death or for 48 hours after discharge from the ICU. After the identification of independent risk factors for NP, a scoring system was developed to arrive at a predictive risk index for NP. RESULTS: Twenty-six (12.8%) patients developed NP. The presence of a nasogastric (NG) tube [odds ratio (OR) = 6.48, 95% confidence intervals (CI) = 2.11 to 19.82], upper abdominal/thoracic surgery (OR = 4.34, 95% CI = 1.43 to 13.14), and bronchoscopy (OR = 2.95, 95% CI = 1.02 to 8.52), most commonly performed for respiratory toilet, were identified as independent risk factors on multivariate analysis. The risks associated with endotracheal intubation and altered consciousness, although not independently significant, were highest when these factors were present for 1 to 4 days after the 72 hours required for study entry (endotracheal intubation, OR = 2.2 to 2.5; altered consciousness, OR = 1.4 to 2.0). The risk then declined; ORs of less than 1 were observed at 7 days. The risk associated with the NG tube was highest during the first 6 days (OR = 6.0 to 19.5). Although a subsequent decrease in risk was observed, the OR was still greater than 2 at 7 days. To obtain a predictive risk index for NP, a scoring system was developed using a multivariate model. This system has a sensitivity of 85% and a specificity of 66% in predicting NP in this ICU population. CONCLUSION: ICU patients can be stratified into high- and low-risk groups for NP using a bedside scoring system. Endotracheal intubation, altered mental status, and NG tube are associated with the highest risk of NP during the first 1 to 6 days of their presence after 72 hours of stay in the ICU. After this time period, the risk associated with these factors decreases. Bronchoscopy may be an independent risk factor for NP that has not been previously recognized. This procedure, often done in the ICU for respiratory toilet, may be an avoidable risk in this group of patients.
We explore the deterrent effect of the tort system by assessing physician perceptions of the risk of being sued and the impact of those perceptions on their own practice. The data are from a mailed survey conducted in 1989 of a random sample of physicians who were practicing in New York State in 1984. The survey results were compared to the actual risk of suit using the between-group (Wald) test and logistic regression methods. We also surveyed physicians about practice changes undertaken in the last ten years, factors influencing practice standards, and the costs of being sued and included these in the analysis. On average, physicians estimate that 19.5 out of one hundred of their colleagues will be sued in a given year, approximately three times the actual rate, with significant differences by specialty, location, and suit history. Perceived risk is associated with self-reported changes in test-ordering frequency and reduction in practice scope. The median number of days lost from practice to defend a malpractice suit was three to five, and 6 percent of the physicians surveyed incurred some out-of-pocket expenses. These findings suggest that physicians respond to the messages sent by litigation in a manner consistent with the deterrent theory of tort litigation.
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.
To explore the epidemiology of adverse events (AEs), which were defined as injuries due to medical treatment, and that subset of AEs caused by negligence, we studied interhospital variation in these outcomes in a sample of 31,000 medical records drawn from a random selection of 51 hospitals in New York in 1984. We found a substantial variation in both AE rates (0.2% to 7.9%; mean, 3.2%) and the percentage of AEs due to negligence (1% to 60%; mean, 24.9%) among hospitals. Univariate analyses of AEs revealed that primary teaching institutions had significantly higher rates (4.1%) and rural hospitals had significantly lower ones (1.0%). The percentage of AEs due to negligence was lower in primary teaching (10.7%) and for-profit (9.5%) hospitals and was significantly higher in hospitals with predominantly (greater than 80%) minority patients who had been discharged (37%). These findings were corroborated by multivariate analysis. Our results suggest that AEs and negligence are not randomly distributed and that certain types of hospitals have significantly higher rates of injuries due to substandard care. These observations may represent an important improvement on existing measures of quality because they take into account the fact that some hospitals' populations may be at risk of suffering a poor outcome.
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.
BACKGROUND: In a sample of 30,195 randomly selected hospital records, we identified 1133 patients (3.7 percent) with disabling injuries caused by medical treatment. We report here an analysis of these adverse events and their relation to error, negligence, and disability. METHODS: Two physician-reviewers independently identified the adverse events and evaluated them with respect to negligence, errors in management, and extent of disability. One of the authors classified each event according to type of injury. We tested the significance of differences in rates of negligence and disability among categories with at least 30 adverse events. RESULTS: Drug complications were the most common type of adverse event (19 percent), followed by wound infections (14 percent) and technical complications (13 percent). Nearly half the adverse events (48 percent) were associated with an operation. Adverse events during surgery were less likely to be caused by negligence (17 percent) than nonsurgical ones (37 percent). The proportion of adverse events due to negligence was highest for diagnostic mishaps (75 percent), noninvasive therapeutic mishaps ("errors of omission") (77 percent), and events occurring in the emergency room (70 percent). Errors in management were identified for 58 percent of the adverse events, among which nearly half were attributed to negligence. CONCLUSIONS: Although the prevention of many adverse events must await improvements in medical knowledge, the high proportion that are due to management errors suggests that many others are potentially preventable now. Reducing the incidence of these events will require identifying their causes and developing methods to prevent error or reduce its effects.
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.
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We retrospectively reviewed the results of open or closed reduction for developmental dysplasia of the hip (DDH) in 49 children younger than 12 months old, who had 57 hip dislocations. Group A (18 hips) developed partial or complete avascular necrosis (AVN), and group B (39 hips) did not develop AVN. Thirty-eight hips were treated by closed reduction, and 17 had open reduction. One patient with bilateral hip dislocation initially had closed reductions followed by bilateral open reduction 3 months later. With the numbers available for study, there was no significant difference in the occurrence of AVN with respect to variables such as preliminary traction, closed versus open reduction, Pavlik harness use, and age at the time of operative intervention. However, the presence of the ossific nucleus before reduction, detected either by radiographs (p < 0.001) or ultrasonography (p = 0.033) was statistically significant in predicting AVN. Only one (4%) of 25 hips with an ossific nucleus developed AVN, whereas 17 (53%) of 32 hips without an ossific nucleus before reduction developed AVN. Our results suggest that the presence of the ossific nucleus before closed or open reduction for DDH may decrease the risk of AVN.
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