Troyen A. Brennan

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.

Incidence and types of adverse events and negligent care in Utah and Colorado

BACKGROUND The ongoing debate on the incidence and types of iatrogenic injuries in American hospitals has been informed primarily by the Harvard Medical Practice Study, which analyzed hospitalizations in New York in 1984. The generalizability of these findings is unknown and has been questioned by other studies. OBJECTIVE We used methods similar to the Harvard Medical Practice Study to estimate the incidence and types of adverse events and negligent adverse events in Utah and Colorado in 1992. DESIGN AND SUBJECTS We selected a representative sample of hospitals from Utah and Colorado and then randomly sampled 15,000 nonpsychiatric 1992 discharges. Each record was screened by a trained nurse-reviewer for 1 of 18 criteria associated with adverse events. If > or =1 criteria were present, the record was reviewed by a trained physician to determine whether an adverse event or negligent adverse event occurred and to classify the type of adverse event. MEASURES The measures were adverse events and negligent adverse events. RESULTS Adverse events occurred in 2.9+/-0.2% (mean+/-SD) of hospitalizations in each state. In Utah, 32.6+/-4% of adverse events were due to negligence; in Colorado, 27.4+/-2.4%. Death occurred in 6.6+/-1.2% of adverse events and 8.8+/-2.5% of negligent adverse events. Operative adverse events comprised 44.9% of all adverse events; 16.9% were negligent, and 16.6% resulted in permanent disability. Adverse drug events were the leading cause of nonoperative adverse events (19.3% of all adverse events; 35.1% were negligent, and 9.7% caused permanent disability). Most adverse events were attributed to surgeons (46.1%, 22.3% negligent) and internists (23.2%, 44.9% negligent). CONCLUSIONS The incidence and types of adverse events in Utah and Colorado in 1992 were similar to those in New York State in 1984. Iatrogenic injury continues to be a significant public health problem. Improving systems of surgical care and drug delivery could substantially reduce the burden of iatrogenic injury.

Is the Professional Satisfaction of General Internists Associated with Patient Satisfaction

AbstractBACKGROUND: The growth of managed care has raised a number of concerns about patient and physician satisfaction. An association between physicians’ professional satisfaction and the satisfaction of their patients could suggest new types of organizational interventions to improve the satisfaction of both. OBJECTIVE: To examine the relation between the satisfaction of general internists and their patients. DESIGN: Cross-sectional surveys of patients and physicians. SETTING: Eleven academically affiliated general internal medicine practices in the greater-Boston area. PARTICIPANTS: A random sample of English-speaking and Spanish-speaking patients (n=2,620) with at least one visit to their physician (n=166) during the preceding year. MEASUREMENTS: Patients’ overall satisfaction with their health care, and their satisfaction with their most recent physician visit. MAIN RESULTS: After adjustment, the patients of physicians who rated themselves to be very or extremely satisfied with their work had higher scores for overall satisfaction with their health care (regression coefficient 2.10; 95% confidence interval 0.73–3.48), and for satisfaction with their most recent physician visit (regression coefficient 1.23; 95% confidence interval 0.26–2.21). In addition, younger patients, those with better overall health status, and those cared for by a physician who worked part-time were significantly more likely to report better satisfaction with both measures. Minority patients and those with managed care insurance also reported lower overal satisfaction. CONCLUSIONS: The patients of physicians who have higher professional satisfaction may themselves be more satisfied with their care. Further research will need to consider factors that may mediate the relation between patient and physician satisfaction.

Impact of Language Barriers on Patient Satisfaction in an Emergency Department

ObjectiveTo examine patient satisfaction and willingness to return to an emergency department (ED) among non-English speakers.DesignCross-sectional survey and follow-up interviews 10 days after ED visit.SettingFive urban teaching hospital EDs in the Northeastern United States.PatientsWe surveyed 2,333 patients who presented to the ED with one of six chief complaints.Measurements and main resultsPatient satisfaction, willingness to return to the same ED if emergency care was needed, and patient-reported problems with care were measured. Three hundred fifty-four (15%) of the patients reported English was not their primary language. Using an overall measure of patient satisfaction, only 52% of non-English-speaking patients were satisfied as compared with 71% of English speakers (p<.01). Among non-English speakers, 14% said they would not return to the same ED if they had another problem requiring emergency care as compared with 9.5% of English speakers (p<.05). In multivariate analysis adjusting for hospital site, age, gender, race/ethnicity, education, income, chief complaint, urgency, insurance status. Medicaid status, ED as the patient’s principal source of care, and presence of a regular provider of care, non-English speakers were significantly less likely to be satisfied (odds ratio [OR] 0.59; 95% confidence interval [CI] 0.39, 0.90) and significantly less willing to return to the same ED (OR 0.57; 95% CI 0.34, 0.95). Non-English speakers also were significantly more likely to report overall problems with care (OR 1.70; 95% CI 1.05, 2.74), communication (OR 1.71; 95% CI 1.18, 2.47), and testing (OR 1.77; 95% CI 1.19, 2.64).ConclusionsNon-English speakers were less satisfied with their care in the ED, less willing to return to the same ED if they had a problem they felt required emergency care, and reported more problems with emergency care. Strategies to improve satisfaction among this group of patients may include appropriate use of professional interpreters and increasing the language concordance between patients and providers.

Full Coverage for Preventive Medications after Myocardial Infarction

BACKGROUND Adherence to medications that are prescribed after myocardial infarction is poor. Eliminating out-of-pocket costs may increase adherence and improve outcomes. METHODS We enrolled patients discharged after myocardial infarction and randomly assigned their insurance-plan sponsors to full prescription coverage (1494 plan sponsors with 2845 patients) or usual prescription coverage (1486 plan sponsors with 3010 patients) for all statins, beta-blockers, angiotensin-converting-enzyme inhibitors, or angiotensin-receptor blockers. The primary outcome was the first major vascular event or revascularization. Secondary outcomes were rates of medication adherence, total major vascular events or revascularization, the first major vascular event, and health expenditures. RESULTS Rates of adherence ranged from 35.9 to 49.0% in the usual-coverage group and were 4 to 6 percentage points higher in the full-coverage group (P<0.001 for all comparisons). There was no significant between-group difference in the primary outcome (17.6 per 100 person-years in the full-coverage group vs. 18.8 in the usual-coverage group; hazard ratio, 0.93; 95% confidence interval [CI], 0.82 to 1.04; P=0.21). The rates of total major vascular events or revascularization were significantly reduced in the full-coverage group (21.5 vs. 23.3; hazard ratio, 0.89; 95% CI, 0.90 to 0.99; P=0.03), as was the rate of the first major vascular event (11.0 vs. 12.8; hazard ratio, 0.86; 95% CI, 0.74 to 0.99; P=0.03). The elimination of copayments did not increase total spending (

Incidence and types of preventable adverse events in elderly patients : population based review of medical records

66,008 for the full-coverage group and

Drug Complications in Outpatients

71,778 for the usual-coverage group; relative spending, 0.89; 95% CI, 0.50 to 1.56; P=0.68). Patient costs were reduced for drugs and other services (relative spending, 0.74; 95% CI, 0.68 to 0.80; P<0.001). CONCLUSIONS The elimination of copayments for drugs prescribed after myocardial infarction did not significantly reduce rates of the trials primary outcome. Enhanced prescription coverage improved medication adherence and rates of first major vascular events and decreased patient spending without increasing overall health costs. (Funded by Aetna and the Commonwealth Fund; MI FREEE ClinicalTrials.gov number, NCT00566774.).

Treatment intensification does not reduce residual HIV-1 viremia in patients on highly active antiretroviral therapy

Abstract Objectives: To determine the incidence and types of preventable adverse events in elderly patients. Design: Review of random sample of medical records in two stage process by nurses and physicians to detect adverse events. Two study investigators then judged preventability. Setting: Hospitals in US states of Utah and Colorado, excluding psychiatric and Veterans Administration hospitals. Subjects: 15 000 hospitalised patients discharged in 1992. Main outcome measures: Incidence of preventable adverse events (number of preventable events per 100 discharges) in elderly patients (65 years old) and non-elderly patients (16-64 years). Results: When results were extrapolated to represent all discharges in 1992 in both states, non-elderly patients had 8901 adverse events (incidence 2.80% (SE 0.18%)) compared with 7419 (5.29% (0.37%)) among elderly patients (P=0.001). Non-elderly patients had 5038 preventable adverse events (incidence 1.58% (0.14%)) compared with 4134 (2.95% (0.28%)) in elderly patients (P=0.001). Elderly patients had a higher incidence of preventable events related to medical procedures (such as thoracentesis, cardiac catheterisation) (0.69% (0.14%) v 0.13% (0.04%)), preventable adverse drug events (0.63% (0.14%) v 0.17% (0.05%)), and preventable falls (0.10% (0.06%) v 0.01% (0.02%)). In multivariate analyses, adjusted for comorbid illnesses and case mix, age was not an independent predictor of preventable adverse events. Conclusion: Preventable adverse events were more common among elderly patients, probably because of the clinical complexity of their care rather than age based discrimination. Preventable adverse drug events, events related to medical procedures, and falls were especially common in elderly patients and should be targets for efforts to prevent errors.

Preventing medical injury.

OBJECTIVE: Outpatient drug complications have not been well studied. We sought to assess the incidence and characteristics of outpatient drug complications, identify their clinical and nonclinical correlates, and evaluate their impact on patient satisfaction. DESIGN: Retrospective chart reviews and patient surveys. SETTING: Eleven Boston-area ambulatory clinics. PATIENTS: We randomly selected 2,248 outpatients, 20 to 75 years old. MEASUREMENTS AND MAIN RESULTS: Among 2,248 patients reporting prescription drug use, 394 (18%) reported a drug complication. In contrast, chart review revealed an adverse drug event in only 64 patients (3%). In univariate analyses, significant correlates of patient-reported drug complications were number of medical problems, number of medications, renal disease, failure to explain side effects before treatment, lower medication compliance, and primary language other than English or Spanish. In multivariate analysis, independent correlates were number of medical problems (odds ratio [OR] 1.17; 95% confidence interval [95% CI] 1.05 to 1.30), failure to explain side effects (OR 1.65; 95% CI, 1.16 to 2.35), and primary language other than English or Spanish (OR 1.40; 95% CI, 1.01 to 1.95). Patient satisfaction was lower among patients who reported drug complications (P < .0001). In addition, 48% of those reporting drug complications sought medical attention and 49% experienced worry or discomfort. On chart review, 3 (5%) of the patients with an adverse drug event required hospitalization and 8 (13%) had a documented previous reaction to the causative drug. CONCLUSIONS: Drug complications in the ambulatory setting were common, although most were not documented in the medical record. These complications increased use of the medical system and correlated with dissatisfaction with care. Our results indicate a need for better communication about potential side effects of medications, especially for patients with multiple medical problems.

Relation between negligent adverse events and the outcomes of medical-malpractice litigation.

In HIV-1-infected individuals on currently recommended antiretroviral therapy (ART), viremia is reduced to <50 copies of HIV-1 RNA per milliliter, but low-level residual viremia appears to persist over the lifetimes of most infected individuals. There is controversy over whether the residual viremia results from ongoing cycles of viral replication. To address this question, we conducted 2 prospective studies to assess the effect of ART intensification with an additional potent drug on residual viremia in 9 HIV-1-infected individuals on successful ART. By using an HIV-1 RNA assay with single-copy sensitivity, we found that levels of viremia were not reduced by ART intensification with any of 3 different antiretroviral drugs (efavirenz, lopinavir/ritonavir, or atazanavir/ritonavir). The lack of response was not associated with the presence of drug-resistant virus or suboptimal drug concentrations. Our results suggest that residual viremia is not the product of ongoing, complete cycles of viral replication, but rather of virus output from stable reservoirs of infection.