E. John Orav

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.

Prevention of nonvertebral fractures with oral vitamin D and dose dependency: a meta-analysis of randomized controlled trials.

BACKGROUND Antifracture efficacy with supplemental vitamin D has been questioned by recent trials. METHODS We performed a meta-analysis on the efficacy of oral supplemental vitamin D in preventing nonvertebral and hip fractures among older individuals (> or =65 years). We included 12 double-blind randomized controlled trials (RCTs) for nonvertebral fractures (n = 42 279) and 8 RCTs for hip fractures (n = 40 886) comparing oral vitamin D, with or without calcium, with calcium or placebo. To incorporate adherence to treatment, we multiplied the dose by the percentage of adherence to estimate the mean received dose (dose x adherence) for each trial. RESULTS The pooled relative risk (RR) was 0.86 (95% confidence interval [CI], 0.77-0.96) for prevention of nonvertebral fractures and 0.91 (95% CI, 0.78-1.05) for the prevention of hip fractures, but with significant heterogeneity for both end points. Including all trials, antifracture efficacy increased significantly with a higher dose and higher achieved blood 25-hydroxyvitamin D levels for both end points. Consistently, pooling trials with a higher received dose of more than 400 IU/d resolved heterogeneity. For the higher dose, the pooled RR was 0.80 (95% CI, 0.72-0.89; n = 33 265 subjects from 9 trials) for nonvertebral fractures and 0.82 (95% CI, 0.69-0.97; n = 31 872 subjects from 5 trials) for hip fractures. The higher dose reduced nonvertebral fractures in community-dwelling individuals (-29%) and institutionalized older individuals (-15%), and its effect was independent of additional calcium supplementation. CONCLUSION Nonvertebral fracture prevention with vitamin D is dose dependent, and a higher dose should reduce fractures by at least 20% for individuals aged 65 years or older.

Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing

BACKGROUND: Standard clinical practice permits the use of either single-chamber ventricular pacemakers or dual-chamber pacemakers for most patients who require cardiac pacing. Ventricular pacemakers are less expensive, but dual-chamber pacemakers are believed to be more physiologic. However, it is not known whether either type of pacemaker results in superior clinical outcomes. METHODS: The Pacemaker Selection in the Elderly study was a 30-month, single-blind, randomized, controlled comparison of ventricular pacing and dual-chamber pacing in 407 patients 65 years of age or older in 29 centers. Patients received a dual-chamber pacemaker that had been randomly programmed to either ventricular pacing or dual-chamber pacing. The primary end point was health-related quality of life as measured by the 36-item Medical Outcomes Study Short-Form General Health Survey. RESULT: The average age of the patients was 76 years (range, 65 to 96), and 60 percent were men. Quality of life improved significantly after pacemaker implantation (P<0.001), but there were no differences between the two pacing modes in either the quality of life or prespecified clinical outcomes (including cardiovascular events or death). However, 53 patients assigned to ventricular pacing (26 percent) were crossed over to dual-chamber pacing because of symptoms related to the pacemaker syndrome. Patients with sinus-node dysfunction, but not those with atrioventricular block, had moderately better quality of life and cardiovascular functional status with dual-chamber pacing than with ventricular pacing. Trends of borderline statistical significance in clinical end points favoring dual-chamber pacing were observed in patients with sinus-node dysfunction, but not in those with atrioventricular block. CONCLUSION: The implantation of a permanent pacemaker improves health-related quality of life. However, the quality-of-life benefits associated with dual-chamber pacing as compared with ventricular pacing are observed principally in the subgroup of patients with sinus-node dysfunction.

Thirty-Day Readmission Rates for Medicare Beneficiaries by Race and Site of Care

CONTEXT Understanding whether and why there are racial disparities in readmissions has implications for efforts to reduce readmissions. OBJECTIVE To determine whether black patients have higher odds of readmission than white patients and whether these disparities are related to where black patients receive care. DESIGN Using national Medicare data, we examined 30-day readmissions after hospitalization for acute myocardial infarction (MI), congestive heart failure (CHF), and pneumonia. We categorized hospitals in the top decile of proportion of black patients as minority-serving. We determined the odds of readmission for black patients compared with white patients at minority-serving vs non-minority-serving hospitals. SETTING AND PARTICIPANTS Medicare Provider Analysis Review files of more than 3.1 million Medicare fee-for-service recipients who were discharged from US hospitals in 2006-2008. MAIN OUTCOME MEASURE Risk-adjusted odds of 30-day readmission. RESULTS Overall, black patients had higher readmission rates than white patients (24.8% vs 22.6%, odds ratio [OR], 1.13; 95% confidence interval [CI], 1.11-1.14; P < .001); patients from minority-serving hospitals had higher readmission rates than those from non-minority-serving hospitals (25.5% vs 22.0%, OR, 1.23; 95% CI, 1.20-1.27; P < .001). Among patients with acute MI and using white patients from non-minority-serving hospitals as the reference group (readmission rate 20.9%), black patients from minority-serving hospitals had the highest readmission rate (26.4%; OR, 1.35; 95% CI, 1.28-1.42), while white patients from minority-serving hospitals had a 24.6% readmission rate (OR, 1.23; 95% CI, 1.18-1.29) and black patients from non-minority-serving hospitals had a 23.3% readmission rate (OR, 1.20; 95% CI, 1.16-1.23; P < .001 for each); patterns were similar for CHF and pneumonia. The results were unchanged after adjusting for hospital characteristics including markers of caring for poor patients. CONCLUSION Among elderly Medicare recipients, black patients were more likely to be readmitted after hospitalization for 3 common conditions, a gap that was related to both race and to the site where care was received.

Ex-vivo gene therapy of human vascular bypass grafts with E2F decoy: the PREVENT single-centre, randomised, controlled trial

BACKGROUND Cell-cycle blockade by ex-vivo gene therapy of experimental vein grafts inhibits the neointimal hyperplasia and subsequent accelerated atherosclerosis that lead to human bypass-graft failure. In a prospective, randomised, controlled trial, we investigated the safety and biological efficacy of intraoperative gene therapy in patients receiving bypass vein grafts. METHODS We studied gene therapy that uses decoy oligodeoxynucleotide, which binds and inactivates the pivotal cell-cycle transcription factor E2F. 41 patients were randomly assigned untreated (16), E2F-decoy-treated (17), or scrambled-oligodeoxynucleotide-treated (eight) human infrainguinal vein grafts. Oligonucleotide was delivered to grafts intraoperatively by ex-vivo pressure-mediated transfection. The primary endpoints were safety and inhibition of target cell-cycle regulatory genes and of DNA synthesis in the grafts. Analysis was by intention to treat. FINDINGS Mean transfection efficiency was 89.0% (SD 1.9). Proliferating-cell nuclear antigen and c-myc mRNA concentrations and bromodeoxyuridine incorporation were decreased in the EF2-decoy group by medians of 73% [IQR 53-84], 70% [50-79], and 74% [56-83], respectively) but not in the scrambled-oligodeoxynucleotide group (p<0.0001). Groups did not differ for postoperative complication rates. At 12 months, fewer graft occlusions, revisions, or critical stenoses were seen in the E2F-decoy group than in the untreated group (hazard ratio 0.34 [95% CI 0.12-0.99]). INTERPRETATION Intraoperative transfection of human bypass vein grafts with E2F-decoy oligodeoxynucleotide is safe, feasible, and can achieve sequence-specific inhibition of cell-cycle gene expression and DNA replication. Application of this genetic-engineering strategy may lower failure rates of human primary bypass vein grafting.

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.

Variation in Surgical-Readmission Rates and Quality of Hospital Care

BACKGROUND Reducing hospital-readmission rates is a clinical and policy priority, but little is known about variation in rates of readmission after major surgery and whether these rates at a given hospital are related to other markers of the quality of surgical care. METHODS Using national Medicare data, we calculated 30-day readmission rates after hospitalization for coronary-artery bypass grafting, pulmonary lobectomy, endovascular repair of abdominal aortic aneurysm, open repair of abdominal aortic aneurysm, colectomy, and hip replacement. We used bivariate and multivariate techniques to assess the relationships between readmission rates and other measures of surgical quality, including adherence to surgical process measures, procedure volume, and mortality. RESULTS For the six index procedures, there were 479,471 discharges from 3004 hospitals. The median risk-adjusted composite readmission rate at 30 days was 13.1% (interquartile range, 9.9 to 17.1). In a multivariate model adjusting for hospital characteristics, we found that hospitals in the highest quartile for surgical volume had a significantly lower composite readmission rate than hospitals in the lowest quartile (12.7% vs. 16.8%, P<0.001), and hospitals with the lowest surgical mortality rates had a significantly lower readmission rate than hospitals with the highest mortality rates (13.3% vs. 14.2%, P<0.001). High adherence to reported surgical process measures was only marginally associated with reduced readmission rates (highest quartile vs. lowest quartile, 13.1% vs. 13.6%; P=0.02). Patterns were similar when each of the six major surgical procedures was examined individually. CONCLUSIONS Nearly one in seven patients hospitalized for a major surgical procedure is readmitted to the hospital within 30 days after discharge. Hospitals with high surgical volume and low surgical mortality have lower rates of surgical readmission than other hospitals.

Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial.

BACKGROUND Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure, but data to support this practice are lacking. Using a technology-based heart failure monitoring system, we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline-driven heart failure care. METHODS This was a randomized, controlled trial. Patients hospitalized with New York Heart Association class III or IV heart failure, with a left ventricular ejection fraction < or =35% were randomized to receive heart failure program care or heart failure program care plus the AlereNet system (Alere Medical, Reno, Nev) and followed-up for 6 months. The primary end point was 6-month hospital readmission rate. Secondary end points included mortality, heart failure hospitalization readmission rate, emergency room visitation rate, and quality of life. RESULTS Two hundred eighty patients from 16 heart failure centers across the United States were randomized: 138 received the AlereNet system and 142 received standard care. Mean age was 59 +/- 15 years and 68% were male. The population had very advanced heart failure, New York Heart Association class III (75%) or IV (25%), as evidenced by serum norepinepherine levels, 6-minute walk distance and outcomes. No differences in hospitalization rates were observed. There was a 56.2% reduction in mortality (P <.003) for patients randomized to the AlereNet group. CONCLUSIONS This is the largest multicenter, randomized trial of a technology-based daily weight and symptom-monitoring system for patients with advanced heart failure. Despite no difference in the primary end point of rehospitalization rates, mortality was significantly reduced for patients randomized to the AlereNet system without an increase in utilization, despite specialized and aggressive heart failure care in both groups.

The association of intraoperative factors with the development of postoperative delirium

PURPOSE To examine the association of intraoperative factors, including route of anesthesia, hemodynamic complications, and blood loss, with the development of postoperative delirium. PATIENTS AND METHODS We studied 1,341 patients 50 years of age and older admitted for major elective noncardiac surgery at an academic medical center. Data on route of anesthesia, intraoperative hypotension, bradycardia and tachycardia, blood loss, number of blood transfusions, and lowest postoperative hematocrit were obtained from the medical record. Delirium was diagnosed by using daily interviews with the Confusion Assessment Method, as well as from the medical record and the hospitals nursing intensity index. RESULTS Postoperative delirium occurred in 117 (9%) patients. Route of anesthesia and intraoperative hemodynamic complications were not associated with delirium. Delirium was associated with greater intraoperative blood loss, more postoperative blood transfusions, and postoperative hematocrit <30%. After adjusting for preoperative risk factors, postoperative hematocrit <30% was associated with an increased risk of delirium (odds ratio = 1.7, 95% confidence interval 1.1-2.7). CONCLUSIONS Further study is required to determine whether transfusion to keep postoperative hematocrit above 30% can reduce the incidence of postoperative delirium.

Using a computerized sign-out program to improve continuity of inpatient care and prevent adverse events.

BACKGROUND Many medical injuries are preventable, but there are few reported successful strategies to prevent such injuries. Previous work identified coverage by house staff not primarily responsible for the patient (cross-coverage) as a significant correlate of risk for preventable adverse events. A four-month intervention--computerized sign-outs--was introduced in 1993 in an urban teaching hospital to improve continuity of care during cross-coverage and thereby reduce risk for preventable adverse events. MEASUREMENTS A previously tested confidential self-report system was used to identify adverse events, which were defined as unexpected complications of medical therapy that resulted in increased length of stay or disability at discharge. A panel of three board-certified internists confirmed events and evaluated preventability based on case summaries. RESULTS After the intervention, the rate of preventable adverse events among the 3,747 patients admitted to the medical service decreased from 1.7% to 1.2% (p < 0.10). Both univariate and multivariate analysis revealed no association between cross coverage and preventable adverse events after the intervention. In the baseline period, the odds ratio (OR) for a patient suffering a preventable adverse event during cross coverage was 5.2 (95% confidence interval [CI], 1.5-18.2; p = 0.01), but was no longer significant after the intervention (OR, 1.5; 95% CI, 0.2-9.0). CONCLUSION House staff are willing participants in efforts to measure and improve the quality of health care systems. The intervention may have reduced the risk for medical injury associated with discontinuity of inpatients care. Four years after the end of the study, the computerized sign-out program remained an integral part of the computing support system for house staff and was widely used.