A cost-effectiveness model for coronary thrombolysis/reperfusion therapy.

A model was designed to examine the relations between incremental costs and benefits of coronary thrombolysis/reperfusion therapy. The model allows for the study of intravenous and intracoronary streptokinase, intravenous tissue plasminogen activator and primary angioplasty. Three strategies for the management of reocclusion are also compared. It was found that each of the following four variables can be responsible for a 2- to 15-fold variation in the costs per additional survivor: 1) the quantity of jeopardized myocardium, 2) the duration of coronary occlusion before the onset of therapy, 3) the time required from the onset of therapy until reperfusion is achieved, and 4) the reocclusion management strategy. Therapeutic strategies involving intravenous administration of thrombolytic agents were found to be consistently more cost effective than were strategies involving intracoronary administration of thrombolytic agents and primary angioplasty. In patients with a large or moderate-sized infarct, proper selection of intravenous protocols and reocclusion management strategies leads to costs of $7,000 to $100,000/additional survivor, costs that are similar to those of many generally accepted medical practices. Substantially higher costs per additional survivor are incurred with the routine use of thrombolytic therapy in patients with a small infarct or the routine use of coronary artery bypass surgery to reduce the risk of reocclusion after successful thrombolytic therapy. Decisions regarding which patients should receive thrombolysis/reperfusion therapy depend on society's willingness to pay for its incremental benefits.

Lovastatin therapy for hypercholesterolemia in cardiac transplant recipients.

Hypercholesterolemia (type II hyperlipidemia) after cardiac transplantation is common and may play a role in the accelerated rate of coronary atherosclerosis seen following the procedure. However, conventional cholesterol-lowering drugs are either ineffective or contraindicated for use in transplant recipients. The presence of type II hyperlipidemia was identified in 11 cardiac transplant recipients during a mean follow-up period of 15 months (range 3 to 41) after transplantation. Lovastatin, at an initial dosage of 20 mg/day, was administered for a period of 1 year. The maximal dosage of lovastatin was 60 mg/day. All patients received maintenance dosages of immunosuppressive agents, including cyclosporine-A, prednisone and, in some instances, azathioprine. Lipid profiles, hepatic transaminases, serum creatinine, creatine kinase and cyclosporine-A serum trough levels were measured quarterly. Total cholesterol decreased by 27% (354 +/- 50 vs 258 +/- 36 mg/dl, p less than 0.01) after 3 months and remained stable thereafter. Similarly, low density lipoprotein cholesterol decreased by 34% (221 +/- 51 vs 146 +/- 40 mg/dl, p less than 0.01) after 3 months and remained constant. Triglycerides, high density lipoprotein, hepatic transaminases, creatinine, creatine kinase and trough cyclosporine-A levels remained stable during the 1-year follow-up period. Lovastatin was uniformly well tolerated in this study group. When given in modest dosages, lovastatin appears to be a safe, effective and well-tolerated therapy for hypercholesterolemia in cardiac transplant recipients.

Cyclosporine A and prednisone-associated osteoporosis in heart transplant recipients.

Immunosuppressive therapy with cyclosporine A or prednisone produces bone loss in some animal models. Although we have clinically observed osteoporotic fractures in our heart recipients, the effects of cyclosporine and prednisone on bone density in transplant populations has not been fully elucidated. This study was undertaken to examine indexes of mineral metabolism and bone mineral density (BMD) in heart transplant recipients referred for evaluation of possible bone disease. Twenty of 93 patients who underwent heart transplantation at our institution were evaluated for osteoporosis. Sixteen of these patients (eight men; eight women) were included in this cross-sectional study (two patients were excluded because of hyperparathyroidism, and two patients were excluded because severe fractures prevented BMD from being measured). The mean age of the heart transplant recipients was 52.4 +/- 2.2 years, and the study was conducted a mean of 33.4 +/- 4.6 (men) and 19.0 +/- 7.0 (women) months after heart transplantation. Forty-four percent of these heart transplant recipients were seen clinically with fractures. Biochemical tests of skeletal homeostasis and BMD measurements with dual energy x-ray absorptiometry were performed. In male and female patients, the indexes of mineral metabolism showed (mean +/- sem) osteocalcin levels of 9.60 +/- 2.3 micrograms/L and 9.46 +/- 1.9 micrograms/L (normal: men, 6.39 +/- 0.69 micrograms/L; women, 5.87 +/- 0.71 micrograms/L) and intact parathyroid hormone levels of 48.8 +/- 10.3 ng/L and 63.4 +/- 10.7 ng/L (normal: men, 26.8 +/- 3.3 ng/L; women, 30.7 +/- 2.1 ng/L), respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Using control charts to analyze serial patient-related data.

The authors collected data from the record of a patient who had recently undergone coronary bypass surgery and used these data to construct control charts. The control charts helped them to interpret the variation in several clinical parameters and to evaluate the clinical responses to this variation.

Developing a corporate-level performance assessment system.

Monmouth Medical Center (Long Branch, New Jersey) developed a corporate-level performance assessment system to provide information to external customers and to use as an internal management tool. In this article, we recount the process used to develop the measurement system and describe some of the indicators included in it.

Assessing organizational performance.

To achieve unprecedented levels of performance, health care organizations may have to redesign the process by which they generate performance-related information and redefine the content of the information itself. In this article, we suggest several principles for accomplishing these objectives.

Using PERT/CPM (Program Evaluation and Review Technique/Critical Path Method) to design and improve clinical processes.

Recent changes in health care have focused attention on new tools for planning and managing clinical processes. The use of one tool in particular, clinical pathways, has increased dramatically. Pathways employ a concept long used in other industries: the explicit design and documentation of a process. However, the most common tools used in other industries to perform process design, the Program Evaluation and Review Technique (PERT) and the Critical Path Method (CPM), have not migrated to health care. This article presents a methodology for incorporating PERT/CPM into the design and management of clinical processes.

The case for using industrial quality management science in health care organizations.

In an effort to provide health care of optimal quality, providers traditionally assess or measure performance and then assure that it conforms to standards. In cases where performance fails to conform, providers attempt to modify or improve physician behavior. The analytic scope of this traditional paradigm may not be broad enough to allow modern health care organizations to provide optimal care. At a theoretical and practical level, many conceptual limitations inherent in the traditional approach are addressed in modern industrial quality science. A fundamental principle of industrial quality control is the recognition, analysis, and elimination of variation. Based on rigorous analysis of variation in outcomes and processes, industrial quality experts have developed principles and techniques for quality improvement. Health care organizations may well make important advances in the quality of care and service through the application of these principles and techniques.

Quality improvement in a hospital pharmacy department.

This article reports the successful implementation of two quality improvement efforts in the central pharmacy of a large tertiary care facility. The authors, who were participants in the project, describe the steps taken and the graphic tools used to document processes and measure improvements. The experience confirms that health care organizations can apply techniques of total quality management taken from other types of organizations.

The relation between experience and outcome in heart transplantation.

BACKGROUND: Current policies related to organ transplantation in the United States are designed to ensure that centers and physicians with experience in transplantation perform these procedures. It is essential to confirm the validity of such policies, since they may limit access to transplantation services. METHODS: To determine the relation between experience with heart transplantation and mortality after the procedure, we merged data from the registry of the International Society for Heart and Lung Transplantation with data from a survey that provided additional information about patients and transplantation centers. Our study included 1123 patients who received a heart transplant at one of 56 hospitals in the United States from 1984 through 1986. We used univariate and bivariate techniques, as well as logistic regression, to analyze our data. RESULTS: We observed an institutional learning curve for heart transplantation. Patients who received one of a center's first five transplants had higher mortality rates than patients who received a subsequent transplant (20 percent vs. 12 percent; P = 0.002; relative risk = 2.2; 95 percent confidence interval, 1.6 to 3.4). In addition, we found a correlation between the training of key personnel on the transplantation team and mortality at new transplantation centers. For example, new centers staffed by cardiologists with previous training in heart transplantation had lower mortality rates among heart-transplant recipients than centers without experienced cardiologists (7 percent vs. 16 percent; P = 0.001; relative risk = 2.7; 95 percent confidence interval, 1.3 to 5.9). By contrast, the previous training of the surgeons who performed transplantations was not related to the mortality rate associated with the procedure. CONCLUSIONS: Experience with heart transplantation is associated with a better outcome for patients after that procedure. Opportunities exist to refine transplantation policies on the basis of the experience of a center and its transplantation team and to develop similar policies for other forms of organ transplantation.

Expediting the turnaround of radiology reports: use of total quality management to facilitate radiologists' report signing.

OBJECTIVE: The purpose of this study was to determine whether total quality management techniques could be used to speed radiologists' performance on the task of signing reports. SUBJECTS AND METHODS: Total quality management represents a group of tools that can be used to improve the functioning of complex processes in the workplace. The steps involved in our total quality management project were as follows: (1) commit to improving radiologists' performance, (2) commission an interdisciplinary study team, (3) propose hypotheses for the causes of signing delays, (4) identify the key issues constraining performance (Pareto analysis), (5) intervene to correct systematic problems in a test system, (6) evaluate the results of intervention on radiologists' report signing performance, and (7) hold the gains achieved by the intervention. An interdisciplinary study team identified five key obstacles to prompt signing of reports: (1) radiologists' absence from the department when reports were available for signing (e.g., nights and weekends), (2) dysfunctional hand-off between transcriptionist and radiologist, (3) requirement that a fellow or resident sign before a staff radiologist, (4) lack of a system for signing by proxy (if primary radiologist is away), (5) perceived lack of impact of signed report on clinical decision making. RESULTS: Interventions included (1) providing home computer terminals, (2) implementing a buddy system for proxy signing, (3) eliminating the requirement for a signature from a fellow or resident, (4) teaming groups of radiologists with specific transcriptionists, and (5) streamlining transcription service. When these enhancements were used in a test system, the mean time required to sign reports decreased 59% from 26.0 +/- 8.4 hr (mean +/- standard error) in the baseline period to 10.6 +/- 2.9 hr (in the enhanced period, p = .05). CONCLUSION: We conclude that total quality management methods can accelerate radiologists' signing of reports.

Systems analysis of adverse drug events. ADE Prevention Study Group.

OBJECTIVE: To identify and evaluate the systems failures that underlie errors causing adverse drug events (ADEs) and potential ADEs. DESIGN: Systems analysis of events from a prospective cohort study. PARTICIPANTS: All admissions to 11 medical and surgical units in two tertiary care hospitals over a 6-month period. MAIN OUTCOME MEASURES: Errors, proximal causes, and systems failures. METHODS: Errors were detected by interviews of those involved. Errors were classified according to proximal cause and underlying systems failure by multidisciplinary teams of physicians, nurses, pharmacists, and systems analysts. RESULTS: During this period, 334 errors were detected as the causes of 264 preventable ADEs and potential ADEs. Sixteen major systems failures were identified as the underlying causes of the errors. The most common systems failure was in the dissemination of drug knowledge, particularly to physicians, accounting for 29% of the 334 errors. Inadequate availability of patient information, such as the results of laboratory tests, was associated with 18% of errors. Seven systems failures accounted for 78% of the errors; all could be improved by better information systems. CONCLUSIONS: Hospital personnel willingly participated in the detection and investigation of drug use errors and were able to identify underlying systems failures. The most common defects were in systems to disseminate knowledge about drugs and to make drug and patient information readily accessible at the time it is needed. Systems changes to improve dissemination and display of drug and patient data should make errors in the use of drugs less likely.

Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group.

OBJECTIVES: To assess incidence and preventability of adverse drug events (ADEs) and potential ADEs. To analyze preventable events to develop prevention strategies. DESIGN: Prospective cohort study. PARTICIPANTS: All 4031 adult admissions to a stratified random sample of 11 medical and surgical units in two tertiary care hospitals over a 6-month period. Units included two medical and three surgical intensive care units and four medical and two surgical general care units. MAIN OUTCOME MEASURES: Adverse drug events and potential ADEs. METHODS: Incidents were detected by stimulated self-report by nurses and pharmacists and by daily review of all charts by nurse investigators. Incidents were subsequently classified by two independent reviewers as to whether they represented ADEs or potential ADEs and as to severity and preventability. RESULTS: Over 6 months, 247 ADEs and 194 potential ADEs were identified. Extrapolated event rates were 6.5 ADEs and 5.5 potential ADEs per 100 nonobstetrical admissions, for mean numbers per hospital per year of approximately 1900 ADEs and 1600 potential ADEs. Of all ADEs, 1% were fatal (none preventable), 12% life-threatening, 30% serious, and 57% significant. Twenty-eight percent were judged preventable. Of the life-threatening and serious ADEs, 42% were preventable, compared with 18% of significant ADEs. Errors resulting in preventable ADEs occurred most often at the stages of ordering (56%) and administration (34%); transcription (6%) and dispensing errors (4%) were less common. Errors were much more likely to be intercepted if the error occurred earlier in the process: 48% at the ordering stage vs 0% at the administration stage. CONCLUSION: Adverse drug events were common and often preventable; serious ADEs were more likely to be preventable. Most resulted from errors at the ordering stage, but many also occurred at the administration stage. Prevention strategies should target both stages of the drug delivery process.