Patients at high risk of sudden cardiac death, yet at low risk of nonsudden death, might be ideal candidates for antiarrhythmic drugs or devices. Most previous studies of prognostic markers for sudden cardiac death have ignored the competitive risk of nonsudden cardiac death. The goal of the present study was to evaluate the ability of clinical factors to distinguish the risks of sudden and nonsudden cardiac death.

Methods

We identified all deaths during a 3.3-year follow-up of 30,680 patients discharged alive after admission to the cardiac care unit of a Seattle hospital. Detailed chart reviews were conducted on 1093 subsequent out-of-hospital sudden deaths, 973 nonsudden cardiac deaths, and 442 randomly selected control patients.

Results

Patients who died in follow-up (suddenly or nonsuddenly) were significantly different for many clinical factors from control patients. In contrast, patients with sudden cardiac death were insignificantly different for most clinical characteristics from patients with nonsudden cardiac death. The mode of death was 20% to 30% less likely to be sudden in women, patients who had angioplasty or bypass surgery, and patients prescribed beta-blockers. The mode of death was 20% to 30% more likely to be sudden in patients with heart failure, frequent ventricular ectopy, or a discharge diagnosis of acute myocardial infarction. A multivariable model had only modest predictive capacity for mode of death (c-index of 0.62).

Conclusion

Standard clinical evaluation is much better at predicting overall risk of death than at predicting the mode of death as sudden or nonsudden.

The use of coronary angiography and revascularization is lower than expected among black patients. It is uncertain whether use of other cardiac procedures also varies according to race and ethnicity and whether outcomes are affected.

Methods

We analyzed discharge abstracts from all nonfederal hospitals in California of patients hospitalized for a primary diagnosis of ventricular tachycardia or ventricular fibrillation between 1992 and 1994. We compared mortality rates and use of electrophysiologic study (EPS) and implantable cardioverter-defibrillator (ICD) procedures according to the race and ethnicity of the patient.

Results

Among 8713 patients admitted with ventricular tachycardia or ventricular fibrillation, 29% (n  2508) had a subsequent EPS procedure, and 9% (n  818) had an ICD implanted. After controlling for potential confounding factors, we found that black patients were significantly less likely than white patients to undergo EPS (odds ratio 0.72, CI 0.56-0.92) or ICD implantation (odds ratio 0.39, CI 0.25-0.60). Blacks discharged alive from the initial hospital admission had higher mortality rates over the next year than white patients, even after controlling for multiple confounding risk factors (risk ratio 1.18, CI 1.03-1.36). The use of EPS and ICD procedures was also significantly affected by several other factors, most notably by on-site procedure availability but also by age, sex, and insurance status.

Conclusions

In a large population of patients hospitalized for ventricular arrhythmia, blacks had significantly lower rates of utilization for EPS and ICD procedures and higher subsequent mortality rates.

Implantable cardioverter defibrillators (ICDs) effectively prevent sudden cardiac death, but selection of appropriate patients for implantation is complex. We evaluated whether risk stratification based on risk of sudden cardiac death alone was sufficient to predict the effectiveness and cost-effectiveness of the ICD.

Methods

We developed a Markov model to evaluate the cost-effectiveness of ICD implantation compared with empiric amiodarone treatment. The model incorporated mortality rates from sudden and nonsudden cardiac death, noncardiac death and costs for each treatment strategy. We based our model inputs on data from randomized clinical trials, registries, and meta-analyses. We assumed that the ICD reduced total mortality rates by 25%, relative to use of amiodarone.

Results

The relationship between cost-effectiveness of the ICD and the total annual cardiac mortality rate is U-shaped; cost-effectiveness becomes unfavorable at both low and high total cardiac mortality rates. If the annual total cardiac mortality rate is 12%, the cost-effectiveness of the ICD varies from $36,000 per quality-adjusted life-year (QALY) gained when the ratio of sudden cardiac death to nonsudden cardiac death is 4 to $116,000 per QALY gained when the ratio is 0.25.

Conclusions

The cost-effectiveness of ICD use relative to amiodarone depends on total cardiac mortality rates as well as the ratio of sudden to nonsudden cardiac death. Studies of candidate diagnostic tests for risk stratification should distinguish patients who die suddenly from those who die nonsuddenly, not just patients who die suddenly from those who live.

Objective. To evaluate the costs and benefits of a group B streptococci screening strategy using a new, rapid polymerase chain reaction test in a hypothetical cohort of expectant mothers in the United States.

Methods. Design. Cost-benefit analysis using the human capital method. We developed a decision model to analyze the costs and benefits of a hypothetical group B streptococci screening strategy using a new, rapid polymerase chain reaction test as compared with the currently recommended group B streptococci screening guidelines-prenatal culture performed at 35 to 37 weeks or risk-factorbased strategy with subsequent intrapartum treatment of the expectant mothers with antibiotics to prevent early-onset group B streptococcal infections in their infants.

Participants. A hypothetical cohort of pregnant women and their newborns.

Interventions. Screening strategies for group B streptococci using the new polymerase chain reaction technique, the 35- to 37-week culture, or maternal risk factors.

Outcome Measures. Infant infections averted, infant deaths, infant disabilities, costs, and societal benefits of healthy infants.

Results. A screening strategy using the new polymerase chain reaction test generates a net benefit of $7 per birth when compared with the maternal risk-factor strategy. For every 1 million births, 80 700 more women would receive antibiotics, 884 fewer infants would become infected with early-onset group B streptococci, and 23 infants would be saved from death or disability. The polymerase chain reaction-based strategy generates a net benefit of $6 per birth when compared with the 35- to 37-week prenatal culture strategy and results in fewer maternal courses of antibiotics (64 080 per million births), fewer perinatal infections with early-onset group B streptococci (218/million), and a reduction in 6 infant deaths and severe infant disability per million births. The benefits hold over a wide range of assumptions regarding key factors in the analysis.

Conclusions. Although additional clinical trials are needed to establish the accuracy of this new polymerase chain reaction test, initial studies suggest that strategies using this test will be superior to the other 2 strategies. Using the rapid polymerase chain reaction test becomes less attractive as the cost of the test increases. The test's greatest strengths lie in its ability to identify women and infants at risk at the time of labor, thereby decreasing the number of false-positives and false-negatives seen with the other 2 strategies and allowing for more accurate and effective intrapartum prophylaxis.

Introduced into clinical use in 1980, the ICD has become smaller and simpler to implant, while providing better methods to detect and treat sustained ventricular tachyarrhythmias (rapid, irregular heart beat). This study found that ICD use expanded more than 10-fold in clinical practice from 1987 to 1995, with improved mortality rates but high medical expenditures and rates of surgical revision. The investigators identified ICD recipients by use of the hospital discharge databases of Medicare beneficiaries for 1987 through 1995 and of California residents for 1991 through 1995. They linked the initial hospital admission for each ICD patient to previous and subsequent admissions and to mortality files to determine the outcomes of ICD use.

During the study period, over 31,000 ICDs were implanted in Medicare patients, most of whom had been hospitalized for heart attack, congestive heart failure, or ventricular tachycardia at that time or during the previous year. Between 1987 and 1995, the number of hospitals performing the procedure increased from roughly 100 to 500, and the volume of ICD implantations per hospital also rose. Patients who died within 30 days of implantation decreased from 6 to 2 percent, and mortality rates within a year of implantation fell from 19 to 11 percent. Mortality rates at 3 years declined as well, but less sharply, from 38 percent in 1987 to 33 percent in 1992.

Subsequent hospitalizations for ICD complications or surgical replacement were very common and within the first year remained about 5 percent. However, the rate of revision/replacement at 3 years declined from 34 percent from 1987 to 1989 to 18 percent for devices implanted from 1990 to 1992, largely as a result of fewer generator replacements due to improvements in device and battery life. Medicare expenditures for these patients within 30 days of ICD implantation have remained close to $40,000 in 1993 dollars, and 3-year expenditures averaged almost $50,000.

OBJECTIVES: To present a methodology for identifying specific medications for which pill splitting is clinically appropriate and cost saving, to present data from a commercial managed care population on current pill-splitting practices, and to estimate additional cost savings from extended use of this strategy.

STUDY DESIGN: Retrospective pharmacy claims analysis.

METHODS: Pharmacy claims data from a commercial managed care health plan covering 19,000 lives and national drug data were used to compile a list of frequently prescribed medications. Excluding medications in which packaging, formulation, and potential adverse pharmacologic outcomes prohibited splitting, we performed a cost analysis of medications amenable to splitting.

RESULTS: Eleven medications amenable to pill splitting were identified based on potential cost savings and clinical appropriateness: clonazepam, doxazosin, atorvastatin, pravastatin, citalopram, sertraline, paroxetine, lisinopril, nefazadone, olanzapine, and sildenafil. For these medications, pill splitting is currently infrequent, accounting for annual savings of $6200 (or $0.03 per member per month), just 2% of the potential $259,500 (or $1.14 per member per month) that more comprehensive pill-splitting practices could save annually.

CONCLUSIONS: Pill splitting can be a cost-saving practice when implemented judiciously using drug- and patient-specific criteria aimed at clinical safety, although this strategy is used infrequently.

Objectives. Concerns have mounted about the complexities of the health care system potentially causing significant unintended adverse effects. With a major national interest in addressing patient safety issues, a wide spectrum of individuals and organizations are working toward developing methods and systems to detect, characterize, and report potentially preventable adverse events. One approach is to develop screening measures based on routinely collected administrative data, such as the patient safety indicators (PSIs) reported here. The purpose of the PSI project is to report 1) literature-based evidence on potential PSIs, 2) clinician panel review results of potential indicators, 3) empirical analyses on a subset of indicators, and 4) recommendations regarding potential PSIs.

Methods. A four-pronged strategy to collect validation data and descriptive information was used: 1) background literature review, 2) structured clinical panel reviews of candidate PSIs, 3) expert review of ICD-9-CM codes in candidate PSIs, and 4) empirical analyses of the potential candidate PSIs. Evidence from these four sources was used to modify and select the most promising indicators for use as a screening tool to provide an accessible and low-cost approach to identifying potential problems in the quality of care related to patient safety.

Main results. A review of previously reported measures in the literature, and of medical coding manuals, resulted in identification of over 200 ICD-9-CM codes representing potential patient safety problems. Most of these codes were grouped into clinically meaningful indicators either based on previous indicator definitions or on clinical and coding expertise. Based on literature review of the published evidence related to their validity, several potential PSIs were eliminated. Because of the limited validation literature available on PSIs and complications indicators from which many PSIs were derived, the research team conducted a clinical panel review process to assess the face validity and to guide refinements to the initial definitions of the 34 most promising PSIs. Response to a questionnaire by clinicians (i.e., physicians from a number of specialties, nurses, and pharmacists) for each indicator, augmented by coding review and initial empirical testing, provided the basis for selecting the indicators expected to be most useful for screening for potentially preventable adverse events. Twenty hospital level PSIs are recommended for implementation as the initial AHRQ PSI set (designated Accepted indicators).

Conclusions and future research. Future validation work should focus on the sensitivity and specificity of these indicators in detecting the occurrence of a complication; the extent to which failures in processes of care at the system or individual level are detected using these indicators; the relationship of these indicators with other measures of quality, such as mortality; and further explorations of bias and risk adjustment. Enhancements to administrative data are worth exploring in the context of further validation studies that utilize data from other sources. The current development and evaluation effort will best be augmented by a continuous communication loop between users of these measures, researchers interested in improving these measures, and policy makers with influence over the resources aimed at data collection and patient safety measurement.