PubMed · 10732504
The source did not provide an abstract. Follow the original record for more information.
Explore connections, maps & timelines
2000. Minimizing OTC drug risks.. https://pubmed.ncbi.nlm.nih.gov/10732504/
Cite the original work for its findings. Save a collection to share your selection of sources.
KEEP EXPLORING
A common objective in health care quality studies involves measuring and comparing the quality of care delivered to cohorts of patients by different health care providers. The data used for inference involve observations on units grouped within clusters, such as patients treated within hospitals. Unlike cluster randomization trials where often clusters are randomized to interventions to learn about individuals, the target of inference in health quality studies is the cluster. Furthermore, randomization is often not performed and the resulting biases may invalidate standard tests. In this paper, we discuss approaches to sample size determination in the design of observational health quality studies when the outcome is binary. Methods for calculating sample size using marginal models are briefly reviewed, but the focus is on hierarchical binomial models. Sample size in unbalanced clusters and stratified designs are characterized. We draw upon the experiences that have arisen from a study funded by the Agency for Healthcare Research and Quality involving assessment of quality of care for patients with cardiovascular disease. If researchers are interested in comparing clusters, hierarchical models are preferred.
BACKGROUND: Both aspirin and warfarin when used alone are effective in the secondary prevention of vascular events and death after acute myocardial infarction. We tested the hypothesis that aspirin and warfarin therapy, when combined, would be more effective than aspirin monotherapy. Methods and Results- We conducted a randomized open-label study to compare the efficacy of warfarin (target international normalized ratio 1.5 to 2.5 IU) plus aspirin (81 mg daily) with the efficacy of aspirin monotherapy (162 mg daily) in reducing the total mortality in 5059 patients enrolled within 14 days of infarction and followed for a median of 2.7 years. Secondary end points included recurrent myocardial infarction, stroke, and major hemorrhage. Four hundred thirty-eight (17.3%) of 2537 patients assigned to the aspirin group and 444 (17.6%) of 2522 patients assigned to the combination group died (log-rank P=0.76). Recurrent myocardial infarction occurred in 333 patients (13.1%) taking aspirin and in 336 patients (13.3%) taking combination therapy (log-rank P=0.78). Stroke occurred in 89 patients (3.5%) taking aspirin and in 79 patients (3.1%) taking combination therapy (log-rank P=0.52). Major bleeding occurred more frequently in the combination therapy group than in the aspirin group (1.28 versus 0.72 events per 100 person years of follow-up, respectively; P<0.001). There were 14 individuals with intracranial bleeds in both the aspirin and combination therapy groups. CONCLUSIONS: In post-myocardial infarction patients, warfarin therapy (at a mean international normalized ratio of 1.8) combined with low-dose aspirin did not provide a clinical benefit beyond that achievable with aspirin monotherapy.
Explore the source record for details and available documents.