Challenges of Decision Making Regarding Futility in a Randomized Trial
| Autor: | Robert F. Woolson, Marco R. Di Tullio, Patrick D. Lyden, Joseph P. Broderick, Yuko Y. Palesch, Lydia D. Foster, Renee H Martin, Sharon D. Yeatts, Christopher S. Coffey, Charles A. Jungreis |
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| Rok vydání: | 2014 |
| Předmět: |
Advanced and Specialized Nursing
Research design medicine.medical_specialty business.industry medicine.disease Surgery law.invention Clinical trial Randomized controlled trial law Modified Rankin Scale Statistical significance Severity of illness Emergency medicine medicine Neurology (clinical) Cardiology and Cardiovascular Medicine business Stroke Fibrinolytic agent |
| Zdroj: | Stroke. 45:1408-1414 |
| ISSN: | 1524-4628 0039-2499 0035-9424 |
| Popis: | Background and Purpose— Interventional Management of Stroke (IMS) III is a randomized, parallel arm trial comparing the approach of intravenous tissue-type plasminogen activator followed by endovascular treatment with intravenous tissue-type plasminogen activator alone in patients with acute ischemic stroke presenting Methods— Conditional power was defined as the likelihood of finding statistical significance at the end of the study, given the accumulated data to date and with the assumption that a minimum hypothesized difference of 10% truly exists between the 2 groups. The evolution of study data leading to futility determination is described, including the interaction between the unblinded study statisticians and the Data and Safety Monitoring Board in the complex deliberation of analysis results. Results— The futility boundary was crossed at the trial’s fourth interim analysis. At this point, based on the conditional power criteria, the Data and Safety Monitoring Board recommended termination of the trial. Conclusions— Even in spite of prespecified interim analysis boundaries, interim looks at data pose challenges in interpretation and decision making, underscoring the importance of objective stopping criteria. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00359424. |
| Databáze: | OpenAIRE |
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