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Trials featuring an "adaptive design" allow modification of some aspects of the trial based on prospectively planned interim data analyses.
Importantly, adaptations (or changes) should not be ad hoc, but by design, based on prospectively planned, prespecified analyses of interim data.
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Clinical response: Based on a prospectively planned expected clinical response rate at least 10% higher (95% CI 4% to 16%) with linezolid, and a control clinical response of 57%, the sample size of our intention-to-treat meta-analysis (N=2000 in each arm) has 99.9% power to detect a clinical response difference of 10% with a significance level of 0.05 (two-tailed).
Mortality: Based on a prospectively planned expected mortality rate at least 5% lower (95% CI −7% to −3%) with linezolid, and a control mortality rate of 15%, the sample size of our intention-to-treat meta-analysis (N=2000 in each arm) has 99.9% power to detect a mortality difference of 5% with a significance level of 0.05 (two-tailed).
Population-based register study based on prospectively collected data.
The cohort design based on prospectively collected high-quality data minimised the impact of information or recall bias.
We conducted this cohort study based on prospectively collected data obtained from population-based medical databases in northern Denmark.
To develop decision trees based on prospectively collected data for determining the appropriateness of cataract extraction.
The Swaziland HIV Incidence Measurement Survey (SHIMS) provides the first national HIV incidence estimate based on prospectively observed HIV seroconversions.
METHODS: This study was based on prospectively collected data including 9,038 blocks performed on 6,920 patients in a single ambulatory surgery center.
This was a retrospective study based on prospectively recorded registry.
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