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It was designed as a large simple trial.
In this supplement, we present practical aspects of organizing and conducting a large simple trial such as DIG.
The Digitalis Investigation Group DIGG) trial was a large simple trial (LST) begun in 1990 as a collaboration between the National Heart , Lung and Blood Institute and the Department of Veterans Affairs (VA) Cooperative Studies Program (CSP).
The study was designed as a large simple trial with a large number of centers (302) in the United States and Canada, many of which were inexperienced in research.
The CRASH trial was a large simple trial of an acute care intervention.
Experience in the OSIRIS and ORACLE studies suggests that a large, simple trial of this scale of a potentially important intervention is feasible [ 63, 53, 54].
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Moreover, a variety of innovative study designs and methodologies have found more widespread use, including noninferiority trials, preresection staging designed to direct therapy more precisely, planned early reports of conditional results, prognostic studies, assessment of an event status at a point in time, and large simple trials.
Examples of pragmatic studies include both large, simple trials and cluster randomized trials.
Ideally, patients should be enrolled into large simple trials with simple outcomes such as recurrence of cancer and death.
Many study designs, like large simple trials, are better described as longitudinal studies with baseline randomisation, rather than as either pure randomised or observational studies.
91 All things being equal (such as risk of bias and implementation), researchers and clinicians have been advised to trust large simple trials rather than meta-analyses of small trials.
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