Selection and Analysis of Endpoints Sample Clauses

Selection and Analysis of Endpoints. Acute stroke clinical trials have varied widely in choice of the assessment scale for primary endpoint analysis and the statistical method of analyzing this endpoint. The FAST- MAG trial will use the modified Xxxxxx Scale as the primary endpoint. As a global measure of disability, the Xxxxxx Scale offers the most comprehensive measure of functional outcome among the several outcome measures routinely employed in acute stroke trials. For this reason, it has been frequently employed as a primary endpoint in stroke trials and has been adopted by the Cochrane Collaboration as the most important measure for analysis when performing meta- analyses or results across trials. FAST-MAG will additionally collect data on other standard measures of outcome (NIHSS, BI, GOS, mortality) and analyze these in prespecified secondary analyses. The additional use of a quality of life scale outcome measure will be an important innovation of the FAST-MAG trial. Quality of life scales are sensitive to fine-grained changes in outcome from mild and moderate stroke undetected by other outcome measures. Additionally, standard measures like the modified Xxxxxx Scale and the Xxxxxxx Index, assess primarily physical aspects of stroke outcome. Quality of life scales can assess other important dimensions of illness outcome, including emotion, communication, cognition, and social role function. The Stroke Impact Scale is a validated assessment of quality of life specifically in patients with stroke. [12] FAST-MAG will be the first NIH-NINDS funded phase 3 acute stroke trial to include a quality of life measure as a major secondary endpoint. The method of statistical analysis of the primary endpoint is always a critical issue in acute stroke trials. Most prior trials employing the Xxxxxx Scale and Xxxxxxx Scale as primary endpoints have used a dichotomous outcome, dividing the scales at various, somewhat arbitrarily chosen cutoffs. [19] Random chance will cause the ideal cutoff point to vary from one trial to the next. Trials may appear positive if one cutoff is employed and negative if another, as occurred with ECASS II and PROACT II. Moreover, many patients enrolled in the trial will not contribute data to a dichotomized outcome. A treated patient who improves from a Xxxxxx 5 to a Xxxxxx 3 will not contribute to an analysis dichotomized for good outcomes at Xxxxxx < 2. This will especially be a problem for drugs like neuroprotective agents in which a treatment effect across the full range...
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