Evolution of the Modified Rankin Scale and Its Use in Future Stroke Trials

Joseph P Broderick, Opeolu Adeoye, Jordan Elm, Joseph P Broderick, Opeolu Adeoye, Jordan Elm

No abstract available

Keywords: clinical trial; modified Rankin Scale; multimedia; stroke.

Conflict of interest statement

Conflicts-of-interests/Disclosure(s): Joseph Broderick: monies to Department of Neurology and Rehabilitation Medicine from Genentech for role on PRISMS Trial and from Astra-Zeneca as consultant for SOCRATES Trial.

Figures

Figure 1

Differences in means of the UW- mRS plotted against differences in proportions of mRS ≤ 3. Size of the circles is proportional to sample size of trial. Red circles are negative trials by both primary dichotomous measure and UW-mRS. Blue solid circles are positive by both measures. Blue circles with clear centers are positive by UW-mRS but negative by primary dichotomous endpoint (like IST3 with mRS of 0–1). Green circles with clear centers are positive by dichotomous primary endpoint but negative by UW-mRS (like PROACT II, TREVO II, and THRACE with mRS of 0–2 and ECASS III with mRS of 0–1). For the REVASCT trial, the two-sided p-value UW-mRS t-test is p=0.0502 which is larger than 0.05 and so it was coded as “- UW-mRS” (green circle*). The SAINT Trial analyzed the whole distribution of scores using the Cochran–Mantel–Haenszel test for its primary analysis that was just statistically positive (odds ratio, 1.20; 95 percent confidence interval, 1.01 to 1.42, green circle*). The ENCHANTED Trial was designed as a non-inferiority trial that was not non-inferior by primary endpoint.