Phone and Video-Based Modalities of Central Blinded Adjudication of Modified Rankin Scores in an XXXX Trial.

@entity64 @entity2653 @entity1188
BACKGROUND AND PURPOSE: The standard outcome measure in @entity64 research is @entity2653 ( @entity2653 ) evaluated by local blinded investigators. We aimed to assess feasibility and reliability of 2 central adjudication methods of @entity2653 in the setting of a randomized @entity64 trial. METHODS: This is a secondary analysis derived from the Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of @entity64 Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset (REVASCAT) trial cohort. Primary outcome was distribution of @entity2653 at 90 days. Local evaluation was done by certified investigators masked to treatment assignment using structured face-to-face interviews. In addition, central assessment was performed by 2 independent raters via structured phone interview (n=120) and via video recordings of the face-to-face interviews with local investigators (n=106). Interrater agreement was evaluated using kappa and discordance statistics. Sensitivity analyses for the primary end point using different adjudication approaches were performed. Correlation between @entity2653 obtained with each modality and 24-hour follow-up @entity1188 volumes was studied. RESULTS: Using local evaluation as the reference, higher agreement rates were noted with central video than with central phone evaluations (kw 0.92 [0.88-0.96] versus 0.77 [0.72-0.83]). Discrepancies in @entity2653 scoring between local and central raters (phone- and video-based) were similar in both treatment allocation arms. Sensitivity analyses showed benefit of endovascular treatment irrespective of adjudication method, but higher odds ratios were observed with local evaluations. Final @entity1188 volume was similarly correlated with @entity2653 across all 3 evaluation modalities. CONCLUSIONS: Central adjudication of @entity2653 is feasible, reducing interrater variability and avoiding potential problems related to lack of blinding. Our findings may have implications in the planning of future randomized @entity64 trials, especially in those including nonpharmacological interventions. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01692379.
