Phone and Video-Based Modalities of Central Blinded Adjudication of Modified Rankin Scores in an Endovascular Stroke Trial
Por:
Lopez-Cancio, E, Salvat, M, Cerda, N, Jimenez, M, Codas, J, Llull, L, Boned, S, Cano, LM, Lara, B, Molina, C, Cobo, E, Davalos, A, Jovin, TG and Serena, J
Publicada:
1 dic 2015
Resumen:
Background and Purpose-The standard outcome measure in stroke research is modified Rankin scale (mRS) evaluated by local blinded investigators. We aimed to assess feasibility and reliability of 2 central adjudication methods of mRS in the setting of a randomized endovascular stroke 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 Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset (REVASCAT) trial cohort. Primary outcome was distribution of mRS 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 mRS obtained with each modality and 24-hour follow-up infarct volumes was studied.
Results-Using local evaluation as the reference, higher agreement rates were noted with central video than with central phone evaluations (k(w) 0.92 [0.88-0.96] versus 0.77 [0.72-0.83]). Discrepancies in mRS 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 infarct volume was similarly correlated with mRS across all 3 evaluation modalities.
Conclusions-Central adjudication of mRS 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 acute stroke trials, especially in those including nonpharmacological interventions.
Filiaciones:
Lopez-Cancio, E:
Univ Autonoma Barcelona, Hosp Germans Trias & Pujol, Dept Neurosci, Barcelona 08916, Spain
Cerda, N:
Bioclever, Dept Stat, Barcelona, Spain
Jimenez, M:
Univ Autonoma Barcelona, Hosp Germans Trias & Pujol, Dept Neurosci, Barcelona 08916, Spain
Codas, J:
Hosp Clin Barcelona, Barcelona, Spain
Llull, L:
Hosp Clin Barcelona, Barcelona, Spain
Boned, S:
Hosp Valle De Hebron, Barcelona, Spain
Cano, LM:
Bellvitge Hosp, Barcelona, Spain
Lara, B:
Bellvitge Hosp, Barcelona, Spain
Molina, C:
Hosp Valle De Hebron, Barcelona, Spain
Cobo, E:
Barcelona Tech, Stat & Operat Res, Barcelona, Spain
:
Univ Autonoma Barcelona, Hosp Germans Trias & Pujol, Dept Neurosci, Barcelona 08916, Spain
Jovin, TG:
UPMC, Dept Neurol, Stroke Inst, Pittsburgh, PA USA
Serena, J:
Hosp Josep Trueta, Stroke Unit, Girona, Spain
Bronze, Green Submitted
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