title: Phone and Video-Based Modalities of Central Blinded Adjudication of Modified Rankin Scores in an Endovascular Stroke Trial.
abstract: OBJECTIVE
  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 (kw 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.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01692379.
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.). elenacancio@gmail.com.
authors.forename: Elena
authors.initials: E
authors.lastname: López-Cancio
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Mercè
authors.initials: M
authors.lastname: Salvat
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Neus
authors.initials: N
authors.lastname: Cerdà
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Marta
authors.initials: M
authors.lastname: Jiménez
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Javier
authors.initials: J
authors.lastname: Codas
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Laura
authors.initials: L
authors.lastname: Llull
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Sandra
authors.initials: S
authors.lastname: Boned
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Luis M
authors.initials: LM
authors.lastname: Cano
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Blanca
authors.initials: B
authors.lastname: Lara
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Carlos
authors.initials: C
authors.lastname: Molina
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Erik
authors.initials: E
authors.lastname: Cobo
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Antoni
authors.initials: A
authors.lastname: Dávalos
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Tudor G
authors.initials: TG
authors.lastname: Jovin
authors.affiliation: From the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain (E.L.-C., M.J., A.D.); Stroke Program, Agency for Health Quality and Assessment of Catalonia, Spain (M.S.); Bioclever, Department of Statistics, Barcelona, Spain (N.C.); Hospital Clínic i Provincial, Barcelona, Spain (J.C., L.L.); Hospital Vall d'Hebron, Barcelona, Spain (S.B., C.M.); Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain (L.M.C., B.L.); Statistics and Operations Research, Barcelona-Tech, Spain (E.C.); Stroke Institute, Department of Neurology, UPMC, Pittsburgh, PA (T.G.J.); and Stroke Unit, Hospital Josep Trueta, Girona, Spain (J.S.).
authors.forename: Joaquín
authors.initials: J
authors.lastname: Serena
mesh_terms: D015331:Cohort Studies; D057510:Endovascular Procedures / Q000379:methods / Q000592:standards*; D005260:Female; D006801:Humans; D007407:Interviews as Topic / Q000379:methods / Q000592:standards*; D008297:Male; D012720:Severity of Illness Index; D016037:Single-Blind Method; D020521:Stroke / Q000175:diagnosis* / Q000601:surgery*; D017216:Telemedicine / Q000379:methods / Q000592:standards; D017131:Thrombectomy / Q000379:methods / Q000592:standards; D014741:Video Recording / Q000379:methods / Q000592:standards*
keywords: Rankin; central adjudication; endovascular; odds ratio; stroke trial