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Agreement between core laboratory and study investigators for imaging scores in a thrombectomy trial.
Fahed, Robert; Ben Maacha, Malek; Ducroux, Célina; Khoury, Naim; Blanc, Raphaël; Piotin, Michel; Lapergue, Bertrand.
Afiliación
  • Fahed R; Interventional Neuroradiology Unit, Fondation Rothschild Hospital, Paris, France.
  • Ben Maacha M; Research and Biostatistics Unit, Fondation Rothschild Hospital, Paris, France.
  • Ducroux C; Interventional Neuroradiology Unit, Fondation Rothschild Hospital, Paris, France.
  • Khoury N; HSHS Neuroscience Center, HSHS St John's Hospital, Springfield, Illinois, USA.
  • Blanc R; Interventional Neuroradiology Unit, Fondation Rothschild Hospital, Paris, France.
  • Piotin M; Interventional Neuroradiology Unit, Fondation Rothschild Hospital, Paris, France.
  • Lapergue B; Neurovascular Unit, Foch Hospital, Suresnes, France.
J Neurointerv Surg ; 10(12): e30, 2018 Dec.
Article en En | MEDLINE | ID: mdl-29760012
PURPOSE: We aimed to assess the agreement between study investigators and the core laboratory (core lab) of a thrombectomy trial for imaging scores. METHODS: The Alberta Stroke Program Early CT Score (ASPECTS), the European Collaborative Acute Stroke Study (ECASS) hemorrhagic transformation (HT) classification, and the Thrombolysis In Cerebral Infarction (TICI) scores as recorded by study investigators were compared with the core lab scores in order to assess interrater agreement, using Cohen's unweighted and weighted kappa statistics. RESULTS: There were frequent discrepancies between study sites and core lab for all the scores. Agreement for ASPECTS and ECASS HT classification was less than substantial, with disagreement occurring in more than one-third of cases. Agreement was higher on MRI-based scores than on CT, and was improved after dichotomization on both CT and MRI. Agreement for TICI scores was moderate (with disagreement occurring in more than 25% of patients), and went above the substantial level (less than 10% disagreement) after dichotomization (TICI 0/1/2a vs 2b/3). CONCLUSION: Discrepancies between scores assessed by the imaging core lab and those reported by study sites occurred in a significant proportion of patients. Disagreement in the assessment of ASPECTS and day 1 HT scores was more frequent on CT than on MRI. The agreement for the dichotomized TICI score (the trial's primary outcome) was substantial, with less than 10% of disagreement between study sites and core lab. TRIAL REGISTRATION NUMBER: NCT02523261, Post-results.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Médicos / Investigadores / Índice de Severidad de la Enfermedad / Diagnóstico por Imagen / Isquemia Encefálica / Técnicas de Laboratorio Clínico / Accidente Cerebrovascular Tipo de estudio: Diagnostic_studies / Observational_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Neurointerv Surg Año: 2018 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Médicos / Investigadores / Índice de Severidad de la Enfermedad / Diagnóstico por Imagen / Isquemia Encefálica / Técnicas de Laboratorio Clínico / Accidente Cerebrovascular Tipo de estudio: Diagnostic_studies / Observational_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Neurointerv Surg Año: 2018 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido