期刊
CIRUGIA ESPANOLA
卷 101, 期 11, 页码 755-764出版社
ELSEVIER ESPANA SLU
DOI: 10.1016/j.ciresp.2023.02.024
关键词
Multicenter clinical study; Infrequent carcinoma; Data-manager; Protocolization; Concordance; Database
类别
This study aims to analyze the concordance and reliability of data protocolization in multicenter clinical studies. The results show that the centralized data protocolization by a data-manager presents similar results to the direct protocolization in the center of origin.
Introduction: In multicenter studies, the protocolization of data is a critical phase that can generate biases. The objective is to analyze the concordance and reliability of the data obtained in a clinical multicenter study between the protocolization in the center of origin and the centralized protocolization of the data by a data-manager. Methods: National multicenter clinical study about an infrequent carcinoma. A double protocolization of the data is carried out: (i) center of origin; and (ii) centralized by a data manager. The concordance between the data is analyzed for the global data and for the two groups of the project: (i) study group (familiar carcinoma, 30 researchers protocolize); (ii) control group (sporadic carcinoma, 4 people protocolize). Interobserver variability is evaluated using Cohen's kappa coefficient. Results: The study includes a total of 689 patients with carcinoma: 252 in the study group and 437 in the control group. Regarding the concordance analysis of the tumor stage, 2.5% of disagreements were observed and the concordance between people who protocolize was near perfect (Kappa = 0.931). Regarding the evaluation of the recurrence risk, disagreements occurred in 7% of the cases and the concordance was near perfect (Kappa = 0.819). Regarding the sonography evaluation (TIRADS), the disagreements were 6.9% and the concordance was near perfect (Kappa = 0.922). Also, 4.6% of transcription errors were detected. Conclusions: In multicenter clinical studies, the centralized data protocolization by a data-manager seems to present similar results to the direct protocolization in the database in the center of origin. (c) 2023 AEC. Published by Elsevier Espana, S.L.U. All rights reserved.
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