Việt hóa và đánh giá độ tin cậy thang điểm roussel uclaf causality assessment method (RUCAM) trong tầm soát tổn thương gan do thuốc

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Tác giả: Hà Xuân Sơn Lê, Chí Công Mai, Diệu Minh Nguyễn, Ngọc Quý Nguyễn, Nữ Phương Thảo Nguyễn, Hồng Thắm Phạm, Phương Hạnh Phạm, Mạnh Hùng Trần, Minh Hoàng Trần

Ngôn ngữ: vie

Ký hiệu phân loại: 543.4 Electrochemical analysis

Thông tin xuất bản: Tạp chí Y học Việt Nam (Tổng hội Y học Việt Nam), 2022

Mô tả vật lý: 400-411

Bộ sưu tập: Metadata

ID: 500703

Thêm vào giỏ

Nghiên cứu tiến hành Việt hóa thang Roussel Uclaf Causality Assessment Method (RUCAM) và đánh giá độ tin cậy của bản dịch trong việc xác định tình trạng tổn thương gan do thuốc (DILI). Đối tượng và phương pháp nghiên cứu: Thang RUCAM, bao gồm hai bảng câu hỏi với bảy tiêu chí đánh giá tổn thương tế bào gan và tổn thương ứ mật hoặc hỗn hợp, được Việt hóa dựa trên hướng dẫn chuyển ngữ của Beaton và cộng sự. Độ tin cậy của bản dịch chính thức được đánh giá bằng phép kiểm test-retest trên bệnh nhân nội trú có tổn thương gan điều trị tại Bệnh viện Nhân Dân Gia Định từ ngày 01/01/2019 đến 31/12/2020. Thang đo được xem là đạt độ tin cậy nếu giá trị intraclass correlation coefficients (ICCs) ≥ 0,6. Kết quả: : Qua năm giai đoạn (dịch thuận, tổng hợp, dịch ngược, đánh giá của hội đồng chuyên gia và kiểm tra thử), thang RUCAM đã được chuyển ngữ phù hợp với văn hóa người Việt Nam, với 97,9% tình nguyện viên đồng tình với cách diễn đạt dễ hiểu của bản dịch. Kết quả đánh giá trên 30 hồ sơ bệnh án của bệnh nhân nội trú có tổn thương gan cho thấy độ tin cậy tốt của thang RUCAM tiếng Việt (ICC=0,874
95% CI: 0,749-0,938). Kết luận: Thang RUCAM tiếng Việt, gồm hai bảng câu hỏi với bảy tiêu chí đánh giá tổn thương tế bào gan và tổn thương ứ mật hoặc hỗn hợp, có độ tin cậy tốt để tầm soát DILI trên bệnh nhân Việt Nam.This research aimed to translate the Roussel Uclaf Causality Assessment Method (RUCAM) scale into Vietnamese and evaluate the reliability of this translation on causality assessment of drug-induced liver injury (DILI). Methods: The Vietnamese translation of the RUCAM scale, including two seven-criterion questionnaires for hepatocellular injury and cholestatic or mixed injury, was based on the guidelines for cross-cultural adaptation proposed by Beaton et al. The reliability of the official version was evaluated by test-retest on inpatients with liver damage at Nhan Dan Gia Dinh Hospital, from January 1st, 2019 to January 31st, 2020. The scale was considered reliable given the intraclass correlation coefficients (ICCs) value ≥ 0.6. Results: Through five stages of translation, synthesis, back translation, expert review, and pre-testing, the complete translation of the RUCAM scale was cross-culturally adapted to the Vietnamese culture, with 97.9% reports of easily understood expressions. Results from test- retest on 30 medical records of inpatients with liver injury indicated good reliability of this Vietnamese RUCAM scale (ICC=0.874, 95% CI: 0.749-0.938). Conclusion: The cross-culturally adapted Vietnamese RUCAM scale, with two sevencriterion questionnaires each assessing hepatocellular injury and cholestatic or mixed injury, has shown good reliability in screening Vietnamese patients for DILI.

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