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Hướng dẫn báo cáo cho nghiên cứu mô phỏng trong chăm sóc sức khỏe: mở rộng cho các tuyên bố CONSORT và STROBE
Tóm tắt
Nghiên cứu dựa trên mô phỏng (SBR) đang mở rộng nhanh chóng nhưng chất lượng báo cáo cần được cải thiện. Để một độc giả có thể đánh giá một nghiên cứu một cách nghiêm túc, các yếu tố của nghiên cứu cần được báo cáo rõ ràng. Mục tiêu của chúng tôi là phát triển các hướng dẫn báo cáo cho SBR bằng cách tạo ra các mở rộng cho các Tiêu chuẩn Tích hợp về Báo cáo Thử nghiệm (CONSORT) và Tăng cường Báo cáo Các Nghiên cứu Quan sát trong Dịch tễ học (STROBE). Một quy trình xây dựng sự đồng thuận theo từng bước lặp đi lặp lại đã được sử dụng dựa trên các bước được khuyến nghị để phát triển các hướng dẫn báo cáo. Quy trình đồng thuận bao gồm các bước sau: (1) phát triển một ủy ban chỉ đạo, (2) xác định phạm vi của các hướng dẫn báo cáo, (3) xác định một hội đồng đồng thuận, (4) tạo danh sách các mục để thảo luận thông qua khảo sát trực tuyến trước cuộc họp, (5) tiến hành một cuộc họp đồng thuận, và (6) soạn thảo các hướng dẫn báo cáo kèm theo tài liệu giải thích và mở rộng. Có 11 mở rộng được khuyến nghị cho CONSORT: mục 1 (tiêu đề/tóm tắt), mục 2 (bối cảnh), mục 5 (can thiệp), mục 6 (kết quả), mục 11 (mù hóa), mục 12 (phương pháp thống kê), mục 15 (dữ liệu cơ bản), mục 17 (kết quả/ước tính), mục 20 (giới hạn), mục 21 (khả năng tổng quát), và mục 25 (tài trợ). Có 10 mở rộng được khuyến nghị cho STROBE: mục 1 (tiêu đề/tóm tắt), mục 2 (bối cảnh/lý do), mục 7 (các biến), mục 8 (nguồn dữ liệu/đo lường), mục 12 (phương pháp thống kê), mục 14 (dữ liệu mô tả), mục 16 (kết quả chính), mục 19 (giới hạn), mục 21 (khả năng tổng quát), và mục 22 (tài trợ). Một tài liệu mở rộng đã được tạo ra để cung cấp ví dụ và giải thích cho từng mở rộng. Chúng tôi đã phát triển các mở rộng cho các Tuyên bố CONSORT và STROBE có thể giúp cải thiện chất lượng báo cáo cho SBR (Sim Healthcare 00:00-00, 2016).
Từ khóa
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