Khảo sát các yếu tố ảnh hưởng đến thái độ và rào cản khi tham gia nghiên cứu thử nghiệm lâm sàng của người dân tại thành phố Hồ Chí Minh

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Tác giả: Đức Quỳnh Châu Nguyễn, Thuỵ Bảo Trân Trần, Quang Trung Võ

Ngôn ngữ: vie

Ký hiệu phân loại: 610.7 Education, research, nursing, related topics

Thông tin xuất bản: Tạp chí Y học Việt Nam (Tổng hội Y học Việt Nam), 2023

Mô tả vật lý: 58-63

Bộ sưu tập: Metadata

ID: 502489

Thêm vào giỏ

Clinical trials (CTs) are conducted on humans to evaluate the safety, clinical efficacy, pharmacological effects, pharmacodynamics, and pharmacokinetics of drugs, vaccines, and medical biological products. Objective: This study was aimed at assessing attitudes toward and barriers to participation in CTs among the population of Ho Chi Minh City (HCMc). Methods: A descriptive cross-sectional study was conducted in February 2022 to distribute a questionnaire developed on the basis of previous research. Items were scored on a five-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The collected data were described and analyzed using the Statistical Package for the Social Sciences (version 22.0). Results: There were 581 valid participants, whose overall scores on attitudes and barriers were 72.8 ± 13.9 and 58.6 ± 14.6, respectively. The respondents showed the highest attitudinal score with respect to the item "participation in clinical trials helps develop new medication" (Percentage Mean Score - PMS = 79.2) and the highest barrier-related score with regard to the item "I am afraid of the risks (safety) of participation in clinical trials" (PMS = 73.0). Health status, chronic disease status, and doctor recommendation to join CTs influenced the participants' attitude-related scores, whereas gender, age, education level, marital status, children, and doctor recommendation to join CTs affected their barrier-related scores. Conclusion: HCMc citizens have positive attitudes toward CTs but encounter above-average barriers to such participation. Assessing public attitudes toward and barriers to participating in CTs helps acquire the data and information necessary to design suitable CT models for the Vietnamese population.Nghiên cứu thử nghiệm lâm sàng (NCTNLS) là một nghiên cứu khoa học thực hiện trên người nhằm đánh giá tính an toàn, hiệu quả lâm sàng, tác dụng dược lý, dược lực và dược động học của thuốc, vắc xin, sinh phẩm y tế... Mục tiêu: Khảo sát thái độ và rào cản khi tham gia NCTNLS của người dân Thành phố Hồ Chí Minh (TPHCM). Đối tượng nghiên cứu: Người dân sinh sống tại TPHCM. Phương pháp nghiên cứu: Thiết kế mô tả cắt ngang thực hiện trong tháng 02/2022. Bộ câu hỏi định lượng được thiết kế theo thang Likert 5 điểm, từ "Hoàn toàn không đồng ý - 1" đến "Hoàn toàn đồng ý - 5". Phân tích và xử lý số liệu bằng SPSS 22.0. Kết quả: Ghi nhận 581 người dân TPHCM tham gia nghiên cứu với điểm trung bình thái độ và rào cản lần lượt 72,8 ± 13,9 và 58,6 ± 14,6. Nhận định có điểm số thái độ cao nhất là "Tham gia NCTNLS giúp phát triển thuốc mới" (PMS = 79,2) và "Những rủi ro ảnh hưởng đến sự an toàn khi tham gia NCTNLS" đạt điểm số rào cản cao nhất (PMS = 73,0). Tình trạng sức khoẻ, có/không có bệnh mạn tính và lời khuyên tham gia NCTNLS của bác sĩ liên quan đến thái độ người tham gia. Giới tính, tuổi, trình độ học vấn, tình trạng hôn nhân, con cái và lời khuyên tham gia NCTNLS của bác sĩ liên quan đến rào cản của họ. Kết luận: Người tham gia tại TPHCM có thái độ tích cực đối với NCTNLS song những rào cản tham gia của họ trên trung bình. Khảo sát thái độ và rào cản của người dân với việc tham gia NCTNLS giúp thu thập những thông tin cần thiết để xây dựng mô hình NCTNLS phù hợp người dân Việt Nam.

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