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《将患者报告结局纳入临床研究的伦理考量:PROs伦理指南》解读

Interpretation of “Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research (The PRO Ethics Guidelines)”

摘要:患者报告结局(Patient-Reported Outcomes ,PROs)可以为医疗决策、卫生政策的制定提供证据,还可作为症状监测的参考指标,以便为个人提供及时的、个性化的医疗照护。随着PROs在临床研究中的广泛应用,一些与之相关的伦理问题受到广泛关注。PROs伦理指南是基于专家共识、专门从伦理角度出发修订的,目的在于为临床研究中PROs内容的伦理考量提供重要参考依据。优化PROs临床研究的伦理问题能够提高PROs的数据质量,同时最大限度地减少受试者的风险、负担和伤害,保护受试者和研究人员的权益。

英文摘要:Patient-reported outcomes (PROs) can provide strong evidence for medical decision making, health policy development, and also serve as a benchmark for monitoring symptoms when provide timely and personalized medical care to participants. With the widespread applications of PROs in clinical research, ethical issues have received deeply attention. This guideline was established to develop an international, consensus-based reference for clinical research that focuses on the ethical considerations of PROs. Addressing ethical issues in PROs can improve the quality of PROs data while minimizing the risk, burden, and harm to patients and protecting the rights of participants and investigators in clinical research.

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[V1] 2022-08-17 18:39:32 chinaXiv:202208.00097V1 下载全文
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