数据的二次使用:非干预性研究规划和协议开发的最佳实践
Juanzhi Fang1, Sara Bruce Wirta2, Kristijan Kahler1
1Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Journal of health economics and outcomes research
|September 4, 2023
概括
本文提出了进行二次数据使用非干预性研究 (NIS) 的最佳实践. 它概述了从概念到传播的理想实施过程,为避免NIS研究中常见的陷提供了指导.
科学领域:
- 健康研究方法的方法论.
- 制药科学 制药科学
- 流行病学 流行病学
背景情况:
- 现有的指导方针涉及非干预性研究 (NIS) 设计,但缺乏具体的实施细节.
- 在NIS中对数据的二次使用需要定制的最佳实践,以实现有效执行.
研究的目的:
- 提出一个最佳实践框架,用于使用二次数据进行非干预性研究 (NIS).
- 为研究人员提供规划,执行和审查NIS的指南.
主要方法:
- 该研究提出了NIS实施的结构化方法:研究概念,协议,分析计划,报告和传播.
- 它在NIS过程的每个阶段审查了常见的错误和关键考虑因素.
主要成果:
- 介绍了NIS二次数据使用的综合最佳实践模型.
- 为NIS生命周期的每个阶段提供了可访问的资源和建议.
结论:
- 遵守建议的最佳实践可以提高二次数据使用NIS的质量和可靠性.
- 该框架作为旨在改善NIS行为和结果的研究人员的实用指南.
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