Fang Juanzhi, Bruce Wirta Sara, Kahler Kristijan
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Novartis Sverige AB, S-183 79 Taby, Sweden.
J Health Econ Outcomes Res. 2017 Apr 24;5(1):27-38. doi: 10.36469/9796. eCollection 2017.
Well established guidelines already exist that address best practices for Non-Interventional Study (NIS) design and methods. These guidelines provide advice on things to consider while designing a study and developing a protocol, but do not necessarily capture specific details related to the implementation of NIS. The intent of this paper is to propose a best practice for conducting secondary use of data NIS. We propose that the ideal implementation of a NIS should include the development of a strong Study Concept, followed by a detailed Protocol, Analysis Plan, Report, and considerations for Dissemination. We review and discuss common mistakes/pitfalls and key considerations at each step from concept to publication. In many cases in this review, we have also provided suggestions or accessible resources that researchers can apply as a "best practices" guide when planning, conducting, or reviewing this investigative method.
已经存在完善的指南，涉及非干预性研究（NIS）设计和方法的最佳实践。这些指南就研究设计和制定方案时需要考虑的事项提供建议，但不一定涵盖与NIS实施相关的具体细节。本文旨在提出对NIS数据进行二次使用的最佳实践。我们建议，NIS的理想实施应包括制定强有力的研究概念，随后是详细的方案、分析计划、报告以及传播方面的考虑。我们回顾并讨论了从概念到发表每个步骤中的常见错误/陷阱和关键考虑因素。在本次综述的许多案例中，我们还提供了建议或可获取的资源，研究人员在规划、开展或审查这种调查方法时可将其作为“最佳实践”指南来应用。
