Center for Health Outcomes, Policy, and Evaluation Studies, Center for Clinical and Translational Science, College of Public Health, The Ohio State University, 174 18th Avenue, Columbus, OH 43210, USA.
J Investig Med. 2009 Oct;57(7):748-55. doi: 10.2310/JIM.0b013e3181b91b3a.
Lean and Six Sigma are business management strategies commonly used in production industries to improve process efficiency and quality. During the past decade, these process improvement techniques increasingly have been applied outside the manufacturing sector, for example, in health care and in software development. This article concerns the potential use of Lean and Six Sigma in improving the processes involved in clinical and translational research. Improving quality, avoiding delays and errors, and speeding up the time to implementation of biomedical discoveries are prime objectives of the National Institutes of Health (NIH) Roadmap for Medical Research and the NIH's Clinical and Translational Science Award program.
This article presents a description of the main principles, practices, and methods used in Lean and Six Sigma. Available literature involving applications of Lean and Six Sigma to health care, laboratory science, and clinical and translational research is reviewed. Specific issues concerning the use of these techniques in different phases of translational research are identified.
Examples of Lean and Six Sigma applications that are being planned at a current Clinical and Translational Science Award site are provided, which could potentially be replicated elsewhere. We describe how different process improvement approaches are best adapted for particular translational research phases.
Lean and Six Sigma process improvement methods are well suited to help achieve NIH's goal of making clinical and translational research more efficient and cost-effective, enhancing the quality of the research, and facilitating the successful adoption of biomedical research findings into practice.
精益和六西格玛是生产行业中常用的商业管理策略，用于提高流程效率和质量。在过去的十年中，这些流程改进技术越来越多地应用于制造业以外的领域，例如医疗保健和软件开发。本文关注的是精益和六西格玛在改善临床和转化研究中所涉及的流程的潜在用途。提高质量、避免延误和错误，并加快生物医学发现的实施速度是美国国立卫生研究院（NIH）医学研究路线图和 NIH 临床和转化科学奖计划的主要目标。
本文介绍了精益和六西格玛中使用的主要原则、实践和方法。回顾了涉及精益和六西格玛在医疗保健、实验室科学以及临床和转化研究中的应用的现有文献。确定了在转化研究的不同阶段使用这些技术的具体问题。
提供了当前临床和转化科学奖现场正在计划的精益和六西格玛应用示例，这些示例可能在其他地方得到复制。我们描述了不同的流程改进方法如何最适合特定的转化研究阶段。
精益和六西格玛流程改进方法非常适合帮助美国国立卫生研究院实现使临床和转化研究更高效、更具成本效益、提高研究质量以及促进将生物医学研究成果成功应用于实践的目标。
