Speroff Theodore, O'Connor Gerald T
Department of Medicine and Preventive Medicine, Center for Health Services Research, Vanderbilt University Medical Center, Nashville, Tenn. 37232, USA.
Qual Manag Health Care. 2004 Jan-Mar;13(1):17-32. doi: 10.1097/00019514-200401000-00002.
The purpose of this article is to discuss strengths and weaknesses of quasi-experimental designs used in health care quality improvement research. The target groups for this article are investigators in plan-do-study-act (PDSA) quality improvement initiatives who wish to improve the rigor of their methodology and publish their work and reviewers who evaluate the quality of research proposals or published work.
A primary purpose of PDSA quality improvement research is to establish a functional relationship between process changes in systems of health care and variation in outcomes. The time series design is the fundamental paradigm for demonstrating such functional relationships. The rigor of a PDSA quality improvement study design is strengthened using replication schemes and research methodology to address extraneous factors that weaken validity of observational studies.
The design of PDSA quality improvement research should follow from the purpose and context of the project. Improving the rigor of the quality improvement literature will build a stronger foundation and more convincing justification for the study and practice of quality improvement in health care.
本文旨在探讨医疗质量改进研究中使用的准实验设计的优点和缺点。本文的目标群体是参与计划-实施-研究-改进（PDSA）质量改进计划的研究人员，他们希望提高其方法的严谨性并发表其研究成果，以及评估研究提案或已发表作品质量的评审人员。
PDSA质量改进研究的主要目的是在医疗保健系统的过程变化与结果差异之间建立功能关系。时间序列设计是证明这种功能关系的基本范式。通过复制方案和研究方法来解决削弱观察性研究有效性的外部因素，从而加强PDSA质量改进研究设计的严谨性。
PDSA质量改进研究的设计应基于项目的目的和背景。提高质量改进文献的严谨性将为医疗保健质量改进的研究和实践建立更坚实的基础和更有说服力的依据。
