摘要
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Topic:
A Critical Introduction to Stepped Wedge Designs for Mental Health Intervention Research
Abstract:
Stepped wedge designs have gained increasing popularity in clinical intervention research generally, and within the mental health field specifically. This presentation aims to provide a critical introduction to stepped wedge cluster randomized trials (SW-CRTs). Drawing on examples of recent mental health SW-CRTs, we will begin by discussing the fundamental concepts of the stepped wedge design, including its structure, key features, and advantages over traditional randomized controlled trials. We then move on to essential methodological considerations for SW-CRTs, including sample size calculation and mainstream statistical analysis methods specific to stepped wedge designs. We will emphasize the importance of the intracluster correlation coefficient in planning such trials, introduce variations in correlation assumptions, and discuss sources of data that may be available to estimate these values. Additionally, we will describe key ingredients in analytical models for SW-CRTs and discuss their implications for data analysis and reporting. Finally, we will critically appraise the current state of SW-CRTs, emphasizing adherence to reporting guidelines such as the CONSORT extension for SW-CRTs. We will discuss common challenges and pitfalls encountered in the design, implementation, and reporting of these trials, providing recommendations for improving quality and transparency in innovative clinical trial designs for mental health intervention research.
Speaker:
Dr Fan LI
Associate Professor
Department of Biostatistics
School of Public Health
Yale University
U.S.A.
Biography:
Fan Li is an Associate Professor in the Department of Biostatistics at Yale University School of Public Health. He obtained his Biostatistics PhD degree from Duke University in 2019 and joined the Yale faculty since 2019. Dr Li’s research aims to develop statistical methods for designing and analyzing pragmatic clinical trials embedded in the healthcare system, causal inference methods for randomized trials and observational studies. Dr Li’s research has been supported by multiple grants from the United States National Institutes of Health (NIH) and Patient-Centered Outcome Research Institute (PCORI) as the Principal Investigator. He has published over 130 peer-reviewed research articles, and currently serve as the Co-Editor in Chief for Epidemiologic Methods, Associate Editor for Statistics in Medicine, Clinical Trials, and Implementation Science.
