Department of Epidemiology and Biostatistics, University of California, San Francisco, California 94110, USA; email:
Department of Medicine, Division of General Internal Medicine at Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco, California 94110, USA.
Annu Rev Public Health. 2018 Apr 1;39:5-25. doi: 10.1146/annurev-publhealth-040617-014128. Epub 2018 Jan 12.
Interventional researchers face many design challenges when assessing intervention implementation in real-world settings. Intervention implementation requires holding fast on internal validity needs while incorporating external validity considerations (such as uptake by diverse subpopulations, acceptability, cost, and sustainability). Quasi-experimental designs (QEDs) are increasingly employed to achieve a balance between internal and external validity. Although these designs are often referred to and summarized in terms of logistical benefits, there is still uncertainty about (a) selecting from among various QEDs and (b) developing strategies to strengthen the internal and external validity of QEDs. We focus here on commonly used QEDs (prepost designs with nonequivalent control groups, interrupted time series, and stepped-wedge designs) and discuss several variants that maximize internal and external validity at the design, execution and implementation, and analysis stages.
介入研究人员在评估真实环境中的干预措施实施情况时面临许多设计挑战。干预措施的实施需要在坚持内部有效性需求的同时,纳入外部有效性考虑因素(例如不同亚人群的接受程度、可接受性、成本和可持续性)。准实验设计(QED)越来越多地被用来在内部和外部有效性之间取得平衡。虽然这些设计通常是根据逻辑上的优势来描述和总结的,但对于(a)在各种 QED 中进行选择,以及(b)制定策略来加强 QED 的内部和外部有效性,仍然存在不确定性。我们在这里重点介绍常用的 QED(无前测对照组的前后设计、时间序列中断设计和阶跃楔形设计),并讨论了在设计、执行和实施以及分析阶段最大限度地提高内部和外部有效性的几种变体。