A new four-arm within-study comparison: Design, implementation, and data.

Observational studies Pub Date : 2025-06-25 eCollection Date: 2025-01-01 DOI:10.1353/obs.2025.a963647
Bryan Keller, Vivian C Wong, Sangbaek Park, Jingru Zhang, Patrick Sheehan, Peter M Steiner
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Abstract

Within-study comparisons (WSCs) use real, rather than simulated, data to compare estimates from observational studies against benchmarks from randomized controlled trials (RCTs). A primary goal of WSCs is to assess whether well-designed quasi-experimental designs (QEDs) can produce internally valid causal effect estimates comparable to those from RCTs. In this paper, we describe the design and implementation of a new type of WSC. Motivated by Shadish et al. (2008), we examine the impact of a mathematics training intervention and a vocabulary study session on posttest scores for mathematics and vocabulary, respectively. We extend the original design in three ways. First, before random assignment, we ask participants to express a preference for either the mathematics or vocabulary training session, after which they are randomly assigned regardless of preferences. This allows us to experimentally identify and estimate the overall average treatment effect (ATE) and two conditional ATEs: the average treatment effect on the treated (ATT) and the average treatment effect on the untreated (ATU). Second, participant recruitment and sample size (N = 2200) were determined through power analyses for comparing RCT and QED estimates, ensuring sufficient power for methodological comparisons. Finally, the study's eligibility criteria, recruitment, treatment allocation, and analysis plan were preregistered on the Open Science Foundation platform, and the data are publicly accessible. We believe that this WSC design and the resulting data set will be valuable for researchers seeking to evaluate causal inference methods and test identification assumptions using real-world data.

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一种新的四臂研究内比较:设计、实施和数据。
研究内比较(WSCs)使用真实而非模拟的数据来比较观察性研究的估计值与随机对照试验(rct)的基准。WSCs的一个主要目标是评估设计良好的准实验设计(qed)是否能产生与随机对照试验相当的内部有效因果效应估计。本文描述了一种新型WSC的设计与实现。受Shadish et al.(2008)的启发,我们分别研究了数学训练干预和词汇学习课程对数学和词汇后测分数的影响。我们从三个方面扩展了原来的设计。首先,在随机分配之前,我们要求参与者表达对数学或词汇训练课程的偏好,之后他们被随机分配,而不考虑偏好。这使我们能够通过实验确定和估计总体平均治疗效果(ATE)和两个条件ATE:对被治疗者的平均治疗效果(ATT)和对未治疗者的平均治疗效果(ATU)。其次,通过比较RCT和QED估计的功率分析确定参与者招募和样本量(N = 2200),以确保方法学比较有足够的功率。最后,研究的资格标准、招募、治疗分配和分析计划在开放科学基金会平台上进行预注册,数据可公开访问。我们相信,这种WSC设计和由此产生的数据集对于寻求评估因果推理方法和使用现实世界数据测试识别假设的研究人员来说是有价值的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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