ArticlePrevention science : the official journal of the Society for Prevention Research2024
Sample Size Calculations for Stepped Wedge Designs with Treatment Effects that May Change with the Duration of Time under Intervention.
Article in Prevention science : the official journal of the Society for Prevention Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 8 citations in OpenAlex.
- Using the NIH Research Methods Resources Website.Prevention science : the official journal of the Society for Prevention Research · 2026Article
- CRT-Estimands Framework: consensus based extension of the ICH E9(R1) addendum for cluster randomised trials.BMJ (Clinical research ed.) · 2026Article
- Factors affecting power in stepped wedge trials when the treatment effect varies with time.Trials · 2026Article
- What scientific inferences can be made with randomized implementation rollout trials.Implementation science : IS · 2025Article
- Designing stepped wedge trials to evaluate physical activity interventions in schools: methodological considerations.The international journal of behavioral nutrition and physical activity · 2025Article
- Rollout trial designs in implementation research are often necessary and sometimes preferred.Implementation science : IS · 2025Article
- Improving the design and analytic methods used in NIH-funded clinical trials involving behavioral interventions.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2025Article
- Implementation Research at NHLBI: Methodological and Design Challenges and Lessons Learned from the DECIPHeR Initiative.Ethnicity & disease · 2023Article
Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
Abstract
The stepped wedge design is often used to evaluate interventions as they are rolled out across schools, health clinics, communities, or other clusters. Most models used in the design and analysis of stepped wedge trials assume that the intervention effect is immediate and constant over time following implementation of the intervention (the "exposure time"). This is known as the IT (immediate treatment effect) assumption. However, recent research has shown that using methods based on the IT assumption when the treatment effect varies over exposure time can give extremely misleading results. In this manuscript, we discuss the need to carefully specify an appropriate measure of the treatment effect when the IT assumption is violated and we show how a stepped wedge trial can be powered when it is anticipated that the treatment effect will vary as a function of the exposure time. Specifically, we describe how to power a trial when the exposure time indicator (ETI) model of Kenny et al. (Statistics in Medicine, 41, 4311-4339, 2022) is used and the estimand of interest is a weighted average of the time-varying treatment effects. We apply these methods to the ADDRESS-BP trial, a type 3 hybrid implementation study designed to address racial disparities in health care by evaluating a practice-based implementation strategy to reduce hypertension in African American communities.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.