Evidence map›Paper›PMID 34488848›Full record

ArticleTrials2021

Power and sample size calculation for stepped-wedge designs with discrete outcomes.

Fan Xia, James P Hughes, Emily C Voldal, Patrick J Heagerty

Abstract read
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. A Cross-Sectional, Questionnaire-Based Survey on Air Infection Control among Romanian People.International journal of environmental research and public health · 2022
    Article
  16. Article
  17. Article
  18. Article
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Fan XiaNational Alzheimer's Coordinating Center, University of Washington, Seattle, WA, USA. fanxia@uw.edu.ORCID http://orcid.org/0000-0002-2435-794X
James P HughesDepartment of Biostatistics, University of Washington, Seattle, WA, USA.
Emily C VoldalDepartment of Biostatistics, University of Washington, Seattle, WA, USA.
Patrick J HeagertyDepartment of Biostatistics, University of Washington, Seattle, WA, USA.

Funding

STATISTICAL ISSUES IN AIDS RESEARCHR37AI029168 · NIAID · UNIVERSITY OF WASHINGTON · PI JAMES P HUGHES · 1999 to 2026
$9.8M
STATISTICAL ISSUES IN AIDS RESEARCHR01AI029168 · NIAID · UNIVERSITY OF WASHINGTON · PI HUGHES, JAMES P · 1989 to 2018
$5.3M
Foundation for the National Institutes of Health AI29168NIAID NIH HHS R01 AI029168NIAID NIH HHS R37 AI029168Patient-Centered Outcomes Research Institute ME-1507-31750
6 · The paper itself

Abstract

backgroundStepped-wedge designs (SWD) are increasingly used to evaluate the impact of changes to the process of care within health care systems. However, to generate definitive evidence, a correct sample size calculation is crucial to ensure such studies are properly powered. The seminal work of Hussey and Hughes (Contemp Clin Trials 28(2):182-91, 2004) provides an analytical formula for power calculations with normal outcomes using a linear model and simple random effects. However, minimal development and evaluation have been done for power calculation with non-normal outcomes on their natural scale (e.g., logit, log). For example, binary endpoints are common, and logistic regression is the natural multilevel model for such clustered data.

methodsWe propose a power calculation formula for SWD with either normal or non-normal outcomes in the context of generalized linear mixed models by adopting the Laplace approximation detailed in Breslow and Clayton (J Am Stat Assoc 88(421):9-25, 1993) to obtain the covariance matrix of the estimated parameters.

resultsWe compare the performance of our proposed method with simulation-based sample size calculation and demonstrate its use on a study of patient-delivered partner therapy for STI treatment and a study that assesses the impact of providing additional benchmark prevalence information in a radiologic imaging report. To facilitate adoption of our methods we also provide a function embedded in the R package "swCRTdesign" for sample size and power calculation for multilevel stepped-wedge designs.

conclusionsOur method requires minimal computational power. Therefore, the proposed procedure facilitates rapid dynamic updates of sample size calculations and can be used to explore a wide range of design options or assumptions.

Indexed as

Research DesignComputer SimulationHumansSample SizeMinimal computational powerNon-normal outcomesPower calculationStepped-wedge designs

Identifiers

PMID34488848
PMCPMC8419932

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.