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Estimands and inference in cluster-randomized vaccine trials.

Publication ,  Journal Article
Kilpatrick, KW; Hudgens, MG; Halloran, ME
Published in: Pharmaceutical statistics
September 2020

Cluster-randomized trials are often conducted to assess vaccine effects. Defining estimands of interest before conducting a trial is integral to the alignment between a study's objectives and the data to be collected and analyzed. This paper considers estimands and estimators for overall, indirect, and total vaccine effects in trials, where clusters of individuals are randomized to vaccine or control. The scenario is considered where individuals self-select whether to participate in the trial, and the outcome of interest is measured on all individuals in each cluster. Unlike the overall, indirect, and total effects, the direct effect of vaccination is shown in general not to be estimable without further assumptions, such as no unmeasured confounding. An illustrative example motivated by a cluster-randomized typhoid vaccine trial is provided.

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Published In

Pharmaceutical statistics

DOI

EISSN

1539-1612

ISSN

1539-1604

Publication Date

September 2020

Volume

19

Issue

5

Start / End Page

710 / 719

Related Subject Headings

  • Typhoid-Paratyphoid Vaccines
  • Statistics & Probability
  • Research Design
  • Randomized Controlled Trials as Topic
  • Patient Selection
  • Humans
  • Data Interpretation, Statistical
  • Confounding Factors, Epidemiologic
  • Cluster Analysis
  • 4905 Statistics
 

Citation

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Kilpatrick, K. W., Hudgens, M. G., & Halloran, M. E. (2020). Estimands and inference in cluster-randomized vaccine trials. Pharmaceutical Statistics, 19(5), 710–719. https://doi.org/10.1002/pst.2026
Kilpatrick, Kayla W., Michael G. Hudgens, and M Elizabeth Halloran. “Estimands and inference in cluster-randomized vaccine trials.Pharmaceutical Statistics 19, no. 5 (September 2020): 710–19. https://doi.org/10.1002/pst.2026.
Kilpatrick KW, Hudgens MG, Halloran ME. Estimands and inference in cluster-randomized vaccine trials. Pharmaceutical statistics. 2020 Sep;19(5):710–9.
Kilpatrick, Kayla W., et al. “Estimands and inference in cluster-randomized vaccine trials.Pharmaceutical Statistics, vol. 19, no. 5, Sept. 2020, pp. 710–19. Epmc, doi:10.1002/pst.2026.
Kilpatrick KW, Hudgens MG, Halloran ME. Estimands and inference in cluster-randomized vaccine trials. Pharmaceutical statistics. 2020 Sep;19(5):710–719.
Journal cover image

Published In

Pharmaceutical statistics

DOI

EISSN

1539-1612

ISSN

1539-1604

Publication Date

September 2020

Volume

19

Issue

5

Start / End Page

710 / 719

Related Subject Headings

  • Typhoid-Paratyphoid Vaccines
  • Statistics & Probability
  • Research Design
  • Randomized Controlled Trials as Topic
  • Patient Selection
  • Humans
  • Data Interpretation, Statistical
  • Confounding Factors, Epidemiologic
  • Cluster Analysis
  • 4905 Statistics