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Comment
. 2016 Sep 1;184(5):354-6.
doi: 10.1093/aje/kww063.

Invited Commentary: Beware the Test-Negative Design

Daniel Westreich, Michael G Hudgens
Comment

Invited Commentary: Beware the Test-Negative Design

Daniel Westreich et al. Am J Epidemiol. .

Abstract

In this issue of the Journal, Sullivan et al. (Am J Epidemiol. 2016;184(5):345-353) carefully examine the theoretical justification for use of the test-negative design, a common observational study design, in assessing the effectiveness of influenza vaccination. Using modern causal inference methods (in particular, directed acyclic graphs), they describe different threats to the validity of inferences drawn about the effect of vaccination from test-negative design studies. These threats include confounding, selection bias, and measurement error in either the exposure or the outcome. While confounding and measurement error are common in observational studies, the potential for selection bias inherent in the test-negative design brings into question the validity of inferences drawn from such studies.

Keywords: confounding; epidemiologic methods; influenza vaccine; selection bias; test-negative study design.

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Comment in

  • RE: "INVITED COMMENTARY: BEWARE THE TEST-NEGATIVE DESIGN".
    Ferdinands JM, Foppa IM, Fry AM, Flannery BL, Belongia EA, Jackson ML. Ferdinands JM, et al. Am J Epidemiol. 2017 Apr 1;185(7):613. doi: 10.1093/aje/kww227. Am J Epidemiol. 2017. PMID: 28338844 No abstract available.
  • THE AUTHORS REPLY.
    Westreich D, Hudgens MG. Westreich D, et al. Am J Epidemiol. 2017 Apr 1;185(7):614-615. doi: 10.1093/aje/kww228. Am J Epidemiol. 2017. PMID: 28338885 Free PMC article. No abstract available.

Comment on

References

    1. Sullivan SG, Tchetgen Tchetgen EJ, Cowling BJ. Theoretical basis of the test-negative study design for assessment of influenza vaccine effectiveness. Am J Epidemiol. 2016;1845:345–353. - PMC - PubMed
    1. Food and Drug Administration, US Department of Health and Human Services. FDA Briefing Document. Vaccines and Related Biological Products Advisory Committee Meeting. May 12, 2015. Licensure of Ebola Vaccines: Demonstration of Effectiveness. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMateria... Washington, DC: Food and Drug Administration; 2015. Accessed August 2, 2016.
    1. Jackson ML, Nelson JC. The test-negative design for estimating influenza vaccine effectiveness. Vaccine. 2013;3117:2165–2168. - PubMed
    1. Greenland S, Robins JM, Pearl J. Confounding and collapsibility in causal inference. Stat Sci. 1999;141:29–46.
    1. Graf E, Schumacher M. Comments on ‘The performance of different propensity score methods for estimating marginal odds ratios’ [letter] Stat Med. 2008;2719:3915–3917. - PubMed