Cluster randomized test-negative design (CR-TND) trials: a novel and efficient method to assess the efficacy of community level dengue interventions
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Published version
Author(s)
Type
Journal Article
Abstract
Cluster randomized trials are the gold standard for assessing efficacy of community-level interventions, such as vector control strategies against dengue. We describe a novel cluster randomized trial methodology with a test-negative design, which offers advantages over traditional approaches. It utilizes outcome-based sampling of patients presenting with a syndrome consistent with the disease of interest, who are subsequently classified as test-positive cases or test-negative controls on the basis of diagnostic testing. We use simulations of a cluster trial to demonstrate validity of efficacy estimates under the test-negative approach. This demonstrates that, provided study arms are balanced for both test-negative and test-positive illness at baseline and that other test-negative design assumptions are met, the efficacy estimates closely match true efficacy. We also briefly discuss analytical considerations for an odds ratio-based effect estimate arising from clustered data, and outline potential approaches to analysis. We conclude that application of the test-negative design to certain cluster randomized trials could increase their efficiency and ease of implementation.
Date Issued
2018-09-01
Date Acceptance
2018-04-27
Citation
American Journal of Epidemiology, 2018, 187 (9), pp.2021-2028
ISSN
1476-6256
Publisher
Oxford University Press
Start Page
2021
End Page
2028
Journal / Book Title
American Journal of Epidemiology
Volume
187
Issue
9
Copyright Statement
© 2018 The Author(s). Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Sponsor
Medical Research Council (MRC)
Bill & Melinda Gates Foundation
National Institute for Health Research
Medical Research Council (MRC)
Grant Number
MR/K010174/1B
OPP1092240
HPRU-2012-10080
MR/R015600/1
Subjects
Science & Technology
Life Sciences & Biomedicine
Public, Environmental & Occupational Health
case-control
cluster-randomized trial
dengue
efficacy
odds ratio
study design
test-negative design
Wolbachia
INFLUENZA VACCINE EFFECTIVENESS
RARE DISEASE ASSUMPTION
COMMON DISEASES
TRANSMISSION
POPULATIONS
ADJUSTMENT
WOLBACHIA
INFERENCE
COHORT
Epidemiology
11 Medical and Health Sciences
01 Mathematical Sciences
Publication Status
Published
Date Publish Online
2018-05-07