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. 2020 Oct 7;10(10):e037295.
doi: 10.1136/bmjopen-2020-037295.

The Seattle Flu Study: a multiarm community-based prospective study protocol for assessing influenza prevalence, transmission and genomic epidemiology

Helen Y Chu  1 , Michael Boeckh  2 , Janet A Englund  3 , Michael Famulare  4 , Barry Lutz  5 , Deborah A Nickerson  6   7 , Mark Rieder  7 , Lea M Starita  6   7 , Amanda Adler  8 , Elisabeth Brandstetter  9 , Chris D Frazer  9 , Peter D Han  7 , Reena K Gulati  10 , James Hadfield  9 , Michael Jackson  11 , Anahita Kiavand  9 , Louise E Kimball  2 , Kirsten Lacombe  8 , Kira Newman  9 , Thomas R Sibley  2 , Jennifer K Logue  12 , Victoria Rachel Lyon  13 , Caitlin R Wolf  9 , Monica Zigman Suchsland  14 , Jay Shendure  6   15 , Trevor Bedford  2   6
Affiliations

The Seattle Flu Study: a multiarm community-based prospective study protocol for assessing influenza prevalence, transmission and genomic epidemiology

Helen Y Chu et al. BMJ Open. .

Abstract

Introduction: Influenza epidemics and pandemics cause significant morbidity and mortality. An effective response to a potential pandemic requires the infrastructure to rapidly detect, characterise, and potentially contain new and emerging influenza strains at both an individual and population level. The objective of this study is to use data gathered simultaneously from community and hospital sites to develop a model of how influenza enters and spreads in a population.

Methods and analysis: Starting in the 2018-2019 season, we have been enrolling individuals with acute respiratory illness from community sites throughout the Seattle metropolitan area, including clinics, childcare facilities, Seattle-Tacoma International Airport, workplaces, college campuses and homeless shelters. At these sites, we collect clinical data and mid-nasal swabs from individuals with at least two acute respiratory symptoms. Additionally, we collect residual nasal swabs and data from individuals who seek care for respiratory symptoms at four regional hospitals. Samples are tested using a multiplex molecular assay, and influenza whole genome sequencing is performed for samples with influenza detected. Geospatial mapping and computational modelling platforms are in development to characterise the regional spread of influenza and other respiratory pathogens.

Ethics and dissemination: The study was approved by the University of Washington's Institutional Review Board (STUDY00006181). Results will be disseminated through talks at conferences, peer-reviewed publications and on the study website (www.seattleflu.org).

Keywords: influenza; protocol; respiratory infection; surveillance; virology.

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Conflict of interest statement

Competing interests: HYC receives research support from Sanofi, Cepheid and Genentech/Roche and is a consultant for Merck. JAE receives research support to her institution from AstraZeneca, GlaxoSmithKline, Merck and Novavax and is a consultant for Sanofi Pasteur and Meissa Vaccines.

Figures

Figure 1
Figure 1
Outline of participant flow for different arms of the Seattle Flu Study. EMR, electronic medical record; HIPAA, Health Insurance Portability and Accountability Act; HH, household; LAR, legally authorised representative; RA, research assistant; sx, symptoms. Active clinical surveillance arm not included in figure. For methods, see Prevention USCfDCa. FluView and Prevention USCfDCa. FluView and Fong et al.
Figure 2
Figure 2
Documentation of written, informed consent by age of participant in the community cross-sectional, and prospective clinical and childcare cohorts of the Seattle Flu Study. If the participant is unable to provide informed consent due to cognitive impairment or because they have not attained the legal age for consent, a legally authorised representative (LAR) may sign the consent form on their behalf. Participants enrolled by Seattle Children’s Hospital staff or participants enrolled into the prospective clinical cohort sign a Health Insurance Portability and Accountability Act (HIPAA) authorisation in addition to the main consent.
Figure 3
Figure 3
Laboratory pipeline for samples included in the Seattle Flu Study from time of collection through sequencing. CT, cycle threshold; EV-D68, enterovirus D68.
See this image and copyright information in PMC

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