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Article: Optimal design of intervention studies to prevent influenza in healthy cohorts

TitleOptimal design of intervention studies to prevent influenza in healthy cohorts
Authors
KeywordsInfluenza vaccine
Cohort analysis
Infection prevention
Outcome assessment
Pandemic influenza
Issue Date2012
PublisherPublic Library of Science. The Journal's web site is located at http://www.plosone.org/home.action
Citation
Plos One, 2012, v. 7 n. 4 How to Cite?
AbstractBackground: Influenza cohort studies, in which participants are monitored for infection over an epidemic period, are invaluable in assessing the effectiveness of control measures such as vaccination, antiviral prophylaxis and non-pharmaceutical interventions (NPIs). Influenza infections and illnesses can be identified through a number of approaches with different costs and logistical requirements. Methodology and Principal Findings: In the context of a randomized controlled trial of an NPI with a constrained budget, we used a simulation approach to examine which approaches to measuring outcomes could provide greater statistical power to identify an effective intervention against confirmed influenza. We found that for a short epidemic season, the optimal design was to collect respiratory specimens at biweekly intervals, as well as following report of acute respiratory illness (ARI), for virologic testing by reverse transcription polymerase chain reaction (RT-PCR). Collection of respiratory specimens only from individuals reporting ARI was also an efficient design particularly for studies in settings with longer periods of influenza activity. Collection of specimens only from individuals reporting a febrile ARI was less efficient. Collection and testing of sera before and after influenza activity appeared to be inferior to collection of respiratory specimens for RT-PCR confirmation of acute infections. The performance of RT-PCR was robust to uncertainty in the costs and diagnostic performance of RT-PCR and serological tests. Conclusions and Significance: Our results suggest that unless the sensitivity or specificity of serology can be increased RT-PCR will remain as the preferable outcome measure in NPI studies. Routine collection of specimens for RT-PCR testing even when study participants do not report acute respiratory illness appears to be the most cost efficient design under most scenarios. © 2012 Klick et al.
Persistent Identifierhttp://hdl.handle.net/10722/146793
ISSN
2015 Impact Factor: 3.057
2015 SCImago Journal Rankings: 1.395
PubMed Central ID
ISI Accession Number ID
Funding AgencyGrant Number
Harvard Center for Communicable Disease Dynamics from the National Institute of General Medical SciencesU54 GM088558
Hong Kong University Grants CommitteeAoE/M-12/06
Research Grants Council, Hong Kong
JST PRESTO
MedImmune Inc.
Funding Information:

This work received financial support from the Harvard Center for Communicable Disease Dynamics from the National Institute of General Medical Sciences (grant no. U54 GM088558) and the Area of Excellence Scheme of the Hong Kong University Grants Committee (grant no. AoE/M-12/06). BK is supported by a Hong Kong PhD Fellowship from the Research Grants Council, Hong Kong. HN is supported by the JST PRESTO program. The funding bodies were not involved in the collection, analysis and interpretation of data, the writing of the manuscript, or the decision to submit for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of General Medical Sciences or the National Institutes of Health.

References
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DC FieldValueLanguage
dc.contributor.authorKlick, Ben_HK
dc.contributor.authorNishiura, Hen_HK
dc.contributor.authorCowling, BJen_HK
dc.date.accessioned2012-05-14T01:37:59Z-
dc.date.available2012-05-14T01:37:59Z-
dc.date.issued2012en_HK
dc.identifier.citationPlos One, 2012, v. 7 n. 4en_HK
dc.identifier.issn1932-6203en_HK
dc.identifier.urihttp://hdl.handle.net/10722/146793-
dc.description.abstractBackground: Influenza cohort studies, in which participants are monitored for infection over an epidemic period, are invaluable in assessing the effectiveness of control measures such as vaccination, antiviral prophylaxis and non-pharmaceutical interventions (NPIs). Influenza infections and illnesses can be identified through a number of approaches with different costs and logistical requirements. Methodology and Principal Findings: In the context of a randomized controlled trial of an NPI with a constrained budget, we used a simulation approach to examine which approaches to measuring outcomes could provide greater statistical power to identify an effective intervention against confirmed influenza. We found that for a short epidemic season, the optimal design was to collect respiratory specimens at biweekly intervals, as well as following report of acute respiratory illness (ARI), for virologic testing by reverse transcription polymerase chain reaction (RT-PCR). Collection of respiratory specimens only from individuals reporting ARI was also an efficient design particularly for studies in settings with longer periods of influenza activity. Collection of specimens only from individuals reporting a febrile ARI was less efficient. Collection and testing of sera before and after influenza activity appeared to be inferior to collection of respiratory specimens for RT-PCR confirmation of acute infections. The performance of RT-PCR was robust to uncertainty in the costs and diagnostic performance of RT-PCR and serological tests. Conclusions and Significance: Our results suggest that unless the sensitivity or specificity of serology can be increased RT-PCR will remain as the preferable outcome measure in NPI studies. Routine collection of specimens for RT-PCR testing even when study participants do not report acute respiratory illness appears to be the most cost efficient design under most scenarios. © 2012 Klick et al.en_HK
dc.languageeng-
dc.publisherPublic Library of Science. The Journal's web site is located at http://www.plosone.org/home.actionen_HK
dc.relation.ispartofPLoS ONEen_HK
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.subjectInfluenza vaccine-
dc.subjectCohort analysis-
dc.subjectInfection prevention-
dc.subjectOutcome assessment-
dc.subjectPandemic influenza-
dc.titleOptimal design of intervention studies to prevent influenza in healthy cohortsen_HK
dc.typeArticleen_HK
dc.identifier.emailNishiura, H:nishiura@hku.hken_HK
dc.identifier.emailCowling, BJ:bcowling@hku.hken_HK
dc.identifier.authorityNishiura, H=rp01488en_HK
dc.identifier.authorityCowling, BJ=rp01326en_HK
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1371/journal.pone.0035166en_HK
dc.identifier.pmid22514718-
dc.identifier.pmcidPMC3325991-
dc.identifier.scopuseid_2-s2.0-84859710652en_HK
dc.identifier.hkuros199512-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-84859710652&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume7en_HK
dc.identifier.issue4en_HK
dc.identifier.isiWOS:000305341600124-
dc.publisher.placeUnited Statesen_HK
dc.relation.projectControl of Pandemic and Inter-pandemic Influenza-
dc.identifier.scopusauthoridKlick, B=23090620800en_HK
dc.identifier.scopusauthoridNishiura, H=7005501836en_HK
dc.identifier.scopusauthoridCowling, BJ=8644765500en_HK

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