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Defining Clinical Malaria: The Specificity and Incidence of Endpoints from Active and Passive Surveillance of Children in Rural Kenya

BACKGROUND: Febrile malaria is the most common clinical manifestation of P. falciparum infection, and is often the primary endpoint in clinical trials and epidemiological studies. Subjective and objective fevers are both used to define the endpoint, but have not been carefully compared, and the rela...

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Autores principales: Olotu, Ally, Fegan, Gregory, Williams, Thomas N., Sasi, Philip, Ogada, Edna, Bauni, Evasius, Wambua, Juliana, Marsh, Kevin, Borrmann, Steffen, Bejon, Philip
Formato: Texto
Lenguaje:English
Publicado: Public Library of Science 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3002959/
https://www.ncbi.nlm.nih.gov/pubmed/21179571
http://dx.doi.org/10.1371/journal.pone.0015569
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author Olotu, Ally
Fegan, Gregory
Williams, Thomas N.
Sasi, Philip
Ogada, Edna
Bauni, Evasius
Wambua, Juliana
Marsh, Kevin
Borrmann, Steffen
Bejon, Philip
author_facet Olotu, Ally
Fegan, Gregory
Williams, Thomas N.
Sasi, Philip
Ogada, Edna
Bauni, Evasius
Wambua, Juliana
Marsh, Kevin
Borrmann, Steffen
Bejon, Philip
author_sort Olotu, Ally
collection PubMed
description BACKGROUND: Febrile malaria is the most common clinical manifestation of P. falciparum infection, and is often the primary endpoint in clinical trials and epidemiological studies. Subjective and objective fevers are both used to define the endpoint, but have not been carefully compared, and the relative incidence of clinical malaria by active and passive case detection is unknown. METHODS: We analyzed data from cohorts under active and passive surveillance, including 19,462 presentations with fever and 5,551 blood tests for asymptomatic parasitaemia. A logistic regression model was used to calculate Malaria Attributable Fractions (MAFs) for various case definitions. Incidences of febrile malaria by active and passive surveillance were compared in a subset of children matched for age and location. RESULTS: Active surveillance identified three times the incidence of clinical malaria as passive surveillance in a subset of children matched for age and location. Objective fever (temperature≥37.5°C) gave consistently higher MAFs than case definitions based on subjective fever. CONCLUSION: The endpoints from active and passive surveillance have high specificity, but the incidence of endpoints is lower on passive surveillance. Subjective fever had low specificity and should not be used in primary endpoint. Passive surveillance will reduce the power of clinical trials but may cost-effectively deliver acceptable sensitivity in studies of large populations.
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spelling pubmed-30029592010-12-21 Defining Clinical Malaria: The Specificity and Incidence of Endpoints from Active and Passive Surveillance of Children in Rural Kenya Olotu, Ally Fegan, Gregory Williams, Thomas N. Sasi, Philip Ogada, Edna Bauni, Evasius Wambua, Juliana Marsh, Kevin Borrmann, Steffen Bejon, Philip PLoS One Research Article BACKGROUND: Febrile malaria is the most common clinical manifestation of P. falciparum infection, and is often the primary endpoint in clinical trials and epidemiological studies. Subjective and objective fevers are both used to define the endpoint, but have not been carefully compared, and the relative incidence of clinical malaria by active and passive case detection is unknown. METHODS: We analyzed data from cohorts under active and passive surveillance, including 19,462 presentations with fever and 5,551 blood tests for asymptomatic parasitaemia. A logistic regression model was used to calculate Malaria Attributable Fractions (MAFs) for various case definitions. Incidences of febrile malaria by active and passive surveillance were compared in a subset of children matched for age and location. RESULTS: Active surveillance identified three times the incidence of clinical malaria as passive surveillance in a subset of children matched for age and location. Objective fever (temperature≥37.5°C) gave consistently higher MAFs than case definitions based on subjective fever. CONCLUSION: The endpoints from active and passive surveillance have high specificity, but the incidence of endpoints is lower on passive surveillance. Subjective fever had low specificity and should not be used in primary endpoint. Passive surveillance will reduce the power of clinical trials but may cost-effectively deliver acceptable sensitivity in studies of large populations. Public Library of Science 2010-12-16 /pmc/articles/PMC3002959/ /pubmed/21179571 http://dx.doi.org/10.1371/journal.pone.0015569 Text en Olotu et al. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Olotu, Ally
Fegan, Gregory
Williams, Thomas N.
Sasi, Philip
Ogada, Edna
Bauni, Evasius
Wambua, Juliana
Marsh, Kevin
Borrmann, Steffen
Bejon, Philip
Defining Clinical Malaria: The Specificity and Incidence of Endpoints from Active and Passive Surveillance of Children in Rural Kenya
title Defining Clinical Malaria: The Specificity and Incidence of Endpoints from Active and Passive Surveillance of Children in Rural Kenya
title_full Defining Clinical Malaria: The Specificity and Incidence of Endpoints from Active and Passive Surveillance of Children in Rural Kenya
title_fullStr Defining Clinical Malaria: The Specificity and Incidence of Endpoints from Active and Passive Surveillance of Children in Rural Kenya
title_full_unstemmed Defining Clinical Malaria: The Specificity and Incidence of Endpoints from Active and Passive Surveillance of Children in Rural Kenya
title_short Defining Clinical Malaria: The Specificity and Incidence of Endpoints from Active and Passive Surveillance of Children in Rural Kenya
title_sort defining clinical malaria: the specificity and incidence of endpoints from active and passive surveillance of children in rural kenya
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3002959/
https://www.ncbi.nlm.nih.gov/pubmed/21179571
http://dx.doi.org/10.1371/journal.pone.0015569
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