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Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale

Field-applicable, high-quality, and low-cost diagnostic tools are urgently needed for Taenia solium. The aim of this paper is to describe the design, challenges, and rationale for the design of a diagnostic accuracy study in low-resource community settings in Zambia. The trial was designed as a pros...

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Autores principales: Van Damme, Inge, Trevisan, Chiara, Mwape, Kabemba E., Schmidt, Veronika, Magnussen, Pascal, Zulu, Gideon, Mubanga, Chishimba, Stelzle, Dominik, Bottieau, Emmanuel, Abatih, Emmanuel, Phiri, Isaac K., Johansen, Maria V., Chabala, Chishala, Winkler, Andrea S., Dorny, Pierre, Gabriël, Sarah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8306489/
https://www.ncbi.nlm.nih.gov/pubmed/34206654
http://dx.doi.org/10.3390/diagnostics11071138
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author Van Damme, Inge
Trevisan, Chiara
Mwape, Kabemba E.
Schmidt, Veronika
Magnussen, Pascal
Zulu, Gideon
Mubanga, Chishimba
Stelzle, Dominik
Bottieau, Emmanuel
Abatih, Emmanuel
Phiri, Isaac K.
Johansen, Maria V.
Chabala, Chishala
Winkler, Andrea S.
Dorny, Pierre
Gabriël, Sarah
author_facet Van Damme, Inge
Trevisan, Chiara
Mwape, Kabemba E.
Schmidt, Veronika
Magnussen, Pascal
Zulu, Gideon
Mubanga, Chishimba
Stelzle, Dominik
Bottieau, Emmanuel
Abatih, Emmanuel
Phiri, Isaac K.
Johansen, Maria V.
Chabala, Chishala
Winkler, Andrea S.
Dorny, Pierre
Gabriël, Sarah
author_sort Van Damme, Inge
collection PubMed
description Field-applicable, high-quality, and low-cost diagnostic tools are urgently needed for Taenia solium. The aim of this paper is to describe the design, challenges, and rationale for the design of a diagnostic accuracy study in low-resource community settings in Zambia. The trial was designed as a prospective study with a two-stage design to evaluate a new point-of-care test (TS POC) for the detection of taeniosis and (neuro)cysticercosis. Participants within randomly selected households were tested with the TS POC test (index test). Participants who tested TS POC positive for taeniosis and/or cysticercosis and a subset of the negatives were requested to give blood and stool samples for reference testing, and to undergo clinical examination and a cerebral CT scan. The difficulties of conducting a clinical trial in settings with limited research and neuroimaging infrastructure as well as peculiarities specifically related to the disease (low prevalence of taeniosis and the lack of a gold standard) were taken into consideration for the design of this study. The two-stage design increased the efficiency of the study by reducing the number of samples, clinical examinations, and CT scans. Simplified flows and sampling processes were preferred over complex follow-up and randomization systems, aiming to reduce bias and increase the generalizability of the study.
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spelling pubmed-83064892021-07-25 Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale Van Damme, Inge Trevisan, Chiara Mwape, Kabemba E. Schmidt, Veronika Magnussen, Pascal Zulu, Gideon Mubanga, Chishimba Stelzle, Dominik Bottieau, Emmanuel Abatih, Emmanuel Phiri, Isaac K. Johansen, Maria V. Chabala, Chishala Winkler, Andrea S. Dorny, Pierre Gabriël, Sarah Diagnostics (Basel) Protocol Field-applicable, high-quality, and low-cost diagnostic tools are urgently needed for Taenia solium. The aim of this paper is to describe the design, challenges, and rationale for the design of a diagnostic accuracy study in low-resource community settings in Zambia. The trial was designed as a prospective study with a two-stage design to evaluate a new point-of-care test (TS POC) for the detection of taeniosis and (neuro)cysticercosis. Participants within randomly selected households were tested with the TS POC test (index test). Participants who tested TS POC positive for taeniosis and/or cysticercosis and a subset of the negatives were requested to give blood and stool samples for reference testing, and to undergo clinical examination and a cerebral CT scan. The difficulties of conducting a clinical trial in settings with limited research and neuroimaging infrastructure as well as peculiarities specifically related to the disease (low prevalence of taeniosis and the lack of a gold standard) were taken into consideration for the design of this study. The two-stage design increased the efficiency of the study by reducing the number of samples, clinical examinations, and CT scans. Simplified flows and sampling processes were preferred over complex follow-up and randomization systems, aiming to reduce bias and increase the generalizability of the study. MDPI 2021-06-22 /pmc/articles/PMC8306489/ /pubmed/34206654 http://dx.doi.org/10.3390/diagnostics11071138 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Protocol
Van Damme, Inge
Trevisan, Chiara
Mwape, Kabemba E.
Schmidt, Veronika
Magnussen, Pascal
Zulu, Gideon
Mubanga, Chishimba
Stelzle, Dominik
Bottieau, Emmanuel
Abatih, Emmanuel
Phiri, Isaac K.
Johansen, Maria V.
Chabala, Chishala
Winkler, Andrea S.
Dorny, Pierre
Gabriël, Sarah
Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale
title Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale
title_full Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale
title_fullStr Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale
title_full_unstemmed Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale
title_short Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale
title_sort trial design for a diagnostic accuracy study of a point-of-care test for the detection of taenia solium taeniosis and (neuro)cysticercosis in community settings of highly endemic, resource-poor areas in zambia: challenges and rationale
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8306489/
https://www.ncbi.nlm.nih.gov/pubmed/34206654
http://dx.doi.org/10.3390/diagnostics11071138
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