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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...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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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. |
format | Online Article Text |
id | pubmed-8306489 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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