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Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania

Taenia solium diagnosis is challenging as trained personnel, good diagnostic tools, and infrastructure is lacking in resource-poor areas. This paper aims to describe the study trial design adopted to evaluate a newly developed rapid point-of-care test that simultaneously detects taeniosis and neuroc...

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Autores principales: Trevisan, Chiara, Damme, Inge Van, Ngowi, Bernard, Schmidt, Veronika, Stelzle, Dominik, Møller, Karen Schou, Kabululu, Mwemezi, Makasi, Charles E., Magnussen, Pascal, Bottieau, Emmanuel, Abatih, Emmanuel, Johansen, Maria V., Ngowi, Helena, Ndawi, Benedict, Mwape, Kabemba E., Zulu, Gideon, Dorny, Pierre, Winkler, Andrea S., Gabriël, Sarah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8470609/
https://www.ncbi.nlm.nih.gov/pubmed/34573870
http://dx.doi.org/10.3390/diagnostics11091528
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author Trevisan, Chiara
Damme, Inge Van
Ngowi, Bernard
Schmidt, Veronika
Stelzle, Dominik
Møller, Karen Schou
Kabululu, Mwemezi
Makasi, Charles E.
Magnussen, Pascal
Bottieau, Emmanuel
Abatih, Emmanuel
Johansen, Maria V.
Ngowi, Helena
Ndawi, Benedict
Mwape, Kabemba E.
Zulu, Gideon
Dorny, Pierre
Winkler, Andrea S.
Gabriël, Sarah
author_facet Trevisan, Chiara
Damme, Inge Van
Ngowi, Bernard
Schmidt, Veronika
Stelzle, Dominik
Møller, Karen Schou
Kabululu, Mwemezi
Makasi, Charles E.
Magnussen, Pascal
Bottieau, Emmanuel
Abatih, Emmanuel
Johansen, Maria V.
Ngowi, Helena
Ndawi, Benedict
Mwape, Kabemba E.
Zulu, Gideon
Dorny, Pierre
Winkler, Andrea S.
Gabriël, Sarah
author_sort Trevisan, Chiara
collection PubMed
description Taenia solium diagnosis is challenging as trained personnel, good diagnostic tools, and infrastructure is lacking in resource-poor areas. This paper aims to describe the study trial design adopted to evaluate a newly developed rapid point-of-care test that simultaneously detects taeniosis and neurocysticercosis (TS POC) in three district hospitals in Tanzania. The two-stage design included three types of patients: patients with specific neurological signs and symptoms (group 1); patients with complaints compatible with intestinal worm infections (group 2); patients with other symptom(s) (group 3). For group 1, all patients were tested using the TS POC test (stage 1), after which all positive, and a subset of negative, patients were selected for laboratory reference tests, clinical examination, and a brain computed tomography (CT) scan (stage 2). For groups 2 and 3, a similar design was adopted, but clinical examination and a brain CT scan (stage 2) were only performed in patients who were TS POC test-positive for cysticercosis. Due to the lack of a gold standard, a Bayesian approach was used to determine test accuracy for taeniosis and cysticercosis. For neurocysticercosis, a composite case definition was used as the reference standard. If successful, this study will help the future developments (commercialization and implementation) of the rapid test and improve patient management and disease prevention.
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spelling pubmed-84706092021-09-27 Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania Trevisan, Chiara Damme, Inge Van Ngowi, Bernard Schmidt, Veronika Stelzle, Dominik Møller, Karen Schou Kabululu, Mwemezi Makasi, Charles E. Magnussen, Pascal Bottieau, Emmanuel Abatih, Emmanuel Johansen, Maria V. Ngowi, Helena Ndawi, Benedict Mwape, Kabemba E. Zulu, Gideon Dorny, Pierre Winkler, Andrea S. Gabriël, Sarah Diagnostics (Basel) Protocol Taenia solium diagnosis is challenging as trained personnel, good diagnostic tools, and infrastructure is lacking in resource-poor areas. This paper aims to describe the study trial design adopted to evaluate a newly developed rapid point-of-care test that simultaneously detects taeniosis and neurocysticercosis (TS POC) in three district hospitals in Tanzania. The two-stage design included three types of patients: patients with specific neurological signs and symptoms (group 1); patients with complaints compatible with intestinal worm infections (group 2); patients with other symptom(s) (group 3). For group 1, all patients were tested using the TS POC test (stage 1), after which all positive, and a subset of negative, patients were selected for laboratory reference tests, clinical examination, and a brain computed tomography (CT) scan (stage 2). For groups 2 and 3, a similar design was adopted, but clinical examination and a brain CT scan (stage 2) were only performed in patients who were TS POC test-positive for cysticercosis. Due to the lack of a gold standard, a Bayesian approach was used to determine test accuracy for taeniosis and cysticercosis. For neurocysticercosis, a composite case definition was used as the reference standard. If successful, this study will help the future developments (commercialization and implementation) of the rapid test and improve patient management and disease prevention. MDPI 2021-08-24 /pmc/articles/PMC8470609/ /pubmed/34573870 http://dx.doi.org/10.3390/diagnostics11091528 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
Trevisan, Chiara
Damme, Inge Van
Ngowi, Bernard
Schmidt, Veronika
Stelzle, Dominik
Møller, Karen Schou
Kabululu, Mwemezi
Makasi, Charles E.
Magnussen, Pascal
Bottieau, Emmanuel
Abatih, Emmanuel
Johansen, Maria V.
Ngowi, Helena
Ndawi, Benedict
Mwape, Kabemba E.
Zulu, Gideon
Dorny, Pierre
Winkler, Andrea S.
Gabriël, Sarah
Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania
title Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania
title_full Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania
title_fullStr Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania
title_full_unstemmed Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania
title_short Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania
title_sort trial design of a prospective multicenter diagnostic accuracy study of a point-of-care test for the detection of taenia solium taeniosis and neurocysticercosis in hospital-based settings in tanzania
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8470609/
https://www.ncbi.nlm.nih.gov/pubmed/34573870
http://dx.doi.org/10.3390/diagnostics11091528
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