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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

Authors :
Inge Van Damme
Chiara Trevisan
Kabemba E. Mwape
Veronika Schmidt
Pascal Magnussen
Gideon Zulu
Chishimba Mubanga
Dominik Stelzle
Emmanuel Bottieau
Emmanuel Abatih
Isaac K. Phiri
Maria V. Johansen
Chishala Chabala
Andrea S. Winkler
Pierre Dorny
Sarah Gabriël
on behalf of the SOLID Consortium
Source :
Diagnostics, Vol 11, Iss 7, p 1138 (2021)
Publication Year :
2021
Publisher :
MDPI AG, 2021.

Abstract

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.

Details

Language :
English
ISSN :
20754418
Volume :
11
Issue :
7
Database :
Directory of Open Access Journals
Journal :
Diagnostics
Publication Type :
Academic Journal
Accession number :
edsdoj.b748bbd7bbc4f86a792ff27e7662ec9
Document Type :
article
Full Text :
https://doi.org/10.3390/diagnostics11071138