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.
Highlights
Taenia solium is a neglected zoonotic parasite ranked first on the global scale of foodborne parasites [1]
The study was designed to minimize potential sources of bias and maximize generalizability, while accounting for the challenges of working in resource-poor community settings and limitations related to the disease, such as the low prevalence of taeniosis and the lack of gold standard for taeniosis and cysticercosis
The total number of reference tests, clinical examinations, and comcomputed tomography (CT) scans was reduced compared to a conventional cohort design
Summary
Taenia solium is a neglected zoonotic parasite ranked first on the global scale of foodborne parasites [1]. T. solium is endemic in sub-Saharan Africa, Latin America, and south-east Asia [2], affecting poor communities with free-range pigs and low levels of sanitation, hygiene, and education. In rural communities of Zambia, high prevalence rates of T. solium have been reported and NCC is considered the main cause of acquired epilepsy in these areas [3,4,5]. Apart from the significant public health impact, NCC has a strong economic and social impact on people suffering from or affected by this disease, as they are often stigmatized and marginalized in their communities. The diagnosis of NCC in such settings is problematic, because it requires access to neuroimaging and trained neurologists, which are scarce in resource-poor areas
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