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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

(2021) DIAGNOSTICS. 11(7).
Author
Organization
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.
Keywords
diagnosis, accuracy, sensitivity, specificity, Taenia solium, taeniosis, cysticercosis, POC test, low-resource settings, point-of-care, PREVALENCE, CYSTICERCOSIS, ANTIGENS, CLONING, DISEASE

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MLA
Van Damme, Inge, et al. “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.” DIAGNOSTICS, vol. 11, no. 7, 2021, doi:10.3390/diagnostics11071138.
APA
Van Damme, I., Trevisan, C., Mwape, K., Schmidt, V., Magnussen, P., Zulu, G., … on behalf of the SOLID Consortium, [missing]. (2021). 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. DIAGNOSTICS, 11(7). https://doi.org/10.3390/diagnostics11071138
Chicago author-date
Van Damme, Inge, Chiara Trevisan, Kabemba Mwape, Veronika Schmidt, Pascal Magnussen, Gideon Zulu, Chishimba Mubanga, et al. 2021. “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.” DIAGNOSTICS 11 (7). https://doi.org/10.3390/diagnostics11071138.
Chicago author-date (all authors)
Van Damme, Inge, Chiara Trevisan, Kabemba Mwape, Veronika Schmidt, Pascal Magnussen, Gideon Zulu, Chishimba Mubanga, Dominik Stelzle, Emmanuel Bottieau, Emmanuel Abatih, Isaac Phiri, Maria Johansen, Chishala Chabala, Andrea Winkler, Pierre Dorny, Sarah Gabriël, and [missing] on behalf of the SOLID Consortium. 2021. “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.” DIAGNOSTICS 11 (7). doi:10.3390/diagnostics11071138.
Vancouver
1.
Van Damme I, Trevisan C, Mwape K, Schmidt V, Magnussen P, Zulu G, et al. 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. DIAGNOSTICS. 2021;11(7).
IEEE
[1]
I. Van Damme et al., “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,” DIAGNOSTICS, vol. 11, no. 7, 2021.
@article{8714019,
  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.}},
  articleno    = {{1138}},
  author       = {{Van Damme, Inge and Trevisan, Chiara and Mwape, Kabemba and Schmidt, Veronika and Magnussen, Pascal and Zulu, Gideon and Mubanga, Chishimba and Stelzle, Dominik and Bottieau, Emmanuel and Abatih, Emmanuel and Phiri, Isaac and Johansen, Maria and Chabala, Chishala and Winkler, Andrea and Dorny, Pierre and Gabriël, Sarah and on behalf of the SOLID Consortium, [missing]}},
  issn         = {{2075-4418}},
  journal      = {{DIAGNOSTICS}},
  keywords     = {{diagnosis,accuracy,sensitivity,specificity,Taenia solium,taeniosis,cysticercosis,POC test,low-resource settings,point-of-care,PREVALENCE,CYSTICERCOSIS,ANTIGENS,CLONING,DISEASE}},
  language     = {{eng}},
  number       = {{7}},
  pages        = {{16}},
  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}},
  url          = {{http://dx.doi.org/10.3390/diagnostics11071138}},
  volume       = {{11}},
  year         = {{2021}},
}

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