A general framework to support cost-efficient fecal egg count methods and study design choices for large-scale STH deworming programs-monitoring of therapeutic drug efficacy as a case study.

<h4>Background</h4>Soil-transmitted helminth (STH) control programs currently lack evidence-based recommendations for cost-efficient survey designs for monitoring and evaluation. Here, we present a framework to provide evidence-based recommendations, using a case study of therapeutic dru...

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Main Authors: Luc E Coffeng, Johnny Vlaminck, Piet Cools, Matthew Denwood, Marco Albonico, Shaali M Ame, Mio Ayana, Daniel Dana, Giuseppe Cringoli, Sake J de Vlas, Alan Fenwick, Michael French, Adama Kazienga, Jennifer Keiser, Stefanie Knopp, Gemechu Leta, Leonardo F Matoso, Maria P Maurelli, Antonio Montresor, Greg Mirams, Zeleke Mekonnen, Rodrigo Corrêa-Oliveira, Simone A Pinto, Laura Rinaldi, Somphou Sayasone, Peter Steinmann, Eurion Thomas, Jozef Vercruysse, Bruno Levecke
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2023-05-01
Series:PLoS Neglected Tropical Diseases
Online Access:https://doi.org/10.1371/journal.pntd.0011071
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author Luc E Coffeng
Johnny Vlaminck
Piet Cools
Matthew Denwood
Marco Albonico
Shaali M Ame
Mio Ayana
Daniel Dana
Giuseppe Cringoli
Sake J de Vlas
Alan Fenwick
Michael French
Adama Kazienga
Jennifer Keiser
Stefanie Knopp
Gemechu Leta
Leonardo F Matoso
Maria P Maurelli
Antonio Montresor
Greg Mirams
Zeleke Mekonnen
Rodrigo Corrêa-Oliveira
Simone A Pinto
Laura Rinaldi
Somphou Sayasone
Peter Steinmann
Eurion Thomas
Jozef Vercruysse
Bruno Levecke
author_facet Luc E Coffeng
Johnny Vlaminck
Piet Cools
Matthew Denwood
Marco Albonico
Shaali M Ame
Mio Ayana
Daniel Dana
Giuseppe Cringoli
Sake J de Vlas
Alan Fenwick
Michael French
Adama Kazienga
Jennifer Keiser
Stefanie Knopp
Gemechu Leta
Leonardo F Matoso
Maria P Maurelli
Antonio Montresor
Greg Mirams
Zeleke Mekonnen
Rodrigo Corrêa-Oliveira
Simone A Pinto
Laura Rinaldi
Somphou Sayasone
Peter Steinmann
Eurion Thomas
Jozef Vercruysse
Bruno Levecke
author_sort Luc E Coffeng
collection DOAJ
description <h4>Background</h4>Soil-transmitted helminth (STH) control programs currently lack evidence-based recommendations for cost-efficient survey designs for monitoring and evaluation. Here, we present a framework to provide evidence-based recommendations, using a case study of therapeutic drug efficacy monitoring based on the examination of helminth eggs in stool.<h4>Methods</h4>We performed an in-depth analysis of the operational costs to process one stool sample for three diagnostic methods (Kato-Katz, Mini-FLOTAC and FECPAKG2). Next, we performed simulations to determine the probability of detecting a truly reduced therapeutic efficacy for different scenarios of STH species (Ascaris lumbricoides, Trichuris trichiura and hookworms), pre-treatment infection levels, survey design (screen and select (SS); screen, select and retest (SSR) and no selection (NS)) and number of subjects enrolled (100-5,000). Finally, we integrated the outcome of the cost assessment into the simulation study to estimate the total survey costs and determined the most cost-efficient survey design.<h4>Principal findings</h4>Kato-Katz allowed for both the highest sample throughput and the lowest cost per test, while FECPAKG2 required both the most laboratory time and was the most expensive. Counting of eggs accounted for 23% (FECPAKG2) or ≥80% (Kato-Katz and Mini-FLOTAC) of the total time-to-result. NS survey designs in combination with Kato-Katz were the most cost-efficient to assess therapeutic drug efficacy in all scenarios of STH species and endemicity.<h4>Conclusions/significance</h4>We confirm that Kato-Katz is the fecal egg counting method of choice for monitoring therapeutic drug efficacy, but that the survey design currently recommended by WHO (SS) should be updated. Our generic framework, which captures laboratory time and material costs, can be used to further support cost-efficient choices for other important surveys informing STH control programs. In addition, it can be used to explore the value of alternative diagnostic techniques, like automated egg counting, which may further reduce operational costs.<h4>Trial registration</h4>ClinicalTrials.gov NCT03465488.
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spelling doaj-art-959546d352cb4673b3dd07a62f24a5e72025-08-20T02:22:24ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352023-05-01175e001107110.1371/journal.pntd.0011071A general framework to support cost-efficient fecal egg count methods and study design choices for large-scale STH deworming programs-monitoring of therapeutic drug efficacy as a case study.Luc E CoffengJohnny VlaminckPiet CoolsMatthew DenwoodMarco AlbonicoShaali M AmeMio AyanaDaniel DanaGiuseppe CringoliSake J de VlasAlan FenwickMichael FrenchAdama KaziengaJennifer KeiserStefanie KnoppGemechu LetaLeonardo F MatosoMaria P MaurelliAntonio MontresorGreg MiramsZeleke MekonnenRodrigo Corrêa-OliveiraSimone A PintoLaura RinaldiSomphou SayasonePeter SteinmannEurion ThomasJozef VercruysseBruno Levecke<h4>Background</h4>Soil-transmitted helminth (STH) control programs currently lack evidence-based recommendations for cost-efficient survey designs for monitoring and evaluation. Here, we present a framework to provide evidence-based recommendations, using a case study of therapeutic drug efficacy monitoring based on the examination of helminth eggs in stool.<h4>Methods</h4>We performed an in-depth analysis of the operational costs to process one stool sample for three diagnostic methods (Kato-Katz, Mini-FLOTAC and FECPAKG2). Next, we performed simulations to determine the probability of detecting a truly reduced therapeutic efficacy for different scenarios of STH species (Ascaris lumbricoides, Trichuris trichiura and hookworms), pre-treatment infection levels, survey design (screen and select (SS); screen, select and retest (SSR) and no selection (NS)) and number of subjects enrolled (100-5,000). Finally, we integrated the outcome of the cost assessment into the simulation study to estimate the total survey costs and determined the most cost-efficient survey design.<h4>Principal findings</h4>Kato-Katz allowed for both the highest sample throughput and the lowest cost per test, while FECPAKG2 required both the most laboratory time and was the most expensive. Counting of eggs accounted for 23% (FECPAKG2) or ≥80% (Kato-Katz and Mini-FLOTAC) of the total time-to-result. NS survey designs in combination with Kato-Katz were the most cost-efficient to assess therapeutic drug efficacy in all scenarios of STH species and endemicity.<h4>Conclusions/significance</h4>We confirm that Kato-Katz is the fecal egg counting method of choice for monitoring therapeutic drug efficacy, but that the survey design currently recommended by WHO (SS) should be updated. Our generic framework, which captures laboratory time and material costs, can be used to further support cost-efficient choices for other important surveys informing STH control programs. In addition, it can be used to explore the value of alternative diagnostic techniques, like automated egg counting, which may further reduce operational costs.<h4>Trial registration</h4>ClinicalTrials.gov NCT03465488.https://doi.org/10.1371/journal.pntd.0011071
spellingShingle Luc E Coffeng
Johnny Vlaminck
Piet Cools
Matthew Denwood
Marco Albonico
Shaali M Ame
Mio Ayana
Daniel Dana
Giuseppe Cringoli
Sake J de Vlas
Alan Fenwick
Michael French
Adama Kazienga
Jennifer Keiser
Stefanie Knopp
Gemechu Leta
Leonardo F Matoso
Maria P Maurelli
Antonio Montresor
Greg Mirams
Zeleke Mekonnen
Rodrigo Corrêa-Oliveira
Simone A Pinto
Laura Rinaldi
Somphou Sayasone
Peter Steinmann
Eurion Thomas
Jozef Vercruysse
Bruno Levecke
A general framework to support cost-efficient fecal egg count methods and study design choices for large-scale STH deworming programs-monitoring of therapeutic drug efficacy as a case study.
PLoS Neglected Tropical Diseases
title A general framework to support cost-efficient fecal egg count methods and study design choices for large-scale STH deworming programs-monitoring of therapeutic drug efficacy as a case study.
title_full A general framework to support cost-efficient fecal egg count methods and study design choices for large-scale STH deworming programs-monitoring of therapeutic drug efficacy as a case study.
title_fullStr A general framework to support cost-efficient fecal egg count methods and study design choices for large-scale STH deworming programs-monitoring of therapeutic drug efficacy as a case study.
title_full_unstemmed A general framework to support cost-efficient fecal egg count methods and study design choices for large-scale STH deworming programs-monitoring of therapeutic drug efficacy as a case study.
title_short A general framework to support cost-efficient fecal egg count methods and study design choices for large-scale STH deworming programs-monitoring of therapeutic drug efficacy as a case study.
title_sort general framework to support cost efficient fecal egg count methods and study design choices for large scale sth deworming programs monitoring of therapeutic drug efficacy as a case study
url https://doi.org/10.1371/journal.pntd.0011071
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