An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections

Detalhes bibliográficos
Autor(a) principal: Vlaminck, Johnny
Data de Publicação: 2020
Outros Autores: Cools, Piet, Albonico, Marco, Ame, Shaali, Ayana, Mio, Dana, Daniel, Keiser, Jennifer, Matoso, Leonardo Ferreira, Montresor, Antonio, Mekonnen, Zeleke, Oliveira, Rodrigo Corrêa, Pinto, Simone A., Sayasone, Somphou, Vercruysse, Jozef, Levecke, Bruno
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/58561
Resumo: Department of Virology. Parasitology and Immunology. Ghent University. Merelbeke, Belgium
id CRUZ_5d1d4e24200147ab6d4a6444d12f5772
oai_identifier_str oai:www.arca.fiocruz.br:icict/58561
network_acronym_str CRUZ
network_name_str Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str 2135
spelling Vlaminck, JohnnyCools, PietAlbonico, MarcoAme, ShaaliAyana, MioDana, DanielKeiser, JenniferMatoso, Leonardo FerreiraMontresor, AntonioMekonnen, ZelekeOliveira, Rodrigo CorrêaPinto, Simone A.Sayasone, SomphouVercruysse, JozefLevecke, Bruno2023-05-22T18:52:21Z2023-05-22T18:52:21Z2020VLAMINCK, Johnny. An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections. PLoS Negl Trop Dis., v. 14, n. 9, e0008625, 2020. doi: 10.1371/journal.pntd.00086251935-2735https://www.arca.fiocruz.br/handle/icict/5856110.1371/journal.pntd.0008625engPublic Library of ScienceAn in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infectionsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleDepartment of Virology. Parasitology and Immunology. Ghent University. Merelbeke, BelgiumDepartment of Virology. Parasitology and Immunology. Ghent University. Merelbeke, BelgiumCenter for Tropical Diseases. Sacro Cuore Don Calabria Hospital. Negrar, Italy/Department of Life Sciences and Systems Biology. University of Turin. Turin, ItalyLaboratory Division, Public Health Laboratory-Ivo de Carneri. Chake Chake, United Republic of TanzaniaJimma University Institute of Health. Jimma University. Jimma, EthiopiaJimma University Institute of Health. Jimma University. Jimma, EthiopiaDepartment of Medical Parasitology and Infection Biology. Swiss Tropical and Public Health Institute. Basel, Switzerland/University of Basel. Basel, SwitzerlandLaboratory of Molecular and Cellular Immunology. Research Center René Rachou. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil/Nursing school. Federal University of Minas Gerais. Belo Horizonte, MG, BrazilDepartment of Control of Neglected Tropical Diseases, World Health Organization, Geneva, SwitzerlandJimma University Institute of Health, Jimma University, Jimma, EthiopiaLaboratory of Molecular and Cellular Immunology. Research Center René Rachou. Oswaldo Cruz Foundation. Belo Horizonte, MG, BrazilNursing school, Federal University of Minas Gerais, Minas Gerais, BrazilLao Tropical and Public Health Institute, Ministry of Health, Vientiane, Lao People's Democratic RepublicDepartment of Virology, Parasitology and Immunology, Ghent University, Merelbeke, BelgiumDepartment of Virology, Parasitology and Immunology, Ghent University, Merelbeke, BelgiumBackground: Efforts to control soil-transmitted helminth (STH) infections have intensified over the past decade. Field-survey data on STH prevalence, infection intensity and drug efficacy is necessary to guide the implementation of control programs and should be of the best possible quality. Methodology: During four clinical trials designed to evaluate the efficacy of albendazole against STHs in Brazil, Ethiopia, Lao PDR and Tanzania, quality control (QC) was performed on the duplicate Kato-Katz thick smears and the data entry. We analyzed datasets following QC on both fecal egg counts (FECs) and data entry, and compared the prevalence of any STH infection and moderate-to-heavy intensity (MHI) infections and the drug efficacy against STH infections. Results: Across the four study sites, a total of 450 out of 4,830 (9.3%) Kato-Katz thick smears were re-examined. Discrepancies in FECs varied from ~3% (hookworms) to ~6.5% (Ascaris lumbricoides and Trichuris trichiura). The difference in STH prevalence and prevalence of MHI infections using the datasets with and without QC of the FECs did not exceed 0.3%, except for hookworm infections in Tanzania, where we noted a 2.2 percentage point increase in MHI infections (pre-QC: 1.6% vs. post-QC: 3.8%). There was a 100% agreement in the classification of drug efficacy of albendazole against STH between the two datasets. In total, 201 of the 28,980 (0.65%) data entries that were made to digitize the FECs were different between both data-entry clerks. Nevertheless, the overall prevalence of STH, the prevalence of MHI infections and the classification of drug efficacy remained largely unaffected. Conclusion/significance: In these trials, where staff was informed that QC would take place, minimal changes in study outcomes were reported following QC on FECs or data entry. Nevertheless, imposing QC did reduce the number of errors. Therefore, application of QC together with proper training of the personnel and the availability of clear standard operating procedures is expected to support higher data quality.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZORIGINALAn in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections.pdfAn in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections.pdfapplication/pdf692903https://www.arca.fiocruz.br/bitstream/icict/58561/2/An%20in-depth%20report%20of%20quality%20control%20on%20Kato-Katz%20and%20data%20entry%20in%20four%20clinical%20trials%20evaluating%20the%20efficacy%20of%20albendazole%20against%20soil-transmitted%20helminth%20infections.pdfd4598d0e1c92d5c4dd7e1e8ab0d84e8dMD52LICENSElicense.txttext/plain1748https://www.arca.fiocruz.br/bitstream/icict/58561/1/license.txt8a4605be74aa9ea9d79846c1fba20a33MD51icict/585612023-05-22 15:52:21.92oai:www.arca.fiocruz.br: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Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-05-22T18:52:21Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.en_US.fl_str_mv An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections
title An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections
spellingShingle An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections
Vlaminck, Johnny
title_short An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections
title_full An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections
title_fullStr An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections
title_full_unstemmed An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections
title_sort An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections
author Vlaminck, Johnny
author_facet Vlaminck, Johnny
Cools, Piet
Albonico, Marco
Ame, Shaali
Ayana, Mio
Dana, Daniel
Keiser, Jennifer
Matoso, Leonardo Ferreira
Montresor, Antonio
Mekonnen, Zeleke
Oliveira, Rodrigo Corrêa
Pinto, Simone A.
Sayasone, Somphou
Vercruysse, Jozef
Levecke, Bruno
author_role author
author2 Cools, Piet
Albonico, Marco
Ame, Shaali
Ayana, Mio
Dana, Daniel
Keiser, Jennifer
Matoso, Leonardo Ferreira
Montresor, Antonio
Mekonnen, Zeleke
Oliveira, Rodrigo Corrêa
Pinto, Simone A.
Sayasone, Somphou
Vercruysse, Jozef
Levecke, Bruno
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Vlaminck, Johnny
Cools, Piet
Albonico, Marco
Ame, Shaali
Ayana, Mio
Dana, Daniel
Keiser, Jennifer
Matoso, Leonardo Ferreira
Montresor, Antonio
Mekonnen, Zeleke
Oliveira, Rodrigo Corrêa
Pinto, Simone A.
Sayasone, Somphou
Vercruysse, Jozef
Levecke, Bruno
description Department of Virology. Parasitology and Immunology. Ghent University. Merelbeke, Belgium
publishDate 2020
dc.date.issued.fl_str_mv 2020
dc.date.accessioned.fl_str_mv 2023-05-22T18:52:21Z
dc.date.available.fl_str_mv 2023-05-22T18:52:21Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv VLAMINCK, Johnny. An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections. PLoS Negl Trop Dis., v. 14, n. 9, e0008625, 2020. doi: 10.1371/journal.pntd.0008625
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/58561
dc.identifier.issn.en_US.fl_str_mv 1935-2735
dc.identifier.doi.none.fl_str_mv 10.1371/journal.pntd.0008625
identifier_str_mv VLAMINCK, Johnny. An in-depth report of quality control on Kato-Katz and data entry in four clinical trials evaluating the efficacy of albendazole against soil-transmitted helminth infections. PLoS Negl Trop Dis., v. 14, n. 9, e0008625, 2020. doi: 10.1371/journal.pntd.0008625
1935-2735
10.1371/journal.pntd.0008625
url https://www.arca.fiocruz.br/handle/icict/58561
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Public Library of Science
publisher.none.fl_str_mv Public Library of Science
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/58561/2/An%20in-depth%20report%20of%20quality%20control%20on%20Kato-Katz%20and%20data%20entry%20in%20four%20clinical%20trials%20evaluating%20the%20efficacy%20of%20albendazole%20against%20soil-transmitted%20helminth%20infections.pdf
https://www.arca.fiocruz.br/bitstream/icict/58561/1/license.txt
bitstream.checksum.fl_str_mv d4598d0e1c92d5c4dd7e1e8ab0d84e8d
8a4605be74aa9ea9d79846c1fba20a33
bitstream.checksumAlgorithm.fl_str_mv MD5
MD5
repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
_version_ 1798324616147501056

Registros relacionados