| Autor | Vlaminck, Johnny | |
| Autor | Cools, Piet | |
| Autor | Albonico, Marco | |
| Autor | Ame, Shaali | |
| Autor | Ayana, Mio | |
| Autor | Dana, Daniel | |
| Autor | Keiser, Jennifer | |
| Autor | Matoso, Leonardo Ferreira | |
| Autor | Montresor, Antonio | |
| Autor | Mekonnen, Zeleke | |
| Autor | Oliveira, Rodrigo Corrêa | |
| Autor | Pinto, Simone A. | |
| Autor | Sayasone, Somphou | |
| Autor | Vercruysse, Jozef | |
| Autor | Levecke, Bruno | |
| Data de acesso | 2023-05-22T18:52:21Z | |
| Data de disponibilização | 2023-05-22T18:52:21Z | |
| Data do publicação | 2020 | |
| Citação | 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 | en_US |
| ISSN | 1935-2735 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/58561 | |
| Idioma | eng | en_US |
| Editor | Public Library of Science | en_US |
| Direito Autoral | open access | en_US |
| Título | 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 | en_US |
| Tipo do documento | Article | en_US |
| DOI | 10.1371/journal.pntd.0008625 | |
| Resumo em Inglês | Background: 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. | en_US |
| Afiliação | Department of Virology. Parasitology and Immunology. Ghent University. Merelbeke, Belgium | en_US |
| Afiliação | Department of Virology. Parasitology and Immunology. Ghent University. Merelbeke, Belgium | en_US |
| Afiliação | Center for Tropical Diseases. Sacro Cuore Don Calabria Hospital. Negrar, Italy/Department of Life Sciences and Systems Biology. University of Turin. Turin, Italy | en_US |
| Afiliação | Laboratory Division, Public Health Laboratory-Ivo de Carneri. Chake Chake, United Republic of Tanzania | en_US |
| Afiliação | Jimma University Institute of Health. Jimma University. Jimma, Ethiopia | en_US |
| Afiliação | Jimma University Institute of Health. Jimma University. Jimma, Ethiopia | en_US |
| Afiliação | Department of Medical Parasitology and Infection Biology. Swiss Tropical and Public Health Institute. Basel, Switzerland/University of Basel. Basel, Switzerland | en_US |
| Afiliação | Laboratory 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, Brazil | en_US |
| Afiliação | Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland | en_US |
| Afiliação | Jimma University Institute of Health, Jimma University, Jimma, Ethiopia | en_US |
| Afiliação | Laboratory of Molecular and Cellular Immunology. Research Center René Rachou. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil | en_US |
| Afiliação | Nursing school, Federal University of Minas Gerais, Minas Gerais, Brazil | en_US |
| Afiliação | Lao Tropical and Public Health Institute, Ministry of Health, Vientiane, Lao People's Democratic Republic | en_US |
| Afiliação | Department of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium | en_US |
| Afiliação | Department of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium | en_US |
