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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

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Abstract
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 similar to 3% (hookworms) to similar to 6.5% (Ascaris lumbricoidesandTrichuris 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.
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DATA ACCURACY

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MLA
Vlaminck, Johnny, et al. “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 NEGLECTED TROPICAL DISEASES, vol. 14, no. 9, 2020, doi:10.1371/journal.pntd.0008625.
APA
Vlaminck, J., Cools, P., Albonico, M., Ame, S., Ayana, M., Medebo, D. D., … Levecke, B. (2020). 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 NEGLECTED TROPICAL DISEASES, 14(9). https://doi.org/10.1371/journal.pntd.0008625
Chicago author-date
Vlaminck, Johnny, Piet Cools, Marco Albonico, Shaali Ame, Mio Ayana, Daniel Dana Medebo, Jennifer Keiser, et al. 2020. “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 NEGLECTED TROPICAL DISEASES 14 (9). https://doi.org/10.1371/journal.pntd.0008625.
Chicago author-date (all authors)
Vlaminck, Johnny, Piet Cools, Marco Albonico, Shaali Ame, Mio Ayana, Daniel Dana Medebo, Jennifer Keiser, Leonardo F. Matoso, Antonio Montresor, Zeleke Mekonnen Kurmane, Rodrigo Correa-Oliveira, Simone A. Pinto, Somphou Sayasone, Jozef Vercruysse, and Bruno Levecke. 2020. “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 NEGLECTED TROPICAL DISEASES 14 (9). doi:10.1371/journal.pntd.0008625.
Vancouver
1.
Vlaminck J, Cools P, Albonico M, Ame S, Ayana M, Medebo DD, et al. 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 NEGLECTED TROPICAL DISEASES. 2020;14(9).
IEEE
[1]
J. Vlaminck et al., “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 NEGLECTED TROPICAL DISEASES, vol. 14, no. 9, 2020.
@article{8697682,
  abstract     = {{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 similar to 3% (hookworms) to similar to 6.5% (Ascaris lumbricoidesandTrichuris 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.}},
  articleno    = {{e0008625}},
  author       = {{Vlaminck, Johnny and Cools, Piet and Albonico, Marco and Ame, Shaali and Ayana, Mio and Medebo, Daniel Dana and Keiser, Jennifer and Matoso, Leonardo F. and Montresor, Antonio and Mekonnen Kurmane, Zeleke and Correa-Oliveira, Rodrigo and Pinto, Simone A. and Sayasone, Somphou and Vercruysse, Jozef and Levecke, Bruno}},
  issn         = {{1935-2735}},
  journal      = {{PLOS NEGLECTED TROPICAL DISEASES}},
  keywords     = {{DATA ACCURACY}},
  language     = {{eng}},
  number       = {{9}},
  pages        = {{14}},
  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}},
  url          = {{http://dx.doi.org/10.1371/journal.pntd.0008625}},
  volume       = {{14}},
  year         = {{2020}},
}

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