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- 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.
- Authors
Vlaminck, Johnny; Cools, Piet; Albonico, Marco; Ame, Shaali; Ayana, Mio; Dana, Daniel; Keiser, Jennifer; Matoso, Leonardo F.; Montresor, Antonio; Mekonnen, Zeleke; Corrêa-Oliveira, Rodrigo; Pinto, Simone A.; Sayasone, Somphou; Vercruysse, Jozef; Levecke, Bruno
- 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 ~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. Author summary: Over the past ten years, there has been a worldwide intensification of large-scale deworming programs aimed at controlling the morbidity of intestinal worms (roundworms, whipworms and hookworms). In order to make well-founded decisions, it is of utmost importance that the program managers have access to high quality data on the prevalence and intensity of these infections, and the therapeutic efficacy of the administered drugs. In the present study, we report the results of the quality control (QC) that was performed on the diagnosis and the data entry. We analyze and discuss how QC affected the study outcomes of four clinical trials designed to assess the therapeutic efficacy of a standard deworming treatment in Brazil, Ethiopia, Lao PDR and Tanzania. Our results indicate that, when staff is aware that QC will be performed, study outcomes were not significantly affected by performing QC on both the diagnosis or the data entry. Nevertheless, it is important to highlight that training, adherence to good standard operating procedures and performing QC does improve the overall quality of the data.
- Subjects
TANZANIA; ETHIOPIA; BRAZIL; DATA entry; HELMINTHIASIS; QUALITY control; EXPERIMENTAL design; CLINICAL trials; HOOKWORM disease
- Publication
PLoS Neglected Tropical Diseases, 2020, Vol 14, Issue 9, p1
- ISSN
1935-2727
- Publication type
Article
- DOI
10.1371/journal.pntd.0008625