Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation

Detalhes bibliográficos
Autor(a) principal: Gerth‑Guyette, Emily
Data de Publicação: 2021
Outros Autores: Adissu, Wondimagegn, Brito, Marcelo, Garbin, Eduardo, Macedo, Marcela, Sharma, Abhijit, Das, Santasabuj, Lacerda, Marcus V. G., Pereira, Dhélio, Talukdar, Arunansu, Yilma, Daniel, Pal, Sampa, Zobrist, Stephanie, Domingo, Gonzalo J.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/56924
Resumo: PATH. Westlake Avenue. Suite 200. Seattle, WA, USA.
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spelling Gerth‑Guyette, EmilyAdissu, WondimagegnBrito, MarceloGarbin, EduardoMacedo, MarcelaSharma, AbhijitDas, SantasabujLacerda, Marcus V. G.Pereira, DhélioTalukdar, ArunansuYilma, DanielPal, SampaZobrist, StephanieDomingo, Gonzalo J.2023-02-07T15:35:57Z2023-02-07T15:35:57Z2021GERTH-GUYETTE, Emily et al. Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation. Malaria Journal, v. 20, n. 307, p. 1-11, 2021.1475-2875https://www.arca.fiocruz.br/handle/icict/5692410.1186/s12936-021-03803-1engUsability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretationinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlePATH. Westlake Avenue. Suite 200. Seattle, WA, USA.Jimma University. School of Medical Laboratory Sciences. Jimma, Ethiopia.Fundação de Medicina Tropical Dr Heitor Vieira Dourado. Manaus, AM, Brazil.Centro de Pesquisa em Medicina Tropical. Porto Velho, RO, Brazil.Centro de Pesquisa em Medicina Tropical. Porto Velho, RO, Brazil.PATH. Westlake Avenue. Suite 200. Seattle, WA, USA.National Institute of Cholera and Enteric Diseases. Indian Council of Medical Research. Kolkata, India.Fundação Oswaldo Cruz. Instituto Leônidas & Maria Deane. Manaus, AM, Brasil.Centro de Pesquisa em Medicina Tropical. Porto Velho, RO, Brazil.Medical College. Department of General Medicine. Kolkata, India.Jimma University. School of Medical Laboratory Sciences. Jimma, Ethiopia.PATH. Westlake Avenue. Suite 200. Seattle, WA, USA.PATH. Westlake Avenue. Suite 200. Seattle, WA, USA.PATH. Westlake Avenue. Suite 200. Seattle, WA, USA.Background: Point-of-care glucose-6-phosphate dehydrogenase (G6PD) testing has the potential to make the use of radical treatment for vivax malaria safer and more efective. Widespread use of G6PD tests as part of malaria case management has been limited, in part due to due concerns regarding product usability, user training, and supervision. This study seeks to assess how well end users can understand the Standard™ G6PD Test (SD Biosensor, Suwon, South Korea) workfow, result output, and label after training. This will ultimately help inform test registration and introduction. Methods: Potential G6PD test users who provide malaria case management at three sites in Brazil, Ethiopia, and India were trained on the use of the SD Biosensor Standard G6PD Test and assessed based on their ability to understand the test workfow and interpret results. The assessment was done through a questionnaire, designed to assess product usability against key technical product specifcations and fulfll regulatory evidence requirements. Any participant who obtained 85% or above correct responses to the questionnaire was considered to adequately comprehend how to use and interpret the test. Results: Forty-fve participants, including malaria microscopists, laboratory staf, nurses, and community health workers took part in the study. Seventy-eight percent of all participants in the study (35/45) obtained passing scores on the assessment with minimal training. Responses to the multiple-choice questions indicate that most participants understood well the test intended use, safety claims, and warnings. The greatest source of error regarding the test was around the correct operating temperature. Most test results were also read and interpreted correctly, with the haemoglobin measurement being a more problematic output to interpret than the G6PD measurement. Conclusions: These data results show how a standardized tool can be used to assess a user’s ability to run a point of-care diagnostic and interpret results. When applied to the SD Biosensor Standard G6PD Test, this tool demonstrates that a range of users across multiple contexts can use the test and suggests improvements to the test instructions and training that can improve product usability, increase user comprehension, and ultimately contribute to more widespread efective use of point-of-care G6PD tests. Trial registration: NCT04033640G6PD defciencyPoint-of-care diagnosticsUsabilityUser profciencyUser trainingLabel comprehension studyMalaria diagnosisinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/56924/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALGerth‑Guyette_Emily_etal_ILMD_2021.pdfGerth‑Guyette_Emily_etal_ILMD_2021.pdfapplication/pdf1908795https://www.arca.fiocruz.br/bitstream/icict/56924/3/Gerth%e2%80%91Guyette_Emily_etal_ILMD_2021.pdf1c7046d1ed96bf681c8cd84690c91d4eMD53icict/569242023-02-07 20:25:49.865oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-02-07T23:25:49Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.en_US.fl_str_mv Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation
title Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation
spellingShingle Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation
Gerth‑Guyette, Emily
G6PD defciency
Point-of-care diagnostics
Usability
User profciency
User training
Label comprehension study
Malaria diagnosis
title_short Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation
title_full Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation
title_fullStr Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation
title_full_unstemmed Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation
title_sort Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation
author Gerth‑Guyette, Emily
author_facet Gerth‑Guyette, Emily
Adissu, Wondimagegn
Brito, Marcelo
Garbin, Eduardo
Macedo, Marcela
Sharma, Abhijit
Das, Santasabuj
Lacerda, Marcus V. G.
Pereira, Dhélio
Talukdar, Arunansu
Yilma, Daniel
Pal, Sampa
Zobrist, Stephanie
Domingo, Gonzalo J.
author_role author
author2 Adissu, Wondimagegn
Brito, Marcelo
Garbin, Eduardo
Macedo, Marcela
Sharma, Abhijit
Das, Santasabuj
Lacerda, Marcus V. G.
Pereira, Dhélio
Talukdar, Arunansu
Yilma, Daniel
Pal, Sampa
Zobrist, Stephanie
Domingo, Gonzalo J.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Gerth‑Guyette, Emily
Adissu, Wondimagegn
Brito, Marcelo
Garbin, Eduardo
Macedo, Marcela
Sharma, Abhijit
Das, Santasabuj
Lacerda, Marcus V. G.
Pereira, Dhélio
Talukdar, Arunansu
Yilma, Daniel
Pal, Sampa
Zobrist, Stephanie
Domingo, Gonzalo J.
dc.subject.en.en_US.fl_str_mv G6PD defciency
Point-of-care diagnostics
Usability
User profciency
User training
Label comprehension study
Malaria diagnosis
topic G6PD defciency
Point-of-care diagnostics
Usability
User profciency
User training
Label comprehension study
Malaria diagnosis
description PATH. Westlake Avenue. Suite 200. Seattle, WA, USA.
publishDate 2021
dc.date.issued.fl_str_mv 2021
dc.date.accessioned.fl_str_mv 2023-02-07T15:35:57Z
dc.date.available.fl_str_mv 2023-02-07T15:35:57Z
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 GERTH-GUYETTE, Emily et al. Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation. Malaria Journal, v. 20, n. 307, p. 1-11, 2021.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/56924
dc.identifier.issn.en_US.fl_str_mv 1475-2875
dc.identifier.doi.none.fl_str_mv 10.1186/s12936-021-03803-1
identifier_str_mv GERTH-GUYETTE, Emily et al. Usability of a point‑of‑care diagnostic to identify glucose‑6‑phosphate dehydrogenase defciency: a multi‑country assessment of test label comprehension and results interpretation. Malaria Journal, v. 20, n. 307, p. 1-11, 2021.
1475-2875
10.1186/s12936-021-03803-1
url https://www.arca.fiocruz.br/handle/icict/56924
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.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/56924/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/56924/3/Gerth%e2%80%91Guyette_Emily_etal_ILMD_2021.pdf
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repository.mail.fl_str_mv repositorio.arca@fiocruz.br
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