Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.

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El Consejo Editorial es un equipo de expertos en el campo de la revista.
Detalles Bibliográficos
Autores: Hernandez, Adrian V., Vinay, Pasupuleti, Deshpande, Abhishek, Thota, Priyaleela, Collins, Jaime A., Vidal, Jose E.
Formato: artículo
Fecha de Publicación:2013
Institución:Seguro Social de Salud
Repositorio:ESSALUD-Institucional
Lenguaje:inglés
OAI Identifier:oai:repositorio.essalud.gob.pe:20.500.12959/548
Enlace del recurso:https://hdl.handle.net/20.500.12959/548
https://doi.org/10.1371/journal.pone.0063272
Nivel de acceso:acceso abierto
Materia:Enfermedades Infecciosas
Infecciones por VIH
Antirretrovirales
https://purl.org/pe-repo/ocde/ford#3.03.02
https://purl.org/pe-repo/ocde/ford#3.03.05
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dc.title.es_PE.fl_str_mv Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
title Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
spellingShingle Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
Hernandez, Adrian V.
Enfermedades Infecciosas
Infecciones por VIH
Antirretrovirales
https://purl.org/pe-repo/ocde/ford#3.03.02
https://purl.org/pe-repo/ocde/ford#3.03.05
title_short Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
title_full Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
title_fullStr Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
title_full_unstemmed Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
title_sort Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
author Hernandez, Adrian V.
author_facet Hernandez, Adrian V.
Vinay, Pasupuleti
Deshpande, Abhishek
Thota, Priyaleela
Collins, Jaime A.
Vidal, Jose E.
author_role author
author2 Vinay, Pasupuleti
Deshpande, Abhishek
Thota, Priyaleela
Collins, Jaime A.
Vidal, Jose E.
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv Hernandez, Adrian V.
Vinay, Pasupuleti
Deshpande, Abhishek
Thota, Priyaleela
Collins, Jaime A.
Vidal, Jose E.
dc.subject.es_PE.fl_str_mv Enfermedades Infecciosas
Infecciones por VIH
Antirretrovirales
topic Enfermedades Infecciosas
Infecciones por VIH
Antirretrovirales
https://purl.org/pe-repo/ocde/ford#3.03.02
https://purl.org/pe-repo/ocde/ford#3.03.05
dc.subject.ocde.es_PE.fl_str_mv https://purl.org/pe-repo/ocde/ford#3.03.02
https://purl.org/pe-repo/ocde/ford#3.03.05
description El Consejo Editorial es un equipo de expertos en el campo de la revista.
publishDate 2013
dc.date.accessioned.none.fl_str_mv 2019-05-17T18:02:20Z
dc.date.available.none.fl_str_mv 2019-05-17T18:02:20Z
dc.date.issued.fl_str_mv 2013-05
dc.type.es_PE.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.citation.es_PE.fl_str_mv Plos One. 2013; 8 (5).
dc.identifier.issn.none.fl_str_mv 1932-6203
dc.identifier.uri.none.fl_str_mv https://hdl.handle.net/20.500.12959/548
dc.identifier.doi.none.fl_str_mv https://doi.org/10.1371/journal.pone.0063272
identifier_str_mv Plos One. 2013; 8 (5).
1932-6203
url https://hdl.handle.net/20.500.12959/548
https://doi.org/10.1371/journal.pone.0063272
dc.language.iso.es_PE.fl_str_mv eng
language eng
dc.relation.uri.none.fl_str_mv https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0063272
dc.rights.es_PE.fl_str_mv info:eu-repo/semantics/openAccess
dc.rights.uri.es_PE.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0/
dc.format.es_PE.fl_str_mv application/pdf
dc.publisher.es_PE.fl_str_mv Editorial Board
dc.publisher.country.es_PE.fl_str_mv PE
dc.source.es_PE.fl_str_mv Seguro Social de Salud (EsSalud)
Repositorio Institucional EsSalud
dc.source.none.fl_str_mv reponame:ESSALUD-Institucional
instname:Seguro Social de Salud
instacron:ESSALUD
instname_str Seguro Social de Salud
instacron_str ESSALUD
institution ESSALUD
reponame_str ESSALUD-Institucional
collection ESSALUD-Institucional
bitstream.url.fl_str_mv https://repositorio.essalud.gob.pe/bitstream/20.500.12959/548/2/license.txt
https://repositorio.essalud.gob.pe/bitstream/20.500.12959/548/1/Deficient%20Reporting%20and%20Interpretation%20of%20Non-Inferiority%20Randomized%20Clinical%20Trials%20in%20HIV%20Patients.PDF
https://repositorio.essalud.gob.pe/bitstream/20.500.12959/548/3/Deficient%20Reporting%20and%20Interpretation%20of%20Non-Inferiority%20Randomized%20Clinical%20Trials%20in%20HIV%20Patients.PDF.txt
https://repositorio.essalud.gob.pe/bitstream/20.500.12959/548/4/Deficient%20Reporting%20and%20Interpretation%20of%20Non-Inferiority%20Randomized%20Clinical%20Trials%20in%20HIV%20Patients.PDF.jpg
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repository.name.fl_str_mv Repositorio Seguro Social de Salud – ESSALUD
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spelling Hernandez, Adrian V.Vinay, PasupuletiDeshpande, AbhishekThota, PriyaleelaCollins, Jaime A.Vidal, Jose E.2019-05-17T18:02:20Z2019-05-17T18:02:20Z2013-05Plos One. 2013; 8 (5).1932-6203https://hdl.handle.net/20.500.12959/548https://doi.org/10.1371/journal.pone.0063272El Consejo Editorial es un equipo de expertos en el campo de la revista.Los exámenes clínicos randomizados de no inferioridad generalmente evalúan la eficacia de nuevas drogas antirretrovirales en pacientes con el virus de inmunodeficiencia humana. Sus informes e interpretación no han sido evaluados sistemáticamente. En el presente estudio se evalúa los informes de exámenes clínicos randomizados de no inferioridad de pacientes con el virus de inmunodeficiencia humana de acuerdo con el CONSORT (Consolidated Standards of Reporting Trials) y el grado de mala interpretación de los exámenes clínicos randomizados cuando la no inferioridad fue poco concluyente o no establecida. Se realizó una revisión sistemática de PubMed, Science y Scopus hasta diciembre 2011. Se encontró información e interpretación deficiente de los exámenes clínicos randomizados de no inferioridad realizados a pacientes con el virus de inmunodeficiencia humana.Objectives: Non-inferiority (NI) randomized clinical trials (RCTs) commonly evaluate efficacy of new antiretroviral (ARV) drugs in human immunodeficiency virus (HIV) patients. Their reporting and interpretation have not been systematically evaluated. We evaluated the reporting of NI RCTs in HIV patients according to the CONSORT statement and assessed the degree of misinterpretation of RCTs when NI was inconclusive or not established. Design: Systematic review. Methods: PubMed, Web of Science, and Scopus were reviewed until December 2011. Selection and extraction was performed independently by three reviewers. Results: Of the 42 RCTs (n = 21,919; range 41–3,316) selected, 23 were in ARV-naı¨ve and 19 in ARV-experienced patients. Twenty-seven (64%) RCTs provided information about prior RCTs of the active comparator, and 37 (88%) used 2-sided CIs. Two thirds of trials used a NI margin between 10 and 12%, although only 12 explained the method to determine it. Blinding was used in 9 studies only. The main conclusion was based on both intention-to-treat (ITT) and per protocol (PP) analyses in 5 trials, on PP analysis only in 4 studies, and on ITT only in 31 studies. Eleven of 16 studies with NI inconclusive or not established highlighted NI or equivalence, and distracted readers with positive secondary results. Conclusions: There is poor reporting and interpretation of NI RCTs performed in HIV patients. Maximizing the reporting of the method of NI margin determination, use of blinding and both ITT and PP analyses, and interpreting negative NI according to actual primary findings will improve the understanding of results and their translation into clinical practice.application/pdfengEditorial BoardPEhttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0063272info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/4.0/Seguro Social de Salud (EsSalud)Repositorio Institucional EsSaludreponame:ESSALUD-Institucionalinstname:Seguro Social de Saludinstacron:ESSALUDEnfermedades InfecciosasInfecciones por VIHAntirretroviraleshttps://purl.org/pe-repo/ocde/ford#3.03.02https://purl.org/pe-repo/ocde/ford#3.03.05Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.info:eu-repo/semantics/articleLICENSElicense.txtlicense.txttext/plain; charset=utf-81748https://repositorio.essalud.gob.pe/bitstream/20.500.12959/548/2/license.txt8a4605be74aa9ea9d79846c1fba20a33MD52ORIGINALDeficient Reporting and Interpretation of Non-Inferiority Randomized Clinical Trials in HIV Patients.PDFDeficient Reporting and Interpretation of Non-Inferiority Randomized Clinical Trials in HIV Patients.PDFapplication/pdf354895https://repositorio.essalud.gob.pe/bitstream/20.500.12959/548/1/Deficient%20Reporting%20and%20Interpretation%20of%20Non-Inferiority%20Randomized%20Clinical%20Trials%20in%20HIV%20Patients.PDFdaa31cb72b73b5fb76101ed4c39c4ac5MD51TEXTDeficient Reporting and Interpretation of Non-Inferiority Randomized Clinical Trials in HIV Patients.PDF.txtDeficient Reporting and Interpretation of Non-Inferiority Randomized Clinical Trials in HIV Patients.PDF.txtExtracted texttext/plain66549https://repositorio.essalud.gob.pe/bitstream/20.500.12959/548/3/Deficient%20Reporting%20and%20Interpretation%20of%20Non-Inferiority%20Randomized%20Clinical%20Trials%20in%20HIV%20Patients.PDF.txt6d9781293d047aeef06c2f21ac984f59MD53THUMBNAILDeficient Reporting and Interpretation of Non-Inferiority Randomized Clinical Trials in HIV Patients.PDF.jpgDeficient Reporting and Interpretation of Non-Inferiority Randomized Clinical Trials in HIV Patients.PDF.jpgGenerated Thumbnailimage/jpeg7335https://repositorio.essalud.gob.pe/bitstream/20.500.12959/548/4/Deficient%20Reporting%20and%20Interpretation%20of%20Non-Inferiority%20Randomized%20Clinical%20Trials%20in%20HIV%20Patients.PDF.jpga3d27aa12fb3511e7e447c46780d896cMD5420.500.12959/548oai:repositorio.essalud.gob.pe:20.500.12959/5482023-07-31 09:42:07.729Repositorio Seguro Social de Salud – ESSALUDbibliotecacentral@essalud.gob.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Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
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