Deficient Reporting and Interpretation of Non-Inferiority Randomized Clinical Trials in HIV Patients: A Systematic Review

5.00
Hdl Handle:
http://hdl.handle.net/10757/316304
Title:
Deficient Reporting and Interpretation of Non-Inferiority Randomized Clinical Trials in HIV Patients: A Systematic Review
Authors:
Hernández, Adrian V. ( 0000-0002-9999-4003 ) ; Pasupuleti, Vinay; Deshpande, Abhishek; Thota, Priyaleela; Collins, Jaime A.; Vidal, Jose E.
Citation:
PLoS ONE 8(5): e63272
Publisher:
Public Library of Science (PLoS)
Journal:
PLoS ONE
Issue Date:
30-Apr-2014
URI:
http://hdl.handle.net/10757/316304
DOI:
10.1371/journal.pone.0063272
Additional Links:
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0063272
Abstract:
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.
Type:
info:eu-repo/semantics/article
Rights:
info:eu-repo/semantics/openAccess
Language:
eng
EISSN:
1932-6203
Sponsors:
This work was funded by the Department of Quantitative Health Sciences, Cleveland Clinic. The funders had no role in study design; data collection, analysis, or interpretation; in writing the report, or in the decision to submit the article for publication. The researchers are all independent from the funding source.

Full metadata record

DC FieldValue Language
dc.contributor.authorHernández, Adrian V.es_PE
dc.contributor.authorPasupuleti, Vinayes_PE
dc.contributor.authorDeshpande, Abhishekes_PE
dc.contributor.authorThota, Priyaleelaes_PE
dc.contributor.authorCollins, Jaime A.es_PE
dc.contributor.authorVidal, Jose E.es_PE
dc.date.accessioned2014-04-30T22:14:39Z-
dc.date.available2014-04-30T22:14:39Z-
dc.date.issued2014-04-30-
dc.identifier.citationPLoS ONE 8(5): e63272es_PE
dc.identifier.doi10.1371/journal.pone.0063272-
dc.identifier.urihttp://hdl.handle.net/10757/316304es_PE
dc.description.abstractObjectives: 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.eng
dc.description.sponsorshipThis work was funded by the Department of Quantitative Health Sciences, Cleveland Clinic. The funders had no role in study design; data collection, analysis, or interpretation; in writing the report, or in the decision to submit the article for publication. The researchers are all independent from the funding source.eng
dc.formatapplication/pdfes_PE
dc.language.isoenges_PE
dc.publisherPublic Library of Science (PLoS)es_PE
dc.relation.urlhttp://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0063272es_PE
dc.rightsinfo:eu-repo/semantics/openAccesses_PE
dc.titleDeficient Reporting and Interpretation of Non-Inferiority Randomized Clinical Trials in HIV Patients: A Systematic Reviewes_PE
dc.typeinfo:eu-repo/semantics/articlees_PE
dc.identifier.eissn1932-6203-
dc.identifier.journalPLoS ONEes_PE
dc.description.peer-reviewRevisión por pareses_PE
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