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Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal

BACKGROUND: Although randomized clinical trials (RCTs) are considered the gold standard of evidence, their reporting is often suboptimal. Trial registries have the potential to contribute important methodologic information for critical appraisal of study results. METHODS AND FINDINGS: The objective...

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Autores principales: Reveiz, Ludovic, Chan, An-Wen, Krleža-Jerić, Karmela, Granados, Carlos Eduardo, Pinart, Mariona, Etxeandia, Itziar, Rada, Diego, Martinez, Monserrat, Bonfill, Xavier, Cardona, Andrés Felipe
Formato: Texto
Lenguaje:English
Publicado: Public Library of Science 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2930852/
https://www.ncbi.nlm.nih.gov/pubmed/20824212
http://dx.doi.org/10.1371/journal.pone.0012484
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author Reveiz, Ludovic
Chan, An-Wen
Krleža-Jerić, Karmela
Granados, Carlos Eduardo
Pinart, Mariona
Etxeandia, Itziar
Rada, Diego
Martinez, Monserrat
Bonfill, Xavier
Cardona, Andrés Felipe
author_facet Reveiz, Ludovic
Chan, An-Wen
Krleža-Jerić, Karmela
Granados, Carlos Eduardo
Pinart, Mariona
Etxeandia, Itziar
Rada, Diego
Martinez, Monserrat
Bonfill, Xavier
Cardona, Andrés Felipe
author_sort Reveiz, Ludovic
collection PubMed
description BACKGROUND: Although randomized clinical trials (RCTs) are considered the gold standard of evidence, their reporting is often suboptimal. Trial registries have the potential to contribute important methodologic information for critical appraisal of study results. METHODS AND FINDINGS: The objective of the study was to evaluate the reporting of key methodologic study characteristics in trial registries. We identified a random sample (n = 265) of actively recruiting RCTs using the World Health Organization International Clinical Trials Registry Platform (ICTRP) search portal in 2008. We assessed the reporting of relevant domains from the Cochrane Collaboration's ‘Risk of bias’ tool and other key methodological aspects. Our primary outcomes were the proportion of registry records with adequate reporting of random sequence generation, allocation concealment, blinding, and trial outcomes. Two reviewers independently assessed each record. Weighted overall proportions in the ICTRP search portal for adequate reporting of sequence generation, allocation concealment, blinding (including and excluding open label RCT) and primary outcomes were 5.7% (95% CI 3.0–8.4%), 1.4% (0–2.8%), 41% (35–47%), 8.4% (4.1–13%), and 66% (60–72%), respectively. The proportion of adequately reported RCTs was higher for registries that used specific methodological fields for describing methods of randomization and allocation concealment compared to registries that did not. Concerning other key methodological aspects, weighted overall proportions of RCTs with adequately reported items were as follows: eligibility criteria (81%), secondary outcomes (46%), harm (5%) follow-up duration (62%), description of the interventions (53%) and sample size calculation (1%). CONCLUSIONS: Trial registries currently contain limited methodologic information about registered RCTs. In order to permit adequate critical appraisal of trial results reported in journals and registries, trial registries should consider requesting details on key RCT methods to complement journal publications. Full protocols remain the most comprehensive source of methodologic information and should be made publicly available.
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spelling pubmed-29308522010-09-03 Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal Reveiz, Ludovic Chan, An-Wen Krleža-Jerić, Karmela Granados, Carlos Eduardo Pinart, Mariona Etxeandia, Itziar Rada, Diego Martinez, Monserrat Bonfill, Xavier Cardona, Andrés Felipe PLoS One Research Article BACKGROUND: Although randomized clinical trials (RCTs) are considered the gold standard of evidence, their reporting is often suboptimal. Trial registries have the potential to contribute important methodologic information for critical appraisal of study results. METHODS AND FINDINGS: The objective of the study was to evaluate the reporting of key methodologic study characteristics in trial registries. We identified a random sample (n = 265) of actively recruiting RCTs using the World Health Organization International Clinical Trials Registry Platform (ICTRP) search portal in 2008. We assessed the reporting of relevant domains from the Cochrane Collaboration's ‘Risk of bias’ tool and other key methodological aspects. Our primary outcomes were the proportion of registry records with adequate reporting of random sequence generation, allocation concealment, blinding, and trial outcomes. Two reviewers independently assessed each record. Weighted overall proportions in the ICTRP search portal for adequate reporting of sequence generation, allocation concealment, blinding (including and excluding open label RCT) and primary outcomes were 5.7% (95% CI 3.0–8.4%), 1.4% (0–2.8%), 41% (35–47%), 8.4% (4.1–13%), and 66% (60–72%), respectively. The proportion of adequately reported RCTs was higher for registries that used specific methodological fields for describing methods of randomization and allocation concealment compared to registries that did not. Concerning other key methodological aspects, weighted overall proportions of RCTs with adequately reported items were as follows: eligibility criteria (81%), secondary outcomes (46%), harm (5%) follow-up duration (62%), description of the interventions (53%) and sample size calculation (1%). CONCLUSIONS: Trial registries currently contain limited methodologic information about registered RCTs. In order to permit adequate critical appraisal of trial results reported in journals and registries, trial registries should consider requesting details on key RCT methods to complement journal publications. Full protocols remain the most comprehensive source of methodologic information and should be made publicly available. Public Library of Science 2010-08-31 /pmc/articles/PMC2930852/ /pubmed/20824212 http://dx.doi.org/10.1371/journal.pone.0012484 Text en Reveiz et al. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Reveiz, Ludovic
Chan, An-Wen
Krleža-Jerić, Karmela
Granados, Carlos Eduardo
Pinart, Mariona
Etxeandia, Itziar
Rada, Diego
Martinez, Monserrat
Bonfill, Xavier
Cardona, Andrés Felipe
Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal
title Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal
title_full Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal
title_fullStr Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal
title_full_unstemmed Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal
title_short Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal
title_sort reporting of methodologic information on trial registries for quality assessment: a study of trial records retrieved from the who search portal
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2930852/
https://www.ncbi.nlm.nih.gov/pubmed/20824212
http://dx.doi.org/10.1371/journal.pone.0012484
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