Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.

<h4>Objective</h4>We assessed the adequacy of randomized controlled trial (RCT) registration, changes to registration data and reporting completeness for articles in ICMJE journals during 2.5 years after registration requirement policy.<h4>Methods</h4>For a set of 149 reports...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Mirjana Huić, Matko Marušić, Ana Marušić
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2011
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/5bf847ecd95046399d35d251c2e96ab7
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:5bf847ecd95046399d35d251c2e96ab7
record_format	dspace
spelling	oai:doaj.org-article:5bf847ecd95046399d35d251c2e96ab72021-11-04T06:08:06ZCompleteness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.1932-620310.1371/journal.pone.0025258https://doaj.org/article/5bf847ecd95046399d35d251c2e96ab72011-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21957485/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Objective</h4>We assessed the adequacy of randomized controlled trial (RCT) registration, changes to registration data and reporting completeness for articles in ICMJE journals during 2.5 years after registration requirement policy.<h4>Methods</h4>For a set of 149 reports of 152 RCTs with ClinicalTrials.gov registration number, published from September 2005 to April 2008, we evaluated the completeness of 9 items from WHO 20-item Minimum Data Set relevant for assessing trial quality. We also assessed changes to the registration elements at the Archive site of ClinicalTrials.gov and compared published and registry data.<h4>Results</h4>RCTs were mostly registered before 13 September 2005 deadline (n = 101, 66.4%); 118 (77.6%) started recruitment before and 31 (20.4%) after registration. At the time of registration, 152 RCTs had a total of 224 missing registry fields, most commonly 'Key secondary outcomes' (44.1% RCTs) and 'Primary outcome' (38.8%). More RCTs with post-registration recruitment had missing Minimum Data Set items than RCTs with pre-registration recruitment: 57/118 (48.3%) vs. 24/31 (77.4%) (χ(2) (1) = 7.255, P = 0.007). Major changes in the data entries were found for 31 (25.2%) RCTs. The number of RCTs with differences between registered and published data ranged from 21 (13.8%) for Study type to 118 (77.6%) for Target sample size.<h4>Conclusions</h4>ICMJE journals published RCTs with proper registration but the registration data were often not adequate, underwent substantial changes in the registry over time and differed in registered and published data. Editors need to establish quality control procedures in the journals so that they continue to contribute to the increased transparency of clinical trials.Mirjana HuićMatko MarušićAna MarušićPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 6, Iss 9, p e25258 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Mirjana Huić Matko Marušić Ana Marušić Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.
description	<h4>Objective</h4>We assessed the adequacy of randomized controlled trial (RCT) registration, changes to registration data and reporting completeness for articles in ICMJE journals during 2.5 years after registration requirement policy.<h4>Methods</h4>For a set of 149 reports of 152 RCTs with ClinicalTrials.gov registration number, published from September 2005 to April 2008, we evaluated the completeness of 9 items from WHO 20-item Minimum Data Set relevant for assessing trial quality. We also assessed changes to the registration elements at the Archive site of ClinicalTrials.gov and compared published and registry data.<h4>Results</h4>RCTs were mostly registered before 13 September 2005 deadline (n = 101, 66.4%); 118 (77.6%) started recruitment before and 31 (20.4%) after registration. At the time of registration, 152 RCTs had a total of 224 missing registry fields, most commonly 'Key secondary outcomes' (44.1% RCTs) and 'Primary outcome' (38.8%). More RCTs with post-registration recruitment had missing Minimum Data Set items than RCTs with pre-registration recruitment: 57/118 (48.3%) vs. 24/31 (77.4%) (χ(2) (1) = 7.255, P = 0.007). Major changes in the data entries were found for 31 (25.2%) RCTs. The number of RCTs with differences between registered and published data ranged from 21 (13.8%) for Study type to 118 (77.6%) for Target sample size.<h4>Conclusions</h4>ICMJE journals published RCTs with proper registration but the registration data were often not adequate, underwent substantial changes in the registry over time and differed in registered and published data. Editors need to establish quality control procedures in the journals so that they continue to contribute to the increased transparency of clinical trials.
format	article
author	Mirjana Huić Matko Marušić Ana Marušić
author_facet	Mirjana Huić Matko Marušić Ana Marušić
author_sort	Mirjana Huić
title	Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.
title_short	Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.
title_full	Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.
title_fullStr	Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.
title_full_unstemmed	Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.
title_sort	completeness and changes in registered data and reporting bias of randomized controlled trials in icmje journals after trial registration policy.
publisher	Public Library of Science (PLoS)
publishDate	2011
url	https://doaj.org/article/5bf847ecd95046399d35d251c2e96ab7
work_keys_str_mv	AT mirjanahuic completenessandchangesinregistereddataandreportingbiasofrandomizedcontrolledtrialsinicmjejournalsaftertrialregistrationpolicy AT matkomarusic completenessandchangesinregistereddataandreportingbiasofrandomizedcontrolledtrialsinicmjejournalsaftertrialregistrationpolicy AT anamarusic completenessandchangesinregistereddataandreportingbiasofrandomizedcontrolledtrialsinicmjejournalsaftertrialregistrationpolicy
_version_	1718445151156699136

Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.

Ejemplares similares