Cargando…

Reporting of participant flow diagrams in published reports of randomized trials

BACKGROUND: Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams publ...

Descripción completa

Detalles Bibliográficos
Autores principales: Hopewell, Sally, Hirst, Allison, Collins, Gary S, Mallett, Sue, Yu, Ly-Mee, Altman, Douglas G
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3260171/
https://www.ncbi.nlm.nih.gov/pubmed/22141446
http://dx.doi.org/10.1186/1745-6215-12-253
_version_ 1782221450469441536
author Hopewell, Sally
Hirst, Allison
Collins, Gary S
Mallett, Sue
Yu, Ly-Mee
Altman, Douglas G
author_facet Hopewell, Sally
Hirst, Allison
Collins, Gary S
Mallett, Sue
Yu, Ly-Mee
Altman, Douglas G
author_sort Hopewell, Sally
collection PubMed
description BACKGROUND: Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. METHODS: A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. RESULTS: Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. CONCLUSIONS: Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented.
format Online
Article
Text
id pubmed-3260171
institution National Center for Biotechnology Information
language English
publishDate 2011
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-32601712012-01-18 Reporting of participant flow diagrams in published reports of randomized trials Hopewell, Sally Hirst, Allison Collins, Gary S Mallett, Sue Yu, Ly-Mee Altman, Douglas G Trials Research BACKGROUND: Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. METHODS: A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. RESULTS: Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. CONCLUSIONS: Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented. BioMed Central 2011-12-05 /pmc/articles/PMC3260171/ /pubmed/22141446 http://dx.doi.org/10.1186/1745-6215-12-253 Text en Copyright ©2011 Hopewell et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Hopewell, Sally
Hirst, Allison
Collins, Gary S
Mallett, Sue
Yu, Ly-Mee
Altman, Douglas G
Reporting of participant flow diagrams in published reports of randomized trials
title Reporting of participant flow diagrams in published reports of randomized trials
title_full Reporting of participant flow diagrams in published reports of randomized trials
title_fullStr Reporting of participant flow diagrams in published reports of randomized trials
title_full_unstemmed Reporting of participant flow diagrams in published reports of randomized trials
title_short Reporting of participant flow diagrams in published reports of randomized trials
title_sort reporting of participant flow diagrams in published reports of randomized trials
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3260171/
https://www.ncbi.nlm.nih.gov/pubmed/22141446
http://dx.doi.org/10.1186/1745-6215-12-253
work_keys_str_mv AT hopewellsally reportingofparticipantflowdiagramsinpublishedreportsofrandomizedtrials
AT hirstallison reportingofparticipantflowdiagramsinpublishedreportsofrandomizedtrials
AT collinsgarys reportingofparticipantflowdiagramsinpublishedreportsofrandomizedtrials
AT mallettsue reportingofparticipantflowdiagramsinpublishedreportsofrandomizedtrials
AT yulymee reportingofparticipantflowdiagramsinpublishedreportsofrandomizedtrials
AT altmandouglasg reportingofparticipantflowdiagramsinpublishedreportsofrandomizedtrials