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Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial

BACKGROUND: Incomplete reporting is a frequent waste in research. Our aim was to evaluate the impact of a writing aid tool (WAT) based on the CONSORT statement and its extension for non-pharmacologic treatments on the completeness of reporting of randomized controlled trials (RCTs). METHODS: We perf...

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Autores principales: Barnes, Caroline, Boutron, Isabelle, Giraudeau, Bruno, Porcher, Raphael, Altman, Douglas G, Ravaud, Philippe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4570037/
https://www.ncbi.nlm.nih.gov/pubmed/26370288
http://dx.doi.org/10.1186/s12916-015-0460-y
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author Barnes, Caroline
Boutron, Isabelle
Giraudeau, Bruno
Porcher, Raphael
Altman, Douglas G
Ravaud, Philippe
author_facet Barnes, Caroline
Boutron, Isabelle
Giraudeau, Bruno
Porcher, Raphael
Altman, Douglas G
Ravaud, Philippe
author_sort Barnes, Caroline
collection PubMed
description BACKGROUND: Incomplete reporting is a frequent waste in research. Our aim was to evaluate the impact of a writing aid tool (WAT) based on the CONSORT statement and its extension for non-pharmacologic treatments on the completeness of reporting of randomized controlled trials (RCTs). METHODS: We performed a ‘split-manuscript’ RCT with blinded outcome assessment. Participants were masters and doctoral students in public health. They were asked to write, over a 4-hour period, the methods section of a manuscript based on a real RCT protocol, with a different protocol provided to each participant. Methods sections were divided into six different domains: ‘trial design’, ‘randomization’, ‘blinding’, ‘participants’, ‘interventions’, and ‘outcomes’. Participants had to draft all six domains with access to the WAT for a random three of six domains. The random sequence was computer-generated and concealed. For each domain, the WAT comprised reminders of the corresponding CONSORT item(s), bullet points detailing all the key elements to be reported, and examples of good reporting. The control intervention consisted of no reminders. The primary outcome was the mean global score for completeness of reporting (scale 0–10) for all domains written with or without the WAT. RESULTS: Forty-one participants wrote 41 different manuscripts of RCT methods sections, corresponding to 246 domains (six for each of the 41 protocols). All domains were analyzed. For the primary outcome, the mean (SD) global score for completeness of reporting was higher with than without use of the WAT: 7.1 (1.2) versus 5.0 (1.6), with a mean (95 % CI) difference 2.1 (1.5–2.7; P <0.01). Completeness of reporting was significantly higher with the WAT for all domains except for blinding and outcomes. CONCLUSION: Use of the WAT could improve the completeness of manuscripts reporting the results of RCTs. TRIAL REGISTRATION: Clinicaltrials.gov (http://clinicaltrials.govNCT02127567, registration date first received April 29, 2014) ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12916-015-0460-y) contains supplementary material, which is available to authorized users.
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spelling pubmed-45700372015-09-16 Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial Barnes, Caroline Boutron, Isabelle Giraudeau, Bruno Porcher, Raphael Altman, Douglas G Ravaud, Philippe BMC Med Research Article BACKGROUND: Incomplete reporting is a frequent waste in research. Our aim was to evaluate the impact of a writing aid tool (WAT) based on the CONSORT statement and its extension for non-pharmacologic treatments on the completeness of reporting of randomized controlled trials (RCTs). METHODS: We performed a ‘split-manuscript’ RCT with blinded outcome assessment. Participants were masters and doctoral students in public health. They were asked to write, over a 4-hour period, the methods section of a manuscript based on a real RCT protocol, with a different protocol provided to each participant. Methods sections were divided into six different domains: ‘trial design’, ‘randomization’, ‘blinding’, ‘participants’, ‘interventions’, and ‘outcomes’. Participants had to draft all six domains with access to the WAT for a random three of six domains. The random sequence was computer-generated and concealed. For each domain, the WAT comprised reminders of the corresponding CONSORT item(s), bullet points detailing all the key elements to be reported, and examples of good reporting. The control intervention consisted of no reminders. The primary outcome was the mean global score for completeness of reporting (scale 0–10) for all domains written with or without the WAT. RESULTS: Forty-one participants wrote 41 different manuscripts of RCT methods sections, corresponding to 246 domains (six for each of the 41 protocols). All domains were analyzed. For the primary outcome, the mean (SD) global score for completeness of reporting was higher with than without use of the WAT: 7.1 (1.2) versus 5.0 (1.6), with a mean (95 % CI) difference 2.1 (1.5–2.7; P <0.01). Completeness of reporting was significantly higher with the WAT for all domains except for blinding and outcomes. CONCLUSION: Use of the WAT could improve the completeness of manuscripts reporting the results of RCTs. TRIAL REGISTRATION: Clinicaltrials.gov (http://clinicaltrials.govNCT02127567, registration date first received April 29, 2014) ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12916-015-0460-y) contains supplementary material, which is available to authorized users. BioMed Central 2015-09-15 /pmc/articles/PMC4570037/ /pubmed/26370288 http://dx.doi.org/10.1186/s12916-015-0460-y Text en © Barnes et al. 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Barnes, Caroline
Boutron, Isabelle
Giraudeau, Bruno
Porcher, Raphael
Altman, Douglas G
Ravaud, Philippe
Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial
title Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial
title_full Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial
title_fullStr Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial
title_full_unstemmed Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial
title_short Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial
title_sort impact of an online writing aid tool for writing a randomized trial report: the cobweb (consort-based web tool) randomized controlled trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4570037/
https://www.ncbi.nlm.nih.gov/pubmed/26370288
http://dx.doi.org/10.1186/s12916-015-0460-y
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