Web-based Tool to Improve Reporting of Randomized Controlled Trials
WebCONSORT
Impact of an Intervention Using a Web-based Tool to Improve the Reporting of Randomized Controlled Trials
1 other identifier
interventional
324
2 countries
2
Brief Summary
The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the reporting of randomized trials. If trials are not well reported it is difficult for clinicians to use best evidence to inform clinical practice and patients may not get the best care. A number of different CONSORT extensions have been developed which specify additional information needed for more complex trials. The aim of this project is to evaluate whether using a simple web-based tool (WEBCONSORT) improves the reporting of clinical trials. The tool combines different CONSORT extensions and allows authors to obtain a checklist and flow diagram which is specific to their individual trial. In this study authors of participating journals are requested, at the manuscript revision stage, to use a web-based tool to improve the reporting of their randomized trial. Authors registering to use the tool are randomized to intervention or control. In the intervention group authors are directed to the WebCONSORT tool. In the control group, authors are directed to a different version of the WebCONSORT tool which includes the flow diagram part of the tool but not the main checklist or elements relating to CONSORT extensions. The aim is that this tool should lead to improvements in the reporting of randomized trials, making it easier for clinicians to read and interpret published findings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2013
CompletedFirst Submitted
Initial submission to the registry
May 24, 2013
CompletedFirst Posted
Study publicly available on registry
July 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2015
CompletedSeptember 17, 2018
September 1, 2018
2.5 years
May 24, 2013
September 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Completeness of reporting
The proportion of most poorly reported CONSORT items (initial and extensions) reported in each article.
Following manuscript revision at 3 months
Other Outcomes (3)
Rejection rate
Following manuscript revision at 3 months
Compliance rate
Following manuscript revision at 3 months
Feedback
Following manuscript revision at 3 months
Study Arms (2)
WebCONSORT tool
EXPERIMENTALThis WebCONSORT tool allows authors to combine different extensions relevant to their trial and generate a list of items and a flowchart specific to their trial design and the type of intervention tested.
Modified WebCONSORT tool
OTHERThis tool will include the flowchart part of the WEBCONSORT tool but not the main checklist or elements relating to CONSORT extensions.
Interventions
Authors are directed to the WebCONSORT tool. The tool allows authors to obtain a customized CONSORT checklist and flow diagram specific to their trial design (e.g., non-inferiority trial, pragmatic trial, cluster trial) and type of intervention (e.g., pharmacological or non pharmacological). The checklist items and flow diagram should then be reported in the manuscript and the completed checklist submitted to the journal along with the revision.
Authors are directed to a different version of the WebCONSORT tool. This tool includes the flow diagram part of the tool but not the main checklist or elements relating to CONSORT extensions.
Eligibility Criteria
You may qualify if:
- Journals which publish reports of randomized trials and endorse the CONSORT Statement (e.g. refer to it on the journal website) but do not actively implement it (e.g. require authors to submit a completed CONSORT checklist at the time of manuscript submission).
You may not qualify if:
- Journals which endorse the CONSORT Statement (e.g. refer to it on the journal website) and actively implement it (e.g. require authors to submit a completed CONSORT checklist at the time of manuscript submission).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- University of Oxfordcollaborator
Study Sites (2)
Université Paris Descartes
Paris, France
University of Oxford
Oxford, United Kingdom
Related Publications (1)
Hopewell S, Boutron I, Altman DG, Barbour G, Moher D, Montori V, Schriger D, Cook J, Gerry S, Omar O, Dutton P, Roberts C, Frangou E, Clifton L, Chiocchia V, Rombach I, Wartolowska K, Ravaud P. Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial. BMC Med. 2016 Nov 28;14(1):199. doi: 10.1186/s12916-016-0736-x.
PMID: 27894295DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Ravaud, PhD
Université Paris Descartes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2013
First Posted
July 3, 2013
Study Start
March 25, 2013
Primary Completion
September 22, 2015
Study Completion
September 22, 2015
Last Updated
September 17, 2018
Record last verified: 2018-09