Web-based Tool to Improve Reporting of Randomized Controlled Trials

Randomized Controlled Trial Clinical Trial

— WebCONSORT  

Official title:

Impact of an Intervention Using a Web-based Tool to Improve the Reporting of Randomized Controlled Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891448
• Other study ID #: RAV008
• Status: Completed
• Phase: N/A
• Start date: March 25, 2013
• Est. completion date: September 22, 2015

Study information

• Verified date: September 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The CONSORT (Consolidated Standards of Reporting Trials) Statement (www.consort-statement.org) is an evidence based guideline which aims to improve the reporting of randomized controlled 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.We are conducting a multicentre randomized controlled trial to evaluate whether using a simple web-based tool (WebCONSORT) improves the completeness of reporting of clinical trials. To be eligible for inclusion in this study journals must 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. Participating journals ask authors to register their manuscript (at the revision stage of the manuscript) on the WebCONSORT website where he or she will be randomized into one of two groups (i.e. intervention and control). In the intervention group, authors will be directed to the WebCONSORT tool. The 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. The checklist of items generated by the WebCONSORT tool should then be reported in the revised paper and the completed checklist and flow diagram submitted to the journal along with the revised manuscript.In the control group, authors will be directed to a different version of the WebCONSORT tool. This tool will include the flowchart part of the WEBCONSORT tool but not the main checklist or elements relating to CONSORT extensions. The primary outcome measure is the percentage of poorly reported methodological items in the submitted manuscript. Secondary outcomes include time spent on the WEBCONSORT website, rejection rate of studies, feedback from authors and compliance rate. It is anticipated that the web-based tool will lead to improvements in the reporting and transparency of trial findings, thus aiding their critical appraisal and interpretation by readers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: September 22, 2015
• Est. primary completion date: September 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Randomized Controlled Trial

Intervention

Other:
• WebCONSORT tool
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.
• Modified WebCONSORT tool
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.

Locations

Country	Name	City	State
France	Université Paris Descartes	Paris
United Kingdom	University of Oxford	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	University of Oxford

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rejection rate	The rejection rate of articles by journal.	Following manuscript revision at 3 months
Other	Compliance rate	The compliance rate of the authors with submitting a checklist to the journal.	Following manuscript revision at 3 months
Other	Feedback	Feedback from authors on the review process after the editor's decision, and feedback from journal editors.	Following manuscript revision at 3 months
Primary	Completeness of reporting	The proportion of most poorly reported CONSORT items (initial and extensions) reported in each article.	Following manuscript revision at 3 months