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

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.

Study Overview

• Status: Completed
• Conditions: Randomized Controlled Trial
• Intervention / Treatment: Other: WebCONSORT tool; Other: Modified WebCONSORT tool

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Université Paris Descartes
• United Kingdom
  • Oxford, United Kingdom
    • University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WebCONSORT tool; This 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.	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.
Other: Modified WebCONSORT tool; This tool will include the flowchart part of the WEBCONSORT tool but not the main checklist or elements relating to CONSORT extensions.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rejection rate	The rejection rate of articles by journal.	Following manuscript revision at 3 months
Compliance rate	The compliance rate of the authors with submitting a checklist to the journal.	Following manuscript revision at 3 months
Feedback	Feedback from authors on the review process after the editor's decision, and feedback from journal editors.	Following manuscript revision at 3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: University of Oxford
• Investigators: Principal Investigator: Philippe Ravaud, PhD, Université Paris Descartes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2013
• Primary Completion (Actual): September 22, 2015
• Study Completion (Actual): September 22, 2015

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: June 28, 2013
• First Posted (Estimate): July 3, 2013

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: RAV008