Web-based Tool to Improve Reporting of Randomized Controlled Trials

NCT ID: NCT01891448

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-25
• Study Completion Date: 2015-09-22

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.

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.

Conditions

Randomized Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

WebCONSORT tool

Intervention Type: OTHER

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

This tool will include the flowchart part of the WEBCONSORT tool but not the main checklist or elements relating to CONSORT extensions.

Group Type: OTHER

Modified WebCONSORT tool

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Ravaud, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Paris Descartes

Locations

Université Paris Descartes

Paris, , France

University of Oxford

Oxford, , United Kingdom

Countries

France; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 27894295 (View on PubMed)

Other Identifiers

RAV008

Identifier Type: -

Identifier Source: org_study_id