The Evaluation of a CONSORT Based Online Writing Tool (COBWEB)

October 27, 2023 updated by: Assistance Publique - Hôpitaux de Paris

The Evaluation of a CONSORT Based Online Writing Tool: a Randomized Controlled Trial

Introduction: Inadequate reporting is a frequent cause of waste of research. For example, essential information for evaluating the risk of bias such as the method of randomization is lacking in 75% of published randomized controlled trials (RCTs), and over 30% of reports do not provide sufficient details to allow replication of the treatment evaluated in the trial in clinical practice. To overcome this issue, the CONSORT statement, an evidence-based, minimum set of recommendations for reporting RCTs was developed in 1996. These guidelines have since been updated in 2001 and more recently in 2010. In addition, extensions to the main CONSORT statement have been developed to give additional guidance for RCTs with specific designs (eg cluster), data (eg harm), and interventions (eg nonpharmacologic treatments). Many journals endorse the CONSORT statement. Some journals provide recommendations to authors to follow the CONSORT guidelines and some editors enforce the use of the CONSORT guidelines by requesting authors to submit a checklist in either the submission or acceptance stage. Nevertheless, inadequate reporting remains.

Our objective is to evaluate the impact of the CONSORT based online writing tool on the completeness of reporting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Context Inadequate reporting is a frequent cause of waste of research. For example, essential information for evaluating the risk of bias such as the method of randomization is lacking in 75% of published randomized controlled trials (RCTs), and over 30% of reports do not provide sufficient details to allow replication of the treatment evaluated in the trial in clinical practice. To overcome this issue, the CONSORT statement, an evidence-based, minimum set of recommendations for reporting RCTs was developed in 1996. These guidelines have since been updated in 2001 and more recently in 2010. In addition, extensions to the main CONSORT statement have been developed to give additional guidance for RCTs with specific designs (eg cluster), data (eg harm), and interventions (eg nonpharmacologic treatments). Many journals endorse the CONSORT statement. Some journals provide recommendations to authors to follow the CONSORT guidelines and some editors enforce the use of the CONSORT guidelines by requesting authors to submit a checklist in either the submission or acceptance stage. Nevertheless, inadequate reporting remains.

Hypothesis We hypothesize that to improve reporting, the CONSORT guidelines must be implemented at the stage of the writing of the manuscript instead of at the stage of journal submission or peer review process. We developed a CONSORT based online writing tool to improve the completeness of reporting. This tool focuses on some domains of the methods section of a 2-arm parallel group randomized controlled trial evaluating pharmacologic or nonpharmacologic treatment.

Objective Our objective is to evaluate the impact of the CONSORT based online writing tool on the completeness of reporting.

Methods Study design: We will perform a "split-manuscript" randomized controlled trial, adapted from the split-body design. We will consider 6 domains of the methods section: trial design, randomization, blinding, participants, interventions, and outcomes. The unit of randomization will be the domain and the allocation ratio 1:1. Each study participant will receive the experimental intervention (the tool) for 3 of the 6 domains and the control intervention (no tool) for thther 3 domains.

Participants: Masters and doctoral students Intervention: The use of the online writing tool for writing the methods section of an article from an RCT protocol.

Comparator: The writing the methods section of an article from an RCT protocol with no specific support.

Primary outcome: The primary outcome will be the average score for completeness of reporting.

Number of participants expected: 40

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75004
        • Hotel Dieu, 1, place du parvis de notre dame

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Adults
  • Masters or doctoral students

Exclusion criteria

  • not in the field of medical research
  • not adults
  • no masters or doctoral level education

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online writing tool
Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting
Other: online writing tool
The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided.
Other: writing with no specific support.
The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.
Other: writing with no specific support
The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary Outcome Will be the Average Score for Completeness of Reporting on a Scale of 0-10.
Time Frame: one time measure after a four-hour writing session
Completeness of reporting will be determined according to a grading rubric individualized to each study protocol, 0 being the lowest and 10 the highest
one time measure after a four-hour writing session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Score for Completeness of Reporting for Randomization
Time Frame: one time measure after a four-hour writing session
The score for completeness of reporting (0-10) for the manuscript section randomization, 0 being the lowest and 10 the highest
one time measure after a four-hour writing session
The Score for Completeness of Reporting for Blinding
Time Frame: one time measure after a four-hour writing session
on a scale from 0 to 10, 0 being the lowest and 10 the highest
one time measure after a four-hour writing session
The Score for Completeness of Reporting for Participants
Time Frame: one time measure after a four-hour writing session
on a scale from 0 to 10, 0 being the lowest and 10 the highest
one time measure after a four-hour writing session
The Score for Completeness of Reporting for Interventions
Time Frame: one time measure after a four-hour writing session
on a scale from 0 to 10, 0 being the lowest and 10 the highest
one time measure after a four-hour writing session
The Score for Completeness of Reporting for Outcomes
Time Frame: one time measure after a four-hour writing session
on a scale from 0 to 10, 0 being the lowest and 10 the highest
one time measure after a four-hour writing session
The Score for Completeness of Reporting for Trial Design
Time Frame: one time measure after a four-hour writing session
on a scale from 0 to 10, 0 being the lowest and 10 the highest
one time measure after a four-hour writing session
Average Score for Completeness of Reporting of Essential Elements
Time Frame: one time four hour writing session
Completeness of reporting scores calculated based on essential elements to report, on a scale from 0 to 10, 0 being the lowest and10 the highest
one time four hour writing session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Isabelle Boutron, Professor, Public hospitals of Paris (APHP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimated)

April 30, 2014

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RAV009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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