The Evaluation of a CONSORT Based Online Writing Tool

Not Applicable

Completed

Conditions: Focus of Study = Medical Writing

Interventions: Other: writing with no specific support
Other: online writing tool

Registration Number: NCT02127567

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary: 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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
writing with no specific support.	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.
Online writing tool	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

Primary Outcome Measures

Name	Time	Method
The Primary Outcome Will be the Average Score for Completeness of Reporting on a Scale of 0-10.	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

Secondary Outcome Measures

Name	Time	Method
The Score for Completeness of Reporting for Trial Design	one time measure after a four-hour writing session	on a scale from 0 to 10, 0 being the lowest and 10 the highest
The Score for Completeness of Reporting for Randomization	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
The Score for Completeness of Reporting for Participants	one time measure after a four-hour writing session	on a scale from 0 to 10, 0 being the lowest and 10 the highest
The Score for Completeness of Reporting for Blinding	one time measure after a four-hour writing session	on a scale from 0 to 10, 0 being the lowest and 10 the highest
The Score for Completeness of Reporting for Interventions	one time measure after a four-hour writing session	on a scale from 0 to 10, 0 being the lowest and 10 the highest
The Score for Completeness of Reporting for Outcomes	one time measure after a four-hour writing session	on a scale from 0 to 10, 0 being the lowest and 10 the highest
Average Score for Completeness of Reporting of Essential Elements	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