The Evaluation of a CONSORT Based Online Writing Tool

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Focus of Study = Medical Writing

Intervention / Treatment
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* Other: online writing tool
* Other: writing with no specific support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Adults Masters or doctoral students Exclusion criteria not in the field of medical research not adults no masters or doctoral level education

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online writing tool<br>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<br>* 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.<br>|
| Other: writing with no specific support.<br>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<br>* 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.<br>|

What is the study measuring?
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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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical writing, reporting, randomized controlled trial