Clinical trial NCT02127567: The Evaluation of a CONSORT Based Online Writing Tool
Official title: The Evaluation of a CONSORT Based Online Writing Tool: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study = Medical Writing
Keywords: medical writing, reporting, randomized controlled trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

Eligibility criteria: Inclusion Criteria

* Adults
* Masters or doctoral students

Exclusion criteria

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

Primary outcomes:
measure: The Primary Outcome Will be the Average Score for Completeness of Reporting on a Scale of 0-10.
timeFrame: one time measure after a four-hour writing session
Secondary outcomes:
measure: The Score for Completeness of Reporting for Randomization
timeFrame: one time measure after a four-hour writing session
measure: The Score for Completeness of Reporting for Blinding
timeFrame: one time measure after a four-hour writing session
measure: The Score for Completeness of Reporting for Participants
timeFrame: one time measure after a four-hour writing session
measure: The Score for Completeness of Reporting for Interventions
timeFrame: one time measure after a four-hour writing session
measure: The Score for Completeness of Reporting for Outcomes
timeFrame: one time measure after a four-hour writing session
measure: The Score for Completeness of Reporting for Trial Design
timeFrame: one time measure after a four-hour writing session
measure: Average Score for Completeness of Reporting of Essential Elements
timeFrame: one time four hour writing session
Other outcomes:
Locations:
city: Paris
country: France
facility: Hotel Dieu, 1, place du parvis de notre dame
Study officials:
affiliation: Public hospitals of Paris (APHP)
name: Isabelle Boutron, Professor
role: STUDY_DIRECTOR
References:
citation: Barnes C, Boutron I, Giraudeau B, Porcher R, Altman DG, Ravaud P. Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial. BMC Med. 2015 Sep 15;13:221. doi: 10.1186/s12916-015-0460-y.