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The Evaluation of a CONSORT Based Online Writing Tool

NCT02127567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-11-21

Study results available
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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.

Conditions

  • Focus of Study = Medical Writing

Interventions

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 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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Isabelle Boutron, Professor · Public hospitals of Paris (APHP)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127567 on ClinicalTrials.gov