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

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ClinicalTrials.gov Identifier: NCT02127567
Recruitment Status : Completed
First Posted : April 30, 2014
Results First Posted : March 20, 2015
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Focus of Study = Medical Writing Other: online writing tool Other: writing with no specific support Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Official Title: The Evaluation of a CONSORT Based Online Writing Tool: a Randomized Controlled Trial
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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.

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127567


Locations
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France
Hotel Dieu, 1, place du parvis de notre dame
Paris, France, 75004
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Isabelle Boutron, Professor Public hospitals of Paris (APHP)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02127567     History of Changes
Other Study ID Numbers: RAV009
First Posted: April 30, 2014    Key Record Dates
Results First Posted: March 20, 2015
Last Update Posted: March 20, 2015
Last Verified: April 2014
Keywords provided by Assistance Publique - Hôpitaux de Paris:
medical writing, reporting, randomized controlled trial