Focus of Study = Medical WritingCOBWEBNCT02127567
The Evaluation of a CONSORT Based Online Writing Tool
A study testing online writing tool and writing with no specific support in people with Focus of Study = Medical Writing, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus of Study = Medical Writing
- What is being tested?
- online writing tool and writing with no specific support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults
- Masters or doctoral students
Who cannot join
- not in the field of medical research
- not adults
- no masters or doctoral level education
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of a CONSORT Based Online Writing Tool: a Randomized Controlled Trial
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.
Read the 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
- Conditions
- Focus of Study = Medical Writing
- Being tested
- online writing tool, writing with no specific support
- Keywords
- medical writing, reporting, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online writing toolOther
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 supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Online writing tool | Experimental | 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 Receives: Other: online writing tool |
| writing with no specific support. | Other | 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. Receives: Other: writing with no specific support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one time measure after a four-hour writing session
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one time four hour writing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus of Study = Medical WritingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Boutron, Professor, Study director, Public hospitals of Paris (APHP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127567
- Sponsor's protocol ID
- RAV009
- Acronym
- COBWEB
- Status last verified
- Apr 2014
- First submitted
- 29 Apr 2014
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26370288
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a CONSORT Based Online Writing Tool: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02127567
- Acronym / sponsor ID
- COBWEB / RAV009
- Conditions
- Focus of Study = Medical Writing
- Keywords
- medical writing, reporting, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Posted 20 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online writing tool | Experimental | Other: online writing toolParticipants 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 |
| writing with no specific support. | Other | Other: writing with no specific supportThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults
- Masters or doctoral students
Key exclusion criteria (3 listed)
- not in the field of medical research
- not adults
- no masters or doctoral level education
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online writing toolThe 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 | Online writing tool |
| writing with no specific supportThe 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. | Other | writing with no specific support. |
Primary outcome
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
7 secondary outcomes
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 for Blinding
Time frame: one time measure after a four-hour writing session
The Score for Completeness of Reporting for Participants
Time frame: one time measure after a four-hour writing session
The Score for Completeness of Reporting for Interventions
Time frame: one time measure after a four-hour writing session
The Score for Completeness of Reporting for Outcomes
Time frame: one time measure after a four-hour writing session
The Score for Completeness of Reporting for Trial Design
Time frame: one time measure after a four-hour writing session
Average Score for Completeness of Reporting of Essential Elements
Time frame: one time four hour writing session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26370288Barnes 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Boutron, Professor study director
Public hospitals of Paris (APHP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online writing tool and writing with no specific support in people with Focus of Study = Medical Writing, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.