Trial Outcomes & Findings for The Evaluation of a CONSORT Based Online Writing Tool (NCT NCT02127567)
NCT ID: NCT02127567
Last Updated: 2023-11-21
Results Overview
Completeness of reporting will be determined according to a grading rubric individualized to each study protocol, 0 being the lowest and 10 the highest
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
one time measure after a four-hour writing session
Results posted on
2023-11-21
Participant Flow
Participant milestones
| Measure |
All Participants
All participants were asked to write the six parts or 'domains' of the methods section describing a randomized controlled trial. Each participant completed 3 parts or 'domains' with the tool and 3 without.
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.
|
|---|---|
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Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Evaluation of a CONSORT Based Online Writing Tool
Baseline characteristics by cohort
| Measure |
All Participants
n=41 Participants
|
|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Education
doctoral students
|
14 participants
n=5 Participants
|
|
Education
masters students
|
27 participants
n=5 Participants
|
|
Familiar with guidelines
Familiar with guidelines
|
24 participant
n=5 Participants
|
|
Familiar with guidelines
Not familiar with guidelines
|
17 participant
n=5 Participants
|
|
Frequency reading RCTs
More than once a year
|
30 Participants
n=5 Participants
|
|
Frequency reading RCTs
once a month
|
6 Participants
n=5 Participants
|
|
Frequency reading RCTs
Once a week
|
5 Participants
n=5 Participants
|
|
Experience writing RCTs
|
7 Participants
n=5 Participants
|
|
Taught about RCTs
|
38 Participants
n=5 Participants
|
|
Previously involved in RCTs
|
18 Participants
n=5 Participants
|
|
Comfortable with English
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one time measure after a four-hour writing sessionCompleteness of reporting will be determined according to a grading rubric individualized to each study protocol, 0 being the lowest and 10 the highest
Outcome measures
| Measure |
Online Writing Tool, Experimental Arm
n=123 domains
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
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, Control Arm
n=123 domains
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.
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.
|
|---|---|---|
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The Primary Outcome Will be the Average Score for Completeness of Reporting on a Scale of 0-10.
|
7.1 units on a scale
Standard Deviation 1.2
|
5.0 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: one time measure after a four-hour writing sessionThe score for completeness of reporting (0-10) for the manuscript section randomization, 0 being the lowest and 10 the highest
Outcome measures
| Measure |
Online Writing Tool, Experimental Arm
n=20 domains
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
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, Control Arm
n=21 domains
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.
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.
|
|---|---|---|
|
The Score for Completeness of Reporting for Randomization
|
8.4 units on a scale
Standard Deviation 2.4
|
4.6 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: one time measure after a four-hour writing sessionon a scale from 0 to 10, 0 being the lowest and 10 the highest
Outcome measures
| Measure |
Online Writing Tool, Experimental Arm
n=21 domains
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
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, Control Arm
n=20 domains
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.
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.
|
|---|---|---|
|
The Score for Completeness of Reporting for Blinding
|
6.9 units on a scale
Standard Deviation 2.4
|
6.2 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: one time measure after a four-hour writing sessionon a scale from 0 to 10, 0 being the lowest and 10 the highest
Outcome measures
| Measure |
Online Writing Tool, Experimental Arm
n=21 domains
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
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, Control Arm
n=20 domains
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.
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.
|
|---|---|---|
|
The Score for Completeness of Reporting for Participants
|
6.7 units on a scale
Standard Deviation 2.0
|
4.5 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: one time measure after a four-hour writing sessionon a scale from 0 to 10, 0 being the lowest and 10 the highest
Outcome measures
| Measure |
Online Writing Tool, Experimental Arm
n=20 Participants
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
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, Control Arm
n=21 domain
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.
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.
|
|---|---|---|
|
The Score for Completeness of Reporting for Interventions
|
7.1 units on a scale
Standard Deviation 1.5
|
5.3 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: one time measure after a four-hour writing sessionon a scale from 0 to 10, 0 being the lowest and 10 the highest
Outcome measures
| Measure |
Online Writing Tool, Experimental Arm
n=20 domain
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
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, Control Arm
n=21 domain
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.
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.
|
|---|---|---|
|
The Score for Completeness of Reporting for Outcomes
|
6.1 units on a scale
Standard Deviation 2.1
|
6.4 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: one time measure after a four-hour writing sessionon a scale from 0 to 10, 0 being the lowest and 10 the highest
Outcome measures
| Measure |
Online Writing Tool, Experimental Arm
n=21 domain
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
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, Control Arm
n=20 domain
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.
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.
|
|---|---|---|
|
The Score for Completeness of Reporting for Trial Design
|
8.1 units on a scale
Standard Deviation 2.3
|
2.7 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: one time four hour writing sessionCompleteness of reporting scores calculated based on essential elements to report, on a scale from 0 to 10, 0 being the lowest and10 the highest
Outcome measures
| Measure |
Online Writing Tool, Experimental Arm
n=123 domains
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
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, Control Arm
n=123 domains
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.
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.
|
|---|---|---|
|
Average Score for Completeness of Reporting of Essential Elements
|
7.8 units on a scale
Standard Deviation 1.6
|
6.4 units on a scale
Standard Deviation 2.3
|
Adverse Events
Online Writing Tool, Experimental Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Writing With no Specific Support, Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Isabelle Boutron
Assistance publique hopitaux de paris
Phone: +33 1 42 34 78 33
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place