N/A
N=41
The Evaluation of a CONSORT Based Online Writing Tool
Focus of Study = Medical Writing
Bottom Line
View on ClinicalTrials.gov: NCT02127567 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: The Primary Outcome Will be the Average Score for Completeness of Reporting on a Scale of 0-10. — 7.1; 5.0 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- online writing tool (Other); writing with no specific support (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Will be the Average Score for Completeness of Reporting on a Scale of 0-10. |
7.1; 5.0 | <0.001 sig |
| SECONDARY The Score for Completeness of Reporting for Randomization |
8.4; 4.6 | <0.01 sig |
| SECONDARY The Score for Completeness of Reporting for Blinding |
6.9; 6.2 | 0.44 |
| SECONDARY The Score for Completeness of Reporting for Participants |
6.7; 4.5 | <0.01 sig |
| SECONDARY The Score for Completeness of Reporting for Interventions |
7.1; 5.3 | <0.01 sig |
| SECONDARY The Score for Completeness of Reporting for Outcomes |
6.1; 6.4 | 0.78 |
| SECONDARY The Score for Completeness of Reporting for Trial Design |
8.1; 2.7 | <0.01 sig |
| SECONDARY Average Score for Completeness of Reporting of Essential Elements |
7.8; 6.4 | 0.002 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02127567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.