Adequate Reporting in Randomized Controlled Trials
Conditions
Brief summary
Transparent and accurate reporting is key, so that readers can adequately interpreting the results of a study. Despite improvement with implementation of the CONSORT Statement (CONsolidated Standards for Reporting Trials), there remain major reporting deficiencies in published randomized controlled trials (RCT). The aim of this project is to evaluate whether reminding peer reviewers of the most important CONSORT items (including a short explanation of those items) will result in higher adherence to CONSORT guidelines in published RCTs. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the CONSORT checklist including the ten most important and poorly reported CONSORT items as defined by a group of experts of the CONSORT Statement (C-short); or (ii) no checklist. The aim is to find an intervention which improves the reporting, making it easier for readers to adequately interpret the presented results.
Detailed description
The CONSORT Statement (CONsolidated Standards for Reporting Trials), is perhaps the most important reporting guideline designed to help improve the transparency and quality of reporting of randomized controlled trials. Despite some improvement in reporting following the implementation of the CONSORT Statement, there still remain major reporting deficiencies in published RCTs. The investigators are conducting a multicentre randomized controlled trial to evaluate whether reminding peer reviewers of the most important CONSORT items (including a short explanation of those items) will result in higher adherence to CONSORT guidelines in published RCTs. During the standard peer-review process, peer-reviewers will be randomly allocated to use either (i) a short version of the CONSORT checklist including the ten most important and poorly reported CONSORT items as defined by a group of experts of the CONSORT Statement (C-short plus usual practice); or (ii) no checklist (usual practice). The primary outcome of this study will be the difference of the mean proportion of adequately reported items of the 10 most important and poorly reported CONSORT items between the two intervention arms. The Full protocol is available on Open Science Framework where the study was prospectively registered (https://osf.io/c4hn8)
Interventions
OTHERC-short plus usual practice
Peer reviewer will be reminded of the following 10 CONSORT items (including a short description): * Outcomes (6a) * Sample size (7a) * Sequence generation (8a) * Allocation concealment (9) * Blinding (11a) * Outcomes and estimation (17a/b) * Harms (19) * Registration (23) * Protocol (24) * Funding (25)
Sponsors
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Included journals must: * Endorse the CONSORT Statement (e.g. assessed via journals Instruction to Authors); * Publish primary results of at least five RCTs in 2017 (identified in a brief PubMed search as publishing RCTs in 2017) Included Manuscript must: -Report primary results of an RCTs for which the journal decides to send out for external peer review (since the 10 chosen CONSORT checklist items are applicable to different study designs, the investigators will include all RCTs regardless of study design \[e.g. parallel group trial, cluster trial, superiority trial, non-inferiority trial\]).
Exclusion criteria
* Articles presenting clearly secondary trial results. * Articles presenting clearly additional time points and not the time point where the primary result was measured. * Economic analyses * Any other analyses derived from an RCT dataset not including the study's main results -- -RCTs which are clearly labelled as a pilot or feasibility study * RCTs randomising animals or cells instead of individuals Included peer-reviewers: -Peer reviewers that were invited following usual journal practice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of reporting | Through study completion, an average of 1 year | The primary outcome of this study will be the difference of the mean proportion of adequately reported items of the 10 most important and poorly reported CONSORT items between the two intervention arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of reporting | Through study completion, an average of 1 year | Mean proportion of adequate reporting of the 10 most important and poorly reported CONSORT items, considering each sub-item (see also Assessment of outcomes) as a separate item. |
| Time from assigning an academic editor until the first decision (as communicated to the author after the first round of peer-review). | Through study completion, an average of 4 months; will be assessed from routinely collected data | — |
| Proportion of articles directly rejected after the first round of peer-review | Through study completion, an average of 4 months; will be assessed from routinely collected data | — |
| Proportion of articles published | Through study completion, an average of 9 months; will be assessed from routinely collected data | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Peer reviewer comments for any reference to CONSORT and trial reporting | Assessed from available peer-reviewer responses; on average 3 months after randomisation | For journals where peer reviewer comments are subsequently published alongside the published article, the investigators will examine the peer reviewer comments for any reference to CONSORT and trial reporting. |
Countries
United Kingdom, United States
Outcome results
None listed