Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R62779/RE001 | Other Identifier | MEDICAL SCIENCES INTERDIVISIONAL RESEARCH ETHICS COMMITTEE, University of Oxford | |
| P300PB_177933 | Other Grant/Funding Number | Swiss National Science Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-short plus usual practice | Experimental | After accepting to review an article, peer reviewers will receive the automated, journal specific standard email with general information as per each journal's usual practice (e.g. where to access the manuscript, date when the peer review report is due). In addition, peer-reviewers who received a manuscript which was randomised to C-short will receive an additional email including a short version of the CONSORT checklist together with a short explanation of those items. |
|
| Usual practice | No Intervention | After accepting to review an article, peer reviewers will receive the automated, journal specific standard email with general information as per each journal's usual practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-short plus usual practice | Other | Peer reviewer will be reminded of the following 10 CONSORT items (including a short description):
|
| Measure | Description | Time Frame |
|---|---|---|
| Completeness of reporting | 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. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Completeness of reporting | 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. | Through study completion, an average of 1 year |
| Completeness of reporting |
| Measure | Description | Time Frame |
|---|---|---|
| Peer reviewer comments for any reference to CONSORT and trial reporting | 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. | Assessed from available peer-reviewer responses; on average 3 months after randomisation |
Inclusion Criteria:
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:
Included peer-reviewers:
-Peer reviewers that were invited following usual journal practice
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sally Hopewell, Ass. Prof | Centre for Statistics in Medicine, Oxford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Library of Science (PLOS) | San Francisco | California | 94111 | United States | ||
| The BMJ Publishing Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37294569 | Derived | Speich B, Mann E, Schonenberger CM, Mellor K, Griessbach AN, Dhiman P, Gandhi P, Lohner S, Agarwal A, Odutayo A, Puebla I, Clark A, Chan AW, Schlussel MM, Ravaud P, Moher D, Briel M, Boutron I, Schroter S, Hopewell S. Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles: Primary Results of 2 Randomized Trials. JAMA Netw Open. 2023 Jun 1;6(6):e2317651. doi: 10.1001/jamanetworkopen.2023.17651. |
Not provided
Not provided
The investigators plan to publish the anonymised data set together with the main publication.
The investigators plan to submit the study protocol to a peer reviewed journal in 2019.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Mean proportion for each of the 10 most important and poorly reported CONSORT items separately (including also separate analysis of sub-items). |
| Through study completion, an average of 1 year |
| 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 |
| London |
| United Kingdom |