Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluating the Impact of Assessing During Peer Review the CONSORT Checklist Submitted by Authors: a Randomised Controlled Trial
Brief Summary: Randomised trials are considered the gold standard in medical research. The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the quality of reporting of randomised trials. Without transparent reporting, readers cannot judge the reliability and validity of trial findings, and therefore these findings cannot inform clinical practice. Different stakeholders, including biomedical journals, have taken different actions to try to improve author adherence to CONSORT. The most popular action among biomedical journals is to instruct authors to submit a completed RG checklist with page numbers indicating where the CONSORT items are addressed when they submit their manuscript. However, this measure alone has been proven not to be effective. In this study, the investigators intend to evaluate in a real editorial context whether assessing during peer review the consistency between the submitted CONSORT checklist and the information reported in the manuscripts of randomised trials, as well as to provide feedback to authors on the inconsistencies found, improves the completeness of reporting of published trials.


Options:
A: Inclusion Criteria:

Manuscripts will be eligible if:

* They have been submitted to BMJ Open,
* They are original research submissions reporting the results of a randomised trial, and
* They have passed the first editorial filters and have been subsequently sent out for peer review.
* Authors of these manuscripts have provided a completed CONSORT checklist.

According to the official CONSORT extensions, the investigators will also consider other study designs (cluster, non-inferiority and equivalence, pragmatic, N-of-1 trials, Pilot and feasibility, and within person trials), and different intervention types (Herbal, non-pharmacologic, acupuncture and Chinese herbal medicine formulas) in all areas of clinical specialty.

Exclusion Criteria:

* Protocols of randomised trials
* Secondary trial analysis studies
B: Inclusion criteria for journals:

It was planned from the beginning that this study will only be conducted at the BMJ Open as it publishes numerous protocols. Hence, no inclusion criteria for the journal were specified.

Inclusion criteria for manuscripts:

All submitted manuscripts sent out for external review that described protocols for RCTs.

Exclusion criterial for manuscripts:

We excluded (i) Manuscripts which were clearly labelled as a pilot or feasibility study (ii) Studies randomizing animals or cells (iii) Separate publications of data analysis plans

Included peer-reviewers:

-Peer reviewers that were invited following usual journal practice
C: 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
D: Inclusion Criteria:

* master students,
* PhD students,
* residents involved in clinical research during their study,
* clinicians who have never reviewed a manuscript

Exclusion Criteria:

* none

Answer: A