Reporting clinical trials

Randomized controlled trials should be presented according to the CONSORT guidelines. At manuscript submission, authors must provide the CONSORT checklist accompanied by a flow diagram that illustrates the progress of patients through the trial, including recruitment, enrollment, randomization, withdrawal and completion, and a detailed description of the randomization procedure. The CONSORT checklist and template flow diagram are available online.

Registration of clinical trials

Registration in a public trials registry is a condition for publication of clinical trials in this journal in accordance with International Committee of Medical Journal Editors recommendations. Trials must register at or before the onset of patient enrolment. A clinical trial is defined as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects of health outcomes. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example drugs, surgical procedures, devices, behavioural treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.