- CONSORT 2010
- checklist of information to include when reporting a randomised trial
Title and abstract
Identification as a randomised trial in the title
Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)
Introduction: Background and Objectives
- Scientific background and explanation of rationale.
- Specific Objecives or hypothesis
Methods
- Trial Design
- Description of trial design (such as parallel, factorial) including allocation ratio
- Important changes to methods after trial commencement (such as eligibility criteria), with reasons
- Participants
- Eligibility criteria for participants
- Settings and locations where the data were collected