Main Body

Background

The Background section should explain the background to the study, its aims, a summary of the existing literature and why this study is necessary or its contribution to the field.

Methods/Design

The methods section should include:

  • the aim, design and setting of the study
  • the characteristics of participants or description of materials
  • a clear description of all processes, interventions and comparisons. Generic drug names should generally be used. When proprietary brands are used in research, include the brand names in parentheses
  • the type of statistical analysis used, including a power calculation if appropriate.

Discussion

This should include a discussion of any practical or operational issues involved in performing the study and any issues not covered in other sections.