9 . Manuscript Formatting – Methods

The following heading should be used for the methods section, as appropriate:

  • Subjects and methods
  • Patients and methods
  • Materials and methods

Components of the methodology which need to be mentioned as applicable are:

  • Ethical review statement
  • Study design
  • Description of the selection of the observational or experimental subjects
  • Study setting
  • Study duration
  • Sampling method
  • Sample size calculations with references
  • Follow-up period
  • Inclusion and exclusion criteria
  • Identification of the methods and apparatus (provide the manufacturer's name and address in parenthesis)
  • Identification of all drugs and chemicals

Do not use sub-headings. Detail the methodology in an organised manner with paragraphs.

The Methods section should include the approval of the Institutional Review Board. If an ethics committee does not exist then the statement, that the research was conducted according to the principles of the Declaration of Helsinki should be included.

Selection and Description of Participants

The inclusion criteria of the study participants, which may be patients, healthy controls or healthy subjects, should be clearly described. Exclusion criteria need to be elaborated. The source of the study subjects should be included.

Technical Information

The primary and secondary objective of the study should be clearly stated. This is at times called the primary and secondary outcome.


Any equipment used in the study should give the manufacturer’s name and address. Procedures should be clearly described so as to facilitate others to reproduce them easily. References are necessary for to established methods, statistical methods, for already published methods not well-known, substantially modified methods with the reasons for using them, along with their limitations. All drugs and chemicals used should be stated in generic name(s), dose(s), and route(s) of administration.


The statistical methods should be described in a simple manner to enable a reader to judge the correctness of the analysis and results. State the statistical software package used along with the version. References should be included where appropriate.

Authors submitting systematic reviews should include a section describing the methods used for locating, selecting, extracting and synthesizing data. These methods should also be summarised in the abstract.

Note that the methodology and results are combined under one heading for the following article categories:

  • Short Report
  • Special Communication