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Systematic Reviews: Protocol and registration

By Paul Levett

Protocol & registration: PRISMA Item 5

A protocol documents the key points of your systematic review. A protocol should include a conceptual discussion of the problem and include the following:

  • Rationale, background
  • Potential contribution of the review to clinical decision making
  • Is there enough relevant literature to merit a systematic review/meta-analysis of studies
  • Inclusion/exclusion criteria
  • PICOS of interest (Population, Intervention, Comparison, Outcomes, Study types to be reviewed)
  • Sources you will use to search the literature (& search syntax if possible)
  • Screening methods
  • Data extraction methods
  • Methods to assess for bias
  • Contact details

The PRISMA group have devised a checklist of items to include in a systematic review protocol. An explanation of the items is on the PRISMA Protocols webpage.

It's also worth looking at example protocols in the PROSPERO database to see how they are written.

If you are undertaking a lengthy systematic review i.e. 1-2 years it would be a good idea to register the protocol in a registry like the PROSPERO database or in OSF so it can then be peer reviewed and to reduce unnecessary duplication of effort among researchers. If your review protocol has been registered you must indicate where it can be accessed, i.e. give the registration number & web address, or describe if you have had the protocol looked over by others e.g. AHRQ or people in your institution. 

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