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Systematic Reviews: Creating a Protocol

A Guide to Conducting Systematic Reviews

What is a Protocol?

A protocol is the roadmap for your systematic review. You will develop your protocol at the very beginning of the process, before you begin your searches. Your protocol may change as you go through your review but it is important to create a thorough protocol to help guide your research process. Yes, you can edit the protocol once it has been submitted. Just submit an amendment to the protocol.

What is in a Protocol?

According to the PRISMA Standards:

1. Introduction detailing:

  • Rationale
  • Objectives
  • Definitions

2. Methods

  • Inclusion and Exclusion criteria
  • Information Sources (Inclusion or exclusion of grey literature, the search strategy, and justification for inclusion or exclusion)
  • Search Strategy
  • Study selection process including how you will resolve disagreements
  • Description of Data Management
  • Data Collection Process
  • Risk of BIAS analysis
  • Data Synthesis

Learn More:

More on Methods

A good methods section is narrative.

It will describe:

  • Resources including interface
  • date the search ended
  • Describe the search overall, which concepts were included
  • Describe limits
  • Describe additional search strategies

You should also include at least one copy and pasted search. 

The exact search string will be included in the appendix.

Registering your protocol

It is recommended that you register your systematic review protocol prior to conducting your review. This will improve transparency and reproducibility, but will also ensure that other research teams do not duplicate efforts.

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
  • Definitions of your subject/topics
  • The 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

 If you are working with the Cochrane or Campbell Collaborations, you will publish your protocol with those organizations. If you are working independently, consider registration with:

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