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Evidence Synthesis (Systematic Reviews): Writing and Registering a Protocol

This guide is intended to provide information on conducting evidence synthesis reviews including systematic reviews

What is a protocol and why do I need one?

The review protocol is a critical document that outlines the methods and approach for conducting an evidence synthesis review, including eligibility criteria, data sources, and planned analysis. A registered or published protocol may be a requirement for publication, ensuring transparency, minimizing bias, and providing a guide for reproducibility. 

Benefits of having a protocol for evidence synthesis:

  • Saves time: Evidence synthesis is a lengthy process, with many steps and moving parts. Drafting a protocol is an opportunity to address questions and potential challenges before the hard work of searching, screening, data extraction, and analysis begins. Additionally, the protocol provides a clear set of instructions that team members can refer to as they move through the steps of the review, preventing time loss due to mistakes or misunderstandings. 
  • Ensures transparency: The protocol is an outline of the methods you intend to follow before you complete your review. It ensures that you are following a systematic and rigorous process and facilitates replication of the work. 
  • Reduces Bias:  Having a set of pre-specified criteria for study selection, data extraction, and analysis can prevent selective reporting of results and holds review teams accountable for justifying any deviations from the original plan. 
  • Is required by some publishers: Some journals require a registered protocol before considering an evidence synthesis review for publication.

A protocol generally includes the following information:

  • Title of the project
  • The research question that the review is seeking to address
  • The type of review (systematic, scoping, rapid, etc..) 
  • Information about the investigators and funders (if applicable)
  • The databases and/or grey literature that will be searched for relevant studies*
  • A preliminary search strategy (Ask a librarian for assistance!)
  • Inclusion and exclusion criteria for the identified studies
  • The methods and/or tools used to screen and extract data 
  • The data points or general information that will be extracted from each study
  • The tools used to assess the quality of the studies 
  • The way(s) in which the evidence will be presented or synthesized

Guidelines and Templates

The resources below include general guidelines and/or templates for writing an evidence synthesis protocol. Some protocol registries (see box to the right) may have their own guidelines/templates. 

Protocol Registries

What does it mean to have a "registered" protocol?

Registration or pre-registration simply means that you have saved your completed protocol to a database prior to starting your review.

When should I register my protocol? 

Ideally, you should register your protocol before the literature searches have been executed.  A protocol can be updated or changed if necessary. For example, you may need to update the search strategy to include new terminology or study filters, there may be new inclusion or exclusion criteria, or the roles of the team members may change. Most protocol registries will allow you to make updates and amendments. Be sure to keep track of these changes and provide a clear reason for making the change to maintain transparency.

IMPORTANT: Do not make changes to your protocol AFTER the data extraction phase, as this could be a source of bias.

How do I register my protocol? 

Some registries, like PROSPERO, only accept systematic review protocols, while others may include additional functionality to track any research project from start to finish. Some registries are free, but others require a fee for registration. Many registries provide a unique identifier or persistent hyperlink (like a DOI) so that you can share your protocol with journals and stakeholders. The registry you choose will depend on the type of review you are doing.

List of Registries That Accept Evidence Synthesis Protocols

Some journals will also accept and publish evidence synthesis protocols. Check the author guidelines for the journal you are considering or see our library guide on Health and Life Science Research: Publishing for links to journal finder resources. 

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