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Systematic Reviews and Related Evidence Syntheses

What is a Protocol?

A protocol is a detailed outline and guiding document for your review. It outlines the rationale, research question, and methods before the review begins. A registered a priori protocol (in advance of the work) is a requirement for many publishers and a recommendation of others.

Why Protocols Are Necessary

 Prevents Bias

Defines methods before selection and analysis to minimize bias.

 Improves Transparency  

Clarifies review methods, supports reproducibility, and facilitates citation and feedback through protocol registration.

 Increases Efficiency

A clear plan streamlines the review process, prevents scope drift, and reduces redundancy.

Stages of Protocol Development


Plan & Identify

  • Select your reporting standard
  • Design the primary database search
  • Select and list additional databases to be searched

Evaluate, Collect & Combine

  • Screen articles (a preliminary set of 100 should suffice)
  • Develop and pilot quality appraisal (see tools in the "Risk of Bias & Synthesis Plan" tab below)
  • Develop and pilot data extraction
  • Determine how you will synthesize the studies

Explain, Summarize & Share

  • Write your protocol
  • Register your protocol
  • Get feedback

What Should a Protocol Include?

Identifying Information includes: 

  • A descriptive title that is specific to the review focus 
  • Members of review team, roles, and contact information
  • Sources of project support (if any)

Introduction 

  • Narrative description of background and rationale for review

  • Review question that includes all elements within the selected framework described in detail

Detailed inclusion and exclusion criteria. Consider: 

  • Population characteristics 

  • Types of interventions and comparators 

  • Outcomes of interest 

  • Study designs (e.g., RCTs, cohort, qualitative) 

  • Justifications for exclusions 

    • Recall that exclusions are exceptions to inclusion criteria (not just stated opposites of inclusion criteria)

  • Search strategy for the most relevant database: Include search terms, date range, language, and any other limits
  • Additional databases. Consider:
    • Databases used in similar reviews
    • Recommendations from your chosen conduct standard
  • Grey literature sources: Government reports, dissertations, organizational publications, unpublished studies, etc.
  • Hand-searching: Plan to manually search key journals or bibliographies
  • 🎥 Watch Designing Effective Systematic Searches (20 minutes) – video included on linked page
Your search should be comprehensive and aim for reproducibility.
Use both keywords and subject headings where available. A librarian can help you refine your strategy and choose the right databases.
  • How many reviewers will be involved in

    • Title/abstract screening

    • Full-text selection of studies

    • Data extraction

  • How will disagreements be settled at each phase?

  • How will citations/studies be divided? (division of labor within team)

  • List out characteristics that will be extracted from studies

  • What software will be used? (i. e. Covidence, Rayyan) 

  • How heterogeneity and sensitivity analyses will be addressed 

Guidance, Registration, Standards & Templates