A systematic review protocol is a predefined plan that outlines the rationale, objectives, and methods of a planned systematic review.

It serves as a methodological roadmap and helps ensure transparency, rigor, and reproducibility in evidence synthesis.

• Research question (often in PICO format)
• Inclusion and exclusion criteria
• Databases and search strategies
• Data extraction and management plans
• Risk of bias assessment tools
• Planned analyses (including meta-analysis, if applicable)
• Timeline and dissemination plan

• Minimize bias by committing to a methodology before knowing the results
• Facilitate peer review and external input early in the process
• Allow for registration in platforms like PROSPERO

A systematic review protocol is a structured plan that outlines how a systematic review will be conducted. It helps minimize bias and ensures transparency and reproducibility.

This guide follows standard methodology recommended by PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols).

Use the PICO format:

• Population: Who is being studied?
• Intervention: What is being tested?
• Comparator: What is the control or alternative?
• Outcome: What results are being measured?

• Recommended: PROSPERO
• Includes title, background, methods, inclusion/exclusion criteria, and update strategy

• Choose databases: e.g., PubMed/MEDLINE, Embase, Cochrane Library
• Include grey literature if needed
• Define search terms and Boolean operators

• Study design (e.g., RCTs, observational studies)
• Language and date limits
• Population characteristics
• Intervention and outcome specifics

• Use two independent reviewers
• Screening titles/abstracts → full texts
• Resolve conflicts through consensus or third reviewer

• Create standardized extraction forms
• Collect data on:
  1. Study characteristics
  2. Participants
  3. Interventions
  4. Outcomes
  5. Results

Use a risk of bias tool appropriate for the study design:

• RoB 2 for RCTs
• ROBINS-I for non-randomized studies
• AMSTAR 2 for other reviews

• Qualitative (narrative) synthesis
• Quantitative synthesis (e.g., meta-analysis) if data are comparable
• Subgroup or sensitivity analysis if applicable

• Ethical approval not typically required for secondary data
• Plan for publishing in peer-reviewed journals or open-access platforms

• Title
• Background and rationale
• Objectives
• Eligibility criteria
• Information sources and search strategy
• Data management
• Selection and extraction process
• Bias assessment
• Strategy for data synthesis
• Timeline