====== Systematic Review Protocol ======

A [[systematic review]] [[protocol]] is a predefined plan that outlines the rationale, objectives, and [[method]]s of a planned [[systematic review]].

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

=== Key Components ===
  * **Research question** (often in [[PICO]] format)
  * **Inclusion and [[exclusion criteria]]**
  * **Databases and search strategies**
  * **[[Data extraction]] and management plans**
  * **Risk of [[bias assessment tool]]s**
  * **Planned analyses** (including meta-analysis, if applicable)
  * **Timeline and dissemination plan**

=== Purpose ===
  * 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 [[https://www.crd.york.ac.uk/prospero/|PROSPERO]]

====== How to Perform a Systematic Review Protocol ======

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

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

=== Step-by-Step Process ===

==== 1. Define the Research Question ====
Use the [[pico|PICO format]]:
  * **P**opulation: Who is being studied?  
  * **I**ntervention: What is being tested?  
  * **C**omparator: What is the control or alternative?  
  * **O**utcome: What results are being measured?

==== 2. Register the Protocol ====
  * Recommended: [[https://www.crd.york.ac.uk/prospero/|PROSPERO]]
  * Includes title, background, methods, inclusion/exclusion criteria, and update strategy

==== 3. Develop the Search Strategy ====
  * Choose databases: e.g., PubMed/MEDLINE, Embase, Cochrane Library  
  * Include grey literature if needed  
  * Define search terms and Boolean operators

==== 4. Define Eligibility Criteria ====
  * Study design (e.g., RCTs, observational studies)  
  * Language and date limits  
  * Population characteristics  
  * Intervention and outcome specifics

==== 5. Plan the Study Selection Process ====
  * Use two independent reviewers  
  * Screening titles/abstracts → full texts  
  * Resolve conflicts through consensus or third reviewer

==== 6. Data Extraction ====
  * Create standardized extraction forms  
  * Collect data on:
    - Study characteristics  
    - Participants  
    - Interventions  
    - Outcomes  
    - Results

==== 7. Assess Risk of Bias ====
Use a [[bias_assessment_tool|risk of bias tool]] appropriate for the study design:
  * [[rob2|RoB 2]] for RCTs  
  * [[robins_i|ROBINS-I]] for non-randomized studies  
  * [[amstar2|AMSTAR 2]] for other reviews

==== 8. Plan the Data Synthesis ====
  * Qualitative (narrative) synthesis  
  * Quantitative synthesis (e.g., [[meta_analysis|meta-analysis]]) if data are comparable  
  * Subgroup or sensitivity analysis if applicable

==== 9. Ethics and Dissemination ====
  * Ethical approval not typically required for secondary data  
  * Plan for publishing in peer-reviewed journals or open-access platforms

=== Template Registration Fields (Example) ===
  * 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