Preparing a Systematic Review Protocol

Answer

Why is it necessary to write a protocol?

Starting any research project with a protocol is essential. This document outlines the research question, its significance, and the methodology for addressing it. Developing a protocol is crucial for ensuring that your research is thorough, ethical, practical, and reproducible.

Many journals, funding organizations, and research ethics committees now mandate the submission of a protocol before commencing research. Even if it's not a requirement, drafting a protocol can help you save time and resources, minimize research waste, maintain accountability, and ensure that you and your team are well-prepared.

What is the difference between a proposal and a protocol?

A proposal is a short overview, and a protocol is a detailed project management plan.

A proposal doesn’t have to be formal.  It’s a chance to define the review question. As more is learned about the topic, sometimes a question is reworked and refined.  A proposal usually includes title and author information, the review question, and its background, rationale, and importance.  It may include a request for funding/resources necessary for the project.

Librarians can help by identifying previous reviews or registered protocols on similar topics, as well as conducting preliminary literature searches. The beginning searching and planning will give you a sense of the scope of the literature and the feasibility of your project, prepping for the detailed protocol. The protocol should be completed by the team.

What should be included in a protocol?

The specific elements of a protocol can vary based on the type of study being conducted and whether the protocol will be published, registered, or used internally by the research team.

Regardless of these factors, drafting a protocol is excellent preparation for your final manuscript. Similar to a journal article, your protocol should outline your research question, provide background information on your topic, describe your data collection and analysis methods, and note any limitations. Additional details might include budget, timelines, safety and ethical considerations, selection criteria, or literature search plan.

After completing your protocol, consider publishing or registering it. This not only establishes your claim on the topic but also adds another publication to your CV.

Protocol Template

Knowledge Synthesis Protocol, this template is based on the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines from McGill University
Open Science Framework (OSF): Locating and Using the Scoping Review Protocol Template (5 min. YouTube video from NIH)
OSF Scoping Review Protocol Template and Guidance Documents: https://osf.io/ym65x

Protocol standards and forms

PRISMA for systematic review protocols (PRISMA-P) checklist
     Sarkis-Onofre R, Catalá-López F, Aromataris E, Lockwood C. How to properly use the PRISMA Statement. Syst Rev. 2021;10(1):117.
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement

Protocol writing advice and guidance

National Academies - Recommended Standards for Developing the Systematic Review Protocol
MECIR Manual - Developing the protocol of the review for new Cochrane Intervention Reviews
Cochrane Interactive Learning Module 2: Writing the review protocol
A Guide for Developing a Protocol for Conducting Literature Reviews from Model Systems Knowledge Translations Center (MSKTC)
This practical guide to Protocol Development for Systematic Reviews from Covidence offers a comprehensive resource for crafting systematic review protocols.
Essentials of Writing a Protocol for a Systematic Review (60 min. YouTube from Covidence)
OSF Scoping Review Protocol Template and Guidance Documents: https://osf.io/ym65x

Registering a protocol

PROSPERO International prospective register of systematic reviews
Start a Registration - Open Science Framework Registries
Pieper, D., Rombey, T. Where to prospectively register a systematic review. Syst Rev 11, 8 (2022). https://doi.org/10.1186/s13643-021-01877-1

  • Last Updated Apr 01, 2025
  • Views 11
  • Answered By Amy Nadell

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