Systematic Reviews: Step 2: Develop a Protocol
Created by Health Science Librarians
About Step 2: Develop a Protocol
In Step 2, you will write your systematic review protocol. This is a detailed work plan for your systematic review. You will:
- Define the criteria you will use to screen literature.
- Decide where and how you will search for literature.
- Choose quality assessment tools to evaluate the literature.
- Decide how you will extract data from the articles you include.
- Upload your protocol to a website or registry to make it available to the public.
This page has checklists and templates to help you write your protocol. Librarians can help you refine your protocol based on systematic review best-practices.
Click an item below to see how it applies to Step 2: Develop a Protocol.
For PRISMA, there are specific items you will want to report in your protocol. For this step, review the PRISMA-P standards and the explanation document.
Covidence is a tool that can be used for screening, quality assessment, and data extraction. Decisions made in this stage will inform the logistics and completion of future review steps. Specify the use of Covidence in the protocol, if applicable, and note team member roles for these tasks.
When writing your protocol, a librarian can help you:
- Develop and refine your research plan according to systematic review best practices
- Advise on your literature searching methods documentation
- Determine if/where to publish or share your completed protocol
Do I need to write a protocol?
What is a protocol?
A protocol is a detailed work plan that describes how and why you are doing a systematic review. It includes your rationale and objectives, how you will search for literature, and how you will screen and synthesize what you find. It is best practice to develop a protocol and make it publicly available before starting a systematic review.
Why should you write a protocol?
Your protocol will help your team navigate the systematic review process. It will also show readers how your completed systematic review might be different from your plan. This can help them understand whether there is any bias in your review results and conclusions.
Uploading your protocol
You can upload a review protocol to a website or registry and make it accessible so researchers can know what reviews are planned or in process. While not an inclusive list, several options of places to upload or deposit your protocol can be found in our Protocol FAQ.
Writing a protocol
Writing a Review Protocol: Good Practice and Common Errors
HSL Protocol Template
What to Include
Many elements of a systematic review will need to be detailed in advance in the protocol. An example of items included in the protocol are:
- Team members
- Rationale and objectives of the review
- Eligibility criteria (also referred to as inclusion and exclusion criteria)
- Databases and key terms of the literature search (ideally, a full search strategy for at least one database)
- Process and tools for study selection (screening), quality assessment, and data extraction
- Data items that will be extracted
- Methods of data synthesis
- and more!
Use PRISMA to write your protocol
PRISMA is a set of standards about what to include in your systematic review. PRISMA 2015 has a special extension specifically for the best protocol reporting methods. The documents linked below (PRISMA-P Statement, E&E, and PRISMA-P Checklist) provide detailed instructions about how to write a good protocol.
- PRISMA-P 2015 StatementPRISMA reporting guideline for systematic review protocols.
- PRISMA-P 2015 E&EPRISMA-P Elaboration & Explanation document of the 2015 Statement (includes examples).
- PRISMA-P 2015 ChecklistChoose between PDF and Word versions of the PRISMA-P 2015 Checklist
Templates
- UNC HSL Systematic Review Protocol TemplateWord document protocol template for systematic review protocols adapted from the PRISMA-P checklist
- Review Protocol Template by Sarah VistintiniA downloadable Word document that can be used to draft a systematic review protocol
- Evidence Synthesis Protocol TemplateA downloadable Word document that can be used to create a systematic review protocol
- PROSPERO Protocol Registration FormA PDF of the PROSPERO registration form
- Open Science Framework (OSF) Systematic Review ProtocolOpen Science Framework's (OSF) protocol template for preregistering systematic reviews, scoping reviews, and meta-analyses
Make your protocol visible
You can upload your protocol to a website or registry and make it available to others. There are several places to upload or deposit your protocol listed below. Alternatively, some journals publish systematic review protocols. If you plan to publish your protocol in a journal, make sure to check the protocol requirements on the journal website before submitting.
Compare protocol registries to see which tool might meet your needs.
- PROSPEROInternational prospective register of systematic reviews. Free.
- Open Science Framework (OSF)Open repository for scientific research. Free.
- Carolina Digital RepositoryLong-term storage and access for scholarly works, datasets, research materials and records produced by the UNC-CH community (free). Choose "Other Deposits" and then select "Poster, Presentation, Protocol, or Paper".
- Research RegistryRegister all types of research studies, from ‘first in man’ case reports to observational/interventional studies to systematic reviews and meta-analyses. Not free.
- INPLASY- The International Platform of Registered Systematic Review and Meta-analysis ProtocolsAn international database created to help researchers around the world to register their systematic review protocols. Not free.
- Protocols.ioA secure platform for developing and sharing reproducible methods. Create a protocol, collaborate with your team, then run as a checklist. Free.