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Systematic Reviews: Protocol

This guide is for the clinician undertaking a systematic review.

What is a protocol?

In the context of systematic reviews and meta-analyses, a protocol is a document that presents an explicit plan for a systematic review. The protocol details the rationale and a priori methodological and analytical approach of the review.

"The systematic review protocol is a detailed description of the objectives and methods of the review. The protocol should include information regarding the context and rationale for the review, primary outcomes of interest, search strategy, inclusion/exclusion criteria, data synthesis strategy, other aspects of the research plan."

For more information, see page #72 of Chapter 2"Standards for Initiating a Systematic Review." Institute of Medicine. Finding What Works in Health Care: Standards for Systematic Reviews. Washington, DC: The National Academies Press, 2011. doi:10.17226/13059.

Protocol development with PRISMA-P

The PRISMA-P checklist contains 17 items considered to be essential and minimum components of a systematic review or meta-analysis protocol. The final PRISMA-P 2015 checklist contains 17 numbered items (26 including sub-items) Items are categorized into three main sections: administrative information, introduction, and methods (Table 3).

  • This article also outlines items that should be included in a protocol:

Moher D et al. "Preferred reporting items for systematic and meta-analysis protocols(PRISMA-P) 2015 statement. Sys Rev. 2015 Jan 1;4:1.

Look for: “PRISMA-P” checklist or Table 3.

  • If you need more information about each section, see this article here:

Shamseer L, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015 Jan 2;349:7647. doi: 10.1136/bmj.g7647. ‚Äč

PRISMA-P 2015 checklist: recommended items to include in a systematic review protocol

Examples of protocols

You can find examples of protocols in the PROSPERO database.

You can type in any topic in the search box and should be provided a list of protocols on that topic.

PROSPERO's basics:
• Free to register
• Free to search
• Users create and update their own records
• Minimum data set required
• Record content is the responsibility of review lead
• Administrators check for “sense” not peer review
• A public audit trail of amendments is maintained
* Authors of systematic reviews are encouraged to add their protocol to PROSPERO. Click here for a PowerPoint presentation on how to register a systematic review on PROSPERO.