The PRISMA-P guideline for writing a protocol of a systematic review.
About this guideline
This guideline is relevant to protocols of systematic reviews
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Reporting guidelines are best used early:
- Use a template to write quickly and avoid the blank page
- Use a checklist to double-check and reassure others that your work is described transparently
Guidance
Approx. 2 min read
Title
1a. Identification
Identify the report as a protocol of a systematic review
1b. Update
If the protocol is for an update of a previous systematic review, identify as such
Registration
2. Registration
If registered, provide the name of the registry (such as PROSPERO) and registration number
Amendments
4. Amendments
If the protocol represents an amendment of a previously completed or published protocol, identify as such and list changes; otherwise, state plan for documenting important protocol amendments
Support
5a. Sources
Indicate sources of financial or other support for the review
5b. Sponsor
Provide name for the review funder and / or sponsor
5c. Role of sponsor or funder
Describe roles of funder(s), sponsor(s), and / or institution(s), if any, in developing the protocol
Introduction
6. Rationale
Describe the rationale for the review in the context of what is already known
7. Objectives
Provide an explicit statement of the question(s) the review will address with reference to participants, interventions, comparators, and outcomes (PICO)
Methods
8. Eligibility criteria
Specify the study characteristics (such as PICO, study design, setting, time frame) and report characteristics (such as years considered, language, publication status) to be used as criteria for eligibility for the review
9. Information sources
Describe all intended information sources (such as electronic databases, contact with study authors, trial registers or other grey literature sources) with planned dates of coverage
10. Search strategy
Present draft of search strategy to be used for at least one electronic database, including planned limits, such that it could be repeated
11a. Study records - data management
Describe the mechanism(s) that will be used to manage records and data throughout the review
11b. Study records - selection process
State the process that will be used for selecting studies (such as two independent reviewers) through each phase of the review (that is, screening, eligibility and inclusion in meta-analysis)
11c. Study records - data collection process
Describe planned method of extracting data from reports (such as piloting forms, done independently, in duplicate), any processes for obtaining and confirming data from investigators
12. Data items
List and define all variables for which data will be sought (such as PICO items, funding sources), any pre-planned data assumptions and simplifications
13. Outcomes and prioritization
List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with rationale
14. Risk of bias in individual studies
Describe anticipated methods for assessing risk of bias of individual studies, including whether this will be done at the outcome or study level, or both; state how this information will be used in data synthesis
15a. Data synthesis
Describe criteria under which study data will be quantitatively synthesised
15b. Data synthesis
If data are appropriate for quantitative synthesis, describe planned summary measures, methods of handling data and methods of combining data from studies, including any planned exploration of consistency (such as I2, Kendall’s τ)
15c. Data synthesis
Describe any proposed additional analyses (such as sensitivity or subgroup analyses, meta-regression)
15d. Data synthesis
If quantitative synthesis is not appropriate, describe the type of summary planned
16. Meta-bias(es)
Specify any planned assessment of meta-bias(es) (such as publication bias across studies, selective reporting within studies)
17. Confidence in cumulative evidence
Describe how the strength of the body of evidence will be assessed (such as GRADE)