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Health Sciences Systematic Reviews

Guidance for conducting health sciences systematic reviews.

Guidelines for Protocols

Protocol Standards:

SR Manuals with Protocol Guidelines:

More resources are listed on the Standards & Guidelines page of this guide. 

Eligibility Criteria

A protocol is a detailed description of the objectives and methods, including eligibility criteria.

Eligibility criteria is # 8 on the PRISMA-P Checklist: 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.

Eligibility Criteria (define inclusion and exclusion criteria for each)
Criteria Example
Disease or condition Define and use explicit criteria for establishing their presence or absence.
Population Determined by factors such as age, sex, race, educational status or the presence of a particular condition.
Setting May focus on a particular setting, such as a community, hospital, nursing home, chronic care institution, or outpatient setting.
Intervention  Include interventions of interest and exclude any others. Consider what is delivered, who delivers it, how it is delivered, where it is delivered, when and how much is delivered, and whether the intervention can be adapted or tailored.
Comparison Alternatives against which the main intervention will be compared (e.g. another intervention, non-exposed control group, or placebo).
Outcomes Reporting of outcomes should rarely determine study eligibility for a review. However, in some circumstances, the measurement of certain outcomes may be a study eligibility criterion (e.g. when addressing the potential for an intervention to prevent a particular outcome or a specific purpose of an intervention that can be used in the same population for different purposes)
Study Design May include specific study designs and exclude others based on designs that best answer the research question
Publication Type Inclusion of both published peer-reviewed literature and unpublished studies and grey literature is recommended to decrease bias.
Publication Date Best practice is to not limit by date, but date ranges may be applied when updating a systematic review or when specific to an intervention or therapy.  
Publication Language Including studies in any language is recommended to reduce bias. If necessary (due to lack of funds/resources), limit to languages that can be read by the review team. 

It is common to amend protocols after the review has started.  Common reasons include extending the period of search to include older and newer studies, broadening eligibility criteria, and adding new analyses suggested by the primary analysis. Researchers should not modify the protocol based on knowledge of the results of analyses.  

Register Your Protocol

Registering or publishing your protocol before conducting the review is highly recommended and required to publish a completed review in many journals. PROSPERO is the most common platform for registering systematic review protocols, but you can publish in a journal or make available through websites and online registries as well.