Protocol of Systematic Review

Identification: Identify the report as a protocol of a systematic review

Update: If the protocol is for an update of a previous systematic review, identify as such

Registration: If registered, provide the name of the registry (such as PROSPERO) and registration number

Contact : Provide name, institutional affiliation, e-mail address of all protocol authors; provide physical mailing address of  corresponding author

Contributions: Describe contributions of protocol authors and identify the guarantor of the review

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

Sources: Indicate sources of financial or other support for the review

Sponsor: Provide name for the review funder and/or sponsor

Role of sponsor or funder: Describe roles of funder(s), sponsor(s), and/or institution(s), if any, in developing the protocol

Rationale: Describe the rationale for the review in the context of what is already known

Objectives: Provide an explicit statement of the question(s) the review will address with reference to participants, interventions, comparators, and outcomes (PICO)

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

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

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

Data management: Describe the mechanism(s) that will be used to manage records and data throughout the review

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)

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

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

Outcomes and prioritization: List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with rationale

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

Describe criteria under which study data will be quantitatively synthesised

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)

Describe any proposed additional analyses (such as sensitivity or subgroup analyses, meta-regression)

If quantitative synthesis is not appropriate, describe the type of summary planned

Meta-bias(es): Specify any planned assessment of meta-bias(es) (such as publication bias across studies, selective reporting within studies)

Confidence in cumulative evidence: Describe how the strength of the body of evidence will be assessed (such as GRADE)

It is strongly recommended that this checklist be read in conjunction with the PRISMA-P Explanation and Elaboration (cite when available) for important  clarification on the items. Amendments to a review protocol should be tracked and dated. The copyright for PRISMA-P (including checklist) is held by the PRISMA-P Group and is distributed under a Creative Commons Attribution Licence 4.0.