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Evidence Syntheses and Systematic Reviews: Protocols

Protocols

Protocols are detailed plans or blueprints that outline the methods and procedures to be followed during the conduct of evidence syntheses, and are an essential part of the process in systematic reviews. They serve as a predefined roadmap for the study and are developed before starting the actual data collection and analysis.  They describe the rationale, hypothesis, and planned methods of systematic reviews.

Detailed protocols should be made publicly available and registered (maintained as a permanent record) in protocol registries such as Campbell Collaboration, Cochrane, PROSPERO, and Open Science. This helps to avoid duplication and to enable the comparing of other review methods that have been reported, with the research plan in the protocol.

They help with improving transparency and reproducibility, and with preventing bias in the review process. They are used as a guide by the research team when conducting the research.

Protocols should generally include the following information:

  • Research question in detail (PICO (Patient/population, Intervention, Comparison, Outcomes), study design, setting, time frame) (this is the best point in the project to prevent "mission creep")
  • Rationale for the systematic review
  • Team members and their roles
  • Project timeline
  • Anticipated search terms, search strategies, and databases
  • Information sources to search
  • Frequency and means of communication between study team members (recommend regular intervals rather than after completion of phases to avoid the worst stalling of the project)
  • Inclusion/exclusion criteria for studies
  • Method for resolving disagreements (e.g.  on studies to be included)
  • Process for addressing shifts in study team membership, including time commitment shifts
  • Dissemination strategy: target conferences/journals

 

Protocol Registries 

Protocol registries were developed in response to a growing number of systematic reviews being written; they are supposed to prevent duplication of systematic reviews being conducted.

Standards

Standards are the generally accepted best practices and guidelines that should be followed when conducting a systematic review. These standards are established to ensure the quality and rigor of the review process, minimize bias, and enhance the transparency and reproducibility of the research.

There are Protocol Standards and Reporting Standards:  

Protocol Standards refer to the Standards used before reviews are conducted. 

Reporting Standards report the results of completed reviews.