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Protocols

Learning Objectives

This sub-chapter will help you:

  • understand what a protocol is and why they are important.
  • find guidance on how to write one and what to include.

A protocol “reduces the impact of review authors’ biases, promotes transparency of methods and processes, reduces the potential for duplication, allows peer review of the planned methods before they have been completed, and offers an opportunity for the review team to plan resources and logistics” (Lasserson et al., 2021, s. 1.5) 

According to Booth et al. (2022), “A protocol is the plan or methodology of the review and is designed so that your methods are protected against the risk of bias, ensures consistency within a review team, and stakes your claim to the topic” (p. 116). It describes why you are doing the review and how you plan to do it (Moher et al., 2015). Protocols vary depending on what type of review you are doing and are developed at the beginning of the review process. Scoping review protocols may need refining or alteration as the review progresses. Any changes to the protocol should be documented in the review. Systematic reviews usually require the protocol to be clearly defined and not changed.

What to include

The content of a protocol varies depending on your review type. In general, a protocol includes the:

  • introduction: including the research objectives and aims
  • search process: where you will search, a sample search strategy
  • screening process: inclusion and exclusion criteria, how agreement between reviewers will be reached, how quality and bias will be assessed if relevant
  • charting process: what data will be extracted and analysed

PRISMA-P is a checklist for reporting systematic review protocols that sets out what should be included and is a great way to make sure you consider everything required. If you are doing a scoping review, some elements will not be required, such as the risk of bias assessment methods, but you can still use the applicable parts.

Activity 3

PRISMA-P checklist

Registration

Many authors register their protocol to stake a “claim to the topic” (Booth et al., 2022, p. 116). It is more common to do this with systematic reviews, although scoping reviews can be registered as well. This helps make sure another team will not conduct the exact review you are doing, reducing the risk of unnecessary duplication. There are several places to register a protocol, although not all accept scoping review or student protocols:

Some peer reviewed journals accept review protocols for publication. Check the aims and scope of the journal.

Example

The following article is an example of a published systematic review protocol.

Sullivan, O., Trujillo, J., Curtin, M., Mahony, J. O., Flynn, R., & Cronin, C. (2023). The use of telehealth interventions to aid transition to self-management for adolescents with allergic conditions: A systematic review [Protocol]. PROSPERO. https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=402430 

Further reading

Shamseer, L., Moher, D., Clarke, M., Ghersi, D., Liberati, A., Petticrew, M., Shekelle, P., & Stewart, L. A. (2015). Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: Elaboration and explanation. BMJ, 349, Article g7647. https://doi.org/10.1136/bmj.g7647

References

Booth, A., Sutton, A., Clowes, M., & Martyn-St James, M. (2022). Systematic approaches to a successful literature review (3rd ed.). SAGE.  

Lasserson, T. J., Thomas, J., & Higgins, J.P.T. (2023). Starting a review. In J. P. T. Higgins, J. Thomas, J. Chandler, M. Cumpston, T. Li, M. J. Page, & V. A. Welch (Eds.), Cochrane handbook for systematic reviews of interventions (version 6.5). Cochrane. https://training.cochrane.org/handbook/current/chapter-01

Moher, D., Shamseer, L., Clarke, M., Ghersi, D., Liberati, A., Petticrew, M., Shekelle, P., Stewart, L. A., & Prisma-P. Group. (2015). Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Systematic Reviews, 4(1), Article 1. https://doi.org/10.1186/2046-4053-4-1  

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