Introduction to protocols and protocol registration

What is a protocol?

• Like a blueprint for a house
• States your rationale, hypothesis, and planned methodology
• Created a priori
• Registered or shared/archived publically for transparency

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How much detail do I need?

PRISMA-P - Preferred Reporting Items for Systematic Reviews & Meta-analysis - for Protocols (http://www.prisma-statement.org/Extensions/Protocols )

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Chapter 5 (Protocols) in Campbell Systematic Reviews: Policies & guidelines

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JBI Systematic & Scoping Reviews: guidance for protocols for the different types of reviews

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Additional guidance for scoping reviews: Peters et al., (2022). Best practice guidance and reporting items for the development of scoping review protocols. JBI Evidence Synthesis, 20(4), 953-968. doi.org/10.11124/JBIES-21-00242

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PRISMA-P(rotocol)

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http://www.prisma-statement.org/Extensions/Protocols

Evidence Synthesis Protocol Templates

Ghezzi-Kopel, Kate, & Porciello, Jaron. (2020). Evidence synthesis protocol template. https://doi.org/10.17605/OSF.IO/ZWD6N

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JBI Scoping Review Template (Link will download a Word Doc)

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PROSPERO template (health-related systematic reviews): If registering on PROSPERO, download the template from their website (Link to PDF version)

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Evidence synthesis protocol registries for social, animal, food, and environmental sciences

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• Social sciences
• Protocols & reviews published in Campbell Systematic Reviews journal

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• Animal and food science protocols

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• Environmental sciences
• Protocols & reviews published in Environmental Evidence journal
• PROCEED repository for protocols

Protocol registries for evidence syntheses with health related outcomes

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• Health outcomes only
• No scoping reviews
• Currently prioritizing COVID-19 protocols

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• Health sciences
• Rigorous submission process
• Cochrane protocols cross-post to PROSPERO

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• Health sciences
• Register is for the use of JBI affiliated entities ONLY
• Systematic reviews

Registries, repositories and more

Protocol registries

• Open Science Framework Registries
• Protocols.io

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Repositories

• Institutional repositories
• Funder repositories
• Pre-print servers

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Open Science Framework: (collaboration space + registry)

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https://osf.io/

• Create your own project space
• Add collaborators
• Auto-generate a DOI
• Pre-register
• Disseminate your project URL
• Add other materials

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Take a look at the example review that you chose

Do the authors mention a protocol in the methods section of the article? Do they provide a link to the protocol?

Respond with:

• 1) Yes or No (respond in the poll)
• 2) If yes, where did they register/store their protocol? (respond in the chat)

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PROSPERO: A systematic review and meta-analysis of the efficacy of vitamin B in the management of diabetic peripheral neuropathy: Protocol

https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=135162

Collaboration for Environmental Evidence: What evidence exists on the impacts of chemicals arising from human activity on tropical reef-building corals? A systematic map protocol

https://environmentalevidencejournal.biomedcentral.com/articles/10.1186/s13750-020-00203-x

• The search strategies are poorly explained - why are they searching both Medline and PubMed? What are their main concepts and search terms?
• Participant inclusions and exclusions are vague, just adults or all ages?
• No details about how screening will be conducted

• There's only one AND in the search string
• The test list was a little confusing
• I was also surprised that 97% (56/58) of their test articles were found in WoS or Scopus.

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Campbell Collaboration: PROTOCOL: Does executive compensation predict publicly traded firms’ financial performance or inaccurate financial reporting?�https://onlinelibrary.wiley.com/doi/full/10.1002/cl2.1064

Open Science Framework: The State of the Literature on Individual and Household Resilience: A Scoping Review Protocol�https://osf.io/5rgb7/

• Shouldn’t titles/abstracts be agreed upon by the two reviewers? States if at least one reviewer votes include, then moves to full text
• A lot of grey literature searching and hand searching! When do we feel comfortable to stop?

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• They add a page for amendments
• They will do a three-step screening process, starting with a title-only screening.
• Odd that the protocol lists definitions of shocks and stressors, micro-scale, and human wellbeing, but nowhere does it explicitly define resilience.
• No search strategy in protocol, but includes searches from actual review

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More general comments

Who comes up with the data extraction worksheet? Must the final extraction method match exactly the one filed in the protocol? Can it be adapted after extraction begins?

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Using Google Scholar as a database is the wrong choice, as it will not allow the search strategy to be reproduced

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Final protocol for the scoping review appears to be posted with the final search strategies. Unclear whether the searches were conducted before the protocol was made public.

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The non-english results are not mentioned, what if they find something in French or other languages?

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Questions?

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