Review Team & Roles | Steps to 3Complete | Writing the Protocol | Registering or Publishing the Protocol | Selecting Tools | Example Protocols
A clear plan and a protocol can hold you accountable and contribute to your success!
Continue reading for guidance on steps of an evidence synthesis review, project management, and protocol writing and publishing.
Review Team & Roles
As you begin your evidence synthesis review, consider who on your team will:
- Provide subject matter expertise and direction?
- Refinement of the research question, inclusion/exclusion criteria, and data to extract
- This is a great role for your Principal Investigator (PI), someone who knows the field
- Manage day-to-day operations?
- Sharing files, scheduling meetings, keeping the team on time and on the same page
- This role requires skills in organization, project management, and communication
- Conduct and document the literature search?
- Reach out to a NIH Librarian – we are search experts!
- Conduct review steps: screening, data extraction, and risk of bias assessment?
- Clear documentation and piloting the different review steps empowers team members to screen and extract data
- Requires familiarity with Excel or other data collection, cleaning, and analysis tools
- Methodological, statistical, and clinical expertise is required for risk of bias assessment
- Statistically analyze data, if conducting a meta-analysis?
- Consult with a statistician
- Write the manuscript?
- All co-authors should review, and agree to be accountable for, the final manuscript
- Who is an author? [International Committee of Medical Journal Editors]
- Some journals require description of Contributor roles according to CRediT
Steps to Complete
Evidence synthesis reviews involve a series of nine steps, presented in the table below.
Duration of each step and evidence synthesis review varies by team, type of review, and topic.
- Typical duration: 6–12 months [Smith et al., 2011; Borah et al., 2017; MGH LibGuide]
- Rapid reviews: Weeks to 6 months
The nine steps of an evidence synthesis review are presented in the table below. The Librarian will be part of the review team and will participate at different steps.
| Step | Description | Who's Involved |
|---|---|---|
| #1: Assess & assemble | Assess the need for your evidence synthesis review and the resources available to conduct the review Assemble your evidence synthesis review team | Librarian provides guidance on searching for previously published reviews and registered protocols Team assesses their skills and knowledge, as well as the resources and time available to conduct the review |
| #2: Question | Develop and refine the evidence synthesis review question | Subject matter expert and persons with lived/living experience inform the development of a meaningful question Librarian advises on frameworks for refining the research question Team discusses and operationalizes concepts in the research question for the purpose of the evidence synthesis review |
| #3: Protocol | Write and disseminate your protocol | Subject matter expert advises on overall direction for review process Librarian writes methods for search and provides feedback on protocol overall Entire team reviews and agrees to protocol Project manager submits or posts protocol |
| #4: Search | Work with a librarian to develop the search Request an update from your librarian only if significant time (more than 6 to 12 months) passed since initial search | Librarian develops methods for search, including database selection, then constructs and executes search Team provides feedback on the search strategy and results Librarian reruns the search, as needed |
| #5: Screen | Test and refine the process for selecting articles in a small pilot Update protocol to reflect any changes made during the pilot Review all titles and abstracts according to predefined criteria Retrieve full text for articles included by title and abstract Review article full text per protocol | Librarian advises on Covidence (evidence synthesis software) Research team pilots process of screening at title/abstract and full text (this does not include the Librarian) Project manager updates protocol, as needed to reflect changes made after pilot Research team selects articles by reading titles and abstracts against eligibility criteria (this does not include the Librarian) Subject matter expert or team resolves disputes NIH Library Document Delivery service retrieves documents unavailable in NIH Library collection Research team selects articles based on reading full text against eligibility criteria (this does not include the Librarian) |
| #6: Data collection | Test and refine the process for collecting data in a small pilot Then, collect data in included studies | Librarian points to resources and tools for data extraction Subject matter and methods experts guide data to extract Research team pilots the process of data collection (this does not include the Librarian) Project manager updates protocol, as needed, to reflect changes made after pilot Research team extracts data from included studies |
| #7: Risk of bias assessment | Test and refine the process for assessing study quality in a small pilot Assess risk of bias in included studies Not all evidence synthesis reviews include this step | Librarian points to resources and tools for risk of bias assessment Subject matter and methods experts guide selection of risk of bias assessment tool Research team pilots process of risk of bias assessment (this does not include the Librarian) Project manager updates protocol, as needed, to reflect changes made after pilot Research team members assess risk of bias in included studies |
| #8: Analysis & synthesis | Analyze and synthesize data according to protocol and research question | Research team analyzes and synthesizes data from included studies (this does not include the Librarian) |
| #9: Writing | Disseminate evidence synthesis review manuscript | Librarian writes methods and results for searching, creates PRISMA Flow Diagram, formats search strategies for supplemental materials Team members draft manuscript following PRISMA reporting guidelines or the appropriate PRISMA extension Entire team agrees to final manuscript |
Writing the Protocol
A good evidence synthesis review starts with a protocol. It serves as a road map for your review.
- Protocols are complete research plans shared with others in your field
- Why are systematic review protocols important? [Cochrane video, 6 minutes]
- Protocols do not specify the same level of detail as internal documents
- Protocols do contain:
- Research question or objectives: Invest time in defining the review question to improve clarity and communicate the value of your review [Cochrane video, 2 minutes]
- Background on the topic
- Rationale for the review
- Your team’s methods for conducting the review
- Primary outcomes of interest
- Protocols may contain a data management plan
- Use the Data Management Plan Template: Systematic Reviews to plan for archiving, preservation, and sharing of the review’s data
- Check for protocols on your research question and/or topic
- Reduce duplication. Is your intended review significantly different from available protocols? If no, consider a different question or research gap to answer
- Search PROSPERO a registry of systematic review and meta-analysis protocols, the Cochrane Database of Systematic Reviews, PubMed by type of review and topic, or journals that publish evidence synthesis protocols such as BMJ Open, Campbell Systematic Reviews, BMC Systematic Reviews, JMIR-Research Protocols, or JBI Evidence Synthesis
- Writing the protocol depends on the type of evidence synthesis review
- Systematic reviews and meta-analyses:
- Use PRISMA-P, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extensions for Protocols as an outline and the Explanation and Elaboration paper for additional details
- Cochrane Handbook for Systematic Reviews of Interventions: Section 1.5 Protocol development
- If you plan to register your systematic review protocol in PROSPERO, also check their registration form, which has additional fields to add to your protocol
- Scoping reviews:
- Use the template and guidance document developed by NIH Librarians and NIH Rehabilitation Medicine Fellows
- Refer to the JBI Manual for Evidence Synthesis (2024) chapter 10 section 2, "Development of a scoping review protocol" and JBI’s scoping review methodology resources
- Umbrella reviews:
- There is not a template or guide specific to rapid and umbrella reviews, but you can use the following as outlines and guides
- See Aromataris E, Fernandez R, Godfrey C, Holly C, Khalil H, Tungpunkom P. Chapter 9.2: Developing of an Umbrella Review Protocol. In: Aromataris E, Lockwood C, Porritt K, Pilla B, Jordan Z, editors. JBI Manual for Evidence Synthesis. JBI; 2024.
- Check Pollock M, Fernandes RM, Becker LA, Pieper D, Hartling L. Chapter V: Overviews of Reviews. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane, 2023.
- Rapid reviews:
- There is not a template or guide specific to rapid and umbrella reviews, but you can use the following as outlines and guides
- Use PRISMA-P, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extensions for Protocols as an outline and the Explanation and Elaboration paper for additional details
- Refer to Garritty C, Hamel C, Trivella M, Gartlehner G, Nussbaumer-Streit B, Devane D, Kamel C, Griebler U, King V, Updated recommendations for the Cochrane rapid review methods guidance for rapid reviews of effectiveness. BMJ 2024; 384 :e076335 doi:10.1136/bmj-2023-076335
- Systematic reviews and meta-analyses:
Selecting Tools
Protocols should identify the tools to be used in the evidence synthesis review. Many tools are available for conducting evidence synthesis reviews, and several are listed on Select, Collect & Synthesize webpage.
- Ask your NIH Librarian about evidence synthesis review tools available via the NIH Library
- Check with your IT department before using any external tools
- Review tool documentation before use
- Assess evidence regarding use of artificial intelligence in the review tool
Attend the NIH Library Training Developing and Publishing your Systematic Review Protocol and contact the NIH Library’s Evidence Synthesis Service for additional help and information.
Registering or Publishing the Protocol
Registering or publishing your review protocol is strongly recommended. Some journals (e.g. American Journal of Obstetrics and Gynecology, Addiction, Advances in Nutrition, Journal of Advanced Nursing and Lancet) require it!
- Disseminating your protocol increases accountability and helps reduce duplication
- Debating registration vs publication?
- Registration is less expensive and quicker
- Publication does result in an article for your CV but is time-consuming, as it involves editorial and peer review, and can require article processing charges (APCs)
- Register your protocol in PROSPERO or the Open Science Framework (OSF)
- Register systematic review protocols with PROSPERO
- Register protocols in OSF for any type of evidence synthesis review (Need help? Watch our registering your protocol on OSF video series.)
- Publish your protocol in journals, such as
The NIH Library also assists NIH and HHS staff with free editing and publication consultation services.
Example Protocols Co-authored by NIH Librarians
Here are a few protocols co-authored with NIH Librarians on the Evidence Synthesis Service. Talk to the NIH Librarian working with you on your review for additional examples of registered and published protocols.
- Maki KA, Alkhatib J, Butera G, Wallen GR. Examining the relationships between sleep physiology and the gut microbiome in preclinical and translational research: protocol for a scoping review. JMIR Res Protoc. 2022;11(6):e38605. Epub 20220621. doi: 10.2196/38605. PubMed PMID: 35727619; PubMed Central PMCID: PMC9257612.
- Ormiston CK, Chiangong J, Livinski A, Tompkins D, Williams F. COVID-19 pandemic and mental health among Hispanic/Latino/a immigrants in the USA: protocol for a scoping review. BMJ Open. 2023;13(12):e073687. Epub 20231212. doi: 10.1136/bmjopen-2023-073687. PubMed PMID: 38086590; PubMed Central PMCID: PMC10729216.
- Ude AO, De Baca TC, Dixon SA, Arboine SA, Terry NL, Chung ST. Transitioning care in youth-onset type 1 and type 2 diabetes: a scoping review protocol using the socio-ecological model framework. BMJ Open. 2022;12(10):e064186. Epub 20221027. doi: 10.1136/bmjopen-2022-064186. PubMed PMID: 36302582; PubMed Central PMCID: PMC9621196.