Systematic Reviews: Creating a Protocol
What is a Protocol?
A protocol is the roadmap for your systematic review. You will develop your protocol at the very beginning of the process, before you begin your searches. Your protocol may change as you go through your review but it is important to create a thorough protocol to help guide your research process. Yes, you can edit the protocol once it has been submitted. Just submit an amendment to the protocol.
What is in a Protocol?
According to the PRISMA Standards:
1. Introduction detailing:
- Rationale
- Objectives
- Definitions
2. Methods
- Inclusion and Exclusion criteria
- Information Sources (Inclusion or exclusion of grey literature, the search strategy, and justification for inclusion or exclusion)
- Search Strategy
- Study selection process including how you will resolve disagreements
- Description of Data Management
- Data Collection Process
- Risk of BIAS analysis
- Data Synthesis
Learn More:
- Evidence Synthesis Protocol TemplateThis document is based on the PRISMA Statement (evidence-based minimum set of items for reporting in systematic reviews and meta-analyses) extensions for systematic review protocols and scoping reviews, and materials developed by The Campbell Collaboration (as referenced below).
- Preparation Checklist for Structured Literature ReviewsWriting a literature review for a research paper or as part of your thesis? Even if you’re not performing a full evidence synthesis, completing the items on this checklist and keeping them as record of your planned work (like a study protocol) ensures reproducibility, transparency, and reduction of bias.
More on Methods
A good methods section is narrative.
It will describe:
- Resources including interface
- date the search ended
- Describe the search overall, which concepts were included
- Describe limits
- Describe additional search strategies
You should also include at least one copy and pasted search.
The exact search string will be included in the appendix.
Registering your protocol
It is recommended that you register your systematic review protocol prior to conducting your review. This will improve transparency and reproducibility, but will also ensure that other research teams do not duplicate efforts.
A protocol documents the key points of your systematic review. A protocol should include a conceptual discussion of the problem and include the following:
- Rationale, background
- Definitions of your subject/topics
- The potential contribution of the review to clinical decision making
- Is there enough relevant literature to merit a systematic review/meta-analysis of studies
- Inclusion/exclusion criteria
- PICOS of interest (Population, Intervention, Comparison, Outcomes, Study types to be reviewed)
- Sources you will use to search the literature (& search syntax if possible)
- Screening methods
- Data extraction methods
- Methods to assess for bias
- Contact details
If you are working with the Cochrane or Campbell Collaborations, you will publish your protocol with those organizations. If you are working independently, consider registration with:
- Campbell Collaboration"The Campbell Collaboration promotes positive social and economic change through the production and use of systematic reviews and other evidence synthesis for evidence-based policy and practice."
Disciplines: Business and Management, Crime and Justice, Disability, Education, International Development, Knowledge Translation and Implementation, Methods, Nutrition, and Social Welfare - Cochrane"Our mission is to promote evidence-informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesized research evidence. Our work is internationally recognized as the benchmark for high-quality information about the effectiveness of health care."
Disciplines: Healthcare - Collaboration for Environmental Evidence"An open community of stakeholders working towards a sustainable global environment and the conservation of biodiversity. CEE seeks to promote and deliver evidence syntheses on issues of greatest concern to environmental policy and practice as a public service."
Disciplines: Environmental issues - Open Science FrameworkAn open source web application that connects and supports the research workflow. Researchers use the OSF to collaborate, document, archive, share, and register research projects, materials, and data. OSF can be used to pre-register a systematic review protocol and to share documents such as a Zotero library, search strategies, and data extraction forms.
Disciplines: Multidisciplinary - PROSPEROAn international database of prospectively registered systematic reviews in health and social care. Key features from the review protocol are recorded and maintained as a permanent record. (Does not accept scoping reviews)
Disciplines: Health and Social Care, Welfare, Public Health, Education, Crime, Justice, and International Development