According to Cochrane (n.d.) a protocol is a plan or set of steps to be followed in a study. It is the pre-defined plan you must adhere to in order to conduct your knowledge syntheses in a transparent and reproducible way. The protocol is your work plan and guidance throughout your review.
The protocol "outlines the question that the review authors are addressing, detailing the criteria against which studies will be assessed for inclusion in the review, and describing how authors will manager the review process....The protocol outlines the process for identifying, assessing, and summarizing the studies in the review. By making this information available, the protocol is a public record of how the review authors intend to answer their research question."
Beyond acting as a roadmap for your research question, protocols, when registered, allows for others to see what type of research you are doing and prevents duplicate research from being created.
Please select either format, Word document or PDF, and complete the template; it must be submitted if requesting to work with a Research and Instruction Librarian on a review project.
|Piece||Information you need to report. Ask yourself these questions for guidance.|
|Title||Identify the report as a protocol for the type of review you're conducting.|
|Registration||Where did you register your protocol? OSF? PROSPERO? Other? Please include the registration number or DOI.|
|Authors||Who is part of your team? List all contributors and their roles. If you are a doing a meta-analysis, have you identified a statistician? Who is the librarian collaborator working on your project? A helpful tool to determine contributions in an unbiased way is to use the CRediT tool.|
|Support||Who's the review funder/sponsor? What's their role in the review?|
|Rationale||What are your reasons for producing this review? What are you trying to achieve? What gap in knowledge is this covering?|
|Objectives||What specific question is your review addressing? State your hypothesis in a PICO format. Identify the participants, interventions, exposure, issue, comparators, and outcomes. If your question does not fit the PICO structure or is exploratory in nature, you are likely doing a scoping review.|
What criteria are you using to include and exclude studies from your review? Your eligibility criteria includes your inclusion and exclusion criteria. Include a detailed definition of your independent and dependent variables. These are the elements that are used to include or exclude studies during review: study design (e.g. randomized controlled trials, observational designs), setting, time frame, participants characteristics? Is there a well justified date limit (e.g. did something seminal happen in your field that changed practice)? Will you include non-English studies (it is highly recommended that you do)? Will you include meeting abstracts, dissertations, or pre-prints?
We recommend a brief pilot of your inclusion and exclusion criteria with a set of articles before you begin formal review.
|Information Sources||What information sources are you gathering information from? E.g. list the databases, trial registers and grey literature & the dates of coverage you're searching. Your librarian collaborator will help you choose appropriate sources.|
|Study Selection Process||What will your process for selecting studies entail? How many reviewers will be required in the title/abstract screening process? How many votes will be required to move a record from the title/abstract screen to the full text screen? How will you reconcile differences? Will you include an analysis of interrater reliability. Describe the process of each phase of your review.|
|Data Extraction and Management||
List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes, with rationales. How will you obtain & confirm data from investigators? If more than one person is doing extractions, how will you reconcile differences? How will you deal with missing data? How are you going to manage your records & data during your review process (e.g. create data extraction tables in Covidence)?
|Risk of Bias and Strength of Evidence||
How will you assess risk of bias in individual studies (will this be done at outcome or study level or both)? There are formal tools (see link). Will you use GRADE or a different tool for analyzing strength of evidence?
Optional for non-systematic reviews.
|Data Synthesis||Describe your plan for analyzing your extracted data. We recommend you consult someone with statistical expertise to make these decisions. Are there any proposed additional analyses (e.g. sensitivity, subgroup analyses, meta-regression)? If not a quantitative synthesis (i.e. qualitative synthesis), describe your method for summarizing data.|