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Systematic Reviews and Meta Analysis

A resource for finding data sources, filters, and standards to support systematic searches of the biomedical literature.

What is a protocol?

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.

Countway Protocol Template

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.

Pieces of the Protocol

Table of Pieces of the Protocol
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?
Introduction  
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. 
Methods  
Eligibility Criteria

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. 

 

Standards and Reporting Guidelines

In an effort to ensure transparency and proper reporting, PRISMA has created a PRISMA-P checklist for protocols. You can use this checklist as a template for writing your protocol. 

You can find the reporting guideline for the type of review being conducted at the Equator Network. 

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