1. Protocol Development

2. Planning Your Review The Review Protocol
What is the role of the review protocol?
Why is a review protocol necessary?
What information does it contain?

3. Role of the Protocol
The protocol is the first milestone of any systematic review
A (rigid) plan or framework for the review
A protocol helps to avoid or minimise bias
Bias may occur in the retrieval, selection, and appraisal of studies, as well as during the extraction, evaluation and interpretation of data
A protocol can (and should be) sent for external peer review

4. Protocol Structure and Content
Overview
Background
Review questions/ objectives
Methods
Search strategy
Selection criteria
Quality assessment
Data extraction
Data synthesis
Conduct issues
Peer review process
Project timetable
Dissemination strategy
Individual responsibilities

5. Background section
Sets the context and provides the rationale for the review:
Patients / disease characteristics, e.g. epidemiology
Importance: clinical and public health implications
Current practice
Alternative interventions
Available evidence, including existing systematic reviews

6. Research questions/ objectives
Precise formulation in relation to key components (PICO):
Population/ patients / problem
Intervention, or exposure
Comparison group
Outcome(s) of interest

7. Search Strategy
The protocol should make it clear how relevant studies are going to be identified:
Specify which databases (including dates) and other sources will be searched
Identify key search terms

8. Study Selection
The protocol should make it clear how studies will be selected for inclusion in the review:
Specify the inclusion (and exclusion) criteria
Report details of selection process
How many reviewers involved?
Will the process be completed independently?
How will disagreements be resolved?

9. Quality Assessment
The protocol should make it clear why and how included studies will be quality assessed:
State the purpose of quality assessment, e.g. is it for selection, data synthesis, interpretation of results?
Describe the criteria / checklist to be used
Detail the quality assessment process / procedure
How many reviewers involved?
Will the process be completed independently?
How will disagreements be resolved?

10. Data Extraction The protocol should report:
What data are to be extracted from primary studies
A draft template for data extraction
How data will be presented in the report
Any planned manipulations of study data, e.g. calculation of summary statistics, ITT-analysis, etc.
The process of data extraction
How many reviewers will be involved?
How will disagreements be resolved?

11. Data Synthesis
The protocol should identify and justify indicate and justify the:
Data that are to be tabulated
Potential sources of heterogeneity to be investigated, e.g. subgroup analysis
Method of synthesis
Any proposed sensitivity analyses
In HBI reviews it may not be possible to be too specific at protocol stage, but these issues need a priori consideration

12. Dissemination
Failing to disseminate research findings is unethical, and the protocol should detail precisely a dissemination strategy:
How will you disseminate the findings?
Where will you publish?
How will you publish your review?
In what format will you publish?
Who is your intended audience?

13. Peer review / Advisory Group
Reviewers should establish an Advisory Group who can provide peer-review at different stages of the review process
Topic experts (including ‘users’) will be able to comment on the relevance of the review question, as well as possible sources of heterogeneity
Methodological experts will be able to comment on whether the proposed methods will answer the review questions
Trainees must obtain protocol approval before starting their SR