Protocol Development

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?

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

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

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

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

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

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?

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?

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?

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

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?

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