Box 19.3.a: Elements of a prospective meta-analysis protocol

Objectives:

o        Define the specific hypotheses/objectives.

Methods: Criteria for considering studies for this review:

Eligibility criteria for trial design (e.g. requirements for randomization, minimum follow-up).

Eligibility criteria for the patient population.

Eligibility criteria for each intervention and comparator.

Outcomes information: specification of primary and secondary endpoints, definitions, measurement instruments, timing.

Details of subgroups.

Methods: Search methods for identification of studies:

o  Describe efforts made to identify ongoing trials.

Methods: Data collection and analysis:

·         Trial details:

List details of trials identified for inclusion.

A statement outlining if, at the time of submission for registration of the PMA, any trial results were known (to anyone outside the trial's own data monitoring committee); Trials should be included only if their results were unknown at the time they were identified and added to the PMA

o  Whether a signed agreement to collaborate has been obtained from the appropriate representative of each trial (e.g. the Sponsor or Principal Investigator).

·         Analysis Plan:

o  Details of sample size and power calculation (for the PMA), interim analyses, subgroup analyses etc.

·  Management and Co-ordination:

o  Details of management structure and committees.

o  Data management (data to be collected, format required, when required, quality assurance procedures, etc).

o  Responsibility for statistical analyses.

·         Publication Policy:

o  Policy regarding authorship (e.g. publication in ‘group’ name).

o  Writing Committee (membership, responsibilities).

o  Policy regarding manuscript (e.g. circulated to all trialists for comment).