Box 19.3.a: Elements of a prospective meta-analysis protocol
o Define the specific hypotheses / objectives.
Methods: Criteria for considering studies for this review:
o Eligibility criteria for trial design (e.g. requirements for randomization, minimum follow-up);
o Eligibility criteria for the patient population;
o Eligibility criteria for each intervention and comparator;
o Outcomes information: specification of primary and secondary endpoints, definitions, measurement instruments, timing ;
o 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:
o List details of trials identified for inclusion;
o 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);
o 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, sub-group analyses etc;
· Management and Coordination:
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).