Objectives:

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).