Box 112 Suggested items to be included in a systematic review protocol

♦ Rationale for systematic review

Underlying biology and epidemiology Review of trials

♦ Objectives

Main comparisons to be made

♦ Search strategies

♦ Inclusion/exclusion criteria

♦ Data to be collected

♦ Brief description of data checking procedures

Main analyses to be performed Primary outcome measures Additional outcome measures

Subset analyses and planned categories (Section 11.5.7.5) Subgroup analyses and planned categories (Section 11.5.7.6)

♦ Organization

Organizational structures, e.g. Steering/Advisory Committee Personnel

♦ Sources of support

♦ Conflict of interest

♦ Publication policy

♦ Provisional timetable

♦ Provisional list of trials to be included

♦ Example data collection forms

♦ Data coding information

IPD meta-analyses are usually carried out as collaborative projects whereby all trialists contributing information from their studies, together with those managing the project, become part of an active collaboration. They are usually managed by a small local organizing group or secretariat, which may be aided in important and strategic decision making by a larger advisory group. Such an advisory group will usually comprise medical and possibly statistical or methodological experts relevant to the question addressed in the meta-analysis, and will often have international representation. The political and communication aspects of running these large collaborative projects are where they differ most from, and where they may be more time consuming than other types of systematic review. For example, during the initiation phase of an IPD project, a secretariat, advisory group and trialists group all need to be established. Moreover, throughout the project communication is essential to ensure that good relationships are developed and maintained with all collaborators, which can sometimes run to over a hundred individuals. The secretariat will usually also organize a face-to-face meeting of all collaborators, to bring individuals together to discuss the preliminary results. All publications and presentations are made in the name of the collaborative group, with members of the group and participating organizations usually listed in an appendix to the text. Prior to this, manuscripts are reviewed by the full collaborative group, which, if large, can be time-consuming.

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