Читать книгу Individual Participant Data Meta-Analysis - Группа авторов - Страница 31

As described in Chapters 1 and 2, IPD meta‐analysis projects are often regarded as a gold standard approach to evidence synthesis. However, they require a broader skillset than conventional systematic reviews, and generally require more resources and take longer to complete. Decisions to embark on IPD projects should therefore not be made lightly, and careful planning is essential. In this chapter, we cover the preparatory phase of an IPD meta‐analysis project and provide guidance for planning and initiation. We outline the importance of carefully refining the research question to be addressed through development of a project scope, building the collaborative framework for the project, and establishing a team equipped with the necessary skills to ensure that it can be delivered successfully. We discuss data‐sharing agreements, outline the potential need for ethical approval, and share our experience of typical timescales and of preparing funding applications. Throughout, we assume that the IPD project aims to synthesise IPD from multiple randomised trials to evaluate treatment effects. However, most of our guidance is also appropriate to other types of IPD meta‐analysis projects including those focused on diagnostic or prognostic topics (Part 5).

Figure 3.1 (phase 1 section) outlines the main activities that need to be completed during the set‐up and initiation phase of an IPD meta‐analysis project, illustrating the approvals that may need to be sought and documentation to be prepared. In order to plan and prepare for an IPD project, and in particular to estimate costs for a funding application, it is necessary to think through all steps of the project at the outset (i.e. all elements of Figure 3.1), as these are often inter‐dependent. Unlike a conventional systematic review and meta‐analysis of existing aggregate data, where if something has been overlooked, syntheses can be unpicked and redone relatively straightforwardly, IPD meta‐analysis projects are not well suited to rapid, frequent or last‐minute changes, because of the considerable additional time that it can take to obtain and check additional data, and re‐run analyses.