The challenges of complex research studies for participants, sites and researchers

Context and background: The design and execution of research studies becomes more challenging as the interventions being evaluated move from simple towards more complex interventions with several components. This is further... [ view full abstract ]

Context and background: The design and execution of research studies becomes more challenging as the interventions being evaluated move from simple towards more complex interventions with several components. This is further compounded when such studies take place across several sites and involve a number of different countries with multiple distinct work packages within the study design.

Aim of the presentation: This presentation will discuss the challenges of complex study processes for participants, sites and researchers involved in a European cluster randomised controlled trial testing a complex intervention in the maternity services. The presentation will offer some practical examples of the challenges encountered and advice on how those challenges can be met.

Key discussion points: There are a number of areas where challenges may arise. These include the design of the intervention, the implementation of the intervention, maintaining the fidelity of the intervention, the characteristics of the context in which the intervention is both delivered and received, the human factors which will affect all aspects of the study, the choice of outcome measurements, the collection and management of study data, evaluation of the study and reporting and dissemination of the study findings. The need to include an economic evaluation may add additional challenges.

Conclusion: The design and execution of complex research studies needs to consider both the process and the outcomes. As well as considering and recognising the inherent challenges before and during a complex study, researchers must also manage and mitigate those challenges. There is a shortage of practical guidance for dealing with the challenges of complex study processes. This presentation aims to fill that gap by offering some practical examples of the challenges encountered during the OptiBIRTH trial and advice on how those challenges can be met.