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In randomised controlled trials designed to assess the effectiveness of a health intervention, it may be relevant to consider per-protocol or as-treated populations when a significant proportion of patients do not receive the intervention as planned. However, the natural adaptation of the intervention to its implementation context makes it difficult to distinguish between adaptations and deviations from the protocol, compromising the definition of the population that actually received the intervention as planned.
The aim of WP1 ‘Defining exposure to the planned intervention when assessing a complex intervention’ is to develop a typology of protocol deviations that may occur in cluster-randomized trials assessing the effectiveness of complex health interventions.
In order to achieve this aim, the participation of those concerned, i.e. experts in the evaluation of health interventions, is crucial. Your participation will enable us to understand the contextual characteristics that make it possible to adapt an intervention without affecting its key functions, and to distinguish deviations from the protocol from adaptations necessary to implement an intervention in a given context. The obtained typology should allow researchers to better characterise fidelity to the protocol by taking account of adaptations to the implementation context, and to facilitate the definition of per-protocol and as-treated populations, i.e. those exposed to the intervention in its key functions.
To meet the objective of the study, we will be using concept mapping, a participatory approach based on a mixed method.