A new era for intervention development studies

Abstract

This editorial introduces a new special series on intervention development in the on-line open access journal Pilot and Feasibility Studies.An intervention development study reports the rationale, decision-making processes, methods and findings which occur between the idea or inception of an intervention until it is ready for formal feasibility, pilot or efficacy testing prior to a full trial or evaluation. This editorial begins to explore some of the challenges associated with this early research stage. It commences a debate about how to produce novel interventions which are fit for purpose and which solve important health and social care problems. By transparently reporting more intervention development studies, scientific rigour will be improved and everyone can learn from the experiences of others.  Intervention development can be viewed as a “black box” or the “Cinderella” of complex intervention trial design. This is because important processes and decision-making in the early stages of intervention development are seldom reported and until now, journals have shown little interest in publishing such studies. Intervention development studies exist in small grant reports and PhD chapters and tend to gather dust on the shelf as researchers move on to secure larger grants and new projects. So anecdotally, researchers encounter recurring pitfalls, spend time in blind alleys and worry about intervention decisions, with little guidance available. In addition, until recently, UK research funding institutions have not prioritised investment in complex intervention development.  The importance of methodological rigour at this early stage is recognised [1], and there is research waste from developing interventions that never impact on health care [2]. With ageing populations, multi-morbidity and lifestyle behaviours that seem remarkably resistant to change effective interventions are needed. In this special series, we begin to open the black box of intervention development. We are particularly interested in complex interventions, where there are several interacting components, rather than drugs or invasive devices which have regulated development processes.