Complex interventions in healthcare: the importance of considering early theoretical development, implementation and design issues

Abstract

Background: The Medical Research Council's Framework (2010) guidelines for the evaluation of complex interventions stresses the importance of early theoretical development and the need to link interventions with implementation and design issues. It highlights how all the stages of developing, evaluating, piloting, reporting and implementing a complex intervention, are equally important. Aims: To explore implementation science principles and explore teething issues around developing and implementing complex interventions; and, to explore how early, theoretical development and modeling approaches can address for these issues. Method: A modeling approach to developing interventions is considered to provide a guide to the active ingredients, appropriate measures, best intervention points and techniques, which can be then tested quantitatively in trials. Modeling a complex intervention, prior to a full scale evaluation, can provide important information about the design of both the intervention and its evaluation. It is therefore important to develop a theoretical understanding of the likely process of change, by including from an early point onwards those targeted by the intervention (service users). A gap continues to exist between what is known to be effective and what is actually delivered in the usual course of healthcare. A participatory action research (PAR) approach is presented in this paper as, particularly, appropriate for use in healthcare research, as it recognizes the importance of relationships, feedback loops and the ability of participants to self-organize (Leykum at al, 2009). Results: A focus on trials often leads to researchers neglecting adequate development or proper consideration of the practical issues of implementation, leading to weaker interventions, that are harder to evaluate or less likely to be implemented (MRC, 2010). Implementation Science Research principles similarly support this approach. Issues highlighted in the literature in relation to developing complex interventions, such as difficulty of standardizing the design and delivery of those, point to the importance of early stages of developing and modeling interventions. Involvement of a team of key individuals, particularly those with a fundamental knowledge of the context and need for improvement, enables a 'joint' leadership structure, which lead to more effective implementation and, therefore, more effective interventions (Leykum at al, 2009). Examples will be provided from a study on a theoretical modeling approach to the development of education resources for the self-management of fatigue in clients with rheumatoid arthritis. Limitations: Researchers need to be aware of the potential pitfalls when undertaking participatory action research. More specifically they have to be comfortable with the fact that this entails much more than a consultation exercise, and it therefore requires a shift towards actual, active involvement of participants in the research process. Conclusion: When developing complex interventions, such as educational resources for the self-management of symptoms in chronic conditions, researchers should acknowledge the importance of gaining a theoretical understanding of the likely process of change, as well as the importance of early exploration of issues which might forecast implementation problems.