Medical Research Council framework for development and evaluation of complex interventions: A comprehensive guidance

Complex intervention framework is extensively used in health service delivery, community, health and social policy, such as education, with important health outcomes. Such interventions are sensitive and flexible to the regional context and culture. Complex interventions introduce the use of two or more information sources or two or more research methods to answer a research question.[1,2] Using more than two research methods with triangulation techniques increases the validity of the research findings. Such studies are considered as mixed methods.[2] Complex intervention framework includes the steps which are not necessarily linear and there is also no clear boundary between simple and complex interventions. Such steps include plan development, feasibility and pilot, evaluation, and implementation. These steps have no linear or cyclic order.[3] This framework emphasizes that any intervention should be presented to the patients tailored to the context and culture of that society (political, social, and geographical). Even if the intervention can be presented equally in different societies, the context of that society cannot be ignored in the face of the intervention because one intervention may have different effects on two different societies. In fact, this framework introduces the mechanisms which are sufficiently relevant to that society in order to achieve some changes. In addition, the context of the society after the intervention should be considered in interpreting the findings.[4] Meanwhile, Lakshman et al. considered the use of this framework to infants' nutritional behaviors in lactation with the analysis of cost-effectiveness of a complex intervention in his study as a challenging, long and costly intervention. He even suggested conducting interventional research with or without a framework to evaluate their effectiveness alongside costs.[5]