The application of complex interventions in the area of public health, clinical research and education is becoming increasingly widespread. The effectiveness of complex interventions may be affected by numerous factors due to the complexity of interventions, intervention pathways or the context of implementation. Therefore, it is significantly important to evaluate the process of complex interventions, which will provide information to understand the implementation of interventions. The British Medical Research Council’s process evaluation guidelines provide a framework for implementing and reporting on process evaluation research. This paper aims to interpret the guide in detail on complex intervention and process evaluation for the references of domestic researchers.
Complex interventions are commonly used in health and social care services, public health practice, and other areas of social and economic policy that have consequences for health. Due to the multiple components of interventions, the complicated mechanisms of change, the diversity of the population involved, and the interaction between the intervention and the context in which it is implemented, the appropriate development and evaluation of complex interventions has become increasingly critical. The UK Medical Research Council published a framework for developing and evaluating complex interventions. The aim of this article is to introduce and interpret the framework to provide guidance on the development and evaluation of complex interventions for domestic researchers.
Traditional Chinese medicine (TCM) is a treasure of the Chinese nation. Presence of clinical effects represents a fundamental issue for TCM development. Nevertheless, the complexities of TCM interventions often result in presented effects deviating from expected ones, a phenomenon so called as "effect off-target"; this issue has become a major challenge for the development and use of TCM interventions. In continuing efforts, we have proposed an innovative evidence-based medicine model for studying the effects of TCM interventions, termed "systems evidence-based medicine (sysEBM)". Essentially, the sysEBM model integrates clinical and non-clinical evaluation to develop a systematic pathway for studying effects of TCM interventions, and the methodological steps typically include the development of PICO framework for a putative effect, exploration of the effect and confirmation of the effect by using animal models, observational studies and clinical trials. As an additional step, multidisciplinary technologies including pharmaceutical, pharmacological, information and biological technologies will be used to provide multidimensional analyses of potential action networks and mechanisms of TCM interventions. Building on this concept, we have developed a sysEBM model ("6R" model) for acupuncture and marketed Chinese patent medicines by integrating real-world evidence, clinical trials, evidence syntheses, and rapid recommendation methodologies, as well as information technology and biomedical technologies. We also applied this model for developing TCM interventions for maternal health, critical care, and knee osteoarthritis.