Abstract
BackgroundComplex interventions in health care are characterized by multiple interacting components as well as by numerous nonlinear interactions with the social systems within which they are being implemented. The process of developing, evaluating and implementing complex interventions is therefore challenging. Established guidance such as the MRC (Medical Research Council) framework for developing and evaluating complex interventions refers to process evaluations as an integral part of the development of complex evidence-based interventions. Even though the need for process evaluations is recognized, the realization of such approaches is challenging because methodological instruction is sparse, and the phenomenon of interest is complex. A number of theoretical approaches indicating how to conduct process evaluations of complex interventions in health care exist, but a systematic and comprehensive overview of these is missing. Thus, the objective of the systematic scoping review described herein is to provide an overview and analysis of theoretical approaches suitable for the planning and conducting of process evaluations.MethodsThe design and conduct of this review will follow the procedures of a systematic scoping review. The search strategy will be developed following the BeHEMoTh (Behaviour of interest; Health context; Exclusions; Models or Theories) template which has been conceptualized for structured reviews of theory. The systematic search of the MEDLINE (via PubMed), CINAHL (via EBSCO) and PsycInfo (via EBSCO) electronic databases will be complemented by “hand searching” techniques. Study selection, data extraction, and data analysis will be performed by tandems of two researchers independently of each other. Divergent decisions and judgements between the two researchers will be discussed by the whole review team.DiscussionThe findings from this scoping review will provide an overview and comparison of theoretical approaches suitable for process evaluations of complex interventions in health care. The review results will support researchers in choosing the theoretical approach that best fits the respective focus of their process evaluation study.Systematic review registrationThis study has been registered with PROSPERO (International Prospective Register of Systematic Reviews) under registration number CRD42020211732.
Highlights
Complex interventions in health care are characterized by multiple interacting components as well as by numerous nonlinear interactions with the social systems within which they are being implemented
Due to this changing definition, it is increasingly recommended to integrate process evaluations in the development and evaluation of complex evidence-based interventions to assess implementation aspects and to gain a better understanding of causal mechanisms and contextual factors associated with variation in outcomes [1, 6,7,8]
The relevance of process evaluations is being increasingly discussed in the scientific discourse on the development and evaluation of complex interventions and is widely recognized [1, 6, 8, 15, 16]
Summary
Complex interventions in health care are characterized by multiple interacting components as well as by numerous nonlinear interactions with the social systems within which they are being implemented. Ongoing debates about which characteristics constitute complex interventions [3,4,5] have complemented this original definition with the awareness that complexity is given “...primarily due to the social systems within which these actions occur, the contextually contingent nature of impacts, and the agency of the groups and individuals whose behaviours they aim to influence” [3] Due to this changing definition, it is increasingly recommended to integrate process evaluations in the development and evaluation of complex evidence-based interventions to assess implementation aspects and to gain a better understanding of causal mechanisms and contextual factors associated with variation in outcomes [1, 6,7,8]. They can prevent a so-called type III error, which refers to the question of whether the intervention has been delivered or if there is something measured that does not exist [10]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
