title: Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework.
abstract: The effectiveness of complex interventions, as well as their success in reaching relevant populations, is critically influenced by their implementation in a given context. Current conceptual frameworks often fail to address context and implementation in an integrated way and, where addressed, they tend to focus on organisational context and are mostly concerned with specific health fields. Our objective was to develop a framework to facilitate the structured and comprehensive conceptualisation and assessment of context and implementation of complex interventions.
  
  
  
  The Context and Implementation of Complex Interventions (CICI) framework was developed in an iterative manner and underwent extensive application. An initial framework based on a scoping review was tested in rapid assessments, revealing inconsistencies with respect to the underlying concepts. Thus, pragmatic utility concept analysis was undertaken to advance the concepts of context and implementation. Based on these findings, the framework was revised and applied in several systematic reviews, one health technology assessment (HTA) and one applicability assessment of very different complex interventions. Lessons learnt from these applications and from peer review were incorporated, resulting in the CICI framework.
  
  
  
  The CICI framework comprises three dimensions-context, implementation and setting-which interact with one another and with the intervention dimension. Context comprises seven domains (i.e., geographical, epidemiological, socio-cultural, socio-economic, ethical, legal, political); implementation consists of five domains (i.e., implementation theory, process, strategies, agents and outcomes); setting refers to the specific physical location, in which the intervention is put into practise. The intervention and the way it is implemented in a given setting and context can occur on a micro, meso and macro level. Tools to operationalise the framework comprise a checklist, data extraction tools for qualitative and quantitative reviews and a consultation guide for applicability assessments.
  
  
  
  The CICI framework addresses and graphically presents context, implementation and setting in an integrated way. It aims at simplifying and structuring complexity in order to advance our understanding of whether and how interventions work. The framework can be applied in systematic reviews and HTA as well as primary research and facilitate communication among teams of researchers and with various stakeholders.
authors.affiliation: Institute for Medical Informatics, Biometry and Epidemiology, LMU Munich, Munich, Germany. pfadenh@ibe.med.uni-muenchen.de.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Pfadenhauer
authors.affiliation: Institute of Public Health and Nursing Research, University of Bremen, Bremen, Germany.|Health Sciences Bremen, University of Bremen, Bremen, Germany.
authors.forename: Ansgar
authors.initials: A
authors.lastname: Gerhardus
authors.affiliation: Institute of Public Health and Nursing Research, University of Bremen, Bremen, Germany.|Health Sciences Bremen, University of Bremen, Bremen, Germany.
authors.forename: Kati
authors.initials: K
authors.lastname: Mozygemba
authors.affiliation: Centre for Medical Ethics, University of Oslo, Oslo, Norway.
authors.forename: Kristin Bakke
authors.initials: KB
authors.lastname: Lysdahl
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Booth
authors.affiliation: Centre for Medical Ethics, University of Oslo, Oslo, Norway.
authors.forename: Bjørn
authors.initials: B
authors.lastname: Hofmann
authors.affiliation: Institute of Public Health and Nursing Research, University of Bremen, Bremen, Germany.
authors.forename: Philip
authors.initials: P
authors.lastname: Wahlster
authors.affiliation: Institute for Medical Informatics, Biometry and Epidemiology, LMU Munich, Munich, Germany.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Polus
authors.affiliation: Institute for Medical Informatics, Biometry and Epidemiology, LMU Munich, Munich, Germany.
authors.forename: Jacob
authors.initials: J
authors.lastname: Burns
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Louise
authors.initials: L
authors.lastname: Brereton
authors.affiliation: Institute for Medical Informatics, Biometry and Epidemiology, LMU Munich, Munich, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Rehfuess
mesh_terms: D001675:Bioethics; D057189:Checklist; D004059:Diffusion of Innovation; D006291:Health Policy; D007878:Legislation as Topic; D015279:Organizational Culture; D012959:Socioeconomic Factors; D013673:Technology Assessment, Biomedical
keywords: Applicability; Complex intervention; Concept analysis; Context; Health technology assessment; Implementation; Public health; Systematic review; Transferability