BackgroundThe 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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-017-0552-5) contains supplementary material, which is available to authorized users.

There is growing interest in the potential for complex systems perspectives in evaluation. This reflects a move away from interest in linear chains of cause-and-effect, towards considering health as an outcome of interlinked elements within a connected whole. Although systems-based approaches have a long history, their concrete implications for health decisions are still being assessed. Similarly, the implications of systems perspectives for the conduct of systematic reviews require further consideration. Such reviews underpin decisions about the implementation of effective interventions, and are a crucial part of the development of guidelines. Although they are tried and tested as a means of synthesising evidence on the effectiveness of interventions, their applicability to the synthesis of evidence about complex interventions and complex systems requires further investigation. This paper, one of a series of papers commissioned by the WHO, sets out the concrete methodological implications of a complexity perspective for the conduct of systematic reviews. It focuses on how review questions can be framed within a complexity perspective, and on the implications for the evidence that is reviewed. It proposes criteria which can be used to determine whether or not a complexity perspective will add value to a review or an evidence-based guideline, and describes how to operationalise key aspects of complexity as concrete research questions. Finally, it shows how these questions map onto specific types of evidence, with a focus on the role of qualitative and quantitative evidence, and other types of information.

SummaryContext and implementation of health interventions have received increasing attention over the past decade, in particular with respect to their influence on effectiveness and reach of complex interventions. The underlying concepts are both considered partially mature, limiting their operationalization in research and practice. We applied systematic literature searches and pragmatic utility (PU) concept analysis to provide a state-of-the-art assessment of the concepts "context" and "implementation" in the health sciences to create a common understanding for their use within systematic reviews and HTA.We performed two separate searches for context (EMBASE, MEDLINE) and implementation (Google Scholar) to identify relevant models, theories and frameworks. 187 publications on context and 365 publications on implementation met our inclusion criteria. PU concept analysis comprises three guiding principles, selection of the literature, organization and structuring of the literature and asking analytic questions of the literature. Both concepts were analysed according to four features of conceptual maturity, i.e. consensual definitions, clear characteristics, fully described preconditions and outcomes, and delineated boundaries.Context and implementation are highly intertwined, with both concepts influencing and interacting with each other. Context is defined as a set of characteristics and circumstances that surround the implementation effort. Implementation is conceptualized as a planned and deliberately initiated effort with the intention to bring an intervention into practice. The concept of implementation presents largely consensual definitions and relatively well-defined boundaries, while distinguishing features, preconditions and outcomes are not yet fully articulated. In contrast, definitions of context vary widely and boundaries with neighbouring concepts, such as setting and environment, are blurred; characteristics, preconditions and outcomes are ill-defined. Therefore, the maturity of both concepts should be advanced further to facilitate operationalization in systematic reviews and HTAs.

Article:Rohwer, A., Pfadenhauer, L., Burns, J. et al. (5 more authors) (2017) Logic models help make sense of complexity in systematic reviews and health technology assessments. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. M A N U S C R I P T A C C E P T E D ACCEPTED MANUSCRIPTObjective: To describe the development and application of logic model templates for systematic 22 reviews and health technology assessments (HTA) of complex interventions 23Study design and setting: This study demonstrates the development of a method to conceptualise 24 complexity and make underlying assumptions transparent. Examples from systematic reviews with 25 specific relevance to sub-Saharan Africa (SSA) and other low-and middle-income countries (LMICs) 26 illustrate its usefulness. 27Results: Two distinct templates are presented: the system-based logic model, describing the system 28 in which the interaction between participants, intervention and context takes place; and the 29 process-orientated logic model, which displays the processes and causal pathways that lead from 30 the intervention to multiple outcomes. 31Conclusion: Logic models can help authors of systematic reviews and HTAs to explicitly address and 32 make sense of complexity, adding value by achieving a better understanding of the interactions 33 between the intervention, its implementation and its multiple outcomes among a given population 34 and context. They thus have the potential to help build systematic review capacity -in SSA and other 35 LMICs -at an individual level, by equipping authors with a tool that facilitates the review process; 36 and at a system-level, by improving communication between producers and potential users of 37 research evidence. 38 Keywords 39Africa, complexity, evidence synthesis, analytical framework, conceptual framework, systems-based 40 thinking 41Running title: Logic models for systematic reviews and HTAs of complex interventions 42Word count: 198 43

SummaryIn spite of frequent claims to the contrary, there is very little evidence that health systems research actually influences policy-making. Based on a case study from Thailand and a literature review, we develop a stakeholder-oriented model of policy-making. We argue that only if stakeholders' needs are taken into consideration during design and implementation of scientific projects and dissemination of the results, research will have a chance to influence the policy process. From this model, we derive a five-step approach to enhance the use of research by various stakeholders. We then propose institutional arrangements and conditions to make the use of research for policy-making more sustainable.keywords Health policy, health care reform, policy-making, decision-making, health system research, evidence-based medicine, research use correspondence Prof. Rainer Sauerborn,