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.

The presented approach for integrating moral issues in HTA has a broad theoretical foundation and has shown to be useful in practice. Integrating ethical issues in HTAs can be of great importance with respect to the dissemination of HTA results and in efficient health policy making.

Demographical changes in high income counties will increase the need of health care services but reduce the number of people to provide them. Welfare technology is launched as an important measure to meet this challenge. As with all types of technologies we must explore its ethical challenges. A literature review reveals that welfare technology is a generic term for a heterogeneous group of technologies and there are few studies documenting their efficacy, effectiveness and efficiency. Many kinds of welfare technology break with the traditional organization of health care. It introduces technology in new areas, such as in private homes, and it provides new functions, e.g. offering social stimuli and entertainment. At the same time welfare technology is developed for groups that traditionally have not been extensive technology users. This raises a series of ethical questions with regard to the development and use of welfare technologies, which are presented in this review. The main challenges identified are: (1) Alienation when advanced technology is used at home, (2) conflicting goals, as welfare technologies have many stakeholders with several ends, (3) respecting confidentiality and privacy when third-party actors are involved, (4) guaranteeing equal access and just distribution, and (5) handling conflicts between instrumental rationality and care in terms of respecting dignity and vulnerability. Addressing these issues is important for developing and implementing welfare technologies in a morally acceptable manner.

Objectives:The aim of this study was to develop and test a generic framework to enable international collaboration for producing and sharing results of health technology assessments (HTAs). Methods: Ten international teams constructed the HTA Core Model, dividing information contained in a comprehensive HTA into standardized pieces, the assessment elements. Each element contains a generic issue that is translated into practical research questions while performing an assessment. Elements were described in detail in element cards. Two pilot assessments, designated as Core HTAs were also produced. The Model and Core HTAs were both validated. Guidance on the use of the HTA Core Model was compiled into a Handbook. Results: The HTA Core Model considers health technologies through nine domains. Two applications of the Model were developed, one for medical and surgical interventions and another for diagnostic technologies. Two Core HTAs were produced in parallel with developing the model, providing the first real-life testing of the Model and input for further development. The results of formal validation and public feedback were primarily positive. Development needs were also identified and considered. An online Handbook is available. Conclusions:The HTA Core Model is a novel approach to HTA. It enables effective international production and sharing of HTA results in a structured format. The face validity of the Model was confirmed during the project, but further testing and refining are needed to ensure optimal usefulness and user-friendliness. Core HTAs are intended to serve as a basis for local HTA reports. Core HTAs do not contain recommendations on technology use.

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.