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.

These findings offer a contemporary perspective as a conceptual basis for future empirical investigation of the advantages and disadvantages of different methods of QES. It is hoped that this will inform appropriate selection of QES approaches.

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:Rehfuess, E.A. orcid.org/0000-0002-4318-8846, Booth, A., Brereton, L. et al. (8 more authors) (2017) Towards a taxonomy of logic models in systematic reviews and health technology assessments: a priori, staged and iterative approaches. Research Synthesis Methods. ISSN 1759ISSN -2879 https://doi.org/10.1002/jrsm.1254 eprints@whiterose.ac.uk https://eprints.whiterose.ac.uk/ Reuse Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by national copyright laws. The publisher or other rights holders may allow further reproduction and re-use of the full text version. This is indicated by the licence information on the White Rose Research Online record for the item. TakedownIf you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing eprints@whiterose.ac.uk including the URL of the record and the reason for the withdrawal request.This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/jrsm.1254 This article is protected by copyright. All rights reserved. Towards a taxonomy of logic models in systematic reviews Short title:A taxonomy of logic models: a priori, staged and iterative approaches This article is protected by copyright. All rights reserved. AbstractThe complexity associated with how interventions result -or fail to result -in outcomes, and how context matters is increasingly recognised. Logic models provide an important tool for handling complexity, with contrasting uses in programme evaluation and evidence synthesis. To reconcile these, we developed an approach that combines the strengths of both traditions, propose a taxonomy of logic models, and provide guidance on how to choose between approaches and types of logic models in systematic reviews and health technology assessments (HTA).The taxonomy distinguishes three approaches (a priori, staged, iterative) and two types (systems-based, process-orientated) of logic models. An a priori logic model is specified at the start of the systematic review/HTA and remains unchanged. With a staged logic model, the reviewer pre-specifies several points, at which major data inputs require a subsequent version. An iterative logic model is continuously modified throughout the systematic review/HTA process. System-based logic models describe the system, in which the interaction between participants, intervention and context takes place; process-orientated models display the causal pathways leading from the intervention to multiple outcomes.The proposed taxonomy of logic models offers an improved understanding of the advantages and limitations of logic models across the spectrum from a priori to fully iterative approaches. Choice ...

Brereton et al 2What is already known about the topic?  Internationally, stakeholder (i.e. lay people and professionals with an interest in the topic) involvement in research and Health Technology Assessment (HTA) is advocated. Stakeholder involvement has the potential to ensure key shared priorities are addressed and research findings translated into practice. The philosophy and views about the best approaches for stakeholder involvement differ across Europe. Stakeholder consultation is seen as one of the most appropriate approaches to involvement in some countries. However, qualitative research is viewed as the most appropriate method of stakeholder involvement in other European countries. Few reports exist about stakeholder involvement in palliative care and the ways this informs decision making in HTA. What this paper adds? This paper demonstrates that it is possible to involve lay (e.g. patients/ex-patients; family carers/excarers; family members and members of public organisations or groups) and professional (e.g. service commissioners, health and social care professionals / academics working in palliative care) stakeholders in HTA. Indeed, stakeholders, even patients and families undergoing palliative care, can be involved in HTA in a range of ways according to local contexts. Several approaches to stakeholder involvement in palliative care research are shown to be feasible and effective ways to identify stakeholder priorities.  Despite the use of different methods of stakeholder involvement, stakeholders highlight a number of issues in palliative care that are 'common' across countries. The researchers used the issues raised to inform decision making for project development. Notably the issues raised informed the focus of the main HTA question and sub questions used in the assessment of specific aspects. Implications for practice, theory or policy? Different methods of stakeholder involvement may be required for different palliative care stakeholder groups in different countries. Brereton et al3  Lay and professional stakeholder involvement is both feasible and worthwhile early in project development as this can identify key issues from the perspectives of service users and providers. Further guidance for stakeholder involvement in palliative care research is needed to ensure that policy and service development is more responsive to the needs of service users and providers. Brereton et al 4 AbstractBackground: Stakeholders are people with an interest in a topic. Internationally, stakeholder involvement in