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      From complex social interventions to interventions in complex social systems: Future directions and unresolved questions for intervention development and evaluation


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          Complex systems approaches to social intervention research are increasingly advocated. However, there have been few attempts to consider how models of intervention science, such as the UK’s Medical Research Council complex interventions framework, might be reframed through a complex systems lens. This article identifies some key areas in which this framework might be reconceptualized, and a number of priority areas where further development is needed if alignment with a systems perspective is to be achieved. We argue that a complex systems perspective broadens the parameters of ‘relevant’ evidence and theory for intervention development, before discussing challenges in defining feasibility in dynamic terms. We argue that whole systems evaluations may be neither attainable, nor necessary; acknowledgment of complexity does not mean that evaluations must be complex, or investigate all facets of complexity. However, a systems lens may add value to evaluation design through guiding identification of key uncertainties, and informing decisions such as timings of follow-up assessments.

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          Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework

          Background 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. Methods 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. Results 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. Conclusions 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. Electronic supplementary material The online version of this article (doi:10.1186/s13012-017-0552-5) contains supplementary material, which is available to authorized users.
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            Limitations of the randomized controlled trial in evaluating population-based health interventions.

            Population- and systems-based interventions need evaluation, but the randomized controlled trial (RCT) research design has significant limitations when applied to their complexity. After some years of being largely dismissed in the ranking of evidence in medicine, alternatives to the RCT have been debated recently in public health and related population and social service fields to identify the trade-offs in their use when randomization is impractical or unethical. This review summarizes recent debates and considers the pragmatic and economic issues associated with evaluating whole-population interventions while maintaining scientific validity and credibility.
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              Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies

              Objectives Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or ‘progression’ criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking. This paper outlines the key issues to consider in the optimal development and review of operational progression criteria for RCTs with an internal pilot phase. Design A structured literature review and exploration of stakeholders' opinions at a Medical Research Council (MRC) Hubs for Trials Methodology Research workshop. Key stakeholders included triallists, methodologists, statisticians and funders. Results There is considerable variation in the use of progression criteria for RCTs with an internal pilot phase, although 3 common issues predominate: trial recruitment, protocol adherence and outcome data. Detailed and systematic reporting around the decision-making process for stopping, amending or proceeding to a main trial is uncommon, which may hamper understanding in the research community about the appropriate and optimal use of RCTs with an internal pilot phase. 10 top tips for the development, use and reporting of progression criteria for internal pilot studies are presented. Conclusions Systematic and transparent reporting of the design, results and evaluation of internal pilot trials in the literature should be encouraged in order to facilitate understanding in the research community and to inform future trials.

                Author and article information

                Evaluation (Lond)
                Evaluation (Lond)
                Evaluation (London, England : 1995)
                SAGE Publications (Sage UK: London, England )
                31 October 2018
                January 2019
                : 25
                : 1
                : 23-45
                [1-1356389018803219]Cardiff University, UK
                [2-1356389018803219]Cardiff University, UK
                [3-1356389018803219]Cardiff University, UK
                [4-1356389018803219]Cardiff University, UK
                [5-1356389018803219]Cardiff University, UK
                [6-1356389018803219]London School of Hygiene & Tropical Medicine, UK
                [7-1356389018803219]Cardiff University, UK
                Author notes
                [*]Graham F. Moore, Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, 1–3 Museum Place, Cardiff, CF10 3BD, UK. Email: MooreG@ 123456cardiff.ac.uk
                © The Author(s) 2018

                This article is distributed under the terms of the Creative Commons Attribution 4.0 License ( http://www.creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).


                complex interventions,complex systems,evaluation,methodology,population health,social intervention


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