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.

Background: Adapting interventions that have worked elsewhere can save resources associated with developing new interventions for each specific context. While a developing body of evidence shows benefits of adapted interventions compared with interventions transported without adaptation, there are also examples of interventions which have been extensively adapted, yet have not worked in the new context. Decisions on when, to what extent, and how to adapt interventions therefore are not straightforward, particularly when conceptualising intervention effects as contingent upon contextual interactions in complex systems. No guidance currently addresses these questions comprehensively. To inform development of an overarching guidance on adaptation of complex population health interventions, this systematic review synthesises the content of the existing guidance papers. Methods: We searched for papers published between January 2000 and October 2018 in 7 bibliographic databases. We used citation tracking and contacted authors and experts to locate further papers. We double screened all the identified records. We extracted data into the following categories: descriptive information, key concepts and definitions, rationale for adaptation, aspects of adaptation, process of adaptation, evaluating and reporting adapted interventions. Data extraction was conducted independently by two reviewers, and retrieved data were synthesised thematically within pre-specified and emergent categories. Results: We retrieved 6694 unique records. Thirty-eight papers were included in the review representing 35 sources of guidance. Most papers were developed in the USA in the context of implementing evidence-informed interventions among different population groups within the country, such as minority populations. We found much agreement on how the papers defined key concepts, aims, and procedures of adaptation, including involvement of key stakeholders, but also identified gaps in scope, conceptualisation, and operationalisation in several categories. Conclusions: Our review found limitations that should be addressed in future guidance on adaptation. Specifically, future guidance needs to be reflective of adaptations in the context of transferring interventions across countries, including macro- (e.g. national-) level interventions, better theorise the role of intervention mechanisms and contextual interactions in the replicability of effects and accordingly conceptualise key concepts, such as fidelity to intervention functions, and finally, suggest evidence-informed strategies for adaptation re-evaluation and reporting. Trial registration: PROSPERO 2018, CRD42018112714.

Background: Globally, 2.8 billion people rely on household solid fuels. Reducing the resulting adverse health, environmental, and development consequences will involve transitioning through a mix of clean fuels and improved solid fuel stoves (IS) of demonstrable effectiveness. To date, achieving uptake of IS has presented significant challenges. Objectives: We performed a systematic review of factors that enable or limit large-scale uptake of IS in low- and middle-income countries. Methods: We conducted systematic searches through multidisciplinary databases, specialist websites, and consulting experts. The review drew on qualitative, quantitative, and case studies and used standardized methods for screening, data extraction, critical appraisal, and synthesis. We summarized our findings as “factors” relating to one of seven domains—fuel and technology characteristics; household and setting characteristics; knowledge and perceptions; finance, tax, and subsidy aspects; market development; regulation, legislation, and standards; programmatic and policy mechanisms—and also recorded issues that impacted equity. Results: We identified 31 factors influencing uptake from 57 studies conducted in Asia, Africa, and Latin America. All domains matter. Although factors such as offering technologies that meet household needs and save fuel, user training and support, effective financing, and facilitative government action appear to be critical, none guarantee success: All factors can be influential, depending on context. The nature of available evidence did not permit further prioritization. Conclusions: Achieving adoption and sustained use of IS at a large scale requires that all factors, spanning household/community and program/societal levels, be assessed and supported by policy. We propose a planning tool that would aid this process and suggest further research to incorporate an evaluation of effectiveness. Citation: Rehfuess EA, Puzzolo E, Stanistreet D, Pope D, Bruce NG. 2014. Enablers and barriers to large-scale uptake of improved solid fuel stoves: a systematic review. Environ Health Perspect 122:120–130; http://dx.doi.org/10.1289/ehp.1306639

Introduction: Evidence-to-decision (EtD) frameworks intend to ensure that all criteria of relevance to a health decision are systematically considered. This paper, part of a series commissioned by the WHO, reports on the development of an EtD framework that is rooted in WHO norms and values, reflective of the changing global health landscape, and suitable for a range of interventions and complexity features. We also sought to assess the value of this framework to decision-makers at global and national levels, and to facilitate uptake through suggestions on how to prioritise criteria and methods to collect evidence. Methods: In an iterative, principles-based approach, we developed the framework structure from WHO norms and values. Preliminary criteria were derived from key documents and supplemented with comprehensive subcriteria obtained through an overview of systematic reviews of criteria employed in health decision-making. We assessed to what extent the framework can accommodate features of complexity, and conducted key informant interviews among WHO guideline developers. Suggestions on methods were drawn from the literature and expert consultation. Results: The new WHO-INTEGRATE (INTEGRATe Evidence) framework comprises six substantive criteria—balance of health benefits and harms, human rights and sociocultural acceptability, health equity, equality and non-discrimination, societal implications, financial and economic considerations, and feasibility and health system considerations—and the meta-criterion quality of evidence. It is intended to facilitate a structured process of reflection and discussion in a problem-specific and context-specific manner from the start of a guideline development or other health decision-making process. For each criterion, the framework offers a definition, subcriteria and example questions; it also suggests relevant primary research and evidence synthesis methods and approaches to assessing quality of evidence. Conclusion: The framework is deliberately labelled version 1.0. We expect further modifications based on focus group discussions in four countries, example applications and input across concerned disciplines.

Health interventions fall along a spectrum from simple to more complex. There is wide interest in methods for reviewing ‘complex interventions’, but few transparent approaches for assessing intervention complexity in systematic reviews. Such assessments may assist review authors in, for example, systematically describing interventions and developing logic models. This paper describes the development and application of the intervention Complexity Assessment Tool for Systematic Reviews (iCAT_SR), a new tool to assess and categorise levels of intervention complexity in systematic reviews. We developed the iCAT_SR by adapting and extending an existing complexity assessment tool for randomized trials. We undertook this adaptation using a consensus approach in which possible complexity dimensions were circulated for feedback to a panel of methodologists with expertise in complex interventions and systematic reviews. Based on these inputs, we developed a draft version of the tool. We then invited a second round of feedback from the panel and a wider group of systematic reviewers. This informed further refinement of the tool. The tool comprises ten dimensions: (1) the number of active components in the intervention; (2) the number of behaviours of recipients to which the intervention is directed; (3) the range and number of organizational levels targeted by the intervention; (4) the degree of tailoring intended or flexibility permitted across sites or individuals in applying or implementing the intervention; (5) the level of skill required by those delivering the intervention; (6) the level of skill required by those receiving the intervention; (7) the degree of interaction between intervention components; (8) the degree to which the effects of the intervention are context dependent; (9) the degree to which the effects of the interventions are changed by recipient or provider factors; (10) and the nature of the causal pathway between intervention and outcome. Dimensions 1–6 are considered ‘core’ dimensions. Dimensions 7–10 are optional and may not be useful for all interventions. The iCAT_SR tool facilitates more in-depth, systematic assessment of the complexity of interventions in systematic reviews and can assist in undertaking reviews and interpreting review findings. Further testing of the tool is now needed.