Table 1
Inclusion and exclusion criteria. *The eligibility criteria for process evaluations are based on the MRC guidance for the process evaluation of complex health interventions [2].
| CRITERIA | SCALE-UP | COMPLEX HEALTH INTERVENTION (CHI) | PROCESS EVALUATION (PE)* |
|---|---|---|---|
| Inclusion | Explicitly state that the aim or objective of the study was related to the scale-up of a health care intervention (e.g., integrated care package for Diabetes and Hypertension, exercise-based rehabilitation). The language used by the study authors was central in assessing this criterion. | The intervention of interest was complex. Herein, we follow the description as provided by the UK Medical Research Council, “An intervention might be considered complex because of properties of the intervention itself, such as the number of components involved; the range of behaviours targeted; expertise and skills required by those delivering and receiving the intervention; the number of groups, settings, or levels targeted; or the permitted level of flexibility of the intervention or its components.” [2]; | 1) The PE entails qualitative and/or quantitative primary research. 2) Only studies that conducted a PE while scaling up and evaluation of the scale-up process itself were included. 3) Explicitly state that a PE was conducted as part of the research study. The nature of these PEs was the subject of this review, and hence, a priori framework or definition was not outlined for these evaluations as such. Therefore, the following criteria were developed. The full text suggested that the study: a) Aimed to conduct a PE in relation to the scale-up of a CHI, or b) conducted implementation research to evaluate structures, resources, and processes in relation to the scale-up of a CHI, or c) evaluated how the scale-up of a CHI produced impact in relation to the scale-up of a CHI, or d) evaluated local context in relation to scale-up of a CHI, or e) a PE was conducted alongside post-evaluation in relation to the scale-up of a CHI. |
| Exclusion |
|
Figure 1
Flow diagram of scoping review in- and exclusion process [79, 80] *Databases: PubMed, Embase, CENTRAL, Web of Science, CINAHL, Global Health, Scielo and African Index Medicus; ** excluded manually.
Table 2
Overview of selected frameworks and theories used to shape the process evaluation during scale-up.
| RE-AIM | RE-AIM guides the planning and evaluation of programs according to the five key RE-AIM outcomes: Reach (the target population), Effectiveness (the impact on outcomes), Adoption (the extent to which individuals and settings adopt the intervention), Implementation (the fidelity and consistency of delivery), and Maintenance (the sustainability of the intervention over time) [7]. While mostly used in the evaluation stages, the RE-AIM framework can be used in the implementation of complex interventions by guiding its planning, execution and evaluation. In this review, RE-AIM was mostly used to map different outcomes of interest in relation to the scale-up process. |
| Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) – Implementation Strategies (FRAME-IS) | FRAME or FRAME-IS is designed to guide researchers and practitioners in reporting adaptations and modifications made to interventions or implementation strategies respectively. It emphasizes transparency and clarity in documenting changes to interventions or strategies, ensuring that the rationale and impact of adaptations are clearly communicated [81]. By reporting adaptations and modifications in the original intervention, using this framework adequately provides information on scale-up. |
| Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework | i-PARIHS helps understand and guide the implementation of evidence-based practices in health services. It considers the interaction between Innovation (the new practice), Recipients (the individuals and teams implementing the practice), Context (the environment in which implementation occurs), and Facilitation (strategies to support implementation) [82]. This framework promotes that the scale-up is tailored to the specific context. |
| Normalization Process Theory | This classic theory focuses on understanding how new practices, technologies, or interventions become embedded and integrated into routine work in healthcare settings. It explores the processes through which individuals and groups make sense of, engage with, and sustainably incorporate innovations into their everyday practices [83]. |
| (updated) Consolidated Framework for Implementation Research (CFIR) | CFIR helps identify barriers and facilitators to implementation, guides strategy design, and evaluates implementation outcomes. It looks at five main areas: the intervention itself (its attributes and advantages), the external context (like policies and collaborations), the internal organizational setting (culture, leadership), individual characteristics (knowledge, attitudes), and the implementation process (planning, execution, sustainability) [84]. |
| WHO ExpandNet | ExpandNet is a network and approach developed by the World Health Organization (WHO) to support the scale-up of successful health interventions. Key components include: systematic planning, stakeholder engagement, adaptive management, monitoring and evaluation, documentation and knowledge sharing [85]. |
| Non-Adoption, Abandonment, Scale-up, Spread and Sustainability (NASSS) framework | A conceptual implementation framework developed to understand the complexity of implementing and sustaining health interventions or technologies within healthcare systems. It provides a structured approach for analyzing various factors (innovation, individual, adopting organization, wider context, socio-technical system, implementation process, and outcomes over time) that influence the success or failure of implementing innovations in healthcare settings [86]. |