Background
Main text
The suggested greyness: when and why it occurs, and how does it show?
Defining the concepts of intervention and implementation
Term | Exclusive definitions |
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Intervene | |
To interfere with the outcome or course, esp. of a condition or process [6] | |
To come in or between things so as to hinder or modify them [7] | |
Come in in the course of an action [59] | |
To become involved in a situation in order to improve or help it; to exist between two events or places [60] | |
Intervention | To happen between two times or between other events or activities [61] |
When someone becomes involved in something [62] |
Term | Exclusive definitions |
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Implement | Carry out, accomplish, especially to give practical effect to and ensure of actual fulfilment by concrete measures; to provide instrument or means of expression for [6] |
A means of achieving and end [7] | |
Carry into effect [59] | |
To make something that has been officially decided start to happen or be used [60] | |
To put a plan or system into operation [61] | |
Implementation | ‘Filling up’ [59] |
Clinical intervention and implementation intervention cases
Falls prevention — a clinical intervention
Stroke rehabilitation — a clinical intervention
An implementation intervention applied to clinical interventions for falls prevention and stroke rehabilitation
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creating a sense of urgency to address the clinical issue (in this case: falls, and associated risks for injuries and mortality, and stroke rehabilitation practices),
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understanding the gap between current practice and effective practice (e.g.: assessments, medication reviews, and exercise programs, including techniques and frequency) and setting priorities for change,
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developing an implementation plan and choosing interventions that fit with the current context and barriers to change (e.g.: education, audit and feedback, reminders), and
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supporting the implementation visibly and symbolically (e.g.: establishing clear department standards, recognising staff efforts to change).
Illustrating the differences and overlaps causing potential greyness between clinical and implementation interventions
Demonstrating combinations of clinical interventions and implementation interventions, and the potential greyness in between
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Scenario A illustrates a well-established evidence base for both the clinical intervention and the implementation intervention. In this case, greyness could occur in relation to what is an effect of the clinical intervention or the implementation intervention, or a combination of the two, in a new context.
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Scenario B illustrates the example of undertaking trials with a primary focus on a clinical intervention, yet combined with an explicit (evidence-based) implementation intervention. In such cases, the effectiveness of the clinical intervention can influence or be influenced by the implementation intervention, and cause greyness. Thus, even with an emphasis on evaluating the clinical intervention, the implementation intervention should be considered, discretely and conjointly: the ‘if’, ‘how’, ‘when’, and ‘why’ it works (or not), in order to investigate how it may affect the clinical intervention.
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Scenario C illustrates a case where the evidence is not settled with regards to the method or strategy to be applied for an implementation intervention while the evidence for the clinical intervention is strong. As the falls prevention and stroke rehabilitation cases elucidate, the primary focus is on testing the relevance of the implementation intervention, while data on the clinical intervention's impact on relevant outcomes are considered.
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Scenario D (indicated by the twin minus-signs of the figure) illustrates cases where neither the evidence base for a clinical intervention is established, nor the evidence with regards to an implementation intervention. While we suggest these conditions are, to the best of our knowledge, rare in health care science, they may occur when a clinical intervention is trialed with an implicit implementation component (that itself is lacking evidence). Such initiatives require particular attention to attribution of observed effects [39].
Using theories, models and frameworks to understand a potential greyness in clinical intervention and implementation interventions
Teasing out greyness by means of reporting guidelines
Conceptual, theoretical and practical aspects considered - where does it leave clinical and implementation interventions and the potential greyness in between?
Standard for Quality Improvement Reporting Excellence (SQUIRE) [57] | Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2) [55] | Developing Standards for Reporting Phase IV Implementation studies (StaRI) [48] | Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide [56] | |
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Overview | 18-item checklist for reporting system-level interventions, where methods focused on attributing change to interventions | 13-item checklist based on development (4 criteria), feasibility and piloting (1 criteria) and evaluation (8 criteria) of complex interventions | 35-item checklist focused on reporting for both intervention impact and implementation process for complex interventions | 13-item checklist for intervention completeness and replicability; applies questions: why, what, who, how, where, when and how much, assessing tailoring, modifications, and how well |
Checklist content | 1. Title – focus on the initiative 2. Abstract – summarize key info 3. Problem description - nature and significance of issue 4. Available knowledge – summary of what is known 5. Rationale – theoretical foundations and assumptions 6. Specific aims – report purpose 7. Context – elements considered key at the outset 8. Intervention(s) – details of intervention and team 9. Study of intervention(s) – approach to assess outcomes 10. Measures – both process and impact measures; methods 11. Analysis – methods for making inferences, assessing variation 12. Ethical considerations – how addressed including formal review, conflicts of interest 13. Results – initial steps, evolution, modifications made, contextual elements, associations, unintended consequences, missing data 14. Summary - key findings and project strengths | 1. Theoretical basis for intervention 2. Intervention components (rationale, aims, core functions) 3. Intended interactions between components 4. Details of context’s characteristics and role in intervention 5. Pilot test description and impact 6. Control condition description and rationale 7. Details of the intervention delivery strategy 8. Details of materials and tools used 9. Details of delivery fidelity relative to study protocol 10. Process evaluation -description, theoretical basis 11. Facilitators and barriers revealed as influencers via process evaluation 12. External factors influencing intervention delivery or how it worked 13. Cost or resources for delivery | 1. Title and abstract Introduction: 2. description of aspect of care that is the focus 3. rationale 4. evidence and 5. theory underpinning the implementation intervention, 6. study aims and distinction between intervention and implementation Method (criteria 7–22): setting, intervention description (new service), population, randomization, data, and analysis details Results (criteria 23–33): population (participation rates and compliance/attrition), fidelity (including modifications/adaptations), outcomes (process and clinical) Discussion: 34. findings interpreted in context of literature, implications General: 35. regulatory, ethical approval, and other registrations, funding, and conflicts of interest | Brief name: 1. name to describe intervention Why: 2. rationale, theory, or goal of intervention components What: 3. physical or other materials, including where to access 4. procedure/process description, including support activities Who provided: 5. intervention provider (expertise, background, and specific training) How: 6. modes of delivery and whether provided individually or in groups Where: 7. type(s) of location(s) of the intervention, including infrastructure or relevant features When and How Much: 8. frequency and time frame Tailoring: 9. details of personalization or adaptation Modifications: 10. description of changes How well: 11. planned (how adherence or fidelity assessed; strategies to enhance fidelity) 12. actual (if adherence/fidelity assessed, extent of intervention delivery as planned) |