Details of how implementation science and other theory-driven approaches can address ethical challenges for trials justified on contextual equipoise to inform sustainable policy-making in resource-poor settings
| Recommendation | Implementation science methodology | Expected outcome |
| Literature review of barriers and facilitators to implementing EBP. | Literature reviews guided by relevant IS determinant frameworks to synthesise evidence for the influence of context on the effectiveness of the implementation strategies on implementation outcomes. A realist review of relevant literature to understand the influence of context on the mechanisms introduced by the methods used to delivery EBP, on key outcomes. | A synthesis of barriers and facilitators that are known to influence the effectiveness of implementation strategies and/or the mechanisms introduced by the implementation strategies in delivering EBP. |
| Evaluation of the local context to identify barriers and/enablers and relevant implementation strategies to implement the proposed EBP. | Use of determinant frameworks, to identify relevant barriers and/or enablers that influence implementation strategies to deliver EBP. Realist evaluation to understand how the context influences the mechanisms introduced by current methods/implementation strategies to deliver EBP. Methods are available that can help to select appropriate implementation strategies including a tool developed by The Expert Recommendations for Implementing Change (ERIC) study.5 The ERIC tool offers a compilation of implementation strategies that are known to be effective in addressing specific contextual barriers. | A synthesis of contextual determinants that can influence the effectiveness of the implementation strategies and/or mechanisms introduced by the implementation strategies in deliver EBP. A list of potential implementation strategies that are known to be effective overcoming identified contextual barriers. |
| Participatory methods to compare findings from the evaluation of the local context and literature review to select appropriate implementation strategies and study design. | Relevant stakeholders in the participatory theory of change (ToC) workshops, can review similarities and differences in contextual determinants for delivering EBP between the literature review and the evaluation of the local context and come to an agreement as to the most salient implementation strategies identified using the ERIC tool. Participatory ToC workshops can also be used to determine if contextual equipoise exists and an RCT ethically justifiable for the set of implementation strategies they selected to deliver the EBP. | Implementation strategies that are deemed to be acceptable and appropriate by the local community. Selection of appropriate study design that is determined by existing evidence on relevant contextual barriers. |
| Effectiveness-implementation hybrid trials | Helps investigator select a study design that can be applied to address contextual equipoise with implementation research.41 There are three types of hybrid trials (ie, type 1, type 2 and type 3), where the type of trial design selected depends on the availability of evidence for both the clinical components of the intervention as well as the implementation strategies for a given context. A hybrid type 1 trial is usually a cluster randomised trial as only strong indirect evidence exists for the effectiveneness of the EBB in the local context. A hybrid type 2 trial can be randomised or quasi-experimental and is appropriate when there is strong indirect evidence as to the influence of context on the implementation strategies and EBP in the local context. A hybrid type 3 trial is usually a quasi-experimental design and is appropriate when there is generalisable evidence as to the influence of context on the effectiveness of implementation strategies and the EBP in the local context. | Selection of an appropriate study design that is based on existing evidence base. |
EBP, evidence-based practice; RCT, randomised controlled trial.