Step 1: Frame your question
What is an implementation science question?
Implementation science is centrally focused on the effectiveness of implementation strategies, rather than interventions or evidence-based practices. Specifically, implementation science attends to the context in which strategies are applied, and how that context shapes effectiveness of implementation strategies.
To lay the foundation for research on the effectiveness of implementation strategies, it is important to understand the barriers and facilitators impacting the adoption and widespread use of evidence based practices. Early work in the field of implementation science focused largely on barriers and facilitators to successful implementation, but the field has now progressed to understanding barriers and facilitators as a necessary first step.
Beyond barriers and facilitators, implementation science questions should examine the context of the implementation strategy or strategies employed, how that context shapes the strategy or strategies, and/or focus on at least one relevant implementation outcome (see Proctor et al 2011 for a list of these outcomes and their definitions).
When to do implementation science
Whether or not it is appropriate to use implementation science depends on the state of evidence that supports the intervention or practice. If an intervention or practice has not yet proven effective, conducting efficacy research is the next step to establish a solid evidence base, not implementation research. However, it is important to note that even at this stage implementation issues should be considered and studied. If an intervention has demonstrated efficacy under controlled conditions but not effectiveness under real-world conditions, then effectiveness research is warranted, perhaps through pragmatic trials. If the intervention has demonstrated effectiveness under real-world conditions, then one can move onto implementation research.
Formative implementation research to understand the context of implementation often includes identifying barriers and facilitators to implementing the intervention or practice. It can also include mapping the broader policy environment that surrounds the intervention or evidence-based practice.
Next is designing and testing implementation strategies, perhaps through implementation trials where the primary outcomes are how much and how well the intervention is delivered. There are many interventions already backed by solid evidence. For these interventions, the priority is not evaluating whether the intervention works, but rather testing strategies or methods for getting it done in routine practice.
If the intervention has not demonstrated effectiveness under real-work conditions, or the evidence is limited in quantity or scope, then we could conduct a hybrid effectiveness-implementation trial where we ask both a “what” and a “how” question in the same study. Hybrid trials blend design characteristics of effectiveness and implementation studies to generate timely uptake of desirable interventions, more effective implementation strategies, and more relevant information for future scale-up activities.
The “subway” map developed by Beidas et al provides a useful visual of this intervention to implementation research pipeline.
Locating yourself on the “subway line” of translational research
*In some cases it may still be appropriate to move forward with a hybrid Type I trial in the absence of effectiveness evidence (e.g. very strong efficacy, indirect evidence supportive of potential effectiveness in context of interest, and/or strong momentum supporting implementation in a health care context).
Adapted from Lane-Fall, M.B., Curran, G.M. & Beidas, R.S. Scoping implementation science for the beginner: Locating yourself on the “subway line” of translational research. BMC Med Res Methodol 19, 133 (2019). https://doi.org/10.1186/s12874-019-0783-z
Key Implementation Science Questions
How do contextual factors influence implementation success or failure? How can they be modified to increase chances of success)?
What are the most effective techniques to incorporate new discoveries and evidence-based practices into care delivery?
What are the most effective techniques to improve the distribution and receipt of evidence in the real world?
What are the most effective techniques to de-implement practices that are no longer effective or were never effective?
In addition to these broad implementation science questions, there are other ways to frame your question. Try using the challenge faced or the objective sought as the starting point for forming an implementation science question.
Questions relating to the challenge of:
❯ How can coverage and usage of a proven intervention be improved to meet set targets?
❯ How can a program be scaled up to broader regions or populations?
❯ Why do established programs lose effectiveness over time?
❯ How can sustainability or health maintenance be achieved?
❯ Why do tested programs exhibit unintended effects when transferred to a new setting or problem?
❯ Why don’t tested programs work when transferred to new settings or work in some settings and not others?
❯ How can implementation be improved to assure replicability?
❯ How can multiple interventions be effectively packaged and delivered within health systems?
❯ How can interventions be delivered to assure integration?
❯ How could program or service delivery be more equitable in settings where financial and human resources are low, or where [differing] cultural and social norms affect health-seeking behaviors?
❯ What is the impact across issues of race, class, education, gender, age, geography (urban-rural) and other relevant factors?
❯ Are there unintended consequences (positive or negative) of the program?
❯ Under what conditions does the program work?
❯ Is the tool, intervention, or strategy worth it? Is it cost-effective?
❯ Does the program achieve the intended public health impact?
Adapted from Fundamentals of Implementation Research (2012)
Questions relating to the objective of:
❯ What are the possible factors and agents responsible for good implementation of a health intervention? For enhancing or expanding a health intervention?
❯ What describes the context in which implementation occurs?
❯ What describes the main factors influencing implementation in a given context?
❯ Is a health outcome due to implementation of the intervention?
❯ How and why does implementation of the intervention lead to effects on health behavior, services, or status in all its variations?
❯ What is the likely course of future implementation?
Adapted from Implementation Research: What it is and how to do it (2013)
To learn more about the importance of deciding which questions to ask, read Dr. Elvin Geng and colleagues’ The question of the question: impactful implementation science to address the HIV epidemic, open access in the Journal of the International AIDS Society.
Pause and reflect
❯ Does your research question address or involve inequities in health outcomes, access, or quality of care among different populations?
❯ Have you (and how have you) engaged with the communities affected by the inequities to ensure their perspectives and needs are reflected in the research question?
❯ Is answering this question or addressing this inequity a priority of the population(s) involved, or do they have different priorities?
❯ Does your research team include anyone from the community or communities you wish to study?
❯ Have you considered the social, economic, and cultural contexts that may influence variation in implementation and subsequent outcomes of the intervention?
❯ Are there system-level factors, such as policies and organizational practices, that could impact equity in the implementation process?
❯ Has the population you wish to conduct research with experienced historical or contemporary harm that could impact their desire to participate or shape the implementation process and outcomes?