Implementation research for digital technologies and tuberculosis
A toolkit for evaluating the implementation and scale-up of digital innovations across the tuberculosis continuum of care.
Developing IR objectives and questions
Module 1 provided information on the preparatory steps for developing an implementation research (IR) study, including how to identify and understand possible implementation challenges and establish a research team. The next step is to use this information to develop research objectives and questions that can effectively address the core implementation issues. In this module, users will transform an implementation challenge into an appropriate research objective and question that can form the basis of an IR study.
Implementation research objectives and questions
A research objective conveys the overall purpose of an IR study and in turn, informs the study design and research methods that will be used. Objectives are typically framed as a statement, and start with a verb, for example: 'to explore', 'to assess' or 'to understand'. Further discussion on how to craft an appropriate objective is presented towards the end of this module.
Returning to the RE-AIM approach outlined in Module 1, this framework can help your team to think about hypotheses that would generate data to best describe the implementation challenge. In Box 10 - 13 are some general examples of the types of questions that could be asked across each of the five RE-AIM domains, based on each of the four digital functions:
As you can see, there are multiple questions and domains that may relate to any specific implementation challenge. Given the complex nature of digital technology interventions, it is likely that there are numerous, simultaneous implementation challenges and questions that relate to your digital intervention. While all domains are important and should be explored, this may not be feasible, and your team may need to prioritize components to focus on. Table 3 provides some criteria that can help you guide prioritization:
The stage of implementation and the maturity of your digital technology intervention can also help to determine the focus of research. For example, for interventions that have been recently implemented or are being considered for implementation, the key challenges may be related to whether or not it will work and/or be used, and therefore an IR study may focus on evaluating elements of Effectiveness, Reach and/or Adoption. Conversely, for digital interventions that are more established, or being considered for scale-up, the focus may be on identifying the Implementation factors that enhance the chances of successful integration within a health system and Maintenance. In Table 4 are some examples of questions related to implementation challenges and how they may relate to project maturity and domain.
Writing an IR proposal: introduction
Now that your research objective and questions have been developed, you can begin writing your IR proposal. This section will focus on the introduction section, which will summarize the research problem, present the justification for the proposed research and outline the intended benefit(s) of addressing the issue. The introduction section will also convey the specific research question(s) and objective(s) with a clear statement of the problem to the rest of the team, the stakeholders and any interested parties.
The introduction should:
- provide the foundation for the further development of the proposal;
- provide background information relevant to the study, including by reporting on similar studies;
- clearly outline the digital technology intervention and its objectives and implementation goal (in order to frame the implementation challenge);
- systematically state why the proposed IR should be undertaken, introduce the research question and objectives and identify which achievements and research outcomes are expected.
Illustrative examples of proposal introductions are provided in each of the case studies. Remember that the generic template provided can be used to develop your own proposal. At the end of every module there is also a checklist to ensure that the proposal contains all the necessary components and that information and has been properly collected.
Study title
The team will need to develop a title that appropriately conveys the key components of the study. The title should be descriptive, concise and clearly indicate the study's focus.
A good title should:
- use action words;
- reference the focus or key outcome of your research;
- include specific target populations;
- include the geographic location of where the study will occur.
Rationale/Literature review
The rationale section of your introduction should provide a clear, succinct argument that can convince policy-makers, donors or funding agencies why your proposal is worthy of their resources and support. The need for research is justified by presenting the scientific, public health and/or policy relevance or need for the proposed research. This requires a review of the existing literature to situate the research question within the broader context and make it clear to the reader how the proposed research will address important information gaps or advance our understanding of a particular issue. You may have identified much of this information already during the earlier stage of identifying and refining your specific implementation challenge and can be included in the rationale.
While developing the rationale, consider the following points:
- How will addressing the IR question align with or support national and international research and policy agendas and priorities, such as national strategic plan for TB and the End TB strategy?
- What does the existing literature say about the demonstrated benefit of your proposed digital technology?
- How will overcoming or addressing your implementation challenge and research question facilitate the implementation of your digital intervention in the longer term?
Statement of the implementation challenge, or problem statement
The problem statement is typically the last paragraph of the introduction and summarises the purpose and direction of the study and makes the connection between the literature review and rationale, and the broad issues that the research intends to address. It is here that the evidence gaps should be articulated in order to set up for introducing the study objectives.
IR objectives and research questions
The proposal introduction should end with the statement of your IR objectives, which outline the overall purpose for conducting the research. The IR study objectives should state clearly what the study is expected to achieve in general terms and signal the expected research outcome(s).
Here are some brief suggestions for framing specific objectives:
- Use words such as purpose, intent or objective to convey the main idea of the research and highlight the key concepts being explored.
- Use action verbs when defining specific objectives (e.g. determine, compare, verify, calculate, describe, establish, evaluate), while avoiding vague, or passive verbs (e.g. appreciate, understand or study).
- Imply the study design that will be used, and the planned data collection and analysis (these elements will be further discussed in the next module and you may find it helpful to come back to this section after familiarizing yourself with appropriate study methods for IR).
You may wish to include specific research questions that will be answered by your study. If so, the questions should be framed by the objective. While the objective outlines the higher-level focus of your study, the research questions specify the type of information you intend to collect.
Research questions should:
- align to the research objective;
- be answerable;
- be shaped by the problem and in turn shape the design of the research;
- be clear and specific.
Proposal checklist: Introduction section
Proposal checklist
Exercise: With your team, work through the check list below to ensure that your introduction section meets the basic criteria for a good quality proposal.
Study title
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Uses action words
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Clearly identifies the target population(s) (e.g. newly diagnosed TB patients, TB treatment providers etc.)
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Includes specific geographic location(s)
Rationale/ literature review
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Summarizes what is and is not known about the topic of your research
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Establishes your credibility in the topic area by demonstrating your knowledge and awareness of knowledge gaps, debates, nuance etc
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Conveys the relevance of your project by making connections to a broader body of knowledge
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Outlines what is being studied and why
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Provides clear succinct rationale for why the project should be funded
Problem statement
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Summarises the purpose of the study (in one paragraph), including outlining the intervention goals
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Links how addressing your IR challenge can advance or support the national or international TB policy environment
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Incorporates the research objectives and uses action words to succinctly outline the purpose of the study
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References the TB challenges in your own country/setting
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Summarises expected outcomes including the anticipated impact(s)
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Leads logically to the research objective
Research objectives and question(s)
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Are clear, specific and feasible
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Objective starts with an action verb and conveys the thrust of the study
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Includes a logical connection between the research objective and questions