PIPELINE AS A HEURISTIC
The pipeline concept is a traditional way of describing the scientific enterprise and how basic and human research makes its way through research processes to having an impact on the health of the public (Kleinman & Mold, 2009; U.S. National Library of Medicine, 2014). Applied to behavioral intervention research, it can be a useful heuristic for understanding intervention development for several reasons. First, it provides an organizing framework for categorizing interventions with regard to their level of development. Understanding where an intervention is along a pipeline helps to evaluate what has been done to date to develop the intervention and what still needs to happen to build a strong evidence base for the intervention. Each specified phase along a pipeline is associated, albeit loosely, with a set of goals, objectives, and actions for advancing an intervention. Thus, identifying and specifying phases along the pipeline structures the activities required for designing, evaluating, or implementing an intervention, and helps to identify what has been accomplished to date and what still needs to be accomplished in building the evidence for an intervention.
Referring to the pipeline is also helpful when seeking funding to support the development, evaluation, or implementation and dissemination of an intervention. Although funding agencies may define phases along the pipeline differentially, it helps to pinpoint the purpose of a proposal for agencies and reviewers by indicating the phase of an intervention’s development along the pipeline (see Chapter 23 on grant writing). For example, when submitting a grant proposal, it is important to indicate whether the research is designed to definitively test the efficacy of an intervention, its effectiveness, or demonstrate proof of concept or feasibility. Reviewers will apply very different evaluative criteria to a proposal designed to evaluate feasibility and proof of concept compared with one that seeks to test efficacy. For the latter, the expectation is that there will be pilot data supporting proof of concept of the intervention and that clinical trial methodology including randomization, control groups, and other rigorous design elements to test the intervention will be proposed (Thabane et al., 2010). For a feasibility study, however, other design strategies including small sampled pre-post studies, focus groups, or use of mixed methods (see Chapter 11), to name a few, would be more appropriate to evaluate tolerability of a particular treatment or adherence to a protocol.
Furthermore, as a heuristic, the idea of a pipeline facilitates asking and answering the following fundamental questions:
- ? What is the level of development of the intervention?
- ? What type of evaluation is needed to move the intervention forward?
- ? Do the investigator and the investigative team have the requisite expertise to advance the intervention?
- ? Are the proposed activities in keeping with the phase of development of the intervention?
- ? Is there sufficient proof of concept to advance the intervention?
- ? Does the intervention have implementation potential? How would the intervention change practice (Craig et al., 2008)?
Finally, the concept of a pipeline itself reflects a particular approach or methodology for advancing an intervention. As an approach or methodology, it can be evaluated, critiqued, and hence modified and improved. That is, by specifying and delineating the phases and associated activities along a pipeline, we can scrutinize the process used for advancing behavioral interventions, experiment with ways to shorten or combine phases through novel methodologies, and adopt strategies for building and rolling out interventions more rapidly and efficiently. For example, we know that proceeding linearly from idea inception to prescribed testing phases may involve a journey of more than 17 years and that very few evidence-based interventions become available to the public or are effectively integrated into communities, clinics, and social service settings or result in change in health policy. Thus, ways to redesign the pipeline for behavioral intervention research to overcome these challenges has become an important topic and focus of attention in the scientific community and among funders.