As noted, there is no consensus or uniformity as to the specific actions that compose this initial prephase of discovery. The Medical Research Council (MRC, 2000) suggests that a wide range of approaches may be used. Emphasized is the importance of drawing upon the best evidence and appropriate theories and then engaging in a series of pilot studies, which we have referred to in Chapter 2 as Phase I and Phase
II activities. The MRC has produced some of the most important documents on developing and evaluating complex interventions; still, specific initial actions are not well identified, and its initial approach emphasizes the traditional four-phase linear and incremental pipeline for advancing interventions (Craig et al., 2008).
Behavioral Intervention Mapping is another schema that offers a step-bystep approach for intervention development. As a planning model for developing theory- and evidence-informed programs, its purpose is “to provide planners with a framework for effective decision making at each step in the intervention development process” (Bartholomew, Parcel, & Kok, 1998, p. 545) and to link each step and related actions. It has been used to address a wide range of health behavior and education programs such as breast and cervical cancer screening for Hispanic farmworkers (Fernandez, Gonzales, Tortolero-Luna, Partida, & Bartholomew, 2005), cervical cancer screening (Hou, Fernandez, & Chen, 2003), increasing effective illness behaviors in mental health patients (Koekkoek, van Meijel, Schene, & Hutschemaekers, 2010), or a worksite physical activity program (McEachan, Lawton, Jackson, Conner, & Lunt, 2008). Specifically, this approach involves highly iterative steps including identifying proximal program objects (e.g., who and what will change from an intervention); selecting a theory base for the methods and strategies employed; designing and organizing the intervention; and detailing implementation and evaluation plans.
Although Intervention Mapping is one of the few systematic approaches for intervention development that has also been formally evaluated (McEachan et al., 2008), it does not address some of the particulars concerning protocol development. On the basis of the MRC and intervention mapping approaches, we conceptualize the process of developing an intervention somewhat differently. We suggest that all interventions must start by fulfilling eight essential and interconnected thinking and action processes that need to be investigated, defined, or addressed prior to moving forward with a formal evaluation of an intervention. As described in Table 3.1, they include deriving a clear definition of the problem for which change is being sought; quantifying the problem that is being targeted for change; specifying the populations that may be at most risk; determining the pathways by which the problem occurs; identifying those pathways most amenable to change; identifying the outcomes of interest; quantifying the magnitude of change that may be possible; and identifying current practices or approaches to address the problem. Here we examine each consideration.