Strategies used and data obtained during treatment fidelity monitoring

Treatment fidelity, also called intervention fidelity, is an important component of testing treatment efficacy. Treatment fidelity is defined as “methodological practices used to ensure that a research study reliably and validly tests a clinical intervention” (Bellg et al., 2004, p. 443). In cognitive behavioral interventions, published recommendations address five components of treatment fidelity: study design, provider training, treatment delivery, treatment receipt, and treatment enactment (Bellg et al., 2004; Borrelli et al., 2005). Strategies are incorporated in these five components to ensure that: theory-based hypotheses can be tested adequately via the study design; the personnel who provide the intervention are competent and consistent; the intervention is delivered as intended without variation; the intervention is received appropriately and understood by participants; and participants enact the intervention as intended in their daily life (Bellg et al., 2004; Borrelli et al., 2005). Capturing measurable data related to treatment fidelity monitoring is important for several reasons. First, variations are likely to occur, given the complexity of cognitive behavioral interventions, range of strategies used to address treatment fidelity components, and resource limitations that can be encountered when conducting clinical trials (Spillane et al., 2007). Second, variations that do occur need to be captured to assess intervention dose adequately (Santacroce, Maccarelli, & Grey, 2004). Third, documenting and evaluating variations in treatment enactment can help in translating interventions from tightly controlled clinical trials to real-world settings (Leventhal & Friedman, 2004). Although examples of the number, type, and complexity of strategies needed to address each of these five components of treatment fidelity have been provided (Resnick et al., 2005; Robb, Burns, Docherty, & Haase, 2011), more data are needed on the variations encountered during fidelity monitoring. The purpose of this report is to describe strategies used and data obtained during treatment fidelity monitoring in the Breathe for Hot Flashes Study (1 R01 CA132927).