Consistent with previous definitions (Bellg et al., 2004; Gearing et al., 2011; Lichstein et al., 1994) and our own experiences, we recommend that a fidelity plan attend to four aspects: the study design, and the delivery, receipt, and enactment of an intervention. We also recommend that strategies be introduced to enhance, monitor, and measure each of these four aspects. An example of a fidelity plan is shown in Table 12.3.

Strategies for Assuring Study Design Integrity

With regard to study design and to ensure trial integrity, a fidelity plan might include, but does not have to be limited to, the development of a Manual of Procedures for implementing the overall trial design, as well as specific interview protocols, codebooks, and certification procedures for training interviewers and other research staff. External collaborators, advisory boards, or Data and Safety Monitoring Boards (DSMBs) can also help monitor fidelity or suggest strategies for fidelity assessment. Randomization efforts should be conducted by an independent investigator who is not part of the project team. In addition, periodic reports should be submitted to a DSMB (see Chapter 13), or another external advisory or oversight board for their fair and impartial review of data collection and fidelity-monitoring procedures.

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