Assessing treatment fidelity in pilot studies assist in designing clinical trials: an illustration from a nurse practitioner community-based intervention for pain.

Treatment fidelity refers to the degree to which treatment is administered as intended, and it is key to interpreting and translating research into practice. As an illustration, we report the benefits of examining treatment fidelity in a pilot study of nurse practitioner-delivered Coping Skills Training for chronic pain. Analysis revealed both strengths and weaknesses of protocol design and treatment delivery. This pilot work formed the basis for subsequently modifying the design of a large-scale clinical trial. Monitoring treatment fidelity throughout the pilot and trial phases of research can dramatically improve the research enterprise and facilitate successful dissemination.