Developing, implementing, and improving assessment and treatment fidelity in clinical aphasia research

Purpose: The purpose of this study was to describe the development and implementation of a fidelity program for an ongoing, multifacility, aphasia intervention study and to explain how initial fidelity measures are being used to improve study integrity. Method: A Clinical Core team developed and incorporated a fidelity plan in this study. The aims of the Clinical Core team were to (a) supervise data collection and data management at each clinical site, (b) optimize and monitor assessment fidelity, and (c) optimize and monitor treatment fidelity. Preliminary data are being used to guide ongoing efforts to preserve and improve the fidelity of this intervention study. Results: Preliminary results show that specific recruitment strategies help to improve appropriate referrals and that accommodations to participants and their families help to maintain excellent retention. A streamlined and centralized training program assures the reliability of assessors and raters for the study’s assessment and treatment protocols. Ongoing monitoring of both assessment and treatment tasks helps to maintain study integrity. Less-than-optimal interrater reliability data for the raters of some of the discourse measures guided the Clinical Core team to address the training and coding inconsistencies in a timely manner. Conclusions: The creation of a Clinical Core team is instrumental in developing and implementing a fidelity plan for improved assessment and treatment fidelity. Intentional planning and assignment of study staff to implement and monitor ongoing fidelity measures assures that clinical data are reliable and valid. Ongoing review of the plan shows areas of strengths and weaknesses for continuing adjustments and improvement of study fidelity.