Center for the Study of Aphasia Recovery, University of South Carolina, Columbia.
Department of Speech and Hearing Sciences, University of New Mexico, Albuquerque.
Am J Speech Lang Pathol. 2020 Feb 7;29(1):286-298. doi: 10.1044/2019_AJSLP-19-00126. Epub 2020 Jan 28.
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.
目的 本研究的目的是描述正在进行的多机构失语症干预研究的保真度计划的制定和实施,并解释如何使用初始保真度措施来提高研究的完整性。
方法 临床核心团队在这项研究中制定并纳入了一个保真度计划。临床核心团队的目标是:(a)监督每个临床站点的数据收集和数据管理,(b)优化和监测评估保真度,以及 (c)优化和监测治疗保真度。初步数据正在被用于指导正在进行的努力,以保持和提高这项干预研究的保真度。
结果 初步结果表明,特定的招募策略有助于改善适当的转介,对参与者及其家属的适应有助于保持良好的保留率。简化和集中的培训计划确保了评估员和评分员对研究评估和治疗方案的可靠性。对评估和治疗任务的持续监测有助于保持研究的完整性。对于一些话语测量的评分者的低至中等的评分者间信度数据,指导临床核心团队及时解决培训和编码不一致的问题。
结论 临床核心团队的建立对于制定和实施改进评估和治疗保真度的保真度计划至关重要。有计划地分配研究人员来实施和监测持续的保真度措施,可确保临床数据的可靠性和有效性。对计划的持续审查显示了继续调整和改进研究保真度的优势和弱点。