Speech and Hearing Sciences, University of New Mexico, Albuquerque, NM 87131, USA.
Speech Pathology and Audiology, Marquette University, Milwaukee, WI 53233, USA.
Mil Med. 2024 Aug 19;189(Suppl 3):568-578. doi: 10.1093/milmed/usae188.
The Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury (CONNECT-TBI) study is an ongoing randomized, double-blinded, sham-controlled multisite clinical trial to determine the enhancing effects of noninvasive neuromodulation when paired with cognitive training in military participants (Veterans and active duty) with mild TBI. Attention Process Training-III (APT-III) was selected for its strong evidence base, manualized procedures, and computerized program. However, many aspects of APT-III that make it ideal for personalization make it less ideal for reliable implementation across participants, clinicians/technicians, and sites. The purpose of this feature article is to highlight APT-III procedures that require additional standardization for reliable administration across participants and sites.
Ten studies using APT-III were reviewed for methodology of APT-III administration. The manual was also scrutinized; aspects of administration that involved clinical decision-making, subjectivity, flexibility, and/or that were identified by the APT-III developers as areas in need of "empirical evaluation" were flagged by clinicians. Literature and manual review findings were presented to the team for discussion and solution-finding. The authors created and refined a standardized process that would allow participants to move through APT-III training, including task movement algorithms and new materials drafts. Refining of algorithms and drafts continued until there was a consensus from team members.
Many gray areas were identified, but we will limit our reporting to focus on (1) dosage, (2) adaptation, (3) metacognitive strategy instruction, and (4) goal attainment scaling. We present APT-III manual details, literature review findings, and CONNECT-TBI decisions and materials for each of these areas of focus.
We have highlighted some of the major gray areas of APT-III administration so that fellow researchers can understand the need to take similar steps in clinical trials using APT-III. We provide examples of our standardization process and resultant rules and materials. Our algorithm, based on prior studies using the APT-III and our own iterative adjustments, allows for adjustment of the difficulty and speed of the training tasks (but within certain parameters) in order to achieve the best balance between individualization and consistency across participants and sites. We provide an example of a workflow and reporting process for future studies.
正在进行的控制网络神经调节以增强复杂创伤性脑损伤患者认知训练（CONNECT-TBI）研究是一项随机、双盲、假对照的多中心临床试验，旨在确定非侵入性神经调节与认知训练相结合对轻度创伤性脑损伤（退伍军人和现役军人）患者的增强效果。注意力处理训练-III（APT-III）因其强大的证据基础、规范化程序和计算机化程序而被选中。然而，APT-III 的许多使其个性化的方面使其在参与者、临床医生/技术人员和地点之间的可靠实施方面不太理想。本文的目的是强调 APT-III 程序，这些程序需要额外的标准化，以便在参与者和地点之间可靠实施。
对使用 APT-III 的 10 项研究进行了回顾，以评估 APT-III 管理的方法学。还仔细审查了手册；涉及临床决策、主观性、灵活性的管理方面，或被 APT-III 开发人员标记为需要“实证评估”的领域，由临床医生标记。文献和手册审查结果提交给团队进行讨论和解决方案寻找。作者创建并完善了一个标准化流程，允许参与者完成 APT-III 培训，包括任务移动算法和新的材料草案。在团队成员达成共识之前，继续改进算法和草稿。
确定了许多灰色区域，但我们将报告限制在关注（1）剂量、（2）适应、（3）元认知策略指导和（4）目标实现量表。我们介绍了 APT-III 手册详细信息、文献综述结果以及每个重点领域的 CONNECT-TBI 决策和材料。
我们强调了 APT-III 管理的一些主要灰色区域，以便其他研究人员能够理解在使用 APT-III 的临床试验中需要采取类似的步骤。我们提供了我们的标准化流程以及相应规则和材料的示例。我们的算法基于之前使用 APT-III 的研究和我们自己的迭代调整，允许调整培训任务的难度和速度（但在某些参数内），以在参与者和地点之间实现个性化和一致性之间的最佳平衡。我们提供了未来研究的工作流程和报告流程示例。
