Clinical Core

摘要(临床核心) 在言语语言或中风康复文献中，相对较少关注对 研究的有效性与治疗的正确实施有关，也与评估程序有关。这些 威胁可能会增加第一类或第二类错误的机会，或结论的额外错误(“第三类”) 当测试或处理实际上没有正确实施时，重要或不重要。 此外，这些威胁可能会阻止因果推论。在缺乏保真度监控的情况下，调查人员 无法确定结果(显著或无关紧要)是否由目标 独立变量或由于引入其他随机因素，因为临床医生从 协议，或通过添加或省略元素来“污染”协议。缺乏对执行的重视， 那么，可能是失语症治疗研究中历史上喜忧参半的结果的一个贡献者， 项目1和项目2。Fridriksson、Hillis、Bonilha、Rorden和Hickok提出的大多数目标都需要 招募和留住病人并收集高质量的数据。高质量的数据要求 评审员使用规定的管理程序，评分员遵循规定的评分程序。 十二个项目的目标中有七个依赖于治疗，而治疗师则坚持处方治疗 程序。研究人员的假设是，临床工作人员充当评估员、评价员和/或 治疗师遵循研究方案。努力优化对评估和治疗的坚持 被称为评估和治疗保真度的程序对拟议的项目至关重要。《临床》 CORE将协调旨在优化保真度的活动，从而防范对有效性和 提高对提出的几乎每一个目标的检测效果的能力。 为了防止由于选择偏差、损耗或丢失数据点而对有效性造成的威胁，临床 CORE将开展与征聘、留用和数据收集有关的培训和监测活动 管理层。以防止漂移、交叉污染、临床医生对... 临床医生可变性，或非盲目性，临床核心将进行广泛的培训，最初和整个 研究和监测活动，以确保对所有临床工作人员进行标准化培训， 评估和治疗已按预期进行，有证据表明已接受治疗 按计划进行。据我们所知，这些将是中风或失语症康复的首批研究之一，以：(1) 纳入针对所有研究成员的多层次培训计划，(2)通过以下方式监测治疗保真度 几种相辅相成的方法，以及(3)通过采用既定治疗来监测评估保真度 富达的指导方针。最后，临床核心还将通过对行为数据进行评分来支持这些项目，这两个数据都是 可靠性措施和盲目的结果衡量标准。因此，核心的主要目标是培训 研究团队，行为数据的评分和管理，并优化对协议的遵守。

Summary (Clinical Core) In speech-language or stroke rehabilitation literature, relatively little attention has been paid to threats to a study’s validity that relate to correct implementation of treatment, and also assessment, procedures. These threats can increase the chance of Type I or Type II error, or the additional error (“Type III”) of concluding significance or nonsignificance when in fact the tests or the treatments were not correctly implemented. Additionally, these threats can prevent causal inference. In the absence of fidelity monitoring, investigators are unable to confidently determine whether or not results (significant or insignificant) were caused by the targeted independent variable or due to other random factors introduced because the clinician “drifted” from the protocol, or “contaminated” the protocol by adding or omitting elements. Lack of attention to implementation, then, could be a contributor to the historically mixed results in aphasia treatment research emphasized by Project 1 and Project 2. Most of the aims proposed by Fridriksson, Hillis, Bonilha, Rorden, and Hickok require recruitment and retention of patients and collection of high quality data. High quality data necessitate that assessors use prescribed administration procedures and raters adhere to prescribed scoring procedures. Seven of twelve project aims rely upon treatment, and therapists that adhere to prescribed treatment procedures. The assumption of the investigators is that clinical staff functioning as assessors, raters, and/or therapists adhere to the study protocol. Efforts to optimize adherence to assessment and treatment procedures, referred to as assessment and treatment fidelity, are critical to the proposed projects. The Clinical Core will coordinate and activities designed to optimize fidelity, thereby guarding against threats to validity and improving the power to detect effects for nearly every aim proposed. To guard against threats to validity stemming from selection bias, attrition, or missing data points, the Clinical Core will conduct training and monitoring activities related to recruitment, retention, and data collection and management. To guard against threats to validity stemming from drift, cross-contamination, clinician-to- clinician variability, or unblinding, the Clinical Core will conduct extensive training, initial and throughout the study, and monitoring activities that will ensure that there is standardized training for all clinical staff, that assessment and treatment was delivered as intended, and that there is evidence that treatment was received as planned. As far as we can tell, these will be among the first studies in stroke or aphasia rehabilitation to: (1) incorporate multiple-tier training programs for all study member staff, (2) monitor treatment fidelity through several complementary methods, and (3) monitor assessment fidelity via adoption of established treatment fidelity guidelines. Finally, the Clinical Core will also support the Projects by scoring behavioral data, both for reliability measures and for blinded measures of outcome. Thus, the main goals of the Core are training the study team, scoring and management of behavioral data, and optimizing adherence to the protocols.