Clinical Core

临床核心

• 批准号: 10617722
• 负责人: Argye E. Hillis
• 金额: $ 23.31万
• 依托单位: UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10617722
• 关键词: Adherence; Adoption; Aphasia; Attention; Behavioral; Blinded; California; Caregivers; Characteristics; Clinical; Clinical Management; Clinical Trials; Cognitive Science; Collaborations; Collection; Communities; Data; Data Analyses; Data Collection; Elements; Ensure; Feedback; Goals; Guidelines; Hospitals; Human Resources; Image; Language; Life; Literature; Longitudinal Studies; Measures; Medical; Methods; Monitor; Neurologist; Neurology; Outcome; Outcome Measure; Participant; Pathologist; Patient Recruitments; Performance; Phase; Procedures; Process Assessment; Protocols documentation; Qualifying; Research; Research Personnel; Sampling; Selection Bias; South Carolina; Speech; Speech-Language Pathology; Standardization; Stroke; Testing; Training; Training Programs; United States National Institutes of Health; Universities; Work; aphasia recovery; aphasia rehabilitation; clinical diagnosis; clinical research site; data management; design; evidence base; experience; improved; member; neuroimaging; participant retention; patient retention; prevent; recruit; spelling; stem; stroke rehabilitation; treatment research

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.

摘要（临床核心） 在言语或中风康复文献中，相对较少关注对患者的威胁。 研究的有效性与正确实施治疗以及评估、程序有关。这些 威胁可能会增加发生 I 类或 II 类错误的可能性，或得出结论的额外错误（“III 类”） 当事实上测试或治疗没有正确实施时，显着性或不显着性。 此外，这些威胁可能会阻止因果推断。在缺乏保真度监控的情况下，调查人员 无法自信地确定结果（显着或不显着）是否是由目标引起的 自变量或由于临床医生“偏离”而引入的其他随机因素 协议，或通过添加或省略元素“污染”协议。缺乏对执行的重视， 那么，可能是失语症治疗研究历史上混合结果的一个贡献者 项目 1 和项目 2。Fridriksson、Hillis、Bonilha、Rorden 和 Hickok 提出的大多数目标都需要 招募和保留患者以及收集高质量数据。高质量的数据需要 评估员使用规定的管理程序，评估者遵守规定的评分程序。 十二个项目目标中有七个依赖于治疗，并且治疗师遵守规定的治疗 程序。研究人员的假设是临床工作人员充当评估者、评分者和/或 治疗师遵守研究方案。努力优化评估和治疗的依从性 被称为评估和处理保真度的程序对于拟议项目至关重要。临床 核心将协调旨在优化保真度的活动，从而防范对有效性和安全性的威胁 提高检测几乎每个提出的目标的效果的能力。 为了防止由于选择偏差、损耗或数据点缺失而对有效性造成的威胁，临床 核心将开展与招聘、保留和数据收集相关的培训和监控活动 管理。防止因漂移、交叉污染、临床医生之间的差异而对有效性造成的威胁 临床医生的可变性或揭盲，临床核心将在初始和整个过程中进行广泛的培训 研究和监测活动，以确保所有临床人员接受标准化培训， 评估和治疗已按预期进行，并且有证据表明已接受治疗 按计划。据我们所知，这些将是中风或失语症康复的首批研究之一：(1) 为所有研究成员纳入多层培训计划，(2) 通过以下方式监测治疗忠诚度： 几种补充方法，以及（3）通过采用既定治疗方法来监测评估保真度 保真度准则。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 可靠性措施和结果的盲法测量。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，以及优化对协议的遵守。