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.

总结（临床核心） 在言语语言或中风康复文献中，相对较少关注对患者的威胁。 研究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I型或II型错误的机会，或者是得出结论的额外错误（“III型”） 当实际上测试或治疗没有正确实施时，显着或不显着。 此外，这些威胁可以阻止因果推理。在没有忠诚度监测的情况下，调查人员 无法自信地确定结果（显著或不显著）是否由目标 独立变量或由于临床医生“偏离” 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中历史上混合结果的贡献者， 项目1和项目2。Fridriksson，Hillis，Bonilha，Rorden和Hickok提出的大多数目标都要求 招募和留住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，评分员遵守规定的评分程序。 十二个项目目标中的七个依赖于治疗，以及坚持规定治疗的治疗师 程序.研究者的假设是，临床工作人员作为评估者、评级者和/或 治疗师遵守研究方案。努力优化对评估和治疗的坚持 被称为评估和处理保真度的程序对拟议项目至关重要。临床 核心将协调和活动，旨在优化保真度，从而防止威胁的有效性和 提高了对几乎每一个提出的目标的检测效果的能力。 为了防止由于选择偏倚、损耗或缺失数据点而对有效性造成的威胁， 核心部门将开展与招聘、留用和数据收集相关的培训和监测活动， 管理为了防止漂移、交叉污染、临床医生对 临床医师变异性或揭盲，临床核心将进行广泛的培训，初始和整个 研究和监测活动，以确保所有临床工作人员得到标准化培训， 评估和治疗按预期进行，并且有证据表明接受了治疗 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） 为所有研究成员工作人员纳入多层培训计划，（2）通过以下方式监测治疗保真度 几种互补的方法，以及（3）通过采用既定的治疗方法来监测评估保真度 忠诚准则最后，临床核心还将通过对行为数据进行评分来支持项目， 可靠性测量和结果的盲法测量。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。