Clinical Core

临床核心

• 批准号: 10094383
• 负责人: Argye E. Hillis
• 金额: $ 22.55万
• 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/10094383
• 关键词: Adherence; Adoption; Aphasia; Attention; Behavioral; Blinded; California; Caregivers; Characteristics; Clinical; Clinical Management; Clinical Trials; Cognitive Science; Collection; Communities; Consult; 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; Patients; Performance; Phase; Procedures; Process Assessment; Protocols documentation; Research; Research Personnel; Sampling; Selection Bias; South Carolina; Speech; Speech-Language Pathology; Standardization; Stroke; Supervision; 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; 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） 在言语语言或中风康复文献中，对威胁的威胁几乎没有关注 研究的有效性与纠正治疗的实施以及评估程序有关。 威胁可能会增加I型或II型错误的机会，或结论的其他错误（“ III”） 实际上测试或治疗方法未正确实施时，显着性或非意义。 此外，这些威胁可以防止因果推断。在没有保真度监测的情况下，调查人员是 无法自信地确定结果是否是由目标引起的 自变量或由于引入其他随机因素而引起的，因为临床从 协议，或通过添加或省略元素“污染”协议。缺乏对实施的关注， 然后，可能是导致历史混杂的结果的贡献者，从 项目1和项目2。弗里德里克森（Fridriksson），希尔斯（Hillis），邦尼哈（Bonilha），罗登（Rorden）和希科克（Hickok）提出的大部分目标 招募和保留患者以及收集高质量数据。需要的高质量数据 评估人员使用规定的管理程序，评估者遵守规定的评分程序。 十二个项目中有七个旨在依靠治疗，而治疗师则遵守处方治疗 程序。调查人员的假设是，临床人员作为评估者，Rators和/或 治疗师遵守研究方案。为优化遵守评估和治疗的努力 程序（称为评估和治疗保真度）对拟议项目至关重要。临床 核心将协调和旨在优化保真度的活动，从而防止对有效性和 提高了几乎每个提出的目标的效果的能力。 为了防止因选择偏见，流失或缺失数据点而对有效性的威胁，临床 核心将进行与招聘，保留和数据收集有关的培训和监视活动，以及 管理。防止因漂移，交叉污染，临床到 - 的威胁 临床变异性或不闪烁，临床核心将进行广泛的初始培训 研究和监视活动，以确保所有临床人员都有标准化的培训 评估和治疗是按预期进行的，并且有证据表明接受治疗 按计划。据我们所知，这些将是中风或失语症康复的第一批研究之一：（1） 通过为所有学习成员组合多层培训计划，（2）通过 几种完整的方法，（3）通过采用既定治疗方法来监视评估保真度 忠实指南。最后，临床核心还将通过评分行为数据来支持项目 可靠性措施和盲目的结果措施。那就是核心的主要目标是训练 研究团队，对行为数据的评分和管理，并优化遵守协议。