Patient and Health Care System Outcomes Following EEA

EEA 后的患者和医疗保健系统成果

• 批准号: 8197477
• 负责人: Paul A. Gardner
• 金额: $ 53.25万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8197477
• 关键词: Age; Benefits and Risks; Brain Neoplasms; Caring; Cephalic; Cerebrum; Clinical Trials Design; Control Groups; Craniotomy; Data; Dissection; Evidence based intervention; Excision; Gender; Goals; Health; Health Personnel; Healthcare Systems; Hospitalization; Inpatients; Intervention; Investigation; Length; Length of Stay; Lesion; Location; Measures; Mission; Modeling; Moods; Nervous System Physiology; Neurosciences; Neurosciences Research; Neurosurgeon; Neurosurgical Procedures; Nose; Operative Surgical Procedures; Outcome; Outcome Assessment; Participant; Pathology; Patient Care; Patients; Persons; Physical Function; Postoperative Period; Procedures; Quality of life; Reporting; Research Personnel; Resected; Resolution; Risk; Role; Sample Size; Symptoms; Techniques; Technology; Testing; Time; Tissues; United States; United States National Institutes of Health; Universities; Work; base; brain tumor resection; case control; cost; cranium; improved; longitudinal design; mortality; multidisciplinary; neuropsychological; prevent; programs; prospective; tumor

DESCRIPTION (provided by applicant): In the late 1990's, a paradigm shift in neurosurgical technique was introduced - the expanded endonasal approach (EEA). Despite the implementation of this ground breaking technique, there have been no reports of systematic clinical trials designed to evaluate the impact of EEA on patient and health care system outcomes. The broad, long-term objective of the study is to examine inpatient and post-discharge outcomes following EEA and to compare outcomes between persons undergoing EEA and those who have undergone standard craniotomy matched on key variables. The specific aims of the project are: 1) using demographically similar controls to control for normal time-based changes in neuropsychological function, to prospectively evaluate changes in neuropsychological function, physical function, and mood from baseline (preoperatively) to 3, 12, and 24 months after the date of surgery 2 weeks in 125 persons undergoing EEA for tumor resection, and 2) to determine whether persons undergoing EEA for tumor resection differ from historical controls who underwent standard craniotomy matched on tumor location, size, and pathology, and age and gender on inpatient and post-discharge outcomes. The study uses a prospective longitudinal design with historical case control and demographically similar control components. A repeated measure analysis by mixed model will be used to evaluate the time effect of physical and neuropsychological function scores. Paired t-tests or Wilcoxon matched-pairs signed-rank tests will be used for comparison of continuous variables between participants undergoing EEA and historical matched controls. Data from the study have the potential to inform health care providers' decisions regarding the utility of EEA and to make a major impact on the lives of persons with a brain tumor, a primary goal of the Blueprint for Neuroscience Research which is part of the mission of NIH. PUBLIC HEALTH RELEVANCE: The proposed study will be the first systematic investigation to provide empirical data on the long-term risks and benefits of EEA, data which are vital for interventions to improve patient and health care system outcomes. Data from the study have the potential to inform health care providers' decisions regarding the utility of EEA and to support evidence based interventions to improve patients' return to usual function. These efforts have the potential to make a major impact on the lives of persons with a brain tumor and those that care for them.

描述（由申请人提供）：在1990年代后期，引入了神经外科技术的范式转变 - 扩展的鼻nasal方法（EEA）。尽管实施了这种破碎技术，但尚未有旨在评估EEA对患者和医疗保健系统结果的影响的系统临床试验的报道。该研究的广泛长期目标是检查EEA之后的住院和入院后结局，并比较接受EEA的人与经历过关键变量匹配的标准颅骨切开术的人之间的结果。该项目的具体目的是：1）使用人口统计学相似的控制来控制神经心理学功能的正常变化，前瞻性评估神经心理学功能，身体机能，身体机能和情绪的变化，从基线（术前（术前）（术前）（3、12和24个月）到手术日期后的3、12和24个月，在125周内，在EEA中，在EEA中是否有其他EEA进行EEA，以确定tumor切除的人，并确定tumor的治疗方法，并确定tumor的治疗方法，以确定tumor的治疗方法，并确定tumor的治疗方法。标准的颅骨切开术在肿瘤位置，大小和病理上匹配，并且在住院和住院后结局上的年龄和性别。该研究使用具有历史案例控制和人口统计学相似控制组件的前瞻性纵向设计。通过混合模型的重复测量分析将用于评估身体和神经心理功能得分的时间效应。配对的t检验或Wilcoxon匹配对签名级测试将用于比较接受EEA和历史匹配控制的参与者之间的连续变量。该研究的数据有可能为医疗保健提供者关于EEA效用的决定提供信息，并对患有脑瘤的人的生活产生重大影响，这是NIH任务的神经科学研究蓝图的主要目标。公共卫生相关性：拟议的研究将是第一次提供有关EEA长期风险和益处的经验数据，这对于改善患者和医疗保健系统结果的干预措施至关重要。该研究的数据有可能为医疗保健提供者关于EEA效用的决定提供信息，并支持基于证据的干预措施，以改善患者的常规功能。这些努力有可能对患有脑肿瘤的人的生活产生重大影响。