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.
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.
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