Measuring/Improving Quality of Life in Acute Lung Injury

描述(由申请人提供)： 克里斯托弗·考克斯博士为这项拟议的K23职业发展奖设定的长期目标是： (1)促进对急性肺损伤(ALI)和急性呼吸窘迫综合征(ARDS)幸存者的健康相关生活质量(HRQL)的测量和了解；(2)获得流行病学、生物统计学和调查方法方面的高级培训，这些培训对于他在危重病护理结果研究方面的职业生涯至关重要。考克斯博士是杜克大学的一名助理教授，他提出了一种教学和临床研究相结合的经验来实现这些目标。 这项培训计划将包括在北卡罗来纳大学公共卫生学院的正式课程作业，参加临床研究研讨会，并在著名研究员詹姆斯·图尔斯基博士的指导下进行一个为期5年的临床研究项目。 大多数ALI/ARDS幸存者带着可能影响他们的HRQL的多系统危重疾病相关问题离开医院。要提高他们的HRQL，就必须能够测量它。然而，对于ALI/ARDS幸存者来说，没有金标准的HRQL测量。通用问卷，如简表36(SF36)和EuroQol(EQ5D)最常用于此目的，尽管它们不评估ALI/ARDS幸存者特有的许多问题，并且它们的响应性和可解释性对于这些患者也没有很好的定义。 为了推动这一领域的发展，必须开发针对这一人群的HRQL仪器。我的具体目标是：(1)确定ALI/ARDS幸存者的HRQL的重要属性，(2)基于这些属性开发和执行ALI/ARDS幸存者特有的HRQL问卷的初步验证，(3)对ALI/ARDS幸存者的前瞻性队列进行ALI/ARDS问卷的最终验证，以及(4)利用最先进的统计技术确定预测ALI/ARDS幸存者HRQL恢复率和程度的临床因素。 我将从杜克大学、达勒姆退伍军人医学中心和北卡罗来纳大学招募总共380名ALI/ARDS幸存者参加一个由三项相关研究组成的单一项目。首先，对50名患者和照顾者的焦点群体进行定性分析，将确定ALI/ARDS影响他们生活的重要方式。接下来，这些独特的属性将被合并到ALI/ARDS特定的HRQL问卷中，该问卷将在对200名ALI/ARDS幸存者进行横断面研究时进行验证和改进，方法是使用因子分析，并将问卷分数与其他量表和临床变量进行比较。最后，我们将在基线、2个月、4个月和6个月收集130名ALI/ARDS幸存者的前瞻性数据，以评估ALI/ARDS问卷以及SF36和EQ5D的心理测量学表现(例如，结构效度、对变化的敏感度、信度、可解释性)。线性混合效应和一般生长混合模型将确定与ALI/ARDS幸存者的HRQL改善相关的ICU和出院后的特定因素，以及确定最需要的患者的特定亚组。这些结果将为临床试验结果提供衡量标准，并突出旨在改善幸存者HRQL的干预目标。

DESCRIPTION (provided by applicant): Dr. Christopher Cox's long-term objectives for this proposed K23 Career Development Award are to: (1) advance the measurement and understanding of health-related quality of life (HRQL) among survivors of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) and (2) obtain advanced training in epidemiology, biostatistics, and survey methods essential to establishing his career in critical care outcomes research. Dr. Cox, an Assistant Professor at Duke, proposes a combined didactic and clinical research experience to achieve these goals. This training program will include formal coursework at the UNC School of Public Health, attendance at clinical research seminars, and conducting a 5-year clinical research project performed under the mentorship of Dr. James Tulsky, an established investigator. Most ALI/ARDS survivors leave the hospital with multisystemic critical illness-associated problems that may impact their HRQL. To improve their HRQL one must be able to measure it. However, there is no gold standard HRQL measure for ALI/ARDS survivors. Generic questionnaires such as the Short Form 36 (SF36) and the EuroQol (EQ5D) have been used most commonly for this purpose, though they do not assess many concerns unique to ALI/ARDS survivors and their responsiveness and interpretability are not well defined for these patients. To move the field forward, HRQL instruments must be developed that are unique to this population. My specific aims are to: (1) Identify the important attributes of ALI/ARDS survivors' HRQL, (2) Develop and perform the initial validation of an ALI/ARDS survivor-specific HRQL questionnaire based on these attributes, (3) Perform final validation of the ALI/ARDS questionnaire in a prospective cohort of ALI/ARDS survivors, and (4) Identify clinical factors that predict the rate and magnitude of ALI/ARDS survivors' HRQL recovery using state-of-the-art statistical techniques. I will enroll a total of 380 ALI/ARDS survivors from Duke, the Durham VA Medical Center, and UNC in a single project composed of three related studies. First, qualitative analysis of focus groups of 50 patients and caregivers will identify important ways that ALI/ARDS impacts their lives. Next, these unique attributes will be incorporated into an ALI/ARDS-specific HRQL questionnaire that will be validated and refined in a cross-sectional study of 200 ALI/ARDS survivors using factor analysis and comparison of questionnaire scores with other scales and clinical variables. Lastly, we will collect data prospectively at baseline, 2, 4, and 6 months on 130 ALI/ARDS survivors to evaluate the psychometric measurement performance (e.g., construct validity, sensitivity to change, reliability, interpretability) of the ALI/ARDS questionnaire as well as the SF36 and the EQ5D. Linear mixed effects and general growth mixture modeling will identify specific ICU- and post-discharge factors that are associated with HRQL improvement among ALI/ARDS survivors, as well as define specific subgroups of patients with the greatest need. These results will inform clinical trial outcomes measures as well as highlight targets for interventions designed to improve survivors' HRQL.