Measuring /Improving Quality of Life in Acute Lung Injury

描述（由申请人提供）： 博士克里斯托弗考克斯的长期目标，这个拟议的K23职业发展奖是： (1)促进急性肺损伤（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）的测量和理解，（2）获得流行病学，生物统计学和调查方法的高级培训，这些方法对建立他在重症监护结局研究方面的职业生涯至关重要。杜克大学的助理教授考克斯博士提出了一种教学和临床研究相结合的经验，以实现这些目标。 该培训计划将包括在公共卫生学院的正式课程，参加临床研究研讨会，并进行一个为期5年的临床研究项目下进行的指导博士。 大多数ALI/ARDS幸存者离开医院时存在可能影响其HRQL的多系统危重病相关问题。为了提高他们的HRQL，必须能够测量它。然而，对于ALI/ARDS幸存者，没有金标准HRQL测量。通用问卷，如简表36（SF 36）和欧洲生活质量量表（EQ 5D），最常用于此目的，尽管它们没有评估许多ALI/ARDS幸存者特有的问题，并且它们的反应性和可解释性对于这些患者没有很好的定义。 为了推动这一领域的发展，必须开发针对这一人群的HRQL工具。我的具体目标是：（1）识别ALI/ARDS幸存者的HRQL的重要属性，（2）基于这些属性开发并执行ALI/ARDS幸存者特异性HRQL问卷的初始验证，（3）在ALI/ARDS幸存者的前瞻性队列中执行ALI/ARDS问卷的最终验证，（4）采用最先进的统计学技术确定预测ALI/ARDS幸存者HRQL恢复率和恢复程度的临床因素。 我将从杜克大学、达勒姆退伍军人医疗中心和耶鲁大学共招募380名ALI/ARDS幸存者，纳入一个由三项相关研究组成的单一项目。 首先，对50名患者和护理人员的焦点小组进行定性分析，以确定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纳入到一个ALI/ARDS特异性HRQL问卷中，该问卷将在一项200名ALI/ARDS幸存者的横断面研究中使用因子分析和问卷评分与其他量表和临床变量的比较进行验证和细化。 最后，我们将在基线、2、4和6个月时前瞻性地收集130名ALI/ARDS幸存者的数据，以评估心理测量性能（例如，结构效度、变化敏感性、可靠性、可解释性）以及SF 36和EQ 5D。 线性混合效应和一般生长混合模型将确定与ALI/ARDS幸存者HRQL改善相关的特定ICU和出院后因素，并定义最需要的特定患者亚组。这些结果将为临床试验结果指标提供信息，并突出旨在改善幸存者HRQL的干预措施的目标。

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.