Patient Outcomes 6 and 12 Months After ALTA, OMEGA and EDEN ARDS Network Trials

描述（由申请人提供）： 我们的总体目标是更好地了解急性肺损伤/急性呼吸窘迫综合征（“ALI”）患者的长期预后，并确定在三项新的NHLBI ARDS网络（ARDSNet）临床试验中测试的治疗是否会影响这些长期预后。ALI是一种引起呼吸衰竭的综合征，需要在重症监护室（ICU）进行机械通气。这种综合征是由不同类型的肺（例如，抽吸）和非肺部（例如，脓毒症）危险因素。急性肺损伤给公共卫生带来了沉重的负担，其发病率高于以往的认识，死亡总数与乳腺癌或艾滋病毒感染相似。随着急性肺损伤的短期死亡率的提高，越来越多的注意力集中在越来越多的急性肺损伤幸存者所面临的重大长期发病率上。目前，对ALI幸存者的长期预后了解不足，对ICU治疗对这些预后的影响知之甚少。这项拟议的辅助研究将评估3项新的ARDSNet试验的6个月和12个月结局。这些试验正在测试3种干预措施（雾化沙丁胺醇与安慰剂，抗炎/抗氧化营养补充剂与安慰剂，以及延迟与早期全热量肠内喂养）对患者短期生存和从机械通气中解脱的有效性。我们将评估急性肺损伤幸存者的整体生活质量，以及他们主要的长期身体、认知和心理健康疾病。具体而言，我们将确定这些试验中测试的3种ICU疗法对（1）通过对所有12个ARDSNet研究中心的幸存者进行电话调查，（目标1a、2a和3a）;以及（2）临床结果，其可能介导患者报告的结果，通过对参与本辅助研究的4个ARDSNet研究中心的幸存者进行面对面评估（目的1b、2b和3b）。所有这些结局评估将不会在母试验中进行，但代表了评价ALI幸存者健康状况和研究中3种治疗的长期效果的宝贵知识。根据ARDSNet长期结局委员会的建议，所有参与者的电话调查将集中在本提案中的4个研究中心中的2个，使用经验证的工具评估身体能力、认知功能和心理健康。将在参与本提案的4家研究中心进行详细的身体和认知功能的面对面评价。将使用整体身体功能、肺功能、肌肉力量和人体测量学的标准临床测试进行身体功能的亲自评估。认知功能的面对面评估将包括使用经验证的工具评估定向、注意力、记忆力、推理和执行功能。 急性肺损伤/急性呼吸窘迫综合征（“ALI”）导致危及生命的呼吸问题，需要在重症监护室（ICU）中使用机械呼吸机（人工呼吸器）。这种综合征的发生频率比以前认识到的更高，比乳腺癌或艾滋病毒感染导致更多的美国人死亡;然而，ALI死亡率的改善导致越来越多的人幸存下来。我们的研究旨在更好地了解ALI幸存者的生活质量及其在ALI后6个月和12个月的主要身体，认知和心理健康结果，并确定在三个新的国立卫生研究院临床试验中测试的治疗是否可以改善这些结果。(End摘要）

DESCRIPTION (provided by applicant): Our overall objective is to better understand the long-term outcomes of patients surviving acute lung injury/acute respiratory distress syndrome ("ALI") and determine if therapies being tested in three new NHLBI ARDS Network (ARDSNet) clinical trials affect these long-term outcomes. ALI is a syndrome causing respiratory failure and requiring mechanical ventilation in an intensive care unit (ICU). This syndrome is caused by a diverse group of both pulmonary (e.g., aspiration) and non-pulmonary (e.g., sepsis) risk factors. ALI imposes a significant public health burden with a higher incidence than previously recognized and a total number of deaths similar to breast cancer or HIV infection. As the short-term mortality rate for ALI has improved, greater attention has focused on the significant longer-term morbidities faced by the growing number of ALI survivors. At present, there is inadequate knowledge regarding long-term outcomes of ALI survivors and little known about the effect of ICU therapies on these outcomes. This proposed ancillary study will evaluate the 6- and 12-month outcomes of 3 new ARDSNet trials. These trials are testing the efficacy of 3 interventions (nebulized albuterol vs. placebo, anti-inflammatory/anti-oxidant nutritional supplement vs. placebo, and delayed vs. early full-calorie enteral feeding) on patients' short-term survival and liberation from mechanical ventilation. We will evaluate ALI survivors' overall quality of life, and their major long-term physical, cognitive and mental health morbidities. Specifically, we will determine the effect of the 3 ICU therapies being tested in these trials on (1) patient-reported long-term outcomes via phone- based surveys of survivors from all 12 ARDSNet study sites (Aims 1a, 2a and 3a); and (2) clinical outcomes, which may mediate the patient-reported outcomes, via in-person evaluations of survivors from a subset of 4 ARDSNet sites participating in this ancillary study (Aims 1b, 2b and 3b). All of these outcome assessments will not otherwise be conducted in the parent trials, but represent invaluable knowledge in evaluating the health status of ALI survivors and the long-term effect of the 3 therapies under study. All phone surveys for participants will be centralized at 2 of the 4 study sites in this proposal, using validated instruments for assessing physical capabilities, cognitive function and mental health, as recommended by the ARDSNet Long-Term Outcomes Committee. Detailed, in-person evaluations of physical and cognitive function will be performed at the 4 study sites participating in this proposal. This in-person evaluation of physical function will be conducted using standard clinical tests of overall physical function, pulmonary function, muscle strength and anthropometrics. In-person evaluation of cognitive function will include use of validated instruments for assessing orientation, attention, memory, reasoning and executive function. Acute lung injury/acute respiratory distress syndrome ("ALI") causes life-threatening breathing problems requiring the use of a mechanical ventilator (artificial respirator) in an intensive care unit (ICU). This syndrome occurs more frequently than previously recognized and kills more Americans than breast cancer or HIV infection; however, an improvement in the mortality rate from ALI has led to a growing number of people surviving this syndrome. Our study aims to better understand ALI survivors' quality of life and their major physical, cognitive and mental health outcomes at 6- and 12-months after ALI and to determine if treatments being tested in three new National Institutes of Health clinical trials can improve these outcomes. (End of Abstract)