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在急性肺损伤/急性呼吸窘迫综合征(ALI)中存活的患者的长期结果，并确定在三个新的NHLBI ARDS网络(ARDSNet)临床试验中测试的疗法是否会影响这些长期结果。ALI是一种导致呼吸衰竭的综合征，需要在重症监护病房(ICU)进行机械呼吸。这种综合征是由各种不同的肺部(如吸入)和非肺部(如败血症)危险因素引起的。ALI造成了重大的公共卫生负担，其发病率比以前认识到的更高，死亡总数类似于乳腺癌或艾滋病毒感染。随着ALI短期死亡率的改善，越来越多的ALI幸存者面临着重大的长期疾病。目前，对ALI幸存者的长期结果了解不足，对ICU治疗对这些结果的影响也知之甚少。这项拟议的辅助研究将评估3个新的ARDSNet试验的6个月和12个月的结果。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、延迟与早期全卡路里肠内喂养)对患者短期存活和脱离机械通气的效果。我们将评估ALI幸存者的总体生活质量，以及他们主要的长期身体、认知和心理健康疾病。具体地说，我们将确定在这些试验中测试的3种ICU疗法对以下方面的影响：(1)通过对所有12个ARDSNet研究地点(目标1a、2a和3a)的幸存者进行电话调查，确定患者报告的长期结果；以及(2)临床结果，可能调解患者报告的结果，通过对参与这项辅助研究的4个ARDSNet站点的幸存者的面对面评估(目标1b、2b和3b)。所有这些结果评估都不会在亲本试验中进行，而是在评估ALI幸存者的健康状况和正在研究的3种疗法的长期效果方面提供了宝贵的知识。按照ARDSNet长期结果委员会的建议，对参与者的所有电话调查将集中在本提案的4个研究地点中的2个，使用经过验证的工具来评估身体能力、认知功能和心理健康。将在参与这项提案的4个研究地点进行详细的、面对面的身体和认知功能评估。这种面对面的身体功能评估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。认知功能的面对面评估将包括使用经过验证的工具来评估定向、注意力、记忆、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，需要在重症监护病房(ICU)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，死于乳腺癌或艾滋病毒感染的美国人比乳腺癌或艾滋病毒感染更多；然而，ALI死亡率的提高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幸存者的生活质量以及他们在ALI后6个月和12个月时的主要身体、认知和心理健康结果，并确定在三个新的美国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。(摘要结束)

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)