Improving Long-Term Outcomes Clinical Research for Acute Respiratory Failure

描述(由申请人提供)： 随着人口老龄化，重症监护病房(ICU)合并急性肺损伤/急性呼吸窘迫综合征(ALI)和其他原因引起的急性呼吸衰竭(ARF)的患者越来越多。重症监护的进步降低了ICU患者的死亡率，但幸存者经常在ICU后患有严重的身体、认知和心理健康疾病，这种疾病在出院后可持续数年。NHLBI最近的一次研讨会建议将长期结果作为所有第三阶段试验的基本部分，并指出需要为ALI/ARF幸存者确定适当的措施。目前，关于使用哪些测量工具和分析方法，以及如何有效地留住ALI/ARF幸存者进行长期随访，存在很大的不确定性。这笔赠款的总体目标是创建并在全国范围内传播资源，以协助ALI/ARF研究人员设计试验，通过创建和在全国范围内传播：(A)一个基于网络的电子数据库，其中包括推荐的调查工具和临床测试方法，用于评估幸存者的长期身体、认知和心理健康结果(目标1)；(B)在长期纵向研究研究中最大限度地保留幸存者的资源(目标2)；以及(C)适当的统计分析方法和程序，以解决在高患者死亡率的情况下评估纵向功能结果时发生的“因死亡而进行的审查”(目标3)。这笔赠款将利用几种方法创建这些资源，包括：(A)严格的系统审查，(B)利用独特的现有数据集进行经验分析，以及(C)有组织的专家协商一致进程。对于资源的全国传播，赠款将利用研究人员在传播方法方面的专业知识，以及他们在这些临床研究资源的相关用户的几个现有国家网络中的访问和领导能力。

DESCRIPTION (provided by applicant): With the aging population, there is a growing number of intensive care unit (ICU) patients with acute lung injury/acute respiratory distress syndrome (ALI) and other causes of acute respiratory failure (ARF). Advances in critical care have decreased ICU patients' mortality, but survivors frequently have substantial post-ICU physical, cognitive and mental health morbidities, which can last for years after discharge. A recent NHLBI workshop recommended that long-term outcomes be a fundamental part of all Phase III trials and indicated a need for determining appropriate measures for ALI/ARF survivors. At present, there is great uncertainty regarding which measurement instruments and analytical methods to use and how to effectively retain a cohort of ALI/ARF survivors for long-term follow-up. The overall goal of this grant is to create and nationally disseminate resources to assist ALI/ARF researchers with designing trials that appropriately evaluate long-term patient outcomes through creating and nationally disseminating: (a) a web-based electronic database of recommended survey instruments and clinical testing methods for evaluating survivors' long-term physical, cognitive and mental health outcomes (Aim 1), (b) resources for maximizing retention of survivors in long-term, longitudinal research studies (Aim 2), and (c) appropriate statistical analysis methods and programs to address "censoring due to death" which occurs when evaluating longitudinal functional outcomes in the setting of high patient mortality (Aim 3). This grant will utilize several methos for creating these resources, including: (a) rigorous systematic reviews, (b) empirical analyses using unique existing datasets, and, (c) structured expert consensus processes. For national dissemination of the resources, the grant will exploit the investigators' expertise in disseminatio methodology and their access and leadership within several existing national networks of relevant users of these clinical research resources.