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.
Research focused on the long-term outcomes of ALI/ARF survivors is at a formative stage, moving from descriptive studies to interventional trials. Timely development of clinical research resources will maximize the efficiency and effectiveness of this research and dramatically speed development of new knowledge necessary to reduce the long-term morbidity experienced by the large and growing number of survivors. (End of Abstract)
|Needham, Dale M (2014) Understanding and improving clinical trial outcome measures in acute respiratory failure. Am J Respir Crit Care Med 189:875-7|