This project’s goal is to create and disseminate resources to assist acute lung injury (ALI)/ acute respiratory failure (ARF) researchers in designing trials that appropriately evaluate long-term patient outcomes, in order to facilitate research aimed at reducing the public health burden of post-intensive care unit (ICU) health impairments. The primary aims are:
1. To create and disseminate a Web-based electronic database of validated survey instruments and clinical testing methods to support consensus-based recommendations for evaluations of long-term physical, cognitive, and mental health outcomes in clinical trials and observational studies
2. To develop and disseminate practical resources for maximizing retention of participants in long-term, longitudinal research studies.
3. To evaluate, implement and disseminate statistical methods and programs for evaluating longitudinal functional outcomes in the presence of high patient mortality (i.e., addressing the “competing risk of mortality”)
Johns Hopkins University – Outcomes After Critical Illness and Surgery (OACIS) Group
Principal Investigator: Dale M. Needham, FCA, MD, PhD
- COS for clinical trials or clinical research
- Systematic review
This project will utilize several methods for creating clinical research resources for the previously-described 3 Aims, including: (a) rigorous systematic reviews to synthesize state-of-the art approaches, (b) empirical analyses using existing clinical studies , and (c) structured expert consensus processes using knowledge from steps (a) and (b).
For dissemination of the resources, the proposed grant will make all resources freely available via the Web and will leverage the investigators’ expertise in dissemination methodology and leadership in several existing national networks of relevant end users.