Core Outcome Measures in Effectiveness Trials

Improving Long-Term Outcomes Research for Acute Respiratory Failure

General Information

Summary:
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”)

Contributors:
Johns Hopkins University – Outcomes After Critical Illness and Surgery (OACIS) Group

Principal Investigator: Dale M. Needham, FCA, MD, PhD

Further Study Information

Current Stage:
Ongoing
Date:
July 2013 - April 2018
Funding source(s):
National Heart, Lung, and Blood Institute of the National Institutes of Health, USA (R24 HL111895)

Health Area

Disease Category
Lungs & airways

Disease Name
Acute lung injury (ALI)
Respiratory failure

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Unknown

Method(s)

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.


Stakeholders Involved

Clinical experts
Researchers

Study Type

COS for clinical trials or clinical research

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