Outcome Measures Working Group.
Clinical research is only as impactful as the measures used to understand its consequences. Mortality at an early landmark time point (usually 28 or 30 days) has been the most common outcome used in acute care trials. However it is apparent that mortality is insensitive, and non-informative for the vast majority of patients who survive their ICU stays, and that the assumptions that guide its use are poorly understood. Moreover outcome measurement in critical illness is chaotic and poorly standardized, with the result that it is challenging to pool the results of multiple trials into meta-analyses.
The activities of the InFACT Outcome Measures working group are focused on four key areas:
· Development of a taxonomy and framework for outcome measures for acute care research
· Development of core outcome measure sets for specific areas of acute care research
· Characterization of the strengths, limitations and performance characteristics of commonly used outcome measures
· Development of novel measures to meet unmet needs in clinical research
To these ends, we have launched a number of key collaborative initiatives:
· Creation of an international Delphi panel that has facilitated the development of core outcome measures sets for studies of mechanical ventilation and long term outcomes from intensive care.
· Promotion of core outcome sets for sepsis, subarachnoid hemorrhage, delirium, cardiac arrest using the methodologic framework developed by the COMET (Core Outcome Measures in Effectiveness Trials) initiative.
· Creation of a novel taxonomy for outcome measures
· Evaluation of the performance characteristics of mortality as an outcome measure in critical care clinical trials
Moving forward we see a role analogous to that played by the OMERACT (Outcome Measures in Rheumatology Clinical Trials) initiative that has achieved international consensus on the selection of outcomes for clinical trials in rheumatic diseases. Moreover we see an opportunity to use clinical trials conducted by member groups as a platform to evaluate novel, non-mortal measures of therapeutic efficacy.