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Beyond mortality or being mortal? Challenges in understanding and improving life after ARDS
  1. Catherine L Hough
  1. Correspondence to Dr Catherine L Hough, Division of Pulmonary and Critical Care Medicine, University of Washington, Seattle, WA 98104, USA; cterrlee{at}uw.edu

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In 2009, the National Heart Lung and Blood Institute (NHLBI) of USA convened a workshop to discuss the state of clinical and translational science for acute respiratory distress syndrome (ARDS). The panel reviewed epidemiological studies and clinical trials suggesting marked declines in ARDS-related mortality, and discussed observational studies that described the enduring morbidities of ARDS survivorship. The report of this meeting described the challenges of clinical trials focused on mortality and charged clinical researchers to move ‘beyond mortality’ (as the report was entitled) by including functional, cost and quality of life outcomes in future research.1

Over the last decade, the charge of measuring these long-term outcomes has indeed been realised. Along with observational studies, large interventional trials have begun to include outcome assessment at 6 and 12 months after initial trial enrolment, including four large trials conducted by the NHLBI ARDS Clinical Trials Network. This work, led by Needham and Hopkins, collectively called the ARDSNet Long-Term Outcome Study (ALTOS), has led to the largest cohort of ARDS survivors described to date, confirming the findings of preceding single-centre cohorts2–4 by revealing an overwhelming degree of post intensive care unit (ICU) morbidity, with persisting impairments in physical, cognitive and mental health function, and health-related quality of life well below expected.5–7

Certainly, ancillary inclusion of long-term outcomes as secondary or exploratory end points provides valuable information. However, proving that specific interventions improve long-term outcomes as well as survival requires primary study end points beyond mortality, such as quality of life or health utilities. While such end points are increasingly common in other fields, there are no large ARDS clinical trials to date with primary outcomes focused on long-term survivorship end points such as quality of life. Since early mortality remains high in ARDS, 20% or more in most randomised trial populations, …

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