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Reporting data on long-term follow-up of critical care trials
  1. May Hua1,
  2. Hannah Wunsch1,2,3
  1. 1Department of Anesthesiology, Columbia University, New York, New York, USA
  2. 2Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  3. 3Department of Anesthesia and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada
  1. Correspondence to Dr Hannah Wunsch, Department of Critical Care Medicine, Sunnybrook Hospital, 2075 Bayview Ave, Rm D1.08, Toronto, ON M4N 3M5, Canada; Hannah.Wunsch{at}

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Over the past 20 years, the lens of critical care research has widened, with 60 or 90 days becoming an increasingly common end point for observation of mortality and other outcomes.1–6 There have also been an increase in studies that follow patients for many years to understand how and when recovery occurs and whether risks attributable to critical illness may diminish.7–9 Correspondingly, when new therapies aimed at improving outcomes are studied, there is increasing recognition that reporting of short-term (ie, hospital) outcomes is not enough and that evaluation of the long-term effects of the intervention can be very important.

Dinglas et al present long-term follow-up data of patients enrolled in the Statins in Acutely Injured Lungs in Sepsis (SAILS) trial, which examined the use of rosuvastatin in patients with sepsis-associated acute respiratory distress syndrome (ARDS).10 The SAILS trial randomised patients within 48 h of enrolment to receive either rosuvastatin or placebo for a maximum of 28 days (or until the third day after discharge from the intensive care unit (ICU), hospital discharge or death). The primary outcome of the original study was 60-day in-hospital mortality. As part of the planned analysis, the authors evaluated the long-term outcome of these patients to determine the safety of in-hospital statin use in survivors of sepsis-associated ARDS.11 The rationale was that there are known adverse effects of statins on skeletal muscle and psychological symptoms that can occur, and critically ill patients represent a population already at risk of physical and psychological difficulties.

The authors collected detailed data on physical performance and psychological symptoms at 6 and …

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