Journal of Critical Care (2011) 26, 111–112
Editorial
Immediacy, impact and intensity In medical-surgical intensive care unit (ICU) patients, there is little research upon which to make evidence-based thromboprophylaxis recommendations in favor of either the well-established, widely available, and inexpensive unfractionated heparin or the newer and more expensive agents low–molecular weight heparin (LMWH). Low–molecular weight heparins provide anticoagulation through antithrombin-mediated inhibition of factor Xa and, to a lesser extent, factor IIa (thrombin). The high bioavailability and predictable anticoagulant effect of LMWHs have led to their increasing use for thromboprophylaxis in medical and surgical patients. Although LMWH thromboprophylaxis has been shown to be more effective than UFH in trauma patients and in patients with spinal cord injury, LMWH may predispose to bleeding and is more expensive. Limitations to the available data include principally small observational studies and a focus on laboratory end points (particularly anti-Xa levels) without examining the strength of association between LMWH exposure and clinical outcomes adjusted for confounding variables. Large randomized trials are needed to understand the role of LMWH in the medical-surgical population, with respect to overall riskbenefit profile, focusing on major morbidities and mortality. In this issue of the Journal of Critical Care, we publish the protocol and analysis report for such a trial in the Open Access Section. The Prophylaxis for ThromboEmbolism in Critical Care Trial's (PROTECT) multicenter international design process, implementation methods, and the a priori data collection and analysis plans are published to highlight the importance of sharing the protocol and analysis plans for large trials to provide clinicians with helpful detail as to how the studies were organized and conducted. It is the hope and intent that such publications provide investigators with potentially useful tips and strategies for future trial conduct and provide confidence that analyses were planned carefully and that “data dredging” or post hoc manipulation did not occur. The PROTECT is the largest academic, peer-review, funded thromboprophylaxis trial in the world led by 2 of the world's most productive research consortia, the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group, along with colleagues in Brazil, Saudi Arabia, the United States, 0883-9441/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.jcrc.2011.03.002
and United Kingdom. The PROTECT was conducted for 4 years in 6 countries, making the results applicable in many settings. It is anticipated that the results of PROTECT and this protocol will be published within a month of each other, the former in the New England Journal of Medicine and the latter in this journal. Another article and accompanying editorial highlighting the difficulties associated with adhering to current low tidal volume guidelines in managing patients requiring mechanical ventilator assistance define familiar frustrations to all critical care teams; the Letters to the Editor Section includes commentaries from author and interrogator, the Electronic Section features abstracts from the Society for Complexity in Acute Illness Annual Meeting, and there is an article highlighting the importance of interpersonal and interprofessional communication to ensure safe patient care. The content is most clearly focused on the ICU, but the message is clearly applicable to all health care providers. The issue highlights increasing awareness in the importance of not only controlling and adjusting sedation prescription to minimize ICU delirium but also of the negative impact that unrecognized and untreated delirium in the acute care setting has on postdischarge recovery and long-term prognosis. The section ends with an article describing a methodology to incorporate screening in resource constrained areas; the underlying importance and increased recognition of this topic cannot be overemphasized. An area of consistent interest in critical care is that of outcome indicators and predictors; the current sophistication of online measurement techniques has spawned a growth in the investigation of the use of specific biomarkers to predict outcome. This issue of the Journal investigates the use of new and traditional analyses with the addition of physiognomy to help predict outcome; unfortunately, the opportunity and/or suggestions for therapeutic intervention and the impact of normalizing abnormal results remains unexplored. The Electronic Section features abstracts from the 2010 Society for Complexity in Acute Illness Annual meeting held in Montebello, Canada, and the articles elucidate the theme “Complexity and Variability at the Bedside.” I think you will be intrigued by the subject matter and the realization that the increasingly sophisticated technology and analysis
112 algorithms are changing the manner in which we interpret patient information and deliver care. Real-time access to complex analytical tools will provide innovations in clinical care that can only be imagined today; however, the included abstracts paint a tantalizing picture of what the future may look like. The question remains whether the advances will affect clinical outcome positively, and the inherent tension between analytical calculations and clinical applications is apparent in this edition of the Journal. The Journal of Critical Care is experiencing strong growth; and thanks to the interest and dedication of
Editorial authors and reviewers, I am confident that the Journal will provide an important forum for disseminating clinical and health systems research information relevant to critical care practice. Philip D. Lumb MB, BS, FCCM Department of Anesthesiology Keck School of Medicine of the University of Southern California Los Angeles, CA 90033, USA E-mail address:
[email protected]