Evidence lost to treatment of critically-ill patients? (original) (raw)
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Respiratory Care, 2007
As the first paper in this Journal Conference on intensive care unit controversies, the editors wished us to set the tone for the debate by discussing the ethics of medical "adventurism" in the intensive care unit. More life-or-death decisions are made in the intensive care unit than elsewhere in the hospital, and the critical care specialist often sees himself or herself as a warrior in a battle with death. This adrenaline-charged calling attracts highly intelligent, hard-working, and compassionate caregivers, as well as fiercely independent clinicians. The result of this is that critical care specialists passionately debate about the meaning and application of published "evidence" and this leads to thoughtful debate, as exemplified by the papers in this and the next issue of RESPIRATORY CARE, as well as thoughtless and often dangerous disregard for evidence-based medicine. Physicians are morally obligated to provide the best and most appropriate care possible for their patients, but when accepted approaches are failing and a critically ill patient is getting worse, the critical care physician must make a decision regarding innovative therapy, based on the patient's prognosis, the available evidence, the resources on hand, the expertise of the physicians, and the values of the patient and the physician. This decision may lead, at times, to trying unproven and innovative strategies to achieve a clinical goal. In such cases, it is to be hoped that this can be done in such a way that data are formally and prospectively collected to increase our knowledge.
Bench-to-bedside review: The evaluation of complex interventions in critical care
Critical Care, 2008
Complex interventions, such as the introduction of medical emergency teams or an early goal-directed therapy protocol, are developed from a number of components that may act both independently and inter-dependently. There is an emerging body of literature advocating the use of integrated complex interventions to optimise the treatment of critically ill patients. As with any other treatment, complex interventions should undergo careful evaluation prior to widespread introduction into clinical practice. During the development of an international collaboration of researchers investigating protocol-based approaches to the resuscitation of patients with severe sepsis, we examined the specific issues related to the evaluation of complex interventions. This review outlines some of these issues. The issues specific to trials of complex interventions that require particular attention include determining an appropriate study population and defining current treatments and outcomes in that population, defining the study intervention and the treatment to be used in the control group, and deploying the intervention in a standardised manner. The context in which the research takes place, including existing staffing levels and existing protocols and procedures, is crucial. We also discuss specific details of trial execution, in particular randomization, blinded outcome adjudication and analysis of the results, which are key to avoiding bias in the design and interpretation of such trials.
BMC Emergency Medicine, 2007
Background: Recently completed clinical trials have shown that certain interventions improve the outcome of the critically ill. To facilitate the implementation of these interventions, professional organizations have developed guidelines. Although the impacts of the individual evidence-based interventions have been well described, the overall impact on outcome of introducing multiple evidence-based protocols has not been well studied. The objective of this study was to determine the impact of introducing multiple evidence-based protocols on patient outcome.
Feasibility, limits and problems of clinical studies in Intensive Care Unit
Minerva anestesiologica, 2007
In critical care medicine there is still a paucity of evidence on how to manage most of the clinical problems commonly encountered in critically ill patients. Randomized controlled trials (RCTs) are the most powerful instruments to evaluate the efficacy of a therapeutic intervention and to generate evidence for clinical practice. Unfortunately, the design and conduct of RCTs in our field are particularly complicated, because of some intrinsic and structural problems (e.g. lack of reliable nosography, concomitant use of different therapies, problems in the definition of end-points besides mortality) that will be discussed in this review. Further challenges are represented by the lack of tradition of large ICU networks, difficulties in linking or integrating physiologic and therapeutic objectives in designing clinical protocols, scarcity of independent or non-profit funds. A particularly stimulating opportunity of development is represented also by the relationship of critical care to...