Medicina intensiva
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[Implementation and evaluation of a protocol for continuous insulin perfusion in critical patients].
To analyze the efficacy and safety of a protocol for the continuous infusion of insulin to maintain blood glucose levels between 100 and 140 mg/dl, evaluating the results by a method that takes all of the hours of treatment into consideration. ⋯ The protocol was safe and enabled adequate control of blood glucose levels. The analysis of all of the hours of treatment might provide more data than a simple study of the percentages of blood glucose measurements within the normal range and the mean blood glucose level.
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The interruption of a randomized clinical trial when the experimental treatment is clearly superior is an ethical obligation. However, performing multiple intermin statistical analyses and the early interruption of the trial increase the possibility of alpha error, favor the overestimation of the effect, and facilitate the introduction of ineffective therapies data monitoring. ⋯ This underlines the need for truly independent data monitoring committees and recommends the use of predefined restrictive rules for the interruption of a trial. Furthermore, clinicians should provide themselves with an adequate dose of skepticism and critical reading skills to enable them to explore some key aspects of these studies.