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筆者は2011年からデクスメデトミジンに関する無作為化比較試験(RCT)であるDESIRE trialを企画し,山村仁先生,森本剛先生らのご指導のお陰で,2016年10月にEuropean Society of Intensive Care Medicine(ESICM)学術集会で発表し,次いで2017年3月にJournal of American Medical Association(JAMA)誌に論文を掲載することができた。この臨床研究が成功するうえでは経験豊富な統計専門家の存在が必要であった。その存在は,統計処理に精通した臨床医とは一線を画し,臨床医と統計家のチームワークを発揮させ,想定を上回る成果を上げることができた。ガイドラインがあふれる時代においてこそ,臨床医にとって目の前の患者のデータをエビデンスにすることが重要である。
I started planning the DESIRE (DExmedetomidine for Sepsis in ICU Randomized Evaluation) trial in 2011 and had no experience performing a clinical trial at that time. Even though I didn't understand how to carry out a randomized clinical trial, the study finished successfully in 2016 with great help from Dr. Takeshi Morimoto, Dr. Hitoshi Yamamura and my colleagues. The trial was presented at the congress of the European Society of Intensive Care Medicine in October 2016. The manuscript was accepted by the Journal of the American Medical Association in February 2017. I wrote how this success story unfolded and the most important point was leadership by the skilled statistician for this study. I also wrote about creating evidence from patient data in the era of “full of medical guidelines”.
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