Blackwood Bronagh, Marshall John, Rose Louise
aCentre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Northern Ireland bLi Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto cDepartment of Critical Care Medicine, Sunnybrook Health Sciences Centre dLawrence S. Bloomberg Faculty of Nursing, University of Toronto eProvincial Centre of Weaning Excellence, Toronto East General Hospital, Toronto, Canada.
Curr Opin Crit Care. 2015 Oct;21(5):439-44. doi: 10.1097/MCC.0000000000000232.
Appropriate selection and definition of outcome measures are essential for clinical trials to be maximally informative. Core outcome sets (an agreed, standardized collection of outcomes measured and reported in all trials for a specific clinical area) were developed due to established inconsistencies in trial outcome selection. This review discusses the rationale for, and methods of, core outcome set development, as well as current initiatives in critical care.
Recent systematic reviews of reported outcomes and measurement instruments relevant to the critically ill highlight inconsistencies in outcome selection, definition, and measurement, thus establishing the need for core outcome sets. Current critical care initiatives include development of core outcome sets for trials aimed at reducing mechanical ventilation duration; rehabilitation following critical illness; long-term outcomes in acute respiratory failure; and epidemic and pandemic studies of severe acute respiratory infection.
Development and utilization of core outcome sets for studies relevant to the critically ill is in its infancy compared to other specialties. Notwithstanding, core outcome set development frameworks and guidelines are available, several sets are in various stages of development, and there is strong support from international investigator-led collaborations including the International Forum for Acute Care Trialists.
对于临床试验而言,恰当选择和定义结局指标对于使其提供最大信息量至关重要。由于在试验结局选择方面存在既定的不一致性,因此制定了核心结局集(针对特定临床领域,在所有试验中测量和报告的一组商定的标准化结局)。本综述讨论了核心结局集制定的基本原理和方法,以及重症监护领域的当前举措。
最近对与危重症患者相关的报告结局和测量工具进行的系统评价凸显了结局选择、定义和测量方面的不一致性,从而确定了核心结局集的必要性。当前的重症监护举措包括为旨在缩短机械通气时间的试验、危重症康复、急性呼吸衰竭的长期结局以及严重急性呼吸道感染的流行和大流行研究制定核心结局集。
与其他专业相比,针对危重症患者相关研究的核心结局集的开发和应用尚处于起步阶段。尽管如此,已有核心结局集开发框架和指南,几套核心结局集正处于不同的开发阶段,并且得到了包括国际急性护理试验专家论坛在内的国际研究者主导合作的大力支持。