METHODS: An updated systematic review informed a two-stage modified Delphi consensus process (domains followed by instruments). Measurement instruments for domains considered \'essential\' were taken through the second stage of the Delphi and a subsequent consensus meeting.
RESULTS: In total, 213 participants (41 patients/caregivers, 50 clinical researchers and 122 healthcare professionals) from 24 countries contributed. Consensus was reached on time points (30 and 90 days post-randomisation). Three domains were considered \'essential\' at 30 days (survival, physical function and Infection) and five at 90 days (survival, physical function, activities of daily living, nutritional status and muscle/nerve function). Core \'essential\' measurement instruments reached consensus for survival and activities of daily living, and \'recommended\' measurement instruments for physical function, nutritional status and muscle/nerve function. No consensus was reached for a measurement instrument for Infection. Four further domains met criteria for \'recommended,\' but not \'essential,\' to measure at 30 days post-randomisation (organ dysfunction, muscle/nerve function, nutritional status and wound healing) and three at 90 days (frailty, body composition and organ dysfunction).
CONCLUSIONS: The CONCISE core outcome set is an internationally agreed minimum set of outcomes for use at 30 and 90 days post-randomisation, in nutritional and metabolic clinical research in critically ill adults.
更新的系统评价为两阶段改进的Delphi共识过程提供了信息(领域之后是工具)。Delphi第二阶段和随后的共识会议采用了被认为“必不可少”的领域的测量仪器。
总共,213名参与者(41名患者/护理人员,来自24个国家的50名临床研究人员和122名医疗保健专业人员)做出了贡献。在时间点(随机化后30天和90天)达成共识。三个域在30天被认为是“必需的”(存活,身体功能和感染)和90天5天(存活率,物理功能,日常生活活动,营养状况和肌肉/神经功能)。核心“必要”测量仪器为日常生活的生存和活动达成共识,和“推荐的物理功能测量仪器”,营养状况和肌肉/神经功能。对于感染的测量仪器没有达成共识。另外四个域符合建议的标准,\'但不是\'必要的,在随机化后30天测量(器官功能障碍,肌肉/神经功能,营养状况和伤口愈合)和90天三次(虚弱,身体成分和器官功能障碍)。
CONCISE核心结果集是在随机化后30天和90天使用的国际商定的最低结果集。在重症成人的营养和代谢临床研究中。