Abstract：
BACKGROUND: Clinical research on nutritional and metabolic interventions in critically ill patients is heterogenous regarding time points, outcomes and measurement instruments used, impeding intervention development and data syntheses, and ultimately worsening clinical outcomes. We aimed to identify and develop a set of core outcome domains and associated measurement instruments to include in all research in critically ill patients.
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.
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.
摘要：
重症患者营养和代谢干预的临床研究在时间点方面具有异质性，结果和使用的测量工具，阻碍干预发展和数据综合，并最终恶化临床结果。我们旨在确定和开发一组核心结果域和相关的测量仪器，以包括在所有危重病人的研究中。
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。
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。
