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. 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. 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). 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.

中文翻译：

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危重疾病营养和代谢干预临床有效性试验的核心结果测量：一项国际修改的德尔福共识研究评估（CONCISE）

危重患者营养和代谢干预的临床研究在时间点、结果和使用的测量仪器方面存在异质性，阻碍了干预措施的开发和数据综合，最终使临床结果恶化。我们的目标是确定和开发一套核心结果领域和相关的测量工具，以包括在危重患者的所有研究中。更新的系统评价为两阶段修改的德尔福共识过程提供了信息（领域后是工具）。被认为是“必要”的领域的测量工具是通过德尔福的第二阶段和随后的共识会议采取的。共有来自 24 个国家的 213 名参与者（41 名患者/护理人员、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。在 30 天时，三个领域（生存、身体功能和感染）被认为是“必要的”，在 90 天时被认为是五个领域（生存、身体功能、日常生活活动、营养状况和肌肉/神经功能）。核心“必要”测量仪器就生存和日常生活活动达成共识，并“推荐”身体功能、营养状况和肌肉/神经功能测量仪器。没有就感染测量仪器达成共识。另外四个领域符合“推荐”标准，但不是“必要”，在随机化后 30 天（器官功能障碍、肌肉/神经功能、营养状况和伤口愈合）进行测量，三个在 90 天（虚弱、身体成分和器官功能障碍）。