Department of Nutrition and Dietetics.
Department of Critical Care.
Curr Opin Clin Nutr Metab Care. 2018 Nov;21(6):417-422. doi: 10.1097/MCO.0000000000000507.
Mortality has long been the gold-standard outcome measure for intensive care clinical trials. However, as the critical care community begins to understand and accept that survivorship is associated with functional disability and a health and socioeconomic burden, the clinical and research focus has begun to shift towards long-term physical function RECENT FINDINGS: To use mortality as a primary outcome measure, one would either have to choose an improbable effect (e.g. a difference of 5-10% in mortality as a result of a single intervention) or recruit a larger number of patients, the latter being unfeasible for most critical care trials.Outcome measures will need to match interventions. As an example, amino acids, or intermittent feeding, can stimulate muscle protein synthesis, and so prevention of muscle wasting may seem an appropriate outcome measure when assessing the effectiveness of these interventions. Testing the effectiveness of these interventions requires the development of novel outcome measures that are targeted and acceptable to patients. We describe advancements in dual-energy X-ray absorptiometry scanning, bio-impedence analysis, MRI and muscle ultrasound in this patient group that are beginning to address this development need.
New approaches to outcome assessment are beginning to appear in post-ICU research, which promise to improve our understanding of nutrition and exercise interventions on skeletal muscle structure, composition and function, without causing undue suffering to the patient.
死亡率一直是重症监护临床试验的金标准结局指标。然而,随着重症监护界开始理解并接受生存与功能障碍以及健康和社会经济负担相关,临床和研究重点已开始转向长期的身体功能。
如果要将死亡率作为主要结局指标,要么选择一个不太可能的效果(例如,单一干预导致死亡率差异 5-10%),要么招募更多的患者,而后者对于大多数重症监护试验来说是不可行的。结局指标需要与干预措施相匹配。例如,氨基酸或间歇性喂养可以刺激肌肉蛋白质合成,因此在评估这些干预措施的有效性时,预防肌肉减少似乎是一个合适的结局指标。测试这些干预措施的有效性需要开发针对患者且可接受的新型结局指标。我们描述了在 ICU 后患者群体中,双能 X 射线吸收测定扫描、生物阻抗分析、MRI 和肌肉超声的进展,这些进展开始满足这一发展需求。
在 ICU 后研究中,开始出现新的结局评估方法,有望提高我们对营养和运动干预对骨骼肌肉结构、组成和功能的理解,同时不会给患者带来不必要的痛苦。