Lau Vincent Issac, Johnson Jeffrey A, Bagshaw Sean M, Rewa Oleksa G, Basmaji John, Lewis Kimberley A, Wilcox M Elizabeth, Barrett Kali, Lamontagne Francois, Lauzier Francois, Ferguson Niall D, Oczkowski Simon J W, Fiest Kirsten M, Niven Daniel J, Stelfox Henry T, Alhazzani Waleed, Herridge Margaret, Fowler Robert, Cook Deborah J, Rochwerg Bram, Xie Feng
Department of Critical Care Medicine, University of Alberta, Edmonton T6G 2B7, AB, Canada.
School of Public Health, Inst Hlth Econ, University of Alberta, Edmonton T6G 2B7, AB, Canada.
World J Crit Care Med. 2022 Jul 9;11(4):236-245. doi: 10.5492/wjccm.v11.i4.236.
Mortality is a well-established patient-important outcome in critical care studies. In contrast, morbidity is less uniformly reported (given the myriad of critical care illnesses and complications of each) but may have a common end-impact on a patient's functional capacity and health-related quality-of-life (HRQoL). Survival with a poor quality-of-life may not be acceptable depending on individual patient values and preferences. Hence, as mortality decreases within critical care, it becomes increasingly important to measure intensive care unit (ICU) survivor HRQoL. HRQoL measurements with a preference-based scoring algorithm can be converted into health utilities on a scale anchored at 0 (representing death) and 1 (representing full health). They can be combined with survival to calculate quality-adjusted life-years (QALY), which are one of the most widely used methods of combining morbidity and mortality into a composite outcome. Although QALYs have been use for health-technology assessment decision-making, an emerging and novel role would be to inform clinical decision-making for patients, families and healthcare providers about what expected HRQoL may be during and after ICU care. Critical care randomized control trials (RCTs) have not routinely measured or reported HRQoL (until more recently), likely due to incapacity of some patients to participate in patient-reported outcome measures. Further differences in HRQoL measurement tools can lead to non-comparable values. To this end, we propose the validation of a gold-standard HRQoL tool in critical care, specifically the EQ-5D-5L. Both combined health-utility and mortality (disaggregated) and QALYs (aggregated) can be reported, with disaggregation allowing for determination of which components are the main drivers of the QALY outcome. Increased use of HRQoL, health-utility, and QALYs in critical care RCTs has the potential to: (1) Increase the likelihood of finding important effects if they exist; (2) improve research efficiency; and (3) help inform optimal management of critically ill patients allowing for decision-making about their HRQoL, in additional to traditional health-technology assessments.
死亡率是重症监护研究中一个公认的对患者至关重要的结局。相比之下，发病率的报告则不太统一（鉴于重症监护疾病种类繁多以及每种疾病的并发症各异），但它可能会对患者的功能能力和健康相关生活质量（HRQoL）产生共同的最终影响。根据患者的个人价值观和偏好，生活质量差的生存状态可能无法接受。因此，随着重症监护中死亡率的降低，测量重症监护病房（ICU）幸存者的HRQoL变得越来越重要。基于偏好的评分算法进行的HRQoL测量可以转换为健康效用值，范围从0（代表死亡）到1（代表完全健康）。它们可以与生存率相结合来计算质量调整生命年（QALY），这是将发病率和死亡率合并为一个综合结局的最广泛使用的方法之一。尽管QALY已用于卫生技术评估决策，但一个新出现的重要作用是，就ICU治疗期间及之后患者可能的预期HRQoL，为患者、家属和医疗服务提供者的临床决策提供信息。重症监护随机对照试验（RCT）通常没有常规测量或报告HRQoL（直到最近才有所改变），这可能是由于一些患者没有能力参与患者报告结局测量。HRQoL测量工具的进一步差异可能导致不可比的值。为此，我们提议在重症监护中验证一种黄金标准的HRQoL工具，特别是EQ-5D-5L。可以同时报告综合健康效用和死亡率（分开报告）以及QALY（综合报告），分开报告有助于确定哪些因素是QALY结局的主要驱动因素。在重症监护RCT中更多地使用HRQoL、健康效用和QALY有可能：（1）如果存在重要影响，增加发现它们的可能性；（2）提高研究效率；（3）除了传统的卫生技术评估外，有助于为重症患者的最佳管理提供信息，以便就他们的HRQoL进行决策。
