Needham Dale M, Sepulveda Kristin A, Dinglas Victor D, Chessare Caroline M, Friedman Lisa Aronson, Bingham Clifton O, Turnbull Alison E
1 Outcomes After Critical Illness and Surgery Group.
2 Division of Pulmonary and Critical Care Medicine, School of Medicine.
Am J Respir Crit Care Med. 2017 Nov 1;196(9):1122-1130. doi: 10.1164/rccm.201702-0372OC.
Research evaluating acute respiratory failure (ARF) survivors' outcomes after hospital discharge has substantial heterogeneity in terms of the measurement instruments used, creating barriers to synthesizing study data.
To identify a minimum set of core outcome measures that are essential to include in all clinical research studies evaluating ARF survivors after discharge.
We conducted a three-round modified Delphi consensus process with 77 participants (47% female, 55% outside the United States), including clinical researchers from more than 16 countries across six continents, patients/caregivers, clinicians, and research funders. Participants reviewed standardized information on measure instruments for seven consensus-derived outcomes plus one recommended outcome.
Response rates were 91 to 97% across the three rounds. Among 75 measurement instruments evaluated, the following met a priori consensus criteria: EQ-5D and 36-item Short Form Health Survey version 2 (optional) for the "satisfaction with life and personal enjoyment" and "pain" outcomes, and both the Hospital Anxiety and Depression Scale and the Impact of Events Scale-Revised for the "mental health" outcome. No measures reached consensus for the following outcomes: cognition, muscle and/or nerve function, physical function, and pulmonary function. All measures considered for pulmonary function met consensus criteria for exclusion. The following measures did not reach the threshold for consensus but achieved the highest scores for their respective outcomes: the Montreal Cognitive Assessment (cognition), manual muscle testing and handgrip dynamometry (muscle and/or nerve function), and 6-minute-walk test (physical function).
This Core Outcome Measurement Set is recommended for use in all clinical research evaluating ARF survivors after hospital discharge. In the future, researchers should evaluate measures for outcomes not reaching consensus.
评估急性呼吸衰竭（ARF）幸存者出院后结局的研究在所用测量工具方面存在很大异质性，这给综合研究数据带来了障碍。
确定在所有评估ARF幸存者出院后情况的临床研究中必须纳入的一组最低限度的核心结局指标。
我们对77名参与者（47%为女性，55%来自美国以外地区）进行了三轮改进的德尔菲共识流程，参与者包括来自六大洲16个以上国家的临床研究人员、患者/护理人员、临床医生和研究资助者。参与者审查了关于七个通过共识得出的结局指标以及一个推荐指标的测量工具的标准化信息。
三轮的回复率为91%至97%。在评估的75种测量工具中，以下工具符合先验共识标准：用于“生活满意度和个人享受”及“疼痛”结局的EQ-5D和36项简明健康调查问卷第2版（可选），以及用于“心理健康”结局的医院焦虑抑郁量表和事件影响量表修订版。对于以下结局指标，没有测量工具达成共识：认知、肌肉和/或神经功能、身体功能以及肺功能。所有考虑用于肺功能的测量工具均符合排除的共识标准。以下测量工具未达到共识阈值，但在各自结局指标中得分最高：蒙特利尔认知评估量表（认知）、徒手肌力测试和握力测量（肌肉和/或神经功能）以及6分钟步行试验（身体功能）。
建议在所有评估ARF幸存者出院后情况的临床研究中使用这一核心结局测量集。未来，研究人员应评估未达成共识的结局指标的测量工具。
