Abstract:
Rationale: Hospital-free days (HFDs), a measure of the number of days alive spent outside the hospital, is increasingly used as an endpoint in studies of patients with acute respiratory failure (ARF) or other critical and serious illnesses. Current approaches to measuring HFDs do not account for decrements in functional status or quality of life that ARF survivors and family members value. Objectives: To develop an acceptable approach to measure quality-weighted HFDs using patient-reported outcomes. Methods: We conducted a four-round modified Delphi process among ARF experts: those with lived or professional experience. Experts rated survivorship domains, instrument and data collection characteristics, and methods to translate responses into quality-weighted HFDs. The consensus threshold was that ⩾70% of respondents rated an item \"totally acceptable\" or \"acceptable\" and ⩽15% of respondents rated the item \"totally unacceptable,\" \"unacceptable,\" or \"slightly unacceptable.\" Results: Fifty-seven experts participated in round 1. Response rates were 82-93% for subsequent rounds. Priority survivorship domains were physical function and health-related quality of life. Participants reached a consensus that data collection during ARF recovery should take less than 15 minutes per assessment, allow surrogate completion when patients are unable, and continue for at least 24 months of follow-up. Using the EuroQol-5 Dimensions (EQ-5D) questionnaire to quality weight HFDs met consensus criteria for acceptability. A majority of panelists preferred quality-weighted HFDs to unweighted HFDs or survival for use in future ARF studies. Conclusions: Quality-weighting HFDs using patient and/or surrogate responses to the EQ-5D captured stakeholder priorities and was acceptable to this Delphi panel.
摘要:
背景:无医院天数(HFDs),衡量在医院外存活的天数,越来越多地用作急性呼吸衰竭(ARF)或其他危重和严重疾病患者研究的终点。目前测量HFDs的方法没有考虑ARF幸存者和家庭成员所重视的功能状态或生活质量的下降。
目的:开发一种可接受的方法,使用患者报告的结果来测量质量加权HFDs。
方法:我们在ARF专家中进行了4轮修改的Delphi,这些专家具有生活或专业经验。专家对生存领域进行了评级,仪器和数据收集特性,以及将响应转化为质量加权HFDs的方法。共识阈值是,>70%的受访者将项目评为“完全可接受”或“可接受”,而<15%的受访者将项目评为“完全不可接受”,\"不可接受\",或\"有点不可接受。\"
结果:57名专家参加了第一轮。随后几轮的反应率为82-93%。优先生存领域是身体功能和健康相关的生活质量。与会者达成共识,即ARF恢复期间的数据收集每次评估应少于15分钟,当患者无法完成时,允许代孕完成,并持续至少24个月的随访。使用EuroQol-5尺寸(EQ-5D)对HFDs进行质量称重符合可接受性的共识标准。大多数小组成员更喜欢质量加权的HFDs而不是未加权的HFDs或生存率,以便在未来的ARF研究中使用。
结论:使用患者和/或对EQ-5D的替代反应的质量加权HFDs捕获了利益相关者的优先级,并且在本Delphi小组中可以接受。