发表机构
MRC Biostatistics Unit, University of Cambridge; Papworth Trials Unit Collaboration, Royal Papworth Hospital; University of Cambridge; Department of Anaesthesia, Royal Papworth Hospital（剑桥大学医学研究委员会生物统计单元; 皇家帕普沃斯医院帕沃斯试验单位合作组织; 剑桥大学; 皇家帕普沃斯医院麻醉科）
机构由 AI 辅助整理，请以论文原文为准。AI 中文总结
本研究比较围手术期试验终点DAOH与DAH，指出DAOH将护理机构天数等同于在家天数，可能掩盖恢复益处并降低统计功效，提出基线调整的DAH作为更准确的恢复替代指标。
AI 中文摘要
院外存活天数（DAOH）和在家存活天数（DAH）日益被用作围手术期试验中以患者为中心的主要终点，近期一篇社论提倡使用DAOH，因其简单且依赖常规收集的数据。我们认为，这两个终点之间的选择会影响统计功效、治疗效果估计和缺失数据，应在设计阶段就考虑到这些后果而做出决定。通过将养老院或康复机构中的天数等同于在家天数，DAOH假设院外状态是良好恢复的有效替代指标，而这一假设受到患者观点（包括NOTACS试验中的观点）的质疑。因此，选择DAH而非DAOH涉及一种权衡：更准确地衡量对患者重要的事项与追踪出院去向所带来的额外负担（包括更大的缺失数据风险）之间的权衡。如果干预措施仅影响住院时长、再入院或死亡率，则两个终点会产生相同的预期治疗效果，而追踪出院去向的额外负担不会带来任何益处。如果干预措施反而使更多患者能够直接回家而非前往护理机构，DAOH可能会掩盖这一益处并降低统计功效。我们提出一种基线调整的DAH，仅计算相对于患者基线代表护理升级的环境中所度过的天数，作为更好的恢复替代指标，同时也能适应医院居家和虚拟病房服务。
英文摘要
Days Alive and Out of Hospital (DAOH) and Days Alive at Home (DAH) are increasingly used as patient-centred primary outcomes in perioperative trials, and a recent editorial has advocated DAOH for its simplicity and reliance on routinely collected data. We argue that the choice between these endpoints affects power, treatment effect estimation and missing data, and should be made at the design stage with these consequences in mind. By treating days in nursing homes or rehabilitation facilities as equivalent to days at home, DAOH assumes that being out of hospital is a valid surrogate for good recovery, an assumption that patient perspectives, including those from the NOTACS trial, call into question. Choosing DAH over DAOH therefore involves a trade-off between measuring what matters to patients more accurately and the added burden of tracking discharge destination, including a greater risk of missing data. If an intervention affects only length of stay, readmission or mortality, the two endpoints yield the same expected treatment effect, and the extra burden of tracking discharge destination brings no benefit. If it instead enables more patients to return directly home rather than to a care facility, DAOH may conceal this benefit and lose statistical power. We propose a baseline-adjusted DAH, which counts only days spent in a setting representing an escalation of care relative to the patient's baseline, as a better proxy for recovery that also accommodates hospital-at-home and virtual ward services.
Comments8 pages, 2 figures
