Division of Critical Care Medicine, Department of Pediatrics, University of Michigan, Ann Arbor, MI, United States; Susan B. Meister Child Health Evaluation and Research Center, University of Michigan, Ann Arbor, MI, United States.
Department of Sociology, College of Literature, Science and Arts, University of Michigan, Ann Arbor, MI, United States.
J Crit Care. 2021 Aug;64:160-164. doi: 10.1016/j.jcrc.2021.04.006. Epub 2021 Apr 17.
To measure the rate of recall of study participation and study attrition in survivors of acute respiratory distress syndrome(ARDS).
MATERIALS/METHODS: In this ancillary study of the Re-evaluation of Systemic Early neuromuscular blockade(ROSE) trial, we measured the rate of study participation recall 3 months following discharge and subsequent study attrition at 6 months. We compared patient and hospital characteristics, and long-term outcomes by recall. As surrogate decision-makers provided initial consent, we measured the rate of patient reconsent and its association with study recall.
Of 487 patients evaluated, recall status was determined in 386(82.7%). Among these, 287(74.4%) patients recalled participation in the ROSE trial, while 99(25.6%) did not. There was no significant difference in 6-month attrition among patients who recalled study participation (9.1%) and those who did not (12.1%) (p = 0.38). Patient characteristics were similar between groups, except SOFA scores, ventilator-free days, and length of stay. 330(68%) were reconsented. Compared to those not reconsented, significantly more patients who were reconsented recalled study participation(78% vs. 66%;p = 0.01).
One in 4 ARDS survivors do not recall their participation in a clinical trial during hospitalization 3 months following hospital discharge, which did not influence 6-month attrition. However, more patients recall study participation if reconsent is obtained.
测量急性呼吸窘迫综合征（ARDS）幸存者对研究参与和研究退出的回忆率。
材料/方法：在重新评估系统性早期神经肌肉阻滞（ROSE）试验的辅助研究中，我们测量了出院后 3 个月的研究参与回忆率，以及 6 个月时的研究退出率。我们通过回忆来比较患者和医院特征以及长期结果。由于替代决策人提供了最初的同意，我们测量了患者重新同意的比例及其与研究回忆的关联。
在评估的 487 名患者中，有 386 名（82.7%）确定了回忆状态。在这些患者中，287 名（74.4%）患者回忆起参与了 ROSE 试验，而 99 名（25.6%）患者没有回忆起。在回忆起研究参与的患者（9.1%）和未回忆起的患者（12.1%）之间，6 个月的退出率没有显著差异（p = 0.38）。除 SOFA 评分、无呼吸机天数和住院时间外，两组患者的特征相似。有 330 名（68%）患者获得了重新同意。与未重新同意的患者相比，获得重新同意的患者明显更多地回忆起了研究参与（78%比 66%；p = 0.01）。
在出院后 3 个月，每 4 名 ARDS 幸存者中就有 1 名不记得他们参加了临床试验，这并没有影响 6 个月的退出率。然而，如果获得重新同意，更多的患者会回忆起研究参与。
