Recall of clinical trial participation and attrition rates in survivors of acute respiratory distress syndrome.
Recall of clinical trial participation and attrition rates in survivors of acute respiratory distress syndrome.
复制标题
DOI：
10.1016/j.jcrc.2021.04.006
复制
发表时间：
2021-08
影响因子：
3.7
通讯作者：
NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Network
中科院分区：
文献类型：
--
作者：
Carlton EF;Ice E;Barbaro RP;Kampuis L;Moss M;Angus DC;Banner-Goodspeed VM;Ginde AA;Gong MN;Grissom CK;Hou PC;Huang DT;Hough CTL;Talmor DS;Thompson BT;Yealy DM;Couper MP;Iwashyna TJ;NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Network
测量急性呼吸窘迫综合征（ARDS）幸存者的研究参与回忆率和研究损耗率。在这项全身早期神经肌肉阻滞（ROSE）试验再评价的辅助研究中，我们测量了出院后3个月的研究参与回忆率和随后6个月的研究脱落率。我们比较了患者和医院的特点，以及通过回忆的长期结果。由于代理决策者提供了最初的同意，我们测量了患者再次同意的比率及其与研究召回的相关性。在评价的487例患者中，386例（82.7%）确定了回忆状态。其中，287例（74.4%）患者回忆起参与ROSE试验，而99例（25.6%）患者未回忆起。回忆参与研究的患者（9.1%）和未回忆参与研究的患者（12.1%）之间的6个月损耗无显著差异（p = 0.38）。除SOFA评分、无呼吸机天数和住院时间外，两组患者特征相似。330例（68%）再次同意。与未重新同意的患者相比，重新同意的患者回忆起参与研究的人数明显更多（78% vs. 66%;p = 0.01）。四分之一的ARDS幸存者在出院后3个月住院期间不记得他们参加过临床试验，这对6个月的自然减员没有影响。然而，如果获得再次同意，更多患者会回忆起参与研究。
To measure the rate of recall of study participation and study attrition in survivors of acute respiratory distress syndrome(ARDS). 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.
登录
查看更多内容
影响因子：
5.3
作者：
Smith, Orla M.;McDonald, Ellen;Cook, Deborah J.
通讯作者：
Cook, Deborah J.
影响因子：
5.9
作者：
Schaeffer, MH;Krantz, DS;Vinicky, JK
通讯作者：
Vinicky, JK
影响因子：
4.7
作者：
Saiepour N;Ware R;Najman J;Baker P;Clavarino A;Williams G
通讯作者：
Williams G
影响因子：
2.7
作者：
Mexas, Fernanda;Efron, Anne;Conde, Marcus B.
通讯作者：
Conde, Marcus B.
影响因子：
4.1
作者：
Chenaud, C.;Merlani, P.;Ricou, B.
通讯作者：
Ricou, B.