Research consent rates before and during a COVID-19 one-visitor policy in a children's hospital.
Research consent rates before and during a COVID-19 one-visitor policy in a children's hospital.
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DOI：
10.1038/s41390-020-01303-7
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发表时间：
2021-05
影响因子：
3.6
通讯作者：
Kannankeril PJ
中科院分区：
文献类型：
--
作者：
Van Driest SL;Madell SM;Crum K;Smith AH;Bichell DP;Kannankeril PJ
方法：我们对在一家三级专科儿童医院进行的一项临床研究的入组情况进行回顾性分析。父母研究是一项经irb批准的观察性队列研究，纳入了自2007年以来接受先天性心脏手术的儿童、青少年和年轻人。所有在Monroe Carell， Jr. Children 's Hospital at Vanderbilt接受先天性心脏手术并随后入住儿科心脏重症监护病房的患者，无论年龄大小，均有资格入选。研究护士在手术前，在住院部或门诊病人手术前一天，与符合条件的受试者的父母/监护人进行接触以纳入研究。值得注意的是，作为一项观察性研究，它的风险很小，对于未成年人，只需要父母/监护人之一的书面同意。2020年3月10日，由于机构对应对COVID-19大流行的研究的限制，该研究的入组暂停。在此之前，对选择性外科手术没有任何限制，允许父母双方在医院陪伴儿童。2020年3月18日，儿科住院和门诊患者的家长/访客仅限一人的限制探视政策开始实施。到2020年5月7日，选择性心脏病病例已经恢复，研究的登记再次开始，但单亲/访客政策仍然有效。
MethodsWe conducted a retrospective review of enrollment in a clinical research study performed at an academic tertiary care children’s hospital. The parent study is an IRB-approved observational cohort study enrolling children, adolescents, and young adults undergoing congenital heart surgery since 2007. 4 All patients undergoing congenital heart surgery at Monroe Carell, Jr. Children’s Hospital at Vanderbilt and subsequently admitted to the pediatric cardiac intensive care unit are eligible for enrollment, regardless of age. The parents/guardians of eligible subjects are approached for enrollment by research nurses prior to the operative procedure, either in the inpatient setting or in the clinic the day before surgery for outpatients. Of note, as an observational study, it is minimal risk, and for minors the written consent of only one parent/guardian is required. On March 10, 2020 enrollment in the study was paused due to institutional restrictions on research in response to the COVID-19 pandemic. Prior to that date, there were no restrictions on elective surgical procedures and both parents were allowed to be with the children in hospital. On March 18, 2020, a restricted visitor policy allowing only one parent/visitor for pediatric inpatients and outpatients was enacted. By May 7, 2020, elective cardiac cases had resumed and enrollment in the study began again, but the one-parent/visitor policy remained in effect.
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影响因子：
8
作者：
Patrick, Stephen W.;Henkhaus, Laura E.;Davis, Matthew M.
通讯作者：
Davis, Matthew M.
影响因子：
2.9
作者：
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影响因子：
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作者：
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通讯作者：
Kannankeril, Prince J.
影响因子：
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通讯作者：
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