Community consultation for Exception from Informed consent (EFIC) before and during the COVID-19 pandemic.
Community consultation for Exception from Informed consent (EFIC) before and during the COVID-19 pandemic.
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DOI：
10.1016/j.resplu.2022.100322
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发表时间：
2022-12
影响因子：
2.4
通讯作者：
Seder, David B.
中科院分区：
文献类型：
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作者：
Gagnon, David J.;Riker, Richard R.;Chessa, Frank;Lord, Christine;Eldridge, Ashley;Searight, Meghan;Bockian, Sarah;McCrum, Barbara;May, Teresa L.;Sawyer, Douglas;Seder, David B.
关键词：
Describe community consultation and surrogate consent rates for two Exception From Informed Consent (EFIC) trials for out-of-hospital cardiac arrest (OOHCA) - before and during the COVID-19 pandemic. The PEARL study (2016–2018) randomized OOHCA patients without ST-elevation to early cardiac catheterization or not. Community consultation included flyers, radio announcements, newspaper advertisements, mailings, and in-person surveys at basketball games and ED waiting rooms. The PROTECT trial (2021-present) randomizes OOHCA survivors to prophylactic ceftriaxone or placebo; the community consultation plan during the pandemic included city council presentations, social media posts, outpatient flyers, but no in-person encounters. Demographics for PROTECT community consultation were compared to PEARL and INTCAR registry data, with p-value < 0.05 considered significant. PEARL surveyed 1,362 adults, including 64 % ≥60 years old, 96 % high school graduates or beyond; research acceptance rate was 92 % for the community and 76 % for personal level. PROTECT initially obtained 221 surveys from electronic media – including fewer males (28 % vs 72 %,p < 0.001) and those > 60 years old (14 % vs 53 %;p < 0.001) compared to INTCAR. These differences prompted a revised community consultation plan, targeting 79 adult in-patients with cardiac disease which better matched PEARL and INTCAR data: the majority were ≥ 60 years old (66 %) and male (54 %). Both PEARL and PROTECT enrolled more patients using surrogate consent vs EFIC (57 %, 61 %), including 71 % as remote electronic consents during PROTECT. Community consultation for EFIC studies changed with the COVID-19 pandemic, resulting in different demographic patterns. We describe effective adaptations to community consultation and surrogate consent during the pandemic.
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影响因子：
9.7
作者：
Feldman, William B.;Hey, Spencer Phillips;Kesselheim, Aaron S.
通讯作者：
Kesselheim, Aaron S.
影响因子：
4.4
作者：
Hsu, Cindy H.;Fowler, Jennifer;Neumar, Robert W.
通讯作者：
Neumar, Robert W.
DOI：
10.1111/acem.14264
发表时间：
2021-10
期刊：
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
影响因子：
--
作者：
Dickert NW;Metz K;Fetters MD;Haggins AN;Harney DK;Speight CD;Silbergleit R
通讯作者：
Silbergleit R
影响因子：
6.5
作者：
Eubank, Louis;Lee, Kwan S.;Kern, Karl B.
通讯作者：
Kern, Karl B.
影响因子：
37.8
作者：
Kern, Karl B.;Radsel, Peter;Noc, Marko
通讯作者：
Noc, Marko