Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial.

Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial.
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DOI:
10.1038/s41372-022-01592-2
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发表时间:
2023-05
影响因子:
2.9
通讯作者:
Kerr, Stephen
Kerr, Stephen
中科院分区:
医学3区
文献类型:
--
作者:
Abu Jawdeh, Elie G.;Hunt, Carl E.;Eichenwald, Eric;Corwin, Michael J.;McEntire, Betty;Heeren, Timothy;Crowell, Lisa M.;Ikponmwonba, Christine;Saroufim, Ariana;Kerr, Stephen

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描述 COVID-19 大流行对多中心随机对照试验中受试者入组的影响。我们评估了五个不同时期的符合条件的婴儿数量,包括基线、流行高峰期和逐渐但不完全的恢复期。这场大流行对向父母寻求同意的能力产生了重大影响。在疫情高峰期,家长接近率从基线的 95.4% 下降至 13.1%,即使在疫情刚刚结束的时期也没有恢复到基线 (84.9%)。尽管接触的受试者有所减少,但该研究的总体同意率没有显着变化。大流行大大限制了向符合条件的婴儿父母寻求同意的能力,仅部分恢复。研究人员和研究协调员与家长互动的机会继续带来限制全面康复的挑战。
Describe the effects of the COVID-19 pandemic on subject enrollment in a multicenter randomized controlled trial. We assessed the number of eligible infants approached and consented for enrollment over five separate epochs including baseline, peak pandemic, and gradual but incomplete recovery. The pandemic had a major effect on ability to approach parents for consent. Parents approached dropped from 95.4% baseline to 13.1% in the peak pandemic epoch and has not recovered to baseline even in the just-completed post-pandemic epoch (84.9%). Despite the decrease in subjects approached, there was no significant change in the overall consent rate for the study The pandemic has significantly limited ability to approach parents of eligible infants for consent, with only partial recovery. Opportunities for interactions of investigators and study coordinators with parents continue to present challenges limiting full recovery.
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发表时间: 2004-06-01
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