Gastrointestinal prophylaxis for COVID-19: an illustration of severe bias arising from inappropriate comparators in observational studies.

Gastrointestinal prophylaxis for COVID-19: an illustration of severe bias arising from inappropriate comparators in observational studies.
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DOI:
10.1016/j.jclinepi.2022.07.009
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发表时间:
2022-11
影响因子:
7.2
通讯作者:
Desai, Rishi J.
Desai, Rishi J.
中科院分区:
医学2区
文献类型:
--
作者:
Lin, Kueiyu Joshua;Feldman, William B.;Wang, Shirley V.;Umarje, Siddhi Pramod;D'Andrea, Elvira;Tesfaye, Helen;Zabotka, Luke E.;Liu, Jun;Desai, Rishi J.

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我们的目的是使用设置适当的比较来估计不同胃肠道(GI)预防药物治疗对COVID-19住院患者的影响,并使用设置不适当的比较来说明不适当的设计选择如何导致偏倚结果。我们于2020年3月至11月识别出3,804名年龄≥ 18岁的COVID-19住院患者。我们比较了不同胃保护剂对COVID-19临床改善的影响,通过已发表的严重程度量表进行测量。我们使用基于倾向评分的精细分层进行混杂调整。根据指南,我们预先规定了具有临床平衡的药物之间的比较,以及重症监护室(ICU)中GI预防的使用者与非使用者之间的不适当比较。在普通病房或ICU接受治疗的患者中,口服法莫替丁与奥美拉唑相比未发现获益。我们还发现,静脉注射法莫替丁与静脉注射泮托拉唑之间没有相关性。对于ICU中使用者与非使用者的不适当比较,法莫替丁使用者的改善概率降低32%-45%,奥美拉唑或泮托拉唑使用者降低21%-48%。我们没有发现任何证据表明GI预防改善了因COVID-19住院的患者的结局。不适当的对照药物选择可能导致重症患者出现虚假关联。
We aimed to use setting-appropriate comparisons to estimate the effects of different gastrointestinal (GI) prophylaxis pharmacotherapies for patients hospitalized with COVID-19 and setting-inappropriate comparisons to illustrate how improper design choices could result in biased results. We identified 3,804 hospitalized patients aged ≥ 18 years with COVID-19 from March to November 2020. We compared the effects of different gastroprotective agents on clinical improvement of COVID-19, as measured by a published severity scale. We used propensity score–based fine-stratification for confounding adjustment. Based on guidelines, we prespecified comparisons between agents with clinical equipoise and inappropriate comparisons of users vs. nonusers of GI prophylaxis in the intensive care unit (ICU). No benefit was detected when comparing oral famotidine to omeprazole in patients treated in the general ward or ICUs. We also found no associations when comparing intravenous famotidine to intravenous pantoprazole. For inappropriate comparisons of users vs. nonusers in the ICU, the probability of improvement was reduced by 32%–45% in famotidine users and 21%–48% in omeprazole or pantoprazole users. We found no evidence that GI prophylaxis improved outcomes for patients hospitalized with COVID-19 in setting-appropriate comparisons. An improper comparator choice can lead to spurious associations in critically ill patients.
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