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羟氯喹临床疗效的先验信念对临床和经济结果的潜在危害——一种模拟方法。

Potential harm caused by physicians' a-priori beliefs in the clinical effectiveness of hydroxychloroquine and its impact on clinical and economic outcome - A simulation approach.

机构信息

Training Center, Humanitas University, Milan, Italy.

Training Center, Humanitas University, Milan, Italy.

出版信息

J Crit Care. 2021 Apr;62:138-144. doi: 10.1016/j.jcrc.2020.12.003. Epub 2020 Dec 9.

Abstract

BACKGROUND

Despite growing controversies around Hydroxychloroquine's effectiveness, the drug is still widely prescribed by clinicians to treat COVID19 patients. Therapeutic judgment under uncertainty and imperfect information may be influenced by personal preference, whereby individuals, to confirm a-priori beliefs, may propose drugs without knowing the clinical benefit. To estimate this disconnect between available evidence and prescribing behavior, we created a Bayesian model analyzing a-priori optimistic belief of physicians in Hydroxychloroquine's effectiveness.

METHODOLOGY

We created a Bayesian model to simulate the impact of different a-priori beliefs related to Hydroxychloroquine's effectiveness on clinical and economic outcome.

RESULTS

Our hypothetical results indicate no significant difference in treatment effect (combined survival benefit and harm) up to a presumed drug's effectiveness level of 20%, with younger individuals being negatively affected by the treatment (RR 0.82, 0.55-1.2; (0.95 (1.1) % expected adverse events versus 0.05 (0.98) % expected death prevented). Simulated cost data indicate overall hospital cost (medicine, hospital stay, complication) of 18.361,41€ per hospitalized patient receiving Hydroxychloroquine treatment.

CONCLUSION

Off-label use of Hydroxychloroquine needs a rational, objective and datadriven evaluation, as personal preferences may be flawed and cause harm to patients and to society.

摘要

背景

尽管羟氯喹的疗效存在争议,但临床医生仍广泛开羟氯喹治疗 COVID-19 患者。在不确定和信息不完善的情况下进行治疗判断可能会受到个人偏好的影响,即个人为了证实先入为主的信念,可能会提出未经证实临床获益的药物。为了估计现有证据与处方行为之间的这种脱节,我们创建了一个贝叶斯模型,分析医生对羟氯喹疗效的先验乐观信念。

方法

我们创建了一个贝叶斯模型来模拟与羟氯喹疗效相关的不同先验信念对临床和经济结果的影响。

结果

我们的假设结果表明,在假定药物有效性水平达到 20%之前,治疗效果(综合生存获益和危害)没有显著差异,年轻个体的治疗效果受到负面影响(RR 0.82,0.55-1.2;(0.95(1.1)%预期不良事件与 0.05(0.98)%预期死亡预防)。模拟的成本数据表明,接受羟氯喹治疗的住院患者每人的总医院成本(药物、住院时间、并发症)为 18361.41 欧元。

结论

羟氯喹的超说明书使用需要进行合理、客观和数据驱动的评估,因为个人偏好可能存在缺陷,并给患者和社会带来危害。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4037/7725088/47b7fe944471/gr1_lrg.jpg

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