关键词: ARR, Absolute risk reduction Absolute risk reduction CDC, Centers for Disease Control and Prevention CER, Control event rate COVID-19 vaccines COVID-19, Coronavirus Disease-2019 Control event rate EER, Experimental event rate Experimental event rate FDA, Food and Drug Administration NNT, Number needed to treat NNV, Number needed to vaccinate Number needed to treat Number needed to vaccinate RR, Relative risk RRR, Relative risk reduction Relative risk Relative risk reduction SARS-CoV-2, Severe Acute Respiratory Syndrome-Coronavirus-2 VE, Vaccine efficacy Vaccine efficacy mRNA, Messenger ribonucleic acid microRNA, Micro ribonucleic acid

来  源:   DOI:10.1016/j.dialog.2022.100074   PDF(Pubmed)

Abstract:
Treatment and vaccine efficacy in clinical trials are often reported in the media and medical journals as the relative risk reduction. The present article explains why the relative risk reduction is a misinformative measure that promotes disinformation when reporting efficacy in clinical research studies such as randomized controlled trials for COVID-19 vaccines. The relative risk reduction is based on the relative risk, a proportional measure or ratio used in epidemiologic studies to estimate the probability of a disease associated with an exposure. The present article demonstrates how the relative risk reduction and relative risk obscure the magnitude of disease risk reduction in clinical research. The absolute risk reduction is shown to be a more precise and reliable measure of treatment and vaccine efficacy in clinical research studies. The absolute risk reduction reciprocal also measures the number needed to treat or vaccinate, and is a more accurate measure than the relative risk reduction for comparing risk reductions of clinical studies. Additionally, the present article reviews consequences of COVID-19 vaccine efficacy misinformation disseminated through media reports. The article concludes that relative risk reduction should not be used to measure treatment and vaccine efficacy in clinical trials.
UNASSIGNED: •Unreliability of relative measures in clinical trials is graphically illustrated, demonstrating constant relative measures as absolute measures change.•Misuse of relative measures in clinical research is historically linked to misinterpretation of Jerome Cornfield\'s advice on measuring causative and associative effects.•Consequences of disinformation and misinformation related to COVID-19 vaccine efficacy and modern clinical medicine are described.•The proper use of absolute measures in meta-analyses is explained.
摘要:
临床试验中的治疗和疫苗疗效通常在媒体和医学期刊上报道为相对风险降低。本文解释了为什么相对风险降低是一种误报措施,在临床研究研究如COVID-19疫苗的随机对照试验中报告疗效时,会助长虚假信息。相对风险降低是基于相对风险,流行病学研究中用于估计与暴露相关的疾病发生概率的比例度量或比率。本文演示了相对风险降低和相对风险如何掩盖临床研究中疾病风险降低的幅度。在临床研究中,绝对风险降低被证明是治疗和疫苗功效的更精确和可靠的衡量标准。绝对风险降低倒数还可以衡量治疗或接种疫苗所需的数量,对于比较临床研究的风险降低,是比相对风险降低更准确的衡量标准。此外,本文回顾了通过媒体报道传播的COVID-19疫苗疗效错误信息的后果.文章得出的结论是,在临床试验中,相对风险降低不应用于衡量治疗和疫苗疗效。
未经评估:•临床试验中相对测量的不可靠性以图形方式说明,随着绝对度量的变化,展示恒定的相对度量。•在临床研究中滥用相关措施在历史上与对JeromeCornfield关于测量因果和关联效应的建议的误解有关。•描述了与COVID-19疫苗功效和现代临床医学相关的虚假信息和错误信息的后果。•解释了在荟萃分析中绝对测量的正确使用。
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