Division of Biomedical Sciences, Clinical Sciences Research Laboratories, Warwick Medical School, University of Warwick, Coventry CV2 2DX, UK; Tommy's National Centre for Miscarriage Research, University Hospitals Coventry and Warwickshire, Coventry CV2 2DX, UK.
Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
Reprod Biomed Online. 2021 Mar;42(3):475-479. doi: 10.1016/j.rbmo.2020.12.009. Epub 2020 Dec 24.
Reproductive medicine is imbued with debates over the results of key trials. This has resulted in heterogeneity in clinical practice and a disconnect between researchers and the patient group they aim to treat. The criticisms of trials originate from the nature of reproductive health conditions and limitations imposed in designing trials to assess effect in a patient group with heterogenous pathologies leading to the same condition. This leads to challenges in balancing the difficulties of recruiting an enriched patient cohort versus the dilutionary effect and need for subgroup analysis from wider recruitment. These challenges manifest as a failure to achieve traditional statistical significance. One potential solution to overcoming these inherent challenges is that of a Bayesian statistical approach. Using examples from the literature we demonstrate the benefits of a Bayesian approach. Taking published data and using a flat prior (no background information used), a Bayesian re-analysis of the PRISM and EAGeR trials is presented. This demonstrated a 94.7% chance of progesterone and a 95.3% probability of aspirin preventing miscarriage, in contrast to the original trial conclusions. These highlight the role a Bayesian approach can play in overcoming the challenges of trials within reproductive health.
生殖医学充满了对关键试验结果的争论。这导致了临床实践的异质性,以及研究人员和他们试图治疗的患者群体之间的脱节。对试验的批评源于生殖健康状况的性质以及在设计试验以评估具有异质病理的患者群体中相同病症的效果时所施加的限制。这导致了在平衡招募丰富的患者队列的困难与从更广泛的招募中进行稀释效应和亚组分析的需求之间的挑战。这些挑战表现为未能达到传统的统计学意义。克服这些固有挑战的一种潜在解决方案是贝叶斯统计方法。我们使用文献中的示例展示了贝叶斯方法的优势。我们采用已发表的数据,并使用平坦先验(不使用背景信息),对 PRISM 和 EAGeR 试验进行了贝叶斯重新分析。这表明孕激素有 94.7%的几率,阿司匹林有 95.3%的几率可以预防流产,与原始试验结论形成对比。这些突出了贝叶斯方法在克服生殖健康领域试验挑战方面可以发挥的作用。