Ethical Problems of Observational Studies and Big Data Compared to Randomized Trials.

IF 1.3 3区 哲学 Q3 ETHICS Journal of Medicine and Philosophy Pub Date : 2024-07-11 DOI:10.1093/jmp/jhae021
Jean Raymond, Robert Fahed, Tim E Darsaut
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Abstract

The temptation to use prospective observational studies (POS) instead of conducting difficult trials (RCTs) has always existed, but with the advent of powerful computers and large databases, it can become almost irresistible. We examine the potential consequences, were this to occur, by comparing two hypothetical studies of a new treatment: one RCT, and one POS. The POS inevitably submits more patients to inferior research methodology. In RCTs, patients are clearly informed of the research context, and 1:1 randomized allocation between experimental and validated treatment balances risks for each patient. In POS, for each patient, the risks of receiving inferior treatment are impossible to estimate. The research context and the uncertainty are down-played, and patients and clinicians are at risk of becoming passive research subjects in studies performed from an outsider's view, which potentially has extraneous objectives, and is conducted without their explicit, autonomous, and voluntary involvement and consent.

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观察研究和大数据与随机试验相比存在的伦理问题。
使用前瞻性观察研究(POS)而不是进行困难试验(RCT)的诱惑一直存在,但随着功能强大的计算机和大型数据库的出现,这种诱惑几乎变得不可抗拒。我们通过比较两种假定的新疗法研究:一种是 RCT,另一种是 POS,来探讨一旦出现这种情况的潜在后果。POS 不可避免地会让更多患者接受低劣的研究方法。在研究性临床试验中,患者会被明确告知研究背景,并在实验治疗和验证治疗之间进行 1:1 随机分配,以平衡每位患者的风险。而在 POS 中,每个病人接受劣质治疗的风险是无法估计的。研究背景和不确定性被淡化,患者和临床医生有可能成为被动的研究对象,从局外人的角度进行研究,这可能具有无关的目的,并且是在没有他们明确、自主、自愿参与和同意的情况下进行的。
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来源期刊
CiteScore
2.90
自引率
6.20%
发文量
30
期刊介绍: This bimonthly publication explores the shared themes and concerns of philosophy and the medical sciences. Central issues in medical research and practice have important philosophical dimensions, for, in treating disease and promoting health, medicine involves presuppositions about human goals and values. Conversely, the concerns of philosophy often significantly relate to those of medicine, as philosophers seek to understand the nature of medical knowledge and the human condition in the modern world. In addition, recent developments in medical technology and treatment create moral problems that raise important philosophical questions. The Journal of Medicine and Philosophy aims to provide an ongoing forum for the discussion of such themes and issues.
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