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
{"title":"Ethical Problems of Observational Studies and Big Data Compared to Randomized Trials.","authors":"Jean Raymond, Robert Fahed, Tim E Darsaut","doi":"10.1093/jmp/jhae021","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47377,"journal":{"name":"Journal of Medicine and Philosophy","volume":" ","pages":"389-398"},"PeriodicalIF":1.3000,"publicationDate":"2024-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Medicine and Philosophy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/jmp/jhae021","RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ETHICS","Score":null,"Total":0}
引用次数: 0

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.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
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.
期刊最新文献
Disability, Offense, and the Expressivist Objection to Medical Aid in Dying. Kidney Sales and Disrespectful Demands: A Reply to Rippon. Plastic Resilience: Rethinking Resilience in Illness with Catherine Malabou. A Defense of the Obligation to Keep Promises to the Dead. Why Moral Bioenhancement Cannot Reliably Produce Virtue.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1