Wouters Roel H P, van der Graaf Rieke, Rigter Tessel, Bunnik Eline M, Ploem M Corrette, de Wert Guido M W R, Dondorp Wybo J, Cornel Martina C, Bredenoord Annelien L
Department of Medical Humanities, Julius Center, University Medical Center Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
Princess Maxima Center for Pediatric Oncology, P.O. Box 113, 3720 AC Utrecht, The Netherlands.
J Pers Med. 2021 Jun 10;11(6):539. doi: 10.3390/jpm11060539.
Learning healthcare systems have recently emerged as a strategy to continuously use experiences and outcomes of clinical care for research purposes in precision medicine. Although it is known that learning healthcare transitions in general raise important ethical challenges, the ethical ramifications of such transitions in the specific context of precision medicine have not extensively been discussed. Here, we describe three levers that institutions can pull to advance learning healthcare systems in precision medicine: (1) changing testing of individual variability (such as genes); (2) changing prescription of treatments on the basis of (genomic) test results; and/or (3) changing the handling of data that link variability and treatment to clinical outcomes. Subsequently, we evaluate how patients can be affected if one of these levers are pulled: (1) patients are tested for different or more factors than before the transformation, (2) patients receive different treatments than before the transformation and/or (3) patients' data obtained through clinical care are used, or used more extensively, for research purposes. Based on an analysis of the aforementioned mechanisms and how these potentially affect patients, we analyze why learning healthcare systems in precision medicine need a different ethical approach and discuss crucial points to consider regarding this approach.
学习型医疗系统最近已成为一种策略，即持续利用临床护理的经验和结果用于精准医学的研究目的。尽管人们知道学习型医疗转型总体上会带来重要的伦理挑战，但在精准医学的特定背景下，这种转型的伦理影响尚未得到广泛讨论。在此，我们描述了机构可以采取的三个举措，以推动精准医学中的学习型医疗系统：（1）改变对个体变异性（如基因）的检测；（2）根据（基因组）检测结果改变治疗方案的开具；和/或（3）改变将变异性和治疗与临床结果相联系的数据处理方式。随后，我们评估如果采取这些举措之一，患者可能会受到怎样的影响：（1）患者接受检测的因素与转型前不同或更多；（2）患者接受的治疗与转型前不同；和/或（3）通过临床护理获得的患者数据被用于或更广泛地用于研究目的。基于对上述机制及其对患者潜在影响的分析，我们分析了为什么精准医学中的学习型医疗系统需要不同的伦理方法，并讨论了关于这种方法需要考虑的关键点。
