Department of Medical Ethics and History of Medicine, University Medical Center Göttingen, Humboldtallee 36, 37073, Göttingen, Germany.
BMC Med Ethics. 2020 May 11;21(1):33. doi: 10.1186/s12910-020-00476-4.
Biomarker research is gaining increasing attention focusing on the preclinical stages of the disease. Such interest requires special attention for communication and disclosure in clinical contexts. Many countries give dementia a high health policy priority by developing national strategies and by improving guidelines addressing disclosure of a diagnosis; however, risk communication is often neglected.
This paper aims to identify the challenges of disclosure in the context of dementia prediction and to find out whether existing clinical guidelines sufficiently address the issues of disclosing a dementia diagnosis and of disclosing the risk of developing dementia in asymptomatic and MCI stage. We will examine clinical guidelines and recommendations of three countries (USA, Canada and Germany) regarding predictive testing and diagnostic disclosure in dementia and Mild Cognitive Impairment (MCI) to show their potentials and limits. This will provide a background to address ethical implications of predictive information and to identify ways how to proceed further. We will start by examining the guidelines and recommendations by focusing on what there is already and what is missing regarding the challenges of disclosing dementia prediction and MCI. Then, we will highlight the novel ethical issues generated by the shift to identify preclinical stages of the disease by biomarkers. We will argue for the need to develop guidelines for disclosing a risk status, which requires different considerations then disclosing a diagnosis of dementia. Finally, we will make some suggestions on how to address the gap and challenges raised by referring to German Stakeholder Conference, which presents us a good starting point to the applicability of involving stakeholders.
This paper underlines the need to develop empirically based guidelines that address the ethical and social strategies for risk communication of dementia prediction by genetic as well as non-genetic biomarkers. According to our analysis, the guidelines do not address the new developments sufficiently. International efforts should aim for specific guidelines on counseling, communicating risk and disclosing results. We argue that guidelines on (risk) disclosure should be developed by involving various stakeholders and should be informed by socio-empirical studies involving laypersons' needs and wishes regarding risk communication.
生物标志物研究越来越受到关注，聚焦于疾病的临床前阶段。这种兴趣需要特别关注临床环境中的沟通和披露。许多国家通过制定国家战略和改进解决诊断披露问题的指南，高度重视痴呆症的卫生政策，但是风险沟通往往被忽视。
本文旨在确定在痴呆症预测背景下披露的挑战，并找出现有的临床指南是否充分解决了在无症状和 MCI 阶段诊断痴呆症和披露痴呆症风险的问题。我们将检查三个国家（美国、加拿大和德国）关于预测性测试和痴呆症及轻度认知障碍（MCI）诊断披露的临床指南和建议，以展示其潜力和局限性。这将为解决预测信息的伦理问题提供背景，并确定进一步的方法。我们将从检查指南和建议开始，重点关注在披露痴呆症预测和 MCI 的挑战方面已经存在的内容和缺失的内容。然后，我们将强调通过生物标志物识别疾病临床前阶段所产生的新的伦理问题。我们将论证制定披露风险状况指南的必要性，这需要与披露痴呆症诊断不同的考虑因素。最后，我们将提出一些建议，以通过参考德国利益相关者会议来解决差距和挑战，该会议为我们提供了一个很好的起点，可以探讨利益相关者参与的适用性。
本文强调需要制定基于经验的指南，以解决通过遗传和非遗传生物标志物进行痴呆症预测的风险沟通的伦理和社会策略。根据我们的分析，这些指南没有充分解决新的发展。国际努力应该旨在制定关于咨询、沟通风险和披露结果的具体指南。我们认为，（风险）披露指南应由各种利益相关者制定，并通过涉及非专业人士对风险沟通的需求和愿望的社会实证研究提供信息。
