Constantin Dan Alexandru, Cioriceanu Ionut Horia, Rogozea Liliana Marcela
Basic, Preventive and Clinical Sciences Department, Transilvania University, Brasov, Romania; and.
Clinical Hospital of Psychiatry and Neurology, Brasov, Romania.
Am J Ther. 2025;32(3):e269-e273. doi: 10.1097/MJT.0000000000001974.
Medical providers started to consider Transcranial Magnetic Stimulation (TMS) for the noninvasive treatment of different psychiatric and neurology disorders as this technique become more popular in recent years. Many medical providers are trying to reach patients using direct-to-consumer (DTC) promotion of approved and off-label indications. Most of the time, these ads exaggerate benefits, create unrealistic expectations, and often exaggerate benefits. The procedure is expensive, and many insurance companies do not reimburse it; some patients may not have access to it. The study examines the ethical issues related to DTC promotion of TMS. It proposes clear ethical guidelines for transparency, equity, informed consent, data privacy, and regulation. These measures aim to encourage responsible marketing practices while ensuring the welfare of patients is protected.
The best practice guide does not include patient autonomy and transparency in DTC advertising for TMS. Examining specialist publications, regulations, and ethical considerations ensures the structuring of ethical guidelines and the responsible promotion of DTC's medical marketing.
A comprehensive literature review was conducted in the PubMed, PsycINFO, BMC, and Google Scholar databases from their inception to 2025 using keywords related to TMS, regulatory compliance, DTC, marketing ethics, and patient impact. Studies that contained information regarding misinformation risks, patients' decision making, ethical guidelines in medical advertising, and DTC promotion were analyzed.
The analysis of these studies identified key ethical concerns that include insufficient regulatory oversight, misleading claims that exaggerate benefits and downplay risks, privacy risks in targeted advertising, lack of standardized informed consent procedures, and limited access due to high treatment costs. Our study proposes ethical guidelines based on the ethical concerns identified that medical providers can use to ensure that patients have equitable access, transparency, and regulatory accountability.
Implementing our guidelines will ensure that patients receive unbiased information, high-quality care, and equitable access, reinforcing TMS's ethical foundation in clinical practice.
近年来，随着经颅磁刺激（TMS）技术越来越普及，医疗服务提供者开始考虑将其用于不同精神疾病和神经疾病的非侵入性治疗。许多医疗服务提供者试图通过直接面向消费者（DTC）推广已获批和未获批的适应症来接触患者。大多数情况下，这些广告夸大了益处，制造了不切实际的期望，且常常夸大疗效。该治疗程序费用高昂，许多保险公司不予报销；一些患者可能无法接受该治疗。本研究探讨了与TMS的DTC推广相关的伦理问题。它提出了关于透明度、公平性、知情同意、数据隐私和监管的明确伦理准则。这些措施旨在鼓励负责任的营销行为，同时确保患者的福利得到保护。
最佳实践指南未涵盖TMS的DTC广告中的患者自主性和透明度。审视专业出版物、法规和伦理考量因素可确保伦理准则的构建以及DTC医疗营销的负责任推广。
使用与TMS、法规合规性、DTC、营销伦理和患者影响相关的关键词，在PubMed、PsycINFO、BMC和谷歌学术数据库中从其创建至2025年进行了全面的文献综述。对包含有关错误信息风险、患者决策、医疗广告伦理准则和DTC推广信息的研究进行了分析。
对这些研究的分析确定了关键的伦理问题，包括监管监督不足、夸大益处和淡化风险的误导性声明、定向广告中的隐私风险、缺乏标准化的知情同意程序以及由于治疗费用高昂导致的获取受限。我们的研究基于所确定的伦理问题提出了伦理准则，医疗服务提供者可利用这些准则确保患者获得公平的机会、透明度和监管问责制。
实施我们的指南将确保患者获得无偏见的信息、高质量的护理和平等的机会，从而加强TMS在临床实践中的伦理基础。
