Dept. of Gastroenterology, Leiden University Medical Centre, Leiden, The Netherlands.
Dept. of Internal Medicine, University of California Los Angeles (UCLA), Los Angeles, California, United States of America.
PLoS One. 2020 Nov 20;15(11):e0242066. doi: 10.1371/journal.pone.0242066. eCollection 2020.
Alongside a clinical and research setting, whole body magnetic resonance imaging (WB-MRI) is increasingly offered as a direct-to-consumer screening service. Data is needed on the clinical relevance of findings and associated psychological impact of such screening. Therefore, we conducted a prospective follow-up study to provide insight in the effectiveness and psychological impact of direct-to-consumer screening using both WB-MRI and cardiological examination.
The study population consisted of 3603 voluntary, primarily middle-aged participants who underwent commercial WB-MRI and cardiological screening at one of 6 study clinics in Germany or the Netherlands between July 2014 and March 2016. MRI investigation consisted of directed scans of the brain, neck, abdomen and pelvis. Cardiovascular examination included pulmonary function, resting electrocardiogram, transthoracic echocardiogram and a bicycle exercise stress test. Findings were assessed by experienced radiologists and cardiologists. In addition, participants were inquired about several (psychological) domains, including the expectations and consequences of the screening procedure. Out of 3603 individuals, 402 (11.2%) demonstrated abnormal MRI (n = 381) and/or cardiological findings (n = 79) for which they were advised to undergo further consultation <3 months in regular healthcare. In 59.1% of cases of abnormal MRI findings which were consulted, fully completed consultations were available in 87.1%. After consultation, 77.6% of initial MRI outcomes were adopted. In 40.9% of cases of abnormal MRI findings, recommendations for consultation were not adhered to during the study period. 71.1% of adopted MRI-findings required treatment or monitoring, including 19 malignancies. For abnormal cardiological findings, 70.9% of cases were consulted in regular healthcare. Of these, 91.1% had a completed follow-up procedure of which 72.5% of initial findings were adopted and 83.8% of these findings required treatment or monitoring. The most frequently reported psychological consequences of the screening procedure were getting reassurance (72.0%) and insight into one's own health status (83.0%). 5.0% reported to feel insecure about their health and 6.2% worried more about their health as a consequence of screening. Main limitations of the study were considered the telephonic follow-up of referred clients and the heterogeneity of screening equipment and assessment of radiologists and cardiologists.
Direct-to-consumer screening using whole-body MRI and cardiological testing is feasible and effective for the detection of clinically relevant and treatable abnormalities. Psychological harm was not frequently reported in study participants.
在临床和研究环境中，全身磁共振成像（WB-MRI）越来越多地作为直接面向消费者的筛查服务提供。需要了解这种筛查的发现的临床相关性和相关的心理影响。因此，我们进行了一项前瞻性随访研究，以提供使用 WB-MRI 和心脏病学检查进行直接面向消费者的筛查的有效性和心理影响的见解。
研究人群由 3603 名自愿参加的、主要为中年参与者组成，他们于 2014 年 7 月至 2016 年 3 月期间在德国或荷兰的 6 个研究诊所之一接受了商业性的 WB-MRI 和心脏病学筛查。MRI 检查包括对大脑、颈部、腹部和骨盆进行定向扫描。心血管检查包括肺功能、静息心电图、经胸超声心动图和自行车运动压力测试。由经验丰富的放射科医生和心脏病专家评估检查结果。此外，还询问了参与者多个（心理）领域的问题，包括筛查程序的期望和后果。在 3603 名个体中，有 402 名（11.2%）表现出异常的 MRI（n = 381）和/或心脏病学发现（n = 79），他们被建议在 3 个月内到常规医疗保健机构进行进一步咨询。在咨询的异常 MRI 结果中，87.1%的情况下可获得完全完成的咨询结果。咨询后，初始 MRI 结果的 77.6%得到采纳。在异常 MRI 结果的 40.9%情况下，在研究期间未遵循咨询建议。71.1%的异常 MRI 结果需要治疗或监测，包括 19 例恶性肿瘤。对于异常的心脏病学发现，有 70.9%的病例在常规医疗保健中进行了咨询。其中，91.1%的病例完成了随访程序，其中 72.5%的初始发现被采纳，83.8%的发现需要治疗或监测。该筛查程序最常报告的心理后果是获得安心（72.0%）和了解自己的健康状况（83.0%）。5.0%的人报告说对自己的健康感到不安，6.2%的人因为筛查而更担心自己的健康。该研究的主要局限性被认为是对转介客户的电话随访以及筛查设备和放射科医生和心脏病专家评估的异质性。
使用全身 MRI 和心脏病学检查进行直接面向消费者的筛查对于检测具有临床相关性和可治疗性的异常是可行且有效的。研究参与者并未经常报告心理伤害。
