Rusu Iulia, Popa-Fotea Nicoleta-Monica, Stanculescu Mihaela Octavia, Rusu Diana, Dumitru Alexandra, Scafa-Udriste Alexandru, Udrea Oana-Maria, Micheu Miruna Mihaela
Department of Cardiology, Clinical Emergency Hospital of Bucharest, 014461 Bucharest, Romania.
Department of Cardiology, "Carol Davila" University of Medicine and Pharmacy, 050474 Bucharest, Romania.
Medicina (Kaunas). 2021 Oct 31;57(11):1180. doi: 10.3390/medicina57111180.
: biomarker-based studies are the cornerstone of precision medicine, providing key data for tailored medical care. Enrollment of the planned number of patients is a critical determinant of a successful clinical trial. Moreover, for inclusive medical care, patients from different socio-demographic backgrounds must be recruited. Still, a significant number of trials fail to reach these prerequisites. Designing the informed consent forms based on the patients' feedback could optimize accrual. We aimed to explore the attitudes of patients from a Romanian tertiary cardiology center towards participation in biomarker-based clinical trials. : three hundred forty inpatients were interviewed based on a semi-structured questionnaire which included four sections: demographics, personal medical history, attitudes and trust. : Roughly, 62.5% of the respondents were interested in enrolling, while altruistic reasons were the most frequently expressed. Clear exposure of the possible risks was most valued (37.78%), followed by the possibility of directly communicating with the research team (23.78%). The most frequently chosen answer by acutely ill patients was improvement of their health, whereas chronically ill individuals indicated the possibility of withdrawal without affecting the quality of medical care. Importantly, the participation rate could be improved if the invitation to enrollment were made by both the current physician and the study coordinator ( = 0.0001). The level of trust in researchers was high in more than 50% of the respondents, and was correlated with therapeutic compliance and with the desire to join a biomarker study. the information gained will facilitate a tailored approach to patient enrollment in future biomarker-based studies in our clinic.
基于生物标志物的研究是精准医学的基石，为个性化医疗提供关键数据。招募计划数量的患者是临床试验成功的关键决定因素。此外，为了提供全面的医疗服务，必须招募来自不同社会人口背景的患者。然而，仍有大量试验未能达到这些先决条件。根据患者反馈设计知情同意书可以优化入组情况。我们旨在探讨罗马尼亚一家三级心脏病中心的患者对参与基于生物标志物的临床试验的态度。对340名住院患者进行了基于半结构化问卷的访谈，问卷包括四个部分：人口统计学、个人病史、态度和信任。大致而言，62.5%的受访者有兴趣入组，其中利他主义原因是最常提及的。明确告知可能的风险最受重视（37.78%），其次是与研究团队直接沟通的可能性（23.78%）。急性病患者最常选择的答案是改善健康状况，而慢性病患者则表示有可能退出而不影响医疗质量。重要的是，如果由现任医生和研究协调员共同发出入组邀请，参与率可能会提高（P = 0.0001）。超过50%的受访者对研究人员的信任度较高，且信任度与治疗依从性以及参与生物标志物研究的意愿相关。所获得的信息将有助于在我们诊所未来基于生物标志物的研究中采用个性化的患者招募方法。
