Mihaela Micheu Miruna, Udrea Oana-Maria, Octavia Popa Mihaela, Rusu Iulia, Gheorghe-Fronea Oana, Scafa-Udriste Alexandru, Dorobantu Maria
Department of Cardiology, Clinical Emergency Hospital of Bucharest, Bucharest, Romania.
Department of Psychology, "Grigore Alexandrescu" Clinical Hospital of Bucharest, Bucharest, Romania.
J Med Life. 2018 Oct-Dec;11(4):320-327. doi: 10.25122/jml-2018-0072.
One of the challenges faced when conducting a clinical trial is the recruitment of the proposed number of participants. Accordingly, identifying barriers to patients' enrollment and developing effective strategies to overcome them is mandatory. One of the main strategies employed to improve participation rate consists of designing the informed consent forms based on patients' feedback. This survey aims to explore the attitude of patients admitted in a Romanian tertiary cardiology center to take part in biomarker-based clinical trials. This is a descriptive, prospective and longitudinal single-center study. Participants will be recruited until the planned sample size will be reached (n=333). The patients will be interviewed based on a semi-structured questionnaire which includes four sections: demographics (7 items), personal medical history (7 items), attitudes (9 items) and trust (4 items). Descriptive statistics will be used to illustrate patients' demographics, medical history, attitudes toward biomarker-based clinical trials and trust in medical researchers. Logistic regression models will be employed to assess relations between patients' attitudes, trust, and different socio-demographic variables. Data analysis will offer answers to key questions addressed by this survey: What amount of and in what form should information be disclosed? Who should make the invitation to participate? The information gained will facilitate tailoring informed consent forms to suit the needs of patients with various demographic, social and educational backgrounds.
开展临床试验时面临的挑战之一是招募到计划数量的参与者。因此，识别患者入组的障碍并制定有效的克服策略是必不可少的。提高参与率的主要策略之一是根据患者反馈设计知情同意书。本调查旨在探讨罗马尼亚一家三级心脏病中心收治的患者参与基于生物标志物的临床试验的态度。这是一项描述性、前瞻性和纵向的单中心研究。将持续招募参与者，直至达到计划样本量（n = 333）。将根据一份半结构化问卷对患者进行访谈，该问卷包括四个部分：人口统计学（7项）、个人病史（7项）、态度（9项）和信任（4项）。描述性统计将用于说明患者的人口统计学特征、病史、对基于生物标志物的临床试验的态度以及对医学研究人员的信任。将采用逻辑回归模型评估患者的态度、信任与不同社会人口学变量之间的关系。数据分析将为本次调查提出的关键问题提供答案：应披露多少信息以及以何种形式披露？应由谁发出参与邀请？所获得的信息将有助于量身定制知情同意书，以满足不同人口统计学、社会和教育背景患者的需求。
