Department of Cardiology, University Hospital Jean Minjoz, EA3920, University of Franche-Comté, 3 Boulevard Fleming, 25000, Besançon, France.
Unité de Soutien Méthodologique à la Recherche - Délégation à la Recherche Clinique et à l'Innovation, François Mitterand University Hospital, Dijon, France.
Aging Clin Exp Res. 2020 Jan;32(1):133-140. doi: 10.1007/s40520-019-01172-z. Epub 2019 Mar 21.
Clinical research is an essential step in the successful translation of knowledge from basic research into concrete clinical applications, yet many people are reluctant to provide consent when actually approached to actively participate in clinical trials.
We investigated the factors that influence older patient's (≥ 65 years) decisions to accept or refuse to participate in a prospective randomized clinical trial in secondary prevention after acute coronary syndrome.
Qualitative approach based on individual semi-structured interviews with patients who were approached for consent to participate in a currently ongoing clinical trial was adopted. Patients were interviewed after the consent process (8 accepted; 8 refused the trial). Interviews were analysed using grounded theory methodology.
Sixteen patients aged ≥ 65 years participated. The main concept to emerge from these interviews is that the actual trial itself does not appear to be the primary determinant in the decision to participate in clinical research. Rather, patients' decisions to participate (or not) in clinical research appear to be primarily determined by their capacity to deal with the current health event that has disrupted their life, and by their available mental and physical resources.
Older patients display varying levels of engagement in their own health, ranging from low engagement with high trust in the medical profession, to high engagement mirrored by distrust of the medical profession. Structural conditions, such as personal benefit from trial participation, or logistic barriers to participation, seem to affect both accepters and refusers in the same manner.
临床研究是将基础研究知识成功转化为具体临床应用的重要步骤，但许多人在实际被邀请积极参与临床试验时，不愿意同意参与。
我们研究了影响老年患者（≥65 岁）接受或拒绝参与急性冠状动脉综合征后二级预防前瞻性随机临床试验的因素。
采用基于个体半结构化访谈的定性方法，对正在进行临床试验的患者进行同意参与的邀请。在同意过程后对患者进行访谈（8 名接受；8 名拒绝参加试验）。使用扎根理论方法对访谈进行分析。
16 名≥65 岁的患者参与了研究。这些访谈中出现的主要概念是，实际的试验本身似乎不是参与临床研究决策的主要决定因素。相反，患者参与（或不参与）临床研究的决定似乎主要取决于他们应对扰乱其生活的当前健康事件的能力，以及他们可用的心理和身体资源。
老年患者在参与自身健康方面表现出不同程度的参与度，从对医疗行业高度信任的低度参与，到对医疗行业不信任的高度参与。结构条件，如参与试验的个人利益，或参与的后勤障碍，似乎以相同的方式影响接受者和拒绝者。
