Division of Anesthesia, Department of Acute Care Medicine, Geneva University Hospitals and Faculty of Medicine University of Geneva, Rue Perret-Gentil 4, Geneva, Switzerland.
Clinical Research Center and Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva, University Hospitals of Geneva, Geneva, Switzerland.
BMC Med Res Methodol. 2020 Mar 19;20(1):67. doi: 10.1186/s12874-020-00949-5.
Clinical trials are essential to improve knowledge of anesthesia and perioperative medicine. Unfortunately, many studies face participant-recruitment issues and fail to include the planned number of participants. There is limited published data about how information delivered about the study or how the experiences and attitudes of prospective participants influence willingness to participate. The purpose of this study was to identify such factors in the domain of anesthesia care.
We performed a cross-sectional study at the Geneva University Hospitals (Switzerland) using a newly developed paper-based questionnaire on a sample of outpatients with a recent hospital stay and that were aged over 18 years, confident speaking French and free of any disease that could hinder participation. We explored patient personal factors, such as current health, past exposure to clinical research and anesthesia, as well as study-related factors. Six different scenarios for clinical studies were assessed. Linear regression modeling was used to assess the specific association between personal and study-related factors and willingness to participate in the studies described in the scenarios.
On the 1318 eligible patients, 398 fully completed the questionnaire. Multivariable adjustment revealed that factors related to altruistic values (β, 9.6, 95% CI 3.4 to 15.7, P = 0.002), to the feeling of benefiting from a more effective treatment (β, 4.7, 95% CI 0.2 to 9.2, P = 0.041) and to the absence of fear about double blinding (β, 5.7, 95% CI 1.3 to 10.2, P = 0.012) were positively associated with willingness to participate. Conversely, concerns about drug-related adverse effects (β, - 11.7, 95% CI - 16.9 to - 6.5, P < 0.001) and anxiety about surgery (β, - 5.2, 95% CI - 10.0 to - 0.5, P = 0.031) were negatively associated with willingness to participate.
Our study was based on vignettes illustrating typical scenarios of clinical trials performed in anesthesia. However, their similarities with real studies still remains hypothetical and our results should be interpreted as such. Nevertheless, the study contributes to improve understanding of factors that may act as incentives or barriers to participation in clinical trials. It highlights the importance of providing appropriate information and reassurance to patients.
临床试验对于提高麻醉学和围手术期医学知识至关重要。然而，许多研究面临参与者招募问题，无法纳入计划的参与者数量。关于研究中提供的信息以及潜在参与者的经验和态度如何影响参与意愿，相关数据有限。本研究旨在确定麻醉护理领域的这些因素。
我们在日内瓦大学医院（瑞士）进行了一项横断面研究，使用新开发的纸质问卷对最近住院且年龄在 18 岁以上、能自信讲法语且无任何可能阻碍参与的疾病的门诊患者进行抽样调查。我们探讨了患者的个人因素，如当前健康状况、既往接触临床研究和麻醉的情况，以及与研究相关的因素。评估了六种不同的临床研究场景。使用线性回归模型评估个人因素和研究相关因素与对研究场景中描述的研究的参与意愿之间的特定关联。
在 1318 名符合条件的患者中，有 398 名患者完整填写了问卷。多变量调整显示，与利他价值观相关的因素（β，9.6，95%置信区间 3.4 至 15.7，P=0.002）、感觉从更有效的治疗中受益（β，4.7，95%置信区间 0.2 至 9.2，P=0.041）和对双盲无恐惧（β，5.7，95%置信区间 1.3 至 10.2，P=0.012）与参与意愿呈正相关。相反，对药物相关不良反应的担忧（β，-11.7，95%置信区间-16.9 至-6.5，P<0.001）和对手术的焦虑（β，-5.2，95%置信区间-10.0 至-0.5，P=0.031）与参与意愿呈负相关。
我们的研究基于描述麻醉学中进行的临床试验典型场景的案例。然而，它们与真实研究的相似性仍然是假设的，我们的结果应以此为依据进行解释。尽管如此，该研究有助于增进对可能成为参与临床试验的激励因素或障碍的因素的理解。它强调了向患者提供适当信息和保证的重要性。
