Centre for Health Studies and Research. Universidade de Coimbra. Coimbra. Portugal.
Acta Med Port. 2024 Sep 2;37(9):601-608. doi: 10.20344/amp.20570. Epub 2024 Jul 19.
Some studies show that participants do not always fully understand the informed consent form (ICF), which is one of the reasons for dropouts. This study aimed to adapt the Quality of Informed Consent (QuIC) questionnaire into a valid instrument to be applied to the Portuguese population and to measure its reliability and validity in the Portuguese population, by applying it to a sample of participants in controlled trials.
The QuIC questionnaire was developed to assess the quality of informed consent in clinical trials and consists of two parts, addressing both the objective (part A) and the subjective (part B) understanding. After being translated and validated into Portuguese, it was implemented in 100 cardiac participants of phase III clinical trials in a University Hospital Center.
The QuIC-PT questionnaire showed excellent stability over time and good validity. All patients evaluated their participation and their health positively and recognized the main purpose of the clinical trial. Almost all participants understood their role in helping future patients and the purpose of the trial and realized that, by signing the ICF, they were participating in a clinical trial. However, none of them knew that their experimental treatment was not proven to be the best alternative for their condition.
The QuIC-PT questionnaire seems to be a valid and useful instrument to evaluate the participants' understanding of the ICF. In this study, we found that some concepts, like 'study protocol' or 'randomization', were not well understood by participants when signing the ICF, especially by participants with lower education levels. They also believed that the experimental intervention would solve their health condition. Greater awareness about the importance of the informed consent process and ICF is necessary so that participants can fully understand the protocol, especially the risks involved, and their rights as participants.
一些研究表明，参与者并不总是完全理解知情同意书（ICF），这也是导致脱落的原因之一。本研究旨在将《知情同意质量问卷》（QuIC）改编为一种适用于葡萄牙人群的有效工具，并在葡萄牙人群中应用该问卷测量其信度和效度，将其应用于临床试验的参与者样本中。
QuIC 问卷用于评估临床试验中的知情同意质量，它由两部分组成，分别针对客观（A 部分）和主观（B 部分）理解。在翻译成葡萄牙语并经过验证后，它被应用于一所大学医院中心的 100 名 III 期临床试验的心脏病患者中。
QuIC-PT 问卷在时间上表现出极好的稳定性和良好的有效性。所有患者对自己的参与和健康状况评价都很积极，认识到临床试验的主要目的。几乎所有的参与者都理解他们在帮助未来患者和临床试验中的作用，并意识到通过签署 ICF，他们正在参与临床试验。然而，他们都不知道他们的实验性治疗方法尚未被证明是他们病情的最佳选择。
QuIC-PT 问卷似乎是一种评估参与者对 ICF 理解的有效且有用的工具。在这项研究中，我们发现一些概念，如“研究方案”或“随机化”，在参与者签署 ICF 时理解得并不透彻，尤其是教育程度较低的参与者。他们还认为实验性干预措施将解决他们的健康状况。有必要提高人们对知情同意过程和 ICF 的重要性的认识，以便参与者能够充分理解方案，特别是涉及的风险，以及他们作为参与者的权利。
