PDF(Pubmed)
Abstract：
BACKGROUND: Clinical trial participation for patients with non-curative cancer is unlikely to present personal clinical benefit, which raises the bar for informed consent. Previous work demonstrates that decisions by patients in this setting are made within a \'trusting relationship\' with healthcare professionals. The current study aimed to further illuminate the nuances of this relationship from both the patients\' and healthcare professionals\' perspectives.
METHODS: Face-to-face interviews using a grounded theory approach were conducted at a regional Cancer Centre in the United Kingdom. Interviews were performed with 34 participants (patients with non-curative cancer, number (n) = 16; healthcare professionals involved in the consent process, n = 18). Data analysis was performed after each interview using open, selective, and theoretical coding.
RESULTS: The \'Trusting relationship\' with healthcare professionals underpinned patient motivation to participate, with many patients \'feeling lucky\' and articulating an unrealistic hope that a clinical trial could provide a cure. Patients adopted the attitude of \'What the doctor thinks is best\' and placed significant trust in healthcare professionals, focusing on mainly positive aspects of the information provided. Healthcare professionals recognised that trial information was not received neutrally by patients, with some expressing concerns that patients would consent to \'please\' them. This raises the question: Within the trusting relationship between patients and healthcare professionals, \'Is it possible to provide balanced information?\'. The theoretical model identified in this study is central to understanding how the trusting professional-patient relationship influences the decision-making process.
CONCLUSIONS: The significant trust placed on healthcare professionals by patients presented an obstacle to delivering balanced trial information, with patients sometimes participating to please the \'experts\'. In this high-stakes scenario, it may be pertinent to consider strategies, such as separation of the clinician-researcher roles and enabling patients to articulate their care priorities and preferences within the informed consent process. Further research is needed to expand on these ethical conundrums and ensure patient choice and autonomy in trial participation are prioritised, particularly when the patient\'s life is limited.
METHODS: Face-to-face interviews using a grounded theory approach were conducted at a regional Cancer Centre in the United Kingdom. Interviews were performed with 34 participants (patients with non-curative cancer, number (n) = 16; healthcare professionals involved in the consent process, n = 18). Data analysis was performed after each interview using open, selective, and theoretical coding.
RESULTS: The \'Trusting relationship\' with healthcare professionals underpinned patient motivation to participate, with many patients \'feeling lucky\' and articulating an unrealistic hope that a clinical trial could provide a cure. Patients adopted the attitude of \'What the doctor thinks is best\' and placed significant trust in healthcare professionals, focusing on mainly positive aspects of the information provided. Healthcare professionals recognised that trial information was not received neutrally by patients, with some expressing concerns that patients would consent to \'please\' them. This raises the question: Within the trusting relationship between patients and healthcare professionals, \'Is it possible to provide balanced information?\'. The theoretical model identified in this study is central to understanding how the trusting professional-patient relationship influences the decision-making process.
CONCLUSIONS: The significant trust placed on healthcare professionals by patients presented an obstacle to delivering balanced trial information, with patients sometimes participating to please the \'experts\'. In this high-stakes scenario, it may be pertinent to consider strategies, such as separation of the clinician-researcher roles and enabling patients to articulate their care priorities and preferences within the informed consent process. Further research is needed to expand on these ethical conundrums and ensure patient choice and autonomy in trial participation are prioritised, particularly when the patient\'s life is limited.
摘要：
背景：参与非治愈性癌症患者的临床试验不太可能带来个人临床益处，这提高了知情同意的门槛。先前的工作表明，在这种情况下，患者的决定是在与医疗保健专业人员的“信任关系”中做出的。当前的研究旨在从患者和医疗保健专业人员的角度进一步阐明这种关系的细微差别。
方法：在英国的一个地区癌症中心进行了使用扎根理论方法的面对面访谈。对34名参与者进行了访谈(非治愈性癌症患者，数量(n)=16；参与同意过程的医疗保健专业人员，n=18)。每次访谈后使用开放式进行数据分析，选择性,和理论编码。
结果：与医疗保健专业人员的“信任关系”支撑了患者参与的动机，许多患者“感到幸运”，并表达了一种不切实际的希望，即临床试验可以提供治愈。患者采取了“医生认为最好的”的态度，并对医疗保健专业人员给予了极大的信任，主要关注所提供信息的积极方面。医疗保健专业人员认识到患者并没有中立地收到试验信息，一些人表示担心患者会同意“请他们”。这提出了一个问题：在患者和医疗保健专业人员之间的信任关系中，\'是否有可能提供平衡的信息？\'。本研究中确定的理论模型对于理解信任的专业患者关系如何影响决策过程至关重要。
结论：患者对医疗保健专业人员的信任阻碍了提供平衡试验信息，患者有时会参与取悦“专家”。在这种高风险的情况下，考虑策略可能是恰当的，例如分离临床医生和研究人员的角色，并使患者能够在知情同意过程中阐明他们的护理优先事项和偏好。需要进一步的研究来扩大这些伦理难题，并确保优先考虑患者的选择和参与试验的自主权。特别是当病人的生命是有限的。
方法：在英国的一个地区癌症中心进行了使用扎根理论方法的面对面访谈。对34名参与者进行了访谈(非治愈性癌症患者，数量(n)=16；参与同意过程的医疗保健专业人员，n=18)。每次访谈后使用开放式进行数据分析，选择性,和理论编码。
结果：与医疗保健专业人员的“信任关系”支撑了患者参与的动机，许多患者“感到幸运”，并表达了一种不切实际的希望，即临床试验可以提供治愈。患者采取了“医生认为最好的”的态度，并对医疗保健专业人员给予了极大的信任，主要关注所提供信息的积极方面。医疗保健专业人员认识到患者并没有中立地收到试验信息，一些人表示担心患者会同意“请他们”。这提出了一个问题：在患者和医疗保健专业人员之间的信任关系中，\'是否有可能提供平衡的信息？\'。本研究中确定的理论模型对于理解信任的专业患者关系如何影响决策过程至关重要。
结论：患者对医疗保健专业人员的信任阻碍了提供平衡试验信息，患者有时会参与取悦“专家”。在这种高风险的情况下，考虑策略可能是恰当的，例如分离临床医生和研究人员的角色，并使患者能够在知情同意过程中阐明他们的护理优先事项和偏好。需要进一步的研究来扩大这些伦理难题，并确保优先考虑患者的选择和参与试验的自主权。特别是当病人的生命是有限的。
