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Gatekeeping in cancer clinical trials in Canada: The ethics of recruiting the “ideal” patient

机译:加拿大癌症临床试验中的术语:招聘“理想”患者的伦理

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Background Perspectives of clinical trial (CT) personnel on accrual to oncology CTs are relatively absent from the literature. This study explores CT personnel's experience recruiting patients to oncology CTs. Methods A qualitative study design was utilized. In‐depth, individual interviews with 12 oncology CT personnel were conducted, including six CT nurses and six physician‐investigators. Interviews were digitally recorded and transcribed verbatim. Data were subjected to thematic and ethical analysis to identify key concepts and themes. Results CT personnel reported considering two ethical commitments in CT recruitment: maintaining trial integrity and ensuring patient autonomy through obtaining informed consent. The process of gatekeeping emerged as a way to navigate these ethical commitments during CT accrual. Gatekeeping was influenced by: (a) perceptions of patients’ personal suitability for a trial, and (b) healthcare resources and infrastructure. CT personnel's discernment of personal suitability was influenced by patients’ cognitive and mental health status, language and cultural background, geographic location, family support, and disease status. Three structural factors impacted gatekeeping: complexity of CTs, consent process, and time limitations in the healthcare system. CT personnel experienced most factors as constraints to accrual and gaining patients’ informed consent. Conclusion CT personnel discussed navigating ethical challenges in CT recruitment by offering enrollment to specific patient populations, exacerbating other ethical tensions. Systems‐level strategies are needed to address barriers to ethical CT recruitment. Future research should investigate the role of policies and/or tools (eg, decision aids) to support patients and CT personnel's discussions about CT participation, promote more ethical recruitment, and potentially increase accrual.
机译:背景技术临床试验(CT)人员对肿瘤学诊断的观点相对不存在。本研究探讨了CT人员招募患者肿瘤学CTS的经验。方法采用定性研究设计。深入了解,对12个肿瘤学CT人员进行个人访谈,包括六名CT护士和六名医生调查人员。采访经过数字录制和翻译逐字。对数据进行专题和道德分析,以确定关键概念和主题。结果CT人员报告了CT招聘中的两个道德承诺:通过获得知情同意,维持审判完整性和确保患者自治。在CT应计中导航这些道德承诺的一种方式出现了纳门的过程。门徒受到影响:(a)患者对审判的个人适用性的看法,以及(b)医疗资源和基础设施。 CT人员对个人适用性的辨别性受到患者的认知和心理健康状况,语言和文化背景,地理位置,家庭支持和疾病状态的影响。三种结构因素受到守门社:医疗保健系统中CTS,同意过程和时间限制的复杂性。 CT人员经历了大多数因素,因为对应计和获得患者知情同意的限制。结论CT人员通过向特定患者群体提供注册,加剧其他道德紧张局势,讨论CT招生中的伦理挑战。需要系统级策略来应对道德CT招募的障碍。未来的研究应该调查政策和/或工具(例如,决策助剂)的作用,以支持患者和CT人员对CT参与的讨论,促进更多道德招聘,并可能增加应计。

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