University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.
University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
AJOB Empir Bioeth. 2024 Jul-Sep;15(3):165-177. doi: 10.1080/23294515.2023.2262992. Epub 2023 Nov 3.
Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.
To examine cancer clinical trial (CCT) participants' perceptions of informed consent processes and variations in perceptions by cancer type.
Cross-sectional survey from mixed-methods study at National Cancer Institute-designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer ( = 334).
Percentages satisfied with consent process and information provided; and assessing participation's perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.
Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did-47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT.
Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making.
知情同意是伦理、严谨研究的基础，对于癌症试验的招募和保留非常重要。
研究癌症临床试验（CCT）参与者对知情同意过程的看法，以及不同癌症类型对看法的差异。
设计、设置和参与者：这是一项来自美国国立癌症研究所指定的东北地区综合癌症中心的混合方法研究的横断面调查。开放式和强制性项目包括：（1）入组和知情同意经历；（2）决策过程，包括风险-效益评估。合格标准：胃肠道或泌尿生殖系统、血液淋巴系统恶性肿瘤、肺癌、乳腺癌或妇科癌症的 CCT 参与者（ = 334）。
对同意过程和提供信息的满意度百分比；评估参与者对风险/收益的看法。多变量逻辑或有序回归分析了不同癌症类型的差异。
大多数患者参与者对同意过程感到信息充分（总体超过 90%，按癌症类型划分也是如此），大多数（87.4%）报告说同意书提供了他们想要的所有信息，尽管近一半（44.8%）表示他们只是略读或较少阅读同意书。超过一半（57.9%）的人表示，与研究人员交谈（即同意过程）对参与决策的影响大于阅读同意书（2.1%）。三分之一（31.1%）的人在知情同意过程之前非常确定会参加研究（几乎一半的肺癌患者都很确定-47.1%）。大多数患者在同意之前亲自评估风险和收益。然而，对医生的信任在决定参加 CCT 方面起着重要作用。
癌症患者对知情同意过程中的书面特征的依赖程度低于从研究人员和他们自己的医生那里获得的信息。研究应侧重于信息和沟通策略，以支持来自转诊医生、研究人员和其他人的知情同意，以改善患者的风险-效益评估和决策。
