具有不同癌症诊断的临床试验参与者的知情同意书。
Informed Consent among Clinical Trial Participants with Different Cancer Diagnoses.
发表日期:2023 Nov 03
作者:
Connie M Ulrich, Sarah J Ratcliffe, Camille J Hochheimer, Qiuping Zhou, Liming Huang, Thomas Gordon, Kathleen Knafl, Therese Richmond, Marilyn M Schapira, Victoria Miller, Jun J Mao, Mary Naylor, Christine Grady
来源:
MEDICINE & SCIENCE IN SPORTS & EXERCISE
摘要:
知情同意对于道德、严谨的研究至关重要,对于癌症试验中的招募和保留也很重要。检查癌症临床试验 (CCT) 参与者对知情同意过程的看法以及不同癌症类型的看法差异。来自混合的横断面调查在国家癌症研究所指定的东北综合癌症中心进行方法研究。开放式和强制选择项目涉及:(1) 登记和知情同意经历;(2) 决策过程,包括风险效益评估。资格:患有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 (N = 334)。对同意过程和提供的信息感到满意的百分比;评估参与者对风险/收益的看法。多变量逻辑回归或序数回归检查了癌症类型的差异。大多数患者参与者对同意过程感到充分知情(总体上超过 90% 且按癌症类型)。大多数人 (87.4%) 表示同意书提供了他们想要的所有信息,但近一半 (44.8%) 表示他们稍微仔细或不太仔细地阅读了该表格。超过一半 (57.9%) 表示,与研究人员交谈(即同意过程)比阅读同意书 (2.1%) 对参与决策的影响更大。三分之一 (31.1%) 非常确定在知情同意程序之前参加研究(几乎一半的肺癌患者这样做了——47.1%)。大多数患者在同意之前都会亲自评估风险和益处。然而,对医生的信任在参加 CCT 的决定中发挥了重要作用。癌症患者不太依赖知情同意过程的书面特征,而是依赖从研究人员及其自己的医生获得的信息。研究应侧重于支持转诊医生、研究人员和其他人知情同意的信息和沟通策略,以改善患者的风险效益评估和决策。
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 (N = 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.