Brandberg Yvonne, Akre Olof, Bergenmar Mia
Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
Department of Urology, Karolinska University Hospital, Stockholm, Sweden; Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
Acta Oncol. 2025 Jan 28;64:167-172. doi: 10.2340/1651-226X.2025.42218.
Informed consent from trial participants is mandatory. In a randomized clinical trial, we investigated (1) differences in knowledge and understanding of trial information between patients who participated and those who refrained, (2) differences in perceptions of information, and (3) differences in satisfaction with the information.
After the decision about participation in the randomized study, 'Surgery versus radiotherapy for locally advanced prostate cancer' (SPCG-15), patients were sent questionnaires ('Quality of Informed Consent', EORTC QLQ-INFO25). Patients were categorized in 'Non-participants' or 'Participants'.
A total of 80 patients (80%) responded, 68% of non-participants and 95% of participants. Between-group differences in knowledge were found for duration of the trial, insurances in the trial, and if the trial intervention had been proven to be superior. Patients had high levels of knowledge (> 80%) regarding the trial aim, that participation implied research, the right to decline, that future patients benefit from research and, of the randomization procedure. Less than 50% responded correctly concerning risks associated with the trial, the unproven nature of the trial and issues about insurances. Non-participants scored lower concerning duration of trial participation, confidentiality of medical records, treatments and procedures in the trial, and experimental nature of treatments. There were no differences regarding satisfaction with information. Non-participants and participants did not differ in satisfaction, or in knowledge and understanding of most aspects of the information. Knowledge levels were low in some areas, and thus, it seems to be room for improvement to fulfill the requirements of informed consent.
试验参与者的知情同意是强制性的。在一项随机临床试验中，我们调查了：（1）参与试验的患者与未参与试验的患者在试验信息的知晓和理解方面的差异；（2）对信息的认知差异；（3）对信息的满意度差异。
在决定参与“局部晚期前列腺癌的手术与放疗对比”（SPCG - 15）这项随机研究后，患者收到了问卷（“知情同意质量”，欧洲癌症研究与治疗组织QLQ - INFO25）。患者被分为“非参与者”或“参与者”。
共有80名患者（80%）做出回应，非参与者的回应率为68%，参与者的回应率为95%。在试验持续时间、试验中的保险情况以及试验干预是否已被证明更优这些方面，发现了组间知识差异。患者对试验目的、参与意味着研究、拒绝的权利、未来患者将从研究中获益以及随机化程序等方面的知晓程度较高（> 80%）。对于与试验相关的风险、试验的未经验证性质以及保险问题，正确回答的比例不到50%。非参与者在试验参与持续时间、病历保密性、试验中的治疗和程序以及治疗的实验性质方面得分较低。在对信息的满意度方面没有差异。非参与者和参与者在满意度方面没有差异，在信息的大多数方面的知识和理解上也没有差异。某些领域的知识水平较低，因此，要满足知情同意的要求似乎还有改进空间。
