Perrone F, De Placido S, Giusti C, Gallo C
Centro Elaborazione Dati Clinici del Mezzogiorno, CNR-ACRO.
Epidemiol Prev. 1995 Sep;19(64):282-90.
To compare two strategies of consent requirement (classical informed consent and randomised consent according to Zelen), the Clinical Data Elaboration Centre of South Italy, within the special project Clinical Application of Oncological Research of the National Research Council of Italy (CNR-ACRO) invited healthy people visiting the 7th edition of the scientific exhibition "Futuro Remoto" to simulate of being ill and receiving the offer of entering a clinical trial. Within informed consent strategy patients are asked to agree to the randomisation process, while, in the randomised consent, randomised treatment assignment is performed before consent requirement and patients should agree directly to the assigned therapy. Major aims of the study were (a) to compare the strategies in terms of refusal rate to a hypothetical clinical trial, and (b) to estimate whether severity of prognosis affected subjects' decision. 3,217 visiting people participated to the simulation; they were prevalently young, males and with a high level of school education. The study was performed in two different scenarios. In the first one, with one choice option, subject refusing consent could receive standard therapy only; refusal rate was 16% after informed consent and 13.4% after randomised consent (for experimental therapy). In the other scenario, with two choice options, subjects refusing consent could choose the preferred therapy; refusal rate was 20.6% after informed consent, 48.1% after randomised consent (for standard therapy) and 13.4% after randomised consent (for experimental therapy).(ABSTRACT TRUNCATED AT 250 WORDS)
为比较两种同意要求策略（传统知情同意和根据泽伦方法的随机同意），意大利南部临床数据处理中心在意大利国家研究委员会（CNR-ACRO）的肿瘤研究临床应用特别项目中，邀请参观第七届“遥远未来”科学展览的健康人模拟患病并接受参与一项临床试验的邀请。在知情同意策略中，要求患者同意随机分组过程，而在随机同意中，随机治疗分配在同意要求之前进行，患者应直接同意分配的治疗方案。该研究的主要目的是：（a）比较两种策略在对假设临床试验的拒绝率方面的差异；（b）评估预后严重程度是否影响受试者的决定。3217名参观者参与了模拟；他们大多为年轻人、男性且受教育程度高。该研究在两种不同场景下进行。在第一种场景中，只有一个选择选项，拒绝同意的受试者只能接受标准治疗；知情同意后的拒绝率为16%，随机同意（针对实验性治疗）后的拒绝率为13.4%。在另一种场景中，有两个选择选项，拒绝同意的受试者可以选择首选治疗；知情同意后的拒绝率为20.6%，随机同意（针对标准治疗）后的拒绝率为48.1%，随机同意（针对实验性治疗）后的拒绝率为13.4%。（摘要截选至250字）
