Genre Dominique, Protière Christel, Macquart-Moulin Geneviève, Maraninchi Dominique
Institut Paoli-Calmettes, 232, boulevard de Sainte-Marguerite, BP 156, 13273 Marseille, France.
Bull Cancer. 2003 Jul;90(7):656-62.
The purpose of this study was to evaluate patients' opinion on the content of an educational booklet (EB) on the objectives of the biomedical research in oncology, and, on the respect of their rights in case of participation to a clinical trial (CT). One hundred and twenty-nine patients treated for cancer at the Institut Paoli-Calmettes (Marseilles, France) and eligible for a CT were included in the study. They received the EB with the information letter and the informed consent sheet related to the CT. After reading, patients completed a survey questionnaire (10 items). About 84% of them stated that the EB content was comprehensible by the majority of patients. However, 18.2% required more information on the different phases of CTs and 39.4% more information on their own treatments. Furthermore, 41.4% were not/not entirely assured that they would receive all the information in case of participation to a CT and about 23% that their rights would be respected. Only 9.6% of patients knew the existence of the local ethical committees (CCPPRB); its intervention (information provided by the EB) was not considered as reassuring by 28.6% of patients. This study has important implications for patients eligible for CTs.
本研究的目的是评估患者对一本关于肿瘤生物医学研究目标的教育手册(EB)内容的看法,以及对他们参与临床试验(CT)时自身权利的尊重情况。129名在法国马赛保利 - 卡尔梅特研究所接受癌症治疗且符合CT条件的患者被纳入研究。他们收到了与CT相关的EB、信息信函和知情同意书。阅读后,患者完成了一份调查问卷(10项)。约84%的患者表示EB内容大多数患者都能理解。然而,18.2%的患者需要更多关于CT不同阶段的信息,39.4%的患者需要更多关于自身治疗的信息。此外,41.4%的患者不确定/不完全确定参与CT时会收到所有信息,约23%的患者不确定其权利会得到尊重。只有9.6%的患者知道当地伦理委员会(CCPPRB)的存在;28.6%的患者认为EB提供的关于该委员会干预的信息不能令人安心。这项研究对符合CT条件的患者具有重要意义。