Davison B Joyce, So Alan, Goldenberg S Larry, Berkowitz Jonathan, Gleave Martin E
Department of Urologic Sciences, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
BJU Int. 2008 Apr;101(8):982-7. doi: 10.1111/j.1464-410X.2007.07349.x. Epub 2007 Nov 13.
To identify factors that patients with prostate cancer believe to be important determinants in their decisions about future enrolment in clinical trials.
In all, 122 patients (within 5 years of a diagnosis of prostate cancer) who had never been asked to participate in a clinical trial were asked to complete a 30-item measure of 'Factors Influencing Participation' in clinical trials.
Factor analysis showed that variables influencing participation can be grouped into three areas: acceptability (e.g. recruitment process and altruistic beliefs); awareness (e.g. impact on quality of life, survivorship and randomization process); and accessibility (e.g. costs to patient, influence of family, age, time and need for extra tests). Awareness items were rated significantly more important by patients with T1 or T2 disease (P = 0.002). Patients who had not made a treatment decision also rated awareness (P = 0.05) and acceptability (P = 0.04) items higher. Patients with less than a university education identified access items as more important (P = 0.03). Helping future patients with prostate cancer, the impact of the study protocol on survival, being fully informed about the study, relationship with specialists, and impact of study on quality of life were identified as the five variables having the most influence on future enrolment.
Men rated items related to awareness and acceptability as being the most important determinants to future enrolment in a clinical trial. Knowledge about what these men believe is important for their future participation in a clinical trial will help researchers to design protocols that address the needs of targeted patient groups.
确定前列腺癌患者认为对其未来参与临床试验决策具有重要决定作用的因素。
总共122例（确诊前列腺癌5年内）从未被邀请参与临床试验的患者被要求完成一项关于临床试验“影响参与因素”的30项测评。
因子分析表明，影响参与的变量可归为三个方面：可接受性（如招募过程和利他信念）；知晓度（如对生活质量、生存期和随机分组过程的影响）；可及性（如患者费用、家庭影响、年龄、时间和额外检查需求）。T1或T2期疾病患者对知晓度项目的评分显著更高（P = 0.002）。尚未做出治疗决定的患者对知晓度（P = 0.05）和可接受性（P = 0.04）项目的评分也更高。大学学历以下的患者认为可及性项目更为重要（P = 0.03）。帮助未来前列腺癌患者、研究方案对生存的影响、充分了解研究、与专科医生的关系以及研究对生活质量的影响被确定为对未来参与影响最大的五个变量。
男性认为与知晓度和可接受性相关的项目是未来参与临床试验的最重要决定因素。了解这些男性认为对其未来参与临床试验重要的因素，将有助于研究人员设计满足目标患者群体需求的方案。
