Department of Nursing, Botucatu School of Medicine, University Estadual Paulista, Botucatu, SP, Brasil.
Clinics (Sao Paulo). 2012;67(6):603-8. doi: 10.6061/clinics/2012(06)10.
The participation of humans in clinical cardiology trials remains essential, but little is known regarding participant perceptions of such studies. We examined the factors that motivated participation in such studies, as well as those that led to participant frustration.
Patients who had participated in hypertension and coronary arterial disease (phases II, III, and IV) clinical trials were invited to answer a questionnaire. They were divided into two groups: Group I, which included participants in placebo-controlled clinical trials after randomization, and Group II, which included participants in clinical trials in which the tested treatment was compared to another drug after randomization and in which a placebo was used in the washout period.
Eighty patients (47 patients in Group I and 33 patients in Group II) with different socio-demographic characteristics were interviewed. Approximately 60% of the patients were motivated to participate in the trial with the expectation of personal benefit. Nine participants (11.2%) expressed the desire to withdraw, which was due to their perception of risk during the testing in the clinical trial (Group I) and to the necessity of repeated returns to the institution (Group II). However, the patients did not withdraw due to fear of termination of hospital treatment.
Although this study had a small patient sample, the possibility of receiving a benefit from the new tested treatment was consistently reported as a motivation to participate in the trials.
尽管人类参与临床心脏病学试验仍然至关重要,但对于参与者对这类研究的看法却知之甚少。我们研究了促使参与者参与此类研究的因素,以及导致参与者感到沮丧的因素。
邀请参与高血压和冠状动脉疾病(II、III 和 IV 期)临床试验的患者回答一份问卷。他们被分为两组:I 组包括随机分组后参与安慰剂对照临床试验的参与者,II 组包括随机分组后参与比较测试治疗与另一种药物的临床试验的参与者,并且在洗脱期使用安慰剂。
共采访了 80 名具有不同社会人口统计学特征的患者(I 组 47 名,II 组 33 名)。大约 60%的患者参加试验的动机是期望个人受益。有 9 名患者(11.2%)表示希望退出,原因是他们在临床试验中(I 组)感到风险,并且需要多次返回医院(II 组)。然而,患者并没有因为担心终止医院治疗而退出。
尽管这项研究的患者样本较小,但从新测试的治疗中获得收益的可能性始终被报道为参与试验的动机。