Gruca Thomas S, Hottel Wesley J, Comstock Janine, Olson Anna, Rosenthal Gary E
University of Iowa, Iowa City, USA.
Cognizant Consulting, New York, USA.
Trials. 2018 May 30;19(1):300. doi: 10.1186/s13063-018-2667-7.
While women are under-represented in research on cardiovascular disease (CVD), little is known about the attitudes of men and women with CVD regarding participation in clinical research studies/clinical trials.
Patients with CVD (and/or risk factors) and patients with other chronic conditions from Iowa were recruited from a commercial panel. An on-line survey assessed willingness to participate (WTP) and other attitudes towards aspects of clinical research studies.
Based on 504 respondents, there were no differences in WTP in patients with CVD compared to patients with other chronic diseases. Across all respondents, men had 14% lower WTP (relative risk (RR) for men, 0.86, 95% CI, 0.72-1.02). Among patients with CVD, there was no significant difference in WTP between women (RR for women = 1) and men (RR for men, 0.96, 95% CI, 0.82-1.14). There were no significant differences based on sex or CVD status for attitudes on randomization, blinding, side effects, conflict of interest, experimental treatments or willingness to talk to one's physician. Women had more favorable attitudes about participants being treated like "guinea pigs" (RR for men, 0.84, 95% CI, 0.73-0.98) and clinical trials being associated with terminally ill patients (RR for men, 0.93, 95% CI, 0.86-1.00).
The findings reported here suggest that the observed lower levels of participation by women are due to factors other than a lower WTP or to women having more negative attitudes towards aspects of study participation. Patients with CVD have similar attitudes and WTP as patients with other chronic conditions.
虽然女性在心血管疾病(CVD)研究中的代表性不足,但对于患有CVD的男性和女性参与临床研究/临床试验的态度知之甚少。
从爱荷华州的一个商业样本中招募患有CVD(和/或风险因素)的患者以及患有其他慢性病的患者。一项在线调查评估了参与意愿(WTP)以及对临床研究各方面的其他态度。
基于504名受访者,与患有其他慢性病的患者相比,患有CVD的患者在WTP方面没有差异。在所有受访者中,男性的WTP低14%(男性的相对风险(RR)为0.86,95%置信区间为0.72 - 1.02)。在患有CVD的患者中,女性(女性的RR = 1)和男性(男性的RR为0.96,95%置信区间为0.82 - 1.14)在WTP方面没有显著差异。在随机分组、设盲、副作用、利益冲突、实验性治疗或与医生交谈的意愿等态度方面,基于性别或CVD状态没有显著差异。女性对参与者被当作“豚鼠”对待(男性的RR为0.84,95%置信区间为0.73 - 0.98)以及临床试验与绝症患者相关(男性的RR为0.93,95%置信区间为0.86 - 1.00)的态度更为积极。
此处报告的研究结果表明,观察到的女性参与水平较低是由于WTP较低之外的因素,或者是女性对研究参与方面有更多负面态度。患有CVD的患者与患有其他慢性病的患者态度和WTP相似。