接受临床试验信息会影响患者的病情吗?

IF 1.6 Q2 MEDICINE, GENERAL & INTERNAL
Journal of clinical medicine research Pub Date : 2025-05-01 Epub Date: 2025-05-28 DOI:10.14740/jocmr6252
Hideaki Shimada, Keisuke Okamura, Tetsuji Ohyama, Hidenori Urata, Osamu Imakyure
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引用次数: 0

摘要

背景:在我们医院进行生活方式相关疾病的临床试验时,我们有时会遇到一些患者,他们在接受试验解释时符合纳入标准,但在1个月后到达提供参与同意书时不再符合标准。在其中一些病例中,我们注意到患者的生活方式随后有所改善。因此,我们假设接受临床试验的信息可能会影响生活方式相关疾病。方法:我们招募了年龄在85岁或以下的患者,他们接受了一项关于难治性高血压(R-HT)或糖尿病肾病的双盲随机临床试验的信息。在这些患者中,我们评估了试验信息是否影响了一系列变量。此外,我们比较了两组之间变量的变化率,即不符合参加条件且未被随机化的患者(早期退出)和决定参加并被随机化的患者(随机接受治疗的患者)。我们还对患者的动机水平、健康意识和行为、期望和关注的变化进行了问卷调查,并对试验前后的变化进行了评估。结果:接受R-HT解释试验的7例患者和接受糖尿病肾病解释试验的14例患者参加了本研究。唯一的显著变化是在R-HT临床试验中,早期辍学组的收缩压和舒张压显著降低。两组在变量变化率上没有显著差异。在收到其中一项研究的信息后,两组患者中更积极主动或参与改变与健康相关行为(如锻炼、饮食习惯)的人数都有所增加。结论:接受有关高血压临床试验的信息可以显著影响血压。未来的研究应该检查提供其他与生活方式相关疾病的临床试验信息是否能激励患者改善他们的生活方式。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Does Receiving Information on Clinical Trials Affect Patients' Condition?

Background: When performing clinical trials on lifestyle-related diseases at our hospital, we have sometimes experienced patients who fulfilled the inclusion criteria at the time of receiving an explanation of the trial but who no longer met the criteria when they arrived to provide their consent to participate 1 month later. In some of these cases, we noticed that the patient's lifestyle subsequently improved. Therefore, we hypothesized that receiving information on clinical trials may affect lifestyle-related diseases.

Methods: We enrolled patients aged 85 years or younger who received information on a double-blind randomized clinical trial on treatment-resistant hypertension (R-HT) or one on diabetic nephropathy. In these patients, we evaluated whether the trial information affected a range of variables. In addition, we compared the rate of change in variables between two groups, i.e., patients who became ineligible to participate and were not randomized (early dropouts) and patients who decided to participate and were randomized (patients randomized to treatment). We also conducted a questionnaire on changes in patients' motivation level, health awareness and behavior, and expectations and concerns and evaluated changes from before to after receiving an explanation of the trial.

Results: Seven patients who received an explanation of the R-HT trial and 14 who received an explanation of the diabetic nephropathy trial participated in the present study. The only significant change in any variable was in the R-HT clinical trial, where systolic and diastolic blood pressure significantly decreased in the early dropout group. There were no significant differences between the two groups in the rate of change in variables. After receiving information about one of the studies, patients who became more proactive or involved in changing their health-related behavior, such as their exercise, eating, and drinking habits, increased in both groups.

Conclusions: Receiving information on a clinical trial on hypertension can significantly affect blood pressure. Future research should examine whether providing information on clinical trials on other lifestyle-related diseases motivates patients to improve their lifestyles.

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