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帕金森病患者的临床特征与治疗误解及参与临床试验的意愿相关。

Clinical features of Parkinson's disease patients are associated with therapeutic misconception and willingness to participate in clinical trials.

作者信息

Reijula Emmi, Pietilä Anna-Maija, Halkoaho Arja, Selander Tuomas, Martikainen Kirsti, Kälviäinen Reetta, Keränen Tapani

机构信息

University of Eastern Finland, Faculty of Health Sciences, Kuopio, Finland.

Kuopio University Hospital, Science Service Center, PO Box 100, 70029, Kuopio, Finland.

出版信息

Trials. 2017 Sep 29;18(1):444. doi: 10.1186/s13063-017-2174-2.

Abstract

BACKGROUND

Clinical trials (CTs) are the "gold standard" to ensure the development of new effective treatments in medicine. A study was conducted to assess knowledge of, and attitudes toward, clinical trials among patients with Parkinson's disease (PD), along with factors that motivate them to participate.

METHODS

A 50-item questionnaire on the views of patients with PD about CTs was developed. It included statements that the respondents assessed on a Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). The questionnaire was mailed to a random sample (n = 2000) of members of the patient organization the Finnish Parkinson Association. In all, 708 response forms were returned, of which 681 were accepted after exclusion (a 34% response rate).

RESULTS

In general, attitudes of patients with PD toward CTs were positive. Older subjects and patients with lower education levels had inadequate knowledge of general issues related to CTs. Older age, low level of education, and lower number of PD medications were significant predictors for failure to understand the nature and purpose of clinical research. Additionally, significant positive correlation was found between education level and willingness to participate in CTs.

CONCLUSIONS

Patients with PD have important gaps in their knowledge of methodological issues associated with CTs. The oldest subjects and those with a low level of education have the greatest information needs. Investigators should pay more attention to ensuring the comprehensibility of the information provided to potential CT participants.

摘要

背景

临床试验是确保医学领域开发新的有效治疗方法的“金标准”。开展了一项研究,以评估帕金森病(PD)患者对临床试验的了解程度和态度,以及促使他们参与的因素。

方法

编制了一份关于PD患者对临床试验看法的包含50个条目的问卷。其中包括让受访者按李克特量表从1(“强烈不同意”)到5(“强烈同意”)进行评估的陈述。问卷被邮寄给芬兰帕金森病协会这个患者组织成员的一个随机样本(n = 2000)。总共返回了708份回复表,排除后接受了681份(回复率为34%)。

结果

总体而言,PD患者对临床试验的态度是积极的。年龄较大的受试者和教育水平较低的患者对与临床试验相关的一般问题了解不足。年龄较大、教育水平低以及服用的PD药物数量较少是未能理解临床研究性质和目的的显著预测因素。此外,发现教育水平与参与临床试验的意愿之间存在显著正相关。

结论

PD患者在与临床试验相关的方法学问题知识方面存在重大差距。年龄最大的受试者和教育水平低的受试者信息需求最大。研究人员应更加注重确保向潜在的临床试验参与者提供的信息易于理解。

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