告知初级保健医生患者参与在专科护理级别进行的临床试验

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
J. A. Schoenenberger-Arnaiz, Montserrat Solanilla-Puertolas, M. Acer-Puig, J. Gómez-Arbonés
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引用次数: 3

摘要

背景:由于合并症或毒性,参加临床试验的患者继续与初级保健医生频繁接触。本研究的目的是分析在不同级别提供的信息,当参与者被纳入在专业护理级别组织的临床试验时。目的是验证纳入过程中是否考虑通知患者的初级保健医生。方法:作者进行了一项横断面研究,包括医院机构审查委员会在过去两年中批准的临床试验。此外,还采访了纳入临床试验的一些参与者,以检查他们对正在进行的研究类型的了解。结果:总共审查了67个方案和随附的知情同意书文件。一半的审查方案(48%)没有向参与者提供身份证。关于初级保健医生的作用,68.6%的临床试验(46/67)以不同的方式考虑到了这一点。只有四项试验记录了联系初级保健医生的方法。总共采访了20名参与者。只有3人(15%)知道他们参与的研究的标题,14人(70%)知道自己的疾病,6人(30%)不知道如何回答这两个问题中的任何一个。几乎所有参与研究的人都知道作为试验主要研究者的医生的名字。结论:提供给没有直接参与由专业医务人员进行的临床试验的医护人员的信息仍然很少。在我们的临床环境中,参与临床试验的患者对此类研究的认识较低。关键词:知情同意书、临床试验、家庭医生、钱包卡
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Informing primary care physicians of patients' involvement in clinical trials carried out at a specialist care level
Background: Patients enrolled in clinical trials continue to have frequent contacts with primary care physicians because of comorbidities or toxicities. The aim of the present study was to analyze the information provided at different levels, when participants are included in clinical trials organized at a specialized care level. The purpose was to verify if informing the patient's primary care physician is contemplated in the inclusion process. Methods: The authors conducted a cross-sectional study that included the clinical trials approved in the last 2 years by the hospital's Institutional Review Board. In addition, some of the participants in the included clinical trials were interviewed in order to check their knowledge of the type of research taking place. Results: In total, 67 protocols and the accompanying informed consent documents were reviewed. Half of the reviewed protocols (48%) did not provide participants with an identification card. Regarding the role of the primary care physician, 68.6% of clinical trials (46/67) had taken it into account in different ways. In only four trials, the method used to contact the primary care physician was documented. In total, 20 participants were interviewed. Only 3 (15%) knew the title of the study in which they were participating, 14 (70%) were aware of their illness and 6 (30%) did not know how to answer any of these two questions. Almost all participants in the study knew the name of the physician who was the principal investigator in the trial. Conclusion: Information given to health care practitioners, who are not directly involved in clinical trials conducted by specialized medical staff, is still scarce. In our clinical setting, patients participating in clinical trials have a low awareness of such studies. Keywords: informed consent, clinical trials, family physician, wallet card
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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