Patients’ experiences of clinical trial participation involving a product remotely assessing study drug adherence

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Catrin Henriksson , Anneli Olsson , Kasper Andersen , Gabriel Arefalk , David Erlinge , Robin Hofmann , Wilhelm Ridderstråle , Annika Rutgersson , Jonas Oldgren , Stefan James
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引用次数: 0

Abstract

Background

The participation of patients in clinical trials is crucial for the development of healthcare. There are several challenges in the recruitment of trial participants with acute medical conditions. The registry-based randomized DAPA-MI clinical trial recruited patients during hospitalization for myocardial infarction and provided study drugs in bottles with smart caps that used wireless technology to transmit monitoring data. This interview study aimed to investigate patients’ experience of participation in a clinical trial and their attitude to the new bottle cap technology.

Methods

A subset of patients participating in the DAPA-MI trial were recruited from four hospitals in Sweden. Semi-structured interviews were conducted and analysed using manifest content analysis.

Results

Video interviews were performed including 21 patients (four women and 17 men). The median age was 59 years (range 44–80). Four categories of patients' experiences were identified. A willingness to contribute consisted of patients’ positive attitudes to participation and to be a part of development and research. The perception of information emphasized the value of the oral information as well as the importance of time for reflection. Be in a vulnerable condition highlighted the impaired ability to perceive and remember in the acute medical condition. Adaptation to a new technology described the overall positive experiences of the smart bottle cap to evaluate adherence.

Conclusions

Patients’ experiences of trial participation were in general positive but some challenges in the acute setting of a myocardial infarction were revealed. The smart bottle cap was well accepted, despite some handling difficulties.

患者参与涉及产品远程评估研究药物依从性的临床试验的经历
背景患者参与临床试验对医疗保健的发展至关重要。招募急性病患者参与试验面临着一些挑战。以登记为基础的随机 DAPA-MI 临床试验招募了因心肌梗塞住院的患者,并将研究药物装在带有智能瓶盖的瓶子里,利用无线技术传输监测数据。这项访谈研究旨在调查患者参与临床试验的经历以及他们对新瓶盖技术的态度。方法从瑞典的四家医院招募了一部分参与 DAPA-MI 试验的患者。结果对 21 名患者(4 名女性和 17 名男性)进行了视频访谈。中位年龄为 59 岁(44-80 岁不等)。患者的经历分为四类。患者对参与和成为开发与研究的一部分持积极态度,愿意做出贡献。对信息的感知强调了口头信息的价值以及思考时间的重要性。处于脆弱状态则强调了急性病患者的感知和记忆能力受损。对新技术的适应描述了使用智能瓶盖评估依从性的总体积极体验。结论患者参与试验的体验总体上是积极的,但也暴露出了在心肌梗塞急性期环境下的一些挑战。尽管在操作上存在一些困难,但智能瓶盖还是被广泛接受。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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