Henriksson Catrin, Olsson Anneli, Andersen Kasper, Arefalk Gabriel, Erlinge David, Hofmann Robin, Ridderstråle Wilhelm, Rutgersson Annika, Oldgren Jonas, James Stefan
Cardiology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Cardiology, Department of Clinical Sciences, Lund University, Lund, Sweden.
Contemp Clin Trials Commun. 2024 May 13;40:101307. doi: 10.1016/j.conctc.2024.101307. eCollection 2024 Aug.
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.
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.
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. consisted of patients' positive attitudes to participation and to be a part of development and research. emphasized the value of the oral information as well as the importance of time for reflection. highlighted the impaired ability to perceive and remember in the acute medical condition. described the overall positive experiences of the smart bottle cap to evaluate adherence.
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.
患者参与临床试验对医疗保健的发展至关重要。招募患有急性疾病的试验参与者存在若干挑战。基于登记处的随机DAPA-MI临床试验在患者因心肌梗死住院期间招募患者，并在装有智能瓶盖的瓶子中提供研究药物，智能瓶盖使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体验以及他们对新瓶盖技术的态度。
从瑞典的四家医院招募了一部分参与DAPA-MI试验的患者。进行了半结构化访谈，并使用显性内容分析法进行分析。
进行了视频访谈，包括21名患者（4名女性和17名男性）。中位年龄为59岁（范围44-80岁）。确定了四类患者体验。包括患者对参与以及成为发展和研究一部分的积极态度。强调了口头信息的价值以及反思时间的重要性。突出了急性疾病状态下感知和记忆能力受损的情况。描述了智能瓶盖在评估依从性方面的总体积极体验。
患者参与试验的体验总体上是积极的，但在心肌梗死的急性情况下也发现了一些挑战。尽管存在一些操作困难，但智能瓶盖还是得到了很好的接受。
