Instituto de Experiencia del Paciente en C/Mieses 1, Majadahonda, 28220, Madrid, Spain.
Patient Centricity Consulting, São Paulo, Brazil.
Adv Ther. 2023 Apr;40(4):1670-1685. doi: 10.1007/s12325-023-02441-0. Epub 2023 Feb 16.
The SARS-CoV-2 virus pandemic has accelerated the growing trend towards using home- and remote-based medical testing (H/RMT). The aim of this study was to gather insights and explore the opinions of patients and healthcare professionals (HCPs) in Spain and Brazil regarding H/RMT and the impact of decentralised clinical trials.
This qualitative study consisted of in-depth open question interviews of HCPs and patients/caregivers followed by a workshop that aimed to determine the advantages and barriers to H/RMT in general, and in the context of clinical trials.
There were 47 participants in the interviews (37 patients, 2 caregivers, 8 HCPs) and 32 in the validation workshops (13 patients, 7 caregivers, 12 HCPs). The main advantages for the use of H/RMT in current practice were the comfort and convenience, the ability to improve the relationship between HCPs and patients and personalise patient care, and the increased patient awareness towards their disease. Barriers to H/RMT included accessibility, digitalisation, and the training requirements for both HCPs and patients. Furthermore, according to the Brazilian participants, there is a general distrust in the logistical management of H/RMT. Patients indicated that the convenience of H/RMT did not influence their decision to participate in a clinical trial, with the main reason for participating in a clinical trial being to improve health; however, H/RMT in clinical research does aid adherence to the long-term follow-up associated with trials and provides access to patients living far from the clinical sites.
Insights from patients and HCPs suggest that the advantages of H/RMT may outweigh the barriers, and that social, cultural and geographical factors and the HCP-patient relationship are critical aspects to be considered. Moreover, the convenience of H/RMT does not appear to be a driver for participating in a clinical trial but can facilitate patient diversity and study adherence.
SARS-CoV-2 病毒大流行加速了家庭和远程医疗检测（H/RMT）日益增长的趋势。本研究旨在收集西班牙和巴西患者和医疗保健专业人员（HCPs）对 H/RMT 以及去中心化临床试验的看法和见解。
这项定性研究包括对 HCPs 和患者/护理人员进行深入的开放式问题访谈，然后进行一次研讨会，旨在确定 H/RMT 的一般优势和障碍，以及在临床试验背景下的优势和障碍。
访谈中有 47 名参与者（37 名患者，2 名护理人员，8 名 HCPs），验证研讨会中有 32 名参与者（13 名患者，7 名护理人员，12 名 HCPs）。目前实践中使用 H/RMT 的主要优势包括舒适和便利、改善 HCPs 与患者之间的关系和个性化患者护理的能力，以及提高患者对自身疾病的认识。H/RMT 的障碍包括可及性、数字化以及 HCPs 和患者的培训需求。此外，根据巴西参与者的说法，人们普遍对 H/RMT 的物流管理缺乏信任。患者表示，H/RMT 的便利性不会影响他们参与临床试验的决定，参与临床试验的主要原因是改善健康；然而，H/RMT 在临床研究中确实有助于遵守与试验相关的长期随访，并为远离临床地点的患者提供了参与机会。
患者和 HCPs 的观点表明，H/RMT 的优势可能超过障碍，社会、文化和地理因素以及 HCP-患者关系是需要考虑的关键方面。此外，H/RMT 的便利性似乎不是参与临床试验的驱动因素，但可以促进患者多样性和研究依从性。
