Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO-Public Health), Valencia, Spain.
Primary Health Center Malvarrosa, Valencia, Spain.
BMC Med Res Methodol. 2021 Dec 5;21(1):273. doi: 10.1186/s12874-021-01474-9.
Traditional clinical trials are conducted at investigator sites. Participants must visit healthcare facilities several times for the trial procedures. Decentralized clinical trials offer an interesting alternative. They use telemedicine and other technological solutions (apps, monitoring devices or web platforms) to decrease the number of visits to study sites, minimise the impact on daily routine, and decrease geographical barriers for participants. Not much information is available on the use of decentralization in randomized clinical trials with vaccines.
A hybrid clinical trial may be assisted by parental recording of symptoms using electronic log diaries in combination with home collected nasal swabs. During two influenza seasons, children aged 12 to 35 months with a history of recurrent acute respiratory infections were recruited in 12 primary health centers of the Valencia Region in Spain. Parents completed a symptom diary through an ad hoc mobile app that subsequently assessed whether it was an acute respiratory infection and requested collection of a nasal swab. Feasibility was measured using the percentage of returned electronic diaries and the validity of nasal swabs collected during the influenza season. Respiratory viruses were detected by real-time PCR.
Ninety-nine toddlers were enrolled. Parents completed 10,476 electronic diaries out of the 10,804 requested (97%). The mobile app detected 188 potential acute respiratory infections (ARIs) and requested a nasal swab. In 173 (92%) ARI episodes a swab was taken. 165 (95.4%) of these swabs were collected at home and 144 (87.3%) of them were considered valid for laboratory testing. Overall, 152 (81%) of the ARIs detected in the study had its corresponding valid sample collected.
Hybrid procedures used in this clinical trial with the influenza vaccine in toddlers were considered adequate, as we diagnosed most of the ARI cases on time, and had a valid swab in 81% of the cases. Hybrid clinical trials improve participant adherence to the study procedures and could improve recruitment and quality of life of the participants and the research team by decreasing the number of visits to the investigator site. This report emphasises that the conduct of hybrid CTs is a valid alternative to traditional CTs with vaccines. This hybrid CT achieved high adherence of participant to the study procedures.
2019-001186-33 (EudraCT).
传统的临床试验是在研究机构进行的。参与者必须多次到医疗机构进行试验程序。分散的临床试验提供了一个有趣的选择。它们使用远程医疗和其他技术解决方案（应用程序、监测设备或网络平台）来减少访问研究地点的次数，最大限度地减少对日常生活的影响，并为参与者减少地理障碍。关于在疫苗随机临床试验中使用分散化的信息并不多。
混合临床试验可以通过父母使用电子日志记录症状来辅助，结合家庭采集的鼻拭子。在两个流感季节期间，在西班牙瓦伦西亚地区的 12 个初级保健中心招募了 12 至 35 个月大、有反复发作急性呼吸道感染史的儿童。父母通过专门的移动应用程序完成症状日记，该应用程序随后评估是否为急性呼吸道感染，并要求采集鼻拭子。通过返回的电子日记的百分比和流感季节采集的鼻拭子的有效性来衡量可行性。通过实时 PCR 检测呼吸道病毒。
99 名幼儿入组。父母完成了 10804 份请求中的 10476 份电子日记（97%）。移动应用程序检测到 188 例潜在急性呼吸道感染（ARI）并请求采集鼻拭子。在 173 例（92%）ARI 发作中采集了拭子。165 份（95.4%）在家中采集，其中 144 份（87.3%）被认为可用于实验室检测。总体而言，在研究中检测到的 152 例（81%）ARI 中，有相应的有效样本被采集。
在幼儿中使用流感疫苗的这项临床试验中的混合程序被认为是合适的，因为我们及时诊断了大多数 ARI 病例，并在 81%的病例中采集了有效的拭子。混合临床试验提高了参与者对研究程序的依从性，并通过减少对研究机构的访问次数，提高了参与者和研究团队的招募率和生活质量。本报告强调，混合 CT 是一种替代传统疫苗 CT 的有效方法。这项混合 CT 实现了参与者对研究程序的高度依从性。
2019-001186-33（EudraCT）。
