Feasibility of a hybrid clinical trial for respiratory virus detection in toddlers during the influenza season.
Feasibility of a hybrid clinical trial for respiratory virus detection in toddlers during the influenza season.
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DOI：
10.1186/s12874-021-01474-9
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发表时间：
2021-12-05
影响因子：
4
通讯作者：
Díez-Domingo J
中科院分区：
文献类型：
--
作者：
Muñoz-Ramírez S;Escribano-López B;Rodrigo-Casares V;Vergara-Hernández C;Gil-Mary D;Sorribes-Monrabal I;Garcés-Sánchez M;Muñoz-Del-Barrio MJ;Albors-Fernández AM;Úbeda-Sansano MI;Planelles-Cantarino MV;Largo-Blanco EM;Suárez-Vicent E;García-Rubio J;Bruijning-Verhagen P;Orrico-Sánchez A;Díez-Domingo J
传统的临床试验是在研究者现场进行的。参与者必须多次访问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。他们使用远程医疗和其他技术解决方案（应用程序、监控设备或网络平台）来减少对研究地点的访问次数，最大限度地减少对日常生活的影响，并减少参与者的地理障碍。关于在疫苗随机临床试验中使用权力下放的信息并不多。混合临床试验可由父母使用电子日志日记记录症状并结合家中收集的鼻拭子进行辅助。在两个流感季节，在西班牙瓦伦西亚地区的12个初级卫生中心招募了有复发性急性呼吸道感染史的12至35个月的儿童。家长通过一个特别的移动应用程序完成症状日记，随后评估是否是急性呼吸道感染，并要求收集鼻拭子。使用归还电子日记的百分比和流感季节收集的鼻拭子的有效性来衡量可行性。采用实时荧光定量PCR检测呼吸道病毒。共有99名幼儿参加了这项研究。在要求的10804份电子日记中，家长完成了10476份（97%）。该移动应用程序检测到188名潜在的急性呼吸道感染（ARIs），并要求使用鼻拭子。在173例（92%）ARI发作中采集了棉签。其中165份（95.4%）在家中采集，144份（87.3%）被认为可用于实验室检测。总体而言，研究中检测到的152例（81%）ARIs收集了相应的有效样本。该临床试验中使用的混合程序与幼儿流感疫苗被认为是适当的，因为我们及时诊断了大多数ARI病例，并且在81%的病例中使用了有效的拭子。混合临床试验提高了受试者对研究程序的依从性，并可以通过减少到研究者现场的访问次数来改善受试者和研究团队的招募和生活质量。该报告强调，进行混合ct是传统ct与疫苗的有效替代方法。这种混合CT使参与者高度遵守研究程序。2019-001186-33 (EudraCT)。
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).
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DOI：
10.1186/s12966-018-0654-8
发表时间：
2018-02-27
期刊：
The international journal of behavioral nutrition and physical activity
影响因子：
--
作者：
Järvelä-Reijonen E;Karhunen L;Sairanen E;Muotka J;Lindroos S;Laitinen J;Puttonen S;Peuhkuri K;Hallikainen M;Pihlajamäki J;Korpela R;Ermes M;Lappalainen R;Kolehmainen M
通讯作者：
Kolehmainen M
影响因子：
5.5
作者：
Lambert, Stephen B.;Allen, Kelly M.;Nolan, Terence M.
通讯作者：
Nolan, Terence M.
影响因子：
5
作者：
Agarwal, Payal;Mukerji, Geetha;Bhatia, R. Sacha
通讯作者：
Bhatia, R. Sacha
影响因子：
3.7
作者：
Akmatov, Manas K.;Gatzemeier, Anja;Pessler, Frank
通讯作者：
Pessler, Frank
影响因子：
7.4
作者：
Persky, Susan
通讯作者：
Persky, Susan