Feasibility of a hybrid clinical trial for respiratory virus detection in toddlers during the influenza season.

Autor: Muñoz-Ramírez S; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO-Public Health), Valencia, Spain. soledad.munoz@fisabio.es., Escribano-López B; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO-Public Health), Valencia, Spain., Rodrigo-Casares V; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO-Public Health), Valencia, Spain., Vergara-Hernández C; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO-Public Health), Valencia, Spain., Gil-Mary D; Primary Health Center Malvarrosa, Valencia, Spain., Sorribes-Monrabal I; Primary Health Center Serrería II, Valencia, Spain., Garcés-Sánchez M; Primary Health Center Nazaret, Valencia, Spain., Muñoz-Del-Barrio MJ; Primary Health Center Trafalgar, Valencia, Spain., Albors-Fernández AM; Primary Health Center Trafalgar, Valencia, Spain., Úbeda-Sansano MI; Primary Health Center L'Eliana, Valencia, Spain., Planelles-Cantarino MV; Primary Health Center Paiporta, Valencia, Spain., Largo-Blanco EM; Primary Health Center Paiporta, Valencia, Spain., Suárez-Vicent E; Primary Health Center Burriana II, Castellón, Spain., García-Rubio J; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO-Public Health), Valencia, Spain., Bruijning-Verhagen P; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands., Orrico-Sánchez A; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO-Public Health), Valencia, Spain., Díez-Domingo J; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO-Public Health), Valencia, Spain.
Jazyk: angličtina
Zdroj: BMC medical research methodology [BMC Med Res Methodol] 2021 Dec 05; Vol. 21 (1), pp. 273. Date of Electronic Publication: 2021 Dec 05.
DOI: 10.1186/s12874-021-01474-9
Abstrakt: Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
Trial Registration: 2019-001186-33 (EudraCT).
(© 2021. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje