RESUMEN
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).
Asunto(s)
Gripe Humana , Virus , Preescolar , Estudios de Factibilidad , Humanos , Gripe Humana/diagnóstico , Gripe Humana/prevención & control , Calidad de Vida , Estaciones del AñoRESUMEN
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Asunto(s)
Humanos , Recién Nacido , Lactante , Preescolar , Niño , Adolescente , Enuresis/epidemiología , Enuresis/etiología , Estreñimiento , Enuresis Diurna , Enuresis NocturnaRESUMEN
BACKGROUND: There is an agreement to use simple formulae (expected bladder capacity and other age based linear formulae) as bladder capacity benchmark. But real normal child's bladder capacity is unknown. AIMS: To offer a systematic review of children's normal bladder capacity, to measure children's normal maximum voided volumes (MVVs), to construct models of MVVs and to compare them with the usual formulae. METHODS: Computerized, manual and grey literature were reviewed until February 2013. Epidemiological, observational, transversal, multicenter study. A consecutive sample of healthy children aged 5-14 years, attending Primary Care centres with no urologic abnormality were selected. Participants filled-in a 3-day frequency-volume chart. Variables were MVVs: maximum of 24 hr, nocturnal, and daytime maximum voided volumes. FACTORS: diuresis and its daytime and nighttime fractions; body-measure data; and gender. The consecutive steps method was used in a multivariate regression model. RESULTS: Twelve articles accomplished systematic review's criteria. Five hundred and fourteen cases were analysed. Three models, one for each of the MVVs, were built. All of them were better adjusted to exponential equations. Diuresis (not age) was the most significant factor. There was poor agreement between MVVs and usual formulae. Nocturnal and daytime maximum voided volumes depend on several factors and are different. CONCLUSIONS: Nocturnal and daytime maximum voided volumes should be used with different meanings in clinical setting. Diuresis is the main factor for bladder capacity. This is the first model for benchmarking normal MVVs with diuresis as its main factor. Current formulae are not suitable for clinical use.