Validity of mobile electronic data capture in clinical studies: a pilot study in a pediatric population

• DOI: 10.1186/s12874-017-0438-x
• Publication Date: 2017-12-07T20:27:00Z
• Authors: Belinda von Niede...; Ramon Saccilotto; Sabine Schädelin; Victoria Ziesenitz; Pascal Benkert; Marie-Luise Decker; Anya Hammann; Julia Bielicki; Marc Pfister; Christiane Pauli-...
• Keywords: Electronic data capture; Clinical endpoint

Clinical studies in children are necessary yet conducting multiple visits at study centers remains challenging. The success of "care-at-home" initiatives and remote clinical trials suggests their potential to facilitate conduct pediatric studies. This pilot aimed the feasibility remotely collecting valid (i.e. complete correct) saliva samples data utilizing mobile technology. Single-center, prospective undergoing elective tonsillectomy University Basel Children's Hospital. Data on pain scores concomitant medication were collected by caregivers two four inpatient days three consecutive home. A tailored application developed for this supported collection. primary endpoint was proportion correct caregiver-collected (pain scale) at-home setting. Secondary endpoints included setting, subjective caregivers, cost. total number 23 which 17 children, median age 6.0 years (IQR 5.0, 7.4), completed study. During phase, 71.9% [CI = 64.4, 78.6] all assessments 53.9% 44.2, 63.4] correct. Overall, 64.7% 58.7, 70.4] home predominant reason incorrectness adherence timing predefined patient actions. Participating reported high levels satisfaction willingness participate similar future. Study costs a sample size 100 patients calculated be 20% lower than traditional in-patient Mobile device conducted may provide cost-effective approach children. Given findings study, collection focus electronic capture rather biological sampling.