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

BMC Medical Research Methodology

Sabine Schädelin¹  Pascal Benkert¹  Belinda von Niederhäusern¹  Anya Hammann¹  Christiane Pauli-Magnus¹  Ramon Saccilotto²  Marc Pfister³  Marie-Luise Decker³  Julia Bielicki³  Victoria Ziesenitz³ 

[1]Clinical Trial Unit, Department of Clinical Research, University and University Hospital of Basel

[2]Department of Clinical Research, University and University Hospital of Basel

[3]Division of Paediatric Pharmacology & Pharmacometrics, University of Basel Children’s Hospital

关键词: Remote studies;    Mobile studies;    Pediatrics;    Data validity;    Data quality;    Feasibility;   

DOI  :  10.1186/s12874-017-0438-x

来源: DOAJ

【 摘 要 】

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

【 授权许可】

Unknown