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. 2017 Dec 8;17(1):163.
doi: 10.1186/s12874-017-0438-x.

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

Belinda von Niederhäusern  1 , Ramon Saccilotto  2 , Sabine Schädelin  3 , Victoria Ziesenitz  4 , Pascal Benkert  3 , Marie-Luise Decker  4 , Anya Hammann  3 , Julia Bielicki  4   5 , Marc Pfister  4 , Christiane Pauli-Magnus  3   2
Affiliations

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

Belinda von Niederhäusern et al. BMC Med Res Methodol. .

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.

Keywords: Data quality; Data validity; Feasibility; Mobile studies; Pediatrics; Remote studies.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for the study “Pediatric pain management after tonsillectomy as a model to assess the feasibility of clinical studies in children in an at-home setting (TOMACHI)” was granted by the Ethics Committee Central- and North-western Switzerland (EKNZ, 2015–00022).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Daily data collection schedule. tM: Timepoint directly after awakening of child, t1: 1 h (+/− 15 min) after administration of first routinely scheduled dose of acetaminophen; t2: 4 h (+2 h) after administration of first routinely scheduled dose of acetaminophen. * “Medication given” indicates the timepoint at which children had either received routine acetaminophen, or not (yes/no). Independent of whether medication was given or not, the app used the recorded time stamp to automatically calculate t1 and t2
Fig. 2
Fig. 2
TOMACHI Study Flow Diagram
See this image and copyright information in PMC

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