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Validity of mobile electronic data capture in clinical studies: a pilot study in a pediatric population
Belinda von Niederhäusern1, Ramon Saccilotto2, Sabine Schädelin3
1Clinical Trial Unit, Department of Clinical Research, University and University Hospital of Basel, Schanzenstrasse 55, 4031, Basel, Switzerland. belinda.vonniederhausern@usb.ch.
Insights
Remote pediatric clinical studies using mobile technology show promise for cost-effective data collection. While saliva sample accuracy at home was lower, electronic data capture demonstrated feasibility for future research.
Area of Science:
- Pediatric clinical research
- Mobile health technology
- Remote data collection
Background:
- Pediatric clinical studies face challenges with multiple in-person visits.
- Remote and at-home care models show potential for improving pediatric study conduct.
- This pilot study evaluated the feasibility of remote data and saliva sample collection in children.
Purpose of the Study:
- To assess the feasibility of remotely collecting valid saliva samples and clinical data using mobile technology in pediatric patients.
- To determine the proportion of complete and correct data and samples collected at home.
- To evaluate caregiver satisfaction and study costs associated with remote data collection.
Main Methods:
- A prospective, single-center pilot study involving children undergoing elective tonsillectomy.
- Caregivers collected pain scores, medication data, and saliva samples over inpatient and at-home study days.
- A custom mobile application facilitated data collection, with primary endpoint being complete and correct at-home data and samples.
Main Results:
- 17 of 23 children completed the study.
- At-home data collection achieved 71.9% accuracy for pain assessments and 53.9% for saliva samples.
- Overall at-home data completeness and correctness was 64.7%; caregiver satisfaction was high, and study costs were estimated to be 20% lower than traditional inpatient studies.
Conclusions:
- Mobile-supported, at-home clinical studies offer a potentially cost-effective method for pediatric research.
- Electronic data capture at home appears more feasible than biological sampling in this setting.
- Future pediatric studies could leverage mobile technology for efficient remote data collection, prioritizing electronic measures.
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.
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