Clinical Effectiveness, Feasibility, Acceptability, and Usability in Mobile Health Applications for Epilepsy: A Systematic Review (Preprint)

BACKGROUND Mobile applications, or “apps”, are widely used by people with epilepsy, their caregivers, and providers. The impact of these apps on the clinical effectiveness (CE) and feasibility, acceptability, or usability (FAU) in epilepsy remains unclear. OBJECTIVE To conduct a systematic review of studies investigating the CE and FAU of mobile applications in epilepsy. METHODS This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards and was registered with the Prospective Register of Systematic Reviews (PROSPERO; CRD42019134848). The search was conducted using MEDLINE ALL (Ovid) and EMBASE (Ovid) from database inception to April 2022. At the screening phase, we excluded conference abstracts, non-English language and review articles, as well as articles studying video telehealth. We determined study quality for case-control or cohort studies using the Newcastle-Ottawa Quality Assessment Scale (NOQAS) and bias in randomized studies using the Cochrane Collaboration Handbook Risk of Bias (RoB) tool. We assessed usability study quality using the validated 15-point Silva scale. Study characteristics were analyzed using summary statistics. RESULTS We identified 6,768 studies, of which 13 (0.2%) were included. Of the 13 studies, 8 (61.5%) addressed CE, 6 (46.2%) acceptability, 5 (38.5%) usability, and 4 (30.8%) feasibility. Four studies (31.0%) evaluated both CE and FAU. Studies comprised prospective cohort (N=6, 46.2%), pilot (N=3, 23.1%), randomized trial (N=3, 23.1%) and pre/post (N=1, 7.7%) designs. Overall, cohort studies demonstrated fair quality (median NOQAS score 5, interquartile range [IQR] 5.0 - 5.8), whereas 2 (66.7%) randomized studies had some concern for bias. Usability studies demonstrated high methodological quality (median Silva score 10, IQR 10 - 11). Apps were most frequently studied in patient users (N=7 (87.5%) CE and 8 (100%) FAU studies). The most common app target in CE studies was physical health (N=5, 62.5%) contrasting with symptom management (N=7, 87.5%) in FAU studies. CONCLUSIONS We found that studies of app use in epilepsy most commonly studied CE and evaluated patient-facing apps. Despite high methodological quality in usability studies and several randomized CE studies, cohort and randomized studies demonstrated fair quality and moderate bias, respectively. Additional high-quality evidence is necessary to evaluate the CE and FAU of app use in epilepsy.