Bring-your-own-device (BYOD) methods for collecting patient-reported outcome (PRO) data in clinical trials can decrease patient burden and improve data quality. However, adoption of BYOD in clinical trials is limited by the absence of publicly available case studies where BYOD PRO data supported regulatory medical product approvals. Anecdotally, we are aware of multiple examples where efficacy and safety label claims were based on BYOD PRO data; however—except for one—these examples have not been made public. The absence of these case studies can lead sponsors to be hesitant to use BYOD for capturing primary and secondary PRO-based endpoints in their trials. This commentary outlines the context of the issue faced and concludes with a call for sponsor transparency with regard to BYOD use through publicizing where approved labeling claims were based on BYOD data. We suggest how this data could be systematically captured going forward. Sharing this information will benefit the clinical trials enterprise by increasing confidence in the utilization of BYOD and provide opportunities to enhance patient-centricity.

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

Objectives: Various digital technologies are increasingly being introduced into the everyday life of children. It is possible that digital addiction has negative effect on psychosocial functions of children. What kind of specific effect does this new "digital environment" have for children? The goal of this research is to check the hypothesis that there is relationship between computer game addiction and low mood in 10year-old children. Methods: We used questionnaire for parents to reveal children with computer game addiction. Experimental group consisted of 30 10-year-old children with computer game addiction. Control group consisted of 30 children without computer game addiction. The children from experimental and control group were matched for gender. We used Revised Children's Anxiety and Depression Scale (RCADS) for assessment of separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder) in children (Child Self-Reported). Results: We used Spearman correlation. Analysis has revealed the significant (p,.05) positive correlation between level of computer game addiction and low mood in children. However, we did not find the correlation between level of computer game addiction and other scales of RCADS. Conclusions: It can be assumed that there is relationship between computer game addiction and low mood in 10-year-old children. However, we need to do additional research using experimental design to approve the hypothesis that computer game addiction can cause the low mood in children.

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