Table 3.
A summary of themes, subthemes, and codes for requirement elicitation.
| Themes and subthemes | Codes extracted from quotations | |
| Functional requirements | ||
|
|
Contextual adaptability | Adaptable solution tailored to different settings |
|
|
Comprehensive data integration | Data type (eg, EEGa, motions, movements, sleep, and video) |
|
|
Alerting and detection efficiency | Alarm, alerting mechanism, and seizure detection |
|
|
Differential diagnostics | Differential diagnosis, epileptic seizures, and nonepileptic events |
|
|
Evolutionary data collection | Seizure phenotyping, treatment, diagnosis, and diagnostic precision |
|
|
Quality of data recording | Quality, data recording, capturing, and video recording |
|
|
Remote monitoring and technological integration | Home monitoring, remote monitoring, and wearables |
|
|
User compliance and system effectiveness | Prolonged seizures, night, alarm, and caregivers |
|
|
Quality and usability concerns | Ease of use, wearable device, user friendly, brain monitoring, and high-quality |
|
|
Use of wearables and devices | Good quality, wearable device, clinical setting, and continuous monitoring |
|
|
Continuous monitoring | Continuous EEG monitoring, uninterrupted patient monitoring, adult, and children |
|
|
Alarm for seizure detection | Health care professionals, alarms, responsive monitoring systems, and nonconvulsive seizures |
|
|
Age-specific considerations | Adults, children, age group, and features |
|
|
Target demographic | Differing physiological and developmental needs, adults, children, specific age, and design |
|
|
Usability and user friendly | Noninvasive, easy to use, user friendly, home care routines, simplicity, and intuitive design |
|
|
Technical specifications | Sensitivity, specificity, customization, and tonic-clonic seizures |
|
|
Information delivery | Inform, seizures, and communication |
|
|
Innovation and development | Innovative, artificial intelligence, and predictive analytics |
| Nonfunctional requirements | ||
|
|
Types of seizures | Duration, nonepileptic, epileptic, nonconvulsive seizures, and tonic-clonic seizures |
|
|
EEG importance | EEG, vital, and seizure |
|
|
Seizure phenotypes | Types, variety, seizure, symptom, and abnormal |
|
|
Duration of seizures | Duration and seizure |
|
|
Materials and contents for training and support | Training, educational materials, on the web, in person, documentation, and digital content |
| Regulatory and compliance needs and data management and security | ||
|
|
Access and storing of data | Complexity, sensitivity, handling patient data, storing, and access |
|
|
GDPRb compliance | GDPR, regulations, and storage |
|
|
Ethical issues | Ethical considerations and authorized personnel |
|
|
Standardization and legal issues | Lack of standardization and regulatory frameworks |
|
|
Case study—Nelli system | Nelli system, developed by Tampere University and Tampere University Hospital |
| Usability and design | ||
|
|
Size and aesthetic considerations for patient devices | Device size, patient movement, younger patients, customizable elements, colorful caps, children, less intimidating, user friendly, and hiding |
|
|
Designing for demographics and user-centered design in medical devices | Children, tailored design, personalized medical devices, patient’s age, user-centered design, and physical psychological needs |
| Cost and accessibility | ||
|
|
Cost of implementation by hospital | Accessibility, affordable services, and brand-new hospital |
|
|
Cost of services by insurance | Insurance and services |
|
|
All public and private hospitals | Public and private |
|
|
Rural areas | Remote and rural areas |
aEEG: electroencephalography.
bGDPR: General Data Protection Regulation.