A new seizure eDiary allows patients and caregivers to easily log seizures and identify triggers, track medications and appointments, and receive customized content. Developed through a collaboration of the Epilepsy Study Consortium, Inc. (ESCI) Working Group, WCG and other industry experts, this eDiary appears meets the needs of participants, sponsors and investigators alike.
Digital Data Collection Essential
In late-phase epilepsy trials, sponsors must collect a large amount of data directly from participants. They need to evaluate seizure frequency and type to assess the effect of treatment. Historically, this information has been collected using a paper diary—an approach with many downsides. That’s why electronic data collection is so important. It offers several benefits over paper, including:
- Eliminating manual transcription of source data into the electronic data capture database
- Creating an audit trail
- Providing time-stamped entries
- Supporting the use of a participant’s own personal device
Industry experts, including those from WCG, collaborated with the ESCI Working Group, made up of epileptologists, sponsors, CROs, and other stakeholders to design a new seizure eDiary.
They shared some results during a poster presentation at the 2023 International Society for Central Nervous System Clinical Trials and Methodology (ISCTM) Annual Meeting.
The poster, “Development and Content Validation of a Seizure eDiary Optimized for Clinical Trials: A Partnership with Industry Epilepsy,” set out to answer this question: Can an innovative seizure eDiary be developed to be fit-for-purpose across protocol and target population needs—and be user friendly for patients, caregivers and investigators?
The answer appears to be “yes.”
Building a User-Friendly eDiary
In developing the eDiary, initial mockups were based on the insights of the working group and industry experts. Subsequent development involved iterative feedback cycles, including two stages of formal qualitative interviews with 10 epilepsy patients and 10 caregivers.
Stage 1 of development included interviews with patients and caregivers — a cognitive debriefing — to help ensure the eDiary’s instructions and content were comprehensible and relevant. In stage 2, subjects tested the usability of the eDiary, including the ease with which they could navigate and use it. Both stages adhered to regulatory emphases on incorporating the patient perspective and aligning with Patient-Reported Outcome (PRO) development best practices.
Usable and User-Friendly
None of the users reported any major issues They did suggest 21 minor modifications during the cognitive debriefing, 18 of which were implemented. Suggested changes included minor rewording (e.g., changing “Individual or Multiple Countable Seizure(s)” to “One or More Countable Seizures”) and formatting (e.g., changing the use of “>” and “<” to number ranges).
Usability testing yielded six minor modification suggestions; three will be addressed in training. Suggested changes included additional text for clarity (e.g., add date to “My tasks” page) and formatting (e.g., increase font size).
Better Patient Experience, Better Data
Following minor modifications, the seizure eDiary demonstrated its usability and content validity in capturing vital seizure experience information in clinical trials, potentially enhancing the evaluation efficacy of investigational products.
By enhancing data collection and management in clinical trials related to epilepsy, the seizure eDiary helps ensure the patient experience is captured accurately and efficiently. Future improvements and adaptations will further refine its utility and user-friendliness. The actual improvement in data quality and user convenience will be validated after the eDiary is implemented. Overall, the eDiary demonstrated reduced patient and caregiver burden.
Learn more about WCG’s eDiary here.
Explore Accurate Symptom Reporting for your study
Complete the form to request a schedule a consultation. We’ll assess your needs, review our training service and demonstrate how WCG can transform symptom reporting for your study.