Tracking epilepsy with an electronic diary

Department of Neurology, Stanford University School of Medicine, Stanford, CA 94305-5235, USA.
Acta Paediatrica (Impact Factor: 1.67). 04/2010; 99(4):516-8. DOI: 10.1111/j.1651-2227.2010.01694.x
Source: PubMed
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    • "Studies of patients who have clusters of seizures have mostly been small and short-term. In contrast, web and mobile-based epilepsy diaries [11] [12] [13] provide novel opportunities to gather self-reported seizure cluster information on very large populations of people with epilepsy. My Epilepsy Diary (MED), developed by the Epilepsy Therapy Project (now conjoined with the Epilepsy Foundation) and Irody, Inc., is a resource used by approximately 30,000 people with epilepsy. "

    Full-text · Dataset · Dec 2015
    • "Several publications from the last 15 years, however, provided unambiguous evidence that patient-reported seizure counts lack validity due to underreporting [6–15,17,23–25,31]; for review see: [1] [11] [16]. For instance, in one recent study using implanted electrodes, patient-reported seizure documentation appeared more or less unrelated to objective seizure records [7]. "

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    • "A review of patient‐reported outcomes (PROs) in epilepsy [35] listed 61 articles involving design and validation of PROs, including scales for Quality of Life, Seizure Severity and Psychosocial Inventories but none analyzing diaries, which is perhaps the most fundamental PRO. Under ideal circumstances, diaries developed for research and clinical trials would also be useful for direct patient care [15]. Seizure diaries have already been found to be useful for patient-based prediction of subsequent seizures [19]. "
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    ABSTRACT: An NINDS-sponsored conference in April of 2011 reviewed issues in epilepsy clinical trials. One goal was to clarify new electronic methods for recording seizure information and other data in clinical trials. This selective literature review and compilation of expert opinion considers advantages and limitations of traditional paper-based seizure diaries in comparison to electronic diaries. Seizure diaries are a type of patient-reported outcome. All seizure diaries depend first on accurate recognition and recording of seizures, which is a problem since about half of seizures recorded during video-EEG monitoring are not known to the patient. Reliability of recording is another key issue. Diaries may not be at hand after a seizure, lost or not brought to clinic visits. On-line electronic diaries have several potential advantages over paper diaries. Smartphones are increasingly accessible as data entry gateways. Data are not easily lost and are accessible from clinic. Entries can be time-stamped and provide immediate feedback, validation or reminders. Data can also can be graphed and pasted into an EMR. Disadvantages include need for digital sophistication, higher cost, increased setup time, and requiring attention to potential privacy issues. The Epilepsy Diary by and Irody, Inc. has over 13,000 registrants and SeizureTracker over 10,000, and both are used for clinical and research purposes. Some studies have documented patient preference and increased compliance for electronic versus paper diaries. Seizure diaries can be challenging in the pediatric population. Children often have multiple seizure types and limited reporting of subjective symptoms. Multiple caregivers during the day require more training to produce reliable and consistent data. Diary-based observational studies have the advantages of low cost, allowing locus-of-control by the patient and testing in a "real-world" environment. Diary-based studies can also be useful as descriptive "snapshots" of a population. However, the type of information available is very different from that obtained by prospective controlled studies. The act of self-recording observations may itself influence the observation, for example, by causing the subject to attend more vigilantly to seizures after changing medication. Pivotal anti-seizure drug or device trials still mostly rely on paper-based seizure diaries. Industry is aware of the potential advantages of electronic diaries, particularly, the promise of real-time transmission of data, time-stamping of entries, reminders to subjects, and potentially automatic interfaces to other devices. However, until diaries are validated as research tools and the regulatory environment becomes clearer, adoption of new types of diaries as markers for a primary study outcome will be cautious. Recommendations from the conference included: further studies of validity of epilepsy diaries and how they can be used to improve adherence; use and further development of core data sets, such as the one recently developed by NINDS; encouraging links of diaries to electronic sensors; development of diary privacy and legal policies; examination of special pediatric diary issues; development of principles for observational research from diaries; and work with the FDA to make electronic diaries more useful in industry-sponsored clinical trials.
    Full-text · Article · May 2012 · Epilepsy & Behavior
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