An online diary for tracking epilepsy

Le, Scheherazade; Shafer, Patricia Osborne; Bartfeld, Eyal; Fisher, Robert S.

doi:10.1016/j.yebeh.2011.08.035

Cited by 44 publications

(49 citation statements)

References 26 publications

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“…Although it is certainly true that such data has some reliability concerns, it is important to reflect on the fact that all outpatient epilepsy drug trials to date rely on self‐reported seizure records, almost always recorded on paper diaries. Paper diaries are likely less reliable than electronic diaries for seizures, though this has yet to be demonstrated conclusively 5, 13. SeizureTracker.com data has the additional limitation that diagnoses are by self‐report, rather than with physician review, raising the possibility that at least some of the data used for this study may have come from patients who do not truly have epilepsy 10.…”

Section: Discussionmentioning

confidence: 94%

Monte Carlo simulations of randomized clinical trials in epilepsy

Goldenholz

Tharayil

Moss³

et al. 2017

Ann Clin Transl Neurol

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BackgroundThe placebo response in epilepsy randomized clinical trials (RCTs) has recently been shown to largely reflect underlying natural variability in seizure frequency. Based on this observation, we sought to explore the parameter space of RCT design to optimize trial efficiency and cost.MethodsWe used one of the world's largest patient reported seizure diary databases, SeizureTracker.com to derive virtual patients for simulated RCTs. We ran 1000 randomly generated simulated trials using bootstrapping (sampling with replacement) for each unique combination of trial parameters, sweeping a large set of parameters in durations of the baseline and test periods, number of patients, eligibility criteria, drug effect size, and patient dropout. We studied the resulting trial efficiency and cost.ResultsA total of 6,732,000 trials were simulated, drawing from 5097 patients in the database. We found that the strongest regression predictors of placebo response were durations of baseline and test periods. Drug effect size had a major impact on trial efficiency and cost. Dropout did not have a major impact on trial efficiency or cost. Eligibility requirements impacted trial efficiency to a limited extent. Cost was minimized while maintaining statistical integrity with very short RCT durations.DiscussionThis study suggests that RCT parameters can be improved over current practice to reduce costs while maintaining statistical power. In addition, use of a large‐scale population dataset in a massively parallel computing analysis allows exploration of the wider parameter space of RCT design prior to running a trial, which could help accelerate drug discovery and approval.

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Section: Discussionmentioning

confidence: 94%

Monte Carlo simulations of randomized clinical trials in epilepsy

Goldenholz

Tharayil

Moss³

et al. 2017

Ann Clin Transl Neurol

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show abstract

“…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.…”

Section: Prior Diary Studiesmentioning

confidence: 99%

Use of an online epilepsy diary to characterize repetitive seizures

Fisher¹,

Bartfeld²,

Cramer

2015

Epilepsy & Behavior

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“…Recently, there have been many attempts to encourage self-management in epilepsy patients using the internet [14][15][16][17][18][19]. However, some epilepsy patients, such as veterans, do not use the internet as a source of information [20].…”

Section: Introductionmentioning

confidence: 99%