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Why the TimeToStop trial failed to recruit: a survey on antiepileptic drug withdrawal after paediatric epilepsy surgery
Author(s) -
Lamberink Herm J.,
Geleijns Karin,
Otte Willem M.,
Arzimanoglou Alexis,
Helen Cross J.,
Korff Christian M.,
Ramantani Georgia,
Braun Kees P.J.
Publication year - 2018
Publication title -
epileptic disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.673
H-Index - 53
eISSN - 1950-6945
pISSN - 1294-9361
DOI - 10.1684/epd.2018.1003
Subject(s) - medicine , epilepsy , retrospective cohort study , antiepileptic drug , drug withdrawal , epilepsy surgery , pediatrics , drug trial , drug resistant epilepsy , clinical trial , cohort , randomized controlled trial , anesthesia , drug , psychiatry , surgery
Aims . Following the results of the multicentre European retrospective “TimeToStop” cohort study, we initiated a randomised trial to determine cognitive benefits of early postoperative antiepileptic drug withdrawal. Unfortunately, the trial failed to recruit and was terminated, as almost all parents preferred early drug withdrawal. The objectives of the current survey were to obtain insight into current practices regarding drug withdrawal after paediatric epilepsy surgery among epileptologists, and better understand the reasons for difficulties in recruitment. Methods . A survey was sent to three international epilepsy surgery networks, questioning drug withdrawal policies. Forty‐seven (19%) surveys were returned. Results . For polytherapy, withdrawal was started at a median of three and six months by the TimeToStop collaborators and other paediatric epileptologists, respectively. Withdrawal was completed at a median of 12 and 20 months, respectively. For monotherapy, tapering was initiated at five and 11 months in these two groups, and ended at a median of seven and 12 months, respectively. Most TimeToStop collaborators believed that it was not justified to wait 12 months after surgery before reducing AEDs, regardless of the number of AEDs taken. Conclusion . Current AED policies in Europe have changed as a consequence of the retrospective TimeToStop results, and this accounts for why recruitment in a randomised trial was not feasible.