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. 2020 Aug 26;10(8):e040635. doi: 10.1136/bmjopen-2020-040635

Table 3.

Schedule of follow-up

Procedures Baseline (T0)* Follow-up schedule
T0+3 months T0+6 months T0+12 months and annually thereafter
Signed consent form X
Assessment of eligibility criteria X
Contact details X
Review of medical history including: X
  • Seizure history

  • Neurological insult

  • Febrile seizures

  • Family history of epilepsy

  • EEG results

  • Imaging results (CT or MRI)

Further investigation (EEG/CT/MRI) (X)
Allocation of study treatment X
Issue of questionnaires in person or by post X X X X
Review of seizure occurrence and hospital admissions X X X
Review of AED use (study treatment and concomitant):
  •  Since last follow-up

X X X
  •  Changes made to treatment plan including reasons

Assessment of adverse reactions (X) (X) (X)
Resource use X X X
Reissue of questionnaire by post or at site to non-responders typically 3 weeks later (X) (X) (X) (X)
Telephone follow-up of questionnaire non-responders typically 3 weeks later (X) (X) (X) (X)
Special assay or procedure consent and obtain saliva or blood sample for later DNA analysis Consent and obtain saliva or blood sample for later DNA analysis (X)

(X)—as indicated/appropriate.

EEG = Electroencephalogram

*At baseline, all procedures should be done before study intervention.

AED, antiepileptic drug.