Table 5.

Key points from SANAD-II trial

Trial name (registration)	SANAD-II28 29 (ISRCTN30294119)
Sponsorship	Academic – Liverpool.
Clinical setting	Epilepsy.
Design	Randomised controlled trial.
Size	N=1510.
Key outcome measure	Time to 12 months without seizure.
Rationale for presentation	Analysis and interpretation.
Key discussion points	The SANAD-II trial. SANAD-II is a pragmatic, UK, multicentre, phase IV randomised controlled trial funded by the National Institute for Health Research Health Technology Assessment programme, assessing the clinical and cost-effectiveness of a number of antiepileptic drugs as first-line treatments for newly diagnosed epilepsy. The primary outcome measure related to a period without seizures. These data were recorded on case report forms (CRFs) by the treating clinical team at outpatient visits. In a study of 98 patients, the team found the seizures were poorly recorded in EHR. Using only EHR data estimated that 74% of patients had spent 1 year seizure free, whereas using only CRF data estimated that only 46% of patients had spent 1 year seizure free. This is a clinically important difference. Researchers need to be able to trust in the completeness of EHR data to use them in reliable analyses or to understand how these data might supplement CRFs. This example cautions against naïve use of routinely collected EHR data.

EHRs, electronic healthcare records; SANAD-II, Standard and New Antiepileptic Drugs II.