Recruitment targets, issues with recruitment and consent
CASTLE, seizure
RECRUITMENT, CASTLE, RECRUITMENT, SECONDARY, REMISSION, SAID
As a key part of quality control, throughout the internal pilot period of the trial, the CASTLE Trial Management Group performed monthly review of the trial screening data by site. The internal pilot trial aimed to assess recruitment and consent during the first 9 months of recruitment. We were guided by clear recruitment progression criteria (see Table Recruitment targetsWe were successful in site initiation; 31 sites were trained, and 29 trial sites were opened (seven more than our goal), most in secondary care paediatric centres. However, of these 29 sites, only 18 had screened at least one patient by month nine of the internal pilot. In total, 100 patients were screened (see Figs. Internal pilot screening and recruitment summaryRecruitment against original target in CASTLE pilotNon-consent for 19 of the 50 eligible patients (38%) was due to some parental preference about treatment: 14 did not want medication, three did not want ‘no treatment’, and two had a ‘treatment preference’ (one against carbamazepine, another in favour of any medication). One patient was too far along their natural course towards remission (seizure free for 4 years). Of the remaining 14 approached, three did not want to take part in research, one said it would be too time-consuming, parental responsibility was not clear for one family and the remaining nine did not provide a reason.