Consultation with health professionals undertaking recruitment
seizures
CASTLE, RECRUITMENT
In recognition of our recruitment challenges, we consulted paediatricians and research nurses responsible for recruitment during the internal pilot to engage in an exercise to understand their perceptions and experiences of recruitment to the trial. Having utilised the HRA decision tool (Despite the disruption to services resulting from the COVID-19 pandemic, 12 clinicians and two research nurses from 14 of the 29 sites shared their views (17th March–15th April 2020) as part of the consultation; seven clinicians and two research nurses were consulted via telephone and five clinicians responded to questions by email. A further five sites acknowledged our request but were unable to provide responses to our consultation as they had neither approached nor recruited families to participate in the trial. Of the 14 sites who engaged in the consultation, four had recruited a child/family, seven sites had experience of families declining to participate (Overall, clinicians were positive about the CASTLE trial considering it to be “However, a significant difficulty for individual sites was identifying potential participants who met the eligibility criteria. Some clinicians explained that fewer patients than expected (pre-trial commencement) met the trial eligibility criteria, typically noting that since the study opened eligible patients were simply “The families were reported as giving the clinicians various reasons for declining to participate in the CASTLE trial. Most frequently, the concept of randomisation in the CASTLE trial was reported as causing some unease amongst families where parents had commented that their child’s seizures were “However, despite the above challenges some initially reluctant families changed their minds about participating due to changing circumstances. One family was reported to have changed their mind after their child started “The clinicians reported that most of the families were interested in the sleep intervention and noted that “In summary, consultation with clinicians highlighted that some parents expressed strong medication related preferences; this meant randomisation to a potentially non-preferred arm discouraged parents. However, clinicians considered that the parent treatment preference issue was less likely to impact on recruitment to a trial that only involved randomisation to either sleep intervention plus usual care or usual care only.