Background: The paediatric diabetes team at our Childrens Hospital were part of a national clinical trial considering whether long term outcomes are better for patients on MDI (multiple daily injection therapy) or insulin pump therapy from diagnosis. Patients and their families had to be approached, consented and treatment for the trial commenced within two weeks of diagnosis. Many centres struggled to recruit, but this was not the case with our centre.
Aim: Our aim was to maximise recruitment into the clinical trial, considering all ethical and practical issues.
Methodology: We looked at what contributed to our successful recruitment strategy. Families were approached at the very first meeting and the research discussed alongside the initial diabetes education and discussion of the diagnosis. Repetitive discussion of the study at each subsequent meeting, in a positive manner, gave the families the knowledge to make informed choices. Families were also shown pumps as well as injection devices, so that they had some understanding of what they were undertaking. All eligible families were approached; including families whose first language was not English, children with autism and those with safeguarding needs. The whole team discussed the study and every team member was equally committed to its success. Patients were all recruited before they had left the hospital after the initial diagnosis, even if they had to return to start pump therapy.
Conclusions: Several factors led to the success of over 60 patients being recruited (more than double the initial target). All members of the team (PDSNs, Consultants, dietitians and support workers) - fully embraced the study within the already established research culture of the Childrens Hospital. The diabetes team ensured that the patients and families best interests were primary, balancing a strong belief in the study with maintenance of the families newly built trust in our service and provision of the very best care.
23 - 25 Nov 2016
British Society for Paediatric Endocrinology and Diabetes