Bespoke design, build and maintenance (including updates) of trial specific pathway for BASIS within the British Spine Registry. This will allow direct data capture of research data as well as electronic consent for participation in the BASIS trial

Descriptions

The BASIS study is a clinical trial, funded by the NIHR HTA programme, aiming to investigate whether night time bracing is as good as full time bracing for patients with adolescent idiopathic scoliosis. The study involves around 20 UK NHS hospital trusts, and is coordinated by the Sheffield CTRU at the University of Sheffield, with Sheffield Children's Hospital as the lead site and Sponsor. At all participating NHS centres, there will be multiple consultants, spinal nurses, research nurses and orthotists involved in the study, and the study is being conducted mostly through electronic methods. Most UK spinal consultants and specialist nurses already use the British Spine Registry in their clinical work. It was therefore agreed at the point the funding application was made, that the British Spine Registry (provided by Amplitude) would be used for the electronic data collection and electronic consent for the BASIS study. As Amplitude could provide the required system within a similar cost profile to the UoS system "Prospect" that is mostly used in CTRU studies, and because most clinicians involved in the study are already familiar with the system, it was agreed that this would be used for BASIS, and alternatives did not need to be considered.