Abstract
Introduction
There is an ever increasing demand for Randomised Controlled Trials (RCTs) in Trauma and Orthopaedic Surgery. Patient recruitment is often challenging. Among other factors, individual surgeon's preference is often quoted as a major obstacle. Collective equipoise based on present or imminent controversy in the expert medical community has been proposed as a solution, but could not help in everyday running of a trial. We wanted to develop a new trial eligibility assessment tool using the Collective Equipoise Principle.
Methods
We developed an online system that quantifies collective uncertainty among a group of surgeons for an individual clinical case in real time. This data was collected for patients in the UK Heel Fracture Trial (UK HeFT) as an independent research project. Both patients who agreed or not to take part in the trial were approached in six weeks follow up clinic to avoid interference with clinical course. For those who agreed, anonymous clinical data together with images (Xrays and CT) was published on a secure on line forum and registered surgeons were alerted via email and SMS. Surgeons submitted their opinion instantly via specially designed interactive voting scale. 80:20 ethical uncertainty distribution limit was applied using Subjective Logic to calculate an Uncertainty Index (UnIx) for every patient. This approach was evaluated as an eligibility assessment tool for RCTs.
Results
70 consecutive patients (77 calcaneal fractures) were assessed by a panel of 12 Consultant Trauma surgeons from hospitals acros the UK. All patients were eligible for the UK HeFT according to standard eligibility criteria approach. UnIx demonstrated reliable correlation with level of uncertainty and confidence about treatment choice expressed by surgeons. The panel was certain about treatment for 9 (13%) patients. The assesment results were available within 48 hours from a case submission to the panel.
Discussion and Conclusion
UnIx is an effective and ethical eligibility assessment tool based on surgeon's opinion. It can be calculated for every patient in Randomised Controlled Trials. This protects patients when there is no controversy about treatment choice. UnIx can potentially increase patient recruitment by including more patients for eligibility assessment and more sceptical surgeons in clinical trials. Patient's perception that his/her condition was assessed by surgical panel may also be important.
