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. 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.Introduction
Methods
There is an ever increasing demand for quality clinical trials in surgery. Surgeons' co-operation and enthusiasm to participate are important, if not crucial in success of such studies, especially if they are multi-centred. Clinician's individual uncertainty (equipoise) about a case has been often cited as an ethical basis for inviting a patient to take part in a clinical trial. This study aims to establish current attitudes of surgeons participating in a national multi-centred randomised controlled trial and explores an on line tool for instant assessment of collective uncertainty (equipoise) for individual clinical cases eligible for a trial. Surgeons taking part in the UK Heel Fracture Trial were invited to take part. If agreed, they were asked to evaluate treatment prognosis for eligible for the trial anonymised cases of calcaneal fractures online by means of specially designed system. The cases were published on a password protected website on ad-hoc basis during the three years course of the trial. Their responses were submitted instantly on line.Study aim
Study design
Randomised controlled clinical trials (RCTs) produce the most reliable evidence about the effects of clinical care. In surgical trials, lack of surgeons’ individual equipoise (state of genuine uncertainty about treatment arms) appears to be one of the greatest obstacles. Collective equipoise based on present or imminent controversy in the expert medical community has been proposed as a solution (Freedman, 1987), but could be applied only at the beginning of a trial to a general trial question. We developed a system that quantifies collective uncertainty among a group of surgeons for an individual clinical case. After a successful pilot study the system was introduced as an independent project within the UK Heel Fracture Trial. The expert panel included 10 surgeons from 8 hospitals. Anonymous clinical data of potentially eligible consecutive cases including CT and X-ray images was published on a secure online forum after 6 weeks follow up clinic to avoid interference with clinical course. Surgeons registered in the panel estimated the probability that the patient would be better or worse by various degrees with operative treatment. 30 clinical cases have been analysed, including 6 bilateral fractures (otherwise excluded). 86.7% could be recommended for inclusion in the trial, compared to 43.3% recruited out of this series in the actual trial. Lack of individual uncertainty within the panel was present in every case. The system not only has a potential to improve recruitment in surgical RCTs, but provides ethically sound grounds to offer or otherwise a patient participation in a trial. Surgeon’s individual equipoise dilemma and responsibility is shared with colleagues. Cases that otherwise will be excluded can be evaluated with broader inclusion criteria. The system is easy to use, cheap and reliable. Limitations include surgeons’ compliance and time lapse (at least 48 hours) for voting to be completed.
