Abstract
Study aim
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.
Study design
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.
Results
16 out of 24 surgeons agreed to participate. The participating surgeons were emailed links to cases (normally in butches of three) less than once a month. It took them 10-15 min to assess all three cases via interactive interface. Of those who agreed 12 submitted their opinion at least once. 7 voted consistently during the course of the trial. Seventy one cases had been published. The data collected from responses allowed to assess individual and collective uncertainty about clinical cases. 4 surgeons demonstrated tendency towards individual uncertainty, balanced by 4 who did not accept it. However, sufficient collective uncertainty was demonstrated in 84.5% of cases.
Discussion
Level of surgeons' enthusiasm towards clinical research appears to be moderate in a selected population of orthopaedic surgeons who already agreed to take part in a randomised clinical trial, despite a very low research time burden of this study. It is important to continue to promote multi-centred studies in order to improve surgeons' attitude towards quality clinical research. Extra efforts by academic clinicians to develop further low research time burden methodologies may increase acceptance and volume of multi-centred clinical research.
This study supports previously expressed view that individual uncertainty is a very unreliable and unnecessary justification to offer a subject to take part in a clinical trial. The system used in the study offers surgeons to express their opinions and preferences freely. The instant on line comparison of opinions provides a clear assessment of collective uncertainty, which can be returned to a treating surgeon and a patient him/herself within 48 hours. In absence of collective uncertainty it would be ethical to offer a patient the best treatment according to current opinion. These cases can then be followed up as part of an inclusive trial, if a subject agrees. We believe that using the system may improve decision making process in randomised controlled trials, for example in selected challenging cases.
