Kulikov, Yuri, Parsons, Nicholas R. and Griffin, Damian R. (2013) Best clinical care versus the common good of research : a solution for challenging surgical trials. The Lancet, Volume 381 . S60. doi:10.1016/S0140-6736(13)60500-0 ISSN 0140-6736.

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Abstract

Randomised controlled trials (RCTs) in surgery are expensive and labour intensive, yet considerable concern remains about applicability of results in clinical practice. Apart from quality issues, this lack of applicability is often due to strict eligibility criteria leading to selection bias. In addition, only a small proportion of eligible patients are randomised, since both clinicians and patients are rarely in equipoise and do not feel comfortable being excluded from the decision making process, especially when substantially different procedures (such as open versus minimally invasive or operative versus non-operative interventions) are compared or surgical innovations are involved.

The Patient Eligibility Assessment through Clinical Equipoise (PEACE) methodological framework is introduced. In this framework, every provisionally eligible patient is regarded as a complex case which is assessed on line by an expert panel. Collected opinions including that of the submitting surgeon are processed to calculate the level of clinical equipoise. A sufficient level of equipoise for random treatment allocation is confirmed or a panel consensus in preference for a certain treatment is advised.

The proposed framework was developed and panel assessment tested in collaboration with a national multicentre trauma randomised controlled trial comparing operative and non-operative interventions. 12 surgeons from nine hospitals acting as principal investigators in the trial formed the expert panel and assessed 77 real clinical cases eligible according to standard inclusion and exclusion criteria during the 3 year course of the trial.

Because every case is assessed for eligibility, initial entrance criteria can be pragmatic and less specific than with the standard approach. A treating surgeon is involved in the decision process through submitting an opinion and has the backing of an expert panel when treatment options and trial participation is discussed with a patient. Cases where there is treatment consensus can also be researched, but should not be randomised on ethical grounds.

Item Type:	Journal Article
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Journal or Publication Title:	The Lancet
Publisher:	Lancet Publishing Group
ISSN:	0140-6736
Official Date:	27 February 2013
Dates:	Date Event 27 February 2013 Published
Volume:	Volume 381
Page Range:	S60
DOI:	10.1016/S0140-6736(13)60500-0
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access

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