How to improve surgical research

Jane Blazeby is Professor of Surgery, University of Bristol, Director
of the MRC ConDuCT Hub for Trials Methodology Research and is an Honorary
Consultant Surgeon; Mark Eveleigh and Natalie Blencowe are NIHR Academic
Surgical Trainees.

We agree with McCulloch's editorial highlighting the urgent need to
change attitudes, training and infrastructure for surgical research (1).
We also agree that fundamental to achieving this culture change is the
requirement for surgeons to work with methodologists to design high
quality multi-centre studies. One design aspect of surgical trials
however, that hitherto has not been widely recognised, is that surgical
interventions are complex and thus their evaluation (and funding for that
purpose) needs to take this into account (2).

Surgery has multiple independent and inter-dependent components, such
as the surgeon and team expertise, availability and quality of equipment,
and the type of anaesthetic and aftercare; all factors which may
individually or synergistically influence outcomes. Designing and
conducting surgical trials therefore, requires consideration of this
complexity, which may be achieved by application of the MRC framework for
evaluation of complex healthcare interventions (3). This means that
development and feasibility work are necessary prior to a full phase-3
trials in surgery (4). During early iterative phases of trial development,
documentation and identification of the key components of the surgical
intervention, concomitant procedures and contextual factors are necessary
so that the intervention can be understood and 'manualised' ready for the
phase-3 trial. In the full trial, surgeons and centres may follow the
manual (with agreed boundaries of optional, mandatory and prohibited
components in the surgical intervention) and fidelity to this can be
monitored, so that trial results may be believed and subsequently
reproduced and implemented in practice (5).

This detailed approach to evaluation of surgical interventions in
trials may mean that they are more expensive and investment into the
creation of a surgical network for trial recruitment will also be
necessary as McCulloch recommends (1). However, these short term hurdles
need to be considered within the longer term provision of surgery in the
NHS. Creation of evidence based surgery (rather than eminence based) will
set standards for surgery and hospitals. It will mean that surgeons will
be able to offer and deliver fully evaluated interventions, with
comparative data and outcomes available to inform choice as well as
minimise complications and costs. The challenge we face now is to see if
methodologists and surgeons can work to together to achieve this and,
crucially, whether funding bodies have the resolve to see it through.

References

1. McCulloch P. How to improve surgical research. BMJ 2011;
343:d4121.

2. Ergina PL, Cook JA, Blazeby JA, Boutron I, Clavein P, Reeves BC,
Seiler CM. for the Balliol Collaboration. Surgical innovation and
evaluation 2: Challenges in evaluating surgical innovation. Lancet.
2009;374:1097-1104.

3. Medical Research Council. A framework for the development and
evaluation of RCTs for complex interventions to improve health. London:
MRC, 2000.

4. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M.
Developing and evaluating complex interventions: the new Medical Research
Council guidance. BMJ 2008;337:a1655.

5. Glasziou P, Chalmers I, Altman DG, Bastian H, Boutron I, Brice A,
Jamtvedt G, Farmer A, Ghersi D, Groves T, Heneghan C, Hill S, Lewin S,
Michie S, Perera R, Pomeroy V, Tilson J, Shepperd S, Williams JW. Taking
healthcare interventions from trial to practice. BMJ 2010;341:c3852.