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Education And Debate

Randomised trials in surgery: problems and possible solutions

BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7351.1448 (Published 15 June 2002) Cite this as: BMJ 2002;324:1448

Rapid Response:

Surgical trials: further thoughts

Dear Sir,

We found McCulloch et al’s article on randomised controlled trials
(RCTs) in surgery useful and of great interest.1 We support many of their
arguments. We add to their analysis some additional observations from our
experience. A major issue is funding.2,3 Surgeons are partly to blame for
this, and is a reflection of their general lack of epidemiological
expertise. For instance, while the epidemiological and trial design
reviews of research proposals may be excellent, surgical reviewers might
comment, inappropriately, that they do not see the need for a particular
trial as the options trialled may not be part of their normal practice.
Such views do not help the surgical community.

RCTs often need large numbers of patients to provide a scientifically
satisfactory answer. By nature, surgeons tend to be competitive
individualists. We therefore strongly support McCulloch et al’s view about
the need to facilitate collaboration to answer questions in surgery that
may have a major impact on public health and public health services. The
current competitive UK University Research Assessment Exercise does not
provide the environment which facilitates inter-unit collaboration, and
does not provide adequate recognition for collaborating units in RCTs.

The lack of commercial pressure to undertake research is another
factor. Companies introducing new devices do not generally need to
evaluate their interventions by RCTs. In our field, Trauma and
Orthopaedics, there are hundreds of different manufacturers of essentially
the same device(s). The high costs of RCTs disadvantage manufacturers who
would like to better evaluate them: they would not be able to compete if
they undertook randomised evaluations and their competitors did not.

McCulloch et al were brave to raise the almost unspeakable: some
surgeons may be strongly influenced by financial gain. In this respect,
surgeons are no different than commercial companies: profit is king, not
science and health. A challenge for the Surgical Colleges and their
membership is to move forward from their traditional “gentleman’s club”
culture to a truly scientific and health focussed one. They need to
collaborate on priorities for research, lobby for the funds to sponsor
these trials, include participation in trials as part of their
accreditation of units and individuals, and ensure that academic surgeons
are adequately trained in epidemiological methods. A barrier for academic
surgeons is the inequality in their financial compensation compared to non
-academic surgeons. These surgeons put themselves out on a limb, earn much
less than jobbing surgeons, and meet barriers in the NHS to pursue
excellence in surgery through trials and adequate research.

Surgical trials involve an element of “skill” that pharmaceutical
trials do not, and probably require more funding than pharmaceutical
trials. In particular, McCulloch et al mention the need to video
operations. We strongly support this - such videos should be considered
part of the archive of evaluations of surgical interventions so that later
scientists can satisfy themselves first hand.

Finally, the NHS still has a strong element of commissioning by
“bean” counting, irrespective of the scientific evidence justifying
policies or interventions in individual cases. We spend millions on
waiting-list initiatives. Perhaps, the NHS is missing a trick by not
employing academic and evidence-based trained surgeons and epidemiologists
to work on evidence-based demand management, with the reward of research
funds for trials for those identifying key questions that will impact on
demand.

Dr Stephen Bridgman, Head of Surgical Trials, Epidemilogy and Public
Health Reseach Unit, University of Keele, and Director of Public Health
Newcastle-under-Lyme Primary Care Trust and

Professor Nicola Maffulli, Professor of Orthopaedic Surgery
University of Keele, and Consultant Orthopaedic Surgeon North
Staffordshire Hospital Trust

References

Johnson AG, Dixon JM. Removing bias in surgical trials. BMJ, 1997,
314, 916-7.

McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised
trials in surgery: problems and possible solutions. BMJ, 2002, 324, 1448-
1451.

Bridgman SA, Elder J, Gray R, Lilford R. Funding is important for
randomised trials of surgery. BMJ, 315, 310, 1997.

Competing interests: No competing interests

05 July 2002
Stephen A Bridgman
Senior Lecturer
Nicola Maffulli
School of Medicine, University of keele, Medical Research Unit, Thornburrow Drive, Hartshill, Stoke-