EURURO-5581; No. of Pages 1

Letter to the Editor

E U R O P E A N U R O L O G Y X X X ( 2 0 1 4 ) X X X – X X X

ava i lable at www.sc iencedirect .com

journa l homepage: www.europea nurology.com

Reply to Behnam Shakiba’s Letter to the Editor re:

Philipp Dahm, James N’Dow, Lars Holmberg, Freddie

Hamdy. The Future of Randomised Controlled Trials in

Urology. Eur Urol. In press. http://dx.doi.org/10.1016/

j.eururo.2014.01.015

We appreciate the insightful comments about our paper [1]

and a potential role for expertise-based randomised

controlled trials in urology. We agree entirely with Shakiba

that, as part of the quest for high-quality evidence, there is a

role and added value for such trials. In an expertise-based

trial, patients are randomised not only to one surgical

approach or more but also to individual dedicated skills for

performing the technique. This design addresses a specific

form of performance bias that may affect surgical trial

outcomes [2]. To date, only eight trials of this design have

been reported in the surgical literature, and none were

urology related [3].

The recommendations of the IDEAL Collaboration for the

assessment stage of surgical innovation specifically refers to

the expertise-based trial as a design that is suited to address

the specific challenge of differential experience and pref-

erences for a given approach [4]. An expertise-based trial

design, for example, would appear amenable to the rigorous

comparison of open versus robot-assisted laparoscopic

cystectomy in muscle-invasive bladder cancer. A recent

survey of urologists and gynaecologists also suggested that

an expertise-based trial design would be well received [5].

Such trials, however, may be difficult to conduct when

multiple centres are involved in recruiting patients for

randomisation to different procedures. In these instances,

quality assurance is essential in surgery, as it is in other

forms of treatment, such as radiation therapy. It is

imperative to ensure that participants will receive accept-

able standards of treatment to allow valid comparisons.

For instance, before including a specific surgeon as the

investigator responsible for delivering surgical treatments

within a clinical trial, one must ensure, through indepen-

dent audit if necessary, that the level of expertise is of

sufficiently high standard with acceptable outcomes and

DOIs of original articles: http://dx.doi.org/10.1016/j.eururo.2014.03.007, htt

Please cite this article in press as: Dahm P, et al. Reply to BehnamLars Holmberg, Freddie Hamdy. The Future of Randomised Cont10.1016/j.eururo.2014.01.015. Eur Urol (2014), http://dx.doi.org/

http://dx.doi.org/10.1016/j.eururo.2014.03.0060302-2838/Published by Elsevier B.V. on behalf of European Association of

would withstand the scrutiny of peer review. Evaluating

surgical skills objectively is challenging, and we agree

entirely that quality and expertise need to be taken into

account in every trial in which such skills are liable to affect

outcomes.

Conflicts of interest: The authors have nothing to disclose.

References

[1] Dahm P, N’Dow J, Holmberg L, Hamdy F. The future of randomised

controlled trials in urology. Eur Urol. In press. http://dx.doi.org/

10.1016/j.eururo.2014.01.015

[2] Devereaux PJ, Bhandari M, Clarke M, et al. Need for expertise based

randomised controlled trials. BMJ 2005;330:88.

[3] Scholtes VA, Nijman TH, van Beers L, Devereaux PJ, Poolman RW.

Emerging designs in orthopaedics: expertise-based randomized

controlled trials. J Bone Joint Surg Am 2012;94(Suppl 1):24–8.

[4] Cook JA, McCulloch P, Blazeby JM, et al. IDEAL framework for

surgical innovation 3: randomised controlled trials in the assess-

ment stage and evaluations in the long term study stage. BMJ 2013;

346:f2820.

[5] Bakali E, Pitchforth E, Tincello DG, et al. Clinicians’ views on the

feasibility of surgical randomized trials in urogynecology: results of

a questionnaire survey. Neurourol Urodyn 2011;30:69–74.

Philipp Dahma,b,*

James N’Dowc

Lars Holmbergd

Freddie Hamdye

aDepartment of Urology, University of Florida, Gainesville, FL, USAbMalcom Randall Veterans Affairs Medical Center, Gainesville, FL, USA

cAcademic Urology Unit, University of Aberdeen, Aberdeen, UKdCancer Epidemiology Group, King’s College London, London, UK

eNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

*Corresponding author. Department of Urology, University of Florida,

Box 100247, Gainesville, FL 32610, USA.

Tel. +1 3522736815; Fax: +1 3522737515.

E-mail address: p.dahm@urology.ufl.edu (P. Dahm).

March 10, 2014

Published online on March 18, 2014

p://dx.doi.org/10.1016/j.eururo.2014.01.015.

Shakiba’s Letter to the Editor re: Philipp Dahm, James N’Dow,rolled Trials in Urology. Eur Urol. In press. http://dx.doi.org/10.1016/j.eururo.2014.03.006

Urology.