BMJ  2005;330:88 (8 January), doi:10.1136/bmj.330.7482.88

Education and debate

Need for expertise based randomised controlled trials

P J Devereaux, assistant professor1, Mohit Bhandari, orthopaedic surgeon2, Mike Clarke, director3, Victor M Montori, assistant professor4, Deborah J Cook, professor1, Salim Yusuf, professor5, David L Sackett, director6, Claudio S Cinà, vascular surgeon2, S D Walter, professor1, Brian Haynes, professor1, Holger J Schünemann, associate professor7, Geoffrey R Norman, professor1, Gordon H Guyatt, professor1

1 Department of Clinical Epidemiology and Biostatistics, McMaster University, 1200 Main Street, West Hamilton ON, Canada L8N 3Z5, 2 Department of Surgery, McMaster University, 3 UK Cochrane Centre, Oxford, 4 Department of Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota, United States, 5 Population Health Research Institute, McMaster University, 6 Trout Research and Education Centre of Irish Lake, Markdale, Ontario, Canada, 7 Departments of Medicine and Social and Preventive Medicine, University at Buffalo, Buffalo, New York, United States

Correspondence to: P J Devereaux, philipj@mcmaster.ca

Surgical procedures are less likely to be rigorously evidence based than drug treatments because of difficulties with randomisation. Expertise based trials could be the way forward

The first 150 words of the full text of this article appear below.

Introduction

Although conventional randomised controlled trials are widely recognised as the most reliable method to evaluate pharmacological interventions,1 2 scepticism about their role in nonpharmacological interventions (such as surgery) remains.3-6 Conventional randomised controlled trials typically randomise participants to one of two intervenions (A or B) and individual clinicians give intervention A to some participants and B to others. An alternative trial design, the expertise based randomised controlled trial, randomises participants to clinicians with expertise in intervention A or clinicians with expertise in intervention B, and the clinicians perform only the procedure they are expert in. We present evidence to support our argument that increased use of the expertise based design will enhance the validity, applicability, feasibility, and ethical integrity of randomised controlled trials in surgery, as well as in other areas. We focus on established surgical interventions rather than new surgical procedures in which clinicians have not established expertise.

Use of expertise based trials

Investigators have used . . . [Full text of this article]

Problems with validity of conventional randomised controlled trials

Differential expertise between procedures
Potential problems related to unblinded surgeons
-->Procedural crossovers

Validity of surgical expertise based randomised controlled trials

Applicability of expertise based randomised controlled trials

Feasibility

Ethics

Applicability to non-surgical areas


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Rapid Responses:

Read all Rapid Responses

Whats the Point?
girish chawla
bmj.com, 7 Jan 2005 [Full text]
Randomised trials in surgery are valueless?
Richard G Fiddian-Green
bmj.com, 8 Jan 2005 [Full text]
Expertise or performance?
Gautham K Suresh
bmj.com, 8 Jan 2005 [Full text]
Shortfalls of expertise based design
Eric Lim
bmj.com, 8 Jan 2005 [Full text]
More questions than answers
Andrew Renaut, MS(Lond) FRCS(Gen) FRACS FDSRCS
bmj.com, 8 Jan 2005 [Full text]
Very interesting
Sanjay Dalmia
bmj.com, 11 Jan 2005 [Full text]
surgical expertise is not a status quo
javaid ahmad BUTT
bmj.com, 12 Jan 2005 [Full text]
Surgical research shares many similarities with psychotherapy research
Simon Hatcher
bmj.com, 19 Jan 2005 [Full text]
The varying effectiveness of surgeons
Simon G Thompson, et al.
bmj.com, 10 Feb 2005 [Full text]
Expertise based randomized trial design - more perspectives and questions
Swaroop S. Vedula, et al.
bmj.com, 26 Mar 2005 [Full text]

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