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Open Access Research

Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility

MK Campbell1*, VA Entwistle2, BH Cuthbertson3, ZC Skea1, AG Sutherland4, AM McDonald1, JD Norrie5, RV Carlson6, S Bridgman7 and KORAL study group1

Author Affiliations

1 Health Services Research Unit, University of Aberdeen, Aberdeen, UK

2 Social Dimensions of Health Institute, Universities of Dundee and St Andrews, UK

3 Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada

4 Department of Surgery, University of Aberdeen, Aberdeen, UK

5 Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK

6 Centre for Medical Education, University of Edinburgh, Edinburgh, UK

7 University Hospital of North Staffordshire NHS Trust, Staffordshire, UK

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Trials 2011, 12:50  doi:10.1186/1745-6215-12-50

Published: 21 February 2011

Abstract

Background

Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK.

Methods

Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed).

Results

There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot.

Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully.

Conclusions

Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this controversy, and the challenges that exist even when ethics committee approval has been granted. It showed that a placebo-controlled trial could be conducted in principle, albeit with difficulty. It also highlighted that not only does a placebo-controlled trial in surgery have to be ethically and scientifically acceptable but that it also must be a feasible course of action. The place of placebo-controlled surgical trials more generally is likely to be limited and require specific circumstances to be met. Suggested criteria are presented.

Trial registration number

The trial was assigned ISRCTN02328576 through http://controlled-trials.com/ webcite in June 2006. The first patient was randomised to the pilot in July 2007.