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

Campbell, M. K., Entwistle, V. A., Cuthbertson, B. H., Skea, Z. C., Sutherland, A. G., McDonald, A. M., Norrie, J. D., Carlson, R. V., Bridgman, S., Cotton, Seonaidh, Donaldson, Angela, Fitzpatrick, Ray, Grant, Adrian, Gray, Alistair, Hutchison, James, Johnston, Marie, Murray, David, Ramsay, Craig, Rowley, David, Vale, Luke and Wigderowitz, Carlos 2011, Developing a placebo-controlled trial in surgery : issues of design, acceptability and feasibility, Trials, vol. 12, no. 50, pp. 1-12.

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Title Developing a placebo-controlled trial in surgery : issues of design, acceptability and feasibility
Author(s) Campbell, M. K.
Entwistle, V. A.
Cuthbertson, B. H.
Skea, Z. C.
Sutherland, A. G.
McDonald, A. M.
Norrie, J. D.
Carlson, R. V.
Bridgman, S.
Cotton, Seonaidh
Donaldson, Angela
Fitzpatrick, Ray
Grant, Adrian
Gray, Alistair
Hutchison, James
Johnston, Marie
Murray, David
Ramsay, Craig
Rowley, David
Vale, Luke
Wigderowitz, Carlos
Journal name Trials
Volume number 12
Issue number 50
Start page 1
End page 12
Total pages 12
Publisher BioMed Central Ltd
Place of publication London, England
Publication date 2011-02-21
ISSN 1745-6215
Keyword(s) surgery
feasibility
placebo
Summary 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.
Language eng
Field of Research 110323 Surgery
Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences
HERDC Research category C1.1 Refereed article in a scholarly journal
Copyright notice ©2011, Campbell et al; licensee BioMed Central Ltd
Persistent URL http://hdl.handle.net/10536/DRO/DU:30044461

Document type: Journal Article
Collection: School of Medicine
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