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Developing a placebo-controlled trial in surgery: issues of design, acceptability and feasibility
M K Campbell1, V A Entwistle, B H Cuthbertson
1Health Services Research Unit, University of Aberdeen, Aberdeen, UK. m.k.campbell@abdn.ac.uk
Trials
|February 23, 2011
Summary
Designing surgical placebo trials for knee osteoarthritis is complex. While feasible, placebo-controlled studies face ethical debates and practical challenges, limiting their general use.
Area of Science:
- Orthopaedic Surgery
- Clinical Trials
- Medical Ethics
Background:
- Surgical placebos are a controversial topic in clinical research.
- This study investigated the design, acceptability, and feasibility of a surgical placebo-controlled trial for arthroscopic lavage in knee osteoarthritis management.
- The trial was registered as ISRCTN02328576, with the first patient randomized in July 2007.
Purpose of the Study:
- To explore the complexities of designing and conducting placebo-controlled surgical trials.
- To evaluate the clinical and cost-effectiveness of arthroscopic lavage for knee osteoarthritis using a placebo control.
- To assess stakeholder acceptability and feasibility of surgical placebo interventions.
Main Methods:
- Conducted focus groups and interviews with surgeons, anaesthetists, patients, and ethics committee chairs.
- Utilized postal surveys for orthopaedic surgeons and anaesthetists.
- Performed a two-centre pilot study involving 49 patients.
Main Results:
- Widespread agreement that placebo control is necessary for scientific rigor in evaluating arthroscopic lavage.
- Placebo surgical procedures (three small incisions) were feasible, but general anaesthesia presented challenges.
- Patients were willing to participate, though some withdrew due to apprehension about receiving placebo surgery.
Conclusions:
- Surgical placebo-controlled trials are ethically contentious and practically challenging, even with ethics approval.
- While a placebo-controlled trial for arthroscopic lavage is feasible in principle, its application faces difficulties.
- The use of placebo-controlled surgical trials is likely limited to specific circumstances requiring careful consideration of ethical and practical factors.
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