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Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines)
David J Beard1, Marion K Campbell2, Jane M Blazeby3
1Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
Lancet (London, England)
|March 9, 2020
Summary
Surgical trials can use placebo controls when ethically justified and scientifically sound, especially for interventions with limited evidence. This approach helps mitigate bias and guides best practices for designing and interpreting these complex randomized controlled trials.
Area of Science:
- Medical research methodology
- Surgical innovation evaluation
Background:
- Placebo controls are increasingly considered for surgical intervention efficacy trials.
- Surgical placebo controls present unique complexities and challenges.
- Understanding their application is crucial for robust clinical trial design.
Purpose of the Study:
- To summarize knowledge on placebo controls in surgical randomized trials.
- To outline the ethical and regulatory considerations for surgical placebos.
- To provide guidance on designing, implementing, and interpreting such trials.
Main Methods:
- Literature review and synthesis of current understanding on placebo controls in surgery.
- Discussion of ethical arguments and regulatory requirements.
- Development of a best-practice outline and checklist (ASPIRE).
Main Results:
- Placebo controls in surgery are justified with strong scientific and ethical rationale.
- They are particularly valuable when intervention efficacy is poorly evidenced or bias risk is high.
- Feasibility work is recommended for optimal trial design and implementation.
Conclusions:
- Surgical placebo controls require careful consideration of scientific and ethical factors.
- The ASPIRE checklist offers guidance for conducting surgical placebo-controlled randomized trials.
- Best practices are essential for the valid assessment of surgical interventions.
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