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Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop
David J Beard1, Marion K Campbell2, Jane M Blazeby3
1Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Health Technology Assessment (Winchester, England)
|September 10, 2021
Summary
Placebo controls in surgical trials are justified with a strong scientific and ethical rationale, especially when evidence is limited. The ASPIRE guidelines offer best practices for designing and conducting these complex randomized controlled trials.
Area of Science:
- Medical research methodology
- Surgical trial design
- Clinical ethics
Background:
- Placebo controls in randomized trials for surgical interventions are increasingly considered.
- Surgical placebo controls present unique challenges despite their potential power.
Purpose of the Study:
- To summarize existing knowledge on placebo controls in surgical trials.
- To develop recommendations for designing, evaluating, and funding placebo-controlled surgical trials.
Main Methods:
- A state-of-the-art workshop involving key stakeholders was conducted.
- Existing knowledge was discussed and summarized to develop new guidelines.
Main Results:
- Placebo controls are justified in surgical trials with strong scientific and ethical rationale.
- Surgical placebos are most appropriate when evidence of efficacy is poor and bias risk is high due to the placebo effect.
Conclusions:
- Placebo-controlled surgical trials are justified under specific conditions.
- Feasibility work is recommended to optimize trial design and implementation.
- The ASPIRE (Applying Surgical Placebo in Randomised Evaluations) guidelines provide a best practice framework.
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