How do US orthopaedic surgeons view placebo-controlled surgical trials? A pilot online survey study.
Michael H BernsteinMaayan N RosenfieldCharlotte BleaseMolly MagillRichard M TerekJulian SavulescuFrancesca L BeaudoinJosiah D RichKarolina Agnieszka WartolowskaPublished in: Journal of medical ethics (2022)
Randomised placebo-controlled trials (RPCTs) are the gold standard for evaluating novel treatments. However, this design is rarely used in the context of orthopaedic interventions where participants are assigned to a real or placebo surgery. The present study examines attitudes towards RPCTs for orthopaedic surgery among 687 orthopaedic surgeons across the USA. When presented with a vignette describing an RPCT for orthopaedic surgery, 52.3% of participants viewed it as 'completely' or 'mostly' unethical. Participants were also asked to rank-order the value of five different types of evidence supporting the efficacy of a surgery, ranging from RPCT to an anecdotal report. Responses regarding RPCTs were polarised with 26.4% viewing it as the least valuable (even less valuable than an anecdote) and 35.7 .% viewing it as the most valuable. Where equipoise exists, if we want to subject orthopaedic surgeries to the highest standard of evidence (RPCTs) before they are implemented in clinical practice, it will be necessary to educate physicians on the value and ethics of placebo surgery control conditions. Otherwise, invasive procedures may be performed without any benefits beyond possible placebo effects.
Keyphrases
- minimally invasive
- placebo controlled
- coronary artery bypass
- double blind
- surgical site infection
- clinical trial
- clinical practice
- phase iii
- public health
- primary care
- physical activity
- social media
- randomized controlled trial
- open label
- squamous cell carcinoma
- coronary artery disease
- percutaneous coronary intervention
- machine learning
- quality improvement
- phase ii
- atrial fibrillation
- phase ii study
- artificial intelligence
- deep learning