Article Text
Abstract
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.
- pain management
Statistics from Altmetric.com
Read the full text or download the PDF:
Other content recommended for you
- Randomised placebo-controlled trials of surgery: ethical analysis and guidelines
- Evidence first, practice second in arthroscopic surgery: use of placebo surgery in randomised controlled trial
- Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel ‘RCT within-a-cohort’ study design
- How does surgery compare to sham surgery or physiotherapy as a treatment for tendinopathy? A systematic review of randomised trials
- Arthroscopic partial meniscectomy for meniscal tears of the knee: a systematic review and meta-analysis
- Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review
- How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review
- Common elective orthopaedic procedures and their clinical effectiveness: umbrella review of level 1 evidence
- Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT): a protocol for a randomised trial comparing arthroscopic subacromial decompression and diagnostic arthroscopy (placebo control), with an exercise therapy control, in the treatment of shoulder impingement syndrome
- SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomised, placebo-controlled trial