Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

A new Review, published in the Lancet, analyses the use of placebo controls in surgery and offers a practical checklist for researchers designing trials.

Surgeon operating

Placebo comparisons are universally used in randomised controlled trials as a critical way to measure the safety and efficacy of new drugs and treatments. But increasingly, placebo controls are being used to assess surgical interventions, raising questions around ethics, risk to patients, and whether their design adds to scientific knowledge.

"The placebo used to evaluate a surgical intervention might involve close replication of the normal surgery, but may have some (or all) of the theoretically beneficial aspects taken away." said David Beard, Professor of Musculoskeletal and Surgical Science at NDORMS. "This is a relatively new, and sometimes controversial, way of evaluating surgery with some special considerations. Placebo interventions have all the potential risks of surgery (which thankfully are low) but with fewer perceived benefits - the methodology and ethical considerations for any such trial are therefore very important. We were keen to provide an up-to-date knowledge resource on all aspects of their use for the ongoing evaluation of some surgical procedures."

The Review, Considerations and methods for placebo controls in surgical trials, outlines what a placebo control entails and explains the present understanding of this approach in the context of surgery. It considers when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted.

The work culminated in the production of practical guidance for researchers: Applying Surgical Placebo in Randomised Evaluations (ASPIRE). The ASPIRE guidelines are designed as a checklist for researchers to ensure that surgical placebo controls in randomised trials meet quality standards in rationale and ethics, design, conduct, and interpretation.

The insights in the Review are mainly based on the outputs of a workshop funded by the UK's National Institute of Health Research and Medical Research Council, which brought together an international team of interdisciplinary experts with research experience in placebo surgery and patients. The workshop included a systematic update of important literature, an in depth discussion of case studies, and an explanation of direct experience and best practice.

The Review concludes that surgical placebo controls in RCTs are not appropriate for all evaluations of surgery. They might be best reserved for operations associated with low surgical complication risk, potentially low efficacy, unjustified usage, and in which a clinically significant placebo response is expected. "In expectation of a complex set of ethical issues, these trials need to have the greatest possible chance of answering the primary research question in a robust manner," said David. "Using the ASPIRE checklist, researchers can ensure they design trials that reach a minimum standard and mitigate any risks associated with the placebo surgical control."

Similar stories

Matthew Costa elected Fellow of Academy of Medical Sciences

Matthew Costa, Professor of Orthopaedic Trauma Surgery at NDORMS, has been elected a Fellow of the Academy of Medical Sciences.

COVID-19’s high blood clot risk

A recent study of patient health records found that around 1 in 100 people with COVID-19 had a venal or arterial thrombosis, with rates higher still among males, and particularly for those hospitalised.

REF 2021 results for medical research in Oxford

Today the UK Funding Bodies have published the outcomes of the recent national research assessment exercise, the Research Excellence Framework (REF) 2021.

Nurses' Day 2022

Today marks Nurses' Day 2022. This year's theme is #BestofNursing, so we chatted to some of our amazing Research Nurses about what the Best of Nursing means to them.

Rethinking pain management after injury

NDORMS researchers are to study whether a pain management treatment using cognitive behavioural therapy will improve recovery for people who have had a major leg injury.

Breakthrough in treatment for Dupuytren’s disease

Injection of the anti-TNF drug adalimumab into Dupuytren’s disease nodules is effective in reducing nodule hardness and nodule size.