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Randomised placebo-controlled trials of surgery: ethical analysis and guidelines
  1. Julian Savulescu1,
  2. Karolina Wartolowska2,
  3. Andy Carr2
  1. 1Faculty of Philosophy, Oxford Uehiro Centre for Practical Ethics, Oxford, UK
  2. 2Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK
  1. Correspondence to Professor Julian Savulescu, Faculty of Philosophy, Oxford Uehiro Centre for Practical Ethics, Suite 8, Littlegate House, 16/17 St Ebbe's St, Oxford OX1 1PT, UK; Julian.savulescu{at}philosophy.ox.ac.uk

Abstract

Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if certain conditions are fulfilled: (1) the presence of equipoise, defined as a lack of unbiased evidence for efficacy of an intervention; (2) clinically important research question; (3) the risk to patients is minimised and reasonable; (4) there is uncertainty about treatment allocation rather than deception; (5) there is preliminary evidence for efficacy, which justifies a placebo-controlled design; and (6) ideally, the placebo procedure should have some direct benefit to the patient, for example, as a diagnostic tool. Placebo-controlled trials in surgery will most often be justified when surgery is performed to improve function or relieve symptoms and when objective outcomes are not available, while the risk of mortality or significant morbidity is low. In line with medical placebo-controlled trials, the surgical trial (1) should be sufficiently powered and (2) standardised so that its results are valid, (3) consent should be valid, (4) the standard treatment or rescue medication should be provided if possible, and (5) after the trial, the patients should be told which treatment they received and there should be provision for post-trial care if the study may result in long-term negative effects. We comment and contrast our guidelines with those of the American Medical Association.

  • Ethics
  • Surgery
  • Research Ethics
  • Policy Guidelines/Inst. Review Boards/Review Cttes.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Julian Savulescu and Karolina Wartolowska are joint first authors.

  • Contributors KW, JS and AC devised the paper, drafted the manuscript and critically revised it for important intellectual content. All authors revised and approved the final version of the article.

  • Funding This study was funded by the NIHR Oxford Musculoskeletal Biomedical Research Unit and Uehiro Foundation on Ethics and Education.

  • Competing interests All authors are involved in a placebo-controlled surgical trial on shoulder pain (NCT01623011). JS is the Editor of the JME and this paper was handled independently by the Conflict of Interest Editor, Ken Boyd.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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