ArticleJournal of medical ethics2016
Randomised placebo-controlled trials of surgery: ethical analysis and guidelines.
Article in Journal of medical ethics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Pooled it
- Intraoperative application of mixed and augmented reality for digital surgery: a systematic review of ethical issues.Frontiers in surgery · 2024Pooled it
- How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review.BMJ open · 2023Pooled it
- Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review.Journal of clinical epidemiology · 2020Pooled it
- Trial
- Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial.Lancet (London, England) · 2018Trial
- Global trends in surgical ethics research: a bibliometric analysis.Updates in surgery · 2026Article
- Ethical Considerations and Equipoise in Cancer Surgery.Indian journal of surgical oncology · 2024Review
- How do US orthopaedic surgeons view placebo-controlled surgical trials? A pilot online survey study.Journal of medical ethics · 2024Article
- General Treatments Promoting Independent Living in Parkinson's Patients and Physical Therapy Approaches for Improving Gait-A Comprehensive Review.Medicina (Kaunas, Lithuania) · 2024Review
- Natural history of occult hernias in adults at a safety-net hospital.Hernia : the journal of hernias and abdominal wall surgery · 2023Article
- Short-Term Outcomes of Phage-Antibiotic Combination Treatment in Adult Patients with Periprosthetic Hip Joint Infection.Viruses · 2023Article
- Ethics of Early Clinical Trials of Bio-Artificial Organs.Transplant international : official journal of the European Society for Organ Transplantation · 2022Article
- Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.Health technology assessment (Winchester, England) · 2021Article
- Article
- Placebo Effect of Sham Spine Procedures in Chronic Low Back Pain: A Systematic Review.Journal of pain research · 2021Review
- Optimizing the design of invasive placebo interventions in randomized controlled trials.The British journal of surgery · 2020Article
- A Pathway for Developing Postoperative Opioid Prescribing Best Practices.Annals of surgery · 2020Review
- Pain, placebo, and test of treatment efficacy: a narrative review.British journal of anaesthesia · 2019Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.