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https://hdl.handle.net/2440/68725
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Type: | Journal article |
Title: | Use of invasive placebos in research on local anaesthetic interventions |
Author: | McGuirk, S. Fahy, C. Costi, D. Cyna, A. |
Citation: | Anaesthesia, 2011; 66(2):84-91 |
Publisher: | Blackwell Publishing Ltd |
Issue Date: | 2011 |
ISSN: | 0003-2409 1365-2044 |
Statement of Responsibility: | S. McGuirk, C. Fahy, D. Costi and A. M. Cyna |
Abstract: | Placebos play a vital role in clinical research, but their invasive use in the context of local anaesthetic blocks is controversial. We assessed whether recently published randomised controlled trials of local anaesthetic blocks risked harming control group patients in contravention of the Declaration of Helsinki. We developed the ‘SHAM’ (Serious Harm and Morbidity) scale to assess risk: grade 0 = no risk (no intervention); grade 1 = minimal risk (for example, skin allergy to dressing); grade 2 = minor risk (for example, subcutaneous haematoma, infection); grade 3 = moderate risk (with or without placebo injection) (for example, neuropraxia); and grade 4 = major risk (such as blindness, pneumothorax, or liver laceration). Placebo interventions of the 59 included trials were given a SHAM grade. Nine hundred and nineteen patients in 31 studies, including six studies with 183 children, received an invasive placebo assessed as SHAM grade ≥ 3. A high level of agreement (78%, κ = 0.80, p < 0.001) for SHAM grades 0–4 increased to 100% following discussion between assessors. More than half of the randomised controlled study designs subjected patients in control groups to risks of serious or irreversible harm. A debate on whether it is justifiable to expose control group patients to risks of serious harm is overdue. |
Keywords: | Humans Placebos Nerve Block Injections Severity of Illness Index Risk Assessment Research Design Helsinki Declaration Randomized Controlled Trials as Topic |
Rights: | © 2011 The Authors. Anaesthesia © 2011 The Association of Anaesthetists of Great Britain and Ireland |
DOI: | 10.1111/j.1365-2044.2010.06560.x |
Published version: | http://dx.doi.org/10.1111/j.1365-2044.2010.06560.x |
Appears in Collections: | Aurora harvest 5 Obstetrics and Gynaecology publications |
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