Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/72732
Citations | ||
Scopus | Web of Science® | Altmetric |
---|---|---|
?
|
?
|
Type: | Journal article |
Title: | Anaesthetists' risk assessment of placebo nerve block studies using the SHAM (Serious Harm and Morbidity) scale |
Author: | Jarman, J. Marks, N. Fahy, C. Costi, D. Cyna, A. |
Citation: | Anaesthesia, 2012; 67(4):361-366 |
Publisher: | Blackwell Publishing Ltd |
Issue Date: | 2012 |
ISSN: | 0003-2409 1365-2044 |
Statement of Responsibility: | J. Jarman, N. Marks, C.J. Fahy, D. Costi and A. M. Cyna |
Abstract: | The SHAM (Serious Harm and Morbidity) scale was developed to categorise the severity of potential complications of placebo control interventions in the context of local anaesthesia research. A convenience sample of 43 anaesthetists used the SHAM scale to grade ten published randomised controlled trials investigating local anaesthesia nerve blocks. The Fleiss j statistic assessed agreement between these anaesthetists and probability of random agreement (Pr(e)) when using the SHAM scale; a j > 0 shows concordance between assessors above random agreement. Overall j was 0.50 (95% CI 0.49–0.51, p < 0.001), Pr(e) = 0.21. There was moderate agreement between assessors in determining whether studies were low-risk (SHAM score 0–2) or high-risk (SHAM score 3–4) (j 0.60 (95% CI 0.58–0.62), Pr(e) = 0.51). Compared with anaesthetists given clinical examples of interventions when applying the SHAM score, anaesthetists who were not given examples showed significantly less inter-individual agreement (j 0.76 (95% CI 0.72–0.81), Pr(e) = 0.5 vs 0.45 (95% CI 0.41–0.49), Pr(e) = 0.52, p < 0.0001). These results suggest that the SHAM score can be successfully used to grade the severity of potential complications of placebo-controlled interventions in local anaesthesia research and represent a first step towards the score’s validation. |
Keywords: | Humans Placebos Observer Variation Anesthesia, Local Nerve Block Severity of Illness Index Risk Assessment Anesthesiology Research Design Adult Aged Middle Aged Australia Female Male Randomized Controlled Trials as Topic |
Rights: | Anaesthesia © 2012 The Association of Anaesthetists of Great Britain and Ireland |
DOI: | 10.1111/j.1365-2044.2011.06998.x |
Published version: | http://dx.doi.org/10.1111/j.1365-2044.2011.06998.x |
Appears in Collections: | Aurora harvest 5 Medicine publications |
Files in This Item:
There are no files associated with this item.
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.