Anaesthetists%26apos; risk assessment of placebo nerve block studies using the SHAM (Serious Harm and Morbidity) scale

作者：Jarman J; Marks N; Fahy C J; Costi D; Cyna A M^*

来源：Anaesthesia, 2012, 67(4): 361-366.

DOI：10.1111/j.1365-2044.2011.06998.x

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 ? statistic assessed agreement between these anaesthetists and probability of random agreement (Pr(e)) when using the SHAM scale; a ? %26gt; 0 shows concordance between assessors above random agreement. Overall ? was 0.50 (95% CI 0.490.51, p %26lt; 0.001), Pr(e) = 0.21. There was moderate agreement between assessors in determining whether studies were low-risk (SHAM score 02) or high-risk (SHAM score 34) (? 0.60 (95% CI 0.580.62), 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 (? 0.76 (95% CI 0.720.81), Pr(e) = 0.5 vs 0.45 (95% CI 0.410.49), Pr(e) = 0.52, p %26lt; 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 scores validation.

• 出版日期2012-4