A simulation design for research evaluating safety innovations in anaesthesia*.
It is notoriously difficult to obtain evidence from clinical randomised controlled trials for safety innovations in healthcare. We have developed a research design using simulation for the evaluation of safety initiatives in anaesthesia. We used a standard and a modified scenario in a human-patient simulator, involving a potentially life-threatening problem requiring prompt attention--either a cardiac arrest or a failure in oxygen supply. The modified scenarios involved distractions such as loud music, a demanding and uncooperative surgeon, telephone calls and frequent questions from a medical student. Twenty anaesthetics were administered by 10 anaesthetists. A mean (SD) of 11.3 (2.8) errors per anaesthetic were identified in the oxygen failure scenarios, compared with 8.0 (3.4) in the cardiac arrest scenarios (ANOVA: p = 0.04). The difference between the combined standard scenarios and the combined modified scenarios was not significant. The mean rate of errors overall was 9.7 per simulation, with a pooled SD of 4.46, so in future studies 21 subjects would provide 80% statistical power to show a reduction in error rate of 30% from baseline with p<or=0.05. Our research design will facilitate the evaluation of safety initiatives in anaesthesia.
Merry
A F
AF
Department of Anaesthesiology, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. a.merry@auckland.ac.nz
Weller
J M
JM
Robinson
B J
BJ
Warman
G R
GR
Davies
E
E
Shaw
J
J
Cheeseman
J F
JF
Wilson
L F
LF
D000328:Adult; D000368:Aged; D000758:Anesthesia / Q000009:adverse effects / Q000592:standards*; D000776:Anesthesiology / Q000295:instrumentation; D002983:Clinical Competence; D003198:Computer Simulation; D004868:Equipment Failure; D005260:Female; D006323:Heart Arrest / Q000628:therapy; D006801:Humans; D008297:Male; D019300:Medical Errors / Q000517:prevention & control; D009520:New Zealand; D010102:Oxygen Inhalation Therapy / Q000295:instrumentation; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D017751:Safety Management / Q000379:methods*