title: A simulation design for research evaluating safety innovations in anaesthesia*.
abstract: 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.
authors.affiliation: Department of Anaesthesiology, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. a.merry@auckland.ac.nz
authors.forename: A F
authors.initials: AF
authors.lastname: Merry
authors.forename: J M
authors.initials: JM
authors.lastname: Weller
authors.forename: B J
authors.initials: BJ
authors.lastname: Robinson
authors.forename: G R
authors.initials: GR
authors.lastname: Warman
authors.forename: E
authors.initials: E
authors.lastname: Davies
authors.forename: J
authors.initials: J
authors.lastname: Shaw
authors.forename: J F
authors.initials: JF
authors.lastname: Cheeseman
authors.forename: L F
authors.initials: LF
authors.lastname: Wilson
mesh_terms: 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*