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Background: Simulation has been used to investigate clinical questions in anesthesia, surgery, and related disciplines, but there are few data demonstrating that results apply to clinical settings. We asked "would results of a simulation-based study justify the same principal conclusions as those of a larger clinical study?", Methods: We compared results from a randomized controlled trial in a simulated environment involving 80 cases at three centers with those from a randomized controlled trial in a clinical environment involving 1,075 cases. In both studies, we compared conventional methods of anesthetic management with the use of a multimodal system (SAFERsleep; Safer Sleep LLC, Nashville, Tennessee) designed to reduce drug administration errors. Forty anesthesiologists each managed two simulated scenarios randomized to conventional methods or the new system. We compared the rate of error in drug administration or recording for the new system versus conventional methods in this simulated randomized controlled trial with that in the clinical randomized controlled trial (primary endpoint). Six experts were asked to indicate a clinically relevant effect size., Results: In this simulated randomized controlled trial, mean (95% CI) rates of error per 100 administrations for the new system versus conventional groups were 6.0 (3.8 to 8.3) versus 11.6 (9.3 to 13.8; P = 0.001) compared with 9.1 (6.9 to 11.4) versus 11.6 (9.3 to 13.9) in the clinical randomized controlled trial (P = 0.045). A 10 to 30% change was considered clinically relevant. The mean (95% CI) difference in effect size was 27.0% (-7.6 to 61.6%)., Conclusions: The results of our simulated randomized controlled trial justified the same primary conclusion as those of our larger clinical randomized controlled trial, but not a finding of equivalence in effect size.

A safety-orientated system of delivering parenteral anaesthetic drugs was assessed in a prospective incident monitoring study at two hospitals. Anaesthetists completed an incident form for every anaesthetic, indicating if an incident occurred. Case mix data were collected and the number of drug administrations made during procedures estimated. From February 1998 at Hospital A and from June 1999 at Hospital B, until November 2003, 74,478 anaesthetics were included, for which 59,273 incident forms were returned (a 79.6% response rate). Fewer parenteral drug errors occurred with the new system than with conventional methods (58 errors in an estimated 183,852 drug administrations (0.032%, 95% CI 0.024-0.041%) vs 268 in 550,105 (0.049%, 95% CI 0.043-0.055%) respectively, p = 0.002), a relative reduction of 35% (difference 0.017%, 95% CI 0.006-0.028%). No major adverse outcomes from these errors were reported with the new system while 11 (0.002%) were reported with conventional methods (p = 0.055). We conclude that targeted system re-design can reduce medical error.

Summary: 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

A new safety-orientated drug infusion label was studied and was compared with conventional methods by prospectively collecting incident reports from November 1998 to November 2003. Anaesthetists were asked to return an incident form for every anaesthetic (87% response rate), the vast majority indicating that no error had occurred. One error was reported with the use of the new label. However, this was due to an incorrect patient weight being recorded in the notes, and the dose was correct for the information available. Therefore, this data point was not included in the analysis. Seven errors were reported in the calculation of dosage using conventional infusion labels during 18 491 anaesthetics compared with no calculation errors in 10 655 anaesthetics with the new label (p = 0.045, Chi-squared test). Despite the difficulties of demonstrating significant benefit from safety initiatives in medicine, these data suggest that targeted system redesign can be effective inreducing error.

Obstetric haemorrhage is a leading cause of maternal death and the most common contributor to serious obstetric morbidity. Maternal mortality audit data suggest that appropriate preparation and good emergency management leads to improved outcome. The aim of this study was to assess facilities relevant to major obstetric haemorrhage management in all units in Australia and New Zealand that offer operative obstetric services. The questionnaire was divided into ten sections: demographics, facilities, staffing, policies and guidelines, drugs, procedures, equipment, point of care testing, availability of O negative blood and free comments. Responses were received from 240 (76.4%) of the 314 hospitals surveyed (187 public and 53 private). One hundred and nine units (45%) had fewer than 500 deliveries per year Distances to referral facilities were frequently very large. Of the 90 hospitals (38.1%) without an onsite blood bank, 12 did not have a supply of blood for emergencies. Half of all units (n=121) had on-site intensive care or high dependency facilities and 72.9% (n=175) had an on-site cardiac arrest team. Only 58.8% of units (n=141) had a written haemorrhage protocol. Findings are presented in the context of other literature, including evidence-based guidelines. Haemorrhage responds well to appropriate treatment, although careful preparation and anticipation of problems is required. In our region geographical factors and different systems of healthcare complicate provision of obstetric services. Where facilities are limited, women should be offered antenatal transfer to a larger centre.

Clinical indicators and complications occurring in the recovery room or post anaesthetic care unit were recorded for patients who had an anaesthetic procedure during 1995, 1996 and 1997 (n = 13 266). Clinical indicators measured were those developed by the Australian Council on Healthcare Standards in conjunction with the Australian and New Zealand College of Anaesthetists, and three other indicators. All patients were assessed and positive data were collected by nursing staff on a standardised form which was checked and collated by the anaesthetist responsible for the recovery room (the author). The rates for some indicators were higher than the Australian Council on Healthcare Standards 1997 rates, but the overall rates of complications were comparable with, or lower than, those in published series. Clinical indicator data are seen as a valuable quantitative tool for quality assurance, particularly if collected as part of a more comprehensive programme.