Identifying unusual performance in Australian and New Zealand intensive care units from 2000 to 2010

BACKGROUND: The Australian and New Zealand Intensive Care Society (ANZICS) Adult Patient Database (APD) collects voluntary data on patient admissions to Australian and New Zealand intensive care units (ICUs). This paper presents an in-depth statistical analysis of risk-adjusted mortality of ICU admissions from 2000 to 2010 for the purpose of identifying ICUs with unusual performance. METHODS: A cohort of 523,462 patients from 144 ICUs was analysed. For each ICU, the natural logarithm of the standardised mortality ratio (log-SMR) was estimated from a risk-adjusted, three-level hierarchical model. This is the first time a three-level model has been fitted to such a large ICU database anywhere. The analysis was conducted in three stages which included the estimation of a null distribution to describe usual ICU performance. Log-SMRs with appropriate estimates of standard errors are presented in a funnel plot using 5% false discovery rate thresholds. False coverage-statement rate confidence intervals are also presented. The observed numbers of deaths for ICUs identified as unusual are compared to the predicted true worst numbers of deaths under the model for usual ICU performance. RESULTS: Seven ICUs were identified as performing unusually over the period 2000 to 2010, in particular, demonstrating high risk-adjusted mortality compared to the majority of ICUs. Four of the seven were ICUs in private hospitals. Our three-stage approach to the analysis detected outlying ICUs which were not identified in a conventional (single) risk-adjusted model for mortality using SMRs to compare ICUs. We also observed a significant linear decline in mortality over the decade. Distinct yearly and weekly respiratory seasonal effects were observed across regions of Australia and New Zealand for the first time. CONCLUSIONS: The statistical approach proposed in this paper is intended to be used for the review of observed ICU and hospital mortality. Two important messages from our study are firstly, that comprehensive risk-adjustment is essential in modelling patient mortality for comparing performance, and secondly, that the appropriate statistical analysis is complicated.Patricia J Solomon, Jessica Kasza, John L Moran and the Australian and New Zealand Intensive Care Society, (ANZICS) Centre for Outcome and Resource Evaluation (CORE

Incidents during out-of-hospital patient transportation

Publisher's copy made available with the permission of the publisher © Australian Society of AnaesthetistsOut-of-hospital patient transportation (retrieval) of critically ill patients occurs within highly complex environments. Adverse events are not uncommon. Incident monitoring provides a means to better understand such events. The aim of this study was to characterize incidents occurring during retrieval to provide a basis for developing corrective strategies. Four organizations contributed 125 reports, documenting 272 incidents; 91% of forms documented incidents as preventable. Incidents related to equipment (37%), patient care (26%), transport operations (11%), interpersonal communication (9%), planning or preparation (9%), retrieval staff (7%) and tasking (2%). Incidents occurred during patient transport to the receiving facility (26%), at patient origin (26%), during patient loading (20%), at the retrieval service base (18%) and receiving facility (9%). Contributing factors were system-based for 54% and human-based for 42%. Haste (7.5%), equipment malfunctioning (7.2%) or missing (5.5%), failure to check (5.8%) and pressure to proceed (5.2%) were the most frequent contributing factors. Harm was documented in 59% of incidents with one death. Minimizing factors were good crew skills/teamwork (42%), checking equipment (17%) and patient (8%), patient monitors (15%), good luck (14%) and good interpersonal communication (4%). Incident monitoring provides sufficient insight into retrieval incidents to be a useful quality improvement tool for retrieval services. Information gathered suggested improvements in retrieval equipment design and use of alternative power sources, the use of pro formae for equipment checking, patient assessment, preparation for transportation and information transfer. Lessons from incidents in other areas applicable to retrieval should be linked for analysis with retrieval incidents.A. Flabouris, W. B. Runciman, B. Levingshttp://www.aaic.net.au/Article.asp?D=200530

Intravenous iron or placebo for anaemia in intensive care: the IRONMAN multicentre randomized blinded trial. A randomized trial of IV iron in critical illness

PURPOSE: Both anaemia and allogenic red blood cell transfusion are common and potentially harmful in patients admitted to the intensive care unit. Whilst intravenous iron may decrease anaemia and RBC transfusion requirement, the safety and efficacy of administering iron intravenously to critically ill patients is uncertain. METHODS: The multicentre, randomized, placebo-controlled, blinded Intravenous Iron or Placebo for Anaemia in Intensive Care (IRONMAN) study was designed to test the hypothesis that, in anaemic critically ill patients admitted to the intensive care unit, early administration of intravenous iron, compared with placebo, reduces allogeneic red blood cell transfusion during hospital stay and increases the haemoglobin level at the time of hospital discharge. RESULTS: Of 140 patients enrolled, 70 were assigned to intravenous iron and 70 to placebo. The iron group received 97 red blood cell units versus 136 red blood cell units in the placebo group, yielding an incidence rate ratio of 0.71 [95 % confidence interval (0.43-1.18), P = 0.19]. Overall, median haemoglobin at hospital discharge was significantly higher in the intravenous iron group than in the placebo group [107 (interquartile ratio IQR 97-115) vs. 100 g/L (IQR 89-111), P = 0.02]. There was no significant difference between the groups in any safety outcome. CONCLUSIONS: In patients admitted to the intensive care unit who were anaemic, intravenous iron, compared with placebo, did not result in a significant lowering of red blood cell transfusion requirement during hospital stay. Patients who received intravenous iron had a significantly higher haemoglobin concentration at hospital discharge. The trial was registered at http://www.anzctr.org.au as # ACTRN12612001249842

A qualitative study exploring the experiences of parents of children admitted to seven Dutch pediatric intensive care units

Purpose: To explore parents' experiences during the admission of their children to a pediatric intensive care unit (PICU). Method: Qualitative method using in-depth interviews. Thematic analysis was applied to capture parents' experiences. Thirty-nine mothers and 25 fathers of 41 children admitted to seven of the eight PICUs in university medical centers in The Netherlands were interviewed. Results: Parents were interviewed within 1 month after their child's discharge from a PICU. Thematic analysis identified 1,514 quotations that were coded into 63 subthemes. The subthemes were categorized into six major themes: attitude of the professionals; coordination of care; emotional intensity; information management; environmental factors; parent participation. Most themes had an overarching relationship representing the array of experiences encountered by parents when their child was staying in a PICU. The theme of emotional intensity was in particular associated with all the other themes. Conclusions: The findings provided a range of themes and subthemes describing the complexity of the parental experiences of a PICU admission. The subthemes presen

The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias

Background: Interim analysis of accumulating trial data is important to protect participant safety during randomized controlled trials (RCTs). Data Monitoring Committees (DMCs) often undertake such analyses, but their widening role may lead to extended use of interim analysis or recommendations that could potentially bias trial results.Methods: Systematic search of eight major publications: Annals of Internal Medicine, BMJ, Circulation, CID, JAMA, JCO, Lancet and NEJM, including all randomised controlled trials ( RCTs) between June 2000 and May 2005 to identify RCTs that reported use of interim analysis, with or without DMC involvement. Recommendations made by the DMC or based on interim analysis were identified and potential sources of bias assessed. Independent double data extraction was performed on all included trials.Results: We identified 1772 RCTs, of which 470 (27%; 470/1772) reported the use of a DMC and a further 116 (7%; 116/1772) trials reported some form of interim analysis without explicit mention of a DMC. There were 28 trials ( 24 with a formal DMC), randomizing a total of 79396 participants, identified as recommending changes to the trial that may have lead to biased results. In most of these, some form of sample size re-estimation was recommended with four trials also reporting changes to trial endpoints. The review relied on information reported in the primary publications and methods papers relating to the trials, higher rates of use may have occurred but not been reported.Conclusion: The reported use of interim analysis and DMCs in clinical trials has been increasing in recent years. It is reassuring that in most cases recommendations were made in the interest of participant safety. However, in practice, recommendations that may lead to potentially biased trial results are being made