Kathryn M Rowan

Intensive Care National Audit & Research Centre ICNARC, Londinium, England, United Kingdom

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Publications (51)414.31 Total impact

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    ABSTRACT: Rationale: Little is known about the utility of provision of high-dependency care (HDC) that is in a geographically separate location from a primary intensive care unit (ICU). Objectives: To determine whether the availability of HDC in a geographically separate unit affects patient flow or mortality for critically ill patients. Methods: Admissions to ICUs in the UK, from 2009-2011, who received Level 3 intensive care in the first 24 hours after admission and subsequently Level 2 HDC. We compared differences in patient flow and outcomes for patients treated in hospitals providing some HDC in a geographically separate unit (dual HDC) versus patients treated in hospitals providing all HDC in the same unit as intensive care (integrated HDC) using multi-level mixed effects models. Measurements and Main Results: In 192 adult general ICUs, 21.4% provided dual HDC. Acute hospital mortality was no different for patients cared for in ICUs with dual HDC versus those with integrated HDC (adjusted odds ratio (AOR) 0.94 (0.86-1.03) p=0.16). Dual HDC was associated with a decreased likelihood of a delayed discharge from the primary unit. But, total duration of critical care and the likelihood of discharge from the primary unit at night were increased with dual HDC. Conclusions: Availability of HDC in a geographically separate unit does not impact acute hospital mortality. The potential benefit of decreasing delays in discharge should be weighed against the increased total duration of critical care and greater likelihood of a transfer out of the primary unit at night.
    American Journal of Respiratory and Critical Care Medicine 12/2014; · 11.99 Impact Factor
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    ABSTRACT: The CALORIES trial is a pragmatic, open, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early nutritional support via the parenteral route compared with early nutritional support via the enteral route in unplanned admissions to adult general critical care units (CCUs) in the United Kingdom. The trial derives from the need for a large, pragmatic RCT to determine the optimal route of delivery for early nutritional support in the critically ill. To describe the proposed statistical analyses for the evaluation of the clinical effectiveness in the CALORIES trial. With the primary and secondary outcomes defined precisely and the approach to safety monitoring and data collection summarised, the planned statistical analyses, including prespecified subgroups and secondary analyses, were developed and are described. The primary outcome is all-cause mortality at 30 days. The primary analysis will be reported as a relative risk and absolute risk reduction and tested with the Fisher exact test. Prespecified subgroup analyses will be based on age, degree of malnutrition, acute severity of illness, mechanical ventilation at admission to the CCU, presence of cancer and time from CCU admission to commencement of early nutritional support. Secondary analyses include adjustment for baseline covariates. In keeping with best trial practice, we have developed, described and published a statistical analysis plan for the CALORIES trial and are placing it in the public domain before inspecting data from the trial.
    Critical care and resuscitation: journal of the Australasian Academy of Critical Care Medicine 12/2014; 16(4):248-54. · 2.15 Impact Factor
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    ABSTRACT: IntroductionPrior to investing in a large, multicentre randomised controlled trial (RCT), the National Institute for Health Research in the UK called for an evaluation of the feasibility and value for money of undertaking a trial on intravenous immunoglobulin (IVIG) as an adjuvant therapy for severe sepsis/septic shock.Methods In response to this call, this paper assessed the clinical and cost-effectiveness of IVIG (using a decision model), and evaluated the value of conducting an RCT (using expected value of information (EVI) analysis). The evidence informing such assessments was obtained through a series of systematic reviews and meta-analyses. Further primary data analyses were also undertaken using the Intensive Care National Audit & Research Centre Case Mix Programme Database, and a Scottish Intensive Care Society research study.ResultsWe found a large degree of statistical heterogeneity in the clinical evidence on treatment effect, and the source of such heterogeneity was unclear. The incremental cost effectiveness ratio of IVIG is within the borderline region of estimates considered to represent value for money, but results appear highly sensitive to the choice of model used for clinical effectiveness. This was also the case with EVI estimates, with maximum payoffs from conducting a further clinical trial between £137 and £1,011 million.Conclusions Our analyses suggest that there is a need for a further RCT. Results on the value of conducting such research, however, were sensitive to the clinical effectiveness model used, reflecting the high level of heterogeneity in the evidence base.
    Critical care (London, England) 12/2014; 18(6):649. · 5.04 Impact Factor
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    ABSTRACT: Background Uncertainty exists about the most effective route for delivery of early nutritional support in critically ill adults. We hypothesized that delivery through the parenteral route is superior to that through the enteral route. Methods We conducted a pragmatic, randomized trial involving adults with an unplanned admission to one of 33 English intensive care units. We randomly assigned patients who could be fed through either the parenteral or the enteral route to a delivery route, with nutritional support initiated within 36 hours after admission and continued for up to 5 days. The primary outcome was all-cause mortality at 30 days. Results We enrolled 2400 patients; 2388 (99.5%) were included in the analysis (1191 in the parenteral group and 1197 in the enteral group). By 30 days, 393 of 1188 patients (33.1%) in the parenteral group and 409 of 1195 patients (34.2%) in the enteral group had died (relative risk in parenteral group, 0.97; 95% confidence interval, 0.86 to 1.08; P=0.57). There were significant reductions in the parenteral group, as compared with the enteral group, in rates of hypoglycemia (44 patients [3.7%] vs. 74 patients [6.2%]; P=0.006) and vomiting (100 patients [8.4%] vs. 194 patients [16.2%]; P<0.001). There were no significant differences between the parenteral group and the enteral group in the mean number of treated infectious complications (0.22 vs. 0.21; P=0.72), 90-day mortality (442 of 1184 patients [37.3%] vs. 464 of 1188 patients [39.1%], P=0.40), in rates of 14 other secondary outcomes, or in rates of adverse events. Caloric intake was similar in the two groups, with the target intake not achieved in most patients. Conclusions We found no significant difference in 30-day mortality associated with the route of delivery of early nutritional support in critically ill adults. (Funded by the United Kingdom National Institute for Health Research; CALORIES Current Controlled Trials number, ISRCTN17386141 .).
    New England Journal of Medicine 10/2014; · 54.42 Impact Factor
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    ABSTRACT: IntroductionResearch has demonstrated that intensivist-led care of the critically ill is associated with reduced intensive care unit (ICU) and hospital mortality. The objective of this study was to evaluate whether a relationship exists between intensivist cover pattern (for example, number of days of continuous cover) and patient outcomes among adult general ICUs in England.Methods We conducted a retrospective cohort study using data from a pooled case mix and outcome database of adult general critical care units participating in the Intensive Care National Audit & Research Centre (ICNARC) Case Mix Programme. Consecutive admissions to participating units for the years 2010 to 2011 were linked to a survey of intensivist cover practices. Our primary outcome of interest was mortality at ultimate discharge from acute hospital.ResultsThe analysis included 80,122 patients admitted to 130 ICUs in 128 hospitals. Multivariable logistic regression analysis was used to assess the relationship between intensivist cover patterns (days of continuous cover, grade of physician staffing at nighttime, and frequency of daily handovers) and acute hospital mortality, adjusting for patient case mix. No relationship was seen between days of continuous cover by a single intensivist or grade of physician staffing at nighttime and acute hospital mortality. Acute hospital mortality and ICU length of stay were not associated with intensivist characteristics, intensivist fulltime equivalents per bed or years of clinical experience. Intensivist participation in handover was associated with increased mortality (odds ratio 1.27, 95% confidence interval 1.04 to 1.55); however, only nine units reported no intensivist participation.Conclusions We found no relationship between days of continuous cover by a single intensivist or grade of physician staffing at nighttime and patient outcomes in adult, general ICUs in England. Intensivist participation in handover was associated with increased mortality; further research to confirm or refute this finding is required.
    Critical care (London, England) 08/2014; 18(4):491. · 5.04 Impact Factor
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    ABSTRACT: Aim The National Cardiac Arrest Audit (NCAA) is the UK national clinical audit for in-hospital cardiac arrest. To make fair comparisons among health care providers, clinical indicators require case mix adjustment using a validated risk model. The aim of this study was to develop and validate risk models to predict outcomes following in-hospital cardiac arrest attended by a hospital-based resuscitation team in UK hospitals. Methods Risk models for two outcomes—return of spontaneous circulation (ROSC) for greater than 20 minutes and survival to hospital discharge—were developed and validated using data for in-hospital cardiac arrests between April 2011 and March 2013. For each outcome, a full model was fitted and then simplified by testing for non-linearity, combining categories and stepwise reduction. Finally, interactions between predictors were considered. Models were assessed for discrimination, calibration and accuracy. Results 22,479 in-hospital cardiac arrests in 143 hospitals were included (14,688 development, 7,791 validation). The final risk model for ROSC > 20 minutes included: age (non-linear); sex; prior length of stay in hospital; reason for attendance; location of arrest; presenting rhythm; and interactions between presenting rhythm and location of arrest. The model for hospital survival included the same predictors, excluding sex. Both models had acceptable performance across the range of measures, although discrimination for hospital mortality exceeded that for ROSC > 20 minutes (c index 0.81 versus 0.72). Conclusions Validated risk models for ROSC > 20 minutes and hospital survival following in-hospital cardiac arrest have been developed. These models will strengthen comparative reporting in NCAA and support local quality improvement.
    Resuscitation 08/2014; · 3.96 Impact Factor
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    ABSTRACT: Previous studies have suggested that there may be long-term harm associated with postoperative complications. Uncertainty exists however, because of the need for risk adjustment and inconsistent definitions of postoperative morbidity.
    BJA British Journal of Anaesthesia 07/2014; · 4.24 Impact Factor
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    ABSTRACT: IMPORTANCE: Small trials suggest that postoperative outcomes may be improved by the use of cardiac output monitoring to guide administration of intravenous fluid and inotropic drugs as part of a hemodynamic therapy algorithm. OBJECTIVE: To evaluate the clinical effectiveness of a perioperative, cardiac output-guided hemodynamic therapy algorithm. DESIGN, SETTING, AND PARTICIPANTS: OPTIMISE was a pragmatic, multicenter, randomized, observer-blinded trial of 734 high-risk patients aged 50 years or older undergoing major gastrointestinal surgery at 17 acute care hospitals in the United Kingdom. An updated systematic review and meta-analysis were also conducted including randomized trials published from 1966 to February 2014. INTERVENTIONS: Patients were randomly assigned to a cardiac output-guided hemodynamic therapy algorithm for intravenous fluid and inotrope (dopexamine) infusion during and 6 hours following surgery (n=368) or to usual care (n=366). MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of predefined 30-day moderate or major complications and mortality. Secondary outcomes were morbidity on day 7; infection, critical care-free days, and all-cause mortality at 30 days; all-cause mortality at 180 days; and length of hospital stay. RESULTS: Baseline patient characteristics, clinical care, and volumes of intravenous fluid were similar between groups. Care was nonadherent to the allocated treatment for less than 10% of patients in each group. The primary outcome occurred in 36.6% of intervention and 43.4% of usual care participants (relative risk [RR], 0.84 [95% CI, 0.71-1.01]; absolute risk reduction, 6.8% [95% CI, -0.3% to 13.9%]; P = .07). There was no significant difference between groups for any secondary outcomes. Five intervention patients (1.4%) experienced cardiovascular serious adverse events within 24 hours compared with none in the usual care group. Findings of the meta-analysis of 38 trials, including data from this study, suggest that the intervention is associated with fewer complications (intervention, 488/1548 [31.5%] vs control, 614/1476 [41.6%]; RR, 0.77 [95% CI, 0.71-0.83]) and a nonsignificant reduction in hospital, 28-day, or 30-day mortality (intervention, 159/3215 deaths [4.9%] vs control, 206/3160 deaths [6.5%]; RR, 0.82 [95% CI, 0.67-1.01]) and mortality at longest follow-up (intervention, 267/3215 deaths [8.3%] vs control, 327/3160 deaths [10.3%]; RR, 0.86 [95% CI, 0.74-1.00]). CONCLUSIONS AND RELEVANCE: In a randomized trial of high-risk patients undergoing major gastrointestinal surgery, use of a cardiac output-guided hemodynamic therapy algorithm compared with usual care did not reduce a composite outcome of complications and 30-day mortality. However, inclusion of these data in an updated meta-analysis indicates that the intervention was associated with a reduction in complication rates. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN04386758.
    JAMA The Journal of the American Medical Association 06/2014; 311(21):2181. · 29.98 Impact Factor
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    ABSTRACT: Evidence supporting selective decontamination of the digestive tract (SDD) is reasonably strong. We set out to determine use in UK critical care units and to compare patient outcomes between units that do and those that do not use SDD. A total of 250 UK general critical care units were surveyed. Case mix, outcomes, and lengths of stay for admissions to SDD units (with and without an i.v. component) and non-SDD units were compared using data from the Intensive Care National Audit & Research Centre Case Mix Programme database. A response was received from all the 250 critical care units surveyed. Of these, 13 (5.2%) reported using SDD on some or all admissions, and of these, 3 reported using an i.v. component. Data on 284 690 admissions (April 2008-March 2011) from units reporting to the ICNARC Case Mix Programme (CMP) were included in the analyses. Admissions to SDD (n=196) and non-SDD (n=9) units were a similar case mix with similar infection rates and average lengths of stay in the unit and hospital. There was no difference in risk-adjusted unit or hospital mortality. The rate of unit-acquired infections in blood was significantly lower in SDD units using an i.v. component. Use of SDD in UK critical care is very low. The rate of unit-acquired infections in blood was significantly lower in SDD units using an i.v. component, but did not translate into a difference in acute hospital mortality or length of stay. There is a need to better understand the barriers to adoption of SDD into clinical practice and such work is underway.
    BJA British Journal of Anaesthesia 05/2014; · 4.24 Impact Factor
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    ABSTRACT: To report the incidence, characteristics and outcome of adult in-hospital cardiac arrest in the United Kingdom (UK) National Cardiac Arrest Audit database. A prospectively defined analysis of the UK National Cardiac Arrest Audit (NCAA) database. 144 acute hospitals contributed data relating to 22,628 patients aged 16 years or over receiving chest compressions and/or defibrillation and attended by a hospital-based resuscitation team in response to a 2222 call. The main outcome measures were incidence of adult in-hospital cardiac arrest and survival to hospital discharge. The overall incidence of adult in-hospital cardiac arrest was 1.6 per 1000 hospital admissions with a median across hospitals of 1.5 (interquartile range 1.2 to 2.2). Incidence varied seasonally, peaking in winter. Overall unadjusted survival to hospital discharge was 18.4%. The presenting rhythm was shockable (ventricular fibrillation or pulseless ventricular tachycardia) in 16.9% and non-shockable (asystole or pulseless electrical activity) in 72.3%; rates of survival to hospital discharge associated with these rhythms were 49.0% and 10.5%, respectively, but varied substantially across hospitals. These first results from the NCAA database describing the current incidence and outcome of adult in-hospital cardiac arrest in UK hospitals will serve as a benchmark from which to assess the future impact of changes in service delivery, organisation and treatment for in-hospital cardiac arrest.
    Resuscitation 04/2014; · 3.96 Impact Factor
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    ABSTRACT: Hospital-acquired infections (HAIs) are a major cause of morbidity and mortality. Critically ill patients in intensive care units (ICUs) are particularly susceptible to these infections. One intervention that has gained much attention in reducing HAIs is selective decontamination of the digestive tract (SDD). SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of intravenous (i.v.) antibiotics. SDD may reduce infections and improve mortality, but has not been widely adopted in the UK or internationally. Hence, there is a need to identify the reasons for low uptake and whether or not further clinical research is needed before wider implementation would be considered appropriate. The project objectives were to (1) identify and describe the SDD intervention, (2) identify views about the evidence base, (3) identify acceptability of further research and (4) identify feasibility of further randomised controlled trials (RCTs). A four-stage approach involving (1) case studies of two ICUs in which SDD is delivered including observations, interviews and documentary analysis, (2) a three-round Delphi study for in-depth investigation of clinicians' views, including semi-structured interviews and two iterations of questionnaires with structured feedback, (3) a nationwide online survey of consultants in intensive care medicine and clinical microbiology and (4) semistructured interviews with international clinical triallists to identify the feasibility of further research. Case studies were set in two UK ICUs. Other stages of this research were conducted by telephone and online with NHS staff working in ICUs. (1) Staff involved in SDD adoption or delivery in two UK ICUs, (2) ICU experts (intensive care consultants, clinical microbiologists, hospital pharmacists and ICU clinical leads), (3) all intensive care consultants and clinical microbiologists in the UK with responsibility for patients in ICUs were invited and (4) international triallists, selected from their research profiles in intensive care, clinical trials and/or implementation trials. SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of i.v. antibiotics. Levels of support for, or opposition to, SDD in UK ICUs; views about the SDD evidence base and about barriers to implementation; and feasibility of further SDD research (e.g. likely participation rates). (1) The two case studies identified complexity in the interplay of clinical and behavioural components of SDD, involving multiple staff. However, from the perspective of individual staff, delivery of SDD was regarded as simple and straightforward. (2) The Delphi study (n = 42) identified (a) specific barriers to SDD implementation, (b) uncertainty about the evidence base and (c) bimodal distributions for key variables, e.g. support for, or opposition to, SDD. (3) The national survey (n = 468) identified uncertainty about the effect of SDD on antimicrobial resistance, infection rates, mortality and cost-effectiveness. Most participants would participate in further SDD research. (4) The triallist interviews (n = 10) focused largely on the substantial challenges of conducting a large, multinational clinical effectiveness trial. There was considerable uncertainty about possible benefits and harms of SDD. Further large-scale clinical effectiveness trials of SDD in ICUs may be required to address these uncertainties, especially relating to antimicrobial resistance. There was a general willingness to participate in a future effectiveness RCT of SDD. However, support was not unanimous. Future research should address the barriers to acceptance and participation in any trial. There was some, but a low level of, interest in adoption of SDD, or studies to encourage implementation of SDD into practice. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 25. See the NIHR Journals Library website for further project information.
    Health technology assessment (Winchester, England). 04/2014; 18(25):1-170.
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    ABSTRACT: It is unknown whether a volume-outcome relationship exists for mechanically ventilated admissions to UK critical care units. This study was conducted to evaluate the volume-outcome relationship for mechanically ventilated admissions to adult, general critical care units in the UK with a view to informing policy, service delivery and organisation of specialist, advanced respiratory care. A retrospective cohort study using data from the Case Mix Programme Database was conducted. The primary exposure of interest was annual volume (absolute number) of mechanically ventilated admissions per critical care unit per year. The primary outcome was ultimate acute hospital mortality. A multivariable analysis was performed to assess the relationship between annual volume and outcome while adjusting for a priori selected confounders. Two interaction tests were performed. The first interaction test was between annual volume and admission type and the second between annual volume and initial acute severity of respiratory failure. Sensitivity analysis excluding volume outlier units and using restricted cubic splines to model volume was also performed. After adjusting for confounding, there was a significant relationship between annual volume and ultimate acute hospital mortality (p < 0.02). The first interaction test revealed a strong interaction between annual volume and admission type, with a more pronounced volume-outcome relationship for non-surgical admissions (p < 0.001). The second interaction test between annual volume and initial acute severity of respiratory failure was not statistically significant (p = 0.12). The analysis using restricted cubic splines demonstrated a similar graphical relationship but the results were not statistically significant (p = 0.87). A volume-outcome relationship was demonstrated for mechanically ventilated admissions to adult, general critical care units in the UK. The relationship is sensitive to the modelling approach used.
    European Journal of Intensive Care Medicine 02/2014; · 5.17 Impact Factor
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    ABSTRACT: Objective To report the incidence, characteristics and outcome of adult in-hospital cardiac arrest in the United Kingdom (UK) National Cardiac Arrest Audit database. Methods A prospectively defined analysis of the UK National Cardiac Arrest Audit (NCAA) database. 144 acute hospitals contributed data relating to 22,628 patients aged 16 years or over receiving chest compressions and/or defibrillation and attended by a hospital-based resuscitation team in response to a 2222 call. The main outcome measures were incidence of adult in-hospital cardiac arrest and survival to hospital discharge. Results The overall incidence of adult in-hospital cardiac arrest was 1.6 per 1000 hospital admissions with a median across hospitals of 1.5 (interquartile range 1.2 to 2.2). Incidence varied seasonally, peaking in winter. Overall unadjusted survival to hospital discharge was 18.4%. The presenting rhythm was shockable (ventricular fibrillation or pulseless ventricular tachycardia) in 16.9% and non-shockable (asystole or pulseless electrical activity) in 72.3%; rates of survival to hospital discharge associated with these rhythms were 49.0% and 10.5%, respectively, but varied substantially across hospitals. Conclusions These first results from the NCAA database describing the current incidence and outcome of adult in-hospital cardiac arrest in UK hospitals will serve as a benchmark from which to assess the future impact of changes in service delivery, organisation and treatment for in-hospital cardiac arrest.
    Resuscitation 01/2014; · 3.96 Impact Factor
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    ABSTRACT: Risk prediction models are used in critical care for risk stratification, summarising and communicating risk, supporting clinical decision-making and benchmarking performance. However, they require validation before they can be used with confidence, ideally using independently collected data from a different source to that used to develop the model. The aim of this study was to validate the Intensive Care National Audit & Research Centre (ICNARC) model using independently collected data from critical care units in Scotland. Data were extracted from the Scottish Intensive Care Society Audit Group (SICSAG) database for the years 2007 to 2009. Recoding and mapping of variables was performed, as required, to apply the ICNARC model (2009 recalibration) to the SICSAG data using standard computer algorithms. The performance of the ICNARC model was assessed for discrimination, calibration and overall fit and compared with that of the Acute Physiology And Chronic Health Evaluation (APACHE) II model. There were 29,626 admissions to 24 adult, general critical care units in Scotland between 1 January 2007 and 31 December 2009. After exclusions, 23,269 admissions were included in the analysis. The ICNARC model outperformed APACHE II on measures of discrimination (c index 0.848 versus 0.806), calibration (Hosmer-Lemeshow chi-squared statistic 18.8 versus 214) and overall fit (Brier's score 0.140 versus 0.157; Shapiro's R 0.652 versus 0.621). Model performance was consistent across the three years studied. The ICNARC model performed well when validated in an external population to that in which it was developed, using independently collected data.
    BMC Anesthesiology 01/2014; 14:116. · 1.33 Impact Factor
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    ABSTRACT: Cities are expanding rapidly in middle-income countries, but their supply of acute care services is unknown. We measured acute care services supply in seven cities of diverse economic background. In a cross-sectional study, we compared cities from two high-income (Boston, USA and Paris, France), three upper-middle-income (Bogota, Colombia; Recife, Brazil; and Liaocheng, China), and two lower-middle-income (Chennai, India and Kumasi, Ghana) countries. We collected standardized data on hospital beds, intensive care unit beds, and ambulances. Where possible, information was collected from local authorities. We expressed results per population (from United Nations) and per acute illness deaths (from Global Burden of Disease project). Supply of hospital beds where intravenous fluids could be delivered varied fourfold from 72.4/100,000 population in Kumasi to 241.5/100,000 in Boston. Intensive care unit (ICU) bed supply varied more than 45-fold from 0.4/100,000 population in Kumasi to 18.8/100,000 in Boston. Ambulance supply varied more than 70-fold. The variation widened when supply was estimated relative to disease burden (e.g., ICU beds varied more than 65-fold from 0.06/100 deaths due to acute illnesses in Kumasi to 4.11/100 in Bogota; ambulance services varied more than 100-fold). Hospital bed per disease burden was associated with gross domestic product (GDP) (R (2) = 0.88, p = 0.01), but ICU supply was not (R (2) = 0.33, p = 0.18). No city provided all requested data, and only two had ICU data. Urban acute care services vary substantially across economic regions, only partially due to differences in GDP. Cities were poor sources of information, which may hinder their future planning.
    European Journal of Intensive Care Medicine 12/2013; 40(3). · 5.17 Impact Factor
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    ABSTRACT: The Protocolised Management in Sepsis (ProMISe) trial is an open, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early, goaldirected, protocolised resuscitation compared with usual resuscitation for patients presenting to emergency departments (EDs) in the United Kingdom with early signs of severe sepsis or septic shock. The rationale for the ProMISe trial derives from a single-centre United States RCT that reported a reduction in hospital mortality from 46.5% to 30.5%. To describe the proposed statistical analyses for the evaluation of clinical effectiveness for the ProMISe trial. It is important to complete this plan before inspecting the data, and before completion of two related international studies, so that post-hoc, data-derived decisions are avoided. The primary and secondary outcomes were defined precisely, and the approach to safety monitoring and data collection summarised, with a description of the planned statistical analyses including prespecified subgroup and secondary analyses. The primary outcome is all-cause mortality at 90 days. The primary analysis will be reported as a relative risk and absolute risk reduction and tested with the Fisher exact test. Prespecified subgroup analyses will be based on age, baseline Medical Emergency Department Sepsis score, baseline Sequential Organ Failure Assessment score, and time from ED presentation to randomisation. Secondary analyses include adjustment for baseline covariates, estimation of learning curve effects and adjustment for noncompliance. In keeping with best practice, we have developed a statistical analysis plan for the ProMISe trial and place it in the public domain before inspecting data from the trial.
    Critical care and resuscitation: journal of the Australasian Academy of Critical Care Medicine 12/2013; 15(4):311-7. · 2.15 Impact Factor
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    ABSTRACT: Objectives This article proposes an integrated approach to the development, validation, and evaluation of new risk prediction models illustrated with the Fungal Infection Risk Evaluation study, which developed risk models to identify non-neutropenic, critically ill adult patients at high risk of invasive fungal disease (IFD). Methods Our decision-analytical model compared alternative strategies for preventing IFD at up to three clinical decision time points (critical care admission, after 24 hours, and end of day 3), followed with antifungal prophylaxis for those judged “high” risk versus “no formal risk assessment.” We developed prognostic models to predict the risk of IFD before critical care unit discharge, with data from 35,455 admissions to 70 UK adult, critical care units, and validated the models externally. The decision model was populated with positive predictive values and negative predictive values from the best-fitting risk models. We projected lifetime cost-effectiveness and expected value of partial perfect information for groups of parameters. Results The risk prediction models performed well in internal and external validation. Risk assessment and prophylaxis at the end of day 3 was the most cost-effective strategy at the 2% and 1% risk threshold. Risk assessment at each time point was the most cost-effective strategy at a 0.5% risk threshold. Expected values of partial perfect information were high for positive predictive values or negative predictive values (£11 million–£13 million) and quality-adjusted life-years (£11 million). Conclusions It is cost-effective to formally assess the risk of IFD for non-neutropenic, critically ill adult patients. This integrated approach to developing and evaluating risk models is useful for informing clinical practice and future research investment.
    Value in Health 12/2013; · 2.89 Impact Factor
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    ABSTRACT: Risk stratification is essential for both clinical risk prediction and comparative audit. There are a variety of risk stratification tools available for use in major noncardiac surgery, but their discrimination and calibration have not previously been systematically reviewed in heterogeneous patient cohorts.Embase, MEDLINE, and Web of Science were searched for studies published between January 1, 1980 and August 6, 2011 in adult patients undergoing major noncardiac, nonneurological surgery. Twenty-seven studies evaluating 34 risk stratification tools were identified which met inclusion criteria. The Portsmouth-Physiology and Operative Severity Score for the enUmeration of Mortality and the Surgical Risk Scale were demonstrated to be the most consistently accurate tools that have been validated in multiple studies; however, both have limitations. Future work should focus on further evaluation of these and other parsimonious risk predictors, including validation in international cohorts. There is also a need for studies examining the impact that the use of these tools has on clinical decision making and patient outcome.
    Anesthesiology 10/2013; 119(4):959-81. · 6.17 Impact Factor
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    Anesthesiology 10/2013; 119(4):959-81. · 6.17 Impact Factor
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    ABSTRACT: To determine the effect of different intensivist staffing models on clinical outcomes for critically ill patients. A sensitive search of electronic databases and hand-search of major critical care journals and conference proceedings was completed in October 2012. Comparative observational studies examining intensivist staffing patterns and reporting hospital or ICU mortality were included. Of 16,774 citations, 52 studies met the inclusion criteria. We used random-effects meta-analytic models unadjusted for case-mix or cluster effects and quantified between-study heterogeneity using I. Study quality was assessed using the Newcastle-Ottawa Score for cohort studies. High-intensity staffing (i.e., transfer of care to an intensivist-led team or mandatory consultation of an intensivist), compared to low-intensity staffing, was associated with lower hospital mortality (risk ratio, 0.83; 95% CI, 0.70-0.99) and ICU mortality (pooled risk ratio, 0.81; 95% CI, 0.68-0.96). Significant reductions in hospital and ICU length of stay were seen (-0.17 d, 95% CI, -0.31 to -0.03 d and -0.38 d, 95% CI, -0.55 to -0.20 d, respectively). Within high-intensity staffing models, 24-hour in-hospital intensivist coverage, compared to daytime only coverage, did not improved hospital or ICU mortality (risk ratio, 0.97; 95% CI, 0.89-1.1 and risk ratio, 0.88; 95% CI, 0.70-1.1). The benefit of high-intensity staffing was concentrated in surgical (risk ratio, 0.84; 95% CI, 0.44-1.6) and combined medical-surgical (risk ratio, 0.76; 95% CI, 0.66-0.83) ICUs, as compared to medical (risk ratio, 1.1; 95% CI, 0.83-1.5) ICUs. The effect on hospital mortality varied throughout different decades; pooled risk ratios were 0.74 (95% CI, 0.63-0.87) from 1980 to 1989, 0.96 (95% CI, 0.69-1.3) from 1990 to 1999, 0.70 (95% CI, 0.54-0.90) from 2000 to 2009, and 1.2 (95% CI, 0.84-1.8) from 2010 to 2012. These findings were similar for ICU mortality. High-intensity staffing is associated with reduced ICU and hospital mortality. Within a high-intensity model, 24-hour in-hospital intensivist coverage did not reduce hospital, or ICU, mortality. Benefits seen in mortality were dependent on the type of ICU and decade of publication.
    Critical care medicine 08/2013; · 6.15 Impact Factor

Publication Stats

1k Citations
414.31 Total Impact Points

Institutions

  • 2004–2014
    • Intensive Care National Audit & Research Centre ICNARC
      Londinium, England, United Kingdom
  • 2013
    • London School of Hygiene and Tropical Medicine
      • Department of Health Services Research and Policy
      Londinium, England, United Kingdom
  • 2012
    • Greater Wellington Regional Council
      Wellington, Wellington, New Zealand
    • McGill University
      • Respiratory Division
      Montréal, Quebec, Canada
    • The University of York
      • Centre for Health Economics
      York, ENG, United Kingdom
  • 2008–2011
    • Columbia University
      • Department of Anesthesiology
      New York City, NY, United States
  • 2005
    • New York Presbyterian Hospital
      • Department of Anesthesiology
      New York City, New York, United States