Showing papers by "Deborah J. Cook published in 2009"

Intensive versus conventional glucose control in critically ill patients.

Abstract: Background: The optimal target range for blood glucose in critically ill patients remains unclear. Methods: Within 24 hours after admission to an intensive care unit (ICU), adults who were expected to require treatment in the ICU on 3 or more consecutive days were randomly assigned to undergo either intensive glucose control, with a target blood glucose range of 81 to 108 mg per deciliter (4.5 to 6.0 mmol per liter), or conventional glucose control, with a target of 180 mg or less per deciliter (10.0 mmol or less per liter). We defined the primary end point as death from any cause within 90 days after randomization. Results: Of the 6104 patients who underwent randomization, 3054 were assigned to undergo intensive control and 3050 to undergo conventional control; data with regard to the primary outcome at day 90 were available for 3010 and 3012 patients, respectively. The two groups had similar characteristics at baseline. A total of 829 patients (27.5%) in the intensive-control group and 751 (24.9%) in the conventional-control group died (odds ratio for intensive control, 1.14; 95% confidence interval, 1.02 to 1.28; P=0.02). The treatment effect did not differ significantly between operative (surgical) patients and nonoperative (medical) patients (odds ratio for death in the intensive-control group, 1.31 and 1.07, respectively; P=0.10). Severe hypoglycemia (blood glucose level, < or = 40 mg per deciliter [2.2 mmol per liter]) was reported in 206 of 3016 patients (6.8%) in the intensive-control group and 15 of 3014 (0.5%) in the conventional-control group (P<0.001). There was no significant difference between the two treatment groups in the median number of days in the ICU (P=0.84) or hospital (P=0.86) or the median number of days of mechanical ventilation (P=0.56) or renal-replacement therapy (P=0.39). Conclusions: In this large, international, randomized trial, we found that intensive glucose control increased mortality among adults in the ICU: a blood glucose target of 180 mg or less per deciliter resulted in lower mortality than did a target of 81 to 108 mg per deciliter. (ClinicalTrials.gov number, NCT00220987.)

Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement (Chinese edition)

Abstract: Provide a structured summary including, as applicable, background, objectives, data sources, study eligibility criteria, participants, interventions, study appraisal and synthesis methods, results, limitations, conclusions and implications of key findings, systematic review registration number 2 Structured summary

Critically ill patients with 2009 influenza A(H1N1) infection in Canada.

Abstract: Context Between March and July 2009, the largest number of confirmed cases of 2009 influenza A(H1N1) infection occurred in North America. Objective To describe characteristics, treatment, and outcomes of critically ill patients in Canada with 2009 influenza A(H1N1) infection. Design, Setting, and Patients A prospective observational study of 168 critically ill patients with 2009 influenza A(H1N1) infection in 38 adult and pediatric intensive care units (ICUs) in Canada between April 16 and August 12, 2009. Main Outcome Measures The primary outcome measures were 28-day and 90-day mortality. Secondary outcomes included frequency and duration of mechanical ventilation and duration of ICU stay. Results Critical illness occurred in 215 patients with confirmed (n = 162), probable (n = 6), or suspected (n = 47) community-acquired 2009 influenza A(H1N1) infection. Among the 168 patients with confirmed or probable 2009 influenza A(H1N1), the mean (SD) age was 32.3 (21.4) years; 113 were female (67.3%) and 50 were children (29.8%). Overall mortality among critically ill patients at 28 days was 14.3% (95% confidence interval, 9.5%-20.7%). There were 43 patients who were aboriginal Canadians (25.6%). The median time from symptom onset to hospital admission was 4 days (interquartile range [IQR], 2-7 days) and from hospitalization to ICU admission was 1 day (IQR, 0-2 days). Shock and nonpulmonary acute organ dysfunction was common (Sequential Organ Failure Assessment mean [SD] score of 6.8 [3.6] on day 1). Neuraminidase inhibitors were administered to 152 patients (90.5%). All patients were severely hypoxemic (mean [SD] ratio of PaO 2 to fraction of inspired oxygen [FIO 2 ] of 147 [128] mm Hg) at ICU admission. Mechanical ventilation was received by 136 patients (81.0%). The median duration of ventilation was 12 days (IQR, 6-20 days) and ICU stay was 12 days (IQR, 5-20 days). Lung rescue therapies included neuromuscular blockade (28% of patients), inhaled nitric oxide (13.7%), high-frequency oscillatory ventilation (11.9%), extracorporeal membrane oxygenation (4.2%), and prone positioning ventilation (3.0%). Overall mortality among critically ill patients at 90 days was 17.3% (95% confidence interval, 12.0%-24.0%; n = 29). Conclusion Critical illness due to 2009 influenza A(H1N1) in Canada occurred rapidly after hospital admission, often in young adults, and was associated with severe hypoxemia, multisystem organ failure, a requirement for prolonged mechanical ventilation, and the frequent use of rescue therapies.Published online October 12, 2009 (doi:10.1001/jama.2009.1496).

Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data

Abstract: Background: Hyperglycemia is associated with increased mortality in critically ill patients. Randomized trials of intensive insulin therapy have reported inconsistent effects on mortality and increased rates of severe hypoglycemia. We conducted a meta-analysis to update the totality of evidence regarding the influence of intensive insulin therapy compared with conventional insulin therapy on mortality and severe hypoglycemia in the intensive care unit (ICU). Methods: We conducted searches of electronic databases, abstracts from scientific conferences and bibliographies of relevant articles. We included published randomized controlled trials conducted in the ICU that directly compared intensive insulin therapy with conventional glucose management and that documented mortality. We included in our meta-analysis the data from the recent NICE-SUGAR (Normoglycemia in Intensive Care Evaluation — Survival Using Glucose Algorithm Regulation) study. Results: We included 26 trials involving a total of 13 567 patients in our meta-analysis. Among the 26 trials that reported mortality, the pooled relative risk (RR) of death with intensive insulin therapy compared with conventional therapy was 0.93 (95% confidence interval [CI] 0.83–1.04). Among the 14 trials that reported hypoglycemia, the pooled RR with intensive insulin therapy was 6.0 (95% CI 4.5–8.0). The ICU setting was a contributing factor, with patients in surgical ICUs appearing to benefit from intensive insulin therapy (RR 0.63, 95% CI 0.44–0.91); patients in the other ICU settings did not (medical ICU: RR 1.0, 95% CI 0.78–1.28; mixed ICU: RR 0.99, 95% CI 0.86–1.12). The different targets of intensive insulin therapy (glucose level ≤ 6.1 mmol/L v. ≤ 8.3 mmol/L) did not influence either mortality or risk of hypoglycemia. Interpretation: Intensive insulin therapy significantly increased the risk of hypoglycemia and conferred no overall mortality benefit among critically ill patients. However, this therapy may be beneficial to patients admitted to a surgical ICU.

Circulating Fibrocytes Are an Indicator of Poor Prognosis in Idiopathic Pulmonary Fibrosis

Abstract: Rationale: The clinical management of idiopathic pulmonary fibrosis (IPF) remains a major challenge due to lack of effective drug therapy or accurate indicators for disease progression. Fibrocytes are circulating mesenchymal cell progenitors that are involved in tissue repair and fibrosis.Objectives: To test the hypothesis that assay of these cells may provide a biomarker for activity and progression of IPF.Methods: Fibrocytes were defined as cells positive for CD45 and collagen-1 by flow cytometry and quantified in patients with stable IPF and during acute exacerbation of the disease. We investigated the clinical and prognostic value of fibrocyte counts by comparison with standard clinical parameters and survival. We used healthy age-matched volunteers and patients with acute respiratory distress syndrome as control subjects.Measurements and Main Results: Fibrocytes were significantly elevated in patients with stable IPF (n = 51), with a further increase during acute disease exacerbation (n = 7; P < 0.00...

Quality of care in for-profit and not-for-profit nursing homes: systematic review and meta-analysis

Abstract: Objective To compare quality of care in for-profit and not-for-profit nursing homes. Design Systematic review and meta-analysis of observational studies and randomised controlled trials investigating quality of care in for-profit versus not-for-profit nursing homes. Results A comprehensive search yielded 8827 citations, of which 956 were judged appropriate for full text review. Study characteristics and results of 82 articles that met inclusion criteria were summarised, and results for the four most frequently reported quality measures were pooled. Included studies reported results dating from 1965 to 2003. In 40 studies, all statistically significant comparisons (P Conclusions This systematic review and meta-analysis of the evidence suggests that, on average, not-for-profit nursing homes deliver higher quality care than do for-profit nursing homes. Many factors may, however, influence this relation in the case of individual institutions.

Written informed consent and selection bias in observational studies using medical records: systematic review

Abstract: Objectives To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies. Design Systematic review. Data sources Embase, Medline, and the Cochrane Library up to March 2008, reference lists from pertinent articles, and searches of electronic citations. Study selection Prospective observational studies reporting characteristics of participants and non-participants approached for informed consent to use their medical records. Studies were selected independently in duplicate; a third reviewer resolved disagreements. Data extraction Age, sex, race, education, income, or health status of participants and non-participants, the participation rate in each study, and susceptibility of these calculations to threats of selection and reporting bias. Results Of 1650 citations 17 unique studies met inclusion criteria and had analysable data. Across all outcomes there were differences between participants and non-participants; however, there was a lack of consistency in the direction and the magnitude of effect. Of 161 604 eligible patients, 66.9% consented to use of data from their medical records. Conclusions Significant differences between participants and non-participants may threaten the validity of results from observational studies that require consent for use of data from medical records. To ensure that legislation on privacy does not unduly bias observational studies using medical records, thoughtful decision making by research ethics boards on the need for mandatory consent is necessary.

Interaction of vasopressin infusion, corticosteroid treatment, and mortality of septic shock

Abstract: OBJECTIVE: Vasopressin and corticosteroids are often added to support cardiovascular dysfunction in patients who have septic shock that is nonresponsive to fluid resuscitation and norepinephrine infusion. However, it is unknown whether vasopressin treatment interacts with corticosteroid treatment. DESIGN: Post hoc substudy of a multicenter randomized blinded controlled trial of vasopressin vs. norepinephrine in septic shock. SETTING: Twenty-seven Intensive Care Units in Canada, Australia, and the United States. PATIENTS: : Seven hundred and seventy-nine patients who had septic shock and were ongoing hypotension requiring at least 5 microg/min of norepinephrine infusion for 6 hours. INTERVENTIONS: Patients were randomized to blinded vasopressin (0.01-0.03 units/min) or norepinephrine (5-15 microg/min) infusion added to open-label vasopressors. Corticosteroids were given according to clinical judgment at any time in the 28-day postrandomization period. MEASUREMENTS: The primary end point was 28-day mortality. We tested for interaction between vasopressin treatment and corticosteroid treatment using logistic regression. Secondary end points were organ dysfunction, use of open-label vasopressors and vasopressin levels. MAIN RESULTS: There was a statistically significant interaction between vasopressin infusion and corticosteroid treatment (p = 0.008). In patients who had septic shock and were also treated with corticosteroids, vasopressin, compared to norepinephrine, was associated with significantly decreased mortality (35.9% vs. 44.7%, respectively, p = 0.03). In contrast, in patients who did not receive corticosteroids, vasopressin was associated with increased mortality compared with norepinephrine (33.7% vs. 21.3%, respectively, p = 0.06). In patients who received vasopressin infusion, use of corticosteroids significantly increased plasma vasopressin levels by 33% at 6 hours (p = 0.006) to 67% at 24 hours (p = 0.025) compared with patients who did not receive corticosteroids. CONCLUSIONS: There is a statistically significant interaction between vasopressin and corticosteroids. The combination of low-dose vasopressin and corticosteroids was associated with decreased mortality and organ dysfunction compared with norepinephrine and corticosteroids.

The design and interpretation of pilot trials in clinical research in critical care

Abstract: Background: Pilot trials are important to ensure that large randomized trials are rigorous, feasible, and economically justifiable. The objective of this review is to highlight the importance of randomized pilot trials and to describe key features of their design and interpretation using examples from critical care. Methods: We searched MEDLINE (1997–2007) and contacted experts to identify pilot randomized trials to exemplify and summarize their key methodologic features including objectives, sample size determination, outcomes, analysis, and reporting. Results: Pilot trials can have distinct and broad objectives. Investigators can predefine explicit criteria for determining their success. Surrogate outcome analyses are common in pilot trials, yet are usually underpowered to detect meaningful differences in clinically important end points and thus, should be cautiously interpreted. Pilot trials can facilitate successful conduct of large clinical trials by informing study design and streamlining protocol implementation. Recommendations: We recommend that investigators define suitable objectives, determine sample size estimates, and select outcomes that will address their specific pilot trial objectives. Clinical effects documented in pilot trials should be reported with caution to avoid undue enthusiasm or pessimism about unstable estimates. Further methodologic work is required to identify optimal pilot trial design, indexing, and reporting.

LOST to follow-up Information in Trials (LOST-IT): a protocol on the potential impact

Abstract: Background Incomplete ascertainment of outcomes in randomized controlled trials (RCTs) is likely to bias final study results if reasons for unavailability of patient data are associated with the outcome of interest. The primary objective of this study is to assess the potential impact of loss to follow-up on the estimates of treatment effect. The secondary objectives are to describe, for published RCTs, (1) the reporting of loss to follow-up information, (2) the analytic methods used for handling loss to follow-up information, and (3) the extent of reported loss to follow-up.

Renal outcomes and mortality following hydroxyethyl starch resuscitation of critically ill patients: systematic review and meta-analysis of randomized trials

Abstract: Background: Hydroxyethyl starch (HES) is a type of colloid fluid that is commonly used for volume resuscitation of patients admitted to the intensive care unit. Data regarding the renal consequences of HES are conflicting. Purpose: To evaluate the effect of HES solutions on renal outcomes and mortality among critically ill patients requiring acute volume resuscitation. Data sources: We searched electronic databases (MEDLINE, EMBASE, the Cochrane Central Registry of Controlled Trials and the SCOPUS database) from 1950 to 2008. Conference proceedings and grey literature sources were searched from 2002 to 2007. Study selection: We included only randomized controlled trials of acute volume resuscitation of critically ill patients comparing HES fluid with an alternative resuscitation fluid. Data synthesis: Two reviewers independently assessed trial eligibility, extracted data and evaluated trial quality. Random-effects models were used for all summary measures of effect. Results: Twenty-two trials (n = 1865 patients) were included. Patients who received HES were more likely to have received renal replacement therapy (odds ratio [OR] 1.90, 95% confidence interval [CI] 1.22–2.96, I 2 9.5%, n = 749). There was no difference in overall mortality (OR 1.07, 95% CI 0.85–1.34, n = 1657). However, in trials that included patients with severe sepsis and septic shock, in high-quality and multicentre trials, and in trials with adequate allocation concealment, there was a trend toward increased risk of death in association with HES. Limitations: Data regarding adverse events, including renal outcomes, were not reported in the majority of published randomized trials. Considerable clinical and methodologic heterogeneity existed among trials. Conclusions: The use of HES for acute volume resuscitation of critically ill patients, and in particular those with severe sepsis and septic shock, appeared to be associated with increased use of renal replacement therapy. Further randomized controlled trials evaluating clinically important end points are required to examine the efficacy and safety of HES fluids for critically ill patients.

Investigator-led clinical research consortia: the Canadian Critical Care Trials Group.

Abstract: Advances in the care of critically ill patients are dependent upon rigorous clinical research undertaken to characterize natural history and risk factors, and determine optimal approaches to the management of the diseases of the critically ill patient. The Canadian Critical Care Trials Group (CCCTG) was formed in 1989 to foster such research. It has grown to become a national, multidisciplinary organization with more than 100 members, and more than 3 dozen active research programs. Its members have been highly successful in obtaining funding for, completing, and publishing well-designed studies that have informed international practice in areas such as transfusion, stress ulcer prophylaxis, long term outcomes from acute respiratory distress syndrome, diagnosis and management of infection in the intensive care unit, and end-of-life care. In the process, the CCCTG has developed a highly effective culture of scientific mentoring, and has served as a model for investigator-led critical care research groups around the world. This review summarizes the history, activities, approaches, and challenges of the CCCTG, in the conviction that investigator-led groups such as ours represent the future of intensive care unit-based research.

A retrospective cohort pilot study to evaluate a triage tool for use in a pandemic

Abstract: The objective of this pilot study was to assess the usability of the draft Ontario triage protocol, to estimate its potential impact on patient outcomes, and ability to increase resource availability based on a retrospective cohort of critically ill patients cared for during a non-pandemic period. Triage officers applied the protocol prospectively to 2 retrospective cohorts of patients admitted to 2 academic medical/surgical ICUs during an 8 week period of peak occupancy. Each patient was assigned a treatment priority (red -- 'highest', yellow -- 'intermediate', green -- 'discharge to ward', or blue/black -- 'expectant') by the triage officers at 3 separate time points (at the time of admission to the ICU, 48, and 120 hours post admission). Overall, triage officers were either confident or very confident in 68.4% of their scores; arbitration was required in 54.9% of cases. Application of the triage protocol would potentially decrease the number of required ventilator days by 49.3% (568 days) and decrease the total ICU days by 52.6% (895 days). On the triage protocol at ICU admission the survival rate in the red (93.7%) and yellow (62.5%) categories were significantly higher then that of the blue category (24.6%) with associated P values of < 0.0001 and 0.0003 respectively. Further, the survival rate of the red group was significantly higher than the overall survival rate of 70.9% observed in the cohort (P < 0.0001). At 48 and 120 hours, survival rates in the blue group increased but remained lower then the red or yellow groups. Refinement of the triage protocol and implementation is required prior to future study, including improved training of triage officers, and protocol modification to minimize the exclusion from critical care of patients who may in fact benefit. However, our results suggest that the triage protocol can help to direct resources to patients who are most likely to benefit, and help to decrease the demands on critical care resources, thereby making available more resources to treat other critically ill patients.

Patients’ preferences for enrolment into critical-care trials

Abstract: Most critically ill patients are incapable of providing informed consent for research. We sought to determine patients’ preferences for different consent frameworks for enrolling incapable patients into critical-care trials. Prospective observational and structured interview study. Five university-affiliated hospitals in Ontario. Two-hundred and forty consecutive capable and consenting survivors of critical illness. Participants considered four frameworks for enrolling incapable patients into clinical trials using a baseline scenario and three permutations for: risk (very low vs. high), treatment type (new vs. currently available), and availability of substitute decision-maker (yes vs. no). For each scenario, patients chose their preferred framework and rated the acceptability of each framework using a seven-point Likert scale. Most (180/240; 76%) patients selected “consent by substitute prior to enrolment” as their preferred framework; this also received the highest baseline acceptability ratings (“acceptable” or “highly acceptable” 207/240; 87%). Modifying risk or treatment type did not substantially change these ratings. A minority of patients rated delayed consent as unacceptable or highly unacceptable in both the baseline scenario (48/240, 20% delayed to substitute; 57/240, 24% delayed to patient) and when a substitute was unavailable (34/240; 15%). Most survivors of critical illness found the usual practice of obtaining informed consent from a substitute decision-maker prior to enrolment in a clinical trial to be acceptable. Nearly half of patients considered foregoing informed consent to be unacceptable, whereas a minority considered enrolment followed by delayed consent to be unacceptable even when a substitute was unavailable. These approaches should, therefore, only be considered when deviating from the usual practice of obtaining consent from a substitute decision-maker is truly justified, such as where treatments being tested need to be delivered as soon as possible in order to be effective.

Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2).

Abstract: Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The St udy O f Trial P olicy Of I nterim T runcation (STOPIT-1), which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic tRCTs can correct observed biases. A better understanding of the extent to which tRCTs exaggerate treatment effects and of the factors associated with the magnitude of this bias can optimize trial design and data monitoring charters, and may aid in the interpretation of the results from trials stopped early for benefit.

"Living with dying": the evolution of family members' experience of mechanical ventilation.

Abstract: Background:Communication with families about mechanical ventilation may be more effective once we gain a better understanding of what families experience and understand about this life support technology when their loved ones are admitted to the intensive care unit (ICU).Methods:We conducted in-dept

Life support decision making in critical care : Identifying and appraising the qualitative research evidence

Abstract: Objective:The objective of this study is to identify and appraise qualitative research evidence on the experience of making life-support decisions in critical care.Data Sources:In six databases and supplementary sources, we sought original research published from January 1990 through June 2008 repor

Bleeding and venous thromboembolism in the critically ill with emphasis on patients with renal insufficiency

Abstract: Purpose of reviewThe purpose of this review is to critique and summarize clinical literature relevant to thromboprophylaxis in critically ill patients with renal insufficiency. The specific objectives are to discuss factors that increase the risks for bleeding and venous thromboembolism in criticall

Increasing Reliability of APACHE II Scores in a Medical-Surgical Intensive Care Unit: A Quality Improvement Study

Abstract: Background Given their clinical, research, and administrative purposes, scores on the Acute Physiology and Chronic Health Evaluation (APACHE) II should be reliable, whether calculated by health care personnel or a clinical information system Objective To determine reliability of APACHE II scores calculated by a clinical information system and by health care personnel before and after a multifaceted quality improvement intervention Methods APACHE II scores of 37 consecutive patients admitted to a closed, 15-bed, university-affiliated intensive care unit were collected by a research coordinator, a database clerk, and a clinical information system After a quality improvement intervention focused on health care personnel and the clinical information system, the same methods were used to collect data on 32 consecutive patients The research coordinator and the clerk did not know each other's scores or the information system's score The data analyst did not know the source of the scores until analysis was complete Results APACHE II scores obtained by the clerk and the research coordinator were highly reliable (intraclass correlation coefficient, 088 before vs 080 after intervention; P = 25) No significant changes were detected after the intervention; however, compared with scores of the research coordinator, the overall reliability of APACHE II scores calculated by the clinical information system improved (intraclass correlation coefficient, 024 before intervention vs 091 after intervention, P Conclusions After completion of a quality improvement intervention, health care personnel and a computerized clinical information system calculated sufficiently reliable APACHE II scores for clinical, research, and administrative purposes

The efficacy and safety of glucose control algorithms in intensive care: a pilot study of the Survival Using Glucose Algorithm Regulation (SUGAR) trial.

Abstract: INTRODUCTION The benefits, harms and feasibility of intensive insulin therapy in critically ill patients remain unclear. Several single center studies have attempted to demonstrate the benefit of intensive insulin therapy in critically ill patients with variable results. OBJECTIVES We conducted a pilot randomized trial to assess the feasibility, safety and clinical outcomes of preprinted glucose management algorithms before the initiation of a large multicenter trial. PATIENTS AND METHODS Within 48 hours of admission to the intensive care unit, we randomized mechanically ventilated patients to either the "high" group (target serum glucose concentration 9-11 mmol/l) or the "low" group (target serum glucose concentration 5-7 mmol/l). To assess feasibility we measured the time to reach target glucose range, time in target range, morning glucose concentrations, average daily glucose concentrations, and number of crossovers. To assess safety, we measured the number of hypoglycemic events (serum glucose <2.2 mmol/l), and other serious adverse events such as cardiac arrests and seizures. RESULTS Sixty-eight patients were enrolled (35 in the high group and 33 in the low group). During the first week, the median proportions of time spent in the target range were 35.7% and 53.0% for the high and low groups, respectlively (p = 0.0001). Morning glucose concentrations were 8.3 +/-1.6 mmol/l and 6.2 -/+1.2 mmol/l. One (2.9%) and 8 (24.2%) episodes of hypoglycemia (<2.2 mmol/l) occurred in the high and low groups, reflecting 0.002 and 0.03 hypoglycemic events per patient-day, respectlively. CONCLUSIONS This pilot trial of intensive insulin therapy identified numerous challenges that helped in the preparation of an international multicenter randomized trial of intensive insulin therapy to evaluate benefits and harms.

Thromboprophylaxis for hospitalized medical patients: a multicenter qualitative study.

Abstract: BACKGROUND: Observational studies have documented that medical patients infrequently receive venous thromboembolism (VTE) prevention. OBJECTIVE: To understand the barriers to, and facilitators of, optimal thromboprophylaxis. PATIENTS: Hospitalized medical patients. DESIGN: We conducted in-depth interviews with 15 nurses, 6 pharmacists, 12 physicians with both clinical and managerial experience, and 3 hospital administrators. SETTING: One university-affiliated and 2 community hospitals. INTERVENTION: Interviews were audiotaped and transcribed verbatim. Transcripts were reviewed and interpreted independently in duplicate. MEASUREMENT: Analysis was conducted using grounded theory. RESULTS: Physicians and pharmacists affirmed that evidence supporting heparin is strong and understood. Clinicians, particularly nurses, reported that mobilization was important, but were uncertain about how much mobilization was enough. Participants believed that depending on individual physicians for VTE prevention is insufficient. The central finding was that multidisciplinary care was also perceived as a barrier to effective VTE prevention because it can lead to unclear accountability by role confusion. Participants believed that a comprehensive, systems approach was necessary. Suggestions included screening and risk-stratifying all patients, preprinted orders at hospital admission that are regularly reevaluated, and audit and feedback programs. Patient or family-mediated reminders, and administrative interventions, such as hiring more physiotherapists and profiling thromboprophylaxis in hospital accreditation, were also endorsed. CONCLUSIONS: Universal consideration of thromboprophylaxis finds common ground in multidisciplinary care. However, results of this qualitative study challenge the conviction that either individual physician efforts or multidisciplinary care are sufficient for optimal prevention. To ensure exemplary medical thromboprophylaxis, clinicians regarded coordinated, systemwide processes, aimed at patients, providers, and administrators as essential. Journal of Hospital Medicine 2009;4:269–275. © 2009 Society of Hospital Medicine.