Monica Taljaard

Incidence of potentially avoidable urgent readmissions and their relation to all-cause urgent readmissions

Background: Urgent, unplanned hospital readmissions are increasingly being used to gauge the quality of care. We reviewed urgent readmissions to determine which were potentially avoidable and compared rates of all-cause and avoidable readmissions. Methods: In a multicentre, prospective cohort study, we reviewed all urgent readmissions that occurred within six months among patients discharged to the community from 11 teaching and community hospitals between October 2002 and July 2006. Summaries of the readmissions were reviewed by at least four practising physicians using standardized methods to judge whether the readmission was an adverse event (poor clinical outcome due to medical care) and whether the adverse event could have been avoided. We used a latent class model to determine whether the probability that each readmission was truly avoidable exceeded 50%. Results: Of the 4812 patients included in the study, 649 (13.5%, 95% confidence interval [CI] 12.5%–14.5%) had an urgent readmission within six months after discharge. We considered 104 of them (16.0% of those readmitted, 95% CI 13.3%–19.1%; 2.2% of those discharged, 95% CI 1.8%–2.6%) to have had a potentially avoidable readmission. The proportion of patients who had an urgent readmission varied significantly by hospital (range 7.5%–22.5%; χ2 = 92.9, p < 0.001); the proportion of readmissions deemed avoidable did not show significant variation by hospital (range 1.2%–3.7%; χ2 = 12.5, p < 0.25). We found no association between the proportion of patients who had an urgent readmission and the proportion of patients who had an avoidable readmission (Pearson correlation 0.294; p = 0.38). In addition, we found no association between hospital rankings by proportion of patients readmitted and rankings by proportion of patients with an avoidable readmission (Spearman correlation coefficient 0.28, p = 0.41). Interpretation: Urgent readmissions deemed potentially avoidable were relatively uncommon, comprising less than 20% of all urgent readmissions following hospital discharge. Hospital-specific proportions of patients who were readmitted were not related to proportions with a potentially avoidable readmission.

The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials

The Ottawa Ethics of Cluster Trials Consensus Group sets out 15 recommendations for the ethical design and conduct of cluster randomized trials.

Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8

Objective To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. Design Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. Data sources A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. Results There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. Conclusion The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.

Outcomes of Urgent Warfarin Reversal With Frozen Plasma Versus Prothrombin Complex Concentrate in the Emergency Department

Backround— Physicians reverse patients’ warfarin anticoagulation with frozen plasma or prothrombin complex concentrate. Our objective was to determine adverse event frequency after urgent reversal with frozen plasma versus the prothrombin complex concentrate Octaplex. Methods and Results— This natural before-after retrospective cohort study in 2 tertiary care emergency departments compared anticoagulation reversal with frozen plasma (September 2006–August 2008) and with Octaplex (September 2008–August 2010), without other system changes. We included adult patients on warfarin with an international normalized ratio ≥1.5 who received frozen plasma or Octaplex. Our primary outcome was serious adverse events (death, ischemic stroke, myocardial infarction, heart failure, venous thromboembolism, or peripheral arterial thromboembolism) within 7 days. Secondary outcomes included time to international normalized ratio reversal, hospital length of stay, and red blood cells transfused within 48 hours. We included 149 patients receiving frozen plasma and 165 receiving Octaplex. The incidence of serious adverse events for the frozen plasma group was 19.5% compared with 9.7% for the Octaplex group (P=0.014; relative risk, 2.0; 95% confidence interval, 1.1–3.5). This remained significant after adjustment for baseline history and reason for treatment (P=0.038; adjusted relative risk, 1.85; 95% confidence interval, 1.03–3.3) in multivariable regression analysis. Median international normalized ratio reversal was 11.8 hours with frozen plasma and 5.7 hours with Octaplex (P<0.0001). Mean red cell transfusion was 3.2 with frozen plasma and 1.4 with Octaplex (P<0.0001). Conclusions— Octaplex for urgent reversal of warfarin resulted in faster reversal and lower red cell transfusion requirement with fewer adverse events than frozen plasma.

The prevalence of stillbirths: a systematic review

BackgroundStillbirth rate is an important indicator of access to and quality of antenatal and delivery care. Obtaining overall estimates across various regions of the world is not straightforward due to variation in definitions, data collection methods and reporting.MethodsWe conducted a systematic review of a range of pregnancy-related conditions including stillbirths and performed meta-analysis of the subset of studies reporting stillbirth rates. We examined variation across rates and used meta-regression techniques to explain observed variation.ResultsWe identified 389 articles on stillbirth prevalence among the 2580 included in the systematic review. We included 70 providing 80 data sets from 50 countries in the meta-analysis. Pooled prevalence rates show variation across various subgroup categories. Rates per 100 births are higher in studies conducted in less developed country settings as compared to more developed (1.17 versus 0.50), of inadequate quality as compared to adequate (1.12 versus 0.66), using sub-national sample as compared to national (1.38 versus 0.68), reporting all stillbirths as compared to late stillbirths (0.95 versus 0.63), published in non-English as compared to English (0.91 versus 0.59) and as journal articles as compared to non-journal (1.37 versus 0.67). The results of the meta-regression show the significance of two predictor variables – development status of the setting and study quality – on stillbirth prevalence.ConclusionStillbirth prevalence at the community level is typically less than 1% in more developed parts of the world and could exceed 3% in less developed regions. Regular reviews of stillbirth rates in appropriately designed and reported studies are useful in monitoring the adequacy of care. Systematic reviews of prevalence studies are helpful in explaining sources of variation across rates. Exploring these methodological issues will lead to improved standards for assessing the burden of reproductive ill-health.

The effect of hospital-acquired infection with Clostridium difficile on length of stay in hospital

Background: The effect of hospital-acquired infection with Clostridium difficile on length of stay in hospital is not yet fully understood. We determined the independent impact of hospital-acquired infection with C. difficile on length of stay in hospital. Methods: We conducted a retrospective observational cohort study of admissions to hospital between July 1, 2002, and Mar. 31, 2009, at a single academic hospital. We measured the association between infection with hospital-acquired C. difficile and time to discharge from hospital using Kaplan–Meier methods and a Cox multivariable proportional hazards regression model. We controlled for baseline risk of death and accounted for C. difficile as a time-varying effect. Results: Hospital-acquired infection with C. difficile was identified in 1393 of 136 877 admissions to hospital (overall risk 1.02%, 95% confidence interval [CI] 0.97%–1.06%). The crude median length of stay in hospital was greater for patients with hospital-acquired C. difficile (34 d) than for those without C. difficile (8 d). Survival analysis showed that hospital-acquired infection with C. difficile increased the median length of stay in hospital by six days. In adjusted analyses, hospital-acquired C. difficile was significantly associated with time to discharge, modified by baseline risk of death and time to acquisition of C. difficile. The hazard ratio for discharge by day 7 among patients with hospital-acquired C. difficile was 0.55 (95% CI 0.39–0.70) for patients in the lowest decile of baseline risk of death and 0.45 (95% CI 0.32–0.58) for those in the highest decile; for discharge by day 28, the corresponding hazard ratios were 0.74 (95% CI 0.60–0.87) and 0.61 (95% CI 0.53–0.68). Interpretation: Hospital-acquired infection with C. difficile significantly prolonged length of stay in hospital independent of baseline risk of death.

Imputation Strategies for Missing Continuous Outcomes in Cluster Randomized Trials

In cluster randomized trials, intact social units such as schools, worksites or medical practices - rather than individuals themselves - are randomly allocated to intervention and control conditions, while the outcomes of interest are then observed on individuals within each cluster. Such trials are becoming increasingly common in the fields of health promotion and health services research. Attrition is a common occurrence in randomized trials, and a standard approach for dealing with the resulting missing values is imputation. We consider imputation strategies for missing continuous outcomes, focusing on trials with a completely randomized design in which fixed cohorts from each cluster are enrolled prior to random assignment. We compare five different imputation strategies with respect to Type I and Type II error rates of the adjusted two-sample t -test for the intervention effect. Cluster mean imputation is compared with multiple imputation, using either within-cluster data or data pooled across clusters in each intervention group. In the case of pooling across clusters, we distinguish between standard multiple imputation procedures which do not account for intracluster correlation and a specialized procedure which does account for intracluster correlation but is not yet available in standard statistical software packages. A simulation study is used to evaluate the influence of cluster size, number of clusters, degree of intracluster correlation, and variability among cluster follow-up rates. We show that cluster mean imputation yields valid inferences and given its simplicity, may be an attractive option in some large community intervention trials which are subject to individual-level attrition only; however, it may yield less powerful inferences than alternative procedures which pool across clusters especially when the cluster sizes are small and cluster follow-up rates are highly variable. When pooling across clusters, the imputation procedure should generally take intracluster correlation into account to obtain valid inferences; however, as long as the intracluster correlation coefficient is small, we show that standard multiple imputation procedures may yield acceptable type I error rates; moreover, these procedures may yield more powerful inferences than a specialized procedure, especially when the number of available clusters is small. Within-cluster multiple imputation is shown to be the least powerful among the procedures considered.

The Effect of Hospital-Acquired Clostridium difficile Infection on In-Hospital Mortality

BACKGROUND The effects of hospital-acquired Clostridium difficile infection (CDI) on patient outcomes are incompletely understood. We conducted this study to determine the independent impact of hospital-acquired CDI on in-hospital mortality after adjusting for the time-varying nature of CDI and baseline mortality risk at hospital admission. METHODS This retrospective observational study used data from the Ottawa Hospital (Ottawa, Ontario, Canada) data warehouse. Inpatient admissions with a start date after July 1, 2002, and a discharge date before March 31, 2009, were included. Stratified analyses and a Cox multivariate proportional hazards regression model were used to determine if hospital-acquired CDI was associated with time to in-hospital death. RESULTS A total of 136 877 admissions were included. Hospital-acquired CDI was identified in 1393 admissions (overall risk per admission, 1.02%; 95% confidence interval [CI], 0.97%-1.06%). The risk of hospital-acquired CDI significantly increased as the baseline mortality risk increased: from 0.2% to 2.6% in the lowest to highest deciles of baseline risk. Hospital-acquired CDI significantly increased the absolute risk of in-hospital death across all deciles of baseline risk (pooled absolute increase, 11%; 95% CI, 9%-13%). Cox regression analysis revealed an average 3-fold increase in the hazard of death associated with hospital-acquired CDI (95% CI, 2.4-3.7); this hazard ratio decreased with increasing baseline mortality risk. CONCLUSIONS Hospital-acquired CDI was independently associated with an increased risk of in-hospital death. Across all baseline risk strata, for every 10 patients acquiring the infection, 1 person died.

When is informed consent required in cluster randomized trials in health research

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice?We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation.

The independent association of provider and information continuity on outcomes after hospital discharge: implications for hospitalists.

BACKGROUND Since hospitalist physicians do not frequently see patients in follow-up after discharge from the hospital, patient continuity of care will decrease. To determine how this influenced patient outcomes, we examined the independent association of several physician continuity and information continuity measures on death or urgent readmission after discharge from hospital. DESIGN Multicenter, prospective cohort study of patients discharged to the community after elective or emergency hospitalization. We measured three physician continuity scores (preadmission; hospital; and postdischarge) and two information continuity scores (discharge summary; postdischarge visit information) as time-dependent covariates. Continuity scores ranged from 0 (perfect discontinuity) to 1 (perfect continuity). The primary outcomes were time to all-cause death or urgent readmission. RESULTS A total of 3876 people were followed for a median of 175 days. Death rate was 2.6 events per 100 patient-years observation (pys) (95% confidence interval [CI], 2.0-3.4) and urgent readmission rate was 19.6 events per 100 pys (95% CI, 15.9-24.3). After adjusting for important covariates and other continuity scores, increased preadmission physician continuity was independently associated with a decreased risk of urgent readmission (adjusted hazard ratio 0.94 [95% CI, 0.91-0.98] for each absolute increase in continuity of 0.1). Other continuity measures-including hospital physician continuity-were not associated with either outcome. CONCLUSIONS After discharge from the hospital, increased continuity with physicians who routinely treated the patient prior to the admission was significantly and independently associated with a decreased risk of urgent readmission. These data suggest that continuity with the hospital physician after discharge did not independently influence the risk of patient death or urgent readmission.