Gudrun Pregartner

Implementation of a Surgical Safety Checklist: Interventions to Optimize the Process and Hints to Increase Compliance

Background A surgical safety checklist (SSC) was implemented and routinely evaluated within our hospital. The purpose of this study was to analyze compliance, knowledge of and satisfaction with the SSC to determine further improvements. Methods The implementation of the SSC was observed in a pilot unit. After roll-out into each operating theater, compliance with the SSC was routinely measured. To assess subjective and objective knowledge, as well as satisfaction with the SSC implementation, an online survey (N = 891) was performed. Results During two test runs in a piloting unit, 305 operations were observed, 175 in test run 1 and 130 in test run 2. The SSC was used in 77.1% of all operations in test run 1 and in 99.2% in test run 2. Within used SSCs, completion rates were 36.3% in test run 1 and 1.6% in test run 2. After roll-out, three unannounced audits took place and showed that the SSC was used in 95.3%, 91.9% and 89.9%. Within used SSCs, completion rates decreased from 81.7% to 60.6% and 53.2%. In 2014, 164 (18.4%) operating team members responded to the online survey, 160 of which were included in the analysis. 146 (91.3%) consultants and nursing staff reported to use the SSC regularly in daily routine. Conclusion These data show that the implementation of new tools such as the adapted WHO SSC needs constant supervision and instruction until it becomes self-evident and accepted. Further efforts, consisting mainly of hands-on leadership and training are necessary.

The Gap between Individual Perception and Compliance: A Qualitative Follow-Up Study of the Surgical Safety Checklist Application

Background “The Surgical Safety Checklist (SSC) is important, but we don’t use it adequately” is a well-suited statement that reflects the SSCs application in hospitals. Our aim was to follow up on our initial study on compliance (2014) by analysing differences between individual perception and compliance with the SSC. Methods We conducted a follow-up online survey to assess healthcare professionals’ individual perception of, as well as satisfaction and compliance with the SSC three years following its thorough implementation. Results 171 (19.5%) of 875 operating team members completed the online survey. 99.4% confirmed using the SSC. Self-estimated subjective knowledge about the intention of the checklist was high, whereas objective knowledge was moderate, but improved as compared to 2014. According to an independent audit the SSC was used in 93.1% of all operations and among the SSCs used the completion rate was 57.2%. The use of the SSC was rated as rather easy [median (IQR): 7 (6–7)], familiar [7 (6–7)], generally important [7 (7–7)], and good for patients [7 (6–7)] as well as for employees [7 (7–7)]. Only comfort of use was rated lower [6 (5–7)]. Conclusion There is a gap between individual perception and actual application of the SSC. Despite healthcare professionals confirming the importance of the SSC, compliance was moderate. The introduction of SSCs in the health care sector remains a constant challenge and requires continuous re-evaluation as well as a sensible integration into existing workflows in hospitals.

Metrics of High-Density Lipoprotein Function and Hospital Mortality in Acute Heart Failure Patients

Objective The functionality of high-density lipoprotein (HDL) is impaired in chronic ischaemic heart failure (HF). However, the relationship between HDL functionality and outcomes in acute HF (AHF) has not been studied. The present study investigates whether the metrics of HDL functionality, including HDL cholesterol efflux capacity and HDL-associated paraoxonase (PON)-1 arylesterase (AE) activity are associated with hospital mortality in AHF patients. Methods and Results The study was performed as a prospective, single-centre, observational research on 152 patients, defined and categorised according to the ESC and ACCF/AHA Guidelines for HF by time of onset, final clinical presentation and ejection fraction. The mean age of the included patients (52% female) was 75.2 years (SD 10.3) and hospital mortality was 14.5%. HDL cholesterol efflux capacity was examined by measuring the capacity of apoB depleted serum to remove tritium-labelled cholesterol from cultured macrophages. The AE activity of the HDL fraction was examined by a photometric assay. In a univariable regression analysis, low cholesterol efflux, but not AE activity, was significantly associated with hospital mortality [odds ratio (OR) 0.78, 95% confidence interval (CI) 0.64–0.96, p = 0.019]. In multivariable analysis progressively adjusting for important clinical and laboratory parameters the association obtained for cholesterol efflux capacity and hospital mortality by univariable analysis, despite a stable OR, did not stay significant (p = 0.179). Conclusion Our results suggest that HDL cholesterol efflux capacity (but not AE activity) contributes to, but is not an independent risk factor for, hospital mortality in AHF patients. Larger studies are needed to draw firm conclusions.

Serum Concentration of HDL Particles Predicts Mortality in Acute Heart Failure Patients

Clinical studies have shown that assessing circulating concentrations of high-density lipoprotein (HDL) particles by nuclear magnetic resonance (NMR) spectroscopy is superior to HDL-cholesterol in predicting cardiovascular risk. We tested the hypothesis that circulating concentrations of HDL particles predict 3-month mortality of patients with acute heart failure (AHF). Out of 152 included patients, 52% were female, additionally the mean patient age was 75.2 ± 10.3 years, and three-month mortality was 27%. Serum lipoprotein profile at admission was determined by NMR spectroscopy. Univariate logistic regression analyses revealed a significant inverse association of total (odds ratio (OR) 0.38 per 1-SD increase, 95% confidence interval (CI) 0.23–0.60, p < 0.001) and small HDL particle concentrations (OR 0.35 per 1-SD increase, 95% CI 0.19–0.60, p < 0.001) with 3-month mortality, whereas concentrations of large HDL particles (p = 0.353) or HDL-cholesterol (p = 0.107) showed no significant association. After adjustment for age, sex, mean arterial pressure, low-density lipoprotein cholesterol, glomerular filtration rate, urea, and N-terminal pro-brain natriuretic peptide, both the total and small HDL particle concentrations remained significantly associated with 3-month mortality. Based on our results, we conclude that total and small HDL particle concentrations strongly and independently predict 3-month mortality in AHF patients.

Cytarabine dose in the consolidation treatment of AML: a systematic review and meta-analysis

To the editor: Acute myeloid leukemia (AML) is the most common acute leukemia in adults with an annual, age-adjusted incidence of 3.5/100 000 men and women rising to 15 to 20 above the age of 60 years.[1][1] Extensive work has now led to the elucidation of its genomic backbone, a refined

Cluster-randomized controlled trials evaluating complex interventions in general practices are mostly ineffective: a systematic review

OBJECTIVES The aim of this study was to evaluate how frequently complex interventions are shown to be superior to routine care in general practice-based cluster-randomized controlled studies (c-RCTs) and to explore whether potential differences explain results that come out in favor of a complex intervention. STUDY DESIGN AND SETTING We performed an unrestricted search in the Central Register of Controlled Trials, MEDLINE, and EMBASE. Included were all c-RCTs that included a patient-relevant primary outcome in a general practice setting with at least 1-year follow-up. We extracted effect sizes, P-values, intracluster correlation coefficients (ICCs), and 22 quality aspects. RESULTS We identified 29 trials with 99 patient-relevant primary outcomes. After adjustment for multiple testing on a trial level, four outcomes (4%) in four studies (14%) remained statistically significant. Of the 11 studies that reported ICCs, in 8, the ICC was equal to or smaller than the assumed ICC. In 16 of the 17 studies with available sample size calculation, effect sizes were smaller than anticipated. CONCLUSION More than 85% of the c-RCTs failed to demonstrate a beneficial effect on a predefined primary endpoint. All but one study were overly optimistic with regard to the expected treatment effect. This highlights the importance of weighing up the potential merit of new treatments and planning prospectively, when designing clinical studies in a general practice setting.

Adiponectin Predicts High-Density Lipoprotein Cholesterol Efflux Capacity in Adults Irrespective of Body Mass Index and Fat Distribution

Context: Obesity is associated with hypoadiponectemia, dyslipidemia, and increased risk of cardiovascular disease (CVD). Mechanisms linking these conditions remain to be fully understood. Cholesterol efflux capacity (CEC) is a crucial functional property of high‐density lipoprotein (HDL) that strongly predicts CVD incidence. Objective: We investigated whether age, fat distribution, and other obesity‐related factors affect CEC in juvenile and adult overweight/obese participants of the STYJOBS/EDECTA cohort (NCT00482924). Design: We performed an observational study. Main Outcome Measures: CEC and its association with body measures and related metabolic parameters was assessed in 683 participants (281 juveniles, of whom 227 were overweight/obese; 402 adults, of whom 197 were overweight/obese). Results: Pearson correlation analysis showed that, after Bonferroni correction, CEC was significantly inversely correlated with body mass index (BMI), carotid diameter, waist circumference, waist‐to‐hip, waist‐to‐height ratio, oxidized low‐density lipoprotein, and uric acid and with the liver markers alanine‐aminotransferase and choline esterase. CEC was positively correlated with HDL cholesterol, total cholesterol, apolipoprotein A1, and adiponectin in adults, whereas in juveniles only apolipoprotein A1 showed a significant positive correlation with CEC. Age‐stratified linear regression analyses with CEC as the outcome variable identified adiponectin as the most significant predictor of CEC in adults. The results did not change when either BMI or waist‐to‐hip ratio as a factor of fat distribution was included in the models. Conclusions: Hypoadiponectemia is a robust predictor of reduced cholesterol efflux capacity in adults irrespective of BMI and fat distribution. Further investigations are needed to assess whether adiponectin is a causal determinant of CEC.

How often are interventions in cluster-randomised controlled trials of complex interventions in general practices effective and reasons for potential shortcomings? Protocol and results of a feasibility project for a systematic review

Introduction Most studies conducted at general practices investigate complex interventions and increasingly use cluster-randomised controlled trail (c-RCT) designs to do so. Our primary objective is to evaluate how frequently complex interventions are shown to be more, equally or less effective than routine care in c-RCTs with a superior design. The secondary aim is to discover whether the quality of a c-RCT determines the likelihood of the complex intervention being effective. Methods and analysis All c-RCTs of any design that have a patient-relevant primary outcome and with a duration of at least 1 year will be included. The search will be performed in three electronic databases (MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews (CDSR)). The screening process, data collection, quality assessment and statistical data analyses (if suitably similar and of adequate quality) will be performed in accordance with requirements of the Cochrane Handbook for Systematic Reviews of Interventions. A feasibility project was carried out that was restricted to a search in MEDLINE and the CCTR for c-RCTs published in 1 of the 8 journals that are most relevant to general practice. The process from trial selection to data collection, assessment and results presentation was piloted. Of the 512 abstracts identified during the feasibility search, 21 studies examined complex interventions in a general practice setting. Extrapolating the preliminary search to include all relevant c-RCTs in three databases, about 5000 abstracts and 150 primary studies are expected to be identified in the main study. 14 studies included in the feasibility project (67%) did not show a positive effect on a primary patient-relevant end point. Ethics and dissemination Ethical approval is not being sought for this review. Findings will be disseminated via peer-reviewed journals that frequently publish articles on the results of c-RCTs and through presentations at international conferences. Trial registration number PROSPERO CRD201400923.

Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery—The BIANCA Observational Study

Nearly 20% of patients will need non-cardiac surgery within 1 year of coronary stenting and their management is complicated by concomitant antiplatelet therapy. Platelet function testing may optimize the timing of surgery in these patients. In this prospective observational study, we explored the association between platelet reactivity and bleeding in patients undergoing non-cardiac surgery treated with clopidogrel with or without aspirin within 7 days before surgery. The timing of surgery was at the surgeons discretion. Blood was drawn at induction of anaesthesia and platelet reactivity assessed by light transmittance aggregometry (LTA), vasodilator stimulated phosphoprotein (VASP) assay, Multiplate Analyzer and Innovance PFA-200. The primary endpoint was surgery-related thrombolysis in myocardial infarction (TIMI) bleeding. Among 197 patients enrolled, 72 and 12% underwent surgery within 24 and 48 hours of the last dose of clopidogrel, respectively. The median (interquartile range [IQR]) for pre-operative maximal adenosine diphosphate (ADP)-induced aggregation was 33.0% (21.0-57.5%), for VASP-platelet reactivity index was 61.5% (40.1-75.4%), for Multiplate was 22.0 (14.5-36.0) U*min and for Innovance PFA-200 was 224 (101.0-300.0) seconds. TIMI bleeding, observed in 25% of patients, decreased with increasing tertiles of platelet reactivity to ADP assessed by LTA (p = 0.031). Additionally, in a multivariable logistic regression analysis, platelet reactivity to ADP assessed by LTA was significantly associated with TIMI bleeding, as were age and urgency of surgery. These results demonstrate that in clopidogrel-treated patients, pre-operative platelet reactivity to ADP is associated with surgical bleeding risk. An objective assessment of pre-operative platelet function may optimize the timing of non-cardiac surgery in these patients.

Acute Heart Failure developed as worsening of Chronic Heart Failure is associated with increased mortality compared to de novo cases

Acute heart failure (AHF) emerges either de novo or from worsening of chronic heart failure (CHF). The aim of the present study was to evaluate the association between worsening of CHF and mortality in AHF patients. Out of 152 included AHF patients, 47 (30.9%) were de novo AHF patients and 105 (69%) were AHF patients with worsening of CHF. The proportion dying in hospital (19.0% vs. 4.3%, p = 0.023) and within 3 months after hospitalization (36.6% vs. 6.7%, p < 0.001) was significantly higher in AHF patients with worsening of CHF. Logistic regression analyses also showed a significant positive association of AHF emerging as worsening of CHF with hospital mortality [odds ratio (OR) and 95% confidence interval (CI): 5.29 (1.46–34.10), p = 0.029] and 3-month mortality [8.09 (2.70–35.03), p = 0.001]. While the association with hospital mortality was no longer significant after adjusting for comorbidities and clinical as well as laboratory parameters known to be associated with mortality in heart failure patients, the association with 3-month mortality remained significant. We conclude that compared to de novo AHF, AHF evolved from worsening of CHF is a more severe condition and is associated with increased mortality.