Endotoxemia Correlates with Kidney Function and Length of Stay in Critically Ill Patients.

INTRODUCTION: Endotoxin is a key driver of sepsis, which frequently causes acute kidney injury (AKI). However, endotoxins may also be found in non-bacteremic critically ill patients, likely from intestinal translocation. Preclinical models show that endotoxins can directly injure the kidneys, and in COVID-19 patients, endotoxemia correlated with AKI. We sought to determine correlations between endotoxemia and kidney and hospital outcomes in a broad group of critically ill patients. METHODS: In this single-center, serial prospective study, 124 predominantly Caucasian adult patients were recruited within 48 h of admission to Stony Brook University Hospital Intensive Care Unit (ICU). Demographics, vital signs, laboratory data, and outcomes were collected. Circulating endotoxin was measured on days 1, 4, and 8 using the endotoxin activity assay (EAA). The association of EAA with outcomes was examined with EAA: (1) categorized as <0.6, ≥0.6, and nonresponders (NRs); and (2) used as a continuous variable. RESULTS: Patients with EAA ≥0.6 had a higher prevalence of proteinuria, and lower arterial oxygen saturation (SaO2) to fraction of inspired oxygen (FiO2) (SaO2/FiO2) ratio versus patients with EAA <0.6. EAA levels positively correlated with serum creatinine (sCr) levels on day 1. Patients whose EAA level stayed ≥0.6 had a slower decline in sCr compared to those whose EAA started at ≥0.6 and subsequently declined. Patients with AKI stage 1 and EAA ≥0.6 on day 1 showed slower decline in sCr compared to patients with stage 1 AKI and EAA <0.6. EAA ≥0.6 and NR patients had longer hospital stay and delayed ICU discharge versus EAA <0.6. CONCLUSIONS: High EAA levels correlated with worse kidney function and outcomes. Patients whose EAA levels fell, and those with AKI stage I and day 1 EAA <0.6 recovered more quickly compared to those with EAA ≥0.6, suggesting that removal of circulating endotoxins may be beneficial in critically ill patients.

Bayesian methods: a potential path forward for sepsis trials.

BACKGROUND: Given the success of recent platform trials for COVID-19, Bayesian statistical methods have become an option for complex, heterogenous syndromes like sepsis. However, study design will require careful consideration of how statistical power varies using Bayesian methods across different choices for how historical data are incorporated through a prior distribution and how the analysis is ultimately conducted. Our objective with the current analysis is to assess how different uses of historical data through a prior distribution, and type of analysis influence results of a proposed trial that will be analyzed using Bayesian statistical methods. METHODS: We conducted a simulation study incorporating historical data from a published multicenter, randomized clinical trial in the US and Canada of polymyxin B hemadsorption for treatment of endotoxemic septic shock. Historical data come from a 179-patient subgroup of the previous trial of adult critically ill patients with septic shock, multiple organ failure and an endotoxin activity of 0.60-0.89. The trial intervention consisted of two polymyxin B hemoadsorption treatments (2 h each) completed within 24 h of enrollment. RESULTS: In our simulations for a new trial of 150 patients, a range of hypothetical results were observed. Across a range of baseline risks and treatment effects and four ways of including historical data, we demonstrate an increase in power with the use of clinically defensible incorporation of historical data. In one possible trial result, for example, with an observed reduction in risk of mortality from 44 to 37%, the probability of benefit is 96% with a fixed weight of 75% on prior data and 90% with a commensurate (adaptive-weighting) prior; the same data give an 80% probability of benefit if historical data are ignored. CONCLUSIONS: Using Bayesian methods and a biologically justifiable use of historical data in a prior distribution yields a study design with higher power than a conventional design that ignores relevant historical data. Bayesian methods may be a viable option for trials in critical care medicine where beneficial treatments have been elusive.

Endotoxemia in Critically Ill Patients with COVID-19.

INTRODUCTION: Mechanism(s) mediating critical illness in coronavirus disease 2019 (COVID-19) remain unclear. Previous reports demonstrate the existence of endotoxemia in viral infections without superimposed gram-negative bacteremia, but the rate and severity of endotoxemia in critically ill patients with COVID-19 requires further exploration. MATERIALS AND METHODS: This is a single-center cross-sectional study of 92 intensive care unit patients diagnosed with COVID-19 pneumonia. Endotoxin activity (EA) was measured in patients that met the following criteria: (1) age ≥18 years and (2) multi-organ dysfunction score >9 from March 24, 2020, to June 20, 2020. RESULTS: A total of 32 patients met the inclusion/exclusion criteria for measurement of EA. The median age of the study cohort was 60 years with a majority male (21/32, 65%) with hypertension (50%). A significant proportion of the patients exhibited either elevated EA in the intermediate range (0.40-0.59 EA units) (10/32, 31%) or high range (≥0.60 EA units) (14/32, 44%) or were nonresponders (NRs, low neutrophil response) to EA (6/32, 19%), with the presence of gram-negative bacteremia only in 2/32 (6%) patients. Low EA was reported in 2/32 patients. NRs (5/6, 83%) and patients with high EA (7/14, 50%) exhibited higher acute kidney injury (AKI) as compared to patients with low/intermediate EA level (1/12, 8.3%). DISCUSSION/CONCLUSION: Elevated EA was observed in a large majority of critically ill patients with COVID-19 and multi-organ dysfunction despite a low incidence of concurrent gram-negative bacteremia. While we observed that elevated EA and nonresponsiveness to EA were associated with AKI in critically ill patients with COVID-19, these findings require further validation in larger longitudinal cohorts.

Percutaneous left ventricular assist device support during ablation of ventricular tachycardia: A meta-analysis of current evidence.

INTRODUCTION: Catheter ablation of ventricular tachycardia (VT) can be an effective therapy to reduce VT burden, but often it is limited by the potential for hemodynamic instability. Percutaneous left ventricular assist devices (pLVADs) have been used to maintain hemodynamic support during VT ablation but the evidence regarding its clinical impact has been inconclusive. METHODS AND RESULTS: We sought to assess the clinical impact of pLVAD when used in VT ablation by conducting a meta-analysis of the current evidence. We searched Pubmed and found nine observational studies that compared clinical outcomes of VT ablation in patients with pLVAD support to controls with no pLVAD support. The pooled data did not show a significant difference in mortality between both groups, nor a difference in acute procedural success or in recurrence of VT. There was also no difference in the number of patients receiving a cardiac transplant or being enrolled in the transplant list. Although there was no difference in the ablation time between the groups, patients in the pLVAD group had a longer total procedural time and more procedure-related adverse effects. CONCLUSION: This meta-analysis did not show clinical benefits from using pLVAD support during VT ablation, whereas it was associated with longer procedure times and more complications. This study was, however, limited by the observational nature of the data. In view of these data, the risk and benefit of pLVAD support during VT ablation should be considered on an individual basis.

Culturally-adapted cognitive behavioural therapy based intervention for maternal depression: a mixed-methods feasibility study.

BACKGROUND: British Pakistanis are one of the largest ethnic minority groups living in the UK, with high rates of maternal depression being reported in this population. Evidence suggests that culturally-adapted Cognitive Behavioural Therapy (CBT)-based interventions for depression, may improve clinical outcomes and patient satisfaction. This study was conducted to develop and test the feasibility and acceptability of a culturally-adapted, CBT-based, manual-assisted intervention in British Pakistani mothers experiencing maternal depression. METHODS: A mixed-method feasibility study that included qualitative interviews followed by the development of a CBT-based intervention for mothers with mild to moderate depression. Following the qualitative interviews, a CBT-based intervention called the Positive Health Program (PHP) was developed and delivered consisting of 12-weekly sessions. A before and after design was used to explore the feasibility and acceptability of the Positive Health Programme. RESULTS: A culturally-adapted CBT-based group intervention (PHP) was acceptable to this group and improvements were reported in depression and health-related quality of life. The women's understanding of 'depression' as a general consensus was in physical terms, but with an onset triggered by psychosocial causes. The most commonly reported factors contributing to depression were marital disharmony, lack of social support, and financial difficulties. Past help offered was primarily antidepressants, which were not welcomed by most of the women. A lack of availability of culturally sensitive interventions and the limited cultural sensitivity of NHS staff was also reported. CONCLUSION: This study provides preliminary evidence for the feasibility and acceptability of a CBT-based culturally-adapted group psychological intervention for British Pakistani mothers. TRIAL REGISTRATION: Study ethics registration number: 10/H1005/62 (University of Manchester).

Can the effects of the mobilization of vulnerable elders in Ontario (MOVE ON) implementation be replicated in new settings: an interrupted time series design.

BACKGROUND: Bed rest for older hospitalized patients places them at risk for hospital-acquired morbidity. We previously evaluated an early mobilization intervention and found it to be effective at improving mobilization rates and decreasing length of stay on internal medicine units. The aim of this study was to conduct a replication study evaluating the impact of the evidence-informed mobilization intervention on surgery, psychiatry, medicine, and cardiology inpatient units. METHODS: A multi-component early mobilization intervention was tailored to the local context at seven hospitals in Ontario, Canada. The primary outcome was patient mobilization measured by conducting visual audits twice a week, three times a day. Secondary outcomes were hospital length of stay and discharge destination, which were obtained from hospital decision support data. The study population was patients aged 65 years and older who were admitted to surgery, psychiatry, medicine, and cardiology inpatient units between March and August 2014. Using an interrupted time series design, the intervention was evaluated over three time periods-pre-intervention, during, and post-intervention. RESULTS: A total of 3098 patients [mean age 78.46 years (SD 8.38)] were included in the overall analysis. There was a significant increase in mobility immediately after the intervention period compared to pre-intervention with a slope change of 1.91 (95% confidence interval [CI] 0.74-3.08, P-value = 0.0014). A decreasing trend in median length of stay was observed in the majority of the participating sites. Overall, a median length of stay of 26.24 days (95% CI 23.67-28.80) was observed pre-intervention compared to 23.81 days (95% CI 20.13-27.49) during the intervention and 24.69 days (95% CI 22.43-26.95) post-intervention. The overall decrease in median length of stay was associated with the increase in mobility across the sites. CONCLUSIONS: MOVE increased mobilization and these results were replicated across surgery, psychiatry, medicine, and cardiology inpatient units.

Scaling-up implementation in community hospitals: a multisite interrupted time series design of the Mobilization of Vulnerable Elders (MOVE) program in Alberta.

BACKGROUND: As the population ages, older hospitalized patients are at increased risk for hospital-acquired morbidity. The Mobilization of Vulnerable Elders (MOVE) program is an evidence-informed early mobilization intervention that was previously evaluated in Ontario, Canada. The program was effective at improving mobilization rates and decreasing length of stay in academic hospitals. The aim of this study was to scale-up the program and conduct a replication study evaluating the impact of the evidence-informed mobilization intervention on various units in community hospitals within a different Canadian province. METHODS: The MOVE program was tailored to the local context at four community hospitals in Alberta, Canada. The study population was patients aged 65 years and older who were admitted to medicine, surgery, rehabilitation and intensive care units between July 2015 and July 2016. The primary outcome was patient mobilization measured by conducting visual audits twice a week, three times a day. The secondary outcomes included hospital length of stay obtained from hospital administrative data, and perceptions of the intervention assessed through a qualitative assessment. Using an interrupted time series design, the intervention was evaluated over three time periods (pre-intervention, during, and post-intervention). RESULTS: A total of 3601 patients [mean age 80.1 years (SD = 8.4 years)] were included in the overall analysis. There was a significant increase in mobilization at the end of the intervention period compared to pre-intervention, with 6% more patients out of bed (95% confidence interval (CI) 1, 11; p-value = 0.0173). A decreasing trend in median length of stay was observed, where patients on average stayed an estimated 3.59 fewer days (95%CI -15.06, 7.88) during the intervention compared to pre-intervention period. CONCLUSIONS: MOVE is a low-cost, effective and adaptable intervention that improves mobilization in older hospitalized patients. This intervention has been replicated and scaled up across various units and hospital settings.

Outcomes of Mobilisation of Vulnerable Elders in Ontario (MOVE ON): a multisite interrupted time series evaluation of an implementation intervention to increase patient mobilisation.

Background: older patients admitted to hospitals are at risk for hospital-acquired morbidity related to immobility. The aim of this study was to implement and evaluate an evidence-based intervention targeting staff to promote early mobilisation in older patients admitted to general medical inpatient units. Methods: the early mobilisation implementation intervention for staff was multi-component and tailored to local context at 14 academic hospitals in Ontario, Canada. The primary outcome was patient mobilisation. Secondary outcomes included length of stay (LOS), discharge destination, falls and functional status. The targeted patients were aged ≥ 65 years and admitted between January 2012 and December 2013. The intervention was evaluated over three time periods-pre-intervention, during and post-intervention using an interrupted time series design. Results: in total, 12,490 patients (mean age 80.0 years [standard deviation 8.36]) were included in the overall analysis. An increase in mobilisation was observed post-intervention, where significantly more patients were out of bed daily (intercept difference = 10.56%, 95% CI: [4.94, 16.18]; P < 0.001) post-intervention compared to pre-intervention. Hospital median LOS was significantly shorter during the intervention period (intercept difference = -3.45 days, 95% CI: [-6.67,-0.23], P = 0.0356) compared to pre-intervention. It continued to decrease post-intervention with significantly fewer days in hospital (intercept difference= -6.1, 95% CI: [-11,-1.2]; P = 0.015) in the post-intervention period compared to pre-intervention. Conclusions: this is a large-scale study evaluating an implementation strategy for early mobilisation in older, general medical inpatients. The positive outcome of this simple intervention on an important functional goal of getting more patients out of bed is a striking success for improving care for hospitalised older patients.

Embracing uncertainty, managing complexity: applying complexity thinking principles to transformation efforts in healthcare systems.

BACKGROUND: Complexity thinking is increasingly being embraced in healthcare, which is often described as a complex adaptive system (CAS). Applying CAS to healthcare as an explanatory model for understanding the nature of the system, and to stimulate changes and transformations within the system, is valuable. MAIN TEXT: A seminar series on systems and complexity thinking hosted at the University of Toronto in 2016 offered a number of insights on applications of CAS perspectives to healthcare that we explore here. We synthesized topics from this series into a set of six insights on how complexity thinking fosters a deeper understanding of accepted ideas in healthcare, applications of CAS to actors within the system, and paradoxes in applications of complexity thinking that may require further debate: 1) a complexity lens helps us better understand the nebulous term "context"; 2) concepts of CAS may be applied differently when actors are cognizant of the system in which they operate; 3) actor responses to uncertainty within a CAS is a mechanism for emergent and intentional adaptation; 4) acknowledging complexity supports patient-centred intersectional approaches to patient care; 5) complexity perspectives can support ways that leaders manage change (and transformation) in healthcare; and 6) complexity demands different ways of implementing ideas and assessing the system. To enhance our exploration of key insights, we augmented the knowledge gleaned from the series with key articles on complexity in the literature. CONCLUSIONS: Ultimately, complexity thinking acknowledges the "messiness" that we seek to control in healthcare and encourages us to embrace it. This means seeing challenges as opportunities for adaptation, stimulating innovative solutions to ensure positive adaptation, leveraging the social system to enable ideas to emerge and spread across the system, and even more important, acknowledging that these adaptive actions are part of system behaviour just as much as periods of stability are. By embracing uncertainty and adapting innovatively, complexity thinking enables system actors to engage meaningfully and comfortably in healthcare system transformation.

Pediatric critical incidents reported over 15 years at a tertiary care teaching hospital of a developing country.

BACKGROUND AND AIMS: The role of critical incident (CI) reporting is well established in improving patient safety but only a limited number of available reports relate to pediatric incidents. Our aim was to analyze the reported CIs specific to pediatric patients in our database and to reevaluate the value of this program in addressing issues in pediatric anesthesia practice. MATERIAL AND METHODS: Incidents related to pediatric population from neonatal period till the age of 12 years were selected. A review of all CI records collected between January 1998 and December 2012, in the Department of Anaesthesiology of Aga Khan University hospital was done. This was retrospective form review. The Department has a structured CI form in use since 1998 which is intermittently evaluated and modified if needed. RESULTS: A total of 451 pediatric CIs were included. Thirty-four percent of the incidents were reported in infants. Ninety-six percent of the reported incidents took place during elective surgery and 4% during emergency surgery. Equipment-related events (n = 114), respiratory events (n = 112), and drug events (n = 110) were equally distributed (25.6%, 25.3%, and 24.7%). Human factors accounted for 74% of reports followed by, equipment failure (10%) and patient factors (8%). Only 5% of the incidents were system errors. Failure to check (equipment/drugs/doses) was the most common cause for human factors. Poor outcome was seen in 7% of cases. CONCLUSION: Medication and equipment are the clinical areas that need to be looked at more closely. We also recommend quality improvement projects in both these areas as well as training of residents and staff in managing airway-related problems in pediatric patients.

Fractionation of crude extracts from controlled dried and commercially available stem bark of Juglans regia and their antimicrobial effects.

The current research investigates the anti-microbial activities of methanol, ethyl acetate, n-hexane , n-butanol and water extracted samples from controlled dried and commercial bark of walnut (Juglans regia) against five bacterial (Staphylococcus aureus, Bacilus subtilis, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumonia and one fungal pathogenic specie (Candida albicans) by discs diffusion susceptibility assay using 0.5 and 1mg disc-1 concentrations. Our results revealed that all the extracts from controlled dried and commercial bark of walnut showed varying degrees of antimicrobial activities. Ethyl acetate fraction from both sources exhibited maximum activity against all tested microbial species followed by n-butanol and crude methanolic extraxt. N-hexane and aqueous extracted samples from controlled dried bark reduced the growth of all studied microbes except Staphylococcus aureus in case of commercial available bark. Aqueous extracted sample showed inhibitory effects against all tested microbes except Candida albicans respectively in case of commercial bark. The most susceptible gram positive bacteria were S. aureus while Bacillus subtilis was the most resistant one. Among Gram negative bacteria, Pseudomonas aeruginosa was the most susceptibility while Klebsella pneumonia showed some resistively. Compared to commercial bark samples, controlled dried bark extract and fractions were found to be more active in reducing the growth of all the tested microbes at both concentrations.

An analysis of perioperative adverse neurological events associated with anesthetic management at a Tertiary Care Center of a developing country.

BACKGROUND AND AIMS: Existing literature on neurological complications related to anesthesia is reported from affluent countries but the trends may vary in less affluent countries. MATERIAL AND METHODS: The objective was to find the associated factors contributing to neurological adverse events occurring within 48 h of anesthesia and surgery. The existing departmental morbidity and mortality database was reviewed from 1992 to 2012 for major adverse neurological events. A standardized methodology was used in reviewing and classifying the data. All adverse events were predefined and categorized before filling the form into the following headers; meningitis, cord/plexus/peripheral nerve injury, stroke, paraparesis/paraplegia/quadriparesis/or quadriplegia, new onset postoperative seizures, postoperative vocal cord injury, and a miscellaneous group. RESULTS: During this period, 195,031 patients underwent anesthesia and twenty-nine patients had major neurological morbidity within 48 h (1:6700). There were three cases of meningitis/meningism, eight cases of cord, plexus or peripheral nerve injury, seven of stroke, four had new onset seizures, one had quadriparesis, five had vocal cord, and one had cranial nerve palsy. Forty-one percent cases received regional anesthesia alone or in combination with the general. In six cases, anesthesia was considered solely responsible. Human error contributed to 93% of these events. CONCLUSION: This data has helped in identifying areas of concern and can serve as a reference for further audits in the region.

Left dominant circulation increases mortality in acute coronary syndrome: A systematic review and meta-analysis of observational studies involving 255,718 patients.

BACKGROUND: The effect of coronary dominance on mortality in patients with acute coronary syndrome (ACS) remains unclear. We performed a meta-analysis to evaluate the effect of coronary dominance in patients with ACS. METHODS: Several data sources were searched for studies which compared studies that compared outcomes between right and left dominant coronary circulation in patients with ACS. The measured outcomes were in-hospital, 30-day or long-term mortality as reported in individual studies. The Generic inverse variance method was used in a random-effects model to pool mortality as an outcome. Odds ratio (OR) was calculated for mortality in the left dominant circulation relative to a right dominant one. Sub-group analysis was performed after stratification of mortality by duration. RESULTS: A total of 5 studies with 8 comparisons and 255,718 participants revealed an increased risk mortality (OR = 1.27 (95% CI: 1.13 - 1.42; P < 0.0001; I(2) = 34%). Sub-group analysis revealed that the increased risk was evident at all time periods after the ACS; in-hospital (OR = 1.37; 95% CI: 1.07 - 1.76; P = 0.01; I(2) = 50%), at 30 days (OR = 1.69; 95% CI: 1.14 - 2.52; P = 0.009; I(2) = 18%) and long-term (OR = 1.15; 95% CI: 1.03 - 1.28; P = 0.01; I(2) = 0%). CONCLUSIONS: In this meta-analysis we found that there is an increased risk of mortality with LD coronary circulation in patients with ACS. The knowledge of coronary dominance may not only be helpful as an incremental prognostic factor beyond pre-procedural risk scores in all patients with ACS, but may also aid in clinical decision making in a subset of these patients. © 2015 Wiley Periodicals, Inc.

Efficacy and safety of transcatheter aortic valve replacement in intermediate surgical risk patients: A systematic review and meta-analysis.

BACKGROUND: The efficacy of transcatheter aortic valve replacement (TAVR) in aortic stenosis patients at high surgical risk has been established. The data on patients with intermediate risk is not conclusive. We performed a meta-analysis of studies which compared TAVR with surgical aortic valve replacement (SAVR) in patients at intermediate surgical risk. METHODS: Several databases searched from inception to February 2015 yielded 7 eligible studies with 2,173 participants. The measured outcome of efficacy was all-cause mortality. Data on safety included stroke, permanent pacemaker implantation (PPI), aortic regurgitation (AR), vascular access complications, and major bleeding. Outcomes were pooled and relative risk (RR) was calculated with the Mantel-Haenszel method. RESULTS: There was no difference in either short-term (RR, 1.02; 95% CI: 0.63-1.63; P = 0.94; I2 = 0%) or medium to long-term all-cause mortality (RR, 0.99; 95% CI: 0.81-1.21; P = 0.91; I2 = 0%). There was increased incidence of stroke (RR, 2.96; 95% CI: 0.87-10.09; P = 0.08; I2 = 0%), AR (RR, 3.59; 95% CI: 2.13-7.19; P < 0.00001; I2 = 2%), PPI (RR, 6.53; 95% CI: 1.91-22.32; P < 0.003; I2 = 0%) and vascular access complications (RR, 3.84; 95% CI: 0.65-22.76; P < 0.14; I2 = 48%) in patients with TAVR. There was a small, albeit increased risk of major or life threatening bleeding with SAVR as compared to TAVR (RR, 1.36; 95% CI: 1.04-1.80; P < 0.03; I2 = 0%). CONCLUSIONS: In this meta-analysis we found that TAVR may be an acceptable alternative to SAVR in patients with intermediate risk for surgery. However, we must await evidence from the current large randomized trials before widespread adoption of this procedure is undertaken. © 2016 Wiley Periodicals, Inc.

Factors that may be influencing the rise in prescription testosterone replacement therapy in adult men: a qualitative study.

OBJECTIVE: To explore and describe the factors that may be influencing the rise of prescribing and use of testosterone replacement therapy (TRT) in adult men. DESIGN: A rapid qualitative research design using semi-structured interviews with providers and patients. SETTING: Ontario, Canada. PARTICIPANTS: Nine men who have used TRT (referred to as "patients"), and six primary care clinicians and seven specialists (collectively referred to as "providers") who prescribed or administered TRT. METHOD: Patients' and providers' perspectives were investigated through semi-structured interviews. A purposive sampling approach was used to recruit all participants. We conducted qualitative analysis using the framework approach for applied health research. MAIN FINDINGS: Participants perceived the following factors to have influenced TRT prescriptions and use in adult men: provider factors (diagnostic ambiguity of age-related hypogonadism and beliefs about appropriateness of TRT) and patient factors (access to information on TRT and drug seeking behavior). They perceived that these factors have perpetuated a rise in prescription in the absence of clear clinical guidelines and unclear research evidence on the safety and efficacy of TRT. CONCLUSION: The findings of this study highlight that much work still needs to be done to improve diagnostic accuracy and encourage appropriate TRT prescription in adult men. In addition, both patients and providers need more information about the risks and long-term effects of TRT in men.

Endoscopic Ultrasound-Guided Biliary Drainage: A Systematic Review and Meta-Analysis.

BACKGROUND AND AIMS: Variable success and adverse event rates have been reported for endoscopic ultrasound-guided biliary drainage (EUS-BD) utilizing either extrahepatic or intrahepatic approach. We aimed to conduct a proportion meta-analysis to evaluate the cumulative efficacy and safety of EUS-BD and to compare the two approaches and transluminal methods of EUS-BD. METHODS: We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, ISI Web of Science, and Scopus from January 2001 through January 5, 2015, to identify studies reporting technical success and adverse events of EUS-BD. A sample size of more than 20 patients was a further criterion. Weighted pooled rate (WPR) for technical success and post-procedure complications was calculated for overall studies and predefined subgroups. Pooled odds ratios were calculated for technical success and adverse events for two approaches and transluminal methods of EUS-BD for distal common bile duct (CBD) strictures. RESULTS: The WPR with 95% confidence interval (CI) for technical success and post-procedure adverse events was 90% (86, 93%) and 17% (13, 22%), respectively, with considerable heterogeneity (I(2) = 77%). For high-quality studies, the WPR for technical success was 94% (91, 96 %), I(2) = 0% and WPR for post-procedure adverse event was 16% (12, 19%), I(2) = 39%. In meta-regression model, distal CBD stricture and transpapillary drainage were associated with higher technical success and intrahepatic access route was associated with higher adverse event rate. There was no difference in technical success using either approach OR 1.27 (0.52, 3.13), I(2) = 0% or transluminal method OR 1.32 (0.51, 3.38), I(2) = 0%. However, the extrahepatic approach appeared significantly safer as compared to the intrahepatic approach OR 0.35 (0.19, 0.67), I(2) = 27%. Likewise, choledochoduodenostomy was found to have less adverse events as compared to hepaticogastrostomy, OR 0.40 (0.18, 0.87), I (2) = 0%. CONCLUSION: In cases of failure of traditional ERC to achieve biliary drainage, EUS-BD appears to be an emerging therapeutic modality with a cumulative success rate of 90% and cumulative adverse events rate of 17%. Randomized controlled trials are required to further evaluate the efficacy and safety of the procedure along with the comparison to traditional modalities like percutaneous transhepatic biliary drainage.

Factors associated with choice of delivery with or without epidural analgesia among laboring women: a cross-sectional survey at a tertiary care hospital of a developing country.

AIMS: The aim of this study was to evaluate the factors responsible for epidural analgesia (EA) refusal among parturient patients. METHODS: In this prospective cross-sectional study of six months, we included all consenting postpartum patients having a non-operative delivery in the obstetric unit of our hospital. Data were collected on a predesigned questionnaire and included information such as parity, education, reasons for delivering with or without EA, source of information and patient satisfaction. Knowledge regarding EA was assessed from patients delivering without EA. RESULTS: From 933 patients enrolled, 730 (78.2%) delivered without EA, and 203 (21.7%) with EA. Only 11 (1.5%) patients refused EA for the reason of having natural birth process. Otherwise common reasons were misconceptions (65.9%) and lack of awareness about EA (20.5%); 70.5% had no knowledge of common side effects of EA. Among patients delivering with EA, 92.6% were offered EA by health care providers and had obstetricians and anesthesiologists as their sources of information. CONCLUSIONS: Patients in developing countries are laboring without EA, even in centers where there is a provision for it. The main reasons for not availing themselves of EA are lack of awareness and knowledge and misconceptions, rather than the desire to have un-medicated natural birth.

Ready, Set, Change! Development and usability testing of an online readiness for change decision support tool for healthcare organizations.

BACKGROUND: To address challenges related to selecting a valid, reliable, and appropriate readiness assessment measure in practice, we developed an online decision support tool to aid frontline implementers in healthcare settings in this process. The focus of this paper is to describe a multi-step, end-user driven approach to developing this tool for use during the planning stages of implementation. METHODS: A multi-phase, end-user driven approach was used to develop and test the usability of a readiness decision support tool. First, readiness assessment measures that are valid, reliable, and appropriate for healthcare settings were identified from a systematic review. Second, a mapping exercise was performed to categorize individual items of included measures according to key readiness constructs from an existing framework. Third, a modified Delphi process was used to collect stakeholder ratings of the included measures on domains of feasibility, relevance, and likelihood to recommend. Fourth, two versions of a decision support tool prototype were developed and evaluated for usability. RESULTS: Nine valid and reliable readiness assessment measures were included in the decision support tool. The mapping exercise revealed that of the nine measures, most measures (78 %) focused on assessing readiness for change at the organizational versus the individual level, and that four measures (44 %) represented all constructs of organizational readiness. During the modified Delphi process, stakeholders rated most measures as feasible and relevant for use in practice, and reported that they would be likely to recommend use of most measures. Using data from the mapping exercise and stakeholder panel, an algorithm was developed to link users to a measure based on characteristics of their organizational setting and their readiness for change assessment priorities. Usability testing yielded recommendations that were used to refine the Ready, Set, Change! decision support tool . CONCLUSIONS: Ready, Set, Change! decision support tool is an implementation support that is designed to facilitate the routine incorporation of a readiness assessment as an early step in implementation. Use of this tool in practice may offer time and resource-saving implications for implementation.

Access to Triptans for Acute Episodic Migraine: A Qualitative Study.

OBJECTIVE: Our study aims to examine factors related to access of triptans among multiple stakeholder groups. BACKGROUND: Triptans are a cornerstone of pain management for the acute treatment of migraine, but actual utilization of triptans is lower than ideal. Initial and continued access to triptans may be an important clinical issue in the acute treatment of migraines, but factors affecting access at the patient, provider, and health-care system levels have not been comprehensively explored. METHODS: A qualitative study was conducted in Ontario, Canada, between August 2013 and January 2014. Three participant groups were recruited to the qualitative study: (1) migraineurs who have experience accessing triptans; (2) physicians, including primary care physicians (PCPs) and neurologists, who have prescribed triptans; and (3) pharmacists who have dispensed triptans. Qualitative data were collected through one-on-one, semi-structured telephone interviews. The framework approach was used for data collection and analysis. RESULTS: Data collected from 19 migraineurs, 6 physicians, and 8 pharmacists were included in the analysis. Study participants discussed various factors that facilitate or hinder access to triptans, which were synthesized into four themes that emerged at the patient, provider, and health-care systems levels: (1) awareness; (2) apathy; (3) advocacy; and (4) affordability. Across all participant groups, awareness of available treatments and coverage policies for those treatments were potential factors relating to timely drug provision. Participants describe apathy in terms of patients' health-seeking behaviors and physicians' lack of concern toward migraine, which were seen as factors that could delay diagnosis and provision of appropriate treatment. Patients engaging in self-advocacy enhanced their ability to seek timely and appropriate provision of triptans at the patient level. At the health-care provider level, pharmacists were identified by patients as advocates for receiving more effective treatments for their migraines; pharmacists also self-identified with the advocate role. The affordability of triptans was a key concern impacting access at the systems level, but coverage limitations (eg, quantity limits) were also described to influence the appropriateness of prescribed migraine treatment. CONCLUSION: This study fills a gap in knowledge about access to triptans and how this may be impacted by patient, provider, and health-care systems barriers. Overall, our study sheds light on the experiences of prescribing, dispensing, and accessing triptans for migraine treatment, and unveils important information that can impact how patients access these drugs.