Prevalence and predictors of oral to intravenous antibiotic switch among adult emergency department patients with acute bacterial skin and skin structure infections: a pilot, prospective cohort study.

OBJECTIVE: To determine the prevalence and predictors of oral to intravenous antibiotic switch among adult emergency department (ED) patients with acute bacterial skin and skin structure infections (ABSSSIs). DESIGN: Multicentre, pilot cohort study. SETTING: Three urban EDs in Dublin, Ireland. PARTICIPANTS: Consecutive ED patients aged >16 years old with ABSSSIs between March 2015 and September 2016. INTERVENTION: Oral flucloxacillin 500 mg-1 g four times a day (alternative in penicillin allergy). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was to determine the prevalence and predictors of oral to intravenous antibiotic switch. Secondary outcomes were to determine the prevalence and predictors of receiving an extended course of oral antibiotic treatment and measurement of interobserver reliability for clinical predictors at enrolment. RESULTS: Overall, 159 patients were enrolled of which eight were lost to follow-up and five were excluded. The majority of patients were male (65.1%) and <50 years of age (58.2%). Oral to intravenous antibiotic switch occurred in 13 patients (8.9%; 95% CI 4.8% to 14.7%). Increased lesion size (OR 1.74; 95% CI 1.09 to 2.79), white cell count (OR 1.32; 95% CI 1.05 to 1.67), athlete's foot (OR 8.00; 95% CI 2.31 to 27.71) and fungal nail infections (OR 7.25; 95% CI 1.99 to 26.35) were associated with oral to intravenous antibiotic switch. 24.8% (95% CI 18.1% to 33.0%) of patients received an extended course of oral antibiotic treatment. CONCLUSION: The prevalence of oral to intravenous antibiotic switch in this pilot study is 8.9% (95% CI 4.8% to 14.7%). We identify the predictors of oral to intravenous switch worthy of future investigation. TRIAL REGISTRATION NUMBER: NCT02230813.

Chest ultrasonography versus supine chest radiography for diagnosis of pneumothorax in trauma patients in the emergency department.

BACKGROUND: Chest X-ray (CXR) is a longstanding method for the diagnosis of pneumothorax but chest ultrasonography (CUS) may be a safer, more rapid, and more accurate modality in trauma patients at the bedside that does not expose the patient to ionizing radiation. This may lead to improved and expedited management of traumatic pneumothorax and improved patient safety and clinical outcomes. OBJECTIVES: To compare the diagnostic accuracy of chest ultrasonography (CUS) by frontline non-radiologist physicians versus chest X-ray (CXR) for diagnosis of pneumothorax in trauma patients in the emergency department (ED). To investigate the effects of potential sources of heterogeneity such as type of CUS operator (frontline non-radiologist physicians), type of trauma (blunt vs penetrating), and type of US probe on test accuracy. SEARCH METHODS: We conducted a comprehensive search of the following electronic databases from database inception to 10 April 2020: Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus, Database of Abstracts of Reviews of Effects, Web of Science Core Collection and Clinicaltrials.gov. We handsearched reference lists of included articles and reviews retrieved via electronic searching; and we carried out forward citation searching of relevant articles in Google Scholar and looked at the "Related articles" on PubMed. SELECTION CRITERIA: We included prospective, paired comparative accuracy studies comparing CUS performed by frontline non-radiologist physicians to supine CXR in trauma patients in the emergency department (ED) suspected of having pneumothorax, and with computed tomography (CT) of the chest or tube thoracostomy as the reference standard. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from each included study using a data extraction form. We included studies using patients as the unit of analysis in the main analysis and we included those using lung fields in the secondary analysis. We performed meta-analyses by using a bivariate model to estimate and compare summary sensitivities and specificities. MAIN RESULTS: We included 13 studies of which nine (410 traumatic pneumothorax patients out of 1271 patients) used patients as the unit of analysis; we thus included them in the primary analysis. The remaining four studies used lung field as the unit of analysis and we included them in the secondary analysis. We judged all studies to be at high or unclear risk of bias in one or more domains, with most studies (11/13, 85%) being judged at high or unclear risk of bias in the patient selection domain. There was substantial heterogeneity in the sensitivity of supine CXR amongst the included studies. In the primary analysis, the summary sensitivity and specificity of CUS were 0.91 (95% confidence interval (CI) 0.85 to 0.94) and 0.99 (95% CI 0.97 to 1.00); and the summary sensitivity and specificity of supine CXR were 0.47 (95% CI 0.31 to 0.63) and 1.00 (95% CI 0.97 to 1.00). There was a significant difference in the sensitivity of CUS compared to CXR with an absolute difference in sensitivity of 0.44 (95% CI 0.27 to 0.61; P < 0.001). In contrast, CUS and CXR had similar specificities: comparing CUS to CXR, the absolute difference in specificity was -0.007 (95% CI -0.018 to 0.005, P = 0.35). The findings imply that in a hypothetical cohort of 100 patients if 30 patients have traumatic pneumothorax (i.e. prevalence of 30%), CUS would miss 3 (95% CI 2 to 4) cases (false negatives) and overdiagnose 1 (95% CI 0 to 2) of those without pneumothorax (false positives); while CXR would miss 16 (95% CI 11 to 21) cases with 0 (95% CI 0 to 2) overdiagnosis of those who do not have pneumothorax. AUTHORS' CONCLUSIONS: The diagnostic accuracy of CUS performed by frontline non-radiologist physicians for the diagnosis of pneumothorax in ED trauma patients is superior to supine CXR, independent of the type of trauma, type of CUS operator, or type of CUS probe used. These findings suggest that CUS for the diagnosis of traumatic pneumothorax should be incorporated into trauma protocols and algorithms in future medical training programmes; and that CUS may beneficially change routine management of trauma.

Development and validation of a data dictionary for a feasibility analysis of emergency department key performance indicators.

OBJECTIVES: The primary study objective was to describe the development of a data dictionary for a feasibility analysis of 11 emergency department (ED) key performance indicators (KPIs). The secondary objective was to internally validate the data dictionary by measuring the inter-observer agreement between data abstractors at participating study sites. METHODS: A list of data variables based on the minimum data set elements relevant to the KPIs was developed by a panel of emergency medicine (EM) specialists and from the EM literature. A summit involving the relevant stakeholders, including ED frontline staff, a health economist, an ED clinical data manager and a health care informatician, was convened. For the feasibility analysis project, each data abstractor was furnished with a copy of the data dictionary and attended a one-hour training session prior to commencing data abstraction. Data was independently abstracted for each KPI by two abstractors at each of 12 participating EDs. Inter-rater agreement between abstractors was calculated using Cohen's kappa and results were reported using the Landis and Koch criteria. RESULTS: A data dictionary was developed by creating clear definitions and establishing abstraction instructions for each variable. A total of 43 data variables were included in the study data dictionary: 4 on patient demographics; 19 time variables; 5 outcome variables; 8 ED service and staffing units and 7 medical definitions. A clear definition and a set of data abstraction instructions including data sources were developed for each variable to aid data abstraction during the feasibility analysis. Overall 9,276 ED patient records were used for data abstraction to internally validate the data dictionary. The median Cohen kappa score ranged between 0.56 to 0.81. CONCLUSION: There is a continued need to standardize definitions of KPIs for the purpose of comparing ED performance and for research purposes. This is a necessary first step in the implementation of valid and reliable ED performance measures. This study successfully developed an internally valid data dictionary that can be used for day-to-day ED operations and for research purposes.

Developing outcome, process and balancing measures for an emergency department longitudinal patient monitoring system using a modified Delphi.

BACKGROUND: Early warning score systems have been widely recommended for use to detect clinical deterioration in patients. The Irish National Emergency Medicine Programme has developed and piloted an emergency department specific early warning score system. The objective of this study was to develop a consensus among frontline healthcare staff, quality and safety staff and health systems researchers regarding evaluation measures for an early warning score system in the Emergency Department. METHODS: Participatory action research including a modified Delphi consensus building technique with frontline hospital staff, quality and safety staff, health systems researchers, local and national emergency medicine stakeholders was the method employed in this study. In Stage One, a workshop was held with the participatory action research team including frontline hospital staff, quality and safety staff and health systems researchers to gather suggestions regarding the evaluation measures. In Stage Two, an electronic modified-Delphi study was undertaken with a panel consisting of the workshop participants, key local and national emergency medicine stakeholders. Descriptive statistics were used to summarise the characteristics of the panellists who completed the questionnaires in each round. The mean Likert rating, standard deviation and 95% bias-corrected bootstrapped confidence interval for each variable was calculated. Bonferroni corrections were applied to take account of multiple testing. Data were analysed using Stata 14.0 SE. RESULTS: Using the Institute for Healthcare Improvement framework, 12 process, outcome and balancing metrics for measuring the effectiveness of an ED-specific early warning score system were developed. CONCLUSION: There are currently no published measures for evaluating the effectiveness of an ED early warning score system. It was possible in this study to develop a suite of evaluation measures using a modified Delphi consensus approach. Using the collective expertise of frontline hospital staff, quality and safety staff and health systems researchers to develop and categorise the initial set of potential measures was an innovative and unique element of this study.

Effect of Overencapsulation on the Disintegration and Dissolution of Licensed Formulations for Blinding in Randomized Controlled Trials.

Overencapsulation is a technique used to conceal tablet products for blinding in randomized controlled trials. A tablet is inserted in an opaque capsule shell with backfill excipient to prevent rattling. Regulatory authorities require evidence that such modification does not materially alter drug release to approve their use in trials. The objective of this study was to assess impact of overencapsulation on disintegration and dissolution of 4 immediate-release drug products (penicillin V, gemfibrozil, ciprofloxacin, and furosemide). Each unmodified tablet was compared to 3 overencapsulated tablets with differing backfill excipient (colloidal silica, lactose monohydrate, or microcrystalline cellulose). All 12 overencapsulated tablets met disintegration and dissolution acceptance criteria. Dissolution acceptance was dependent on apparatus as only 4/12 formulations met specifications using the rotating basket compared to 12/12 using the rotating paddle. Significant differences in release were observed at early time points (T5-T15). No correlation was observed between aqueous solubility and release, although dissolution of the lipophilic drug gemfibrozil was least impacted by overencapsulation. There was evidence that type/quantity of backfill delays release at early time points. These findings indicate that under the specified conditions, overencapsulated formulations of 4 drugs, 1 from each class of the Biopharmaceutics Classification System, met compendial requirements for release testing.

Validation of the short form of the International Crowding Measure in Emergency Departments: an international study.

OBJECTIVE: There is little consensus on the best way to measure emergency department (ED) crowding. We have previously developed a consensus-based measure, the International Crowding Measure in Emergency Departments. We aimed to externally validate a short form of the International Crowding Measure in Emergency Department (sICMED) against emergency physician's perceptions of crowding and danger. METHODS: We performed an observational validation study in seven EDs in five different countries. We recorded sICMED observations and the most senior available emergency physician's perceptions of crowding and danger at the same time. We performed a times series regression model. RESULTS: A total of 397 measurements were analysed. The sICMED showed moderate positive correlations with emergency physician's perceptions of crowding, r = 0.4110, P < 0.05) and safety (r = 0.4566, P < 0.05). There was considerable variation in the performance of the sICMED between different EDs. The sICMED was only slightly better than measuring occupancy or ED boarding time. CONCLUSION: The sICMED has moderate face validity at predicting clinician's concerns about crowding and safety, but the strength of this validity varies between different EDs and different countries.

Capturing data for emergency department performance monitoring purposes.

Background: Good-quality data is required for valid and reliable key performance indicators. Little is known of the facilitators and barriers of capturing the required data for emergency department key performance indicators. This study aimed to explore and understand how current emergency department data collection systems relevant to emergency department key performance indicators are integrated into routine service delivery, and to identify the resources required to capture these data elements. Methods: Following pilot testing, we conducted two focus groups with a multi-disciplinary panel of 14 emergency department stakeholders drawn from urban and rural emergency departments, respectively. Focus groups were analyzed using Attride-Stirling's framework for thematic network analysis. Results: The global theme "Understanding facilitators and barriers for emergency department data collection systems" emerged from three organizing themes: "understanding current emergency department data collection systems"; "achieving the ideal emergency department data capture system for the implementation of emergency department key performance indicators"; and "emergency department data capture systems for performance monitoring purposes within the wider context". Conclusion: The pathways to improving emergency department data capture systems for emergency department key performance indicators include upgrading emergency department information systems and investment in hardware technology and data managers. Educating stakeholders outside the emergency department regarding the importance of emergency department key performance indicators as hospital-wide performance indicators underpins the successful implementation of valid and reliable emergency department key performance indicators.

Risk factors for amendment in type, duration and setting of prescribed outpatient parenteral antimicrobial therapy (OPAT) for adult patients with cellulitis: a retrospective cohort study and CART analysis.

PURPOSE OF THE STUDY: To measure the percentage rate and risk factors for amendment in the type, duration and setting of outpatient parenteral antimicrobial therapy (OPAT) for the treatment of cellulitis. STUDY DESIGN: A retrospective cohort study of adult patients receiving OPAT for cellulitis was performed. Treatment amendment (TA) was defined as hospital admission or change in antibiotic therapy in order to achieve clinical response. Multivariable logistic regression (MVLR) and classification and regression tree (CART) analysis were performed. RESULTS: There were 307 patients enrolled. TA occurred in 36 patients (11.7%). Significant risk factors for TA on MVLR were increased age, increased Numerical Pain Scale Score (NPSS) and immunocompromise. The median OPAT duration was 7 days. Increased age, heart rate and C reactive protein were associated with treatment prolongation. CART analysis selected age <64.5 years, female gender and NPSS <2.5 in the final model, generating a low-sensitivity (27.8%), high-specificity (97.1%) decision tree. CONCLUSIONS: Increased age, NPSS and immunocompromise were associated with OPAT amendment. These identified risk factors can be used to support an evidence-based approach to patient selection for OPAT in cellulitis. The CART algorithm has good specificity but lacks sensitivity and is shown to be inferior in this study to logistic regression modelling.

Simple aspiration versus intercostal tube drainage for primary spontaneous pneumothorax in adults.

BACKGROUND: For management of pneumothorax that occurs without underlying lung disease, also referred to as primary spontaneous pneumothorax, simple aspiration is technically easier to perform than intercostal tube drainage. In this systematic review, we seek to compare the clinical efficacy and safety of simple aspiration versus intercostal tube drainage for management of primary spontaneous pneumothorax. This review was first published in 2007 and was updated in 2017. OBJECTIVES: To compare the clinical efficacy and safety of simple aspiration versus intercostal tube drainage for management of primary spontaneous pneumothorax. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 1) in the Cochrane Library; MEDLINE (1966 to January 2017); and Embase (1980 to January 2017). We searched the World Health Organization (WHO) International Clinical Trials Registry for ongoing trials (January 2017). We checked the reference lists of included trials and contacted trial authors. We imposed no language restrictions. SELECTION CRITERIA: We included randomized controlled trials (RCTs) of adults 18 years of age and older with primary spontaneous pneumothorax that compared simple aspiration versus intercostal tube drainage. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, assessed trial quality, and extracted data. We combined studies using the random-effects model. MAIN RESULTS: Of 2332 publications obtained through the search strategy, seven studies met the inclusion criteria; one study was ongoing and six studies of 435 participants were eligible for inclusion in the updated review. Data show a significant difference in immediate success rates of procedures favouring tube drainage over simple aspiration for management of primary spontaneous pneumothorax (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.69 to 0.89; 435 participants, 6 studies; moderate-quality evidence). Duration of hospitalization however was significantly less for patients treated by simple aspiration (mean difference (MD) -1.66, 95% CI -2.28 to -1.04; 387 participants, 5 studies; moderate-quality evidence). A narrative synthesis of evidence revealed that simple aspiration led to fewer adverse events (245 participants, 3 studies; low-quality evidence), but data suggest no differences between groups in terms of one-year success rate (RR 1.07, 95% CI 0.96 to 1.18; 318 participants, 4 studies; moderate-quality evidence), hospitalization rate (RR 0.60, 95% CI 0.25 to 1.47; 245 participants, 3 studies; very low-quality evidence), and patient satisfaction (median between-group difference of 0.5 on a scale from 1 to 10; 48 participants, 1 study; low-quality evidence). No studies provided data on cost-effectiveness. AUTHORS' CONCLUSIONS: Available trials showed low to moderate-quality evidence that intercostal tube drainage produced higher rates of immediate success, while simple aspiration resulted in a shorter duration of hospitalization. Although adverse events were reported more commonly for patients treated with tube drainage, the low quality of the evidence warrants caution in interpreting these findings. Similarly, although this review observed no differences between groups when early failure rate, one-year success rate, or hospital admission rate was evaluated, this too needs to be put into the perspective of the quality of evidence, specifically, for evidence of very low and low quality for hospitalization rate and patient satisfaction, respectively. Future adequately powered research is needed to strengthen the evidence presented in this review.