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The acquisition and maintenance of individual competency is a critical component of effective emergency care systems. This article summarizes consensus working group deliberations and recommendations focusing on the topic "Simulation-based education to ensure provider competency within the healthcare system." The authors presented this work for discussion and feedback at the 2017 Academic Emergency Medicine Consensus Conference on "Catalyzing System Change Through Healthcare Simulation: Systems, Competency, and Outcomes," held on May 16, 2017, in Orlando, Florida. Although simulation-based training is a quality and safety imperative in other high-reliability professions such as aviation, nuclear power, and the military, health care professions still lag behind in applying simulation more broadly. This is likely a result of a number of factors, including cost, assessment challenges, and resistance to change. This consensus subgroup focused on identifying current gaps in knowledge and process related to the use of simulation for developing, enhancing, and maintaining individual provider competency. The resulting product is a research agenda informed by expert consensus and literature review.

Over the past decade, emergency medicine took a lead role in healthcare simulation in part due to its demands for successful interprofessional and multidisciplinary collaboration, along with educational needs in a diverse array of cognitive and procedural skills. Simulation-based methodologies have the capacity to support training and research platforms that model micro-, meso- and macro- systems of healthcare. To fully capitalize on the potential of simulation-based research to improve emergency healthcare delivery will require the application of rigorous methods from engineering, social science, and basic science disciplines. The Academic Emergency Medicine (AEM) Consensus Conference, “Catalyzing System Change Through Healthcare Simulation: Systems, Competency, and Outcome” was conceived to foster discussion among experts in emergency medicine, engineering, and social sciences, focusing on key barriers and opportunities in simulation-based research. This executive summary describes the overall rationale for the conference, conference planning, consensus-building approaches, and outlines the focus of the eight breakout sessions. The consensus outcomes from each breakout session are summarized in Proceedings papers published in this issue of Academic Emergency Medicine. Each paper provides an overview of methodological and knowledge gaps in simulation research and identifies future research targets aimed at improving the safety and quality of healthcare.

Background This study aims to assess the reliability and scale structure of the Chinese translation of the Student Satisfaction and Self-Confidence (SSSC) scale for evaluating satisfaction and self-confidence in simulation education for Chinese students. Method The Chinese SSSC was obtained from the original English version by the standard forward-backward translation process. A total of 161 nurses were recruited from an advanced cardiac life support provider course after the institutional review board approval. Result Using confirmatory factor analysis, the final two-factor structure had satisfactory fit after allowing for correlated errors, with χ 2 = 92.12 (df = 54), root mean square error of approximation = 0.07 (90% confidence interval = 0.04-0.09), comparative fix index = 0.98, and non-normed fit index = 0.96. A total of 161 nurses joined this study. Both the satisfaction and self-confidence scale components of the SSSC had high internal reliability, with Cronbach's alpha as 0.95 and 0.97, respectively. Conclusion The Chinese SSSC is a reliable and valid tool to assess student satisfaction and self-confidence in medical simulation.

INTRODUCTION We aimed to determine the publication rate for abstracts presented at the International Meeting for Simulation in Healthcare (IMSH) and the time between abstract presentation and publication. We also aimed to describe the study features influencing subsequent publication and the relationship between these features and journal impact factors (IFs). METHODS All types of accepted abstracts from the 2012 and 2013 IMSH were reviewed. We extracted the following data from each abstract in duplicate: presentation format, subject, type of scholarship, research method, study design, outcome measure, number of institutions in authorship group, and number of study sites. PubMed and Google Scholar were searched (January 1, 2012 to August 1, 2016) using the names of the first, second, and last author for comparison with abstracts. Journal of publication and IF were recorded. Data were summarized with descriptive statistics. Bivariate and multivariate analysis was performed to explore the association between publication status and other variables. RESULTS Of 541 abstracts, 22% (119/541) were published with a median time to publication of 16 months (interquartile range = 8.525), ranging from 0 to 43 months. The study characteristics associated with a greater likelihood of publication were the following: research-type abstract, quantitative studies, randomized trials, studies with patient or healthcare-related outcomes, multiple institutions represented in authorship group, and multicenter studies. Studies with multiple institutions in authorship group and multicenter studies were published in higher IF journals (P < 0.05). CONCLUSIONS The publication rate of 22% for abstracts presented at IMSH is low, indicative of the relatively new nature of simulation-based research in healthcare.

Objectives: To prospectively validate a previously published out-of-hospital clinical decision rule to identify seriously injured children involved in motor vehicle crashes (MVCs). Methods: The authors selected 20 Los Angeles County Fire Department fire stations, based on pediatric MVC call volume and geographic diversity, and 21 associated hospitals for participation in the study. Immediately following an MVC call involving a pediatric patient aged 0‐14 years, each engine/paramedic squad completed a data form (15 variables, including vital signs, Glasgow Coma Scale score, and vehicular and crash characteristics). This study was conducted over a 24-month period. Outcomes included: 1) ‘‘serious injury’’ as defined by an Injury Severity Score (ISS) $ 16 (primary outcome), and 2) need for specialized trauma care (emergent intubation, major nonorthopedic operative intervention or death in the first 24 hours, or pediatric intensive care unit stay longer than 48 hours), as assessed by retrospective chart review. Accuracy measures and binominal confidence intervals (CIs) were calculated for the decision rule validation. Results: One hundred seventy-five children were prospectively enrolled in the study; 36 children were excluded due to lack of hospital participation or missing hospital charts. There were four children with ISS $ 16 (3%) and six children requiring specialized trauma care (4%). The sensitivities and specificities of the rule were: 100% (95% CI = 40% to 100%) and 73% (95% CI = 65% to 81%) for serious injury, and 83% (95% CI = 36% to 100%) and 74% (95% CI = 65% to 81%) for specialized trauma care, respectively. Conclusions: Although definitive conclusions are limited by the sample size, the decision rule identified all seriously injured children involved in MVCs and had moderate specificity. The decision rule was less sensitive for identifying children requiring specialized trauma care. Larger validation studies are needed to adequately assess the utility of this rule before implementation. Key words: clinical decision rule; pediatrics; motor vehicle collisions; trauma; prediction. ACADEMIC EMERGENCY MEDICINE 2005; 12:679‐687.

Federal rules and regulations exist to ensure the protection of human subjects involved in research (Belmont Report 1979; Title 45, Code of Federal Regulations, part 46 2001); but it is the institutional review board (IRB) that interprets, implements, and applies these guidelines in a given health care or research facility (Moreno, Caplan, and Wolpe 1998; Title 45, Code of Federal Regulations, part 46 2001). Additional federal research regulations, the Health Insurance Portability and Accountability Act (HIPAA) “Privacy Rule,” and the requirement for federalwide assurances have recently been implemented with the intent of further protecting patient privacy and standardizing institutional research standards (Title 45, Code of Federal Regulations, part 46 2001; Title 45, Code of Federal Regulations, parts 160 and 164 2002). The Privacy Rule, as applied to research, requires strict confidentiality and limited access to individual protected health information unless informed consent is provided or the research qualifies for a waiver. Federalwide assurances serve as a document or agreement that defines an institutional obligation to comply with federal research regulations (Newgard and Lewis 2002). Such “assurances” have existed for many years, being provided to centers for multiple studies or for a single study after central (i.e., federal) review of a given research protocol. In 1998, the Office for Human Research Protections began a paradigm shift of decentralizing responsibility for protocol review, changing accountability, “simplifying” assurances, and promoting the concept of accreditation and education with a single, broadly applicable federal assurance (i.e., the federalwide assurance) for all institutions participating in federally supported or federally conducted research (Newgard and Lewis 2002). While the Privacy Rule and federalwide assurances are only strictly applicable to federally supported or federally conducted research and to hospitals receiving federal funds, they have been broadly applied throughout the health care system. Whether these regulations confer any additional protection for human subjects involved in research is unclear, and concerns have been raised about the potentially negative effect of these regulations on research, particularly on population-based health services research (Kulynych and Korn 2002). In the case of federalwide assurances, there is no evidence to suggest that such an assurance further improves the protection of human subjects, particularly for minimal risk research conducted in nonacademic institutions where the individual tasked with obtaining and signing the assurance often has no involvement in or direct supervision over such research activities. Including patients from many different practice settings (e.g., academic, tertiary, and community) in health services research is important to produce valid results with broad generalizability. Regulatory burden may threaten broad participation (Kulynych and Korn 2002), especially among centers that would rarely, if ever, participate in research activities. Policies that effectively restrict the selection of research subjects to those in academic centers may have the unintentional result of reducing the generalizability of subsequent study results and raise concerns about whether important findings truly apply to the vast majority of patients who receive care in nonacademic centers. Finally, such restricted selection of research subjects potentially violates the principle of justice in research (Belmont Report 1979). The objective of this study was to describe (1) the institutional variability in study approval and willingness to obtain federalwide assurance documents for a federally supported, minimal risk health services research project conducted during the implementation of the Privacy Rule and federalwide assurances, and (2) the potential impact of such policy on selection of research subjects and generalizability of study results.

Study objective Randomized trials suggest that nonoperative treatment of uncomplicated appendicitis with antibiotics-first is safe. No trial has evaluated outpatient treatment and no US randomized trial has been conducted, to our knowledge. This pilot study assessed feasibility of a multicenter US study comparing antibiotics-first, including outpatient management, with appendectomy. Methods Patients aged 5 years or older with uncomplicated appendicitis at 1 US hospital were randomized to appendectomy or intravenous ertapenem greater than or equal to 48 hours and oral cefdinir and metronidazole. Stable antibiotics-first-treated participants older than 13 years could be discharged after greater than or equal to 6-hour emergency department (ED) observation with next-day follow-up. Outcomes included 1-month major complication rate (primary) and hospital duration, pain, disability, quality of life, and hospital charges, and antibiotics-first appendectomy rate. Results Of 48 eligible patients, 30 (62.5%) consented, of whom 16 (53.3%) were randomized to antibiotics-first and 14 (46.7%) to appendectomy. Median age was 33 years (range 9 to 73 years), median WBC count was 15,000/μL (range 6,200 to 23,100/μL), and median computed tomography appendiceal diameter was 10 mm (range 7 to 18 mm). Of 15 antibiotic-treated adults, 14 (93.3%) were discharged from the ED and all had symptom resolution. At 1 month, major complications occurred in 2 appendectomy participants (14.3%; 95% confidence interval [CI] 1.8% to 42.8%) and 1 antibiotics-first participant (6.3%; 95% CI 0.2% to 30.2%). Antibiotics-first participants had less total hospital time than appendectomy participants, 16.2 versus 42.1 hours, respectively. Antibiotics-first-treated participants had less pain and disability. During median 12-month follow-up, 2 of 15 antibiotics-first-treated participants (13.3%; 95% CI 3.7% to 37.9%) developed appendicitis and 1 was treated successfully with antibiotics; 1 had appendectomy. No more major complications occurred in either group. Conclusion A multicenter US trial comparing antibiotics-first to appendectomy, including outpatient management, is feasible to evaluate efficacy and safety.

Background Simulation-based research (SBR) is rapidly expanding but the quality of reporting needs improvement. For a reader to critically assess a study, the elements of the study need to be clearly reported. Our objective was to develop reporting guidelines for SBR by creating extensions to the Consolidated Standards of Reporting Trials (CONSORT) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statements. Methods An iterative multistep consensus-building process was used on the basis of the recommended steps for developing reporting guidelines. The consensus process involved the following: (1) developing a steering committee, (2) defining the scope of the reporting guidelines, (3) identifying a consensus panel, (4) generating a list of items for discussion via online premeeting survey, (5) conducting a consensus meeting, and (6) drafting reporting guidelines with an explanation and elaboration document. Results The following 11 extensions were recommended for CONSORT: item 1 (title/abstract), item 2 (background), item 5 (interventions), item 6 (outcomes), item 11 (blinding), item 12 (statistical methods), item 15 (baseline data), item 17 (outcomes/ estimation), item 20 (limitations), item 21 (generalizability), and item 25 (funding). The following 10 extensions were recommended for STROBE: item 1 (title/abstract), item 2 (background/rationale), item 7 (variables), item 8 (data sources/measurement), item 12 (statistical methods), item 14 (descriptive data), item 16 (main results), item 19 (limitations), item 21 (generalizability), and item 22 (funding). An elaboration document was created to provide examples and explanation for each extension. Conclusions We have developed extensions for the CONSORT and STROBE Statements that can help improve the quality of reporting for SBR (Sim Healthcare 00:00-00, 2016). Electronic supplementary material The online version of this article (doi:10.1186/s41077-016-0025-y) contains supplementary material, which is available to authorized users.