Search

XiaoXiao Jia,1,2,* Ming Shi,3,* Qifei Wang,1,2 Jessica Hui,4 Joshua Hui Shofaro,1,2 Ryenchindorj Erkhembayar,5 Mizhou Hui,1,2 Chenzhe Gao,1 Munkh-Amgalan Gantumur1 1College of Life Science, Northeast Agricultural University, Harbin, People’s Republic of China; 2College of Veterinary Medicine, Qingdao Agricultural University, Qingdao, People’s Republic of China; 3School of Life Science and Technology, Harbin Institute of Technology, Harbin, People’s Republic of China; 4Center for Cancer Cell Therapy, Stanford Cancer Institute, Stanford University School of Medicine, Stanford, CA, USA; 5Department of International Cyber Education, Graduate School, Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia*These authors contributed equally to this workCorrespondence: Mizhou Hui; Munkh-Amgalan Gantumur, Email huimizhou@163.com; mnkh.calm@gmail.comBackground: Hyaluronic acid (HA) and HA fragments interact with a variety of human body receptors and are involved in the regulation of various physiological functions and leukocyte trafficking in the body. Accordingly, the development of an injectable HA fragment with good tissue permeability, the identification of its indications, and molecular mechanisms are of great significance for its clinical application. The previous studies showed that the clinical effects of injectable 35kDa B-HA result from B-HA binding to multiple receptors in different cells, tissues, and organs. This study lays the foundation for further studies on the comprehensive clinical effects of injectable B-HA.Methods: We elaborated on the production process, bioactivity assay, efficacy analyses, and safety evaluation of an injectable novel HA fragment with an average molecular weight of 35 kDa (35 kDa B-HA), produced by recombinant human hyaluronidase PH20 digestion.Results: The results showed that 35 kDa B-HA induced human erythrocyte aggregation (rouleaux formation) and accelerated erythrocyte sedimentation rates through the CD44 receptor. B-HA application and injection treatment significantly promoted the removal of mononuclear cells from the site of inflammation and into the lymphatic circulation. At a low concentration, 35 kDa B-HA inhibited production of reactive oxygen species and tumor necrosis factor by neutrophils; at a higher concentration, 35 kDa B-HA promoted the migration of monocytes. Furthermore, 35 kDa B-HA significantly inhibited the migration of neutrophils with or without lipopolysaccharide treatment, suggesting that in local tissues, higher concentrations of 35 kDa B-HA have antiinflammatory effects. After 99mTc radiolabeled 35 kDa B-HA was intravenously injected into mice, it quickly entered into the spleen, liver, lungs, kidneys and other organs through the blood circulation.Conclusion: This study demonstrated that the HA fragment B-HA has good tissue permeability and antiinflammatory effects, laying a theoretical foundation for further clinical studies.Keywords: hyaluronic acid, 35kDa hyaluronic acid fragment, B-HA/HA35, molecular weight, inflammation, inflammatory cells, reactive oxygen species, injection safety

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.

A main reason for writing a research proposal is to obtain funding or other non-monetary support. For this chapter, the purpose and predominant theme of writing a research proposal is for obtaining funds to support the research project. Many of our readers already know there is no one research proposal “formula” that can be applied to all funding applications. Many of the opportunities and application processes have similar steps and may request much of the same information, however one should not “cut and paste” a previous proposal into another organization’s or agency’s application process as there are significant differences. Proposals will need some degree of repackaging to properly align to what the organization or funding agency is seeking. This chapter will offer just a glimpse of some of those common steps, and address items that make healthcare simulation unique from a research application process. It will explore some common pitfalls that can result in a research proposal’s rejection.

In this chapter, we discuss the theoretical foundation for research and why theory is important for conducting experiments. We begin with a brief discussion of theory and its role in research. Next, we address the relationship between theory and hypotheses and distinguish between research questions and hypotheses. We then discuss theoretical constructs and how operational definitions make the constructs measurable. Next, we address the experiment and its role in establishing a plan to test the hypothesis. Finally, we offer an example from the literature of an experiment grounded in theory, the hypothesis that was tested, and the conclusions the authors were able to draw based on the hypothesis. We conclude by emphasizing that theory development and refinement does not result from a single experiment, but instead requires a process of research that takes time and commitment.

In contrast to qualitative research, quantitative research focuses primarily on the testing of hypotheses using variables that are measured numerically and analyzed using statistical procedures. If appropriately designed, quantitative approaches provide the ability to establish causal relationships between variables. Hypothesis testing is a critical component of quantitative methods, and requires appropriately framed research questions, knowledge of the appropriate literature, and guidance from relevant theoretical frameworks. Within the field of simulation, two broad categories of quantitative research exist: studies that investigate the use of simulation as a variable and studies using simulation to investigate other questions and issues. In this chapter we review common study designs and introduce some key concepts pertaining to measurement and statistical analysis. We conclude the chapter with a survey of common errors in quantitative study design and implementation.

This book is the product of an international community of scholars in healthcare simulation research. Although the book has a strong focus on simulation as an educational method, the contents reflect wider applications of simulation. The book covers a broad range of approaches to research design. It is written for anyone embarking on research in healthcare simulation for the first time, or considering the use of a technique or method outside their usual practice. In this chapter, we share the origins of the book, an orientation to each part of the book, some biographical information on the editors and contributors, finishing with our own tips on developing research expertise in healthcare simulation.

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.

The information contained in large collections of clinical data can be used for many valuable purposes, such as epidemiological studies, evidence-based medicine, monitoring compliance with best clinical practices, and cost-benefit analyses. However, the emerging standards for the electronic representation of clinical data, such as the Clinical Document Architecture (CDA) [4], are very complex and new tools are required to effectively extract and utilize the information contained in these documents. In this paper, we present HIWAS, a research prototype of a new tool that creates a structural summary of a collection of XML documents, thereby enabling users to find relevant information for a specific purpose within complex XML documents. A HIWAS user can create a target model that contains just the information they need, in a simplified representation that can be queried efficiently and is compatible with existing relational business intelligence technology. By making these complex XML documents digestible with conventional tools, HIWAS lowers a key barrier to meaningful use of aggregated clinical data.

Open data analysis platforms are being adopted to support collaboration in science and business. Studies suggest that analytic work in an enterprise occurs in a complex ecosystem of people, data, and software working in a coordinated manner. These studies also point to friction between the elements of this ecosystem that reduces user productivity and quality of work. LabBook is an open, social, and collaborative data analysis platform designed explicitly to reduce this friction and accelerate discovery. Its goal is to help users leverage each other's knowledge and experience to find the data, tools and collaborators they need to integrate, visualize, and analyze data. The key insight is to collect and use more metadata about all elements of the analytic ecosystem by means of an architecture and user experience that reduce the cost of contributing such metadata. We demonstrate how metadata can be exploited to improve the collaborative user experience and facilitate collaborative data integration and recommendations. We describe a specific use case and discuss several design issues concerning the capture, representation, querying and use of metadata.

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.

To describe (1) the institutional variability in study approval and willingness to obtain federal 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.Primary data collection from 2001 to 2004.We provide a descriptive analysis of a prospective, observational, out-of-hospital study.Twenty-seven pediatric receiving hospitals were approached for participation in a study validating a decision rule to identify seriously injured children involved in motor vehicle crashes in Los Angeles County. Two federal research policies, the Privacy Rule and the requirement for federalwide assurances, were implemented during the project.All 27 hospitals were sent an identical research protocol requesting approval to review charts of children transported to their facility. The research protocol included strict confidentiality protections, was noninterventional, did not alter the standard of care at the scene or at the hospital, and met requirements for waivers of both informed consent and the Health Insurance Portability and Accountability Act. Because the project was federally supported, all participating hospitals were required to have a federalwide assurance. The hospitals receiving the research protocol were the unit of analysis and outcomes included: approval of the research protocol, total number of days to study approval, and successfully obtaining a federalwide assurance.Overall, 6 of 27 (22 percent) hospitals refused to participate in the study, all of which were community hospitals. The median time from submitting an application to study approval was 118 days (interquartile range 34-254, range 12-960 days) and time to study approval differed when hospitals were categorized by type and the presence of an institutional review board (p=.053). No institutional review resulted in a change in the basic study protocol, although one hospital required paramedic consent. Following intensive efforts to secure federalwide assurances, 12 of 27 hospitals (44 percent) possessed the necessary assurance to conduct the study. If all patients transported to hospitals that failed to obtain such an assurance were omitted, the sample size would have been reduced by 62 percent and would have excluded all children transported to community hospitals.There is substantial institutional variability in approval of a minimal risk observational study and in willingness to obtain a federalwide assurance, particularly among community hospitals. Federal research policy involving patient privacy and institutional assurances may be contributing to this variability, which can adversely affect selection of research subjects, disrupt population-based study design, and threaten the generalizability of study results.

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.