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EXPRESS—Examining Pediatric Resuscitation Education Using Simulation and Scripting: The Birth of an International Pediatric Simulation Research Collaborative—From Concept to Reality

Cheng, Adam MD; Hunt, Elizabeth A. MD; Donoghue, Aaron MD; Nelson, Kristen MD; Leflore, Judy PhD; Anderson, JoDee MD; Eppich, Walter MD; Simon, Robert EdD; Rudolph, Jenny PhD; Nadkarni, Vinay MDfor the EXPRESS Pediatric Simulation Research Investigators

Simulation in Healthcare: The Journal of the Society for Simulation in Healthcare: February 2011 - Volume 6 - Issue 1 - p 34-41
doi: 10.1097/SIH.0b013e3181f6a887
Special Article
Free

Over the past decade, medical simulation has evolved into an essential component of pediatric resuscitation education and team training. Evidence to support its value as an adjunct to traditional methods of education is expanding; however, large multicenter studies are very rare. Simulation-based researchers currently face many challenges related to small sample sizes, poor generalizability, and paucity of clinically proven and relevant outcome measures. The Examining Pediatric Resuscitation Education Using Simulation and Scripting (EXPRESS) pediatric simulation research collaborative was formed in an attempt to directly address and overcome these challenges. The primary mission of the EXPRESS collaborative is to improve the delivery of medical care to critically ill children by answering important research questions pertaining to pediatric resuscitation and education and is focused on using simulation either as a key intervention of interest or as the outcome measurement tool. Going forward, the collaborative aims to expand its membership internationally and collectively identify pediatric resuscitation and simulation-based research priorities and use these to guide future projects. Ultimately, we hope that with innovative and high-quality research, the EXPRESS pediatric simulation research collaborative will help to build momentum for simulation-based research on an international level.

From the British Columbia Children's Hospital (A.C.), Vancouver, Canada; Johns Hopkins Children's Hospital (E.A.H., K.N.), Baltimore, MD; Children's Hospital of Philadelphia (A.D., V.N.), Philadelphia, PA; Children's Medical Center of Dallas (J.L.), Dallas, TX; Oregon Health Sciences University (J.A.), Portland, OR; Children's Memorial Hospital (W.E.), Chicago, IL; and Center for Medical Simulation (R.S., J.R.), Boston, MA.

Supported by an educational research grant provided by the American Heart Association and the Pediatric Critical Care Medicine Endowed Chair Funds at the Children's Hospital of Philadelphia. The infrastructure of the EXPRESS collaborative is funded by grant support from the Laerdal Foundation for Acute Medicine.

The EXPRESS Pediatric Simulation Research Investigators are listed at the end of this article.

Reprints: Adam Cheng, MD, Division of Emergency Medicine, BC Children's Hospital, 4480 Oak Street, Vancouver, BC, Canada V6H 3V4 (e-mail: acheng@cw.bc.ca).

The field of medical simulation has made great advances over the past decade. The use of human patient simulators to recreate physical and physiologic responses in mannequins has been effectively used to teach medical knowledge,1–3 clinical skills,4–10 procedural skills,11–13 and teamwork concepts14–17 in various settings. Several national and international simulation societies, such as the Society for Simulation in Healthcare and the Society in Europe for Simulation Applied to Medicine, run annual scientific meetings that showcase the breadth of current simulation research. Despite this growing body of evidence, simulation-based researchers still face a significant challenge: evaluating the effect of medical simulation on actual patient outcomes.18

As a relatively new field in medical education research, many of the simulation-based research studies suffer from smaller sample sizes, suboptimal design, or lack of clinically significant outcome measures.18,19 Despite the expanding breadth of simulation-based assessment tools,20–24 few have been pilot tested or validated in the real clinical environment, thus leaving the question of clinical relevance up in the air. Although there exist some examples of outstanding collaborations among simulation-based educators,25,26 there are no published reports of simulation-based research networks developed to conduct larger multicenter simulation-based research trials. In this article, we describe the conception, formation, and growth of an international pediatric simulation research collaborative. Through the conduct of our first multicenter trial, Examining Pediatric Resuscitation Education using Simulation and Scripting (EXPRESS), we have experienced the benefits of collaboration and discovered strategies to overcome some of the barriers faced in doing multicenter simulation-based research.

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BARRIERS TO SIMULATION-BASED RESEARCH

Despite the pressing need to expand the body of literature that critically evaluates the use of simulation, there are still significant obstacles to conducting high-quality simulation research that need to be overcome. Many of the simulation research barriers are the same as the challenges faced by medical education researchers.19,27–30 These include the following:

  • Limited pool of potential subjects at single institutions. Simulation and educational research depends highly on the availability of learners/subjects within an individual institution to achieve the predetermined sample size. Single-center studies may struggle with recruiting an appropriate number of subjects, especially if there are concurrent studies recruiting similar subjects within the same center.31
  • Generalizability. Most medical education research studies are conducted in single institutions or tertiary care pediatric hospitals from one area or country, which may limit the generalizability of the findings. Inclusion of subjects from multiple sites (eg, adult hospitals, rural hospitals, and hospitals from various countries) would help to enhance generalizability and ensure applicability across broad groups of subjects.19
  • Adequate funding. The quality of published medical education research is associated with adequate study funding.32 Adequate funding for educational research can be challenging to obtain because methodological limitations often make it difficult to properly assess whether outcomes are truly advancing the ultimate aim of improving patient outcomes.19 In addition, funding for medical education research is scarce,30,31 and faculty members who engage in educational research often do not have formal research training.32

Several barriers that are specific to simulation-based research exist, as well. Some of these are the following:

  • The need to identify and/or develop assessment tools to help support the effectiveness of simulation-based research. Much like medical education research, more meaningful and clinically relevant outcomes in simulation-based research will improve the overall quality of research in this area.33,34
  • Efficient means of distributing simulation videos for analysis and data extraction. Capturing and distributing simulation videos for review by multiple independent reviewers are necessary to facilitate enhanced research productivity and quality. Attempting to coordinate a video review process with local and offsite reviewers can be logistically challenging and cost-prohibitive, and hard-copy methods of distribution (mail and courier) may lead to prolonged periods of delay.
  • Research prioritization and coordination. Most researchers are working in isolated silos, with little knowledge of similar work that others may be doing at the same time. Recently, some groups/disciplines have come together to develop consensus statements on research needs and prioritization in their specific fields.18,19 Currently, there is no pediatric group, society or network that works collaboratively to identify knowledge gaps in an effort to establish pediatric simulation research priorities.
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BENEFITS OF RESEARCH NETWORKS AND COLLABORATIVES

In the field of medical research, there are several networks that have consistently demonstrated the benefits of collaboration by producing high-impact publications that have had a direct influence on patient care and outcomes.35–41 The most effective networks have been able to capitalize on the collective experience of its members to amplify the benefits of research collaboration. Many of these benefits help to directly address the barriers outlined above and include the following:

  • Ability to recruit from multiple centers, allowing for larger sample sizes.
  • Inclusion of recruitment sites representing various subject populations (eg, ethnicities or countries) adds to the generalizability of studies.
  • Funding opportunities are more numerous when conducting multicenter studies involving experts with existing track records in research.
  • Ability to easily access the rich and diverse experience of other network members to help with protocol design and implementation.
  • Regular and planned communication within networks allows for groups to develop consensus-derived, well-informed, timely, and relevant research agendas to guide network projects.

Recognizing the challenges we faced in simulation-based research, and more importantly, the tremendous potential benefits of working together, a small group of interested individuals came together to establish the first simulation-based research collaborative.

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FORMATION OF EXPRESS COLLABORATIVE

The EXPRESS Pediatric Simulation Research Collaborative was established to bring together leaders and innovators in pediatric simulation interested in answering important research questions pertaining to pediatric resuscitation and simulation-based education. The collaborative was first established in February 2007 when 25 pediatric simulation and pediatric advanced life support (PALS) experts from various institutions across North America gathered together at the Children's Hospital of Philadelphia to discuss possible strategies to effectively incorporate simulation-based education into future PALS courses. This meeting, funded by Pediatric Critical Care Medicine Endowed Chair Funds at the Children's Hospital of Philadelphia, served as a springboard for discussion of simulation-based research ideas and provided validation of the pressing need for more collaborative, multicenter research in this field. Attendees at this meeting had a strong desire to move forward with research as a team, and collectively agreed that research of this sort would likely require dedication and commitment beyond regular work hours. From this, the EXPRESS research collaborative was born, with the first major project aimed to evaluate the effect of scripted versus unscripted debriefing and high- versus low-fidelity simulation on attainment and retention of PALS-based educational outcomes for healthcare professionals.

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VISION, GOALS, AND MANDATE

The primary aim of the EXPRESS collaborative is to improve the delivery of medical care to critically ill children by answering important research questions pertaining to pediatric resuscitation, education, and simulation. In particular, we aim to conduct robust, adequately powered, and appropriately designed trials with an emphasis on simulation and multicenter collaboration. In our collaborative research model, we also aim to facilitate the academic growth of new investigators by exposing them to established mentors and nurturing the skills necessary to become successful researchers. Specifically, young investigators will be mentored through the process of selecting an appropriate research idea, developing objectives and specific aims, writing research proposals, applying for grant support, executing research protocols, presenting emerging data at national and international conferences, and bringing projects to print via peer-review publication. We anticipate and hope that the acquisition of a steady stream of grant support will help to promote the growth of our collaborative.

Through this process, we expect to build expertise and knowledge that gains momentum for collaborative simulation- based research on an international level. Currently, the EXPRESS collaborative comprises researchers and educators from various centers in Canada, United States, and Australia (Fig. 1). For our first study, 15 sites served as recruitment centers, with investigators from various other sites helping as either consultants or expert video reviewers (Table 1). Since the completion of our first study, we have expanded our collaborative internationally by including more sites in Canada, Europe, and Asia, with the eventual aim of conducting trials with truly global representation. This strategy should help focus our research on universally important issues, and subsequently, more applicable to various populations around the globe.

Figure 1.

Figure 1.

Table 1

Table 1

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STRATEGIC LEADERSHIP AND MEMBERSHIP

To help build the infrastructure for our collaborative, we sought to include individuals who could provide the leadership and vision necessary to ensure our collective success. The founding members of our collaborative represent leadership from various societies or committees who play a crucial role in organizing and delivering resuscitation and simulation-based education at local, regional, national, and international levels (Table 2). Their earlier experience in helping large networks of individuals move forward with a common agenda in mind is invaluable in helping our collaborative achieve its research goals. This strong leadership foundation, combined with a clear vision and mandate for the collaborative, has allowed our group to move forward collectively without disruption from competing interests and goals.

Table 2

Table 2

The composition of a team, and factors such as diversity and previous collaborative experience can affect the success of a team project.42,43 In fact, research has demonstrated that expert teams consisting of individuals with diverse perspectives improve collective understanding and problem solving compared with teams of like-minded individuals.44,45 Building on this theory, other founding members of the collaborative with a broad scope of expertise were strategically recruited to help bridge the gap between research ideas and research productivity. Members with a background in pediatric nursing, neonatology, pediatric emergency medicine, and pediatric intensive care ensure that we have the medical expertise necessary to identify important clinical issues and to design protocols that are medically relevant. Experts in education and human factors provide guidance in the optimal implementation of educational philosophy and evaluation into our research studies. Simulation center directors from our various recruitment sites are critical to help develop feasible simulation scenarios and protocols and to enable video-assisted data collection during simulation sessions. Those with advanced degrees in clinical epidemiology and biostatistics are essential to the study design and data analysis process. Finally, energetic and dedicated young investigators willing to take on the primary investigator and study site principal investigator roles serve as the stimulant for new initiatives and are relied on for their enthusiasm and their commitment to bring projects to fruition.

With such a broad spectrum of individuals coming together to form a research collaborative, we anticipated the potential for competing interests and goals, as well as issues surrounding the time and commitment necessary to achieve our research aims. To help circumvent these potential problems, our leadership implemented a policy of transparency and open communication. The goals, objectives, and funding of the collaborative, as well as the workload expectation and deliverables of each member were clearly outlined through individual communication with leadership, frequent group conference calls, and face-to-face collaborative meetings. By creating an open and transparent environment, members were easily engaged in frank discussion, and any pertinent issues related to research were quickly resolved through group consensus.

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RESEARCH PORTAL

Simulation-based research often requires the use of assessment tools to rate subject or team performance via videotaped sessions. The process of collecting and organizing videos, allowing for synchronous or asynchronous video review, scoring and discussion by study investigators, and simultaneously ensuring that all videos are maintained in a secure environment is a challenge that required a novel solution. With this in mind, we developed a universally applicable research website as part of a previously existing Learning Management System to help facilitate simulation-based research. Located on the Internet at www.CESEI.org, this research portal helps researchers to design their project, setup and manage data collection, and finally, allow for upload and review of external data, such as videos, images, and other assets. This research portal allowed us to streamline our video review process, saving us a significant amount of both money and time. For our first project (EXPRESS study), we were able to successfully manage data collected from more than 400 study subjects from 15 different recruitment sites using the research portal. In total, >350 videos were uploaded to the portal for review using three different assessment tools by our team of 24 video review experts from around the world. The research portal enabled seamless extraction of data via the video review process and rapid reporting of these data via immediate download in excel spreadsheet format. This research portal will form the foundation for our future projects, and we believe that its use will enable novice and expert researchers to carry out their projects in an efficient, coordinated, and timely manner, thus helping to advance the field of simulation worldwide.

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CURRENT PROJECTS/ASSESSMENT TOOLS

Our first project (EXPRESS study) aims to evaluate whether scripted debriefing by novice instructors after a simulated pediatric resuscitation scenario will improve the knowledge, cognitive performance, and behavioral performance of team members when compared with more traditional, nonscripted debriefing. Our secondary aim is to evaluate the impact of high- versus low-fidelity mannequin simulation for PALS-based educational outcomes, such as knowledge, cognitive performance, and behavioral performance. As such we are using a factorial design to assess the independent and potentially combined effect of these two interventions (script vs. no script and high- vs. low-fidelity mannequin) on the outcomes described. Also, we will test whether novice instructors performing a scripted debriefing rated higher than those facilitating a nonscripted debriefing, as assessed by a debriefing assessment tool. Data collection and analysis for this research is now complete, and results of this research will be published in the near future.

Before implementation in the EXPRESS study, we recognized the need to identify and/or further develop assessment tools, which were proven to be both valid and reliable for a defined population and clinical context. Through several pilot studies and work done before the main EXPRESS study, we aimed to validate four separate assessment tools for the population and clinical context we used in this study: (1) a cognitive performance tool, (2) a behavioral assessment tool, (3) a multiple choice test for PALS-based objectives, and (4) the debriefing assessment for simulation in healthcare tool. We believe that this work will help to solidify the role of these tools as part of future simulation-based research and educational projects. Our current research effort includes eight projects led by diverse teams of investigators; these projects are summarized in Table 3.

Table 3

Table 3

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RESEARCH PROCESS—PROBLEMS AND CHALLENGES MITIGATED

During the EXPRESS study, our team encountered several issues in study design that were unique to the implementation of multicenter, simulation-based research. To ensure standardization across all 15 recruitment sites, we had to carefully consider the following issues: what type of simulator do these sites have? How can we ensure that the resuscitation scenario is run in the same fashion from site to site? How do we control for environmental factors? How do we ensure that we have similar quality of data from each site, ie, standardized video angles, audio quality, similar length of scenarios? We sought to mitigate these issues through healthy discussion and heated debate.

To address these challenges, we ensured that all recruitment sites had access to the same model infant simulator. Next, the research scenario was designed and standardized to include cues for the research assistant to provide at various predetermined intervals during the scenario (eg, providing the team with capillary refill time). The scenario was carefully controlled by ensuring that progression from one phase to the next was dependent on a standardized time in each phase or by a specific intervention that was executed by the team. The research environment was also controlled—all teams had a standard list of equipment made available to them, and the crash cart was located in the exact same spot and distance relative to the patient bed during the simulated research scenarios. These efforts were critical to reduce variability inherent in simulation environments. Piloting the simulation scenarios before enrolling subjects was an essential step in identifying elements that had not been adequately described in our protocol to ensure standardization. We then edited the protocols in an iterative fashion until they were similarly interpreted and followed across diverse institutions before going live with the study.

Another major challenge was how to optimize the reliability and use of our preselected assessment tools. In tackling this problem, we instituted a number of important measures: standardization of camera angles, multiple camera angles for video review, review by videotape and not in real time (thus allowing our reviewers time to review and pause the scenario to capture proper data and minimize errors), and most importantly, rater training and calibration sessions for each of the assessment tools before implementation in the study.

As with most multicenter research studies, there were a variety of other motivational factors (eg, clinical and academic workload, funding, personal lives) influencing individual investigators' execution of the research protocol that were out of the control of our leadership team. To guarantee compliance with the research protocol, each recruitment site signed a subsite agreement with the coordinating research site (BC Children's Hospital). In addition, two backup recruitment sites were identified a priori, both of which were eventually asked to participate partway through the research project when subject recruitment was going poorly at other sites.

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MANUSCRIPT OVERSIGHT COMMITTEE

To ensure transparency and avoid conflict of interest during the writing process, a manuscript oversight committee was formed consisting of three senior members of EXPRESS. The committee was responsible for ensuring that appropriate academic credit was allocated to contributors of the various projects in a consistent, fair, and logical manner. In particular, the committee attempted to prioritize young investigators as contributing authors (A.C., E.A.H., and A.D.) when appropriate. They were also tasked with the responsibility of facilitating identification and management of conflicts of interest, if they were to arise. Finally, this committee assisted in the enforcement of timelines for analysis, presentation, and publication of data. This guided approach helped to ensure consistent productivity from our young investigators and has led to the presentation of numerous research abstracts at various conferences, as well as the preparation and recent submission of several manuscripts for publication (Table 3). Although individual manuscript quality and review will be handled by dedicated writing teams, this committee will provide ongoing oversight by suggesting ideal journals for manuscript submission and ensuring writing teams are on task with their timelines.

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FUTURE DIRECTIONS AND GOALS

Going forward, our research collaborative has targeted several areas for new research. These include innovation and technology in improving the quality of pediatric resuscitation, communication and teamwork during resuscitation, and characterizing and improving postresuscitation or postsimulation debriefing. Our overarching goals and objectives as a collaborative over the next 3 years will be to:

  • Establish and maintain an efficient, functional, and funded infrastructure to support ongoing research on an international level.
  • Identify and leverage new web-based collaboration tools to advance multicenter research.
  • Identify additional best practices in researcher networks and adapt EXPRESS accordingly.
  • Identify pediatric resuscitation and simulation-based research priorities and use these to guide future projects.
  • Develop a structured application process for new membership, capable of efficiently and effectively connecting new members to new or ongoing research projects.
  • Expand membership to include collaborators representing countries worldwide.
  • Expand membership to include other professions and disciplines (eg, Anesthesiology, Surgery, Respiratory Therapy, and Qualitative Research Expertise), thus broadening the functional diversity of our collaborative and enabling us to stay informed of research outside the pediatric discipline.
  • Continue to mentor and support young investigators interested in simulation-based research and education.
  • Expand and build on the capabilities of the existing research portal to incorporate qualitative feedback and outcome measures generated by simulators.
  • Disseminate knowledge and expertise by conducting courses and workshops at relevant simulation, resuscitation, and pediatric conferences.

To help achieve these goals, our collaborative plans to meet bi-annually through face-to-face meetings in conjunction with two major simulation conferences: International Meeting on Simulation in Healthcare and the International Pediatric Simulation Symposium and Workshops. At these meetings, project leaders will give updates on ongoing research and recent presentations. In addition, new research ideas will be discussed among focused working groups of interested members before grant proposals are prepared and submitted. Ultimately, we anticipate that these bi-annual meetings will grow in popularity and with this may require restructuring of the meeting agenda to accommodate the needs of our collaborative. To ensure long-term sustainability of EXPRESS, we have secured grant funding to build on our existing infrastructure. This funding will be used to enhance the research portal, expand our technological and administrative support, and to further develop other web-based applications; all of which will help to improve the efficiency of communication and workflow. Furthermore, our collaborative will be gathering for a face-to-face research retreat in the near future, aimed at discussing future plans for governance of the collaborative, outlining a strategy to secure both short- and long-term funding, and maintaining a heightened level of enthusiasm and dedication among all EXPRESS members.

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CONCLUSION

The primary mission of the EXPRESS collaborative is to improve the delivery of medical care to critically ill children by answering important research questions pertaining to pediatric resuscitation, education, and simulation. In an era where web-based applications for social networks are burgeoning, the EXPRESS collaborative concept seeks to bring the synergy of professional networks to bear on important clinical problems. Comprising a team of simulation, pediatric resuscitation, education, research, and human factors experts, the EXPRESS collaborative has successfully conducted its first multicenter randomized-controlled trial, assessing the value of scripting and high-fidelity simulation in improving PALS-related educational outcomes. During this process, members of the collaborative have also developed and analyzed four separate assessment tools for use in simulation-based education and implemented an Internet-based, universally applicable and adaptable research portal capable of facilitating simulation-based research. Going forward, the collaborative aims to expand its membership internationally and collectively identify pediatric resuscitation and simulation-based research priorities, and use these to guide future projects.

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EXPRESS Pediatric Simulation Research Investigators

Akira Nishisaki, MD; Mike Moyer, BS, MS; Marisa Brett-Fleegler, MD; Monica Kleinman, MD; Matthew Braga, MD; Susanne Kost, MD; Glenn Stryjewski, MD; Steve Min, MD; John Podraza, MD; Joseph Lopreiato, MD; Melinda Fiedor Hamilton, MD; Jonathan Duff, MD; Jeffrey Hopkins, RN; Kimberly Stone, MD, Jennifer Reid, MD, Douglas Leonard, MD; Kathleen Ventre, MD; Laura Corbin, MD; Kristine Boyle, MS; Marino Festa, MBBS; Frank Overly, MD; Stephanie Sudikoff, MD, Takanari Ikeyama, MD, Louis Halamek, MD; Stephen Schexnayder, MD; Jack Boulet, PhD; John Gosbee, MD; Laura Gosbee, MASc; and Matthew Richard, BSc.

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ACKNOWLEDGMENTS

The authors thank Anne Marie White, EXPRESS research coordinator, for her hard work and commitment to this project. They also thank the AV/IT team at CESEI for their support—Albert Ho and Ferooz Sekandarpoor for setting up the videotaping and processing hundreds of videos, Byron Tredwell for his innovative design of the research portal, Gary Cody for the beautiful posters, and Karim Qayumi and Marlene Woschee for their continued support of our research.

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Keywords:

Simulation; Pediatric; Resuscitation; Research; Collaboration

© 2011 Society for Simulation in Healthcare