Clinical Researcher—April 2024 (Volume 38, Issue 2)

PEER REVIEWED

Muhammad Waseem, MBBS, MS, FAAP, FACEP, FAHA, FSSH

 

 

 

Using simulation to demonstrate the theoretical and practical aspects of research design has yet to be explored. Identifying what simulation can achieve for educational and research objectives that other modalities cannot achieve is essential. This review discusses whether simulation can be used to teach the research process. The value of simulation can’t be determined by randomized trials alone. A qualitative approach to assessing the value of teaching research via simulation adds a well-rounded perspective. Simulation has tremendous potential and can be used as a research tool. This review aims to develop the fundamental research question, namely, can we use simulation to educate about the research process?

What is Simulation?

“Simulation is a methodology by which we recreate a portion of the healthcare delivery experience to educate and assess people, groups of people, teams, and environments of care.”{1} Simulation creates a practical context in which skills can be learned, applied, and mastered. It has emerged as an effective teaching methodology.{2} It is increasingly employed to improve knowledge and skills.{3} It has spread to almost every discipline and domain.{4} It represents an actual event for practicing, learning, evaluating, testing, or understanding systems or human actions.

In other words, simulation either mimics or amplifies real experiences with guided experiences that evoke or replicate real-world circumstances. {5,6} It is an ideal modality to practice and learn management of critical events.{7}

Several simulation applications have been in clinical practice (see Table 1). The Simulation Research Summit organized by the Society of Simulation in Healthcare guided the research-based use of simulation.{8,9}

 

Table 1: Application of Simulation
                                                                                                                                   

Clinical performance

Decision making

Clinical processes

Human factors

Training

Research

 

Practice in Simulation First

Simulation creates a safe learning environment that allows testing new clinical processes and enhancing individual and team skills before encountering actual patients. Since patient safety has become an essential agenda item, the clinical setting is no longer the only place to learn and practice skills. Human subjects should be protected whenever possible and not perceived as commodities for training conveniences. Simulation provides a structured training opportunity with defined learning objectives.

Simulation could support the investigation of phenomena that are difficult to study by more conventional methods. It is based more strictly on theories or conceptual frameworks. Several variables can be controlled in a simulated environment compared to actual situations where every component aspect varies.

Standardization of the environment allows the researcher to control many potential threats to internal validity.{10} In other words, the participants’ performances comprise the only difference between actual and simulated situations. Indeed, the differences in performance are illustrative of an intrinsic human factor.

What Can be Simulated?

It is not incorrect to say that almost anything and possibly everything can be simulated. In recent years, the research agenda has shifted from “if” simulation works to examining the “who, what, when, where, why, and how” of the simulation process.{11} Hence, the critical question is when should we use simulation? And how do we effectively use simulation?

Although a situation is simulated, this approach may produce emotional realism, allowing the participants to learn “as if it were a real situation.” This requires establishing a “fiction contract: acting as if things are real.” In other words, a voluntary commitment from the learner to do what they would do to act as if the experience is real.

Research Using Simulation

The simulation research process is similar to the conventional research process. It has become commonplace in clinical education. The focus of simulation research is education, as well as an assessment of processes and performance. Identifying what simulation can achieve as educational and research objectives that other modalities cannot achieve is essential. We believe simulation is an effective instructional method for teaching the research process. Simulation-based research can be classified into two categories{12} (see Table 2):

• Research about simulation allows for testing or improving simulation techniques. Here, simulation is the focus or objective of the research and serves as a dependent variable. This approach also involves the clinical impact of simulation as an educational tool.
• Research uses simulation to study other issues, such as human performance, clinical cognition, or clinical care processes. This means that simulation is used to investigate other research questions. Simulation is used as a research tool and serves as an independent variable. It offers unique features and can be considered a complementary window into the clinical world relative to other modalities. It can be applied, for example, when complex phenomena such as medical team processes are studied. For instance, how teams adapt from routine to non-routine situations and how such adaptations are related to performance, communication processes such as information processing, problem-solving and decision-making, and coordination requirements during resuscitation. Using simulation as a research method and choosing a simulator or tool depends on the research question or objective.

 

Table 2: Types of Simulation Research

Research About Simulation                                     Research Using Simulation

                                                                                                                                                     
Focus              Investigates simulation                      Investigates other research questions

Purpose          Simulation is the objective                 Simulation serves as a research method

Variable           Dependent                                         Independent

Outcome         Improves simulation                          Depends on the study question/objective

Creating a Simulated Environment

Simulation recreates the actual situation and provides an experience that closely mimics the conditions encountered in the real environment. The most important step is carefully designing scenarios that align with the objective. Researchers should ensure the scenarios are realistic and relevant to the skill taught. This helps the participants to immerse themselves in the simulation.

Scenario-based simulation is a structured activity with a timeline of events and clear learning goals that aim to replicate a clinical situation. Since the simulated environment can be standardized, simulation is a robust research methodology for studying clinically relevant issues in a controlled manner. Unlike in the actual clinical setting where all these elements would be variables, they are precisely controlled in the simulated environment.

The difference between the simulated and real environments is the absence of real human subjects. However, “standardized subjects” are recruited to perform role play using simulation. These individuals are carefully coached to present their illnesses in a standardized way. Standardized patient rooms can be incorporated into simulation centers to improve fidelity.

Virtual models created by software can be used for teaching research. These can be customized to meet the needs and experiences of learners. Also, these can be adapted, allowing them to interact with the simulation. This is especially well-suited to conduct research that is difficult to accomplish in a real clinical environment.{13}

Simulation research can help determine what works best for training purposes. Additional benefits include research regarding patient outcomes, improving safe health delivery practices, and error reduction.{14,15} This can further the analysis of system issues that yield successful outcomes or result in failure.

Teaching the Research Process

Simulation is used to study clinical settings. It helps to facilitate controlled studies, which expose one group but not the other(s) to intervention. Simulation can be used to learn about implementing new processes or protocols. In that sense, it can be applied to teach the research process. It can study human factors and improve knowledge of human error and system performance. We believe it can enhance work systems in an organized manner by helping to identify and remove systemic sources of error.

Simulation in the research context provides clarity and improves participation in the research process. Research process integrity depends on the planning and organization of the process. The institutional review board (IRB) for a study site oversees all research activities involving human subjects and monitors regulatory compliance. The board’s primary responsibility is to protect the rights and welfare of human subjects. Studies have shown that IRBs operate at different levels of efficiency, and decisions made by IRBs and their members may not always be in accord with regulatory guidance.{16} Simulation can also assess the consistency of IRB decisions and help to identify latent issues.

A simulation environment allows for uncovering latent errors, especially under extreme circumstances and unexpected outcomes. Early research efforts justify simulation as a modality for teaching multiple aspects of research{17} (see Table 3).

 

Table 3: Required Elements of the Research Enrollment Process
                                                                                                                                                           

Objective and Purpose of the Research

Research Design and Methods

Study Procedures

Recruitment of Subjects

Informed Consent Process

Adequate Protection of Human Subjects

Risks/Benefits Assessment

Privacy and Data Confidentiality (Health Insurance Portability and Accountability Act’s Privacy Rule outlines individuals’ rights regarding their protected health information)

Regulatory Compliance and Record-Keeping
                                                                                                                                                             

 

In recent years, simulation has been used to retest clinical randomized trial hypotheses. This repeated the clinical trial in a simulated environment. The purpose is to determine whether the conclusion will remain the same as that of the clinical trial.{18} Computer simulation of clinical trials has been used to improve the drug development process.{19}

Teaching the Consent Process

Simulation can be used to teach about the informed consent process. An informed consent is necessary for the successful conduct of a research project. It takes some time before one becomes competent and comfortable with this process, and this is a risk-free way to iron out the kinks before approaching real human subjects.

Human subjects must enter the study voluntarily, with sufficient information and adequate understanding (see Table 4). The consent process and associated concepts can be taught and practiced using simulation. Informed consent is an essential ethical safeguard, ensuring prospective subjects fully understand any research protocol’s study procedures, risks, and benefits. It is not merely a form that is signed and documented. It is a process in which the subject understands the research and its risks. The voluntary expression of consent and adequate information disclosure about the research procedure are essential to the informed consent process.

 

Table 4: Core Elements of Consent Process
                                                                                                                                                           

Adequate disclosure of information

Comprehension and understanding

Voluntary participation

Informed decision-making without undue influence
                                                                                                                                                           

 

The consent process uses simulation with volunteers (simulated research participants) by role-playing. A checklist can be used to identify the essential elements of informed consent (see Table 5).

 

Table 5: Informed Consent Checklist
                                                                                                                                                           

Research and experimental status

Purpose of the research

Expected duration of the subject’s participation

Procedures to be followed and identify any experimental procedures

Foreseeable risks or discomforts to the subject

Benefits to the subject or others that may be expected from the research

Disclosure of appropriate alternative procedures and treatment

Extent of confidentiality maintenance

Identification of contact person

A statement that their participation is voluntary, refusal to participate will involve no penalty, and they can withdraw at any time

Additional costs to subjects or compensation paid (if any)
                                                                                                                                                           

Electronic informed consent (eIC) creates opportunities to improve the consenting process.{20} This format improves participants’ engagement and enhances their understanding.{21} Computer-based platforms with audio-visual and interactive features are available. It is much more than obtaining a subject’s signature; it’s a process by which participants understand the study and its risks. The research team must assess the subject’s understanding of the information presented during the eIC process. This should allow adequate opportunity to ask questions and consider whether to participate.

The aforementioned Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a required component that operates in tandem with the consent process. It is a federal law that requires the development of national standards to keep sensitive, protected health information (PHI) from being disclosed without a patient’s consent or knowledge. The HIPAA Privacy Rule was issued by the U.S. Department of Health and Human Services to implement the requirements of HIPAA. It establishes the conditions under which covered entities may use or disclose PHI for research purposes. It also defines how individuals will be informed of the uses and disclosures of their medical information for research purposes. Its implementation is imperative as we engage in more complex research, particularly genetic testing. Periodic monitoring to assess safeguards protecting PHI is essential. Simulation exercises can be used to achieve this goal.

Some limitations must be recognized. Although it may be helpful in research, this analogy may not work for everyone as a person’s way of learning may vary. One potential disadvantage of using simulation as a research method is becoming overwhelmed by technology, assuming that simulation almost always involves technology. Also, simulation research assesses outcomes in simulated environments. It remains to be seen how findings in simulated environments will translate into the real-world environment.

Conclusions

Simulation is a beneficial but rarely employed research strategy. The current use of simulation in healthcare hasn’t reached its full potential. We need to explore its potential applicability further to make it more effective.

Moving simulation research forward requires thoughtful planning and organization. This modality is well-suited for conducting research that is difficult to achieve in a real-world environment. It can contribute to a better understanding of how simulation can provide education regarding research principles in a clinical work environment. Given the multiple and diverse uses for simulation, it is essential to expand its implementation Furthermore, research can be advanced by embracing simulation‐based training.

References

1. https://simulatinghealthcare.net/2023/08/24/what-is-simulation-the-question-that-caught-me-off-guard/
2. McGaghie WC, Issenberg SB, Cohen ER, Barsuk J, Wayne D. 2011. Does simulation-based medical education with deliberate practice yield better results than traditional clinical education? A meta-analytic comparative review of the evidence. Acad Med 86:706–11.
3. Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. 2011. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA 306(9):978–88.
4. Reznek M, Smith-Coggins R, Howard S, Kiran K, Harter P, Sowb Y, Gaba D, Krummel T. 2003. Emergency medicine crisis resource management (EMCRM): pilot study of a simulation-based crisis management course for emergency medicine. Acad Emerg Med 10(4):386–9.
5. Lateef F. 2010. Simulation-based learning: Just like the real thing. J Emerg Trauma Shock 3(4):348–52.
6. Gaba DM. 2004. The future vision of simulation in health care. Qual Saf Health Care 13(Suppl 1):i2–10.
7. Datta R, Upadhyay K, Jaideep C. 2012. Simulation and its role in medical education. Med J Armed Forces India 68(2):167–72.
8. Crawford CL, Lopez CM. 2014. The research process and simulation in nursing: what it is and what it is not. J Nurses Prof Dev 30(3):127–33.
9. Anton N, Calhoun AC, Stefanidis D. 2022. Current Research Priorities in Healthcare Simulation: Results of a Delphi Survey. Simul Healthc 17(1):e1–7.
10. Cheng A, Kessler D, Mackinnon R, Chang TP, Nadkarni VM, Hunt EA, Duval-Arnould J, Lin Y, Cook DA, Pusic M, Hui J, Moher D, Egger M, Auerbach M. 2016. Reporting guidelines for health care simulation research: extensions to the CONSORT and STROBE statements. Simul Healthc 11(4)238–48. https://pubmed.ncbi.nlm.nih.gov/27465839/
11. Cook DA, Hamstra SJ, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hatala R. 2013. Comparative effectiveness of instructional design features in simulation-based education: systematic review and meta-analysis. Med Teach 35(1):e867–98.
12. LeBlanc VR, Manser T, Weinger MB, et al. 2011. The study of factors affecting human and systems performance in healthcare using simulation. Simul Healthc 6:S24–9.
13. Cheng A, Auerbach M, Hunt EA, Chang TP, Pusic M, Nadkarni V, Kessler D. 2014. Designing and conducting simulation-based research. Pediatrics 133(6):1091–101.
14. Radhakrishnan K, Roche JP, Cunningham H. 2007. Measuring clinical practice parameters with human patient simulation: a pilot study. Int J Nurs Educ Scholarsh 4:Article 8.
15. Brazil V, Purdy EI, Bajaj K. 2019. Connecting simulation and quality improvement: how can healthcare simulation really improve patient care? BMJ Qual Saf 28(11):862–5.
16. Silberman G, Kahn KL. 2011. Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform. Milbank Q 89(4):599–627.
17. Eppich W, Reedy G. 2022. Advancing healthcare simulation research: innovations in theory, methodology, and method. Adv Simul 7(1):23.
18. Alan F. Merry, Jacqueline A. Hannam, Craig S. Webster, Kylie-Ellen Edwards, Jane Torrie, Chris Frampton, Daniel W. Wheeler, Arun K. Gupta, Ravi P. Mahajan, Rachel Evley, Jennifer M. Weller. 2017. Retesting the Hypothesis of a Clinical Randomized Controlled Trial in a Simulation Environment to Validate Anesthesia Simulation in Error Research (the VASER Study). Anesthesiology 126:472–81.
19. Holford NH, Kimko HC, Monteleone JP, Peck CC. 2000. Simulation of clinical trials. Annu Rev Pharmacol Toxicol 40:209–34.
20. Chimonas S, Lipitz-Snyderman A, Matsoukas K, Kuperman G. 2023. Electronic consent in clinical care: an international scoping review. BMJ Health Care Inform 30(1):e100726.
21. Robins D, Brody R, Parvanova I, Finkelstein J. 2021. Cognitive Testing of an Electronic Consent Platform: Researcher Perspectives. Stud Health Technol Inform 284:457–62.

Muhammad Waseem, MBBS, MS, FAAP, FACEP, FAHA, FSSH, is a Professor at Weill Cornell Medicine and an Attending Physician and Research Director for Emergency Medicine at Lincoln Medical & Mental Health Center, where he is also Vice Chair of the Institutional Review Board. Among other organizations, he is active with the Society for Simulation in Healthcare, Public Responsibility in Medicine and Research, the American College of Emergency Physicians, American Academy of Pediatrics, and the American Heart Association.