Does simulation suffice? Teaching procedural skills in undergraduate medical students- observational quasi-experimental study. CURRENT

Background . Medical simulation as a teaching method is concerned with close mirroring of the real clinical conditions, it is designed to develop skills from the clinical environment, under the guidance of experienced instructors, it allows standardization and repeatability of the skills taught. As a result, students acquire skills and competences, become acquainted with the medical equipment needed to perform a given procedure without endangering patients. The presented research attempts to evaluate the application of medical simulation techniques in the teaching of basic clinical skills using original instructional videos and the Peyton approach. Also, an attempt was made to assess how the applied interventions affect the assessment regarding the usefulness of the course by the students of medicine in comparison with the results of practical assessment in the form of OSCE. Materials . The research was conducted in the period from May 2015 to June 2017, among 750 students of the medical faculty of the Medical University in Lublin. The study used a self-reported questionnaire and documentation analysis with the results of practical assessment. The obtained results were statistically analyzed. Results . The overall students scored the BCS course high (good and very good). The highest values were assigned to Stage III of the research. The introduction of simulation techniques along with the original instructional videos and the Peyton approach positively reflected in the results obtained in the final assessment, OSCE, especially in case of invasive procedures: peripheral vein cannulation and urinary bladder catheterization. Conclusions. Consequently, obtained results allowed concluding that the use of medical simulation techniques in the teaching of basic clinical skills using modern methodologies and teaching interventions: original instructional videos and the Peyton approach affected the positive assessment of the usefulness of the simulation course by students, as well as improve and support the process of acquiring basic skills clinical in the early years of medical training.

process of ensuring patient safety, education, and training of healthcare professionals at all levels of education remain a crucial issue. The teaching methods used remain a very important element of the training process, both in terms of acquired skills, knowledge and acquired competencies (3) Continuous development and introduction of new didactic methods (e.g., medical simulation, virtual patients) to the training of medical personnel should improve the training environment and the effectiveness of the education process. It seems that medical simulation can help participants better understand and practice skills that will later be used to save patients' lives and improve their care (4,5).
On the other hand, rapid technological development and the introduction of advanced educational devices do not always improve the quality of education (6). Repeatedly, expensive technology without relying on its adaptation curricula does not meet the expectations of either educators nor learners themselves. Technology becomes only sophisticated toys in the form of advanced simulators (7)(8)(9).
Published research confirms that simple trainers used as teaching aids can help reproduce simple clinical situations that will better prepare medical staff to perform their duties at the patient's bedside. The use of training tools in the form of low fidelity simulations enables learning in a safe environment (10)(11)(12). However, their proper use during the educational process requires not only the right equipment but above all, the implementation of the appropriate skills (3,(13)(14)(15). Moreover, the complexity of the simulation technology used should be adapted to the current level of skills, knowledge, and experience of students to meet the educational requirements and achieve the objectives set (16). These tools should be used appropriately and gradually so as not to discourage or demotivate inexperienced students concerning this form of training in the future (11,17,18).
The correct allocation and use of financial resources is a critical aspect raised increasingly in the environment of medical educators. This issue is particularly important when introducing expensive devices during simulation, especially the so-called high fidelity equipment. The financial aspect is especially important considering that the cost of an interactive patient simulator can be up to PLN 1,000,000 and often requires a dedicated space and trained staff to support it, by ensuring its proper use during the teaching process.
Published studies prove the effectiveness of training with the use of simple task trainers in the process of teaching specific psychomotor skills (19,20). In 2014, at the request of the Ministry of Health of Poland, a document entitled "Centers of Interdisciplinary Medical Education," based on which a standard for teaching based on medical simulation in Poland was developed. The presented document contained recommendations for creating technical and procedural skill rooms at Polish medical universities for faculties financed by the project support by the Ministry of Health as part of the POWER program (medical, dental, obstetrics and nursing)(21). Since the rules and teaching and assessment methods have not been specified in detail, as well as the correct selection of teaching and assessment methods in the context of procedural methods is an important research issue. Dr. David Gaby described simulation as a technique, not a technology (22). Therefore, simulation requires extensive planning in the educational process, not only the introduction of the equipment itself.
In the presented work, we evaluate the use of medical simulation techniques in teaching basic clinical skills accompanied by original instructional videos and Peyton's four-step approach by assessing how the used interventions affected the students' subjective assessment compared to the results of practical assessment in the form of Objective Structured Clinical Examination.

Methods
This study was reviewed and approved by the local ethical committee (KE-0254/309/2015), which granted its acceptance of our study.

Participants
The sample population consisted of 806 first-, second-and fourth-year medical students enrolled in The study scheme is presented in Figure 1.

Research instruments
The research method was a diagnostic survey, and the tools -an original questionnaire and analysis of the practical final examination results of basic clinical skills.
Subjective feedback was collected using an original questionnaire with a five-point Likert scale (1)(2)(3)(4)(5) with the following answering format: Similarly, the third educational intervention in 2017, when the Peyton approach was introduced to the methodology of BSC laboratories, included questions on the opinion on the original instructional videos, the general course assessment, and its content. Three sociodemographic questions also were incorporated: age, year of study, and place of residence.
The research also analyzed documentation from practical exams OSCE carried out at the end of the course Basic Clinical Skills in 2015, 2016, and 2017. Data from the examination documentation were selected and used for this work.
The data included the content of checklists used during the OSCE: the total score of students from each of the five OSCE examination stations, individual results of students from each of the five OSCE examination stations.

Statistical analyses
Data obtained from the examination documentation and questionnaires were collected in the Descriptive and inferential statistical analyses were employed, depending on the variables tested.
Significance tests were completed to examine the relationships between variables.
To study the differences between the two groups, the Student t-test was used for dependent samples as well as non-parametric tests for variable related tests (Wilcoxon test) and independent (Mann Whitney test). The χ² test was used to assess the significant relationships between the analyzed qualitative variables. When the number of rows was not greater or equal to five in each cell of the Logistic regression analysis investigated the impact of one variable on the other.
P-values less than 0.05 were considered as statistically significant.
The values of the analyzed qualitative data from the open responses were examined by the authors using a thematic analysis method to identify emerging themes. The study employed two coding strategies: a priori and a posteriori categorization of data. A priori coding focused on developing appropriate categories. A posteriori coding refers to developing categories based on the received data (23).

Course Goal, Learning Objectives, Learning Method, and Activities
Due to guidelines aimed at reducing the number of medical errors in invasive procedures, medical curricula are seeking ways to assist their students with mastering them through medical simulation (24).
The overall purpose of the course (in all three editions) was to help students acquire a deeper understanding and ability to perform most commonly performed basic procedural skills.
The implemented on the task simulators ensuring the repetitiveness of the procedure, using online resources. BCS was implemented in the summer semester, just before students began nursing holiday clerkship. Assigned learning objectives were extracted from the Polish national regulation on teaching standards in the fields of medicine, dentistry, nursing, and obstetrics (25). Classes were conducted in groups of five by an interprofessional and interdisciplinary team of academic teachers with a minimum of 2-semester experience. Each year, the course coordinator organized a 3-hour training course to prepare for conducting laboratories to ensure teaching standardization. In the next stage, the instructors were trained by the technical team to use the appropriate task trainers.

BSC 2015
The first educational interventions in the form of teaching using medical simulation techniques were introduced for second-year medical students, the 2013-2019 study program ( Figure 2).

BCS 2016
Subsequent educational intervention introduced into the structure of the BCS course based on

BSC 2017
The next educational intervention modified the teaching methodology of the BCS course by introducing the Peyton's approach, i.e., four-step methods: demonstration, deconstruction, comprehension, practice (26) in an academic semetre 2017/2018 ( Figure 4).

Objective Structured Clinical Examination
The Objective Structured Clinical Examination was implemented at the end of the course, to provide an objective assessment of the skills acquired as it was found to be a reliable tool in assessing technical skills (27).
A division into five OSCE stations was introduced: auscultation of the heart and pulse rate, noninvasive blood pressure measurement, peripheral vein cannulation, urinary bladder catheterization and per rectum examination in the first stage of the examination, and intramuscular injection in the second and third stage instead of DRE with an adequate checklist for each station. The stations are described in the OSCE blueprint (Appendix 1).
To build a reliable assessment tool covering a range of basic clinical skills that were considered crucial for nursing clerkship, the OSCE scope was assembled using the Delphi method. Constructing This process was intended to ensure that the tasks were appropriate to the student syllabus and whether they rated/checked what we wanted to assess with proper accuracy (its reliability). The panel of experts also assessed the consistency of the checklists used (28,29).
Each consecutive year, teachers leading the assessment, as well as educationalists, analysed used binary checklists and submitted requested changes or modifications to the OSCE coordinator.

Results
The study results were allocated in two groups: 1) results from student scores of the summative final examinations OSCE, 2) results from the analysis of the survey questionnaires including students' perspectives on the overall course assessment in all three stages of the research as well as the students' perspectives concerning the substantial value of BCS course.

Participants
Seven hundred fifty medical students of MUL returned filled opinion questionnaires (93%). The four student populations did not differ significantly in the ratio of men to women. However, a statistically significant difference was noticed in terms of age. Details are presented in Table 1.

Final OSCE Scores
Results   Table 2.

Subjective opinions of the participating medical students
When analyzing results of the students' assessment concerning the BCS course (1-5 on Likert scale) between the groups from the three stages of the research, a persistent high percentage of positive evaluations expressed by medical students at all stages of the study is visible . In all four cohorts, at least 90% of respondents rated the course good or very good (4 or 5 on the Likert scale). There is a slight increase visible from 96% in Stage I to 98% in both groups in Stage III of the research ( Figure   6).
Additionally, we investigated the relationship between variables the overall subjective assessment of the BCS course and its substantive value scored by all the study respondents. In the case of the first edition of the course (Stage I, solely low fidelity simulation), the correlation was characterized by an average level as it was in the range of 0.3 <= r <0.5, nevertheless it was still statistically significant (p <0.05). Similar strength of correlation was noted in Stage III, both groups, average but statistically significant. However, in the second edition of BCS course (Stage II with original instructional video) was high, in the range of 0.5 <= R <0.7 and was statistically significant (p <0.05). Details are presented in Table 3.
Linear regression examined the relationship between BCS subjective assessment and the overall results of the OSCE. No linear relationship was detected with regards to these two variables in any of the groups studied. Details are presented in Table 4.
As a result of our investigation, the model of care concerning simulation teaching in medical education has been formulated. The model adhered to the theory of constructive alignment and starts with formulating appropriate learning objectives by the teachers based on their knowledge and experience. When the content of the course is known, a process of identifying appropriate teaching methods is implemented. The next step is concerned with designing suitable assessment, adhering to the learning objectives and teaching methods. In accordance with the theory of constructive alignment: the assessment was to support learning, and to reflect the implemented teaching methodology (63). Afterward, those elements are opinionated by the teachers and students to introduce necessary adjustments and modifications to increase the quality of learning process when it is next delivered. The process is presented on Figure 7. simulation-based flipped classroom approach is one to advance laparoscopic intracorporeal knot-tying skill acquisition in medical students (34).

Discussion
Another concept that has emerged over the past few years and relates to the methodological framework employed in our BCS course is blended learning. This approach relates to the combination of multimedia resources with face-to-face teaching (36). Blended learning postulates a link between video-based teaching and other methodological methods and means, using both online and face-toface communication to provide participants with beneficial learning experiences and relevant outcomes as a result of these classes (37). Introduced BCS course was designed to combine the use of medical simulation techniques, exercises in small groups, video demonstrations, and Peyton's fourstep approach as well as online resources in its final form. Blended learning was an underlying framework in that process. Instructional videos themselves are placed within the cognitive theory of multimedia learning framework, documented as influential in terms of raising student motivation and improving their learning outcomes. This theory is based on three principles: 1) the existence of two different channels for processing visual and verbal stimuli; 2) each channel is characterized by limited capacity and a limited amount of information to be processed at once; 3) active processing is essential for learning to take place. These three stages concerned with choosing, organizing, and integrating information between those channels function as follows: students select the appropriate sounds, words, and images to be processed; afterward, they systematize them into a "mental model," i.e., they learn.
Later, learners integrate it with their previous knowledge. So learning occurs through appropriate involvement in these three processes. For learning to happen, we must not only store knowledge in our long-term memory but be able to retrieve and employ it (31,40). Mayer proved that the cognitive theory of multimedia learning resulted in the best results in students with low knowledge (41). Hence, novice undergraduate medical students from our research seem to be an ideal target group; and they confirmed that fact by assessing the course with original instructional videos positively (Me= 4 and 5).
BCS course was also an opportunity to practice invasive skills in a safe environment, ensuring repeatability and learning from your mistakes. Participants expressed their satisfaction with its format, assessing the positively overall idea of the course, as well as its substantive value. Even teaching (47). BCS course preceded nursing practices, during which students had the opportunity to prepare for the clinical environment in conditions similar to them. Through immersion in a simulated clinical environment during students' performance of the taught procedures, participants practiced in conditions corresponding to the real ones. Without causing harm and pain, medical students could implement basic clinical procedures, step by step, acquaint themselves with the necessary equipment, and the correct method of operating this equipment (48). In the studies of other authors, the importance of these issues has been growing with decreasing acceptance of making mistakes while performing these procedures on patients (49,50).
Similarly, introducing Peyton four-step approach adheres to the AAMC Recommendations on teaching procedural skills. This document emphasizes the patient's centered approach associated with practicing the entire procedure, step by step, just like with a real patient in a clinical setting. What is more, the experience is also student-centered, as each participant practices the procedure as many times as required by mastering it in an interactive environment (47).
When analyzing obtained data, an increase in overall results of OSCE the Stage III is visible, compared to Stage I and Stage II. However, there is noticeable a significant increase in pass rates in invasive procedures: peripheral vein cannulation and urinary bladder catheterization. That effect was achieved in the group taught in our study with all three interventions (low fidelity simulation, original instructional videos, and Peyton's four-step approach. Their improvement was noticeable when performing urinary catheterization and peripheral vein cannulation, the two-invasive procedure prone to errors when performed in a clinical environment, as well as causing amplified discomfort when inappropriately implemented (51,52). Body of evidence outlined a prove concerning the usefulness of instructional videos in teaching urinary bladder catheterization procedure ((46) and Peyton's four-step approach in teaching peripheral vein cannulation (26). Nevertheless, a combination of both is a novelty in those procedures.
What is essential, employed educational interventions did not require any modification in the time devoted to laboratories or additional financial input (53). All groups had five sessions, 135 minutes each. There was no increase in student to educator ratio. The learning experience was effective as it was high in active practice, but not generating additional cost. That cost-effectiveness is a crucial factor in determining modification in medical curricula (54). That cost-effectiveness also sought to correspond to results in reducing the number of medical errors (55,56).
Three implemented educational intervention possess some limitations, reported in the literature. The absence of changing conditions can be used as a counterargument to the benefits of low fidelity simulations (6,11,57). Whereas, in the case of instructional videos, there is research that found no correlation between the introduction of the instructional videos themselves during the courses and improving the results during the exam (58)(59)(60). Similarly, the implementation of the Peyton four-step approach showed a lack of improvement in taught skills (61,62). However, this research included individual educational intervention, not supported by other teaching methods.

Limitations
The following limitations apply to our research. Firstly: we implemented the study with a cohort of medical students from one institution. Their particular level of training and education might have affected the results in a different way than an assessment of medical professionals would have had.
There was no randomization of the procedure, as they were implemented in a course embedded in the curriculum. Also, course assessment and its substantial value were self-rated; this may have played a role.

Conclusions
The

Consent for publication
The authors consent to the publishing of the article in BMC Education.
Availability of data and material The study datasets are available from the corresponding author on reasonable request due to the data protection.
Competing interests: The authors report no financial and non-financial competing interests. The authors alone are responsible for the content and writing of the paper.

Authors' contributions
KT and KN has made substantial contributions to conception and design of the article; KN was involved in acquisition of data; KN was responsible for data analysis and interpretation of data However, it did not play any role in in the design of the study; collection, analysis, or interpretation of data; and in writing the manuscript.  Table 4. Linear regression analysis for overall OSCE results and course evaluation. Figure 1 Scheme of the research.

Figure 2
The structure of the Basic Clinical Skills class in 2015.

Figure 3
The structure of the Basic Clinical Skills class in 2016.

Figure 4
The structure of BSC supplemented with Peyton's approach in 2017.

Figure 5
Results of final OSCE among four groups of participants.  Model of care over the quality of education in the medical simulation environment.