Abstract
Gastrointestinal problems are common and affect quality of life, leading patients to seek treatment. Safe pharmaceutical prescribing and health education are essential to ensure quality healthcare, but require evidence-based training. The aim of this study was to evaluate the development of clinical skills for the management of five gastrointestinal issues by pharmacists and students in a training course. This is a quasi-experimental study carried out with participants in a minor illness scheme training course. The course included classes with specialists, theoretical assessments and initial and final practical simulations. After applying the eligibility criteria, 17 participants were selected for the study. In the knowledge analysis, the topics that progressed the most were diarrhea and nausea and vomiting, in which the participants' confidence level increased significantly in the final evaluations. In addition, in the behavioral analysis there was a 70% progression, with better scores for diarrhea and aphthous stomatitis. The clinical guidelines-based course proved to be a viable strategy for promoting knowledge and confidence in the management of gastrointestinal problems. Researchers can comprehensively explore the domains involved in the formation of competencies and skills necessary for clinical practice.
Keywords:
Evidence-based pharmacy practice; Professional training; Gastrointestinal tract; Education; Pharmacy; Simulation training.
INTRODUCTION
Gastrointestinal problems are common public health issues, negatively impacting patients' quality of life. Patients often turn to community pharmacies in search of treatment, either by purchasing overthe-counter (OTC) drugs or receiving advice from pharmacists. Educational interventions carried out by these professionals have had an impact on improving gastrointestinal symptoms, mainly by promoting healthy lifestyle habits (Ababei et al., 2021; Puig-Moltó et al., 2023; Puig-Moltó et al., 2024).
Due to their widespread presence and convenient access, community pharmacies play a crucial role, often serving as the initial source of healthcare for patients (Amador-Fernández et al., 2022; Owczarek et al., 2023; Puig-Moltó et al., 2023; Puig-Moltó et al., 2024).
Over the past few decades, the responsibilities of pharmacists in Brazil have changed considerably, shifting towards patientcentered activities through clinical services. This point is illustrated by the publication of Resolutions 585 and 586 of 2013 by the Federal Pharmacy Council (FPC) and the introduction of Law 13.021 of 2014, which designates pharmacies as a health-related entity. This progress has strengthened the role of pharmacists in the process of caring for and improving health, directly impacting on patients' quality of life (Ababei et al., 2021).
According to Resolution 586/2013 from the FPC, pharmaceutical prescriptions can be used to address patients health needs, relying on up-to-date scientific evidence. In managing gastrointestinal issues, this prescription allows pharmacists to recommend and provide OTC products, contributing to the relief of symptoms and promoting the rational use of medications. Properly prescribing medications and providing health education are crucial components for maintaining patient safety and delivering high-quality care. Research highlights the significant role of pharmacists in the management of gastrointestinal symptoms in community pharmacies. These professionals are also responsible for offering advice, recognizing warning signs and referring patients to other specialists when necessary (Owczarek et al., 2023; Tatarusanu et al., 2021).
Nevertheless, there is growing concern about the unreasonable consumption of medication. Focusing on relieving symptoms without investigating the underlying causes and without encouraging healthier lifestyle changes an prolong gastrointestinal issues and delay the patient's engagement with healthcare services, ultimately jeopardizing effective and safe treatment (Curley et al., 2016; Sihvo, Hemminki, 1999).
To enhance self-care and reduce the risk of inappropriate diagnosis and treatment, the implementation of training programs and clinical guidelines for professionals has been advocated to ensure comprehensive patient care. The use of evidencebased guidelines and adequate training ensures appropriate recommendations for the management of these conditions, potentially reducing the workload and costs in other health services. Continuing education for pharmacists and ongoing professional development for pharmacy students are essential to improve clinical skills, reinforcing the growing role of these professionals in healthcare (Bell et al., 2016; Boura et al., 2023; Curley et al., 2016; Terajima et al., 2020).
Acknowledging the critical role of managing gastrointestinal disorders, this study aims to evaluate the effectiveness of training pharmacists and students to develop clinical skills in the management of heartburn and dyspepsia, constipation, diarrhea, aphthous stomatitis, and nausea and vomiting.
MATERIAL AND METHODS
This is a quasi-experimental, non-randomized study, based on preand post-intervention, conducted from March to July 2024, with pharmacists and pharmacy students from a public university in the Federal District, Brazil. Following the registration of both professionals and students through an electronic registration form published on social media, participants were selected according tocertain inclusion criteria: a) pharmacists with active registration with their professional council; and b) students in the Community Pharmacy internship course at the public university.
The entire course lasted 12 weeks, and encompassed a workload of 80 hours, distributed across face-toface classes, realistic simulations and asynchronous activities. The content covered topics related to the management of self-limiting health issues, including 26 conditions commonly addressed by pharmacists in community pharmacies. For the purposes of this article, activities related to the management of gastrointestinal tract disorders were considered, including conditions such as heartburn and dyspepsia, constipation, diarrhea, aphthous stomatitis, and nausea and vomiting.
To enrich the learning process, participants in the course received clinical guidelines and review activities as teaching material. These guidelines were prepared by professionals from outside the course team for the book Evidence-Based Pharmacy, developed by the Laboratory of Evidence and Pharmaceutical Studies at the University of Brasilia (Santana, Reis, 2025). The methodology of the face-to-face lectures included the presentation of topics, discussions of clinical cases, clarification of doubts and presentation of videos of realistic simulations of standard care.
The requirements for passing the course included the scored earned in the theoretical knowledge assessments, carried out both at the beginning and at the end of the course, as well as the practical simulations of care held at those same intervals. Participants who completed all the course activities and had at least 50% attendance have been approved. The effectiveness of the course was assessed using two levels of Kirkpatrick's model, focusing the levels of learning outcomes and behavioral changes (Smidt et al., 2009).
The participants' comprehension was measured using a theoretical knowledge assessment before and after the course. The questionnaire contained 15 multiplechoice questions with five alternatives each, covering the health conditions discussed in the gastrointestinal tract module. The questions were presented in a clinical case format. The number of questions was set to address the content studied, with three questions for each topic, including possible outcomes of non-pharmacological interventions, pharmacological intervention and referrals. Both the initial and final assessments contained the same questions; however, the order of the questions and the choices provided were changed. In addition, participants did not have access to the template after completing the initial assessment. In both assessments, the participants were allowed a single chance to solve the questions and there was an interval of more than 90 days between the applicationsto reduce the risk of memorization bias, also cited by Santana et al. (2022). Furthermore, at this stage it was also possible to measure the participants' level of confidence about utilizing their knowledge to each disease, whose answers ranged on a Likert scale from 1 (not very confident) to 5 (very confident).
The subsequent stage focused on behavior change, assessing whether the skills acquired by the participants were applied in a visible and measurable way in their professional activities. This competence was assessed through realistic simulations involving course participants and simulated patients. The process includes stages such as receiving the patient, assessment (anamnesis and vital signs), care plan (prevention, nonpharmacological and pharmacological measures, and referral), monitoring of results and communication (verbal and non-verbal). Subsequently, with the recordings of the initial and final simulations, each item was scored independently by three evaluators, who assigned scores from 0 to 2, indicating whether the participant did not perform (0) or performed satisfactorily (2) each aspect. Ultimately, a total score was calculated by adding up the scores, which were classified between 00 and 30 points (evaluation instrument not yet published).
The kappa test was used to assess the level of agreement between the simulation evaluators, aiming to minimize randomness or low consistency in the results (Thompson, Walter, 1988). In the agreement analysis, the evaluators defined a score of 0 as “low”, a score of 1 as “intermediate” and a score of 2 as “high”. The data collected was systematized in an Excel spreadsheet. Statistical analysis was carried out using Jamovi software. The Student's t-test was applied to paired variables to determine whether there was a significant difference between the means of the assessments compared to the simulations.
After the practical simulations, a debriefing session was held with the participants, conducted in a systematic and structured way by the three professors who organized the course and the simulated patient. During this discussion, the participants evaluated their ownperformance during the clinical experience, based on the defined goals, actions and decisions of the group members (Coutinho, Martins, Pereira, 2017). Aspects such as feelings, a summary of the case, actions deemed effective, moments of insecurity, main challenges, strategies that could be improved, lessons learned and other relevant points were considered for this debriefing.
The research was submitted to and approved by the Research Ethics Committee of the Faculty of Health Sciences of the University of Brasília, in accordance with Resolution 466 of December 12, 2012, with approval number 5.171.224. All participants receive an online Free and Informed Consent Form to read and agree to take part in the research. Personal data collected was kept confidential and destroyed after the end of the study. The study was registered with the Brazilian Registry of Clinical Trials under the number RBR-6x8bx3y.
RESULTS
A total of 20 individuals agreed to participate in the module on the gastrointestinal tract. After applying the eligibility criteria, 17 participants were selected for the study. Two of the 20 participants did not respond to the final evaluation, and one did not complete the final simulation, which resulted in his exclusion from the study. The final sample consisted of 13 pharmacy students and four pharmacists, 88.2% of whom were female.
Learning analysis
The learning analysis was conducted with the participants who had completed the initial and final knowledge assessments. By calculating the percentage of correct answers per question and then per topic, we could obtain the average percentage of correct answers for each topic, as shown in Table I.
An analysis of the participants' performance shows that the issue with the highest percentages of progression were diarrhea, and nausea and vomiting. In contrast, heartburn and dyspepsia showed no improvement. The progression of aphthous stomatitis was positive, yet it marked the smallest increase in relation to the other topics, implying an improvement, but not as significant as in other categories.
The participants' confidence levels were assessed at the beginning and end of the course for the five specific topics. The percentages of participants who still felt unconfident/weakly confident/moderately confident, as well as confident/very confident, are shown in Table II.
Behavior analysis
The kappa statistic calculated after the simulation evaluation round was 0.518 for the initial simulations and 0.412 for the final simulations, corresponding to a moderate level of agreement. In the analysis of behavior, by means of realistic simulations, the overall average for all the themes rose from 10.3 to 17.6, representing an increase of approximately 70%. In the initial simulation, participants had average competency scores ranging from initial to intermediate, with values ranging from 8.4 for constipation to 12.2 for heartburn and dyspepsia. In the final simulation, the scores 11.2 for constipation to 23.0 for aphthous stomatitis, as reflected a significant advance in skills, ranging from shown in Table III.
To assess the progression of the simulations, researchers employed a t-test for paired samples, which compared the mean scores of all the initial and final simulations of all the subjects. The test revealed a statistically significant difference between the simulations, with Student's t-value = -6.35 and p-value = <.001. This result suggests that the training program positively influenced the participants' behavioral skills, as evidenced by their enhanced scores in simulations.
DISCUSSION
The results of this study indicate that, after the training course, there was an increase in the participants' level of knowledge and clinical skills. This progress was evidenced by the increase in evaluation rates, simulations and confidence, resulting in improved performance percentages. A significant challenge faced by pharmaceutical professionals is a lack of technical knowledge, which adversely impacts the quality of patient counseling. These limitations emphasize the need for a critical analysis of the adaptation of educational methods to improve pharmaceutical care (Packeiser, Castro, 2020).
Implementing clinical guidelines is an important strategy to standardize and enhance the quality of pharmaceutical advice (Amador-Fernández et al., 2022). Running the course based on these guidelines was key to strengthening the healthcare plan. Insufficient clinical training is a significant barrier to provide services for managing self-limiting health issues, and training can fill the gaps in knowledge and skills necessary for effectively service delivery (Ayele et al., 2018).
A systematic review by Obreli-Neto et al. (2016) considered the effects of continuing education programs on the delivery of clinical services in community pharmacy settings. The analysis revealed that although there is no clear evidence on which continuing education methods are most effective, the majority of programs were effective for the outcomes studied, including live classes, simulated patient visits and direct observation. The authors suggest that Kirkpatrick's model may be a viable alternative for standardizing outcome measures and improving program evaluation (Obreli-Neto et al., 2016b).
Similar to our study, a clinical trial conducted with pharmacists looked into the effectiveness of a distance continuing education program in the management of self-limiting health problems in community pharmacy environments. The findings indicated a significant increase in learning and practice scores, demonstrating the importance of developing and evaluating new educational tools to improve patient care (Nguyen et al., 2018; Obreli-Neto et al., 2016a).
Regarding the level of knowledge and trust, a study conducted by Peletidi and Kayyali (2022) showed similar results to ours. That study showed that the training had a statistically significant effect on increasing the participants' level of knowledge and confidence after the intervention. Similar to our research, they used the same evaluation questionnaire before and after training to check progression, confirming an overall positive impact of training (Peletidi, Kayyali, 2022). The study of Santana et al. (2022) also showed the positive impact of a training course for pharmacy assistants, with a significant increase in final evaluation scores.
To achieve these goals, it is essential that the education of healthcare professionals is aligned with practical realities and that continuous learning is encouraged. This not only improves professionals' knowledge, but also increases their confidence, enhances relationships with patients and the quality of care, strengthening the pharmacist's role in public health (Bertolin, Cordeiro, 2022; Crespo-Gonzalez et al., 2022; Lorenzoni et al., 2021).
Given that most of our participants were students, it is crucial that pharmacy curricula provide adequate training and opportunities to prepare them for patient care, which is consistent with the study of Blakely and Ekong (2021), This study reveals that practical training and experiences in care transitions can increase pharmacy students' confidence and readiness to offer effective guidance in their future professional workplaces.
Learning analysis
George Miller has developed an assessment model for teaching in the health professions that highlights the importance of assessing practical skills and competencies, alongside theoretical knowledge. This model suggests that professional practice, or “doing”, is based on “knowing how to do”, which in turn is based on theoretical knowledge, or “knowing”. In order to qualify for professional practice, during their training, students must demonstrate that they have mastered the necessary skills and competencies. This is what Miller describes as “showing how to do it”. In our assessment, which used clinical cases, we focused on the two basic levels of Miller's Pyramid: “knowing” and “knowing how to do”. The participants demonstrated their ability to understand, interpret and solve the cases presented, which reflected common occurrences in community pharmacy settings (Miller, 1990; Panúncio-Pinto, Troncon, 2014).
The conditions that showed the greatest progress in the evaluation were diarrhea and nausea and vomiting, indicating a significant increase in knowledge about the management of these issues. This outcome can be attributed to the greater frequency of these cases in the participants' daily practice, in which the high prevalence of diarrhea and the underlying causes of nausea and vomiting explain the need for constant management of these problems. These cases are commonly observed in everyday life, both of which require careful advice on preventing dehydration, in which the pharmacist plays a decisive role (Farthing et al., 2013; Olden, Chepyala, 2008).
Conversely, the results of the assessments of aphthous stomatitis and heartburn and dyspepsia showed a reduced rate of progress. This lower performance may have been influenced by the complexity of the topics, the similarity of their symptoms with various disorders and their recurrence, which complicates the precise management of these problems (Armstrong, Nakhla, 2016).
An overall average score increase of around 22% suggests a positive impact of the training module, reflecting the improvement in participants' knowledge, which should translate into better patient care. To improve future training, it might be beneficial to focus on the conditions that showed the least progress and consider more interactive teaching-learning strategies in the classes on the topics (Freitas et al., 2016; Roman et al., 2017).
The result of the analysis of the participants' confidence level demonstrates a significant positive impact of the participants in managing the different gastrointestinal conditions. These results support similar findings by Lahrman et al. (2019) in the increase of participants' confidence level after the training program. These data highlight the importance of well-structured educational initiatives to develop professionals, resulting in improved patient care (Lahrman et al., 2019).
Nakhla, Houle and Taylor (2024) conducted a study in two Canadian provinces to assess the degree of confidence pharmacists have when dealing with heartburn management. The results showed that pharmacists' confidence ranged from moderate to high. The study also revealed that as confidence decreases, referral rates to other health professionals increase, which aligns with the results of this investigation (Nakhla, Houle, Taylor, 2024).
On the other hand, the Marklund et al. (2003) demonstrated the effectiveness of training based on clinical guidelines for the management of dyspepsia among pharmacists. The qualified pharmacists provided safe and appropriate advice, including referrals when necessary. In 90% of the cases referred, it was found that the patients actually require a medical examination and/ or medication, confirming the appropriateness of the pharmacists' recommendations. These findings highlight the crucial role of pharmacists and the importance of clinical guidelines to ensure the appropriate use of services in community pharmacies (Marklund et al., 2003). A different investigation conducted in Swedish pharmacies, for example, found that using clinical guidelines as a national standard resulted in high-quality referrals and better counselingself-care strategies for patients (Westerlund, Andersson, Marklund, 2007).
Behavior analysis
The second part of this study covered the third level of Miller's pyramid, in which simulations allow to evaluate the know-how of participants. This methodology facilitates the identification of areas that need to be improved, enhancing skills and knowledge and preparing professionals more efficiently for their practice (Roman et al., 2017). The implementation of this stage resulted in a progression of 70% in clinical skills and understanding.
The statistical analyses indicated improvements with a positive and measurable impact on the simulations. However, the variation in the percentages of progress between the different problems suggests that some of the content could be enhanced. Participation in the debriefing enriched the experiences lived, as this moment can increase trust, develop supportive relationships, identify difficulties in actions and improve emotional management skills (Costa et al., 2020).
Although we didn't measure the impact of debriefing on participants after the practical simulations, this method stimulates reflective thinking, helping to improve self-assessment and feedback skills (Olaussen, Heggdal, Tvedt, 2020; Coutinho, Martins, Pereira, 2017).
Coutinho, Martins and Pereira (2017) evaluated the impact of debriefing with simulated practice, revealing that the experimental group achieved significantly higher averages compared to the control group. These results suggest that there is a positive impact on the development of students' skills, addressing the psychosocial, cognitive and affective dimensions, as well as positively influencing the results associated with the practice.
Our results corroborate Omer´s (2016) investigation involving nurses, which demonstrated that learning through practical simulations increased the participants' confidence. This confidence translated into the ability to recognize signs and symptoms of diseases, as well as the execution of tasks necessary for clinical practice. Although realistic simulation has proven to be an effective learning strategy, they cannot substitute for real-life practical experience and should be used alongside with suchexperiences (Omer, 2016).
This study reveals a few shortcomings. First, the sample size was small and there was a reduction in the number of participants, which might jeopardize the generalization of the data. Moreover, it was not possible to collect information on how satisfied participants were with the course, nor to evaluate the impacts and outcomes that the course provided in clinical practice, which correspond to levels 1 and 4 of the Kirkpatrick model, respectively.
CONCLUSION
The educational approach centered around clinical guidelines proved to be an effective method, facilitating the advancement of participants' understanding and behavior in handling five gastrointestinal issues. The learning increased the participants' confidence in the practical application of the content, which can be reproduced in clinical practice in the area of expertise. Practical learning produces more effective results, being an important strategy to be incorporated into undergraduate curricula and training courses. Extending its reach to other areas of pharmaceutical practice can also be beneficial.
It is not possible to claim that learning and performance in simulated activities alone are sufficient to change participants' behavior in their professional routine. It emphasizes the need for other studies that comprehensively explore the domains involved in the development of competencies and skills for clinical practice. Therefore, it is important to investigate educational approaches that can contribute to a more comprehensive and effective training.
ACKNOWLEDGMENTS
We express our gratitude to the Coordination for the Improvement of Higher Education Personnel (CAPES), for the scholarship granted and the essential support for the research.
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AUTHORS' CONTRIBUTIONSAuthor contributions not reported.
DATA AVAILABILITY STATEMENT
Use of data not disclosed.
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Edited by
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Associate Editor:
Inajara Rotta
