https://orcid.org/0000-0002-1723-1070
Abstract
Teaching epidemiological concepts in academic settings poses a challenge due to the intricate nature of the discipline as both a science and a practice. Whereas traditional classroom-based teaching methods are commonly employed, evidence suggests they may not be the most effective approach for fostering core competencies and skills required in real-life scientific work. In this article, we describe our process of transitioning from traditional classroom teaching of epidemiology towards practice-based coaching to convey epidemiological concepts to bachelor's and master's students in Biomedicine. We chose the framework of randomized controlled trials (RCT) since they offer a great opportunity to teach epidemiological concepts in a hands-on course. This practice-based course encompasses the entire life cycle of a study, allowing students to design and conduct a short-term experiment, analyse its data and prepare a scientific paper. We provide a comprehensive overview of the course structure, content, learning objectives and course evaluation, while also discussing the advantages and disadvantages of this innovative format. Our approach offers a promising alternative to classroom teaching by incorporating practical, hands-on experiences offering students a high level of independence and self-determination, as well as facilitation and coaching by faculty. It has the potential to be applied across diverse academic settings, providing students with valuable skills and competencies in epidemiology.
We developed a practice-based course to teach epidemiological concepts, while integrating key principles of successful learning and linking the course content to specific core competencies in epidemiology.
We present a case study of our practice-based learning format and the evaluation of its implementation for coaching epidemiological concepts using the framework of randomized controlled trials.
The practice-based coaching approach is well received by students and holds potential for further development and scalability in diverse academic settings.
Introduction
High-quality teaching and training of the next generation of researchers is central for improving population health.1–3 Teaching epidemiological concepts poses a challenge, particularly when aiming to achieve a higher level of competence, such as applying key concepts in a different scientific context and advancing research methods. In other fields, teaching strategies that actively engage students in the learning process (‘active learning’) and that implement meaningful and stimulating learning activities have been studied for decades.4 Extensive evidence supports the association between active learning and greater academic achievement, as well as positive attitudes towards learning.5,6 In this context, a number of key principles have been identified as critical for students’ learning, such as clear and conceptually demanding learning goals, strategies that consider students learning perspectives, social interaction and dialoguing, and feedback practices.7–9
Building on this knowledge, we developed a practice-based block course to teach epidemiological concepts while integrating key principles of successful learning and linking the course content to specific core competencies,10 herein referred to as practice-based coaching. The term coaching aligns with the perspective of the course leaders, who implement key principles of successful learning, create an environment that stimulates discussion, social interaction and critical thinking and supports active learning. This course was designed for bachelor’s (BSc) and master’s students (MSc) in Biomedicine and later adapted for PhD students from various disciplines. The course intends to convey fundamental principles of epidemiology while drawing attention to future roles of epidemiologists in academic research, as well as to high-level challenges of design, execution or management of interdisciplinary, complex health research studies involving multiple stakeholders.
In this article, we describe our 4-year experience of moving from a classroom-based teaching approach to practice-based, interactive coaching of epidemiological concepts within a block course that used the framework of randomized controlled trials (RCTs).
Methods
Development of a framework to coach key epidemiological concepts in academia
Traditionally, the key concepts of epidemiology have been taught and structured around specific methods, measures of disease burden, or study designs. From our own experience and based on student feedback, we noticed that a teaching structure around methods was often perceived by students as only loosely connected and lacking a bigger picture. We also realized that students did not understand thoroughly when to use what type of study design and to appreciate the merits of study designs like case-control studies, depending on the state of evidence. Thus early on in 2014, we decided to develop and apply an overarching framework to strengthen a coherent narrative of the methods of epidemiology. More information is provided in the Supplementary Material, available as Supplementary data at IJE online.
The framework is based on two key concepts: (i) the science of epidemiology addresses different research questions and uses different study designs to address these questions, depending on the state of evidence. The Discovery and Evaluation Coil (Figure 1) reflects the interplay of these three elements and helps students to orient themselves as to which study designs are the most appropriate, both in terms of scientific and resource considerations and options for a specific research question given the current level of evidence.
Discovery and Evaluation Coil
From classical classroom teaching to practice-based coaching
Even though the introduction of the Discovery & Evaluation Coil and a stronger overarching narrative may have improved the overall experience of classroom learning, we felt that this overall still relatively passive learning approach hindered a more intense dealing of students with the core concepts of epidemiology. We felt that classical classroom teaching methods did not adequately reflect the real challenges encountered in scientific work, such as the importance of interdisciplinary collaboration and the central role of communication. We also noticed that studying and discussing research articles in small groups was time intensive and did not result in the integration of core epidemiological concepts; a different approach was needed
Thus, we decided to restructure the curriculum towards a practice-based learning course considering key elements of successful learning and fostering positive attitudes towards learning.2,7,8 This article describes the learning goals, layout and content of our block course on RCTs, and shares experiences from courses with Biomedicine students at BSc and MSc levels.
Outline of block course on randomized controlled trials
We chose RCTs as case studies for this course because they provide an excellent opportunity to teach key epidemiological concepts like confounding and means to minimize information bias in a practical, applied setting, acknowledging that RCTs are vulnerable to other types of bias such as selection bias due to attrition. The use of other study designs for experiments would be practically unfeasible in such an intensive 3-week block course, but are addressed in lectures applying the Discovery and Evaluation Coil (Figure 1). A detailed description of the course is given in Table 1. The course covers the entire life cycle of an RCT, and the various topics are linked to specific core competencies that define the learning goals.10
Overview of course content and learning goals.
| Days | Topic(s) of input lectures and learning goals | Content of group work | Core competencies [10] |
|---|---|---|---|
| Day 1 (4 h) | Lecture: Introduction to course and its concept Fundamentals of RCTs: why and when to do RCTs, types of RCTs, evolvement of evidence, history of RCTs, life cycle of a trial Students understand some of the rich history of RCTs; why RCTs are key for evaluation of prevention and treatment; the different types of RCTs and how the study question and current evidence determine the design of a trial Lecture: Introduction to group work Overview about course organization, introduction to team, group work and expected outcome. | Welcome and group formation, introductory reading of topics of interventions. Students share ideas about possible study questions and define roles within their team (e.g. principal investigator, intervention manager, outcome assessor, statistician) Students have first hands-on experiences with the tests (e.g. sit-to-stand test, cold-pressor test) Goals for the day: students have defined the roles within their group | Domain: Development of scientific question
Domain: Overarching Core Competencies
|
| Day 2 (8 h) | Lecture: Development of scientific question, review of literature, defining the target, source and study population, developing an intervention Students understand: how to frame a research question; how to review the literature to inform a study (short introduction); the distinction between the target, source and study population; and how interventions are developed to be tested in RCTs Lecture: Introduction to outcome measures Students understand: the different types of outcome measures; basic principles on the selection of outcomes; the role of primary and secondary outcomes; and the role of testing of outcome measures for study protocol development | Students discuss the content of the input lectures and define the target, source and study population (e.g. eligibility criteria) applicable to their research question. Students start pilot testing Students define outcome measures and estimate the time needed for all measurements Goals for the day: students have defined the details of their PICO (Population-Intervention-Comparator-Outcome) and tested them out, if possible. No details on methods yet (e.g. how to randomize, conceal random allocation, masking etc) | Domain: Development of scientific question
|
| Day 3 (8 h) | Lectures: - Introduction to ethics and regulation - Protocol of a clinical trial, participant information and consent form - Introduction to Research Electronic Data Capture (REDCap) Students understand: the need for ethics in clinical research (brief historical perspective); how the legislation on human research is organized in Switzerland; and the role of different stakeholders. Students know the structure and main content of a trial protocol, participant information and consent form. They get a brief introduction into REDCap | Students work on the study protocol (template tailored to this course) and start drafting a participant information and consent form. They watch introductory videos on REDCap (https://projectredcap.org/resources/videos/) and get first hands-on experience with REDCap. Students continue pilot testing Goals for the day: students have completed the first parts of the study protocol and understand the basic functions of REDCap | Domain: Development of scientific question
Domain: Study planning
|
| Day 4 (8 h) | Input lecture: Types of biases: (i) definitions and information bias; (ii) principles of confounding; (iii) randomization and allocation concealment; (iv) prevention of other biases Students understand: the definitions and key principles of bias (information bias, selection bias, confounding); randomization and allocation concealment; and ways to minimize bias | Students add methods to their study protocol, eligibility criteria and handling of drop-outs, and start implementing their outcomes in REDCap Goals for the day: most parts of the study protocol should be specified (except statistical analysis). Additionally, the main instruments should be set up in REDCap (except randomization) | Domain: Study planning
|
| Day 5 (4 h) | Input lecture: Introduction of core terminology and tools in statistics. Analysis plan, randomization, sample size planning, and baseline measurements Students understand: the content of a statistical analysis plan; different methods for randomization, sample size calculation including real life examples; and usefulness of baseline measurement adjustments in RCTs | Group work/discussion with team members: General questions and answers around the statistical analysis plan. A biostatistician is available for all groups (45 min per group) | Domain: Study conduct and analysis
|
| Day 6 (8 h) | Group work: The course organizers prepare a schedule for the experiments on Days 7 and 8. At the end of the day, course organizers share the study documents (participant information/consent form and survey link, if applicable) with all groups Students learn how to write a study protocol | Students work on the study protocol, participant information and consent form. They finalize the REDCap database and practise the experiments Goals for the day: students submit the final study documents to the course faculty and a link to an online survey for study participants, if applicable | Domain: Study planning
|
| Days 7/8 (8 h) | Trial conduct Students learn how to run a study visit, e.g. obtain informed consent; check trial eligibility criteria; perform randomization; and carry out the experiments following the trial protocol | Students conduct their own trials and take part in the experiments of the other groups | Domain: Study conduct and analysis
|
| Day 9 (8 h) | Input lecture: Introduction to reporting guidelines for main study types including RCTs (https://www.equator-network.org/) and the Cochrane risk-of-bias Tool (ROB-2) Students understand the main content of reporting guidelines for RCTs (CONSORT checklist, flow chart), and get insights into the Cochrane risk-of-bias tool | Students analyze their data and write up a publication following respective reporting guidelines. A biostatistician is available and visits all groups (45 min per group) | Domain: Communication and translation
|
| Day 10 (4 h) | Group work: Students learn to write a study protocol for an RCT | Students finalize their publication and start preparing a powerpoint presentation Goals for the day: by the end of the day groups should have analyzed their data and drafted Tables 1 and 2, and/or Figure 1 (and more if appropriate) and put their protocol and findings according to respective reporting guidelines | Domain: Communication and translation
|
| Day 11 (8 h) | Input lecture: Special topics I: RCTs in nutrition This day enables students to look at RCTs from a different angle, i.e. how can one design an RCT if the outcome takes years to develop (such as cancer), or if the exposures are complex and difficult to adhere to over a long period (e.g. dietary or physical activity interventions). In addition, pragmatic trials will be discussed Students understand: the differences between RCTs with short- and long-term outcomes and complex interactions; and how to plan trials with complex interventions such as diet | Students engage in short group exercises to plan an RCT with a complex intervention, to evaluate the results of existing nutrition and physical activity interventions, and to evaluate the ‘pragmaticness’ of a trial. | Domain: Study planning
|
| Day 12 (4 h) | Input lecture and interactive group work: Communication & translation The input lecture introduces knowledge transfer frameworks, based on five questions and exemplified by two case studies. In small groups, students prepare key messages for a particular study for different stakeholders and present their key messages in the plenum Students understand the importance of translating research findings to diverse stakeholders, and gain practical experience in effectively communicating with them | Students discuss and develop, in groups of 4–5 persons, key messages of the same study specifically for one of the following stakeholders: patients, service providers, insurers, politicians. Each group prepares a short presentation with the focus of one of the four stakeholders but also discusses the other ones | Domain: Communication and translation
|
| Day 13 (4 h) | Online session: Special topics II: Insights into RCTs in industry This online session offers students insights into the developmental lifecycle of a drug for the treatment of Alzheimer's disease Students understand the different phases of trials and get an idea about the complexity of drug development trials | Students engage in short group exercises (breakout rooms) related to the case example given in this online session. | Content and learning goals are not directly applicable to core competencies. |
| Day 14 (3 h) | Presentations: The students present their study findings (maximum 12–15 min). Course participants are encouraged to ask questions. Course faculty members lead the discussion Feedback round At the end of the course, the course organizers and participants engage in an open discussion on the course organization, course content, quality of input lectures and learning goals. In addition, students complete a feedback survey within 10 days | N/A | Domain: Communication and translation
|
| Course end ±7 days | Peer-review feedback on manuscript: Within ±7 days after the course, students receive peer-review feedback on their manuscripts from teaching assistants and the course faculty. With this exercise, we aim to mimic a classical peer-review process. Students do not have to revise their manuscript | N/A | N/A |
| Days | Topic(s) of input lectures and learning goals | Content of group work | Core competencies [10] |
|---|---|---|---|
| Day 1 (4 h) | Lecture: Introduction to course and its concept Fundamentals of RCTs: why and when to do RCTs, types of RCTs, evolvement of evidence, history of RCTs, life cycle of a trial Students understand some of the rich history of RCTs; why RCTs are key for evaluation of prevention and treatment; the different types of RCTs and how the study question and current evidence determine the design of a trial Lecture: Introduction to group work Overview about course organization, introduction to team, group work and expected outcome. | Welcome and group formation, introductory reading of topics of interventions. Students share ideas about possible study questions and define roles within their team (e.g. principal investigator, intervention manager, outcome assessor, statistician) Students have first hands-on experiences with the tests (e.g. sit-to-stand test, cold-pressor test) Goals for the day: students have defined the roles within their group | Domain: Development of scientific question
Domain: Overarching Core Competencies
|
| Day 2 (8 h) | Lecture: Development of scientific question, review of literature, defining the target, source and study population, developing an intervention Students understand: how to frame a research question; how to review the literature to inform a study (short introduction); the distinction between the target, source and study population; and how interventions are developed to be tested in RCTs Lecture: Introduction to outcome measures Students understand: the different types of outcome measures; basic principles on the selection of outcomes; the role of primary and secondary outcomes; and the role of testing of outcome measures for study protocol development | Students discuss the content of the input lectures and define the target, source and study population (e.g. eligibility criteria) applicable to their research question. Students start pilot testing Students define outcome measures and estimate the time needed for all measurements Goals for the day: students have defined the details of their PICO (Population-Intervention-Comparator-Outcome) and tested them out, if possible. No details on methods yet (e.g. how to randomize, conceal random allocation, masking etc) | Domain: Development of scientific question
|
| Day 3 (8 h) | Lectures: - Introduction to ethics and regulation - Protocol of a clinical trial, participant information and consent form - Introduction to Research Electronic Data Capture (REDCap) Students understand: the need for ethics in clinical research (brief historical perspective); how the legislation on human research is organized in Switzerland; and the role of different stakeholders. Students know the structure and main content of a trial protocol, participant information and consent form. They get a brief introduction into REDCap | Students work on the study protocol (template tailored to this course) and start drafting a participant information and consent form. They watch introductory videos on REDCap (https://projectredcap.org/resources/videos/) and get first hands-on experience with REDCap. Students continue pilot testing Goals for the day: students have completed the first parts of the study protocol and understand the basic functions of REDCap | Domain: Development of scientific question
Domain: Study planning
|
| Day 4 (8 h) | Input lecture: Types of biases: (i) definitions and information bias; (ii) principles of confounding; (iii) randomization and allocation concealment; (iv) prevention of other biases Students understand: the definitions and key principles of bias (information bias, selection bias, confounding); randomization and allocation concealment; and ways to minimize bias | Students add methods to their study protocol, eligibility criteria and handling of drop-outs, and start implementing their outcomes in REDCap Goals for the day: most parts of the study protocol should be specified (except statistical analysis). Additionally, the main instruments should be set up in REDCap (except randomization) | Domain: Study planning
|
| Day 5 (4 h) | Input lecture: Introduction of core terminology and tools in statistics. Analysis plan, randomization, sample size planning, and baseline measurements Students understand: the content of a statistical analysis plan; different methods for randomization, sample size calculation including real life examples; and usefulness of baseline measurement adjustments in RCTs | Group work/discussion with team members: General questions and answers around the statistical analysis plan. A biostatistician is available for all groups (45 min per group) | Domain: Study conduct and analysis
|
| Day 6 (8 h) | Group work: The course organizers prepare a schedule for the experiments on Days 7 and 8. At the end of the day, course organizers share the study documents (participant information/consent form and survey link, if applicable) with all groups Students learn how to write a study protocol | Students work on the study protocol, participant information and consent form. They finalize the REDCap database and practise the experiments Goals for the day: students submit the final study documents to the course faculty and a link to an online survey for study participants, if applicable | Domain: Study planning
|
| Days 7/8 (8 h) | Trial conduct Students learn how to run a study visit, e.g. obtain informed consent; check trial eligibility criteria; perform randomization; and carry out the experiments following the trial protocol | Students conduct their own trials and take part in the experiments of the other groups | Domain: Study conduct and analysis
|
| Day 9 (8 h) | Input lecture: Introduction to reporting guidelines for main study types including RCTs (https://www.equator-network.org/) and the Cochrane risk-of-bias Tool (ROB-2) Students understand the main content of reporting guidelines for RCTs (CONSORT checklist, flow chart), and get insights into the Cochrane risk-of-bias tool | Students analyze their data and write up a publication following respective reporting guidelines. A biostatistician is available and visits all groups (45 min per group) | Domain: Communication and translation
|
| Day 10 (4 h) | Group work: Students learn to write a study protocol for an RCT | Students finalize their publication and start preparing a powerpoint presentation Goals for the day: by the end of the day groups should have analyzed their data and drafted Tables 1 and 2, and/or Figure 1 (and more if appropriate) and put their protocol and findings according to respective reporting guidelines | Domain: Communication and translation
|
| Day 11 (8 h) | Input lecture: Special topics I: RCTs in nutrition This day enables students to look at RCTs from a different angle, i.e. how can one design an RCT if the outcome takes years to develop (such as cancer), or if the exposures are complex and difficult to adhere to over a long period (e.g. dietary or physical activity interventions). In addition, pragmatic trials will be discussed Students understand: the differences between RCTs with short- and long-term outcomes and complex interactions; and how to plan trials with complex interventions such as diet | Students engage in short group exercises to plan an RCT with a complex intervention, to evaluate the results of existing nutrition and physical activity interventions, and to evaluate the ‘pragmaticness’ of a trial. | Domain: Study planning
|
| Day 12 (4 h) | Input lecture and interactive group work: Communication & translation The input lecture introduces knowledge transfer frameworks, based on five questions and exemplified by two case studies. In small groups, students prepare key messages for a particular study for different stakeholders and present their key messages in the plenum Students understand the importance of translating research findings to diverse stakeholders, and gain practical experience in effectively communicating with them | Students discuss and develop, in groups of 4–5 persons, key messages of the same study specifically for one of the following stakeholders: patients, service providers, insurers, politicians. Each group prepares a short presentation with the focus of one of the four stakeholders but also discusses the other ones | Domain: Communication and translation
|
| Day 13 (4 h) | Online session: Special topics II: Insights into RCTs in industry This online session offers students insights into the developmental lifecycle of a drug for the treatment of Alzheimer's disease Students understand the different phases of trials and get an idea about the complexity of drug development trials | Students engage in short group exercises (breakout rooms) related to the case example given in this online session. | Content and learning goals are not directly applicable to core competencies. |
| Day 14 (3 h) | Presentations: The students present their study findings (maximum 12–15 min). Course participants are encouraged to ask questions. Course faculty members lead the discussion Feedback round At the end of the course, the course organizers and participants engage in an open discussion on the course organization, course content, quality of input lectures and learning goals. In addition, students complete a feedback survey within 10 days | N/A | Domain: Communication and translation
|
| Course end ±7 days | Peer-review feedback on manuscript: Within ±7 days after the course, students receive peer-review feedback on their manuscripts from teaching assistants and the course faculty. With this exercise, we aim to mimic a classical peer-review process. Students do not have to revise their manuscript | N/A | N/A |
RCT, randomized controlled trial; REDCap, Research Electronic Data Capture. REDCap (Vanderbilt University, USA) is a web-based application for building and managing databases and online surveys.
Overview of course content and learning goals.
| Days | Topic(s) of input lectures and learning goals | Content of group work | Core competencies [10] |
|---|---|---|---|
| Day 1 (4 h) | Lecture: Introduction to course and its concept Fundamentals of RCTs: why and when to do RCTs, types of RCTs, evolvement of evidence, history of RCTs, life cycle of a trial Students understand some of the rich history of RCTs; why RCTs are key for evaluation of prevention and treatment; the different types of RCTs and how the study question and current evidence determine the design of a trial Lecture: Introduction to group work Overview about course organization, introduction to team, group work and expected outcome. | Welcome and group formation, introductory reading of topics of interventions. Students share ideas about possible study questions and define roles within their team (e.g. principal investigator, intervention manager, outcome assessor, statistician) Students have first hands-on experiences with the tests (e.g. sit-to-stand test, cold-pressor test) Goals for the day: students have defined the roles within their group | Domain: Development of scientific question
Domain: Overarching Core Competencies
|
| Day 2 (8 h) | Lecture: Development of scientific question, review of literature, defining the target, source and study population, developing an intervention Students understand: how to frame a research question; how to review the literature to inform a study (short introduction); the distinction between the target, source and study population; and how interventions are developed to be tested in RCTs Lecture: Introduction to outcome measures Students understand: the different types of outcome measures; basic principles on the selection of outcomes; the role of primary and secondary outcomes; and the role of testing of outcome measures for study protocol development | Students discuss the content of the input lectures and define the target, source and study population (e.g. eligibility criteria) applicable to their research question. Students start pilot testing Students define outcome measures and estimate the time needed for all measurements Goals for the day: students have defined the details of their PICO (Population-Intervention-Comparator-Outcome) and tested them out, if possible. No details on methods yet (e.g. how to randomize, conceal random allocation, masking etc) | Domain: Development of scientific question
|
| Day 3 (8 h) | Lectures: - Introduction to ethics and regulation - Protocol of a clinical trial, participant information and consent form - Introduction to Research Electronic Data Capture (REDCap) Students understand: the need for ethics in clinical research (brief historical perspective); how the legislation on human research is organized in Switzerland; and the role of different stakeholders. Students know the structure and main content of a trial protocol, participant information and consent form. They get a brief introduction into REDCap | Students work on the study protocol (template tailored to this course) and start drafting a participant information and consent form. They watch introductory videos on REDCap (https://projectredcap.org/resources/videos/) and get first hands-on experience with REDCap. Students continue pilot testing Goals for the day: students have completed the first parts of the study protocol and understand the basic functions of REDCap | Domain: Development of scientific question
Domain: Study planning
|
| Day 4 (8 h) | Input lecture: Types of biases: (i) definitions and information bias; (ii) principles of confounding; (iii) randomization and allocation concealment; (iv) prevention of other biases Students understand: the definitions and key principles of bias (information bias, selection bias, confounding); randomization and allocation concealment; and ways to minimize bias | Students add methods to their study protocol, eligibility criteria and handling of drop-outs, and start implementing their outcomes in REDCap Goals for the day: most parts of the study protocol should be specified (except statistical analysis). Additionally, the main instruments should be set up in REDCap (except randomization) | Domain: Study planning
|
| Day 5 (4 h) | Input lecture: Introduction of core terminology and tools in statistics. Analysis plan, randomization, sample size planning, and baseline measurements Students understand: the content of a statistical analysis plan; different methods for randomization, sample size calculation including real life examples; and usefulness of baseline measurement adjustments in RCTs | Group work/discussion with team members: General questions and answers around the statistical analysis plan. A biostatistician is available for all groups (45 min per group) | Domain: Study conduct and analysis
|
| Day 6 (8 h) | Group work: The course organizers prepare a schedule for the experiments on Days 7 and 8. At the end of the day, course organizers share the study documents (participant information/consent form and survey link, if applicable) with all groups Students learn how to write a study protocol | Students work on the study protocol, participant information and consent form. They finalize the REDCap database and practise the experiments Goals for the day: students submit the final study documents to the course faculty and a link to an online survey for study participants, if applicable | Domain: Study planning
|
| Days 7/8 (8 h) | Trial conduct Students learn how to run a study visit, e.g. obtain informed consent; check trial eligibility criteria; perform randomization; and carry out the experiments following the trial protocol | Students conduct their own trials and take part in the experiments of the other groups | Domain: Study conduct and analysis
|
| Day 9 (8 h) | Input lecture: Introduction to reporting guidelines for main study types including RCTs (https://www.equator-network.org/) and the Cochrane risk-of-bias Tool (ROB-2) Students understand the main content of reporting guidelines for RCTs (CONSORT checklist, flow chart), and get insights into the Cochrane risk-of-bias tool | Students analyze their data and write up a publication following respective reporting guidelines. A biostatistician is available and visits all groups (45 min per group) | Domain: Communication and translation
|
| Day 10 (4 h) | Group work: Students learn to write a study protocol for an RCT | Students finalize their publication and start preparing a powerpoint presentation Goals for the day: by the end of the day groups should have analyzed their data and drafted Tables 1 and 2, and/or Figure 1 (and more if appropriate) and put their protocol and findings according to respective reporting guidelines | Domain: Communication and translation
|
| Day 11 (8 h) | Input lecture: Special topics I: RCTs in nutrition This day enables students to look at RCTs from a different angle, i.e. how can one design an RCT if the outcome takes years to develop (such as cancer), or if the exposures are complex and difficult to adhere to over a long period (e.g. dietary or physical activity interventions). In addition, pragmatic trials will be discussed Students understand: the differences between RCTs with short- and long-term outcomes and complex interactions; and how to plan trials with complex interventions such as diet | Students engage in short group exercises to plan an RCT with a complex intervention, to evaluate the results of existing nutrition and physical activity interventions, and to evaluate the ‘pragmaticness’ of a trial. | Domain: Study planning
|
| Day 12 (4 h) | Input lecture and interactive group work: Communication & translation The input lecture introduces knowledge transfer frameworks, based on five questions and exemplified by two case studies. In small groups, students prepare key messages for a particular study for different stakeholders and present their key messages in the plenum Students understand the importance of translating research findings to diverse stakeholders, and gain practical experience in effectively communicating with them | Students discuss and develop, in groups of 4–5 persons, key messages of the same study specifically for one of the following stakeholders: patients, service providers, insurers, politicians. Each group prepares a short presentation with the focus of one of the four stakeholders but also discusses the other ones | Domain: Communication and translation
|
| Day 13 (4 h) | Online session: Special topics II: Insights into RCTs in industry This online session offers students insights into the developmental lifecycle of a drug for the treatment of Alzheimer's disease Students understand the different phases of trials and get an idea about the complexity of drug development trials | Students engage in short group exercises (breakout rooms) related to the case example given in this online session. | Content and learning goals are not directly applicable to core competencies. |
| Day 14 (3 h) | Presentations: The students present their study findings (maximum 12–15 min). Course participants are encouraged to ask questions. Course faculty members lead the discussion Feedback round At the end of the course, the course organizers and participants engage in an open discussion on the course organization, course content, quality of input lectures and learning goals. In addition, students complete a feedback survey within 10 days | N/A | Domain: Communication and translation
|
| Course end ±7 days | Peer-review feedback on manuscript: Within ±7 days after the course, students receive peer-review feedback on their manuscripts from teaching assistants and the course faculty. With this exercise, we aim to mimic a classical peer-review process. Students do not have to revise their manuscript | N/A | N/A |
| Days | Topic(s) of input lectures and learning goals | Content of group work | Core competencies [10] |
|---|---|---|---|
| Day 1 (4 h) | Lecture: Introduction to course and its concept Fundamentals of RCTs: why and when to do RCTs, types of RCTs, evolvement of evidence, history of RCTs, life cycle of a trial Students understand some of the rich history of RCTs; why RCTs are key for evaluation of prevention and treatment; the different types of RCTs and how the study question and current evidence determine the design of a trial Lecture: Introduction to group work Overview about course organization, introduction to team, group work and expected outcome. | Welcome and group formation, introductory reading of topics of interventions. Students share ideas about possible study questions and define roles within their team (e.g. principal investigator, intervention manager, outcome assessor, statistician) Students have first hands-on experiences with the tests (e.g. sit-to-stand test, cold-pressor test) Goals for the day: students have defined the roles within their group | Domain: Development of scientific question
Domain: Overarching Core Competencies
|
| Day 2 (8 h) | Lecture: Development of scientific question, review of literature, defining the target, source and study population, developing an intervention Students understand: how to frame a research question; how to review the literature to inform a study (short introduction); the distinction between the target, source and study population; and how interventions are developed to be tested in RCTs Lecture: Introduction to outcome measures Students understand: the different types of outcome measures; basic principles on the selection of outcomes; the role of primary and secondary outcomes; and the role of testing of outcome measures for study protocol development | Students discuss the content of the input lectures and define the target, source and study population (e.g. eligibility criteria) applicable to their research question. Students start pilot testing Students define outcome measures and estimate the time needed for all measurements Goals for the day: students have defined the details of their PICO (Population-Intervention-Comparator-Outcome) and tested them out, if possible. No details on methods yet (e.g. how to randomize, conceal random allocation, masking etc) | Domain: Development of scientific question
|
| Day 3 (8 h) | Lectures: - Introduction to ethics and regulation - Protocol of a clinical trial, participant information and consent form - Introduction to Research Electronic Data Capture (REDCap) Students understand: the need for ethics in clinical research (brief historical perspective); how the legislation on human research is organized in Switzerland; and the role of different stakeholders. Students know the structure and main content of a trial protocol, participant information and consent form. They get a brief introduction into REDCap | Students work on the study protocol (template tailored to this course) and start drafting a participant information and consent form. They watch introductory videos on REDCap (https://projectredcap.org/resources/videos/) and get first hands-on experience with REDCap. Students continue pilot testing Goals for the day: students have completed the first parts of the study protocol and understand the basic functions of REDCap | Domain: Development of scientific question
Domain: Study planning
|
| Day 4 (8 h) | Input lecture: Types of biases: (i) definitions and information bias; (ii) principles of confounding; (iii) randomization and allocation concealment; (iv) prevention of other biases Students understand: the definitions and key principles of bias (information bias, selection bias, confounding); randomization and allocation concealment; and ways to minimize bias | Students add methods to their study protocol, eligibility criteria and handling of drop-outs, and start implementing their outcomes in REDCap Goals for the day: most parts of the study protocol should be specified (except statistical analysis). Additionally, the main instruments should be set up in REDCap (except randomization) | Domain: Study planning
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| Day 5 (4 h) | Input lecture: Introduction of core terminology and tools in statistics. Analysis plan, randomization, sample size planning, and baseline measurements Students understand: the content of a statistical analysis plan; different methods for randomization, sample size calculation including real life examples; and usefulness of baseline measurement adjustments in RCTs | Group work/discussion with team members: General questions and answers around the statistical analysis plan. A biostatistician is available for all groups (45 min per group) | Domain: Study conduct and analysis
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| Day 6 (8 h) | Group work: The course organizers prepare a schedule for the experiments on Days 7 and 8. At the end of the day, course organizers share the study documents (participant information/consent form and survey link, if applicable) with all groups Students learn how to write a study protocol | Students work on the study protocol, participant information and consent form. They finalize the REDCap database and practise the experiments Goals for the day: students submit the final study documents to the course faculty and a link to an online survey for study participants, if applicable | Domain: Study planning
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| Days 7/8 (8 h) | Trial conduct Students learn how to run a study visit, e.g. obtain informed consent; check trial eligibility criteria; perform randomization; and carry out the experiments following the trial protocol | Students conduct their own trials and take part in the experiments of the other groups | Domain: Study conduct and analysis
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| Day 9 (8 h) | Input lecture: Introduction to reporting guidelines for main study types including RCTs (https://www.equator-network.org/) and the Cochrane risk-of-bias Tool (ROB-2) Students understand the main content of reporting guidelines for RCTs (CONSORT checklist, flow chart), and get insights into the Cochrane risk-of-bias tool | Students analyze their data and write up a publication following respective reporting guidelines. A biostatistician is available and visits all groups (45 min per group) | Domain: Communication and translation
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| Day 10 (4 h) | Group work: Students learn to write a study protocol for an RCT | Students finalize their publication and start preparing a powerpoint presentation Goals for the day: by the end of the day groups should have analyzed their data and drafted Tables 1 and 2, and/or Figure 1 (and more if appropriate) and put their protocol and findings according to respective reporting guidelines | Domain: Communication and translation
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| Day 11 (8 h) | Input lecture: Special topics I: RCTs in nutrition This day enables students to look at RCTs from a different angle, i.e. how can one design an RCT if the outcome takes years to develop (such as cancer), or if the exposures are complex and difficult to adhere to over a long period (e.g. dietary or physical activity interventions). In addition, pragmatic trials will be discussed Students understand: the differences between RCTs with short- and long-term outcomes and complex interactions; and how to plan trials with complex interventions such as diet | Students engage in short group exercises to plan an RCT with a complex intervention, to evaluate the results of existing nutrition and physical activity interventions, and to evaluate the ‘pragmaticness’ of a trial. | Domain: Study planning
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| Day 12 (4 h) | Input lecture and interactive group work: Communication & translation The input lecture introduces knowledge transfer frameworks, based on five questions and exemplified by two case studies. In small groups, students prepare key messages for a particular study for different stakeholders and present their key messages in the plenum Students understand the importance of translating research findings to diverse stakeholders, and gain practical experience in effectively communicating with them | Students discuss and develop, in groups of 4–5 persons, key messages of the same study specifically for one of the following stakeholders: patients, service providers, insurers, politicians. Each group prepares a short presentation with the focus of one of the four stakeholders but also discusses the other ones | Domain: Communication and translation
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| Day 13 (4 h) | Online session: Special topics II: Insights into RCTs in industry This online session offers students insights into the developmental lifecycle of a drug for the treatment of Alzheimer's disease Students understand the different phases of trials and get an idea about the complexity of drug development trials | Students engage in short group exercises (breakout rooms) related to the case example given in this online session. | Content and learning goals are not directly applicable to core competencies. |
| Day 14 (3 h) | Presentations: The students present their study findings (maximum 12–15 min). Course participants are encouraged to ask questions. Course faculty members lead the discussion Feedback round At the end of the course, the course organizers and participants engage in an open discussion on the course organization, course content, quality of input lectures and learning goals. In addition, students complete a feedback survey within 10 days | N/A | Domain: Communication and translation
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| Course end ±7 days | Peer-review feedback on manuscript: Within ±7 days after the course, students receive peer-review feedback on their manuscripts from teaching assistants and the course faculty. With this exercise, we aim to mimic a classical peer-review process. Students do not have to revise their manuscript | N/A | N/A |
RCT, randomized controlled trial; REDCap, Research Electronic Data Capture. REDCap (Vanderbilt University, USA) is a web-based application for building and managing databases and online surveys.
The course consists of input lectures delivered by the faculty, and practical group work supervised by PhD students. In small groups of 6–8 students, course participants design and carry out small experiments, analyze data, prepare a manuscript in a collaborative effort and finally present their study findings to the entire class. Teaching assistants provide guidance to ensure shared workload. In addition, students gain insights into trials in nutritional epidemiology and the pharmaceutical industry through applied ‘special topics’ sessions. They also have a practical session on communication and translation, during which they practice communicating research findings to various target groups (Table 1).
At the end of each course, the students present their study results to all course participants and engage in discussion rounds moderated by the faculty. In addition, they submit a final project report. There is no final examination, due to the already demanding workload. While the faculty and teaching assistants provide written feedback to students (‘peer review’), the students are not obligated to submit a revised version of their report. For the interested reader, two examples of representative publications are available in the Supplementary Material, as Supplementary data at IJE online.
Overview of course-specific experiments
Students conduct short-term experiments using the cold-pressor test,11,12 1-minute sit-to-stand test,13,14 short-term memory tasks,15 or manual therapy interventions such as heat application in combination with massage of the lower back or yoga. Examples of interventions are provided by the course faculty (i.e. the test is predefined for each group), but the students need to develop their specific research question(s) and chose appropriate endpoints and assessment methods. Teaching assistants guide students and stimulate discussions in their groups to support this process. Examples of research questions and trial characteristics are shown in Supplementary Table S1, available as Supplementary data at IJE online.
Results
Course outcome
After each course, we request feedback from students using a standardized online feedback form, and we have an open feedback round with the participants, faculty and teaching assistants. The results from the course evaluation over the past 4-years are available in the Supplementary Material (Supplementary Figures S1–S7, available as Supplementary data at IJE online, plus additional free-text comments). Overall, students provided positive feedback on the courses, with many acknowledging the course layout, content, organization and communication. The format of knowledge presentation was also well received. As a course team, we provide an open feedback culture and highlight the importance of providing critical feedback. It is important to note that the course team is constantly learning from the feedback of course participants, and we have made several adaptations to the course programme over the years.
Discussion
We present a case study of our practice-based learning format and the evaluation of its implementation for coaching epidemiological concepts to BSc and MSc students. We believe that this format could be of interest to a wider community of academics who teach epidemiological concepts. Additionally, it could serve as a basis for practice-oriented teaching and be further developed and transferred to other fields. We aim to discuss our personal experience with this new course layout and to highlight advantages, also addressing its limitations for widespread use in low-resource settings.
Research has shown that active learning formats are associated with better academic achievement, motivation and student engagement.7,8,16,17 Most students appreciate problem-based and active learning formats.18–20 and factors such as experienced small-group tutors, well-structured tutorials, authentic case studies, constructive feedback and easy access to learning materials are key to student satisfaction.21 Conceptually, our course integrates several of these key factors which are linked to students’ satisfaction, but also to specific core competencies.10 In our courses, students reported high levels of satisfaction (with some variation over time) regarding the general course format, the lecturers and small-group tutors: see Supplementary Figure S1 (available as Supplementary data at IJE online).
Prior to the start of the course, students are given access to all course materials (via web client), and we incorporate specific learning goals in each lecture (Table 1). Our approach is to act as coaches and to stimulate discussions without providing immediate solutions. One of the most challenging tasks for the course faculty was to select appropriate experiments. The experiments had to be realistic, easily implementable but also attractive to students. Most students perceived the amount of content covered, the group size, learning pace and environment as stimulating, and they reported that the experiments helped them obtain a deeper understanding of the course concepts, although some students wished they had more time to prepare for the experiments: see Supplementary Figures S2 and S6 (available as Supplementary data at IJE online). We have realized that students engage much faster in deep and more complex methodological discussions compared with classical classroom teaching, although we have never compared learning achievements between the two different teaching formats. Our experience is supported by extensive evidence from systematic reviews and meta-analyses suggesting that integration of key principles of active learning (e.g. clear and conceptually demanding learning goals, social interaction and feedback practices) are associated with greater academic achievements.7,8 The course creates a dynamic and challenging environment, and the level of difficulty seems appropriate for students: see Supplementary Figure S2 (available as Supplementary data at IJE online). In a few situations, the group dynamic can be a challenge, particularly if responsibilities and leadership roles are not entirely clear for students or if students perceive a lack of subject knowledge.18 At the beginning of the course, when students come together in small groups and start brainstorming about their experiment, we encourage them to define roles (e.g. principal investigator, intervention provider, outcome assessor, database manager, statistician), which helps them find their place within their team.
Strengths and limitations of our approach
The strengths of our educational approach are notable through students’ positive feedback and contribute to the overall effectiveness of the learning environment. First, the highly interactive nature of the approach fosters active engagement among students, enabling them to participate actively in their own learning process. This interactive learning environment promotes critical thinking, group collaboration and knowledge retention to support the learning process.9 Moreover, the approach allows a high level of independence and self-determination for students. By providing them with the autonomy to explore and navigate their learning journey, it encourages self-directed learning and cultivates important skills such as problem-solving, decision-making and self-motivation. This aspect is particularly beneficial in preparing students for real-world scenarios where independent thinking and decision-making are crucial. The clearly defined learning goals are another strength.7,8 By explicitly outlining the expected learning outcomes, students have a clear understanding of what is expected from them and can align their efforts accordingly.7 This clarity enhances their focus and facilitates effective learning. Feedback from students indicates a high level of appreciation for the format of the course, with positive responses to both the layout and content. This positive feedback serves as a testament to the acceptance of the approach in engaging students and facilitating their learning experience. Furthermore, the approach does not require expensive equipment, making it more accessible and cost-effective.
The implementation of this educational approach is subject to certain limitations that need to be acknowledged. First, space requirements for both lectures and group work can pose challenges, particularly in settings with limited physical infrastructure. Adequate space is essential to facilitate group discussions and collaborative activities. Another limitation is the teacher:student ratio. Our approach requires enough instructors covering several specialties to effectively guide and support students through their learning process. Teaching assistants vary in skills and mentoring experience, influencing group dynamics. Completing our block courses is a prerequisite for becoming a teaching assistant, to ensure a certain level of expertise. Feedback discussions with teaching assistants indicate some challenges in their role as coaches, particularly since students are often at similar stages in their education and PhD journey. The successful implementation of the approach, involving communication/translation and industry parts, may be challenging in settings where resource constraints limit the availability of a suitable number of qualified personnel. In such contexts, the implementation of this approach may require significant adjustments and adaptations to overcome these limitations. Moreover, since we do not conduct examinations in block courses, we are not able to compare academic achievements and understanding of key epidemiological concepts between the classroom-based approach and the practice-based approach. However, our positive experience with the new course format is supported by the large body of evidence on active learning.4–7 Finally, this course predominantly emphasizes RCTs, with other study designs briefly covered through the recurrent application of the Discovery and Evaluation Coil in our lectures, though not in extensive detail.
Conclusion
Our practice-based approach of coaching key epidemiological concepts through practice-based coursework is well received by students, teaching assistants and faculty. Our concept may serve as a case study with potential for further development, modification and scalability across diverse academic settings.
Ethics approval
Ethical approval is not required for methodological studies of graduate students pursuant to Art. 2 of the Swiss Federal Act on Research involving Human Beings (Human Research Act, HRA). The course evaluation is an integral component of the standard curriculum for block courses. Students’ survey responses are voluntary and collected anonymously.
Data availability
The data underlying this article are available in the article and in its online Supplementary material.
Supplementary data
Supplementary data are available at IJE online.
Author contributions
M.A.P., V.v.W. and T.R. conceived the study. A.F., M.A.P., S.R.H., S.R., V.v.W. and T.R. contributed to data collection. S.R.H. conducted statistical analyses and prepared all Supplementary figures. T.R. drafted the initial manuscript version, with contributions from M.A.P. and V.v.W. All authors critically reviewed and revised the manuscript for important intellectual content and read and approved the final manuscript.
Funding
None declared.
Conflict of interest
None declared.
