- Email: [email protected]
Health technology assessment teaching for BME
Chapter 118
Health technology assessment teaching for BME Leandro Pecchiaa, Davide Piaggioa, Nicolas Pallikarakisb, Ernesto Iadanzac a
School of Engineering, University of Warwick, Coventry, United Kingdom, bUniversity of Patras, Patras, Greece, cIFMBE HTA Division, School of Engineering, University of Florence, Florence, Italy
Introduction Writing the second edition of the Handbook of Clinical Engineering is also a great opportunity to reflect on the several achievements made by biomedical engineering (BME) in the past 20 years. In fact, the first edition of this book was designed at the end of the 1990s and published in 2004. After 20 years, the scenario in which this book is conceived is significantly different. One of the main differences is in the extent to which BME is recognized from international policy-makers. This opens novel opportunities for BME and requires BMEs to take more responsibility in the way they contribute to face socioeconomic challenges. Understanding this change is a fundamental step toward the designing of BME education in the next decades. For instance, the European Union Journal (2015/C 291/07) recognized that “BME is not simply a subset of modern medicine. Modern medicine predominantly secures important advances through the use of the products of BME.” It is the first time that BME receives globally such an important recognition. In addition, the World Health Organization (WHO) stated recently that “trained and qualified BME professionals are required to design, evaluate, regulate, maintain, and manage medical devices, and train on their safe use in health systems around the world.”a This was probably the first time that a United Nation Agency called for more BMEs and stated the importance of BME in contributing to medical device regulation on evaluation, beyond the traditional recognition of BME contribution to medical device design, maintenance, and management. In addition, several European countries have started to legislate on BME and clinical engineering professional recognition. Therefore, after several years, it seems that international policy makers clearly understand the importance of BME. a. WHO website, last access medical_devices/support/en/.
832
20.04.2019:
https://www.who.int/
How can the BME community respond to such an unprecedented attention from policy makers? One of the answers is to study more health technology assessment (HTA), which is the front end between BME and policy decision-makers at local (hospital deciding which medical device should be acquired), Regional/National (deciding which healthcare technology should be reimbursed with taxpayer money) and National/International (assessing which technology should be supported with public investments) level. One of the reasons for the growing attention around the BME profession lies in the dizzying growth of the global medical device market. A possible estimator for this growth is the number of patent applications submitted per year. In fact, while pharma research is growing very fast with about 6000 novel patent applications each year from 2006 to 2016, the number of patent applications for medical technologies moved from 8000 per year in 2006 in to more than 12,000 novel patent applications in 2016 (Europe, 2018). Moreover, the time-to-the-market for a medical device is becoming shorter and shorter. Those two factors suggest that the world is going to face a “tsunami” of medical devices, which will further revolutionize medicine and the way we approach health and well-being management. Who will be looking after the assessment of those medical devices? Who is going to help decision-maker prioritizing public-budget to be invested in the most cost-effective medical devices? The answer is certainly BMEs and clinical engineers. In fact, during the writing of this chapter, we have often wondered (and been asked) why a BME should be familiar with the HTA. The answer is that, differently from pharma products, medical devices are designed and produced mainly by small and micro-sized BME companies. In Europe, more than 600,000 workers are employed by 27,000 companies of which 95% are micro, small, or m edium enterprises (SMEs). It is very difficult for an SME to have a dedicated unit coping Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00119-X Copyright © 2020 Elsevier Inc. All rights reserved.
Health technology assessment teaching for BME Chapter | 118 833
with the assessment of their products. Therefore, it is crucial that each BME familiarizes with the principles, if not with the whole framework, of medical device HTA. Differently from the pharma products, medical devices are linked intimately to their innovators. Moreover, the model of innovation of medical devices is often incremental and not disruptive (as for pharma or biotech). Finally, medical devices life span is much shorter than the one of drugs, with components becoming obsolete even before the medical device itself, while pharma compounds longevity can be far longer than the drugs they compose. These differences require the practitioners of HTA to be continuously familiar with the ongoing research and innovation in the field, more than it is required for drugs. In the same way, BMEs should be familiar with HTA in order to foster the impact of their main outputs: medical devices. It is very difficult that in the near future the MD sector will employ many independent experts specifically tuned on regulation or assessment, as it happened for drugs. It is more likely that each BMEs will be required to be competent with HTA creating a real need for integrating more HTA contents in the BME education programs. The International Federation of Medical and Biological Engineering (IFMBE) has already gone in this direction, anticipating this trend of few years. The IFMBE has in fact invested a significant amount of resources for building a proactive community of BMEs experienced in HTA, which have been working since June 2012 for promoting the BME role in HTA beyond the BME community. This chapter describes part of this effort and offers an overview of the eLearning platform (https://htad.ifmbe.org/) that the IFMBE has published for disseminating the HTA culture among BME worldwide.
The IFMBE HTAD In 2012, the IFMBE reactivated the IFMBE Health Technology Division (HTAD, https://htad.ifmbe.org/), which was established in the 1980s but get quite dormant for few decades. In 2012, the IFMBE reactivated the IFMBE Health Technology Division (HTAD, https://htad.ifmbe.org/), which was established in the 1980s but got quite dormant for a few decades. The IFMBE HTAD was reformed in 2012 by Prof Nicolas Pallikarakis, who was appointed as Chair (2012–15) of the IFMBE HTAD during the IUPESM World Congress in China World Congress on Medical Physics and Biomedical 2012 (26–31 May 2012, Beijing, China). Professor Nicolas Pallikarakis coordinated the effort of restarting the IFMEB HTAD, supported by Dr. Patricia Trbovich (IFMBE HTAD Secretary 2012–15) and Dr. Leandro Pecchia (IFMBE HTAD Treasurer 2012–15). In 2015, Dr. Leandro Pecchia was appointed as Chair (2015–18) of the IFMBE HTAD during the IUPESM World Congress on Medical Physics and BME (June 7–12, 2015, Toronto, Canada). Dr. Pecchia, supported by Dr. Patricia Trbovich (IFMBE Treasurer 2012–15) and Dr. Marjan Hummel (IFMBE HTAD Secretary) coordinated the
work of the IFMBE HTAD starting from redefining the vision, strategy, and mission of the division and articulating its activities in 12 projects, of which 3 dedicated to the preparation of teaching contents for HTA. In June 2018, Dr. Ernesto Iadanza was appointed as Chair (2018–21) of the IFMBE HTAD during the IUPESM World Congress on Medical Physics and BME (3–8 June 2018, Prague, Czech Republic). Dr. Iadanza, supported by Dr. Marjan Hummel (Secretary 2018–21) and … (Treasurer 2018–21) has revised the IFMBE HTAD strategy and further supported the investment in HTA training.
The IFMBE HTA summer school During the 2015–18 mandate, the IFMBE HTAD launched the IFMBE HTA Summer Schools Series. The first edition was held at the University of Warwick, UK, from September 8–10, 2015, Chaired by Dr. Leandro Pecchia. The second was held at the University of Patra, Greece, from September 28–30, 2017, cochaired by Dr. Pecchia and Prof. Pallikarakis. Both Summer Schools were organized in 3 days: ●
●
●
the first day aimed at offering to the attendees an introduction to fundamental topics on which the HTA bases, including the evidence generation in medicine, principles of health economics and decision-making in health care; the second day was dedicated to the HTA of medical devices and the extent to which medical devices require different approaches, methods, and tools than the one adopted from HTA of drugs; the last day was dedicated to the deepening of two specific topics: ○ in Warwick, the third day was focused on the socalled early HTA (eHTA), which consist in applying reverse-engineering methods to health economics in order to inform the design of medical devices with the HTA perspective. ○ in Patra, the third day was dedicated to the use of multicriteria decision analysis (MCDA) in HTA of medical devices.
During both the summer schools more than 60 h of HTA lectures specifically designed for BMEs were delivered and video recorded. Those lectures were then converted in eLearning objects and uploaded on a completely free eLearning platform, designed, sponsored, edited, and managed by the IFMBE HTAD.
The IFMBE HTA eLearning platform and contents The IFMBE eLearning platform was designed in 2016 and launched in May 2017. Its goal was to become a repository for HTA related contents (lectures, seminaries, and talks) to be then structured in HTA courses, which can be freely utilized from BMEs and BME lectures all over the world. At the moment this chapter is written, the platform
834 SECTION | 12 Health technology assessment
contains 31 lectures, which have been collected during the two IFMBE HTA Summer Schools and during the International Symposium on Analytic Hierarchy Process (ISAHP2016, August 4–7, 2016, London, UK, http://www.isahp.org/). Those lectures have been organized in nine sections: (1) Introduction to HTA: this section contains basic and advanced lectures to fundamental topics of HTA and health economics: (a) Intro to health economics and HTA of medical devices (Dr. Leandro Pecchia) (b) HTA, an Introduction (Dr. Patrizio Armeni) (2) Evidence generation in medicine (a) Evidence generation in medicine and biomedical engineering (Dr. L. Pecchia) (b) Evidence generation in medicine (Prof. S. Stranges) (c) The value proposition: promise versus evidence (Prof. D. Clark) (3) Systematic literature review and meta-analysis (a) Evidence-based BME and meta-analysis (Dr. L. Pecchia) (b) Introduction to the meta-analysis (Dr. L. Pecchia) (c) Practical lab on meta-analysis with OpenMetaAnalyst (Dr. P. Melillo) (d) Meta-analysis with missing data (Dr. P. Melillo) (4) Multicriteria decision analysis (MCDA) (a) Multicriteria decision analysis (MCDA) for early HTA (Dr. M. Hummel) (b) Multicriteria decision analysis (MCDA) in eHTA (Dr. L. Pecchia) (c) Analytic hierarchy process and data-mining (Dr. P. Melillo) (d) Multiple criteria decision aiding (MCDA) and its potentials to support sustainability and resilience assessment (Dr. M. Cinelli) (5) IFMBE HTAD activities (a) IFMBE HTAD activities 2015–17 (Dr. L. Pecchia) (b) Introduction to the II IFMBE HTAD Summer School (Prof. N. Pallikarakis)
FIG. 1 The IFMBE HTAD utilization per year since its launch in June 2016.
(6)
(7)
(8)
(9)
(c) Introduction to the first IFMBE Summer School on HTA (Dr. L. Pecchia) Early HTA (a) Early health economic evaluations and eHTA (Dr. L. Pecchia) (b) Early stage HTA via decision tree (Dr. M. Craven) (c) Early stage HTA via Markov models (Dr. M. Craven) (d) Multicriteria decision analysis (MCDA) in eHTA (Dr. M. Hummel) HTA of medical devices (a) The industry of medical devices and medical devices regulation of in the EU (Prof. N. Pallikarakis) (b) The industry, the regulation and the challenges in assessing medical devices (Prof. R. Tarricone) (c) Institutional HTA: the European perspective (Dr. O. Ciani) (d) Medical device assessments at CADTH (Dr. J. Polisena) User-need elicitation (a) User-need elicitation via AHP (Dr. L. Pecchia) (b) MCDA in user need elicitation for HTA (Dr. L. Pecchia) WHO, BME, medical devices, and global health (a) Selection of priority medical devices (A. Velazquez, WHO) (b) The role of BME to develop appropriate technologies for low-middle income countries and settings (A. Velazquez, WHO)
Results and platform utilization Measuring the impact of the IFMBE HTAD activities focusing on training BME in HTA-related topics is not easily quantifiable. Probably, its main benefits will become clearer in the next 10 years. Nonetheless, it is possible to report on the utilization of the eLearning platform since its launch. In June 2017, after 12 months from its launch, the eLearning platform was utilized from 10 countries with up to 300 visits per country. From June 2017 to June 2018, the platform
Health technology assessment teaching for BME Chapter | 118 835
was utilized by more than 25 countries with up to 829 users per country. From the Fig. 1, it is also evident that the main use of the platform has been done from the so-called “great south,” which hosts mainly middle-income countries in South America and many low-income countries in Africa.
Further reading Beukelman, T., Brunner, H.I., 2016. Trial design, measurement, and analysis of clinical investigations. In: Textbook of Pediatric Rheumatology. WB Saunders, pp. 54–77. e52. Bhopal, R.S., 2016. Concepts of Epidemiology: Integrating the Ideas, Theories, Principles, and Methods of Epidemiology. Oxford University Press. Bland, J.M., Altman, D.G., 2000. The odds ratio. BMJ 320 (7247), 1468. Durkheim, E., 2005. Suicide: A Study in Sociology. Routledge. Ernster, V.L., 1994. Nested case-control studies. Prev. Med. 23 (5), 587–590.
Jadad, A., 1998. Randomised Controlled Trials. BMJ Books, London. Mathes, T., Pieper, D., 2017. Clarifying the distinction between case series and cohort studies in systematic reviews of comparative studies: potential impact on body of evidence and workload. BMC Med. Res. Methodol. 17 (1), 107. Morgenstern, H., 1995. Ecologic studies in epidemiology: concepts, principles, and methods. Annu. Rev. Public Health 16 (1), 61–81. Parab, S., Bhalerao, S., 2010. Study designs. Int. J. Ayurveda Res. 1 (2), 128. Pocock, S.J., 1992. When to stop a clinical trial. BMJ 305 (6847), 235. Pocock, S.J., 2013. Clinical Trials: A Practical Approach. John Wiley & Sons. Rosenbaum, P.R., 2010. Design of Observational Studies. Springer. Schlesselman, J.J., 1982. Case-Control Studies: Design, Conduct, Analysis. Oxford University Press. Setia, M.S., 2016. Methodology series module 3: cross-sectional studies. Indian J. Dermatol. 61 (3), 261.
Health technology assessment teaching for BME Leandro Pecchiaa, Davide Piaggioa, Nicolas Pallikarakisb, Ernesto Iadanzac a
School of Engineering, University of Warwick, Coventry, United Kingdom, bUniversity of Patras, Patras, Greece, cIFMBE HTA Division, School of Engineering, University of Florence, Florence, Italy
Introduction Writing the second edition of the Handbook of Clinical Engineering is also a great opportunity to reflect on the several achievements made by biomedical engineering (BME) in the past 20 years. In fact, the first edition of this book was designed at the end of the 1990s and published in 2004. After 20 years, the scenario in which this book is conceived is significantly different. One of the main differences is in the extent to which BME is recognized from international policy-makers. This opens novel opportunities for BME and requires BMEs to take more responsibility in the way they contribute to face socioeconomic challenges. Understanding this change is a fundamental step toward the designing of BME education in the next decades. For instance, the European Union Journal (2015/C 291/07) recognized that “BME is not simply a subset of modern medicine. Modern medicine predominantly secures important advances through the use of the products of BME.” It is the first time that BME receives globally such an important recognition. In addition, the World Health Organization (WHO) stated recently that “trained and qualified BME professionals are required to design, evaluate, regulate, maintain, and manage medical devices, and train on their safe use in health systems around the world.”a This was probably the first time that a United Nation Agency called for more BMEs and stated the importance of BME in contributing to medical device regulation on evaluation, beyond the traditional recognition of BME contribution to medical device design, maintenance, and management. In addition, several European countries have started to legislate on BME and clinical engineering professional recognition. Therefore, after several years, it seems that international policy makers clearly understand the importance of BME. a. WHO website, last access medical_devices/support/en/.
832
20.04.2019:
https://www.who.int/
How can the BME community respond to such an unprecedented attention from policy makers? One of the answers is to study more health technology assessment (HTA), which is the front end between BME and policy decision-makers at local (hospital deciding which medical device should be acquired), Regional/National (deciding which healthcare technology should be reimbursed with taxpayer money) and National/International (assessing which technology should be supported with public investments) level. One of the reasons for the growing attention around the BME profession lies in the dizzying growth of the global medical device market. A possible estimator for this growth is the number of patent applications submitted per year. In fact, while pharma research is growing very fast with about 6000 novel patent applications each year from 2006 to 2016, the number of patent applications for medical technologies moved from 8000 per year in 2006 in to more than 12,000 novel patent applications in 2016 (Europe, 2018). Moreover, the time-to-the-market for a medical device is becoming shorter and shorter. Those two factors suggest that the world is going to face a “tsunami” of medical devices, which will further revolutionize medicine and the way we approach health and well-being management. Who will be looking after the assessment of those medical devices? Who is going to help decision-maker prioritizing public-budget to be invested in the most cost-effective medical devices? The answer is certainly BMEs and clinical engineers. In fact, during the writing of this chapter, we have often wondered (and been asked) why a BME should be familiar with the HTA. The answer is that, differently from pharma products, medical devices are designed and produced mainly by small and micro-sized BME companies. In Europe, more than 600,000 workers are employed by 27,000 companies of which 95% are micro, small, or m edium enterprises (SMEs). It is very difficult for an SME to have a dedicated unit coping Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00119-X Copyright © 2020 Elsevier Inc. All rights reserved.
Health technology assessment teaching for BME Chapter | 118 833
with the assessment of their products. Therefore, it is crucial that each BME familiarizes with the principles, if not with the whole framework, of medical device HTA. Differently from the pharma products, medical devices are linked intimately to their innovators. Moreover, the model of innovation of medical devices is often incremental and not disruptive (as for pharma or biotech). Finally, medical devices life span is much shorter than the one of drugs, with components becoming obsolete even before the medical device itself, while pharma compounds longevity can be far longer than the drugs they compose. These differences require the practitioners of HTA to be continuously familiar with the ongoing research and innovation in the field, more than it is required for drugs. In the same way, BMEs should be familiar with HTA in order to foster the impact of their main outputs: medical devices. It is very difficult that in the near future the MD sector will employ many independent experts specifically tuned on regulation or assessment, as it happened for drugs. It is more likely that each BMEs will be required to be competent with HTA creating a real need for integrating more HTA contents in the BME education programs. The International Federation of Medical and Biological Engineering (IFMBE) has already gone in this direction, anticipating this trend of few years. The IFMBE has in fact invested a significant amount of resources for building a proactive community of BMEs experienced in HTA, which have been working since June 2012 for promoting the BME role in HTA beyond the BME community. This chapter describes part of this effort and offers an overview of the eLearning platform (https://htad.ifmbe.org/) that the IFMBE has published for disseminating the HTA culture among BME worldwide.
The IFMBE HTAD In 2012, the IFMBE reactivated the IFMBE Health Technology Division (HTAD, https://htad.ifmbe.org/), which was established in the 1980s but get quite dormant for few decades. In 2012, the IFMBE reactivated the IFMBE Health Technology Division (HTAD, https://htad.ifmbe.org/), which was established in the 1980s but got quite dormant for a few decades. The IFMBE HTAD was reformed in 2012 by Prof Nicolas Pallikarakis, who was appointed as Chair (2012–15) of the IFMBE HTAD during the IUPESM World Congress in China World Congress on Medical Physics and Biomedical 2012 (26–31 May 2012, Beijing, China). Professor Nicolas Pallikarakis coordinated the effort of restarting the IFMEB HTAD, supported by Dr. Patricia Trbovich (IFMBE HTAD Secretary 2012–15) and Dr. Leandro Pecchia (IFMBE HTAD Treasurer 2012–15). In 2015, Dr. Leandro Pecchia was appointed as Chair (2015–18) of the IFMBE HTAD during the IUPESM World Congress on Medical Physics and BME (June 7–12, 2015, Toronto, Canada). Dr. Pecchia, supported by Dr. Patricia Trbovich (IFMBE Treasurer 2012–15) and Dr. Marjan Hummel (IFMBE HTAD Secretary) coordinated the
work of the IFMBE HTAD starting from redefining the vision, strategy, and mission of the division and articulating its activities in 12 projects, of which 3 dedicated to the preparation of teaching contents for HTA. In June 2018, Dr. Ernesto Iadanza was appointed as Chair (2018–21) of the IFMBE HTAD during the IUPESM World Congress on Medical Physics and BME (3–8 June 2018, Prague, Czech Republic). Dr. Iadanza, supported by Dr. Marjan Hummel (Secretary 2018–21) and … (Treasurer 2018–21) has revised the IFMBE HTAD strategy and further supported the investment in HTA training.
The IFMBE HTA summer school During the 2015–18 mandate, the IFMBE HTAD launched the IFMBE HTA Summer Schools Series. The first edition was held at the University of Warwick, UK, from September 8–10, 2015, Chaired by Dr. Leandro Pecchia. The second was held at the University of Patra, Greece, from September 28–30, 2017, cochaired by Dr. Pecchia and Prof. Pallikarakis. Both Summer Schools were organized in 3 days: ●
●
●
the first day aimed at offering to the attendees an introduction to fundamental topics on which the HTA bases, including the evidence generation in medicine, principles of health economics and decision-making in health care; the second day was dedicated to the HTA of medical devices and the extent to which medical devices require different approaches, methods, and tools than the one adopted from HTA of drugs; the last day was dedicated to the deepening of two specific topics: ○ in Warwick, the third day was focused on the socalled early HTA (eHTA), which consist in applying reverse-engineering methods to health economics in order to inform the design of medical devices with the HTA perspective. ○ in Patra, the third day was dedicated to the use of multicriteria decision analysis (MCDA) in HTA of medical devices.
During both the summer schools more than 60 h of HTA lectures specifically designed for BMEs were delivered and video recorded. Those lectures were then converted in eLearning objects and uploaded on a completely free eLearning platform, designed, sponsored, edited, and managed by the IFMBE HTAD.
The IFMBE HTA eLearning platform and contents The IFMBE eLearning platform was designed in 2016 and launched in May 2017. Its goal was to become a repository for HTA related contents (lectures, seminaries, and talks) to be then structured in HTA courses, which can be freely utilized from BMEs and BME lectures all over the world. At the moment this chapter is written, the platform
834 SECTION | 12 Health technology assessment
contains 31 lectures, which have been collected during the two IFMBE HTA Summer Schools and during the International Symposium on Analytic Hierarchy Process (ISAHP2016, August 4–7, 2016, London, UK, http://www.isahp.org/). Those lectures have been organized in nine sections: (1) Introduction to HTA: this section contains basic and advanced lectures to fundamental topics of HTA and health economics: (a) Intro to health economics and HTA of medical devices (Dr. Leandro Pecchia) (b) HTA, an Introduction (Dr. Patrizio Armeni) (2) Evidence generation in medicine (a) Evidence generation in medicine and biomedical engineering (Dr. L. Pecchia) (b) Evidence generation in medicine (Prof. S. Stranges) (c) The value proposition: promise versus evidence (Prof. D. Clark) (3) Systematic literature review and meta-analysis (a) Evidence-based BME and meta-analysis (Dr. L. Pecchia) (b) Introduction to the meta-analysis (Dr. L. Pecchia) (c) Practical lab on meta-analysis with OpenMetaAnalyst (Dr. P. Melillo) (d) Meta-analysis with missing data (Dr. P. Melillo) (4) Multicriteria decision analysis (MCDA) (a) Multicriteria decision analysis (MCDA) for early HTA (Dr. M. Hummel) (b) Multicriteria decision analysis (MCDA) in eHTA (Dr. L. Pecchia) (c) Analytic hierarchy process and data-mining (Dr. P. Melillo) (d) Multiple criteria decision aiding (MCDA) and its potentials to support sustainability and resilience assessment (Dr. M. Cinelli) (5) IFMBE HTAD activities (a) IFMBE HTAD activities 2015–17 (Dr. L. Pecchia) (b) Introduction to the II IFMBE HTAD Summer School (Prof. N. Pallikarakis)
FIG. 1 The IFMBE HTAD utilization per year since its launch in June 2016.
(6)
(7)
(8)
(9)
(c) Introduction to the first IFMBE Summer School on HTA (Dr. L. Pecchia) Early HTA (a) Early health economic evaluations and eHTA (Dr. L. Pecchia) (b) Early stage HTA via decision tree (Dr. M. Craven) (c) Early stage HTA via Markov models (Dr. M. Craven) (d) Multicriteria decision analysis (MCDA) in eHTA (Dr. M. Hummel) HTA of medical devices (a) The industry of medical devices and medical devices regulation of in the EU (Prof. N. Pallikarakis) (b) The industry, the regulation and the challenges in assessing medical devices (Prof. R. Tarricone) (c) Institutional HTA: the European perspective (Dr. O. Ciani) (d) Medical device assessments at CADTH (Dr. J. Polisena) User-need elicitation (a) User-need elicitation via AHP (Dr. L. Pecchia) (b) MCDA in user need elicitation for HTA (Dr. L. Pecchia) WHO, BME, medical devices, and global health (a) Selection of priority medical devices (A. Velazquez, WHO) (b) The role of BME to develop appropriate technologies for low-middle income countries and settings (A. Velazquez, WHO)
Results and platform utilization Measuring the impact of the IFMBE HTAD activities focusing on training BME in HTA-related topics is not easily quantifiable. Probably, its main benefits will become clearer in the next 10 years. Nonetheless, it is possible to report on the utilization of the eLearning platform since its launch. In June 2017, after 12 months from its launch, the eLearning platform was utilized from 10 countries with up to 300 visits per country. From June 2017 to June 2018, the platform
Health technology assessment teaching for BME Chapter | 118 835
was utilized by more than 25 countries with up to 829 users per country. From the Fig. 1, it is also evident that the main use of the platform has been done from the so-called “great south,” which hosts mainly middle-income countries in South America and many low-income countries in Africa.
Further reading Beukelman, T., Brunner, H.I., 2016. Trial design, measurement, and analysis of clinical investigations. In: Textbook of Pediatric Rheumatology. WB Saunders, pp. 54–77. e52. Bhopal, R.S., 2016. Concepts of Epidemiology: Integrating the Ideas, Theories, Principles, and Methods of Epidemiology. Oxford University Press. Bland, J.M., Altman, D.G., 2000. The odds ratio. BMJ 320 (7247), 1468. Durkheim, E., 2005. Suicide: A Study in Sociology. Routledge. Ernster, V.L., 1994. Nested case-control studies. Prev. Med. 23 (5), 587–590.
Jadad, A., 1998. Randomised Controlled Trials. BMJ Books, London. Mathes, T., Pieper, D., 2017. Clarifying the distinction between case series and cohort studies in systematic reviews of comparative studies: potential impact on body of evidence and workload. BMC Med. Res. Methodol. 17 (1), 107. Morgenstern, H., 1995. Ecologic studies in epidemiology: concepts, principles, and methods. Annu. Rev. Public Health 16 (1), 61–81. Parab, S., Bhalerao, S., 2010. Study designs. Int. J. Ayurveda Res. 1 (2), 128. Pocock, S.J., 1992. When to stop a clinical trial. BMJ 305 (6847), 235. Pocock, S.J., 2013. Clinical Trials: A Practical Approach. John Wiley & Sons. Rosenbaum, P.R., 2010. Design of Observational Studies. Springer. Schlesselman, J.J., 1982. Case-Control Studies: Design, Conduct, Analysis. Oxford University Press. Setia, M.S., 2016. Methodology series module 3: cross-sectional studies. Indian J. Dermatol. 61 (3), 261.