",isbn:"978-1-83969-545-2",printIsbn:"978-1-83969-544-5",pdfIsbn:"978-1-83969-546-9",doi:null,price:0,priceEur:0,priceUsd:0,slug:null,numberOfPages:0,isOpenForSubmission:!0,hash:"c77f99db5569e8d0325b856cb7d75b17",bookSignature:"Prof. Maged Marghany",publishedDate:null,coverURL:"https://cdn.intechopen.com/books/images_new/10854.jpg",keywords:"Optical, Radar, Algorithm, Programming, Big Data, Deep Learning, Image Processing, Time Series Data Analysis, Large Scale Methods, Signal Processing, Computer Vision, Remote Sensing",numberOfDownloads:null,numberOfWosCitations:0,numberOfCrossrefCitations:null,numberOfDimensionsCitations:null,numberOfTotalCitations:null,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"February 18th 2021",dateEndSecondStepPublish:"March 18th 2021",dateEndThirdStepPublish:"May 17th 2021",dateEndFourthStepPublish:"August 5th 2021",dateEndFifthStepPublish:"October 4th 2021",remainingDaysToSecondStep:"9 days",secondStepPassed:!1,currentStepOfPublishingProcess:2,editedByType:null,kuFlag:!1,biosketch:'Prof. Marghany was recently ranked among the top two percent scientists in a global list compiled by the prestigious Stanford University. 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1. Introduction
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Most countries in the world prioritized the agenda to expand enrolments in HE through aggressive policy changes. The UN [1] contends that “Higher education (HE) across the world is in a state of change, quickly shifting from being the privilege of an elite few to mass participation, providing equal access to affordable and quality university education for all women and men, which is a global goal for 2030”. Supporting this view, Tsiplakides [2] declares that HE has experienced a significant expansion in many countries and this resulted in the massification of this critical societal sector. Learning in higher education (HE) is accessed through different modes including distance, full time, or part time. Nitecki [3] maintains that the universities that provide open distance learning (ODL) programs rely on technology to make higher education more accessible to students.
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The phenomenon of Open and Distance Education is made possible by the advent of technological discoveries, which impact heavily on the mode of curriculum delivery. The challenge to the agenda of wider HE participation is whether the massive student enrolments are translated into success rates or are just statistics of wider HE participation. There are a number of factors that contribute toward low students’ success rate. These factors include the following: students’ underpreparedness and lack of contact with lecturers and working students [4]. This chapter does not intend to disregard some of the fundamental factors that are contributing to low success rates of students, but its focus is on the assumption that an ODL constructively aligned and technology-mediated teaching can improve students’ success rates. The principles of constructive alignment have long been promoted as powerful approaches to facilitating enhanced student outcomes [5]. A number of sections constitute this chapter. In the next section, I explore what open and distance learning entail, and then the concept of constructive alignment will be theorized. The rest of the discussions include the following sections: perspectives on students’ success rates in ODL contexts, benefits of students’ success rates, the need for constructively aligned and technology-driven ODL curriculum, designing teaching strategies and assessment strategies, and finally the intended learning outcomes for improved student success rates.
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2. Describing open and distance learning
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Tuition in open and distance learning contexts is conducted differently from face-to-face higher education settings. The economic challenges facing countries are impacting HE participation negatively and demand interventions which will enhance participation and success in HE sector. Manzoor [6] argues that the introduction of open and distance learning universities was regarded as a groundbreaking option in expanding access to higher education. Open and distance education is critical in ensuring that socioeconomic challenges facing the majority of countries of the world are alleviated.
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The advent of ODL settings marked an error that is distinct from the traditional Higher Education provision. Open and distance learning is usually contrasted with conventional or face-to-face education, which may be described as the form of education which takes place in a classroom or an auditorium [7, 8]. In ODL settings, students receive tuition away from the physical structure of the institution [9], and this is a distinguishing feature between full-time learning and distance learning. Agiomirgianakis et al. [10] define distance education as any educational process in which all or most of the teaching is conducted by someone geographically removed from the learner, with all or most of the communication between teachers and learners being conducted through electronic or print mediums. Allen and Seaman [11] define distance education as “that which uses one or more technologies to deliver instruction to students who are separated from the instructor and to support regular and substantive interaction between the students and the instructor synchronously or asynchronously”. Teaching in ODL “encompasses a broad range of teaching, coaching, mentoring and monitoring activities that guide students through their courses, mediating the packaged learning materials and facilitating the learning process [12]”. ODL settings by their nature provide learning opportunities to students who are mature and working and who are unable to acquire access education in full-time, contact, and campus-based institutions [13].
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According to Chawinga and Zozie [14], ODL is the type of teaching and learning which does not include face-to-face interaction between the student and the lecturer, and Chawinga and Zozie [14] further argue that the main objective of introducing ODL is to provide education to those students who are geographically distanced from the lecturers. Anderson and Dron [15] contend that since ODL started operating decades ago, distance education experienced different changes, and to these scholars, distance education can be classified into three distinct generations. According to Biggs [16], “the first generation of distance education technology was by postal correspondence, this was followed by a second generation, defined by the mass media of television, radio, and film production. Third-generation distance education introduced interactive technologies, first audio, then text, video, and then web and immersive conferencing.”
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Flowing from the assertions above, largely, teaching in an ODL context should not be traditionally pedagogical but also technological driven due to the nature of these institutions. This will help in improving students’ graduation rate. In view of the above and given the nature of the distance instruction, Biggs [16] advocate for a distance education that is technologically mediated in order for it to reach students who are detached from the real classroom and also breach a gap between them and their teachers.
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3. Theorizing constructive alignment
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Cain et al. [17] are the advocates of the principles of constructive alignment. The principles of constructivism to teaching were critical when the theory of constructive alignment was formulated. Cain et al. [17] identified two critical important concepts of the constructive alignment theory, namely constructivism and alignment. According to them, the former concept relates to students giving meaning to what they are learning through relevant learning activities and the latter deals with what the teachers are doing. Constructive alignment uses constructivism as a guiding philosophy [18]. Theorists who believe in constructivism view knowledge as a human construction, which denotes the combination of constructivist learning theories and the curriculum that is aligned [18]. Biggs [19] believes in the motto: “It is what the student learns that counts”. The constructive alignment theory represents the idea that students should know in advance what is entailed in their learning, how they should learn, and how they are going to be tested in their learning [20, 21]. Cain and Babar [21] further argue that these principles advocate for teaching designed to involve students in learning activities, teaching that optimizes the chances of student success, with the assessment tasks which are designed to enable clear findings as to how well learning outcomes have been attained [20].
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Demuth [22] contends that the constructive alignment theory is a model of teaching that combines constructivist learning theory and aligned instruction design that intends to improve learning. According to Biggs [23], the main concepts of constructive alignment are learning objectives, learning activities, and assessment tasks. Tadesse et al. [24] postulate that the priority thing in the constructive alignment process is the development of intended learning outcomes. To them, teachers should first clarify and define learning outcomes, then describe teaching approaches and activities that will help to achieve the outcomes and ensure that what is being taught is directly linked to what students are expected to learn. The final step is to develop assessment strategies and activities linked to both teaching strategies and learning outcomes. When the elements of teaching such as learning outcomes, teaching, and assessment strategies are not linked, Tadesse et al. [24] describe such an education system as a poor education system.
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Teachers through their engagement have to create learning opportunities that have to enable students to create meaning in their learning. The teaching activities decided upon should support the achievement of the learning outcomes. In the next section, it shall be argued that the constructively aligned learning outcomes, teaching and assessment strategies should be taught through technology to help achieve high student success rate.
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Figure 1 (attached as appendix) represents the application of the principles of constructive alignment in ODL contexts. The figure also provides a picture of how pedagogy can be mediated through technological advances such as computers platforms such as laptops, tablets, and cell phones. The figure demonstrates a relationship of these constructive and collaborated pedagogical practices, which promote student graduation rates. Teaching strategies and assessment methods are both designed in a manner that student learning and achievement is promoted.
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Figure 1.
Constructively aligned and technology-mediated pedagogical practices (Adapted from Victoria University of Wellington, (2015) and modified).
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4. Technology-enabled open and distance learning
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The use of Information and Communication Technology (ICT) in ODL institutions is critical in helping improving students’ graduation records. Tadesse et al. [24] contend that the use of ICT enhances learning and the organization and the management of learning institutions. Tadesse et al. [24] further argue it is in teaching essential to the progress and development of both teachers and students. Englund et al. [25] maintain that over the last 25 years, educational technology in Higher Education (HE), particularly ODL, has been promoted as having the potential to transform teaching and learning. Adding their views on the importance of technology in HE, Ramdass and Masithulela [26] and Farah [27] are of the view that the advent of the digital era has brought with it very important changes in various aspects of the education system, and it is very difficult to provide tuition to students in ODL environments without the practice of technology and this creates an atmosphere which Farah et al. [27] refer to as the “digital disconnect.” Technological advances have radically transformed the way in which education is delivered and received in HE institutions, particularly in ODL settings. Using technological platforms such as smart phones, tablets, and eBooks promote wider participation in HE ODL institutions and provides students with opportunities to understand their learning. Seconding this assertion, Kalelo-Phiri and Brown [28] are of the view that “Open and Distance Learning (ODL) in the form of print, radio/audio or video helps to reach out to learners who do not only experience geographical barriers but time barriers also.”
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In this chapter, it can be argued that the creation of an environment in which pedagogical practices are aligned and delivered to students through enhanced technology can improve students’ success rates in ODL settings. Employing technological platforms such as e-resources constitutes effective learning and teaching tools that help overcome barriers in ODL environments [29]. Research indicates that advances in technologically based approaches enhance tuition in higher education sectors [29]. As argued earlier, students who study in ODL institutions are geographically distanced from the physical environment and the academics. Because of the nature of ODL institutions, tuition is largely dependent on technology-driven platforms and systems that mediate teaching. To this end, there should be an effort in mediating pedagogical practices within a collaborated context. Put simply, to improve the students’ success rates, pedagogical practices based on the principles of constructive alignment in ODL contexts should be technology collaborated and driven. The change in curriculum delivery requires ODL staff members to reconsider the manner in which they teach their students. They have to be technology literate to help students achieve their objectives.
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5. Perspectives on student success rates in ODL contexts
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As argued earlier, open distance education has grown exponentially over the past few years. Credible research statistics on the students’ success rates constantly paint a shocking and uncomfortable picture in the HE sector throughout the world. This happens despite the sectors’ efforts of providing opportunities of success to all students [30]. There is an abundance of empirical evidence on the factors that contribute toward low students’ success rates [31]. The challenges and the complexities that face HE institutions, especially those that are related to the graduation rates are huge, and Mattie [32] points out that “HE environment continues to be complex, with increasing expectations about performance.” Student success rate is understood and described differently by different scholars. Nitecki [3] describes student success rate as the process where students successfully complete their qualifications such as a degree. In this chapter, students’ success is described as the ability of HE through ODL mode to help students graduate or complete the programs they are enrolled for in a stipulated time, for example, finishing a three-year qualification within specified record time.
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The pass percentage rate at HE, particularly in ODL, is alarming [33]. Brock [34] laments that “although access to higher education has increased substantially over the past forty years, student success as measured by persistence and degree attainment, has not improved at all.” Upholding and adding to the viewpoint above, Agiomirgianakis et al. [10] claim that “despite substantial government funding incentives, numerous policy initiatives and well-intentioned institutional efforts, retention and success rates remain extremely poor.” Leadership in ODL settings have a huge responsibility and are under pressure to ensure that constructively aligned instruction opportunities are created and technologically mediated to boost the academic achievements of students.
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Doley [35] is of the view that students who now participate in HE through ODL system have increased, but despite such growth, ODL institutions continue to face low student graduation rates because some of the enrolled students do not complete their qualifications within regulated specifications and some drop out of the system. Credible empirical research findings conducted by organizations such as UNESCO and UNICEF paint a gloomy picture of matters related to the students’ graduation rates across the continents. What makes matters worse is the fact that ODL institutions do not only face low students’ pass rates but the majority also drops out from the system. Figures supplied by Van Stolk et al. [36] supported by UNESCO [37] show a sturdy increase in enrolments, and the numbers recorded were above 170 million. Unfortunately, statistics continue to show that despite this increased participation, the majority of these students do not complete their qualifications and some drop out from the system.
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The main argument advanced in this chapter is that when teaching and assessment strategies in ODL settings are aligned and students are provided with opportunities to construct their own meaning through appropriate technology, the intended learning outcomes are achieved and result in the promotion of the graduation rates of students. Biggs and Tang [38] are of the view that some HE staff members associate the decline of academic standards with intellectual abilities of today’s students. Adding their voices to these debates, Tremblay et al. [39] postulate that “in the context of massive expansion of higher education systems and wider participation, there are persistent concerns related to the quality and relevance of students’ preparation for higher education.” In the next section, this chapter focuses on the benefits of students’ success.
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6. Benefits of student success rates
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An education system that aims at producing high quality graduates assists in solving the challenges the world faces. The majority of countries face challenges, which are socioeconomic and political in nature. These current global socioeconomic and political challenges require a generation that is educationally enlightened, and hence, in 2000, 189 countries of the world came together to chart the strategy in an attempt to propose future solutions, and from that gathering, 59 sustainable development goals (SDGs) were identified. Though 59 sustainable goals have been identified, this section mainly focuses on the implications of improved student success rates on only three SDGs, namely the alleviation of poverty, decent work and economic growth, and industry, innovation, and infrastructure. The intention of HE is to produce the human capital that is able to respond to the societal needs [10]. Individuals who have attended universities become professionals and transformed because they are highly skilled and knowledgeable which is critical and helpful in the societies they come from. Through their skills, the communities they come from are economically advanced than communities with individuals who did not attend HE. The Sustainable Development Goals Report [40] maintains that “the objective of sustainable development goal number one is to ensure that people in every part of the world are given support that they need to lift themselves out of poverty in all its manifestations.”
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It can be argued that constructively aligned and technology-mediated pedagogical practices can help improve student success rates which can indirectly assist in the alleviation of poverty, particularly in most poverty-stricken countries. This constitutes the very essence of sustainable development. “The fundamental goal focuses on ending poverty through interrelated strategies, including the promotion of social protection systems, decent employment and the resilience of the poor [40].” One of the strategies beneficial to societies in alleviating poverty is through the provision of constructively aligned ODL and technology-mediated tuition. Once the majority of the poor receive education, they will be able to sustain themselves either through creating employment or finding employment in the job market.
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HE is playing a fundamental role in the countries’ economic improvement and development, and through educated graduates, sustainable growth is easy to achieve [41]. The British Council [42] also believes that the massification of HE is a major contributor toward national wealth and economic development. In supporting this assertion, Wood and Breyer [43] postulate that by “providing higher education opportunities to most students, governments adopt a human capital approach by investing heavily in higher education, believing that there are positive associations between higher education, transition to the labor market and economic growth.” Further, Wood and Breyer [43] maintain that the fundamental reason for the establishment of HE is mainly for the production of workforce that is adequately capacitated to firstly benefit the individual, secondly the communities, and thirdly the economies of the world. According to Mirowsky and Ross [44], holding a university qualification means status and prestige and improves the socioeconomic positions of individuals.
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Industrialization is also critical in the absorption of human capital that is produced through constructively aligned and technology-driven mediated ODL curriculum. Wong [45] supported by Baumol [46] is of the view that “the production of adequate industrialists and graduates who are innovation driven by Higher Education through ODL settings is critical in achieving the goal focusing on industry, innovation and infrastructure.” Improved graduation rates are critical in helping in the achievement of sustainable development goals. The British Council [42] claims that the quality of graduates who are produced by HE lacks requisite industrial knowledge needed to boost business performance and confidence. University education provides students with an opportunity to achieve innovative skills that are needed in maintaining sustainable development. Wang [41] contends that universities play a critical role in the training of technically talented graduates for local economic development and innovation and entrepreneurship education. In the next section, the need for designing constructively aligned ODL curriculum shall be explored.
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7. Rethinking ODL curriculum development: the need for constructively aligned and technology-driven ODL curriculum
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This section provides insights and understanding in the development of constructively aligned and technology driven open and distance education curriculum. The notion curriculum encompasses a number of educationally related aspects, in this chapter without ignoring other critical aspects of this concept; the focus is on the learning outcomes, teaching and assessment strategies. In designing a curriculum in ODL settings, designers should always apply the principles of constructive alignment [7, 8]. Developing a fit-for-purpose curriculum requires the designers to think of the nature and the contexts in which ODL institutions operate. This involves selecting appropriate technology [47] that will enhance students’ success rates because technology in ODL settings has proven to be of great help to both students and lecturers [48]. The purpose of using technology in ODL curriculum is to provide opportunities for students to master the content to improve their graduation rates.
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In improving the graduation rates at ODL institutions, it is very important to reconsider teacher development. ICT training should constitute the critical part of teacher development and training because introducing technology in education will change the manner in which teaching and learning takes place. The millennial generation understands better when technology becomes part of their studies. Curriculum developers should take into cognizance that for tuition to be effective, the principles of constructive alignment and technology-driven pedagogical practices constitute part of the process because Tadesse et al. [24] postulate that the use of Information and Communication Technology (ICT) can be beneficial for the pedagogy in ODL systems. Supporting the assertion, Henderson et al. [47] contend that “digital technologies currently form an integral feature of the university student experiences and as such, academic research has understandably focused on the potential of various digital technologies to enable, extend and even ‘enhance’ student learning.” For this reason, in this chapter, it is argued that constructively aligned teaching, learning, assessment and using appropriate technological tools improves the graduation rates of students.
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8. Designing teaching strategies, assessment strategies, and learning outcomes for improved students’ success rate
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8.1. Learning outcomes
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Learning outcomes are foundational, and poorly developed learning outcomes defeat the purpose and the rationale of the program and contribute toward high failure rate. Learning outcomes are foundational in the sense that they predict the kind of teaching and assessment strategies that are supposed to be developed. They also provide opportunities for students to develop their capabilities [49]. It is therefore critical that in designing, defining, and specifying learning outcomes, critical analysis of the nature and the context of ODL be taken into consideration. Designing effective learning outcomes should not be detached from developing the teaching and assessment strategies. This means that the process should not be an isolated process where the three components involved in constructive alignment are individually formulated. Learning outcomes should indicate the content that students are expected to know at the end of the lesson. The learning outcomes are written statements of what the students are expected to know, understand, and be able to do after completion of a learning unit [50]. The learning outcomes should be linked to the purpose and the rationale of the program and take into considerations the nature and mode of learning and teaching which is targeted at ODL students. In designing learning outcomes, developers should avoid crafting vague statements. “Good learning outcomes focus on the application and integration of the knowledge and skills acquired in a particular unit of instruction (e.g., activity, course program, etc.), and emerge from a process of reflection on the essential contents of a course” [51, 52]. According to Centre for Teaching Support and Innovation [53], the following characterizes good learning outcomes: they should be “smart, meaning manageable, applicable, realistic, time-bound, transparent, and transferable. Technological consideration is very critical in the design of learning outcomes [27]”.
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8.2. Teaching strategies and activities
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Developing well-designed components of pedagogical practices such as teaching and learning strategies is very critical, particularly in ODL settings. These teaching strategies and activities should be guided by the learning outcomes that have been defined from the beginning. Teaching, learning, and assessment strategies should be demonstrated by appropriate activities that are intended to help students achieve well-defined learning outcomes. Teaching in an ODL environment is conducted differently from ordinary universities or other institutions of higher learning because as indicated earlier, students are not full time in classes. They are geographically detached from the classes. It is critical that teaching in these contexts take into account that the environments in which learners find themselves differ, they face different challenges and barriers, and because of that, teaching should employ different approaches and strategies that will make learning easier. In their pedagogical practices, teachers should always bear in mind the principles of technology-driven and constructive-alignment curriculum.
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8.3. Assessment strategies and activities
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Assessment is critical in ODL curriculum [54]. In administering assessment, academics must ensure that the process enhances students’ learning experiences and their academic achievement. Assessing students forms an important part of teaching and learning process. It also assists in the identification of the weakness in the teaching process, and the areas which needs improvement. “Assessment also helps students to become more self-regulated, reflexive, independent individuals with the skills to exercise high-level assessment on their own and others’ work that enhances lifelong learning” [54]. Cain and Babar [21] identify the following benefits of assessment: making the difference to student motivation, informing students’ future study choices, providing a means of measuring the effectiveness of the module content and teaching methods, and providing information to teachers to help facilitate quality assurance and improvement. Cain and Babar [21] are of the view that assessment feedback is critical in constructive alignment and helps students understand their progress. Sadler [49] contends that “assessment should not be poorly designed, should not be ambiguous, should be interpreted the same by different students, should be clearly spelt out and specified and its intentions should be to assist students achieve the intended outcomes.” Poorly designed assessment tasks and activities contribute toward low student success rate. Evans et al. [54] point out that even though students might be able to escape the effects of poor teaching, they are unlikely to succeed in escaping the effects of poor assessment. Technology-driven assessment strategies and activities are critical in improving student success rates. Mafenya [55] believes that the use of technology supports assessment and also feedback. The technology tools that are selected in assessing students should not be barriers to students’ achievements, and they should rather make it easier for students to understand what they have learnt.
\n
\n
\n
\n
9. Conclusion
\n
This chapter has argued that designing a constructively aligned pedagogy and mediating it through technological tools in ODL settings improve students’ success rate. In this chapter, it has been indicated that most of the countries of the world massified higher education through distance education. Yet, despite providing higher education services to the majority of students, there remains a challenge of international proportions of low student success rates. Various critical themes were explored, and among them were included the description of ODL settings, theorization of the principles of constructive alignment, technology enhanced ODL, perspectives on students’ success rate, benefits of students’ success rate and designing electronically mediated constructively aligned ODL curriculum. It was argued that constructively aligned and technologically mediated pedagogical practices can help improve students’ success rates.
\n
\n\n',keywords:"open distance learning, constructive alignment, student success rates, technology-mediated pedagogical practices, ODL settings",chapterPDFUrl:"https://cdn.intechopen.com/pdfs/60139.pdf",chapterXML:"https://mts.intechopen.com/source/xml/60139.xml",downloadPdfUrl:"/chapter/pdf-download/60139",previewPdfUrl:"/chapter/pdf-preview/60139",totalDownloads:964,totalViews:536,totalCrossrefCites:1,totalDimensionsCites:1,hasAltmetrics:0,dateSubmitted:"October 3rd 2017",dateReviewed:"February 19th 2018",datePrePublished:"March 22nd 2018",datePublished:"August 1st 2018",dateFinished:null,readingETA:"0",abstract:"Statistics indicate that participation and access to higher education (HE) improved drastically, particularly through distance education. Despite the generosity of the massification of HE, a sizeable number of students do not complete their programs on record time. The majority of some of these students drop out. A convincing body of knowledge demonstrates that a plethora of factors contributes toward low student success rates in open distance learning (ODL) contexts. The main purpose of this conceptual argument is that technology-mediated constructively aligned pedagogical practices in ODL contexts can leverage student success rates. This chapter is qualitative and constructivist in nature and largely draws from the theory of constructive alignment and extant scholarship analysis to provide insights and understanding in improving students’ graduation rates in ODL settings. Drawing from the theory of constructive alignment, in this conceptual argument, it can be concluded that aligning the activities of the pedagogical practices (teaching, assessment, and learning outcomes) and delivering them through information and communication technology promotes students’ graduation rates.",reviewType:"peer-reviewed",bibtexUrl:"/chapter/bibtex/60139",risUrl:"/chapter/ris/60139",book:{slug:"trends-in-e-learning"},signatures:"Shuti Steph Khumalo",authors:[{id:"224476",title:"Dr.",name:"Shuti Steph",middleName:null,surname:"Khumalo",fullName:"Shuti Steph Khumalo",slug:"shuti-steph-khumalo",email:"ekhumass@unisa.ac.za",position:null,institution:null}],sections:[{id:"sec_1",title:"1. Introduction",level:"1"},{id:"sec_2",title:"2. Describing open and distance learning",level:"1"},{id:"sec_3",title:"3. Theorizing constructive alignment",level:"1"},{id:"sec_4",title:"4. Technology-enabled open and distance learning",level:"1"},{id:"sec_5",title:"5. Perspectives on student success rates in ODL contexts",level:"1"},{id:"sec_6",title:"6. Benefits of student success rates",level:"1"},{id:"sec_7",title:"7. Rethinking ODL curriculum development: the need for constructively aligned and technology-driven ODL curriculum",level:"1"},{id:"sec_8",title:"8. Designing teaching strategies, assessment strategies, and learning outcomes for improved students’ success rate",level:"1"},{id:"sec_8_2",title:"8.1. Learning outcomes",level:"2"},{id:"sec_9_2",title:"8.2. Teaching strategies and activities",level:"2"},{id:"sec_10_2",title:"8.3. Assessment strategies and activities",level:"2"},{id:"sec_12",title:"9. Conclusion",level:"1"}],chapterReferences:[{id:"B1",body:'UN. Transforming Our World: The 2030 Agenda for Sustainable Development [Internet]. 2015. Available from: http://www.un.org/ga [Accessed: November 07, 2015]\n'},{id:"B2",body:'Tsiplakides I. 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South Africa: University of South Africa; 2016\n'}],footnotes:[],contributors:[{corresp:"yes",contributorFullName:"Shuti Steph Khumalo",address:"ekhumass@unisa.ac.za",affiliation:'
University of South Africa, Republic of South Africa
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1. Introduction
Ménière’s disease (MD), also called idiopathic endolymphatic hydrops, is one of the most common causes of dizziness originating in the inner ear. The typical clinical manifestations are frequent spontaneous vertigo, fluctuating sensorineural hearing loss, tinnitus, and/or aural fullness. Vertigo is typically the most debilitating symptom, and control of vertiginous episodes is the primary goal of therapeutic interventions for most patients.
There are numerous available therapeutic options for MD including conservative treatments with dietary modifications, oral medication, procedural treatments with intratympanic therapies, and surgical treatments. A failure of conservative therapy often introduces the need for a more aggressive therapy on the treatment algorithm.
Surgical intervention or intratympanic aminoglycosides can be used in patients with intractable vertigo, which, ideally, should control the vertigo while preserving the hearing level and balance. The side effects of aminoglycosides are well-know. The risks of vestibular and cochlear toxicity are mainly related to types of aminoglycosides, route of administration, duration of the therapy, total or cumulative dose, individual susceptibility, renal function, patient’s age, etc.
In 1948, Fowler [1] first used systemic streptomycin to treat vertigo attacks in patients with intractable MD. The results showed that vertigo attacks could be well controlled, but treatment carried the risks of bilateral vestibulopathy, nephrotoxicity, and unpredictable results. In 1957, Schuknekt [2] may have been the first to use intratympanic streptomycin to alleviate vertigo attacks in patients with unilateral intractable MD, and it was firstly named “chemical labyrinthectomy”. Intratympanic gentamicin (ITG) for the treatment of severe vertigo was reported by Lange [3]. The initial approach was complete vestibular ablation to control the vertigo. However, with this approach, the hearing was at a greater risk. Over the past decades, the pharmacological mechanisms of aminoglycosides have been progressively studied in depth and clinical trials have been extensively developed.
At present, intratympanic injection of gentamicin is probably the most effective non-surgical treatment to eradicate vertigo in MD and is gradually gaining popularity in the worldwide. Compared with the treatment regimen decades ago, several modifications for ITG treatment have emerged regarding the concentration of the gentamicin solution, the frequency of injections, and the method of delivery. In this chapter, the history, background, and progression of ITG treatment for MD are discussed, as well as the basic science, therapeutic method, treatment efficacy, indications, contraindications, and complications.
2. History of intratympanic gentamicin
Aminoglycosides are highly potent, broad-spectrum antibiotics and are widely used by various routes of injection to treat serious infections caused by Gram-negative bacteria (e.g., Pseudomonas aeruginosa, Proteus species, Escherichia coli, Klebsiella-Enterobacter-Serratia species, and Citrobacter species), and are sometimes used as an adjuvant treatment for infections caused by Gram-positive bacteria (e.g., Staphylococcus species). The basic chemical structure required for both potency and the spectrum of antimicrobial activity of aminoglycosides is that of one, or several, aminated sugars joined in glycosidic linkages to a dibasic cyclitol. Aminoglycosides act primarily by impairing bacterial protein synthesis through binding to prokaryotic ribosomes [4].
Streptomycin, which was discovered in 1944, is the first aminoglycoside antibiotic in human history and was thereafter marked by the successive introduction of a series of milestone compounds (kanamycin discovered in 1957, gentamicin in 1963, and neomycin in 1970s) which definitively established the usefulness of this class of antibiotics for the treatment of Gram-negative bacillary infections. From the 1960s to 1970s, aminoglycosides were widely used, but due to their serious ototoxicity and nephrotoxicity, their systemic application was limited, and they were gradually fading out of the ranks of first-line drugs. At the beginning, the most common side effect of streptomycin used by intravenous injection was temporary imbalance without vertigo or nystagmus. Higher systemic doses increased the chance of permanent imbalance and, occasionally, deafness. These early observations led to animal and cadaver studies which confirmed the vestibulotoxic and cochleotoxic effects of high-dose streptomycin.
Based on its vestibulotoxicity, streptomycin foremost unveiled its potential in the treatment of vestibular diseases. In 1948, about 4 years after streptomycin was discovered, Fowler [1] first used systemic streptomycin to treat vertigo attacks in patients with intractable MD which was refractory to traditional medical treatment. He and others used between 2 and 4 g of intramuscular streptomycin per day in patients with unilateral or bilateral MD, typically until onset of severe imbalance, and reported that vertigo attacks could be well controlled without loss of hearing. Often, and especially with higher dosing, vertigo control was accompanied with the troubling symptoms of permanent, severe imbalance, and oscillopsia.
In 1957, Schuknecht [2] may have been the first to use intratympanic streptomycin to alleviate vertigo attacks in patients with unilateral MD that was uncontrolled by traditional medical management. He conceived of this idea after noting that intratympanic formalin will readily pass into the inner ear and prevented post-mortem degeneration of the inner ear membranous structures in patients. He correctly theorized that streptomycin could also pass into the inner ear and devised a cat animal model that demonstrated clinical and pathologic vestibulotoxicity with intratympanic streptomycin. Based on these results, he devised a clinical trial of intratympanic streptomycin administration to patients with uncontrolled unilateral MD. He administered variable amounts of streptomycin (between 0.125 and 0.5 g), either hourly or over 4 hours, over a variable amount of days. The first group of three patients who received 1 or 2 days of treatment achieved only brief control of their vertigo, but did not lose any hearing. Subsequently, an additional group of five patients received streptomycin for 3 days or longer. These patients had permanent resolution of their vertigo episodes, but at the cost of deafening the ear. Schuknekt coined the term “chemical labyrinthectomy” to describe this phenomenon. He concluded that intratympanic streptomycin at the therapeutic dosage failed to preserve hearing, and should only be considered for patients who are not good surgical candidates, but would otherwise be proper candidates for inner ear ablation [2].
With the administration of intratympanic aminoglycosides, chemical ablation of the inner ear via systemic administration of aminoglycosides fell into disfavor due to the side effects of bilateral vestibulopathy, nephrotoxicity, and unpredictable results. However, choosing which kind of aminoglycoside for intratympanic injection has gradually changed. In 1977, Lange [3] appears to be the first to have used IT administration of gentamicin. He reported about 55 patients suffering from severe unilateral MD, seen over a period of 3–10 years. Patients were treated with intratympanic administration of streptomycin or better, gentamicin. The medication was given using a plastic tube inserted behind the annulus within the transmeatal approach, and 0.1 ml gentamicin (earlier streptomycin) was instilled every 5 hours until the first signs of inner ear reaction (nystagmus or vertigo) appeared. In 90% of the cases, vertiginous attacks ceased after therapy, and hearing was preserved in 76%.
Entering the 1990s, intratympanic gentamicin had gained widespread popularity in the treatment of MD. Compared with streptomycin, ITG for treatment of MD provided equivalently excellent vertigo control while showing a lower incidence of hearing loss in early clinical data. Gentamicin gained popularity over streptomycin and gradually came to be the drug of choice for chemical ablation of inner ear.
In 1993, Nedzelski et al. [5] studied 50 patients with unilateral MD by treatment of microcatheter administration of streptomycin over a 5 h treatment, 4 treatments within 48 hours, and the rate of vertigo control was up to 96%; only 24% of his patients experienced various degrees of hearing loss. Although streptomycin was being used in the study, he advocated for using gentamicin instead for its theoretical reduction of cochleotoxicity.
Beck and Schmidt [6] reported on their 10 years of experience with intratympanally applied streptomycin and gentamicin in the therapy of MD. They theorized that the dosage might be a critical factor for hearing preservation with vertigo control. Aminoglycosides could be titrated to impede the secretory epithelium of the vestibular apparatus without destroying the sensory cells, thus achieving vertigo control while maintaining caloric response, that is, vestibulo-ocular reflex. More importantly, risk of deafness could potentially be eliminated. By reducing the dosage delivered and titrating, they were able to achieve excellent rates of vertigo control (92%) while also achieving respectable hearing preservation rates (15% hearing loss with no cases of deafness).
During the same era, around the early 1990s, two schools of thought emerged in an effort to standardize ITG treatment, dubbed the “shotgun” approach, and the “low-dose” approach. The shotgun approach, championed by Nedzelski and others [5], was characterized by daily IT injections to a fixed endpoint or to a clinical threshold that heralded damage to the inner ear. Proponents of this approach attempted to achieve adequate vestibular ablation for long-term vertigo control. The low-dose approach, championed by Magnusson and others [7], was characterized by weekly IT injections, also to a fixed endpoint or to clinical effect. Proponents of this approach tried to achieve vertigo control while minimizing damage to hearing and potentially preserving the caloric response as well.
Today, intratympanic injection of gentamicin is probably the most effective non-surgical treatment to eradicate vertigo in MD. Yet, it is an ablative method that carries a non-negligible risk of hearing loss. Currently, gentamicin is usually instilled via IT injection or through a tympanostomy tube to the round window niche. These injections are repeated over a variable amount of time, typically between daily to weekly injections, until a clinical endpoint is achieved or until there is a decline in hearing. No consensus has been reached so far on the overall dosage, dosing methods, timing of delivery, treatment duration, clinical endpoint of therapy, or concentration of gentamicin. Both clinical evidence and basic science models should be further studied to scientifically elicit the most effective and safe regimen.
3. Mechanism of action
Aminoglycoside antibiotics have a well-documented history of cochleotoxic and vestibulotoxic effects. Administration of intratympanic aminoglycoside antibiotics to patients with MD is based on the notion that the patient’s vestibular symptoms are due to the damaged and distorted vestibular signals emanating from their ear and that they are better off with no signal than with a damaged and distorted signal. The objective of ITG is to weaken vestibular signals in the Ménière’s ear to the point at which they are no longer strong enough to generate a vertigo attack. Ideally, aminoglycosides would act to reduce vestibular function, and thus alleviate the patient’s symptoms of vertigo, while preserving hearing. The degree to which a drug is cochleotoxic or vestibulotoxic differs among aminoglycosides. Gentamicin and streptomycin, for instance, are reported to be more vestibulotoxic. Other aminoglycosides, such as amikacin, are considered to be relatively more cochleotoxic and thus are not used transtympanically. The best evidence for this is the simple clinical observation that patients undergoing systemic gentamicin or streptomycin therapy experience vestibulopathy much more commonly than hearing loss. This feature has been used by otologists to control the vestibular symptoms of MD, initially provided through systemic delivery by Fowler [1] and subsequently through IT injections by Schuknecht [2, 8]. Use of streptomycin has been largely replaced by gentamicin which is thought to be more selectively vestibulotoxic and better able to preserve residual hearing in patients with unilateral MD refractory to medical management [9, 10].
Within the bony labyrinth, several studies have investigated the trafficking and distribution of aminoglycosides, finding different patterns of distribution dependent upon the dose, duration, and route of administration. IT-injected aminoglycosides appear to gain access to the inner ear via the oval window and the round window [11, 12], and uptake either by passive diffusion or by endocytosis [13, 14]. Salt et al. recently quantified diffusion of gentamicin through the oval (35%) versus the round window (57%) [12, 15]. Access to these membranous structures is however uncertain, partly due to their variable permeability in individuals, resulting in unpredictable drug exposure of the inner ear [16, 17, 18]. Similar mechanisms of cellular trafficking (active diffusion and endocytosis) have been proposed in the transport of aminoglycosides into cells of the inner ear [19].
Once the drug crosses the oval window and the round window, the situation becomes more complex and the precise mechanism by which aminoglycosides exert their toxic effects on hair cells is unknown, to date. Previous animal studies showed that in the cochlea, sensory hair cells, the spiral ligament including the stria vascularis, and spiral ganglion cells had a very early uptake of gentamicin. Similarly, hair cells, dark cells, and vestibular ganglion cells are the primary targets in the vestibular system. This may demonstrate that gentamicin most likely diffuses across the inner ear membranes, readily achieving concentrations within the scala vestibuli, cochlear duct, and vestibule and then exerts its cellular toxicity.
Multiple mechanisms, including disruption of calcium-dependent cytokine production resulting in the damage to hair cell membrane integrity, increased superoxide production, hair cell transduction blockage, glutamate decarboxylase inhibition, ornithine decarboxylase inhibition, and free radical damage, all have been developed to explain aminoglycosides’ direct toxicity to hair cells [10, 20, 21]. While most cells of the inner ear demonstrate aminoglycoside penetration, several studies have identified preferential loss of the hair cells at the basal turn of the cochlea over the apical hair cells and vestibular type I hair cells over their type II counterparts [22, 23, 24, 25, 26]. Direct damage to the spiral ganglion has also been observed [27] and histologic studies in rhesus monkeys suggest relative sparing of the maculae [28].
In parallel to previous findings, several studies have demonstrated that direct application of gentamicin into the vestibular labyrinth also causes greater loss of type I versus type II vestibular hair cells [29, 30]. Recently, Lyford-Pike et al. [26] used the animal model, chinchilla, to provide the evidence that the selective loss of type I hair cells assuredly occurred because these cells preferentially accumulate gentamicin acutely after intratympanic administration. Type II hair cells and supporting cells concentrate substantially less gentamicin. These results might theoretically ameliorate the more profound symptom of vertigo (driven by type I hair cells) while preserving cochlear function.
Aminoglycosides may also act to inhibit production of endolymph, restoring the balance between endolymphatic and perilymphatic pressure. This would also act to alleviate all symptoms of endolymphatic hydrops. Additionally, aminoglycosides are theorized to cause selective damage to the cells of the cochlear stria vascularis and planum semilunatum in the cristae ampullae of the semicircular canals, which are involved in ionic regulation and endolymph production [31]. It is also known that gentamicin utilizes the cellular machinery of endolymph production to traffic into the inner ear after systemic administration [32]. The theory that vestibular dark cells and, thus, endolymphatic flow, are the targets by which aminoglycosides alleviate vertigo is of significant clinical interest because it suggests that it is not necessarily important to ablate the vestibule to achieve vertigo control in MD. This idea can explain why patients with intact caloric responses can still achieve significant vertigo control after intratympanic aminoglycoside administration.
In conclusion, direct toxicity to vestibular hair cells and direct toxicity to the endolymph producing apparatus might be the two major mechanisms of action by ITG. Most importantly, gentamicin has been proved to be more vestibulotoxic than cochleotoxic in humans. The inner ear toxicity of gentamicin might follow an order. Secretory dark cells of the vestibule might be the first to be damaged, followed by the vestibular neuroepithelium and the afferent vestibular fibers, and finally, the hair cells of the organ of Corti are destroyed [33, 34].
4. Therapeutic method and treatment efficacy
Ménière’s disease is manifested by episodic vertigo, tinnitus, aural fullness, and fluctuating hearing loss. The treatment of patients with MD is usually directed at the most disabling symptom, which is the debilitating vertigo. MD treatment protocols typically measure vertigo control according to AAO-HNS Committee on Hearing and Equilibrium guidelines for grading vertigo severity [35]. Often, clinical trials also attempt to assess other disease sequelae such as hearing loss, tinnitus, and aural fullness.
As a well-known relapsing-remitting disease, it is rather difficult to accurately evaluate the efficacy of ITG in treatment of MD. Firstly, the natural history of remission and exacerbation of symptoms make evaluation of the effectiveness of treatment remarkably difficult. Commonly, vertigo attacks can improve without treatment of any kind as periods of remission are not uncommon. Thus, a clinical trial without controls will not account for this finding. Another difficulty is that clinical researchers attempt to show hearing preservation with IT gentamicin protocol, but hearing tends to worsen over time in MD regardless of treatment. Finally, the variable nature of MD with fluctuation in levels of hearing and even frequency and severity of vertigo can make clinical trials difficult.
To date, there have only been a few interventional randomized controlled trials investigating the true efficacy of ITG in the treatment of MD. In 2004, the first prospective, double-blind, randomized clinical trial of intratympanic gentamicin versus intratympanic buffer solution (placebo) in patients with active MD was reported by Stokroos et al. [36]. They performed ITG injections with buffered gentamicin (30 mg/ml) every 6 weeks until the vertigo complaints disappeared (12 patients received gentamicin versus 10 for placebo), outcome measures included the number of vertiginous spells, degree of sensorineural hearing loss, labyrinthine function, and labyrinthine asymmetry. Compared to the placebo group, topical gentamicin provided a significant improvement in the number of vertiginous attacks per year at follow up which varied between 6 and 28 months. There was no statistically significant change in hearing or other outcomes in two groups. However, hearing had a tendency to deteriorate in the placebo-treated patients, due to the natural course of the disease, which suggests that early treatment with topical gentamicin may preserve residual sensorineural hearing in active MD.
In 2008, Postema et al. [37] reported another prospective, double-blind, randomized, placebo-controlled trial associated with ITG therapy for control of vertigo in unilateral MD. They used weekly injections of 0.4 ml of gentamicin (30 mg/ml). A total of 4 injections were given through a ventilation tube (16 patients received gentamicin and 12 received a placebo). The results showed that gentamicin treatment resulted in a significant reduction of the score for vertigo complaints (including vertigo severity) and the score for perceived aural fullness. They also noted that a small increase in hearing loss (average of losses at 0.5, 1, 2, and 4 kHz: 8 dB HL) was measured in the gentamicin group.
In 2016, Patel et al. [38] performed a randomized, double-blind, comparative effectiveness trial of intratympanic methylprednisolone (n = 30) versus gentamicin (n = 30) in patients with refractory unilateral MD. Patients were randomly assigned (1:1) to two intratympanic methylprednisolone (62.5 mg/ml) or gentamicin (40 mg/ml) injections given 2 weeks apart, and were followed up for 2 years. In the methylprednisolone group, complete vertigo control (Class A) was achieved in 21/30 patients (70%) compared to 25/30 (83.3%) in the gentamicin group. After methylprednisolone, 22 patients (78.5%) experienced an improved functional level score and 8 patients (28.7%) better pure-tone hearing and speech discrimination. There were also reductions for tinnitus, dizziness, and aural fullness. Fifteen patients (50%) required further courses of methylprednisolone. Two patients were deemed treatment failures and were assigned ITG treatment. The study showed no significant difference between the methylprednisolone and gentamicin for the control of vertigo, total number of injections, number of patients with relapsing vertigo, or the amount of pain from injection but better speech discrimination after methylprednisolone.
Based on the above prospective, double-blind, randomized controlled clinical trials, intratympanic gentamicin, as a medically ablative method, seems to be the most effective non-surgical treatment to eradicate vertigo in intractable MD, but with a potential risk of hearing loss. However, there is no consensus on the treatment protocol of ITG, especially for the concentration of gentamicin, dosage in each application, number of injection, and the time interval between two doses.
In the over 40 years of clinical trials in the treatment of MD by ITG, the majority are case series without controls, mainly because of the significant difficulties in conducting the randomized controlled clinical trials or case/control trials [33]. In earlier studies, the highest rate of vertigo control was reported with daily injections or multiple titrations. On the other hand, considerable hearing loss was experienced in several studies. Moller et al. [39] treated 15 patients with disabling MD with daily injections for periods ranging from 3 to 11 days. They achieved 93.4% of vertigo control, but also 33.4% of hearing loss. They reported that none of the patients were responsive to caloric stimulation. Laitakari [40] reported 90% of vertigo control and 45% of hearing loss in 20 patients who had daily ITG for a minimum of 3 consecutive days. Parnes and Riddell [41] reported 41.7% worsening of the hearing in their group of patients who received three daily injections within 4 days. Murofushi et al. [42], using several daily injections, reported hearing loss in 30% of cases. Corsten et al. [43] reported 81% vertigo control but 57% hearing loss in patients (n = 21) who had gentamicin instillation 3 times a day for 4 consecutive days. Kaplan et al. [44] reviewed the 10-year long-term results of 114 patients treated with gentamicin instillation 3 times a day for 4 consecutive days. They achieved 93.4% of vertigo control and 25.6% of hearing loss.
In the early 2000s, regarding patients with hearing deterioration and even those becoming deaf, there was a discussion about reducing the gentamicin dose or performing the application at longer intervals. Daily titration methods were abandoned. Transtympanic gentamicin therapy was modified to weekly or monthly intervals as “needed” or “on demand” to reduce the symptoms of MD, aiming to maintain cochlear as well as vestibular function. Harner et al. [45] reported a very high rate of vertigo control with preservation of hearing in 43 patients. There were no patients with changes in cochlear function and ablation of the labyrinth. All patients received one injection, and half of them received a repeat injection 1 month after therapy. Minor [46] used gentamicin on weekly intervals until the development of spontaneous nystagmus, head-shaking nystagmus, or head thrust sign. Vertigo was controlled in 91% of the patients, and profound hearing loss only occurred in 1 patient. Atlas and Parnes [47] reviewed the outcomes of 83 patients who received weekly injections. They reported hearing loss in 17% of the patients, with vertigo control in 84%. Martin and Perez [48] reported vertigo control in 83.1% of the patients and hearing loss in 15.5% of them after gentamicin at weekly intervals. De Beer et al. [49] reported 15.8% with hearing loss and 80.7% with vertigo control after, between 1 and 10, intratympanic injections at a minimum interval of 27 days. Casani et al. [50] reported 12% hearing loss after a maximum of 2 injections of gentamicin and 81% vertigo control.
Most recently, Vlastarakos et al. [51] published a systematic review looking at sustained-release delivery of IT gentamicin (dynamic-release versus sustained-release vehicles). Dynamic release (microcatheter at the round window) was found to provide satisfactory vertigo control in 89.3% (70.9% reporting complete control). Sustained-release preparations (gentamicin-soaked wick/pledget) provided 82.2% satisfactory control in the pool of patients (75% with complete control). In patients receiving sustained-release preparations, complete hearing loss was reported in 31.1% patients with another 23.3% of patients experiencing partial hearing loss. This adverse change in hearing was unacceptably high, reinforcing the suggestion of using a sustained-release vehicle only in patients who had failed IT gentamicin injections previously or those without serviceable hearing.
Commonly, intratympanic injection under otoscope or microscope is a simple and recommendable technique. The desired amount of gentamicin is injected over the round window through the posterosuperior quadrant of the tympanic membrane. There are two common doses of gentamicin for injection. The standard intravenous preparation of gentamicin is 40 mg/ml, which can be buffered with 8.4% sodium bicarbonate so that discomfort on injection is reduced. A total of 1.5 ml of gentamicin mixed with 0.5 ml of sodium bicarbonate at these concentrations will produce a final concentration of 26.6 mg/ml gentamicin. Approximately 0.3–0.5 ml of solution is usually adequate to bathe the round window in solution. Typically, patients will remain lying flat with the injected ear up for 10 min to 1 h. This procedure is generally well tolerated by patients, who should be told to expect brief pain on injection, followed by possible vertigo or disequilibrium. Warming the medication can help in this regard (preventing a cold caloric response).
Based on the combination of current clinical practice, basic science models, and results from clinical trials, low drug dose and long interval between injections, mainly in order to reduce the risk of deafness, are reasonably encouraged. The low dose method involves using 1–2 injections of gentamicin and waiting a month or 2 weeks between injections. The rate of vertigo control may be up to 80–90%, with no significant side effects. The second injection is given only if there has been a vertigo spell 2 weeks prior. In other words, instead of titrating to the onset of damage to the vestibular system, the criterion is a positive effect on the disease. Occasionally, a third dose is given.
In short, whatever technique is used, the goal is to apply gentamicin to the round window in sufficient concentration and over a sufficient amount of time that it achieves a therapeutic effect while avoiding both local and systemic side effects, especially hearing loss.
5. Indications and contraindications
Not all patients with MD can be treated with ITG. Based on the international consensus on treatment of MD obtained from the IFOS meeting 2017 [52], MD should be treated with a step-by-step therapy. The first line of treatment includes the medical conservative treatment, such as dietary modification and oral medicine. After this line of treatment, 80% of patients with MD are cured or in remission. When the vertigo of MD fails to be controlled by the first-line treatment for more than 6 months, it will be regarded as intractable MD. Then the second line is the IT injections, mainly IT steroids as a conservative treatment and ITG in the case of IT steroid failure, and preferentially in patients with hearing impairment. After the second line treatment, 90–95% of the total patients are cured or in remission. The third line is the surgical, either conservative or destructive, treatment. For unilateral intractable MD with serviceable hearing (i.e., speech reception threshold better than 50 dB HL and speech discrimination score of more than 50%) in the treated ear, treatment protocol with an injection repetition not shorter than 1 week between adjacent injections or one with injections on a monthly basis as “needed” is preferred. These methods provide the same level of vertigo control yet offer better preservation of hearing functions [33].
The best indication for ITG treatment appears to be the control of vertigo in profound hearing loss or non-serviceable ears, in which speech reception threshold is worse than 50 dB HL and speech discrimination score less than 50% [53, 54]. Under these scenarios, there is no need to consider the risk of deafness, and titration methods or multiple injections on a daily basis are preferred, since these methods have significantly elevated incidence of hearing loss [33]. Transmastoid labyrinthectomy has traditionally been offered for non-serviceable ears in patients with MD. This method has been the gold standard, and it is very effective in eradication of vertigo in more than 94% of patients. In comparison, ITG therapy provides a minimally invasive ambulatory substitute with low morbidity and fewer side-effects, which is also very cost effective to manage vertigo in these MD patients with non-serviceable ears [53].
Another important indicator is the control of vertigo in patients who have failed endolymphatic sac surgery. Marzo and Leonetti [55] have shown the effectiveness of ITG therapy for patients who have failed endolymphatic sac surgery, thus reducing the need for vestibular neurectomy in those with intractable disease.
To be allergic and hypersensitive to aminoglycosides are two absolute contraindications for ITG. It is worth noting that patients who carried the mitochondrial mutation of the gene MT-RNR1 (mitochondrially encoded 12S ribosomal RNA) are hypersensitive to aminoglycosides. A single injection of aminoglycosides results in complete and definitive deafness in subjects with this mutation [56]. A systematic genetic screening of MD patients is highly recommended to prevent the occurrence of bilateral deafness. The treatment is intended for the abolition of vestibular function; thus, administration of gentamicin must be done carefully in the elderly, who have difficulty attaining vestibular compensation, in patients with complications, or in those with bilateral MD. Taking also into consideration the fact that individual’s drug sensitivity depends on their genetic background, investigation of appropriate drug levels according to evidence-based medicine remains a future task.
6. Complications
The complications of ITG treatment are primarily bi-fold: one is the risk caused by drug toxicity of gentamicin, the other is the risk caused by intratympanic injection. Undoubtedly, the main risk of ITG treatment for vertigo is the sensorineural hearing loss and associated prolonged disequilibrium and ataxia, which are common complaints after this treatment. Less common side effects include local hemorrhage, allergic response and tympanic membrane perforation (especially in an irradiated or otherwise damaged tympanic membrane), local discomfort, inflammation, otitis media or externa, and transient vertigo caused by a caloric reflex effect from the instilled fluid [38, 57]. It is also critical to educate all patients who are given intratympanic aminoglycosides that bilateral permanent hearing loss is possible, even from one single unilateral injection.
7. Conclusions
Intratympanic injection of gentamicin is probably the most effective non-surgical treatment to eradicate vertigo in MD. But it is also an ablative method that carries a non-negligible risk of hearing loss. Gentamicin has been proved to be more vestibulotoxic than cochleotoxic; direct toxicity to vestibular hair cells and direct toxicity to the endolymph producing apparatus might be the two major mechanisms of action. To date, no consensus has been reached on the dosage, dosing methods, timing of delivery, treatment duration, clinical endpoint of therapy, and concentration of gentamicin. However, based on the combination of current clinical practice, basic science models, and results from clinical trials, low drug dose and long intervals between injections are reasonably recommended. The application of gentamicin-induced vestibular ablation has minimized the number of more invasive procedures such as unilateral labyrinthectomy and vestibular neurectomy. In comparison with surgery, the vertigo control is comparable, the overall cost is reduced, and complications are limited. ITG in treating intractable MD has gradually become a prevalent therapy during the past decades. However, to administer ITG treatment, multiple factors should be comprehensively considered including patient selection, pharmacological mechanism, drug dose, the interval of administration, complications, indications, and contraindications.
Acknowledgments
The authors thank Alisa Hetrick for her comments on an earlier version of the article.
Conflict of interest
The authors declare no competing financial interest.
\n',keywords:"intratympanic, gentamicin, Ménière’s disease, management, aminoglycosides, vertigo, vestibulotoxicity, ototoxicity",chapterPDFUrl:"https://cdn.intechopen.com/pdfs/67598.pdf",chapterXML:"https://mts.intechopen.com/source/xml/67598.xml",downloadPdfUrl:"/chapter/pdf-download/67598",previewPdfUrl:"/chapter/pdf-preview/67598",totalDownloads:623,totalViews:0,totalCrossrefCites:1,dateSubmitted:"September 25th 2018",dateReviewed:"May 11th 2019",datePrePublished:"June 10th 2019",datePublished:"May 27th 2020",dateFinished:null,readingETA:"0",abstract:"Ménière’s disease (MD) is an inner-ear disease mostly characterized by frequent spontaneous vertigo and fluctuating sensorineural hearing loss. The main purpose of treatment for MD is to reduce or control the vertigo while maximizing the preservation of hearing. Among the various treatments, one that is effective for refractory MD, intratympanic gentamicin (ITG), relies on its ototoxic property to effectively control the vertigo symptoms of most patients. ITG treatment has relatively few side effects compared with surgically destructive treatments, but it also carries a nonnegligible risk of sensorineural hearing loss. So far, there is no consensus on the dosage and treatment duration of ITG. Most researchers recommend that intratympanic injection of gentamicin is more suitable for patients with unilateral onset and impaired hearing function, who are younger than 65 years old, as well as with frequent and severe vertigo attacks, and ineffective prior conservative treatment. Before an ITG treatment, patients should be adequately informed about the risk of hearing loss, and in order to reduce the risk of deafness, low drug dose and long intervals between injections are recommended. In short, to administer an ITG injection, multiple factors should be comprehensively considered including patient selection, pharmacological mechanism, drug dose, the interval of administration, complications, indications, and contraindications.",reviewType:"peer-reviewed",bibtexUrl:"/chapter/bibtex/67598",risUrl:"/chapter/ris/67598",signatures:"Yongchuan Chai and Hongzhe Li",book:{id:"7891",title:"Meniere's Disease",subtitle:null,fullTitle:"Meniere's Disease",slug:"meniere-s-disease",publishedDate:"May 27th 2020",bookSignature:"Fayez Bahmad Jr.",coverURL:"https://cdn.intechopen.com/books/images_new/7891.jpg",licenceType:"CC BY 3.0",editedByType:"Edited by",editors:[{id:"77351",title:"Prof.",name:"Fayez",middleName:null,surname:"Bahmad Jr",slug:"fayez-bahmad-jr",fullName:"Fayez Bahmad Jr"}],productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"}},authors:[{id:"277753",title:"Dr.",name:"Hongzhe",middleName:null,surname:"Li",fullName:"Hongzhe Li",slug:"hongzhe-li",email:"hongzhe@gmail.com",position:null,institution:null},{id:"277754",title:"Dr.",name:"Yongchuan",middleName:null,surname:"Chai",fullName:"Yongchuan Chai",slug:"yongchuan-chai",email:"cycperfect@163.com",position:null,institution:null}],sections:[{id:"sec_1",title:"1. Introduction",level:"1"},{id:"sec_2",title:"2. History of intratympanic gentamicin",level:"1"},{id:"sec_3",title:"3. Mechanism of action",level:"1"},{id:"sec_4",title:"4. Therapeutic method and treatment efficacy",level:"1"},{id:"sec_5",title:"5. Indications and contraindications",level:"1"},{id:"sec_6",title:"6. Complications",level:"1"},{id:"sec_7",title:"7. Conclusions",level:"1"},{id:"sec_8",title:"Acknowledgments",level:"1"},{id:"sec_11",title:"Conflict of interest",level:"1"}],chapterReferences:[{id:"B1",body:'Fowler EP Jr. Streptomycin treatment of vertigo. Transactions of the American Academy of Ophthalmology and Otolaryngology. 1948;52:293-301'},{id:"B2",body:'Schuknecht HF. Ablation therapy in the management of Meniere’s disease. Acta Oto-Laryngologica. Supplementum. 1957;132:1-42'},{id:"B3",body:'Lange G. The intratympanic treatment of Meniere’s disease with ototoxic antibiotics. A follow-up study of 55 cases (author’s transl). 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Acta Oto-Laryngologica. 2008;128:876-880'},{id:"B38",body:'Patel M, Agarwal K, Arshad Q , Hariri M, Rea P, Seemungal BM, et al. Intratympanic methylprednisolone versus gentamicin in patients with unilateral Meniere’s disease: A randomized, double-blind, comparative effectiveness trial. Lancet. 2016;388:2753-2762'},{id:"B39",body:'Moller C, Odkvist LM, Thell J, Larsby B, Hyden D. Vestibular and audiologic functions in gentamicin-treated Meniere’s disease. The American Journal of Otology. 1988;9:383-391'},{id:"B40",body:'Laitakari K. Intratympanic gentamycin in severe Meniere’s disease. Clinical Otolaryngology and Allied Sciences. 1990;15:545-548'},{id:"B41",body:'Parnes LS, Riddell D. Irritative spontaneous nystagmus following intratympanic gentamicin for Meniere’s disease. The Laryngoscope. 1993;103:745-749'},{id:"B42",body:'Murofushi T, Halmagyi GM, Yavor RA. Intratympanic gentamicin in Meniere’s disease: Results of therapy. The American Journal of Otology. 1997;18:52-57'},{id:"B43",body:'Corsten M, Marsan J, Schramm D, Robichaud J. Treatment of intractable Meniere’s disease with intratympanic gentamicin: Review of the University of Ottawa experience. The Journal of Otolaryngology. 1997;26:361-364'},{id:"B44",body:'Kaplan DM, Nedzelski JM, Al-Abidi A, Chen JM, Shipp DB. Hearing loss following intratympanic instillation of gentamicin for the treatment of unilateral Meniere’s disease. The Journal of Otolaryngology. 2002;31:106-111'},{id:"B45",body:'Harner SG, Kasperbauer JL, Facer GW, Beatty CW. Transtympanic gentamicin for Meniere’s syndrome. The Laryngoscope. 1998;108:1446-1449'},{id:"B46",body:'Minor LB. Intratympanic gentamicin for control of vertigo in Meniere’s disease: Vestibular signs that specify completion of therapy. The American Journal of Otology. 1999;20:209-219'},{id:"B47",body:'Atlas JT, Parnes LS. Intratympanic gentamicin titration therapy for intractable Meniere’s disease. The American Journal of Otology. 1999;20:357-363'},{id:"B48",body:'Martin E, Perez N. Hearing loss after intratympanic gentamicin therapy for unilateral Meniere’s disease. Otology and Neurotology. 2003;24:800-806'},{id:"B49",body:'De Beer L, Stokroos R, Kingma H. Intratympanic gentamicin therapy for intractable Meniere’s disease. Acta Oto-Laryngologica. 2007;127:605-612'},{id:"B50",body:'Casani AP, Piaggi P, Cerchiai N, Seccia V, Franceschini SS, Dallan I. Intratympanic treatment of intractable unilateral Meniere disease: Gentamicin or dexamethasone? A randomized controlled trial. Otolaryngolog—Head and Neck Surgery. 2012;146:430-437'},{id:"B51",body:'Vlastarakos PV, Iacovou E, Nikolopoulos TP. Is gentamycin delivery via sustained-release vehicles a safe and effective treatment for refractory Meniere’s disease? A critical analysis of published interventional studies. European Archives of Oto-Rhino-Laryngology. 2017;274:1309-1315'},{id:"B52",body:'Nevoux J, Barbara M, Dornhoffer J, Gibson W, Kitahara T, Darrouzet V. International consensus (ICON) on treatment of Meniere’s disease. European Annals of Otorhinolaryngology, Head and Neck Diseases. 2018;135:S29-S32'},{id:"B53",body:'Bauer PW, MacDonald CB, Cox LC. Intratympanic gentamicin therapy for vertigo in nonserviceable ears. American Journal of Otolaryngology. 2001;22:111-115'},{id:"B54",body:'Sajjadi H, Paparella MM. Meniere’s disease. Lancet. 2008;372:406-414'},{id:"B55",body:'Marzo SJ, Leonetti JP. Intratympanic gentamicin therapy for persistent vertigo after endolymphatic sac surgery. Otolaryngology—Head and Neck Surgery. 2002;126:31-33'},{id:"B56",body:'Prezant TR, Agapian JV, Bohlman MC, Bu X, Oztas S, Qiu WQ , et al. Mitochondrial ribosomal RNA mutation associated with both antibiotic-induced and non-syndromic deafness. Nature Genetics. 1993;4:289-294'},{id:"B57",body:'Liu YC, Chi FH, Yang TH, Liu TC. Assessment of complications due to intratympanic injections. World Journal of Otorhinolaryngology—Head and Neck Surgery. 2016;2:13-16'}],footnotes:[],contributors:[{corresp:null,contributorFullName:"Yongchuan Chai",address:null,affiliation:'
Research Service, VA Loma Linda Healthcare System, United States
Loma Linda University School of Medicine, United States
Department of Otorhinolaryngology—Head and Neck Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, China
Ear Institute, Shanghai Jiao Tong University School of Medicine, China
Shanghai Key Laboratory of Translational Medicine on Ear and Nose Diseases, China
Research Service, VA Loma Linda Healthcare System, United States
Loma Linda University School of Medicine, United States
Department of Otolaryngology—Head and Neck Surgery, Loma Linda University School of Medicine, United States
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