Planned versus actual coverage of the survey.
\r\n\tCongenital hearing loss means hearing loss that is present at birth. I have managed children with hearing loss for many years, and the most touching thing is the light that blooms on the face while the hearing-impaired child heard his mother's voice at first time. The scene of "happy tears" impressed me so much. To hear the voice that has not been heard is so pleasant, as if this ordinary listening experience is a supreme listening enjoyment.
\r\n\r\n\tAge-related hearing loss means a progressive loss of ability to hear high frequencies with aging, also known as presbycusis. Among them are the influence of internal and external factors such as genes, drugs and noise exposure. The studies pointed out that the brain stimulation of the hearing-impaired person is greatly reduced compared with subjects with normal hearing. The connection of auditory cortex and other brain areas has declined a lot, which is probably one of the important causes of dementia or even depression in the elderly.
\r\n\r\n\tNoise-induced hearing loss is hearing impairment resulting from exposure to loud sound. There is actually continuous and endless noise in many workplaces, which may cause chronic and cumulative damage. Some young people often work hard but easily neglect to protect themselves. In addition, in recent years, entertainment noise (such as nightclubs, concerts, and personal listening devices) has caused hearing impairment in young people. These should be avoidable and preventable.
\r\n\r\n\tHearing Science is the study of impaired auditory perception, the technologies and other rehabilitation strategies for persons with hearing loss. Public health has been defined as "the science and art of preventing disease", improving quality of life through organized efforts. To avoid the “epidemic” of hearing loss, it is necessary to promote early screening, use hearing protection, and change public attitudes toward noise.
\r\n\r\n\tBased on these concepts, the book incorporates updated developments as well as future perspectives in the ever-expanding field of hearing loss. Besides, it is also a great reference for audiologists, otolaryngologists, neurologists, specialists in public health, basic and clinical researchers.
",isbn:"978-1-83968-678-8",printIsbn:"978-1-83968-677-1",pdfIsbn:"978-1-83968-679-5",doi:null,price:0,priceEur:0,priceUsd:0,slug:null,numberOfPages:0,isOpenForSubmission:!1,hash:"a4b7dbb02ba00e7412422cd5dbffa029",bookSignature:"Dr. Tang-Chuan Wang",publishedDate:null,coverURL:"https://cdn.intechopen.com/books/images_new/10529.jpg",keywords:"Hidden Hearing Loss, Plasticity, Electrophysiology, Otoacoustic Emission, Newborn Hearing Screening, Genetics, Aging, Hearing Aids, Noise Exposure, Occupational Hearing Loss, Epidemiology, Prevention",numberOfDownloads:null,numberOfWosCitations:0,numberOfCrossrefCitations:null,numberOfDimensionsCitations:null,numberOfTotalCitations:null,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"September 3rd 2020",dateEndSecondStepPublish:"October 1st 2020",dateEndThirdStepPublish:"November 30th 2020",dateEndFourthStepPublish:"February 18th 2021",dateEndFifthStepPublish:"April 19th 2021",remainingDaysToSecondStep:"4 months",secondStepPassed:!0,currentStepOfPublishingProcess:4,editedByType:null,kuFlag:!1,biosketch:"Dr. Tang-Chuan Wang is an excellent otolaryngologist-head and neck surgeon in Taiwan; a research scholar of Harvard Medical School and University of Iowa Hospitals. He worked in the Hospital of the University of Pennsylvania, Boston Children's Hospital, and Massachusetts Eye and Ear. Due to his contribution to biomedical engineering, he was invited into the executive committee of HIWIN-CMU Joint R & D Center in Taiwan.",coeditorOneBiosketch:null,coeditorTwoBiosketch:null,coeditorThreeBiosketch:null,coeditorFourBiosketch:null,coeditorFiveBiosketch:null,editors:[{id:"201262",title:"Dr.",name:"Tang-Chuan",middleName:null,surname:"Wang",slug:"tang-chuan-wang",fullName:"Tang-Chuan Wang",profilePictureURL:"https://mts.intechopen.com/storage/users/201262/images/system/201262.gif",biography:'Dr. Tang-Chuan Wang is an excellent otolaryngologist – head and neck surgeon in Taiwan. He is also a research scholar of Harvard Medical School and University of Iowa Hospitals. During his substantial experience, he worked in Hospital of the University of Pennsylvania, Boston Children\'s Hospital and Massachusetts Eye and Ear. Besides, he is not only working hard on clinical & basic medicine but also launching out into public health in Taiwan. In recent years, he devotes himself to innovation. He always says that "in theoretical or practical aspects, no innovation is a step backward". Due to his contribution to biomedical engineering, he was invited into executive committee of HIWIN-CMU Joint R & D Center in Taiwan.',institutionString:"China Medical University Hospital",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"2",totalChapterViews:"0",totalEditedBooks:"2",institution:{name:"China Medical University Hospital",institutionURL:null,country:{name:"Taiwan"}}}],coeditorOne:null,coeditorTwo:null,coeditorThree:null,coeditorFour:null,coeditorFive:null,topics:[{id:"16",title:"Medicine",slug:"medicine"}],chapters:null,productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"},personalPublishingAssistant:{id:"252211",firstName:"Sara",lastName:"Debeuc",middleName:null,title:"Ms.",imageUrl:"https://mts.intechopen.com/storage/users/252211/images/7239_n.png",email:"sara.d@intechopen.com",biography:"As an Author Service Manager my responsibilities include monitoring and facilitating all publishing activities for authors and editors. From chapter submission and review, to approval and revision, copyediting and design, until final publication, I work closely with authors and editors to ensure a simple and easy publishing process. I maintain constant and effective communication with authors, editors and reviewers, which allows for a level of personal support that enables contributors to fully commit and concentrate on the chapters they are writing, editing, or reviewing. I assist authors in the preparation of their full chapter submissions and track important deadlines and ensure they are met. I help to coordinate internal processes such as linguistic review, and monitor the technical aspects of the process. As an ASM I am also involved in the acquisition of editors. 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Mauricio Barría",coverURL:"https://cdn.intechopen.com/books/images_new/6550.jpg",editedByType:"Edited by",editors:[{id:"88861",title:"Dr.",name:"René Mauricio",surname:"Barría",slug:"rene-mauricio-barria",fullName:"René Mauricio Barría"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"1591",title:"Infrared Spectroscopy",subtitle:"Materials Science, Engineering and Technology",isOpenForSubmission:!1,hash:"99b4b7b71a8caeb693ed762b40b017f4",slug:"infrared-spectroscopy-materials-science-engineering-and-technology",bookSignature:"Theophile Theophanides",coverURL:"https://cdn.intechopen.com/books/images_new/1591.jpg",editedByType:"Edited by",editors:[{id:"37194",title:"Dr.",name:"Theophanides",surname:"Theophile",slug:"theophanides-theophile",fullName:"Theophanides Theophile"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"3092",title:"Anopheles mosquitoes",subtitle:"New insights into malaria vectors",isOpenForSubmission:!1,hash:"c9e622485316d5e296288bf24d2b0d64",slug:"anopheles-mosquitoes-new-insights-into-malaria-vectors",bookSignature:"Sylvie Manguin",coverURL:"https://cdn.intechopen.com/books/images_new/3092.jpg",editedByType:"Edited by",editors:[{id:"50017",title:"Prof.",name:"Sylvie",surname:"Manguin",slug:"sylvie-manguin",fullName:"Sylvie Manguin"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"3161",title:"Frontiers in Guided Wave Optics and Optoelectronics",subtitle:null,isOpenForSubmission:!1,hash:"deb44e9c99f82bbce1083abea743146c",slug:"frontiers-in-guided-wave-optics-and-optoelectronics",bookSignature:"Bishnu Pal",coverURL:"https://cdn.intechopen.com/books/images_new/3161.jpg",editedByType:"Edited by",editors:[{id:"4782",title:"Prof.",name:"Bishnu",surname:"Pal",slug:"bishnu-pal",fullName:"Bishnu Pal"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"72",title:"Ionic Liquids",subtitle:"Theory, Properties, New Approaches",isOpenForSubmission:!1,hash:"d94ffa3cfa10505e3b1d676d46fcd3f5",slug:"ionic-liquids-theory-properties-new-approaches",bookSignature:"Alexander Kokorin",coverURL:"https://cdn.intechopen.com/books/images_new/72.jpg",editedByType:"Edited by",editors:[{id:"19816",title:"Prof.",name:"Alexander",surname:"Kokorin",slug:"alexander-kokorin",fullName:"Alexander Kokorin"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"1373",title:"Ionic Liquids",subtitle:"Applications and Perspectives",isOpenForSubmission:!1,hash:"5e9ae5ae9167cde4b344e499a792c41c",slug:"ionic-liquids-applications-and-perspectives",bookSignature:"Alexander Kokorin",coverURL:"https://cdn.intechopen.com/books/images_new/1373.jpg",editedByType:"Edited by",editors:[{id:"19816",title:"Prof.",name:"Alexander",surname:"Kokorin",slug:"alexander-kokorin",fullName:"Alexander Kokorin"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"57",title:"Physics and Applications of Graphene",subtitle:"Experiments",isOpenForSubmission:!1,hash:"0e6622a71cf4f02f45bfdd5691e1189a",slug:"physics-and-applications-of-graphene-experiments",bookSignature:"Sergey Mikhailov",coverURL:"https://cdn.intechopen.com/books/images_new/57.jpg",editedByType:"Edited by",editors:[{id:"16042",title:"Dr.",name:"Sergey",surname:"Mikhailov",slug:"sergey-mikhailov",fullName:"Sergey Mikhailov"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"371",title:"Abiotic Stress in Plants",subtitle:"Mechanisms and Adaptations",isOpenForSubmission:!1,hash:"588466f487e307619849d72389178a74",slug:"abiotic-stress-in-plants-mechanisms-and-adaptations",bookSignature:"Arun Shanker and B. Venkateswarlu",coverURL:"https://cdn.intechopen.com/books/images_new/371.jpg",editedByType:"Edited by",editors:[{id:"58592",title:"Dr.",name:"Arun",surname:"Shanker",slug:"arun-shanker",fullName:"Arun Shanker"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}}]},chapter:{item:{type:"chapter",id:"48761",title:"Leukemogenesis in Down syndrome",doi:"10.5772/60598",slug:"leukemogenesis-in-down-syndrome-",body:'The risk of solid tumors is significantly reduced in Down syndrome (DS) patients compared with the general population [1-3]. Studies utilizing mouse models have shown that distinct mechanisms caused by the elevated dosage of multiple genes are implicated in the protection from tumor progression depending on the type of solid neoplasm. In contrast, DS children have an increased risk of developing leukemias. Specifically, acute megakaryoblastic leukemia (AMKL) and acute lymphoblastic leukemia (ALL) are approximately 500 and 10-50 times more prevalent in children with DS compared to healthy controls, respectively [4-6].
Recent analyses have uncovered that a distinct pattern of acquired genetic mutations is implicated in the leukemogenesis restricted to DS children. In particular, acquired mutations in the GATA1 gene are associated with leukemogenesis of DS-associated AMKL and transient myeloproliferative disorder (TMD), a preleukemic disorder unique to neonates with DS. The mutations are clustered in the region corresponding to the N-terminal domain of GATA1 and result in the production of a short form of GATA1 (GATA1-S), which utilizes Met84 as an alternative translation initiation codon. The function of GATA1 has been studied extensively, and the analyses present a prototype for the study of lineage-restricted transcription factors that play essential roles in the differentiation, proliferation, and apoptosis of erythroid cells, megakaryocytes, mast cells, and eosinophils. In this chapter, we summarize recent progress in the research on leukemias related to DS. Research of mouse models of DS TMD and AMKL has been undertaken, as these models seem to provide important insights into the pathogenesis of multistep leukemogenesis.
There are substantial biological differences between the leukemias that occur in DS and non-DS children. It becomes increasingly clear that molecular mechanisms based on trisomy 21 affect not only the high incidence of leukemias but also the characteristic features of DS-associated leukemias.
Approximately 5-30% of DS babies are born with a leukocytosis with an erythroid-megakaryocytic immunophenotype. The severity of the clinical course varies with each case, from asymptomatic cases likely to have been considered peaceful births to severe cases resulting in critical injuries with blast cell infiltration of the organs. In severe cases, death from multiorgan failure or hepatic fibrosis is possible, requiring intensive care for the babies. Except for the most severe cases, symptoms usually resolve naturally (Figure 1). Therefore, DS-related leukocytosis is referred to as transient abnormal myelopoiesis (TAM) or transient myeloproliferative disorder (TMD). Patients suffering from TAM spontaneously achieve complete remission by 6 months of age. While the mechanisms of this spontaneous remission are still under investigation, one recent report showed that type I interferon signaling activated in bone marrow appears to attenuate the hyper-proliferation of megakaryocytes caused by the GATA1-S mutation [7].
Multistep leukemogenesis of DS-associated AMKL. Megakaryocytic progenitors that have acquired various types of GATA1 gene mutations eventually converge to GATA1-S, which develops TMD in DS fetus. The hyperproliferation phenotype of TAM blasts is canceled after birth. However, unknown genetic alterations transform the residual blasts to genuine leukemia.
After several years of asymptomatic periods, approximately 20% of DS children with a history of TAM develop genuine AMKL requiring intensive chemotherapy (Figure 1). It has been hypothesized that every DS child first diagnosed with AMKL has a history of asymptomatic TAM at birth. As a result, the incidence of AMKL in DS children is more than 500 times higher than in children without trisomy 21. Thus, this characteristic feature of DS-associated AMKL represents a potentially tractable model of multistep leukemogenesis. Chemotherapy in children with DS-associated AMKL shows a high cure rate. Therefore, the outcome of DS children with AMKL is statistically better than that of AMKL patents without trisomy 21 [8], probably due to the unique biological characteristics of blast cells. The molecular mechanisms of these remarkable differences remain as yet unknown.
In 2001, it was discovered that somatic mutations on the GATA1 gene are frequently found in AMKL cases occurring in DS children [9]. Supporting evidence has appeared following the release of a paper describing the GATA1 gene mutations found in TAM and DS-associated AMKL cases (Figure 1). Of note, the mutations are clustered in the region corresponding to the N-terminal domain of GATA1 and result in the production of the short form of GATA1 (GATA1-S) utilizing Met84 as an alternative translation initiation codon (Figure 1). A clinical study utilizing Guthrie blood shows that the GATA1 gene mutation is found in the 3.8% of DS babies who are not diagnosed with TAM at their birth [10]. In some non-DS AMKL cases with the GATA1 gene mutation, leukemic blasts originate from the cells that have somatically acquired trisomy 21 during myeloid development [11]. Similar cases are also observed in cells carrying trisomy 21 in mosaic models [12], suggesting that a cell-autonomous program provoked by the GATA1 mutation and trisomy 21 contributes to the onset of TAM. Relatively few cases of AMKL harboring mutations in the GATA1 gene exist in the absence of trisomy 21 [13, 14]. Therefore, the pathogenesis of TAM seems to be closely associated with GATA1 dysfunction in combination with the impact provided by the extra chromosome 21. One of the important remaining questions is how DS children frequently acquire the GATA1 gene mutation.
Sequential surveys of cases of TAM-AMKL have revealed that the type of GATA1 gene mutations detected in AMKL blasts is frequently identical to that found in TAM blasts in each individual case, suggesting that AMKL develops in the TAM blasts. It seems plausible that TAM blasts survive during an asymptomatic period and some of the blasts receive additional hits and become genuine leukemic stem cell (Figure 1). Indeed, exome sequencings of TAM and AMKL blasts have revealed that the TAM blasts from one case have a singular GATA1 gene mutation, while multiple mutations in the genes encoding for the cohesin components and epigenetic regulators are accumulated in the AMKL blasts in addition to the original mutation in the GATA1 gene [15].
Acute lymphoblastic leukemia (ALL) is one of the most common malignant diseases in children, and DS children have a higher incidence of this disease than non-DS children. In contrast to the DS-associated AMKL cases, the prognosis of DS-associated ALL is worse than ALL without DS. This may be because DS children are prone to suffer from significant toxicity of chemotherapy, as DS-associated ALL blasts retain high resistance against conventional chemotherapy regimens [16-18]. Intrachromosomal amplification of chromosome 21 (iAMP21) is also recurrently found in pediatric B cell leukemia, and this finding is considered to be an adverse prognostic factor [19, 20]. It has been demonstrated that target genes of the polycom repressor complex 2 (PRC2) are upregulated in both DS-associated ALL and ALL with iAMP21 [21], indicating that an epigenetic regulation provoked by trisomy 21 is a key mediator of the pathogenesis of this type of leukemia.
Mutations in the developmental genes for B-cell and T-cell lineages are often implicated in the pathogenesis of ALL, irrespective of the presence of Down syndrome. In addition to these genes, the incidence of mutations on genes involving the JAK/STAT pathway and RAS signaling have been found to be increased in DS-associated ALL [22-24], suggesting that molecular changes provided by these mutations may be the reason for the poor survival rate in children with DS-associated ALL.
It has been shown that hematopoietic homeostasis is significantly disturbed in DS fetus [25]. For example, frequencies of hematopoietic stem cells and megakaryocyte-erythroid progenitors are markedly increased showing high clonogenic characteristics, whereas that of granulocyte-macrophage progenitors is reduced [25-27]. In addition, committed pre-proB lymphoid and proB lymphoid progenitors are markedly reduced [25, 26]. This hematological abnormality may be a predominant cause of AMKL and ALL in DS babies. While the hematological abnormalities observed in newborns and infants with DS vary case by case, the following abnormalities are often observed: macrocytosis, neutrophilia, thrombocytopenia, and polycythemia [28-30]. In contrast to the high risk of leukemias in the pediatric period, leukemias are no longer a common cause of death in adults with DS [31]. Instead, macrocytosis and leucopenia are often observed in adult DS cases, leading to the early onset of myelodysplastic syndrome and bone marrow failure [32].
Strictly speaking, DS is defined by the possession of three copies of DS critical region (DSCR) of human chromosome 21 instead of two. However, the expression of genes located on chromosome 21 or the DSCR in DS patients is not always increased to 1.5-fold that of healthy controls. Depending on the expression levels, genes on human chromosome 21 or DSCR are divided into three categories: i) overexpressed genes, ii) genes expressed comparable to those in diploid healthy controls, and iii) genes whose levels are varied in individuals with DS. It has been reported that the frequency of genes overexpressed (type i) in B lymphocytes of DS patients is 22-39%, and the set of overexpressed genes in B lymphocytes differs from that found in fibroblasts [33, 34]. Therefore, it seems likely that the genes that proportionally increased due to the gene-dosage effect contribute to the common characteristic feature of DS, while the genes whose expression is varied in individuals determine the conditions of the individuals. In addition, microRNAs may be involved in the determination of DS disease types [35]. Expressional imbalances of chromosome 21-derived microRNAs may contribute to the diversified symptoms in DS patients.
To investigate the contribution of trisomy 21, three groups have independently established iPS (induced pluripotent stem) cells originated from DS patients and analyzed the hematopoietic differentiation. When iPS cells are cultured under the condition of primitive hematopoiesis (the first phase of hematopoiesis in yolk sacs), erythropoiesis is enhanced and myelopoiesis is reduced, while megakaryocytes are normally produced [36]. In contrast, when cultured under the condition of preferentially differentiating into fetal liver–derived definitive hematopoietic cells (the second phase of hematopoiesis in the fetal liver), iPS cells with trisomy 21 show increased multilineage colony-forming potential, and the number of cells with a myeloid and erythroid bipotential phenotype is increased [37]. However, trisomic iPS cells show no difference from isomic iPS cells when they are cultured in a condition suitable to generate erythroblast co-expressing embryonic and fetal globin genes [38]. Thus, the iPS studies suggest that the influence of one extra chromosome 21 to hematopoiesis is altered depending on the hematopoietic microenvironment.
Hematopoietic phenotypes have been examined in multiple lines of DS-model mice. Tc1 mice harbor an aneuploidy, carrying freely segregating human chromosome 21. The Tc1 mice show macrocytic anemia and an increased number of megakaryocytes with extramedullary hematopoiesis in the elderly. On the contrary, significant changes in frequencies of megakaryocytes, erythroid, and myeloid progenitors were not observed in the fetal liver [39]. Ts16 mice were generated by crossing mice with Robertsonian translocation Rb (14;16) and Rb (9;16), resulting in animals trisomic for mouse chromosome 16 (synthetic of human chromosome 21). Ts16 mice show increased erythropoiesis and reduced myelopoiesis during the embryonic period [40], but defects in hematopoiesis after the neonatal and infantile periods are uncertain, as Ts16 mice do not survive the postnatal period.
Ts65Dn, Tc1Cje, and Ts1Rh mice have been established as lines of euploid DS-model mice bearing a segmented region of mouse chromosome 16 containing 104, 81, and 33 genes, respectively. The Ts65Dn mice suffer from macrocytic anemia with defects of stem cell function and progressive myeloproliferative diseases [41]. In contrast, erythropoiesis is disturbed in Tc1Cje mice, but the mice never develop thrombocytosis or myeloproliferative diseases [42]. Hematopoietic analyses have been performed in Ts1Rhr mice, which are trisomic for the mouse equivalent of the hypothetical human DSCR; these mice show anemia and thrombocytosis in adulthood. Bone marrow cells of the mice preferentially differentiate toward the granulo-monocyte pathway, while the number of B cell progenitors is reduced [21, 43]. During the embryonic stage, hematological abnormalities are not found in Ts1Rhr mice, except for a significant increase in the hematopoietic stem cell population. Although each line of DS-model mice shows partially overlapping hematological phenotypes with those observed in patients with DS, none of the mice develop leukemia or acquire the Gata1 gene mutation.
GATA1 is a founding member of the GATA family transcription factors that recognize consensus GATA binding motif. In mammals, the hematopoietic GATA subfamily is composed of GATA1, GATA2, and GATA3, which are expressed in erythroid and megakaryocytic cells, hematopoietic stem and progenitor cells, and T cells, respectively [44]. The expressions of GATA1 and GATA2 are partially overlapping, and these two GATA factors regulate the expression of each other. In early erythroid-megakaryocytic progenitors, GATA2 initiates GATA1 gene expression, while GATA1 downregulates GATA2 gene expression together with activation of its own gene expression [45]. We refer to this network regulation of GATA2 and GATA1 as GATA factor switching [45]. In addition, GATA1 and GATA2 share, at least in part, their target genes [46]. Consequently, GATA1 and GATA2 competitively or redundantly work for the expressions of their target genes dependent on the gene properties. Therefore, the functional balance of GATA1 and GATA2 is important for the maintenance of hematopoietic homeostasis.
The GATA1 gene is composed of one untranslated first exon and five translated exons (Figure 2). The translation initiation codon located in the second exon is usually utilized to produce the full length of GATA1. Interestingly, an alternative splicing variant caused by the skipping of the second exon has been noticed in healthy humans, producing a short form of GATA1 protein lacking amino (N)-terminus 83 amino acids, which is identical to GATA1-S, utilizing an alternative translation initiation codon located in the third exon (Figure 2) [47]. In the case of mice, a short isoform of GATA1, a mouse ortholog of human GATA1-S, is also generated by the use of an alternative translation initiation codon in a single mRNA shared with the full-length of GATA1 [48]. Thus, two forms of GATA1 protein, GATA1 and GATA1-S, are both present simultaneously in healthy humans and mice, although the physiological roles of the GATA1-S isoform remain to be clarified.
GATA1 gene construction and splicing variants.\n\t\t\t\t\t\tGATA1 gene is composed of an untranslated first exon and five translated exons. Full-length GATA1 is produced utilizing a translation initiation codon located in the second exon (upper panels). On the other hand, the GATA1-S variant is produced based on an alternative splicing variant, skipping the second exon and utilizing a methionine codon AUG corresponding to the 84th amino acid of full length of GATA1 (lower panels). Consequently, GATA1-S lacks the N-terminus 83 amino acids.
The GATA1 mutations in TAM cases are clustered in the second exon of the GATA1 gene, leading to the production of frame-shift misincorporation with the premature translation termination codon. Alternatively, mutations inducing pathological skipping of the second exon have also been reported [49]. Thus, the GATA1-S, but not the full-length GATA1, is exclusively produced in the TAM/AMKL blasts, indicating that aberrant function of GATA1-S in the absence of the expression of the full-length GATA1, rather than simple loss-of-GATA1-function, is involved in the onset of TAM.
GATA1 has four functional domains, two transactivation domains in the N- and carboxy (C)-terminal regions and two zinc-finger domains in the middle of body, which are important for the interaction with DNA and multiple cofactors (Figure 3A). Conventional cell-based luciferase reporter assays show that transactivation activity of GATA1-S is reduced into 30% of the full-length of GATA1, which is supported by the function of the C-terminal domain [50]. Functional analyses in mice in vivo indicate that the N-terminal and C-terminal transactivation domains differentially and cooperatively contribute to gene expression, depending on the property of GATA1 target genes. GATA1 target genes can be divided into three categories: the first group of genes requires only the N-terminal domain, the second group of genes requires only the C-terminal domain, and the third group of genes requires both domains [50]. The expression of only GATA1-S leads to the imbalance of GATA1 target gene expression, which may be implicated in the pathogenesis of TAM.
Importantly, provability of transformation into AMKL inversely correlates with the expression level of GATA1-S, and the latter is heavily dependent on the type of mutations in GATA1 gene [48]. In the case of the mutations producing high amounts of GATA1-S, the incidence of AMKL is relatively low. However, such cases frequently suffer from high blast counts in the peripheral blood and require chemotherapy to prevent organ infiltration with the blasts. In contrast, patients with low amounts of GATA1-S frequently develop AMKL. Thus, the expression levels of GATA1-S influence leukemia progression and disease status.
Recently, two types of internally deleted (ID)-type GATA1 proteins were reported as a cause of TAM (Figure 3B) [51]. In the blasts of these cases, aberrant transcripts are produced due to splicing mutations in the GATA1, and, consequently, GATA1 proteins lacking amino acid residues 77-119 or 74-88 are produced. The N-terminal end of GATA1 is retained in the newly identified ID-type GATA1 mutants, while retinoblastoma protein (Rb)-binding motif LXCXE located around the Met84 is commonly deleted in GATA1-S and the ID-type GATA1 mutants (Figure 3B). Because binding potential with the Rb protein is important for the GATA1 functions of controlling cell proliferation and promoting erythroid differentiation [52], loss of the interaction with Rb protein may contribute, at least in part, to the GATA1 dysfunction leading to the pathological process of TAM.
Rb-binding motif is commonly deleted in GATA1-S and the ID-type GATA1 mutants. A: domain structure of GATA1. Of note is that a pRb-binding motif LxCxE (aa 81-85) is commonly in wild-type GATA1. B: when the pRb-binding motif is eliminated in the GATA1-S and ID-type GATA1, the loss-of-function of the LxCxE motif appears to contribute to the TAM genesis.
GATA1/Gata1 gene is located on the X chromosome in humans and mice. Hemizygous male mice with the GATA1-null germline mutation die in utero due to insufficient primitive erythropoiesis [53]. CFU-Meg (colony-forming unit-megakaryocyte) is significantly reduced in the yolk sac of Gata1-null embryos, indicating that GATA1 is indispensable for the primitive erythropoiesis and megakaryopoiesis. Independently, the GATA1-knockdown allele has also been constructed by inserting a neomycin resistance cassette just upstream from the first exon [54]. In this strain of mice, the strong promoter activity within the neomycin cassette directly interferes with the expression of the Gata1 gene to approximately 5% of the wild-type level [54]. Hemizygous Gata1-knockdown mice also die in utero, showing a similar phenotype to the Gata1-null mice. These results indicate that 5% of the GATA1 level cannot support primitive erythropoiesis.
These two lines of Gata1-deficient mice have been maintained through heterozygous female mice. In female mice carrying the Gata1 mutations, two types of hematopoietic progenitor cells are developed depending on the X chromosome inactivation. Hematopoietic progenitors with inactivated wild-type X chromosome and activated X chromosome with the Gata1 mutation cannot differentiate into mature erythroid and megakaryocytic cells because of the defect in GATA1 function. In contrast, hematopoietic progenitors in which wild-type X chromosome is activated (and X chromosome with Gata1 mutation is inactivated) differentiate normally to produce erythrocytes and platelets. Therefore, while Gata1-null and Gata1-knockdown heterozygous female embryos are anemic, these mice are born alive and grow normally.
However, interestingly, the female Gata1-knockdown mice frequently develop leukemia, while female Gata1-null mice never develop leukemia and have a normal life expectancy [55]. Characterization of leukemia cells shows that the cells are positive for c-Kit (a stem cell factor receptor) and CD71 (a transferrin receptor) antibodies but negative against the Ter119 (a molecule associated with glycophorin A) antibody. Further analyses have revealed that the leukemia is provoked by the residual 5% GATA1 in the immature erythroid progenitor cells carrying the activated Gata1-knockdown allele. In contrast, the progenitor cells with the activated Gata1-null allele never commit to leukemogenesis.
Because simple GATA1-deficiency causes a lethal embryonic phenotype, the roles of GATA1 in adult hematopoiesis are investigated using mice with conditional Gata1 gene ablation. Adult Gata1-null mice produced by a conditional deletion of whole coding exons suffer from severe anemia and thrombocytopenia [56]. These mice lack erythroid progenitors, showing a phenotype resembling that of pure red cell aplasia. These results unequivocally indicate that GATA1 is required for erythroid commitment and erythropoiesis in the early stage of hematopoiesis. In addition, well-lobulated mature megakaryocytes that are positive for acetylcholine esterase (AchE) staining are accumulated in the hematopoietic organs of conditional Gata1-null mice, indicating that GATA1 is dispensable from the early stage of megakaryopoiesis and megakaryocyte development to matured polyploid megakaryocytes [56].
An additional line of GATA1-deficient mice (referred to as Gata1ΔIE) has been produced by a conditional deletion of the promoter/first exon of the Gata1 gene [57]. The conditional adult Gata1ΔIE mice also suffer from anemia. However, unlike the conditional Gata1-null mice, immature erythroid progenitors lacking terminal maturation potential to produce enucleated erythrocytes are accumulated in the hematopoietic organs of conditional Gata1ΔIE mice. Also in these conditional Gata1ΔIE mice, a small amount of aberrant Gata1 transcript is produced in the erythroid progenitors utilizing alternative first exons located in the first and the second introns. These transcripts produce a small amount of GATA1-S, which supports the erythroid commitment of hematopoietic progenitors, but the cells fail to complete terminal erythroid maturation. In contrast, these aberrant transcripts are not produced in the megakaryocytes, and the megakaryocytic phenotype of the conditional Gata1ΔIE mice is identical to that of the conditional Gata1-null mice.
We have generated germline Gata1ΔIE mice by crossing the original flox mice with general Cre-expressing mice. It is worth noting that heterozygous female mice with the germline Gata1ΔIE allele are prone to developing erythroleukemia, similar to the female Gata1-knockdown mice [58]. Thus, the impacts of changes in the expression level of GATA1 lead to the progression to leukemia in the mice, while the consequences also affect the erythroid differentiation differentially.
A transgenic complementation rescue approach has been successfully applied for the investigation of GATA1 function in vivo. Expression of full-length GATA1 under the transcriptional regulatory influences of Gata1 recapitulates the GATA1 function in vivo and rescues various GATA1-deficient mice nicely from embryonic lethality [59]. Because transgene-derived mutant GATA1 is exclusively expressed in the rescued mice, one can reasonably expect that the phenotypes observed in the rescued mice occur due to the mutation.
Exploiting this rescue strategy, we have established transgenic lines of mice expressing GATA1-S. Transgenic expression of GATA1-S rescues the GATA1-deficient males from embryonic lethality [60]. Strikingly, immature megakaryocytes are accumulated in the fetal livers of the rescued mice, but this phenotype disappears after birth [61], indicating that the simple GATA1-S mutation provokes TMD-like phenotype in mice regardless of the presence of disomy or trisomy of chromosome 16 (the equivalent of human chromosome 21). In a colony-forming assay, progenitors with the GATA1-S mutation produced multiple progenies and generated enormously large colonies, consisting of innumerable immature megakaryocytes that were faintly positive for the AchE staining. In this assay, the number of CFU-Megs in the rescued embryos was equivalent to that in the wild-type embryos. Thus, GATA1-S failed to control proliferation and differentiation during the megakaryocyte differentiation process, resulting in an uncontrolled growth of immature megakaryocytes. It should be noted that TAM appears to be generated by single or a couple of hematopoietic progenitors acquiring the GATA1-S mutation, whereas in the rescued mice, all progenitors express GATA1-S. These observations suggest that the condition provided by trisomy 21 may lead to the onset of TAM by exploiting two pathways: one increases the frequency of GATA1-S mutation, while the other activates cellular mechanisms that magnify the impacts of the GATA1-S mutation.
One of the strong advantages of the transgenic complementation rescue assay is that levels of transgene-derived GATA1-S can be controlled. Because the expression levels of transgene-derived transcript vary between transgenic mouse lines depending on the integrated positions and/or copy numbers of the transgene, transgenic mouse lines expressing high-level GATA1-S and low-level GATA1-S have been used for the rescue analyses. The mice expressing high levels of GATA1-S never develop leukemia, whereas mice expressing low levels of GATA1-S are prone to developing leukemia. The leukemic cells have biphenotypic characteristics of erythroid and megakaryocyte lineages, closely resembling the human DS-associated AMKL (our unpublished observation). Thus, the expression levels of GATA1-S appear to be reflected in the transformation process of TAM blasts to genuine leukemia, consistent with the case of leukemogenesis in the erythroid progenitors of Gata1-knockdown mice caused by GATA1-deficiency.
Mice expressing GATA1 lacking N-terminal 63 amino acids have been established by gene targeting [62]. This line of mice showed transient hyper-proliferation of megakaryocytes in the fetal livers during the early stage of development, whereas the phenotype of the megakaryocytes in the later embryonic stages was close to normal. Because this mutant GATA1 molecule preserves the consensus Rb-binding motif, the effect of GATA1 mutation may be reduced. Another line of mice has been established by second exon deletion (Gata1Δe2), and, consequently, only GATA-S is expressed in the Gata1Δe2 mice [62]. This line of mice also shows transient hyper-proliferation of megakaryocytes during the early embryonic stage, similar to the GATA1 mutants lacking N-terminal 63 amino acids. In addition, the megakaryocyte progenitors derived from bone marrow of the adult Gata1Δe2 mice are hyper-proliferative and formed significantly larger colonies than those in wild-type mice [7]. While the mechanism underlying the difference in the phenotypes of the rescued mice (hyper-proliferation of megakaryocytic progenitors until the perinatal stage [61]) and the Gata1Δe2 mice (hyper-proliferation of megakaryocytic progenitors only in the early embryonic stages [62]) is unclear at present, these data congruently support the contention that the GATA1-S mutation alone gives rise to the hyper-proliferation of megakaryocytic progenitors in fetal mouse livers.
By crossing Gata1Δe2 mice with DS-model lines of mice, i.e., Tc1 and Ts1Rh, the contributions of GATA1-S mutation in combination with the trisomy of chromosome 21 to the leukemogenesis have been analyzed. The frequency of CFU-Megs in fetal livers is increased by the combination of Gata1Δe2 and Tc1 mutations. However, this finding appears insufficient to provoke the onset of leukemia [39]. Similarly, when Ts1Rh mice are mated with Gata1Δe2 mice, the compound mice did not show more phenotypes compared to the Gata1Δe2 mutant mice in adulthood, except for further enlargement of megakaryocyte colony sizes [43]. The Ts1Rh and Gata1Δe2 compound mutant mice never develop leukemia. However, intriguingly, bone marrow cells are prone to transformation into leukemic cells when MPLW515L are retrovirally overexpressed in the compound mutant mouse cells [43]. MPLW515L is an activating mutation of the thrombopoietin receptor, which is frequently found in patients with myeloproliferative neoplasms [63]. Therefore, it seems plausible that the megakaryocyte progenitors carrying the GATA1-S mutation become sensitive to the oncogenic mutation by the presence of trisomy 21. Thus, GATA1-S mutation in combination with trisomy 21 seems to give rise to the high transformation potential, which may be involved in the increased risk of leukemogenesis in DS children.
GATA1 is a lineage restricted transcription factor that is responsible for the hematopoiesis in erythroid and megakaryocyte lineages. GATA1 dysfunction leads to two types of leukemias. One type originates from the quantitative deficit of GATA1, which causes accumulation of immature erythroblasts and finally triggers erythroleukemia in mice [55]. The other type originates from the qualitative defect of GATA1 (TMD and DS-associated AMKL) [64]. In the latter case, the GATA1-S mutation is provoked in high frequency, and the mutation contributes to the pathogenesis of TMD and DS-associated AMKL [49]. This structural change causes the accumulation of immature megakaryoblasts and finally triggers megakaryoblastic leukemia in mice and humans. Mice carrying a single GATA1-S mutation develop a phenotype resembling TAM [61]. In addition, trisomy 21 alters the function of hematopoietic cells [25-27], and in cooperation with GATA1-S, it leads to the pathogenesis of TMD and DS-associated AMKL. We surmise that the mouse models discussed in this chapter will provide important insights into the pathogenesis of TMD and DS-associated AMKL.
This study was supported in part by grants from JSPS (M.Y.), CREST program of JST and the Mitsubishi Foundation (to M.Y. and R.S.), and Friends of Leukemia Research Fund (R.S.). We also thank Ms. Aya Gotoh and Eriko Naganuma for their help.
Research methodology is the path through which researchers need to conduct their research. It shows the path through which these researchers formulate their problem and objective and present their result from the data obtained during the study period. This research design and methodology chapter also shows how the research outcome at the end will be obtained in line with meeting the objective of the study. This chapter hence discusses the research methods that were used during the research process. It includes the research methodology of the study from the research strategy to the result dissemination. For emphasis, in this chapter, the author outlines the research strategy, research design, research methodology, the study area, data sources such as primary data sources and secondary data, population consideration and sample size determination such as questionnaires sample size determination and workplace site exposure measurement sample determination, data collection methods like primary data collection methods including workplace site observation data collection and data collection through desk review, data collection through questionnaires, data obtained from experts opinion, workplace site exposure measurement, data collection tools pretest, secondary data collection methods, methods of data analysis used such as quantitative data analysis and qualitative data analysis, data analysis software, the reliability and validity analysis of the quantitative data, reliability of data, reliability analysis, validity, data quality management, inclusion criteria, ethical consideration and dissemination of result and its utilization approaches. In order to satisfy the objectives of the study, a qualitative and quantitative research method is apprehended in general. The study used these mixed strategies because the data were obtained from all aspects of the data source during the study time. Therefore, the purpose of this methodology is to satisfy the research plan and target devised by the researcher.
The research design is intended to provide an appropriate framework for a study. A very significant decision in research design process is the choice to be made regarding research approach since it determines how relevant information for a study will be obtained; however, the research design process involves many interrelated decisions [1].
This study employed a mixed type of methods. The first part of the study consisted of a series of well-structured questionnaires (for management, employee’s representatives, and technician of industries) and semi-structured interviews with key stakeholders (government bodies, ministries, and industries) in participating organizations. The other design used is an interview of employees to know how they feel about safety and health of their workplace, and field observation at the selected industrial sites was undertaken.
Hence, this study employs a descriptive research design to agree on the effects of occupational safety and health management system on employee health, safety, and property damage for selected manufacturing industries. Saunders et al. [2] and Miller [3] say that descriptive research portrays an accurate profile of persons, events, or situations. This design offers to the researchers a profile of described relevant aspects of the phenomena of interest from an individual, organizational, and industry-oriented perspective. Therefore, this research design enabled the researchers to gather data from a wide range of respondents on the impact of safety and health on manufacturing industries in Ethiopia. And this helped in analyzing the response obtained on how it affects the manufacturing industries’ workplace safety and health. The research overall design and flow process are depicted in Figure 1.
Research methods and processes (author design).
To address the key research objectives, this research used both qualitative and quantitative methods and combination of primary and secondary sources. The qualitative data supports the quantitative data analysis and results. The result obtained is triangulated since the researcher utilized the qualitative and quantitative data types in the data analysis. The study area, data sources, and sampling techniques were discussed under this section.
According to Fraenkel and Warren [4] studies, population refers to the complete set of individuals (subjects or events) having common characteristics in which the researcher is interested. The population of the study was determined based on random sampling system. This data collection was conducted from March 07, 2015 to December 10, 2016, from selected manufacturing industries found in Addis Ababa city and around. The manufacturing companies were selected based on their employee number, established year, and the potential accidents prevailing and the manufacturing industry type even though all criterions were difficult to satisfy.
It was obtained from the original source of information. The primary data were more reliable and have more confidence level of decision-making with the trusted analysis having direct intact with occurrence of the events. The primary data sources are industries’ working environment (through observation, pictures, and photograph) and industry employees (management and bottom workers) (interview, questionnaires and discussions).
Desk review has been conducted to collect data from various secondary sources. This includes reports and project documents at each manufacturing sectors (more on medium and large level). Secondary data sources have been obtained from literatures regarding OSH, and the remaining data were from the companies’ manuals, reports, and some management documents which were included under the desk review. Reputable journals, books, different articles, periodicals, proceedings, magazines, newsletters, newspapers, websites, and other sources were considered on the manufacturing industrial sectors. The data also obtained from the existing working documents, manuals, procedures, reports, statistical data, policies, regulations, and standards were taken into account for the review.
In general, for this research study, the desk review has been completed to this end, and it had been polished and modified upon manuals and documents obtained from the selected companies.
The study population consisted of manufacturing industries’ employees in Addis Ababa city and around as there are more representative manufacturing industrial clusters found. To select representative manufacturing industrial sector population, the types of the industries expected were more potential to accidents based on random and purposive sampling considered. The population of data was from textile, leather, metal, chemicals, and food manufacturing industries. A total of 189 sample sizes of industries responded to the questionnaire survey from the priority areas of the government. Random sample sizes and disproportionate methods were used, and 80 from wood, metal, and iron works; 30 from food, beverage, and tobacco products; 50 from leather, textile, and garments; 20 from chemical and chemical products; and 9 from other remaining 9 clusters of manufacturing industries responded.
A simple random sampling and purposive sampling methods were used to select the representative manufacturing industries and respondents for the study. The simple random sampling ensures that each member of the population has an equal chance for the selection or the chance of getting a response which can be more than equal to the chance depending on the data analysis justification. Sample size determination procedure was used to get optimum and reasonable information. In this study, both probability (simple random sampling) and nonprobability (convenience, quota, purposive, and judgmental) sampling methods were used as the nature of the industries are varied. This is because of the characteristics of data sources which permitted the researchers to follow the multi-methods. This helps the analysis to triangulate the data obtained and increase the reliability of the research outcome and its decision. The companies’ establishment time and its engagement in operation, the number of employees and the proportion it has, the owner types (government and private), type of manufacturing industry/production, types of resource used at work, and the location it is found in the city and around were some of the criteria for the selections.
The determination of the sample size was adopted from Daniel [5] and Cochran [6] formula. The formula used was for unknown population size Eq. (1) and is given as
where n = sample size, Z = statistic for a level of confidence, P = expected prevalence or proportion (in proportion of one; if 50%, P = 0.5), and d = precision (in proportion of one; if 6%, d = 0.06). Z statistic (Z): for the level of confidence of 95%, which is conventional, Z value is 1.96. In this study, investigators present their results with 95% confidence intervals (CI).
The expected sample number was 267 at the marginal error of 6% for 95% confidence interval of manufacturing industries. However, the collected data indicated that only 189 populations were used for the analysis after rejecting some data having more missing values in the responses from the industries. Hence, the actual data collection resulted in 71% response rate. The 267 population were assumed to be satisfactory and representative for the data analysis.
The sample size for the experimental exposure measurements of physical work environment has been considered based on the physical data prepared for questionnaires and respondents. The response of positive were considered for exposure measurement factors to be considered for the physical environment health and disease causing such as noise intensity, light intensity, pressure/stress, vibration, temperature/coldness, or hotness and dust particles on 20 workplace sites. The selection method was using random sampling in line with purposive method. The measurement of the exposure factors was done in collaboration with Addis Ababa city Administration and Oromia Bureau of Labour and Social Affair (AACBOLSA). Some measuring instruments were obtained from the Addis Ababa city and Oromia Bureau of Labour and Social Affair.
Data collection methods were focused on the followings basic techniques. These included secondary and primary data collections focusing on both qualitative and quantitative data as defined in the previous section. The data collection mechanisms are devised and prepared with their proper procedures.
Primary data sources are qualitative and quantitative. The qualitative sources are field observation, interview, and informal discussions, while that of quantitative data sources are survey questionnaires and interview questions. The next sections elaborate how the data were obtained from the primary sources.
Observation is an important aspect of science. Observation is tightly connected to data collection, and there are different sources for this: documentation, archival records, interviews, direct observations, and participant observations. Observational research findings are considered strong in validity because the researcher is able to collect a depth of information about a particular behavior. In this dissertation, the researchers used observation method as one tool for collecting information and data before questionnaire design and after the start of research too. The researcher made more than 20 specific observations of manufacturing industries in the study areas. During the observations, it found a deeper understanding of the working environment and the different sections in the production system and OSH practices.
Interview is a loosely structured qualitative in-depth interview with people who are considered to be particularly knowledgeable about the topic of interest. The semi-structured interview is usually conducted in a face-to-face setting which permits the researcher to seek new insights, ask questions, and assess phenomena in different perspectives. It let the researcher to know the in-depth of the present working environment influential factors and consequences. It has provided opportunities for refining data collection efforts and examining specialized systems or processes. It was used when the researcher faces written records or published document limitation or wanted to triangulate the data obtained from other primary and secondary data sources.
This dissertation is also conducted with a qualitative approach and conducting interviews. The advantage of using interviews as a method is that it allows respondents to raise issues that the interviewer may not have expected. All interviews with employees, management, and technicians were conducted by the corresponding researcher, on a face-to-face basis at workplace. All interviews were recorded and transcribed.
The main tool for gaining primary information in practical research is questionnaires, due to the fact that the researcher can decide on the sample and the types of questions to be asked [2].
In this dissertation, each respondent is requested to reply to an identical list of questions mixed so that biasness was prevented. Initially the questionnaire design was coded and mixed up from specific topic based on uniform structures. Consequently, the questionnaire produced valuable data which was required to achieve the dissertation objectives.
The questionnaires developed were based on a five-item Likert scale. Responses were given to each statement using a five-point Likert-type scale, for which 1 = “strongly disagree” to 5 = “strongly agree.” The responses were summed up to produce a score for the measures.
The data was also obtained from the expert’s opinion related to the comparison of the knowledge, management, collaboration, and technology utilization including their sub-factors. The data obtained in this way was used for prioritization and decision-making of OSH, improving factor priority. The prioritization of the factors was using Saaty scales (1–9) and then converting to Fuzzy set values obtained from previous researches using triangular fuzzy set [7].
The researcher has measured the workplace environment for dust, vibration, heat, pressure, light, and noise to know how much is the level of each variable. The primary data sources planned and an actual coverage has been compared as shown in Table 1.
Planned versus actual coverage of the survey.
The response rate for the proposed data source was good, and the pilot test also proved the reliability of questionnaires. Interview/discussion resulted in 87% of responses among the respondents; the survey questionnaire response rate obtained was 71%, and the field observation response rate was 90% for the whole data analysis process. Hence, the data organization quality level has not been compromised.
This response rate is considered to be representative of studies of organizations. As the study agrees on the response rate to be 30%, it is considered acceptable [8]. Saunders et al. [2] argued that the questionnaire with a scale response of 20% response rate is acceptable. Low response rate should not discourage the researchers, because a great deal of published research work also achieves low response rate. Hence, the response rate of this study is acceptable and very good for the purpose of meeting the study objectives.
The pretest for questionnaires, interviews, and tools were conducted to validate that the tool content is valid or not in the sense of the respondents’ understanding. Hence, content validity (in which the questions are answered to the target without excluding important points), internal validity (in which the questions raised answer the outcomes of researchers’ target), and external validity (in which the result can generalize to all the population from the survey sample population) were reflected. It has been proved with this pilot test prior to the start of the basic data collections. Following feedback process, a few minor changes were made to the originally designed data collect tools. The pilot test made for the questionnaire test was on 10 sample sizes selected randomly from the target sectors and experts.
The secondary data refers to data that was collected by someone other than the user. This data source gives insights of the research area of the current state-of-the-art method. It also makes some sort of research gap that needs to be filled by the researcher. This secondary data sources could be internal and external data sources of information that may cover a wide range of areas.
Literature/desk review and industry documents and reports: To achieve the dissertation’s objectives, the researcher has conducted excessive document review and reports of the companies in both online and offline modes. From a methodological point of view, literature reviews can be comprehended as content analysis, where quantitative and qualitative aspects are mixed to assess structural (descriptive) as well as content criteria.
A literature search was conducted using the database sources like MEDLINE; Emerald; Taylor and Francis publications; EMBASE (medical literature); PsycINFO (psychological literature); Sociological Abstracts (sociological literature); accident prevention journals; US Statistics of Labor, European Safety and Health database; ABI Inform; Business Source Premier (business/management literature); EconLit (economic literature); Social Service Abstracts (social work and social service literature); and other related materials. The search strategy was focused on articles or reports that measure one or more of the dimensions within the research OSH model framework. This search strategy was based on a framework and measurement filter strategy developed by the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) group. Based on screening, unrelated articles to the research model and objectives were excluded. Prior to screening, researcher (principal investigator) reviewed a sample of more than 2000 articles, websites, reports, and guidelines to determine whether they should be included for further review or reject. Discrepancies were thoroughly identified and resolved before the review of the main group of more than 300 articles commenced. After excluding the articles based on the title, keywords, and abstract, the remaining articles were reviewed in detail, and the information was extracted on the instrument that was used to assess the dimension of research interest. A complete list of items was then collated within each research targets or objectives and reviewed to identify any missing elements.
Data analysis method follows the procedures listed under the following sections. The data analysis part answered the basic questions raised in the problem statement. The detailed analysis of the developed and developing countries’ experiences on OSH regarding manufacturing industries was analyzed, discussed, compared and contrasted, and synthesized.
Quantitative data were obtained from primary and secondary data discussed above in this chapter. This data analysis was based on their data type using Excel, SPSS 20.0, Office Word format, and other tools. This data analysis focuses on numerical/quantitative data analysis.
Before analysis, data coding of responses and analysis were made. In order to analyze the data obtained easily, the data were coded to SPSS 20.0 software as the data obtained from questionnaires. This task involved identifying, classifying, and assigning a numeric or character symbol to data, which was done in only one way pre-coded [9, 10]. In this study, all of the responses were pre-coded. They were taken from the list of responses, a number of corresponding to a particular selection was given. This process was applied to every earlier question that needed this treatment. Upon completion, the data were then entered to a statistical analysis software package, SPSS version 20.0 on Windows 10 for the next steps.
Under the data analysis, exploration of data has been made with descriptive statistics and graphical analysis. The analysis included exploring the relationship between variables and comparing groups how they affect each other. This has been done using cross tabulation/chi square, correlation, and factor analysis and using nonparametric statistic.
Qualitative data analysis used for triangulation of the quantitative data analysis. The interview, observation, and report records were used to support the findings. The analysis has been incorporated with the quantitative discussion results in the data analysis parts.
The data were entered using SPSS 20.0 on Windows 10 and analyzed. The analysis supported with SPSS software much contributed to the finding. It had contributed to the data validation and correctness of the SPSS results. The software analyzed and compared the results of different variables used in the research questionnaires. Excel is also used to draw the pictures and calculate some analytical solutions.
The reliability of measurements specifies the amount to which it is without bias (error free) and hence ensures consistent measurement across time and across the various items in the instrument [8]. In reliability analysis, it has been checked for the stability and consistency of the data. In the case of reliability analysis, the researcher checked the accuracy and precision of the procedure of measurement. Reliability has numerous definitions and approaches, but in several environments, the concept comes to be consistent [8]. The measurement fulfills the requirements of reliability when it produces consistent results during data analysis procedure. The reliability is determined through Cranach’s alpha as shown in Table 2.
Internal consistency and reliability test of questionnaires items.
K stands for knowledge; M, management; T, technology; C, collaboration; P, policy, standards, and regulation; H, hazards and accident conditions; PPE, personal protective equipment.
Cronbach’s alpha is a measure of internal consistency, i.e., how closely related a set of items are as a group [11]. It is considered to be a measure of scale reliability. The reliability of internal consistency most of the time is measured based on the Cronbach’s alpha value. Reliability coefficient of 0.70 and above is considered “acceptable” in most research situations [12]. In this study, reliability analysis for internal consistency of Likert-scale measurement after deleting 13 items was found similar; the reliability coefficients were found for 76 items were 0.964 and for the individual groupings made shown in Table 2. It was also found internally consistent using the Cronbach’s alpha test. Table 2 shows the internal consistency of the seven major instruments in which their reliability falls in the acceptable range for this research.
Face validity used as defined by Babbie [13] is an indicator that makes it seem a reasonable measure of some variables, and it is the subjective judgment that the instrument measures what it intends to measure in terms of relevance [14]. Thus, the researcher ensured, in this study, when developing the instruments that uncertainties were eliminated by using appropriate words and concepts in order to enhance clarity and general suitability [14]. Furthermore, the researcher submitted the instruments to the research supervisor and the joint supervisor who are both occupational health experts, to ensure validity of the measuring instruments and determine whether the instruments could be considered valid on face value.
In this study, the researcher was guided by reviewed literature related to compliance with the occupational health and safety conditions and data collection methods before he could develop the measuring instruments. In addition, the pretest study that was conducted prior to the main study assisted the researcher to avoid uncertainties of the contents in the data collection measuring instruments. A thorough inspection of the measuring instruments by the statistician and the researcher’s supervisor and joint experts, to ensure that all concepts pertaining to the study were included, ensured that the instruments were enriched.
Insight has been given to the data collectors on how to approach companies, and many of the questionnaires were distributed through MSc students at Addis Ababa Institute of Technology (AAiT) and manufacturing industries’ experience experts. This made the data quality reliable as it has been continually discussed with them. Pretesting for questionnaire was done on 10 workers to assure the quality of the data and for improvement of data collection tools. Supervision during data collection was done to understand how the data collectors are handling the questionnaire, and each filled questionnaires was checked for its completeness, accuracy, clarity, and consistency on a daily basis either face-to-face or by phone/email. The data expected in poor quality were rejected out of the acting during the screening time. Among planned 267 questionnaires, 189 were responded back. Finally, it was analyzed by the principal investigator.
The data were collected from the company representative with the knowledge of OSH. Articles written in English and Amharic were included in this study. Database information obtained in relation to articles and those who have OSH area such as interventions method, method of accident identification, impact of occupational accidents, types of occupational injuries/disease, and impact of occupational accidents, and disease on productivity and costs of company and have used at least one form of feedback mechanism. No specific time period was chosen in order to access all available published papers. The questionnaire statements which are similar in the questionnaire have been rejected from the data analysis.
Ethical clearance was obtained from the School of Mechanical and Industrial Engineering, Institute of Technology, Addis Ababa University. Official letters were written from the School of Mechanical and Industrial Engineering to the respective manufacturing industries. The purpose of the study was explained to the study subjects. The study subjects were told that the information they provided was kept confidential and that their identities would not be revealed in association with the information they provided. Informed consent was secured from each participant. For bad working environment assessment findings, feedback will be given to all manufacturing industries involved in the study. There is a plan to give a copy of the result to the respective study manufacturing industries’ and ministries’ offices. The respondents’ privacy and their responses were not individually analyzed and included in the report.
The result of this study will be presented to the Addis Ababa University, AAiT, School of Mechanical and Industrial Engineering. It will also be communicated to the Ethiopian manufacturing industries, Ministry of Labor and Social Affair, Ministry of Industry, and Ministry of Health from where the data was collected. The result will also be availed by publication and online presentation in Google Scholars. To this end, about five articles were published and disseminated to the whole world.
The research methodology and design indicated overall process of the flow of the research for the given study. The data sources and data collection methods were used. The overall research strategies and framework are indicated in this research process from problem formulation to problem validation including all the parameters. It has laid some foundation and how research methodology is devised and framed for researchers. This means, it helps researchers to consider it as one of the samples and models for the research data collection and process from the beginning of the problem statement to the research finding. Especially, this research flow helps new researchers to the research environment and methodology in particular.
There is no “conflict of interest.”
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\n\nIn instances where permission is obtained from the publisher for reusing or republishing the Book, or significant parts of the Book, all of the following conditions apply:
\n\nEvery single Work that is used has to be attributed in the way described. If you are unsure about proper attribution, please write to permissions@intechopen.com.
\n\nIndividual Works originally published in IntechOpen books are licensed under Creative Commons licenses and can be freely used under terms of the respective CC license, if properly attributed. In order to properly attribute the Work you must respect all the conditions outlined below:
\n\nEvery single Work that is used has to be attributed in the way as described. If you are unsure about proper attribution, please contact Us at permissions@intechopen.com.
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\n\nIntechOpen does not have any claims on newly created copyrighted Works, but the Works originally published by IntechOpen must be properly attributed.
\n\nAll these rules apply to BOTH online and offline use.
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