Risk, injury, failure, loss of kidney function and end-stage kidney disease (RIFLE) classification of acute kidney injury [12].
\r\n\t
\r\n\tSince they involve very small amounts of energy, high sound pressure levels are increasingly simpler and cheaper to emit. Noise is everywhere - it can be emitted as an energy waste by traffic or factories, but also by teenagers looking for loneliness in an overpopulated world.
\r\n\t
\r\n\tWhen the noise emission ends, it will not be possible to find its footprint in the environment, hence it is necessary to be in the right place at the right time to measure it. Moreover, having adequate instruments, updated protocols and trained personnel are mandatory to achieve that. Even then, decision makers must clearly understand the reported situation to decide the need and importance of taking further actions.
\r\n\t
\r\n\tThis book will address issues of noise in the city, in the neighborhood or at work, aspects about management and consequences of exposure to high sound pressure levels ranging from the auditory, extra-auditory and psychophysics effects to the addiction to noise and the loss of solidarity.
\r\n\t
\r\n\tThe book aims to provide a various points of view and analysis of cases regarding this omnipresent pollutant.
Acute kidney injury (AKI) is a major public health concern and is associated with high morbidity, mortality, and healthcare costs. The incidence of AKI has increased lately, both in the hospital and community setting. It is estimated that more than 13 million people are affected by AKI annually with an incidence of 21.6% in adults and 33.7% in children during a single hospital episode of care [1, 2]. Despite all the advances in the field, the mortality of AKI remains very high estimated at 23.9% in adults and 13.8% in children [2]. In addition to the high mortality (1.7 million per year), AKI is associated with high morbidity and high costs [1]. In the United States, at least $5 billion in hospital costs are related to AKI, while in England AKI consumes 1% of the National Health Service budget [3]. In the developed world, AKI manifests mainly in older patients and in the intensive care settings; while in the developing countries, adults and women are particularly more commonly affected [4, 5]. Recovery from AKI is not always, as previously thought, complete and many patients progress to develop chronic kidney disease (CKD), end-stage renal disease (ESRD), or worsening of preexisting CKD later on in life [6, 7, 8, 9]. Treatment of AKI is needed to reduce the high morbidity and mortality and improve recovery of renal function. A part of dialysis, there are no other interventions that reliably improve survival, limit injury, or enhance recovery. The multifactorial etiology and the heterogeneous patient population coupled with the complicated clinical course of patients with AKI has created challenges in the search for effective pharmacological therapy [10]. In some scenarios, such as surgery or administration of intravenous contrast, the onset of AKI can be predicted providing a window of opportunity for intervention and prevention. In the majority of cases, however, intervention takes place after the onset of AKI with the aim to shorten the course and enhance recovery of renal function. In this chapter, various aspects of AKI will be discussed with a particular focus on definition and staging, etiology, pathophysiology, clinical presentation, diagnosis, management, prognosis, and prevention.
The term AKI has replaced old terms such as acute renal failure and acute renal insufficiency, which previously had been used to describe the same clinical condition. AKI is not just failure; it also incorporates the entire spectrum of the syndrome, from minor changes in renal function to the most severe form, where renal replacement therapy (RRT) may be required.
Over the last few decades, more than 35 different definitions have been used to define AKI [11]. The most commonly used definition is based on urine output and/or serum creatinine criteria. The most commonly used classifications of AKI are the “risk, injury, failure, loss of kidney function, and end-stage kidney disease” (RIFLE) [12] and the Acute Kidney Injury Network (AKIN) classifications [13].
The RIFLE classification is based on serum creatinine and urine output determinants, and considers three severity classes of AKI (risk, injury and failure), according to the variations in serum creatinine and or urine output, and two outcome classes (loss of kidney function and end-stage kidney disease). The patient should be classified using the criteria which leads to the worst classification (maximum RIFLE), Table 1. On the other hand, AKI is classified/staged by the AKIN into three stages as shown in Table 2.
Class | GFR | Urine output |
---|---|---|
Risk | ↑ SCr × 1.5 or ↓ GFR >25% | <0.5 mL/kg/h × 6 h |
Injury | ↑ SCr × 2 or ↓ GFR >50% | <0.5 mL/kg/h × 12 h |
Failure | ↑ SCr × 3 or ↓ GFR >75% or if baseline SCr ≥353.6 μmol/L (≥4 mg/dL) ↑ SCr >44.2 μmol/L (>0.5 mg/dL) | <0.3 mL/kg/h × 24 h or anuria × 12 h |
Loss of kidney function | Complete loss of kidney function >4 weeks | |
End-stage kidney disease | Complete loss of kidney function >3 months |
Risk, injury, failure, loss of kidney function and end-stage kidney disease (RIFLE) classification of acute kidney injury [12].
GFR, glomerular filtration rate; SCr, serum creatinine.
Stage | Change in serum creatinine | Urine output |
---|---|---|
1 | Increase ≥0.3 mg/dL (26.52 μmol/L) or ≥150–200% from baseline | <0.5 mL/kg/h for more than 6 h |
2 | Increase >200–300% from baseline | <0.5 mL/kg/h for more than 12 h |
3 | Increase >300% from baseline or ≥4.0 mg/dL (353.60 μmol/L) with an acute rise of at least 0.5 mg/dL (44.20 μmol/L) | <0.3 mL/kg/h for 24 h or anuria for 12 h |
Acute Kidney Injury Network (AKIN) classifications of acute kidney injury [13].
The Kidney Disease Improving Global Outcomes (KDIGO) work group has combined the RIFLE and AKIN classifications in order to establish one classification of AKI for practice, research and public health. Therefore, AKI is now defined as an abrupt reduction in renal function (within 48 h) based on an increase in serum creatinine level of more than or equal to 0.3 mg/dL (≥26.4 μmol/L), a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria of less than 0.5 mL/kg/h for more than 6 h) or a combination of these factors [14].
The etiology of AKI can be divided into three categories, Table 3 [15]:
Prerenal (caused by decreased renal perfusion, often due to volume depletion)
Intrinsic renal (caused by a process within the kidneys)
Postrenal (caused by a process distal to the kidneys such as obstruction)
Prerenal |
Intrarenal vasoconstriction (hemodynamically mediated): |
Medications: nonsteroidal anti-inflammatory drugs, angiotensin system blockers, calcineurin inhibitors |
Cardiorenal syndrome: advanced heart failure |
Hepatorenal syndrome: liver cirrhosis |
Abdominal compartment syndrome |
Hypercalcemia |
Systemic vasodilation: sepsis |
Volume depletion: |
Renal loss: diuretics, osmotic diuresis (severe hyperglycemia), salt wasting |
Extrarenal loss: blood loss, gastrointestinal loss (vomiting, diarrhea), skin (burns, sweating) |
Intrinsic renal |
Glomerulonephritis (isolated or a part of systemic diseases) |
Interstitial nephritis: |
Medications: antibiotics (β lactams, sulfonamides, quinolones, rifampin), phenytoin, antiretrovirals, proton pump inhibitors, nonsteroidal anti-inflammatory drugs |
Infections: viruses (Epstein-Barr virus, cytomegalovirus, human immunodeficiency virus), bacteria (tuberculosis, legionella species), fungi (candidiasis, histoplasmosis) |
Systemic disease: sarcoidosis, connective tissue diseases |
Tubular necrosis: |
Ischemic: prolonged hypotension |
Nephrotoxic: exogenous toxins (radiographic contrast agents, aminoglycosides, cisplatin, methotrexate, amphotericin B) |
Endogenous toxins: pigment induced (hemolysis and rhabdomyolysis), tumor lysis syndrome, multiple myeloma |
Vascular |
Renal artery and vein thrombosis, malignant hypertension, scleroderma renal crisis, atheroembolic disease, microangiopathies |
Post renal |
Extrarenal obstruction: outlet obstruction (prostate hypertrophy, neurogenic bladder; malignancy of the urogenital tract), retroperitoneal fibrosis |
Intrarenal obstruction: stones, crystals (acyclovir, indinavir, ethylene glycol), blood clots, tumors |
Of these three categories, only “intrinsic” AKI represents a true kidney disease, while pre- and postrenal AKI are the consequence of extrarenal processes that lead to decreased glomerular filtration rate (GFR). Both pre- and postrenal conditions, if persist and not managed in a timely manner, may eventually evolve into intrinsic renal damage. Patients with CKD and those admitted to the intensive care unit (ICU) are particularly prone to develop AKI. The AKI-EPI study demonstrated that AKI occurred in more than half of the patients in ICU; mostly due to sepsis and hypovolemia followed by nephrotoxic agents [16].
Despite the identification of several cellular mechanisms thought to underlie the development of AKI, the pathophysiology of AKI is still poorly understood. Animal models of AKI representing ischemia–reperfusion injury and drug nephrotoxicity have been instrumental in understanding the pathophysiology of AKI in humans. Although the current in vivo models of AKI in healthy rodents provide valuable information about the pathophysiological mechanisms of renal injury, they do not reflect the complexity of disease in humans characterized by population’s heterogeneity and preexisting comorbidities such as diabetes, hypertension, and CKD. A few and not all mechanisms of AKI will be discussed.
The renal microvasculature plays a key role in the pathophysiology of AKI. The kidney is a vascular organ receiving 25% of the cardiac output and has a high energy demand with relatively low oxygen (O2) extraction. Under normal steady-state, the O2 supply to the kidney is well regulated. Adequate O2 delivery is crucial for the production of mitochondrial adenosine triphosphate (ATP), nitric oxide (NO), and reactive oxygen species (ROS) necessary for homeostatic control of renal function [10, 17]. The vascular architecture of the outer medulla is particularly susceptible to ischemic injury due to the marginal oxygenation of this part of the kidney.
With injury, the microcirculation is compromised leading to an imbalance in NO, ROS, and O2 supply and consumption. Subsequent pathogenic events follow including hypoxia and oxidative stress. Injury to the microvascular endothelium and changes in the glycocalyx lead to endothelial cell activation and expression of cell surface markers that promote recruitment and adhesion of leukocytes and platelets, leading to further changes in perfusion and O2 delivery; and to additional endothelial cell injury and inflammation [18, 19]. As a result, increased vascular permeability and development of interstitial edema lead to further compromise of blood flow exacerbating the initial insult. In addition, production of vasoactive prostaglandins by damaged tubular cells coupled with oxidative stress further impairs O2 delivery by worsening the local microvascular occlusion [18, 19]. The main long-term result of microvascular injury is a reduction in peritubular capillary density, a response to decreased vascular endothelial growth factor (VEGF) and increased transforming growth factor beta (TGF-β) signaling, which contributes to ongoing hypoxia and development of renal fibrosis [20].
The endoplasmic reticulum (ER) plays an important role in the maintenance of protein homeostasis through its control of the concentration, conformation, folding, and trafficking of client proteins. As a result of endothelial or epithelial cell stress, unfolded or misfolded proteins accumulate in the ER, triggering the unfolded protein response (UPR) [21]. The UPR initially serves as an adaptive response, but will also induce apoptosis in cells under severe or prolonged ER stress. Accumulating evidence indicates that apoptosis in tubules resulting from epithelial cell damage is caused, at least in part, by the proapoptotic UPR [22]. Therefore, targeting the UPR may present a possible approach to prevent or treat AKI.
The ER and mitochondria have multiple contact sites termed the mitochondrial-ER-associated membrane (MAM). The MAM contains proteins from the two organelles and appears as ER tubules closely apposed to the mitochondria on electron micrographs [23]. During cellular stress situations, like an altered cellular redox state, the MAM alters its set of regulatory proteins and thus alters MAM functions. In the pathogenesis of AKI, proximal tubules are especially vulnerable to mitochondrial dysfunction as they depend on aerobic metabolism and their mitochondria are in a more oxidized state than those in the distal tubular cells which can use glycolysis [24]. Following either ATP depletion or cisplatin treatment of rat renal tubular cells, mitochondrial fragmentation was observed prior to cytochrome c release and apoptosis [25]. Targeting mitochondrial dysfunction along with a better understanding of the regulation of mitochondrial dynamics and its pathogenic changes may emerge as a new modality to treat AKI [26].
Autophagy is a catabolic process in which proteins, organelles, and cytoplasmic components are delivered to lysosomes for degradation and recycling. Autophagy is induced in renal tubular cells during AKI [27]. It is initiated by encapsulating cytoplasmic proteins and organelles in autophagosomes, which fuse with lysosomes for degradation. Once activated, it may decrease cellular stress by removing ER membranes containing UPR sensors and/or clearing abnormal proteins from the ER. In animal models, blocking the autophagic flux-enhanced AKI, while activation of autophagy was found to be protective against cisplatin-induced AKI [27]. In addition, resolution of autophagy may promote proliferation and regeneration of tubular cells in the recovery phase of AKI [28]. Autophagy may be targeted as an inflammatory modulator for the treatment of various kidney diseases [29].
Inflammation plays a major role in the pathophysiology of AKI resulting from ischemia [30]. Changes in protein folding and mitochondrial function influence the innate immune response, contributing to inflammation. In addition, several cytokines and inflammatory pathways are activated in AKI [30]. Moreover, immune cells of both the innate and adaptive immune systems, such as neutrophils, dendritic cells, macrophages, and lymphocytes, contribute to the pathogenesis of renal injury after ischemia–reperfusion injury, and some cells also participate in the repair process [31]. Neutrophils and monocytes mediate the acute phase within the first 24 h of injury [32], whereas T and B lymphocytes are important in the evolution phase of renal injury [31]. Inhibition of leukocyte infiltration into the kidney ameliorates the loss in renal function, decreases renal injury, cell death, and long-term fibrosis [33]. There is experimental evidence that inducible nitric oxide synthase (iNOS) may contribute to tubular injury during AKI [34]. It has been shown that hypoxia in isolated proximal tubules increases nitric oxide release [35], and that iNOS protein expression is increased in ischemic kidneys [36]. In vivo use of an antisense oligonucleotide to block the up-regulation of iNOS was protective against ischemia induced renal injury in rat models [36]. Similarly, tubules from iNOS knockout mice were protected against hypoxic injury [37].
Phospholipase A2 (PLA2) is a family of enzymes that hydrolyzes the acyl group from the sn-2 position of phospholipids, generating free fatty acids [38, 39]. PLA2 activity is increased during hypoxic injury to the renal tubules. Inhibiting PLA2 by exogenous fatty acids such as arachidonic acid has been shown to be protective against hypoxia-induced injury in isolated proximal renal tubules [40, 41].
Sepsis is a severe inflammatory response to infection characterized by a whole-body inflammatory state with severe consequences, including multiple organ failure [42]. AKI is a frequent and serious complication of sepsis among ICU patients and is associated with a high in-hospital and long-term mortality [43, 44]. The multinational AKI-EPI study has demonstrated that AKI affected more than 50% of ICU patients, and increasing AKI severity was associated with increased mortality [16].
Although septic shock is a leading cause of AKI, the underlying mechanisms are not completely understood. The pathophysiology of AKI in sepsis is complex and multifactorial involving multiple processes including intrarenal hemodynamic perturbations, endothelial dysfunction, infiltration of inflammatory cells, up-regulation of inflammatory cytokines, intraglomerular thrombosis, induction of apoptosis, and tubular obstruction with necrotic cells and debris [42, 45, 46]. Activation of pro- and anti-inflammatory mechanisms is believed to play a key role in the induction of sepsis [47].
Activation of the innate immune response takes place after initial host-microbial encounter, which coordinates a defensive response involving both humoral and cellular components [48]. This leads to activation and secretion of various cytokines, most importantly interleukin-1 (IL-1), tumor necrosis factor-α (TNF-α), and IL-6 that progress to a state of cytokine storm, hemodynamic instability, and eventually organ dysfunction and septic shock [42].
Lipopolysaccharide (LPS), a component of the outer membrane of Gram-negative bacteria, is a potent and rapid activator of a variety of cell types such as leukocytes, monocytes, and macrophages [49]. Activation of inflammatory cells by LPS constitutes the first step in a cascade of events that lead to the manifestation of Gram-negative sepsis. LPS initiates multiple intracellular signaling events, including the activation of nuclear factor-κB (NF-κB), which ultimately leads to the synthesis and release of a number of pro-inflammatory mediators, including IL-1, IL-6,IL-8, and TNF-a. The pathway that leads to activation of NF-κB has been shown to be mediated by members of the toll-like receptors (TLRs), a family of transmembrane proteins that play an important role in the defense against pathogenic microbial infection [50]. In the setting of sepsis, there is a significant up-regulation of TLRs, in particular TLR-2 and TLR-4 expression [51]. Both TLR-2 and TLR-4 are activated by LPS in a response that depends on LPS-binding protein and is enhanced by CD14 [49, 52]. An overview of the TLR signaling pathway is depicted in Figure 1 [53]. Figure 2 depicts the key pathways involved in the clinical course of sepsis that also have implications in the pathophysiology of sepsis-induced AKI [42].
Toll-like receptor (TLR) signaling pathway. When TLRs are stimulated by their respective ligands, they dimerize and recruit downstream adaptor molecules, such as myeloid differentiation primary-response protein 88 (MyD88), MyD88-adaptor-like (MAL), toll/interleukin (IL)-1 receptor (TIR)-domain-containing adaptor-inducing interferon-β (TRIF), TRIF-related adaptor molecule (TRAM), which activate other downstream molecules leading to the activation of signaling cascades that converge at the nuclear factor-κB (NF-κB), interferon (IFN) response factors (IRFs), and mitogen-activated protein (MAP) kinases. These molecules induce the transcription of several pro-inflammatory molecules, such as interleukin (IL)-6, IL-8, IL-12, and tumor necrosis factor-α (TNF-α). AP1, activator protein 1; ATF, activating transcription factor; dsRNA, double-stranded RNA; ERK, extracellular signal-regulated kinase; IKK, inhibitor of kappa light polypeptide gene enhancer in B-cell kinase; IRAK, IL-1 receptor-associated kinase; JNK, c-Jun N-terminal kinase; LPS, lipopolysaccharide; MD, myeloid differentiation factor; MKK, MAPK kinase; NA, nucleic acid; TAB, transforming growth factor-β-activated kinase 1/MAP3K7-binding protein; TAK, transforming growth factor-activated kinase; TRAF, tumor necrosis factor receptor-associated factor; RIP1, receptor-interacting protein 1. Adapted from Anwar et al. [53].
Key pathogenic pathways involved in sepsis that also have implications in the pathophysiology of sepsis-induced acute kidney injury. Adapted from Zarjou and Agarwal [42].
Modulation of TLRs may become a novel therapeutic target in the treatment of organ dysfunction associated with sepsis including AKI. Similarly, cytokine adsorption to the membrane during continuous renal replacement therapy may emerge as a treatment modality in patients with sepsis and AKI [54].
The clinical presentation of AKI depends on the cause and severity of renal insult. Mild to moderate AKI is asymptomatic and patients are identified based on laboratory testing. However, patients with severe AKI often present with a variety of symptoms including fatigue, anorexia, nausea, vomiting, restlessness, confusion, fluid retention, and weight gain. Severe and prolonged AKI may cause central nervous system manifestations such as uremic encephalopathy with asterixis, confusion, and seizure; bleeding tendency due to platelet dysfunction and severe anemia. Patients with AKI may have normal urine output, oliguria (urine output less than 400 mL/24 h) or anuria (urine output less than 100 mL/24 h).
History and physical examination, with an emphasis on assessing the patient’s volume status, are crucial for determining the cause of AKI. The history should inquire about the use of nephrotoxic medications or presence of systemic illnesses that might impair renal perfusion or directly impair renal function. Physical examination should assess the intravascular volume status and any skin rashes that indicate systemic diseases. The initial laboratory evaluation should include urinalysis, urine microscopy, complete blood count, electrolytes, serum creatinine or cystatin C level, and fractional excretion of sodium (FENa). Urinalysis and urine microscopy are essential in the initial work up of AKI. Findings on urinalysis and urine microscopy guide the differential diagnosis and direct further investigation. Imaging studies in particular ultrasonography can help in the initial work up of AKI. Ultrasonography is particularly important in older men with AKI who may have bladder outlet obstruction as a result of prostate hypertrophy [55, 56]. Renal biopsy is reserved for patients with AKI where the cause is not clear. Renal biopsy is particularly important when there is suspicion of an underlying disease that requires specific therapy such as glomerulonephritis or interstitial nephritis. Renal biopsy should be performed urgently in cases of rapidly progressive glomerulonephritis as indicated by rising serum creatinine or cystatin C and presence of red blood cell casts or dysmorphic red blood cells on urine microscopy.
Although the RIFLE and AKIN criteria, based on serum creatinine and urine output, were a step forward in diagnosing AKI, a reliable tool to differentiate between true parenchymal and prerenal azotemia in clinical practice is still lacking [57]. Lately, several papers on the use of new urinary and serum biomarkers for the diagnosis and prognostication of AKI have been published with the hope that these biomarkers will lead to a new era of earlier diagnosis, better prognostication and treatment. Some of the studied biomarkers are listed in Table 4. Although these biomarkers may help to understand some of the biochemical and biological processes during AKI, their utility in preventing and treating AKI at present is at most very limited [58].
Acronym | Legend | Main source |
---|---|---|
AP | Alkaline phosphatase | Liver, bone, intestine, placenta, brush border proximal convoluted tubules |
α1MG | Alpha 1 microglobulin | Liver. Reabsorption by renal proximal tubular cells |
α1acidGP | Alpha 1 acid glycoprotein | Liver. Reabsorption by renal proximal tubular cells |
Β2MG | Beta 2 microglobulin | All nucleated cells. Reabsorption by renal proximal tubular cells |
Cystatin C | Cystatin C | All nucleated cells. Reabsorption by renal proximal tubular cells |
FENA | Fractional excretion of sodium | |
GGTP | Gamma glutamyl transpeptidase | All cells except myocytes. Mainly liver and kidney (brush border proximal convoluted tubules and loop of Henle) |
αGST | Alpha-glutathione S-transferase | Expressed in almost all tissues. Kidney: proximal tubular cells (cytoplasmatic) |
πGST | Pi glutathione S-transferase | Expressed in almost all tissues. Kidney: distal tubular cells (cytoplasmatic) |
HGF | Hepatocyte growth factor | Mesenchymal cells |
IL-6 | Interleukin 6 | T lymphocytes, macrophages, endothelial cells, monocytes |
IL-8 | Interleukin 8 | Monocytes, macrophages, epithelial cells, endothelial cells |
IL-10 | Interleukin 10 | Monocytes, lymphocytes, macrophages |
IL-18 | Interleukin 18 | Monocytes, dendritic cells, macrophages and epithelial cells |
KIM-1 | Kidney injury molecule 1 | Kidney: proximal tubular cells |
LFABP | Liver-type fatty acid-binding protein | Hepatocytes, kidney: proximal tubular cells |
NGAL | Neutrophil gelatinase-associated lipocalin | Leucocytes, loop of Henle and collecting ducts |
NAG | N-Acetyl beta glucosaminidase | Several tissues (liver, brain, spleen, etc.). Kidney: proximal tubular cells (lysosomal) |
PAI-1 | Plasminogen activator inhibitor 1 | Endothelium |
PCX | Podocalyxin | Podocytes |
RBP | Retinol-binding protein | Liver. Reabsorption by renal proximal tubular cells |
sTNFR-I | Soluble tumor necrosis factor receptor I | Most cells and tissues (cytotoxic, apoptotic, and pro-inflammatory effects) |
sTNFR-II | Soluble tumor necrosis factor receptor II | Most cells and tissues (proliferative and anti-apoptotic effects) |
TNF-α | Tumor necrosis factor alpha | Macrophages, lymphoid cells, renal parenchymal cells |
11 k-TXB2 | 11-keto-Thromboxane B2 | Platelets |
vWF | Von Willebrand factor | Endothelium, megakaryocytes, subendothelial connective tissue |
TIMP-2 | Tissue inhibitor of metalloproteinase-2 | Ubiquitous expression. Renal tubular cells |
IGFBP7 | Insulin-like growth factor-binding protein 7 | Ubiquitous expression. Renal tubular cells |
Urinary and serum biomarkers for the diagnosis of acute kidney injury.
Adapted and modified from Vanmassenhove [57].
Management of AKI mandates close collaboration among nephrologists and other physicians involved in the care of the patient. The clinical evaluation of AKI includes a careful history and thorough physical examination. Drug history should include over-the-counter medications, herbal remedies, and recreational drugs [59]. Once established, management of AKI is mainly supportive. Most patients with AKI should be hospitalized unless the condition is mild and attributed to an easily reversible cause. The evaluation and initial management of patients with AKI should include: (1) an assessment of the contributing causes of the kidney injury, (2) an assessment of the clinical course including comorbidities, (3) a careful assessment of volume status, and (4) the institution of appropriate therapeutic measures designed to reverse or prevent worsening of functional or structural kidney abnormalities [60]. The initial assessment of patients with AKI should include the differentiation between prerenal, renal, and postrenal causes [34, 61, 62, 63]. In the majority of cases, the exclusion of postrenal causes using ultrasonography is an established approach and sufficient for the initial assessment. Differentiation between prerenal and renal causes is more challenging as renal hypoperfusion may coexist with any stage of AKI.
Assuring adequate renal perfusion by achieving and maintaining hemodynamic stability and avoiding hypovolemia is crucial in the initial management of AKI. Measurement of central venous pressures may be helpful in case of difficulty in assessing intravascular volume. Prerenal azotemia is rapidly reversible when the underlying cause is corrected [34, 60, 61, 62, 63]. It is important to point out that certain elements of the definition of prerenal azotemia have diagnostic limitations. In the setting of renal hypoperfusion, compensatory mechanisms aimed at maintaining GFR may become operative. These compensatory mechanisms include efferent arteriolar vasoconstriction, afferent arteriolar dilation, and neuro/hormonal changes that lead to increased tubular reabsorption of solutes and water [64]. This implies that patients with renal hypoperfusion may be classified as having AKI by urine output criteria without having a significant change in serum creatinine concentration.
Volume resuscitation can correct prerenal conditions resulting from absolute or relative hypovolemia. However, renal hypoperfusion resulting from low cardiac output (severe cardiomyopathy) and reduced renal perfusion pressure (sepsis, or end-stage liver disease) cannot always be corrected by fluid administration [60]. Isotonic solutions (e.g., 0.9 sodium chloride) are preferred over hyperoncotic solutions due to the detrimental effect of these solutions (e.g., dextrans, hydroxyethyl starch, and albumin) [65, 66]. The use of hydroxyethyl starch as a plasma-volume expander has been shown to be an independent risk factor for AKI in patients with severe sepsis or septic shock [65]. In patients with persistent hypotension, vasopressors may be needed to maintain a mean blood pressure of 65 mmHg [66].
A number of pharmacologic interventions have been evaluated in the early management of AKI. Some have been designed to improve renal perfusion and others to modulate intrarenal pathophysiology. In patients with hyperdynamic septic shock, both norepinephrine and terlipressin were effective in raising mean arterial blood pressure (MAP) leading to an improvement in renal function [67].
Low-dose (renal-dose) dopamine was frequently used in the ICU setting for its presumed renoprotective effects. Low-dose dopamine may increase the urine output on the first day of use, but prospective and retrospective studies as well as several meta-analyses have not shown positive effect in prevention of AKI or improvement in renal function in patients with AKI [68, 69, 70, 71]. To the contrary, low-dose dopamine has been shown to worsen renal perfusion in patients with established AKI [72]. Therefore, the routine use of low-dose dopamine in critically ill patients should be abandoned.
Randomized controlled trials of early AKI and contrast nephropathy studying fenoldopam, a selective dopamine A1 agonist, proved this agent is ineffective at protecting renal function or reducing the need for renal replacement [73, 74]. Fenoldopam has been shown, however, to lower the risk of AKI in cardiac and major surgery patients according to some meta-analyses, without an effect on renal replacement or hospital mortality [75, 76]. In most of these studies, fenoldopam was associated with hypotension.
High-chloride fluids may be associated with increased risk of AKI and mortality in patients with sepsis [77]. Early goal-directed therapy with close monitoring of central venous pressure, mean arterial pressure, and oxygen saturation has been shown to be protective against AKI in patients admitted to the intensive care unit with sepsis [78, 79].
Atrial natriuretic peptide (ANP) is produced by cardiac atrial myocytes in response to atrial distension or increased atrial pressure. It induces afferent dilatation and efferent vasoconstriction, thereby increasing glomerular filtration and urinary sodium excretion [80]. B-type (brain) natriuretic peptide (BNP) is primarily produced in the cardiac ventricles and has similar effects [81, 82]. Low doses of recombinant human ANP-enhanced renal excretory function, decreased the probability of dialysis, and improved dialysis-free survival in early, ischemic acute renal dysfunction after complicated cardiac surgery [83]. Similar effects were observed in patients undergoing liver transplantation [84, 85]. However, larger doses of ANP were not effective in improving dialysis-free survival or reduction in dialysis in large randomized clinical trials [86, 87].
Theophylline, an adenosine antagonist has been shown in several preliminary reports to be beneficial in the prevention of contrast nephropathy and cisplatin nephrotoxicity [88, 89, 90]. A few adjunctive agents such as flavonoids (silymarin) and carotenoids (lycopene), have been tried in pilot studies in cancer patients receiving cisplatin with limited success in some but not all studies [91, 92, 93]. Adequately powered, controlled studies to support the efficacy of these agents are lacking.
Levosimendan, a calcium sensitizer, has inodilator, cardioprotective, and anti-inflammatory effects [94]. Two meta-analyses suggested that the use of levosimendan was associated with a reduction of renal replacement therapy in critically ill patients and patients undergoing cardiac surgery [95, 96]. The studies in both meta-analyses were small, heterogeneous, and AKI was not always a predefined endpoint.
The role of loop diuretics and osmotic agents in the prevention and treatment of AKI in humans has been disappointing despite their ability to decrease the tubular oxygen consumption and relieve intratubular obstruction in animal models [97, 98, 99]. A metanalysis has shown that frusemide was not associated with any significant clinical benefits in the prevention and treatment of AKI in adults, in addition to the concern of increased risk of ototoxicity associated with high doses [100].
N-acetyl-cysteine, a thiol-containing antioxidant has been investigated in several trials, mainly in the prevention of contrast-induced nephropathy. Despite some positive reports [101, 102], the protective effect of N-acetyl-cysteine is still controversial [103, 104, 105, 106]. Similarly, N-acetyl-cysteine was not found to be protective against other causes of AKI particularly in hypotensive patients in the ICU or patients undergoing cardiac surgery [107, 108]. Hydration with sodium bicarbonate, as compared to normal saline, has been shown in some studies to be superior to normal saline in the prevention of contrast-induced nephropathy [109, 110, 111]. Other studies have shown no superiority of sodium bicarbonate over saline in the prevention of contrast nephropathy [112, 113]. Hydration with isotonic solutions either normal saline or sodium bicarbonate in addition to the use of low osmolar contrast agents is the most effective strategy to prevent contrast-induced nephropathy.
Statins may have a beneficial effect in high-risk patients exposed to contrast administration for angiography. In a randomized multicenter clinical trial, the short-term use of rosuvastatin was found to be protective against contrast nephropathy in diabetic patients with concomitant CKD who underwent coronary/peripheral arterial angiography [114]. In another single center trial high-dose rosuvastatin (40 mg on admission followed by 20 mg daily) given to statin-naïve patients with acute coronary syndrome who were scheduled for an early invasive procedure was protective against contrast-induced AKI and improved the short-term clinical outcome [115]. 6.7% of patients in the early high-dose rosuvastatin group developed AKI compared to 15.1% in the control group. The 30-day rate of adverse cardiovascular and renal events was also reduced in the rosuvastatin group (3.6 versus 7.9%). In a subgroup analysis of this study, rosuvastatin had a protective effect among female diabetic patients with CKD [116]. Similarly, a single high dose of atorvastatin (80 mg) administered within 24 h before exposure to intravenous contrast was effective in reducing the rate of AKI in diabetic patients with renal dysfunction [117, 118]. The protective effect of statins has been confirmed in multiple meta-analyses [119, 120, 121]. However, the beneficial effect of statins in patients undergoing coronary interventions was not observed in patients undergoing cardiac surgery. In this group of patients, the use of statin either showed no benefit or was detrimental [122, 123, 124].
There is a wide variation in clinical practice relating to the indication for and timing of RRT for patients with AKI. There is also no agreement on the selection of the specific modality of RRT and prescription of intensity of therapy. Among the several modalities of RRT, continuous renal replacement therapy has become very popular, especially in the ICU setting where patients may be hemodynamically unstable to tolerate intermittent hemodialysis. There does not appear to be a significant difference in either mortality or recovery of renal function associated with the various modalities of RRT. This is discussed in details in other sections of the book designated for RRT.
Acute kidney injury is particularly common in ICU patients affecting more than 50% and is associated with increased mortality and morbidity [16]. The Working Group on Prevention, AKI section, European Society of Intensive Care Medicine has recently issued recommendations for the prevention of AKI, specifically addressing the role of fluids, diuretics, inotropes, vasopressors/vasodilators, hormonal and nutritional interventions, sedatives, statins, remote ischemic preconditioning, and care bundles as shown in Table 5 [125]. The recommendations are summarized as follows: timely resuscitation with fluids, vasopressors, and inotropic agents remains the cornerstone in the prevention of AKI. Volume expansion with isotonic crystalloids is reserved for true and suspected hypovolemia. The use of starches and dextrans should be avoided. In hypotensive patients, vasoconstrictors, preferably norepinephrine, should be administered with or following volume expansion. Mean arterial pressure (MAP) of 65–70 mmHg is adequate in most patients except in cases of preexisting chronic hypertension where a higher MAP (80–85 mmHg) should be targeted. Review of all medications and cessation of nephrotoxic agents is mandatory. Diuretics should not be used for prevention of AKI but may benefit in cases of volume overload and congestion. Hyperglycemia should be avoided. The effect of statins appears to depend on the setting, with promising results in contrast administration but no effect or even harm in cardiac surgery patients [125].
Volume expansion |
Controlled fluid resuscitation in volume depletion, while, however, avoiding volume overload (1 C) |
Avoidance of starches, gelatine, and dextrans (2C) |
Correction of hypovolemia/dehydration using isotonic crystalloids in patients receiving intravascular contrast media (1 B) |
Regular monitoring of chloride levels and acid–base status in situations where chloride-rich solutions are used (BPS) |
Use of balanced crystalloids for large volume resuscitation (2C) |
Use of human albumin if necessary for the treatment of patients with septic shock (2C). |
Use of diuretics |
No loop diuretics for the prevention of AKI (Grade 1B) |
Diuretics to control or avoid fluid overload in patients that are diuretic-responsive (Grade 2D) |
Use of vasopressors |
Titrating vasopressors to a MAP of 65–70 mmHg (Grade 1B) in patients with septic shock and to (80–85 mmHg) for patients with chronic HTN (Grade 1C). |
lowering SBP to 140–190 mmHg in patients with acute cerebral hemorrhage with severe admission hypertension (Grade 1C) |
Norepinephrine as the first-choice vasopressor to protect kidney function (Grade 1B) and vasopressin in patients with vasoplegic shock after cardiac surgery (Grade 2C). |
Individualizing target pressure when premorbid blood pressure is available (BPS) |
Use of vasodilators |
No low-dose dopamine for protection against AKI (Grade 1A) |
No levosimendan for renal protection in patients with sepsis and in cardiac surgery patients with poor preoperative left ventricular function (Grade 1B). |
No fenoldopam or natriuretic peptides for renal protection in critically ill or cardiovascular surgery patients at risk of AKI (Grade 2B). |
Sedatives |
Shorter sedation using propofol or dexmedetomidine (BPS) |
Hormonal manipulation |
Target a blood glucose level of at least below 180 mg/dL (10 mmol/l) (Grade 2B). |
Use of erythropoietin or steroids (Grade 2 B) |
Metabolic interventions |
Avoid using high-dose IV selenium for renal protection in critically ill patients (1B) |
Avoid using N-acetylcysteine to prevent contrast-associated AKI in critically ill patients (Grade 2B) |
Provide adequate nutritional support preferably through the enteral route (BPS) |
Statins |
Avoid the use of high-dose statins to prevent postoperative AKI in cardiac surgery (Grade 1A) |
Use atorvastatin or rosuvastatin to prevent contrast-associated AKI in high-risk patients undergoing coronary contrast angiography (Grade 2B) |
Remote ischemic preconditioning |
Do not use remote ischemic preconditioning for prevention of AKI in critically ill patients |
AKI care bundles |
Use of the KDIGO recommendations to reduce the incidence of AKI after cardiac surgery (Grade 2C). |
Use of AKI care bundles outside the intensive care unit has some benefits, including the potential to improve the outcome of AKI (BPS). |
Expert opinion of the Working Group on Prevention, AKI section, European Society of Intensive Care Medicine [125].
AKI, acute kidney injury; HTN, hypertension; MAP, mean arterial pressure; BPS, best practice statement.
With the advent of agreed definition and classification of AKI based on changes in serum creatinine and urine output, there is now increasing awareness of the poor prognosis following AKI. Multiple studies have shown that patients with AKI are at high risk for progression to advanced stage CKD and death following hospital discharge. In a meta-analysis of 13 cohort studies comparing the risk of CKD, ESRD, and death in patients with and without AKI, the pooled incidence of CKD and ESRD were 25.8/100 person-years and 8.6/100 person-years, respectively [8]. Patients with AKI had higher risks of developing CKD (pooled adjusted hazard ratio 8.8), ESRD (pooled adjusted HR 3.1), and mortality (pooled adjusted HR 2.0) than patients without AKI [8]. In another meta-analysis of 48 studies containing 47,107 patients between 1985 and 2007 the incidence rate of mortality was 8.9 deaths/100 person-years in survivors of AKI compared to 4.3 deaths/100 patient-years in survivors without AKI (rate ratio 2.59) [126]. The incidence rate of CKD after an episode of AKI was 7.8 events/100 patient-years, and the rate of ESRD was 4.9 events/100 patient-years [126]. In an observational cohort study with a median follow-up of 9 years the intermediate-term (30–364 days) adjusted mortality HRs for AKI versus no AKI were 2.48, 2.50, 1.90, and 1.63 for baseline eGFRs ≥60, 45–59, 30–44, and <30 mL/min/1.73 m2, respectively [127]. This indicates that baseline renal function is an important determinant factor for outcome following an episode of AKI. A retrospective cohort study showed that patients who developed AKI during a hospitalization were at substantial risk for the development of CKD in the following year, and the timing of recovery was a strong predictor, even for the mildest forms of AKI [128].
The multinational AKI-EPI study on ICU patients in 97 centers showed that increasing AKI severity was associated with increased mortality, and AKI patients had worse renal function at the time of hospital discharge [16].
According to the United States Renal Data System, acute tubular necrosis (ATN) without recovery as a cause of ESRD increased from 1.2% in 1994 to 1998 to 1.7% in 1999 to 2003 [129]. The incidence will likely continue to rise with the aging population and increase in comorbidities in patients admitted to the ICU.
Risk factors associated with progressing to CKD among AKI survivors have been identified and include advanced age, diabetes mellitus, decreased baseline glomerular filtration rate, severity of AKI, and a low concentration of serum albumin [6, 130].
Acute kidney injury, previously named acute renal failure, is characterized by abrupt deterioration in renal function. The incidence of AKI has lately increased, both in the hospital and community setting. Management of AKI involves fluid resuscitation, avoidance of nephrotoxic agents, adjustment of medications, and correction of fluid, acid-base and electrolyte imbalance. Depending on the severity of renal insult, AKI may require renal replacement therapy in the form of dialysis or continuous renal replacement. Despite all the advances in the field, AKI still carries a high mortality and long term consequences. Recognition of risk factors, early diagnosis, and management of AKI are crucial to improve the long-term patient’s outcome.
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.
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\\n\\nAll Works are published under the CC BY 3.0 license. However, please note that book Chapters may fall under a different CC license, depending on their publication date as indicated in the table below:
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The CC BY 3.0 license permits Works to be freely shared in any medium or format, as well as the reuse and adaptation of the original contents of Works (e.g. figures and tables created by the Authors), as long as the source Work is cited and its Authors are acknowledged in the following manner:
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\\n\\nRepublishing – More about Attribution Policy can be found here.
\\n\\nThe same principles apply to Works published under the CC BY-NC-SA 3.0 license, with the caveats that (1) the content may not be used for commercial purposes, and (2) derivative works building on this content must be distributed under the same license. The restrictions contained in these license terms may, however, be waived by the copyright holder(s). Users wishing to circumvent any of the license terms are required to obtain explicit permission to do so from the copyright holder(s).
\\n\\nDISCLAIMER: Neither the CC BY 3.0 license, nor any other license IntechOpen currently uses or has used before, applies to figures and tables reproduced from other works, as they may be subject to different terms of reuse. In such cases, if the copyright holder is not noted in the source of a figure or table, it is the responsibility of the User to investigate and determine the exact copyright status of any information utilised. Users requiring assistance in that regard are welcome to send an inquiry to permissions@intechopen.com.
\\n\\nAll rights to Books and all other compilations published on the IntechOpen platform and in print are reserved by IntechOpen.
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\\n\\nPolicy last updated: 2016-06-08
\\n"}]'},components:[{type:"htmlEditorComponent",content:'Copyright is the term used to describe the rights related to the publication and distribution of original Works. Most importantly from a publisher's perspective, copyright governs how Authors, publishers and the general public can use, publish, and distribute publications.
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\n\nCopyright on the individual Works belongs to the specific Author, subject to an agreement with IntechOpen. The Creative Common license is granted to all others to:
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LICENSE | \n\t\t\tUSED FROM - | \n\t\t\tUP TO - | \n\t\t
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The CC BY 3.0 license permits Works to be freely shared in any medium or format, as well as the reuse and adaptation of the original contents of Works (e.g. figures and tables created by the Authors), as long as the source Work is cited and its Authors are acknowledged in the following manner:
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\n\nRepublishing – More about Attribution Policy can be found here.
\n\nThe same principles apply to Works published under the CC BY-NC-SA 3.0 license, with the caveats that (1) the content may not be used for commercial purposes, and (2) derivative works building on this content must be distributed under the same license. The restrictions contained in these license terms may, however, be waived by the copyright holder(s). Users wishing to circumvent any of the license terms are required to obtain explicit permission to do so from the copyright holder(s).
\n\nDISCLAIMER: Neither the CC BY 3.0 license, nor any other license IntechOpen currently uses or has used before, applies to figures and tables reproduced from other works, as they may be subject to different terms of reuse. In such cases, if the copyright holder is not noted in the source of a figure or table, it is the responsibility of the User to investigate and determine the exact copyright status of any information utilised. Users requiring assistance in that regard are welcome to send an inquiry to permissions@intechopen.com.
\n\nAll rights to Books and all other compilations published on the IntechOpen platform and in print are reserved by IntechOpen.
\n\nThe copyright to Books and other compilations is subject to separate copyright from those that exist in the included Works.
\n\nAll Long Form Monographs/Compacts are licensed under the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) license granted to all others.
\n\nCopyright to the individual Works (Chapters) belongs to their specific Authors, subject to an agreement with IntechOpen and the Creative Common license granted to all others to:
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\n\nThere must be an Attribution, giving appropriate credit, provision of a link to the license, and indication if any changes were made.
\n\nNonCommercial - The use of the material for commercial purposes is prohibited. Commercial rights are reserved to IntechOpen or its licensees.
\n\nNo additional restrictions that apply legal terms or technological measures that restrict others from doing anything the license permits are allowed.
\n\nThe CC BY-NC 4.0 license permits Works to be freely shared in any medium or format, as well as reuse and adaptation of the original contents of Works (e.g. figures and tables created by the Authors), as long as it is not used for commercial purposes. The source Work must be cited and its Authors acknowledged in the following manner:
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\n\nAll Book cover design elements, as well as Video image graphics are subject to copyright by IntechOpen.
\n\nEvery reproduction of a front cover image must be accompanied by an appropriate Copyright Notice displayed adjacent to the image. The exact Copyright Notice depends on who the Author of a particular cover image is. Users wishing to reproduce cover images should contact permissions@intechopen.com.
\n\nAll Video Lectures under IntechOpen's production are subject to copyright and are property of IntechOpen, unless defined otherwise, and are licensed under the Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) license. This grants all others the right to:
\n\nShare — copy and redistribute the material in any medium or format
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\n\n© {year} IntechOpen. Published under CC BY-NC-ND 4.0 license. Available from: {DOI}
\n\nUsers wishing to reuse, modify, or adapt the Video Lectures in a way not permitted by the license are welcome to contact us at permissions@intechopen.com to discuss waiving particular license terms.
\n\nAll software used on the IntechOpen platform, any used during the publishing process, and the copyright in the code constituting such software, is the property of IntechOpen or its software suppliers. As such, it may not be downloaded or copied without permission.
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\n\nPolicy last updated: 2016-06-08
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