Wednesday, 24 March 2021

Lupine Publishers| New Materials: Current Development Under Simulation Techniques

 Lupine Publishers| Modern Approaches on Material Science


Abstract

In the present short communication, a point of view on the contemporary tendencies in the development of the Science of Materials is offered. And for this, the main lines of research (personal criteria) in this area are considered, linked to problems of great importance for humanity: the care and preservation of the environment, renewable sources of energy and the health of people.

Keywords: Nanomaterials; Nanotechnology; E-skin

Introduction

In order to appreciate, in all its magnitude, the development of new materials (the totally new, the derivated, the transformed and combined ones), we need to observe through a prism of several faces, but all its converging on the plane of the climate change urgencies and the survival of the human being as a species on the planet Earth. Thus, the development of new atomic and molecular structures, the transformation of others already known, is a phenomenon closely linked to contemporary and high priority problems, such as the depletion of non-renewable sources of energy, the care and protection of the environment, and the health of people. It is possible to sustain that the emergence of modern approaches to new materials had its initial rebound in two periods of great activity: from 1821 to 1851, three decades in which it was understood at the macroscopic level and discovered the possibilities of thermoelectric; and from 1930, when it was possible to understand, from the microscopic level, thermoelectricity. This second stage led to many of the current new materials [1]. In this sense, the emergence of alternative refrigeration technologies was also decisive at the beginning of the 1990s, as a result of the combination of environmental factors and the negative evidence of global climate change. In general, the development of contemporary approaches and perspectives in the creation of new materials or the well-intentioned modification of “old” materials, is a cross-cutting phenomenon to these crucial problems of humanity, which solutions go beyond specific fields. And at the same time, in a general way, they could focus from science to suprainfim levels: nanotechnology. The manufacture of materials with great structural precision at the nanoscale has led to extremely important applications for those fields of high research demand, such as energy, environmental sciences, device technology and biomedicine. Thus, nanoarchitecture is introduced as a rising tide within the current science of nanomaterials [2]. A broad horizon, in this sense, is the discovery of graphene (“wonderful material”) and, from it, the obtaining of new two-dimensional materials such as graphyne, graphdiyne, graphone and graphane. Graphyne and graphdiyne are two-dimensional allotropes of graphene carbon with honeycomb structures. Graphone and graphane are hydrogenated derivatives of graphene. The advanced and unique properties of these new materials make them highly promising for nanoelectronics applications of next generation [3]. The already known as wonderful material has also been a bridge to reach new discoveries on principles of design and predictions of new semimetals: Dirac’s semimetals, which allow to create heterostructures from a direct layer by layer stacking, which provides an electronic coupling that facilitates a remarkable load transfer between those layers. Such structures are, apparently, very promising for the electronics of the future (Q. D. [4,5]. The material science has also managed to create crystals with optical properties that are not found in nature, whose most hopeful applications are framed in optical circuits, molecular sensors based on the resonance of surface plasmons. Comin and Manna, in their research [6] firstly explain the basic processes involved in surface plasmon resonances in nanoparticles, and later discuss the classes of nanocrystals that are particularly promising for plasmonic tunable. In the field of medicine, new materials are also playing a decisive role. For example, there are the new absorbent materials for solid phase extraction (SPE), which is the fastest growing sample preparation procedure; most usual technique in the treatment and concentration of samples before their analysis by different methods. PES are structures formed from solutions of ionic surfactants, which can be absorbed on the surfaces of active solids, resulting in sorbents capable of simultaneously extracting a wide range of analytes with an extremely varied polarity. The performance of these new SPE materials is based on molecular recognition, which mimics the selective or specific affinity of several biomolecules towards their target compounds: these absorbents include molecularly imprinted materials, immunosorbents and surfaces modified with aptamer [7]. The SPE can be considered as a giant step in the issue of obtaining samples, because the analysis of chemical compounds presents in very low concentrations in complex matrices (for example, residues and contaminants in food samples), generally requires a complex analytical approximation, involving sampling, sample preparation, isolation of analytes and qualitative and quantitative determination. In medicine, most analysts believe that the sample preparation is the Achilles heel, since it is generally time-consuming, it is prone to the introduction of contamination and it is more difficult to automate [8]. The current development of robotics is also inextricably linked to the field of medicine and novel approaches to materials. Thus, for example, the creation of an adaptable, flexible and stretchable electronic system requires the distribution of electronic products on large non-flat surfaces and mobile components. The focus of current research in this direction is marked by the use of new materials or by the intelligent engineering of traditional materials to develop new sensors, electronic components on substrates that can be wrapped around curved surfaces. Attempts are being made to achieve flexibility and elasticity in the electronic “skin”, while maintaining a reliable operation. Information about various materials that have been used in the development of flexible electronics for e-skin applications, can be found in [9]. Another current trend is the development of magnetic materials to take advantage of the magnetocaloric effect (MCE). The research focuses mainly on magnetic materials that respect the environment and their applications in heating, cooling and magnetic energy conversion technologies. However, great attention is also paid to the growing number of medical applications of the MCE, such as, for example, controllable administration and release of drugs and biomedical substances in defined places in the human body and applications of magnetic hyperthermia (cancer treatment) [10]. In the field of energy, the issue of storage is key. In studies published in 2013, electrochemical properties of materials derived from NaTi3O6 (OH) · 2H2O are revealed. The higher density and the potential for a greater speed capacity of this derivative, in comparison with the carbonaceous materials with similar voltage and reversible capacities, constitute a convincing case for its development as an anode material, both for lithium ion and sodium batteries [11]. Also, today there is a wide selection of new absorbents that can be promising for the transformation and storage of heat at low temperatures of renewable heat sources: optimization of zeolites by dealumination, further development of the aluminophosphates, the compounds “salt in the host porous matrix “, the metal-organic frames. Particular attention is focused on the chemical behavior of nano-adaptation and adjustable tuning of these materials to satisfy the demands of the appropriate cycles of heat transformation [12]. Finally, reference is made to hybrid materials, that is, materials that incorporate organic and inorganic parts. These materials have become popular in a variety of fields. The technique is not so contemporary anymore, but the incorporation of hybrid materials has given rise to a great variety of new materials and techniques to produce them. One of the most recent is the combination of the deposition of the atomic layer (ALD), which produces inorganic materials, and the deposition of the molecular layer (MLD), which produces organic materials. A variant, known as infiltration, has allowed the modification of a variety of natural and synthetic polymers with surprising results related to their general mechanical properties [13]. And what role mathematical simulation techniques has played and is playing in all the above? As has been seen, natural and artificial materials often depend on functional interfaces between organic and inorganic compounds. Examples include skeletal and biomineral tissues, drug delivery systems, catalysts, sensors, separation media, energy conversion devices and polymer nanocomposites. Current laboratory techniques are limited to monitoring and manipulating the assembly on a scale of 1 to 100nm, they are time-consuming and expensive. The confidence in the computational methods, to understand the assembly and the yield of the materials, has remarkably grown. A review of the value of the simulations compared to the experiment on the scale of 1 to 100nm, including the connections to scales of smaller length of quantum mechanics and scales of larger length of coarse-grained models, can be consulted in [14].

Conclusion

The Science of Materials, supported by its own development, and strongly “pushed upwards” by the increasing computing power, and the development of increasingly efficient and innovative simulation techniques, leads humanity towards discovery and creation of increasingly surprising materials and with a wide range of application possibilities. However, it is vitally important that such development and such possibilities do not become homicidal.

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Tuesday, 23 March 2021

Lupine Publishers| Do You Know Your New Molecular Entity (NME)?

 Lupine Publishers| Drug Designing & Intellectual Properties International Journal


Introduction

During the last decades, life science startup companies have relatively rapidly increased their presence in the pharmaceutical landscape. Pharmaceutical development has evolved because technology (analytical and process development) and clinical development (hybrid design in phase 1, including patients in phase 1B) have evolved in parallel allowing in certain cases to decrease the time to regulatory filings (IND, CTA, NDA, NDA 505 (b)(2),..), which seemed attractive for startup companies. However, new molecular entities have become more complex since polypeptides, proteins, and monoclonal antibodies drug products take more and more place in many therapeutic areas (more than 50% in the 50 best seller drugs) along with the more conventional small molecules. But it is not the end of small molecules; research institutes, startup companies are still busy working hard to develop more powerful small molecules, since the physiopathology has also evolved and helped finding some new targets to enhance their efficacy and decrease their lack of selectivity. Startup companies are mostly driven by high level scientists and few of them are familiar with the drug development process, including its early phases. Scientists do know their NMEs from a scientific point of view however, much less and, sometimes, not at all in terms of potential drug product candidates.

The authors of this paper cumulate more than 50 years in drug development at various phases with different kind of molecules; they will try to illustrate how what you do not know about your NMEs can and will hurt you and also present how to avoid surprises that may occur down the road of drug development.

People do not know their NME.... however the NME is the most important ingredient of a drug

These three (3) main questions should be asked:

    a) Why do we not know our NME?

    b) When and how does it hurt?

    c) What can we do to prevent it?

    a) Why do we not know our NME?

Figure 1: Drug Development Timeline by PhRMA.

Lupinepublishers-openaccess-Drugdesigning-Intellectualproperties

As illustrated in (Figure 1) below and going through different Gantt charts coming from different websites, pharmaceutical development is not a popular topic in the overall drug development scheme and especially for startup companies. Below summarizes somehow most of the drug development pathways as illustrated in pharmaceutical companies and agencies. Two main conclusion scan be extracted from this above timeline:

    a) Things are presented sequentially but that in reality they are done in parallel.

    b) Clinical steps are starting right after the preclinical steps, increasing the statement that PR&D is not something very popular in drug development overall.

Figure 2: Interaction and timing of the different drug development steps. Adapted and modified from Modern Pharmaceutics (ref...).

Lupinepublishers-openaccess-Drugdesigning-Intellectualproperties

The (Figure 2) above illustrates, in our sense how drug development should be done, regardless of the NME. The following things should be kept in mind then:

    a) Many drug development activities are done in parallel (and not sequentially).

    b) PR&D should start almost during drug discovery, or when lead compounds (and backups) have been selected.

From a regulatory standpoint, according to Pharmaceutical Development ICH Q8 Guideline, the aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. It means that irrespective of the development steps and the scale, both the NME and the dosage form should be reliable, reproducible, stable and develop in such a way thatthe changes (scale-up, fine tuning) through development should not require, in a ideal world, bridging studies. A lot of people working in the PR&D area have noticed that this last ICH Q8 was more than a challenge to achieve. It represents one of the reasons why drug development will hurt. Questions are then the following:

How it can and will hurt- Where does it start?

    a) With the NME: although drug development requires a scientific approach, science should be used to meet regulatory requirements.

    b) The NME needs to be developed into an active pharmaceutical ingredient (API) irrespective of its indication.

    c) Even though outstanding results were obtained during the proof of concept (POC), a NME is not in itself an API, even less a dosage form.

Why do we not know our API?

Typical Biotech/start-up situation:

    a) Licensed technology/molecule from a university or research center, where the scope and objectives (research is oriented to advance science and knowledge) do not totally meet those of the pharmaceutical industry (research is oriented to serve medical needs within the confines of regulations ultimately allowing bringing a drug product to market).

    b) High knowledge of the chemistry, the biology, the proof of mechanism (not necessary the physiopathology).

    c) Lack of knowledge of the pharmaceutical sciences /drug development process.

    d) In the quest for nanomolar binding efficiency and biological potency, there has been a gradual shift of new pipeline compounds biopharmaceutical characteristics into less "druggable" compounds. The result then is a higher challenge to develop and maintain a reliable/reproducible dosage form regardless of the scale and the development steps.

Why do we not know our API?

Typical Biotech/start-up situation

    a) Lack of available funds for several reasons (due diligence, overhead, routes of administration were different during nonclinical steps resulting in lack of reliability/efficacy, poor NME characterization at the gram scale, poor development plan).

    b) Money is kept for what is perceived as absolutely necessary: the clinic whereas the phase 1 clinical trial may not be the most expensive step (depending the indication), CMC, formulation development and nonclinical could be extremely expensive for a sterile biological product.

    c) Need to deliver something quickly.

    d) Public companies are driven by market expectations.

    e) Private companies need results to get financing.

    f) Prepare samples for pre-clinical/toxicological studies with available material.

    g) Most of the time, formulations used in preclinical and toxicological studies are not optimized and do not reflect the formulation to be brought to clinical studies.

    h) Lack of knowledge of the regulatory requirements for drug development and therefore the associated cost.

    i) Drug development is a lengthy process and the regulatory environment changes, so will the cost.

When does it hurt?

    a) Throughout the drug development process.

    b) Typical biotech situation: jumping in the drug development arena without required knowledge and expertise, relying on CMOs and CROs to fill the gap.

    c) When trying to secure a business partner.

    d) Typical biotech situation: licensing after a phase IIA, which needs an un neglect able amount funds.

    e) Usually a Big Pharma with a high knowledge of drug development process.

    f) Due diligence can be deadly: team of experts with high expectations on availability of data, QA audits.

    g) When preparing the market application.

    h) After commercialization middle size pharma are buying products to fill their pipelines where most of the challenges lie in chemistry, manufacture and controls.

    i) Getting out of the laboratory: going to the pilot plant up to GMP facilities.

    j) What works at the gram scale usually does not work at the kilo scale.

    k) Process parameters change (equipment train, operating conditions, crystallization/purification solvents, mass and heat transfers, etc.)

    l) Preparation of the test articles for GLP toxicological studies may not be reliable from the bench to the CRO, root cause being unknown because not investigated.

    m) All these impact the quality attributes of the Apian therefore the rest of the drug development chain.

Due Diligence Topics

NME:

    a) Synthesis: yield and scale-up feasibility.

    b) Analytical development: wet and solid-state chemistry (which is neglected despite the lack of solubility, the high log P of the more recent NME).

    c) Comments on whether there are any correlations between physical characteristics and formulation orbio availability (polymorphism is somehow neglected).

Non-clinical development and GLP toxicology:

    a) How was the proof of mechanism demonstrated (versus gold standard? Route of administration? Reliability?).

    b) There is evidence that most sponsors have a good understanding of the toxicology program that is required to bring a product to Phase I; however, the rest of the early phases of drug development (i.e. the development of the actual drug product in a suitable dosage form) is not given the same level of attention despite the increasing poor "drug ability" properties of modern-day NMEs.

    c) Current Approaches to Fisrt-In-Human Phase I Clinical Supplies.

    d) "Formulated" product approach: Clinical formulation that is a precursor of the desired commercial formulation.

    e) Exploratory formulation approach: Uses the simplest possible formulation (e.g. NME only in bottles or capsules).

    f) Keeping in mind that the focus of Phase I testing is mainly to evaluate safety, which approach is applicable and why?

    g) Phase I-II clinical programs are rarely rejected from a clinical standpoint. But care should be taken with the clinical supplies: was the formulation the same than during non- clinical proof of concept and GLP toxicological studies? If the formulation has changed, has it modified the Maximum Tolerated Dose, the MEC (minimum effective concentration to get a PD effect), and the No Observed Adverse Event Level (NOAEL)?

When and how does it hurt?

    a) If the NME is not well characterized (frequent), the changes that occur are difficult to identify and the basic quality attributes cannot be properly maintained. It will then generate a snow balling effect throughout drug development.

    b) What is the impact of the NME manufacturing (physicochemical characteristics) and formulation development processes (differences in the formulation from non-clinical POC, GLP tox studies, and from phase I to III, scale up) on drug product performance, especially since drug are getting less and less soluble and then "druggable".

    c) CMC: preparation of early phase clinical application documents, and modules 2 and 3 of the CTD.

    d) Happens after years of drug development initiation.

    e) Very often, data was generated way back by people that are no longer in the organization.

    f) Characterizing the impurity profile is important not only from a CMC standpoint but also for toxicology and clinical studies. Impurities present at levels above ICH standards should be qualified.

    g) If the NME is not well characterized, changes that occurred through the various phases of development cannot be identified and the basic quality attributes cannot be properly maintained.

    h) Wet chemical characterization is not enough to portray the complete NME behavior Physical characterization is essential.

    i) If there a relationship between the structure and the activity of an NME, (complex NME and biologics), bioassays are more than recommended (and mandatory for most of the agencies).

    j) Both the NME and the dosage form will go through "Site changes", going from "laboratory" to "pilot" and then to production scale.

    k) Site change: bench top scale to cGMP (kilo and pilot scales) facility.

    l) cGLP non-clinical, phase I/II clinical studies: safety and "exploratory (dose ranging/finding)" efficacy data acquisition.

    m) Impurities? (Safety and CMC are concerned).

    n) Polymorphic forms? (CMC, safety and efficacy are concerned) ite changes: from cGMP pilot to cGMP commercial scales.

    o) Phase III clinical studies: generation of safety and efficacy data.

    p) Pivotal clinical studies.

    q) Should use the « final and best » NME and dosage form.

    r) Surprises are not welcome at this late stage.

    s) When submitting a market application, it is necessary to demonstrate a similarity between the batches used in the clinic and the formula of the proposed commercial product.

    t) This applies to both the NME and the dosage form.

    u) Late surprises can lead to questioning the validity of clinical batches that have generated data and support the safety and efficacy of the commercial product.

Pre clinical and non-clinical sections

a) How has the POC been demonstrated (Which lot? Which physico-chemical characteristics? Versus standard of care? Route of administration? Animal model? Reproducibility and reliability? (Ex: IC50 (in vitro)/Cmax (in vivo) if the formulation may impact the way the NME may be absorbed, the Cmax may change form one formulation/experiment to another, the ratio may become biased.

Clinical

    a) Closely connected with the above mentioned poor "druggability", the current approaches for early clinical phases (I/IIa) in drug development

    b) Approach with formulated products, where clinical batches will be precursors based on commercial formulation (almost 90% of the final formulation).

    c) Exploratory approach: use the simplest formulation: powder in a bottle or capsule.

    d) Keep in mind that the goal of Phase I is safety and pharmacokinetics (even if cohort (s) of patients are part of phase IB).

    e) (Figure 3) illustrates the risks of using a non-optimal formulation in phase I/IIa:

    f) Increased nonlinear or proportional AUC due to solubility problems (saturation of absorption).

Figure 3: Observed AUC and PK linearity Vs dose in mg.

Lupinepublishers-openaccess-Drugdesigning-Intellectualproperties

    g) No conclusions can be drawn about MTD (maximum tolerated dose, NOAEL, and safety margin,....p

What can be done to prevent this?

    a) A good knowledge of the drug development process

    b) Get familiar with regulatory requirements at the various stages of development; do not rely only on CROs or consultants.

    c) Get the required expertise and build strategies early for pharmaceutical development.

Evolving Regulatory Requirements

Phase I studies

    a) Brief and focus is on safety, PK and if possible, trend of efficacy (biomarkers, endpoint,..).

    b) Clinical design are evolving: SAD/MAD studies, food effects, patients, Therefore the goal of getting an "almost" final formulation is getting more and interesting to increase the reliability form one phase to another. Sponsors do not want the formulation to be held responsible of unexpected results.

Phase II studies

    a) Evidence to reasonably support the proposed chemical structure of the drug substance should be provided: what is the impact on tox, formulation development, clinical studies (dose ranging-finding) and primary efficacy results.

Phase III studies

    a) Final market image! Biobatches, product monograph and expiry date will be based on this scale.

Late surprises may lead to question the validity of clinical batches to support efficacy and safety of the propose commercial product.

Conclusion

In conclusion, a NME should be developed with complementary people, such as the steps illustrated in (Figure 3) the fact that people get a scientific degree does not make them specialist in all the fields. The regulations will change over time: and so will scientific knowledge and technical/analytical capabilities. It should be kept in mind that Guidance/Guideline documents represent current thinking of regulators and that some are withdrawn and new ones are issued. These documents must be interpreted in the context of the product being developed. There should be a harmonized balance between regulatory and technical/scientific requirements. Knowledge about the NEM should let people streamline their drug product correctly (safety and efficacy) through the whole drug development process, keeping in mind that everything is done in parallel, not sequentially. Since people (from investors to scientists and developers) do not share the same language, it is highly recommended to try to hire the relevant expertise as early as possible, at the early stage, better drug development strategies will be developed planned and well budgeted resulting in a nice risk management position, where "manageable" surprises only may occur down the road, without jeopardizing any launching.

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Monday, 22 March 2021

Lupine Publishers| Future Trends in Production and Consumption in Textile and Fashion Design: The Fourth Industrial Revolution

 Lupine Publishers| Latest Trends in Textile and Fashion Designing


Opinion

Designers create products, services and systems to fulfill the society’s needs and desires. The adoption of Information Technology (IT) has changed the way designers develop new products. The collaborative work environment is a new paradigm of product design that integrates designers to quickly build, evaluate, optimize and select the best solution to complex problems [1]. In the last 20 years, internet has changed the way people communicate. The first era (1995), internet was an integrated hypermedia, in the second era (2000) internet had a programming media approach, that changed to people’s web service in the third era (2005), and the fourth era - which encompasses nowadays – represents a new level of organization and management of the entire value chain on the products’ life cycle. The Industrie 4.0 or Fourth Industrial Revolution is an integrative cyber-physical system based on modern control systems, embedded software systems and Internet addresses. This industrial revolution is based on improvement of brainwork, especially in engineering activities, and fast decision-making [2].

According to the German Academy of Science and Engineering (Deutsch Akademie der Technnikwissenschaft - Acatech), the Industrie (Industry, in German) 4.0 is the next industrial revolution. The main goal is to improve the value chains among the product´s lifecycle. In this context, the improvement of industrial competitiveness is achieved by organizing and controlling value, new business models and networks creation process [3]. The result of the Fourth Industrial Revolution will be the Smart Factory, where Cyber Physical Systems (CPS) and Internet of Things (IoT) are the key technologies for achieving the production goals. In a smart factory, humans, machines and resources communicate with each other as easily as in a social network [4,5].

The CPS interconnects the physical world with the information technology. CPS are technical systems containing both virtual (cyber) and real (physical) systems. By “cyberizing the physical” and “physicalizing the cyber”, it is possible to specify physical subsystems with software-controlled behavior [3,6]. The IoT is an approach to equip real systems with embedded systems so that they become interconnected in the so-called “smart systems”. The IoT intends to attach technology to devices and to integrate networks with the internet to enable the creation of a global network ubiquitous computing [3].

Kitchin [7] states that data are the key element for our contemporary society. Big Data include information from a multitude of sources, including social media, smart phones, data sharing, sensor-oriented machines and devices for the consumer (wearable computers). The origin of the textile production is closely related to the origin of humanity, and is considered a basic human need. In addition, it is a form of self-expression and sense of belonging that becomes even more important for individuals and social groups [8]. Once this field plays an important role in the Industrial Revolution, the Industrie 4.0 will modify the way clothing are made and consumed.

New management strategies can generate valuable data for product development, online marketing and campaigns. Manufacturing, supply chain and logistics will benefit from the adoption of digital sensors and smart tags that will offer visibility, flexibility and control of product flows. Two production models are examples from those new strategies: smart factory and minifactory. The smart factory integrates stakeholders in a virtual and collaborative environment, while mini-factories are based on ondemand production. The yarn and fabric production processes will be remote monitored using QR Code (Quick Response Code) and RFID (Radio Frequency IDentification).

The steps of cutting and sewing are the biggest problems of textile manufacturing. In this sense, initiatives such as the adoption of artificial intelligence and genetic algorithm, intelligent hybrid systems, robots and fully automated and intelligent lines represent new directions for the textile industry in the context of Industrie 4.0. Smart machines that are able to predict failure or quality problems, and organize their decision-making process and self-optimization are another scenario for the Industrie 4.0 [9].

Internet, Virtual and Augmented Reality will support the buying experience. In addition, 3D scanning will provide consumers the opportunity to scan, build a 3D model and begin ordering custom clothing. Technology tends to be incorporate in fibers, yarn, fabrics and clothing in the form of functional materials, which includes biomedical and electronic textiles. The textile production processes offer the possibility of creating a new generation of materials and products, which interact with different electronic devices. It is important to highlight that the textile industry must follow all these innovations that will not only affect production, but also models of education, business, consumer habits and social and cultural aspects in the coming years.

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Friday, 19 March 2021

Lupine Publishers | Underwater Optical Image Processing

 Lupine Publishers | Journal of Oceanography and Petrochemical Sciences


Editorial

Image processing can be defined as performing any process on the visual data or vision signals such as a stored digital image, a photo from a scene or a video frame [1]. The output of an image processor might be another image or a set of special signals and sometimes some variables related to that image. Most of image processing techniques consider an image as a 2-D signal and then do a suitable signal processing on it. Nowadays, image processing is one of the best tools for feature extraction in natural studies like environmental interactions and behavior analysis. In human visual system, a similar process is done by our brain which finally helps.com to better decision making, however, the main aim of image processing is not implementation of intellectual functions of human in terms of received data from our eye (as an optical bio-sensor) related to various observations, because these functional activities are so complex. In fact, pre-processing and some specific processing steps in order to data mining, pattern recognition and knowledge extraction are key approaches of image processing in analysis of nature. An image usually follows the following steps after creation by imaging sensor:

    a) Digitalization including sampling and quantization after reception from imaging block (camera and so on), this process is required to give.com the ability for processing and storage.

    b) Pre-processing, this step contains some corrections and image enhancements in order to do main processing (e.g., noise reduction, image alignment, histogram equalization).

    c) Classification (supervised or unsupervised), it is done for recognizing patterns.

    d) Data Analysis, which is related to a practical, natural or industrial application.

Based on the recent advances in developing optical devices for underwater imaging and also image processing tools, detection, tracking and recognition of underwater objects and targets are possible and underwater optical image processing has become a hot topic of research. In addition, some real systems for practical aspects in undersea/ocean monitoring [2,3] have been made. Thus, we want to emphasize on this research field as a critical and interesting area and encourage relevant researches to have attention to these new findings. In order to have some detailed information about underwater optical imaging and image processing, we should firstly know the behavior of sunlight in undersea environment. Its wavelength includes a range from 400 to 700 nm. Since the light is an electromagnetic wave, it has a limited propagation range in water and so it is damped soon. Figure 1 shows that the range of propagation before a full damp is depended on the frequency of light components (from red to blue in the spectrum of white light) such that the blue wavelength has the highest range and the red has the lowest. Such restrictions are factors that make images low quality in which they are needed to image processing (images taken by underwater optical sensors), so their quality is highly related to the depth of imaging. Another similar area is sonar image processing which is done on the images taken by a type of acoustic imaging sensors.

Figure 1: The range for different components of white light.

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Thursday, 18 March 2021

Lupine Publishers | The Dynamics of Mounds-Clusters in the Mouhoun Bend (Burkina Faso)

 Lupine Publishers | Journal of Anthropological Sciences


Abstract

Mounds are human made accumulations of settlements debris of varying size and shapes, found in different parts of the world. In West Africa, they tend to be located in relatively flat lands, at low elevations, in wetlands, marshlands or flood plains. Some are large single mound sites. Others are made of groups of scattered or clustered mounds – mound-clusters -, spread over varying surface extent. The dynamics of such settlement systems is still poorly understood partly because of inadequate field methodology. Ethno-historical and ethnographic data from West Africa recent past are relied upon to suggest some of the key processes behind mounds clustering: ethnicity, craft affiliations, or a combination of both. The Mouhoun Bend Archaeological Project (MOBAP 1997- 2000) was designed to address this issue. The field methodology was articulated on testing all mounds parts of the mound-clusters under investigation. Two mound-clustering strategies were identified:

a. Tight-clustering resulting in the formation of a large “single mound site”, and
b. Loose-clustering with scattered individual mounds of different size and shape.

Residential and craft requirements combined differentially in the 2000 years Mouhoun Bend settlement history, have generated the settlement patterns investigated in the study area. The ethnicity component of the identified dynamics – that is plausible – could not be tracked with the current methodology and is accordingly undecidable.

Introduction

The Mouhoun bend was settled by iron-using communities in the first millennium BCE (Figure 1, Table 1). The climate was wetter [1]. The Sudanian savanna and the Mouhoun River offered a diversified resources mix that allowed for the stabilization and growth of these mixed farming fishing populations. Their settlements consisted of multi-mound complexes – moundclusters. The sample of sites excavated within the Mouhoun Bend Archaeological Project (MOBAP 1997 – 2000) offers an entry into the dynamics of this kind of settlement that developed and spread in the study area for a little more than 2000 years, from ca. 700/500 BCE to 1650 CE (Figure 1, Table 1).

Table 1: Radiocarbon dates from the Mouhoun Bend Archaeological Project.

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Key: LLNL = Lawrence Livermore National Laboratory:
* Radiocarbon dates from iron objects processed by Dr. Andrea C. Cook at Lawrence Livermore National Laboratory, UC Berkeley.
*1 = from an iron ring
*2 = from a small iron spear
*3 = from a large iron spear

Mounds result from the piling up on the same spot of human occupation by-products. They include habitation features, craft installations, collapsed building material as well as discarded and abandoned material culture. They are therefore exclusively human-made and, depending on circumstances, can be either well preserved or significantly disturbed by erosion agencies. These formation processes that combine cultural (C-transforms) and natural (N-transforms) are well understood in general [2,3].

Habitation mounds dating from the Late Stone Age onwards are recorded in different parts of West Africa, from the Chadian basin to Mali and Guinea [4-18]. They consist either of a single small or large mound or of multiple mounds (mound-cluster). It has been suggested that mound-clusters may have derived from residential segregation, inhabited by different specialized more or less endogamic groups such as blacksmiths, potters, hunters, fishing folks, bards, etc. [19,20]. Distinct mounds are thus axiomatically considered to materialize residential segregation, and as such, are the signature of craft-specialization. The explanation is tautological. No excavation program was implemented to test the accuracy the hypothesis mentioned above. The testing procedure may have required an appropriate methodology, consisting at least of the probing of all the mounds part of the settlement complex under investigation, a precise and fine-grained chronology backing detailed analyses of material culture, architecture, and subsistence remains. It is then and only then that variation – or lack thereof – can be assigned to differences in social status. These principles have guided the field strategy implemented in the Mouhoun Bend Archaeological Project [21,22].

The Mouhoun River flows from the SW to NE, winds its course in a U-shape bend to follow a N-S direction (Figure 1). The study area located in the Sudano-sahelian zone is delimited in the north and northeast by the meandering river course. It measures 40km East-West (3o 11’ North / 3o 32’ East) and 38km North-South (12o 30’/ 12o 45’ latitude North). The land, prone to cyclical droughts, is flat with elevation ranging from 294 to 249m above sea level. The vegetation is characteristically a highly anthropic wooded savanna, with the protected shea-butter tree (Butyrospermum parkii) largely predominant, followed by different kinds of Acacia sp.

Figure 1: Distribution of archaeological sites in the Mouhoun Bend (Burkina Faso).

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Three mound-clusters located in in different environments were selected for excavation: Diekono in the Mouhoun River floodplain, Kerebe-Sira-Tomo (KST) on the cliff delimiting the river valley, and Tora-Sira-Tomo (TST) and its satellite Gnambakouon-Sira- Tomo (GST) on the topographic rise in the central part of the study area. Each of the above mentioned sites is comprised of a number of mounds of different size and shape, iron-working workshops, and laterite quarries.

The Dynamics of TST and KST Mound-clusters

The long-term pattern of growth of inhabited space within a mound cannot be assessed with the field methodology implemented in this case, with one test unit per mound. A general time line of the settlement complex formation can nonetheless be reconstructed.

TST settlement complex (12o 35’ 07” N and 3o 22’ 07” E) is located at 280m asl. With 17 distinct mounds, it is the largest settlement complex of the study area, spread over 900m westeast and 500m north-south, some 45ha in total surface extent (Figure 2). TST-3, the largest mound stretched along the north edge measures 260m west-east, and 120m north-south. All 17 mounds were tested after three field seasons (1997, 1999, and 2000). Five, TST-1 (Iron smelting), TST-2 (quarry), TST-4 (cloth weaving and dyeing workshop), TST-9 (cemetery), and TST-17 (oil production workshop), are special purpose sites. The fourteen remaining ones were standard habitation mounds with varying occupation intensity

Figure 2: Tora-Sira-Tomo settlement complex.

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KST settlement complex is located on the cliff top along the edge of the Mouhoun River valley (Figure 3). The complex consists of eleven more or less distinct mounds stretched on 350m westeast and 600m north-south. The cluster is made of three distinct sites categories: a quarry (KST-2) located at some 800m east, iron-working stations both smelting and forging, and habitation mounds. Habitations mounds, clustered in the north, resulted in the formation of a large 15ha village site. All iron-working stations, arranged along a roughly ENE-WSW axis, are concentrated at 100 to 200m along the south flank of the main habitation cluster. KST settlement complex was inhabited from the second half of the first millennium BC to the second half of the thirteenth-century AD, with an important 500 years occupation hiatus in the second half of the 1st millennium AD. The development of TST and KST settlement complexes can be arranged in four successive phases, from the middle of the first millennium BC to the middle of the second millennium AD.

Figure 3: The evolution of TST settlement complex.

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Phase I (650 BC-800 AD)

At TST, the initial settlement phase (650 BC-800 AD) that started in the mid-1st millennium BC is documented at TST-1, TST-2, and TST-3-East (Figure 4, Table 2). The earliest occupations are found at TST-1, an iron-smelting site dated to 650-395 BC (Figure 5), TST-2, the quarry site that provided raw material for house construction and iron production, and finally, the blacksmith workshop exposed at the bottom of TST-3-East probe.

Figure 4: View of TST-1 iron smelting furnace.

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Figure 5: Differential mounds size in m2 during TST phase IV (1400 – 1650 CE).

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Table 2: Tora-Sira-Tomo mound cluster at Phase I (650 BC – 800 AD).

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KST settlement complex phase I dated to 350 BC-150 AD was shorter. It is documented in the west-central part of the complex, in KST-1A and KST-2 the quarry site (Figure 6). KST complex grew in two directions during its phase II dated to 250 – 550 AD. KST- 1B and KST-3 areas were settled. The mound was of an irregular potato- shape, oriented SW-NE. KST-2, the quarry site, was relied upon for the supply of iron ore and construction material during the whole existence of the settlement complex

Figure 6: Kerebe-Sira-Tomo settlement complex.

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Phase II (800 – 1100 AD)

TST Phase II (800-1100 CE) settlement with a total of 8 mounds, witnessed the foundation of 5 new sites. They were arranged in two sub-clusters of four sites each: TST-1, TST-2, TST-3, and TST-6 in the west, and TST-4, TST-12, TST-13, and TST-15 in the east (Figure 4, Table 3). The western sub-cluster consisted of two residential mounds: TST-3 and TST-6, and two special purpose sites: TST- 1(iron-smelting and ritual) and TST-2 (quarry). The eastern subcluster includes TST-13 and TST-15 residential sites, and TST-4 (weaving and cloth dyeing workshop) and TST-12 (a blacksmith workshop) special purpose sites (Holl 2014). KST complex was abandoned during all the second half of the 1st millennium AD, from ca. 550 to 1000 AD.

Table 3: Tora-Sira-Tomo mound cluster in Phase II (800 – 1100 AD).

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Phase III (1100 – 1400 AD)

TST settlement complex reached its maximum extent during phase III (1100-1400 AD) with the addition of 7 new sites. All 15 mounds (Figure 4 & 7, Table 4) were located in the space delineated during phase I and II. The new additions are set in two patterns. TST-5, TST-7, TST-8, and TST-10 present a rectilinear arrangement of equidistant mounds at 100m from one to the next. TST-5, TST- 7, and TST-8 residential mounds ‘sits’ on burials dug deep in the laterite crust in what may have been an earlier cemetery. TST-14, TST-16, and TST-17 are along the northeastern flank of the complex, at 100m from one to the next, in a linear east-west arrangement. TST-14 and TST-16, were residential and TST-17 a karité oil production workshop.

Table 4: Tora-Sira-Tomo mound cluster in Phase III (1100 – 1400 AD).

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Figure 7: The evolution of KST settlement complex.

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KST complex also witnessed an accelerated growth during Phase III (1000-1250). KST-IA and 1B, KST-2 (quarry site), KST-3, KST-4 (occupation I and II), KST-5, and KST-6 (Figure 6) were all inhabited and in use. Fire destroyed habitation units from KST-3 occupation I and KST-4 occupation II (Figure 8 & 9), located along the southeast flank of the complex. There was also a significant intensification of iron-working, with the foundation of workshops devoted to iron-smelting, blow-pipes making, and blacksmithing along the south margins of the main village.

Phase IV (1400 -1650 AD)

TST settlement complex shrunk significantly during Phase IV (1400-1650 AD). The number of inhabited sites dropped from 15 to 9. The eastern part of the cluster was abandoned (Table 5, Figure 4). A new restricted access cemetery was founded at TST-9. TST-3, TST-4, TST-5, TST-6, TST-7, and TST-8, were residential. TST-1, TST- 2, and TST-9, respectively iron-smelting site, quarry, and cemetery, were special purpose sites. In general, with the exception of TST- 8 set between TST-4 and TST-7 (Figure 4), the distance between neighboring mounds oscillates around 100m.

An identical phenomenon occurred at KST. The inhabited space also shrunk considerably during KST phase IV (1250-1450 AD) (Figure 6). Shallow occupation evidence is documented at KST-4 occupation III and IV, then used as a cemetery.

Figure 8: Partial view of KST phase III domestic unit.

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Figure 9: Habitation complexes from Phase III KST-4 .

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Table 5: Tora-Sira-Tomo mound cluster in Phase IV (1400 – 1650 AD).

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Variability of mounds clustering processes

Data collected from the excavation of four settlement complexes point to the existence of two main mound-clustering strategies: a tight and a loose one. KST settlement complex that lasted from ca. 350 BC to 1450 AD, with a half millennium occupation hiatus in the second half of the 1st millennium AD, features tight-clustering (Figure 7 & 8). All the residential sites, with the exception of KST- 4, are tightly packed in a 15ha village. Iron-working sites located along the south periphery of the village display no habitation. Craft people and work crews were KST villagers who commuted to their workshops during the iron-production seasons.

TST-GST settlement complex with a total of 20 mounds features the loose-clustering strategy. The mound-sites, 17 for TST and 3 for GST are well demarcated, with each sub-set presenting a large dominant mound. Residential and special purpose sites are represented in varying combinations all along TST settlement complex occupation history.

Archaeological data indicate that flexible strategies were adopted by the different ‘self-sustaining’ autonomous ancient villages during the 2200 years’ occupation of the Mouhoun bend. In KST, craft people resided in the village and commuted to their workshops located in the southern outskirts of the complex. In the TST alternative, with more or less inter-phase variations, craft people built their residence in distinct places and supplied local communities from their workshops. There is no fixed and permanent pattern of residential and occupational segregation in the analyzed archaeological record [21,22].

Peer-village interaction

The study area is relatively flat. The recorded settlement complexes are more or less evenly distributed in the landscape. In site-catchment analysis terms, each village is surrounded by rings of cultivated fields, fallow zones, and bush [23,24]. At their peak, during the first centuries of the 2nd millennium AD, each of the recorded settlement complex was a large autonomous and selfsustaining village. Some, like KST and Kirikongo, were compact villages with a few outlying mounds and special purpose sites. Others, as was the case for TST – GST and Diekono, were spread out with a multiplicity of distinct mounds.

There are no significant wealth differences. Grave-goods and burial offerings are too marginal to be significant. Some individuals, male, female, children, and infants, were nonetheless buried in “restricted access” cemeteries while others were buried in their compounds. This differential treatment points to subtle variations in social status without detectable and/or durable material correlates. The accelerated growth at the beginning of the 2nd millennium AD initiated a scramble for land, villages rivalry, violence, and wars.

Fire: accidents or wars?

Burnt houses were recorded in some of the excavated mounds. It is the case at TST-3-West in occupation I and II, dated to 1000- 1150 AD. Domestic installations belonging to two successive occupations were totally burnt down. KST complex also present two instances of burnt domestic installations dated to 1050 – 1380 AD: one at KST-3 occupation I and the other at KST-4 occupation II. In the latter case, a whole household complex with its food supply was destroyed by fire (Figure 9). Similar cases of burnt installations dated to 1300-1450 AD were recorded at Kirikongo, Mound III, level 8 and Mound IV, level 7 [8]. These events took place during a period of accelerated growth that triggered violent confrontations.

War, Violence and surgery

There is no direct one to one correlation but the unrest indicated by burnt houses is partly corroborated by traumatic injuries found on some of the deceased. Two male and female adult individuals buried in the same context at TST-7 appears to have been victims of the same violent encounter. One, a 35-50 years old adult female presents 4 well healed cranial fractures on the occipital, frontal, and left parietal. The other, an impressive 1.95m tall 45+ years old male presents two distinct episodes of trauma. He recovered from previous blows indicated by a well healed circular defect on the occipital. He has multiple trephinations with no signs of healing on the right, left parietals and frontal, showing that the second series of blows was fatal. Remarkably, both adults present similar blows patterns: they were hit on the frontal, occipital, left and right parietals, as if the aggressors were well trained fighters [25-27]. The surgery may have taken place after a violent raid. Finally, a 9-11 years old pre-adolescent, individual 18 from phase IV TST- 9 cemetery, presents multiple peri-mortem depressed cranial features made by a sharp object, that was very likely the cause of death [26].

The recorded evidence on traumatic injuries is dated to phase III (1000-1200 AD) and IV (1250-1500 AD) when the area witnessed a significant growth acceleration followed by the onset of devolution. There are convincing evidence of conflict and intervillage warfare during the first half of the second millennium AD. The nature and characteristics of the kind of warfare that may have developed in the area during this phase of accelerated growth are difficult to decipher. The tactics involved may have consisted of surprise raiding and counter-raiding with the aim of seizing supplies and host [27-37].

Conclusion

Each village had its autonomous system of government, with horizontally differentiated groups. These mixed farming communities included a number of craft specialists, potters, ironsmelters and blacksmiths, masons, cloths weavers and dyers, karite-oil producers, as well as part-time warriors, and healers (surgeons). The Mouhoun Bend peer-villages were autonomous and self-sustaining but not autarkic. A general compatibility of “worldviews” is suggested by the strong coherence of mortuary practices. Despite variations, pottery decoration techniques and syntax suggest a shared cultural universe. The mound-dwellers of the Mouhoun Bend developed an original socio-political system that, for approximately two centuries, from 1200 to 1400 AD, existed on the periphery of the powerful expansionist Mali Empire.

Acknowledgments

The Mouhoun Bend Archaeological Project (Burkina Faso 1997- 2000) was funded by a CNRS grant in 1997, a National Geographic Society Research Grant # 6378-98 in 1998, and a Faculty Startup Fund from the University of California, San Diego in 2000. The author is grateful of the support of these institutions and also wish to thank the CNRST – Centre National de la Recherche Scientifique et Technique – for the research permit and the Archaeology Laboratory of Ouagadougou University for logistical support. Students from the University of Paris X Nanterre, the University of Ouagadougou, and the University of California, San Diego participated with enthusiasm to the field programs.

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Wednesday, 17 March 2021

Lupine Publishers| Association of Mother’s Genetic Sensitivity to the Taste of 6-N-Propylthiouracil (Prop) and Their Children’s Dental Caries Status in Nepal

 Lupine Publishers| Interventions in Pediatric Dentistry Open Access Journal (IPDOAJ)



Abstract

Introduction: Dental caries is a multifactorial disease and is one of the most prevalent infectious disease that affects mankind. Young children present a unique risk for dental caries as their host-defense systems and bacterial flora are in the process of being developed and also because the newly erupted tooth surfaces are more susceptible to dental caries. Mothers are the persons who generally influence their children via their own food preferences. Hence the mother’s taste perception plays an important role in the development of dental caries in their children. The need of this study is to examine the association of mother’s taste perception to 6-n-propylthiouracil with caries prevalence in their young children as well as with other caries risk determinants such as mothers and their children’s oral hygiene practices.

Material and Method: 180 pair of mothers and their children in the age group of 3 to 6 years of both sexes were selected for the study & 6-n-propylthiouracil testing is done. A trained and calibrated examiner who did not have any knowledge of the mother’s PROP test performed a comprehensive clinical examination of the children to determine the presence or absence of DMFT/dmft.

Results: It is observed that nonstarter mother and children have higher caries prevalence than medium tasters and supertasters. Discussion- Genetic sensitivity to taste is an inherited trait in children from their parents, inheritance from mother being more pronounced.

Conclusion: Dental caries is multifactorial. No significant correlation between susceptibility of mother and child to genetic sensitivity exists, and genetic sensitivity is not the only criteria for severity.

Keywords: 6-n-Propylthiouracil; dental caries; dietary habits

Introduction

Dental caries is a multifactorial disease and is one of the most prevalent infectious disease that affects mankind. The development of dental caries depends on several critical interactions between a susceptible tooth surface, oral bacteria, fermentable carbohydrates and frequency of consumption of sugar [1,2]. Young children present a unique risk for dental caries as their host-defense systems and bacterial flora are in the process of being developed and also because the newly erupted tooth surfaces are more susceptible to dental caries [3]. Parents must also negotiate the dietary transition from bottle feeding to solid food and also take into consideration the child’s tastes. Several risk factors such as salivary counts of mutant’s streptococci, past carious experience and frequency of sugar intake have been evaluated to identify children at high risk of caries [1,4-7]. However, none of the currently available caries screening methods can identify children at high risk of caries quite effectively [1,8].

The role of diet as a direct cause of dental caries has been extensively reported [1,4,9,10]. A high intake of sugar has been correlated with a high dental caries in pre-school and school aged children. A high sugar intake reflects a preference for a sweet substance. Genetic sensitivity to taste may be associated with a preference or no preference of some food by children. Sensitivity to taste is an inherited trait in children [1,11]. In 1991 it was found that there is a genetic variation in the ability to taste the bitterness of the chemical 6-n-propylthiouracil (PROP) [1,12]. This variation was found to be associated with food preferences in children. Fox in 1931 found that some individuals perceived chemicals related to PROP as bitter (supertaster) while others could hardly perceive them at all (nonstarter). Those who are PROP super taster are typically supertasters in general and tend to dislike sweet while those who are PROP none tasters like sweet food and prefer strong tasting food products. Mothers are the persons who generally influence their children via their own food preferences. In many households’ mothers generally reward their children using sugary snacks which might increase their children’s preference for that kind of food. Hence the mother’s taste perception plays an important role in the development of dental caries in their children. This study was carries out with following aims and objectives:

Aim

To find the association between mother’s sensitivity to 6-n-propylthiouracil (PROP) and their children’s dental caries status

Objectives

To compare mother’s and child’s oral hygiene practices with their dental caries status. To determine the taste quality and taste preferences of food products among these study groups.

Materials and Methods

220 pairs of mother and children were randomly selected from consecutive children who were accompanied by their mothers visiting the Department of Pedodontics and Preventive Dentistry in the institution. Out of these 220 pairs of mother and children 180 pairs fulfilled the inclusion criteria. A single trained and calibrated examiner who did not have any knowledge of the mother’s PROP test performed a comprehensive clinical examination of the children to determine the presence or absence of DMFT/dmft. All examinations were performed with a mouth mirror and explorer in a lighted operatory after taking consent from the mother. Demographic information of mothers, their oral hygiene practices, their oral health status and the presence of grandparents in the household was collected by an open-ended questionnaire. A second questionnaire was used to collect data regarding the oral hygiene and feeding practices of the child (e.g. frequency of tooth brushing, intake of sugary food and frequency of intake of sugary food).

Inclusion Criteria

For children

a) Age groups of 3 to 6 years.
b) ASA physical status I/II and stable mental condition
c) Should be accompanied by mother.

For mother

a) Participant cooperation and acceptance of the study programmer.
b) Should be healthy and mentally stable.
c) Should be literate.

Exclusion Criteria

For children

a) Should not be less than three years and not over six years
b) Should not have any medical / hereditary conditions.
c) No acute dental diseases.

For mothers

a) Should not be pregnant
b) Should not suffer from systemic diseases
c) Should not be allergic to 6-n-propylthiouracil (PROP)
d) Should not be under any medications that could alter the taste sensation and affect salivary flow.

Prop testing

Figure 1: Filter paper with PROP solution.

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single examiner who did not have any knowledge of the mother’s and children’s oral health status had conducted the PROP test on the mothers. A small piece of filter paper (2 cm circle of Whatman’s grade 1 filter paper) containing approximately 1.6 mg (measured by calibrated dropper) of 6-n-propylthiouracil (PROP) was used to determine each mother’s taste type (Figure 1). The mother was asked to put the piece of filter paper in the mouth and moisten it with saliva for 30 seconds (Figure 2). After removing the filter paper, the mother was asked to quantify the intensity of bitter taste on the modified Green’s scale and was classified of supertasters (>60), medium tasters (12-60) and no tasters (<12). All examinations and PROP testing were carried out at the same time of the day (mid-morning) throughout the study. All the data gathered was tabulated and statistically analyzed. Student’s paired t test and chi square test was done.

Figure 2: PROP test on mother.

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Figure 3: Distribution of population (children) according to gender.

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Figure 4: Distribution of taster among mother.

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Figure 5: Distribution of oral hygiene practices among children.

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Figure 6: Distribution of oral hygiene practices among mother.

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Figure 7: Distribution of sugar consumption by children from their grandparents.

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Figure 8: Association of children of supertaster & non taster mothers with sweet food.

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Figure 9: Association of supertaster & Non taster mother with sweet food.

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Figure 10: Distribution of mean DMFT/dmft score of supertasters, non-taster mothers and their Children.

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Table 1: Association of supertaster & non taster mothers and their children with sweet food.

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Table 2: Distribution of mean DMFT/dmft score of supertasters, non-taster mothers and their Children.

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Discussion

The present study comprised of 180 pairs of mother and child. The mothers were subjected to PROP testing and classified into super tasters, medium tasters and non-tasters according to the Green’s labeled magnitude scale. The mothers who were super tasters found the taste of PROP to be extremely bitter and the non-taster mothers described the taste of PROP to be tasteless while the medium taster mothers failed to categories the taste of PROP. The super taster mothers perceived the taste of PROP in lower concentration (1.6 mg per ml). This may be due to the presence of high-density fungiform papilla and taste receptors in the tongue compared to medium tasters and non-tasters. This may make the super taster mothers dislike sugary food. Mothers being the primary care givers to children influences the food habit of children. Mothers who prefers sugary foods are more likely to prepare and feed their children the same then those who do no prefer sugary food. In our study it was found that the mean dmft/ DMFT score among non-taster mothers (1.32) and their children (1.27) was higher than the mean dmft/ DMFT of super taster mothers (0.17) and their children (0.16) respectively. The influence of grandparents in the family cannot be neglected. Even in children of super taster mothers, 23 children reported they were given sugary snacks by their grandparents regularly while 47 children of non-taster mothers reported the same.
The pampering of grand parents may also be a causative factor for dental caries in children. The finding of the present study also showed that children who brushed their teeth once or twice per day experienced more dental caries if their mothers were non tasters whereas children of super tasters had less dental caries. This can be explained by the frequent intake of sugary food in case of children of non-taster mothers and also may be influenced by the food prepared by their mothers. Similarly, mothers who were non tasters had a higher dental caries experience than the super taster mothers. This may be due to their increased susceptibility to sugary food. In the present study when the super tasters and non-taster mothers were asked about their liking for sugary food, majority of the super taster mothers (64) stated that they did not prefer sweet food, while 95 non taster mothers stated that they preferred sugary food. In case of the children of super taster and non-taster mothers, the results were significant. The mother’s dietary habits and tastes probably affected the oral health status of the child. When the association between the preference of sugary food in super taster and non-taster mothers and their children was seen, it was found that the children of super taster mothers did not prefer sugary food while it was vice versa for the children of non-taster mothers. This may be due to genetic factors and also might be due to the dietary habits of the mothers which influenced the dental caries status of their children.

Conclusion

In the present study, the results suggested that the children of the mothers who are non-tasters or who prefers sweet food have higher dental caries experience. Factors such as the presence of grandparents in the household, frequency of brushing, preference of food and dietary habits may play an important role in the development of dental caries in children. Thus, mother’s genetic sensitivity to the bitter taste of prop can be used as a useful adjunct to identify children who are at risk of developing dental caries.

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Tuesday, 16 March 2021

Lupine Publishers| Parental Perspective Pre- and Post-Cochlear Implantation in Tanzania

 Lupine Publishers| Scholarly Journal of Otolaryngology




Abstract

Background: The National Cochlear implant program in Tanzania was established in the year 2017. Prior to this, very few children with Profound Sensorineural Hearing Loss benefited from this surgery abroad through grants from the Ministry of Health. Since the establishment of the local program, there is an increased awareness amongst parents’, and many are seeking to benefit from this initiative. The challenge, however, remains the measurements of expectations of the parents and the actual outcomes after the surgery. This is mainly due to the perspective of the parents which comes about from their understanding of the whole process of surgery and the rehabilitation after surgery that determines expected outcomes.

Aim: This study aims to establish a direct link between the parental perspective pre and post cochlear implant surgery. Participants: A total of 18 children between ages of 3 years and 6 years, divided in two groups, G1=children who have been implanted for 1-2 years (n=8) and G2=children who have been implanted for 0-1 years (n=10).

Method: A non-standardized closed ended questionnaire with questions on perspectives of three domains i.e. Communication, Listening Skills and Speech and Language development was administered to the parents, pre-implantation and 1year post implantation for G1 and 6 months post-implantation for G2.

Results: In all of the 18 cases, pre-implantation expectations were higher than the actual perspectives post-implantation. However, G1 parents had higher scores than G2 i.e. The preimplantation expectations were somehow met after 1 year of implantation.

Conclusion: The study demonstrates the ability of Cochlear Implantation to meet the parental expectations in the 3 outcome domains i.e. communication, listening skills and the development of speech and language. However, this is subject to the time frame post implantation i.e. the longer the time, the better the pre-implant perspectives are met.

Introduction

Cochlear implants, as prosthetic devices designed to replace the function of the inner ear, have become a widely used intervention method for people with severe to profound sensorineural hearing losses who gain little or no benefit from conventional hearing aids. Since their approval by the United States Food & Drug Administration (FDA) in 1990 for children as young as the age of two [1], pediatric cochlear implantation has become an increasingly routine procedure in numerous countries worldwide as a management option for permanent childhood hearing loss. The foundation of cochlear implant programs for these patients began in developed countries and over time the devices, surgical methods, and rehabilitation programs improved, which thus led to their initiation in developing countries. Prior to the commencement of locally performed cochlear implant surgeries in Tanzania, candidates for implantation had to travel to other countries for the procedure. This was a costly and intensive process for privately and government funded patients alike, a factor that fueled the need for a local program. In 2017, six children were implanted for the first time at Muhimbili National Hospital in Dar es Salaam, Tanzania, and to date a total of thirty patients have been implanted altogether. Over the time, since the first surgeries, local professionals and rehabilitation centers have become more proficient in evaluating and caring for these patients, and an increased awareness of hearing impairments as a whole has been observed. Perceptions regarding cochlear implants of health professionals, the general public, and in particular parents of implantees and potential candidates have also been seen to change, becoming more informed and understanding. Candidacy for cochlear implants is assessed on a case-by-case basis, with referrals for assessment primarily made according to candidacy criteria set out by the Cochlear Implant Group Tanzania [2].

Currently, the indications for cochlear implantation from an audiological perspective are as follows; bilateral severe to profound sensorineural hearing loss (typically >90dBHL at 2kHz and onwards), limited benefit from hearing aids, and the absence of contraindications for implantation. The candidates undergo thorough examinations by audiologists, speech-language pathologists, radiologists, otorhinolaryngologists, pediatricians, social services, psychologists, and other professionals where necessary. This process is not unlike guidelines in other countries with cochlear implant programs, and the National Institute for Health and Care Excellence (NICE) in the United Kingdom make similar recommendations, although in 2018 with suggestions from the British Cochlear Implant Group (BCIG) updated the eligibility criteria to define severe to profound deafness as only hearing sounds greater or equal to 80dBHL at two or more frequencies between 500Hz and 4kHz [3]. These recommendations and procedures differ slightly between countries and programs and may also change depending on whether the candidate is privately or publicly funded. Outcomes for pediatric cochlear implantation worldwide have encouraged their use as an intervention method for hearing impairments, reinforced by their widespread success and relatively low rate of complication [4]. A prospective longitudinal study of spoken language development in children implanted before the age of five, conducted over a period of three years, revealed significant improvements in spoken language performance (comprehension and expression) particularly over the first three years of device use. Greater improvements were seen in younger children and children with more residual hearing prior to implantation, although in all children outcomes surpassed the improvements predicted by their pre-implant assessment baseline scores [5]. A retrospective study evaluating the outcomes of cochlear implantation in relation to age of implantation conducted by Govaerts et al. [6] studied children with congenital deafness who were implanted before the age of six with a multichannel cochlear implant, evaluating them using Categories of Auditory Performance (CAP) scores and correlating outcomes with age of implantation.

All children demonstrated an increase in scores postimplantation, appearing to benefit from the device. The study identified that implantation between the ages of two and four always resulted in age-appropriate CAP scores after three years of implant usage, while implantation before the age of two years always resulted in immediate normalization of CAP scores. Implantation after the age of four, however, hardly resulted in normal CAP scores, signifying the importance of early intervention in preventing losses of auditory performance following the procedure, and only 20% to 30% of these children were eventually fully integrated into mainstream primary schools [6]. While this study reinforces the significance of age at implantation as a predictor of auditory and language outcomes, it also demonstrates the efficacy of cochlear implants as intervention for pre-lingually deafened children; even in patients implanted later than recommended, significant benefits were observed and a percentage of these patients developed the ability to integrate into mainstream education.

An integral part of the process towards pediatric implantation is continued counselling of parents of patients regarding their child’s impairment, amplification, the device, the surgery, rehabilitation, and of their expectations and outcomes. Parental expectations prior to implantation are considered a key factor in the process of candidacy assessment, so much so that they have been used previously as a criterion in the evaluation of the child’s eligibility for an implant [7]. Without the appropriate counselling and guidance, parents can be led to believe that the implant will work on its own, and that the child will be able to hear and speak shortly after switch-on [8]. Kampfe et al. [7] identified that these expectations can be influenced by the fact that the device is very expensive and high-tech, leading to unreasonable expectations. They also suggest that these expectations can also be partly due to the influence of the media, which presents the implant as an immediate change to hearing – often showcasing only significant reactions of patients in response to sounds [7]. Twenty-six years later, this statement still holds truth, as videos of ‘sensational’ reactions to sounds by implantees are spread on social media and on the news, particularly in countries where programs are in their infancy. These can lead to unrealistic expectations, subsequent stress, and disappointment when their expectations are not met. Families’ stress in relation to cochlear implants has been looked at in numerous studies and is due to a number of sources [9]. One such source is the surgical procedure itself. Although the procedure is quite safe with a low chance of complications [4], it is still a surgical procedure that has its risks, and this results in some anxiety or worry experienced by the parents [9]. It is vital that the procedure is explained appropriately to parents, and sources of clear information about it and the risks it may pose are made easily available. Another source of stress, as previously identified, is the parent’s perceptions when their expectations are not immediately met [10]. Over time this lessens as a stressor particularly as children begin to show improvements. In order to better understand parental expectations, it is important for clinicians to be aware of the reasoning behind their choice in going forward with implantation. A study by Sach & Whynes [11] interviewed 216 parents of children implanted at the Nottingham Pediatric Cochlear Implant Programmes using a mix of structured and open-ended interview formats. When asked about the decision to implant their child, 38% of parents stated that the benefit they expected was ‘improved hearing’, 23% anticipated psychosocial and behavioural benefits, 19% mentioned greater opportunities later in life while 16% cited improvements in speech [12].

In most cases outcomes were reported to be in line with their expectations, and 93% of interviews mentioned ‘improved hearing’ as an outcome of implantation. When interviewed about their expectations, 5% of parents admitted to having high and unrealistic expectations, while 16% mentioned that initial expectations had been low. With its large sample size and extensive data collection, this study has provided an insight into parental perspectives of cochlear implantations and the effect various factors can have on stress, expectations, and outcomes [12]. A study by Hyde et al.

investigating parental expectations and [13] experiences related to their children’s outcomes with implants, surveyed 247 parents in eastern Australia, and compared reports of pre-implant expectations with post-implant outcomes. Findings from this study indicated that while parents had relatively high expectations, these had mostly been met by their children’s outcomes post-implantation. 10% of parents, however, reported that expectations had not been met. Furthermore, the study established that professionals generally did a good job in providing parents with realistic expectations prior to implantation and during rehabilitation [13].

A child’s home and family environment can lead to variations in outcomes seen in implanted children [10,14,15]. Perspectives of parents and guardians towards the device and their children can influence development of the implanted child, as they can affect factors such as the level of support given at home, roles undertaken by family members in therapy, their interactions with the child, and organization and control in homes [14]. Amongst outcome predictors such as duration of deafness and learning style, family structure and support has been identified as a significant predictor of outcome following cochlear implantation as demonstrated by use of the Nottingham children’s implant profile (NChIP) to assess children, family, and support services prior to implantation [16]. Various studies into predictors of spoken language development and good outcomes with cochlear implantation have supported these findings. Better outcomes have been associated with lower ages at implantation [17], early identification of hearing impairment, number of active electrode channels effectively ‘mapped’, and bilateral implantation when compared with unilateral or bimodal stimulation [17]. Boons et al. [17] divide predictors of language development in pediatric cochlear implant recipients into three categories:

a) Auditory factors such as age of implantation or identification,

b) Child-related factors such as the presence of other disabilities and etiology of hearing loss, and

c) Environmental factors such as parental involvement and socioeconomic status.

A retrospective study into these factors involving 288 prelingually deaf children with cochlear implants was conducted through the use of numerous validated outcome measures and standardized questionnaires. The study identified that amongst the factors that can influence outcomes of cochlear implantation, environmental factors related to parental characteristics played an important role. One such factor was the communication mode between parents and their child, as participants were asked whether communication was oral, total (using signs along with spoken language), or bilingual. Another factor looked at whether the parents’ involvement in the rehabilitation process was ‘sufficient’, as it would be in a well-functioning family, or ‘insufficient’ if parents were seen to be unmotivated or unable to fulfill commitments in relation to the child (Table 1).

Table 1: The DR lesion types descriptions.

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Boons et al. [17]acknowledge the oversimplification of these classifications and have identified that while it is not a validated measure of parental involvement it can suggest an undesirable attitude of parents towards the child’s impairment and rehabilitation. 96% of parents in this study were seen to be sufficiently involved in their child’s rehabilitation, but in 4% of cases issues were mentioned highlighting insufficient involvement in the process. This factor did not show a significant variation in outcomes in the first two years following implantation, but after a certain amount of time the study identified that the advantages and possible positive effects of a supportive environment become measurable. Multilingualism in communicating with the child also consistently correlated with lower language scores over time and was accompanied by low parental involvement in rehabilitation. These findings suggest that the effects of environmental factors increased as time went on and were more measurable after two years post-implantation [15,17] also reported more significant individual variations in outcomes in children over time and found that levels of parental involvement in the rehabilitation process was associated with children’s linguistic ability four years after implantation [15]. In comparison, higher language achievement in implanted children was associated with parents reporting lengthier and detailed processes in deciding about the implant pre-implantation and who showed a higher level of involvement and commitment with the child’s rehabilitation post-implantation [15]. This correlation was also identified by Niparko et al. [5], who found higher parent-child interaction scores being significantly associated with greater rates of increase in comprehension and expression of spoken language [5]. These findings are supportive of the conclusion that variability in parental involvement, quality and quantity of parent-child interactions, and commitment to rehabilitation are significant factors in outcomes of children with cochlear implant and can lead to significant measurable differences in spoken language development after longer periods of time.

Objectives

This paper aims to study the perspectives of parents and guardians of children implanted in Dar es Salaam, Tanzania. As identified previously, parental perspectives can be a factor contributing to a child’s outcomes particularly in the first few years after implantation. It is important therefore that parents have realistic expectations and information and are aware of their role in children’s development. Being a young program, it is believed that an insight into parental perspectives regarding cochlear implantation in Tanzania will aid clinicians in further understanding the factors that can cause variations in outcomes of these children, particularly in relation to family and social support, and will also show the extent to which parent’s expectations have been met post-implantation. This article therefore aims to address the following research questions:

a) What are parents’ expectations of cochlear implantation for their children prior to implantation with regards to listening without lip-reading, communicating with others, and the development of speech and language?

b) Post-implantation, what are parent’s experiences with their implanted children? Have they noticed positive changes in communication with others, listening without lip-reading, and in spoken language?

c) How do the changes noticed by parent’s post-implantation relate to their expectations in those specific domains?

d) Are parents still concerned about their children’s development in communication, listening without lip-reading, and spoken language at one-year post-implantation?

e) Are there any differences in parental perspectives of noticeable changes across the identified domains and in their concerns about the child’s development between parents of patients who have been implanted for longer when compared to more recent implantees?

Materials and Method

A prospective longitudinal study design was adapted to collect data from the parents of twenty-one children with a bilateral severe to profound hearing impairment who underwent cochlear implantation in Tanzania. A quantitative approach to data collection and statistical analysis was determined appropriate due to the advantage of quantitative research in giving an overview of the area being studied, allowing a description of parental perspectives towards cochlear implantation to be discerned. As this is the first study to research this domain in Tanzania, it is believed that the employment of quantitative data analysis will aid in guiding future qualitative studies that may be required to explore the topic in more detail (Kelle, 2006). Parent’s expectations pre-implantation and perspectives on outcomes post-implantation were thus recorded using a quantitative survey.

Participants

The participants of the survey were parents of children who underwent cochlear implantation in Tanzania between June 2017 and January 2019 (n=21). All children underwent comprehensive assessments as part of the candidacy evaluation for cochlear implantation outlined by recommendations made by the Cochlear Implant Group Tanzania (CIGT), undergoing extensive audiology, radiology, medical, psychological, and social assessments before being selected as suitable candidates [2]. Three children were excluded from this study; one child with auditory neuropathy spectrum disorder (ANSD) identified through an audiological evaluation that revealed an abnormal auditory brainstem response and present otoacoustic emissions, which can be taken as evidence of ANSD [18]. Due to the variety of pathologies and wide variability in outcomes in children with auditory neuropathy spectrum disorder seen in other studies and the absence of an electrically evoked electrophysiology testing to predict benefit from implantation [13], outcomes and thus parental perspectives may be different from other children. The other child was identified by a pediatrician and a speech and language pathologist as a child with autism spectrum disorder, which can also result in different experiences and outcomes with cochlear implants when compared to the general pediatric implant population [19]. The third child to be excluded from the study suffered from a post-operative surgical site infection ten months post-implantation that resulted in inconsistent and eventually non-use of the processor, and subsequent explant of the device due to exposure of the implant.

All children (n=18) were implanted unilaterally with the twelve channel MED-EL Sonata Ti100 implant in combination with the 31.5mm ‘standard’ electrode array. All patients use the MED-EL Opus 2 behind-the-ear speech processor, have undergone mapping and follow up as clinically appropriate. The programming of their MAPs was conducted by audiologists trained in cochlear implant programming through a combination of behavioral and objective methods, using electrically evoked stapedial reflex thresholds (eSRTs) in fifteen children and electrically evoked compound action potentials (eCAPs) in three children. In patients with whom reliable feedback through behavioral techniques for speech processor programming is not obtainable, objective methods such as eSRTs and eCAPs have been shown to correlate significantly with behavioral thresholds and thus are useful with these populations, especially in pediatric implantees [20,21]. Out of these 18 children, 8 were male (44.4%) and 10 were female participants (55.6%). The mean age of all participants at the time of the post implant survey was 4.8 years, ranging between 4.1 years and 6.6 years. The mean age at implantation was 3.6 years, ranging from 2.3 years to 5.9 years. Between Group 1 and Group 2, the mean age at the time of the survey was the same (4.8 years). Age at implantation, however, varied significantly; the mean age at implantation for group 1 (n=8) was 3.0 years while the mean age at implantation for group 2 (n=10) was 4.1 years. The age ranges also varied between the two groups; group 1 participants ranged between 2.3 years to 3.7 years at the time of implantation, while group 2 participants ranged between 3.4 years to 5.9 years when implanted.

Measures

A questionnaire devised by Nikolopoulos, Lloyd and Archbold (2001) was determined suitable for the purpose of this study (Appendix 1), adapted from an article titled “Pediatric Cochlear Implantation: The Parent’s Perspective” (Nikolopoulos, Lloyd, & Archbold, 2001). The survey was administered after the completion of the patient’s candidacy assessment and decision to continue with implantation, having undergone all the necessary investigations outlined previously. Parents completed this questionnaire in writing within the final two weeks pre-implantation. Either one or both parents were present at this time. The pre-implantation survey required parents to respond regarding their expectations in three main areas;

a) Their expectations about the child’s communication with others

b) Listening to speech without lipreading

c) Their expectations of the implant’s effect on their child’s development of speech and language.

Post-implantation, questions were asked in relation to these three domains. The questionnaires were administered postimplantation with data collection from patients dependent on date of implantation. The patients have been divided into two groups; Group 1 (G1) being children who have been implanted for between one to two years, and Group 2 (G2) being children implanted for between six to twelve months. Surveys were once again completed in writing with either one or both parents. The three areas identified previously were enquired about in two subsets; the first asking parents if they noticed any positive changes in relation to

a) communication with others,

b) Listening to speech without lipreading and

c) development of speech and language, while the second enquired about the parent’s concerns about the child’s development in

i. Communication with others

ii. Listening to speech without lipreading and

iii. Spoken language

The format of the questions was the same as utilized by Nikolopoulos, Lloyd and Archbold [22], using a five-point Likert scale that allowed patients to choose an answer between ‘certainly yes’, ‘mostly yes’, ‘mostly no’, ‘certainly no’, or ‘unable to answer’ [22].

Results

Prior to the intervention, all parents responded positively to all three questions when asked whether they believe the device will help their child in communication with others, listening to speech without lipreading, and in the development of speech and language. 100% of responses (n=54) were either “Certainly Yes” (n=41, 75.9%) or “Mostly Yes” (n=13, 24.1%). Expectations were much higher with regards to communication and the development of speech and language, with 31 out of 36 responses across these two domains (86.1%) being “Certainly Yes”, signifying that the parents expected a definite improvement in these two areas after implantation. Much lower were the expectations of benefit in listening to speech without lip reading, as 10 out of 18 parents (55.6%) expecting a definite improvement (“Certainly Yes”), with the remaining 8 parents answering “Mostly Yes”. In communication with others when surveyed post implantation, 100% of parents were satisfied to some extent; 14 out of 18 parents responded “Certainly Yes” when asked if they noticed positive changes in this domain, while the remaining 4 parents responded “Mostly Yes”. An important difference can be noted between the responses from the two groups, with respondents from group 1 (who have been using the device for over one year) all answering “Certainly Yes” (n=8), while in group 2 (implant use less than one year) 60% of parents responded “Certainly Yes” and the remaining 40% responded “Mostly Yes”. These responses allow an insight into parent’s experiences of benefits with the device over time, as all parents perceived a difference in the child’s ability to communicate post implantation, but over time this difference was more noticeable and parents were more assured of the positive changes caused by the intervention. They also demonstrate that parental expectations prior to the surgery were sufficiently met by their experiences with the child’s ability to communicate with others post implantation in both groups.

A similar result was obtained when asking about noticeable positive changes in spoken language. All parents (n=18) responded either “Mostly Yes” (22.2%) or “Certainly Yes” (77.8%) to this question. The difference between the two groups was the same as with the question regarding communication with others: 100% of group 1 (n=8) parents noticed a definite improvement in spoken language in their children, while in group 2 (n=10) 60% of parents responded “Certainly Yes” and 40% responded “Mostly Yes”. These responses highlight that an improvement in spoken language also becomes more apparent as time of implant use increases, and that parental expectations in this domain are sufficiently met post implantation.

When asked about their experiences with their child’s ability to listen to speech without lip reading, less parents in both groups gave a definite “Certainly Yes” answer. Overall, 10 parents (55.6%) gave this answer, while 7 parents answered, “Mostly Yes”. These positive responses accounted for 94.4% of answers, as one parent answered, “Mostly No”. Looking at the individual groups, in group 1 five parents answered, “Certainly Yes” and the remaining three answered “Mostly Yes”. In group 2, five parents (50% of respondents) answered “Certainly Yes”, four parents answered, “Mostly Yes”, and one parent answered, “Mostly No”. This was the only instance where such an answer was recorded for questions related to positive changes noticed by the parents. It is possible that this may have been due to the parent’s high expectations of the child being able to understand speech without visual cues post implantation, or because of the relatively short duration of implant use and rehabilitation making changes in this domain less noticeable. This particular patient was the oldest implantees in the study, being implanted at the age of 5.9 years and having built up a reliance on lip reading even while wearing conventional hearing aids prior to implantation. To further look into parent’s perspectives post implantation, the next set of questions aimed to get an insight into their concerns regarding their child’s development in communication with others, listening to speech without lip reading, and spoken language. In Group 1, 54.2% of responses across all three domains were “Certainly No”, with all eight parents denying any concerns in communicating with others.

This highlights the benefits perceived from the surgery – all children were seen to be better at communicating, and parents were not worried about the development of this ability. In concerns about developing spoken language, 3 parents (37.5%) answered “Certainly No” and a further 3 answered “Mostly No”, while 2 parents (25%) answered “Mostly Yes”. This showed that even over a year after the surgery, parents still had some concerns about spoken language, although more qualitative studies would be needed to discern the exact areas of concern in this regard. For concerns about listening to speech without lip reading, 50% of parents selected “Mostly Yes” as their answer while the other 50% selected either “Mostly No” or “Certainly No”. This could be indicative of higher expectations in the child’s ability to listen without visual support. More parental concerns were noted in children implanted for less than one year. In Group 2, two (20%) parents answered, “Mostly Yes” with regards to concerns about development of communication with others, with the other eight parents answering, “Mostly No” and “Certainly No”. Five parents answered, “Mostly Yes” (50%) about their concerns in listening to speech without lip reading, and one parent in this domain answered “Certainly Yes”; 60% of responses in this area were therefore in the affirmative. With regards to development of spoken language, 40% of responses in this group were “Mostly Yes” and one parent answered “Certainly Yes”. The higher number of affirmative responses about concerns in the child’s development in Group 2 suggest that while parents may have noted a general improvement in some of their child’s abilities, they were still worried about development in other aspects, and that the outcomes perceivable by these parents in the time period post implantation may not have fully met their expectations of the benefit they may have thought they would see.

Discussion

The support an implanted child receives from their parents, environmental factors, and social surroundings are considered as influential factors on developmental outcomes, especially as time goes on [15]. Parental expectations of the surgery and their perspectives on the benefit can influence their attitudes towards rehabilitation and communication with the child, along with commitment to appointments, therapy, and home-based exercises. These expectations are swayed by a number of things: parent’s hopes that the implant will enable the child to develop and function normally [11], their observations of other implantees or hearing-impaired people, their experiences with the professionals they have met, the portrayal by the media of cochlear implants as a ‘cure’ for deafness [7], and the counselling they receive both pre-operatively and post operatively. Results obtained from this survey show that pre-implantation expectations for most, if not all, parents are quite high. They expect that the surgery will help the child in communication with others and in speech and language development, and most parents do not doubt the device’s ability to assist their children in this regard. This is consistent with findings from the study performed by Nikolopoulos et al. [21], wherein 81% and 86% of parents responded “Certainly Yes” in these two fields respectively. Although in listening to speech without lip reading only 35% of parents responded similarly, another 40% of parents responded “Mostly Yes” for this domain i.e. 75% of patients believed they will help the child in this domain to some extent [21].

Post implantation responses from parents in both groups generally show that their experiences with their children indicate to them that there are positive changes due to use of the device. Across both groups, 70.4% (38 out of 54) responses over all three domains were “Certainly Yes”, suggestive of a definite positive change being noticeable in the child. A further 27.8% (15 out of 54) responses were marked “Mostly Yes”, and only one response was “Mostly No”. This response was recorded in response to the ‘listening to speech without lip reading’ question by a parent from group 2 (0 – 1 years since implant), and therefore may be due to the relatively short time since implantation. As shown by the responses recorded by parents in group 1, after a year of implant use parents largely report positive changes in this domain too. This suggests that cochlear implantation has significantly met parental expectations recorded prior to implantation, possibly further reinforcing their efforts in rehabilitation and in support of the child. As time progresses, it can be deduced that parents see more of their expectations being met. Alternatively, this could also mean that parent’s expectations are lowered and more realistic as they realize the limitations of the device and the challenges posed to implantees, even though the surgery is seen to be greatly beneficial to the recipient.

Are parents still concerned about their children’s development in communication, listening without lip-reading, and spoken language at one-year post-implantation? The answers received about future concerns regarding the children’s development allow us to further understand expectations and perspectives, especially as time progresses and implant use increases. In group 1, 6 out of 24 (25%) answers were in the affirmative (all being “Mostly Yes”. 4 out of these 6 responses were with regards to listening to speech without lip reading. Meanwhile, in group 2, 13 out of 30 (43.3%) responses were in the affirmative, and 2 of these 13 answers were “Certainly Yes”. This answer was given by the parent of the oldest implantees across both groups (5.9 years being the age at implantation) when asked about concerns regarding development of listening to speech without lip reading and spoken language. Age at implantation being a significant factor in influencing outcomes post implantation [6,17], it could be a contributing factor in the parents’ concerns about their child’s development, particularly as professionals would ideally have made them aware of age’s influence on outcomes. Parent’s reports of their concerns also indicate that as implant use increases, they are less worried and concerned about outcomes. Boons et al. [17] found that over time, some of their study participants reported that their expectations changed over time, as they saw the child progress. A large variety was seen in parental expectations, with some parents reporting high expectations while others reported low expectations. Most parents noted that outcomes were largely in line with their expectations. This study had a relatively low sample size, and therefore a higher sample size would be desirable in generalizing the results to a wider population. A more long-term study could also be undertaken to highlight and understand variability in outcomes and parent’s experiences with their implanted children [23].

Conclusion

Between the results seen in both groups, a higher percentage of parents in group 1 have noticed positive changes across all three domains and have also reported being less concerned in all areas than parents of children in group 2. As time passes, children generally can be said to meet parent’s expectations more than at earlier stages after implantation. From the three areas considered in this study, they seemed to be more concerned about their child’s ability to listen to speech without lip reading, noticing a slower rate of improvement in this area than in the other domains. In conclusion, this study has given an insight into parental perspectives of cochlear implantation in Tanzania. Results are largely correlating with findings from studies in other countries and programs. However, further research is needed into other factors affecting outcomes, perspectives of implantees, and those of their families. Qualitative research into other factors influencing these influences on outcomes and expectations is needed, in order to highlight areas where professionals and parents can further collaborate in the process of cochlear implant and its rehabilitation.

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