Engaging Communities on Health Innovation: Experiences in Implementing Design Thinking.

Design thinking is an approach gaining momentum as a strategy for promoting empathy-driven, human-centered innovation. To evaluate the implementation of design thinking for engaging with communities about health and well-being, we undertook a qualitative analysis of an engagement between students and relevant community stakeholders during a project to develop a health intervention aimed at increasing medication compliance in an elderly community in South Africa. Major findings from this research indicated that design thinking offers opportunities for enriching community-university engagements. However, given constraints on time and procedure that are associated with the academy, the fast, dynamic style of design thinking is not optimally suited for developing the level of trust and rapport that is required for engagements in communities where social-cultural differences operate as barriers. Researchers who wish to utilize design thinking will need to devise and tailor additions to tool kits to meet the specific needs of engagements related to personal health and well-being.

Towards understanding the drivers of policy change: a case study of infection control policies for multi-drug resistant tuberculosis in South Africa.

BACKGROUND: Explaining policy change is one of the central tasks of contemporary policy analysis. In this article, we examine the changes in infection control policies for multi-drug resistant tuberculosis (MDR-TB) in South Africa from the time the country made the transition to democracy in 1994, until 2015. We focus on MDR-TB infection control and refer to decentralised management as a form of infection control. Using Kingdon's theoretical framework of policy streams, we explore the temporal ordering of policy framework changes. We also consider the role of research in motivating policy changes. METHODS: Policy documents addressing MDR-TB in South Africa over the period 1994 to 2014 were extracted. Literature on MDR-TB infection control in South Africa was extracted from PubMed using key search terms. The documents were analysed to identify the changes that occurred and the factors driving them. RESULTS: During the period under study, five different policy frameworks were implemented. The policies were meant to address the overwhelming challenge of MDR-TB in South Africa, contextualised by high prevalence of HIV infection, that threatened to undermine public health programmes and the success of antiretroviral therapy rollouts. Policy changes in MDR-TB infection control were supported by research evidence and driven by the high incidence and complexity of the disease, increasing levels of dissatisfaction among patients, challenges of physical, human and financial resources in public hospitals, and the ideologies of the political leadership. Activists and people living with HIV played an important role in highlighting the importance of MDR-TB as well as exerting pressure on policymakers, while the mass media drew public attention to infection control as both a cause of and a solution to MDR-TB. CONCLUSION: The critical factors for policy change for infection control of MDR-TB in South Africa were rooted in the socioeconomic and political environment, were supported by extensive research, and can be framed using Kingdon's policy streams approach as an interplay of the problem of the disease, political forces that prevailed and alternative proposals.

Monte-Carlo simulation of a slot-scanning digital mammography system for tomosynthesis.

BACKGROUND: Digital breast tomosynthesis (DBT) reconstructs planar slices of the breast based on two-dimensional angular projections. Early studies and clinical trials show that DBT is an improvement over full field digital mammography (FFDM) because it provides the radiologist with better image quality and more information. OBJECTIVE: This paper presents a simulation system to model the performance of a slot-scanning FFDM and DBT system. METHODS: A tissue-equivalent three dimensional (3D) breast phantom was constructed, validated for slot-scanning digital mammography and used in simulating digital breast tomosynthesis. The simulation system was validated by comparing images acquired with a slot-scanning mammography machine with simulated phantom images, using the edge-test method and image quality metrics modulation transfer function (MTF), noise power spectrum (NPS) and detective quantum efficiency (DQE). Different two-dimensional (2D) projections of the 3D phantom were simulated and the phantom was reconstructed using filtered backprojection. RESULTS: Image quality metrics showed equivalence between simulated and real images. CONCLUSIONS: The simulation tool is suitable for slot-scanning FFDM and DBT and may be used for the design and comparison of mammography systems.

Dynamic multi feature-class Gaussian process models.

In model-based medical image analysis, three relevant features are the shape of structures of interest, their relative pose, and image intensity profiles representative of some physical properties. Often, these features are modelled separately through statistical models by decomposing the object's features into a set of basis functions through principal geodesic analysis or principal component analysis. However, analysing articulated objects in an image using independent single object models may lead to large uncertainties and impingement, especially around organ boundaries. Questions that come to mind are the feasibility of building a unique model that combines all three features of interest in the same statistical space, and what advantages can be gained for image analysis. This study presents a statistical modelling method for automatic analysis of shape, pose and intensity features in medical images which we call the Dynamic multi feature-class Gaussian process models (DMFC-GPM). The DMFC-GPM is a Gaussian process (GP)-based model with a shared latent space that encodes linear and non-linear variations. Our method is defined in a continuous domain with a principled way to represent shape, pose and intensity feature-classes in a linear space, based on deformation fields. A deformation field-based metric is adapted in the method for modelling shape and intensity variation as well as for comparing rigid transformations (pose). Moreover, DMFC-GPMs inherit properties intrinsic to GPs including marginalisation and regression. Furthermore, they allow for adding additional pose variability on top of those obtained from the image acquisition process; what we term as permutation modelling. For image analysis tasks using DMFC-GPMs, we adapt Metropolis-Hastings algorithms making the prediction of features fully probabilistic. We validate the method using controlled synthetic data and we perform experiments on bone structures from CT images of the shoulder to illustrate the efficacy of the model for pose and shape prediction. The model performance results suggest that this new modelling paradigm is robust, accurate, accessible, and has potential applications in a multitude of scenarios including the management of musculoskeletal disorders, clinical decision making and image processing.

Are linear measurements and computerized volumetric ratios determined from axial MRI useful for diagnosing hydrocephalus in children with tuberculous meningitis?

PURPOSE: This study aimed to evaluate linear measurements and computerized volumetric ratios on axial magnetic resonance imaging (MRI) scans against the diagnosis of hydrocephalus in children with tuberculous meningitis (TBM). METHODS: MRI scans and clinical notes of children with culture positive TBM were reviewed. Patients with surgical drainage of ventricles were considered positive for hydrocephalus. Alternatively, predefined radiological criteria of hydrocephalus in combination with any clinical criteria were considered positive for hydrocephalus. Axial T2-weighted MRI scans were used for measurement by a radiologist. Linear measurements included the Evans index, frontal-occipital horn ratio, and frontal-occipital horn width ratio. Computer-assisted segmentation of the MRI volume was performed on a slice-by-slice basis using the number of pixels comprising each region to calculate the ratios: ventricular volume: brain volume and cerebrospinal fluid (CSF)/(brain + CSF) for all slices and for a single slice at the level of the lateral ventricles. RESULTS: Twenty-two children (mean age 3.7 years) comprised ten patients with a 'final' diagnosis of hydrocephalus (six communicating, four non-communicating). None of the linear measurements showed a statistical correlation with the 'final' diagnosis of hydrocephalus. The frontal-occipital horn width ratio (FOHWR) (p = 0.09) was the closest to demonstrate statistical significance. The highest sensitivity was attained with FOR (90%) followed by FOHWR (85%). The highest specificity was reached with FOHWR (70%). Volumetric ratios were inferior to linear measures. CONCLUSION: Linear measures of hydrocephalus in TBM were more reliable than volumetric ratios. Hydrocephalus can be quantified most reliably using the FOHWR. This is useful for serial follow-up and for research of TBM.

Measurement of prevertebral cervical soft tissue thickness on lateral digital radiographs.

BACKGROUND: Widening of the prevertebral soft tissues is one of several significant indirect signs of cervical spine trauma. This paper provides pediatric radiographic reference measurements for prevertebral soft tissues at C2 and C6, and for the ratio of soft tissue to vertebral width at C6. METHODS: We reviewed 327 radiographs of consecutive patients under 14 years of age presenting at a trauma unit and obtained the relevant measurements using a software tool. Patients included in the study had no clinical features of cervical spine injury. Interobserver reliability of the measurements was assessed using the intraclass correlation coefficient of reliability. The effect of age category on the measurements was tested. RESULTS: Interobserver reliability was high for all measurements. The mean soft tissue width at C6 was significantly different across 3 age categories, whereas there was no significant difference for the soft tissue at C2 or the C6 ratio. The highest C2 soft tissue measurement was 10.6 mm, whereas the mean was 4.3 mm. The highest ratio at C6 was 1.2, with a mean ratio of 0.69. CONCLUSIONS AND CLINICAL RELEVANCE: We present prevertebral soft tissue measurements from a larger sample of subjects than published previously, which allows our values to be used with more confidence as a tool in screening for cervical spine injury.

The association between crawling as a first mode of mobilisation and the presentation of atraumatic shoulder instability: a retrospective cohort study.

BACKGROUND AND PURPOSE: To investigate if there is an association between whether an infant crawls as their first mode of mobilisation and the subsequent presentation of atraumatic shoulder instability. PATIENTS AND METHODS: A retrospective cohort of 50 consecutive patients who had presented to a national specialist centre for shoulder instability with a diagnosis of atraumatic instability was compared with a cohort of 50 participants who did not have shoulder instability. Primary outcomes were presence of atraumatic shoulder instability and whether or not the patient crawled as their first mode of mobility. A Pearson chi-squared test was used to evaluate associations. RESULTS: There was a significant association between crawling and shoulder instability (X 2(1) ≥ 11.93, p = 0.001) with a higher prevalence of non-crawlers in the group with shoulder instability compared to the control group. INTERPRETATION: There may be an association between developmental milestones and atraumatic shoulder instability. It cannot be concluded from this study whether association is causal and additional research is needed to further investigate this relationship. Asking patients presenting with shoulder instability about their developmental milestones as part of a full subjective history could guide a more targeted sensorimotor rehabilitation programme.

A review of facial image analysis for delineation of the facial phenotype associated with fetal alcohol syndrome.

The facial anomalies associated with fetal alcohol syndrome (FAS), some of which are also present in individuals with less severe forms of the broader category of fetal alcohol spectrum disorders (FASD), are typically identified with the aid of linear distance measurements taken between facial landmarks. Digital facial imaging methods are increasingly being used in syndrome delineation. Distance measurements derived from stereo-photogrammetry and facial surface imaging have been used to study the FAS facial anomalies. Geometric morphometric methods capture the spatial arrangement between landmarks, providing a statistical platform for comparison of facial shapes, and have been shown to hold promise for characterizing the FAS facial shape. We review the progression in the use of imaging and image analysis methods in studies on the facial phenotype associated with FAS.

Morphometric analysis and classification of the facial phenotype associated with fetal alcohol syndrome in 5- and 12-year-old children.

Landmark-based morphometric analysis holds promise for quantitative assessment of craniofacial dysmorphology. We describe an application of facial shape analysis to characterize the facial anomalies associated with fetal alcohol syndrome (FAS) in a mixed ancestry population. Generalized Procrustes analysis, regression and discriminant function analysis were applied to stereo-photogrammetrically derived 3D coordinates of landmarks taken from 34 subjects (n = 17 FAS and n = 17 normal controls). Four shape analyses were carried out, namely a comparison of the FAS and control facial shapes at age 5, and one at age 12; a comparison of the FAS facial shapes at ages 5 and 12; and a comparison of control facial shapes at ages 5 and 12. The first two analyses showed that the FAS face is characterized by small palpebral fissures, a thin upper lip, and midfacial hypoplasia. Classification of subjects as having FAS using leave-one-out cross-validation showed that the 5-year-old group could be classified with 95.46% accuracy and the 12-year-olds with 80.13% accuracy. The third and fourth analyses revealed that the differences in facial shape between FAS individuals in different age groups were more pronounced than for control individuals, supporting the notion that FAS facial anomalies diminish with age. Geometric morphometric analysis of stereo-photogrammetrically derived 3D facial landmarks allows visualization of the facial anomalies associated with FAS, as well as classification of facial shapes.

A user-centred design framework for mHealth.

BACKGROUND: Mobile health (mHealth) has the potential to improve access to healthcare, especially in developing countries. The proliferation of mHealth has not been accompanied by a corresponding growth in design guidelines for mHealth applications. This paper proposes a framework for mHealth application design that combines the Information Systems Research (ISR) framework and design thinking. We demonstrate a use case for the proposed framework in the form of an app to read the result of the tuberculin skin test (TST), which is used to screen for latent tuberculosis infection. The framework was used in the re-design of the TST reading app but could also be used in earlier stages of mHealth app design. METHODS: The ISR framework and design thinking were merged based on how the modes of design thinking integrate with the cycles of the ISR framework. Using the combined framework, we re-designed an mHealth app for TST reading, intended to be used primarily in a developing context by healthcare workers. Using the proposed framework, the app was iterated upon and developed with the aid of personas, observations, prototyping and questionnaires. RESULT: The combined framework was applied through engagement with end-users, namely ten healthcare workers and ten graduate students. Through review of the literature and iterations of the app prototype, we identified various usability requirements and limitations. These included challenges related to image capture and a misunderstanding of instructions. These insights influenced the development and improvement of the app. CONCLUSION: The combined framework allowed for engagement with end-users and for low-cost, rapid development of the app while addressing contextual challenges and needs. The integration of design thinking modes with the ISR cycles was effective in achieving the objectives of each approach. The combined framework acknowledges the importance of engaging users when implementing mHealth technologies, especially in developing and under-resourced contexts. Findings from this study support the use of this framework as a guide in the design of user-centred mHealth interventions.

The use of the Statscan digital X-ray unit in paediatric polytrauma.

We present a 3-year review of clinical paediatric experience with the Statscan (Lodox Systems, Johannesburg, South Africa), a low-dose, digital, whole-body, slit-scanning X-ray machine. While focusing on the role of the unit in paediatric polytrauma, insight into its applications in other paediatric settings is provided.

Statistical shape-kinematics models of the skeletal joints: Application to the shoulder complex.

Patient-specific biomechanical simulations of joints require accurate reconstruction of bony anatomy from medical image data. The articular geometries of the joints may influence their biomechanics. Statistical shape models (SSMs) have become ubiquitous in the literature and aim to capture the natural variation of biological objects. They work by learning the variation from training examples to define the space of valid biological shapes. However, the kinematic information descriptive of the anato-physiological relationship of two interacting objects is not generally encoded in the SSM. Here, we propose a framework for developing combined statistical shape and kinematics models (SSKMs) as Gaussian process morphable models to analyse the shape and kinematics relationship. We demonstrate the framework on a three-dimensional (3D) image data set consisting of ten right-handed cadaveric shoulder joints acquired using computed tomography. Additionally, we simulate specific bone motions to encode kinematics in the combined model. Our SSKM built from shoulder data (matching scapulae and humeri) correctly depicts a correlation between the shape and kinematics as hypothesized. We furthermore demonstrate the ability to marginalize from the SSKM to obtain shape-only variation and kinematics-only variation. Future work aims to use the SSKM framework to understand the relationships between kinematics and shape for various joints as well as to develop patient-specific computational models to evaluate joint biomechanics.

Review of 2-D/3-D Reconstruction Using Statistical Shape and Intensity Models and X-Ray Image Synthesis: Toward a Unified Framework.

Patient-specific three-dimensional (3-D) bone models are useful for a number of clinical applications such as surgery planning, postoperative evaluation, as well as implant and prosthesis design. Two-dimensional-to-3-D (2-D/3-D) reconstruction, also known as model-to-modality or atlas-based 2-D/3-D registration, provides a means of obtaining a 3-D model of a patient's bones from their 2-D radiographs when 3-D imaging modalities are not available. The preferred approach for estimating both shape and density information (that would be present in a patient's computed tomography data) for 2-D/3-D reconstruction makes use of digitally reconstructed radiographs and deformable models in an iterative, non-rigid, intensity-based approach. Based on a large number of state-of-the-art 2-D/3-D bone reconstruction methods, a unified mathematical formulation of the problem is proposed in a common conceptual framework, using unambiguous terminology. In addition, shortcomings, recent adaptations, and persisting challenges are discussed along with insights for future research.

Fuzzy clustering to detect tuberculous meningitis-associated hyperdensity in CT images.

Hyperdensity in head CT images has been shown to be a specific feature for diagnosing tuberculous meningitis (TBM) in children. We describe the extraction of hyperdense regions using fuzzy c-means clustering and fuzzy maximum likelihood estimation, thus providing a tool for the enhancement of an often subtle radiological feature. We calculate an asymmetry measure and confirm that normal and TBM images have different patterns of hyperdensity. Our results may be used in computer-assisted diagnosis of TBM.

Nanomedicine for drug delivery in South Africa: a protocol for systematic review.

BACKGROUND: The emergence of nanomedicine in the past decade has changed the landscape of disease diagnosis and treatment. Nanomedicine makes use of nanostructures for applications in different fields of medicine, including drug delivery, biosensors, neuro-electronic interfaces, in vivo imaging, and cell-specific molecular interactions. Despite its relative infancy, nanomedicine has generated a significant body of research as evidenced by peer reviewed literature and several patents. This proposed systematic review will focus specifically on drug delivery systems in which nanoparticles are used to enhance the pharmacological and therapeutic properties of drugs. The strength of nanoparticulate drug delivery systems is their ability to alter the pharmacokinetics and bio-distribution of drugs. Globally, the discourse on nanomedicine is dominated by research being done in the developed countries of Europe and in the United States of America. Less attention has been given to the applications of nanomedicine in developing countries, particularly Africa. There is dearth of information on the applications of nanomedicine in terms of drug delivery with particular reference to which diseases are being targeted generally in Africa. The review will describe the specific diseases that are being targeted and the progress being made in South Africa, with a view to determining whether the applications of nanomedicine are being appropriated to address the context-specific challenges in this country or if they mimic what is being done globally. METHODS: Keywords related to nanomedicine and drug delivery will be combined to build a search strategy for each of the following databases: PubMed, Cochrane Library (including Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, Cochrane Methodology Register), Google Scholar, NHS Health Technology Assessment Database and Web of Science. We will also check reference lists of included studies for other eligible reports and search unpublished data. To ensure that the search is comprehensive, grey literature will be searched extensively. Literature to be included will have nanomedicine in drug delivery as the primary application and report on the specific diseases that are targeted in South Africa. Two authors will independently screen the search output, select studies and extract data; discrepancies will be resolved by consensus and discussion. When no consensus is reached, the third author will be consulted DISCUSSION: The systematic review will inform the government, policy-makers, investors, health professionals, scientists, and engineers about the applications of nanomedicine in drug delivery. In particular, it will identify the diseases targeted by the application of nanomedicine for drug delivery and the progress being made in South Africa as the disease burden of this country differs from that of developed countries where nanomedicine has been widely used for drug delivery. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017057388.

Open source modular ptosis crutch for the treatment of myasthenia gravis.

INTRODUCTION: Pharmacologic treatment of Myasthenia Gravis presents challenges due to poor tolerability in some patients. Conventional ptosis crutches have limitations such as interference with blinking which causes ocular surface drying, and frequent irritation of the eyes. To address this problem, a modular and adjustable ptosis crutch for elevating the upper eyelid in Myasthenia Gravis patients has been proposed as a non-surgical and low-cost solution. AREAS COVERED: This paper reviews the literature on the challenges in the treatment of Myasthenia Gravis globally and focuses on a modular and adjustable ptosis crutch that has been developed by the Medical Device Laboratory at the University of Cape Town. EXPERT COMMENTARY: The new medical device has potential as a simple, effective and unobtrusive solution to elevate the drooping upper eyelid(s) above the visual axis without the need for medication and surgery. Access to the technology is provided through an open source platform which makes it available globally. Open access provides opportunities for further open innovation to address the current limitations of the device, ultimately for the benefit not only of people suffering from Myasthenia Gravis but also of those with ptosis from other aetiologies.

A modified stakeholder participation assessment framework for design thinking in health innovation.

Increasing pressure to improve health outcomes of populations with limited resources has prompted an emphasis on innovation. Design thinking has been proposed as a systematic approach to innovation in health, owing to its human-centred methodology that prioritises deep empathy for the end-users' desires, needs and challenges, which results in a better understanding of the problem in order to develop more comprehensive and effective solutions. A key feature of design thinking is stakeholder participation. If design thinking is going to be used as an approach to design and implement effective, equitable and sustainable health solutions, assessing stakeholder participation should be integrated into the process. Therefore, the purpose of this review is to i) provide an analysis of the literature on assessing stakeholder participation in health and ii) propose a framework based on the literature analysis that can be used to assess stakeholder participation during the design thinking process in health innovation. Drawing from participatory research in health, where stakeholder participation is recognised as a core principle that facilitates the implementation of solutions, we integrate stakeholder evaluation tools into the design thinking approach. We draw on an assessment framework that describes levels of stakeholder participation by their involvement in making decisions about their health. Using a 5-point continuum where the lower end represents the medical approach (professionals make all the decisions) and the upper end represents the community development approach (all stakeholders are key decision makers), we propose a modified assessment framework to evaluate stakeholder participation during the design thinking process. The modified framework provides a simple and practical tool to evaluate stakeholder participation. Stakeholders can rate their perceived level of participation, as well as that of the other stakeholders. Evaluation of participation in a design thinking project may be used to improve participation, and therefore the uptake and sustainability of innovations. The framework may also be used in design thinking beyond health applications.

Mobile phone-based evaluation of latent tuberculosis infection: Proof of concept for an integrated image capture and analysis system.

BACKGROUND: The tuberculin skin test is the most widely used method for detecting latent tuberculosis infection in adults and active tuberculosis in children. We present the development of a mobile-phone based screening tool for measuring the tuberculin skin test induration. METHOD: The tool makes use of a mobile application developed on the Android platform to capture images of an induration, and photogrammetric reconstruction using Agisoft PhotoScan to reconstruct the induration in 3D, followed by 3D measurement of the induration with the aid of functions from the Python programming language. The system enables capture of images by the person being screened for latent tuberculosis infection. Measurement precision was tested using a 3D printed induration. Real-world use of the tool was simulated by application to a set of mock skin indurations, created by a make-up artist, and the performance of the tool was evaluated. The usability of the application was assessed with the aid of a questionnaire completed by participants. RESULTS: The tool was found to measure the 3D printed induration with greater precision than the current ruler and pen method, as indicated by the lower standard deviation produced (0.3 mm versus 1.1 mm in the literature). There was high correlation between manual and algorithm measurement of mock skin indurations. The height of the skin induration and the definition of its margins were found to influence the accuracy of 3D reconstruction and therefore the measurement error, under simulated real-world conditions. Based on assessment of the user experience in capturing images, a simplified user interface would benefit wide-spread implementation. CONCLUSIONS: The mobile application shows good agreement with direct measurement. It provides an alternative method for measuring tuberculin skin test indurations and may remove the need for an in-person follow-up visit after test administration, thus improving latent tuberculosis infection screening throughput.

Stereo image matching for facial feature measurement to aid in fetal alcohol syndrome screening.

The facial phenotype associated with fetal alcohol syndrome is identified through the measurement of facial distances and their comparison to population norms. As an alternative to time-consuming direct manual measurements, stereo photogrammetry has been used to obtain the required facial measurements from stereo digital photographs. While stereo photogrammetric measurement is faster, it requires manual marking of relevant facial landmarks on digital images. We present an algorithm that automatically finds matched feature points on the second of a pair of stereo images, after manual marking of the first. Standard image processing tools are used for preprocessing. Matching is based on a simple exhaustive search in an image window, with the sum of squared differences of the pixel intensities in the two images as the objective function. Eye measurements, namely palpebral fissure length, interpupillary distance, inner canthal distance and outer canthal distance, as well as distances that can be used to approximate the circularity of the upper lip, were obtained using the manual method of marking both images, and the method of automatic marking of the second image. Comparison revealed mean differences less than 1mm.