A cable actuated flexible digit with tactile feedback for use in clinical applications

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An assessment of the technique and clinical application of visual evoked response measurements

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Form follows function:model-driven engineering for clinical trials

We argue that, for certain constrained domains, elaborate model transformation technologies-implemented from scratch in general-purpose programming languages-are unnecessary for model-driven engineering; instead, lightweight configuration of commercial off-the-shelf productivity tools suffices. In particular, in the CancerGrid project, we have been developing model-driven techniques for the generation of software tools to support clinical trials. A domain metamodel captures the community's best practice in trial design. A scientist authors a trial protocol, modelling their trial by instantiating the metamodel; customized software artifacts to support trial execution are generated automatically from the scientist's model. The metamodel is expressed as an XML Schema, in such a way that it can be instantiated by completing a form to generate a conformant XML document. The same process works at a second level for trial execution: among the artifacts generated from the protocol are models of the data to be collected, and the clinician conducting the trial instantiates such models in reporting observations-again by completing a form to create a conformant XML document, representing the data gathered during that observation. Simple standard form management tools are all that is needed. Our approach is applicable to a wide variety of information-modelling domains: not just clinical trials, but also electronic public sector computing, customer relationship management, document workflow, and so on. © 2012 Springer-Verlag.

Developing a probabilistic graphical structure from a model of mental-health clinical risk expertise

This paper explores the process of developing a principled approach for translating a model of mental-health risk expertise into a probabilistic graphical structure. The Galatean Risk Screening Tool [1] is a psychological model for mental health risk assessment based on fuzzy sets. This paper details how the knowledge encapsulated in the psychological model was used to develop the structure of the probability graph by exploiting the semantics of the clinical expertise. These semantics are formalised by a detailed specification for an XML structure used to represent the expertise. The component parts were then mapped to equivalent probabilistic graphical structures such as Bayesian Belief Nets and Markov Random Fields to produce a composite chain graph that provides a probabilistic classification of risk expertise to complement the expert clinical judgements. © Springer-Verlag 2010.

Visual hallucinations in the psychosis spectrum and comparative information from neurodegenerative disorders and eye disease

Much of the research on visual hallucinations (VHs) has been conducted in the context of eye disease and neurodegenerative conditions, but little is known about these phenomena in psychiatric and nonclinical populations. The purpose of this article is to bring together current knowledge regarding VHs in the psychosis phenotype and contrast this data with the literature drawn from neurodegenerative disorders and eye disease. The evidence challenges the traditional views that VHs are atypical or uncommon in psychosis. The weighted mean for VHs is 27% in schizophrenia, 15% in affective psychosis, and 7.3% in the general community. VHs are linked to a more severe psychopathological profile and less favorable outcome in psychosis and neurodegenerative conditions. VHs typically co-occur with auditory hallucinations, suggesting a common etiological cause. VHs in psychosis are also remarkably complex, negative in content, and are interpreted to have personal relevance. The cognitive mechanisms of VHs in psychosis have rarely been investigated, but existing studies point to source-monitoring deficits and distortions in top-down mechanisms, although evidence for visual processing deficits, which feature strongly in the organic literature, is lacking. Brain imaging studies point to the activation of visual cortex during hallucinations on a background of structural and connectivity changes within wider brain networks. The relationship between VHs in psychosis, eye disease, and neurodegeneration remains unclear, although the pattern of similarities and differences described in this review suggests that comparative studies may have potentially important clinical and theoretical implications. © 2014 The Author.

Flexible tactile digital feedback for clinical applications

Trauma and damage to the delicate structures of the inner ear frequently occurs during insertion of electrode array into the cochlea. This is strongly related to the excessive manual insertion force of the surgeon without any tool/tissue interaction feedback. The research is examined tool-tissue interaction of large prototype scale (12.5:1) digit embedded with distributive tactile sensor based upon cochlear electrode and large prototype scale (4.5:1) cochlea phantom for simulating the human cochlear which could lead to small scale digit requirements. This flexible digit classified the tactile information from the digit-phantom interaction such as contact status, tip penetration, obstacles, relative shape and location, contact orientation and multiple contacts. The digit, distributive tactile sensors embedded with silicon-substrate is inserted into the cochlea phantom to measure any digit/phantom interaction and position of the digit in order to minimize tissue and trauma damage during the electrode cochlear insertion. The digit is pre-curved in cochlea shape so that the digit better conforms to the shape of the scala tympani to lightly hug the modiolar wall of a scala. The digit have provided information on the characteristics of touch, digit-phantom interaction during the digit insertion. The tests demonstrated that even devices of such a relative simple design with low cost have potential to improve cochlear implants surgery and other lumen mapping applications by providing tactile feedback information by controlling the insertion through sensing and control of the tip of the implant during the insertion. In that approach, the surgeon could minimize the tissue damage and potential damage to the delicate structures within the cochlear caused by current manual electrode insertion of the cochlear implantation. This approach also can be applied diagnosis and path navigation procedures. The digit is a large scale stage and could be miniaturized in future to include more realistic surgical procedures.

Clinical Decision Support System Sonares

A decision support system SonaRes destined to guide and help the ultrasound operators is proposed and compared with the existing ones. The system is based on rules and images and can be used as a second opinion in the process of ultrasound examination.

Application of the Artificial Intelligence Algorithms for System Analysis of Multi Dimension Physiological Data for Developing Polyparametric Information System of Public Health Diagnostics

The polyparametric intelligence information system for diagnostics human functional state in medicine and public health is developed. The essence of the system consists in polyparametric describing of human functional state with the unified set of physiological parameters and using the polyparametric cognitive model developed as the tool for a system analysis of multitude data and diagnostics of a human functional state. The model is developed on the basis of general principles geometry and symmetry by algorithms of artificial intelligence systems. The architecture of the system is represented. The model allows analyzing traditional signs - absolute values of electrophysiological parameters and new signs generated by the model – relationships of ones. The classification of physiological multidimensional data is made with a transformer of the model. The results are presented to a physician in a form of visual graph – a pattern individual functional state. This graph allows performing clinical syndrome analysis. A level of human functional state is defined in the case of the developed standard (“ideal”) functional state. The complete formalization of results makes it possible to accumulate physiological data and to analyze them by mathematics methods.

Myopic foveoschisis:a clinical review

To review the literature on epidemiology, clinical features, diagnostic imaging, natural history, management, therapeutic approaches, and prognosis of myopic foveoschisis. A systematic Pubmed search was conducted using search terms: myopia, myopic, staphyloma, foveoschisis, and myopic foveoschisis. The evidence base for each section was organised and reviewed. Where possible an authors' interpretation or conclusion is provided for each section. The term myopic foveoschisis was first coined in 1999. It is associated with posterior staphyloma in high myopia, and is often asymptomatic initially but progresses slowly, leading to loss of central vision from foveal detachment or macular hole formation. Optical coherence tomography is used to diagnose the splitting of the neural retina into a thicker inner layer and a thinner outer layer, but compound variants of the splits have been identified. Vitrectomy with an internal limiting membrane peel and gas tamponade is the preferred approach for eyes with vision decline. There has been a surge of new information on myopic foveoschisis. Advances in optical coherence tomography will continually improve our understanding of the pathogenesis of retinal splitting, and the mechanisms that lead to macular damage and visual loss. Currently, there is a good level of consensus that surgical intervention should be considered when there is progressive visual decline from myopic foveoschisis.

A randomised controlled trial of the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia:the ECLIPSE trial

BACKGROUND: Heavy menstrual bleeding (HMB) is a common problem, yet evidence to inform decisions about initial medical treatment is limited. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena(®), Bayer) compared with usual medical treatment, with exploration of women's perspectives on treatment. DESIGN: A pragmatic, multicentre randomised trial with an economic evaluation and a longitudinal qualitative study. SETTING: Women who presented in primary care. PARTICIPANTS: A total of 571 women with HMB. A purposeful sample of 27 women who were randomised or ineligible owing to treatment preference participated in semistructured face-to-face interviews around 2 and 12 months after commencing treatment. INTERVENTIONS: LNG-IUS or usual medical treatment (tranexamic acid, mefenamic acid, combined oestrogen-progestogen or progesterone alone). Women could subsequently swap or cease their allocated treatment. OUTCOME MEASURES: The primary outcome was the patient-reported score on the Menorrhagia Multi-Attribute Scale (MMAS) assessed over a 2-year period and then again at 5 years. Secondary outcomes included general quality of life (QoL), sexual activity, surgical intervention and safety. Data were analysed using iterative constant comparison. A state transition model-based cost-utility analysis was undertaken alongside the randomised trial. Quality-adjusted life-years (QALYs) were derived from the European Quality of Life-5 Dimensions (EQ-5D) and the Short Form questionnaire-6 Dimensions (SF-6D). The intention-to-treat analyses were reported as cost per QALY gained. Uncertainty was explored by conducting both deterministic and probabilistic sensitivity analyses. RESULTS: The MMAS total scores improved significantly in both groups at all time points, but were significantly greater for the LNG-IUS than for usual treatment [mean difference over 2 years was 13.4 points, 95% confidence interval (CI) 9.9 to 16.9 points; p < 0.001]. However, this difference between groups was reduced and no longer significant by 5 years (mean difference in scores 3.9 points, 95% CI -0.6 to 8.3 points; p = 0.09). By 5 years, only 47% of women had a LNG-IUS in place and 15% were still taking usual medical treatment. Five-year surgery rates were low, at 20%, and were similar, irrespective of initial treatments. There were no significant differences in serious adverse events between groups. Using the EQ-5D, at 2 years, the relative cost-effectiveness of the LNG-IUS compared with usual medical treatment was £1600 per QALY, which by 5 years was reduced to £114 per QALY. Using the SF-6D, usual medical treatment dominates the LNG-IUS. The qualitative findings show that women's experiences and expectations of medical treatments for HMB vary considerably and change over time. Women had high expectations of a prompt effect from medical treatments. CONCLUSIONS: The LNG-IUS, compared with usual medical therapies, resulted in greater improvement over 2 years in women's assessments of the effect of HMB on their daily routine, including work, social and family life, and psychological and physical well-being. At 5 years, the differences were no longer significant. A similar low proportion of women required surgical intervention in both groups. The LNG-IUS is cost-effective in both the short and medium term, using the method generally recommended by the National Institute for Health and Care Excellence. Using the alternative measures to value QoL will have a considerable impact on cost-effectiveness decisions. It will be important to explore the clinical and health-care trajectories of the ECLIPSE (clinical effectiveness and cost-effectiveness of levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia) trial participants to 10 years, by which time half of the cohort will have reached menopause. TRIAL REGISTRATION: Current Controlled Trials ISRCTN86566246. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 88. See the NIHR Journals Library website for further project information.

Monocyte subpopulation counts and TNF alpha associations with clinical outcome post ST elevation myocardial infarction

Background Monocytes are implicated in the initiation and progression of the atherosclerotic plaque contributing to its instability and rupture. Although peripheral monocytosis has been related to poor clinical outcome post ST elevation myocardial infarction (STEMI), only scarce information is available of mechanisms of this association. Tumour necrosis factor alpha (TNFα) is a key cytokine in the acute phase inflammatory response, and it is predominantly produced by inflammatory macrophages. Little is known about TNFα association with circulating monocyte subpopulations post STEMI. Method A total of 142 STEMI patients (mean age 62±13 years; 72% male) treated with percutaneous revascularization were recruited with blood samples obtained within first 24 hours from the onset and on day 10-14. Peripheral blood monocyte subpopulations were enumerated and characterized using flow cytometry after staining for CD14, CD16 and CCR2 and were defined as: CD14++CD16-CCR2+ (Mon1), CD14++CD16+CCR+ (Mon2) and CD14+CD16++CCR2- (Mon3) cells. Plasma levels of TNFα were measured by enzyme-linked immunosorbent assay (ELISA, Peprotec system, UK). Major adverse cardiac events (MACE), defined as recurrent STEMI, new diagnosis of heart failure and death were recorded at follow up, mean of 164±134 days. Results TNFα levels were significantly higher 24 hours post STEMI, compared to day 14 (paired t-test, p <0.001) with day 1 levels weakly correlated with total monocyte count as well as Mon1 (Spearman’s correlation, r=0.19, p=0.02 and r=0.22, p=0.01, respectively). There was no correlation between TNFα and Mon2 or Mon3 subpopulations. TNFα levels were significantly higher in patients with a recorded MACE (n=28, Mann-Whitney test, p<0.001) (figure 1).⇓

Global trends in myopia management attitudes and strategies in clinical practice

PURPOSE: Myopia is a global public health issue; however, no information exists as to how potential myopia retardation strategies are being adopted globally. METHODS: A self-administrated, internet-based questionnaire was distributed in six languages, through professional bodies to eye care practitioners globally. The questions examined: awareness of increasing myopia prevalence, perceived efficacy and adoption of available strategies, and reasons for not adopting specific strategies. RESULTS: Of the 971 respondents, concern was higher (median 9/10) in Asia than in any other continent (7/10, p<0.001) and they considered themselves more active in implementing myopia control strategies (8/10) than Australasia and Europe (7/10), with North (4/10) and South America (5/10) being least proactive (p<0.001). Orthokeratology was perceived to be the most effective method of myopia control, followed by increased time outdoors and pharmaceutical approaches, with under-correction and single vision spectacles felt to be the least effective (p<0.05). Although significant intra-regional differences existed, overall most practitioners 67.5 (±37.8)% prescribed single vision spectacles or contact lenses as the primary mode of correction for myopic patients. The main justifications for their reluctance to prescribe alternatives to single vision refractive corrections were increased cost (35.6%), inadequate information (33.3%) and the unpredictability of outcomes (28.2%). CONCLUSIONS: Regardless of practitioners' awareness of the efficacy of myopia control techniques, the vast majority still prescribe single vision interventions to young myopes. In view of the increasing prevalence of myopia and existing evidence for interventions to slow myopia progression, clear guidelines for myopia management need to be established.

Quality of the written information about suicide attempters

INTRODUCTION: The aim of the study was to assess the quality of the clinical records of the patients who are seen in public hospitals in Madrid after a suicide attempt in a blind observation. METHODS: Observational, descriptive cross-sectional study conducted at four general public hospitals in Madrid (Spain). Analyses of the presence of seven indicators of information quality (previous psychiatric treatment, recent suicidal ideation, recent suicide planning behaviour, medical lethality of suicide attempt, previous suicide attempts, attitude towards the attempt, and social or family support) in 993 clinical records of 907 patients (64.5% women), ages ranging from 6 to 92 years (mean 37.1±15), admitted to hospital after a suicide attempt or who committed an attempt whilst in hospital. RESULTS: Of patients who attempted suicide, 94.9% received a psychosocial assessment. All seven indicators were documented in 22.5% of the records, whilst 23.6% recorded four or less than four indicators. Previous suicide attempts and medical lethality of current attempt were the indicators most often missed in the records. The study found no difference between the records of men and women (z=0.296; p=0.767, two tailed Mann-Whitney U test), although clinical records of patients discharged after an emergency unit intervention were more incomplete than the ones from hospitalised patients (z=2.731; p=0.006), and clinical records of repeaters were also more incomplete than the ones from non-repeaters (z=3.511; p<0.001). CONCLUSIONS: Clinical records of patients who have attempted suicide are not complete. The use of semi-structured screening instruments may improve the evaluation of patients who have self- harmed.

Clinical significance of medication reconciliation in children admitted to a UK pediatric hospital:observational study of neurosurgical patients

Background: In December 2007, the National Institute for Health and Clinical Excellence and the National Patient Safety Agency in the UK (NICE-NPSA) published guidance that recommends all adults admitted to hospital receive medication reconciliation, usually by pharmacy staff. A costing and report tool was provided indicating a resource requirement of d12.9 million for England per year. Pediatric patients are excluded from this guidance. Objective: To determine the clinical significance of medication reconciliation in children on admission to hospital. Methods: A prospective observational study included pediatric patients admitted to a neurosurgical ward at Birmingham Childrens Hospital, Birmingham, England, between September 2006 and March 2007. Medication reconciliation was conducted by a pharmacist after the admission of each of 100 consecutive eligible patients aged 4 months to 16 years. The clinical significance of prescribing disparities between pre-admission medications and initial admission medication orders was determined by an expert multidisciplinary panel and quantified using an analog scale. The main outcome measure was the clinical signficance of unintentional variations between hospital admission medication orders and physician-prescribed pre-admission medication for repeat (continuing) medications. Results: Initial admission medication orders for children differed from prescribed pre-admission medication in 39%of cases. Half of all resulting prescribing variations in this setting had the potential to cause moderate or severe discomfort or clinical deterioration. These results mirror findings for adults. Conclusions: The introduction of medication reconciliation in children on admission to hospital has the potential to reduce discomfort or clinical deterioration by reducing unintentional changes to repeat prescribed medication. Consequently, there is no justification for the omission of children from the NICENPSA guidance concerning medication reconciliation in hospitals, and costing tools should include pediatric patients. © 2010 Adis Data Information BV. All rights reserved.

Clinical translation of a hand-held optical imager for breast cancer diagnostics: In vitro and in vivo tomography studies

Optical imaging is an emerging technology towards non-invasive breast cancer diagnostics. In recent years, portable and patient comfortable hand-held optical imagers are developed towards two-dimensional (2D) tumor detections. However, these imagers are not capable of three-dimensional (3D) tomography because they cannot register the positional information of the hand-held probe onto the imaged tissue. A hand-held optical imager has been developed in our Optical Imaging Laboratory with 3D tomography capabilities, as demonstrated from tissue phantom studies. The overall goal of my dissertation is towards the translation of our imager to the clinical setting for 3D tomographic imaging in human breast tissues. A systematic experimental approach was designed and executed as follows: (i) fast 2D imaging, (ii) coregistered imaging, and (iii) 3D tomographic imaging studies. (i) Fast 2D imaging was initially demonstrated in tissue phantoms (1% Liposyn solution) and in vitro (minced chicken breast and 1% Liposyn). A 0.45 cm3 fluorescent target at 1:0 contrast ratio was detectable up to 2.5 cm deep. Fast 2D imaging experiments performed in vivo with healthy female subjects also detected a 0.45 cm3 fluorescent target superficially placed ∼2.5 cm under the breast tissue. (ii) Coregistered imaging was automated and validated in phantoms with ∼0.19 cm error in the probe’s positional information. Coregistration also improved the target depth detection to 3.5 cm, from multi-location imaging approach. Coregistered imaging was further validated in-vivo , although the error in probe’s positional information increased to ∼0.9 cm (subject to soft tissue deformation and movement). (iii) Three-dimensional tomography studies were successfully demonstrated in vitro using 0.45 cm3 fluorescence targets. The feasibility of 3D tomography was demonstrated for the first time in breast tissues using the hand-held optical imager, wherein a 0.45 cm3 fluorescent target (superficially placed) was recovered along with artifacts. Diffuse optical imaging studies were performed in two breast cancer patients with invasive ductal carcinoma. The images showed greater absorption at the tumor cites (as observed from x-ray mammography, ultrasound, and/or MRI). In summary, my dissertation demonstrated the potential of a hand-held optical imager towards 2D breast tumor detection and 3D breast tomography, holding a promise for extensive clinical translational efforts.