TECHNOLOGY ASSESSMENT: SMALL-VOLUME INFUSION PUMPS

"Technology assessment is a comprehensive form of policy research that examines the short- and long-term social consequences of the application or use of technology" (US Congress 1967).^ This study explored a research methodology appropriate for technology assessment (TA) within the health industry. The case studied was utilization of external Small-Volume Infusion Pumps (SVIP) at a cancer treatment and research center. Primary and secondary data were collected in three project phases. In Phase I, hospital prescription records (N = 14,979) represented SVIP adoption and utilization for the years 1982-1984. The Candidate Adoption-Use (CA-U) diffusion paradigm developed for this study was germane. Compared to classic and unorthodox curves, CA-U more accurately simulated empiric experience. The hospital SVIP 1983-1984 trends denoted assurance in prescribing chemotherapy and concomitant balloon SVIP efficacy and efficiency. Abandonment of battery pumps was predicted while exponential demand for balloon SVIP was forecast for 1985-1987. In Phase II, patients using SVIP (N = 117) were prospectively surveyed from July to October 1984; the data represented a single episode of therapy. The questionnaire and indices, specifically designed to measure the impact of SVIP, evinced face validity. Compeer group data were from pre-SVIP case reviews rather than from an inpatient sample. Statistically significant results indicated that outpatients using SVIP interacted socially more than inpatients using the alternative technology. Additionally, the hospital's education program effectively taught clients to discriminate between self care and professional SVIP services. In these contexts, there was sufficient evidence that the alternative technology restricted patients activity whereas SVIP permitted patients to function more independently and in a social lifestyle, thus adding quality to life. In Phase III, diffusion forecast and patient survey findings were combined with direct observation of clinic services to profile some economic dimensions of SVIP. These three project phases provide a foundation for executing: (1) cost effectiveness analysis of external versus internal infusors, (2) institutional resource allocation, and (3) technology deployment to epidemiology-significant communities. The models and methods tested in this research of clinical technology assessment are innovative and do assess biotechnology. ^

Assessment of executive function before and after vitamin D replacement in vulnerable adults who self-neglect

Purpose: Self-neglect (SN) is the inability to maintain self-care needs. It is thought that older adults who have impaired executive function (EF) develop the inability to do self-care and to protect themselves. The specific aims were to (1) determine the feasibility of using multiple EF measures with community-dwelling elders with SN, (2) identify changes in EF between baseline and 5-months in community-dwelling elders with SN who receive 50,000 IU or 400 IU of oral vitamin D monthly and (2) explore changes in specific dimensions of EF between the groups. ^ Methods: Fifty adults, 65 years of age and older, were recruited from Adult Protective Services with confirmed SN. A research nurse administered the following tests at baseline and five-months: Delis-Kaplan Card Sort Test (D-KEFS), Executive Interview (EXIT 25), CLOX Drawing Test (CLOX I, II), Trails Making Test A and B (TMT A & B) and the Mini-Mental State Examination (MMSE). Demographic data was collected at baseline and serum 25-OHD levels were collected at baseline and five-months. ^ Results: Older adults with SN were more likely to fail the CLOX1 and D-KEFS, while passing the MMSE, CLOX II, TMT A & B and the EXIT 25. At five-months, the only statistically significant difference between groups was in the TMT A & B test scores; the control group did better than the treatment group. There was a non-significant increase in serum vitamin D levels for both groups and no difference between groups. ^ Conclusions: Results from this study provide support that individuals who SN will complete a battery of EF tests and that they exhibit the following impairments consistent with executive dysfunction: 'concept generation', 'planning', 'inhibition', and 'spatial working memory'. Utilizing only one EF measure in individuals with intact cognition may result in unidentification of individuals with executive dysfunction, thus delaying necessary treatment. Future studies should attempt to determine different etiologies of executive dysfunction and determine if early treatment can prevent or reverse SN. ^ Key Words: Self-neglect, Executive Dysfunction, Executive Function, Adult Protective Services, Community-dwelling, Vitamin D ^

Analysis of The Key Parameters in Pedestrian Safety Assessment for the European Vehicle Fleet Using Multibody and Finite Element Mathematical Models

Esta tesis investiga cuales son los parámetros más críticos que condicionan los resultados que obtienen en los ensayos de protección de peatones la flota Europea de vehículos, según la reglamentación europea de protección de peatones de 2003 (Directiva CE 2003/102) y el posterior Reglamento de 2009 (Reglamento CE 2009/78). En primer lugar se ha analizado el contexto de la protección de peatones en Europa, viendo la historia de las diferentes propuestas de procedimientos de ensayo así como los cambios (y las razones de los mismos) que han sufrido a lo largo del proceso de definición de la normativa Europea. Con la información disponible de más de 400 de estos ensayos se han desarrollado corredores de rigidez para los frontales de los diferentes segmentos de la flota de vehículos europea, siendo este uno de los resultados más relevantes de esta tesis. Posteriormente, esta tesis ha realizado un estudio accidentológico en detalle de los escenarios de atropello de peatones, identificando sus características más relevantes, los grupos de población con mayor riesgo y los tipos de lesiones más importantes que aparecen (en frecuencia y severidad), que han sentado las bases para analizar con modelos matemáticos hasta qué punto los métodos de ensayo propuestos realmente tienen estos factores en cuenta. Estos análisis no habrían sido posibles sin el desarrollo de las nuevas herramientas que se presentan en esta tesis, que permiten construir instantáneamente el modelo matemático de cualquier vehículo y cualquier peatón adulto para analizar su iteración. Así, esta tesis ha desarrollado una metodología rápida para desarrollar modelos matemáticos de vehículos a demanda, de cualquier marca y modelo y con las características geométricas y de rigidez deseados que permitan representarlo matemáticamente y del mismo modo, ha investigado cómo evoluciona el comportamiento del cuerpo humano durante el envejecimiento y ha implementado una funcionalidad de escalado en edad al modelo de peatón en multicuerpo de MADYMO (ya escalable en tamaño) para permitir modelar ad hoc cualquier peatón adulto (en género y edad). Finalmente, esta tesis también ha realizado, utilizando modelos de elementos finitos del cuerpo humano, diferentes estudios sobre la biomecánica de las lesiones más frecuentes de este tipo de accidentes, (en piernas y cabeza) con el objetivo de mejorar los procedimientos de ensayo para que predigan mejor el tipo de lesiones que se quieren evitar. Con el marco temporal y las condiciones de contorno de esta tesis se han centrado los esfuerzos en reforzar algunos aspectos críticos pero puntuales sobre cómo mejorar el ensayo de cabeza y, sobretodo, en proponer soluciones viables y con un valor añadido real al ensayo de pierna contra parachoques, sin cambiar la esencia del mismo pero proponiendo un nuevo impactador mejorado que incorpore una masa extra que representa a la parte superior del cuerpo y sea válido para toda la flota europea de vehículos independiente de la geometría de su frontal.

In-field assessment of batteries and PV modules in a large photovoltaic rural electrification programme

Assuring the sustainability of quality in photovoltaic rural electrification programmes involves enhancing the reliability of the components of solar home systems as well as the characterization of the overall programme cost structure. Batteries and photovoltaic modules have a great impact on both the reliability and the cost assessment, the battery being the weakest component of the solar home system and consequently the most expensive element of the programme. The photovoltaic module, despite being the most reliable component, has a significant impact cost-wise on the initial investment, even at current market prices. This paper focuses on the in-field testing of both batteries and photovoltaic modules working under real operating conditions within a sample of 41 solar home systems belonging to a large photovoltaic rural electrification programme with more than 13,000 installed photovoltaic systems. Different reliability parameters such as lifetime have been evaluated, taking into account different factors, for example energy consumption rates, or the manufacturing quality of batteries. A degradation model has been proposed relating both loss of capacity and time of operation. The user e solar home system binomial is also analysed in order to understand the meaning of battery lifetime in rural electrification.

Differences in frontal cortical activation by a working memory task after substitution of risperidone for typical antipsychotic drugs in patients with schizophrenia

Antipsychotic drug treatment of schizophrenia may be complicated by side effects of widespread dopaminergic antagonism, including exacerbation of negative and cognitive symptoms due to frontal cortical hypodopaminergia. Atypical antipsychotics have been shown to enhance frontal dopaminergic activity in animal models. We predicted that substitution of risperidone for typical antipsychotic drugs in the treatment of schizophrenia would be associated with enhanced functional activation of frontal cortex. We measured cerebral blood oxygenation changes during periodic performance of a verbal working memory task, using functional MRI, on two occasions (baseline and 6 weeks later) in two cohorts of schizophrenic patients. One cohort (n = 10) was treated with typical antipsychotic drugs throughout the study. Risperidone was substituted for typical antipsychotics after baseline assessment in the second cohort (n = 10). A matched group of healthy volunteers (n = 10) was also studied on a single occasion. A network comprising bilateral dorsolateral prefrontal and lateral premotor cortex, the supplementary motor area, and posterior parietal cortex was activated by working memory task performance in both the patients and comparison subjects. A two-way analysis of covariance was used to estimate the effect of substituting risperidone for typical antipsychotics on power of functional response in the patient group. Substitution of risperidone increased functional activation in right prefrontal cortex, supplementary motor area, and posterior parietal cortex at both voxel and regional levels of analysis. This study provides direct evidence for significantly enhanced frontal function in schizophrenic patients after substitution of risperidone for typical antipsychotic drugs, and it indicates the potential value of functional MRI as a tool for longitudinal assessment of psychopharmacological effects on cerebral physiology.

The Spanish version of the Prenatal Breast-feeding Self-efficacy Scale: Reliability and validity assessment

Background: Only a minority of infants are exclusively breastfed for the recommended 6 months postpartum. Breast-feeding self-efficacy is a mother's confidence in her ability to breastfeed and is predictive of breastfeeding behaviors. The Prenatal Breast-feeding Self-efficacy Scale (PBSES) was developed among English-speaking mothers to measure breastfeeding self-efficacy before delivery. Objectives: To translate the PBSES into Spanish and assess its psychometric properties. Design: Reliability and validity assessment. Setting: A public hospital in Yecla, Spain. Participants: A convenience sample of 234 pregnant women in their third trimester of pregnancy. Methods: The PBSES was translated into Spanish using forward and back translation. A battery of self-administered questionnaires was completed by participants, including a questionnaire on sociodemographic variables, breastfeeding experience and intention, as well as the Spanish version of the PBSES. Also, data on exclusive breastfeeding at discharge were collected from hospital database. Dimensional structure, internal consistency and construct validity of the Spanish version of PBSES were assessed. Results: Confirmatory factor analysis suggested the presence of one construct, self-efficacy, with four dimensions or latent variables. Cronbach's alpha coefficient for internal consistency was 0.91. Response patterns based on decision to breastfeed during pregnancy provided evidence of construct validity. In addition, the scores of the Spanish version of the PBSES significantly predicted exclusive breastfeeding at discharge. Conclusions: The Spanish version of PBSES shows evidences of reliability, and contrasting group and predictive validity. Confirmatory factor analysis indicated marginal fit and further studies are needed to provide new evidence on the structure of the scale. The Spanish version of the PBSES can be considered a reliable measure and shows validity evidences.

Genetic and environmental sources of covariance between reading tests used in neuropsychological assessment and IQ subtests

In this study, we examined genetic and environmental influences on covariation among two reading tests used in neuropsychological assessment (Cambridge Contextual Reading Test [CCRT], [Beardsall, L., and Huppert, F. A. ( 1994). J. Clin. Exp. Neuropsychol. 16: 232 - 242], Schonell Graded Word Reading Test [SGWRT], [ Schonell, F. J., and Schonell, P. E. ( 1960). Diagnostic and attainment testing. Edinburgh: Oliver and Boyd.]) and among a selection of IQ subtests from the Multidimensional Aptitude Battery (MAB), [Jackson, D. N. (1984). Multidimensional aptitude battery, Ontario: Research Psychologists Press.] and the Wechsler Adult Intelligence Scale-Revised (WAIS-R) [Wechsler, D. (1981). Manual for the Wechsler Adult Intelligence Scale-Revised (WAIS-R). San Antonio: The Psychological Corporation]. Participants were 225 monozygotic and 275 dizygotic twin pairs aged from 15 years to 18 years ( mean, 16 years). For Verbal IQ subtests, phenotypic correlations with the reading tests ranged from 0.44 to 0.65. For Performance IQ subtests, phenotypic correlations with the reading tests ranged from 0.23 to 0.34. Results of Structural Equation Modeling (SEM) supported a model with one genetic General factor and three genetic group factors ( Verbal, Performance, Reading). Reading performance was influenced by the genetic General factor ( accounting for 13% and 20% of the variance for the CCRT and SGWRT, respectively), the genetic Verbal factor ( explaining 17% and 19% of variance for the CCRT and SGWRT), and the genetic Reading factor ( explaining 21% of the variance for both the CCRT and SGWRT). A common environment factor accounted for 25% and 14% of the CCRT and SGWRT variance, respectively. Genetic influences accounted for more than half of the phenotypic covariance between the reading tests and each of the IQ subtests. The heritabilities of the CCRT and SGWRT were 0.54 and 0.65, respectively. Observable covariance between reading assessments used by neuropsychologists to estimate IQ and IQ subtests appears to be largely due to genetic effects.

An Internet-based telerehabilitation system for the assessment of motor speech disorders: A pilot study

Purpose: This pilot study explored the feasibility and effectiveness of an Internet-based telerehabilitation application for the assessment of motor speech disorders in adults with acquired neurological impairment. Method: Using a counterbalanced, repeated measures research design, 2 speech-language pathologists assessed 19 speakers with dysarthria on a battery of perceptual assessments. The assessments included a 19-item version of the Frenchay Dysarthria Assessment (FDA; P. Enderby, 1983), the Assessment of Intelligibility of Dysarthric Speech (K. M. Yorkston & D. R. Beukelman, 1981), perceptual analysis of a speech sample, and an overall rating of severity of the dysarthria. One assessment was conducted in the traditional face-to-face manner, whereas the other assessment was conducted using an online, custom-built telerehabilitation application. This application enabled real-time videoconferencing at 128 kb/s and the transfer of store-and-forward audio and video data between the speaker and speech-language pathologist sites. The assessment methods were compared using the J.M.Bland and D.G.Altman (1986, 1999) limits-of-agreement method and percentage level of agreement between the 2 methods. Results: Measurements of severity of dysarthria, percentage intelligibility in sentences, and most perceptual ratings made in the telerehabilitation environment were found to fall within the clinically acceptable criteria. However, several ratings on the FDA were not comparable between the environments, and explanations for these results were explored. Conclusions: The online assessment of motor speech disorders using an Internet-based telerehabilitation system is feasible. This study suggests that with additional refinement of the technology and assessment protocols, reliable assessment of motor speech disorders over the Internet is possible. Future research methods are outlined.

Assessment of statistical change criteria used to define significant change in neuropsychological test performance following cardiac surgery

Objective: This paper compares four techniques used to assess change in neuropsychological test scores before and after coronary artery bypass graft surgery (CABG), and includes a rationale for the classification of a patient as overall impaired. Methods: A total of 55 patients were tested before and after surgery on the MicroCog neuropsychological test battery. A matched control group underwent the same testing regime to generate test–retest reliabilities and practice effects. Two techniques designed to assess statistical change were used: the Reliable Change Index (RCI), modified for practice, and the Standardised Regression-based (SRB) technique. These were compared against two fixed cutoff techniques (standard deviation and 20% change methods). Results: The incidence of decline across test scores varied markedly depending on which technique was used to describe change. The SRB method identified more patients as declined on most measures. In comparison, the two fixed cutoff techniques displayed relatively reduced sensitivity in the detection of change. Conclusions: Overall change in an individual can be described provided the investigators choose a rational cutoff based on likely spread of scores due to chance. A cutoff value of ≥20% of test scores used provided acceptable probability based on the number of tests commonly encountered. Investigators must also choose a test battery that minimises shared variance among test scores.

Psychometric assessment of recovery from mild traumatic brain injury

The Rapid Screen of Concussion (RSC) is a brief psychometric test battery, designed to provide a functional criterion to aid clinical diagnosis of mild traumatic brain injury (mTBI). The present research aimed to examine the utility of this instrument for assessing recovery after mTBI. Three studies were conducted. In Study 1, Discriminant Function Analysis was performed to determine how well the RSC differentiated uninjured controls (N¼16), from mTBI patients (N¼22) and moderate to severe TBI patients (N¼14), several months post-injury. As predicted, moderate to severe TBI patients achieved lower scores than the mTBI and control groups. The RSC also successfully differentiated between each of the diagnostic groups, yielding an overall correct classification rate of 75%. Study 2 examined the predictive utility of the RSC in the mTBI sample (N¼22). Acute injury performance on the RSC was correlated with post-injury scores at an average of 5.5 months post-injury. Statistically significant partial correlation coefficients (r¼0.53r¼0.80) were found for each of the subtests, showing that low acute RSC scores were predictive of poor recovery scores on the RSC after mTBI. In the third study, Reliable Change Indices were calculated on the RSC subtests to examine individual patterns of recovery from mTBI. While 17 of the 23 participants made a significant improvement on their acute injury DSST scores (74%), only 13 of 25 made a significant improvement on the Rapid Sentence Judgement Test (52%), highlighting differential recovery of function, and challenging the notion of full recovery from mTBI within 3 months. These overall results offer support for the construct and predictive validity of the RSC and demonstrate that inexpensive tests of brain function may be useful for managing mTBI acutely for prognosis.

The spectrum and severity of FUS-immunoreactive inclusions in the frontal and temporal lobes of ten cases of neuronal intermediate filament inclusion disease

Neuronal intermediate filament inclusion disease (NIFID), a rare form of frontotemporal lobar degeneration (FTLD), is characterized neuropathologically by focal atrophy of the frontal and temporal lobes, neuronal loss, gliosis, and neuronal cytoplasmic inclusions (NCI) containing epitopes of ubiquitin and neuronal intermediate filament proteins. Recently, the 'fused in sarcoma' (FUS) protein (encoded by the FUS gene) has been shown to be a component of the inclusions of familial amyotrophic lateral sclerosis with FUS mutation, NIFID, basophilic inclusion body disease, and atypical FTLD with ubiquitin-immunoreactive inclusions (aFTLD-U). To further characterize FUS proteinopathy in NIFID, and to determine whether the pathology revealed by FUS immunohistochemistry (IHC) is more extensive than a-internexin, we have undertaken a quantitative assessment of ten clinically and neuropathologically well-characterized cases using FUS IHC. The densities of NCI were greatest in the dentate gyrus (DG) and in sectors CA1/2 of the hippocampus. Anti-FUS antibodies also labeled glial inclusions (GI), neuronal intranuclear inclusions (NII), and dystrophic neurites (DN). Vacuolation was extensive across upper and lower cortical layers. Significantly greater densities of abnormally enlarged neurons and glial cell nuclei were present in the lower compared with the upper cortical laminae. FUS IHC revealed significantly greater numbers of NCI in all brain regions especially the DG. Our data suggest: (1) significant densities of FUS-immunoreactive NCI in NIFID especially in the DG and CA1/2; (2) infrequent FUS-immunoreactive GI, NII, and DN; (3) widely distributed vacuolation across the cortex, and (4) significantly more NCI revealed by FUS than a-internexin IHC.

Congenital prosopagnosia in a child:neuropsychological assessment, eye movement recordings and training

Here we report the assessment and treatment of a 6-year-old boy (L.G.) who was referred to us for congenital prosopagnosia (CP). We investigated his performance using a test battery and eye movement recordings pre- and post-training. L.G. showed deficits in recognising relatives and learning new faces, and misrecognition of unfamiliar people. Eye movement recordings showed that L.G. focused on the lower part of stimuli in naming tasks based on familiar or unfamiliar incomplete or complete faces. The training focused on improving his ability to explore internal features of faces, to discriminate specific facial features of familiar and unfamiliar faces, and to provide his family with strategies to use in the future. At the end of the training programme L.G. no longer failed to recognise close and distant relatives and classmates and did not falsely recognise unknown people.

The impact of ageing and gender on visual mental imagery processes:a study of performance on tasks from the Complete Visual Mental Imagery Battery (CVMIB)

In this study we aim to evaluate the impact of ageing and gender on different visual mental imagery processes. Two hundred and fifty-one participants (130 women and 121 men; age range = 18–77 years) were given an extensive neuropsychological battery including tasks probing the generation, maintenance, inspection, and transformation of visual mental images (Complete Visual Mental Imagery Battery, CVMIB). Our results show that all mental imagery processes with the exception of the maintenance are affected by ageing, suggesting that other deficits, such as working memory deficits, could account for this effect. However, the analysis of the transformation process, investigated in terms of mental rotation and mental folding skills, shows a steeper decline in mental rotation, suggesting that age could affect rigid transformations of objects and spare non-rigid transformations. Our study also adds to previous ones in showing gender differences favoring men across the lifespan in the transformation process, and, interestingly, it shows a steeper decline in men than in women in inspecting mental images, which could partially account for the mixed results about the effect of ageing on this specific process. We also discuss the possibility to introduce the CVMIB in clinical assessment in the context of theoretical models of mental imagery.

Principal component analysis and assessment of language network activation patterns in pediatric epilepsy

This dissertation establishes a novel data-driven method to identify language network activation patterns in pediatric epilepsy through the use of the Principal Component Analysis (PCA) on functional magnetic resonance imaging (fMRI). A total of 122 subjects’ data sets from five different hospitals were included in the study through a web-based repository site designed here at FIU. Research was conducted to evaluate different classification and clustering techniques in identifying hidden activation patterns and their associations with meaningful clinical variables. The results were assessed through agreement analysis with the conventional methods of lateralization index (LI) and visual rating. What is unique in this approach is the new mechanism designed for projecting language network patterns in the PCA-based decisional space. Synthetic activation maps were randomly generated from real data sets to uniquely establish nonlinear decision functions (NDF) which are then used to classify any new fMRI activation map into typical or atypical. The best nonlinear classifier was obtained on a 4D space with a complexity (nonlinearity) degree of 7. Based on the significant association of language dominance and intensities with the top eigenvectors of the PCA decisional space, a new algorithm was deployed to delineate primary cluster members without intensity normalization. In this case, three distinct activations patterns (groups) were identified (averaged kappa with rating 0.65, with LI 0.76) and were characterized by the regions of: (1) the left inferior frontal Gyrus (IFG) and left superior temporal gyrus (STG), considered typical for the language task; (2) the IFG, left mesial frontal lobe, right cerebellum regions, representing a variant left dominant pattern by higher activation; and (3) the right homologues of the first pattern in Broca's and Wernicke's language areas. Interestingly, group 2 was found to reflect a different language compensation mechanism than reorganization. Its high intensity activation suggests a possible remote effect on the right hemisphere focus on traditionally left-lateralized functions. In retrospect, this data-driven method provides new insights into mechanisms for brain compensation/reorganization and neural plasticity in pediatric epilepsy.

Principal Component Analysis and Assessment of Language Network Activation Patterns in Pediatric Epilepsy

This dissertation establishes a novel data-driven method to identify language network activation patterns in pediatric epilepsy through the use of the Principal Component Analysis (PCA) on functional magnetic resonance imaging (fMRI). A total of 122 subjects’ data sets from five different hospitals were included in the study through a web-based repository site designed here at FIU. Research was conducted to evaluate different classification and clustering techniques in identifying hidden activation patterns and their associations with meaningful clinical variables. The results were assessed through agreement analysis with the conventional methods of lateralization index (LI) and visual rating. What is unique in this approach is the new mechanism designed for projecting language network patterns in the PCA-based decisional space. Synthetic activation maps were randomly generated from real data sets to uniquely establish nonlinear decision functions (NDF) which are then used to classify any new fMRI activation map into typical or atypical. The best nonlinear classifier was obtained on a 4D space with a complexity (nonlinearity) degree of 7. Based on the significant association of language dominance and intensities with the top eigenvectors of the PCA decisional space, a new algorithm was deployed to delineate primary cluster members without intensity normalization. In this case, three distinct activations patterns (groups) were identified (averaged kappa with rating 0.65, with LI 0.76) and were characterized by the regions of: 1) the left inferior frontal Gyrus (IFG) and left superior temporal gyrus (STG), considered typical for the language task; 2) the IFG, left mesial frontal lobe, right cerebellum regions, representing a variant left dominant pattern by higher activation; and 3) the right homologues of the first pattern in Broca's and Wernicke's language areas. Interestingly, group 2 was found to reflect a different language compensation mechanism than reorganization. Its high intensity activation suggests a possible remote effect on the right hemisphere focus on traditionally left-lateralized functions. In retrospect, this data-driven method provides new insights into mechanisms for brain compensation/reorganization and neural plasticity in pediatric epilepsy.