Patient based method of assessing adverse events in clinical trials in rheumatology: the revised Stanford Toxicity Index

We describe the progress towards developing a patient rated toxicity index that meets all of the patient-important attributes defined by the OMERACT Drug Safety Working Party, These attributes are frequency, severity. importance to patient, importance to the clinician, impact on economics, impact on activities, and integration of adverse effects with benefits. The Stanford Toxicity Index (STI) has been revised to collect all attributes with the exception of impact on activities. However, since the STI is a part of the Health Assessment Questionnaire (HAQ). impact on activities is collected by the HAQ. In particular, a new question asks patients to rate overall satisfaction, taking into consideration both benefits and adverse effects. The nest step in the development of this tool is to ensure that the STI meets the OMERACT filter of truth, discrimination, and feasibility. Although truth and feasibility have been confirmed by comparisons within the ARAMIS database, discrimination needs to be assessed in clinical trials.

Development of motor system dysfunction following whiplash injury

Dysfunction in the motor system is a feature of persistent whiplash associated disorders. Little is known about motor dysfunction in the early stages following injury and of its progress in those persons who recover and those who develop persistent symptoms. This study measured prospectively, motor system function (cervical range of movement (ROM), joint position error (JPE) and activity of the superficial neck flexors (EMG) during a test of cranio-cervical flexion) as well as a measure of fear of re-injury (TAMPA) in 66 whiplash subjects within 1 month of injury and then 2 and 3 months post injury. Subjects were classified at 3 months post injury using scores on the neck disability index: recovered (30). Motor system function was also measured in 20 control subjects. All whiplash groups demonstrated decreased ROM and increased EMG (compared to controls) at 1 month post injury. This deficit persisted in the group with moderate/severe symptoms but returned to within normal limits in those who had recovered or reported persistent mild pain at 3 months. Increased EMG persisted for 3 months in all whiplash groups. Only the moderate/severe group showed greater JPE, within 1 month of injury, which remained unchanged at 3 months. TAMPA scores of the moderate/severe group were higher than those of the other two groups. The differences in TAMPA did not impact on ROM, EMG or JPE. This study identifies, for the first time, deficits in the motor system, as early as 1 month post whiplash injury, that persisted not only in those reporting moderate/severe symptoms at 3 months but also in subjects who recovered and those with persistent mild symptoms. (C) 2002 International Association for the Study of Pain. Published by Elsevier Science B.V. All rights reserved.

Development of a quality use of medicines coding system to rate clinical pharmacists' medication review recommendations

Objective: To develop a 'quality use of medicines' coding system for the assessment of pharmacists' medication reviews and to apply it to an appropriate cohort. Method: A 'quality use of medicines' coding system was developed based on findings in the literature. These codes were then applied to 216 (111 intervention, 105 control) veterans' medication profiles by an independent clinical pharmacist who was supported by a clinical pharmacologist with the aim to assess the appropriateness of pharmacy interventions. The profiles were provided for veterans participating in a randomised, controlled trial in private hospitals evaluating the effect of medication review and discharge counselling. The reliability of the coding was tested by two independent clinical pharmacists in a random sample of 23 veterans from the study population. Main outcome measure: Interrater reliability was assessed by applying Cohen's kappa score on aggregated codes. Results: The coding system based on the literature consisted of 19 codes. The results from the three clinical pharmacists suggested that the original coding system had two major problems: (a) a lack of discrimination for certain recommendations e. g. adverse drug reactions, toxicity and mortality may be seen as variations in degree of a single effect and (b) certain codes e. g. essential therapy were in low prevalence. The interrater reliability for an aggregation of all codes into positive, negative and clinically non-significant codes ranged from 0.49-0.58 (good to fair). The interrater reliability increased to 0.72-0.79 (excellent) when all negative codes were excluded. Analysis of the sample of 216 profiles showed that the most prevalent recommendations from the clinical pharmacists were a positive impact in reducing adverse responses (31.9%), an improvement in good clinical pharmacy practice (25.5%) and a positive impact in reducing drug toxicity (11.1%). Most medications were assigned the clinically non-significant code (96.6%). In fact, the interventions led to a statistically significant difference in pharmacist recommendations in the categories; adverse response, toxicity and good clinical pharmacy practice measured by the quality use of medicine coding system. Conclusion: It was possible to use the quality use of medicine coding system to rate the quality and potential health impact of pharmacists' medication reviews, and the system did pick up differences between intervention and control patients. The interrater reliability for the summarised coding system was fair, but a larger sample of medication regimens is needed to assess the non-summarised quality use of medicines coding system.

Development of TNBS-induced colitis: animal model to test new pharmacological approaches

IBD is a gastro-intestinal disorder marked with chronic inflammation of intestinal epithelium, damaging mucosal tissue and manifests into several intestinal and extra-intestinal symptoms. Currently used medical therapy is able to induce and maintain the patient in remission, however no modifies or reverses the underlying pathogenic mechanism. The research of other medical approaches is crucial to the treatment of IBD and, for this, it´s important to use animal models to mimic the characteristics of disease in real life. The aim of the study is to develop an animal model of TNBS-induced colitis to test new pharmacological approaches. TNBS was instilled intracolonic single dose as described by Morris et al. It was administered 2,5% TNBS in 50% ethanol through a catheter carefully inserted into the colon. Mice were kept in a Tredelenburg position to avoid reflux. On day 4 and 7, the animals were sacrificed by cervical dislocation. The induction was confirmed based on clinical symptoms/signs, ALP determination and histopathological analysis. At day 4, TNBS group presented a decreased body weight and an alteration of intestinal motility characterized by diarrhea, severe edema of the anus and moderate morbidity, while in the two control groups weren’t identified any alteration on the clinical symptoms/signs with an increase of the body weight. TNBS group presented the highest concentrations of ALP comparing with control groups. The histopathology analysis revealed severe necrosis of the mucosa with widespread necrosis of the intestinal glands. Severe hemorrhagic and purulent exsudates were observed in the submucosa, muscular and serosa. TNBS group presented clinical symptoms/signs and histopathological features compatible with a correct induction of UC. The peak of manifestations became maximal at day 4 after induction. This study allows concluding that it’s possible to develop a TNBS induced colitis 4 days after instillation.

Desenvolvimento do método de Índice de Qualidade ("QIM-Quality Index Method") para as lapas (Patella candei e Patella aspera) e estudo das suas condições de transporte

Dissertação de Mestrado, Estudos Integrados dos Oceanos, 15 de Março de 2016, Universidade dos Açores.

Evaluation of maternal and neonatal hospital care: quality index of completeness

OBJECTIVE Develop an index to evaluate the maternal and neonatal hospital care of the Brazilian Unified Health System.METHODS This descriptive cross-sectional study of national scope was based on the structure-process-outcome framework proposed by Donabedian and on comprehensive health care. Data from the Hospital Information System and the National Registry of Health Establishments were used. The maternal and neonatal network of Brazilian Unified Health System consisted of 3,400 hospitals that performed at least 12 deliveries in 2009 or whose number of deliveries represented 10.0% or more of the total admissions in 2009. Relevance and reliability were defined as criteria for the selection of variables. Simple and composite indicators and the index of completeness were constructed and evaluated, and the distribution of maternal and neonatal hospital care was assessed in different regions of the country.RESULTS A total of 40 variables were selected, from which 27 single indicators, five composite indicators, and the index of completeness of care were built. Composite indicators were constructed by grouping simple indicators and included the following variables: hospital size, level of complexity, delivery care practice, recommended hospital practice, and epidemiological practice. The index of completeness of care grouped the five variables and classified them in ascending order, thereby yielding five levels of completeness of maternal and neonatal hospital care: very low, low, intermediate, high, and very high. The hospital network was predominantly of small size and low complexity, with inadequate child delivery care and poor development of recommended and epidemiological practices. The index showed that more than 80.0% hospitals had a low index of completeness of care and that most qualified heath care services were concentrated in the more developed regions of the country.CONCLUSIONS The index of completeness proved to be of great value for monitoring the maternal and neonatal hospital care of Brazilian Unified Health System and indicated that the quality of health care was unsatisfactory. However, its application does not replace specific evaluations.

Effect of the exposure to maternal smoking during pregnancy and childhood on the body mass index until adolescence

OBJECTIVE Investigate the effect of exposure to smoking during pregnancy and early childhood on changes in the body mass index (BMI) from birth to adolescence.METHODS A population-based cohort of children (0-5 years old) from Cuiabá, Midwest Brazil, was assessed in 1999-2000 (n = 2,405). Between 2009 and 2011, the cohort was re-evaluated. Information about birth weight was obtained from medical records, and exposure to smoking during pregnancy and childhood was assessed at the first interview. Linear mixed effects models were used to estimate the association between exposure to maternal smoking during pregnancy and preschool age, and the body mass index of children at birth, childhood and adolescence.RESULTS Only 11.3% of the mothers reported smoking during pregnancy, but most of them (78.2%) also smoked during early childhood. Among mothers who smoked only during pregnancy (n = 59), 97.7% had smoked only in the first trimester. The changes in body mass index at birth and in childhood were similar for children exposed and those not exposed to maternal smoking. However, from childhood to adolescence the rate of change in the body mass index was higher among those exposed only during pregnancy than among those who were not exposed.CONCLUSIONS Exposure to smoking only during pregnancy, especially in the first trimester, seems to affect changes in the body mass index until adolescence, supporting guidelines that recommend women of childbearing age to stop smoking.

Content validity and reliability of test of gross motor development in Chilean children

ABSTRACT OBJECTIVE To validate a Spanish version of the Test of Gross Motor Development (TGMD-2) for the Chilean population. METHODS Descriptive, transversal, non-experimental validity and reliability study. Four translators, three experts and 92 Chilean children, from five to 10 years, students from a primary school in Santiago, Chile, have participated. The Committee of Experts has carried out translation, back-translation and revision processes to determine the translinguistic equivalence and content validity of the test, using the content validity index in 2013. In addition, a pilot implementation was achieved to determine test reliability in Spanish, by using the intraclass correlation coefficient and Bland-Altman method. We evaluated whether the results presented significant differences by replacing the bat with a racket, using T-test. RESULTS We obtained a content validity index higher than 0.80 for language clarity and relevance of the TGMD-2 for children. There were significant differences in the object control subtest when comparing the results with bat and racket. The intraclass correlation coefficient for reliability inter-rater, intra-rater and test-retest reliability was greater than 0.80 in all cases. CONCLUSIONS The TGMD-2 has appropriate content validity to be applied in the Chilean population. The reliability of this test is within the appropriate parameters and its use could be recommended in this population after the establishment of normative data, setting a further precedent for the validation in other Latin American countries.

Design state exploration applied to the development of a remote lab for projectile launch experiments

This paper describes the application of Design State Exploration techniques in the development of a remote lab for projectile motion experiments. The application was enabled by the existence of two independent teams: one composed of a series of internships that started first and another with two grantees that started a few months later. The paper presents evidence on how this approach provided gains in the development process conducted by the second team that benefited from design state exploration studies performed by the first team. This particular aspect is highlighted in relation to the work already presented in the 10th Remote Engineering and Virtual Instrumentation (REV) conference.

Development and validation of a risk model for prediction of hazardous alcohol consumption in general practice attendees : the PredictAL study

Background: Little is known about the risk of progression to hazardous alcohol use in people currently drinking at safe limits. We aimed to develop a prediction model (predictAL) for the development of hazardous drinking in safe drinkers. Methods: A prospective cohort study of adult general practice attendees in six European countries and Chile followed up over 6 months. We recruited 10,045 attendees between April 2003 to February 2005. 6193 European and 2462 Chilean attendees recorded AUDIT scores below 8 in men and 5 in women at recruitment and were used in modelling risk. 38 risk factors were measured to construct a risk model for the development of hazardous drinking using stepwise logistic regression. The model was corrected for over fitting and tested in an external population. The main outcome was hazardous drinking defined by an AUDIT score >= 8 in men and >= 5 in women. Results: 69.0% of attendees were recruited, of whom 89.5% participated again after six months. The risk factors in the final predictAL model were sex, age, country, baseline AUDIT score, panic syndrome and lifetime alcohol problem. The predictAL model's average c-index across all six European countries was 0.839 (95% CI 0.805, 0.873). The Hedge's g effect size for the difference in log odds of predicted probability between safe drinkers in Europe who subsequently developed hazardous alcohol use and those who did not was 1.38 (95% CI 1.25, 1.51). External validation of the algorithm in Chilean safe drinkers resulted in a c-index of 0.781 (95% CI 0.717, 0.846) and Hedge's g of 0.68 (95% CI 0.57, 0.78). Conclusions: The predictAL risk model for development of hazardous consumption in safe drinkers compares favourably with risk algorithms for disorders in other medical settings and can be a useful first step in prevention of alcohol misuse.

Software development for estimation of optical clearing agent’s diffusion coefficients in biological tissues

The study of chemical diffusion in biological tissues is a research field of high importance and with application in many clinical, research and industrial areas. The evaluation of diffusion and viscosity properties of chemicals in tissues is necessary to characterize treatments or inclusion of preservatives in tissues or organs for low temperature conservation. Recently, we have demonstrated experimentally that the diffusion properties and dynamic viscosity of sugars and alcohols can be evaluated from optical measurements. Our studies were performed in skeletal muscle, but our results have revealed that the same methodology can be used with other tissues and different chemicals. Considering the significant number of studies that can be made with this method, it becomes necessary to turn data processing and calculation easier. With this objective, we have developed a software application that integrates all processing and calculations, turning the researcher work easier and faster. Using the same experimental data that previously was used to estimate the diffusion and viscosity of glucose in skeletal muscle, we have repeated the calculations with the new application. Comparing between the results obtained with the new application and with previous independent routines we have demonstrated great similarity and consequently validated the application. This new tool is now available to be used in similar research to obtain the diffusion properties of other chemicals in different tissues or organs.

DISCORDANCE BETWEEN BODY MASS INDEX AND ANTHROPOMETRIC MEASUREMENTS AMONG HIV-1-INFECTED PATIENTS ON ANTIRETROVIRAL THERAPY AND WITH LIPOATROPHY/LIPOHYPERTROPHY SYNDROME

Introduction: Highly Active Antiretroviral Therapy (HAART) has improved and extended the lives of thousands of people living with HIV/AIDS around the world. However, this treatment can lead to the development of adverse reactions such as lipoatrophy/lipohypertrophy syndrome (LLS) and its associated risks. Objective: This study was designed to assess the prevalence of self-reported lipodystrophy and nutritional status by anthropometric measurements in patients with HIV/AIDS. Methods: An observational study of 227 adult patients in the Secondary Immunodeficiencies Outpatient Department of Dermatology, Hospital das Clínicas, Faculty of Medicine, University of São Paulo (3002 ADEE-HCFMUSP). The sample was divided into three groups; Group 1 = 92 patients on HAART and with self-reported lipodystrophy, Group 2 = 70 patients on HAART without self-reported lipodystrophy and Group 3 = 65 patients not taking HAART. The nutritional status of individuals in the study sample was determined by body mass index (BMI) and percentage of body fat (% BF). The cardiovascular risk and diseases associated with abdominal obesity were determined by waist/hip ratio (WHR) and waist circumference (WC). Results: The prevalence of self-reported lipoatrophy/lipohypertrophy syndrome was 33% among women and 59% among men. Anthropometry showed depletion of fat mass in the evaluation of the triceps (TSF) in the treatment groups with HAART and was statistically independent of gender; for men p = 0.001, and for women p = 0.007. Similar results were found in the measurement of skin folds of the upper and lower body (p = 0.001 and p = 0.003 respectively). In assessing the nutritional status of groups by BMI and % BF, excess weight and body fat were more prevalent among women compared to men (p = 0.726). The WHR and WC revealed risks for cardiovascular and other diseases associated with abdominal obesity for women on HAART and with self-reported LLS (p = 0.005) and (p = 0.011). Conclusions: Anthropometric measurements were useful in the confirmation of the prevalence of LLS. BMI alone does not appear to be a good parameter for assessing the nutritional status of HIV-infected patients on HAART and with LLS. Other anthropometric measurements are needed to evaluate patients with the lipoatrophy/lipohypertrophy syndrome.

Development of new oxygen therapeutics using fluorinated ionic liquids

Dissertação apresentada na Faculdade de Ciências e Tecnologia da Universidade Nova de Lisboa para obtenção do grau Mestre em Engenharia Biomédica

Recent droughts and the impact of North Atlantic Oscillation in Iberia; a spatiotemporal analysis based on vegetation temperature condition Index (VTCI)

Dissertation submitted in partial fulfillment of the requirements for the Degree of Master of Science in Geospatial Technologies.

Groundwater quality, vulnerability and potential assessment in Kobo Valley development project, Ethiopia

This study deals with investigating the groundwater quality for irrigation purpose, the vulnerability of the aquifer system to pollution and also the aquifer potential for sustainable water resources development in Kobo Valley development project. The groundwater quality is evaluated up on predicting the best possible distribution of hydrogeochemicals using geostatistical method and comparing them with the water quality guidelines given for the purpose of irrigation. The hydro geochemical parameters considered are SAR, EC, TDS, Cl-, Na+, Ca++, SO4 2- and HCO3 -. The spatial variability map reveals that these parameters falls under safe, moderate and severe or increasing problems. In order to present it clearly, the aggregated Water Quality Index (WQI) map is constructed using Weighted Arithmetic Mean method. It is found that Kobo-Gerbi sub basin is suffered from bad water quality for the irrigation purpose. Waja Golesha sub-basin has moderate and Hormat Golena is the better sub basin in terms of water quality. The groundwater vulnerability assessment of the study area is made using the GOD rating system. It is found that the whole area is experiencing moderate to high risk of vulnerability and it is a good warning for proper management of the resource. The high risks of vulnerability are noticed in Hormat Golena and Waja Golesha sub basins. The aquifer potential of the study area is obtained using weighted overlay analysis and 73.3% of the total area is a good site for future water well development. The rest 26.7% of the area is not considered as a good site for spotting groundwater wells. Most of this area fall under Kobo-Gerbi sub basin.