Expressing medicine side effects: assessing the effectiveness of absolute risk, relative risk, and number needed to harm, and the provision of baseline risk information

Objective: To assess the effectiveness of absolute risk, relative risk, and number needed to harm formats for medicine side effects, with and without the provision of baseline risk information. Methods: A two factor, risk increase format (relative, absolute and NNH) x baseline (present/absent) between participants design was used. A sample of 268 women was given a scenario about increase in side effect risk with third generation oral contraceptives, and were required to answer written questions to assess their understanding, satisfaction, and likelihood of continuing to take the drug. Results: Provision of baseline information significantly improved risk estimates and increased satisfaction, although the estimates were still considerably higher than the actual risk. No differences between presentation formats were observed when baseline information was presented. Without baseline information, absolute risk led to the most accurate performance. Conclusion: The findings support the importance of informing people about baseline level of risk when describing risk increases. In contrast, they offer no support for using number needed to harm. Practice implications: Health professionals should provide baseline risk information when presenting information about risk increases or decreases. More research is needed before numbers needed to harm (or treat) should be given to members of the general populations. (c) 2005 Elsevier Ireland Ltd. All rights reserved.

Incorporating IT & AT Convergence into Lean Thinking/Six Sigma via the Smarter Operation Transformation (SOT) Methodology

The growing demands for industrial products are imposing an increasingly intense level of competitiveness on the industrial operations. In the meantime, the convergence of information technology (IT) and automation technology (AT) is showing itself to be a tool of great potential for the modernization and improvement of industrial plants. However, for this technology fully to achieve its potential, several obstacles need to be overcome, including the demonstration of the reasoning behind estimations of benefits, investments and risks used to plan the implementation of corporative technology solutions. This article focuses on the evolutionary development of planning and adopting processes of IT & AT convergence. It proposes the incorporation of IT & AT convergence practices into Lean Thinking/Six Sigma, via the method used for planning the convergence of technological activities, known as the Smarter Operation Transformation (SOT) methodology. This article illustrates the SOT methodology through its application in a Brazilian company in the sector of consumer goods. In this application, it is shown that with IT & AT convergence is possible with low investment, in order to reduce the risk of not achieving the goals of key indicators.

Credit risk of financial institutions

A Work Project, presented as part of the requirements for the Award of a Masters Degree in Finance from the NOVA – School of Business and Economics

Genetic variants influencing circulating lipid levels and risk of coronary artery disease.

OBJECTIVE: Genetic studies might provide new insights into the biological mechanisms underlying lipid metabolism and risk of CAD. We therefore conducted a genome-wide association study to identify novel genetic determinants of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides. METHODS AND RESULTS: We combined genome-wide association data from 8 studies, comprising up to 17 723 participants with information on circulating lipid concentrations. We did independent replication studies in up to 37 774 participants from 8 populations and also in a population of Indian Asian descent. We also assessed the association between single-nucleotide polymorphisms (SNPs) at lipid loci and risk of CAD in up to 9 633 cases and 38 684 controls. We identified 4 novel genetic loci that showed reproducible associations with lipids (probability values, 1.6×10(-8) to 3.1×10(-10)). These include a potentially functional SNP in the SLC39A8 gene for HDL-C, an SNP near the MYLIP/GMPR and PPP1R3B genes for LDL-C, and at the AFF1 gene for triglycerides. SNPs showing strong statistical association with 1 or more lipid traits at the CELSR2, APOB, APOE-C1-C4-C2 cluster, LPL, ZNF259-APOA5-A4-C3-A1 cluster and TRIB1 loci were also associated with CAD risk (probability values, 1.1×10(-3) to 1.2×10(-9)). CONCLUSIONS: We have identified 4 novel loci associated with circulating lipids. We also show that in addition to those that are largely associated with LDL-C, genetic loci mainly associated with circulating triglycerides and HDL-C are also associated with risk of CAD. These findings potentially provide new insights into the biological mechanisms underlying lipid metabolism and CAD risk.

Should I stay or should I go – Factors associated with hospitalization risk among older persons in Sweden

An increasingly older population will most likely lead to greater demands on the health care system, as older age is associated with an increased risk of having acute and chronic conditions. The number of diseases or disabilities is not the only marker of the amount of health care utilized, as persons may seek hospitalization without a disease and/or illness that requires hospital healthcare. Hospitalization may pose a severe risk to older persons, as exposure to the hospital environment may lead to increased risks of iatrogenic disorders, confusion, falls and nosocomial infections, i.e., disorders that may involve unnecessary suffering and lead to serious consequences. Aims: The overall aim of this thesis was to describe and explore individual trajectories of cognitive development in relation to hospitalization and risk factors for hospitalization among older persons living in different accommodations in Sweden and to explore older persons' reasons for being transferred to a hospital. Methods: The study designs were longitudinal, prospective and descriptive, and both quantitative and qualitative methods were used. Specifically, latent growth curve modelling was used to assess the association of cognitive development with hospitalization. The Cox proportional hazards regression model was used to analyse factors associated with hospitalization risk overtime. In addition, an explorative descriptive design was used to explore how home health care patients experienced and perceived their decision to seek hospital care. Results: The most common reasons for hospitalization were cardiovascular diseases, which caused more than one-quarter of first hospitalizations among the persons living in ordinary housing and nursing home residents (NHRs). The persons who had been hospitalized had a lower mean level of cognitive performance in general cognition, verbal, spatial/fluid, memory and processing speed abilities compared to those who had not been hospitalized. Significantly steeper declines in general cognition, spatial/fluid and processing speed abilities were observed among the persons who had been hospitalized. Cox proportional hazards regression analysis showed that the number of diseases, number of drugs used, having experienced a fall and being assessed as malnourished according to the Mini Nutritional Assessment scale were related to an increased hospitalization risk among the NHRs. Among the older persons living in ordinary housing, the risk factors for hospitalization were related to marital status, i.e., unmarried persons and widows/widowers had a decreased hospitalization risk. In addition, among social factors, receipt of support from relatives was related to an increased hospitalization risk, while receipt of support from friends was related to a decreased risk. The number of illnesses was not associated with the hospitalization risk for older persons in any age group or for those of either sex, when controlling for other variables. The older persons who received home health care described different reasons for their decisions to seek hospital care. The underlying theme of the home health care patients’ perceptions of their transfer to a hospital involved trust in hospitals. This trust was shared by the home health care patients, their relatives and the home health care staff, according to the patients. Conclusions: This thesis revealed that middle-aged and older persons who had been hospitalized exhibited a steeper decline in cognition. Specifically, spatial/fluid, processing speed, and general cognitive abilities were affected. The steeper decline in cognition among those who had been hospitalized remained even after controlling for comorbidities. The most common causes of hospitalization among the older persons living in ordinary housing and in nursing homes were cardiovascular diseases, tumours and falls. Not only health-related factors, such as the number of diseases, number of drugs used, and being assessed as malnourished, but also social factors and marital status were related to the hospitalization risk among the older persons living in ordinary housing and in nursing homes. Some risk factors associated with hospitalization differed not only between the men and women but also among the different age groups. The information provided in this thesis could be applied in care settings by professionals who interact with older persons before they decide to seek hospital care. To meet the needs of an older population, health care systems need to offer the proper health care at the most appropriate level, and they need to increase integration and coordination among health care delivered by different care services.

Clinical results after coronary stenting with the Genous (TM) Bio-engineered R stent (TM): 12-month outcomes of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry

Aims: e-HEALING is a worldwide, internet-based registry designed to capture post marketing clinical data on the use of the Genous (TM) EPC capturing R stent (TM). Rapid restoration of a healthy endothelial layer after stent placement by capturing circulating endothelial progenitor cells may reduce both stent thrombosis (ST) and in-stent-restenosis. Methods and results: We planned a 5,000 patient registry with >= 1 lesion suitable for stenting. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularisation. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularisation (TLR), and individual outcomes including ST. A total of 4,939 patients received >= 1 Genous stent between 2005 and 2007. Baseline characteristics showed a median age of 63 years, 79% males, 25% diabetics, and 37% with prior MI. A total of 49% of lesions treated were ACC/AHA type B2 or C; 1.1 stents per lesion were used. At 12 months, TVF occurred in 8.4% and the composite of cardiac death, MI or TLR in 7.9%. Twelve-month TLR and ST were 5.7% and 1.1%, respectively. Conclusions: Coronary stenting with the Genous results in good clinical outcomes, and low incidences of repeat revascularisation and ST.

Controlo do programa de manutenção dos motociclos Harley-Davidson em Portugal

No actual ambiente competitivo, o baixo custo, a alta qualidade e um grau crescente de personalização são exigências para a sobrevivência das empresas que têm influenciado as acções dos profissionais de manutenção com vista ao aperfeiçoamento das políticas de manutenção. Como resultado, surgiu na área de manutenção industrial uma grande quantidade de métodos, softwares, modelos e ferramentas de gestão, onde se destaca o RCM (Reliability Centered Maintenance ou Manutenção Centrada na Fiabilidade) de origem Norte Americana na década de 60. Inicialmente começou-se a utilizar este método na indústria de aviação passando posteriormente a ser utilizada também pelo Exército dos E.U.A. e a partir da década de 80 por outras indústrias comerciais. Após a explicação da metodologia RCM e tendo como base o modelo da moto Softail, começou-se por definir o sistema através da preparação para a análise, selecção do equipamento a ser analisado e identificação das funções. Após definição do sistema passa-se à sua análise. Neste caso optou-se pela análise FMEA onde se identificam as falhas funcionais, os efeitos e causas dessas mesmas falhas, conhecendo-se o histórico de avarias do modelo Softail durante o período de garantia, desde 1999 até ao presente ano. Do histórico de avarias durante o período de garantia, e após estudo do mesmo, conclui-se que 28,35% das avarias são cosméticas, relativas a problemas de cromados (danos ou qualidade dos cromados) avarias essas que não influenciam o desempenho do motociclo; 9,58% de problemas relativos a baterias, problemas esses que poderão influenciar o normal funcionamento do motociclo e que se deverá ter mais atenção; 7,66% dos motociclos tiveram problemas de entrada de água para o interior do velocímetro, uma vez mais este problema não interfere com o bom desempenho do motociclo; 4,6% relativos a danos na pintura, uma vez mais problema cosmético que não interfere com o bom desempenho do motociclo; segue-se 4,21% devido a barulhos na frente do motociclo e que deverá requerer alguma atenção; 4,21% de mau funcionamento da instrumentação eléctrica, onde se deverá ter também atenção. No estudo da FMEA conclui-se que o principal efeito/consequência gerado pela falha da bateria (falha com maior frequência) é o não funcionamento do motor por falta de alimentação do sistema de gestão electrónica do motociclo e consequente imobilização do mesmo. Com base na FMEA realizada foram salientados os aspectos, em termos de modos de falha, que são mais importantes, com base nas reclamações em prazo de garantia, tais como questões estéticas dos cromados e pinturas e problemas relacionados com o funcionamento da bateria, entre outros. Na FMEA podem ser vistos em termos criticidade todos os modos de falha, através do RPN (Risk Priority Number), ou em português Número de Prioridade de Risco, mostrando assim onde a marca pode aplicar prioridades em termos de acções de projecto ou manutenção. Com estas alterações pretende-se aumentar a fiabilidade do modelo Softail, podendo no futuro alargar este novo plano de manutenção às restantes famílias da gama Harley-Davidson.

Entomological aspects of Chagas' disease transmission in the domestic habitat, Argentina

OBJECTIVE: To study the risk of Trypanosoma cruzi domestic transmission using an entomological index and to explore its relationship with household's characteristics and cultural aspects. METHODS: There were studied 158 households in an endemic area in Argentina. Each household was classified according to an entomological risk indicator (number of risky bites/human). A questionnaire was administered to evaluate risk factors among householders. RESULTS: Infested households showed a wide range of risk values (0 to 5 risky bites/human) with skewed distribution, a high frequency of lower values and few very high risk households. Of all collected Triatoma infestans, 44% had had human blood meals whereas 27% had had dogs or chickens blood meals. Having dogs and birds sharing room with humans increased the risk values. Tidy clean households had contributed significantly to lower risk values as a result of low vector density. The infested households showed a 24.3% correlation between time after insecticide application and the number of vectors. But there was no correlation between the time after insecticide application and T. infestans' infectivity. The statistical analysis showed a high correlation between current values of the entomological risk indicator and Trypanosoma cruzi seroprevalence in children. CONCLUSIONS: The risk of T. cruzi domestic transmission assessed using an entomological index show a correlation with children seroprevalence for Chagas' disease and householders' habits.

Implementação da análise dos modos de falha e seus efeitos no processo de fabricação de peças em material compósito

Dissertação para obtenção do Grau de Mestre em Engenharia e Gestão Industrial

Impact of adjunct cytogenetic abnormalities for prognostic stratification in patients with myelodysplastic syndrome and deletion 5q.

This cooperative study assessed prognostic factors for overall survival (OS) and risk of transformation to acute myeloid leukemia (AML) in 541 patients with de novo myelodysplastic syndrome (MDS) and deletion 5q. Additional chromosomal abnormalities were strongly related to different patients' characteristics. In multivariate analysis, the most important predictors of both OS and AML transformation risk were number of chromosomal abnormalities (P<0.001 for both outcomes), platelet count (P<0.001 and P=0.001, respectively) and proportion of bone marrow blasts (P<0.001 and P=0.016, respectively). The number of chromosomal abnormalities defined three risk categories for AML transformation (del(5q), del(5q)+1 and del(5q)+ ≥ 2 abnormalities) and two for OS (one group: del(5q) and del(5q)+1; and del(5q)+ ≥ 2 abnormalities, as the other one); with a median survival time of 58.0 and 6.8 months, respectively. Platelet count (P=0.001) and age (P=0.034) predicted OS in patients with '5q-syndrome'. This study demonstrates the importance of additional chromosomal abnormalities in MDS patients with deletion 5q, challenges the current '5q-syndrome' definition and constitutes a useful reference series to properly analyze the results of clinical trials in these patients.

The ADVANCE trial: clarifying the role of perindopril/indapamide fixed-dose combination in the reduction of cardiovascular and renal events in patients with diabetes mellitus.

Patients with type 2 diabetes mellitus exhibit a marked increase in cardiovascular and renal risk. A number of interventional trials have shown that these patients benefit greatly from aggressive BP lowering, especially when the drug regimen comprises an inhibitor of the renin-angiotensin system. The results of the placebo-controlled ADVANCE (Action in Diabetes and Vascular disease: PreterAx and DiamicroN MR Controlled Evaluation) trial, conducted in patients with type 2 diabetes, are exemplary in this respect. The systematic use of a fixed-dose combination containing the ACE inhibitor perindopril and the diuretic indapamide afforded substantial protection against cardiovascular mortality and myocardial infarction, while providing important renoprotection, reducing the development of micro- and macroalbuminuria, and allowing regression of nephropathy. The beneficial effects were obtained regardless of baseline BP and whether or not the patients were receiving antihypertensive therapy.

Lower limb lymphedema and neurological complications after lymphadenectomy for gynecological cancer.

OBJECTIVE: Lymphadenectomy is a frequent procedure for surgical staging of gynecological malignancies. Nevertheless, minor complications, such as lower limb lymphedema (LLL) and neurological complications (NCs), after pelvic and aorto-caval lymphadenectomy still remain underinvestigated. The present study considers short-term and long-term incidence and risk factors for LLL and NC in patients with gynecological cancer who underwent lymphadenectomy. MATERIALS AND METHODS: In 2 different institutions, University of Turin and University of Lausanne, a total of 152 patients who received lymphadenectomy for endometrial, cervical, or ovarian cancer were retrospectively identified. During the follow-up, data about LLL and NC were collected by means of a questionnaire. Short-term and long-term incidence of LLL and NC was evaluated, and risk factors, such as age, body mass index, type of cancer, surgical approach, number and extension of the removed lymph nodes, presence of lymph node metastasis, and adjuvant treatments, were analyzed. RESULTS: Short-term incidence of LLL and NC after lymphadenectomy was high (36%) and predictive of long-term persistence. Between the analyzed risk factors, number of removed lymph nodes and adjuvant radiotherapy were significantly associated with an increased incidence of minor complications (P < 0.05). CONCLUSIONS: Lower limb lymphedema and NC are more frequent than expected. They are related to the radicality of lymphadenectomy and adjuvant radiotherapy. They affect the quality of life of the patients treated for gynecological cancer and their perceptions of healing. Minor complications are commonly persistent and need a prompt diagnosis and a specialized management to improve their prognosis.

Failure Mode and Effect Analysis (FMEA) for confectionery manufacturing in developing countries: Turkish delight production as a case study

The Failure Mode and Effect Analysis (FMEA) was applied for risk assessment of confectionary manufacturing, in whichthe traditional methods and equipment were intensively used in the production. Potential failure modes and effects as well as their possible causes were identified in the process flow. Processing stages that involve intensive handling of food by workers had the highest risk priority numbers (RPN = 216 and 189), followed by chemical contamination risks in different stages of the process. The application of corrective actions substantially reduced the RPN (risk priority number) values. Therefore, the implementation of FMEA (The Failure Mode and Effect Analysis) model in confectionary manufacturing improved the safety and quality of the final products.

Identificación de barreras administrativas de acceso en el servicio de gineco-obstetricia en cuatro instituciones prestadoras de servicios de salud en Bogotá

El estudio realizado se basó en la aplicación de la metodología de investigación científica y el análisis exploratorio, cuantitativo de tipo descriptivo de corte transversal, utilizando análisis de relaciones de datos obtenidos en cada una de las IPS y relaciones de perfiles entre de la población atendida. El análisis de la información mostró que las barreras administrativas de acceso a los servicios de Gineco-Obstetricia existen en las IPS estudiadas, caracterizando fundamentalmente aspectos relacionados con la falta de registro de información en las historias clínicas de los pacientes, la falta de registro de la no asistencia de un paciente a una cita, la inexistencia de acciones registradas frente a la identificación e inscripción de la población objeto de control prenatal con clasificación del riesgo, el régimen de afiliación, la ocupación, las acciones correctivas por fallas en los servicios de salud, el registro de fallas en los servicios de salud y el nivel educativo. Es valiosa la información que es registrada en las historias clínicas, sin embargo las IPS que participaron en el presente estudio no le dan la importancia necesaria a las evidencias obtenidas, en especial frente a acciones correctivas. Las relaciones entre las variables como el número de embarazos, el número de controles prenatales, el número de abortos, las IPS, los perfiles de la población de pacientes, la falta de registro de la no asistencia de un paciente a una cita, la clasificación del riesgo, el número de partos, el estado civil, los grupos de edad, el nivel educativo, el registro de fallas, el registro de las acciones correctivas y la ocupación, permiten identificar barreras de acceso administrativas. Se realizó una entrevista a los líderes de los procesos de calidad o directores generales de las IPS que participaron en el presente estudio y se encontró que los parámetros de calidad son claros y que la información existe en diferentes proporciones y protocolos institucionales. No obstante, las IPS no aplican en su totalidad el modelo de los canones establecidos. Es necesario que las instituciones apliquen las normas de calidad en su totalidad lo que seguramente las llevará a lograr mejores resultados.

análise experimental do efeito da diversificação em carteiras de ações: a relação entre risco e quantidade de ativos sob a ótica da estratégia ingênua

The objective is to analyze the relationship between risk and number of stocks of a portfolio for an individual investor when stocks are chosen by "naive strategy". For this, we carried out an experiment in which individuals select actions to reproduce this relationship. 126 participants were informed that the risk of first choice would be an asset average of all standard deviations of the portfolios consist of a single asset, and the same procedure should be used for portfolios composed of two, three and so on, up to 30 actions . They selected the assets they want in their portfolios without the support of a financial analysis. For comparison we also tested a hypothetical simulation of 126 investors who selected shares the same universe, through a random number generator. Thus, each real participant is compensated for random hypothetical investor facing the same opportunity. Patterns were observed in the portfolios of individual participants, characterizing the curves for the components of the samples. Because these groupings are somewhat arbitrary, it was used a more objective measure of behavior: a simple linear regression for each participant, in order to predict the variance of the portfolio depending on the number of assets. In addition, we conducted a pooled regression on all observations by analyzing cross-section. The result of pattern occurs on average but not for most individuals, many of which effectively "de-diversify" when adding seemingly random bonds. Furthermore, the results are slightly worse using a random number generator. This finding challenges the belief that only a small number of titles is necessary for diversification and shows that there is only applicable to a large sample. The implications are important since many individual investors holding few stocks in their portfolios