The impact of national and international observers in democratic elections: A randomized control trial from the Mozambican elections of 2009

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

Fair value measurement: Is the debate around level II and level III assets and liabilities relevant

Double Degree. 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 and a Masters Degree in Business Engineering from Louvain school of Management

The effect of Lactobacillus casei and Bifidobacterium breve on antibiotic-associated diarrhea treatment: randomized double-blind clinical trial

INTRODUCTION: Antibiotic-associated diarrhea (AAD) is an important side effect of this specific class of drugs. The objective of this study was to investigate the effect of the use of probiotics in the treatment of AAD. METHODS: A group of hospitalized patients, who contracted diarrhea during or after 7 days of suspension of antimicrobial medication, was blindly randomized to receive a standardized diet associated with the use of the probiotics (Lactobacillus casei and Bifidobacterium breve) or its corresponding placebo, three times a day. RESULTS: Seventy patients were studied. For the experimental (n=35) and control (n=35) groups, respectively, the average time of treatment was 5.06±2.18 and 5.49±3.17 days (p=0.95), and the average duration of diarrhea, among those who were healed, was 4.87±2.13 and 4.52±2.55 days (p=0.36). Four (11.4%) patients who received probiotics and ten (28.6%) who received the placebo were not cured (p=0.13), and relapse rates were similar between both groups. Seven patients from each group, in addition to diarrhea, presented cases of bloating and/or abdominal cramps and/or vomiting (p=1.00). CONCLUSIONS: In this light, it is concluded that L. casei associated with B. breve, in the administered dosage and frequency, has no effect on the antibiotic-associated diarrhea. Similar studies need to be conducted with higher doses of these or other probiotics.

Artesunate + amodiaquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in the Colombian Pacific region: a noninferiority trial

INTRODUCTION: In Colombia, there are no published studies for the treatment of uncomplicated Plasmodium falciparum malaria comparing artemisinin combination therapies. Hence, it is intended to demonstrate the non-inferior efficacy/safety profiles of artesunate + amodiaquine versus artemether-lumefantrine treatments. METHODS: A randomized, controlled, open-label, noninferiority (Δ≤5%) clinical trial was performed in adults with uncomplicated P. falciparum malaria using the 28‑day World Health Organization validated design/definitions. Patients were randomized 1:1 to either oral artesunate + amodiaquine or artemether-lumefantrine. The primary efficacy endpoint: adequate clinical and parasitological response; secondary endpoints: - treatment failures defined per the World Health Organization. Safety: assessed through adverse events. RESULTS: A total of 105 patients was included in each group: zero censored observations. Mean (95%CI - Confidence interval) adequate clinical and parasitological response rates: 100% for artesunate + amodiaquine and 99% for artemether-lumefantrine; the noninferiority criteria was met (Δ=1.7%). There was one late parasitological therapeutic failure (1%; artemether-lumefantrine group), typified by polymerase chain reaction as the MAD20 MSP1 allele. The fever clearance time (artesunate + amodiaquine group) was significantly shorter (p=0.002). Respectively, abdominal pain for artesunate + amodiaquine and artemether-lumefantrine was 1.9% and 3.8% at baseline (p=0.68) and 1% and 13.3% after treatment (p<0.001). CONCLUSIONS: Uncomplicated P. falciparum malaria treatment with artesunate + amodiaquine is noninferior to the artemether-lumefantrine standard treatment. The efficacy/safety profiles grant further studies in this and similar populations.

Semantics bias in cross-national comparative analyses : Is it good or bad to have "fair" health?

The Health Behavior in School-aged Children is a cross-national study collecting data on social and health indicators on adolescents in 43 countries. The study provides comparable data on health behaviors and health outcomes through the use of a common protocol, which have been a back bone of the study sine its initiation in 1983. Recent years, researchers within the study have noticed a questionable comparability on the widely used item on self-rated health. One of the four response categories to the item "Would you say your health is….?" showed particular variation, as the response category "Fair" varied from 20 % in Latvia and Moldova to 3-4 % in Bulgaria and Macedonia. A qualitative mini-survey of the back-translations showed that the response category "Fair" had a negative slant in 25 countries, a positive slant in 10 countries and was considered neutral in 9 countries. This finding indicates that there are what may be called semantic issues affecting comparability in international studies, since the same original word (in an English original) is interpreted differently across countries and cultures. The paper test and discuss a few possible explanations to this, however, only leaving to future studies to hold a cautious approach to international comparisons if working with the self-rated health item with four response categories.

Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil

Introduction Parenteral antimony-based compounds are still the standard of care for cutaneous leishmaniasis (CL) treatment in many countries, despite their high toxicity. Previous studies showed that oral azithromycin could be an option for CL treatment. The aim of this study was to evaluate efficacy and safety of oral azithromycin (AZ) for CL treatment compared with injectable meglumine antimoniate (MA). Methods This was a randomized, open-label, 2-arm, non-inferiority clinical trial. Treatment-naïve patients with localized CL were treated with MA (15mg/kg/day up to 1,215mg) or AZ (500mg/day) during 20 consecutive days. The primary efficacy end point was a CL cure 90 days after treatment completion. The analysis was performed with intention-to-treat (ITT) and per protocol (PP) analyses. After an anticipated interim analysis, the study was interrupted due to the high failure rate in the azithromycin group. Results Twenty-four volunteers were included in each group. The MA group had a higher cure rate than the AZ group with the ITT and PP analyses, which were 54.2% versus 20.8% [relative risk (RR) 1.97; 95% confidence intervals (95%CI) 1.13-3.42] and 72.2% versus 23.8% (RR 3.03; 95%CI 1.34-6.87), respectively. No unexpected adverse events were observed. Conclusions Azithromycin is ineffective for CL treatment and does not seem to have a role in the therapeutic arsenal for CL.

Conventional approach x laparoscopic abdominoperineal resection for rectal cancer treatment after neoadjuvant chemoradiation: results of a prospective randomized trial

OBJECTIVE: The aims of this study were to evaluate the safety and efficacy of laparoscopic abdominoperineal resection compared to conventional approach for surgical treatment of patients with distal rectal cancer presenting with incomplete response after chemoradiation. METHOD: Twenty eight patients with distal rectal adenocarcinoma were randomized to undergo surgical treatment by laparoscopic abdominoperineal resection or conventional approach and evaluated prospectively. Thirteen underwent laparoscopic abdominoperineal resection and 15 conventional approach. RESULTS: There was no significant difference (p<0,05) between the two studied groups regarding: gender, age, body mass index, patients with previous abdominal surgeries, intra and post operative complications, need for blood transfusion, hospital stay after surgery, length of resected segment and pathological staging. Mean operation time was 228 minutes for the laparoscopic abdominoperineal resection versus 284 minutes for the conventional approach (p=0.04). Mean anesthesia duration was shorter (p=0.03) for laparoscopic abdominoperineal resection when compared to conventional approach : 304 and 362 minutes, respectively. There was no need for conversion to open approach in this series. After a mean follow-up of 47.2 months and with the exclusion of two patients in the conventional abdominoperineal resection who presented with unsuspected synchronic metastasis during surgery, local recurrence was observed in two patients in the conventional group and in none in the laparoscopic group. CONCLUSIONS: We conclude that laparoscopic abdominoperineal resection is feasible, similar to conventional approach concerning surgery duration, intra operative morbidity, blood requirements and post operative morbidity. Larger number of cases and an extended follow-up are required to adequate evaluation of oncological results for patients undergoing laparoscopic abdominoperineal resection after chemoradiation for radical treatment of distal rectal cancer.

Cost-effective and lightweight mobile units for MixAR: A comparative trial among different setups

Cultural heritage has arousing the interest of the general public (e.g. tourists), resulting in the increasing number of visitations to archaeological sites. However, many buildings and monuments are severely damaged or completely destroyed, which doesn’t allow to get a full experience of “travelling in time”. Over the years, several Augmented Reality (AR) approaches were proposed to overcome these issues by providing three-dimensional visualization of reconstructed ancient structures in situ. However, most of these systems were made available through heavy and expensive technological bundles. Alternatively, MixAR intends to be a lightweight and cost-effective Mixed Reality system which aims to provide the visualization of virtual ancient buildings reconstructions in situ, properly superimposed and aligned with real-world ruins. This paper proposes and compares different AR mobile units setups to be used in the MixAR system, with low-cost and lightweight requirements in mind, providing different levels of immersion. It was propounded four different mobile units, based on: a laptop computer, a single-board computer (SBC), a tablet and a smartphone, which underwent a set of tests to evaluate their performances. The results show that mobile units based on laptop computer and SBC reached a good overall performance while mobile units based on tablet and smartphone did not meet such a satisfactory result even though they are acceptable for the intended use.

Predictors of dropout in a controlled clinical trial of psychotherapy for moderate depression

A significant number of psychotherapy clients remain untreated, and dropping out is one of the main reasons. Still, the literature around this subject is incoherent. The present study explores potential pre-treatment predictors of dropout in a sample of clients who took part in a clinical trial designed to test the efficacy of narrative therapy for major depressive disorder compared to cognitive-behavioral therapy. Logistic regression analysis showed that: (1) treatment assignment did not predict dropout, (2) clients taking psychiatric medication at intake were 80% less likely to drop out from therapy, compared to clients who were not taking medication, and (3) clients presenting anxious comorbidity at intake were 82% less likely to dropout compared to those clients not presenting anxious comorbidity. Results suggest that clinicians should pay attention to depressed clients who are not taking psychiatric medication or have no comorbid anxiety. More research is needed in order to understand this relationship.

Myopia control with a novel peripheral gradient soft lens and orthokeratology: a 2-year clinical trial

Objective. To evaluate the degree of axial elongation with soft radial refractive gradient (SRRG) contact lenses, orthokeratology (OK), and single vision (SV) spectacle lenses (control) during a period of 1 year before treatment and 2 years after treatment. Methods. This was a prospective, longitudinal, nonrandomized study. The study groups consisted of 30, 29, and 41 children, respectively. The axial length (AL) was measured during 2 years after recruitment and lens fitting. Results. The baseline refractive sphere was correlated significantly (r 2 = 0.542; P < 0.0001) with the amount of myopia progression before baseline. After 2 years, the mean myopia progression values for the SRRG, OK, and SV groups were −0.56 ± 0.51, −0.32 ± 0.53, and −0.98 ± 0.58 diopter, respectively. The results represent reductions in myopic progression of 43% and 67% for the SRRG and OK groups, respectively, compared to the SV group. The AL increased more in the SV group compared to the SRRG and OK groups, with 27% and 38% lower axial elongation, respectively, compared to the SV group at the 2-year visit (P < 0.05). SRRG and OK showed no differences (P = 0.430). Conclusion. The SRRG lens significantly decreased AL elongation compared to the SV control group. The SRRG lens was similarly effective to OK in preventing myopia progression in myopic children and adolescent.

Cognitive stimulation for portuguese older adults with cognitive impairment: a randomized controlled trial of efficacy, comparative duration, feasibility and experiential relevance

Although some studies point to cognitive stimulation as a beneficial therapy for older adults with cognitive impairments, this area of research and practice is still lacking dissemination and is underrepresented in many countries. Moreover, the comparative effects of different intervention durations remain to be established and, besides cognitive effects, pragmatic parameters, such as cost-effectiveness and experiential relevance to participants, are seldom explored. In this work, we present a randomized con- trolled wait-list trial evaluating 2 different intervention durations (standard 1⁄4 17 vs brief 1⁄4 11 sessions) of a cognitive stimulation program developed for older adults with cognitive impairments with or without dementia. 20 participants were randomly assigned to the standard duration intervention program (17 sessions, 1.5 months) or to a wait-list group. At postintervention of the standard intervention group, the wait-list group crossed over to receive the brief intervention program (11 sessions, 1 month). Changes in neuropsychological, functionality, quality of life, and caregiver outcomes were evaluated. Experience during intervention and costs and feasibility were also evaluated. The current cognitive stimulation programs (ie, standard and brief) showed high values of experiential relevance for both intervention durations. High adherence, completion rates, and reasonable costs were found for both formats. Further studies are needed to definitively establish the potential efficacy, optimal duration, cost-effectiveness, and experiential relevance for participants of cognitive intervention approaches.

A comparative analysis of primary stenting and optimal balloon coronary angioplasty in acute myocardial infarction. Six month results from the STENT PAMI trial

OBJECTIVE: To compare the outcome of balloon PTCA with final coronary stenosis diameter (SD) <=30%, with elective coronary stenting. METHODS: We performed a comparative analysis of the 6 month outcomes in patients treated with primary stenting and those who obtained an optimal balloon PTCA result treated during the first 12 hours of AMI onset included in the STENT PAMI randomized trial. RESULTS: The results were analysed into 3 groups: primary stenting (441 patients, SD=22±6%), optimal PTCA (245 patients), and nonoptimal PTCA (182 patients, SD= 37±5%). At the end of the 6 months primary stent group presented with the lowest restenosis(23 vs. 31 vs. 45%, p=0.001, respectively). Ischemia-driven target vessel revascularization rate (TVR) (7 vs. 15.5 vs. 19%, p=0.001, respectively). CONCLUSION: At the 6 month follow-up, primary stenting offered the lowest restenosis and ischemia-driven TVR rates. Compared to optimal balloon PTCA. Nonoptimal primary balloon PTCA pts (SD=31-50%), had the worst late angiographic outcomes and should be treated more actively with coronary stent implantation.

One-year follow-up after primary coronary intervention for acute myocardial infarction in diabetic patients: a substudy of the STENT PAMI trial

OBJECTIVE - This analysis was undertaken to determine the composite incidence of cumulative adverse events (death, reinfarction, disabling stroke, and target vessel revascularization) at the end of the first year after acute myocardial infarction, in diabetic patients who underwent coronary stenting or primary coronary balloon angioplasty. METHODS - From the STENT PAMI trial, we analyzed the 6-month angiographic and 1-year clinical outcomes of 135 diabetic (112, noninsulin dependent) patients who underwent the randomization process of the trial and compared them with 758 nondiabetic patients. RESULTS - Coronary stenting did not significantly reduce the primary composite clinical end point when compared with PTCA (20 vs. 30%, p=0.2). A significant benefit from stenting was observed in patients with noninsulin dependent diabetes, with a trend toward a lesser need for new revascularization procedures (10 vs. 21%, p<.001), with a significant reduction in the primary composite clinical end point at 1 year (12 vs. 28%, p=. 04). At 6 months, the restenosis rate were significantly reduced only in nondiabetic patients (18 vs. 33%, p<. 001). Diabetic patients had the same restenosis rate (38%) either with stenting or balloon PTCA. CONCLUSIONS - Coronary Stenting in diabetics noninsulin dependent offered a significant reduction in the composite incidence of major clinical adverse events compared with balloon PTCA.

El valor razonable como concepto vinculado a la pertinencia del valor. Fair value as a concept related to value relevance.

IDENTIFICACIÓN Y CARACTERIZACIÓN DEL PROBLEMA - HIPÓTESIS Según la NIC 39, el valor razonable es la cantidad por la que puede ser intercambiado un activo o cancelado un pasivo entre un comprador y un vendedor interesados y debidamente informados, en condiciones de independencia mutua. La definición del FASB (SFAC 7) es muy similar, y define el valor razonable como el monto mediante el que un activo podría ser enajenado en una transacción entre partes independientes, dispuestas a realizar la operación en situaciones diferentes a la de una liquidación o a la de una venta forzada. Puede apreciarse que esta definición de valor razonable es limitada porque, a excepción de escenarios que se correspondan con mercados perfectos y completos, el concepto puede abarcar valores de entrada, valores de salida y valores en uso, los cuales pueden ser muy diferentes (Beaver, 1987). El valor de entrada es el valor de adquisición o de reemplazo, el valor de salida es el precio al cual un activo puede ser vendido o liquidado, y el valor en uso es el valor incremental de una empresa atribuible a un activo (se correspondería con el valor presente mencionado anteriormente). Dado que el IASB y la FASB se ocupan de la valuación de activos que una empresa posee, y no de activos que serán adquiridos en un futuro, su definición de valor razonable debería ser interpretada desde la perspectiva del vendedor. Por lo tanto, el concepto de valor razonable que manejan el IASB y la FASB se asemeja a un valor de salida, tal como lo propusieron Chambers y Stirling hace bastantes años atrás.Planteado esto, lo que tratará de dilucidar este proyecto de investigación es si este concepto de valor razonable es realmente novedoso o es una simple regresión a los valores corrientes de salida defendidos por los autores de la década del setenta. OBJETIVOS GENERALES Y ESPECÍFICOS General Analizar si el concepto “valor razonable” tal como es definido por la normativa actual se corresponde con una definición novedosa o es una adaptación/modificación/regresión de conceptos ya existentes (valores corrientes de salida). Específicos Revisar la literatura específica desde el punto de vista de la teoría contable y las normas de las que dispone la profesión referidas a los siguientes aspectos: a) Valores corrientes b) Valor razonable MATERIALES Y MÉTODOS El análisis que se llevará a cabo comprenderá dos aspectos. El primero consiste en la revisión de la doctrina contable. Para ello se analizará bibliografía significativa y trabajos de eventos académicos relacionados con el valor razonable. En segundo término se revisará la normativa profesional a nivel nacional e internacional. Después de concluido con los pasos anteriores se analizará la novedad del concepto valor razonable y su semejanza con el valor corriente de salida planteado por los autores de la década del setenta. IMPORTANCIA DEL PROYECTO – IMPACTO Se pretende revisar si el concepto valor razonable planteado por la normativa actual resulta realmente novedoso o es una adaptación de viejos conceptos planteados en la década del setenta del siglo pasado. El proyecto resulta importante porque es un tema no desarrollado en la literatura, ni planteado en congresos. Se estima lograr material de publicación y presentación en eventos académicos. According to the NIC 39, fair value is the quantity for the one that can be exchanged an asset or cancelled a liability between a buyer and a seller interested and due informed, in conditions of mutual independence. The definition of the FASB (SFAC 7) is very similar, and defines fair value as the amount by means of which an assets might be alienated in a transaction between independent parts, ready to realize the operation in situations different from that of a liquidation or to that of a forced sale. This definition of reasonable value is limited because, with the exception of scenes that fit with perfect and complete markets, the concept can include values of entry, values of exit and values in use, which can be very different (Beaver, 1987). The value of entry is the value of acquisition or of replacement, the value of exit is the price to which an asset can be sold or liquidated, and the value in use is the incremental value of a company attributable to an asset. Provided that the IASB and the FASB deal with the appraisal of assets that a company possesses, and not of assets that will be acquired in a future, this definition of fair value should be interpreted from the perspective of the seller. Therefore, the concept of reasonable value that they handle the IASB and the FASB is alike a value of exit, as Chambers and Stirling proposed it enough years ago behind. We will review if the concept of "fair value" is really new or if it is an adaptation of old concepts.

Improving Post-Discharge Medication Adherence in Patients with CVD: A Pilot Randomized Trial

Background:Effective interventions to improve medication adherence are usually complex and expensive.Objective:To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD.Method:A pilot RCT was conducted at a teaching hospital. Intervention was based on the four-item Morisky Medication Adherence Scale (MMAS-4). The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline, at 1 month post hospital discharge and re-assessed 1 year after hospital discharge. Other outcomes included readmission and mortality rates.Results:61 patients were randomized to intervention (n = 30) and control (n = 31) groups. The mean age of the patients was 61 years (SD 12.73), 52.5% were males, and 57.4% were married or living with a partner. Mean number of prescribed medications per patient was 4.5 (SD 3.3). Medication adherence was correlated to intervention (p = 0.04) and after 1 month, 48.4% of patients in the control group and 83.3% in the intervention group were considered adherent. However, this difference decreased after 1 year, when adherence was 34.8% and 60.9%, respectively. Readmission and mortality rates were related to low adherence in both groups.Conclusion:The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit. However, a larger study is required to assess the real impact of intervention on these outcomes.