Executive Order Number Seven, June 27, 2008

This Executive Order establishes an Iowa Task Force to Rebuild Iowa, after the storms and flood in May and June of 2008.

Cohort study of trials submitted to ethics committee identified discrepant reporting of outcomes in publications.

OBJECTIVES: To identify factors associated with discrepant outcome reporting in randomized drug trials. STUDY DESIGN AND SETTING: Cohort study of protocols submitted to a Swiss ethics committee 1988-1998: 227 protocols and amendments were compared with 333 matching articles published during 1990-2008. Discrepant reporting was defined as addition, omission, or reclassification of outcomes. RESULTS: Overall, 870 of 2,966 unique outcomes were reported discrepantly (29.3%). Among protocol-defined primary outcomes, 6.9% were not reported (19 of 274), whereas 10.4% of reported outcomes (30 of 288) were not defined in the protocol. Corresponding percentages for secondary outcomes were 19.0% (284 of 1,495) and 14.1% (334 of 2,375). Discrepant reporting was more likely if P values were <0.05 compared with P ≥ 0.05 [adjusted odds ratio (aOR): 1.38; 95% confidence interval (CI): 1.07, 1.78], more likely for efficacy compared with harm outcomes (aOR: 2.99; 95% CI: 2.08, 4.30) and more likely for composite than for single outcomes (aOR: 1.48; 95% CI: 1.00, 2.20). Cardiology (aOR: 2.34; 95% CI: 1.44, 3.79) and infectious diseases (aOR: 1.77; 95% CI: 1.01, 3.13) had more discrepancies compared with all specialties combined. CONCLUSION: Discrepant reporting was associated with statistical significance of results, type of outcome, and specialty area. Trial protocols should be made freely available, and the publications should describe and justify any changes made to protocol-defined outcomes.

Adverse events to antiretrovirals in the Swiss HIV Cohort Study: effect on mortality and treatment modification.

BACKGROUND: Antiretroviral therapy (ART) decreases morbidity and mortality in HIV-infected patients but is associated with considerable adverse events (AEs). METHODS: We examined the effect of AEs to ART on mortality, treatment modifications and drop-out in the Swiss HIV Cohort Study. A cross-sectional evaluation of prevalence of 13 clinical and 11 laboratory parameters was performed in 1999 in 1,078 patients on ART. AEs were defined as abnormalities probably or certainly related to ART. A score including the number and severity of AEs was defined. The subsequent progression to death, drop-out and treatment modification due to intolerance were evaluated according to the baseline AE score and characteristics of individual AEs. RESULTS: Of the 1,078 patients, laboratory AEs were reported in 23% and clinical AEs in 45%. During a median follow up of 5.9 years, laboratory AEs were associated with higher mortality with an adjusted hazard ratio (HR) of 1.3 (95% confidence interval [CI] 1.2-1.5; P < 0.001) per score point. For clinical AEs no significant association with increased mortality was found. In contrast, an increasing score for clinical AEs (HR 1.11,95% CI 1.04-1.18; P = 0.002), but not for laboratory AEs (HR 1.07, 95% CI 0.97-1.17; P = 0.17), was associated with antiretroviral treatment modification. AEs were not associated with a higher drop-out rate. CONCLUSIONS: The burden of laboratory AEs to antiretroviral drugs is associated with a higher mortality. Physicians seem to change treatments to relieve clinical symptoms, while accepting laboratory AEs. Minimizing laboratory drug toxicity seems warranted and its influence on survival should be further evaluated.

lntergenerational differences in overweight and obesity levels in Switzerland

Background/Introduction: There is little information regarding intergenerational trends in obesity levels in Switzerland. We aimed at assessing generational differences in obesity levels. Methods: Data from MONICA (1984-1986) and CoLaus-(2003-2006) surveys. Analyses were stratified by gender and age groups (35-44, 45-54, 55-64 and 65-74 years). Results: No changes were found for body mass index (BMI) between surveys (26.2±3.4 vs. 26.6±4.0 kg/m2 in men and 24.8±4.3 vs. 25.1±4.8 kg/m2 in women, for MONICA and CoLaus, respectively). ln men, the prevalence of overweight decreased from 48.6% to 46.0% and the prevalence of obesity increased slightly from 12.4% to 16.7% (p=NS). ln women, the prevalence of overweight decreased from 29.4% to 28.4% and the prevalence of obesity increased slightly from 12.9% to 14.5% (p=NS). After multivariate adjustment on age, education and smoking levels, the odds ratio (OR) and (95% confidence interval) of being obese in 2003-6 relative to 1984-6 was 1.36 (1.01-1.83) in men and 1.44 (1.07-1.93) in women, while no significant trend was found for overweight. After stratifying for age, no increase in BMI levels was found for bath genders. Obesity levels increased in participants aged 35-44 years (from 6.2% to 11.5% in men and from 4.9% to 10.0% in women, p<0.001) and 45-54 years (from 6.2% to 14.5% in men and 4.9% to 14.5% in women, p<0.001 ). After multivariate adjustment on age, education and smoking levels, the increase in obesity levels was signifiant in women aged 35-44, OR=2.10 (1.02-4.30), while a similar, albeit nonsignificant trend was obser11ed in men: 1.85 (0.97-3.51 ). Conclusion: BMI levels appear to have levelled off in Switzerland, but the prevalence of obesity is still on the rise. The increase in obesity levels among the youngest generations is of particular concern.

Boro total e solúvel e suas relações com alguns atributos dos solos do estado do Ceará

Foram avaliados os teores de boro total e solúvel, por meio de três extratores, usados como índices de disponibilidade para as plantas, e suas relações com as propriedades do solo em unidades de mapeamento representativas do estado do Ceará. Utilizaram-se 48 amostras compostas da camada superficial (0-20 cm) de solos classificados como: Areia Quartzosa (AQd), Aluvial (Ae), Planossolo (PL), Bruno Não-Cálcico (NC), Cambissolo (Ce), Podzólico Vermelho-Amarelo (PV), Latossolo Vermelho-Amarelo (LV) e Litossolo (Re). O boro total foi determinado após fusão com carbonato de sódio, e o boro solúvel por meio dos extratores: água quente, HCl 0,05 mol L-1 e Mehlich-1. O B total variou entre 8,3 e 52,2 mg kg-1, com média geral de 16,0 mg kg-1, verificando-se as menores médias nos solos NC, Re e AQd e as maiores nos solos LV, PL e PV. Os teores de B solúvel variaram entre 0,22 e 1,22 mg kg-1, com média de 0,60 mg kg-1, na água quente; entre 0,21 e 1,24 mg kg-1, com média de 0,53 mg kg-1, no HCl 0,05 mol L-1; e entre 0,50 e 1,81 mg kg-1, com média de 1,07 mg kg-1, no Mehlich-1, representando 3,76; 3,32 e 6,76% do B total, respectivamente. As menores médias foram apresentadas pelos solos AQd e LV, e as maiores pelo Ce. Os três extratores correlacionaram-se de forma positiva e altamente significativa. O B total e a matéria orgânica explicaram 28,8 e 38,3% do B extraído pela água quente, respectivamente. O conteúdo de argila, os óxidos de Mn e os sesquióxidos de Fe e Al amorfos e cristalinos influenciaram em menor proporção. A inclusão dessas características numa análise de regressão múltipla melhorou os coeficientes de correlação.

Investigating the possible causal association of smoking with depression and anxiety using Mendelian randomisation meta-analysis: the CARTA consortium.

OBJECTIVES: To investigate whether associations of smoking with depression and anxiety are likely to be causal, using a Mendelian randomisation approach. DESIGN: Mendelian randomisation meta-analyses using a genetic variant (rs16969968/rs1051730) as a proxy for smoking heaviness, and observational meta-analyses of the associations of smoking status and smoking heaviness with depression, anxiety and psychological distress. PARTICIPANTS: Current, former and never smokers of European ancestry aged ≥16 years from 25 studies in the Consortium for Causal Analysis Research in Tobacco and Alcohol (CARTA). PRIMARY OUTCOME MEASURES: Binary definitions of depression, anxiety and psychological distress assessed by clinical interview, symptom scales or self-reported recall of clinician diagnosis. RESULTS: The analytic sample included up to 58 176 never smokers, 37 428 former smokers and 32 028 current smokers (total N=127 632). In observational analyses, current smokers had 1.85 times greater odds of depression (95% CI 1.65 to 2.07), 1.71 times greater odds of anxiety (95% CI 1.54 to 1.90) and 1.69 times greater odds of psychological distress (95% CI 1.56 to 1.83) than never smokers. Former smokers also had greater odds of depression, anxiety and psychological distress than never smokers. There was evidence for positive associations of smoking heaviness with depression, anxiety and psychological distress (ORs per cigarette per day: 1.03 (95% CI 1.02 to 1.04), 1.03 (95% CI 1.02 to 1.04) and 1.02 (95% CI 1.02 to 1.03) respectively). In Mendelian randomisation analyses, there was no strong evidence that the minor allele of rs16969968/rs1051730 was associated with depression (OR=1.00, 95% CI 0.95 to 1.05), anxiety (OR=1.02, 95% CI 0.97 to 1.07) or psychological distress (OR=1.02, 95% CI 0.98 to 1.06) in current smokers. Results were similar for former smokers. CONCLUSIONS: Findings from Mendelian randomisation analyses do not support a causal role of smoking heaviness in the development of depression and anxiety.

n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia.

BACKGROUND: The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown. METHODS: In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here. RESULTS: During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P=0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P=0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P=0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P=0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups. CONCLUSIONS: Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).

Bullying among adolescents in a sub-Saharan middle-income setting.

PURPOSE: This study explored factors associated with self-reported bullying among adolescents in a sub-Saharan country. METHODS: A cross-sectional sample of adolescents (n = 1,427) in the Seychelles was drawn from the Global School-based Student Health Survey. Bullied adolescents were compared with non-bullied adolescents with respect to several sociodemographic factors. Bivariate and multivariate analyses were performed. RESULTS: Within a 30 day period, 38.8% of adolescents reported being bullied. Bullied youths were more likely to be depressed (adjusted odds ratio [aOR] = 1.63; confidence intervals [CI] = 1.27-1.07) and socially deprived (aOR = 1.85; CI = 1.30-2.61). Being older (aOR = .83; CI = .77-.90) and having close friends (aOR = .53; CI = .31-.91) were protective factors. CONCLUSIONS: The prevalence of bullying in the Seychelles is high, and social correlates are similar to those in industrialized settings. More research is needed to examine bullying patterns outside the school environment.

Strong time dependence of the 76-gene prognostic signature for node-negative breast cancer patients in the TRANSBIG multicenter independent validation series.

PURPOSE: Recently, a 76-gene prognostic signature able to predict distant metastases in lymph node-negative (N(-)) breast cancer patients was reported. The aims of this study conducted by TRANSBIG were to independently validate these results and to compare the outcome with clinical risk assessment. EXPERIMENTAL DESIGN: Gene expression profiling of frozen samples from 198 N(-) systemically untreated patients was done at the Bordet Institute, blinded to clinical data and independent of Veridex. Genomic risk was defined by Veridex, blinded to clinical data. Survival analyses, done by an independent statistician, were done with the genomic risk and adjusted for the clinical risk, defined by Adjuvant! Online. RESULTS: The actual 5- and 10-year time to distant metastasis were 98% (88-100%) and 94% (83-98%), respectively, for the good profile group and 76% (68-82%) and 73% (65-79%), respectively, for the poor profile group. The actual 5- and 10-year overall survival were 98% (88-100%) and 87% (73-94%), respectively, for the good profile group and 84% (77-89%) and 72% (63-78%), respectively, for the poor profile group. We observed a strong time dependence of this signature, leading to an adjusted hazard ratio of 13.58 (1.85-99.63) and 8.20 (1.10-60.90) at 5 years and 5.11 (1.57-16.67) and 2.55 (1.07-6.10) at 10 years for time to distant metastasis and overall survival, respectively. CONCLUSION: This independent validation confirmed the performance of the 76-gene signature and adds to the growing evidence that gene expression signatures are of clinical relevance, especially for identifying patients at high risk of early distant metastases.

Mineralização da palhada e crescimento de raízes de cana-de-açúcar relacionados com a adubação nitrogenada de plantio

O experimento foi realizado em canavial comercial, com a variedade SP81 3250, na Usina São Martinho (Pradópolis-SP), em Latossolo Vermelho-Escuro de textura argilosa, com o objetivo de avaliar a mineralização da palha de cana-de-açúcar e sua composição após um ciclo de desenvolvimento da cultura. Foi utilizado um delineamento experimental de blocos completos casualizados, com quatro repetições. Sacos de telas que continham palha marcada em 15N (1,07 % de átomos de 15N), em quantidades equivalentes a 9 t ha-1 de matéria seca, foram colocados entre as fileiras de cana-planta, em todos os tratamentos (0, 40, 80 e 120 kg ha-1 de N). Após 14 meses (de junho 2005 a agosto 2006), foram retirados os sacos para a quantificação do material seco remanescente e para determinações de N, de isótopos de 15N e do teor de C, por espectrometria de massas. A decomposição da palhada nos sacos foi maior nos tratamentos adubados com N e o balanço de massa subestimou a liberação do N da palha em comparação com os dados obtidos com a técnica isotópica. Após 14 meses, verificou-se que 37 a 65 % da matéria seca do material da palhada remanescente sobre o solo eram compostos por restos de raízes da cana cultivada durante esse período, pela contaminação por solo e por microrganismos que se desenvolveram na palhada, indicando que os processos ocorridos durante a decomposição da palhada são mais dinâmicos do que os avaliados pelo balanço de massas.

Choice of Initial Combination Antiretroviral Therapy in Individuals With HIV Infection: Determinants and Outcomes.

BACKGROUND Current guidelines give recommendations for preferred combination antiretroviral therapy (cART). We investigated factors influencing the choice of initial cART in clinical practice and its outcome. METHODS We analyzed treatment-naive adults with human immunodeficiency virus (HIV) infection participating in the Swiss HIV Cohort Study and starting cART from January 1, 2005, through December 31, 2009. The primary end point was the choice of the initial antiretroviral regimen. Secondary end points were virologic suppression, the increase in CD4 cell counts from baseline, and treatment modification within 12 months after starting treatment. RESULTS A total of 1957 patients were analyzed. Tenofovir-emtricitabine (TDF-FTC)-efavirenz was the most frequently prescribed cART (29.9%), followed by TDF-FTC-lopinavir/r (16.9%), TDF-FTC-atazanavir/r (12.9%), zidovudine-lamivudine (ZDV-3TC)-lopinavir/r (12.8%), and abacavir/lamivudine (ABC-3TC)-efavirenz (5.7%). Differences in prescription were noted among different Swiss HIV Cohort Study sites (P < .001). In multivariate analysis, compared with TDF-FTC-efavirenz, starting TDF-FTC-lopinavir/r was associated with prior AIDS (relative risk ratio, 2.78; 95% CI, 1.78-4.35), HIV-RNA greater than 100 000 copies/mL (1.53; 1.07-2.18), and CD4 greater than 350 cells/μL (1.67; 1.04-2.70); TDF-FTC-atazanavir/r with a depressive disorder (1.77; 1.04-3.01), HIV-RNA greater than 100 000 copies/mL (1.54; 1.05-2.25), and an opiate substitution program (2.76; 1.09-7.00); and ZDV-3TC-lopinavir/r with female sex (3.89; 2.39-6.31) and CD4 cell counts greater than 350 cells/μL (4.50; 2.58-7.86). At 12 months, 1715 patients (87.6%) achieved viral load less than 50 copies/mL and CD4 cell counts increased by a median (interquartile range) of 173 (89-269) cells/μL. Virologic suppression was more likely with TDF-FTC-efavirenz, and CD4 increase was higher with ZDV-3TC-lopinavir/r. No differences in outcome were observed among Swiss HIV Cohort Study sites. CONCLUSIONS Large differences in prescription but not in outcome were observed among study sites. A trend toward individualized cART was noted suggesting that initial cART is significantly influenced by physician's preference and patient characteristics. Our study highlights the need for evidence-based data for determining the best initial regimen for different HIV-infected persons.

Transient Ischemic Dilation (TID) ratio measurement during Rb-82 cardiac PET: Comparison between three different software packages.

Background: TIDratio indirectly reflects myocardial ischemia and is correlated with cardiacprognosis. We aimed at comparing the influence of three different softwarepackages for the assessment of TID using Rb-82 cardiac PET/CT. Methods: Intotal, data of 30 patients were used based on normal myocardial perfusion(SSS<3 and SRS<3) and stress myocardial blood flow 2mL/min/g)assessed by Rb-82 cardiac PET/CT. After reconstruction using 2D OSEM (2Iterations, 28 subsets), 3-D filtering (Butterworth, order=10, ωc=0.5), data were automatically processed, and then manually processed fordefining identical basal and apical limits on both stress and rest images.TIDratio were determined with Myometrix®, ECToolbox® and QGS®software packages. Comparisons used ANOVA, Student t-tests and Lin concordancetest (ρc). Results: All of the 90 processings were successfullyperformed. TID ratio were not statistically different between software packageswhen data were processed automatically (P=0.2) or manually (P=0.17). There was a slight, butsignificant relative overestimation of TID with automatic processing incomparison to manual processing using ECToolbox® (1.07 ± 0.13 vs 1.0± 0.13, P=0.001)and Myometrix® (1.07 ± 0.15 vs 1.01 ± 0.11, P=0.003) but not using QGS®(1.02 ±0.12 vs 1.05 ± 0.11, P=0.16). The best concordance was achieved between ECToolbox®and Myometrix® manual (ρc=0.67) processing.Conclusion: Using automatic or manual mode TID estimation was not significantlyinfluenced by software type. Using Myometrix® or ECToolbox®TID was significantly different between automatic and manual processing, butnot using QGS®. Software package should be account for when definingTID normal reference limits, as well as when used in multicenter studies. QGS®software seemed to be the most operator-independent software package, whileECToolbox® and Myometrix® produced the closest results.

IPI Newsletter, July 2006

A quarterly newsletter produced by Iowa Prison Industries

CARBONO ORGÂNICO TOTAL E AGREGAÇÃO DO SOLO EM SISTEMA DE PLANTIO DIRETO AGROECOLÓGICO E CONVENCIONAL DE CEBOLA

Decorrente dos sistemas de manejo empregados no solo, como o sistema de preparo convencional (SPC) versus o sistema de plantio direto de hortaliças (SPDH), modificações nos atributos edáficos ocorrem; por exemplo, nos índices de agregação do solo e seu teor de carbono orgânico total (COT). Objetivaram-se quantificar os teores de COT e avaliar os índices de agregação do solo e a distribuição dos agregados por classes de diâmetro sob cultivo de cebola em SPDH e SPC, comparados a uma área de mata adjacente em Ituporanga, SC. Os tratamentos constituíram-se da semeadura de plantas de cobertura, solteiras e consorciadas, em SPDH: vegetação espontânea (VE); 100 % aveia; 100 % centeio; 100 % nabo-forrageiro; consórcio de nabo-forrageiro (14 %) e centeio (86 %); e consórcio de nabo-forrageiro (14 %) e aveia (86 %). Adicionalmente, foram avaliadas uma área de cultivo de cebola em SPC por ±37 anos e uma área de mata (floresta secundária; ±30 anos), ambas adjacentes ao experimento. Em setembro de 2013, cinco anos após a implantação dos tratamentos com plantas de cobertura, foram coletadas amostras indeformadas do solo nas camadas de 0-5, 5-10 e 10-20 cm e separados os agregados para avaliar a estabilidade via úmida. Nos agregados, foi quantificado o COT; após a separação em classes de diâmetro (8,00 mm>Ø≥0,105 mm), calcularam-se o diâmetro médio ponderado (DMP) e o geométrico (DMG) dos agregados; a distribuição deles em macroagregados (Ø≥2,0 mm), mesoagregados (2,0>Ø≥0,25 mm) e microagregados (Ø<0,25 mm); e o seu índice de sensibilidade (IS). Os dados foram submetidos à análise de variância e de componentes principais (ACP). Os maiores teores de COT foram encontrados na área de mata (52,83; 37,77; e 26,70 g kg-1, respectivamente para 0-5, 5-10 e 10-20 cm); e os menores, no SPC (18,23 g kg-1, 0-5 cm). Os tratamentos com plantas de cobertura, solteiras ou consorciadas, não apresentaram diferenças entre si (p≤0,05) para o COT, nem em relação à área testemunha (VE). O SPC apresentou os menores índices de DMP (3,425; 3,573; e 3,401 mm), DMG (2,438; 2,682; e 2,541 mm) e IS (0,77; 0,79; e 0,81), nas três camadas avaliadas. Para o DMP e DMG, não foram verificadas diferenças (p≤0,05) entre tratamentos no SPDH; porém, esses índices foram superiores aos do SPC; os de DMP, iguais aos da área de mata; e os de DMG, maiores na camada de 0-5 e 5-10 cm. Na camada de 10-20 cm, no SPDH, o tratamento com nabo-forrageiro apresentou maiores valores de DMP (4,520 mm), DMG (4,284 mm) e IS (1,07). Em relação à distribuição dos agregados por classes de diâmetro, o SPC evidenciou, respectivamente, os menores (14,22; 14,75; e 13,86 g) e maiores (4,94; 3,44; e 3,52 g/3,0; 3,0; e 3,76 g) valores para macro e meso/microagregados, enquanto o SPDH demonstrou maiores valores de macroagregados (médias de 19,90; 20,48; e 18,56 g) em comparação à mata (16,0; 16,31; e 15,47 g) e ao SPC (14,22; 14,75; e 13,86 g) nas três camadas avaliadas. O uso de plantas de cobertura, solteiras ou consorciadas, em SPD de cebola foi eficiente para recuperar e aumentar os teores de COT e os índices de DMP, DMG e IS em relação ao SPC; e, em comparação à área de mata, aumentou o DMG (0-5 e 5-10 cm). O nabo-forrageiro aumentou a agregação do solo (DMG e IS) na camada de 10-20 cm em relação aos demais tratamentos com plantas de cobertura. A ACP evidenciou a perda de COT e o aumento dos meso e microagregados no SPC, assim como a substituição do SPC por SPDH com plantas de cobertura elevou a formação de macroagregados estáveis em água, com posterior aumento do DMP, DMG e IS.