Iowa Soybean Promotion Board, August 31, 2002 & August 31, 2003

State Agency Audit Report

A mixed approach for proving non-inferiority in clinical trials with binary endpoints

When a new treatment is compared to an established one in a randomized clinical trial, it is standard practice to statistically test for non-inferiority rather than for superiority. When the endpoint is binary, one usually compares two treatments using either an odds-ratio or a difference of proportions. In this paper, we propose a mixed approach which uses both concepts. One first defines the non-inferiority margin using an odds-ratio and one ultimately proves non-inferiority statistically using a difference of proportions. The mixed approach is shown to be more powerful than the conventional odds-ratio approach when the efficacy of the established treatment is known (with good precision) and high (e.g. with more than 56% of success). The gain of power achieved may lead in turn to a substantial reduction in the sample size needed to prove non-inferiority. The mixed approach can be generalized to ordinal endpoints.

Monitoring compliance in resistant hypertension: an important step in patient management.

Poor compliance with antihypertensive drug regimens is one recognized cause of inadequate blood pressure control. Compliance is difficult to measure, so poor adherence to treatment remains largely undiagnosed in clinical practice. When the therapeutic response to a drug is not the one expected, it is a major challenge for many physicians to decide whether the patient is a non-responder or a non-complier. Poor compliance is therefore often incorrectly interpreted as a lack of response to treatment. Not detecting non-compliance can lead to the wrong measures being taken. Electronic monitoring of compliance provides important longitudinal information about drug-intake behaviour that cannot be obtained in the clinic. Such monitoring can improve both compliance and blood pressure control, and help physicians to make more rational therapeutic decisions. A reliable assessment of compliance could have a great impact on medical costs by preventing unnecessary investigations or dose adaptations in patients who are not taking their drugs adequately, or potentially reducing the number of hospitalizations. Side-effects and lack of effectiveness are two frequent causes of poor compliance. The right choice of antihypertensive drug can therefore contribute to compliance. In this respect, it is important to find a drug regimen that is effective, long-acting and well tolerated. Long-acting antihypertensive drugs that provide good blood pressure control beyond the 24-h dosing period should perhaps be considered as drugs of choice in non-compliant patients with hypertension because they help to prevent the consequences of occasional drug omissions.

Use of non-invasive ambulatory blood pressure monitoring to screen for high-risk hypertensive patients.

Blood pressures measured casually by a doctor often differ considerably from those recorded during everyday activities away from the medical environment. In the present study, we compared office and ambulatory recorded pressures in 475 consecutive untreated patients diagnosed hypertensive by physicians. Blood pressure monitored non-invasively during the day was, on average 15/7 mmHg lower than the corresponding office pressures. The difference between office and ambulatory recorded pressure tended to be greatest in those patients with the highest office blood pressure levels, although the relationship between the two types of measurement was too weak (r = 0.50 and 0.38 for systolic and diastolic pressure, respectively) to have any predictive value in the individual patient. Office blood pressures were at least 10 mmHg higher than ambulatory pressures in 62% of patients for systolic and 42% for diastolic pressure. Blood pressure levels recorded during ambulatory monitoring were higher than in the doctor's office for 18% of patients for systolic and 22% for diastolic pressure. Among patients with systolic pressures of between 161 and 180 mmHg or diastolic pressures between 96 and 105 mmHg when facing a doctor, 27 and 37% respectively, showed markedly lower systolic (less than 140 mmHg) or diastolic (less than 90 mmHg) ambulatory recorded pressures. These data therefore indicate that ambulatory blood pressure monitoring may help to identify those truly hypertensive patients who are most likely to benefit from antihypertensive therapy.

Ocorrências éticas com profissionais de enfermagem: um estudo quantitativo

Este trabalho teve por objetivo identificar as características das ocorrências éticas, envolvendo a assistência de enfermagem, em um hospital particular de grande porte do município de São Paulo. Houve 190 ocorrências comunicadas à Comissão de Ética de Enfermagem (CEE) da Instituição, entre 1995 e 2004. Na maioria das ocorrências éticas não houve dano ao paciente, nem à Instituição de saúde ou ao profissional envolvido. Do total de 398 providências tomadas, em 94,5% dos casos foram de orientações dadas pela CEE aos profissionais de enfermagem, destacando-se também orientações feitas pela chefia imediata deles. Em 93,7% das ocorrências, envolvia apenas um profissional. As unidades de internação constituíram o cenário para 76,3% das ocorrências éticas. Como resultado, pode-se mencionar que o estudo demonstrou a importância da orientação aos profissionais, para prevenir ocorrências danosas à clientela.

Hypotensive effect of human factor XII active fragment in conscious normotensive rats: role of bradykinin.

The active fragment derived from factor XII (factor XIIf) was purified from human plasma and administered intravenously to normotensive conscious rats. Factor XIIf-mediated hypotension was dose-dependent and augmented by pretreatment with captopril, an inhibitor of the bradykinin-processing enzyme kininase II. These results therefore suggest that factor XIIf-mediated hypotension is due to the formation of bradykinin.

Lateralization of olfactory processing: Differential impact of right and left temporal lobe epilepsies.

Olfactory processes were reported to be lateralized. The purpose of this study was to further explore this phenomenon and investigate the effect of the hemispheric localization of epileptogenic foci on olfactory deficits in patients with temporal lobe epilepsy (TLE). Olfactory functioning was assessed in 61 patients and 60 healthy control (HC) subjects. The patients and HC subjects were asked to rate the intensity, pleasantness, familiarity, and edibility of 12 common odorants and then identify them. Stimulations were delivered monorhinally in the nostril ipsilateral to the epileptogenic focus in TLE and arbitrarily in either the left or the right nostril in the HC subjects. The results demonstrated that regardless of the side of stimulation, patients with TLE had reduced performance in all olfactory tasks compared with the HC subjects. With regard to the side of the epileptogenic focus, patients with left TLE judged odors as less pleasant and had more difficulty with identification than patients with right TLE, underlining a privileged role of the left hemisphere in the emotional and semantic processing of odors. Finally, irrespective of group, a tendency towards a right-nostril advantage for judging odor familiarity was found in agreement with a prominent role of the right hemisphere in odor memory processing.

Le roman de Christine : roman dramatique / Georges Spitzmuller

Collection : Le livre national ; n° 293

Situação de trabalho dos profissionais da Estratégia Saúde da Família em Ceará-Mirim

O objetivo deste estudo foi analisar as situações de trabalho vivenciadas pelos profissionais da Estratégia Saúde da Família (ESF). Estudo descritivo realizado em Ceará-Mirim, Rio Grande do Norte, em 2007. A população constituiu-se de 190 profissionais da ESF, na qual foi aplicada um questionário com questões fechadas. Os resultados apontaram que o conhecimento da área geográfica adstrita pelos profissionais da ESF foi considerado como um aspecto positivo para a realização das atividades executadas por 83,2% dos profissionais, e o número de famílias acompanhadas por equipe foi considerado como uma dificuldade por 40,5%. Em relação às condições de trabalho, 93,2% referiram a presença de profissionais com perfil em saúde pública, e 86,8%, indisponibilidade de equipamentos e instrumentos. Dos profissionais que trabalham exclusivamente na ESF, 74% são agentes comunitários de saúde. O compromisso e a responsabilidade para substituir as práticas tradicionais de assistência devem ser de todos, havendo a necessidade de interação de fatores históricos, políticos, sociais, econômicos e culturais.

[Archives de la Parole]. , Halbein chatoeinu / Cantor G. Sirota of the Warsaw Synagogue [i.e. Gershon Sirota], ténor ; accompagnement d'orgue

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