978 resultados para Institutional Review Boards


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OBJECTIVE To analyze whether the level of institutional and matrix support is associated with better certification of primary healthcare teams.METHODS In this cross-sectional study, we evaluated two kinds of primary healthcare support – 14,489 teams received institutional support and 14,306 teams received matrix support. Logistic regression models were applied. In the institutional support model, the independent variable was “level of support” (as calculated by the sum of supporting activities for both modalities). In the matrix support model, in turn, the independent variables were the supporting activities. The multivariate analysis has considered variables with p < 0.20. The model was adjusted by the Hosmer-Lemeshow test.RESULTS The teams had institutional and matrix supporting activities (84.0% and 85.0%), respectively, with 55.0% of them performing between six and eight activities. For the institutional support, we have observed 1.96 and 3.77 chances for teams who had medium and high levels of support to have very good or good certification, respectively. For the matrix support, the chances of their having very good or good certification were 1.79 and 3.29, respectively. Regarding to the association between institutional support activities and the certification, the very good or good certification was positively associated with self-assessment (OR = 1.95), permanent education (OR = 1.43), shared evaluation (OR = 1.40), and supervision and evaluation of indicators (OR = 1.37). In regards to the matrix support, the very good or good certification was positively associated with permanent education (OR = 1.50), interventions in the territory (OR = 1.30), and discussion in the work processes (OR = 1.23).CONCLUSIONS In Brazil, supporting activities are being incorporated in primary healthcare, and there is an association between the level of support, both matrix and institutional, and the certification result.

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OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use.METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords “Readability and Package Leaflet” and “Readability and Package Insert” in the academic search engine Biblioteca do Conhecimento Online,comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded.RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions.CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.

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OBJECTIVE To review the frequency of and factors associated with fetal death in the Brazilian scientific literature.METHODS A systematic review of Brazilian studies on fetal deaths published between 2003 and 2013 was conducted. In total, 27 studies were analyzed; of these, 4 studies addressed the quality of data, 12 were descriptive studies, and 11 studies evaluated the factors associated with fetal death. The databases searched were PubMed and Lilacs, and data extraction and synthesis were independently performed by two or more examiners.RESULTS The level of completeness of fetal death certificates was deficient, both in the completion of variables, particularly sociodemographic variables, and in defining the underlying causes of death. Fetal deaths have decreased in Brazil; however, inequalities persist. Analysis of the causes of death indicated maternal morbidities that could be prevented and treated. The main factors associated with fetal deaths were absent or inadequate prenatal care, low education level, maternal morbidity, and adverse reproductive history.CONCLUSIONS Prenatal care should prioritize women that are most vulnerable (considering their social environment or their reproductive history and morbidities) with the aim of decreasing the fetal mortality rate in Brazil. Adequate completion of death certificates and investment in the committees that investigate fetal and infant deaths are necessary.

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OBJECTIVE To evaluate the prevalence of self-medication in Brazil’s adult population.METHODS Systematic review of cross-sectional population-based studies. The following databases were used: Medline, Embase, Scopus, ISI, CINAHL, Cochrane Library, CRD, Lilacs, SciELO, the Banco de teses brasileiras(Brazilian theses database) (Capes) and files from the Portal Domínio Público (Brazilian Public Domain). In addition, the reference lists from relevant studies were examined to identify potentially eligible articles. There were no applied restrictions in terms of the publication date, language or publication status. Data related to publication, population, methods and prevalence of self-medication were extracted by three independent researchers. Methodological quality was assessed following eight criteria related to sampling, measurement and presentation of results. The prevalences were measured from participants who used at least one medication during the recall period of the studies.RESULTS The literature screening identified 2,778 records, from which 12 were included for analysis. Most studies were conducted in the Southeastern region of Brazil, after 2000 and with a 15-day recall period. Only five studies achieved high methodological quality, of which one study had a 7-day recall period, in which the prevalence of self-medication was 22.9% (95%CI 14.6;33.9). The prevalence of self-medication in three studies of high methodological quality with a 15-day recall period was 35.0% (95%CI 29.0;40.0, I2 = 83.9%) in the adult Brazilian population.CONCLUSIONS Despite differences in the methodologies of the included studies, the results of this systematic review indicate that a significant proportion of the adult Brazilian population self-medicates. It is suggested that future research projects that assess self-medication in Brazil standardize their methods.

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OBJECTIVE Analyze the profile of women, in health services, who carry out treatment for smoking cessation.METHODS Systematic review that used the following sources of information: Cummulative Index to Nursing and Allied Health Literature (CINAHL), PubMed,Biblioteca Virtual em Saúde (BVS), Scopus and Web of Science. We included quantitative studies that addressed the characterization of women, in health services, who carried out treatment for smoking cessation, resulting in 12 articles for analysis. The assessment of the methodological quality of the studies was performed using the instrument MAStARI from Joanna Briggs Institute.RESULTS The predominant profile of women who carried out treatment for smoking cessation in health services was composed of white, married, employed, and highly level educated women. Women who carried out the treatment for smoking cessation in specialized services had a more advanced age, were white, were married and had a diagnosis of depression. The quality level of most studies was moderate.CONCLUSIONS The profile of women who carry out treatment for smoking cessation, either in general or specialized health services, is composed of white, married, and highly level educated women. Publications about smoking women are scarce and the lack of Brazilian studies characterizing the profile of women who start treatment for smoking cessation shows the need for studies that explore this subject.

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OBJECTIVE To estimate the prevalence of hepatitis C virus infection in Brazil’s inmate population.METHODS Systematic review on hepatitis C virus infection in the inmate population. Brazilian studies published from January 1, 1989 to February 20, 2014 were evaluated. The methodological quality of the studies was assessed using a scale of 0 to 8 points.RESULTS Eleven eligible studies were analyzed and provided data on hepatitis C virus infection among 4,375 inmates from seven states of Brazil, with a mean quality classification of 7.4. The overall hepatitis C virus prevalence among Brazilian inmates was 13.6% (ranging from 1.0% to 41.0%, depending on the study). The chances of inmates being seropositive for hepatitis C virus in the states of Minas Gerais (MG), Sergipe (SE), Mato Grosso do Sul (MS), Rio Grande do Sul (RS), Goiás (GO) and Espirito Santo (ES) were 84.0% (95%CI 0.06;0.45), 92.0% (95%CI 0.04;0.13), 88.0% (95%CI 0.09;0.18), 74.0% (95%CI 0.16;0.42), 84.0% (95%CI 0.08;0.31) and 89.0% (95%CI 0.01;0.05) respectively, lower than that observed in the Sao Paulo state (seroprevalence of 29.3%). The four studies conducted in the city of Sao Paulo revealed a lower prevalence in more recent studies compared to older ones.CONCLUSIONS The highest prevalence of hepatitis C virus infection in Brazil’s inmate population was found in Sao Paulo, which may reflect the urban diversity of the country. Despite Brazilian studies having good methodological quality to evaluate the prevalence of the hepatitis C virus, they are scarce and lack data on risk factors associated with this infection, which could support decisions on prevention and implementation of public health policies for Brazilian prisons.

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The aim of this study was to evaluate the adequacy of the Brazilian legislation about fluoride toothpaste. A search was conducted in LILACS, Medline and SciELO databases about the fluoride concentration found in Brazilians toothpastes, using descriptors on health. Publications since 1981 have shown that some Brazilian toothpastes are not able to maintain, during their expiration time, a minimum of 1,000 ppm F of soluble fluoride in the formulation. However, the Brazilian regulation (ANVISA, Resolution 79, August 28, 2000) only sets the maximum total fluoride (0.15%; 1,500 ppm F) that a toothpaste may contain but not the minimum concentration of soluble fluoride that it should contain to have anticaries potential, which according to systematic reviews should be 1,000 ppm F. Therefore, the Brazilian regulation on fluoride toothpastes needs to be revised to assure the efficacy of those products for caries control.

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OBJECTIVE To estimate worldwide prevalence of chronic low back pain according to age and sex. METHODS We consulted Medline (PubMed), LILACS and EMBASE electronic databases. The search strategy used the following descriptors and combinations: back pain, prevalence, musculoskeletal diseases, chronic musculoskeletal pain, rheumatic, low back pain, musculoskeletal disorders and chronic low back pain. We selected cross-sectional population-based or cohort studies that assessed chronic low back pain as an outcome. We also assessed the quality of the selected studies as well as the chronic low back pain prevalence according to age and sex. RESULTS The review included 28 studies. Based on our qualitative evaluation, around one third of the studies had low scores, mainly due to high non-response rates. Chronic low back pain prevalence was 4.2% in individuals aged between 24 and 39 years old and 19.6% in those aged between 20 and 59. Of nine studies with individuals aged 18 and above, six reported chronic low back pain between 3.9% and 10.2% and three, prevalence between 13.1% and 20.3%. In the Brazilian older population, chronic low back pain prevalence was 25.4%. CONCLUSIONS Chronic low back pain prevalence increases linearly from the third decade of life on, until the 60 years of age, being more prevalent in women. Methodological approaches aiming to reduce high heterogeneity in case definitions of chronic low back pain are essential to consistency and comparative analysis between studies. A standard chronic low back pain definition should include the precise description of the anatomical area, pain duration and limitation level.

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ABSTRACT OBJECTIVE To identify factors associated with exclusive breastfeeding in the first six months of life in Brazil. METHODS Systematic review of epidemiological studies conducted in Brazil with exclusive breastfeeding as outcome. Medline and LILACS databases were used. After the selection of articles, a hierarchical theoretical model was proposed according to the proximity of the variable to the outcome. RESULTS Of the 67 articles identified, we selected 20 cross-sectional studies and seven cohort studies, conducted between 1998 and 2010, comprising 77,866 children. We identified 36 factors associated with exclusive breastfeeding, being more often associated the distal factors: place of residence, maternal age and education, and the proximal factors: maternal labor, age of the child, use of a pacifier, and financing of primary health care. CONCLUSIONS The theoretical model developed may contribute to future research, and factors associated with exclusive breastfeeding may subsidize public policies on health and nutrition.

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Objective: Summarize all relevant findings in published literature regarding the potential dose reduction related to image quality using Sinogram-Affirmed Iterative Reconstruction (SAFIRE) compared to Filtered Back Projection (FBP). Background: Computed Tomography (CT) is one of the most used radiographic modalities in clinical practice providing high spatial and contrast resolution. However it also delivers a relatively high radiation dose to the patient. Reconstructing raw-data using Iterative Reconstruction (IR) algorithms has the potential to iteratively reduce image noise while maintaining or improving image quality of low dose standard FBP reconstructions. Nevertheless, long reconstruction times made IR unpractical for clinical use until recently. Siemens Medical developed a new IR algorithm called SAFIRE, which uses up to 5 different strength levels, and poses an alternative to the conventional IR with a significant reconstruction time reduction. Methods: MEDLINE, ScienceDirect and CINAHL databases were used for gathering literature. Eleven articles were included in this review (from 2012 to July 2014). Discussion: This narrative review summarizes the results of eleven articles (using studies on both patients and phantoms) and describes SAFIRE strengths for noise reduction in low dose acquisitions while providing acceptable image quality. Conclusion: Even though the results differ slightly, the literature gathered for this review suggests that the dose in current CT protocols can be reduced at least 50% while maintaining or improving image quality. There is however a lack of literature concerning paediatric population (with increased radiation sensitivity). Further studies should also assess the impact of SAFIRE on diagnostic accuracy.

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Patients scheduled for a magnetic resonance imaging (MRI) scan sometimes require screening for ferromagnetic Intra Orbital Foreign Bodies (IOFBs). To assess this, they are required to fill out a screening protocol questionnaire before their scan. If it is established that a patient is at high risk, radiographic imaging is necessary. This review examines literature to evaluate which imaging modality should be used to screen for IOFBs, considering that the eye is highly sensitive to ionising radiation and any dose should be minimised. Method: Several websites and books were searched for information, these were as follows: PubMed, Science Direct, Web of Knowledge and Google Scholar. The terms searched related to IOFB, Ionising radiation, Magnetic Resonance Imaging Safety, Image Quality, Effective Dose, Orbits and X-ray. Thirty five articles were found, several were rejected due to age or irrelevance; twenty eight were eventually accepted. Results: There are several imaging techniques that can be used. Some articles investigated the use of ultrasound for investigation of ferromagnetic IOFBs of the eye and others discussed using Computed Tomography (CT) and X-ray. Some gaps in the literature were identified, mainly that there are no articles which discuss the lowest effective dose while having adequate image quality for orbital imaging. Conclusion: X-ray is the best method to identify IOFBs. The only problem is that there is no research which highlights exposure factors that maintain sufficient image quality for viewing IOFBs and keep the effective dose to the eye As Low As Reasonably Achievable (ALARA).

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This paper reviews the literature for lowering of dose to paediatric patients through use of exposure factors and additional filtration. Dose reference levels set by The International Commission on Radiological Protection (ICRP) will be considered. Guidance was put in place in 1996 requires updating to come into line with modern imaging equipment. There is a wide range of literature that specifies that grids should not be used on paediatric patients. Although much of the literature advocates additional filtration, contrasting views on the relative benefits of using aluminium or copper filtration, and their effects on dose reduction and image quality can vary. Changing kVp and mAs has an effect on the dose to the patient and image quality. Collimation protects adjacent structures whilst reducing scattered radiation.

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ABSTRACT OBJECTIVE To describe the methodological characteristics of the studies selected and assess variables associated with sedentary behavior in Brazilian children and adolescents. METHODS For this systematic review, we searched four electronic databases: PubMed, Web of Knowledge, LILACS, SciELO. Also, electronic searches were applied in Google Scholar. A supplementary search was conducted in the references lists of the included articles and in non-indexed journals. We included observational studies with children and adolescents aged from three to 19 years developed in Brazil, presenting analyses of associations based on regression methods and published until September 30, 2014. RESULTS Of the 255 potential references retrieved by the searches, 49 met the inclusion criteria and composed the descriptive synthesis. In this set, we identified a great number of cross-sectional studies (n = 43; 88.0%) and high methodological variability on the types of sedentary behavior assessed, measurement tools and cut-off points used. The variables most often associated with sedentary behavior were “high levels of body weight” (in 15 out of 27 studies; 55.0%) and “lower level of physical activity” (in eight out of 16 studies; 50.0%). CONCLUSIONS The findings of this review raise the following demands to the Brazilian agenda of sedentary behavior research geared to children and adolescents: development of longitudinal studies, validation of measuring tools, establishment of risk cut-offs, measurement of sedentary behavior beyond screen time and use of objective measures in addition to questionnaires. In the articles available, the associations between sedentary behavior with “high levels of body weight” and “low levels of physical activity” were observed in different regions of Brazil.

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ABSTRACT OBJECTIVE To analyze the scientific literature about the effects of exposure to psychosocial risk factors in work contexts. METHODS A systematic review was performed using the terms “psychosocial factors” AND “COPSOQ” in the databases PubMed, Medline, and Scopus. The period analyzed was from January 1, 2004 to June 30, 2012. We have included articles that used the Copenhagen Psychosocial Questionnaire (COPSOQ) as a measuring instrument of the psychosocial factors and the presentation of quantitative or qualitative results. German articles, psychometric studies or studies that did not analyze individual or work factors were excluded. RESULTS We included 22 articles in the analysis. Individual factors, such as gender, age, and socioeconomic status, were analyzed along with work-related factors such as labor demands, work organization and content, social relationships and leadership, work-individual interface, workplace values, justice and respect, personality, health and well-being, and offensive behaviors. We analyzed the sample type and the applied experimental designs. Some population groups, such as young people and migrants, are more vulnerable. The deteriorated working psychosocial environment is associated with physical health indicators and weak mental health. This environment is also a risk factor for the development of moderate to severe clinical conditions, predicting absenteeism or intention of leaving the job. CONCLUSIONS The literature shows the contribution of exposure to psychosocial risk factors in work environments and their impact on mental health and well-being of workers. It allows the design of practical interventions in the work context to be based on scientific evidences. Investigations in specific populations, such as industry, and studies with more robust designs are lacking.

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ABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to treat obesity. RESULTS Only four controlled studies met the inclusion criteria. One randomized, placebo-controlled trial on Fenproporex was found on electronic databases. Three placebo-controlled studies (in non-indexed journals) were identified by hand-searching. Patients with cardiovascular and other comorbidities were excluded in all studies. Trials lasted from 40 to 364 days and doses ranged from 20 to 33.6 mg/d. All controlled studies found that weight loss among Fenproporex-treated patients was greater than that produced by the placebo, but drug effect was modest. Fenproporex produced additional weight reductions of 4.7 kg (one year), 3.8 kg (six months) and 1.55 kg (two months) in average, in relation to diet and exercise only (three trials). Insomnia, irritability, and anxiety were the most frequently reported side effects in the four studies. CONCLUSIONS There is a paucity of randomized, placebo-controlled trials on Fenproporex and those identified here present major methodological flaws. These studies suggest that Fenproporex is modestly effective in promoting weight loss. Nonetheless, they failed to provide evidence that it reduces obesity-associated morbidity and mortality. Data from these studies are insufficient to determine the risk-benefit profile of Fenproporex. Abuse potential and amphetamine-like adverse effects are causes for concern.