Readability of medicinal package leaflets: a systematic review

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.

Submitral left ventricular aneurysm. Case report and review of published Brazilian cases

Submitral left ventricular aneurysm is a cardiac pathology widely recognized, but relatively unknown, occurred almost exclusively in African black patients. Although still this idea of racial prevalence exists, cases have been described in patients of all the races. Ten Brazilian cases were reported. One of them was presented inside an Italian paper that refers the surgical treatment of a Brazilian patient of black race. We reported one more submitral left ventricular aneurysm case in a brown female patient, with antecedents of peripheral thromboembolism initially not identified as consequence of the cardiac pathology.

Genomic characterization of a Brazilian TT Virus isolate closely related to SEN virus-F

SEN virus (SENV) is a circular, single stranded DNA virus that has been first characterized in the serum of a human immunodeficiency virus type 1 (HIV-1)-infected patient. Eight genotypes of SENV (A-H) have been identified and further recognized as variants of TT virus (TTV) in the family Circoviridae. Here we describe the first genomic characterization of a SENV isolate (5-A) from South America. Using 'universal' primers, able to amplify most, if not all, TTV/SENV genotypes, a segment of > 3 kb was amplified by polymerase chain reaction from the serum of an HIV-1 infected patient. The amplicon was cloned and a 3087-nucleotide sequence was determined, that showed a high (85%) homology with the sequence of the Italian isolate SENV-F. Proteins encoded by open reading frames (ORFs) 1 to 4 consisted of 758, 129, 276, and 267 amino acids, respectively. By phylogenetic analysis, isolate 5-A was classified into TTV genotype 19 (phylogenetic group 3), together with SENV-F and TTV isolate SAa-38.

Quality uncertainty and allocation of decision rights in the European protected designation of origin

The paper considers some issue in the governance of the European Protected Designation of Origin (PDO). The PDO systems are the outcomes of both farmers and consumers expectations and connect the valorisation of the agricultural and rural resources of given territories to the quality of typical products. A critical point in the governance of the PDO systems is represented by the connection between the quality strategies and the uncertainty. The paper argues that the PDO systems can be thought of as strictly coordinated subsystems in which the ex post governance play a critical role in coping with quality uncertainty. The study suggests that the society's inducements given raise to complex organizational systems in which the allocation of decision rights to PDO collective organizations play a major role. The empirical analysis is carried out by examining ten Italian PDO systems in order to identify the decision rights allocated.

Soil aggregation in a crop-livestock integration system under no-tillage

Grazing intensities can influence soil aggregation, which can be temporarily and permanently affected. The objective of this study was to evaluate the aggregate stability in water at the end of a soybean cycle and during pasture development in a crop-livestock integration system under no-tillage and grazing intensities. The experiment was initiated in 2001, in a dystrophic Red Latosol, after soybean harvest. Treatments consisted of pasture (black oat + Italian ryegrass) at heights of 10, 20 and 40 cm, grazed by young cattle, and a control (no grazing), followed by soybean cultivation, in a randomized block design. Soil samples were collected at the end of the soybean cycle (May/2007), during animal grazing (September/2007) and at the end of the grazing cycle (November/2007). The grazing period influences aggregate distribution, since in the September sampling (0-5 cm layer), there was a higher proportion of aggregates > 4.76 mm at all grazing intensities. Soil aggregation is higher in no-tillage crop-livestock integration systems in grazed than in ungrazed areas.

Carbon and nitrogen cycling in an integrated soybean-beef cattle production system under different grazing intensities

Abstract:The objective of this work was to evaluate the effect of grazing intensity on the decomposition of cover crop pasture, dung, and soybean residues, as well as the C and N release rates from these residues in a long-term integrated soybean-beef cattle system under no-tillage. The experiment was initiated in 2001, with soybean cultivated in summer and black oat + Italian ryegrass in winter. The treatments consisted of four sward heights (10, 20, 30, and 40 cm), plus an ungrazed area, as the control. In 2009-2011, residues from pasture, dung, and soybean stems and leaves were placed in nylon-mesh litter bags and allowed to decompose for up to 258 days. With increasing grazing intensity, residual dry matter of the pasture decreased and that of dung increased. Pasture and dung lignin concentrations and C release rates were lower with moderate grazing intensity. C and N release rates from soybean residues are not affected by grazing intensity. The moderate grazing intensity produces higher quality residues, both for pasture and dung. Total C and N release is influenced by the greater residual dry matter produced when pastures were either lightly grazed or ungrazed.