Educational sessions in pharmacovigilance: What do the doctors think?

Background: The aim of this study was to determine physicians"opinion regarding pharmacovigilance feedback sessions. A survey was conducted in a teaching hospital, and the physicians who attended the sessions were invited to participate by filling out a structured questionnaire. All sessions included a review of adverse drug reactions identified at the hospital and information on pharmacovigilance issues (news on warnings released by regulatory agencies or drug toxicity problems identified by recently published studies in medical journals). The survey questions were related to the interest, satisfaction, and belief in the utility of the sessions. A Likert scale (0-10 points) was used to assess physicians" opinions. Findings: A total of 159 physicians attended the sessions and 115 (72.3%) participated in the survey. The mean (SD) age was 38.9 (12.1) years, and 72 (62.6%) were men. The mean (SD) scores of interest, satisfaction with the information provided, and belief in the utility of these sessions were 7.52 (1.61), 7.58 (1.46), and 8.05 (1.38) respectively. Significant differences were observed among physicians according to medical category and speciality in terms of interest, satisfaction, and belief in the utility of those sessions. Conclusions: Educational activities for physicians, such as feedback sessions, can be integrated into the pharmacovigilance activities. Doctors who attend the sessions are interested in and satisfied with the information provided and consider the sessions to be useful. Additional studies on the development and effectiveness of educational activities in pharmacovigilance are necessary.

Confirmatory factor analysis of an inventory of perception of insecurity and fear of crime

This paper focuses on the study of the factorial structure of an inventory to estimate the subjective perception of insecurity and fear of crime. Made from the review of the literature on the subject and the results obtained in previous works, this factor structure shows that this attitude towards insecurity and fear of crime is identified through a number of latent factors which are schematically summarized in (a) personal safety, (b) the perception of personal and social control, (c) the presence of threatening people or situations, (d) the processes of identity and space appropriation, (e) satisfaction with the environment, and (f) the environmental and the use of space. Such factors are relevant dimensions to analyze the phenomenon. Method: A sample of 571 participants in a neighborhood of Barcelona was evaluated with the proposed inventory, which yielded data from the distributions of all the items provided. The administration was conducted by researchers specially trained for it and the results were analyzed by using standard procedures in the confirmatory factor analysis (CFA) from the hypothesized theoretical structure. The analysis was performed by decatypes according to the different response scales prepared in the inventory and their ordinal nature, and by estimating the polychoric correlation coefficients. The results show an acceptable fit of the proposed model, an appropriate behavior of the residuals and statistically significant estimates of the factor loadings. This would indicate the goodness of the proposed factor structure.

A topical microemulsion for the prevention of allergic rhinitis symptoms: results of a randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial (Nares study)

Background: Since barrier protection measures to avoid contact with allergens are being increasingly developed, we assessed the clinical efficacy and tolerability of a topical nasal microemulsion made of glycerol esters in patients with allergic rhinitis. Methods: Randomized, controlled, double-blind, parallel group, multicentre, multinational clinical trial in which adult patients with allergic rhinitis or rhinoconjunctivitis due to sensitization to birch, grass or olive tree pollens received treatment with topical microemulsion or placebo during the pollen seasons. Efficacy variables included scores in the mini-RQLQ questionnaire, number and severity of nasal, ocular and lung signs and symptoms, need for symptomatic medications and patients" satisfaction with treatment. Adverse events were also recorded. Results: Demographic characteristics were homogeneous between groups and mini-RQLQ scores did not differ significantly at baseline (visit 1). From symptoms recorded in the diary cards, the ME group showed statistically significant better scores for nasal congestion (0.72 vs. 1.01; p = 0.017) and mean total nasal symptoms (0.7 vs. 0.9; p = 0.045). At visit 2 (pollen season), lower values were observed in the mini-RQLQ in the ME group, although there were no statistically significant differences between groups in both full analysis set (FAS) and patients completing treatment (PPS) populations. The results obtained in the nasal symptoms domain of the mini-RQLQ at visit 2 showed the highest difference (−0.43; 95% CI: -0.88 to 0.02) for the ME group in the FAS population. The topical microemulsion was safe and well tolerated and no major discomforts were observed. Satisfaction rating with the treatment was similar between the groups. Conclusions: The topical application of the microemulsion is a feasible and safe therapy in the prevention of allergic symptoms, particularly nasal congestion.

Escala de satisfacción con el tratamiento recibido (CRES-4): la versión en español

The satisfaction of consumers and users with the products and services is an issue that in recent years has been taking more and more importance and now it even reaches psychotherapy. This paper presents the Spanish adaptation of the Consumer Reports Effectiveness Scale (CRES-4)consisting of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. Its global score is intended to reflect treatment effectiveness as percived by the patient. Existing studies suggest that the CRES-4 is a good complementary tool to judge, in particular, satisfaction with treatment received.