Meta-analysis, megatrials, and clinical practice in cardiology

One of the factors that raises more scepticism and concern in physicians is the combination of data from different clinical trials. In order to combine the results of different trials three requisites must be followed through: similar treatment, the patients have the same disease, and the main outcome variables must be the same. Publication bias is one important limitation of meta-analysis, and it occurs when studies with negative results are not published, which causes the effect of the treatment to be overestimated. It might seem reasonable that the demonstrated effect in the entire study population with a large sample size could be easily analyzed in different subgroups of patients, getting closer to the prediction of effect in the individual patient. This apparently obvious observation is a fallacy and subgroup analysis is often problematic. Possibly the most important condition in the analysis of subgroups is the definition of the subgroups in the design stage of the study, which can permit an adequate presight of the necessary requisites for the validity of the study. The problem of generalization of the results has been traditionally related with of extrapolation of the results to certain groups of patients not included in the clinical trial. In these cases it is important to consider other nonexperimental epidemiological studies, its internal validity and the consistency of their results. The most important characteristics that differentiate conventional clinical trials from megatrials are the following: megatrials recruit a very large and heterogenous population, with few inclusion and exclusion criteria; the only outcome variable that can be better assessed in these heterogenous conditions is eventually mortality; due to their very large sample size, results are obtained with a high level of precision (very narrow confidence intervals).     

Impact of a soy drink on climacteric symptoms: an open-label,crossover, randomized clinical trial

Objectives: The objective of this study is to evaluate the effects of a soy drink with a high concentration of isoflavones (ViveSoy®) on climacteric symptoms.

Methods: An open-label, controlled, crossover clinical trial was conducted in 147 peri- and postmenopausal women. Eligible women were recruited from 13 Spanish health centers and randomly assigned to one of the two sequence groups (control or ViveSoy®, 500?mL per day, 15?g of protein and 50?mg of isoflavones). Each intervention phase lasted for 12 weeks with a 6-week washout period. Changes on the Menopause Rating Scale and quality of life questionnaires, as well as lipid profile, cardiovascular risk and carbohydrate and bone metabolism were assessed. Statistical analysis was performed using a mixed-effects model.

Results: A sample of 147 female volunteers was recruited of which 90 were evaluable. In both sequence groups, adherence to the intervention was high. Regular consumption of ViveSoy® reduced climacteric symptoms by 20.4% (p?=?0.001) and symptoms in the urogenital domain by 21.3% (p?p?<0.05).

Conclusion: Regular consumption of ViveSoy® improves both the somatic and urogenital domain symptoms of menopause, as well as health-related quality of life in peri- and postmenopausal women.     

Validation of a loop-mediated isothermal amplification assay for rapid diagnosis of pertussis infection in nasopharyngeal samples

Objective: To develop and validate a novel loop-mediated amplification (LAMP) assay for rapid diagnosis (<1 hour) of whooping cough in nasopharyngeal samples versus the gold standard: real-time PCR.

Methods: The study included all nasopharyngeal samples (n = 213) collected from children with clinical suspicion of pertussis admitted to Children’s University Hospital Sant Joan de Déu (Barcelona, Spain) during July–December 2014. Fresh samples were routinely analyzed by real-time PCR and stored for retrospective LAMP analysis, following an easy 30 minute DNA extraction step by Chelex-100.

Results: Performance results of the LAMP assay were: linearity, 10⁵–10¹ CFU/ml; Limit of Detection, 2 CFU/ml; precision (mean CV), 7.38%; diagnostic sensitivity, 96.55%; diagnostic specificity, 99.46%; time to detection, 12–30 minutes.

Conclusion: The new test was shown to be 2.5-fold faster than real-time PCR while maintaining similar levels of analytical and clinical performance. Therefore it could become a useful diagnostic tool for molecular point-of-care testing.     

Effectiveness of virosomal subunit influenza vaccine in preventing influenza-related illnesses and its social and economic consequences in children aged 3-14 years: a prospective cohort study

To evaluate the effectiveness of a virosomal subunit influenza vaccine in preventing influenza-related illnesses and its social and economic consequences in children aged 3-14 years, a prospective cohort study was carried out during the 2004-2005 influenza season in 11 private pediatric clinics in the Barcelona metropolitan area. One dose of a virosomal subunit inactivated influenza vaccine (Inflexal V Berna) was given during September and October 2004 to healthy children aged 3-14 years attended in 5 of the 11 clinics. Who comprised the vaccinated cohort (n=966). The non-vaccinated cohort (n=985) was comprised of children attended in the other six clinics. Informed consent was obtained from all parents. The follow up was performed between 1 November 2004 and 31 March 2005. Using a self-administered questionnaire, information was collected from parents or guardians on any type of acute, febrile respiratory illness suffered by their children during the study period, including antibiotic use, and absence from school or work-loss of parents as a result of the illness. RT-PCR (influenza A+B+C) was carried out on pharyngeal and nasal samples obtained from children attended by pediatricians during this period in these clinics with the following symptoms: fever> or =38.5 degrees lasting at least 72h, cough or sore throat (influenza-like illness). Adjusted vaccination effectiveness was 58.6% (95% CI 49.2-66.3) in preventing acute febrile respiratory illnesses, 75.1% (95% CI 61.0-84.1) in preventing cases of influenza-like illnesses and 88.4% (95% CI 49.2-97.3) in preventing laboratory-confirmed cases of influenza A. The adjusted vaccination effectiveness in reducing antibiotic use (18.6%, 95% CI -4.2 to 3.64), absence from school (57.8%, 95% CI 47.9-65.9) and work-loss of parents (33.3%, 95% CI 8.9-51.2) in children affected by an acute febrile respiratory illness was somewhat lower. Vaccination of children aged 3-14 years in pediatric practices with one dose of virosomal subunit inactivated influenza vaccine has the potential to considerably reduce the health and social burdens caused by influenza-related illnesses.     

Factores de riesgo cardiovascular y atención primaria: evaluación e intervención

There is high prevalence of major cardiovascular risk factors (MCVRF) in Spain, equal or greater than the rest of the countries in Europe, with a tendency to increase, while the their control is in general sub-optimal. In the clinical setting, and in Primary Care clinics in particular, preventive activities and early detection (screening) of MCVRF that are well established by the scientific evidence should be carried out. Smoking should be tackled and treated with decisively, even more so in the context of the favourable current legislation. The measurement of risk factors makes it easy to take decisions in clinical practice, but should not be substituted for clinical judgement, given the limitation of the currently available calculation methods. The concept of overall focus on cardiovascular risks can obtain a reduction of the risk by the synergetic action on the different MCVRF in each individual case. The aim must be to reduce the probability of having a cardiovascular disease in the future, as well as the loss in quality of life, incapacity and associated mortality.     

Carcinoma ductal salival: claves diagnósticas,histología y tratamiento

Salivary duct carcinoma is a very rare, highly-malignant epithelial tumour. We present a case of a 75-year-old man with a rapidly- growing salivary duct carcinoma in the parotid gland, of one month's evolution. Histopathologically, salivary duct carcinoma is characterised by its resemblance to ductal carcinoma of the breast. It usually develops aggressively with possibilities of early distant metastasis and local recurrence. The tumour is managed with total parotidectomy, ipsilateral neck dissection and adjunctive radiation. In advanced cases, we recommend treatment with anti-Her-2 monoclonal antibodies such as trastuzumab.     

Primary pulmonary Hodgkin��s lymphoma

A 21-year-old man presented to hospital with a two-month history of productive cough with no other symptoms. Radiology revealed a cavitating lesion in the left upper lobe for which a variety of diagnoses were considered. A biopsy revealed primary pulmonary Hodgkin’s lymphoma. Primary pulmonary Hodgkin’s lymphoma is an uncommon initial presentation; lung lesions usually occur later in the course of the disease. Following diagnosis, the patient began chemotherapy and full remission was achieved.