BODYFAT: a new calculator to determine the risk of being overweight validated in Spanish children between 11 and 17 years of age.

The assessment of body fat of children in primary care requires consideration of the dynamic changes in height, weight, lean mass, and fat mass during childhood growth. To achieve this, we aim to develop a predictive equation based on anthropometric values, with optimal diagnostic utility. This is a cross-sectional observational study, involving schoolgoers aged 11-17 years in the Vigo metropolitan area. Out of 10,747 individuals, 577 were randomly recruited. VARIABLES: age, sex, ethnicity/country of origin, weight, height, 8 skinfolds, 3 diameters, 7 perimeters, and 85% percentile of body fat mass as the gold standard. Generalized additive regression was selected by cross-validation and compared using receiver operating characteristic curves (ROC curves). Sensitivity, specificity, positive and negative predictive values, true positive and true negative values, false positive and false negative values, accuracy, and positive and negative likelihood ratios were calculated. Two models were identified. The optimal model includes sex, weight, height, leg perimeter, and arm perimeter, with sensitivity of 0.93 (0.83-1.00), specificity of 0.91 (0.83-0.96), accuracy of 0.91 (0.84-0.96), and area under the curve (AUC) of 0.957 (0.928-0.986). The second model includes sex, age, and body mass index, with sensitivity of 0.93 (0.81-1.00), specificity of 0.90 (0.80-0.97), accuracy of 0.90 (0.82-0.96), and an AUC of 0.944 (0.903-0.984). CONCLUSION: Two predictive models, with the 85th percentile of fat mass as the gold standard, built with basic anthropometric measures, show very high diagnostic utility parameters. Their calculation is facilitated by a complementary online calculator. WHAT IS KNOWN: • In routine clinical practice, mainly in primary care, BMI is used to determine overweight and obesity. This index has its weaknesses in the assessment of children. WHAT IS NEW: • We provide a calculator whose validated algorithm, through the determination of fat mass by impedanciometry, makes it possible to determine the risk of overweight and obesity in the community setting, through anthropometric measurements, providing a new practical, accessible and reliable model that improves the classification of overweight and obesity in children with respect to that obtained by determining BMI.

Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).

BACKGROUND: Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS: An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS: The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION: The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION: Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.

The safety and efficacy of the tetanus vaccine intramuscularly versus subcutaneously in anticoagulated patients: a randomized clinical trial.

BACKGROUND: In patients treated with oral anticoagulants, subcutaneous injections of anti-tetanus vaccine are usually recommended to reduce the risk of bleeding, although the effectiveness of the vaccine has only been proven for intramuscular injection. The objective of this study was to compare the safety and efficacy of intramuscular and subcutaneous injections of tetanus-diphtheria vaccine in patients treated with oral anticoagulants. METHODS/DESIGN: We present a prospective, double blinded, clinical trial comparing two groups of patients with oral anticoagulants: one group was administered tetanus-diphtheria vaccine by intramuscular injection, while the other was administered the same vaccine by subcutaneous injection. Allocation to each group was randomized and the duration of the study was six years. STUDY POPULATION: all patients treated with oral anticoagulants, who had been administered with at least one dose of vaccine, at 15 Health Centres in Vigo (Spain), and who agreed to participate in the study. The sample size was 115 patients in each group. The main variables for the safety analysis were the measurement of the brachial diameter, the appearance of basic injuries at the vaccine administration site, the appearance of pain and systemic reactions. The variable used for the efficacy analysis was a significant increase in the titres of anti-tetanus toxoid antibodies.An Intention-to-treat analysis will be performed. Details will be classified according to the administration route, while within each group a 3-tiered stratification will be defined by the administered number of doses. As a measure of association, relative risk will be estimated; the reduction of relative risk will also measured. For safety and to control the confounder effect, a logistic regression analysis will be carried out. As a measure of impact the reduction of absolute risk in relation to the total number of patients to be treated and the Number Needed to Treat will be estimated.CONSORT 2010 guidelines were applied for reporting parallel group randomised trials. DISCUSSION: The most significant difficulties on the project are related to the large number of participating centres, required to obtain a viable study population sample size, and the coordination given the scattering of the centres and researchers. TRIAL REGISTRATION: ISRCTN69942081.

[Working with our smoker patients in primary care. Analysis of cost-effectiveness]. / Trabajando con nuestros pacientes fumadores en atención primaria. Un análisis de coste-efectividad.

OBJECTIVE: The aim of this work is to realize an economic evaluation of the smoking interventions in Primary Care (PC). DESIGN: Cost-Effectiveness Analysis comparing two intervention strategies; intensive and brief. SETTING: Patients in a general practitioner's list in a peri-urban Health Centre. PARTICIPANTS: All the medical histories labelled as smokers; 235 and 37 in the group of brief and intensive intervention respectively. INTERVENTIONS: The brief intervention (BI) was made in the context of consultation for another purpose (1-5 minutes). The intensive intervention (II) was exclusively for smoking consultation (10-15 minutes). MAIN MEASUREMENTS: The effectiveness data are obtained by the evaluation of intervention for smokers, in a general practitioner's list, after 6 years. We employ direct sanitary costs. We exclude drugs, non- sanitary and indirect costs. We apply the valuation of incremental cost-effectiveness ratio (ICER) of the brief interventions, intensive and total (brief + intensive) to compare not taking part with each type of intervention and II with regard to BI and probabilistic analysis to treat the uncertainty. RESULTS: The total cost per abstinent patient was 406,74 €: 129,83 € for BI and 1.034,99 € for I.I. ICER Total intervention = €498, 87/patient who stops smoking. ICER BI = €235, 32/patient who stops smoking. ICER II = €1.232, 85/patient who stops smoking. ICER II/BI = €7.772,25/patient who stops smoking. CONCLUSIONS: Smoking interventions in PC are efficient. A proposal for smoking intervention in PC from an effective cost perspective could be an BI for smokers and an II on those who find more difficult to leave the habit.

Interrupted Time Series Analysis of Pediatric Infectious Diseases and the Consumption of Antibiotics in an Atlantic European Region during the SARS-CoV-2 Pandemic.

The increasing concern about bacterial resistance has made the rational prescription of antibiotics even more urgent. The non-pharmacological measures established to reduce the impact of the SARS-CoV-2 pandemic have modified the epidemiology of pediatric infections and, consequently, the use of antibiotics. Interrupted time series (ITS) analyses are quasi-experimental studies that allow for the estimation of causal effects with observational data in "natural experiments", such as changes in health policies or pandemics. The effect of the SARS-CoV-2 pandemic on the incidence of infectious diseases and the use of antibiotics between 2018 and 2020 in the Health Area of Vigo (Galicia, Spain) was quantified and analyzed. This paper outlines a real-world data study with administrative records from primary care services provided for the pediatric population. The records were related to episodes classified as infectious by the International Classification of Primary Care (ICPC-2) and oral medication in the therapeutic subgroup J01, corresponding to antibiotics for systemic use, according to the World Health Organization's Anatomical Therapeutic Chemical (ATC) classification system. The records were classified according to incident episodes, age, dose per inhabitant, and year. Segmented regression models were applied using an algorithm that automatically identifies the number and position of the change points. During the SARS-CoV-2 pandemic, the number of infectious diseases being transmitted between individuals, through the air and through the fecal-oral route, significantly decreased, and a slight decrease in infections transmitted via other mechanisms (urinary tract infections) was also found. In parallel, during the months of the pandemic, there has been a marked and significant reduction in antibacterial agent utilization, mainly of penicillins, cephalosporins, and macrolides.

Effectiveness and safety of tetanus vaccine administration by intramuscular vs. subcutaneous route in anticoagulated patients: Randomized clinical trial in primary care.

Design: Prospective, double-blind clinical trial comparing tetanus-diphtheria vaccine administration routes, intramuscular (IM) vs. subcutaneous (SC) injection, in patients with oral anticoagulants. ISRCTN69942081. Study population: Patients treated with oral anticoagulants, 15 health centers, Vigo (Spain). Sample size, 117 in each group. Outcome variables: Safety analysis: systemic reactions and, at the vaccine administration site, erythematic, swelling, hematoma, granuloma, pain.Effectiveness analysis: differences in tetanus toxoid antibody titers.Independent variables: route, sex, age, baseline serology, number of doses administered. Analysis: Following the CONSORT guidelines, we performed an intention-to-treat analysis. We conducted a descriptive study of the variables included in both groups (117 in each group) and a bivariate analysis. Fewer than 5% of missing values. Imputation in baseline and final serology with the median was performed. Lost values were assumed to be values missing at random. We conducted a descriptive study of the variables and compared routes. For safety, multivariate logistic regression was applied, with each safety criterion as outcome and the independent variables. Odds ratios (ORs) were calculated. For effectiveness, a generalized additive mixed model, with the difference between final and initial antibody titers as outcome. Due to the bimodal distribution of the outcome, the normal mixture fitting with gamlssMX was used. All statistical analyses were performed with the gamlss.mx and texreg packages of the R free software environment. Results: A previously published protocol was used across the 6-year study period. The breakdown by sex and route showed: 102 women and 132 men; and 117 IM and 117 SC, with one dose administered in over 80% of participants. There were no differences between groups in any independent variable. The second and third doses administered were not analyzed, due to the low number of cases. In terms of safety, there were no severe general reactions. Locally, significant adjusted differences were observed: in pain, by sex (male, OR: 0.39) and route (SC, OR: 0.55); in erythema, by sex (male, OR: 0.34) and route (SC, OR: 5.21); and in swelling, by sex (male, OR: 0.37) and route (SC, OR: 2.75). In terms of effectiveness, the model selected was the one adjusted for baseline serology.

Adverse events analysis as an educational tool to improve patient safety culture in primary care: a randomized trial.

BACKGROUND: Patient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience. Our study aims to achieve the following:--Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia.--Find and analyze educational tools to improve patient safety culture in primary care.--Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care. DESIGN: Experimental unifactorial study of two groups, control and intervention. STUDY POPULATION: Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain. SAMPLE: From the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned. INTERVENTION: Residents and their respective tutor (tutor-resident pair) in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group--either intervention or control--through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent feedback, after receiving instruction on the process. No action will be taken in the control group. After the intervention has ended, the survey will once again be provided to all participants. OUTCOME MEASURES: Change in safety culture as measured by Hospital Survey on Patient Safety CultureCONSORT Extension for Non-Pharmacologic Treatments 2008 was applied. DISCUSSION: The most significant limitations on the project are related to selecting a tool to measure the safety environment, the training calendar of residents in Family and Community Medicine in last year of studies and the no-answer bias inherent to research conducted through self-administered surveys.The development and application of a safety culture in the health sector, specifically in primary care, is as yet limited. Thus, identifying the strengths and weaknesses in the safety environment may assist in designing strategies for improvement in the primary care health centers of our region. TRIAL REGISTRATION: ISRCTN: ISRCTN41911128.