Impact of a multifaceted intervention to improve the clinical management of osteoporosis. The ESOSVAL-F study

<p>Abstract</p> <p>Background</p> <p>A study to evaluate the impact of a combined intervention (in-class and on-line training courses, a practicum and economic incentives) to improve anti-osteoporosis treatment and to improve recordkeeping for specific information about osteoporosis.</p> <p>Methods/design</p> <p>A before/after study with a non-equivalent control group to evaluate the impact of the interventions associated with participation in the ESOSVAL-R cohort study (intervention group) compared to a group receiving no intervention (control group). The units of analysis are medical practices identified by a Healthcare Position Code (HPC) referring to a specific medical position in primary care general medicine in a Healthcare Department of the Region of Valencia, Spain. The subjects of the study are the 400 participating "practices" (population assigned to health care professionals, doctors and/or nurses) selected by the Healthcare Departments of the Valencia Healthcare Agency for participation as associate researchers in the ESOSVAL-R study (intervention group), compared to 400 participating "practices" assigned to primary care professionals NOT selected for participation as associate researchers in the ESOSVAL-R study, who are selected on the basis of their working in the same Healthcare Centers as the practices receiving the interventions (control group). The study's primary endpoint is the appropriateness of treatment according by the Spanish National Health System guide (2010) and the National Osteoporosis Foundation (NOF, 2008) and International Osteoporosis Foundation guidance (IOF, 2008).</p> <p>The study will also evaluate a series of secondary and tertiary endpoints. The former are the suitability of treatment and evaluation of the risk of fracture; and the latter are the volume of information registered in the electronic clinical records, and the evaluation of risks and the suitability of treatment.</p

Development and validation of a population-based prediction scale for osteoporotic fracture in the region of Valencia, Spain: the ESOSVAL-R study

<p>Abstract</p> <p>Background</p> <p>Today, while there are effective drugs that reduce the risk of osteoporotic fracture, yet there are no broadly accepted criteria that can be used to estimate risks and decide who should receive treatment. One of the actual priorities of clinical research is to develop a set of simple and readily-available clinical data that can be used in routine clinical practice to identify patients at high risk of bone fracture, and to establish thresholds for therapeutic interventions. Such a tool would have high impact on healthcare policies. The main objective of the ESOSVAL-R is to develop a risk prediction scale of osteoporotic fracture in adult population using data from the Region of Valencia, Spain.</p> <p>Methods/Design</p> <p><it>Study design</it>: An observational, longitudinal, prospective cohort study, undertaken in the Region of Valencia, with an initial follow-up period of five years; <it>Subjects</it>: 14,500 men and women over the age of 50, residing in the Region and receiving healthcare from centers where the ABUCASIS electronic clinical records system is implanted; <it>Sources of data</it>: The ABUCASIS electronic clinical record system, complemented with hospital morbidity registers, hospital Accidents & Emergency records and the Regional Ministry of Health's mortality register; <it>Measurement of results</it>: Incident osteoporotic fracture (in the hip and/or major osteoporotic fracture) during the study's follow-up period. Independent variables include clinical data and complementary examinations; <it>Analysis</it>: 1) Descriptive analysis of the cohorts' baseline data; 2) Upon completion of the follow-up period, analysis of the strength of association between the risk factors and the incidence of osteoporotic fracture using Cox's proportional hazards model; 3) Development and validation of a model to predict risk of osteoporotic fracture; the validated model will serve to develop a simplified scale that can be used during routine clinical visits.</p> <p>Discussion</p> <p>The ESOSVAL-R study will establish a prediction scale for osteoporotic fracture in Spanish adult population. This scale not only will constitute a useful prognostic tool, but also it will allow identifying intervention thresholds to support treatment decision-making in the Valencia setting, based mainly on the information registered in the electronic clinical records.</p

Updating the Food-Based Dietary Guidelines for the Spanish Population: The Spanish Society of Community Nutrition (SENC) Proposal

Diet-related risk factors and physical inactivity are among the leading risk factors for disability and are responsible for a large proportion of the burden of chronic non-communicable diseases. Food-based dietary guidelines (FBDGs) are useful tools for nutrition policies and public health strategies to promote healthier eating and physical activity. In this paper, we discuss the process followed in developing the dietary guidelines for the Spanish population by the Spanish Society of Community Nutrition (SENC) and further explain the collaboration with primary healthcare practitioners as presented in the context of the NUTRIMAD 2018 international congress of SENC. From a health in all policies approach, SENC convened a group of experts in nutrition and public health to review the evidence on diet-health, nutrient intake and food consumption in the Spanish population, as well as food preparation, determinants and impact of diet on environmental sustainability. The collaborative group drafted the document and designed the graphic icon, which was then subject to a consultation process, discussion, and qualitative evaluation. Next, a collaborative group was established to plan a dissemination strategy, involving delegates from all the primary healthcare scientific societies in Spain. A product of this collaboration was the release of an attractive, easy-to-understand publication

Prevalence of metabolic syndrome-related disorders in a large adult population in Turkey

BACKGROUND: There are few existing large population studies on the epidemiology of metabolic syndrome-related disorders of Turkey. The purpose of this study was to assess the prevalence of metabolic syndrome-related disorders in the Turkish adult population, to address sex, age, educational and geographical differences, and to examine blood pressure, body mass index, fasting blood glucose and serum lipids in Turkey. METHODS: This study was executed under the population study "The Healthy Nutrition for Healthy Heart Study" conducted between December 2000 and December 2002 by the Health Ministry of Turkey. Overall, 15,468 Caucasian inhabitants aged over 30 were recruited in 14 centers in the seven main different regions of Turkey. The data were analyzed with the Students' t, ANOVA or Chi-Square tests. RESULTS: Overall, more than one-third (35.08 %) of the participants was obese. The hypertensive people ratio in the population was 13.66 %, while these ratios for DM and metabolic syndrome were 4.16 % and 17.91 %, respectively. The prevalence of hypertension, metabolic syndrome and obesity were higher in females than males, whereas diabetes mellitus was higher in males than females. The prevalence of metabolic syndrome and related disorders were found to be significantly different across educational attainments for both men and women. The prevalence of hypertension increased with age, while it was remarkable that in the age group of 60–69 years, prevalence of diabetes mellitus and metabolic syndrome reached a peak value and than decreased. For obesity, the peak prevalence occurred in the 50–59 year old group. The prevalence of metabolic syndrome and related disorders were found to be significantly different according to geographical region. CONCLUSION: In conclusion, high prevalence of obesity and metabolic syndrome, particularly among women, is one of the major public health problems in Turkey. Interestingly, obesity prevalence is relatively high, but the prevalence of hypertension and hypercholesterolemia is relatively low in Turkish people. Future studies may focus on elucidating the reasons behind this controversy. Our findings may be helpful in formulating public health policy and prevention strategies on future health in Turkey

Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Evidence-based nutritional recommendations for the prevention and treatment of overweight and obesity in adults (FESNAD-SEEDO consensus document): The role of diet in obesity prevention (II/III) Recomendaciones nutricionales basadas en la evidencia para la prevención y el tratamiento del sobrepeso y la obesidad en adultos (Consenso FESNAD-SEEDO): La dieta en la prevención de la obesidad (II/III)

This study is a consensus document of two Spanish scientific associations, FESNAD (Spanish Federation of Nutrition, Food and Dietetetic Associations) and SEEDO (Spanish Association for the Study of Obesity), about the role of the diet in the prevention and of overweight and obesity in adults. It is the result of a careful and systematic review of the data published in the medical literature from January 1st 1996 to January 31st 2011 concerning the role of the diet on obesity prevention. The conclusions obtained have been classified according several evidence levels. Subsequently, in agreement with these evidence levels, different degree recommendations are established. These recommendations could be potentially useful to design food guides as part of strategies to prevent overweight and obesity.Se presenta un consenso de la Federación Española de Sociedades de Nutrición, Alimentación y Dietética (FESNAD) y la Sociedad Española para el Estudio de la Obesidad (SEEDO) sobre la dieta en la prevención del sobrepeso y la obesidad, tras efectuar una revisión sistemática de los datos de la literatura médica desde el 1 de enero de 1996 al 31 de enero de 2011. Las conclusiones obtenidas se han catalogado según niveles de evidencia. Se establecen unas recomendaciones clasificadas según grados que pueden servir de guía y orientación en el diseño de pautas alimentarias dirigidas a la prevención de la obesidad o el sobrepeso

Evidence-based nutritional recommendations for the prevention and treatment of overweight and obesity in adults (FESNAD-SEEDO consensus document): The role of diet in obesity treatment (III/III) Recomendaciones nutricionales basadas en la evidencia para la prevención y el tratamiento del sobrepeso y la obesidad en adultos (Consenso FESNAD-SEEDO): La dieta en el tratamiento de la obesidad (III/III)

This study is a consensus document of two Spanish scientific associations, FESNAD (Spanish Federation of Nutrition, Food and Dietetic Associations) and SEEDO (Spanish Association for the Study of Obesity), about the role of the diet in the treatment of overweight and obesity in adults. It is the result of a careful and systematic review of the data published in the medical literature from January 1st 1996 to January 31st 2011 concerning the role of the diet on obesity treatment. The achieved conclusions have been classified into various evidence levels. Subsequently in agreement with these evidence levels, different degree recommendations are established being potentially useful to design food guides as part of strategies addressed to the treatment overweight and obesity.Se presenta un consenso de la Federación Española de Sociedades de Nutrición, Alimentación y Dietética (FESNAD) y la Sociedad Española para el Estudio de la Obesidad (SEEDO)) sobre la dieta en el tratamiento de la obesidad, tras efectuar una revisión sistemática de los datos de la literatura médica desde el 1 de enero de 1996 al 31 de enero de 2011. Las conclusiones obtenidas se han catalogado según niveles de evidencia. Se establecen unas recomendaciones clasificadas según grados que pueden servir de guía y orientación en el diseño de pautas alimentarias dirigidas al tratamiento de la obesidad o el sobrepeso