Long-Term Effect of Home Blood Pressure Self-Monitoring Plus Medication Self-Titration for Patients With Hypertension: A Secondary Analysis of the ADAMPA Randomized Clinical Trial.

Importance: Patient empowerment through pharmacologic self-management is a common strategy for some chronic diseases such as diabetes, but it is rarely used for controlling blood pressure (BP). Several trials have shown its potential for reducing BP in the short term, but evidence in the longer term is scarce.

Objective: To evaluate the longer-term effectiveness of BP self-monitoring plus self-titration of antihypertensive medication vs usual care for patients with poorly controlled hypertension, with passive follow-up and primary-care nursing involvement.

Home Blood Pressure Self-monitoring plus Self-titration of Antihypertensive Medication for Poorly Controlled Hypertension in Primary Care: the ADAMPA Randomized Clinical Trial.

Background: Patient empowerment through pharmacological self-management is a common strategy in some chronic diseases such as diabetes, but it is rarely used for controlling blood pressure.

Objective: This study aimed to assess self-monitoring plus self-titration of antihypertensive medication versus usual care for reducing systolic blood pressure (SBP) at 12 months in poorly controlled hypertensive patients.

Design: The ADAMPA study was a pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms in Valencia, Spain.

Predictive Performance of the FRAX Tool Calibrated for Spain vs. an Age and Sex Model: Prospective Cohort Study with 9082 Women and Men Followed for up to 8 Years.

In Spain, the Fracture Risk Assessment Tool (FRAX) was adapted using studies with a small number of patients, and there are only a few external validation studies that present limitations. In this prospective cohort study, we compared the performance of FRAX and a simple age and sex model. We used data from the ESOSVAL cohort, a cohort composed of a Mediterranean population of 11,035 women and men aged 50 years and over, followed for up to 8 years, to compare the discrimination, calibration, and reclassification of FRAX calibrated for Spain and a logistic model including only age and sex as variables.

Primary care doctors' views on self-monitoring of blood pressure and self-titration among patients with uncontrolled hypertension in Spain. The ADAMPA trial focus group study.

Background: Despite the increased use of blood pressure (BP) monitoring devices at home, the hypertension of more than 50% of European patients remains uncontrolled. Nevertheless, the self-management of BP, through the combination of home monitoring of BP with self-titration, could be anaccessible and effective tool for improving hypertension control in the primary care setting. The ADAMPA study is a trial with participants randomised to BP self-management (BPSM) with self-titration of antihypertensive medication or to usual care, in a population of patients with poorly controlled hypertension.

Trends and Geographical Variability in Osteoporosis Treatment After Hip Fracture: A Multilevel Analysis of 30,965 Patients in the Region of Valencia, Spain.

Despite improvements in the therapeutic arsenal and the recommendations of guidelines, low rates of prescribing osteoporosis medications are being reported worldwide for patients surviving a hip fracture, and important geographical variation remain. We aimed to describe trends in the proportion of patients that receive osteoporosis medication after hip fracture and to analyze the geographical variation in the prescription of drug therapy and its associated factors in the region of Valencia, Spain. We studied a population-based retrospective cohort of 30,965 patients aged 65 years and older, discharged from hospital after a hip fracture from January 2008 to December 2015, who were followed up for 3 months after discharge to identify the presence of any prescription of osteoporosis medication.

Impact of Drug Safety Warnings and Cost-Sharing Policies on Osteoporosis Drug Utilization in Spain: A Major Reduction But With the Persistence of Over and Underuse. Data From the ESOSVAL Cohort From 2009 to 2015.

Recent studies in several countries show a significant decrease in the consumption of osteoporosis drugs from a peak around 2009, mainly attributed to bisphosphonate safety warnings issued by regulatory agencies on jaw osteonecrosis, atypical fractures, and esophageal cancer, but no studies have assessed the impact of these warnings by risk of fracture strata. The aim of this work is to assess changes in the utilization of osteoporosis drugs in the region of Valencia (Spain) after safety warnings from regulatory agencies and cost-sharing changes, according to patient socio-demographic and risk of fracture characteristics. We constructed a monthly series of osteoporosis drug consumption for 2009-2015 from the ESOSVAL cohort (n = 11,035; women: 48%; mean age: 65 years old) and used interrupted time series and segmented linear regression models to assess changes in osteoporosis drug utilization while controlling for previous levels and trends after three natural intervention dates: the issue of the Spanish Agency for Drugs and Medical Products (AEMPS) Osteonecrosis Jaw Warning (Sept 2009), the AEMPS Atypical femur Fracture Warning (Apr 2011), and the modification of the cost-sharing scheme (Jul 2012).

Improving the accuracy of medication adherence measures using linked prescription and dispensation data: findings from the ESOSVAL cohort of patients treated with osteoporosis drugs.

We compare estimates of proportion of days covered (PDC) based on dispensation-only data versus linked prescription and dispensation information, and we analyse their differences in a real-world cohort of patients with osteoporosis. Prospective cohort study. We compared four alternative measures of PDC, using dispensation-only data: a) with a fixed assessment interval; b) censoring the assessment interval at the moment of the last refill; and using linked prescription and dispensation data: c) considering a minimum prescription gap of three months to interpret interruption by the physician; and d) considering any prescription gap.

Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol.

Background: Lack of control of hypertension is one of the most prevalent problems encountered by general practitioners (GPs). Self-measured blood pressure monitoring at home (SMBP) and self-titration of medication could be a good strategy to improve hypertension management, however, evidence is limited and not conclusive. We aimed to assess the effectiveness, in the primary care setting, of an intervention that includes educational components, SMBP and self-titration of antihypertensive medication to decrease systolic blood pressure compared to usual care, in a population with poorly controlled hypertension, during a 12-month period.

Primary and secondary non-adherence to osteoporotic medications after hip fracture in Spain. The PREV2FO population-based retrospective cohort study.

Osteoporotic medication after hip fracture is widely recommended by clinical practice guidelines, and medication adherence is essential to meet clinical trial risk reduction figures in the real world. We assessed primary and secondary non-adherence to osteoporosis medications in patients discharged following a hip fracture and identified factors associated with secondary non-adherence. From a population-based retrospective cohort of 19,405 patients aged 65 years and over discharged from a hip fracture in the region of Valencia (Spain) from January 1, 2008 and June 30, 2012, we followed, over a minimum of 365 days, 4,856 patients with at least one osteoporotic medication prescribed within the first six months after discharge.

Overuse and Underuse of Antiosteoporotic Treatments According to Highly Influential Osteoporosis Guidelines: A Population-Based Cross-Sectional Study in Spain.

Inappropriate prescribing of antiosteoporotic medications has been observed; however, the joint study of both overuse and underuse has barely been attempted. Spain, with its high utilization rates, constitutes a good example to assess differences in over and under use according to diverse highly-influential osteoporosis guidelines (HIOG) worldwide. We used data of a population-based cross-sectional study including 824 post-menopausal women ≥50 years old living in the city of Valencia, Spain and aimed to estimate the percentage of women eligible for treatment, and the proportion of overuse and underuse of antiosteoporotic treatment according to HIOG.

Impact on the population of different bone mineral density testing criteria and appropriateness of densitometries in the ESOSVAL cohort, Spain.

Context: There is little consensus regarding which individuals should be recommended for bone mineral density (BMD) testing, a situation that could eventually affect the appropriateness of routine clinical practice.

Objectives: The aim of this study was to estimate the impact on the population of the application of the BMD testing criteria provided by the National Osteoporosis Guideline Group (NOGG), National Osteoporosis Foundation (NOF), and Osteoporosis Canada and to assess the appropriateness of the BMD tests currently performed.

Design: A cross-sectional study was conducted using the baseline data of the ESOSVAL cohort.

Prevalence, determinants, and inappropriateness of calcium supplementation among men and women in a Spanish Mediterranean area: cross-sectional data from the ESOSVAL cohort.

Recently, safety concerns about calcium supplementation have arisen. In this situation, ensuring appropriateness of use is highly important. We aimed to describe the use of calcium and vitamin D supplements, the factors related to it, and to assess the appropriateness of calcium prescription among men and women aged 50 years or older.

[Variability in the recommendations for the clinical management of osteoporosis].

Background And Objective: Analysis of the variability in the recommendations of the main guidelines and clinical documents for the management of osteoporosis.

Material And Method: Searches were carried out in PubMed, Google, web pages of national and international scientific societies related to the management of osteoporosis, and agencies that develop guidelines. We analyzed guidelines and clinical documents that included recommendations for the indication of bone densitometry and/or pharmacological treatment, which could influence the management of osteoporosis in the Spanish National Health System, which have been published between 2006 and 2012.

Vertebral fracture risk factors in postmenopausal women over 50 in Valencia, Spain. A population-based cross-sectional study.

Purpose: This study aims to estimate the prevalence of risk factors for osteoporotic vertebral fracture and analyze the possible associations between these factors and the presence of densitometric osteoporosis and prevalent morphometric vertebral fracture.

Methods: Data from a population-based cross-sectional sample of 804 postmenopausal women over the age of 50 years old living in the city of Valencia (Spain) were used. The women were interviewed to identify the prevalence of osteoporotic fracture risk factors and underwent a densitometry and a dorsolumbar spine X-ray.

Prevalence of osteoporotic fracture risk factors and antiosteoporotic treatments in the Valencia region, Spain. The baseline characteristics of the ESOSVAL cohort.

Unlabelled: This study provides information on the prevalence of the most important risk factors for osteoporosis and osteoporotic fracture in a large sample of women and men from the Valencia region and also provides the FRAX 10-year major and hip fracture risks for this population, as well as data about the use of diagnostic tests and antiosteoporotic treatments.

Introduction: The purpose of this study was to describe demographic characteristics, osteoporosis risk factors, the 10-year risk of osteoporotic fracture, and the use of densitometry and antiosteoporotic treatments in the Valencia region, Spain.

Methods: A cross-sectional study using the ESOSVAL cohort baseline data was conducted.

Agreement between semi-automatic radiographic morphometry and Genant semi-quantitative method in the assessment of vertebral fractures.

Unlabelled: Semi-automatic morphometry is highly reproducible and not time intensive; however, no study has evaluated agreement between semi-automated morphometric methods and the Genant semi-quantitative method performed as a rule by radiologists. Our study shows substantial agreement between both methods; however, semi-automatic morphometry upgrades mild deformities and overestimates the prevalence of fractures.

Introduction: The aim of this study was to evaluate the agreement between radiologists using the Genant semi-quantitative (SQ) method and semi-automated morphometry in the diagnosis of vertebral fractures in post-menopausal women.

Adherence to and appropriateness of anti-osteoporotic treatments in patients aged 50 and over in the Valencia Region (Spain). The ESOSVAL-AD study.

Background: A study to evaluate the adherence to and appropriateness of anti-osteoporotic treatments in a cohort of men and women aged 50 and over participating in the ESOSVAL-R study.

Design: An observational, longitudinal, prospective cohort study;

Study Subjects: Men and women aged 50 and over living in the Valencia Region (Spain) who initiated treatment between June 15, 2009, and June 15, 2011, in primary healthcare centers with electronic medical records;

Data Sources: The main data source will be electronic medical records. Measurement of results: Degree of compliance with and persistence of anti-osteoporotic treatments, and the proportion of patients with appropriate anti-osteoporotic treatment in accordance with the most relevant and high impact recommendations with clearly defined treatment algorithms in Spain (the Spanish National Health System guide (2010), the General Practitioners' Society (2007) and the General Directorate for Pharmacy and Medical Products of Madrid (2007)), and with the National Osteoporosis Foundation (NOF, 2010), and the International Osteoporosis Foundation guidelines (IOF, 2008);

Analysis: 1.

Impact of osteoporosis and vertebral fractures on quality-of-life. a population-based study in Valencia, Spain (The FRAVO Study).

Background: To describe the health related quality of life in a population sample of postmenopausal women over the age of 50 and resident in the city of Valencia (Spain), according to the presence/absence of osteoporosis and the severity of prevalent morphometric vertebral fractures.

Methods: A cross-sectional age-stratified population-based sample of 804 postmenopausal women of 50 years of age and older were assessed with the SF-12 questionnaire. Information about demographic features, lifestyle, clinical features, educational level, anti-osteoporotic and other treatments, comorbidities and risk factors for osteoporosis were collected using an interviewer-administered questionnaire and densitometric evaluation of spine and hip and spine x-rays were carried out.

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

Background: 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.

Methods/design: 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 population-based prevalence of osteoporotic vertebral fracture and densitometric osteoporosis in postmenopausal women over 50 in Valencia, Spain (the FRAVO study).

Purpose: To estimate the prevalence of vertebral fracture and densitometric osteoporosis in postmenopausal women over the age of 50 in Valencia, Spain.

Methods: This cross-sectional study was conducted in 2006-2007. An age-stratified population-based random sample of 824 postmenopausal women over the age of 50 answered a questionnaire and received a densitometric examination of the lumbar spine and hip with dual-energy X-ray absorptiometry and a lateral X-ray of the thoracic spine and lumbar regions.

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

Background: 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.

[Restless legs syndrome: detection, diagnosis, impact on health and utilization of health care resources].

Introduction: Despite the high prevalence of Restless Legs Syndrome (RLS) reported, little information is available about this disorder in Spain. The present study was conducted to obtain information on this condition from patients identified by a simple screening questionnaire and subsequent diagnostic confirmation by the Primary Care Practitioner (PCP).

Materials And Methods: Three-stage, cross-sectional and retrospective (resource utilization), observational study in a sample of adult patients (2,047 subject) attending 10 outpatient Primary Care centers in Madrid, Barcelona and Valencia.

Determinant factors of osteoporosis patients' reported therapeutic adherence to calcium and/or vitamin D supplements: a cross-sectional, observational study of postmenopausal women.

Background: Among the various treatments for osteoporosis, calcium and/or vitamin D supplements are frequently included.

Objective: The objective of the study was to analyse adherence to calcium and/or vitamin D treatment and to identify related predictors of non-adherence in a sample of postmenopausal women treated for osteoporosis in primary care.

Methods: A cross-sectional, observational study was conducted in a sample of postmenopausal women receiving pharmaceutical treatment for osteoporosis with vitamin D and/or calcium.