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. Design, Setting, and Participants: The ADAMPA (Impact of Self-Monitoring of Blood Pressure and Self-Titration of Medication in the Control of Hypertension) study was a randomized, unblinded clinical trial with 2 parallel arms conducted in Valencia, Spain. Included participants were patients 40 years or older, with systolic BP (SBP) over 145 mm Hg and/or diastolic BP (DBP) over 90 mm Hg, recruited from July 21, 2017, to June 30, 2018 (study completion, August 25, 2020). Statistical analysis was conducted on an intention-to-treat basis from August 2022 to February 2024. Interventions: Participants were randomized 1:1 to usual care vs an individualized, prearranged plan based on BP self-monitoring plus medication self-titration. Main Outcomes and Measures: The main outome was the adjusted mean difference (AMD) in SBP between groups at 24 months of follow-up. Secondary outcomes were the AMD in DBP between groups at 24 months of follow-up, proportion of patients reaching the BP target (SBP <140 mm Hg and DBP <90 mm Hg), change in behaviors, quality of life, health service use, and adverse events. Results: Among 312 patients included in main trial, data on BP measurements at 24 months were available for 219 patients (111 in the intervention group and 108 in the control group). The mean (SD) age was 64.3 (10.1) years, and 120 patients (54.8%) were female; the mean (SD) SBP was 155.6 (13.1) mm Hg, and the mean (SD) diastolic BP was 90.8 (7.7) mm Hg. The median follow-up was 23.8 months (IQR, 19.8-24.5 months). The AMD in SBP at the end of follow-up was -3.4 mm Hg (95% CI, -4.7 to -2.1 mm Hg; P < .001), and the AMD in DBP was -2.5 mm Hg (95% CI, -3.5 to -1.6 mm Hg; P < .001). Subgroup analysis for the main outcome showed consistent results. Sensitivity analyses confirmed the robustness of the main findings. No differences were observed between groups in behaviors, quality of life, use of health services, or adverse events. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, BP self-monitoring plus self-titration of antihypertensive medication based on an individualized prearranged plan used in primary care reduced BP in the longer term with passive follow-up compared with usual care, without increasing health care use or adverse events. These results suggest that simple, inexpensive, and easy-to-implement self-management interventions have the potential to improve the long-term control of hypertension in routine clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT03242785.

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. PARTICIPANTS: Hypertensive patients older than 40 years, with SBP over 145 mmHg and/or diastolic blood pressure (DBP) over 90 mmHg, were recruited from July 2017 to June 2018. INTERVENTION: Participants were randomized 1:1 to usual care versus an individualized, pre-arranged plan based on self-monitoring plus self-titration. MAIN MEASURE: The primary outcome was the adjusted mean difference (AMD) in SBP between groups at 12 months. KEY RESULTS: Primary outcome data were available for 312 patients (intervention n=156, control n=156) of the 366 who were initially recruited. The AMD in SBP at 12 months (main analysis) was -2.9 mmHg (95% CI, -5.9 to 0.1, p=0.061), while the AMD in DBP was -1.9 mmHg (95% CI, -3.7 to 0.0, p=0.052). The results of the subgroup analysis were consistent with these for the main outcome measures. More patients in the intervention group achieved good blood pressure control (<140/90 mmHg) at 12 months than in the control group (55.8% vs 42.3%, difference 13.5%, 95% CI, 2.5 to 24.5%, p=0.017). At 12 months, no differences were observed in behavior, quality of life, use of health services, or adverse events. CONCLUSION: Self-monitoring plus self-titration of antihypertensive medication based on an individualized pre-arranged plan used in primary care may be a promising strategy for reducing blood pressure at 12 months compared to usual care, without increasing healthcare utilization or adverse events. TRIAL REGISTRATION: EudraCT, number 2016-003986-25 (registered 17 March 2017) and clinicaltrials.gov , NCT03242785.

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. We found virtually identical AUC, 83.55% for FRAX (CI 95%: 80.46, 86.63) and 84.10% for the age and sex model (CI 95%: 80.91, 87.29), and there were similar observed-to-predicted ratios. In the reclassification analyses, patients with a hip fracture that were reclassified correctly as high risk by FRAX, compared to the age and sex model, were -2.86%, using either the 3% threshold or the observed incidence, 1.54% (95%CI: -8.44, 2.72 for the 3% threshold; 95%CI: -7.68, 1.97 for the incidence threshold). Remarkably simple and inexpensive tools that are easily transferable into electronic medical record environments may offer a comparable predictive ability to that of FRAX.

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. AIM: To explore the views and attitudes of primary care doctors participating in the ADAMPA trial regarding BPSM with self-titration. DESIGN & SETTING: A focus group study took place with primary care doctors participating in the ADAMPA trial, which was carried out in one health district of the Valencia Health System in Spain. METHOD: Nine primary care doctors participating in the ADAMPA trial were included in the focus group. Three researchers (two using manual methods and one using NVivo software) independently conducted a content analysis, reading the transcripts, identifying, classifying, and coding the contents, and developing a conceptual scheme based on these topics. RESULTS: Participating doctors clearly support home BP monitoring (HBPM), the setting of individual BP targets, and incorporating patient readings into decision-making. They consider it an investment to educate patients for medication self-adjustment and estimate that an important proportion of their patients are potential candidates for hypertension self-management with medication self-titration. However, they show important divergences regarding the role of nursing in BP control. CONCLUSION: Primary care doctors participating in the ADAMPA trial feel comfortable with BPSM with self-titration, and would consider extending its use (or the use of some components, such as BP target setting) to other patients with hypertension outside the trial.

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. We conducted a multilevel multiple logistic regression analysis with two levels (individuals and health departments [HD]) to determine which individual covariates were associated with receiving a prescription of osteoporosis medication in the 3 months after discharge, as well as the importance of the HD of hospitalization. The percentage of patients treated in the region decreased from a maximum of 28.9% in 2009 to 16.4% in 2015. By sex, the proportion of women treated reached a maximum of 33.4% in 2009 and declined to 19% in 2015, while the proportion of men reached a maximum of 14% in 2011 and reduced to 8.1% in 2015. By health department, there was a noticeable variability in the rate of patients treated, ranging from 40.9% to 11.1% in the whole period (intraclass correlation coefficient [ICC] = 7.54%; median odds ratio [MOR] = 1.64). Proportion of treated patients decreased in 20 of the 24 HDs. Variability could be also observed with regard to choice of medication by HD. This situation pressingly demands action (both at the organizational and professional levels) focused on populations at a higher risk (such as hip fracture patients) that particularly address underutilization and unwarranted variation.

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.

Background: 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. Aim: 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. Patients and Methods: 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). Results: The AEMPS Osteonecrosis Jaw Warning was not associated with a decline in the consumption of osteoporosis drugs, while the warning on atypical fracture (a downward trend of 0.11% fewer people treated each month) and the increase in the cost-sharing scheme (immediate change level of -1.07% in the proportion of people treated) were associated with a strong decline in the proportion of patients treated, so that by the end of 2015 osteoporosis drug consumption was around half that of 2009. The relative decline was similar in people with both a high and low risk of fracture. Conclusion: The AEMPS Atypical femur Fracture Warning of Apr 2010 was associated with a significant decrease in the number of people treated, reinforced by the increase in the pharmaceutical cost-sharing in 2012. Decreases in treatment affected patients both at a low and higher risk of fracture.

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

Objective: 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.Methods: 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.Results: The mean PDC at 12 months for new users was 63.1% using dispensation-only data and a fixed interval, 86.0% using dispensation-only data and a last-refill interval, 81% using linked dispensation and prescription data and censoring any period without prescription, and 78.3% when using linked prescription and dispensation data and censoring periods of at least 3 months. For experienced users, the figures were 80.0%, 88.9%, 83% and 81%, respectively. Overall, dispensation-based measures presented issues of patient misclassification.Conclusions: Linked prescription and dispensation data allows for more precise PDC estimates than dispensation-only data, as both primary non-adherence and early non-adherence periods, and fully non-adherent patients, are all identified and accounted for.

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. METHODS: Pragmatic, controlled, randomized, unblinded clinical trial with two parallel groups assigned in a ratio of 1:1 to self-management (which includes educational components, SBMP and self-titration of antihypertensive medication based on a patient's GP's pre-established adjustment plan) or to usual care (with educational components too). DISCUSSION: If the data from this trial show positive results, the study may contribute to a change of strategy in the treatment of hypertension, focusing on the patient as the main actor to achieve blood pressure control. Furthermore, this approach might contribute to the financial sustainability of the National Health Service. TRIAL REGISTRATION: This trial has been registered in the database with reference number EudraCT: 2016-003986-25. Registered 05 May 2017, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-003986-25.

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. Less than one third of the patients discharged alive after a hip fracture received osteoporotic treatment. Primary non-adherence among naïve patients was low. However, long-term secondary adherence measured by Proportion of Days Covered with medication (PDC) and persistence was largely suboptimal, with naïve users having worse results than experienced patients. Secondary non-adherence was associated with primary non-adherence and age, dementia or sedative treatments for naïve users and with being male, being older than 85 and having dementia for experienced users. Three quarters of naïve users and two thirds of experienced users had interrupted treatment at 48 months.

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. The prevalence of antiosteoporotic treatment in postmenopausal women ≥ 50 in Valencia was 20.9% (95%CI:17.6-24.4). The type of antiosteoporotic drugs prescribed varied greatly depending on the medical specialty responsible of the initial prescription. When applying the HIOG, the percentage of women 50 and over who should be treated varied from less than 9% to over 44%. In real terms, from the approximately eight million women of 50 years old and over in Spain, the number eligible for treatment would range from 0.7 to 3.8 million, depending on the guideline used. A huge proportion of inappropriate treatments was found when applying these guidelines to the Spanish population, combining a high overuse (42-78% depending on the guideline used) and underuse (7-41%). In conclusion, we found that the pharmacological management of osteoporosis in women of 50 and over in this population combines an important overuse and, to a lesser extent, underuse, although the level of inappropriateness varied strikingly depending on the CPG used. It seems urgent to reduce treatment overuse without neglecting underuse, as is urgent an attempt to reach wider agreement worldwide regarding osteoporosis management, in order to facilitate appropriate treatment and development of policies to reduce effectively treatment inappropriateness.

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. PARTICIPANTS: Participants included 11 035 men and women aged 50 years old and over attending primary health care centers in the Valencia region, Spain (2009-2010). MAIN OUTCOME AND MEASURES: BMD testing by dual-energy X-ray absorptiometry was recorded. RESULTS: Of the 10 710 people included in the study, 1617 (15.1%; 95% confidence interval [CI]: 14.4-15.8) received a BMD test. When applying the NOGG criteria, BMD testing would be recommended in 17.4% (95% CI: 16.7-18.1) of individuals, whereas this percentage would rise to 74.6% (95% CI: 73.7-75.4) and 80.1% (95% CI: 79.4-80.9) when using the Osteoporosis Canada and the NOF criteria, respectively. Regarding the appropriateness of the BMD tests performed in the ESOSVAL cohort, 40.7% (95% CI: 38.3-43.1), 86.0% (95% CI: 84.3-87.7), and 82.2% (95% CI: 80.3-84.1) of individuals having a BMD test met the NOGG, NOF, and the Canadian guidelines criteria, respectively. Of the tests performed, 40.7% would be deemed as appropriate, whereas 10.7% would be considered inappropriate. CONCLUSIONS: The impact on the population of the different recommendations is enormous, varying from 17% to 80% of the population over 50 who would be tested. Although in men it seems that a clinical rationale exists between the presence of risk factors and the rates of BMD testing, this pattern does not seem to exist in women. One in 10 of the densitometric tests performed were inappropriate according to all the guidelines.

[Variability in the recommendations for the clinical management of osteoporosis]. / Variabilidad en las recomendaciones para el abordaje clínico de la 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. RESULTS: We included 12 documents. Eleven recommend performing bone densitometry upon assessing women risk factors, but the number and type of risk factors vary between documents: 6 recommend its implementation to all women over 65 years, 4 in men aged 65-70 years, and 3 when there is radiological suspicion of osteoporosis. There is agreement on the recommendations on the indication for densitometry to monitor drug response. In primary prevention, all national documents combined risk factors and densitometric osteoporosis and 3 of them recommend individual assessment according to risk factors. Most of the international guidelines require the calculation of risk with the FRAX(®) tool. In secondary prevention, all documents recommend treatment in cases of hip or clinical vertebral fracture; in men, and for the rest of fractures, the recommendations are heterogeneous. CONCLUSIONS: Overall there is a high variability in the recommendations of guidelines and other documents for the management of osteoporosis.

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. We performed a cross-sectional study in 2009-2010 including 11,035 adults who belong to the ESOSVAL cohort and attend 272 primary healthcare centers in the Valencia region of Spain. Criteria for the inappropriateness of calcium prescription, based on guidelines and recent evidence, were: excessive or insufficient daily total intake (diet plus supplements), excessive single doses of supplements, excessive or insufficient association with vitamin D, and overall inappropriateness. Calcium and/or vitamin D were prescribed to about 17% of the population. Older age, antiosteoporotic treatment, use of glucocorticoids, and a diagnosis of osteoporosis were related to prescription. The presence of other secondary causes of osteoporosis determined supplementation only in men. Calcium dietary intake was not related to the prescription of supplements. Among calcium users, 85.8% met at least one criterion of inappropriate prescription; 29% had an inappropriate daily total intake mainly resulting from excessive consumption (>2000 mg/day); 53.8% of patients were given calcium supplements in quantities higher than 500 mg per dose; and 38.9% of individuals receiving calcium supplements had inappropriate (absent or below 800 UI/day) vitamin D supplementation (all of them at high risk). In conclusion, we found high inappropriateness of calcium supplementation, mainly because of calcium overdosing, and also to undertreatment and underdosing of vitamin D in high-risk patients. Physicians should be encouraged to assess calcium dietary intakes before supplementation, recommending intake from food whenever possible, and to prescribe low calcium doses and high vitamin D doses when given in fixed-dose combinations, or vitamin D alone when calcium is not necessary.

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. RESULTS: The most prevalent risk factors were densitometric osteoporosis (31.7%), history of parental hip fracture (19.4%), hypoestrogenism (19%), and body mass index (BMI) ≥ 30 kg/m(2) (35.2%). After adjusting for all covariables, densitometric osteoporosis was associated with increased age [odds ratio (OR)(65-69 years): 2.84, 95% confidence interval (CI): 1.75-4.61; OR(70-74 years): 4.01, 95% CI: 2.47-6.52; OR(75+years): 5.96, 95% CI: 3.27-10.87] and inversely associated with high BMI (OR(25.0-29.9): 0.51, 95% CI: 0.34-0.76; OR(≥ 30): 0.30, 95% CI: 0.19-0.46). Morphometric vertebral fracture was associated with age (OR(65-69 years): 2.04, 95% CI: 1.03-4.05; OR(70-74 years): 4.05, 95% CI: 2.11-7.77; OR(75+years): 8.43, 95% CI: 3.97-17.93), poor educational level (OR: 1.70, 95% CI: 1.06-2.72) and with densitometric osteoporosis and BMI ≥ 30 kg/m(2) (OR: 3.35, 95% CI: 1.85-6.07). CONCLUSIONS: The most prevalent osteoporotic fracture risk factors were having a high BMI and the presence of densitometric osteoporosis. A higher risk of morphometric vertebral fracture in women with both low bone mineral density and high BMI was found. This association, if confirmed, has important implications for clinical practice and fracture risk tools. We also found a higher risk in women with a poor educational level. More attention should be addressed to these populations in order to control modifiable risk factors.

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.) Descriptive analysis of patients undergoing treatment and the treatments prescribed; 2.) Descriptive analysis of compliance with and persistence of anti-osteoporotic treatments; 3.) ANALYSIS of factors associated with compliance with and persistence of treatments by Cox proportional hazard regression models, 4.) Descriptive analysis of appropriateness of treatment; 5.) ANALYSIS of factors associated with the appropriateness of treatment by multilevel models (4 levels: patient, doctor, Basic Healthcare Zone/Primary Healthcare Center, and Health Area variables). DISCUSSION: ESOSVAL-AD will provide information regarding adherence to osteoporosis treatments and the factors associated with a higher or lower adherence (including the appropriateness of the treatment) in the Spanish context. A better understanding of this phenomenon and the interventions needed to address it would contribute to the increased effectiveness of therapeutic measures, a reduction in morbidity and mortality, and a corresponding reduction in healthcare costs.

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. RESULTS: In the non-adjusted analysis, mild and moderate-severe vertebral fractures were associated with decreased scores in the SF-12 Physical Component Summary (PCS) but not in the Mental Component Summary (MCS), while densitometric osteoporosis with no accompanying fracture was not associated with a worse health related quality of life. In multivariate analysis worse PCS scores were associated to the age groups over 70 (-2.43 for 70-74 group and -2.97 for 75 and older), chronic conditions (-4.66, -6.79 and -11.8 according to the presence of 1, 2 or at least 3 conditions), obesity (-5.35), peripheral fracture antecedents (-3.28), hypoestrogenism antecedents (-2.61) and the presence of vertebral fracture (-2.05). CONCLUSIONS: After adjusting for confounding factors, the physical components of health related quality of life were significantly lower in women with prevalent osteoporotic vertebral fractures than in women--osteoporotic or not--without vertebral fractures.

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 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).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.

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. Osteoporosis was defined as a T-score less than or equal to -2.5 compared to a population of young women, and the presence of vertebral fractures was classified according to Genant's semiquantitative method. RESULTS: The average age of the women was 64 years (range 50-87 years). The prevalence for all vertebral fractures was 21.4% (95% CI: 17.7%-25.1%) and 9.7% (95% CI: 6.7%-12.7%) for moderate-severe fractures. In women over the age of 75, the respective values were 46.3% (95% CI: 34.2%-58.3%) and 23.9% (95% CI:13.6%-34.2%). Only 1.5% of the women with vertebral fractures were aware of their condition. The prevalence of osteoporosis was estimated as 27.0% (95% CI:23.1%-30.8%) for the lumbar spine, 15.1% (95% CI:11.7%-18.5%) in the femoral neck, and 31.8% (95% CI:27.8%-35.7%) at either sites. CONCLUSIONS: The study confirms that osteoporosis (1 in 3 women over the age of 50) and vertebral fracture (1 in 5 for all fractures and 1 in 10 for moderate-severe fractures) constitute a major public health and healthcare challenge; measuring their real impact will depend in part on the criteria used to define a fracture.

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. 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. STUDY DESIGN: An observational, longitudinal, prospective cohort study, undertaken in the Region of Valencia, with an initial follow-up period of five years; SUBJECTS: 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; SOURCES OF DATA: The ABUCASIS electronic clinical record system, complemented with hospital morbidity registers, hospital Accidents & Emergency records and the Regional Ministry of Health's mortality register; Measurement of results: 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; ANALYSIS: 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. DISCUSSION: 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.

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. Sociodemographic, general and osteoporosis-related data were collected. Patient's perceptions of the adverse effects of treatment, their knowledge of osteoporosis (Batalla test), their attitude towards treatment (Morisky-Green test) and their self-reported therapeutic adherence (Haynes-Sackett test) were assessed. RESULTS: Of 630 women (mean age +/- SD 64.1 +/- 8.7 years) evaluated, 36.2% (95% CI 32.4, 39.9) had problems with treatment tolerability, 63.5% (95% CI 59.7, 67.3) had good knowledge of osteoporosis, 20.5% (95% CI 17.3, 23.6) had a good attitude to treatment and 50.0% (95% CI 46.1, 53.9) had good self-reported adherence to treatment. Patients in the poor adherence group had higher mean body mass index (p = 0.014), more concurrent pathologies (p = 0.003), more tolerability problems (p < 0.001) and worse attitude to treatment (p < 0.001). The multivariate model showed a positive relationship between therapeutic adherence and good attitude to treatment (odds ratio [OR] = 11.7; p < 0.001), not having tolerability problems (OR = 3.3; p < 0.001) and no polymedication (OR = 0.80; p = 0.017). CONCLUSIONS: Only one in two postmenopausal women with osteoporosis who take calcium and/or vitamin D have good self-reported therapeutic adherence to this treatment. Determinant factors of adherence to calcium and/or vitamin D treatment were patient's attitude to the treatment, tolerability problems with the treatment and number of concurrent treatments.