Secondary fracture prevention in Spanish primary care: results of the PREFRAOS Study.

This study demonstrated a large treatment gap in elderly subjects experiencing fragility fracture in Spanish primary care, a low treatment persistence among subjects who do receive treatment, and more than one-quarter having no follow-up visits post-fracture. These data highlight the need to improve secondary fracture prevention in primary care. PURPOSE: To describe osteoporosis (OP) treatment patterns and follow-up in subjects with fragility fracture seen in Spanish primary care (PC). METHODS: This observational, retrospective chart review included subjects aged ≥ 70 years listed in the centers' records (November 2018 to March 2020), with ≥ 1 fragility fracture and prior consultation for any reason; subjects who had participated in another study were excluded. Outcomes included OP treatments and follow-up visits post-fragility fracture. RESULTS: Of 665 subjects included, most (87%) were women; overall mean (SD) age, 82 years. Fewer than two thirds (61%) had received any prior OP treatment (women, 65%; men, 38%); of these, 38% had received > 1 treatment (women, 25%; men, 13%). Among treated subjects, the most frequent first-line treatments were alendronate (43%) and RANKL inhibitor denosumab (22%), with a higher discontinuation rate and shorter treatment duration observed for alendronate (discontinuation, 42% vs 16%; median treatment duration, 2.5 vs 2.1 years). Over one-quarter (26%) of subjects had no follow-up visits post-fragility fracture, with this gap higher in women than men (35% versus 25%). The most common schedule of follow-up visits was yearly (43% of subjects with a fragility fracture), followed by half-yearly (17%) and biennial (10%), with a similar trend in men and women. Most OP treatments were prescribed by PC physicians, other than teriparatide and zoledronate. CONCLUSIONS: Across Spanish PC, we observed a large gap in the treatment and follow-up of elderly subjects experiencing a fragility fracture. Our data highlights the urgent need to improve secondary fracture prevention in PC.

Spanish National Registry of Major Osteoporotic Fractures (REFRA) seen at Fracture Liaison Services (FLS): objectives and quality standards.

REFRA-FLS is a new registry in Spain aimed at identifying individuals over 50 years of age with a fragility fracture. Using this registry, we found hip fracture is the most prevalent fracture. Treatment for osteoporosis was 87.7%, with 65.3% adherence. REFRA-FLS provides fundamental data in the study of fragility fractures. PURPOSE: Fragility fractures are a growing public health concern in modern-aged societies. Fracture Liaison Services (FLS) have been shown to successfully lower rates of secondary fractures. A new registry (REFRA-FLS) has been created to monitor quality indicators of FLS units in Spain and to explore the occurrence and characteristic of fragility fractures identified by these centers. METHODS: We conducted a prospective cohort study based on fragility fractures recorded in the REFRA-FLS registry. Participants were individuals 50 years or above who suffered a low energy fragility fracture identified by the 10 participating FLS units during the study period. The type of FLS unit, the characteristics of the individuals at baseline, along with patient outcomes as quality indicators among those who completed 1 year of follow-up were analyzed. RESULTS: A total of 2965 patients and 3067 fragility fractures were identified, and the most frequent locations were hip (n = 1709, 55.7%) and spine (n = 492, 16.0%). A total of 43 refractures (4.5%) and 46 deaths (4.9%) were observed among 948 individuals in the follow-up analyses. Time from fracture to evaluation was less than 3 months in 76.7% of individuals. Osteoporosis treatment was prescribed in 87.7%, and adherence was 65.3% in Morisky-Green test. CONCLUSION: Our results provide a comprehensive picture of fragility fractures identified in FLS units from Spain. Overall, quality indicators are satisfactory although a much higher use of DXA would be desirable. As the registry grows with the incorporation of new FLS units and longer follow-up, incoming analyses will provide valuable insight.

Development and external validation of a 1- and 5-year fracture prediction tool based on electronic medical records data: The EPIC risk algorithm.

OBJECTIVES: We aimed to develop and validate a fracture risk algorithm for the automatic identification of subjects at high risk of imminent and long-term fracture risk. RESEARCH, DESIGN, AND METHODS: A cohort of subjects aged 50-85, between 2007 and 2017, was extracted from the Catalan information system for the development of research in primary care database (SIDIAP). Participants were followed until the earliest of death, transfer out, fracture, or 12/31/2017. Potential risk factors were obtained based on the existing literature. Cox regression was used to model 1 and 5-year risk of hip and major fracture. The original cohort was randomly split in 80:20 for development and internal validation purposes respectively. External validation was explored in a cohort extracted from the Spanish database for pharmaco-epidemiological research in primary care. RESULTS: A total of 1.76 million people were included from SIDIAP (50.7 % women with mean age of 65.4 years). Hip and major fracture incidence rates were 3.57 [95%CI 3.53 to 3.60] and 11.61 [95%CI 11.54 to 11.68] per 1000 person-years, respectively. The derived model included 19 risk factors. Internal validity showed good results on calibration and discrimination. The 1-year C-statistic for hip and major fracture were 0.851 (95%CI 0.853 to 0.864), and 0.717 (95%CI 0.742 to 0.749) respectively. The 5-year C-statistic for hip and major fracture were 0.849 (95%CI 0.847 to 0.852) and 0.724 (95%CI 0.721 to 0.727) respectively. External validation showed good performance for hip and major fracture risk prediction. CONCLUSIONS: We have developed and validated a clinical prediction tool for 1- and 5-year hip and major osteoporotic fracture risks using electronic primary care data. The proposed algorithm can be automatically estimated at the population level using the available primary care records. Future work is needed on the cost-effectiveness of its use for population-based screening and targeted prevention of osteoporotic fractures.

Mortality, Falls, and Fracture Risk Are Positively Associated With Frailty: A SIDIAP Cohort Study of 890 000 Patients.

BACKGROUND: Frail subjects are at increased risk of adverse outcomes. We aimed to assess their risk of falls, all-cause mortality, and fractures. METHOD: We used a retrospective cohort study using the Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària database (>6 million residents). Subjects aged 75 years and older with ≥1 year of valid data (2007-2015) were included. Follow-up was carried out from (the latest of) the date of cohort entry up to migration, end of the study period or outcome (whichever came first). The eFRAGICAP classified subjects as fit, mild, moderate, or severely frail. Outcomes (10th revision of the International Classification of Diseases) were incident falls, fractures (overall/hip/vertebral), and all-cause mortality during the study period. Statistics: hazard ratios (HRs), 95% CI adjusted (per age, sex, and socioeconomic status), and unadjusted cause-specific Cox models, accounting for competing risk of death (fit group as the reference). RESULTS: A total of 893 211 subjects were analyzed; 54.4% were classified as fit, 34.0% as mild, 9.9% as moderate, and 1.6% as severely frail. Compared with the fit, frail had an increased risk of falls (adjusted HR [95% CI] of 1.55 [1.52-1.58], 2.74 [2.66-2.84], and 5.94 [5.52-6.40]), all-cause mortality (adjusted HR [95% CI] of 1.36 [1.35-1.37], 2.19 [2.16-2.23], and 4.29 [4.13-4.45]), and fractures (adjusted HR [95% CI] of 1.21 [1.20-1.23], 1.51 [1.47-1.55], and 2.36 [2.20-2.53]) for mild, moderate, and severe frailty, respectively. Severely frail had a high risk of vertebral (HR of 2.49 [1.99-3.11]) and hip fracture (HR [95% CI] of 1.85 [1.50-2.28]). Accounting for competing risk of death did not change results. CONCLUSION: Frail subjects are at increased risk of death, fractures, and falls. The eFRAGICAP tool can easily assess frailty in electronic primary care databases in Spain.

Association of Tramadol vs Codeine Prescription Dispensation With Mortality and Other Adverse Clinical Outcomes.

Importance: Although tramadol is increasingly used to manage chronic noncancer pain, few safety studies have compared it with other opioids. Objective: To assess the associations of tramadol, compared with codeine, with mortality and other adverse clinical outcomes as used in outpatient settings. Design, Setting, and Participants: Retrospective, population-based, propensity score-matched cohort study using a primary care database with routinely collected medical records and pharmacy dispensations covering more than 80% of the population of Catalonia, Spain (≈6 million people). Patients 18 years or older with 1 or more year of available data and dispensation of tramadol or codeine (2007-2017) were included and followed up to December 31, 2017. Exposures: New prescription dispensation of tramadol or codeine (no dispensation in the previous year). Main Outcomes and Measures: Outcomes studied were all-cause mortality, cardiovascular events, fractures, constipation, delirium, falls, opioid abuse/dependence, and sleep disorders within 1 year after the first dispensation. Absolute rate differences (ARDs) and hazard ratios (HRs) with 95% confidence intervals were calculated using cause-specific Cox models. Results: Of the 1 093 064 patients with a tramadol or codeine dispensation during the study period (326 921 for tramadol, 762 492 for codeine, 3651 for both drugs concomitantly), a total of 368 960 patients (184 480 propensity score-matched pairs) were included after study exclusions and propensity score matching (mean age, 53.1 [SD, 16.1] years; 57.3% women). Compared with codeine, tramadol dispensation was significantly associated with a higher risk of all-cause mortality (incidence, 13.00 vs 5.61 per 1000 person-years; HR, 2.31 [95% CI, 2.08-2.56]; ARD, 7.37 [95% CI, 6.09-8.78] per 1000 person-years), cardiovascular events (incidence, 10.03 vs 8.67 per 1000 person-years; HR, 1.15 [95% CI, 1.05-1.27]; ARD, 1.36 [95% CI, 0.45-2.36] per 1000 person-years), and fractures (incidence, 12.26 vs 8.13 per 1000 person-years; HR, 1.50 [95% CI, 1.37-1.65]; ARD, 4.10 [95% CI, 3.02-5.29] per 1000 person-years). No significant difference was observed for the risk of falls, delirium, constipation, opioid abuse/dependence, or sleep disorders. Conclusions and Relevance: In this population-based cohort study, a new prescription dispensation of tramadol, compared with codeine, was significantly associated with a higher risk of subsequent all-cause mortality, cardiovascular events, and fractures, but there was no significant difference in the risk of constipation, delirium, falls, opioid abuse/dependence, or sleep disorders. The findings should be interpreted cautiously, given the potential for residual confounding.

Validation of fragility fractures in primary care electronic medical records: a population-based study / Validación de las fracturas por fragilidad en la historia clínica informatizada de atención primaria: un estudio poblacional

PURPUSE: Electronic medical records databases use pre-specified lists of diagnostic codes to identify fractures. These codes, however, are not specific enough to disentangle traumatic from fragility-related fractures. We report on the proportion of fragility fractures identified in a random sample of coded fractures in SIDIAP. METHODS: Patients≥50 years old with any fracture recorded in 2012 (as per pre-specified ICD-10 codes) and alive at the time of recruitment were eligible for this retrospective observational study in 6 primary care centres contributing to the SIDIAP database (www.sidiap.org). Those with previous fracture/s, non-responders, and those with dementia or a serious psychiatric disease were excluded. Data on fracture type (traumatic vs fragility), skeletal site, and basic patient characteristics were collected. RESULTS: Of 491/616 (79.7%) patients with a registered fracture in 2012 who were contacted, 331 (349 fractures) were included. The most common fractures were forearm (82), ribs (38), and humerus (32), and 225/349 (64.5%) were fragility fractures, with higher proportions for classic osteoporotic sites: hip, 91.7%; spine, 87.7%; and major fractures, 80.5%. This proportion was higher in women, the elderly, and patients with a previously coded diagnosis of osteoporosis. CONCLUSIONS: More than 4 in 5 major fractures recorded in SIDIAP are due to fragility (non-traumatic), with higher proportions for hip (92%) and vertebral (88%) fracture, and a lower proportion for fractures other than major ones. Our data support the validity of SIDIAP for the study of the epidemiology of osteoporotic fractures

OBJETIVOS: La historia clínica informatizada utiliza una lista de códigos diagnósticos pre-especificados para identiticar fracturas, pero estos códigos no permiten distinguir entre fracturas traumáticas y fracturas por fragilidad. Se reporta la proporción de fracturas por fragilidad identificadas en una muestra aleatorizada de fracturas codificadas en SIDIAP. MÉTODOS: Estudio observacional retrospectivo realizado en 6 centros de atención primaria que contribuyen a la base de datos SIDIAP (www.sidiap.org). Se seleccionaron pacientes ≥50 años con cualquier fractura registrada en 2012 (mediante códigos CIE-10) que permanecieran vivos en el reclutamiento y excluyendo aquellos con fractura previa, contacto imposible o aquellos con demencia o trastorno mental severo. Se recogió información sobre tipo de fractura (traumática o fragilidad), localización y características descriptivas de los pacientes. RESULTADOS: Un total de 491/616 (79,7%) de los pacientes con fractura en 2012 fueron contactados y 331 (349 fracturas) fueron incluidos. Las fracturas más comunes fueron antebrazo (82), costillas (38) y húmero (32); 225/349 (64,5%) fueron fracturas por fragilidad, con mayor proporción para las localizaciones típicas de la osteoporosis: fémur (91,7%), columna vertebral (87,7%) y fracturas principales (80,5%). La proporción fue mayor en mujeres, edad avanzada y pacientes con diagnóstico previo de osteoporosis. CONCLUSIONES: Más de 4 de cada 5 fracturas principales registradas en SIDIAP son por fragilidad, con una mayor proporción para fémur (92%) y columna verterbal (88%), y menor proporción para otras localizaciones no típicas. Nuestros datos apoyan la validación de SIDIAP para el estudio epidemiológico de las fracturas osteoporóticas

Validation of fragility fractures in primary care electronic medical records: A population-based study.

PURPOSE: Electronic medical records databases use pre-specified lists of diagnostic codes to identify fractures. These codes, however, are not specific enough to disentangle traumatic from fragility-related fractures. We report on the proportion of fragility fractures identified in a random sample of coded fractures in SIDIAP. METHODS: Patients≥50 years old with any fracture recorded in 2012 (as per pre-specified ICD-10 codes) and alive at the time of recruitment were eligible for this retrospective observational study in 6 primary care centres contributing to the SIDIAP database (www.sidiap.org). Those with previous fracture/s, non-responders, and those with dementia or a serious psychiatric disease were excluded. Data on fracture type (traumatic vs fragility), skeletal site, and basic patient characteristics were collected. RESULTS: Of 491/616 (79.7%) patients with a registered fracture in 2012 who were contacted, 331 (349 fractures) were included. The most common fractures were forearm (82), ribs (38), and humerus (32), and 225/349 (64.5%) were fragility fractures, with higher proportions for classic osteoporotic sites: hip, 91.7%; spine, 87.7%; and major fractures, 80.5%. This proportion was higher in women, the elderly, and patients with a previously coded diagnosis of osteoporosis. CONCLUSIONS: More than 4 in 5 major fractures recorded in SIDIAP are due to fragility (non-traumatic), with higher proportions for hip (92%) and vertebral (88%) fracture, and a lower proportion for fractures other than major ones. Our data support the validity of SIDIAP for the study of the epidemiology of osteoporotic fractures.

"Burden of osteoporotic fractures in primary health care in Catalonia (Spain): a population-based study".

BACKGROUND: Knowledge on the epidemiology of non-hip fractures in Spain is limited and somewhat outdated. Using computerized primary care records from the SIDIAP database, we derived age and sex-specific fracture incidence rates for the region of Catalonia during the year 2009. METHODS: The SIDIAP database contains quality-checked clinical information from computerized medical records of a representative sample of >5,800,000 patients (80% of the population of Catalonia). We conducted a retrospective cohort study including all patients aged ≥50 years, and followed them from January 1 to December 31, 2009. Major osteoporotic fractures registered in SIDIAP were ascertained using ICD-10 codes and validated by comparing data to hospital admission and patient-reported fractures records. Incidence rates and 95% confidence intervals were calculated. RESULTS: In total, 2,011,430 subjects were studied (54.6% women). Overall fracture rates were 10.91/1,000 person-years (py) [95%CI 10.89-10.92]: 15.18/1,000 py [15.15-15.21] in women and 5.78/1,000 py [5.76-5.79] in men. The most common fracture among women was wrist/forearm (3.86/1,000 py [3.74-3.98]), while among men it was clinical spine (1.25/1,000 py [1.18-1.33]). All fracture rates increased with age, but varying patterns were observed: while most of the fractures (hip, proximal humerus, clinical spine and pelvis) increased continuously with age, wrist and multiple rib fractures peaked at age 75-80 and then reached a plateau. CONCLUSIONS: Our study provides local estimates of age, sex and site-specific fracture burden in primary health care, which will be helpful for health-care planning and delivery. A proportion of fractures are not reported in primary care records, leading to underestimation of fracture incidence rates in these data.

The association between fracture and obesity is site-dependent: a population-based study in postmenopausal women.

The association between obesity and fracture is controversial. We investigated the relationship between body mass index (BMI) and fracture at different skeletal sites in women aged ≥50 years using data from the Sistema d' Informació per al Desenvolupament de la Investigació en Atenció Primària (SIDIAP) database. SIDIAP contains the computerized medical records of >3400 general practitioners in Catalonia (northeastern Spain), with information on a representative 80% of the population (>5 million people). In 2009, 1,039,878 women aged ≥50 years were eligible, of whom 832,775 (80.1%) had a BMI measurement. These were categorized into underweight/normal (302,414 women), overweight (266,798), and obese (263,563). Fractures were ascertained using the International Classification of Diseases, 10th revision (ICD-10) codes. Multivariate Poisson regression models were fitted to adjust for age, smoking, high alcohol intake, type 2 diabetes, and oral corticosteroid use. Hip fractures were significantly less common in overweight and obese women than in normal/underweight women (rate ratio [RR] 0.77 [95% confidence interval (CI) 0.68 to 0.88], RR 0.63 [95% CI 0.64 to 0.79], p < 0.001, respectively). Pelvis fracture rates were lower in the overweight (RR 0.78 [95% CI 0.63 to 0.96], p = 0.017) and obese (RR 0.58 [95% CI 0.47 to 0.73], p < 0.001) groups. Conversely, obese women were at significantly higher risk of proximal humerus fracture than the normal/underweight group (RR 1.28 [95% CI 1.04 to 1.58], p = 0.018). Clinical spine, wrist, tibial, and multiple rib fracture rates were not significantly different between groups. An age-related increase in incidence was seen for all BMI groups at all fracture sites; obese women with hip, clinical spine, and pelvis fracture were significantly younger at the time of fracture than normal/underweight women, whereas those with wrist fracture were significantly older. The association between obesity and fracture in postmenopausal women is site-dependent, obesity being protective against hip and pelvis fractures but associated with an almost 30% increase in risk for proximal humerus fractures when compared with normal/underweight women. The reasons for these site-specific variations are unknown but may be related to different patterns of falls and attenuation of their impact by adipose tissue.

Análisis del cumplimiento terapéutico en mujeres con osteoporosis / Analysis of therapeutic compliance in women with osteoporosis

Objetivo: Evaluar el cumplimiento del tratamiento farmacológico de la osteoporosis en mujeres atendidas en el ámbito de la Atención Primaria (AP). En la osteoporosis, como en otras enfermedades crónicas, el fomento del tratamiento a largo plazo es fundamental. Pacientes y métodos: Se trata de un estudio observacional, descriptivo, transversal y multicéntrico, realizado en Centros de Salud de AP de las 17 Comunidades Autónomas. Se reclutaron 1.649 mujeres que habían iniciado tratamiento farmacológico para la osteoporosis al menos 3 meses antes. Para evaluar el cumplimiento se utilizaron dos cuestionarios: el test de Haynes-Sackett o de cumplimiento autocomunicado (CA) y el test de Morisky-Green (MG). Resultados: La edad media (± DE) de las pacientes era de 66,6 años (9,5) y el tiempo medio desde el diagnóstico era de 5,1 años (4,9). El tratamiento más prescrito fueron los bisfosfonatos (82% de las pacientes) y sólo un 52% recibía suplementos de calcio y vitamina D. El análisis del nivel de cumplimiento muestra que el 68,7% fue incumplidora según el test de MG, y el 11,2% fue incumplidora según el test de CA. Conclusiones: Un porcentaje importante de las mujeres con osteoporosis posmenopáusicas atendidas en AP en España presenta un elevado incumplimiento terapéutico (AU)

Objective: To assess therapeutic compliance in osteoporosis in women in a Primary Care (PC) setting. Patients and methods: Observational, descriptive, cross-sectional and multicenter study, conducted in PC centers of the 17 Spanish Autonomous Regions. 1,649women who had initiated treatment for osteoporosis at least 3 months before entering the study were recruited. To assess therapeutic compliance, two questionnaires, the Haynes-Sackett or self-communicated compliance test (AC) and the Morisky-Green test (MG) were used. Results: Patients’ mean age (±SD) was 66.59 years (9.5) and the mean time since diagnosis was 5.08 years (4.87). Bisphosphonates were the most precribed drugs (82% of the patients) and only 52% of the patients were taking calcium and vitaminDsupplements. Analysis of the therapeutic compliance level shows that, as per the MG test, 68.7% of the patients were non-compliers, and 11.2% were non-compliers as per the AC test. Conclusions: An important percentage ofwomenwith post-menopausal osteoporosis in Spain’s PC setting show a high level of non-compliance (AU)

[Analysis of therapeutic compliance in women with osteoporosis]. / Análisis del cumplimiento terapéutico en mujeres con osteoporosis.

OBJECTIVE: To assess therapeutic compliance in osteoporosis in women in a Primary Care (PC) setting. PATIENTS AND METHODS: Observational, descriptive, cross-sectional and multicenter study, conducted in PC centers of the 17 Spanish Autonomous Regions. 1,649 women who had initiated treatment for osteoporosis at least 3 months before entering the study were recruited. To assess therapeutic compliance, two questionnaires, the Haynes-Sackett or self-communicated compliance test (AC) and the Morisky-Green test (MG) were used. RESULTS: Patients' mean age (± SD) was 66.59 years (9.5) and the mean time since diagnosis was 5.08 years (4.87). Bisphosphonates were the most precribed drugs (82% of the patients) and only 52% of the patients were taking calcium and vitamin D supplements. Analysis of the therapeutic compliance level shows that, as per the MG test, 68.7% of the patients were non-compliers, and 11.2% were non-compliers as per the AC test. CONCLUSIONS: An important percentage of women with post-menopausal osteoporosis in Spain's PC setting show a high level of non-compliance.