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

Abstract

BackgroundToday, 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.Methods/DesignStudy 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.DiscussionThe 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.

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

“…The recruitment and characteristics of the ESOSVAL cohort have been fully described elsewhere . In brief, the cohort consists of 11,035 women and men aged 50 years and over attending 272 primary healthcare centers in the VHA for any health problem between November 2009 and September 2010.…”

“…The exclusion criteria included temporary residents, individuals with cognitive impairment, people receiving their usual care through private insurance companies, people physically unable to attend their primary healthcare center, and people of Asian or African descent. The criteria for the selection of clinicians and patients have been fully described previously …”

“…The recruitment and characteristics of the ESOSVAL cohort have been fully described elsewhere. (30,31) In brief, the cohort consists of 11,035 women and men aged 50 years and over attending 272 primary healthcare centers in the VHA for any health problem between November 2009 and September 2010. The subjects were recruited opportunistically by 329 general practitioners and 279 primary-care nurses collaborating in the ESOSVAL study and following definite criteria, attempting to get the age distribution as close as possible to the distribution of the region's population.…”

Cost-effectiveness of bazedoxifene versus raloxifene in the treatment of postmenopausal women in Spain

“…A recent cost-effectiveness analysis comparing bazedoxifene with placebo used the FRAX® tool (World Health Organization Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK) that provides fracture probabilities for specific populations 18. Although FRAX can be used to predict the probability of hip or other major osteoporotic fractures, the criteria should not be generalized to other countries having different fracture incidence rates and health care costs 21. Therefore, when comparing the cost-effectiveness of bazedoxifene with raloxifene in Spanish women with osteoporosis, it is important to take into account that the incidence of fractures is different between southern European countries and countries in the Scandinavian region 22,23.…”

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

“…Its objective is to develop a predictive risk scale for osteoporotic fractures for the adult population of the Valencia Region, to evaluate its validity, and to generate the information necessary for defining treatment criteria based on the fracture risk [18]. …”