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

Risk of bleeding in patients undergoing percutaneous endoscopic gastrotrostomy (PEG) tube insertion under antiplatelet therapy: a systematic review with a meta-analysis

Background and aim: Patients undergoing percutaneous endoscopic gastrostomy (PEG) tube placement often are under antiplatelet therapy with a potential thromboembolic risk if these medications are discontinued. This systematic review aims to assess if maintaining aspirin and/or clopidogrel treatment increases the risk of bleeding following PEG placement. Methods: A systematic search of the MEDLINE, EMBASE, and SCOPUS databases was developed for studies investigating the risk of bleeding in patients on antiplatelet therapy undergoing PEG tube insertion. Summary estimates, including 95 % confidence intervals (CI), were calculated. A fixed or random effects model was used depending on heterogeneity (I²). Publication bias risks were assessed by means of funnel plot analysis. Results: Eleven studies with a total of 6,233 patients (among whom 3,665 were undergoing antiplatelet treatment), met the inclusion criteria and were included in the quantitative summary. Any PEG tube placement-related bleeding was found in 2.67 % (95 % CI 1.66 %, 3.91 %) of the entire population and in 2.7 % (95 % CI 1.5 %, 4.1 %) of patients not receiving antiplatelet therapy. Pooled relative risk (RR) for bleeding in patients under aspirin, when compared to controls, was 1.43 (95 % CI 0.89, 2.29; I² = 0 %); pooled RR for clopidogrel was 1.21 (95 % CI 0.48, 3.04; I² = 0 %) and for dual antiplatelet therapy, 2.13; (95 % CI 0.77, 5.91; I² = 47 %). No significant publication bias was evident for the different medications analyzed. Conclusion: Antiplatelet therapy was safe among patients undergoing PEG tube insertion. Future prospective and randomized studies with larger sample sizes are required to confirm the results of this study

Transcultural adaptation and validation of the "Adult Eosinophilic Esophagitis Quality of Life Questionnaire" into Spanish

Background: The "Adult Eosinophilic Esophagitis Quality of Life (EoE-QoL-A) Questionnaire" was developed in English as a valid, reliable, and disease-specific health-related QoL measure. This research aims to adapt and validate this questionnaire for Spanish-speaking patients. Patients and methods: A multicenter, observational, prospective study was conducted at 8 Spanish hospitals. The cultural adaptation of the original EoE-QoL-A questionnaire was undertaken through a standardized 3-phase procedure: 1. Translation; 2. Retrotranslation; and 3. Pilot study. Patients completed the Hospital Anxiety and Depression Scale (HADS), the Short Form (SF)-12, the Brief Illness Perception Questionnaire (BIPQ), and the adapted EoE-QoL-A, with a retest 3 months later. Statistical analysis included construct validity, internal consistency, criterion validity, and reproducibility. Results: One hundred and seventy adult EoE patients (73.5 % male; aged 33.5 ± 11.4-y) were included in the study. With regard to internal validity, all Cronbach alpha values were > 0.75. A significant correlation between items assessed in the SF-12, BIPQ and EoE-QoL-A questionnaires (p < 0.001) was observed. Correlations with the HADS were stronger for anxiety than for depression levels. Anxiety related to disease diagnosis and choking were the most affected dimensions; less affected were the dimensions related to eating, social, and emotional development. Intraclass correlation coefficients between the test and retest assessments were acceptable for all questionnaires, with the highest values (0.73-0.84) calculated for the EoE-QoL-A Spanish version. Conclusion: The Spanish version of the EoE-QoL-A is a reliable, valid, and responsive questionnaire. Diagnosis and choking anxiety were the most affected dimensions in the health-related QoL in adult EoE patients