Global epidemiology of hip fractures: a study protocol using a common analytical platform among multiple countries

INTRODUCTION: Hip fractures are associated with a high burden of morbidity and mortality. Globally, there is wide variation in the incidence of hip fracture in people aged 50 years and older. Longitudinal and cross-geographical comparisons of health data can provide insights on aetiology, risk factors, and healthcare practices. However, systematic reviews of studies that use different methods and study periods do not permit direct comparison across geographical regions. Thus, the objective of this study is to investigate global secular trends in hip fracture incidence, mortality and use of postfracture pharmacological treatment across Asia, Oceania, North and South America, and Western and Northern Europe using a unified methodology applied to health records. METHODS AND ANALYSIS: This retrospective cohort study will use a common protocol and an analytical common data model approach to examine incidence of hip fracture across population-based databases in different geographical regions and healthcare settings. The study period will be from 2005 to 2018 subject to data availability in study sites. Patients aged 50 years and older and hospitalised due to hip fracture during the study period will be included. The primary outcome will be expressed as the annual incidence of hip fracture. Secondary outcomes will be the pharmacological treatment rate and mortality within 12 months following initial hip fracture by year. For the primary outcome, crude and standardised incidence of hip fracture will be reported. Linear regression will be used to test for time trends in the annual incidence. For secondary outcomes, the crude mortality and standardised mortality incidence will be reported. ETHICS AND DISSEMINATION: Each participating site will follow the relevant local ethics and regulatory frameworks for study approval. The results of the study will be submitted for peer-reviewed scientific publications and presented at scientific conferences

Systematic review and meta-analysis of Transurethral Needle Ablation in symptomatic Benign Prostatic Hyperplasia

BACKGROUND: Benign prostatic hyperplasia (BPH) constitutes a major clinical problem. Minimally invasive therapies for the treatment of symptomatic BPH include Transurethral Needle Ablation (TUNA), but it is unclear what impact this technique has on the disease and its role among other currently available therapeutic options. The objective of this study is to ascertain the efficacy and safety of TUNA in the treatment of BPH. METHODS: Systematic review of the literature until January 2005 and meta-analysis of clinical studies assessing TUNA in symptomatic BPH. Studies were critically appraised. Estimates of effect were calculated according to the random-effects model. RESULTS: 35 studies (9 comparative, 26 non-comparative) were included. Although evidence was limited by methodological issues, the analysis of relevant outcomes indicates that while TUNA significantly improves BPH parameters with respect to baseline, it does not reach the same level of efficacy as TURP in respect to all subjective and objective variables. Further, its efficacy declines in the long-term with a rate of secondary-treatment significantly higher than of TURP [OR: 7.44 (2.47, 22.43)]. Conversely, TUNA seems to be a relatively safe technique and shows a lower rate of complications than TURP [OR:0.14 (0.05, 0.14)] with differences being particularly noteworthy in terms of postoperative bleeding and sexual disorders. Likewise, TUNA has fewer anesthetic requirements and generates a shorter hospital stay than TURP [WMD: -1.9 days (-2.75, -1.05)]. Scarce data and lack of replication of comparisons hinder the assessment of TUNA vs. other local therapies. No comparisons with medical treatment were found. CONCLUSION: The body of evidence on which TUNA has been introduced into clinical practice is of only moderate-low quality. Available evidence suggest that TUNA is a relatively effective and safe technique that may eventually prove to have a role in selected patients with symptomatic BPH. TUNA significantly improves BPH parameters with respect to baseline values, but it does not reach the same level of efficacy and long-lasting success as TURP. On the other hand, TUNA seems to be superior to TURP in terms of associated morbidity, anesthetic requirements and length of hospital stay. With respect to the role of TUNA vis-à-vis other minimally invasive therapies, the results of this review indicate that there are insufficient data to define this with any degree of accuracy. Overall cost-effectiveness and the role of TUNA versus medical treatment need further evaluation

The association of allergic symptoms with sensitization to inhalant allergens in childhood

Although it is generally agreed that sensitization is an important risk factor for allergic diseases, the extent to which sensitization accounts for allergic symptoms in children is controversial. As part of the Aalst Allergy Study, this cross-sectional study investigated the prevalence of allergic symptoms and their association with sensitization in an unselected population of Flemish children aged 3.4-14.8 yr. Skin prick testing with the most common aeroallergens was performed and allergic symptoms were documented by a parental questionnaire. In the children older than 6 yr, a significant association of current wheezing, current dyspnea, airway hyperreactivity, rhinoconjunctivitis, and current eczema with sensitization was found, while in the pre-school children these associations were less pronounced. The association with sensitization was strongest for rhinoconjunctivitis and current respiratory symptoms - the association was less striking for children with current eczema. The impact of a positive family history of allergy on the association with sensitization was more important for eczema than for the other analyzed allergic symptoms. Persistent and late-onset wheezers were significantly more likely than non-wheezers and transient early wheezers to be associated with sensitization and a personal history of rhinoconjunctivitis. Late-onset wheezing was associated with a positive family history of allergy, while transient early wheezing was associated with day-care attendance. An association with eczema was found for all three childhood wheezing phenotypes. The association of allergic symptoms with sensitization is significant in the older but less pronounced in pre-school children and is more pronounced for current allergic symptoms. Diagnosis and disease definition of allergy symptoms remains difficult at pre-school age. The influence of a positive family history of allergy on the association of the respective allergic symptoms with sensitization was most important for eczema. Our data confirm the atopic characteristics of the different wheeze phenotypes

Tiotropium Handihaler and the risk of cardio- or cerebrovascular events and mortality in patients with COPD

Background: Tiotropium has been associated with an increased risk of mortality and/or cardiovascular events. Recent data from RCTs suggests tiotropium Handihaler to be safe, but its safety has not yet been fully investigated under real-life circumstances. Methods: We conducted 2 nested case-control studies in a COPD cohort from the Dutch IPCI database. In the first case-control study, cases had a cardiovascular or cerebrovascular endpoint (CCVE): stroke and transient ischemic attack (TIA), myocardial infarction, heart failure and/or ventricular arrhythmia. In the second, cases were all patients who died. Cases were matched to controls on age, sex and index date. Conditional logistic regression analysis was used to calculate adjusted odds ratios ( Results: Within a cohort of 6788 COPD patients, 784 CCVE's and 1032 deaths were reported. Compared to current LABA use, use of tiotropium Handihaler was neither associated with an increased risk of a CCVE (ORadj 0.89, 95% 0.55-1.44) nor with an increased risk of death (ORadj 0.79, 95% Cl 0.49-1.28). Conclusions: In real life, use of tiotropium Handihaler in COPD patients is not associated with an increased risk of a CCVE or mortality compared to LABA. (C) 2011 Elsevier Ltd. All rights reserved

Databases for pediatric medicine research in Europe - Assessment and critical appraisal

Purpose: To identify and describe European health care databases that can be used for pediatric pharmacoepidemiological research. Methods: A web-based survey was conducted among all European databases that were listed on the website of the International Society of Pharmacoepidemiology (ISPE)and/or known by an expert group. The survey comprised of questions regarding (a) the nature of the database, (b) database size, (c) demographic, clinical and drug related data provided, (d) cost, and (e) accessibility of the database. Results: A total of 25 data sources from 12 European countries were identified and invited to participate in the survey. Responses were obtained from 21 (84%) databases located in 10 different European countries. Seventeen databases were included in the assessment comprising a total of at least 9 million children aged 0-18 years. The majority of databases are based on outpatient data and all keep either prescription or drug dispensing data. Ten databases are based on electronic patient records from primary care physicians and five databases are predominantly claims oriented. Three databases do not belong to either of the above mentioned categories. Almost all of the databases can be used for pediatric drug utilization studies. For drug safety studies it is more appropriate to use electronic patient record databases because of the available clinical information and the potential to obtain additional information. Conclusions: There are many European healthcare databases providing an enormous potential for pediatric pharmacoepidemiological research. Future research should focus on methods to bring data from different databases together to use the full capacity effectively. Copyright © 2008 John Wiley & Sons, Ltd.link_to_subscribed_fulltex

Comparison of antiepileptic drug prescribing in children in three European countries

Purpose: Antiepileptic drug (AED) use in young people is increasing. However, evidence of its use at a multinational level is limited. This study aims to characterize AED prescribing in the young in three European countries and to assess the capacity of drug safety surveillance. Methods: A retrospective cohort study was conducted in 2001-2005 using primary care databases: PEDIANET (Italy, 0-11 years), IPCI (The Netherlands, 0-18 years), and IMS Disease Analyzer (United Kingdom, 0-18 years). Prescribing prevalence was calculated by country, patient age, and drug type. Results: In 2005, AED prevalence in children (0-11 years) was highest in Italy [3.9 subjects/1,000 person-years (PY)] followed by the United Kingdom (3.0 subjects/1,000 PY) and The Netherlands (2.2 subjects/1,000 PY). Over the study period, prescribing prevalence in 0-11 year olds was stable in all countries. In contrast, a steady rise of AED prevalence was observed in adolescents (12-18 years) in the United Kingdom (p = 0.0003) but not in The Netherlands (p = 0.88). All countries showed a slight increase in prevalence for newer AEDs. Simultaneously, the prevalence of conventional AEDs decreased in The Netherlands and Italy, but not in the United Kingdom. In 2005, lamotrigine use was highest in The Netherlands and the United Kingdom, whereas topiramate was favored in Italy. Discussion: In Europe, conventional AEDs are still the main treatment choice for children with epilepsy, and the use of newer AEDs remains low. Our study highlights a lack of research capacity to conduct multinational AED safety studies in children. Further work should explore large databases and other health care settings to meet these research needs. © 2009 International League Against Epilepsy.link_to_subscribed_fulltex