Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting.

Validity of the Global Activity Limitation Indicator (GALI) to evaluate severity of disability.

Our aim was to estimate the validity of the Global Activity Limitation Indicator (GALI) when measuring the severity level of disability. Data came from 153 residents of Spain, who requested an evaluation of their degree of disability. We compared disability classifications (severe vs.

Systematic review and meta-analysis of endovenous cyanoacrylate adhesive ablation for incompetent saphenous veins.

Objective: The objective of this study was to assess the effectiveness, safety, and quality of care afforded by cyanoacrylate ablation (CA) vs existing options in treating great saphenous vein incompetence.

Methods: We conducted a systematic review; used the Grading of Recommendations Assessment, Development, and Evaluation framework; assessed the quality of randomized clinical trials using the Cochrane risk of bias tool; and performed a meta-analysis on the available comparative measurements.

Results: Three comparative studies, two randomized controlled trials and one observational study comprising 1057 participants, were included for effectiveness assessment purposes.

Associations between chronic conditions, body functions, activity limitations and participation restrictions: a cross-sectional approach in Spanish non-clinical populations.

Objectives: To analyse the relationships between chronic conditions, body functions, activity limitations and participation restrictions in the International Classification of Functioning, Disability and Health (ICF) framework.

Design: A cross-sectional study.

Setting: 2 geographical areas in the Autonomous Region of Aragon, Spain, namely, a rural area, Cinco Villas, and an urban area in the city of Zaragoza.

Economic evaluation of Chagas disease screening in Spain.

Although Spain is the European country with the highest Chagas disease burden, the country does not have a national control program of the disease. The purpose of this study is to evaluate the efficiency of several strategies for Chagas disease screening among Latin American residents living in Spain. The following screening strategies were evaluated: (1) non-screening; (2) screening of the Latin American pregnant women and their newborns; (3) screening also the relatives of the positive pregnant women; (4) screening also the relatives of the negative pregnant women.

Budget impact and cost-utility analysis of universal infant rotavirus vaccination in Spain.

Rotavirus is not included in the Spanish mass infant vaccination schedule but has also not been economically evaluated for its inclusion. We analysed cost-utility of the universal infant rotavirus vaccination using RotaTeq® versus no vaccination in Spain. We also carried out a budget impact analysis and determined the effect on results of different variables introduced in the model.

Diagnosis and management of acute pharyngitis in a paediatric population: a cost-effectiveness analysis.

Acute pharyngitis is one of the most frequent causes of primary care physician visits; however, there is no agreement about which is the best strategy to diagnose and manage acute pharyngitis in children. The aim of the current study was to evaluate the cost-effectiveness of the recommended strategies to diagnose and manage acute pharyngitis in a paediatric population. A decision tree analysis was performed to compare the following six strategies: "treat all", "clinical scoring", "rapid test", "culture", "rapid test + culture" and "clinical scoring + rapid test".

[Smoking-attributable deaths in Spain, 2006].

Background And Objective: This study estimates smoking-attributable mortality in Spain in 2006.

Population And Method: Source data included 1) smoking prevalence in Spain; 2) deaths occurred in Spain; and 3) relative risks of mortality by tobacco-caused diseases drawn from the Cancer Prevention Study II. All data corresponded to individuals aged 35 years and older.

Internal evaluation of the European network for health technology assessment project.

Objectives: The internal evaluation studied the development of the European network for Health Technology Assessment (EUnetHTA) Project in achieving the general objective of establishing an effective and a sustainable network of health technology assessment (HTA) in Europe.

Methods: The Work Package 3 group was dedicated to this task and performed the work. Information on activities during the project was collected from three sources.

Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis.

Background: Intragastric balloons have been used since 1985 to treat obesity, but an evidence-based systematic review had not been previously performed. The objective of this study is to determine the safety, efficacy, and effectiveness of the most widely used balloon, BioEnterics Intragastric Balloon (BIB), to treat obesity.

Methods: Systematic literature review of Medline, Embase, and other information sources from inception to March 2006.

[Recent decrease in smoking-attributable mortality in Spain].

Background And Objective: Certain diseases related to smoking have recently decreased in Spanish adults. This study estimated the burden of smoking-attributable mortality in Spain currently and in previous years.

Population And Method: Smoking prevalence and mortality in Spain, and relative risks for death from the Cancer Prevention Study II were used to estimate tobacco-attributable mortality in the Spanish population aged 35 years and over.

[Characteristics of 107 Spanish healthcare registries and evaluation of the utilization thereof].

Background: The information concerning the currently existing healthcare registries in our country is not readily accessible, is scarce and some are not well-known, possibly being underused in comparison to their many potential uses. This study is aimed at evaluating the characteristics of the Spanish Healthcare registries and the utilization thereof, especially in Healthcare technology assessment.

Methods: Descriptive, cross-sectional study of the Spanish Healthcare registries within the 1997-2002 period.

Subjective health of male ex-smokers: relationship with time since smoking cessation, intensity and duration of tobacco consumption.

Background: To examine the relationship of subjective health with time since smoking cessation and amount and duration of tobacco consumption among male ex-smokers.

Methods: Pooled analysis of three household interview surveys conducted in 1993 (n = 8,494), 1995 (n = 2,556), and 1997 (n = 2,624) on samples representative of the noninstitutionalized population aged 16 and over in Spain.

Results: After controlling for the main confounders, ex-smokers with smoking burden < or =13 pack-years had a lower frequency of suboptimal health (fair, poor, or very poor) than current smokers (OR, 0.