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. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.

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. non-severe) from GALI against those from the 36-item questionnaire WHODAS 2.0, the current gold standard measure of disability. The sensitivity of GALI to detect severe disability was 58.3% [95% confidence interval (CI):43.2-72.4], and the specificity was 84.8% (95% CI: 76.4-91.0). Thus, the validity of GALI to accurately categorize the degree of severity of an individual's disability is not high, this in great part due to its limited sensitivity.

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. PARTICIPANTS: 864 individuals selected by simple random sampling from the register of Social Security card holders, aged 50 years and over, positive to disability screening. MAIN OUTCOME MEASURES: ICF Checklist-body function domains, WHO Disability Assessment Schedule 2.0 (WHODAS 2.0, 36-item (WHODAS-36)) global scores and medical diagnoses (chronic conditions) from primary care records. RESULTS: Mild disability (WHODAS-36 level 5-24%) was present in 51.5% of the sample. In the adjusted ordinal regression model with WHODAS-36 as the dependent variable, disability was substantially associated with moderate-to-complete impairment in the following functions: mental, OR 212.8 (95% CI 72 to 628.9); neuromusculoskeletal, OR 44.8 (24.2 to 82.8); and sensory and pain, OR 6.3 (3.5 to 11.2). In the relationship between health conditions and body function impairments, the strongest links were seen for: dementia with mental functions, OR 50.6 (25.1 to 102.1); cerebrovascular disease with neuromusculoskeletal function, OR 5.8 (3.5 to 9.7); and chronic renal failure with sensory function and pain, OR 3.0 (1.49 to 6.4). Dementia, OR 8.1 (4.4 to 14.7) and cerebrovascular disease, OR 4.1 (2.7 to 6.4) were associated with WHODAS-36 scores. CONCLUSIONS: Body functions are heterogeneously linked to limitations in activities and restrictions on participation, with the highest impact being due to mental and musculoskeletal functions. This may be relevant for disability assessment and intervention design, particularly if defined on a body function basis. Control of specific health conditions, such as dementia and cerebrovascular disease, appears to be paramount in reducing disability among persons aged 50 years and over.

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. A cost-utility analysis was carried out to compare the four strategies from two perspectives, the societal and the Spanish National Health System (SNHS). A decision tree representing the clinical evolution of Chagas disease throughout patient's life was built. The strategies were compared through the incremental cost-utility ratio, using euros as cost measurement and quality-adjusted life years as utility measurement. A sensitivity analysis was performed to test the model parameters and their influence on the results. We found the "Non-screening" as the most expensive and less effective of the evaluated strategies, from both the societal and the SNHS perspectives. Among the screening evaluated strategies the most efficient was, from both perspectives, to extent the antenatal screening of the Latin American pregnant women and their newborns up to the relatives of the positive women. Several parameters influenced significantly on the sensitivity analyses, particularly the chronic treatment efficacy or the prevalence of Chagas disease. In conclusion, for the general Latin American immigrants living in Spain the most efficient would be to screen the Latin American mothers, their newborns and the close relatives of the mothers with a positive serology. However for higher prevalence immigrant population the most efficient intervention would be to extend the program to the close relatives of the negative mothers.

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. A deterministic Markov model was built considering loss of quality of life for children and their parents, and introducing direct and indirect costs updated to 2011. The introduction of the vaccination using RotaTeq® as a universal infant vaccination would increase the annual health care budget in 10.43 million euro and would result in a gain of an additional Quality Adjusted Life Year at a cost of 280,338€ from the healthcare system perspective and 210,167€ from the societal perspective. The model was stable to variable modifications. To sum up, according to our model and estimates, the introduction of a universal infant rotavirus vaccination with RotaTeq® in Spain would cause a large impact on the health care budget and would not be efficient unless significant variations in vaccine price, vaccine efficacy and/or utilities took place.

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". The cost data came from the Spanish National Health Service sources. Cost-effectiveness was calculated from the payer's perspective. Effectiveness was measured as the proportion of patients cured without complications from the disease and did not have any reaction to penicillin therapy; a sensitivity analysis was performed. The findings revealed that the "clinical scoring + rapid test" strategy is the most cost-effective, with a cost-effectiveness ratio of 50.72 . This strategy dominated all others except "culture", which was the most effective but also the most costly. The sensitivity analysis showed that "rapid test" became the most cost-effective strategy when the clinical scoring sensitivity was <91% and its specificity was ≤9%. In conclusion, the use of a clinical scoring system to triage the diagnoses and performing a rapid antigen test for those with a high score is the most cost-effective strategy for the diagnosis and management of acute pharyngitis in children. When the clinical scoring system has a low diagnostic accuracy, testing all patients with rapid test becomes the most cost-effective strategy.

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. First, three yearly cross-sectional studies surveyed the participants' opinions. Responses were by individuals or by institutions. The last round included surveys to the Steering Committee, the Stakeholder Forum, and the Secretariat. Second, the Work Package Lead Partners were interviewed bi-annually, five times in total, to update the information on the Project's progress. Third, additional information was sought in available documents. RESULTS: The organizational structure remained stable. The Project succeeded in developing tools aimed at providing common methodology with intent to establish a standard of conducting and reporting HTA and to facilitate greater collaboration among agencies. The participants/agencies expressed their belief in a network and in maintaining local/national autonomy. The Work Package Leaders expressed a strong belief in the solid base of the Project for a future network on which to build, but were aware of the need for funding and governmental support. CONCLUSIONS: Participants and Work Package Leaders have expressed support for a future network that will improve national and international collaboration in HTA based on the experience from the EUnetHTA project.

[Characteristics of 107 Spanish healthcare registries and evaluation of the utilization thereof]. / Características de 107 registros sanitarios españoles y valoración de su utilización.

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. These registries were identified by means ofa bibliographic databases search and by way of a survey of Scientific Societies and Central and Autonomic Healthcare Administration. Another bibliographic databases search was conducted of the publications which use data from the healthcare registries included and have been evaluated by applying the scientific evidence quality criteria. RESULTS: A total of 107 healthcare registries were identified, most of which of local or regional coverage (71%), preferably were under Autonomic government authority (64.5%). The areas showing the largest number of registries identified were those related to death statistics (16.8%) and cancer (15.9%). A total of 298 publications were retrieved which analyze data produced by the registries identified, most of which are devoted to the study of the frequency and distribution of the events recorded (58.1%) and less frequently to the conducting of healthcare technology assessment studies (24.4%). CONCLUSIONS: The critical evaluation of the publications made it possible to identify some elements related to the analysis methodology and design which would heighten the quality of the healthcare technology assessment. Healthcare registries in Spain have developed recently and to differing degrees. Important areas without any records and improvement elements related to the use of healthcare registries for healthcare technology assessment were detected. It would be advisable to avail of a register of registries which would provide relevant, up-dated information thereon.

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, 0.59; 95% Cl, 0.38-0.91) during the first year after cessation; thereafter, it reached a value similar to that of never-smokers 11 years or more after cessation. Among those with burden >13 pack-years, frequency of suboptimal health during the first year after cessation was higher than in current smokers (OR, 1.28; 95% CI, 1.00-1.63). Afterwards, it fell progressively, approaching the value of never-smokers 11 years or more after cessation. Frequency of suboptimal health in ex-smokers increased with duration (years) of smoking (P linear trend = 0.045), but did not vary with the number of cigarettes smoked. CONCLUSIONS: Suboptimal health declined with time since smoking cessation, to reach the frequency of never-smokers. Longer duration of tobacco consumption is associated with worse subjective health.