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.

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. The safety assessment also included 10 case series. Available evidence allowed comparison of CA with radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) but not with other treatments. The comparative effectiveness analysis showed that whereas all three treatments reduced disease severity, none was significantly better than any other in terms of effectiveness. In terms of safety, however, CA devices gave rise to fewer adverse events and less severity at 12 months of follow-up than did EVLA or RFA. Other important advantages of CA over EVLA or RFA were linked to quality of care; patients reported less pain during intervention with CA than with RFA or EVLA devices and registered shorter intervention and recovery times. Furthermore, tumescent anesthesia and compression bandages were not necessary, making this technique more comfortable for the patients than endothermal techniques. CONCLUSIONS: Compared with EVLA and RFA, CA treatments yield comparable effectiveness outcomes and lead to less frequent and fewer mild adverse events, without difference in major adverse events. Furthermore, CA devices have advantages in terms of quality of care indicators, such as pain during intervention, treatment and recovery times, lower use of anesthesia, and zero use of compression bandages after treatment.

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.

Mortalidad atribuible al consumo de tabaco en España en 2006 / Smoking-attributable deaths in Spain, 2006

Fundamento y objetivo: Estimar la mortalidad atribuible al consumo de tabaco en España en 2006, y compararla con las estimaciones de años anteriores. Población y método:A partir de la prevalencia de tabaquismo y la mortalidad correspondientes a España, y los riesgos relativos de muerte por enfermedades causadas por el tabaquismo, procedentes del Cancer Prevention Study II, se ha calculado la mortalidad atribuible al tabaquismo en los individuos de edad ≥ 35 años. Resultados: En el año 2006 se produjeron 53.155 muertes atribuibles al tabaquismo en individuos ≥ 35 años, lo que supone el 14,7% (25,1% en varones y 3,4% en mujeres) de todas las muertes ocurridas en los mismos. El 88,7% (47.174) de estas muertes atribuibles corresponde a varones y el 11,3% (5.981) a mujeres. Por causas, destacan las muertes atribuibles por: tumores malignos (24.058), especialmente cáncer de pulmón (16.482), enfermedades cardiovasculares (17.560), especialmente cardiopatía isquémica (6.263) e ictus (4.283), y enfermedades respiratorias (11.537), especialmente enfermedad pulmonar obstructiva crónica (9.886). Desde el año 2001 prosigue el descenso en la mortalidad atribuible en los varones y el ascenso en las mujeres.Conclusiones: Una de cada 7 muertes ocurridas cada año en individuos mayores de 35 años en España es atribuible al consumo de tabaco (una de cada 4 en varones y una de cada 29 en mujeres). A pesar del descenso de las muertes atribuibles al tabaquismo respecto a años anteriores (excepto en las mujeres, en quienes aumenta), este número de muertes y el porcentaje de la mortalidad total que representa sigue siendo muy elevado (AU)

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. Results: In 2006, 53,155 smoking-attributable deaths were estimated (14.7% of all deaths occurred in individuals ≥ 35 years; 25.1% in men and 3.4% in women). Almost 90% (47,174) of these attributable deaths corresponded to men, and 11.3% (5,981) to women. The most frequent attributable deaths were: cancer (24,058), specially lung cancer (16,482), cardiovascular disease (17,560), specially ischemic heart disease (6,263) and stroke (4,283), and respiratory disease (11,537), specially chronic obstructive lung disease (9,886). Since 2001, a decrease in smoking-attributable mortality was observed in men and an increase in women. Conclusions:About one out of 7 deaths occurring annually in individuals ≥ 35 years in Spain is attributable to smoking (one in 4 in men and one in 29 in women). Despite a decreasing trend in the number of smoking-attributable deaths over time (except in women, where they increase), the toll of estimated attributable deaths is still very high (AU)

[Smoking-attributable deaths in Spain, 2006]. / Mortalidad atribuible al consumo de tabaco en España en 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. RESULTS: In 2006, 53,155 smoking-attributable deaths were estimated (14.7% of all deaths occurred in individuals≥35 years; 25.1% in men and 3.4% in women). Almost 90% (47,174) of these attributable deaths corresponded to men, and 11.3% (5,981) to women. The most frequent attributable deaths were: cancer (24,058), specially lung cancer (16,482), cardiovascular disease (17,560), specially ischemic heart disease (6,263) and stroke (4,283), and respiratory disease (11,537), specially chronic obstructive lung disease (9,886). Since 2001, a decrease in smoking-attributable mortality was observed in men and an increase in women. CONCLUSIONS: About one out of 7 deaths occurring annually in individuals≥35 years in Spain is attributable to smoking (one in 4 in men and one in 29 in women). Despite a decreasing trend in the number of smoking-attributable deaths over time (except in women, where they increase), the toll of estimated attributable deaths is still very high.

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.

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. The quality of selected studies was assessed. Meta-analysis of weighted mean difference was made using the inverse variance method. RESULTS: We pooled 15 articles (3,608 patients) to estimate BIBs effectiveness. The estimates for weight lost at balloon removal for BIB were the following: 14.7 kg, 12.2% of initial weight, 5.7 kg/m(2), and 32.1% of excess weight. However, data were scant after balloon removal. Yet, efficacy at balloon removal was estimated with a meta-analysis of two randomized controlled trials (75 patients) that compared balloon versus placebo, indicating the balloon group lost more weight than the placebo group. These differences in weight lost were 6.7 kg, 1.5% of initial weight, 3.2 kg/m(2), and 17.6% of excess weight. Regarding BIB safety, the majority of complications were mild and the early removal rate was 4.2%. CONCLUSION: The use of the BIB, within a multidisciplinary weight management program, is a short-term effective treatment to lose weight, but it is not yet possible to verify its capacity to maintain the weight lost over a long period of time.

[Recent decrease in smoking-attributable mortality in Spain]. / La mortalidad atribuible al tabaquismo comienza a descender en España.

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. RESULTS: In 2001, 54,233 deaths were attributable to tobacco use (49,366 in men and 4,867 in women). This represents a global reduction in comparison with the 55,613 deaths attributed to tobacco in 1998 (51,431 in men and 4,182 in women). One out of four current attributable deaths were untimely deaths occurred before age 65 years. CONCLUSIONS: A reduction in the number of smoking-attributable deaths is observed for the first time in Spain, as a result of a clear reduction among men. However, the overall decrease of smoking-related deaths is too small, and the burden of smoking-attributable mortality in Spain remains too high.

La mortalidad atribuible al tabaquismo comienza a descender en España / Recent decrease in smokingattributable mortality in Spain

FUNDAMENTO Y OBJETIVO: Las muertes por algunas de las principales enfermedades relacionadas con el tabaquismo han comenzado a descender en la población adulta española. Este trabajo estima la mortalidad atribuible al tabaquismo en España actualmente y la compara con años anteriores. POBLACIÓN Y MÉTODO: A partir de la prevalencia de tabaquismo y la mortalidad en España, y los riesgos relativos de muerte del Cancer Prevention Study II, se calcula la mortalidad atribuible al tabaquismo en la población española de 35 y más años. RESULTADOS: En 2001 el tabaquismo ocasionó54.233 muertes (49.366 en varones y4.867 en mujeres). Esta cifra supone un descenso global respecto a las 55.613 atribuidas al tabaco en 1998 (51.431 en varones y 4.182 en mujeres). Una cuarta parte de las muertes atribuibles son muertes prematuras ocurridas antes de los 65 años. CONCLUSIONES: Por primera vez se aprecia en España una disminución del número de muertes atribuibles al consumo de tabaco, causada por la clara reducción de éste en los varones. Sin embargo, el descenso globales muy moderado y la carga de mortalidad atribuible al tabaquismo en España sigue siendo muy alta

BACKGROUND AND OBJECTIVE: Certain diseases related to smoking have recently decreased in Spanish adults. This study estimated the burden of smoking-attributable mortality inSpain currently and in previous years. POPULATION AND METHOD: Smoking prevalence and mortality in Spain, and relative risks for death from the Cancer Prevention StudyII were used to estimate tobacco-attributable mortality in the Spanish population aged 35 years and over. RESULTS: In 2001, 54,233 deaths were attributable to tobacco use (49,366 in men and 4,867 in women). This represents a global reduction in comparison with the55,613 deaths attributed to tobacco in1998 (51,431 in men and 4,182 in women).One out of four current attributable deaths were untimely deaths occurred before age 65 years. CONCLUSIONS: A reduction in the number of smoking-attributable deaths is observed for the first time in Spain, as a result of a clear reduction among men. However, the overall decrease of smoking-related deaths is too small, and the burden of smoking-attributable mortality in Spain remains too high

[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.

Características de 107 registros sanitarios españoles y valoración de su utilización / Characteristics of 107 Spanish Healthcare Registries and Evaluation of the Utilization Thereof

Fundamento: La información sobre los registros sanitarios existentesen nuestro país es poco accesible y escasa y algunos son pococonocidos, pudiendo estar infrautilizados en relación con sus múltiplesusos potenciales. El objetivo de este trabajo es evaluar las característicasde los Registros Sanitarios españoles y su utilización, especialmenteen Evaluación de Tecnologías Sanitarias.Métodos: Estudio descriptivo transversal de los Registros Sanitariosespañoles entre 1997 y 2002. La identificación de los registros serealizó a través de búsqueda bibliográfica y mediante encuesta a SociedadesCientíficas y Administración sanitaria central y autonómica. Seha realizado una búsqueda bibliográfica específica de las publicacionesque utilizan datos de los registros sanitarios incluidos y se han evaluadoaplicando los criterios de calidad de la evidencia científica.Resultados: Se han identificado 107 registros sanitarios, preferentementede cobertura local o regional (71%) y dependientes en sumayoría de la Administración autonómica (64,5%). Las áreas conmayor número de registros identificados corresponden a la mortalidad(16,8%) y al cáncer (15,9%). Se han recuperado 298 publicacionesque analizan datos producidos por los registros identificados, delas que la mayoría se dedican al estudio de la frecuencia y distribuciónde los eventos registrados (58,1%) y con menor frecuencia a la realizaciónde estudios de evaluación de tecnologías sanitarias (24,4%).Conclusiones: La evaluación crítica de las publicaciones ha permitidoidentificar algunos elementos relacionados con el diseño y lametodología de análisis que incrementarían la calidad de los estudiosde evaluación de tecnologías sanitarias.Los registros sanitarios enEspaña han tenido un desarrollo desigual y reciente. Se han detectadoáreas relevantes sin registros y elementos de mejora relacionadoscon la utilización de los registros sanitarios para estudios de evaluaciónde tecnologías sanitarias. Sería recomendable contar con unregistro de registros que proporcionara información relevante yactualizada sobre los mismos

Background: The information concerning the currently- existinghealthcare registries in our country is not readily accessible, is scarceand some are not well-known, possibly being underused in comparisonto their many potential uses. This study is aimed at evaluating thecharacteristics of the Spanish Healthcare registries and the utilizationthereof, especially in Healthcare technology assessment.Methods: Descriptive, cross-sectional study of the SpanishHealthcare registries within the 1997-2002 period. These registrieswere identified by means of a bibliographic databases search and byway of a survey of Scientific Societies and Central and AutonomicHealthcare Administration. Another bibliographic databases searchwas conducted of the publications which use data from the healthcareregistries included and have been evaluated by applying the scientificevidence quality criteria.Results: A total of 107 healthcare registries were identified,most of which of local or regional coverage (71%), preferably wereunder Autonomic government authority (64.5%). The areas showingthe largest number of registries identified were those related to deathstatistics (16.8%) and cancer (15.9%). A total of 298 publicationswere retrieved which analyze data produced by the registries identified,most of which are devoted to the study of the frequency and distributionof the events recorded (58.1%) and less frequently to theconducting of healthcare technology assessment studies (24.4%).Conclusions: The critical evaluation of the publications made itpossible to identify some elements related to the analysis methodologyand design which would heighten the quality of the healthcaretechnology assessment. Healthcare registries in Spain have developedrecently and to differing degrees. Important areas without anyrecords and improvement elements related to the use of healthcareregistries for healthcare technology assessment were detected. Itwould be advisable to avail of a register of registries which wouldprovide 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.

Mortalidad atribuible al tabaquismo en España en 1998 / Smoking-attributable deaths in Spain in 1998

FUNDAMENTO: Entre 1993 y 1997 la prevalencia de tabaquismo se mantuvo estable, pero las tasas ajustadas de muerte por sus enfermedades asociadas disminuyó en España. En este trabajo se estima la mortalidad atribuible al tabaquismo en España en 1998. POBLACIÓN Y MÉTODO: A partir de la prevalencia de tabaquismo y la mortalidad en España, y los riesgos relativos de muerte del Cancer Prevention Study II, se calcula la mortalidad atribuible al tabaquismo en la población española de 35 o más años en 1998. RESULTADOS: En 1998 el tabaquismo ocasionó 55.613 fallecimientos Una de cada 4 muertes en varones y una de cada 40 en mujeres se atribuyeron al tabaquismo. Dos tercios fueron muertes por cáncer de pulmón, enfermedad pulmonar obstructiva crónica cardiopatía isquémica y enfermedad cerebrovascular. CONCLUSIONES: En España la mortalidad atribuible al tabaco siguió aumentando en 1998 (AU)

Niveles de anticuerpos bactericidas frente a meningococo C tras la vacunación de niños de 2 a 6 años de edad en Andalucía / Levels of bactericidal antibodies against meningococcus C following the vaccination of children between 2 and 6 years of age in Andalusia

FUNDAMENTO: En 1997 el 18,5 por ciento de los casos de enfermedad meningocócica por serogrupo C en Andalucía fueron niños de 2 a 4 años de edad; edades donde respuesta inmune inicial y duración de la vacuna antimeningocócica de polisacárido capsular A+C, es menor que en edades superiores. Se diseñó una investigación para medir la respuesta inmune producida por esta vacuna, en niños de 2 a 6 años de edad, y compararla con la inmunidad natural presente en niños no vacunados. MÉTODOS: I.- Doble estudio de seguimiento: a) grupos de niños previamente vacunados y grupos control, b) grupo de niños que iba a ser vacunado, para análisis pre y postvacunal (1, 6 y 12 meses) y grupo control. II.- La actividad bactericida se midió según protocolo estandarizado del CDC frente a cepa de N. meningítidis C-11. Los sueros con título de actividad bactericida (TAB) ³ 1:8 se consideraron protectores. RESULTADOS: Al mes y a los 2 meses de vacunarse la proporción de TAB³ 1:8 era significativamente superior a la del grupo control (65,5 por ciento y 73,9 por ciento frente a 2,2 por ciento y 12 por ciento. En el prevacunal y en el postvacunal a los 6, 7, 12 y 13 meses no se observó diferencia significativa entre vacunados y controles. CONCLUSIONES: Las diferencias entre vacunados y no vacunados 1 y 2 meses después de la vacunación indican seroconversión en los vacunados. Para el grupo de edad de 2 a 6 años la actividad bactericida adquirida declina rápidamente, ya que a los 6 meses dejan de observarse diferencias con el grupo control (AU)