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El Cuestionario de Salud SF-36 español: una década de experiencia y nuevos desarrollos

Objetivo: El Cuestionario SF-36 es uno de los instrumentos de Calidad de Vida Relacionada con la Salud (CVRS) mas utilizados y evaluados. Tras una decada de uso este articulo revisa criticamente el contenido, propiedades metricas y nuevos desarrollos de la version espanola. Metodos: Revision de los articulos indizados en Medline (PubMed) y en las bases de datos IBECS e IME que han utilizado la version espanola del cuestionario. Se seleccionaron los articulos con informacion sobre modelo de medida, fiabilidad, validez y sensibilidad al cambio del instrumento. Resultados: Se encontraron 79 articulos, 17 de los cuales describian caracteristicas metricas del cuestionario. En el 96% las escalas superaron el estandar propuesto de fiabilidad (α de Cronbach) de 0,7. Las estimaciones agrupadas obtenidas por metaanalisis fueron superiores a 0,7 en todos los casos. El SF-36 mostro buena discriminacion entre grupos de gravedad, correlacion moderada con indicadores clinicos y alta con otros instrumentos de CVRS. El SF-36 predijo mortalidad y detecto mejoria tras la angioplastia coronaria, la cirugia de hipertrofia prostatica benigna o la ventilacion domiciliaria no invasiva. Los nuevos desarrollos descritos (puntuaciones basadas en normas, la version 2, el SF-12 y el SF-8) mejoraron sus propiedades metricas y su interpretacion. Conclusiones: El SF-36, conjuntamente con las nuevas versiones desarrolladas, es un instrumento muy adecuado para su uso en investigacion y en la practica clinica.

Long-Term Outcome of Aortic Dissection With Patent False Lumen Predictive Role of Entry Tear Size and Location

Background— Patent false lumen in aortic dissection has been associated with poor prognosis. We aimed to assess the natural evolution of this condition and predictive factors. Methods and Results— One hundred eighty-four consecutive patients, 108 surgically treated type A and 76 medically treated type B, were discharged after an acute aortic dissection with patent false lumen. Transesophageal echocardiography was performed before discharge, and computed tomography was performed at 3 months and yearly thereafter. Median follow-up was 6.42 years (quartile 1 to quartile 3: 3.31–10.49). Forty-nine patients died during follow-up (22 type A, 27 type B), 31 suddenly. Surgical or endovascular treatment was indicated in 10 type A and 25 type B cases. Survival free from sudden death and surgical-endovascular treatment was 0.90, 0.81, and 0.46 (95% CI, 0.36–0.55) at 3, 5, and 10 years, respectively. Multivariate analysis identified baseline maximum descending aorta diameter (hazard ratio [HR]: 1.32 [1.10–1.59]; P =0.003), proximal location (HR: 1.84 [1.06–3.19]; P =0.03), and entry tear size (HR: 1.13 [1.08–1.2]; P <0.001) as predictors of dissection-related adverse events, whereas mortality was predicted by baseline maximum descending aorta diameter (HR: 1.36 [1.08–1.70]; P =0.008), entry tear size (HR: 1.1 [1.04–1.16]; P =0.001), and Marfan syndrome (HR: 3.66 [1.65–8.13]; P =0.001). Conclusions— Aortic dissection with persistent patent false lumen carries a high risk of complications. In addition to Marfan syndrome and aorta diameter, a large entry tear located in the proximal part of the dissection identifies a high-risk subgroup of patients who may benefit from earlier and more aggressive therapy. # Clinical Perspective {#article-title-39}Background— Patent false lumen in aortic dissection has been associated with poor prognosis. We aimed to assess the natural evolution of this condition and predictive factors. Methods and Results— One hundred eighty-four consecutive patients, 108 surgically treated type A and 76 medically treated type B, were discharged after an acute aortic dissection with patent false lumen. Transesophageal echocardiography was performed before discharge, and computed tomography was performed at 3 months and yearly thereafter. Median follow-up was 6.42 years (quartile 1 to quartile 3: 3.31–10.49). Forty-nine patients died during follow-up (22 type A, 27 type B), 31 suddenly. Surgical or endovascular treatment was indicated in 10 type A and 25 type B cases. Survival free from sudden death and surgical-endovascular treatment was 0.90, 0.81, and 0.46 (95% CI, 0.36–0.55) at 3, 5, and 10 years, respectively. Multivariate analysis identified baseline maximum descending aorta diameter (hazard ratio [HR]: 1.32 [1.10–1.59]; P=0.003), proximal location (HR: 1.84 [1.06–3.19]; P=0.03), and entry tear size (HR: 1.13 [1.08–1.2]; P<0.001) as predictors of dissection-related adverse events, whereas mortality was predicted by baseline maximum descending aorta diameter (HR: 1.36 [1.08–1.70]; P=0.008), entry tear size (HR: 1.1 [1.04–1.16]; P=0.001), and Marfan syndrome (HR: 3.66 [1.65–8.13]; P=0.001). Conclusions— Aortic dissection with persistent patent false lumen carries a high risk of complications. In addition to Marfan syndrome and aorta diameter, a large entry tear located in the proximal part of the dissection identifies a high-risk subgroup of patients who may benefit from earlier and more aggressive therapy.

Worldwide distribution of blood lipids and lipoproteins in childhood and adolescence: a review study

Review and pooled analysis of the relevant worldwide literature was investigated from 1975 to 1996. Eighteen surveys out of 54 were suitable for analysis according to the selection criteria. This represents a total of 60494 observations from 26 countries all over the world. Data suggests differences as great as 76 mg/dl when comparing northern European countries to black African children. The overall curve of cholesterol with age observed in the pooled population indicates a pre-adolescent peak and then a slightly inverse change is observed for both boys and girls, from 3 to 12 years old being almost coincident absolute values. Beyond age 12, values for boys continue to slightly decrease to age 16, while for girls values tend to increase through this age-range. The curve in the late teens (16-18 years) tends to reach pre-teen levels for both sexes, although girls have consistently higher absolute values than boys. There is a great variation in the specific age-sex and race levels of cholesterol among different populations or even in the same populations over a period of time. However, an apparently universal pattern of an early rise, a fall, and a subsequent rise in mean values of total cholesterol by age from the preadolescence to late teens is observed. More data are needed on total cholesterol and lipid fractions between late school age and mid-adulthood.

Background, Incidence, and Predictors of Antiplatelet Therapy Discontinuation During the First Year After Drug-Eluting Stent Implantation

Background— Predictors of antiplatelet therapy discontinuation (ATD) during the first year after drug-eluting stent implantation are poorly known. Methods and Results— This was a prospective study with 3-, 6-, 9-, and 12-month follow-up of patients receiving at least 1 drug-eluting stent between January and April 2008 in 29 hospitals. Individual- and hospital-level predictors of ATD were assessed by hierarchical-multinomial regression analysis. ATD could be assessed in 1622 candidates for follow-up (82.5%). A total of 234 patients (14.4%) interrupted at least 1 antiplatelet therapy drug, predominantly clopidogrel (n=182, 11.8%). Bleeding events or invasive procedures led to ATD in 109 patients. This was predicted by renal impairment (odds ratio [OR] 2.81, 95% confidence interval [CI] 1.48 to 5.34), prior major hemorrhage (OR 3.77, 95% CI 1.41 to 10.03), and peripheral arterial disease (OR 1.78, 95% CI 1.01 to 3.15). Medical decisions led to ATD in 70 patients; this was predicted by long-term use of anticoagulant therapy (OR 3.88, 95% CI 1.26 to 11.98), undergoing the procedure in a private hospital (OR 13.3, 95% CI 1.69 to 105), and not receiving instructions about medication (OR 2.8, 95% CI 1.23 to 6.36). Thirty-nine patients interrupted ATD on their own initiative, mainly immigrants (OR 3.78, 95% CI 1.2 to 11.98) and consumers of psychotropic drugs (OR 2.58, 95% CI 1.3 to 5.12). Conclusions— ATD during the first year after drug-eluting stent implantation is based mainly on patient decision or a medical decision not associated with major bleeding events or major surgical procedures. Individual- and hospital-level variables are important to predict ATD.

Double Antiplatelet Therapy After Drug-Eluting Stent Implantation Risk Associated With Discontinuation Within the First Year

OBJECTIVES The goal of this study was to assess the risk associated with double antiplatelet therapy (DAT) discontinuation, and specifically, temporary discontinuation, during the first year after drug-eluting stent (DES) implantation. BACKGROUND Doubts remain about the risk of temporary DAT discontinuation within 1 year after DES implantation. METHODS A total of 1,622 consecutive patients undergoing DES implantation at 29 hospitals were followed up at 3, 6, 9, and 12 months to record the 1-year antiplatelet therapy discontinuation (ATD) rate, the number of days without DAT, and the rate of 1-year major cardiac events. Cox regression was used to analyze the association between ATD considered as a time-dependent covariate and 1-year cardiac events. RESULTS One hundred seventy-two (10.6%) patients interrupted at least 1 antiplatelet drug during the first year after DES implantation, although only 1 during the first month. Most (n=111, 64.5%) interrupted DAT temporarily (median: 7 days; range: 5 to 8.5): 79 clopidogrel (31 temporarily), 38 aspirin (27 temporarily), and 55 both drugs (53 temporarily). Discontinuation was followed by acute coronary syndrome in 7 (4.1%; 95% confidence interval [CI]: 1.7 to 8.2), a similar rate of major cardiac events to that in patients without ATD (n=80; 5.5%; 95% CI: 4.4 to 6.8; p=0.23). ATD was not independently associated with 1-year major cardiac events (hazard ratio: 1.32 [95% CI: 0.56 to 3.12]). CONCLUSIONS ATD within the first year and beyond the first month after DES is not exceptional, is usually temporary, and does not appear to have a large impact on risk.

Validación de la versión española del Minnesota Living with Heart Failure Questionnaire

Introduccion y objetivos El Minnesota Living with Heart Failure Questionnaire (MLHFQ) es el instrumento mas utilizado para la evaluacion de la calidad de vida en pacientes con insuficiencia cardiaca. Contiene 21 items y dos dimensiones: fisica y emocional. El objetivo de este estudio es evaluar las propiedades metricas de la version espanola del MLHFQ. Metodos Se aplico, 1 y 2 meses despues del alta, el MLHFQ y el SF-36 a 677 pacientes ingresados por insuficiencia cardiaca. A partir de la clasificacion NYHA y otras 3 variables de capacidad funcional, se definio a los pacientes como estables (n = 245) o con cambio (n = 103). De la fiabilidad, se estudio: la consistencia interna (alfa de Cronbach) y la reproducibilidad (coeficiente de correlacion intraclase [CCI]). La validez se estudio con las puntuaciones segun la clase funcional y las correlaciones con las dimensiones del SF-36. La sensibilidad al cambio se evaluo por el tamano del efecto. Resultados El alfa de Cronbach fue ≥0,8 en las tres puntuaciones, y el CCI tambien fue elevado (0,74-0,83). Las puntuaciones del MLHFQ mostraron diferencias segun la clase funcional (p Conclusiones La version espanola del MLHFQ ha mostrado unas adecuadas propiedades metricas, igual que la original. Estos resultados respaldan el uso del MLHFQ en pacientes espanoles con insuficiencia cardiaca, aunque seria recomendable reevaluar su sensibilidad al cambio.

Características basales y determinantes de la evolución en pacientes ingresados por insuficiencia cardíaca en un hospital general

Introduccion y objetivos Analizar las caracteristicas basales, los patrones de manejo y los resultados clinicos a los 18 meses del ingreso en pacientes diagnosticados de insuficiencia cardiaca en un hospital terciario de Cataluna. Metodos Se identificaron y analizaron las historias clinicas de los 256 pacientes ingresados en el Hospital General Vall d’Hebron desde julio a diciembre de 1998, diagnosticados de insuficiencia cardiaca y que cumplieran los criterios del estudio. Se entrevisto a los pacientes telefonicamente 18 meses despues. Resultados La edad media de los pacientes era de 75 ± 12 anos, el 42% correspondia a varones, el 19% habia ingresado por enfermedades distintas de la insuficiencia cardiaca y el 62% tenia comorbilidad significativa. Se estudio la funcion ventricular en el 68% (basicamente en pacientes con mejor pronostico), y se considero normal en un 41%. Se administraron inhibidores de la enzima conversiva o antagonistas de la angiotensina II en un 54% y bloqueadores beta en un 4%. La mortalidad a los 18 meses fue del 46%, siendo de causa cardiaca en el 77% de estos. Los predictores independientes de mortalidad fueron la edad avanzada, la insuficiencia cardiaca grave o antigua y la comorbilidad. A los 18 meses, un 69% de los supervivientes se hallaba en clase funcional I o II. Conclusiones 1) Al igual que sucede en otras areas geograficas, los pacientes de este estudio constituyen, como media, una poblacion anciana y con pobre supervivencia; 2) los patrones de manejo registrados son claramente mejorables; 3) la comorbilidad afecta significativamente al pronostico, y 4) la calidad de vida despues del alta es aceptable en una llamativa proporcion de supervivientes.

Patient Registries of Acute Coronary Syndrome Assessing or Biasing the Clinical Real World Data

Background—The risk of selection bias in registries and its consequences are relatively unexplored. We sought to assess selection bias in a recent registry about acute coronary syndrome and to explore the way of conducting and reporting patient registries of acute coronary syndrome. Methods and Results—We analyzed data from patients of a national acute coronary syndrome registry undergoing an audit about the comprehensiveness of the recruitment/inclusion. Patients initially included by hospital investigators (n=3265) were compared to eligible nonincluded (missed) patients (n=1439). We assessed, for 25 exposure variables, the deviation of the in-hospital mortality relative risks calculated in the initial sample from the actual relative risks. Missed patients were of higher risk and received less recommended therapies than the included patients. In-hospital mortality was almost 3 times higher in the missed population (9.34% [95% CI, 7.84 to 10.85] versus 3.9% [95% CI, 2.89 to 4.92]). Initial relative risks diverged from the actual relative risks more than expected by chance (P<0.05) in 21 variables, being higher than 10% in 17 variables. This deviation persisted on a smaller degree on multivariable analysis. Additionally, we reviewed a sample of 129 patient registries focused on acute coronary syndrome published in thirteen journals, collecting information on good registry performance items. Only in 38 (29.4%) and 48 (37.2%) registries was any audit of recruitment/inclusion and data abstraction, respectively, mentioned. Only 4 (3.1%) authors acknowledged potential selection bias because of incomplete recruitment. Conclusions—Irregular inclusion can introduce substantial systematic bias in registries. This problem has not been explicitly addressed in a substantial number of them.

Outcomes of a contemporary cohort of 536 consecutive patients with acute ischemic stroke treated with endovascular therapy.

Background and Purpose— We sought to assess outcomes after endovascular treatment/therapy of acute ischemic stroke, overall and by subgroups, and looked for predictors of outcome. Methods— We used data from a mandatory, population-based registry that includes external monitoring of completeness, which assesses reperfusion therapies for consecutive patients with acute ischemic stroke since 2011. We described outcomes overall and by subgroups (age ⩽ or >80 years; onset-to-groin puncture ⩽ or >6 hours; anterior or posterior strokes; previous IV recombinant tissue-type plasminogen activator or isolated endovascular treatment/therapy; revascularization or no revascularization), and determined independent predictors of good outcome (modified Rankin Scale score ⩽2) and mortality at 3 months by multivariate modeling. Results— We analyzed 536 patients, of whom 285 received previous IV recombinant tissue-type plasminogen activator. Overall, revascularization (modified Thrombolysis In Cerebral Infarction scores, 2b and 3) occurred in 73.9%, 5.6% developed symptomatic intracerebral hemorrhages, 43.3% achieved good functional outcome, and 22.2% were dead at 90 days. Adjusted comparisons by subgroups systematically favored revascularization (lower proportion of symptomatic intracerebral hemorrhages and death rates and higher proportion of good outcome). Multivariate analyses confirmed the independent protective effect of revascularization. Additionally, age >80 years, stroke severity, hypertension (deleterious), atrial fibrillation, and onset-to-groin puncture ⩽6 hours (protective) also predicted good outcome, whereas lack of previous disability and anterior circulation strokes (protective) as well as and hypertension (deleterious) independently predicted mortality. Conclusions— This study reinforces the role of revascularization and time to treatment to achieve enhanced functional outcomes and identifies other clinical features that independently predict good/fatal outcome after endovascular treatment/therapy.

Assessing health-related quality of life in patients with heart failure: a systematic, standardized comparison of available measures

To systematically evaluate available health-related quality of life (HRQL) instruments for use in patients with heart failure (HF). Seven HF-specific HRQL questionnaires and associated studies of their metric properties were identified by systematic review: the Chronic Heart Failure Assessment Tool, the Cardiac Health Profile congestive heart failure, the Chronic Heart Failure Questionnaire (CHFQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Left Ventricular Disease Questionnaire (LVDQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Quality of Life in Severe Heart Failure Questionnaire. Each instrument was assessed by four experts using a standardized tool for evaluating patient-reported outcomes (EMPRO; scores from 0 to 100). Four questionnaires were given adequate scores (median >50) for the attribute “conceptual model.” The LVDQ had the highest rated median for “reliability” (72.8). The CHFQ, the KCCQ, and the MLHFQ all got reasonable scores for “validity” (from 54.4 to 76.4). The reviewers rated the KCCQ the highest in terms of “sensitivity to change” (median 94.4). Only the CHFQ (50.0) and the KCCQ (72.2) received adequate scores for the “interpretability” attribute. The most highly rated instruments based on the overall EMPRO score were the KCCQ (64.4) and the MLHFQ (60.7), followed by the CHFQ (59.2). Based on the first systematic and reliable expert-based evaluation of available HF-specific HRQL questionnaires, the evidence seems to support the choice of the KCCQ, the MLHFQ, and the CHFQ over the others, which require further research on metric properties.